earned - Nasdaq Corporate Solutions

MEDIVATION, INC.
FORM
10-K
(Annual Report)
Filed 02/26/16 for the Period Ending 12/31/15
Address
Telephone
CIK
Symbol
SIC Code
Industry
Sector
Fiscal Year
525 MARKET STREET
36TH FLOOR
SAN FRANCISCO, CA 94105
415-543-3470
0001011835
MDVN
2834 - Pharmaceutical Preparations
Biotechnology & Drugs
Healthcare
12/31
http://www.edgar-online.com
© Copyright 2016, EDGAR Online, Inc. All Rights Reserved.
Distribution and use of this document restricted under EDGAR Online, Inc. Terms of Use.
uNITEd
STATES
SECuRITIES
ANd
EXChANgE
COMMISSION
Washington,
d.C.
20549
Form
10-k
x
ANNuAl
REPORT
PuRSuANT
TO
SECTION
13
OR
15(d)
OF
ThE
SECuRITIES
EXChANgE
ACT
OF
1934
For the Fiscal Year Ended December 31, 2015
OR
o
TRANSITION
REPORT
PuRSuANT
TO
SECTION
13
OR
15(d)
OF
ThE
SECuRITIES
EXChANgE
ACT
OF
1934
For the Transition period from
to
.
Commission file number: 001-32836
MEdIvATION,
INC.
(Exact
name
of
Registrant
as
specified
in
its
charter)
delaware
13-3863260
(State or other jurisdiction of incorporation or organization)
(I.R.S. Employer Identification No.)
525
Market
Street,
36th
Floor
San
Francisco,
California
94105
(Address
of
principal
executive
offices)
(Zip
Code)
Registrant’s telephone number, including area code: (415) 543-3470
Securities
registered
pursuant
to
Section
12(b)
of
the
Act:
Title
of
Each
Class
Name
of
Each
Exchange
on
Which
Registered
Common Stock, par value $0.01 per share
The NASDAQ Stock Market LLC
Securities
registered
pursuant
to
Section
12(g)
of
the
Act:
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
YES o
NO x
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. YES o
NO x
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90
days. YES x
NO o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§229.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit and post such files). YES x
NO o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be
contained to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K. x
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions
of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
x
Accelerated filer
o
Non-accelerated filer
o
(Do not check if a smaller reporting company)
Smaller reporting company
o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act.).
YES o
NO x
The aggregate market value of the voting stock held by non-affiliates of the registrant was approximately $7.7 billion as of June 30, 2015, based upon the closing sale
price on The NASDAQ Global Market reported on June 30, 2015. Excludes an aggregate of 24,807,840 shares of the registrant’s common stock (on a post-split basis) held by
officers, directors and affiliated stockholders. For purposes of determining whether a stockholder was an affiliate of the registrant at June 30, 2015, the registrant assumed that a
stockholder was an affiliate of the registrant at June 30, 2015 if such stockholder (i) beneficially owned 10% or more of the registrant’s common stock, as determined based on
public filings, and/or (ii) was an executive officer or director or was affiliated with an executive officer or director of the registrant at June 30, 2015. Exclusion of such shares
should not be construed to indicate that any such person possesses the power, direct or indirect, to direct or cause the direction of the management or policies of the registrant or
that such person is controlled by or under common control with the registrant.
There were 164,233,527 shares of Registrant’s Common Stock, par value $0.01 per share, outstanding as of February 16, 2016.
dOCuMENTS
INCORPORATEd
By
REFERENCE
Portions of the registrant’s definitive Proxy Statement for the 2016 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission pursuant to
Regulation 14A not later than 120 days after the end of the fiscal year covered by this Form 10-K are incorporated by reference in Part III, Items 10-14 of this Form 10-K.
MEDIVATION, INC.
2015 ANNUAL REPORT ON FORM 10-K
TABLE OF CONTENTS
Page
PART I
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
BUSINESS
RISK FACTORS
UNRESOLVED STAFF COMMENTS
PROPERTIES
LEGAL PROCEEDINGS
MINE SAFETY DISCLOSURES
2
21
44
45
45
45
PART II
Item 5.
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
SELECTED FINANCIAL DATA
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
CONTROLS AND PROCEDURES
OTHER INFORMATION
46
48
49
67
68
68
68
69
70
70
Item 13.
Item 14.
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
EXECUTIVE COMPENSATION
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER
MATTERS
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
PRINCIPAL ACCOUNTING FEES AND SERVICES
PART IV
Item 15.
EXHIBITS, FINANCIAL STATEMENT SCHEDULES
71
PART III
Item 10.
Item 11.
Item 12.
70
70
70
S IGNATURES
72
FINANCIAL STATEMENTS
REPORT OF PRICEWATERHOUSECOOPERS LLP, INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED STATEMENTS OF OPERATIONS
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
CONSOLIDATED STATEMENTS OF CASH FLOWS
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
73
74
75
76
77
78
79
i
FORWARd-lOOkINg
STATEMENTS
This
Annual
Report
on
Form
10-K,
or
Annual
Report,
includes
“forward-looking
statements”
within
the
meaning
of
Section
27A
of
the
Securities
Act
of
1933,
as
amended,
and
Section
21E
of
the
Securities
Exchange
Act
of
1934,
as
amended,
or
the
Exchange
Act.
We
intend
that
these
forward-looking
statements
be
subject
to
the
safe
harbors
created
by
those
provisions.
Forward-looking
statements
are
generally
written
in
the
future
tense
and/or
are
preceded
by
words
such
as
“may,”
“should,”
“could,”
“expect,”
“suggest,”
“believe,”
“estimate,”
“continue,”
“anticipate,”
“intend,”
“plan,”
or
similar
words,
or
negatives
of
such
terms
or
other
variations
on
such
terms
of
comparable
terminology.
These
forward-looking
statements
include,
but
are
not
limited
to,
statements
regarding
the
commercialization
of
XTANDI
®
(enzalutamide)
capsules,
or
XTANDI,
the
continuation
and
success
of
our
collaboration
with
Astellas
Pharma,
Inc.,
or
Astellas,
the
timing,
progress
and
results
of
our
clinical
trials,
and
our
future
drug
development
activities,
including
those
with
respect
to
talazoparib
(which
is
referred
to
as
MDV3800)
and
pidilizumab
(which
is
referred
to
as
MDV9300).
The
forward-looking
statements
contained
in
this
Annual
Report
involve
a
number
of
risks,
uncertainties,
and
assumptions,
many
of
which
are
outside
of
our
control.
Factors
that
could
cause
actual
results
to
differ
materially
from
projected
results
include,
but
are
not
limited
to,
those
discussed
in
“Risk
Factors”
included
elsewhere
in
this
Annual
Report.
Readers
are
expressly
advised
to
review
and
consider
those
Risk
Factors.
Although
we
believe
that
the
assumptions
underlying
the
forward-looking
statements
contained
in
this
Annual
Report
are
reasonable,
any
of
the
assumptions
could
be
inaccurate,
and
therefore
there
can
be
no
assurance
that
the
results
anticipated
by
such
statements
will
occur.
In
light
of
the
significant
uncertainties
inherent
in
the
forward-looking
statements
included
herein,
the
inclusion
of
such
information
should
not
be
regarded
as
a
representation
by
us
or
any
other
person
that
the
results
or
conditions
described
in
such
statements
or
our
objectives
and
plans
will
be
achieved.
Furthermore,
past
financial
or
operations
performance
is
not
necessarily
indicative
of
future
performance.
We
disclaim
any
intention
or
obligation
to
update,
supplement,
or
revise
any
forward-looking
statements,
whether
as
a
result
of
new
information,
future
events
or
otherwise.
1
PART
I
Item
1.
Business.
OvERvIEW
We are a biopharmaceutical company focused on the development and commercialization of medically innovative therapies to treat serious diseases for
which there are limited treatment options. We have one commercial product, XTANDI ® (enzalutamide) capsules, or XTANDI, through our collaboration with
Astellas Pharma, Inc., or Astellas. XTANDI has received marketing approval in the United States, Europe and numerous other countries worldwide for the
treatment of patients with metastatic castration-resistant prostate cancer, or mCRPC, and in Japan for the treatment of patients with castration-resistant prostate
cancer, or CRPC. We and Astellas are also conducting investigational studies of enzalutamide in prostate cancer, advanced breast cancer, and hepatocellular
carcinoma. Under our collaboration agreement with Astellas, we share equally with Astellas all profits (losses) related to U.S. net sales of XTANDI. We also
receive royalties ranging from the low teens to the low twenties as a percentage of ex-U.S. XTANDI net sales. The collaboration also involved certain milestone
payments from Astellas to us upon the achievement of defined development, regulatory and sales events, all of which have been achieved as of December 31, 2015.
We seek to become a more fully-integrated biopharmaceutical company through the continued commercialization of XTANDI, the acquisition or in-license
and development and commercialization of other product opportunities, and through the advancement of our own proprietary research and development programs.
We expect that our future growth may come from both internal research efforts and third-party business development activities. In the fourth quarter of 2015, we
acquired all worldwide rights to talazoparib (which we refer to as MDV3800), an orally available poly-ADP ribose polymerase, or PARP, inhibitor, from BioMarin
Pharmaceutical Inc., or BioMarin. MDV3800 is currently in a Phase 3 clinical trial for the treatment of patients with germline BRCA, or gBRCA, mutated
advanced breast cancer (i.e., advanced breast cancer in patients whose BRCA genes contain germline mutations). We are targeting a number of other indications in
which to investigate MDV3800, including breast cancer (beyond gBRCA mutations), prostate cancer, small cell lung cancer, and ovarian cancer. In the fourth
quarter of 2014, we licensed exclusive worldwide rights to pidilizumab (which we refer to as MDV9300), an antibody with immune-mediated anti-tumor effects for
all potential indications from CureTech, Ltd., or CureTech. Under the license agreement, we are responsible for all development, regulatory, manufacturing, and
commercialization activities for MDV9300. We initiated a Phase 2 clinical trial evaluating MDV9300 in patients with relapsed or refractory diffuse large B-cell
lymphoma in the fourth quarter of 2015, which is on partial clinical hold pending our revision of certain investigator brochure, protocols and informed consent
documents. We submitted the revised documents to the FDA in early February 2016 and the FDA has 30 days thereafter to notify us if the partial hold is lifted. We
also plan to develop MDV9300 in other hematologic malignancies such as multiple myeloma.
In addition to the above activities, we have various internal research and discovery efforts focused in oncology, neurology and other areas. A summary of
our commercial product and clinical stage pipeline is provided below:
Target/Drug
Compound
Indication
Status
XTANDI
Enzalutamide
Enzalutamide
Enzalutamide
Enzalutamide
Enzalutamide
Enzalutamide
Enzalutamide
metastatic
CRPC
non-metastatic
CRPC
non-metastatic
HSPC
(rising
PSA)
metastatic
HSPC
hepatocellular
carcinoma
AR+
TNBC
ER/PR+
&
HER2
normal
breast
cancer
AR+
HER2
amplified
breast
cancer
Commercial
Phase
3
Phase
3
Phase
3
(initiating)
Phase
2
Phase
2
Phase
2
Phase
2
Talazoparib
(MDV3800)
gBRCA
mutated
advanced
HER2
normal
breast
cancer
Phase
3
Pidilizumab
(MDV9300)
Relapsed
or
refractory
diffuse
large
B-cell
lymphoma
Phase
2
(potentially
pivotal)
MDV4463
Nonalcoholic
steatohepatitis
Phase
1
Additional information regarding XTANDI and our development programs for enzalutamide, MDV3800, MDV9300 and other research and drug discovery
programs is included below.
OuR
ENZAluTAMIdE
PROgRAM
Summary
of
Our
Enzalutamide
Program
We and our collaboration partner Astellas have a number of clinical trials for which enrollment is ongoing or completed, including those described in the
sections that follow.
2
Prostate
Cancer
According to the American Cancer Society, prostate cancer is the most commonly diagnosed cancer in men in the United States, other than skin cancer. The
American Cancer Society estimates that approximately 221,000 new cases of prostate cancer were diagnosed, and approximately 28,000 men died of prostate
cancer, in the United States alone during 2015. Prostate cancer is thus the second-leading cause of cancer death in men in the United States, after lung cancer.
According to the American Cancer Society, about 1 in 7 men will be diagnosed with prostate cancer during his lifetime and about 1 in 38 men will die of prostate
cancer.
Prostate cancer is generally seen as a slowly-progressing disease. According to the American Cancer Society, when including all stages of disease, the
relative 15-year survival rate is 94%. In the United States, prostate cancer patients are typically managed clinically by two different physician specialties—
urologists and oncologists. Urologists typically manage prostate cancer patients for the large majority of a patient’s disease course, starting with the initial
diagnosis and continuing for many years until the patient develops castration-resistant disease and symptoms. Once the patient develops symptoms, such as pain
from metastases of his prostate cancer to his bone, he is typically referred to an oncologist to manage the final stages of his disease, which typically represent the
last 9 to 13 months of the patient’s life.
Prostate cancer is frequently diagnosed at a stage where it is believed to be confined to the prostate gland and its immediate surroundings—i.e., it has not yet
spread to other areas of the body. Prostate cancer detected at this stage generally is treated either with prostatectomy (surgical removal of the prostate gland) or with
radiation. For most men, these procedures are successful in curing the disease. However, for some men, these procedures are not curative and their prostate cancer
continues to spread. This disease progression is typically detected by rising levels of serum prostate-specific antigen, or PSA, a marker of tumor burden in prostate
cancer. Men whose disease continues to progress following surgery or radiation are considered to have advanced prostate cancer.
Because the male sex hormone testosterone is the primary fuel of prostate cancer growth, first-line therapy for advanced prostate cancer typically entails
treatment with a class of hormonal drugs known as luteinizing-hormone releasing hormone analogs, or LHRH analogs, which reduce testosterone to castrate levels
—i.e., the levels that would be achieved following surgical castration. Patients treated with LHRH analogs typically remain on those drugs for the remainder of
their lives to keep testosterone levels suppressed to castrate levels. Patients typically respond to LHRH analog treatment, as evidenced by reduced PSA levels.
Eventually, however, virtually all advanced prostate cancers will become resistant to LHRH analogs, and the patient’s PSA level will begin to rise. Once a patient
progresses beyond hormone sensitive prostate cancer, or HSPC, while being treated with an LHRH analog, he is said to have castration-resistant prostate cancer, or
CRPC. The term “castration-resistant” refers to the fact that these patients have had their serum testosterone reduced to castrate levels, and yet their prostate
cancers continue to progress.
Once a patient has developed CRPC, the typical second line therapy is a class of hormonal drugs known as anti-androgens, which block the ability of
testosterone to bind its receptor, the androgen receptor. Bicalutamide, widely available in generic form, is the most commonly used anti-androgen drug. Like
LHRH analogs, bicalutamide typically suppresses tumor growth for a certain period of time, as evidenced by a declining PSA level. However, virtually all prostate
cancers become resistant to bicalutamide as well. In addition, once prostate cancer becomes resistant to bicalutamide, the effect of that drug may convert from
suppressing tumor growth to fueling tumor growth. For this reason, bicalutamide treatment is typically discontinued once patients begin to progress on the drug.
The next line of treatment for CRPC patients who have failed treatment on both LHRH analogs and anti-androgen drugs is frequently the chemotherapy
drug Taxotere ® (docetaxel), which has been shown in clinical studies to prolong survival. However, docetaxel is an infused cytotoxic chemotherapy, and thus
entails an increased risk of serious adverse effects, including fluid retention, liver toxicity, low white blood cell counts, and death. Prior to 2010, there were no
treatments approved by the U.S. Food and Drug Administration, or FDA, for CRPC patients whose prostate cancer had progressed following treatment with
docetaxel. These patients typically had only palliative care, or pain reducing, options available to them. Since 2010, four new agents in addition to XTANDI have
been approved by the FDA for the treatment of patients with mCRPC: Jevtana ® (cabazitaxel); Provenge ® (sipuleucel-T); Zytiga ® (abiraterone acetate) plus
prednisone; and Xofigo ® (radium RA-223 dichloride); and others are currently being studied.
Based on the above treatment algorithm, advanced prostate cancer patients are generally subdivided into various sub-populations that regulatory agencies
typically consider to be distinct patient populations. Because they view them as distinct, regulatory agencies typically require separate clinical studies in each
patient population to grant marketing approval covering that patient population. These sub-populations are defined primarily by two factors: (a) the prior treatments
the patient has undergone; and (b) whether the patient has metastatic disease. The sub-populations are the following:
•
Patients
with
HSPC.
Patients in this sub-population have progressive prostate cancer, are not castrate, and have not yet been treated with an LHRH
analog drug, an anti-androgen drug or any other hormonal drug for progressive disease. Hormone-sensitive prostate cancer patients may have
metastatic or non-metastatic disease.
3
•
Patients
with
CRPC.
Patients with CRPC have advanced prostate cancer that has progressed after treatment with an LHRH analog drug or surgical
castration. They may also have failed treatment on an anti-androgen drug, but are not required to have done so. Patients with CRPC ma y be in turn
further subdivided into pre-chemotherapy CRPC patients and post-chemotherapy CRPC patients. Both pre-chemotherapy and post-chemotherapy
CRPC patients may have mCRPC or non-metastatic CRPC. Pre-chemotherapy CRPC patients typically constitute a mix of metastatic and nonmetastatic disease. However, by the time they have progressed to the post-chemotherapy state, virtually all CRPC patients will have developed
metastatic disease.
Our
Prostate
Cancer
Clinical
Trials
•
TERRAIN – The Phase 2 TERRAIN trial was initiated in March 2011 and completed enrollment in July 2013. The trial evaluated enzalutamide
head-to-head versus bicalutamide, the leading marketed anti-androgen drug, in 375 pre-chemotherapy mCRPC patients. The randomized, doubleblind trial was conducted primarily in Europe. The primary endpoint of the trial was progression-free survival, or PFS, defined as time from
randomization to centrally determined radiographic progression, skeletal-related event, initiation of new anti-neoplastic therapy or death, whichever
occurred first. In January 2015, we and Astellas reported top-line results from the Phase 2 TERRAIN trial. The trial achieved its primary endpoint
demonstrating a statistically significant increase in PFS for patients with mCRPC for enzalutamide compared to bicalutamide (Hazard Ratio = 0.44;
95% Confidence Interval (CI): 0.34, 0.57; p < 0.0001). Median PFS was 15.7 months in the enzalutamide group compared to 5.8 months in the
bicalutamide group. The median time on treatment in the TERRAIN trial was 11.7 months in the enzalutamide group versus 5.8 months in the
bicalutamide group. Serious adverse events were reported in 31.1% of enzalutamide-treated patients and 23.3% of bicalutamide-treated patients.
Grade 3 or higher cardiac adverse events were reported in 5.5% of enzalutamide-treated patients versus 2.1% of bicalutamide-treated patients. Two
seizures were reported in the enzalutamide group and one in the bicalutamide group. Results from the TERRAIN trial were published in an online
issue of Lancet
Oncology
in January 2016. We have submitted the results of the TERRAIN trial to regulatory agencies for potential inclusion in the
relevant clinical trials sections of the XTANDI label within the current metastatic CRPC indication. The Prescription Drug User Fee Act, or PDUFA,
goal date for a decision by the FDA is October 22, 2016.
•
STRIVE – The Phase 2 STRIVE trial was initiated in August 2012 and completed enrollment in March 2014. The trial evaluated enzalutamide headto-head versus bicalutamide, the leading marketed anti-androgen drug, in 396 pre-chemotherapy CRPC patients. The randomized, double-blind trial
enrolled both metastatic and non-metastatic patients and was conducted in the United States. The primary endpoint of the trial was PFS defined as
time from randomization to radiographic (bone or soft tissue) progression, PSA progression (defined by Prostate Cancer Working Group 2 criteria),
or death due to any cause, whichever occurs first. In April 2015, we and Astellas reported top-line results from the Phase 2 STRIVE trial. The trial
achieved its primary endpoint demonstrating a statistically significant prolongation of PFS for patients with CRPC for enzalutamide compared with
bicalutamide (Hazard Ratio = 0.24; 95% CI: 0.18, 0.32; p < 0.0001). Median PFS was 19.4 months in the enzalutamide group compared with 5.7
months in the bicalutamide group. The median time on treatment in the STRIVE trial was 14.7 months in the enzalutamide group versus 8.4 months
in the bicalutamide group. Serious adverse events were reported in 29.4% of enzalutamide-treated patients and 28.3% of bicalutamide-treated
patients. Grade 3 or higher cardiac adverse events were reported in 5.1% of enzalutamide-treated patients versus 4.0% of bicalutamide-treated
patients. One seizure was reported in the trial in the enzalutamide-treated group and none in the bicalutamide-treated group. Results from the
STRIVE trial were published in an online issue of Journal
of
Clinical
Oncology
in January 2016. We have submitted the results of STRIVE to
regulatory agencies for potential inclusion in the relevant clinical trials sections of the XTANDI label within the current metastatic CRPC indication.
The PDUFA goal date for a decision by the FDA is October 22, 2016.
•
PROSPER – The first patient was enrolled in the Phase 3 PROSPER trial in December 2013. The trial is evaluating the safety and efficacy of
enzalutamide in patients with non-metastatic CRPC. The PROSPER trial is intended to enroll a high-risk subgroup of patients with prostate cancer
who are progressing despite androgen deprivation therapy, but who are asymptomatic with no prior or present evidence of metastatic disease. The
Phase 3 randomized, double-blind, placebo-controlled, multi-national trial is designed to enroll approximately 1,560 patients with non-metastatic
CRPC. The primary endpoint of the trial is metastasis-free survival.
•
EMBARK – The first patient was enrolled in the Phase 3 EMBARK trial in January 2015. The trial is intended to evaluate the efficacy and safety of
enzalutamide alone or in combination with androgen deprivation therapy compared with androgen deprivation therapy alone in patients with highrisk, hormone-sensitive, non-metastatic prostate cancer that has biochemically recurred (rising PSA level) following definitive local therapy with
radical prostatectomy and/or radiation. The purpose of the trial is to help determine if enzalutamide can delay or prevent the development of
metastatic prostate cancer in high-risk men with a rapidly rising PSA. The trial is designed to enroll approximately 1,860 patients. The primary
endpoint of the trial is metastasis-free survival.
•
PLATO – The Phase 4 PLATO trial was initiated in November 2013 and completed enrollment in September 2014. The trial is evaluating the
efficacy and safety of continued treatment with enzalutamide plus abiraterone acetate and
4
prednisone as compared to abirat erone acetate and prednisone alone in patients with chemotherapy-naive CRPC whose disease has progressed
following enzalutamide therapy. The purpose of the trial is to help determine the potential clinical benefit of continued enzalutamide treatment after
progression on enzalutamide therapy. The global randomized, double-blind, placebo-controlled trial has enrolled 509 chemotherapy-naive patients
with mCRPC. The primary endpoint of the trial is PFS defined as time from randomization to radiographic progress ion, un equivocal clinical
progression, or death , whichever occurs first. Top-line results from PLATO may be available as early as the second half of 2016.
•
M1 HSPC – In January 2016, Astellas initiated start-up activities for a Phase 3 trial in patients with metastatic hormone-sensitive prostate cancer, or
mHSPC. The trial is intended to evaluate the efficacy and safety of enzalutamide in combination with androgen deprivation therapy compared with
androgen deprivation therapy alone in approximately 1,100 patients. The primary endpoint of the trial is overall survival.
•
AFFIRM – Our FDA approval in post-chemotherapy mCRPC was based on the results of the AFFIRM trial, a randomized, double-blind Phase 3 trial
evaluating XTANDI (160 mg once daily) as compared to placebo in 1,199 post-chemotherapy mCRPC patients. The primary endpoint of the
AFFIRM trial was overall survival. Data from the AFFIRM trial were first reported in November 2011 and were published in The
New
England
Journal
of
Medicine
in August 2012. The AFFIRM trial also led to the initial marketing approvals of XTANDI by regulatory authorities in Europe,
Japan and numerous other countries worldwide. The open-label extension of this trial is ongoing.
•
PREVAIL – Our FDA approval in pre-chemotherapy mCRPC was based on the results of the PREVAIL trial, a randomized, double-blind, placebocontrolled Phase 3 trial, evaluating enzalutamide (160 mg once daily) as compared to placebo in 1,717 patients with pre-chemotherapy mCRPC. The
co-primary endpoints were radiographic PFS and overall survival. Positive results from the PREVAIL trial were first reported in October 2013 and
were published in The
New
England
Journal
of
Medicine
in June 2014. The PREVAIL trial also led to expanded marketing approvals by regulatory
authorities in Europe, Japan, and numerous other countries worldwide. In July 2015, the FDA approved a label update for XTANDI based on an
updated overall survival analysis of the Phase 3 PREVAIL trial. This analysis was conducted when 784 deaths were observed and found an overall
survival benefit with a 23% reduction in risk of death (Hazard ratio = 0.77; 95% CI: 0.67, 0.88) and a 4-month improvement in median survival with
enzalutamide (35.3 months [95% CI: 32.2, not yet reached]) over placebo (31.3 months [95% CI: 28.8, 34.2]). The open-label extension of this trial
is ongoing.
Breast
Cancer
According to the American Cancer Society, breast cancer is the most common cancer in women in the United States, other than skin cancer. The American
Cancer Society estimates that approximately 234,000 new cases of breast cancer were diagnosed in women, and approximately 41,000 women died of breast
cancer, in the United States alone during 2015. Breast cancer is the second-leading cause of cancer death in women in the United States, after lung cancer.
According to the American Cancer Society, the chance that breast cancer will be responsible for a woman’s death is about 1 in 36. Death rates from breast cancer
have been declining since about 1989, with larger decreases in women younger than 50. These decreases are believed to be the result of earlier detection through
screening and increased awareness, as well as improved treatment.
Systemic treatment of recurrent/advanced breast cancer has been shown, in some situations, to prolong survival and/or quality of life, but it is not
curative. Therefore treatments associated with minimal toxicity are preferred. There are many chemotherapies approved for use in breast cancer. Most are given
as single agents as there is no compelling evidence that combination regimens are superior to sequential single agents once the disease has recurred. The length of
treatment depends on whether the cancer shrinks, how much it shrinks, and how well the treatment is tolerated. A central component of the treatment of breast
cancer is full knowledge of its biologic features, which provides information that may predict a patient’s response to therapy. These factors are determined by
examination of excised tissue and routinely provided in a written pathology report and are based, in part, on three targeted receptors in breast cancer cells – the
estrogen receptor, or ER, progesterone receptor, or PgR, and human epidermal growth factor receptor 2, or HER2. Androgen receptor expression has been observed
in the majority of ER/PgR+ (>65%) and HER2 amplified (>50%) breast cancer and in up to one-third of triple negative breast cancer.
The estrogen and progesterone receptors are in the nuclear steroid receptor family and their expression is observed in two-thirds of all breast cancer. There
are five commonly used agents approved for use in patients whose tumor express one or both of these receptors: tamoxifen, fulvestrant, exemestane, letrozole and
anastrozole. The use of minimally toxic endocrine therapies is preferred to the use of cytotoxic therapy whenever reasonable. Everolimus and palbociclib have
recently been approved in combination with exemestane and with letrozole or fulvestrant, respectively, for the treatment of this subtype of disease that is advanced.
Overexpression of the growth-promoting protein known as HER2 is found in about 20% of breast cancer and, in the absence of HER2 targeted therapy, is
associated with a worse prognosis. A number of drugs have been developed that target HER2: trastuzumab, Ado-trastuzumab emtansine and pertuzumab, which are
monoclonal antibodies that are administered intravenously, and lapatinib which is administered orally. Breast cancer that is HER2+ may, or may not, also express
ER or PgR.
5
Triple negative breast cancer, or TNBC, is a type of breast cancer that is so named by the observation that it lacks expression of the three targeted receptors
in breast cancer, namely ER, PgR and HER2. It is estimated that approximately 20% of women with metastatic breast cancer are in this category. Triple negative
breast cancer has no recognized target and standard therapy is cytotoxic chemotherapy.
Our
Breast
Cancer
Clinical
Trials
In April 2012, we and Astellas expanded the clinical development of enzalutamide to include breast cancer. We currently have three Phase 2 clinical trials
evaluating enzalutamide in three subsets of breast cancer:
•
AR+, TNBC – This Phase 2 open-label, single arm, multicenter clinical trial evaluated enzalutamide as a single agent for the treatment of advanced
androgen receptor positive, or AR+, TNBC. 118 women with advanced TNBC were enrolled in this Simon 2 stage study at sites in the United States,
Canada, and Europe. The objective of the study was to evaluate the safety and clinical benefit of enzalutamide, 160 mg/day orally, for advanced
TNBC and to identify a biomarker to better select those women more likely to respond to enzalutamide. The primary endpoint of the trial was the
clinical benefit rate at 16 weeks, or CBR16, defined as the proportion of evaluable patients with a complete response, or CR, partial response, or PR,
or stable disease for at least 16 weeks. Secondary endpoints of the trial included clinical benefit rate at 24 weeks, or CBR24, and PFS, defined as
time from the date of first dose of study drug until documented disease progression or death due to any cause, overall survival, and safety.
The primary endpoint analysis was pre-specified to be conducted in the evaluable patient population, defined as all patients who had at least one
follow-up tumor assessment after starting enzalutamide and whose TNBC had at least 10% of the tumor cells stain positive for AR using a central
immunohistochemistry, or IHC, assay. The evaluable population was pre-specified based on the hypothesis that patients whose tumor tissue
expressed higher levels of AR protein may be more likely to receive benefit from enzalutamide than those whose tumors had less than 10% cells
with AR expression. Of the 118 patients enrolled into the study, 75 were evaluable. Analyses for clinical benefit and safety were also conducted in
all 118 patients enrolled.
The study met its primary endpoint, achieving a CBR16 of 35% (95% CI: 24, 46), including six CRs or PRs (8%) in the evaluable population based
on results as of March 25, 2015. The secondary endpoint of CBR24 was 29% (95% CI: 20, 41), and the median PFS on enzalutamide therapy was
14.7 weeks (95% CI: 8.1, 19.3) in the evaluable population. Using the total intent-to-treat, or ITT, population, CBR16 was achieved in 25% (95%
CI: 17, 33) including seven CRs or PRs (6%), CBR24 was achieved in 20% (95% CI: 14, 29), and the median PFS was 12.6 weeks (95% CI: 8.1,
15.7).
Nearly half of the enrolled patients (47%) tested positive for a novel gene expression profile. Of these 56 diagnostic positive women with advanced
TNBC, 39% achieved CBR16 (95% CI: 27, 53) and 36% achieved CBR24 (95% CI: 24, 49). Of the 62 women who were diagnostic negative for the
novel gene expression profile, 11% achieved a CBR16 (95% CI: 5, 21) and 6% achieved CBR24 (95% CI: 2, 16). Median PFS in the diagnostic
positive group was 16.1 weeks (95% CI: 13.3, 27.4) compared with 8.1 weeks in the diagnostic negative group (95% CI: 7.4, 12.6). Over half (n=62)
of the ITT patients enrolled received enzalutamide as their first- or second-line treatment and median PFS on enzalutamide in diagnostic positive
patients was 40.4 weeks (95% CI: 16.1, not yet reached) whereas it was 9 weeks (95% CI: 7.3, 15.7) in the diagnostic negative group.
An exploratory analysis of overall survival data collected as of September 15, 2015 demonstrated that patients treated with enzalutamide whose
tumors tested positive according to the novel diagnostic assay experienced a 13.8-month longer median overall survival duration compared to those
patients whose tumors tested negative for the novel gene expression profile. Median overall survival in the diagnostic positive group treated with
enzalutamide was 21.3 months (95% CI: 12.9, 21.3) compared with 7.5 (95% CI: 4.8, 11.2) months for the diagnostic negative group treated with
enzalutamide.
Multicovariate analyses demonstrated that only diagnostic status (positive) and number of prior lines of therapy (0-1) were statistically significantly
and independently associated with both improved PFS and overall survival outcomes. Additional variables included in the multi-covariate analyses
were age (≥65 vs. < 65 years), disease free interval between primary and metastatic disease (≥12 months vs. <12 months), AR IHC (≥10% vs.
<10%).
The most common (reported in ≥10% of patients) adverse events reported as related to enzalutamide treatment in the ITT population were fatigue
(35%), nausea (26%), decreased appetite (13%), diarrhea (10%), and hot flush (10%).
Additionally, we entered into a collaboration agreement with NanoString Technologies, Inc. and our partner Astellas, in January 2016, to translate
our gene expression profile into a companion diagnostic assay using NanoString’s nCounter® Dx Analysis System for potential use as a companion
diagnostic test for enzalutamide for TNBC.
6
•
ER+ or PgR+ and HER2 Normal – The Phase 2 trial was initiated i n December 2013 and completed enrollment of 247 patients in March 2015. The
trial is evaluating exemestane in combination with enz alutamide and exemestane in combination with placebo in women with advanced breast
cancer that is estrogen receptor positive, or ER+, or progesterone receptor positive, or PgR+, and HER2 normal. The Phase 2 randomized, doubleblind, placebo-controlled, mul ticenter trial will assess outcomes in two parallel enrolled cohorts. The first cohort enrolled patients who had not
previously received hormonal treatment for advanced breast cancer. The second cohort enrolled patients who had previously progressed follow ing
one hormonal treatment for advanced disease. The primary endpoint of the trial is PFS in all patients and by cohort and PFS in the subset of patients
whose tumors test positive for a diagnostic assay. Top-line results from this trial may be available a s early as the second half of 2016.
•
AR+ HER2 Amplified – In August 2014, Astellas initiated a Simon 2 stage Phase 2 clinical trial evaluating the safety and efficacy of adding
enzalutamide to trastuzumab in approximately 80 patients with advanced breast cancer that is AR+ and HER2 amplified. Patients must also have
previously received and progressed on trastuzumab. The primary endpoint of the trial is clinical benefit rate defined as complete response or partial
response or stable disease for at least 24 weeks. The trial met the criteria to proceed to stage 2 which required a minimum of three evaluable patients
in the first 21 evaluable patients to achieve CBR24. Like the TNBC clinical trial, the evaluable population consists of patients with at least one
follow-up tumor assessment after starting enzalutamide and whose breast cancer has AR protein expression by central IHC testing in at least 10% of
tumor cells.
Hepatocellular
Carcinoma
The American Cancer Society estimates that approximately 36,000 new cases of liver cancer were diagnosed in the United States alone during 2015,
approximately three-fourths of which were hepatocellular carcinoma, or HCC. Liver cancer incidence rates are about three times higher in men than in women, and
have doubled in each sex over the past two decades. Common symptoms, which do not usually appear until the cancer is advanced, include abdominal pain and/or
swelling, weight loss, weakness, loss of appetite, jaundice and fever. Enlargement of the liver is the most common physical sign. The most important risk factors
for liver cancer are obesity, diabetes, alcoholic liver disease, chronic infection with hepatitis B virus and/or hepatitis C virus, and tobacco smoking. Early stage
liver cancer can sometimes be treated successfully with partial hepatectomy (surgical removal of the liver); however, only a limited number of patients have
sufficient healthy liver tissue for this to be an option. Liver transplantation may be an option for individuals with small tumors who are not candidates for partial
hepatectomy. Other treatment options include ablation (techniques used to destroy liver tumors without removing them) or embolization (a procedure that injects
substances to try to block or reduce the blood flow to cancer cells). Fewer treatment options exist for patients diagnosed at an advanced stage. Sorafenib is a
targeted drug approved for the treatment of HCC when it cannot be treated with surgery.
In January 2016, Astellas enrolled the first patient into a Phase 2 trial evaluating enzalutamide in hepatocellular carcinoma. The trial will assess
approximately 144 patients with advanced hepatocellular carcinoma that have failed sorafenib or other anti-vascular endothelial growth factor therapies. The
primary endpoint of the trial is overall survival.
The
Astellas
Collaboration
Agreement
We have a collaboration agreement with Astellas, or the Astellas Collaboration Agreement, pursuant to which we are collaborating to develop and
commercialize XTANDI globally for all indications, dosages, and formulations of enzalutamide. We licensed the intellectual property rights covering XTANDI
from the Regents of the University of California, or UCLA or Regents, pursuant to a license agreement described in the section below titled, “License Agreement
with UCLA.” Under the Astellas Collaboration Agreement, Astellas paid us a non-refundable, upfront cash payment of $110.0 million in 2009. As of December
31, 2015, we have earned all development and sales milestone payments under the Astellas Collaboration Agreement, totaling $655.0 million, including $245.0
million, $307.0 million, and $45.0 million in the years ended December 31, 2015, 2014, and 2013, respectively.
In the United States, decisions are generally made by consensus, pre-tax profits and losses are shared equally, and, subject to certain exceptions,
development and commercialization costs are also shared equally. Outside the United States, decisions are generally made by Astellas and all development and
commercialization costs are borne by Astellas. Astellas retains all ex-U.S. profits and losses, and pays us a tiered royalty ranging from the low teens to the low
twenties as a percentage of aggregate net sales of XTANDI outside the United States, or ex-U.S. XTANDI net sales.
The Astellas Collaboration Agreement establishes several joint committees consisting of representatives from both parties that operate by consensus to
oversee the collaboration. In the event that a joint committee is unable to reach consensus on a particular issue, then, depending on the issue, a dispute may be
decided at the joint committee level by the party with the final decision on the issue or escalated to senior management of the parties. If a dispute is escalated to
senior management and no consensus is reached, then the dispute may be decided by the party to whom the contract grants final decision on such issue. Other
issues can only be decided by consensus of the parties, and unless and until the parties’ representatives reach agreement on such issue, no decision on such issue
will be made, and the status quo will be maintained.
7
Unless terminated earlier by us or Astellas pursuant to the terms thereof, the Astellas Collaboration Agreement will remain in effect: (a) in the United States,
until such time as Astellas notifies us that Astellas has permanently stopped selling products covered by the Astellas Collaboration Agreement in the United States;
and (b) in each other country o f the world, on a country-by-country basis, until such time as (i) products covered by the Astellas Collaboration Agreement cease to
be protected by patents or regulatory exclusivity in such country and (ii) commercial sales of generic equivalent products have commenced in such country.
We and Astellas are each permitted to terminate the Astellas Collaboration Agreement for an uncured material breach by the other party or for the
insolvency of the other party. Astellas has the right to terminate the Astellas Collaboration Agreement unilaterally by advance written notice to us. Following any
termination of the Astellas Collaboration Agreement in its entirety, all rights to develop and commercialize XTANDI will revert to us, and Astellas will grant a
license to us to enable us to continue such development and commercialization. In addition, except in the case of termination by Astellas for our uncured material
breach, Astellas will supply XTANDI to us during a specified transition period.
The Astellas Collaboration Agreement further provides for a standstill period during which Astellas and its Affiliates, as defined in the Astellas
Collaboration Agreement, agreed to certain restrictive covenants, including that they would not, directly or indirectly (subject to certain exceptions), unless invited
to do so by us, acquire (a) all or substantially all of our consolidated assets or (b) beneficial ownership of more than five percent of any voting securities of us or
any subsidiary or Affiliate of us. The standstill period will expire in September 2016.
Additional information about the Astellas Collaboration Agreement, including geographic financial information, is included in Note 3, “Collaboration
Agreement,” to our audited consolidated financial statements included elsewhere in this Annual Report.
License
Agreement
with
UCLA
Under an August 2005 license agreement with UCLA, our subsidiary Medivation Prostate Therapeutics, Inc. holds an exclusive worldwide license under
several UCLA patents and patent applications covering XTANDI and related compounds. Under the Astellas Collaboration Agreement, we granted Astellas a
sublicense under the patent rights licensed to us by UCLA.
We are required to pay UCLA (a) an annual maintenance fee, (b) $2.8 million in aggregate milestone payments upon achievement of certain development
and regulatory milestone events with respect to XTANDI (all of which has been paid as of December 31, 2015), (c) ten percent of all Sublicensing Income, as
defined in the agreement, which we earn under the Astellas Collaboration Agreement, and (d) a four percent royalty on global net sales of XTANDI, as defined.
Under the terms of the Astellas Collaboration Agreement, we share this royalty obligation equally with Astellas with respect to sales in the United States, and
Astellas is responsible for this entire royalty obligation with respect to sales outside of the United States. We are currently involved in litigation with UCLA
regarding this agreement. For more information about this litigation, see “Legal Proceedings” in Item 3 of Part I below.
UCLA may terminate the agreement if we do not meet a general obligation to diligently proceed with the development, manufacturing and sale of licensed
products, or if we commit any other uncured material breach of the agreement. We may terminate the agreement at any time upon advance written notice to UCLA.
If neither party terminates the agreement early, the agreement will continue in force until the expiration of the last-to-expire patent on a country-by-country basis.
Mdv3800
(TAlAZOPARIB)
PROgRAM
In the fourth quarter of 2015, we acquired all worldwide rights to talazoparib (which we refer to as MDV3800) from BioMarin Pharmaceutical Inc., or
BioMarin. Upon closing of the transaction, we paid BioMarin an upfront cash payment of $410.0 million. We also assumed certain costs for ongoing clinical trials
of MDV3800, and commitments under certain agreements previously entered into or assumed by BioMarin and assigned to us. BioMarin is eligible to receive up
to an additional $160.0 million upon the achievement of defined regulatory and sales-based milestones, and mid-single digit royalties on net sales of products that
contain MDV3800 during the royalty term specified in the asset purchase agreement. We further entered into a transition services agreement at the closing of the
transaction to facilitate the transition of research and development activities relating to MDV3800 from BioMarin to us, including responsibility for the ongoing
clinical studies.
MDV3800 is an orally available poly-ADP ribose polymerase, or PARP, inhibitor currently in a Phase 3 clinical trial for the treatment of patients with
gBRCA mutated breast cancer. The Phase 3 EMBRACA trial is an open-label, 2:1 randomized, parallel, two-arm study of MDV3800 as compared to the protocolspecified physicians’ choice of chemotherapy (capecitabine, eribulin, gemcitabine or vinorelbine) in gBRCA-mutated locally advanced and/or metastatic breast
cancer patients who have received prior chemotherapy for their metastatic disease. The study is enrolling up to 430 patients. The primary objective of the study is
to compare PFS of patients treated with MDV3800 as a monotherapy relative to those treated with protocol-specified physicians’ choice. We anticipate fully
enrolling this trial by the end of 2016 with top-line results as early as the first half of 2017. We are targeting a number of other indications in which to investigate
MDV3800, including breast cancer (beyond gBRCA mutations), prostate cancer, small cell lung cancer, and ovarian cancer.
8
PARP
Inhibitors
PARP is a family of proteins involved in a wide range of cellular functions including deoxyribonucleic acid, or DNA, transcription, DNA damage response,
genomic stability maintenance, cell cycle regulation, and cell death. One well-studied area of PARP activity relates to DNA repair. Since DNA is the vehicle by
which fundamental information is passed on when a cell divides, it is critical to the viability of cells and human health that DNA damage can be repaired. If a cell’s
DNA damage repair system is impaired, the cell will die.
DNA can be damaged as a result of environmental exposure or agents, or through errors introduced during replication. Cells have a number of different
mechanisms to repair damaged DNA. PARPs aid in repair by binding to single-strand breaks in DNA and recruiting additional repair proteins to the site of damage,
a process called base excision repair. PARP inhibitors are thought to block this activity, thus preventing the repair of DNA. PARP inhibitors exert a cytotoxic
effect by two mechanisms: (a) catalytic inhibition of PARP enzyme activity and (b) PARP trapping.
A single-stranded DNA break signals PARP protein to attach to DNA, a critical step in DNA repair. Inhibition of PARP’s catalytic activity impairs the
recruitment of additional DNA repair proteins critical for base excision repair and single stranded breaks can become double stranded breaks which require
homologous recombination for repair. Cells harboring mutations or deficiencies in homologous recombination (e.g., cells with BRCA1/2 mutations), are
particularly susceptible to the cytotoxic effects of PARP inhibitors as these cells tend to accumulate double strand breaks that are inaccurately repaired by
alternative pathways.
Another potentially important mechanism of action to MDV3800 is the phenomenon called PARP trapping. The attachment and release of PARP molecules
to DNA is facilitated by the reduction of nicotinamide adenine dinucleotide to its reduced form. MDV3800 traps the PARP molecule on the DNA creating a large
protein moiety that interferes with the cell’s ability to replicate its DNA thereby causing cell death.
DNA damaging therapies such as radiation and chemotherapy (alkylating agents like temozolomide) modify DNA and initiate PARP-dependent repair
processes including base excision repair. Single strand breaks resulting from these therapies create additional sites for PARP to be trapped by MDV3800 thereby
further increasing its cytotoxicity. In 2015 in the U.S. alone, approximately 500,000 patients received DNA damaging radiation therapy, while more than 500,000
received DNA damaging chemotherapy. As single-stranded breaks are potential sites for PARP trapping, MDV3800 in combination with these DNA damaging
agents may have broad activity beyond tumors harboring BRCA1/2 mutations which represent only a small portion of the total oncology market.
Mdv9300
(PIdIlIZuMAB)
PROgRAM
In the fourth quarter of 2014, we licensed exclusive worldwide rights to MDV9300, an antibody with immune-mediated anti-tumor effects, for all potential
indications, from Israel-based CureTech. Under the license agreement, we are responsible for all development, regulatory, manufacturing, and commercialization
activities for MDV9300.
MDV9300 was not generated against a single purified recombinant protein but, rather, was generated against a lymphoblast cell line called
DAUDI. Although the molecule was originally understood to work primarily via PD-1 (Programmed Death-1) binding, our work as well as that of others has
shown other potential activity as well. In the year since we acquired rights to the molecule, we conducted testing and characterization work to better identify the
binding target and, in late December 2015, we concluded that MDV9300 does not bind PD-1. Clinical and preclinical data continue to indicate that MDV9300
administration is associated with enhanced maturation and survival of T lymphocytes, which may improve adaptive immunity, as well as activation of natural killer
cells, which may improve innate immunity that facilitates anti-tumor activity. Such broad effects on both sides of the immune response are not widely reported
with checkpoint inhibitors and may serve to differentiate MDV9300 from other agents in the competitive PD-1 landscape.
Prior to concluding non-binding of PD-1, in the fourth quarter of 2015, we initiated a Phase 2 clinical trial evaluating MDV9300 in patients with relapsed or
refractory diffuse large B-cell lymphoma, or DLBCL. The open-label trial is expected to enroll approximately 180 patients with an incomplete response following
salvage therapy or autologous stem cell transplantation for relapsed or refractory CD20+ diffuse large B cell lymphoma, transformed indolent lymphoma or
primary mediastinal B-cell lymphoma. Patients will be assessed in two parallel cohorts of approximately 90 patients each. One cohort will enroll patients who have
received an autologous stem cell transplant, and the second cohort will enroll patients who have received salvage chemotherapy, but are transplant ineligible.
MDV9300 will be administered at a dose of 200 mg by IV infusion. The primary endpoint of the trial is best overall response rate.
In early January 2016, we promptly advised FDA of our conclusion that MDV9300 does not bind PD-1, and the agency placed the IND on partial clinical
hold and requested that we revise our characterization of MDV9300 in the related investigator brochure, protocols and informed consent documents. The partial
clinical hold was not related to concerns regarding the safety of MDV9300. Under the hold, we may not enroll patients into the Phase 2 DLBCL trial until such
documents are revised. We since submitted the revised documents in early February 2016 to the agency, and the FDA has 30 days thereafter to notify us if the
partial hold is lifted.
9
Although the Phase 2 clinical trial was initiated in December 2015, no patients have been enrolled to date. Under the partial clinical hold, patients who are
currently receiving MDV9300 through investigator-sponsored trials of MDV9300 that cross-reference our IND may continue on treatment, but we must inform
those investigators to update their protocols and informed consent documents to state that MDV9300 is not an anti-PD-1 antibody .
In addition, we intend to submit an amendment to the Chemistry, Manufacturing and Controls, or CMC, section of our IND for MDV9300 to provide for
larger manufacturing lot sizes to better support our planned clinical activities with MDV9300. We plan to submit the CMC amendment in the first half of 2016 and
we intend that patients in our Phase 2 DLBCL trial will be treated with MDV9300 manufactured in accordance with the amended IND. This decision will also
contribute to a later timeline for completion of the Phase 2 DLBCL trial.
We continue to deepen our understanding of the properties of MDV9300, which we believe may differentiate it from the other immuno-oncology agents in
development. Based on clinical and preclinical data, including data from Dr. Benson presented at the American Society of Hematology, we plan to develop
MDV9300 in other hematologic malignancies such as multiple myeloma.
RESEARCh
ANd
dRug
dISCOvERy
PROgRAMS
An important element of our corporate strategy is to diversify beyond XTANDI to build a portfolio of multiple approved products. To further this strategy,
we are investing in a number of research and drug discovery programs, from the discovery stage through early clinical studies. In the discovery stage, we identify
disease states of interest and therapeutic approaches that we believe may be safe and effective in treating a disease state. We conduct preclinical studies designed to
identify one or more development candidates. A development candidate is a specific product candidate that embodies the therapeutic approach of interest and
which we believe may possess the properties necessary to successfully complete the subsequent preclinical and clinical testing required to support an application
for marketing approval. Once we identify a development candidate, we conduct any additional preclinical testing required to support an application for regulatory
approval to begin human testing. Once such approval is granted, we may conduct Phase 1 trials where the development candidate is introduced into healthy human
subjects or patients with the target indication and tested for safety, dosage tolerance, absorption, metabolism, distribution, and excretion, and, if possible, early
evidence on effectiveness. Our current internal research and drug discovery programs are focused in oncology, neurology and other areas.
From our research and drug discovery efforts, we have developed a novel small molecule inhibitor of the sterol regulatory element-binding protein, or
SREBP, pathway which we refer to as MDV4463. SREBPs are master regulators of cholesterol and lipid biosynthesis. SREBP modulates the expression of
multiple metabolic proteins, including but not limited to PCSK9 and HMG-CoA reductase, the target of all statins. In some preclinical studies, we have
demonstrated that MDV4463 lowers triglycerides, cholesterol, glucose, insulin and weight in animals. MDV4463 also reduced lipids in the liver of animal models
of nonalcoholic steatohepatitis, or NASH. MDV4463 is currently in a Phase 1 trial in healthy volunteers.
Our research and drug discovery activities are conducted largely on an outsourced basis at facilities owned and operated by independent third party
contractors, with oversight and monitoring by our employees. In 2015, we constructed certain limited internal research, development and pharmaceutical operations
capabilities in laboratory space that is currently leased in San Francisco, California.
INTEllECTuAl
PROPERTy
Our success is dependent in part on our ability to protect the products we develop, acquire, or license and we rely on patent protection as well as trade
secrets.
We have an exclusive license to multiple issued patents and pending patent applications covering XTANDI, related compounds and uses thereof, including
issued composition of matter patents covering XTANDI in the United States, Europe, and Japan. The terms of these issued XTANDI composition of matter patents
have a base expiry in 2027 in the United States and in 2026 in Europe and Japan. Supplemental Protection Certificates, or SPCs, and patent term extensions are
pending or have been granted in Europe and Japan. Certain of the issued U.S. patents are listed in the FDA’s Approved Drug Products with Therapeutic
Equivalence Evaluations, commonly known as the Orange Book. U.S. federal law provides that, for a period of five years following approval of a drug containing a
new molecular entity, no abbreviated new drug application for a generic version of such drug can be submitted unless the submission contains a Paragraph IV
certification stating that the patents listed in the Orange Book are invalid or will not be infringed by the generic version of the drug, in which case the submission
may be made four years following the original product approval. XTANDI was approved by the FDA on August 31, 2012 and was a new molecular entity at the
time of its approval. Companies seeking approval to market a generic version of a reference drug may also seek to challenge the validity of the patents covering
such reference drug by filing petitions for inter partes review with the U.S. Patent and Trademark Office. For more information regarding the review and approval
process of generic drugs, see the section below titled “Government
Regulation—Abbreviated
New
Drug
Applications
and
Section
505(b)(2)
New
Drug
Applications.
”
10
We have an exclusive license to multiple issued patents and pending patent applications covering MDV9300, including the antibody and methods of use of
MDV9300. In addition, we expect to rely on the 12 years of data exclusivity available for biologic products. For more information regarding the review and
approval of biosimilars, see the section below titled “ Government
Regulation—Biologics
Price
Competition
and
Innovation
Act.
”
Our acquisition of worldwide rights to MDV3800 included issued patents, pending patent applications and know-how covering MDV3800’s composition of
matter as well as methods of use and methods of manufacturing MDV3800. As we continue to develop MDV3800, MDV9300 and product candidates discovered
from our own research and drug discovery programs, we will actively seek patent protection for such inventions. However, the actual protection afforded by a
patent, which can vary from country to country, depends on the type of patent, the scope of its coverage and the availability of legal remedies in the country. Other
pharmaceutical and biotechnology companies, universities and research institutions may have filed patent applications or may have been granted patents that cover
technologies similar to the technologies owned or licensed to us. Because patent applications are confidential for a period of time, we may not know if we were the
first to invent or the first to file an application covering an invention that is the subject of our patent applications.
We rely upon trade secret protection for our confidential and proprietary information. It is our policy to require our employees and consultants, outside
collaborators, and other advisors who receive confidential information from us to execute confidentiality agreements upon the commencement of employment,
consulting or other relationships with us. There can be no assurance, however, that these agreements will provide meaningful protection or adequate remedies for
our trade secrets in the event of unauthorized use or disclosure of such information.
XTANDI ® is a registered trademark of Astellas Pharma, Inc. and is referred to as XTANDI throughout this Annual Report.
COMPETITION
The pharmaceutical and biopharmaceutical industries are highly competitive and require an ongoing, extensive search for technological innovation. These
industries are characterized by rapidly evolving technologies, intense competition and a strong emphasis on proprietary products. They also require, among other
things, the ability to effectively discover, develop, and obtain regulatory approval for products, as well as the ability to effectively commercialize, market, and
promote approved products. Once a product is approved, it must compete successfully against other commercial products primarily on efficacy, safety, tolerability,
acceptance by physicians, ease of patient compliance, patent protection, ease of use, price, insurance, and other reimbursement coverage, distribution, and
marketing. Many of our competitors are large pharmaceutical companies with considerably greater financial resources, human resources and experience than us.
XTANDI
XTANDI faces and will continue to face intense competition as we market it in its approved indications, develop it across the prostate cancer treatment
paradigm and seek additional marketing approvals in new indications. Our competition will be determined in part by the potential indications for which drugs are
developed and ultimately approved by regulatory authorities. Additionally, the timing of market introduction of some of our potential products or of competitors’
products may be an important competitive factor.
Many products currently compete or are expected to compete with XTANDI for the treatment of advanced prostate cancer. Products approved for advanced
prostate cancer include Casodex ® (bicalutamide), which is widely available in generic form and its generic pricing constitutes a competitive advantage relative to
any branded drugs that are, or may later be, approved to treat pre-chemotherapy or non-metastatic CRPC or HSPC; Jevtana ® (cabazitaxel); Provenge ® (sipuleucelT); Zytiga ® (abiraterone acetate) plus prednisone; and Xofigo ® (radium RA-223 dichloride). Drugs still in development for advanced prostate cancer include
apalutamide (formerly JNJ-56021927, or JNJ-927, and ARN-509) by Johnson & Johnson’s subsidiary Aragon Pharmaceuticals, or Aragon; ODM-201, which is
being developed by Bayer and Orion Corporation; and galeterone (formerly TOK-001) which is being developed by Tokai. For information about certain pending
litigation between us and Aragon, among other parties, concerning apalutamide, see “Legal Proceedings” in Item 3 of Part I below.
11
Enzalutamide
for
the
Treatment
of
Breast
Cancer
There are many products available or currently in development for patients with breast cancer and which could compete with enzalutamide for the treatment
of advanced breast cancer, including the following:
•
Bicalutamide
–
Bicalutamide is approved for prostate cancer and is being studied in several Phase 2 studies in androgen receptor-positive breast
cancer. Positive proof-of-concept with enzalutamide or other drugs targeting androgen receptor signaling may encourage spontaneous use of
bicalutamide in breast cancer.
•
Ibrance
TM
(palbociclib)
– Pfizer’s kinase inhibitor targeting CDK4/6 is approved in combination with letrozole or with fulvestrant for estrogen
receptor-positive, HER2-negative, advanced breast cancer.
•
Pembrolizumab
– Merck’s monoclonal antibody targeting PD-1 is being studied in a randomized Phase 3 study comparing the effects of
pembrolizumab against investigator’s choice chemotherapy in patients with metastatic triple-negative breast cancer who have received 1-2 prior
therapies for metastatic disease.
•
Atezolizumab
– Roche’s monoclonal antibody targeting PD-L1 is being studied in a randomized Phase 3 study comparing the effects of atezolizumab
in combination with nab-paclitaxel against nab-paclitaxel in patients with previously untreated, metastatic, triple-negative breast cancer.
•
Enobosarm
– GTx Therapeutics’ investigational androgen receptor modulator is being studied in a Phase 2 open-label trial to assess preliminary
efficacy in advanced triple-negative breast cancer patients whose tumors are deemed positive for androgen receptor expression.
MDV3800
MDV3800 faces competition from other PARP inhibitors, including:
•
Lynparza™
(olaparib)
– AstraZeneca’s product is approved for patients with deleterious or suspected deleterious gBRCA mutated advanced ovarian
cancer. Olaparib is being studied in a Phase 3 trial comparing the effects of olaparib against investigator’s choice chemotherapy in metastatic, HER2negative breast cancer patients with deleterious germline BRCA1/2 mutations, and in Phase 2 studies for several other tumor types.
•
Rucaparib
– Rucaparib is an investigational PARP inhibitor being developed by Clovis Oncology. Rucaparib is currently in several clinical studies,
including a randomized, double-blind pivotal Phase 3 study in woman with platinum-sensitive, relapsed, high grade serous or endometrioid ovarian
fallopian tube, or primary peritoneal cancer comparing the effects of rucaparib against placebo to evaluate whether rucaparib given as a maintenance
therapy to platinum-sensitive patients can extend the period of time for which the disease is controlled after a positive outcome with platinum-based
chemotherapy. In April 2015, the FDA granted Breakthrough Therapy designation for rucaparib as monotherapy treatment of advanced ovarian
cancer in patients who have received at least two lines of prior platinum-containing therapy, with BRCA-mutated tumors, inclusive of both germline
BRCA and somatic BRCA.
•
Veliparib
- Veliparib is an investigational PARP inhibitor being developed by AbbVie. It is currently in Phase 3 clinical trials for the treatment of
HER2-negative, germline BRCA1/2-mutated breast cancer and non-small cell lung cancer, and Phase 2 studies for a variety of other cancers.
•
Niraparib
– Niraparib is an investigational PARP inhibitor being developed by Tesaro. It is currently in Phase 3 clinical trials for ovarian cancer and
BRCA+ breast cancer.
MDV9300
The development and commercialization of MDV9300 will face strong competition from other immuno-oncology agents which are currently approved and
on the market for certain indications and being developed for additional indications by larger companies with substantial resources and relatively more experience
developing, manufacturing, and commercializing biologic molecules. The immuno-oncology field is competitively crowded with more than 100 drug therapy
agents, including biologic molecules, vaccines, modified T-cells, and adjuvants, in development for various tumor types and patient populations by larger more
experienced companies than ours, such as Bristol Myers Squibb, Roche, AstraZeneca, Pfizer and Merck. Specifically in DLBCL, MDV9300’s development and
commercialization may face competition from Bristol Myers Squibb’s monoclonal antibody nivolumab (targeting PD-1), currently being studied in a potentially
registrational Phase 2 study in relapsed/refractory DLBCL patients.
12
gOvERNMENT
REgulATION
Government authorities in the United States, at the federal, state and local level, and in other countries extensively regulate, among other things, the
research, development, testing, manufacture, safety, storage, tracking, recordkeeping, approval, labeling, pricing, promotion and marketing, distribution, postapproval monitoring and reporting, sampling, and import and export of pharmaceutical products. A new drug must be approved by the FDA through the new drug
application, or NDA, process and a new biologic must be approved by the FDA through the biologics license application, or BLA, process before it can be legally
marketed in the United States.
Depending on the circumstances, violations of federal and state healthcare laws, including those described below, can result in penalties, including but not
limited to criminal, civil and/or administrative penalties, damages, fines, civil monetary penalties, disgorgement, individual imprisonment, the curtailment or
restructuring of operations, and exclusion from participation in federal healthcare programs, among others.
FDA
Approval
Process
In the United States, the FDA regulates drugs under the federal Food, Drug, and Cosmetic Act, or FDCA, and in the case of biologics, also under the Public
Health Service Act, or PHSA, and implementing regulations. Failure to comply with applicable U.S. law and regulations at any time during the product
development process, approval process, or after approval, may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to
approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls, product seizures, total or partial suspension of production
or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement, or civil penalties, and criminal prosecution. Any agency or judicial
enforcement action could have a material adverse effect on us. The process required by the FDA before a drug or biologic may be marketed in the United States
generally involves the following:
•
completion of preclinical laboratory tests, animal studies and formulation studies according to current Good Laboratory Practices or other applicable
regulations;
•
submission to the FDA of an investigational new drug application, or IND, which must become effective before human clinical trials may begin;
•
performance of adequate and well-controlled human clinical trials according to current Good Clinical Practices, or cGCP, to establish the safety and
efficacy of the proposed drug for its intended use;
•
submission to the FDA of an NDA or BLA after completion of all pivotal clinical trials;
•
satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the active pharmaceutical ingredient,
or API, and finished drug product is manufactured and tested to assess compliance with current Good Manufacturing Practices, or cGMP; and
•
FDA review and approval of the NDA or BLA prior to any commercial marketing or sale of the drug in the United States.
Before clinical testing can begin in humans, a sponsor must submit the results of the preclinical tests, together with manufacturing information and
analytical data, to the FDA as part of the IND. The sponsor will also include a protocol, detailing, among other things, the objectives of the first phase of the
clinical trials, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated, if applicable.
Clinical trials involve the administration of the investigational drug to healthy volunteers or patients under the supervision of a qualified investigator.
Clinical trials must be conducted: (a) in compliance with federal regulations; (b) in compliance with cGCP, an international standard meant to protect the rights and
health of patients and to define the roles of clinical trial sponsors, administrators, and monitors; as well as (c) under protocols detailing the objectives of the trial,
the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated. Each protocol involving testing on U.S. patients and subsequent
protocol amendments must be submitted to the FDA as part of the IND.
The FDA may order the temporary or permanent discontinuation of a clinical trial at any time, or impose other sanctions, if it believes that the clinical trial
either is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial patients. The study protocol and informed
consent information for patients in clinical trials must also be submitted to an institutional review board, or IRB, or Ethics Committee, or EC, for approval. An
IRB/EC may also require the clinical trial at the site to be halted, either temporarily or permanently, for failure to comply with the IRB/EC’s requirements, or may
impose other conditions.
Human clinical trials are typically conducted in three sequential phases, but the phases may overlap or be combined:
Phase
1:
The product candidate is initially introduced into healthy human subjects or patients with the target indication and tested for safety, dosage
tolerance, absorption, metabolism, distribution, and excretion, and, if possible, early evidence on effectiveness.
13
Phase
2:
The product candidate is administered to a limited patient population to identify possible adverse side effects and s afety risks, to preliminarily
evaluate the efficacy of the product candidate for specific target indication and to determine dosage tolerance and optimal dosage.
Phase
3:
When Phase 2 evaluations demonstrate that a dosage range of the drug is effective and has an acceptable safety profile, Phase 3 clinical trials are
undertaken to confirm the clinical efficacy from Phase 2 and to further test for safety in an expanded population at geographically dispersed clinical trial
sites.
In the United States, the results of product development, preclinical studies and clinical trials must be submitted to the FDA for review and approval prior to
marketing and commercial distribution of the product candidate. The NDA (for a drug) or BLA (for a biologic) must include a substantial amount of data and other
information concerning safety and effectiveness (for a drug) and safety, purity and potency (for a biologic) of the compound from laboratory, animal and clinical
testing, as well as data and information on manufacturing, product stability, and proposed product labeling.
Once an NDA or BLA is submitted for FDA approval, the FDA will accept the NDA or BLA for filing if deemed complete, thereby triggering substantive
review of the application. The FDA can refuse to file any NDA or BLA that it deems incomplete or not properly reviewable. The FDA has 60 days from its receipt
of an NDA or BLA to determine whether the application will be accepted for filing. NDAs or BLAs that are accepted for review will receive either standard or
priority review. Priority review can be applied to drugs that the FDA determines offer major advances in treatment, or provide a treatment in which no adequate
therapy exists. For biologics, priority review is further limited only for drugs intended to treat a serious or life-threatening disease relative to the currently approved
products. The FDA has established performance goals for the review of NDAs and BLAs: six months for priority applications and ten months for regular
applications, with two additional months added to each period for new molecular entities. However, the FDA is not legally required to complete its review within
these periods and these performance goals may change over time. Moreover, the outcome of the review, even if generally favorable, typically is not an actual
approval but a “complete response” letter that describes additional work that must be done before the application can be approved. The FDA’s review of an
application may involve review and recommendations by an independent FDA advisory committee. The FDA is not bound by the recommendation of an advisory
committee, but it generally follows such recommendations.
If the FDA approves a product, it will limit the approved therapeutic uses for the product as described in the product labeling, may require that
contraindications or warning statements be included in the product labeling, may require that additional studies or clinical trials be conducted following approval as
a condition of the approval, may impose restrictions and conditions on product distribution, prescribing or dispensing in the form of a risk evaluation and mitigation
strategy, or REMS, or may otherwise limit the scope of any approval. Under REMS, the FDA may impose significant restrictions on distribution and use of a
marketed product, may require the distribution of medication guides to patients and/or healthcare professionals or patient communication plans, and may impose a
timetable for submission of assessments of the effectiveness of REMS. Once issued, the FDA may withdraw a product approval if compliance with regulatory
standards is not maintained, including failure to conduct and submit post-marketing studies, or if problems are identified following initial marketing. The FDA may
also impose REMS after product approval, or require labeling changes. In addition, the FDA may require testing and surveillance programs to monitor the effect of
approved products that have been commercialized, and the agency has the power to prevent or limit further marketing of a product based on the results of the postmarketing programs.
The process of obtaining regulatory approvals and subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations require
the expenditure of substantial time and financial resources. Satisfaction of the above FDA requirements or similar requirements of state, local, and foreign
regulatory agencies typically takes several years or more and the actual time required may vary substantially, based on the type, complexity and novelty of the
product candidate. Government regulation may delay or prevent marketing of potential products for a considerable period of time or permanently and impose costly
procedures upon a company’s activities. Even if a product candidate receives regulatory approval, the approval may be significantly limited to specific indications.
Further, even after regulatory approval is obtained, later discovery of previously unknown problems with a product may result in restrictions on the product,
labeling changes or even complete withdrawal of the product from the market. Delays in obtaining, or failures to obtain and maintain, regulatory approvals would
harm our business.
Marketing our product candidates abroad will require similar regulatory approvals and is subject to similar risks. In addition, we cannot predict what adverse
governmental regulations may arise from future U.S. or foreign governmental action.
14
Abbreviated
New
Drug
Applications
and
Section
505(b)(2)
New
Drug
Applications
Once an NDA is approved, the product covered thereby becomes a listed drug. The NDA, in turn, can be relied upon by potential competitors in support of
approval of an abbreviated new drug application, or ANDA, or 505(b)(2) NDA. The FDA may approve an ANDA if the product is the same in important respects
as the listed drug or if the FDA has declared it suitable for an ANDA submission. In these situations, applicants must submit studies showing that the product is
bioequivalent to the listed drug, meaning that the rate and extent of absorption of the drug does not show a significant difference from the rate and extent of
absorption of the listed drug. ANDA applicants are not required to conduct or submit results of preclinical or clinical tests to prove the safety or effectiveness of
their drug product, other that the requirement for bioequivalence testing. Conducting bioequivalence testing is generally less time-consuming and costly than
conducting preclinical and clinical trials necessary to support an NDA. Drugs approved via ANDAs on the basis that they are the “same” as a listed drug are
commonly referred to as “generic equivalents” to the listed drug, and can often be and are substituted by pharmacists under prescriptions written for the original
listed drug.
In seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent with claims that cover the applicant’s product or
method of using the product. Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDA’s Approved Drug
Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. An ANDA applicant relying on a listed drug is required to certify to
the FDA concerning any patents for the listed drug product in the FDA’s Orange Book. Specifically, the applicant must certify with respect to each patent that:
(1) the required patent information has not been filed; (2) the listed patent has expired; (3) the listed patent has not expired, but will expire on a particular date and
approval is sought after patent expiration; or (4) the listed patent is invalid, unenforceable, or will not be infringed by the new product.
A certification that the proposed generic product will not infringe the already approved product’s listed patents, or that such patents are invalid or
unenforceable, is called a Paragraph IV certification. If the ANDA applicant does not challenge the listed patents or indicate that it is not seeking approval of a
patented method of use, the ANDA application will not be approved until all the listed patents claiming the referenced product have expired.
If the ANDA applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the
NDA and patent holders once the ANDA has been accepted for filing by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in
response to the notice of the Paragraph IV certification. The filing of a patent infringement lawsuit within 45 days of the receipt of a Paragraph IV certification
automatically prevents the FDA from approving the ANDA until the earlier of 30 months, expiration of the patent, settlement of the lawsuit, or a decision in the
infringement case that is favorable to the ANDA applicant.
The ANDA also will not be approved until any applicable non-patent exclusivity period, such as exclusivity for obtaining approval of a new chemical entity,
for the referenced product has expired, unless the exclusivity period protects an indication or other aspect of labeling that can be “carved out” of the labeling for the
proposed generic product. Federal law provides a period of five years following approval of a drug containing no previously approved active moiety during which
ANDAs for generic versions of those drugs cannot be submitted unless the submission contains a Paragraph IV challenge to a listed patent, in which case the
submission may be made four years following the original product approval. U.S. federal law provides for a period of three years of exclusivity during which the
FDA cannot grant effective approval of an ANDA if a listed drug contains a previously approved active moiety but FDA requires as a condition of approval new
clinical trials conducted by or for the sponsor. This three-year exclusivity period often protects changes to a previously approved product, such as a new dosage
form, route of administration, combination, or indication.
Most drug products obtain FDA marketing approval pursuant to an NDA or an ANDA. A third alternative is a special type of NDA, commonly referred to
as a Section 505(b)(2) NDA, which enables the applicant to rely, in part, on the FDA’s previous approval of a similar product, or published literature, in support of
its application. Section 505(b)(2) NDAs often provide an alternate path to FDA approval for new or improved formulations or new uses of previously approved
products. Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies not conducted by or for
the applicant and for which the applicant has not obtained a right of reference. If the Section 505(b)(2) applicant can establish that reliance on the FDA’s previous
approval is scientifically appropriate, it may eliminate the need to conduct certain preclinical or clinical studies of the new product. The FDA may also require
companies to perform additional studies or measurements to support the change from the approved product. The FDA may then approve the new product candidate
for all or some of the labeled indications for which the referenced product has been approved, as well as for any new indication(s) sought by the Section 505(b)(2)
applicant.
To the extent that the Section 505(b)(2) applicant is relying on studies conducted for an already approved product, the applicant is required to certify to the
FDA concerning any patents listed for the approved product in the Orange Book to the same extent that an ANDA applicant would be required to do so. As a result,
approval of a Section 505(b)(2) NDA can be prevented until all the listed patents claiming the referenced product have expired, until any non-patent exclusivity,
such as exclusivity for obtaining approval of a new chemical entity, listed in the Orange Book for the referenced product has expired, and, in the case of a
Paragraph IV certification and subsequent patent infringement suit, until the earlier of 30 months, settlement of the lawsuit or a decision in the infringement case
that is favorable to the Section 505(b)(2) applicant.
15
Biologics
Price
Competition
and
Innovation
Act
Under the Biologics Price Competition and Innovation Act, or BPCIA, enacted in the United States in 2010, the FDA has the authority to approve biosimilar
and interchangeable versions of previously-approved biological products through an abbreviated pathway following periods of data and marketing exclusivity.
Biosimilarity sufficient to reference a prior FDA-approved product requires that there be no differences in condition of use, route of administration, dosage form,
and strength, and no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency. In order to
meet the standards of interchangeability, a sponsor must demonstrate that the biosimilar product can be expected to produce the same clinical results as the
reference product, and for a product that is administered more than once, that the risk of switching between the reference product and the biosimilar product is not
greater than the risk of maintaining the patient on the reference product. Such biosimilars would reference biological products approved in the United States. The
law establishes a period of 12 years of data exclusivity for referenced products, which protects the data in the original BLA by prohibiting sponsors of biosimilars
from gaining FDA approval based in part on reference to data in the original BLA. Should we obtain product approvals under BLAs, those products could be
reference products for such abbreviated BLAs.
Post-Approval
Requirements
After a drug or biologic has been approved by the FDA for marketing, the FDA may require that certain post-approval requirements be satisfied, including
the conduct of additional clinical studies or post-marketing testing, known as Phase 4 testing, REMS, and surveillance to monitor the effects of an approved
product, or the FDA may place conditions on an approval that could restrict the distribution or use of the product and requires routine pharmacovigilance (postmarketing adverse event monitoring). We and Astellas are required to conduct an open-label safety study of XTANDI in patients with known risk factor(s) for
seizure and to report the results of that study to the FDA in 2019. In addition, holders of an approved NDA or BLA are required to (i) report certain adverse
reactions to the FDA and maintain pharmacovigilance programs to proactively look for these adverse events; (ii) comply with certain requirements concerning
advertising and promotional labeling for their products; and (iii) continue to have quality control and manufacturing procedures conform to cGMPs after approval.
If post-approval conditions are not satisfied, the FDA may withdraw its approval of the drug or biologic.
The FDA periodically inspects the sponsor’s records related to safety reporting and/or manufacturing facilities, including assessment of ongoing compliance
with cGMPs. Accordingly, manufacturers must continue to expend considerable time, money and effort in the areas of production and quality control to maintain
compliance with cGMP. Regulatory authorities may withdraw product approvals or request product recalls if a company fails to comply with regulatory standards,
if it encounters problems following initial marketing, or if previously unrecognized problems are subsequently discovered. In addition, prescription drug
manufacturers in the United States must comply with applicable provisions of the Drug Supply Chain Security Act and provide and receive product tracing
information, maintain appropriate licenses, ensure they only work with properly licensed entities, and have procedures in place to identify and properly handle
suspect and illegitimate products.
In the event of certain changes to an approved product, such as adding new indications, making certain manufacturing changes, or making certain additional
labeling claims, such changes are subject to further FDA review and approval. Approval for additional indications typically requires additional clinical studies to be
conducted and submitted through either a new or supplemental NDA.
Expedited
Review
and
Approval
The FDA has various programs, including Fast Track, Breakthrough Therapy Designation, priority review, and accelerated approval, which are intended to
expedite or simplify the process for reviewing drugs, and/or provide for approval on the basis of surrogate endpoints. Even if a drug qualifies for one or more of
these programs, the FDA may later decide that the drug no longer meets the conditions for qualification or that the time period for FDA review or approval will not
be shortened. Generally, drugs that may be eligible for these programs are those for serious or life-threatening conditions, those with the potential to address unmet
medical needs, and those that offer meaningful benefits over existing treatments. For example, Fast Track is a process designed to facilitate the development, and
expedite the review, of drugs to treat serious diseases and fill an unmet medical need. The request may be made at the time of IND submission and generally no
later than the pre-BLA or pre-NDA meeting. The FDA will respond within 60 calendar days of receipt of the request. Breakthrough Therapy Designation is
available for drugs that are intended to treat a serious condition where preliminary clinical evidence indicates that the drug may demonstrate substantial
improvement on a clinically significant endpoint(s) over available therapies. The request may be made at the time of IND submission and generally no later than
end-of-phase 2 meeting. The FDA will respond within 60 calendar days of receipt of the request. Breakthrough Therapy Designation conveys all of the Fast Track
program features along with more intensive FDA guidance and interaction and eligibility for rolling review and priority review. Priority review, which is requested
at the time of BLA or NDA submission, is designed to give drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists an
initial review within six months as compared to a standard review time of ten months. Although Fast Track, Breakthrough Therapy Designation and priority review
do not affect the standards for approval, the FDA will attempt to expedite review of the application. Accelerated approval provides an earlier approval of drugs to
treat serious diseases, and that fill an unmet medical need based on a surrogate endpoint, which is a laboratory measurement or physical sign used as an indirect or
substitute measurement representing a clinically meaningful outcome.
16
Discussions with the FDA about the feasibility of an accelerated approval typically begin early in the development of the drug in order to identify, among other
things, an appropriate endpoint. As a condition of approval , the FDA may require that a sponsor of a drug receiving accelerated approval perform post-marketing
clinical trials to confirm the appropriateness of the surrogate marker trial.
Orphan
Drug
Designation
and
Exclusivity
Under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is generally a disease
or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000 individuals in the United States and for which there is no
reasonable expectation that the cost of developing and making available in the U.S. a drug for this type of disease or condition will be recovered from sales in the
United States for that drug. Orphan drug designation must be requested before submitting an NDA or BLA. After the FDA grants orphan drug designation, the
identity of the therapeutic agent and its potential orphan use will be disclosed publicly by the FDA; the posting will also indicate whether a drug is no longer
designated as an orphan drug. More than one product candidate may receive an orphan drug designation for the same indication. Orphan drug designation does not
convey any advantage in or shorten the duration of the regulatory review and approval process.
If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is
entitled to seven years of orphan product exclusivity. During the seven-year exclusivity period, the FDA may not approve any other applications to market a drug
or biological product containing the same active moiety for the same disease, except in very limited circumstances, such as a showing of clinical superiority to the
product with orphan drug exclusivity. A product is clinically superior if it is safer, more effective or makes a major contribution to patient care. Thus, orphan drug
exclusivity could block the approval of one of our products for seven years if a competitor obtains approval of the same drug as defined by the FDA and we are not
able to show the clinical superiority of our drug or if our product candidate’s indication is determined to be contained within the competitor’s product orphan
indication. In addition, the FDA will not recognize orphan drug exclusivity if a sponsor fails to demonstrate upon approval that the drug is clinically superior to a
previously approved drug containing the same active moiety for the same orphan condition, regardless of whether or not the approved drug was designated an
orphan drug or had orphan drug exclusivity.
Data
Privacy
and
Security
Regulations
We are also subject to laws and regulations regarding the privacy and security of health-related and other personal information. The Health Insurance
Portability and Accountability Act, or HIPAA, as amended by the Health Information Technology and Clinical Health Act, or HITECH, and its implementing
regulations, imposes certain federal requirements relating to the privacy, security and transmission of individually identifiable health information. We are also
subject to other state and federal privacy and security laws that are not specific to the healthcare industry, such as the Federal Trade Commission’s enforcement of
Section 5 of the Federal Trade Commission Act and state security breach notification laws. The EU Data Protection Directive, as implemented into national laws
by the EU member states, imposes strict obligations and restrictions on the ability to collect, analyze and transfer personal data, including health data from clinical
trials and adverse event reporting. Failing to comply with these laws could lead to government enforcement actions and significant penalties against us, and
adversely impact our operating results.
Advertising
and
Promotion
Any products distributed by us pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including advertising and
promotion restrictions. The FDA’s rules for advertising and promotion require, among other things, that we do not promote our products for unapproved uses and
that our promotion be fairly balanced and adequately substantiated by clinical studies. The FDA closely regulates the post-approval marketing and promotion of
drugs, including but not limited to, standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational
activities and promotional activities involving the internet. The FDA also enforces the requirements of the Prescription Drug Marketing Act, or PDMA, which,
among other things, imposes various requirements in connection with the distribution of product samples to physicians.
Drugs may be marketed only for the approved indications and in accordance with the provisions of the approved labeling. Changes to some of the
conditions established in an approved application, including changes in indications, labeling, or manufacturing processes or facilities, require submission and FDA
approval of a new or supplemental NDA or BLA before the change can be implemented. An NDA or BLA supplement for a new indication typically requires
clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing supplements as it does in reviewing NDAs
and BLAs.
17
A
nti-Kickback
Statutes,
Sunshine
Act,
and
Federal
False
Claims
Act
Our business activities, including, but not limited to, research, sales, marketing, promotion, distribution, medical education and other activities are subject to
regulation by numerous regulatory and enforcement authorities in the United States and abroad. Government officials have focused their enforcement efforts on
marketing of health care services and products, among other activities, and recently have brought cases against companies, and certain sales, marketing, and
executive personnel, for allegedly offering unlawful inducements to potential or existing customers in an attempt to procure their business.
The Anti-Kickback Statute prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving, or providing
remuneration, directly or indirectly, in cash or in kind, in exchange for or to induce either the referral of an individual, or the furnishing or arranging for a good or
service, for which payment may be made under a federal health care program such as Medicare or Medicaid. The definition of “remuneration” has been broadly
interpreted to include anything of value, including for example gifts, certain discounts, the furnishing of free supplies, equipment or services, credit arrangements,
payment of cash and waivers of payment. Liability under the Anti-Kickback Statute may be established without a person or entity having actual knowledge of the
statute or specific intent to violate it. Penalties include criminal penalties and civil sanctions such fines, imprisonment, and possible exclusion from Medicare,
Medicaid and other federal health care programs.
Many states also have statutes or regulations similar to the Anti-Kickback Statute. Some of these state provisions apply to referral of patients for health care
items or services reimbursed by any source, not only the Medicare and Medicaid programs.
Another development affecting the health care industry is the increased use of the Federal False Claims Act, or FFCA, and, in particular, action brought
pursuant to the FFCA’s “whistleblower” or “qui tam” provisions. The FFCA imposes liability on any person or entity who, among other things, knowingly presents
or causes to be presented a false or fraudulent claim for payment by the federal government, including a federal health care program, such as Medicare and
Medicaid. The qui tam provisions of the FFCA allow a private individual to bring actions on behalf of the federal government alleging that the defendant has
submitted a false claim to the federal government, and to share a proportion of any monetary recovery. In recent years, the number of suits brought against health
care providers and entities by private individuals has increased dramatically. In addition, various states now have enacted false claims laws analogous to the FFCA,
although many of these state laws apply where a claim is submitted to any third-party payor, including private insurance companies, and not merely a federal health
care program.
When a person or entity is determined to have violated the FFCA, it may be required to pay up to three times the actual damages sustained by the
government, plus civil penalties. Liability arises primarily when an entity knowingly submits or causes another to submit a false claim for reimbursement to the
federal government. The federal government has used the FFCA to assert liability on, among other things, the basis of inadequate care, kickbacks, and other
improper referrals, and the improper use of Medicare numbers when detailing the provider of services, in addition to the more predictable allegations as to
misrepresentations with respect to the services rendered. In addition, the federal government has prosecuted companies under the FFCA in connection with offlabel promotion of products. We are unable to predict whether we will be subject to actions under the FFCA or a similar state law, or the impact of such actions.
However, the costs of defending such claims, as well as any sanctions imposed, could significantly impact our financial performance.
Additionally, the civil monetary penalties statute imposes penalties against any person or entity that, among other things, is determined to have presented or
caused to be presented a claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is
false or fraudulent.
HIPAA created new federal criminal statutes that prohibit, among other actions, knowingly and willfully executing or attempting to execute a scheme to
defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program,
willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making
any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Like the federal AntiKickback Statute, liability may be established without a person or entity having actual knowledge of the statute or specific intent to violate it.
We and our business activities are also subject to the federal Physician Payments Sunshine Act which requires certain manufacturers of drugs, devices,
biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to
report information related to certain payments or other transfers of value provided to physicians and teaching hospitals, or to entities or individuals at the request of,
or designated on behalf of, the physicians and teaching hospitals and to report annually certain ownership and investment interests held by physicians and their
immediate family members. The reported information is made publicly available by the Centers for Medicare and Medicaid Services on a searchable website. We
are current on all required submissions of information related to the federal Physician Payments Sunshine Act.
18
If our operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, including state laws
that are similar to the aforementioned federal laws, we may be subject to penalties, including witho ut limitation, civil, criminal and/or administrative penalties,
damages, fines, disgorgement, exclusion from participation in government programs, such as Medicare and Medicaid, injunctions, refusal to allow us to enter into
government contracts, contractu al damages, reputational harm, administrative burdens, diminished profits and future earnings, and the imposition of a Corporate
Integrity Agreement or similar government oversight program or curtailment or restructuring of our operations, any of which cou ld adversely affect our ability to
operate our business and our results of operations.
Foreign
Corrupt
Practices
Act
The Foreign Corrupt Practices Act of 1977, as amended, or FCPA, prohibits U.S. companies and their representatives from offering, processing,
authorizing or making payments to foreign officials for the purpose of obtaining or retaining business abroad. In many countries, the health care professionals we
regularly interact with may meet the definition of a foreign government official for the purposes of the FCPA. The FCPA also requires public companies to make
and keep books and records that accurately and fairly reflect their transactions and to devise and maintain an adequate system of internal accounting controls. Our
international activities create the risk of unauthorized payments or offers of payments by our employees, consultants and agents, even though they may not always
be subject to our control. We discourage these practices by our employees, consultants, and agents. However, our existing safeguards may prove to be less than
effective, and our employees, consultants and agents may engage in conduct for which we might be held responsible.
Pharmaceutical
Coverage,
Pricing
and
Reimbursement
Sales of XTANDI and any future products of ours are dependent in significant part on the availability of coverage and adequate reimbursement from thirdparty payors, including federal and state programs such as Medicare and Medicaid, and private organizations such as commercial health insurance and managed
care companies. Astellas is responsible for negotiating favorable coverage determinations and adequate reimbursement rates with third-party payors for XTANDI.
Although there are currently no direct government price controls over private sector purchases in the United States, federal legislation requires
pharmaceutical manufacturers to pay prescribed rebates on certain drugs to enable them to be eligible for reimbursement under certain public healthcare programs
such as Medicaid. Various states have adopted further mechanisms under Medicaid and other programs that seek to control drug prices, including by disfavoring
certain higher priced drugs and by seeking supplemental rebates from manufacturers. Managed care has also increased downward pressure on the prices of
pharmaceutical products.
Third-party payors are increasingly challenging the prices charged for medical products and services and examining the medical necessity and costeffectiveness of medical products and services, in addition to their safety and efficacy. If these third-party payors do not consider our products to be cost-effective
compared to other available therapies, they may not cover our products after approval as a benefit under their plans or, if they do, the level of payment may not be
sufficient to allow us to sell our products at a profit. Third-party payors may provide coverage but place stringent limitations on such coverage, such as requiring
alternative treatments to be tried first. The U.S. government, state legislatures and foreign governments have shown significant interest in implementing costcontainment programs to limit the growth of government-paid health care costs, including price controls, restrictions on reimbursement and requirements for
substituting generic equivalents for branded prescription drugs. Adoption of such controls and measures and tightening of existing policies could limit payments for
our products and could adversely affect our business.
Different pricing and reimbursement schemes exist in other countries. For example, in the European Union, some governments influence the price of
pharmaceutical products through reference pricing approaches to pharmaceutical reimbursement for national healthcare systems that fund a large part of the cost of
such products to consumers. The approach taken varies from member state to member state. Some jurisdictions operate positive and/or negative list systems under
which products may only be marketed once a reimbursement price has been agreed. Other member states allow companies to fix their own prices for medicines, but
monitor and control company profits and may limit or restrict reimbursement. The downward pressure on healthcare costs in general, particularly prescription
drugs, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products, as exemplified by the National Institute for
Health and Care Excellence, or NICE, in the United Kingdom which evaluates the data supporting new medicines and passes reimbursement recommendations to
the government. In addition, in some countries cross-border imports from low-priced markets (parallel imports) exert commercial pressure on pricing within a
country.
19
Foreign
Regulations
In addition to regulation in the United States, we are subject to a variety of foreign regulations governing clinical trials and commercial sales and
distribution of products. Whether or not we obtain FDA approval for a drug candidate, we must obtain approval by the comparable regulatory authorities of foreign
countries and economic areas, such as the European Union, before we can commence clinical trials or market products in those countries or areas. The approval
process and requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from place to place, and the time may
be longer or shorter than that required for FDA approval.
Other
Applicable
Laws
We are also subject to various other federal, state and local laws, including laws regarding working conditions and the storage, transportation, or discharge
of items that may be considered hazardous substances, hazardous waste, or environmental contaminants. We monitor our compliance with laws on an ongoing
basis.
As a publicly-traded company, we are also subject to significant regulations and laws, including the Sarbanes-Oxley Act of 2002. Since its enactment, we
have developed and instituted a corporate compliance program based on what we believe are current best practices and we continue to update the program in
response to newly implemented or changing regulatory requirements.
MANuFACTuRINg
Pursuant to the Astellas Collaboration Agreement, Astellas has global manufacturing responsibility for XTANDI as currently formulated. Astellas intends to
fulfill clinical and commercial requirements of XTANDI largely through third-party contract manufacturers.
We are a party to agreements with contract manufacturers for clinical supply of drug substances and drug products for our MDV3800 and MDV9300
programs. These agreements are managed by professionals within our organization who have expertise in pharmaceutical and biologic manufacturing, product
development, regulatory compliance, quality assurance, and supply chain management. We may further expand our capabilities.
We currently do not have specific plans to imminently develop our own manufacturing operations.
OuR
FINANCIAl
hISTORy
We had net income of $244.7 million for the year ended December 31, 2015. Our 2015 results benefited from $245.0 million of milestones earned from
Astellas as a result of the achievement of defined sales milestone events. As of December 31, 2015, we have earned all development and sales milestone payments
under the Astellas Collaboration Agreement. In 2014, we earned sales and development milestones in excess of $300.0 million under the agreement. We have a
history of net losses since our inception through 2013, and we have only now achieved two sequential years of profitability.
A significant portion of our operating expense is related to research and development, and we intend to maintain our strong commitment to research and
development. Our research and development activities currently include activities related to enzalutamide, MDV3800, MDV9300 and early stage programs. For the
years ended December 31, 2015, 2014, and 2013, we recorded $232.1 million, $189.6 million, and $119.0 million, respectively, of research and development
expenses representing 44%, 44%, and 40% of total operating expenses for the years ended December 31, 2015, 2014, and 2013, respectively.
We anticipate that we will incur higher operating costs in the foreseeable future in order to continue to commercialize XTANDI in the U.S. market, to
conduct clinical and preclinical studies of enzalutamide, MDV3800, MDV9300 and early-stage programs, to carry out potential business development activities,
and to provide expanded facilities to support our growth. We have funded our operations in prior years primarily through public offerings of our common stock, the
issuance of 2.625% convertible senior notes due April 1, 2017, or the Convertible Notes (which we redeemed in July 2015 and are no longer outstanding). More
recently, we funded our cash requirements from collaboration revenue associated with the global growth of XTANDI and, to a lesser extent, from short-term
borrowings under our Revolving Credit Facility. The portion of collaboration revenue derived from sales and development milestones earned from Astellas
exceeded $550.0 million in the two calendar years just completed.
EMPlOyEES
At December 31, 2015, we had 628 full-time employees, none of whom are represented by labor unions or covered by collective bargaining agreements. We
consider our relationships with our employees to be good.
20
ABOuT
MEdIvATION,
INC.
We are a corporation formed in Delaware in October 1995, under our former name, Orion Acquisition Corp. II. We, together with our subsidiaries, operate
in one business segment. All of our revenue is currently derived from our collaboration agreement with Astellas. Our long-lived assets are primarily located in the
United States, except for certain de minimus laboratory equipment. Information regarding our collaboration agreement revenue, profit or loss, and total assets is
included in our audited consolidated financial statements in Part II, Item 8 of this Annual Report.
AvAIlABlE
INFORMATION
We file or furnish electronically with the Securities and Exchange Commission, or SEC, our annual reports on Form 10-K, quarterly reports on Form 10-Q,
current reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act. The SEC maintains a
website that contains reports, proxy and information statements and other information regarding our filings at www.sec.gov . You may also read and copy any of
our materials filed with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549. Information regarding the operation of the
Public Reference Room can be obtained by calling the SEC at 1-800-SEC-0330.
We make available on or through our website at www.medivation.com , free of charge, copies of these reports as soon as reasonably practicable after we
electronically file such material with, or furnish it to, the SEC. Information found on, or that can be accessed through, our website is not incorporated by reference
into this Annual Report.
Item
1A.
Risk
Factors.
Our
business
faces
significant
risks,
some
of
which
are
set
forth
below
to
enable
readers
to
assess,
and
be
appropriately
apprised
of,
many
of
the
risks
and
uncertainties
applicable
to
the
forward-looking
statements
made
in
this
Annual
Report.
You
should
carefully
consider
these
risk
factors
as
each
of
these
risks
could
adversely
affect
our
business,
operating
results,
cash
flows
and
financial
condition.
If
any
of
the
events
or
circumstances
described
in
the
following
risk
factors
actually
occurs,
our
business
may
suffer,
the
trading
price
of
our
common
stock
could
decline
and
our
financial
condition
or
results
of
operations
could
be
harmed.
Given
these
risks
and
uncertainties,
you
are
cautioned
not
to
place
undue
reliance
on
forward-looking
statements.
These
risks
should
be
read
in
conjunction
with
the
other
information
set
forth
in
this
Annual
Report.
The
risks
and
uncertainties
described
below
are
not
the
only
ones
we
face.
Additional
risks
and
uncertainties
not
currently
known
to
us,
or
that
we
currently
believe
to
be
immaterial,
may
also
adversely
affect
our
business.
Risks
Related
to
XTANdI
®
(enzalutamide)
capsules
We
and
Astellas
may
not
be
able
to
further
commercialize
XTANDI
in
the
United
States,
and
may
fail
to
continue
to
generate
significant
revenue
from
the
sale
of
XTANDI
in
the
United
States.
XTANDI
may
fail
to
obtain
regulatory
approval
and
reimbursement,
to
be
successfully
commercialized
and
to
generate
significant
revenue
outside
the
United
States.
We only have one commercial product, XTANDI ® (enzalutamide) capsules, or XTANDI, which is approved in the United States to treat men with
metastatic castration-resistant prostate cancer, or mCRPC. However, the further commercialization of XTANDI in the United States for the treatment of mCRPC
and any other patient populations for which XTANDI is being developed and may subsequently be approved, may not be successful for a number of reasons,
including:
•
we and our collaboration partner, Astellas Pharma, Inc., or Astellas, may not be able to establish or demonstrate in the medical community the safety
and efficacy of XTANDI and its potential advantages over, and side effects compared to, competing therapeutics and products currently in clinical
development for each applicable patient population;
•
our limited experience in marketing XTANDI to urologists;
•
reimbursement and coverage policies of government and private payors such as Medicare, Medicaid, insurance companies, health maintenance
organizations and other plan administrators;
•
the price of XTANDI as compared to alternative treatment options;
•
changes or increases in regulatory restrictions;
•
changes to the label for XTANDI that further restrict how we and Astellas market XTANDI, including as a result of routine pharmacovigilance
activities and/or data collected from the safety study in patients with known risk factor(s) for seizure that the FDA required us to undertake as a postmarketing requirement or from any other ongoing or future studies;
•
we and Astellas may not have adequate financial or other resources to successfully commercialize XTANDI; and
•
we and Astellas may not be able to obtain adequate commercial supplies of XTANDI to meet demand or at an acceptable cost.
21
If the further commercialization of XTANDI in the United States is unsuccessful, our ability to generate revenue from product sales and maintain
profitability would be adversely affected and our business could be severely negatively impacted.
XTANDI has received marketing approval in the European Union (or Europe, or EU) for the treatment of patients with mCRPC and in Japan for the
treatment of patients with castration-resistant prostate cancer, and numerous other countries worldwide for the treatment of patients with mCRPC. Additional
marketing applications for the mCRPC indication are under review in numerous other countries. Unless we and Astellas can obtain additional regulatory approval
and reimbursement of XTANDI outside the United States, Japan and the EU, Astellas’ ability to successfully commercialize XTANDI further and our ability to
generate additional revenue from XTANDI worldwide, could be significantly limited.
XTANDI
may
fail
to
effectively
compete
commercially
with
other
approved
products
and
other
products
in
development.
There are a number of currently marketed therapies for advanced prostate cancer that compete directly with XTANDI. In addition, several companies are
currently developing products or are expected to be marketing products in the near future that compete or may compete directly with XTANDI in its currently
approved indication for mCRPC and any other indication for which enzalutamide may be subsequently approved. Our current and future competitors are generally
large pharmaceutical companies with considerably greater financial, human, and development and commercialization resources and experiences than ours,
including Johnson & Johnson, Sanofi, and Bayer Pharma AG. Some competitive drugs already have acquired substantial shares in these markets or are generic
which may make it more difficult for us to compete successfully in these markets notwithstanding any positive results that we may generate from our current or
potential future clinical trials for enzalutamide. Also, intense competition from products and compounds in development could impact our ability to successfully
conduct upstream clinical trials, as trials may become more difficult to enroll, or complete successfully, as patients may have more treatment options with
demonstrated efficacy and safety. Factors upon which XTANDI would have to compete successfully include efficacy, safety, price and cost effectiveness. We
cannot guarantee that we and Astellas will be able to compete successfully in the context of any of these factors.
Pricing
pressure
from
third
parties
and
price
competition
could
substantially
impact
Astellas’
or
our
ability
to
generate
revenue
from
XTANDI
and,
therefore,
negatively
impact
our
business.
The realized price of XTANDI could be subject to pricing pressure from aggressive competitive pricing activity and managed care organizations and
institutional purchasers, who use cost considerations to restrict the sale of preferred drugs that their physicians may prescribe. To the extent that payors believe
similar lower-priced, branded or generic competitor products may be suitable alternatives for patients, we and our partner Astellas may consider reducing the price
of XTANDI or be subject to formulary restrictions, which could result in a loss of sales revenue and/or market share. Additionally, XTANDI currently competes
against products and could compete in the future with products marketed by some of the world’s largest and most experienced pharmaceutical companies, such as
Johnson & Johnson, who have more resources and greater flexibility to engage in aggressive price competition in order to gain revenues and market share. It is
uncertain whether we and Astellas could successfully compete with such competition and our failure to compete or a decision to reduce the price of XTANDI in
order to compete could severely impact our business.
Moreover, non-profit groups have recently petitioned the U.S. federal government to exercise their “march-in” rights under the Bayh-Dole Act due to the
difference in price of XTANDI in the U.S. versus abroad since certain patents which cover XTANDI were allegedly developed with federal funding. While the
government has yet to exercise its march-in rights in response to pricing pressures or shortage problems, it may do so in the future which would significantly
negatively impact our ability to generate revenue from XTANDI.
Competition
from
other
approved
products,
including
those
that
mechanistically
operate
similarly
to
XTANDI,
could
negatively
impact
the
expected
use
or
duration
of
therapy
of
XTANDI,
and
impact
our
ability
to
generate
revenue.
We are competing and will continue to compete against drugs that operate similarly to XTANDI. If XTANDI is unable to successfully compete for a
position in the prostate cancer treatment paradigm ahead of drugs like Zytiga and/or potentially apalutamide (formerly JNJ-56021927, or JNJ-927, and ARN-509),
which are now being investigated in Phase 3 clinical studies in earlier stage prostate cancer, sales of XTANDI may be negatively impacted. In addition, the
availability of multiple other approved agents to treat the same patients being treated with XTANDI could cause treating physicians to switch patients off of
XTANDI and onto competing therapies more quickly than would otherwise be the case, which could also negatively impact XTANDI net sales.
Competition
from
generic
products
could
potentially
harm
our
business
and
result
in
a
decrease
in
our
revenue.
Like other branded pharmaceutical companies, we face competition from generic products that could potentially harm our business and result in a decrease
in our revenue. Such competition may arise from the loss or expiration of intellectual property rights on enzalutamide or a competitor product, or the approval by
the FDA of a generic of our product or a competitor product, such as Zytiga, any of which could adversely affect our business by putting downward pressure on the
price and market share of XTANDI. Generic products for the treatment of prostate cancer that have already been approved by the FDA, e.g., Casodex, are generally
sold at a lower price than branded drugs. Furthermore, Abbreviated New Drug Applications (ANDAs) requesting approval
22
for generic versions of Zytiga were submitted to the FDA on April 28, 2015. See the risk factor below entitled, “Risks Related to the Pharmaceutical Industry,
Including the Activities of Me divation, Inc.— If the FDA or other applicable regulatory authorities approve generic products that compete with any of our
products or product candidates, the sales of our products or product candidates may be adversely affected,” for additional informati on regarding general risks
related to generic and biosimilar competition in our industry.
We
have
recently
increased
our
promotional
efforts
and
focus
in
the
United
States
to
include
urologists
as
well
as
oncologists.
If
we
are
not
successful
in
marketing
XTANDI
to
these
physician
audiences,
the
commercial
potential
of
XTANDI
may
not
be
realized.
We have recently increased promotional efforts in the United States to include urologists as well as oncologists as a result of the expanded label of XTANDI
in the United States to treat mCRPC patients who have not yet received chemotherapy (September 2014). Our efforts include expanding and dividing our sales
force into urology- and oncology-focused teams. Failure to successfully commercialize XTANDI to urologists and oncologists would have a negative impact on our
business and future prospects.
We
are
dependent
upon
our
collaborative
relationship
with
Astellas
to
further
develop,
fund,
manufacture
and
commercialize
XTANDI,
and
if
such
relationship
is
unsuccessful,
or
if
Astellas
terminates
our
collaboration
agreement
with
them,
it
could
negatively
impact
our
ability
to
conduct
our
business
and
generate
revenue
from
XTANDI.
Under our collaboration agreement with Astellas, Astellas is responsible for developing, seeking regulatory approval for, and commercializing XTANDI
outside the United States and is responsible globally for all manufacture of product for both clinical and commercial purposes. We and Astellas are jointly
responsible for commercializing XTANDI in the United States. We and Astellas share equally the costs (subject to certain exceptions), profits and losses arising
from development and commercialization of XTANDI in the United States. For clinical trials useful both in the United States and in Europe or Japan, we are
responsible for one-third of the total costs and Astellas is responsible for the remaining two-thirds. We are subject to a number of risks associated with our
dependence on our collaborative relationship with Astellas, including:
•
Astellas’ right to terminate the collaboration agreement with us on limited notice for convenience (subject to certain limitations), or for other reasons
specified in the collaboration agreement;
•
the need for us to identify and secure on commercially reasonable terms the services of third parties to perform key activities currently performed by
Astellas in the event that Astellas were to terminate its collaboration with us, including development and commercialization activities outside of the
United States and manufacturing activities globally;
•
adverse decisions by Astellas regarding the amount and timing of resource expenditures for the commercialization of XTANDI;
•
adverse decisions by Astellas regarding whether or not to initiate claims or litigation against third parties for infringement of proprietary rights
protecting XTANDI or to determine the scope and validity of proprietary rights covering XTANDI or proprietary rights held by competitors;
•
failure by Astellas to negotiate favorable coverage determinations and adequate reimbursement rates with third-party payors;
•
decisions by Astellas to prioritize other of its present or future products more highly than XTANDI for either development and/or commercial
purposes;
•
possible disagreements with Astellas as to the timing, nature and extent of our development plans, including clinical trials or regulatory approval
strategy, which if we disagree could significantly delay or halt development of XTANDI; and
•
the financial returns to us, if any, under our collaboration agreement with Astellas, depend in large part on the generation of product sales, and if
Astellas fails to perform or satisfy its obligations to us, the development or commercialization of XTANDI would be delayed or may not occur and
our business and prospects could be materially and adversely affected.
Due to these factors and other possible disagreements with Astellas, we may be delayed or prevented from further developing, manufacturing or
commercializing XTANDI or we may become involved in litigation or arbitration, which would be time consuming and expensive. For example, we understand
that Astellas has not made a final decision on the phase 3 clinical trial evaluating enzalutamide in triple negative breast cancer.
If Astellas were to terminate our collaborative relationship unilaterally, we would need to undertake development and commercialization activities for
XTANDI solely at our own expense and/or seek one or more other partners for some or all of these activities, worldwide. If we pursued these activities on our own,
it would significantly increase our capital and infrastructure requirements, might limit the indications we are able to pursue for XTANDI, and could prevent us
from effectively commercializing XTANDI. If we sought to find one or more other pharmaceutical company partners for some or all of these activities, we may not
be successful in such efforts, or they may result in collaborations that have us expending greater funds and efforts than our current relationship with Astellas.
23
We
are
dependent
on
third-party
manufacturers
for
commercial
supply
of
XTANDI
and
for
clinical
trial
materials
and
if
we
fail
to
receive
such
adequate
supplies,
global
sales
of
XTANDI
could
be
limited
and
clinical
trials
could
be
delayed.
We require adequate supplies of enzalutamide for commercial supply of XTANDI, and for use in clinical trials. Under our collaboration agreement, Astellas
has the responsibility to manufacture commercial supplies of XTANDI for all markets and provide material for clinical studies. Astellas fulfills its manufacturing
and supply obligations largely through third-party contract manufacturers. Consequently, we are, and expect to remain, dependent on Astellas and its contract
manufacturers for commercial and clinical trial materials. If Astellas cannot provide the materials on a timely basis due to, for example, raw materials availability,
quality issues or failure of the contracting facilities to perform, it could result in decreased sales or put at risk ongoing clinical studies. If Astellas or its contract
manufacturers do not perform, we may be forced to incur additional expenses, delays, or both, to arrange or take responsibility for contract manufacturers to
manufacture or package XTANDI or enzalutamide on our behalf, as we do not have any internal manufacturing or packaging capabilities.
We also rely on our own third-party vendors for clinical supplies. If clinical supplies cannot be provided on a timely basis it could put at risk our sponsored
clinical studies with XTANDI or enzalutamide.
In some instances, we and Astellas are dependent on third-party suppliers of raw materials, intermediates or finished goods of commercial supplies of
XTANDI and clinical trial materials. If any of these suppliers or subcontractors fails to meet our or Astellas’ needs, we may not have readily available alternatives.
If we or Astellas experience a material supplier or subcontractor inability to supply, our ability to satisfactorily and timely complete our clinical trial or delivery
obligations could be negatively impacted which could result in reduced sales, termination of contracts and damages to our relationships with clinical trial sites and
the medical community. We could also incur additional costs to address and resolve such an issue. Any of these events could have a negative impact on our results
of operations and financial condition.
We
are
dependent
on
Astellas
to
distribute
and
sell
XTANDI,
and
if
Astellas
fails
to
adequately
perform
these
activities,
our
business
would
be
negatively
impacted.
Under our collaboration agreement with Astellas, we and Astellas have the right to jointly promote XTANDI to customers in the United States. However,
Astellas has the sole right to distribute and sell XTANDI to customers in the United States and the sole right to promote, distribute and sell XTANDI to customers
outside the United States. We are thus partially dependent on Astellas to successfully promote XTANDI in the United States, and solely dependent on Astellas to
successfully distribute and sell XTANDI in the United States and to promote, distribute and sell XTANDI outside of the United States. In the United States, we
depend on customer support from specialty pharmaceutical distributors and wholesalers in Astellas’ network. Astellas has contracted with a limited number of
specialty pharmaceutical distributors and wholesalers to deliver XTANDI to end users. The use of specialty pharmacies and wholesalers requires significant
coordination with Astellas’ sales and marketing, medical affairs, regulatory affairs, legal and finance organizations and involves risks, including but not limited to
risks that these specialty pharmacies and wholesalers will:
•
not provide Astellas accurate or timely information regarding their inventories, patient- or account-level data or safety complaints regarding
XTANDI;
•
not effectively sell or support XTANDI;
•
not devote the resources necessary to sell XTANDI in the volumes and within the timeframes that we expect; or
•
cease operations.
We generally do not have control over the resource or degree of effort that any of the specialty pharmacies and distributors may devote to XTANDI, and if
their performance is substandard, this will adversely affect sales of XTANDI. If Astellas’ network of specialty pharmacies and distributors fails to adequately
perform, it could negatively impact sales of XTANDI, which would negatively impact our business, results of our operations, cash flows and liquidity.
XTANDI
may
not
be
commercially
successful
if
not
widely
covered
and
appropriately
reimbursed
by
third-party
payors,
and
we
are
dependent
upon
Astellas
for
the
execution
of
third-party
payor
access
and
reimbursement
strategies
for
XTANDI.
Our ability to successfully commercialize XTANDI for its approved indications depends, in part, on the extent to which coverage and adequate
reimbursement for XTANDI is available from government and health administration authorities, private health insurers, managed care programs and other thirdparty payors, both in the United States and globally.
24
In addition, even if third-party payors ultimately elect to cover and reimburse XTANDI, most payors will not reimburse 100% of the cost, but rather require
patients to pay a portion of the cost through a c o-payment. Thus, even if reimbursement is available, the percentage of drug cost required to be borne by patients
may make use of XTANDI financially difficult or impossible for certain patients, which would have a negative impact on sales of XTANDI. For ex ample, in the
United States there exists a coverage gap, or “donut hole”, in the Medicare Part D coverage for prescription medications for participants, which renews annually
each January 1st. While in the donut hole, Medicare Part D participants, includin g many patients in XTANDI’s approved indication, may have to pay out-ofpocket a substantial portion of their prescription drug costs, which may discourage physicians from prescribing or patients from accessing XTANDI. It is
increasingly difficult to obtai n coverage and adequate reimbursement levels from third-party payors, and we may be unable to achieve these objectives. Moreover,
our commercial prospects would be further weakened if payors approve coverage for XTANDI only as second- or later-line treatme nts, or if they place XTANDI
in tiers requiring unacceptably high patient co-payments. Since launch, several third-party payors have included in their coverage criteria use of XTANDI after
patient treatment on Zytiga plus prednisone or if there is a contra -indication to prednisone or Zytiga. These coverage situations may persist even with expanded
indications for XTANDI. Because XTANDI works via a similar molecular signaling pathway as Zytiga does, patients who have already failed treatment with
Zytiga may not have as strong a response on XTANDI as would patients who are Zytiga-naïve. Failure to overturn coverage decisions or stop additional coverage
decisions could materially harm our (or our partner’s) ability to successfully market XTANDI in the United St ates. Achieving coverage and acceptable
reimbursement levels typically involves negotiating with individual payors and is a time-consuming and costly process. Therefore, obtaining acceptable coverage
and reimbursement from one payor does not guarantee simi lar acceptable coverage or reimbursement from another payor. Additionally, even if favorable coverage
and adequate reimbursement levels are achieved, the payor may change its decision in the future. We are dependent upon Astellas globally for the achieveme nt of
such coverage and acceptable reimbursement, and for negotiation with individual payors.
We
and
Astellas
are
required
to
undertake
certain
studies
to
comply
with
post-marketing
requirements
or
commitments
in
the
EU
and
the
United
States,
which
could
result
in
adverse
modifications
to
XTANDI’s
existing
labeling,
and
risk
XTANDI’s
ability
to
obtain
additional
regulatory
approvals
for
additional
patient
populations.
In the EU, we and Astellas are required to collect efficacy data on mCRPC patients previously treated with Zytiga to determine XTANDI’s efficacy
response in such patients, which we do not expect to be as good as in patients naïve to Zytiga, and anticipate that these results may be available as early as 2016. In
the United States, we and Astellas are required to conduct an open-label safety study of XTANDI in patients with known risk factor(s) for seizure and to report the
results of that study to the FDA in 2019. If the results of this study reveal unacceptable safety risks, this could result in decreased commercial utilization of
XTANDI for mCRPC patients in the United States and in the EU, failure to obtain approval in other indications, and modifications to the existing label for
XTANDI, including potentially a boxed warning, or additional clinical testing. Any one or more of these outcomes would seriously harm our business.
Additionally, we could receive additional post-marketing requirements as we seek approval of XTANDI in additional patient populations. Failure to conduct the
post-marketing requirements or commitments in a timely manner may result in withdrawal of approval for XTANDI and substantial civil and/or criminal penalties.
If
significant
patient
safety
issues
were
to
arise
for
XTANDI
or
our
other
product
candidates,
our
future
sales
may
be
reduced,
adversely
affecting
our
results
of
operations.
The data supporting the marketing approvals for our products and forming the basis for the safety warnings in our product labels were obtained in controlled
clinical trials of limited duration and, in some cases, from post-approval use. As our products are used over longer periods of time by many patients with underlying
health problems, taking numerous other medicines, we expect to continue to find new issues such as safety, resistance or drug interactions of XTANDI or in other
products, which may require us to provide additional warnings or contraindications on our labels or narrow our approved indications, each of which could reduce
the market acceptance of these products. For example, in 2015, based upon routine pharmacovigilance review and signal detection, we and Astellas submitted a
label change to the FDA after identifying two post-marketing reports of posterior reversible encephalopathy syndrome, or PRES, in patients receiving XTANDI.
PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual
and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic
resonance imaging, or MRI. Because PRES was reported voluntarily from a post-marketing population of uncertain size, it is not possible to reliably estimate the
frequency or establish a causal relationship to XTANDI. Discontinue XTANDI in patients who develop PRES.
Regulatory authorities have been moving towards more active and transparent pharmacovigilance and are making greater amounts of stand-alone safety
information directly available to the public through websites and other means, e.g., periodic safety update report summaries, risk management plan summaries and
various adverse event data. Safety information, without the appropriate context and expertise, may be misinterpreted and lead to misperception or legal action
which may potentially cause our product sales or stock price to decline.
Further, if serious safety, resistance or drug interaction issues arise with XTANDI, product sales could be limited or halted by us or by regulatory authorities
and our results of operations would be adversely affected.
25
XTANDI
and
any
other
product
candidates
that
may
receive
regulatory
approval
in
the
future
will
be
subject
to
ongoing
regulatory
obligations
and
continued
regulatory
review,
which
may
result
in
significant
additional
expense
as
well
as
significant
penalties
if
we
fail
to
comply
with
regulatory
requirements
or
experience
unanticipated
problems
with
our
products
and
product
candidates.
We are required to monitor the safety and efficacy of XTANDI and any other products candidates that are approved by the FDA. In addition, the
manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for any
approved products, such as XTANDI, will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and
other post-marketing information and reports, registration and listing, as well as continued compliance with current good clinical practices, or cGCP, for any
clinical trials that we conduct post-approval. We and our contract manufacturers will be subject to periodic unannounced inspections by the FDA to monitor and
ensure compliance with current good manufacturing practices, or cGMP. We must also comply with requirements concerning advertising and promotion for
XTANDI and any other product candidates for which we obtain marketing approval in the future. Promotional communications with respect to prescription drugs,
including biologics, are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved labeling.
Thus, we will not be able to promote XTANDI or any other products candidates for which we might obtain approval in the future for indications or uses for which
they are not approved. Later discovery of previously unknown problems with XTANDI or any other product candidate for which we might obtain approval in the
future, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers or manufacturing processes, or failure to comply with
regulatory requirements, may result in, among other things:
•
restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials;
•
restrictions on such products’ manufacturing processes;
•
restrictions on the marketing of a product;
•
restrictions on product distribution;
•
requirements to conduct post-marketing clinical trials;
•
untitled or warning letters;
•
withdrawal of the products from the market;
•
refusal to approve pending applications or supplements to approved applications that we submit;
•
recall of products;
•
fines, restitution or disgorgement of profits or revenue;
•
suspension or withdrawal of regulatory approvals;
•
refusal to permit the import or export of our products;
•
product seizure;
•
injunctions;
•
imposition of civil penalties; or
•
criminal prosecution.
The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could affect the marketing of
XTANDI or prevent, limit or delay regulatory approval of our other product candidates. We cannot predict the likelihood, nature or extent of government
regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in
existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval
that we may have obtained and we may not sustain profitability.
If
we
are
unable
to
successfully
develop
enzalutamide
for
breast
cancer
with
a
suitable
diagnostic,
we
may
not
be
able
to
obtain
regulatory
approval
for
enzalutamide
for
breast
cancer
or
realize
the
full
potential
for
enzalutamide.
We may initiate a Phase 3 clinical trial evaluating enzalutamide in triple negative breast cancer, or TNBC. A key element of our strategy to develop
enzalutamide in TNBC is the use of a companion diagnostic to identify patients with TNBC appropriate for treatment with enzalutamide. Patients whose tumors
test positive for a gene expression profile may be more likely to respond to treatment with enzalutamide; patients whose tumors test negative may not be responsive
to treatment with enzalutamide. Both regulatory approval and, if approval is obtained, successful commercialization of enzalutamide in TNBC will, therefore,
likely depend on our successful development of such a companion diagnostic.
26
We and Astellas have entered into a collaboration with NanoString Technologies, Inc. to translate our gene expression signature algorithm into a companion
diagnostic assay using NanoString’s nCounter Dx Analysis System. However, we may encounter difficulties in developing enzalutamide for TNBC and/or
developing the companion diagnostic for clinical, regulatory and/or commercial reasons including issues related to analytical validation, reproducibility or clinical
validation.
Companion diagnostics are subject to regulation by the FDA as a medical device and require separate regulatory clearance prior to commercialization.
Companion diagnostics are also subject to regulation by foreign regulatory authorities and such regulations may change or new regulations may be enacted during
our development of the companion diagnostic. We may be unable to alter our development program in time to comply with the revised or new regulations, or we
may only be able to do so by expending greater funds and efforts, and any delay or failure to obtain regulatory approval could delay or prevent the approval of
enzalutamide for TNBC.
Risks
Related
to
our
license
and
Manufacturing
and
Supply
Agreement
with
CureTech,
ltd.
The
clinical
molecule
MDV9300
we
licensed
from
CureTech
is
a
biologic
molecule,
and
we
do
not
have
long-standing
experience
or
expertise
in
the
development,
manufacture,
or
commercialization
of
biologic
molecules.
Under the license agreement, we are responsible for all development, manufacturing, and commercialization activities for MDV9300 for all indications,
including in oncology. We have limited history, experience, or expertise in the development, manufacturing and commercialization, including regulatory
interactions, commercial manufacturing, and distribution of biologic molecules, like MDV9300.
The successful development, testing, manufacturing and commercialization of biologics involves a long, expensive, and uncertain process. There are unique
risks and uncertainties with biologics, including:
•
The development, manufacturing and marketing of biologics are subject to regulation by the FDA, the European Medicines Agency or EMA, and
other regulatory bodies. These regulations are often more complex and extensive than the regulations applicable to other pharmaceutical products;
•
Manufacturing biologics, especially in large quantities, is often complex and may require the use of innovative technologies to handle living cells.
Each lot of an approved biologic must undergo thorough testing for identity, strength, quality, purity and potency. Manufacturing biologics requires
facilities specifically designed for and validated for this purpose, and sophisticated quality assurance and quality control procedures are necessary.
Slight deviations anywhere in the manufacturing process, including filling, labeling, packaging, storage and shipping and quality control and testing,
may result in lot failures, product recalls or spoilage. When changes are made to the manufacturing process, we may be required to provide
preclinical and clinical data showing the comparable identity, strength, quality, purity or potency of the products before and after such changes. For
MDV9300, we plan to implement changes in manufacturing site and to improve the manufacturing process to provide for larger manufacturing lot
sizes, as well as the critical analytical assays. Comparability data will be required to support these changes; and
•
The use of biologically derived ingredients can lead to allegations of harm, including infections or allergic reactions, or closure of product facilities
due to possible contamination. Any of these events could result in substantial costs.
We are currently dependent on CureTech to produce clinical supply of MDV9300 that meets global regulatory standards and CureTech is dependent on its
suppliers for sufficient quantities of raw materials, starting materials, and supplies. If CureTech fails to manufacture clinical supply of MDV9300 in sufficient
quantities or fails to source raw or starting materials or supplies in sufficient quantities, our ability to conduct clinical trials could be further delayed or otherwise
negatively impacted.
Our failure to successfully develop, manufacture, or commercialize MDV9300 could significantly impact our ability to generate value from the License
Agreement with CureTech.
27
The
IND
for
MDV9300
was
recently
placed
on
partial
clinical
hold
by
the
FDA,
and
we
now
intend
to
modify
the
production
process
for
MDV9300,
resulting
in
a
delay
of
our
Phase
2
clinical
trial
of
MDV9300
in
DLBCL
as
well
as
potential
subsequent
trials
.
In early January 2016, we advised the FDA of our conclusion that MDV9300 does not bind PD-1, and the agency placed the IND on partial clinical hold and
requested that we revise our characterization of MDV9300 in the related investigator brochure, protocols and informed consent documents. While we submitted the
revised documents in early February 2016, and the FDA has 30 days thereafter to notify us if the partial clinical hold is lifted, the FDA may request additional
information in response to our submission or may determine that our response did not satisfactorily address their request. In addition, we intend to submit an
amendment to our IND for MDV9300 to modify the production process to better support our planned clinical activities. We plan to submit the IND amendment in
the first half of 2016 and intend that patients in our Phase 2 DLBCL trial will be treated with MDV9300 manufactured in accordance with the amended IND. Since
we cannot enroll patients in the Phase 2 DLBCL trial until the partial clinical hold is lifted and do not intend to proceed with the trial until MDV9300 manufactured
in accordance with the amended IND is available, there will be a delay in the resumption of our planned clinical trial of MDV9300 for DLBCL. These
circumstances could result in increased cost and could delay, prevent or limit our ability to generate value from and realize the commercial potential of MDV9300.
If
we
are
unable
to
determine
the
binding
target
for
MDV9300,
we
may
fail
to
successfully
develop
MDV9300
for
DLBCL,
multiple
myeloma
or
any
other
indication,
and
we
may
not
be
able
to
obtain
regulatory
approval
or
realize
the
full
potential
for
MDV9300.
Although the molecule was originally understood to work primarily via PD-1 (Programmed Death-1) binding, our work as well as that of others has shown
other potential activity as well. In the year since we acquired rights to the molecule, we conducted testing and characterization work to better identify the binding
target and, in late December 2015, we concluded that MDV9300 does not bind PD-1. While we intend to continue work to identify the binding target and thereafter
develop a target-specific release assay, these activities are time consuming, expensive and there is no assurance that we will be successful since the binding
mechanism is currently unknown. Furthermore, there can be no assurance that we will not experience additional development issues in the future which may cause
further delays or unanticipated costs, or that we will be able to solve such development issues. Our failure to identify the binding target for MDV9300 or to develop
a target-specific release assay would significantly impact our ability to obtain regulatory approval and could materially harm our business.
The
development
and
commercialization
of
MDV9300
may
face
strong
competition
from
other
immuno-oncology
agents
that
have
already
received
marketing
approval
and
are
being
developed
for
additional
indications
by
larger
companies
with
substantial
resources
and
relatively
more
experience
developing,
manufacturing,
and
commercializing
biologic
molecules.
The immuno-oncology field is competitively crowded with more than 100 immuno-oncology agents, including biologic molecules, vaccines, modified Tcells, and adjuvants, currently approved and on the market or in development for various tumor types and patient populations by larger more experienced
companies than ours, such as Bristol Myers Squibb, Roche, AstraZeneca, Pfizer and Merck. This competitive environment could compromise our ability to develop
MDV9300 by limiting the availability of clinical trial investigators, sites, and/or appropriate clinical patients, which could slow, delay or limit the progress of
MDV9300’s development. Even if we are able to successfully develop MDV9300 and obtain regulatory approval for it in an oncology indication, the competition
from already approved immuno-oncology molecules and other agents in the same or similar oncology indications could significantly limit our ability to generate
revenue from MDV9300. While we have some experience developing and in certain aspects of the commercialization of small molecule products, we may be
required to hire additional qualified employees with experience developing, manufacturing, and commercializing, including regulatory interactions, commercial
manufacturing, and distributing biological molecules, like MDV9300. Many of our competitors are large, multinational pharmaceutical and biotechnology
companies with considerably more resources and experience with biological molecules than us.
Risks
Related
to
Our
Future
Product
development
Candidates
Our
business
strategy
depends
on
our
ability
to
identify
and
acquire
additional
product
candidates.
We
may
never
acquire
or
identify
such
product
candidates
for
reasons
that
may
not
be
in
our
control,
or
are
otherwise
unforeseen
or
unforeseeable
to
us.
A key component of our business strategy is to diversify our product development risk by identifying and acquiring new product opportunities for
development. However, we may not be able to identify promising new technologies. In addition, the competition to acquire promising biomedical technologies is
fierce, and many of our competitors are large, multinational pharmaceutical, biotechnology and medical device companies with considerably more financial,
development and commercialization resources and experience than we have. Thus, even if we succeed in identifying promising technologies, we may not be able to
compete against our larger competitors with considerably more financial resources or we may not be able to acquire rights to them on acceptable terms or at all. If
we are unable to identify and acquire new technologies, we will be unable to diversify our product risk. We believe that any such failure would have a significant
negative impact on our prospects.
28
Pharmaceutical
and
biological
product
candidates
require
extensive,
time-consuming
and
expensive
preclinical
and
clinical
testing
to
establish
safety
and
efficacy,
and
to
obtain
regulator
y
approval.
If
we
are
unable
to
successfully
develop
and
test
our
product
candidates,
we
will
not
be
successful.
The research and development of pharmaceuticals and biological products is an extremely risky industry. Only a small percentage of product candidates that
enter the development process ever receive regulatory approval. The process of conducting the preclinical and clinical testing required to establish safety and
efficacy and obtain regulatory approval is expensive and uncertain and takes many years. If we are unable to complete preclinical or clinical trials of current or
future product candidates, due to safety concerns with a product candidate, or if the results of these trials are not satisfactory to convince regulatory authorities of
their safety or efficacy, we will not be able to obtain regulatory approval for commercialization. We cannot be certain if any of our product candidates will be
approved by regulatory authorities. Furthermore, even if we are able to obtain regulatory approvals for any of our product candidates, those approvals may be for
indications that are not as broad as desired or may contain other limitations that would adversely affect our ability to generate revenue from sales of those products.
If this occurs, our business would be materially harmed and our ability to generate revenue would be severely impaired.
Enrollment
and
retention
of
patients
in
clinical
trials
of
enzalutamide
and
other
product
candidates
are
expensive
and
time-consuming
processes,
could
be
made
more
difficult
or
rendered
impossible
by
competing
treatments
or
clinical
trials
of
competing
drugs
in
the
same
or
other
indications,
and
could
result
in
significant
delays,
cost
overruns,
or
both,
in
our
product
development
activities,
or
in
the
failure
of
such
activities.
We may encounter delays in enrolling, or be unable to enroll, a sufficient number of patients to complete any of our clinical trials, and even once enrolled
we may be unable to retain a sufficient number of patients to complete any of our trials. Patient enrollment and retention in clinical trials depends on many factors,
including the size of the patient population, the nature of the trial protocol, the existing body of safety and efficacy data with respect to the study drug, the number
and nature of competing treatments and ongoing clinical trials of competing drugs for the same indication, the proximity of patients to clinical sites and the
eligibility criteria for the study. Furthermore, any negative results we may report in clinical trials of enzalutamide or any potential future product candidates may
make it difficult or impossible to recruit and retain patients in other clinical studies of that same product candidate. Delays or failures in planned patient enrollment
and/or retention may result in increased costs, program delays or both, which could have a harmful effect on our ability to develop enzalutamide or any product
candidates, or could render further development impossible.
Our
reliance
on
third
parties
for
the
operation
of
our
business
may
result
in
material
delays,
cost
overruns
and/or
quality
deficiencies
in
our
development
programs.
We currently rely on third parties to perform key product development tasks, such as laboratories to conduct preclinical testing, clinical research
organizations to help us manage our clinical studies, investigators and investigative sites who conduct the clinical trials, and contract manufacturing organizations
to manufacture our product candidates at appropriate scale for preclinical and clinical trials. In addition, we currently rely on Astellas and its third party vendors to
supply commercial quantities of XTANDI. To manage our business successfully, we will need to identify, engage and properly manage qualified third parties that
will perform these development and manufacturing activities. For example, we need to monitor the activities of our vendors closely to ensure that they are
performing their tasks correctly, on time, on budget and in compliance with strictly enforced regulatory standards. We need to monitor investigators who participate
in our clinical trials to ensure that they are conducting the trial in compliance with the protocol, good clinical practices and all applicable laws. Our ability to
identify and retain key vendors, investigators and investigative sites with the requisite knowledge is critical to our business and the failure to do so could negatively
impact our business. Because all of our key vendors perform services for other clients in addition to us, we also need to ensure that they are appropriately
prioritizing our projects. If we fail to manage our key vendors well, we could incur material delays, cost overruns or quality deficiencies in our development and
commercialization programs, as well as other material disruptions to our business.
Patient
safety
issues
may
arise
from
investigator-sponsored
research
with
our
product
candidates,
which
may
adversely
affect
our
development
program
for
such
product
candidates.
We are committed to improving patient care through research that advances the medical and scientific knowledge of XTANDI and our product
candidates. In support of this commitment, we, in collaboration with our partner Astellas, have established an investigator-sponsored research program as a
mechanism for independent researchers to seek support for preclinical and clinical research studies with enzalutamide. We also provide support for investigatorsponsored research with MDV3800 and MDV9300. However, because we are not the sponsor of investigator-sponsored research studies, we cannot control how
such studies are conducted. If new patient safety issues arise from use of our product candidates in these investigator-sponsored research studies, our development
programs may be adversely affected which could impact our business and the results of our operations.
29
Risks
Related
to
the
Operation
of
our
Business
We
may
incur
substantial
costs
in
the
foreseeable
future
as
we
continue
our
development
and
commercialization
activities
and
may
not
maintain
or
increase
profitability
on
a
quarterly
or
annual
basis.
We have incurred significant costs principally from funding our research and development activities, from general and administrative expenses and from our
XTANDI commercialization activities. We may incur substantial costs in the foreseeable future as we continue to finance the commercialization of XTANDI in the
U.S. market, preclinical and clinical studies of enzalutamide, MDV3800, MDV9300 and early stage programs, potential business development activities, and our
corporate overhead costs, which could impact our ability to maintain or increase profitability on a quarterly or annual basis. Our ability to generate revenue
sufficient to offset these costs in order to maintain or increase profitability on a quarterly or annual basis is dependent on our ability, alone or with collaboration
partners, to successfully commercialize products for which we receive marketing approval.
Our
operating
results
are
unpredictable
and
may
fluctuate.
If
our
operating
results
are
below
the
expectations
of
securities
analysts
or
investors,
the
market
value
of
our
common
stock
could
decline.
Our operating results are difficult to predict and will likely fluctuate from quarter to quarter and year to year. Due to the competitive market for mCRPC
therapies, XTANDI net sales will be difficult to predict from period to period. As a result, you should not rely on XTANDI net sales results in any period as being
indicative of future performance and sales of XTANDI may be below the expectation of securities analysts or investors in the future. Additionally, you should not
place undue reliance on the forward-looking statements about expectations for future XTANDI net sales from our partner Astellas, as we may not agree with such
statements, or from us, as XTANDI net sales results are difficult to predict. We believe that our quarterly and annual results of operations may be affected by a
variety of factors, including:
•
the price and level of demand for XTANDI;
•
the extent to which coverage and reimbursement for XTANDI is available from government and health administration authorities, private health
insurers, managed care programs and other third-party payors;
•
the timing, cost and level of investment in our and Astellas’ sales and marketing efforts to support XTANDI sales;
•
the timing, cost and level of investment in our research and development activities involving XTANDI and our product candidates;
•
the cost of manufacturing XTANDI, and the amount of legally mandated discounts to government entities, other discounts and rebates, product
returns and other gross-to-net deductions;
•
the risk/benefit profile, cost and reimbursement of existing and potential future branded and generic drugs which compete with XTANDI;
•
the timeliness and accuracy of financial information we receive from Astellas regarding XTANDI net sales globally, and shared U.S. development
and commercialization costs for XTANDI incurred by Astellas, including the accuracy of the estimates Astellas uses in calculating any such
financial information including for gross-to-net revenue adjustments;
•
inventory levels at pharmaceutical wholesalers and distributors;
•
expenditures that we will or may incur to acquire or develop additional technologies, product candidates and products; and
•
the impact of fluctuations in foreign currency exchange rates.
In addition, we measure compensation cost for stock-based awards made to employees at the grant date of the award, based on the fair value of the award,
and recognize the cost as a non-cash operating expense over the employee’s requisite service period. As the variables that we use as a basis for valuing these
awards change over time, including our underlying stock price and stock price volatility, the magnitude of the non-cash expense that we must recognize may vary
significantly.
We are required to evaluate the fair value of intangible assets, including in-process research and development, or IPR&D, for impairment at least annually
or more frequently if impairment indicators exist. These assets are initially measured at fair value and therefore any change to our assumptions used in the
valuations could potentially lead to impairment. Some of the more common potential risks leading to impairment include competition, earlier than expected loss of
exclusivity, pricing pressures, adverse regulatory changes or clinical trial results, delay or failure to obtain regulatory approval and additional development costs,
inability to achieve expected synergies, higher operating costs, changes in tax laws and other macro-economic changes. If any of these or similar issues arise during
development, we may need to re-evaluate our IPR&D and incur a non-cash impairment charge, adversely affecting our consolidated results of operations.
30
Additionally, each reporting period, we revalu e contingent consideration obligations associated with business acquisitions to their fair value and record
increases in fair value as non-cash contingent consideration expense and decreases in fair value as non-cash contingent consideration income. Change s in
contingent consideration result from changes in assumptions regarding the probability of successful achievement of related milestones, the estimated timing in
which the milestones may be achieved and the discount rates used to estimate the fair value of the liability. Contingent consideration may change significantly as
our development programs progress, revenue estimates evolve and additional data is obtained, impacting our estimates.
For these and other reasons, it is difficult for us to accurately forecast future profits or losses. As a result, it is possible that in some quarters our operating
results could be below the expectations of securities analysts or investors.
Sales
fluctuations
of
XTANDI
as
a
result
of
inventory
levels
at
Astellas’
customers
(such
as
pharmaceutical
wholesalers
and
distributors)
may
cause
our
revenue
to
fluctuate,
which
could
adversely
affect
our
financial
results
and
the
market
value
of
our
common
stock.
The pharmaceutical wholesalers and distributors with whom Astellas has entered into inventory management agreements make estimates to determine end
user demand and may not always be effective in matching their inventory levels to actual end user demand. As a result, changes in inventory levels held by those
wholesalers and distributors can cause our operating results to fluctuate unexpectedly if sales of XTANDI to these wholesalers do not match end user
demand. Adverse changes in economic conditions or other factors may cause wholesalers and distributors to reduce their inventories of XTANDI. As inventory of
XTANDI in the distribution channel fluctuates from quarter to quarter, we may see corresponding fluctuations in reported collaboration revenue from XTANDI net
sales.
A
significant
and
growing
amount
of
the
collaboration
revenue
we
generate
is
in
currency
other
than
U.S.
dollars,
primarily
the
Euro
and
the
Japanese
yen,
thereby
exposing
us
to
foreign
currency
exchange
rate
risk.
A significant and growing amount of our collaboration revenue is generated from royalties on ex-U.S. net sales of XTANDI. The royalties we receive from
Astellas on net sales of XTANDI outside of the United States are calculated by converting the respective countries’ XTANDI net sales in local currency to U.S.
dollars for payment to us on a quarterly basis. A strengthening of the U.S. dollar relative to current currency exchange rates would result in lower collaboration
revenue related to ex-U.S. XTANDI net sales than otherwise would have been reported by us and paid to us.
In 2016, we intend to hedge a portion of our exposure to fluctuating currency rates for the Euro and the Japanese yen in order to mitigate unexpected shortterm volatility of such rates. Depending on the size of the exposures and the relative movements of exchange rates, if we fail to effectively hedge our exposures, we
could experience adverse effects on our reported financial results.
If
we
fail
to
attract
and
keep
senior
management
personnel,
we
may
be
unable
to
successfully
develop
our
product
candidates,
identify
and
acquire
promising
new
technologies,
conduct
our
clinical
trials,
and
commercialize
our
products,
and
our
business
could
be
harmed.
Our future success depends upon the continued services of our executive officers and our ability to attract, retain, and motivate highly qualified management
to oversee our business. None of our executive officers is bound by an employment agreement for any specific term, and they may terminate their employment at
any time. We are particularly dependent on the continued services of David Hung, M.D., our president and chief executive officer and a member of our board of
directors. Dr. Hung identified enzalutamide for acquisition and has primary responsibility for identifying and evaluating other potential product candidates. We
believe that Dr. Hung’s services in this capacity would be difficult to replace.
Although we have not historically experienced unique difficulties attracting and retaining qualified employees, we could experience such problems in the
future. For example, competition for qualified personnel in the biotechnology and pharmaceutical fields is intense, especially in the San Francisco Bay Area. The
loss of any of our executive officers or a significant turnover in our senior management could impair the successful commercialization of XTANDI, delay or
prevent continued development activities for enzalutamide, MDV3800, MDV9300 and other product candidates, delay or prevent the transfer and integration of
MDV3800 into our business and adversely affect or preclude the identification and acquisition of new product candidates, any of which events could harm our
business.
In addition, we will need to hire additional personnel as we expand our clinical development and commercial activities. We may not be able to attract and
retain qualified personnel on acceptable terms.
31
We
may
encounter
difficulty
managing
our
growth
and
expanding
our
operations
successfully.
Our business has experienced significant growth, which we expect will continue as we expand our commercialization efforts for XTANDI, seek to advance
our product candidates through clinical trials, and integrate the acquisition of MDV3800 and other potential business development activities. We expect that we
will need to expand our development, regulatory, manufacturing, and commercial capabilities in concert with contracting with third parties to provide certain of
these activities for us. To that end, we must be able to hire, train and integrate additional personnel effectively in order to manage our commercialization and
development activities.
We may not be able to accomplish these tasks, and our failure to accomplish any of them could prevent us from successfully growing our company. Our
management may need to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time to managing
these growth activities. If we are not able to effectively manage the expansion of our operations, it may result in weaknesses in our infrastructure, operational
mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees. In addition, our expenses may increase more
than expected, our ability to generate and/or grow revenues could be reduced, and we may not be able to implement our business strategy. Thus, o ur future
financial performance and our ability to develop and commercialize our product candidates and to compete effectively will depend, in part, on our ability to
manage any future growth effectively.
We
will
need
to
expand
our
organization
to
successfully
commercialize
our
un-partnered
product
candidates
outside
of
the
United
States
in
some
degree,
and
we
may
experience
difficulties,
which
could
disrupt
our
operations
and
harm
our
business
.
We have no experience marketing or selling outside of the United States. To successfully commercialize MDV3800, MDV9300, or any other products that
emerge from our development programs, we will need to build or otherwise secure these capabilities from third parties. Developing a commercial infrastructure
outside the United States is a significant undertaking that requires substantial financial and managerial resources. We may need to establish internal marketing and
sales capabilities for several major ex-U.S. geographies to reach the commercial potential of MDV3800, MDV9300, or any other products that result from our
development programs. Such expansion would require attracting, retaining and motivating the necessary skilled personnel and, in addition, it may require
significant capital and operating expenditures. As a result, such activity may divert human and financial resources from other projects, such as the development or
acquisition of additional product candidates. If we encounter unexpected or unforeseen delays in establishing a commercial infrastructure outside the United States,
for example, it may negatively impact our ability to launch a commercial product or it may increase the cost and number of resources required for successful
commercialization. In addition, it may negatively impact the future financial performance of our business and our ability to generate sufficient revenue to sustain
our business. In the future, as a result of these financial and execution risks of expanding geographically ourselves, we may choose to partner with others who have
existing capability to commercialize these products.
Our
significant
level
of
debt
and
lease
obligations
could
adversely
affect
our
financial
condition.
In
addition,
we
may
not
have
sufficient
funds
to
service
our
debt
and
lease
obligations
when
payments
are
due.
At December 31, 2015, we had $75.0 million outstanding under our Revolving Credit Facility and approximately $54.9 million of minimum lease
commitments. We may incur additional indebtedness to meet future financing needs, including for example in connection with business development activities and
for other general corporate purposes. Substantial indebtedness could have significant effects on our business, results of operations and financial condition. For
example, it could:
•
make it more difficult for us to satisfy our financial obligations, including with respect to our debt and lease obligations;
•
increase our vulnerability to general adverse economic, industry and competitive conditions;
•
reduce the availability of our cash resources to fund our operations because we will be required to dedicate a substantial portion of our cash resources
to the payment of principal and interest on our indebtedness and lease payments;
•
limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate;
•
place us at a competitive disadvantage compared to our competitors that are less highly leveraged and that, therefore, may be able to take advantage
of opportunities that our leverage prevents us from exploring; and
•
limit our ability to obtain financing.
Each of these factors may have a material and adverse effect on our financial condition and viability.
32
With
the
acquisition
of
new
product
candidates
in
recent
periods,
we
may
need
additional
funds
to
support
our
operations,
and
such
funding
may
not
be
available
to
us
on
acceptable
terms,
or
at
all,
which
wo
uld
force
us
to
delay,
scale
back
or
eliminate
some
or
all
of
our
currently-planned
development
programs
and
other
operations,
to
restructure
or
refinance
our
indebtedness,
or
to
determine
to
do
any
combination
of
the
foregoing.
Raising
additional
capital
may
subject
us
to
unfavorable
terms
or
conditions,
may
cause
dilution
to
our
existing
stockholders,
or
may
restrict
our
operations
or
require
us
to
relinquish
rights
to
our
product
candidates
and
technologies.
We require significant capital to fund our operations. We have historically funded our operations primarily through public offerings of our common stock,
the issuance of the Convertible Notes (which we redeemed in July 2015 and are no longer outstanding), and from the upfront, milestone, and cost-sharing payments
under agreements with our current and former collaboration partners, from collaboration revenue related to XTANDI net sales and, more recently and to a lesser
extent, from short-term borrowings under a Revolving Credit Facility. At December 31, 2015, we had cash and cash equivalents totaling $225.9 million available to
fund our operations. We expect to devote substantial financial resources to our future operations. Based on our current expectations, we believe our current capital
resources, amounts available to us under our Revolving Credit Facility, and projected operating and other cash flows will be sufficient to fund our currently
planned operations for at least the next twelve months. This estimate is based on a number of assumptions that may prove to be wrong, including assumptions
regarding the amount and timing of net sales of XTANDI, potential XTANDI approvals in new markets and for other indications, and potential receipt of profit
sharing and royalty payments under our Astellas Collaboration Agreement, causing us to exhaust our available cash, cash equivalents, and short-term investments
sooner than anticipated. For example, we may be required or choose to seek additional funds for the commercialization of XTANDI in the United States, to expand
our preclinical and clinical development activities for enzalutamide, MDV3800, MDV9300 and other existing or potential future product candidates, to fund
business acquisitions, investments or to in-license technologies, particularly if we face challenges or delays in connection with our clinical trials, and to maintain
minimum cash balances that we deem reasonable and prudent. Our ability to raise additional funds on acceptable terms will be dependent on the climate of
worldwide capital markets, which could be challenging for companies such as ours.
We
may
be
constrained
by
our
obligations
under
the
Revolving
Credit
Facility
to
operate
our
business
to
its
full
potential.
The terms of our Revolving Credit Facility contain customary representations and warranties and customary affirmative and negative covenants, including,
among other things, restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness and dividends and other distributions.
Furthermore, under the terms of the Revolving Credit Facility, we are required to comply with a maximum senior secured net leverage ratio and minimum interest
coverage ratio covenants. These terms may restrict our ability to operate our business in the manner we deem most effective or desirable, and may restrict our
ability to fund our operations through new public offerings of our common stock or strengthen our candidate development pipeline through acquisitions or inlicenses which cause us to exceed our maximum senior secured net leverage ratio.
Failure to comply with the representations and warranties or affirmative and negative covenants could constitute an event of default which, if continued
beyond the cure period, would allow the Administrative Agent (as defined in the Revolving Credit Facility), at the request of or with the consent of the Lenders
holding a majority of the loans and commitments under the facility, to terminate the commitments of the Lenders to make further loans and declare all the
obligations of the Loan Parties under the Revolving Credit Facility to be immediately due and payable, either of which would harm our business.
We
may
have
additional
tax
liabilities.
We are subject to income taxes in various jurisdictions. Significant judgment is required in determining our provision for income taxes and other tax
liabilities. Our effective income tax rate in the future is subject to volatility and could be adversely affected by a number of factors, including interpretations of
existing tax laws, changes in tax laws and rates, future levels of research and development expenditures, changes in the mix of earnings in countries with differing
statutory tax rates in which we may conduct business, changes in the valuation of deferred tax assets and liabilities, state income taxes, the tax impact of stockbased compensation, changes in estimates of prior years’ items, tax costs for acquisition-related items, changes in accounting standards, non-deductible officers’
compensation, limitations on the utilization of net operating losses and tax credits due to changes in ownership, and overall levels of income before taxes. The
impact of our income tax provision resulting from these items may be significant and could have a negative impact on our net income.
We are also subject to non-income based taxes, such as payroll, sales, use, net worth, property, and goods and services taxes in the United States. We may
have additional exposure to non-income based tax liabilities.
We are regularly subject to audits by tax authorities in the jurisdictions in which we conduct business. Although we believe our tax positions are reasonable,
the final outcome of tax audits and related litigation could be materially different than that reflected in our historical income tax provisions and accruals, and we
could be subject to assessments of additional taxes and/or substantial fines or penalties. The resolution of any audits or litigation could have an adverse effect on
our financial position and results of operations.
33
We and our subsidiaries are engaged in a number of intercompany transactions. Although we believe that these transactions reflect arm’s length terms and
that proper transfer pricing doc umentation is in place, which should be respected for tax purposes, the transfer prices and terms and conditions of such transactions
may be scrutinized by tax authorities, which could result in additional tax and/or penalties becoming due.
Intellectual
property
protection
for
our
product
candidates
is
crucial
to
our
business,
and
is
subject
to
a
significant
degree
of
legal
risk,
particularly
in
the
life
sciences
industry.
The success of our business will depend in part on our ability to obtain and maintain intellectual property protection, primarily patent protection for the
XTANDI product and any potential future product candidates, as well as successfully asserting and defending these patents against third-party challenges. We
and/or our collaborators will only be able to protect the XTANDI product and our potential future product candidates from unauthorized commercialization by third
parties to the extent that valid and enforceable patents or trade secrets cover them. Furthermore, future protection of our proprietary rights is uncertain because legal
means may afford only limited protection and may not adequately protect our rights or permit us or our potential future collaborators to gain or keep our
competitive advantage.
The patent positions of life sciences companies can be highly uncertain and involve complex legal and factual questions for which important legal principles
remain unresolved. Further, changes in either the patent laws or in interpretations of patent laws in the United States or other countries may diminish the value of
our intellectual property rights. Accordingly, we cannot predict the breadth of claims that may be granted or enforced for our patents or for third-party patents that
we have licensed. For example:
•
we or our licensors might not have been the first to make the inventions covered by each of our pending patent applications and issued patents;
•
we or our licensors might not have been the first to file patent applications for these inventions;
•
others may independently develop similar or alternative technologies or duplicate any of our technologies;
•
it is possible that none of our pending patent applications or the pending patent applications of our licensors will result in issued patents;
•
our issued patents and future issued patents, or those of our licensors, may not provide a basis for protecting commercially viable products, may not
provide us with any competitive advantages, or may be challenged by third parties and invalidated or rendered unenforceable; and
•
we may not develop additional proprietary technologies or product candidates that are patentable.
Further, even if we can obtain protection for and defend the intellectual property position of the XTANDI product or any potential future product
candidates, we or any of our potential future collaborators still may not be able to exclude competitors from developing or marketing competing drugs. Should this
occur, we and our potential future collaborators may not generate any revenues or profits from the XTANDI product or any potential future product candidates or
our revenue or profits would be significantly decreased.
We
could
become
subject
to
litigation
or
other
challenges
regarding
intellectual
property
rights,
which
could
divert
management
attention,
cause
us
to
incur
significant
costs,
prevent
us
from
selling
or
using
the
challenged
technology
and/or
subject
us
to
competition
by
lower
priced
generic
products.
During the course of obtaining patent protection, we may receive rejections from national patent offices or be subject to pre-grant opposition proceedings
instituted by third parties. Even after a patent is granted and issued by the national patent office, many countries allow post-grant opposition proceedings. In the
U.S., these post-grant opposition proceedings include inter partes review whereby a third party can seek to challenge and invalidate an issued patent in an
administrative proceeding before the U.S. Patent and Trademark Office, rather than through litigation in court, which is often lengthier and costlier. Our patents
and patent applications, or those of our licensors, could face other challenges, such as interference proceedings, opposition proceedings, re-examination
proceedings, derivation proceedings and pre-grant submissions. Any such challenge, if successful, could result in the invalidation of, or in a narrowing of the scope
of, any of our patents and patent applications subject to the challenge. Any such challenges, regardless of their success, would likely be time-consuming and
expensive to defend and resolve and would divert our management’s time and attention.
Generic and other pharmaceutical manufacturers are and have been very aggressive in challenging the validity of patents held by proprietary pharmaceutical
companies, especially if these patents are commercially significant. Pursuant to the provisions of the Hatch-Waxman Act, the XTANDI patents listed in the FDA
“Orange Book” could be challenged by generic manufacturers as early as four years from the initial approval of the XTANDI product in the United States, which
occurred on August 31, 2012. Companies seeking approval to market a generic version of a reference drug may also seek to challenge the validity of patents listed
in the Orange Book or other patents covering such reference drug by filing petitions for inter partes review with the U.S. Patent and Trademark Office. If a generic
pharmaceutical company or other third party were able to successfully invalidate any of our present or future
34
patents, the XTANDI product and any potential future product candidates that may ultimately receive marketing approval could face additiona l competition from
lower-priced generic products that would result in significant price and revenue erosion and have a significantly negative impact on the commercial viability of the
affected product candidate(s).
In addition, we may be a party to litigation to protect our intellectual property or to defend our activities in response to alleged infringement of a third
party’s intellectual property. These claims and any resulting lawsuit, if successful, could subject us to significant liability for damages and invalidation, or a
narrowing of the scope, of our proprietary rights. These lawsuits, regardless of their success, would likely be time-consuming and expensive to litigate and resolve
and would divert management time and attention. Any potential intellectual property litigation also could force us or our potential licensees to do one or more of
the following:
•
discontinue our products that use or are covered by the challenged intellectual property; or
•
obtain from the owner of the allegedly infringed intellectual property right a license to sell or use the relevant technology, which license may not be
available on reasonable terms, or at all.
If we or our potential licensees are forced to take any of these actions, our business may be seriously harmed. Although we carry general liability insurance,
our insurance does not cover potential claims of this type.
We may in the future initiate claims or litigation against third parties for infringement to protect our proprietary rights or to determine the scope and validity
of our proprietary rights or the proprietary rights of competitors. These claims could result in costly litigation and the diversion of our technical and management
personnel and we may not prevail in making these claims.
We
rely
on
license
agreements
for
certain
aspects
of
our
product
candidates
and
our
technology,
and
failure
to
meet
our
obligations
under
those
agreements
could
severely
negatively
impact
our
business,
and
ability
to
generate
revenue.
We have entered into agreements with third-party commercial and academic institutions to license intellectual property rights and technology. For example,
we have a license agreement with UCLA pursuant to which we were granted exclusive worldwide rights to certain UCLA patents related to XTANDI and a family
of related compounds. Some of these license agreements, including our license agreement with UCLA, contain diligence and milestone-based termination
provisions, in which case our failure to meet any agreed upon diligence requirements or milestones may allow the licensor to terminate the agreement. If our
licensors terminate our license agreements or if we are unable to maintain the exclusivity of our exclusive license agreements, we may be unable to continue to
develop and commercialize XTANDI or any potential future product candidates based on licensed intellectual property rights and technology.
In
the
future,
we
may
need
to
obtain
additional
licenses
of
third-party
technology
that
may
not
be
available
to
us
or
are
available
only
on
commercially
unreasonable
terms,
and
which
may
cause
us
to
operate
our
business
in
a
more
costly
or
otherwise
adverse
manner
that
was
not
anticipated.
From time to time we may be required to license technology from additional third parties to further develop XTANDI and any future product candidates.
Should we be required to obtain licenses to any third-party technology, including any such patents based on biological activities or required to manufacture our
product candidates, such licenses may not be available to us on commercially reasonable terms, or at all. The inability to obtain any third-party license required to
develop any of our product candidates could cause us to abandon any related development efforts, which could seriously harm our business and operations.
We
may
become
involved
in
disputes
with
Astellas,
NanoString
or
any
potential
future
collaborators
over
intellectual
property
ownership,
and
publications
by
our
research
collaborators
and
scientific
advisors
could
impair
our
ability
to
obtain
patent
protection
or
protect
our
proprietary
information,
which,
in
either
case,
could
have
a
significant
impact
on
our
business.
Inventions discovered under research, material transfer or other such collaboration agreements, including the Astellas Collaboration Agreement or
NanoString collaboration agreement, may become jointly owned by us and the other party(ies) to such agreements in some cases and the exclusive property of one
of the parties in other cases. Under some circumstances, it may be difficult to determine who owns a particular invention, or whether it is jointly owned, and
disputes could arise regarding ownership of those inventions. These disputes could be costly and time consuming and an unfavorable outcome could have a
significant adverse effect on our business if we were not able to protect or license rights to these inventions. In addition, our research collaborators and scientific
advisors generally have contractual rights to publish our data and other proprietary information, subject to our prior review. Publications by our research
collaborators and scientific advisors containing such information, either with our permission or in contravention of the terms of their agreements with us, may
impair our ability to obtain patent protection or protect our proprietary information, which could significantly harm our business.
Trade
secrets
may
not
provide
adequate
protection
for
our
business
and
technology.
We also rely on trade secrets to protect our technology, especially where we believe patent protection is not appropriate or obtainable. However, trade
secrets are difficult to protect. While we use reasonable efforts to protect our trade secrets, our or any
35
potential collaborators’ employees, consultants, contractors or scientific and oth er advisors may unintentionally or willfully disclose our information to
competitors. If we were to enforce a claim that a third party had illegally obtained and was using our trade secrets, our enforcement efforts would be expensive and
time consuming, an d the outcome would be unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets.
Moreover, if our competitors independently develop equivalent knowledge, methods or know-how, it will be more difficult or impossible for us to enforce our
rights and our business could be harmed.
Significant
disruptions
of
information
technology
systems
or
breaches
of
data
security
could
adversely
affect
our
business.
Our business is increasingly dependent on critical, complex and interdependent information technology systems to record and maintain financial, clinical
trial, safety, laboratory and other corporate records. The size and complexity of our computerized information systems make them vulnerable to breakdown,
malicious intrusion, catastrophic events, computer viruses, and human error. We have experienced at least one successful intrusion into our computer systems, and
although it did not have a material adverse effect on our operations, there can be no assurance of a similar result in the future as cyberattacks are increasing in their
frequency, sophistication and intensity.
We have developed systems and processes that are designed to protect our information and prevent data loss and other security breaches, including systems
and processes designed to reduce the impact of a security breach; however, such measures cannot provide absolute security, and we have taken and are continually
taking additional security measures to protect against any future intrusion, including employee training. Moreover, the prevalent use of mobile devices that access
our systems and confidential information and our relationships with third party vendors, who may or could have access to our confidential information, increases
the risk of data security breaches.
A data or security breach of our systems, or that of our third party vendors, such as third party clinical research organizations, third party clinical
manufacturing organization, clinical trial sites, and administrators of our corporate employee benefit plans or of our current and potential future collaboration
partners, could lead to public exposure of personal information of our employees, clinical trial patients, customers and other business partners, modification of or
prevent us from accessing our clinical trial databases, or the loss of trade secrets or other intellectual property.
If we or our third party vendors or business partners experience significant data security breaches, we could suffer harm to our reputation, be compelled to
comply with federal and/or state breach notification laws and foreign law equivalents, be subjected to liability under laws and regulations that protect personal data,
be subjected to mandatory corrective action or government enforcement action, need to verify the correctness of clinical trial database contents, or be exposed to
litigation claims. In addition, because these breaches and other inappropriate access can be difficult to detect, and any delay in identifying them may lead to
increased harm of the type described above. Prolonged disruption would divert management’s attention and could result in a delay to the development of our
product candidate.
While we do carry some insurance for these types of claims, our insurance may not be sufficient in type or amount.
Risks
generally
associated
with
our
company-wide
implementation
of
an
enterprise
resource
planning
(ERP)
system
may
adversely
affect
our
business
and
results
of
operations
or
the
effectiveness
of
our
internal
controls
over
financial
reporting.
We commenced implementation of a company-wide ERP system to upgrade certain existing business, operational, and financial processes. ERP
implementations are typically complex and time-consuming projects that may require substantial time and resources to complete. Our results of operations could be
adversely affected if we experience delays or cost overruns during the ERP implementation process, or if the ERP system or associated process changes do not give
rise to the benefits that we expect.
Risks
Related
to
the
Pharmaceutical
Industry,
Including
the
Activities
of
Medivation,
Inc.
Our
industry
is
highly
regulated
by
the
FDA
and
comparable
foreign
regulatory
agencies.
We
must
comply
with
extensive,
strictly
enforced
regulatory
requirements
to
develop,
obtain,
and
maintain
marketing
approval
for
any
of
our
product
candidates.
Securing FDA approval requires the submission of extensive preclinical and clinical data and supporting information for each therapeutic indication to
establish the product candidate’s safety and efficacy for its intended use. It takes years to complete the testing of a new drug, biologic or medical device and
development delays and/or failure can occur at any stage of testing. Any of our present and future clinical trials may be delayed, halted or approval of any of our
products may be delayed or may not be obtained due to any of the following:
•
any preclinical test or clinical trial may fail to produce safety and efficacy results satisfactory to the FDA or foreign regulatory authorities;
•
preclinical and clinical data can be interpreted in different ways, which could delay, limit or prevent regulatory approval;
36
•
negative or inconclusive results from a preclinical test or clinical trial or adverse medical events during a clinical trial could cause a preclinical study
or clinical trial to be repeated or a program to be terminated, even if other studies or trials relating to the program are ongoing or have been
completed and were successful;
•
the FDA or foreign regulatory authorities can place a clinical hold on a trial if, among other reasons, it finds that patients enrolled in the trial are or
would be exposed to an unreasonable and significant risk of illness or injury;
•
the facilities that we utilize, or the processes or facilities of third party vendors, including without limitation the contract manufacturers who will be
manufacturing drug substance and drug product for us or any potential collaborators, may not complete successful inspections by the FDA or foreign
regulatory authorities; and
•
we may encounter delays or rejections based on changes in FDA policies or the policies of foreign regulatory authorities during the period in which
we develop a product candidate or the period required for review of any final regulatory approval before we are able to market any product
candidate.
In addition, information generated during the clinical trial process is susceptible to varying interpretations that could delay, limit, or prevent regulatory
approval at any stage of the approval process. Moreover, early positive preclinical or clinical trial results may not be replicated in later clinical trials. Failure to
demonstrate adequately the quality, safety and efficacy of any of our product candidates would delay or prevent regulatory approval of the applicable product
candidate. There can be no assurance that if clinical trials are completed, either we or our collaborative partners will submit applications for required authorizations
to manufacture or market potential products or that any such application will be reviewed and approved by appropriate regulatory authorities in a timely manner, if
at all.
We
may
be
subject,
directly
or
indirectly,
to
federal
and
state
healthcare
fraud
and
abuse
and
false
claims
laws
and
regulations.
Prosecutions
under
such
laws
have
increased
in
recent
years
and
we
may
become
subject
to
such
litigation.
If
we
are
unable
to
comply,
or
have
not
fully
complied,
with
such
laws,
we
could
face
substantial
penalties.
Commercialization of drugs and biologics that receive FDA approval are subject, directly or indirectly, to various state and federal fraud and abuse laws,
including, without limitation, the federal Anti-Kickback Statute and federal False Claims Act and the state law equivalents of such laws. These laws may impact,
among other things, our sales, marketing, and education programs.
The federal Anti-Kickback Statute prohibits persons and entities from knowingly and willingly soliciting, offering, receiving or providing remuneration,
directly or indirectly, in exchange for or to induce either the referral of an individual, or the furnishing or arranging for a good or service, for which payment may
be made under a federal healthcare program such as the Medicare and Medicaid programs. The Anti-Kickback Statute is broad, and despite a series of narrow
regulatory safe harbors and statutory exceptions, prohibits many arrangements and practices that are lawful in businesses outside of the healthcare industry.
Penalties for violations of the federal Anti-Kickback Statute include, among other things, criminal and administrative penalties and civil sanctions such as fines,
imprisonment and possible exclusion from Medicare, Medicaid and other federal healthcare programs. Many states have adopted laws similar to the federal AntiKickback Statute, some of which apply to the referral of patients for healthcare items or services reimbursed by any source, including private insurance programs.
The federal False Claims Act prohibits persons and entities from knowingly filing, or causing to be filed, a false claim, or the knowing use of false
statements, to obtain payment from the federal government. Suits filed under the False Claims Act, known as “qui tam” actions, can be brought by any individual
on behalf of the government, and such individuals, commonly known as “whistleblowers,” may share in a proportion of any amounts paid by the entity to the
government in fines or settlement. The frequency of filing qui tam actions has increased significantly in recent years, causing greater numbers of biotechnology and
pharmaceutical companies to have to defend False Claims Act actions. When it is determined that an entity has violated the False Claims Act, the entity may be
required to pay up to three times the actual damages sustained by the government, plus civil penalties for each separate false claim. Various states have also enacted
laws modeled after the federal False Claims Act. Although we have developed, implemented, and continue to improve a program for compliance with all federal
and state laws, we cannot guarantee that our compliance program will be sufficient or effective, that our employees will comply with our policies and that our
employees will notify us of any violation of our policies, that we will have the ability to take appropriate and timely corrective action in response to any such
violation, or that we will make decisions and take actions that will necessarily limit or avoid liability for whistleblower claims that individuals, such as employees
or former employees, may bring against us or that governmental authorities may prosecute against us based on information provided by individuals. If one or more
individuals bring a whistleblower claim against us or if a governmental authority prosecutes a claim against us on the basis of information provided by one or more
individuals, and if we are found liable and a fine and/or an injunction and/or a Corporate Integrity Agreement or similar government oversight program is imposed
on us or we agree to pay a fine and/or accept an injunction and/or a Corporate Integrity Agreement or similar government oversight program in settlement of the
claim, they could have a material adverse effect on our financial condition and impair or prevent us from conducting our business. In addition, the costs and fees
associated with defending a whistleblower claim would be significant.
37
We may also be subject to federal criminal healthcare fraud statutes that were created by the federal Health Insurance Portability and Accountability Act of
1996, or HIPAA, as amende d by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH. The HIPAA health care fraud
statute prohibits, among other things, knowingly and willfully executing, or attempting to execute a scheme to defraud any healthcar e benefit program, including
private payors. A violation of this statute is a felony and may result in fines, imprisonment, and/or exclusion from government sponsored programs. The HIPAA
false statements statute prohibits, among other things, knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false,
fictitious or fraudulent statement or representation in connection with the delivery of or payment for healthcare benefits, items or services. A violation of t his
statute is a felony and may result in fines and/or imprisonment.
We, and our business activities, are also subject to the federal Physician Payments Sunshine Act, which is within the Patient Protection and Affordable Care
Act, as amended by the Health Care Education and Reconciliation Act, (collectively, “PPACA”). The federal Physician Payments Sunshine Act, and its
implementing regulations, require certain manufacturers of drugs, devices, biological, and medical supplies for which payment is available under Medicare,
Medicaid, or the Children’s Health Insurance Program (with certain exceptions) to report annually information related to certain payments or other transfers of
value provided to physicians and teaching hospitals and other healthcare providers. In addition, there has been a recent trend of increased federal and state
regulation on payments made to physicians. Certain states mandate implementation of commercial compliance programs, impose restrictions on drug manufacturer
marketing practices, and/or the tracking and reporting of gifts, compensation and remuneration to physicians.
We are unable to predict whether we could be subject to actions under any of these or other fraud and abuse laws, or the impact of such actions. If we are
found to be in violation of any of the laws described above and other applicable state and federal fraud and abuse laws, we may be subject to penalties, including
civil and criminal penalties, damages, fines, exclusion from government healthcare reimbursement programs and the curtailment or restructuring of our operations,
any of which could have a material adverse effect on our business and results of operations.
We
could
be
adversely
affected
by
violations
of
the
U.S.
Foreign
Corrupt
Practices
Act
and
other
worldwide
anti-bribery
laws.
We are subject to the U.S. Foreign Corrupt Practices Act, or FCPA, which generally prohibits companies and their intermediaries from making payments to
non-U.S. government officials for purpose of obtaining or retaining business or securing any other improper advantage. We are also subject to similar anti-bribery
laws in the jurisdictions in which we operate. Failure to comply with the FCPA or related laws governing the conduct of business with foreign government entities
could disrupt our business and lead to severe criminal and civil penalties, including criminal and civil fines, denial of government reimbursement for our products
and exclusion from participation in government healthcare programs. Other remedial measures could include further changes or enhancements to our procedures,
policies, and controls and potential personnel changes and/or disciplinary actions, any of which could have a material adverse impact on our business, financial
condition, results of operations and liquidity. We could also be affected by any allegation that we, or any third party vendors that we rely on to perform key product
development tasks, violated such laws.
If
the
FDA
or
other
applicable
regulatory
authorities
approve
generic
products
that
compete
with
any
of
our
products
or
product
candidates,
the
sales
of
our
products
or
product
candidates
may
be
adversely
affected.
Once an NDA is approved, the product covered thereby becomes a “listed drug” which, in turn can be relied upon by potential competitors in support of an
approval of an ANDA or 505(b)(2) application. U.S. laws and other applicable policies provide incentives to manufacturers to create modified, non-infringing
versions of a drug to facilitate the approval of an ANDA or other application for a generic substitute. These manufacturers might only be required to conduct a
relatively inexpensive study to show that their product has the same active ingredient(s), dosage form, strength, route of administration, and conditions of use, or
labeling, as our product or product candidate and that the generic product is bioequivalent to ours, meaning it is absorbed in the body at the same rate and to the
same extent as our product or product candidate. These generic equivalents, which must meet the same quality standards as branded pharmaceuticals, would be
significantly less costly than ours to bring to market and companies that produce generic equivalents are generally able to offer their products at lower prices. Thus,
after the introduction of a generic competitor, a significant percentage of sales of any branded product is typically lost to the generic product. Accordingly,
competition from generic equivalents to our products or product candidates would materially adversely impact our revenues, profitability and cash flows and
substantially limit our ability to obtain a return on the investments that we have made in our product candidates.
To the extent that we receive regulatory approval to market biological products in the future, we will face competition from biosimilar products. A growing
number of companies have announced their intention to develop biosimilar products, some of which could potentially compete with our product candidates.
Because of the abbreviated pathway for approval of biosimilars in the United State and abroad, we may in the future face greater competition from biosimilar
products. This additional competition could have a material adverse effect on our business and results of operations.
38
Healthcare
reform
initiatives
and
other
third
party
cost-containment
pressures
could
cause
us
to
sell
our
products
at
lower
prices,
resulting
in
decreased
revenues.
The United States and some foreign jurisdictions have enacted or are considering enacting a number of legislative and regulatory proposals to change the
healthcare system in ways that could affect our ability to profitably sell XTANDI and other product candidates should they receive marketing approval. Among
policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of
containing healthcare costs, improving quality and/or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these
efforts and has been significantly affected by major legislative initiatives.
In March 2010, the PPACA became law in the United States. PPACA substantially changed and will continue to change the way healthcare is financed by
both governmental and private insurers and significantly affects the pharmaceutical industry. The provisions of PPACA most relevant to the pharmaceutical
industry include:
•
an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among
these entities according to their market share in certain governmental health care programs, not including orphan drug sales;
•
an increase in the rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13% of the average manufacturer price
for branded and generic drugs, respectively;
•
Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of
applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturers’ outpatient drugs to be covered
under Medicare Part D;
•
extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care
organizations;
•
expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals
with income at or below 133% of the Federal Poverty Level beginning in 2014, thereby potentially increasing manufacturers’ Medicaid rebate
liability;
•
expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
•
a new requirement to report certain financial arrangements with physicians and teaching hospitals, as defined in PPACA and its implementing
regulations, including reporting any payment or “transfers of value” made or distributed to physicians and teaching hospitals, and reporting any
ownership and investment interests held by physicians and their immediate family members and applicable group purchasing organizations;
•
expansion of health care fraud and abuse laws, including the federal False Claims Act and Anti-Kickback Statute, new government investigative
powers, and enhanced penalties for noncompliance;
•
a licensure framework for follow-on biologic products; and
•
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along
with funding for such research.
We anticipate that the PPACA, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria
or maximum monthly out-of-pocket costs for patients, either of which could put additional downward pressure on the price that we receive for any approved
product, and could seriously harm our business. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in
payments from private payors. If we fail to successfully secure and maintain adequate coverage and reimbursement of our products or are significantly delayed in
doing so, we will have difficulty achieving market acceptance of our products and expected revenue and profitability which would have a material adverse effect on
our business, results of operations and financial condition. In addition, we will face competition from other approved drugs against which we compete, and the
marketers of such other drugs are likely to be significantly larger than us and therefore enjoy significantly more negotiating leverage with respect to the individual
payors than we may have.
39
We
could
experience
adverse
outcomes
under
existing
litigation
or
become
subject
to
product
liability
or
other
litigation,
which
could
harm
our
ability
to
efficiently
and
effectively
conduct
our
business,
and,
if
successful,
could
materially
and
adversely
harm
our
business
and
financial
condition
as
a
result
of
the
costs
of
lia
bilities
that
may
be
imposed
thereby.
Our business exposes us to the risk of product liability claims that is inherent in the development, manufacturing, distribution and sale of pharmaceutical
products. If XTANDI, MDV3800, MDV9300 or any other potential future product candidate harms people, or is alleged to be harmful, we may be subject to costly
and damaging product liability claims brought against us by clinical trial participants, consumers, health care providers, corporate partners or others. We have
product liability insurance covering commercial sales of XTANDI and our ongoing clinical trials. However, the amount of insurance we maintain may not be
adequate to cover all liabilities that we may incur. If we are unable to obtain insurance at an acceptable cost or otherwise protect against potential product liability
claims, we may be exposed to significant litigation costs and liabilities, which may materially and adversely affect our business and financial position. If we are
sued for injuries allegedly caused by XTANDI, MDV3800, MDV9300 or any other of our current or future product candidates, our litigation costs and liability
could exceed our total assets and our ability to pay. Regardless of merit or eventual outcome, liability claims may result in:
•
decreased demand for XTANDI and any potential future product candidate that we may develop;
•
injury to our reputation;
•
withdrawal of clinical trial participants;
•
significant costs to defend the related litigation;
•
substantial monetary awards to trial participants or patients;
•
loss of revenue; and
•
the inability to commercialize any other products that we may develop.
In addition, we may from time to time become involved in various lawsuits and legal proceedings which arise in the ordinary course of our business, such as
our litigation with the Regents of the University of California, or Regents. See Part II, Item 1, “Legal Proceedings” for additional information on this litigation. Any
litigation to which we are subject could require significant involvement of our senior management and may divert management’s attention from our business and
operations. Litigation costs or an adverse result in any existing litigation, including our litigation with the Regents for which a decision by the appellate court on the
appeal is due within 90 days of the oral argument which occurred on February 23, 2016, or any new litigation that may arise from time to time may adversely
impact our operating results or financial condition.
Risks
Related
to
Business
Acquisitions,
licenses,
Investments
and
Strategic
Alliances
We
may
not
be
able
to
successfully
integrate
MDV3800,
MDV9300
or
any
other
potential
future
product
candidates
we
may
acquire
or
we
may
otherwise
fail
to
realize
their
full
potential.
A key component of our business strategy is to diversify our product development risk by identifying and acquiring new product opportunities for
development such as our recent acquisition of MDV3800 from BioMarin and our earlier license of MDV9300 from CureTech. However, we cannot ensure that we
will be able to manage the risks associated with the transfer of development, regulatory and manufacturing activities for the ongoing clinical trials of MDV3800
from BioMarin to us or manage the risks associated with integrating MDV3800 and MDV9300 into our existing business and infrastructure. We may encounter
unexpected difficulties during the transfer, integration or further development of MDV3800 or MDV9300, any of which may cause us to expend greater funds and
efforts or may slow, delay or limit the progress of MDV3800’s or MDV9300’s development. Unexpected difficulties may further be disruptive to our ongoing
development efforts, put a strain on our existing personnel, infrastructure and business and divert management’s time and attention.
Other companies, such as AstraZeneca, Clovis Oncology, AbbVie, and Tesaro are developing PARP inhibitors for various oncology indications, some of
which have already been approved and on the market and others which are further along in development than MDV3800, both of which could limit our
development opportunities for MDV3800. The competitive environment could further compromise our ability to successfully enroll the ongoing clinical trial by
limiting the availability of clinical trial investigators, sites and/or patients which could slow, delay or limit the progress of MDV3800’s development.
As a result of these or other problems and risks, we may never receive regulatory approval for MDV3800 or MDV9300, we may not realize the full
potential or we may never generate significant value or revenues from these assets.
40
Business
acquisitions,
licenses,
investments
and
strategic
alliances
could
disrupt
our
operations
and
may
expose
us
to
increased
costs
and
un
expected
liabilities.
We may acquire or make investments in other companies, enter into other strategic relationships, or in-license technologies, such as our acquisition of
MDV3800 and license of MDV9300. To do so, we may use cash, issue equity that could dilute our current stockholders, or incur debt or assume indebtedness.
These transactions involve numerous risks, including but not limited to:
•
difficulty integrating acquired technologies, products, operations, and personnel with our existing business;
•
diversion of management’s attention in connection with both negotiating the acquisition or license and integrating the business;
•
strain on managerial and operational resources;
•
difficulty implementing and maintaining effective internal control over financial reporting at businesses that we acquire, particularly if they are not
located near our existing operations;
•
exposure to unforeseen liabilities of acquired companies or companies in which we invest;
•
potential costly and time-consuming litigation, including stockholder lawsuits;
•
potential issuance of securities to equity holders of the company being acquired which may have a dilutive effect on our stockholders;
•
the need to incur additional debt or use our existing cash balances; and
•
the requirement to record potentially significant additional future non-cash operating costs for the amortization of intangible assets and potential
future impairment or write-down of intangible assets and/or goodwill as well as potentially significant non-cash adjustments to contingent
consideration liabilities which would be recorded within operating expenses.
As a result of these or other problems and risks, businesses we acquire or invest in may not produce the revenues, earnings or business synergies that we
anticipated, acquired or licensed technologies may not result in regulatory approvals, and acquired or licensed commercial products may not perform as expected.
As a result, we may incur higher costs and realize lower revenues than we had anticipated. We cannot assure you that any acquisitions or investments we have
made or may make in the future will be successfully identified and completed or that, if completed, the acquired business, licenses, investments, products, or
technologies will generate sufficient revenue to offset the negative costs or other negative effects on our business. Failure to manage effectively our growth through
acquisition or in-licensing transactions could adversely affect our growth prospects, business, results of operations, financial condition, and cash flow.
Funding
may
not
be
available
for
us
to
make
acquisitions,
investments,
strategic
alliances
or
in-license
technologies
in
order
to
grow
our
business.
We have made and anticipate that we may continue to engage in strategic transactions to grow our business through acquisitions, investments, strategic
alliances or in-licensing of technologies. In particular, we may choose to partner in certain geographies to commercialize our successful product candidates. Our
growth plans rely, in part, on the successful identification and completion of these various strategic transactions. At any particular time, we may need to raise
substantial additional cash or issue additional equity to finance such transactions, in addition to any amounts available from operations or under our Revolving
Credit Facility. There is no assurance that we will be able to secure additional funding on acceptable terms, or at all, or obtain stockholder approvals necessary to
issue additional equity to finance such transactions. If we are unsuccessful in obtaining financing, our business would be adversely affected.
Our
consolidated
financial
statements
may
be
impacted
in
future
periods
based
on
the
accuracy
of
our
valuations
of
our
acquired
businesses
and
other
agreements.
Certain of our asset acquisition or license agreements may be accounted for as a business combination. Accounting for business combinations may involve
complex and subjective valuations of the assets and liabilities recorded, and in some instances contingent consideration, which is recorded in our consolidated
financial statements pursuant to the standards applicable for business combinations in accordance with accounting principles generally accepted in the United
States. Differences between the inputs and assumptions used in the valuations and actual results experienced at a later date could have a material effect on our
consolidated financial statements in future periods.
41
We
have
substantial
intangible
assets
and
goodwill
as
a
result
of
the
acquisition
of
MDV3800
from
BioMarin
and
the
license
of
MDV9300
from
CureTech.
A
significant
impairment
or
write-dow
n
of
intangible
assets
and/or
goodwill
would
have
a
material
adverse
effect
on
our
consolidated
financial
statements.
We are required to perform an annual, or in certain situations a more frequent, assessment of intangible assets and goodwill for possible impairment for
accounting purposes. We recorded significant intangible assets and goodwill as a result of the CureTech and BioMarin transactions during the years ended
December 31, 2014 and 2015, respectively. At December 31, 2015, we had intangible assets and goodwill of approximately $662.9 million, or approximately 46%
of our total assets. During the fourth quarter of 2015, we recorded a $30.0 million impairment charge related to our IPR&D asset for MDV9300. If our
development activities with respect to IPR&D for acquired product candidates are not successful in future periods, we may be required to incur further non-cash
impairment charges that could materially adversely affect our consolidated results of operations or our recorded assets and liabilities.
Risks
Related
to
Ownership
of
Our
Common
Stock
Our
stock
price
has
been
and
may
continue
to
be
volatile
and
our
stockholders’
investment
in
our
common
stock
could
decline
in
value.
The market prices for our securities and those of other life sciences companies have been highly volatile and often unrelated or disproportionate to the
operating performance of those companies, and may continue to be highly volatile in the future. There has been particular volatility in the market prices of
securities of life sciences companies because of problems or successes in a given market segment or because investor interest has shifted to other segments. These
broad market and industry factors may cause the market price of our common stock to decline, regardless of our operating performance. We have no control over
this volatility and can only focus our efforts on our own operations, and even these may be affected due to the state of the capital markets.
The following factors, in addition to other risk factors described herein, may have a significant impact on the market price of our common stock:
•
comments made by securities analysts, including changes in their recommendations;
•
selling by existing stockholders and short-sellers;
•
sales of our common stock by our directors, officers or significant stockholders, including sales effected pursuant to predetermined trading plans
adopted under the safe-harbor afforded by Rule 10b5-1;
•
negative opinions that are misleading and/or inaccurate regarding our business, management or future prospects published by certain market
participants intent on putting downward pressure on the price of our common stock;
•
lack of volume of stock trading leading to low liquidity;
•
announcements by us of financing transactions and/or future sales of equity or debt securities;
•
the recruitment or departure of key management personnel;
•
our ability to meet the expectations of investors and securities analysts related to collaboration revenue generated from net sales of XTANDI,
including the timing and amount thereof, and other financial metrics;
•
changes in our financial guidance or financial estimates by any securities analysts who might cover our company, or our failure to meet our financial
guidance or estimates made by securities analysts;
•
variations in our quarterly financial results or those of companies that are perceived to be similar to us;
•
new products, product candidates or uses for existing products or technologies introduced or announced by our competitors and the timing of these
introductions and announcements;
•
the progress and results of preclinical studies and clinical trials of our product candidates conducted by us, Astellas or any future collaborative
partners or licensees, if any, and any delays in enrolling a sufficient number of patients to complete clinical trials of our product candidates;
•
developments concerning our collaboration with Astellas or any future collaborations;
•
our dependence on third parties, including Astellas, clinical manufacturing organizations and clinical research organizations, clinical trial sponsors
and clinical investigators;
•
legislation or regulatory developments in the United States or other countries affecting XTANDI or product candidates, including those of our
competitors, including the passage of laws, rules or regulations relating to healthcare and reimbursement or the public announcement of inquiries
relating to these subjects;
•
developments or disputes concerning patent applications, issued patents or other proprietary rights;
•
the receipt or failure to receive funding necessary to conduct our business;
•
changes in the market valuations of other companies in our industry;
42
•
litigation; and
•
general economic, industry and market conditions and other factors that may be unrelated to our operating performance, including market conditions
in the pharmaceutical and biotechnology sectors.
These factors and fluctuations, as well as political and other market conditions, may adversely affect the market price of our common stock. Securitiesrelated class action litigation is often brought against a company following periods of volatility in the market price of its securities. Securities-related litigation,
whether with or without merit, could result in substantial costs and divert management’s attention and financial resources, which could harm our business and
financial condition, as well as the market price of our common stock. Additionally, volatility or lack of positive performance in our stock price may adversely
affect our ability to retain or recruit key employees, all of whom have been or will be granted equity awards as a part of their compensation.
If
our
operating
results
are
below
the
expectations
of
securities
analysts,
the
market
price
of
our
common
stock
could
decline.
Various securities analysts follow our financial results and issue reports on us. These reports include information about our historical financial results, our
projected development expenses, as well as the analysts’ estimates of our future performance. The analysts’ estimates are based upon their own opinions and are
often different from our estimates or expectations. We expect our projected development expenses to increase as we advance our product pipeline and grow our
infrastructure. While management believes these expenses are an investment in the Company’s long-term prospects, such expenses could substantially reduce our
near-term earnings below the expectations of security analysts. If our operating results are below their expectations, the market value of our common stock could
decline, perhaps substantially.
We
do
not
intend
to
pay
cash
dividends
on
our
common
stock
for
the
foreseeable
future.
We do not expect for the foreseeable future to pay cash dividends on our common stock. Any future determination to pay cash dividends on or repurchase
shares of our common stock will be at the discretion of our board of directors and will depend upon, among other factors, our success in completing sales or
partnerships of our programs, our results of operations, financial condition, capital requirements, contractual restrictions (such as our Revolving Credit Facility) and
applicable law.
Provisions
of
our
corporate
charter
documents,
our
stockholder
rights
plan
and
Delaware
law
could
make
it
more
difficult
for
a
third
party
to
acquire
us,
even
if
the
offer
may
be
considered
beneficial
by
our
stockholders.
Provisions of the Delaware General Corporation Law could discourage potential acquisition proposals and could delay, deter or prevent a change in control.
The anti-takeover provisions of the Delaware General Corporation Law impose various impediments to the ability of a third party to acquire control of us, even if a
change in control would be beneficial to our existing stockholders. Specifically, Section 203 of the Delaware General Corporation Law, unless its application has
been waived, provides certain default anti-takeover protections in connection with transactions between us and an “interested stockholder.” Generally, Section 203
prohibits stockholders who, alone or together with their affiliates and associates, own more than 15% of the subject company from engaging in certain business
combinations for a period of three years following the date that the stockholder became an interested stockholder of such subject company without approval of the
board or the vote of two-thirds of the shares held by the independent stockholders. Our board of directors has also adopted a stockholder rights plan, or “poison
pill,” which would significantly dilute the ownership of a hostile acquirer. Additionally, provisions of our amended and restated certificate of incorporation and
bylaws could deter, delay or prevent a third party from acquiring us, even if doing so would benefit our stockholders, including without limitation, the authority of
the board of directors to issue, without stockholder approval, preferred stock with such terms as the board of directors may determine.
We
may
issue
additional
shares
of
our
common
stock
or
instruments
convertible
into
shares
of
our
common
stock,
which
could
cause
our
stock
price
to
fall
and
cause
dilution
to
existing
stockholders.
In
addition,
a
sale
of
a
substantial
number
of
shares
of
our
common
stock
in
the
public
market
could
cause
the
market
price
of
our
common
stock
to
decline
significantly.
We may from time to time issue additional shares of common stock or other instruments convertible into, or exchangeable or exercisable for, shares of our
common stock, including in connection with potential in-licensing and acquisition transactions. The issuance of additional shares of our common stock would
dilute the ownership interests of existing holders of our common stock.
The issuance of a substantial number of shares of our common stock, the sale of a substantial number of shares of our common stock that were previously
restricted from sale in the public market, or the perception that these issuances or sales might occur, could depress the market price of our common stock. As a
result, investors may not be able to sell their shares of our securities at a price equal to or above the price they paid to acquire them.
Furthermore, the issuance of additional shares of our common stock, or the perception that such issuances might occur, could impair our ability to raise
capital through the sale of additional equity securities.
43
We
rely
on
Astellas
to
timely
deliver
important
financial
information
relating
to
net
sales
of
XTANDI.
In
the
event
that
this
information
is
inaccurate,
incomplete,
or
not
timely,
we
may
not
be
able
to
timely
or
fully
meet
our
f
inancial
reporting
obligations
as
required
by
the
SEC.
Under the Astellas Collaboration Agreement, Astellas has exclusive control over the flow of information relating to net sales of XTANDI that we are
dependent upon to meet our SEC reporting obligations. Astellas is required under the Astellas Collaboration Agreement to provide us with timely and accurate
financial data related to net sales of XTANDI so that we may meet our reporting obligations under federal securities laws. In the event that Astellas fails to provide
us with timely and accurate information, we may incur significant liability with respect to federal securities laws, our internal controls and procedures under the
Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, may be inadequate, and we could be required to record adjustments in future periods, any of which could
adversely affect the market price of our common stock and subject us to securities litigation.
To
the
extent
that
we
create
any
joint
ventures
or
have
any
variable
interest
entities
for
which
we
are
required
to
consolidate,
we
would
need
to
rely
on
those
entities
to
timely
deliver
important
financial
information
to
us.
In
the
event
that
the
financial
information
is
inaccurate,
incomplete,
or
not
timely,
we
would
not
be
able
to
meet
our
financial
reporting
obligations
as
required
by
the
SEC.
While we currently do not have any joint ventures or variable interest entities that we are required to consolidate, to the extent we create such joint ventures
or variable interest entities for which we would be required to consolidate and the financial statements of such entities are not prepared by us, we will not have
direct control over their financial statement preparation. As a result, we will, for our financial reporting, depend on what these entities report to us, which could
result in us adding monitoring and audit processes, which could increase the difficulty of implementing and maintaining adequate controls over our financial
processes and reporting in the future. This may be particularly true when such entities do not have sophisticated financial accounting processes in place, or where
we are entering into new relationships at a rapid pace, straining our integration capacity. Additionally, if we do not receive the information from the joint venture or
variable interest entity on a timely basis, this could cause delays in our external reporting obligations as required by the SEC.
Changes
in,
or
interpretations
of,
accounting
principles
could
have
a
significant
impact
on
our
financial
position
and
results
of
operations.
We prepare our consolidated financial statements in accordance with accounting principles generally accepted in the United States of America, or U.S.
GAAP. These principles are subject to interpretation by the SEC and various other bodies formed to interpret and create appropriate accounting principles. A
change in these principles can have a significant effect on our reported results and may even retroactively affect previously reported transactions.
For example, the Financial Accounting Standards Board, or FASB, is currently working together with the International Accounting Standards Board, or
IASB, on several projects to further align accounting principles and facilitate more comparable financial reporting between companies who are required to follow
U.S. GAAP under SEC regulations and those who are required to follow International Financial Reporting Standards outside of the United States. These efforts by
the FASB and the IASB may result in different accounting principles under U.S. GAAP that may result in materially different financial results for us in areas
including, but not limited to, principles for recognizing revenue and lease accounting.
Failure
to
maintain
effective
internal
control
over
financial
reporting
in
accordance
with
the
Sarbanes-Oxley
Act
could
have
a
material
adverse
effect
on
our
stock
price.
Section 404 of the Sarbanes-Oxley Act and the related rules and regulations of the SEC require an annual management assessment of the effectiveness of
our internal control over financial reporting and a report by our independent registered public accounting firm attesting to the effectiveness of our internal control
over financial reporting at the end of the fiscal year. If we fail to maintain the adequacy of our internal control over financial reporting, as such standards are
modified, supplemented or amended from time to time, we may not be able to ensure that we can conclude on an ongoing basis that we have effective control over
financial reporting in accordance with the Sarbanes-Oxley Act and the related rules and regulations of the SEC. If we cannot in the future favorably assess, or our
independent registered public accounting firm is unable to provide an unqualified attestation report on, the effectiveness of our internal control over financial
reporting, investor confidence in the reliability of our financial reports may be adversely affected, which could have a material adverse effect on our stock price.
Item
1B.
unresolved
Staff
Comments.
None.
44
Item
2.
P
roperties.
We currently do not own any properties. Our leased properties are as follows:
Approximate
Square
Feet
location
Purpose
Term
143,000
San Francisco, California
Corporate headquarters
Expiration June 2019
with an option to
extend the lease for an
additional five years
44,000
San Francisco, California
Office and
laboratory facility
Expiration August 2024
with an option to
extend the lease for up
to an additional five
years
15,000
Oakbrook Terrace, Illinois
Former commercial
headquarters (subleased to
a third party)
Expiration December
2019
We believe our properties are adequately maintained and suitable for their intended use. As we continue to expand our operations, we may need to lease
additional or alternate facilities.
Item
3.
legal
Proceedings.
We are involved in legal proceedings, investigations, and claims in the ordinary course of our business, including the matters described below.
In May 2011, we filed a lawsuit in San Francisco Superior Court against the Regents of the University of California, and one of its professors, alleging
breach of contract and fraud claims, among others. Our allegations in this lawsuit include that we have exclusive commercial rights to apalutamide, an
investigational drug originally known as ARN-509 (previously also referred to as JNJ-56021927, or JNJ-927), which is currently being developed by Aragon
Pharmaceuticals, or Aragon. In August 2013, Johnson & Johnson and Aragon completed a transaction in which Johnson & Johnson acquired all apalutamide assets
owned by Aragon. We sought remedies including a declaration that we are the proper licensee of apalutamide, contractual remedies conferring to us exclusive
patent license rights regarding apalutamide, and other equitable and monetary relief. On August 7, 2012, the Regents filed a cross-complaint against us seeking
declaratory relief that the Regents are entitled to ten percent of any sales milestone payments under the Astellas Collaboration Agreement.
On December 20, 2012, and January 25, 2013, the Court granted summary judgment motions filed by defendants Regents and Aragon, resulting in dismissal
of all claims against Regents and Aragon, but denied such motions filed by the remaining Regents professor. On April 15, 2013, we filed a Notice of Appeal
seeking appeal of the judgment in favor of Aragon, which is now wholly-owned by Johnson & Johnson. The bench trial of the Regent’s cross-complaint against us
was conducted in July 2013, and on January 15, 2014, the Court entered a judgment in the cross-complaint in favor of Regents. We appealed this judgment on
February 13, 2014 along with the December 2012 summary judgment order in favor of Regents. The jury trial of our breach of contract and fraud claims against the
remaining Regents professor was conducted in October and November 2013. On November 15, 2013, the jury rendered a verdict in the case, finding in our favor on
one of the breach of contract claims, and in favor of the Regents professor on the fraud claims. The Company appealed the resulting judgment on the fraud
claims. All appeals from this matter were consolidated, and oral arguments were heard on February 23, 2016. A decision of the appellate court is required to be
rendered within 90 days of the oral argument.
On April 11, 2014, the Regents filed a complaint against us in which UCLA alleges that the “Operating Profits” we have received (and will continue to
receive) from Astellas, as a result of the Astellas Collaboration Agreement, constitute Sublicensing Income under the license agreement between us and the
Regents and that we and our subsidiary, Medivation Prostate Therapeutics, Inc., have failed to pay the Regents ten percent of such Operating Profits. We deny the
Regents’ allegations and are vigorously defending the litigation. We are currently awaiting a trial date to be set by the Courts.
While we believe we have meritorious positions with respect to the claims above and intend to advance our positions in these lawsuits vigorously, including
on appeal, the process of resolving matters through litigation or other means is inherently uncertain, and it is not possible to predict the ultimate resolution of any
such proceeding. The actual costs of defending our position may be significant, and we may not prevail.
Item
4.
Mine
Safety
disclosures.
None.
45
PART
II
Item
5.
Market
for
Registrant’s
Common
Equity,
Related
Stockholder
Matters
and
Issuer
Purchases
of
Equity
Securities.
Market
Information
Our common stock, par value $0.01, is listed on the NASDAQ Global Select Market under the symbol “MDVN.” The following table sets forth on a per
share basis the high and low intraday sales prices of our common stock as reported by the NASDAQ Global Select Market:
high
(1)
2015:
Quarter ended March 31, 2015
Quarter ended June 30, 2015
Quarter ended September 30, 2015
Quarter ended December 31, 2015
2014:
Quarter ended March 31, 2014
Quarter ended June 30, 2014
Quarter ended September 30, 2014
Quarter ended December 31, 2014
(1)
low
(1)
$
$
$
$
70.79
67.67
58.08
48.77
$
$
$
$
48.80
54.93
38.08
37.63
$
$
$
$
44.10
39.18
51.94
58.62
$
$
$
$
30.31
27.19
34.56
43.24
All sales prices have been retroactively adjusted to reflect our September 15, 2015, two-for-one forward stock split effected through a stock dividend.
Stockholders
As of the close of business on February 16, 2016, there were 18 stockholders of record of our common stock. The number of stockholders of record is based
upon the actual number of stockholders registered at such date and does not include holders of shares in “street names” or persons, partnerships, associates, or
corporations, or other entities identified in security listings maintained by depositories.
dividends
We have never paid our stockholders cash dividends and we do not anticipate paying any cash dividends in the foreseeable future as we intend to retain all
of our cash for use in our business. Any future determination to pay dividends will be at the discretion of our Board of Directors, and will depend on a number of
factors, including but not limited to any contractual restrictions on paying dividends, outstanding indebtedness, earnings, capital requirements, financial condition
and future prospects, and applicable Delaware law. Our Revolving Credit Facility imposes contractual restrictions on us with respect to paying cash dividends.
46
Performance
graph
We have presented below the cumulative total return to our stockholders during the period from December 31, 2010 through December 31, 2015, in
comparison to the cumulative total returns of the NASDAQ Composite Index and the NASDAQ Biotechnology Index. All values assume a $100 initial investment
and the reinvestment of the full amount of all dividends and are calculated as of the last stock trading day of each year. The comparisons are based on historical
data and are not indicative of, nor intended to forecast, the future performance of our common stock.
Medivation, Inc.
NASDAQ Composite Index
NASDAQ Biotechnology Index
2010
$
$
$
100.00
100.00
100.00
2011
$
$
$
304.22
99.17
112.07
2012
$
$
$
674.93
116.48
148.26
2013
$
$
$
841.95
163.21
246.14
2014
$
$
$
1,314.25
187.27
330.83
2015
$
$
$
1,275.46
200.31
369.75
The information under “Performance Graph” is not deemed to be “soliciting material” or “filed” with the Securities and Exchange Commission or subject to
Regulation 14A or 14C, or to the liabilities of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference in any
filing of Medivation under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of
this Annual Report on Form 10-K and irrespective of any general incorporation language in those filings.
Recent
Sales
of
unregistered
Securities
None.
Repurchases
of
Equity
Securities
None.
47
Item
6.
Selected
Financial
data.
The following is a summary of our historical consolidated financial data for the years ended and on the dates indicated below. The historical consolidated
financial data for the years ended December 31, 2015, 2014 and 2013 and as of December 31, 2015 and 2014 have been derived from our audited consolidated
financial statements included in this Annual Report on Form 10-K, or Annual Report. The historical financial data for the years ended December 31, 2012 and 2011
and as of December 31, 2013, 2012 and 2011 have been derived from our audited consolidated financial statements not included in this Annual Report. The
information below is not necessarily indicative of results of future operations, and should be read in conjunction with Item 7, “Management’s Discussion and
Analysis of Financial Condition and Results of Operations,” and the consolidated financial statements and related notes thereto included in this Annual Report to
fully understand factors that may affect the comparability of the information presented below.
Consolidated
Statement
of
Operations
data:
Collaboration revenue
Operating expenses:
Research and development expenses
Selling, general and administrative expenses
Total operating expenses
Income (loss) from operations
Other income (expense), net:
Loss on extinguishment of convertible debt
Interest expense
Other, net
Total other income (expense), net
Income (loss) before income tax benefit (expense)
Income tax benefit (expense)
Net income (loss)
2015
$
years
Ended
december
31,
2014
2013
2012
(in
thousands,
except
per
share
data)
943,258
$
232,100
296,545
528,645
414,613
710,487
$
272,942
$
181,696
2011
$
60,389
189,570
239,071
428,641
281,846
118,952
176,231
295,183
(22,241)
95,628
112,282
207,910
(26,214)
73,432
29,887
103,319
(42,930)
—
(21,690)
38
(21,652)
260,194
16,258
276,452 $
—
(20,249)
(8)
(20,257)
(42,498)
(115)
(42,613) $
—
(14,985)
(51)
(15,036)
(41,250)
(7)
(41,257) $
—
—
(242)
(242)
(43,172)
4,331
(38,841)
$
(21,087)
(12,483)
275
(33,295)
381,318
(136,593)
244,725 $
Basic net income (loss) per common share (1)
$
1.53
$
1.80
$
(0.28) $
(0.28) $
(0.28)
Diluted net income (loss) per common share (1)
$
1.47
$
1.71
$
(0.28) $
(0.28) $
(0.28)
Weighted-average common shares used in the calculation
of basic net income (loss) per common share (1)
160,345
153,859
150,331
146,949
139,842
Weighted-average common shares used in the calculation
of diluted net income (loss) per common share (1)
169,324
170,001
150,331
146,949
139,842
Consolidated
Balance
Sheet
data:
Cash, cash equivalents and short-term investments
Working capital
Total assets
Convertible Notes, net of unamortized discount
Retained earnings (accumulated deficit)
Total stockholders’ equity
(1)
2015
2014
december
31,
2013
(in
thousands)
2012
2011
$
$
$
$
$
225,853
368,115
1,431,591
—
186,199
872,679
$
$
$
$
$
$
502,677
602,216
911,619
222,140
(57,709)
449,299
$
$
$
$
$
$
228,788
258,290
392,650
208,414
(334,161)
76,947
$
$
$
$
$
$
296,240
259,330
371,866
196,007
(291,548)
73,645
$
$
$
$
$
145,132
78,555
175,117
—
(250,291)
1,321
All share and per share amounts have been retroactively adjusted to reflect our September 15, 2015, two-for-one forward stock split effected through a stock
dividend, which resulted in the issuance of approximately 81.7 million shares of our common stock, and our September 21, 2012, two-for-one forward stock
split, which resulted in the increase of approximately 37.0 million shares of our outstanding common stock.
48
Item
7.
Management’s
discussion
and
Analysis
of
Financial
Condition
and
R
esults
of
Operations.
The
following
discussion
and
analysis
should
be
read
in
conjunction
with
our
audited
consolidated
financial
statements
and
notes
thereto
for
the
year
ended
December
31,
2015,
included
elsewhere
in
this
Annual
Report
on
Form
10-K,
or
Annual
Report.
The
following
discussion
and
analysis
contains
“forward-looking
statements”
within
the
meaning
of
Section
27A
of
the
Securities
Act
of
1933,
as
amended,
and
Section
21E
of
the
Securities
Exchange
Act
of
1934,
as
amended,
or
the
Exchange
Act.
We
intend
that
these
forward-looking
statements
be
subject
to
the
safe
harbors
created
by
those
provisions.
Please
see
the
section
entitled
“Forward-Looking
Statements”
at
the
beginning
of
this
Annual
Report
for
important
information
you
should
know
regarding
these
forward-looking
statements
and
how
to
identify
them,
including
cautionary
language
regarding
undue
reliance
on
these
forward-looking
statements.
We
disclaim
any
intention
or
obligation
to
update,
supplement
or
revise
any
forward-looking
statements,
whether
as
a
result
of
new
information,
future
events
or
otherwise.
OvERvIEW
We are a biopharmaceutical company focused on the development and commercialization of medically innovative therapies to treat serious diseases for
which there are limited treatment options. We have one commercial product, XTANDI ® (enzalutamide) capsules, or XTANDI, through our collaboration with
Astellas Pharma, Inc., or Astellas. XTANDI has received marketing approval in the United States, Europe and numerous other countries worldwide for the
treatment of patients with metastatic castration-resistant prostate cancer, or mCRPC, and in Japan for the treatment of patients with castration-resistant prostate
cancer, or CRPC. We and Astellas are also conducting investigational studies of enzalutamide in prostate cancer, advanced breast cancer, and hepatocellular
carcinoma. Under our collaboration agreement with Astellas, we share equally with Astellas all profits (losses) related to U.S. net sales of XTANDI. We also
receive royalties ranging from the low teens to the low twenties as a percentage of ex-U.S. XTANDI net sales. The collaboration also involved certain milestone
payments from Astellas to us upon the achievement of defined development, regulatory and sales events, all of which have been achieved as of December 31, 2015.
We seek to become a more fully-integrated biopharmaceutical company through the continued commercialization of XTANDI, the acquisition or in-license
and development and commercialization of other product opportunities, and through the advancement of our own proprietary research and development programs.
We expect that our future growth may come from both internal research efforts and third-party business development activities. In the fourth quarter of 2015, we
acquired all worldwide rights to talazoparib (which we refer to as MDV3800), an orally available poly-ADP ribose polymerase, or PARP, inhibitor, from BioMarin
Pharmaceutical Inc., or BioMarin. MDV3800 is currently in a Phase 3 clinical trial for the treatment of patients with germline BRCA, or gBRCA, mutated
advanced breast cancer (i.e., advanced breast cancer in patients whose BRCA genes contain germline mutations). We are targeting a number of other indications in
which to investigate MDV3800, including breast cancer (beyond gBRCA mutations), prostate cancer, small cell lung cancer, and ovarian cancer. In the fourth
quarter of 2014, we licensed exclusive worldwide rights to pidilizumab (which we refer to as MDV9300), an antibody with immune-mediated anti-tumor effects for
all potential indications from CureTech, Ltd., or CureTech. Under the license agreement, we are responsible for all development, regulatory, manufacturing, and
commercialization activities for MDV9300. We initiated a Phase 2 clinical trial evaluating MDV9300 in patients with relapsed or refractory diffuse large B-cell
lymphoma in the fourth quarter of 2015, which is on partial clinical hold pending our revision of certain investigator brochure, protocols and informed consent
documents. We submitted the revised documents to the FDA in early February 2016 and the FDA has 30 days thereafter to notify us if the partial hold is lifted. We
also plan to develop MDV9300 in other hematologic malignancies such as multiple myeloma.
In addition to the above activities, we have various internal research and discovery efforts focused in oncology, neurology and other areas. Additional
information regarding our business is included in Part I, Item 1, “Business,” included elsewhere in this Annual Report. Business and financial highlights for the
year ended December 31, 2015 are included below in the sections entitled, “2015 Clinical and Business Highlights” and “2015 Financial Highlights,” respectively.
OuTlOOk
2016
In 2016, our key objectives are to increase the commercial potential of XTANDI and advance our pipeline.
The largest opportunity for XTANDI lies in earlier stage prostate cancer, which is primarily treated by urologists. In late 2015, we expanded our sales
force and created separate urology- and oncology-focused teams. This, along with the potential inclusion of data from STRIVE and TERRAIN into the relevant
clinical trials section of our XTANDI label within the current mCRPC indication, which may occur as early as the second half of 2016, may help us capture the
next wave of growth for XTANDI. We are sensitive, however, to conditions that may affect XTANDI’s growth, such as pricing pressure from third party payors
and advocacy groups to reduce healthcare costs in the U.S. and abroad.
49
From a research and development perspective, we plan to continue to invest in our ongoing clinical studies to cover the continuum of prostate cancer care,
advance our development of enzalutamide for the treatment of advanced breast cancer, fully enroll our gBRCA mutated advanced breast cancer clinical trial for
MDV3800, advance MDV9300 in DLBCL and prepare for other hematologic indications such as multiple myeloma, and further the development and growth of our
internal pipeline. Furthermore, we also plan t o initiate start-up activities for a number of phase 2 and potentially pivotal clinical trials to develop MDV3800
beyond gBRCA mutations. As a result, we expect that our research and development and selling, general and administrative expenses will notabl y increase above
the levels recorded in 2015.
2015
ClINICAl
ANd
BuSINESS
hIghlIghTS
The following summarizes our recent clinical and business highlights:
•
In December 2015, we expanded our XTANDI U.S. sales force and created separate urology- and oncology-focused teams. We believe this structure
will afford us greater ability to reach and detail the respective physician audiences more effectively.
•
During 2015, we presented updated data from our Phase 2 study evaluating the investigational use of enzalutamide as a single agent for the treatment
of advanced androgen receptor, or AR, positive, triple-negative breast cancer, or TNBC. An exploratory analysis of overall survival data collected as
of September 15, 2015 demonstrated that patients treated with enzalutamide whose tumors tested positive according to a novel diagnostic assay
experienced a 13.8-month longer median overall survival duration compared to those patients whose tumor tested negative for the novel gene
expression profile. Median overall survival in the diagnostic positive group treated with enzalutamide was 21.3 months (95% CI: 12.9, 21.3)
compared with 7.5 (95% CI: 4.8, 11.2) months for the diagnostic negative group treated with enzalutamide. Multicovariate analyses demonstrated
that only diagnostic status (positive) and number of prior lines of therapy (0-1) were statistically significantly and independently associated with both
improved PFS and overall survival outcomes. Additional variables included in the multi-covariate analyses were age (≥65 vs. < 65 years), disease
free interval between primary and metastatic disease (≥12 months vs. <12 months), AR immunohistochemistry (≥10% vs. <10%). The most common
(reported in ³
10% of patients) adverse events reported as related to enzalutamide treatment were fatigue (34%), nausea (25%), decreased appetite
(13%), diarrhea (10%), and hot flush (10%).
Additionally, we entered into a collaboration agreement with NanoString Technologies, Inc. and our partner Astellas, in January 2016, to translate
our gene expression profile into a companion diagnostic assay using NanoString’s nCounter® Dx Analysis System for potential use as a companion
diagnostic test for enzalutamide for TNBC.
•
In October 2015, we completed an acquisition of all rights to MDV3800 from BioMarin pursuant to an asset purchase agreement. The acquired
MDV3800 assets include all patents, data, know-how, third-party agreements, regulatory materials and pre-commercial inventories. We also
assumed certain costs for ongoing clinical trials of MDV3800, and commitments under certain agreements previously entered into or assumed by
BioMarin and assigned to us. In connection with the transaction, we paid BioMarin an upfront cash payment of $410.0 million in the fourth quarter
of 2015. BioMarin is eligible to receive up to an additional $160.0 million upon the achievement of defined regulatory and sales-based milestones
and mid-single digit royalties on net sales of products that contain MDV3800 during the royalty term specified in the agreement. The parties entered
into a transition services agreement at the closing of the transaction to facilitate the transition of the research and development activities relating to
MDV3800 from BioMarin to us, including responsibility for the ongoing clinical studies.
•
In September 2015, we entered into a Credit Agreement, or the Original Credit Agreement, with JPMorgan Chase Bank, N.A., which provided for
(i) a one-year $75.0 million revolving loan facility and (ii) an uncommitted accordion facility subject to the satisfaction of certain conditions. We
executed a borrowing of $75.0 million under this facility in September 2015. In October 2015, we entered into an amendment and restatement of the
Original Credit Agreement, or the Credit Agreement, which provides for (i) a five-year $300.0 million revolving loan facility, or the Revolving
Credit Facility, and (ii) an uncommitted accordion facility subject to the satisfaction of certain conditions. In October 2015, we borrowed $75.0
million under the Revolving Credit Facility, which was used to repay the $75.0 million outstanding at September 30, 2015 under the Original Credit
Agreement. In January 2016, we repaid the $75.0 million outstanding under the Revolving Credit Facility. Additional information is included in
Note 10, “Debt,” to our consolidated financial statements included elsewhere in this Annual Report.
•
In July 2015, the U.S. Food and Drug Administration, or FDA, approved a label update for XTANDI based on an updated overall survival analysis
of the Phase 3 PREVAIL trial. This analysis was conducted when 784 deaths were observed and found an overall survival benefit with a 23%
reduction in risk of death (Hazard ratio = 0.77; 95% CI: 0.67, 0.88) and a 4-month improvement in median survival with enzalutamide (35.3 months
[95% CI: 32.2, not yet reached]) over placebo (31.3 months [95% CI: 28.8, 34.2]).
50
•
In April 2015, we and Astellas reported top-line results from the Phase 2 STRIVE trial. The trial achieved its primary endpoint demonstrating a
statistically significant increase in PFS, defined as time from randomization to radiographic (bone or soft tissue) progression, prostate-specific
antigen (PSA) progression (defined by Prostate Cancer Working Group 2 criteria), or death due to any cause, whichever occurs first , for patients
with CRPC for enzalutamide compared with bicalutamide (Hazard Ratio = 0. 24; 95% CI: 0.18, 0.32; p < 0.0001). Median PFS was 19.4 months in
the enzalutamide group compared with 5.7 months in the bicalutamide group. The median time on treatment in the STRIVE trial was 14.7 months in
the enzalutamide group versus 8.4 months in th e bicalutamide group. Serious adverse events were reported in 29.4% of enzalutamide-treated
patients and 28.3% of bicalutamide-treated patients. Grade 3 or higher cardiac adverse events were reported in 5.1% of enzalutamide-treated patients
versus 4.0% of bicalutamide-treated patients. One seizure was reported in the trial in the enzalutamide-treated group and none in the bicalutamidetreated group.
•
In January 2015, we and Astellas reported top-line results from the Phase 2 TERRAIN trial. The trial achieved its primary endpoint demonstrating a
statistically significant increase in PFS, defined as time from randomization to centrally determined radiographic progression, skeletal-related event,
initiation of new anti-neoplastic therapy or death, whichever occurred first, for patients with metastatic CRPC for enzalutamide compared to
bicalutamide (Hazard Ratio = 0.44; 95% CI: 0.34, 0.57; p < 0.0001). Median PFS was 15.7 months in the enzalutamide group compared to 5.8
months in the bicalutamide group. The median time on treatment in the TERRAIN trial was 11.7 months in the enzalutamide group versus 5.8
months in the bicalutamide group. Serious adverse events were reported in 31.1% of enzalutamide-treated patients and 23.3% of bicalutamide-treated
patients. Grade 3 or higher cardiac adverse events were reported in 5.5% of enzalutamide-treated patients versus 2.1% of bicalutamide-treated
patients. Two seizures were reported in the enzalutamide group and one in the bicalutamide group.
2015
FINANCIAl
hIghlIghTS
•
Net sales of XTANDI as reported by Astellas and collaboration revenue related to net sales of XTANDI are summarized in the table below (dollars
in millions):
years
Ended
december
31,
2015
2014
Worldwide net sales of XTANDI (as reported by Astellas)
Increase year-over-year
Percentage change
$
$
1,908
$
847
80%
1,061
U.S. XTANDI net sales (as reported by Astellas)
Increase year-over-year
Percentage change
$
$
1,151
$
471
69%
680
Ex-U.S. XTANDI net sales (as reported by Astellas)
Increase year-over-year
Percentage change
$
$
757
$
376
99%
381
Collaboration revenue
Increase year-over-year
Percentage change
$
$
943
$
233
33%
710
•
Milestone payments earned under the Astellas Collaboration Agreement were $245.0 million for the year ended December 31, 2015. During the third
quarter of 2015, we earned a $70.0 million sales milestone payment triggered by the achievement of $1.2 billion in worldwide XTANDI net sales, as
reported by Astellas. During the fourth quarter of 2015, we earned a $175.0 million sales milestone payment triggered by the achievement of $1.6
billion in worldwide XTANDI net sales, as reported by Astellas. As of December 31, 2015, we have earned all development and sales milestone
payments under the Astellas Collaboration Agreement.
•
Total operating expenses for the year ended December 31, 2015 were $528.6 million, an increase of $100.0 million, or 23%, from the year ended
December 31, 2014. Operating expenses included non-cash stock-based compensation expense of $54.9 million and $45.1 million for the years
ended December 31, 2015 and 2014, respectively. Operating expenses for the year ended December 31, 2015 also included non-cash expense of
$30.0 million resulting from an impairment charge related to our intangible assets.
•
Cash and cash equivalents were $225.9 million at December 31, 2015, a decrease of $276.8 million, or 56%, from $502.7 million at December 31,
2014. During the fourth quarter of 2015, we utilized $410.0 million of cash and cash equivalents to pay the upfront fee to BioMarin under the terms
of the asset purchase agreement for MDV3800 as discussed elsewhere
51
in this Annual Report. At December 31, 2015, the collaboration receivable from Astellas was $391.6 million, all of which was received in the first
quarter of 2016.
ChANgES
TO
CAPITAl
STRuCTuRE
•
On June 15, 2015, we filed a Certificate of Amendment to our Amended and Restated Certificate of Incorporation, as amended, effecting an increase
in the total number of authorized shares of our capital stock from 171,000,000 to 341,000,000 and an increase in the total number of shares of
authorized shares of our common stock from 170,000,000 to 340,000,000.
•
On September 15, 2015, we effected a two-for-one forward stock split of our common stock in the form of a stock dividend. Stockholders of record
as of August 13, 2015, received one additional share of our common stock, par value $0.01, for each share they held as of the record date. We issued
approximately 81.7 million shares of our common stock as a result of the stock dividend. The par value of our common stock remained unchanged at
$0.01 per share.
•
During the year ended December 31, 2015, we settled $258.8 million aggregate principal amount of our 2.625% convertible senior notes due April 1,
2017, or the Convertible Notes, through a combination of $259.9 million in cash and 5,638,576 shares of our common stock. We recorded a non-cash
loss on extinguishment of the Convertible Notes of $21.1 million for the year ended December 31, 2015. Upon settlement, the Convertible Notes
were no longer outstanding, interest ceased to accrue thereon, and all rights of the holders of the Convertible Notes ceased to exist.
CRITICAl
ACCOuNTINg
POlICIES
ANd
ThE
uSE
OF
ESTIMATES
The preparation of our consolidated financial statements and related footnotes requires us to make estimates, assumptions and judgments in certain
circumstances that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and
the reported amounts of revenues and expenses during the reporting period. We have based our estimates on historical experience and on various other assumptions
that we believe to be reasonable under the circumstances. We have discussed the development, selection and disclosure of these estimates with the Audit
Committee of our Board of Directors. Actual results could differ materially from these estimates under different assumptions or conditions.
An accounting policy is considered to be critical if it requires an accounting estimate to be made based on assumptions about matters that are highly
uncertain at the time the estimate is made, and if different estimates that reasonably could have been used, or changes in the accounting estimates that are
reasonably likely to occur periodically, could materially impact the consolidated financial statements. We believe that certain of our accounting policies are critical
because they are the most important to the preparation of our consolidated financial statements. These policies require our most subjective and complex judgments,
often requiring the use of estimates about the effects of matters that are inherently uncertain. Once adopted, we consistently apply our critical accounting policies.
A detailed description of our significant accounting policies is included in the footnotes to our audited consolidated financial statements included elsewhere
in this Annual Report. A subsection of these accounting policies identified by management as “Critical Accounting Policies” are included below.
Collaboration
Agreements
Estimated
Performance
Periods
Our collaboration agreements contain multiple elements and deliverables. We evaluated the facts and circumstances of the Astellas Collaboration
Agreement and concluded that we had multiple deliverables, including deliverables relating to grants of technology licenses, and performance of manufacturing,
regulatory and clinical development activities in the United States. Under the Astellas Collaboration Agreement, the period in which we performed our deliverables
began in the fourth quarter of 2009 and concluded during the third quarter of 2015 upon completion of our remaining performance obligations. We also concluded
that our deliverables under the Astellas collaboration should be accounted for as a single unit.
Estimation of the performance periods of our deliverables requires the use of our management’s judgment. Significant factors considered in management’s
evaluation of the estimated performance periods include, but are not limited to, our experience, along with our collaboration partner’s experience, in conducting
manufacturing, clinical development and regulatory activities. We review the estimated duration of our performance period under our collaboration agreements on
a quarterly basis and make any appropriate adjustments on a prospective basis.
Collaboration
Agreement
Payments
We account for the various payment flows under the Astellas Collaboration Agreement in a consistent manner, as follows:
Upfront
Payments.
We received a non-refundable, upfront cash payment of $110.0 million pursuant to the Astellas Collaboration Agreement. We
recognized the payment as collaboration revenue on a straight-line basis over the applicable estimated
52
performance period. As of December 31, 2015, there was no deferred revenue related to payments received under the Ast ellas Collaboration Agreement .
Milestone
Payments
.
We have been eligible to receive milestone payments under the Astellas Collaboration Agreement based on achievement of specified
development, regulatory and commercial events. We evaluated the nature of the events triggering these contingent payments, and concluded that these events fall
into two categories: (a) events which involve the performance of our obligations under the Astellas Collaboration Agreement, and (b) events which do not involve
the performance of our obligations under the Astellas Collaboration Agreement.
The former category of milestone payments consists of those triggered by development and regulatory activities in the United States and by the acceptance
for review of marketing applications in Europe and Japan. We concluded that each of these payments, with one exception, constitute substantive milestone
payments. This conclusion was based primarily on the facts that (i) each triggering event represented a specific outcome that could be achieved only through
successful performance by us of one or more of our deliverables, (ii) achievement of each triggering event was subject to inherent risk and uncertainty and would
result in additional payments becoming due to us, (iii) each of the milestone payments was non-refundable, (iv) substantial effort was required to complete each
milestone, (v) the amount of each milestone payment was reasonable in relation to the value created in achieving the milestone, (vi) a substantial amount of time
was expected to pass between the upfront payment and the potential milestone payments, and (vii) the milestone payments related solely to past performance.
Based on the foregoing, we recognized any revenue from these milestone payments in the period in which the underlying triggering event occurs. The one
exception is the milestone payment for initiation of the Phase 3 PREVAIL trial, an event which we deemed to be reasonably assured at the inception of the Astellas
collaboration. This milestone payment was triggered in the third quarter of 2010, and we recognized it as collaboration revenue on a straight-line basis over the
estimated remaining performance period of the Astellas Collaboration Agreement.
The latter category of milestone payments consist of those triggered by potential marketing approvals in Europe and Japan, and commercial activities
globally, all of which were areas in which we had no pertinent contractual responsibilities under the Astellas Collaboration Agreement. We concluded that these
payments constitute contingent revenues and thus recognized them as revenue in the period in which the contingency was met.
As of December 31, 2015, we have earned all development and sales milestone payments under the Astellas Collaboration Agreement.
Royalties
and
Profit
(Loss)
Sharing
Payments.
Under the Astellas Collaboration Agreement, we share equally profit (losses) on sales of products in the
United States and we are eligible to receive royalties on sales of products outside the United States. We consider these payments to be contingent revenues, and we
recognize them as revenue in the period in which the applicable contingency is resolved.
Cost-Sharing
Payments.
Under the Astellas Collaboration Agreement, we and Astellas share certain development and commercialization costs in the United
States, including cost of goods sold and the royalty on net sales payable to The Regents of the University of California, or UCLA (or the Regents), under our
license agreement with UCLA. We and Astellas make quarterly cost-sharing payments to one another in amounts necessary to ensure that each party bears its
contractual share of the overall shared U.S. development and commercialization costs incurred. Our policy is to account for cost-sharing payments to our
collaboration partners as increases in expense in our consolidated statements of operations, while cost-sharing payments by our collaboration partners to us are
accounted for as reductions in expense. Cost-sharing payments related to development activities and commercialization activities are recorded in research and
development expenses, or R&D expenses, and selling, general and administrative expenses, or SG&A expenses, respectively.
Reliance
on
Third-Party
Information.
Under the Astellas Collaboration Agreement, Astellas records all XTANDI sales globally and has operational
responsibility for certain development and commercialization activities in the United States for which we share costs. Thus, Astellas has control over certain
XTANDI-related financial information needed to prepare our financial statements and related disclosures, including information regarding gross sales, net sales,
gross-to-net sales deductions, including estimates of potential future product returns, and shared U.S. development and commercialization costs incurred by
Astellas. We are dependent on Astellas to provide us with such information in a timely and accurate manner for use in preparing our consolidated financial
statements and related disclosures. Certain of this information provided by Astellas is subject to estimates, including estimates used in determining gross-to-net
revenue deductions such as payor mix, discounts (including legally mandated discounts to government entities), returns, chargebacks, rebates, and participation
levels in patient assistance programs, and estimates regarding accrued development and commercialization costs incurred by Astellas. Under the Astellas
Collaboration Agreement, the deductions from gross sales used to derive net sales of XTANDI are determined in a manner consistent with GAAP, consistently
applied. Should Astellas fail to provide us with any such financial information in a timely manner, or should any such financial information provided by Astellas,
or any of the estimates upon which such financial information was based, prove to be inaccurate ,
we could be required to record adjustments in future periods.
53
Research
and
Development
Expense
and
Accruals
R&D expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process
development costs, research costs, upfront and development milestone payments under license agreements, and other consulting services. Research and
development costs are expensed as incurred unless there is an alternative future use in other research and development projects. Non-refundable advance payment
for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have
been received rather than when payment has been made. In instances where we enter into agreements with third parties to provide research and development
services to us, costs are expensed as services are performed. Amounts due under such arrangements may be either fixed fee or fee for service, and may include
upfront payments, monthly payments, and payments upon the completion of milestones or receipt of deliverables.
Our accruals for clinical trials and other research and development activities are based on estimates of the services received and efforts expended pursuant to
contracts with numerous clinical trial centers, contract research organizations, and clinical manufacturing organizations. In the normal course of business we
contract with third parties to perform various research and development activities in the on-going development of our product candidates, including without
limitation, third-party clinical trial centers and contract research organizations that perform and administer our clinical trials on our behalf and clinical
manufacturing organizations that manufacture clinical trial materials. The financial terms of these agreements are subject to negotiation and vary from contract to
contract and may result in uneven payment flows. Payments under these agreements depend on factors such as the achievement of certain events, the successful
enrollment of patients, and the completion of portions of the clinical trial or similar conditions. The objective of our accrual policy is to match the recording of
expenses in our consolidated financial statements to the actual services received and efforts expended. As such, expense accruals related to clinical trials and other
research and development activities are recognized based on our estimate of the degree of completion of the event or events specified in the specific agreement.
Our accrual estimates are dependent upon the timeliness and accuracy of data provided by third parties regarding the status and cost of studies, and may not
match the actual services performed by these organizations. During the course of a clinical trial, we adjust our rate of clinical trial expense recognition if actual
results differ from our estimates. We make estimates of our accrued clinical trial expense as of each balance sheet date based on facts and circumstances known at
that time. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services
performed relative to the actual status and timing of services performed may vary and result in us reporting amounts that are too high or too low for any particular
period. This could result in adjustment to our R&D expense in future periods. We have had no significant adjustments to previously recorded amounts.
Stock-Based
Compensation
We have outstanding stock options, restricted stock units, and stock appreciation rights pursuant to our Amended and Restated 2004 Equity Incentive Award
Plan, or the Medivation Equity Incentive Plan, and eligible employees may purchase shares pursuant to the Medivation, Inc. 2013 Employee Stock Purchase Plan,
or ESPP.
Stock-based compensation expense associated with stock options is based on the estimated grant date fair value using the Black-Scholes valuation model,
which requires the use of subjective assumptions related to the expected stock price volatility, option term, risk-free interest rate and dividend yield. We recognize
compensation expense over the vesting period of the awards that are ultimately expected to vest.
Stock-based compensation expense associated with restricted stock units is based on the fair value of our common stock on the grant date, which equals the
closing market price of our common stock on the grant date. For restricted stock units, we recognize compensation expense over the vesting period of the awards
that are ultimately expected to vest.
The fair value of stock-settled and cash-settled stock appreciation rights is initially measured on the grant date using the Black-Scholes valuation model,
which requires the use of subjective assumptions related to the expected stock price volatility, term, risk-free interest rate and dividend yield. Similar to stock
options, compensation expense for stock-settled stock appreciation rights is recognized over the vesting period of the awards that are ultimately expected to vest
based on the grant-date fair value. Cash-settled stock appreciation rights are liability-classified awards for which compensation expense and the associated liability
are remeasured at each reporting date through the date of settlement based on the portion of the requisite service period rendered. Upon the conversion of cashsettled stock appreciation rights to stock-settled stock appreciation rights, the awards are remeasured using the then-current Black-Scholes assumptions and the
remeasured liability is reclassified to additional paid-in capital.
Equity awards to consultants are typically remeasured at fair value at each reporting date until the awards vest.
We account for the ESPP as a compensatory plan. The fair value of each purchase under the ESPP is estimated on the date of the beginning of the offering
period using the Black-Scholes valuation model, which requires the use of subjective assumptions related to the expected stock price volatility, term, risk-free
interest rate and dividend yield. We recognize compensation expense over the vesting period of the awards that are ultimately expected to vest.
54
Determining an estimate of the fair value of equity awards using the Black-Scholes valuation model requires the use of highly subjective assumptions
related to expected stock price volatility, term, risk-free interest rate and dividend yield. The Black-Scholes valuat ion model was developed for use in estimating
the fair value of traded options that have no vesting restrictions and are fully transferable; characteristics not present in the our stock options, stock appreciation
rights, or ESPP shares. If the model permi tted consideration of the unique characteristics of employee stock options, stock appreciation rights, and ESPP shares,
the resulting estimate of fair value of the stock options, stock appreciation rights, and ESPP shares could be different. In addition, i f we had made different
assumptions and estimates for use in the Black-Scholes valuation model, the amount of recognized and to be recognized stock-based compensation expense could
have been different. Please refer to the footnotes to the audited consolida ted financial statements included elsewhere in this Annual Report for further information
about the assumptions made by us and the impact of such assumptions.
We apply a forfeiture rate when determining stock-based compensation expense to account for an estimate of the granted awards not expected to vest. If
actual forfeitures differ from the expected rate, we may be required to make additional adjustments to compensation expense in future periods.
Leases
We use a consistent lease period (generally, the initial non-cancellable lease term plus renewal option periods provided for in the lease that can be
reasonably assured) when calculating amortization of leasehold improvements and in determining straight-line rent expense and classification of a lease as either an
operating lease or capital lease. The lease term and straight-line rent expense commence on the date when we take possession and have the right to control the use
of the leased premises. Funds received from the lessor intended to reimburse us for the cost of leasehold improvements are recorded as deferred rent resulting from
a lease incentive and are amortized over the lease term as a reduction to rent expense.
Build-to-Suit
Lease
Accounting
In certain lease arrangements, we are involved in the construction of the building. To the extent we are involved with structural improvements of the
construction project or take construction risk prior to the commencement of a lease, Financial Accounting Standards Board, or FASB, Accounting Standards
Codification, or ASC, 840-40, “Leases – Sale-Leaseback Transactions (Subsection 05-5)”, requires us to be considered the owner for accounting purposes of these
types of projects during the construction period. Therefore, we record an asset in property and equipment, net on the consolidated balance sheets, including
capitalized interest costs, for the replacement cost of our portion of the pre-existing building plus the amount of estimated structural construction costs incurred by
the landlord and us as of the balance sheet date. We record a corresponding build-to-suit lease obligation on our consolidated balance sheets representing the
amounts paid by the lessor.
Once construction is complete, we consider the requirements for sale-leaseback accounting treatment, including evaluating whether all risks of ownership
have been transferred back to the landlord, as evidenced by a lack of continuing involvement in the leased property. If the arrangement does not qualify for saleleaseback accounting treatment, the building asset remains on our consolidated balance sheets at its historical cost, and such asset is depreciated over its estimated
useful life. We bifurcate our lease payments into a portion allocated to the building, and a portion allocated to the parcel of land on which the building has been
built. The portion of the lease payments allocated to the land are treated for accounting purposes as operating lease payments, and therefore recorded as rent
expense in the consolidated statements of operations. The portion of the lease payments allocated to the building is further bifurcated into a portion allocated to
interest expense and a portion allocated to reduce the build-to-suit lease obligation.
The interest rate used for the build-to-suit lease obligation represents our estimated incremental borrowing rate, adjusted to reduce any built in loss.
The initial recording of these assets and liabilities is classified as non-cash investing and financing items, respectively, for purposes of the consolidated
statements of cash flows.
The most significant estimates used by management in accounting for build-to-suit leases and the impact of these estimates are as follows:
•
Expected lease term - Our expected lease term includes both contractual lease periods and cancelable option extension periods in which failure to
exercise such options would result in an economic penalty. The expected lease term is used in determining the depreciable life of the asset or the
straight-line rent recognition period for the portion of the lease payment allocable to the land component. Increasing the expected lease term to
include cancelable optional extension periods would generally result in higher interest and depreciation expense for a build-to-suit lease recorded on
our consolidated balance sheet.
•
Incremental borrowing rate - We estimate our incremental borrowing rate using treasury rates for debt with maturities comparable to the expected
lease term and our credit spread. For build-to-suit leases recorded on our consolidated balance
55
sheet with a related build-to-suit lease o bligation, the incremental borrowing rate is used in allocating our rental payments between interest expense
and a reduction of the outstanding build-to-suit lease obligation.
•
Fair market value of leased asset - The fair market value of a build-to-suit lease property is based on replacement cost of the pre-construction shell
and comparable market data. Fair market value is used in determining the amount of the property asset and related build-to-suit lease obligation to be
recognized on our consolidated balance sheet for build-to-suit leases.
Goodwill
and
Intangible
Assets
Assets acquired and liabilities assumed in business combinations are recognized at the date of acquisition at their respective fair values. Any excess of the
purchase price over the estimated fair values of the net assets acquired is recognized as goodwill. We determine the fair value of intangible assets, including inprocess research and development, or IPR&D, using the multi-period excess earnings model of the “income method.” This method starts with a forecast of net cash
flows, risk adjusted for estimated probabilities of technical and regulatory success and adjusted to present value using an appropriate discount rate that reflects the
risk associated with the cash flow streams. The valuation process is very complex and requires significant input and judgment using internal and external sources.
Although the valuations are required to be finalized within a one-year period, we must consider all and only those facts and evidence available at the acquisition
date. The most complex and judgmental matters applicable to the valuation process are summarized below:
•
Unit of account—In valuing the IPR&D we consider whether the intangible asset should be valued as a single global asset rather than multiple assets
for each jurisdiction or indication after considering the development stage, expected levels of incremental costs to obtain the initial and subsequent
regulatory approvals, risks associated with further development, amount and timing of benefits expected to be derived in the future, expected patent
lives in various jurisdictions and the intention to promote the assets as a global brand.
•
Estimated useful life—The asset life expected to contribute meaningful cash flows is determined after considering all pertinent matters associated
with the asset, including expected regulatory approval dates (if unapproved), exclusivity periods, and other legal, regulatory, or contractual periods
as well as the effects of any obsolescence, demand, competition, and other economic factors, including barriers to entry.
•
Probability of Technical and Regulatory Success (“PTS”) rate—PTS rates are determined considering industry averages of the respective program’s
development stage and disease indication and adjusted for specific information or data known at the acquisition date. Subsequent clinical results or
other internal or external data obtained could alter the PTS rate and materially impact the estimated fair value of the intangible asset in subsequent
periods leading to non-cash impairment charges in the consolidated statement of operations.
•
Projections—Future revenues are estimated after considering many factors such as initial market opportunity, pricing, sales trajectories to peak sales
levels, competitive environment and product evolution. Future costs and expenses are estimated after considering historical trends, market
participant synergies and timing and level of additional development costs to obtain the initial or additional regulatory approvals, maintain or further
enhance the product. We generally assume initial positive cash flows to commence shortly after the receipt of expected regulatory approvals which
typically may not occur for a number of years. Actual cash flows attributable to the project are likely to be different than those assumed since
projections are subjected to multiple factors including trial results and regulatory matters which could materially change the ultimate commercial
success of the asset as well as significantly alter the costs to develop the respective asset into commercially viable products.
•
Discount rate— Discount rates are selected after considering the risks inherent in the future cash flows; the assessment of the asset’s life cycle and
the competitive trends impacting the asset, including consideration of any technical, legal, regulatory, or economic barriers to entry, as well as
expected changes in standards of practices for indications addressed by the asset.
Goodwill is tested at least annually for impairment or when events or changes in circumstances indicate that the carrying amount of such assets may not be
recoverable, on an enterprise level by assessing qualitative factors or performing a quantitative analysis in determining whether it is more likely than not that its fair
value exceeds the carrying value. Examples of qualitative factors include our share price, our financial performance compared to budgets, long-term financial plans,
macroeconomic, industry and market conditions as well as the substantial excess of fair value over the carrying value of net assets.
We test IPR&D for impairment at least annually or more frequently if impairment indicators exist. These assets are initially measured at fair value and
therefore any reduction in expectations used in the valuations could potentially lead to impairment. Some of the more common potential risks leading to
impairment include competition, earlier than expected loss of exclusivity, pricing pressures, adverse regulatory changes or clinical trial results, delay or failure to
obtain regulatory approval and additional development costs, inability to achieve expected synergies, higher operating costs, changes in tax laws and other macroeconomic changes. The complexity in estimating the fair value of intangible assets in connection with an impairment test is similar to the initial valuation.
56
During the fourth quarter of 2015, we recorded a $ 30.0 million i mpairment charge related to our IPR&D asset for MDV9300 as a result of an extended
clinical development timeline and other factors . In the fourth quarter, we concluded our testing that revealed MDV9300 is not an anti-PD-1 antibody and , after
advising the FDA of this conclusion in early- January 2016, our IND was placed on partial clinical hold pen ding revision of all related study documentation
characterizing MDV9300 as an anti-PD-1 antibody. While we believe the partial clinical hold does not relate to concerns regarding the safety or previouslyobserved efficacy of MDV9300, we extended our clinic al study timelines which, in turn, gave rise to changes to the significant inputs to our IPR&D valuation
including forecasted revenues and probabilities of success. The quantitative assessment resulted in a net impairment charge, which we recorded as a red uction in
the IPR&D asset and an increase to R&D expense in the fourth quarter.
Considering the high-risk nature of research and development and the industry’s success rate of bringing developmental compounds to market, IPR&D
impairment charges are not uncommon. IPR&D is monitored and assessed each reporting period for possible triggering events that could lead to impairment.
Contingent
Consideration
We initially determine the fair value of contingent consideration obligations at the acquisition date using a probability-based income approach utilizing an
appropriate discount rate. Each reporting period we revalue the contingent consideration obligations associated with acquisitions to their fair value and record
increases in the fair value as non-cash contingent consideration expense and decreases in the fair value as non-cash contingent consideration income in the
consolidated statements of operations. Changes in contingent consideration could result from changes in the assumptions regarding probabilities of successful
achievement of related milestones, the estimated timing in which the milestones are expected to be achieved and the discount rate used to estimate the fair value of
the liability. Contingent consideration may change significantly as our development programs progress, revenue estimates evolve and additional data are obtained,
impacting our assumptions. The assumptions used in estimating fair value require significant judgment. The use of different assumptions and judgments could
result in a materially different estimate of fair value which may have a material impact on our results from operations and financial position.
In connection with the acquisitions of MDV9300 and MDV3800, we recorded contingent consideration liabilities pertaining to amounts potentially payable
to CureTech and BioMarin, respectively. During the year ended December 31, 2015, we recorded fair value adjustments of $2.6 million and $7.7 million as a
decrease to R&D expenses and SG&A expenses, respectively, related to the CureTech contingent consideration liability. Since the date of the fourth quarter
acquisition of MDV3800 , we also recorded nominal fair value adjustments to the related contingent consideration liability. Such adjustments were primarily due to
the time value of money.
Convertible
Notes
We account for convertible debt instruments that may be settled in cash upon conversion by separating the liability and the equity components of the
instruments in a manner that reflects our nonconvertible debt borrowing rate when we recognize interest expense in subsequent periods. The debt component of the
Convertible Notes, which excludes the associated equity conversion feature, was recorded at fair value on the issuance date. The equity component, representing
the difference between the aggregate principal amount of the Convertible Notes and the fair value of the debt component, was recorded in additional paid-in capital
on the consolidated balance sheet. The discount initially excluded from the carrying value of the Convertible Notes due to the bifurcation will be subsequently
accreted to the Convertible Notes principal amount through the recognition of non-cash interest expense.
Costs related to the issuance of the Convertible Notes, consisting primarily of investment banking, legal and other professional fees were allocated to the
debt and equity components of the Convertible Notes in proportion to the allocation of the principal proceeds. Amounts allocated to the debt component were
capitalized and are being amortized as non-cash interest expense using the effective yield method over the five-year contract term of the Convertible Notes.
Amounts allocated to the equity component were charged against additional paid-in capital.
Determining the fair value of the debt component of the Convertible Notes requires the use of management estimates and assumptions, including without
limitation estimates of the fair value of similar debt instruments that do not include an equity conversion feature. These estimates and assumptions are judgmental
in nature and could have a significant impact on our consolidated financial statements, including the carrying value of the Convertible Notes, the associated debt
discount, and the amounts of non-cash interest expense reported.
During the year ended December 31, 2015, all of our Convertible Notes were settled.
Litigation
We are party to legal proceedings, investigations, and claims in the ordinary course of business. We record accruals for outstanding legal matters when we
believe that it is both probable that a liability has been incurred and the amount of such liability can be reasonably estimated. We evaluate, on a quarterly basis,
developments in significant legal matters that could affect the amount of
57
any accrual and deve lopments that would make a loss contingency both probable and reasonably estimable. To the extent new information is obtained and our
views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in our a ccrued liabilities would be recorded in
the period in which such determination is made. In addition, in accordance with the relevant authoritative guidance, for matters for which the likelihood of material
loss is at least reasonably possible, we provide d isclosure of the possible loss or range of loss; however, if a reasonable estimate cannot be made, we will provide
disclosure to that effect. Gain contingencies, if any, are recorded when they are realized.
Income
Taxes
We record a valuation allowance to reduce our deferred tax assets to reflect the net amount that we believe is more likely than not to be realized. Realization
of our deferred tax assets is dependent upon the generation of future taxable income, the amount and timing of which are uncertain. The valuation allowance
requires an assessment of both positive and negative evidence when determining whether it is more likely than not that deferred tax assets are recoverable; such
assessment is required on a jurisdiction by jurisdiction basis. Based upon the weight of available evidence at December 31, 2014, we determined that it was more
likely than not that a portion of our deferred tax assets would be realizable and consequently we released our valuation allowance against Federal and certain state
net deferred tax assets and recorded a discrete tax benefit of $33.4 million during the fourth quarter of 2014. The decision to reverse a portion of the valuation
allowance was made after management considered all available evidence, both positive and negative, including but not limited to our historical operating results,
income or loss in recent periods, cumulative income in recent years, forecasted earnings, future taxable income, and significant risk and uncertainty related to
forecasts. The release of the valuation allowance resulted in the recognition of certain deferred tax assets and a decrease to income tax expense.
Significant judgment is required in evaluating our uncertain income tax positions based on the guidance in ASC 740-10-25, “Accounting for Uncertainty in
Income Taxes.” We recognize a tax benefit from an uncertain tax position only if it is more likely than not that the position will be sustained upon examination by
tax authorities. The tax benefit recognized in the financial statements on a particular tax position is measured on the largest benefit that is more likely than not to be
realized. We evaluate uncertain tax positions on a quarterly basis and adjust the liability for changes in facts and circumstances, such as new regulations or
interpretations by the taxing authorities, new information obtained during a tax examination, significant amendment to an existing tax law, or resolution of an
examination. To the extent that the final tax outcome of these matters is different than the amounts recorded, such differences will impact the income tax provision
in the period in which such determination is made. The resolution of our uncertain income tax positions is dependent on uncontrollable factors such as law changes,
new case law, and the willingness of the income tax authorities to settle, including the timing thereof and other factors. Although we do not anticipate significant
changes to our uncertain income tax positions in the next twelve months, items outside of our control could cause our uncertain income tax positions to change in
the future, which would be recorded in our consolidated statements of operations. Interest and/or penalties related to income tax matters are recognized as a
component of income tax expense as incurred.
Net
Income
(Loss)
Per
Common
Share
We apply the guidance in ASC 260, “Earnings per Share,” when calculating net income per common share. The provisions of ASC 260 require that for
contracts which provide a company with a choice of settlement methods, the company is to assume that the contract will be settled in shares. That presumption may
be overcome if past experience or a stated policy provides for a reasonable basis to believe that it is probable that the contract will be paid partially or wholly in
cash.
During the second quarter of 2015, we asserted our intent and ability to settle the outstanding Convertible Notes for a combination of cash and common
stock. Under the “cash settlement” method, interest is not added back to the numerator, and only the contingently issuable shares related to the conversion spread
are included in the denominator, if dilutive. Under such method, the settlement of the conversion spread has a dilutive effect when the average share price of our
common stock during the period exceeds the conversion price. The computation of diluted net income per share for the year ended December 31, 2015 reflects the
application of the “if-converted” method for the first quarter of 2015 and the “cash settlement” method for the second and third quarters of 2015 given the
demonstrated and asserted redemption of the outstanding debt. We completed the settlement of all of our Convertible Notes during the third quarter of 2015 as
described elsewhere in this Annual Report. The calculation of diluted net income per common share for the year ended December 31, 2015 includes approximately
3.9 million contingently issuable shares related to the Convertible Notes.
We used the “if-converted” method to compute the dilutive effect of the Convertible Notes for the calculation of diluted net income per common share for
the year ended December 31, 2014. Under the “if-converted” method, interest expense, net of tax, related to the Convertible Notes is added back to net income, and
the Convertible Notes are assumed to have been converted into common shares at the beginning of the period in periods in which there would have been a dilutive
effect. The calculation of diluted net income per common share for the year ended December 31, 2014 includes approximately 10.1 million contingently issuable
shares related to the Convertible Notes.
Additional information regarding net income per common share is included in Note 6, “Net Income (Loss) per Common Share,” to our consolidated
financial statements included elsewhere in this Annual Report.
58
RESulTS
OF
OPERATIONS
Collaboration
Revenue
We have a collaboration agreement with Astellas pursuant to which we are collaborating with Astellas to develop and commercialize XTANDI globally.
The terms of the collaboration agreement are described in Note 3 “Collaboration Agreement,” to our audited consolidated financial statements included elsewhere
in this Annual Report. Collaboration revenue consists of three components: (a) collaboration revenue related to U.S. XTANDI net sales; (b) collaboration revenue
related to ex-U.S. XTANDI net sales; and (c) collaboration revenue related to upfront and milestone payments.
Collaboration revenue was as follows (in thousands):
Collaboration revenue:
Related to U.S. XTANDI net sales
Related to ex-U.S. XTANDI net sales
Related to upfront and milestone payments
Total
2015
$
$
years
Ended
december
31,
2014
575,658
119,778
247,822
943,258
$
$
339,902
49,476
321,109
710,487
$
$
2013
196,208
6,338
70,396
272,942
We are required to pay UCLA ten percent of all Sublicensing Income, as defined in our license agreement with UCLA. We are currently involved in
litigation with UCLA regarding certain terms of the license agreement and other matters, which are discussed in Part I, Item 3, “Legal Proceedings.”
Collaboration
Revenue
Related
to
U.S.
XTANDI
Net
Sales
Collaboration revenue related to U.S. XTANDI net sales was as follows (in thousands):
2015
U.S. XTANDI net sales (as reported by Astellas)
Shared U.S. development and commercialization costs
Pre-tax U.S. profit
$
Medivation’s share of pre-tax U.S. profit
Reimbursement of Medivation’s share of shared U.S. costs
Collaboration revenue related to U.S. XTANDI net sales
$
$
$
years
Ended
december
31,
2014
1,151,317 $
(375,008)
776,309 $
388,154
187,504
575,658
$
$
679,805 $
(323,730)
356,075 $
178,037
161,865
339,902
$
$
2013
392,415
(241,106)
151,309
75,655
120,553
196,208
U.S. net sales of XTANDI (as reported by Astellas) for the year ended December 31, 2015 were $1.2 billion, an increase of $471.5 million, or 69%,
compared with net sales for the prior year. The majority of the increase was due to higher sales volume with a minor increase resulting from changes in price
elements. The increase in price elements includes a net favorable adjustment in 2015 of $20.0 million related to changes in prior period estimates of deductions
against gross sales.
U.S. net sales of XTANDI (as reported by Astellas) for the year ended December 31, 2014 were $679.8 million, an increase of $287.4 million, or 73%,
compared with net sales for the prior year. Approximately 83% of the increase was due to higher sales volume and approximately 17% of the increase was due to
changes in price elements. The increase in price elements includes a net favorable adjustment in 2014 of $14.9 million related to changes in prior period estimates
of deductions against gross sales.
In the fourth quarters of 2015 and 2014, we experienced cyclical buying patterns of XTANDI in the U.S. by the Astellas distribution channel
partners. Specifically, fourth quarter U.S. XTANDI net sales (as reported by Astellas) in 2015 and 2014 included approximately one-half week and one week of
additional channel partner inventory, respectively. As experienced a year ago, we anticipate that the fourth quarter 2015 channel partner inventory levels may be
reduced slightly in the first quarter of 2016. We also anticipate that the estimated gross-to-net sales discount applied by Astellas in the first quarter of 2016 may be
several percentage points higher than that utilized in the fourth quarter of 2015 because of the impact of Medicare Part D coverage and other government programs
in the new calendar year.
Collaboration revenue related to U.S. XTANDI net sales for the year ended December 31, 2015 was $575.7 million, an increase of $235.8 million, or 69%,
from the prior year. Collaboration revenue related to U.S. XTANDI net sales for the year ended December 31, 2014 was $339.9 million, an increase of $143.7
million, or 73%, from the prior year. The increases in 2015 and 2014 were the result of an increase in our share of pre-tax U.S. profit in the collaboration with
Astellas as well as an increase in their reimbursement of our shared U.S. costs.
59
Along with other manufacturers of branded pharmaceutical products, we are subject to various provisions of the Patient Protection and Affordable Care Act
of 2010, or PPACA, and other healthcare reform legislation. The stated goals of this legislation include reducing the number of uninsured Americans, improving
the quality of healthcare delivery and reducing projected U.S. healthcare costs. The largest component of the deduc tions from gross sales used in deriving net sales
of XTANDI in the United States is legally mandated discounts or rebates to Medicare and other government programs such as Medicaid. Although the full impact
to us of all elements of PPACA and other healthca re reform legislation cannot be specifically determined, we estimate that legally mandated discounts or rebates
for Medicaid and Medicare Part D programs, including the 23.1% rebate and the Medicare Part D coverage gap provisions, reduced U.S. XTANDI net s ales by
approximately 2% for the year ended December 31, 2015. These provisions are anticipated to continue to impact U.S. sales of XTANDI to a similar degree in
future periods. The financial impact of U.S. healthcare reform legislation to our consolidated financial statements in future periods depends on a number of factors,
including the timing of and changes in sales volumes for our products and the number of patients eligible for these government programs. Additional information
regarding the impact of the provisions of PPACA and other healthcare reform legislation on us is included in Part I, Item 1A, “Risk Factors.”
Collaboration
Revenue
Related
to
Ex-U.S.
XTANDI
Net
Sales
Net sales of XTANDI outside of the United States (as reported by Astellas) were approximately $757.0 million, $381.0 million and $53.0 million for the
years ended December 31, 2015, 2014 and 2013, respectively. Collaboration revenue attributable to ex-U.S. XTANDI net sales was $119.8 million, $49.5 million
and $6.3 million for the years ended December 31, 2015, 2014 and 2013, respectively. XTANDI was first approved for sale outside of the United States in June
2013.
Net sales of XTANDI outside of the United States (as reported by Astellas) in 2015 increased by approximately 99% compared to net sales in 2014.
Changes in foreign currency exchange rates reduced the U.S. dollar equivalent of such 2015 net sales (as reported by Astellas) by approximately 14% compared
with 2014.
Collaboration
Revenue
Related
to
Upfront
and
Milestone
Payments
Collaboration revenue related to upfront and milestone payments was as follows (in thousands):
Sales milestones earned
Development milestones earned
Amortization of deferred upfront and
development milestones
Total
2015
$
$
years
Ended
december
31,
2014
245,000
—
2,822
247,822
$
$
50,000
257,000
14,109
321,109
$
$
2013
25,000
20,000
25,396
70,396
Collaboration revenue related to upfront and milestone payments from Astellas for the year ended December 31, 2015 was $247.8 million, a decrease of
$73.3 million, or 23%, from $321.1 million for the prior year. The decrease in collaboration revenue related to upfront and milestone payments from Astellas was
primarily due to the timing of the recognition of development and sales milestone payments upon the achievement of certain defined milestone events. Additional
information regarding the milestones earned during 2015 is included in the section of Management’s Discussion and Analysis of Financial Condition and Results of
Operations entitled “2015 Financial Highlights.”
Collaboration revenue related to upfront and milestone payments from Astellas for the year ended December 31, 2014 was $321.1 million, an increase of
$250.7 million, or 356% from $70.4 million for the prior year. The increase in collaboration revenue related to upfront and milestone payments from Astellas was
due to the timing of the recognition of development and sales milestone payments upon the achievement of certain defined milestone events as well as a change in
the estimated remaining performance period under the Astellas Collaboration Agreement.
As of December 31, 2015, we have earned all development and sales milestone payments under the Astellas Collaboration Agreement, totaling $655.0
million, including $245.0 million, $307.0 million, and $45.0 million in the years ended December 31, 2015, 2014, and 2013, respectively.
Research
and
Development
Expenses
Research and development, or R&D, expenses were as follows (dollars in thousands):
Research and development expenses
Percentage change
2015
$
60
years
Ended
december
31,
2014
232,100
$
22%
189,570
$
59%
2013
118,952
R&D expenses increased by $42.5 million, or 22%, to $232.1 million for the year ended December 31, 2015, from $189.6 million for the prior year. The
increase was primarily due to a $27.8 million increase in third-party clinical and preclinical development costs as a result of increased activities, including those
related to the acquisition of MDV3800 during the fourth quarter of 2015, a $30.0 million impairment charge related to intangible assets, a $15.4 million increase in
personnel costs resulting from higher staffing levels and a $7.0 million increase in facilities and information technology costs, partially offset by $25.7 million of
payments to UCLA related to the development milestone payments we earned from Astellas during the year ended December 31, 2014 and a $12.0 million upfront
license and research agreement fee to a third party, both of which were not repeated in the year ended December 31, 2015.
R&D expenses increased by $70.6 million, or 59%, to $189.6 million, for the year ended December 31, 2014, from $119.0 million for the prior year. The
increase was primarily due to an increase of approximately $27.2 million of third-party clinical and preclinical development costs as a result of increased clinical
and preclinical activities, a $23.7 million increase in payments to UCLA related to the development milestone payments we earned from Astellas, a $10.1 million
increase in facilities and information technology infrastructure costs, and a $9.6 million increase in personnel costs resulting from higher staffing levels.
We expect that R&D expenses will increase in 2016 as a result of higher personnel costs related to additional headcount and higher third-party clinical and
preclinical development costs as a result of increased activities, including those related to clinical manufacturing of MDV9300 and costs to develop certain limited
laboratory and pharmaceutical operations capabilities. In addition, with the acquisition of MDV3800 from BioMarin that was completed in October 2015, we are
responsible for ongoing clinical trial costs for the compound from that date forward as well as the costs of any new trials we might elect to initiate in the future.
Under the Astellas Collaboration Agreement, we and Astellas share certain development costs in the United States. Development cost-sharing payments
from Astellas were $60.8 million, $63.5 million and $46.6 million for the years ended December 31, 2015, 2014 and 2013, respectively. Development cost-sharing
payments from Astellas are recorded as reductions in R&D expenses.
We were engaged in four R&D programs during the periods presented: (1) the development of enzalutamide for the treatment of prostate cancer, advanced
breast cancer, and hepatocellular carcinoma; (2) the development of MDV3800; (3) the development of MDV9300; and (4) multiple proprietary research and drug
discovery projects. R&D costs are identified as either directly allocable to one of our R&D programs or indirect costs, with only direct costs being tracked by
specific program. Direct costs consist primarily of clinical, preclinical, and drug discovery costs, cost of supplying drug substance and drug product for use in
clinical and preclinical studies, including clinical manufacturing costs, upfront and development milestone payments under license agreements, non-cash fair value
adjustments related to contingent purchase consideration, non-cash IPR&D impairment charges, personnel costs, contract research organization fees, and other
contracted services pertaining to specific clinical and preclinical studies. Indirect costs consist of corporate overhead costs and other administrative and support
costs. The following table summarizes the direct costs attributable to each program and total indirect costs (in thousands):
Direct costs:
XTANDI (enzalutamide) program (1)
MDV3800 program
MDV9300 program (2)
Early-stage programs
Total direct costs
Indirect costs
Total
2015
$
$
years
Ended
december
31,
2014
74,616
12,454
59,099
59,071
205,240
26,860
232,100
$
$
102,669
—
5,949
61,063
169,681
19,889
189,570
$
$
2013
73,076
—
—
36,140
109,216
9,736
118,952
(1) Direct costs for the XTANDI (enzalutamide) program include $25.7 million and $2.0 million for the years ended December 31, 2014 and 2013, respectively,
of payments to UCLA related to the development milestones we earned from Astellas during those periods.
(2) Direct costs for the MDV9300 program include $30.0 million for the year ended December 31, 2015 resulting from the partial impairment of the IPR&D
intangible asset.
Our R&D programs may be subject to change from time to time as we evaluate our priorities and available resources.
For a detailed discussion of the risks and uncertainties associated with the timing and cost of completing a product development plan, see Part I, Item 1A,
“Risk Factors—Risks Related to Our Future Product Development Candidates” of this Annual Report.
61
Selling,
General
and
Administrative
Expenses
Selling, general and administrative, or SG&A, expenses were as follows (dollars in thousands):
Selling, general and administrative expenses
Percentage change
2015
$
years
Ended
december
31,
2014
296,545
$
24%
239,071
$
36%
2013
176,231
SG&A expenses increased by $57.5 million, or 24%, to $296.5 million for the year ended December 31, 2015, from $239.1 million for the prior year. The
increase was primarily due to higher sales, marketing and medical affairs costs, as well as higher administrative and personnel-related costs. We incurred $8.8
million in higher royalty expenses as a result of an increase in net sales of XTANDI. SG&A expenses for the year ended December 31, 2015 included $24.5 million
to UCLA associated with sales milestones that we earned from Astellas during 2015, as well as non-cash fair value adjustments of $7.9 million, which were
recorded as a reduction to SG&A expenses, for contingent consideration related to our CureTech and BioMarin acquisitions.
SG&A expenses increased by $62.8 million, or 36%, to $239.1 million, for the year ended December 31, 2014, from $176.2 million for the prior year. The
increase was primarily due to higher sales and marketing costs as well as certain medical affairs costs and other initiatives associated with launch of XTANDI in
the pre-chemotherapy setting in the United States. These included higher collaboration expenses from Astellas and additional internal personnel costs due to higher
staffing levels. In addition, we incurred approximately $8.0 million higher royalty expense based on sales and accrued payments to UCLA associated with sales
milestones we earned from Astellas, partially offset by a reduction in legal fees.
We expect that SG&A expenses will increase in 2016 as a result of increased personnel costs related to additional headcount, an increase in sales, marketing
and medical affairs activities, and higher corporate overhead costs in support of our expanded research, development, and commercial activities.
Under our collaboration with Astellas, we are responsible for fifty percent of the cost of goods sold and the royalty payable to UCLA on U.S. net sales of
XTANDI. Our share of these items is included in SG&A expenses in our consolidated statements of operations. As such, those components of our reported SG&A
expenses will fluctuate in correlation with net sales of XTANDI in the United States.
On July 28, 2014, the IRS issued final rules and regulations in the U.S. for the Branded Prescription Drug Fee, an annual fee payable to the federal
government under PPACA based on an allocation for a given year based on a company’s market share for branded prescription drugs sold to certain government
programs in the prior year. The final rules have the effect of accelerating the expense recognition criteria for the fee obligation from the year in which the fee is
paid, to the year in which the market share used to allocate the fee is determined. This change requires us and other industry participants to recognize an additional
year of Branded Prescription Drug Fee expense in 2014. We share this annual fee equally with Astellas with respect to U.S. XTANDI sales sold through these
government programs. As a result, an additional expense of $6.4 million was recognized as commercialization cost-sharing payments to Astellas within SG&A
during the year ended December 31, 2014.
Under the Astellas Collaboration Agreement, we and Astellas share certain commercialization costs in the United States. Commercialization cost-sharing
payments to Astellas were $37.5 million, $36.1 million and $12.0 million for the years ended December 31, 2015, 2014 and 2013, respectively. Commercialization
cost-sharing payments to Astellas are recorded as increases in SG&A expenses.
Other
Income
(Expense),
net
The components of other income (expense), net were as follows (in thousands):
Other income (expense), net:
Non-cash loss on extinguishment of Convertible Notes
Non-cash amortization of debt discount and issuance
costs
Coupon interest expense
Other, net
Total
2015
$
years
Ended
december
31,
2014
(21,087) $
(8,613)
(3,870)
275
(33,295)
62
—
(14,898)
(6,792)
38
(21,652)
$
2013
—
(13,456)
(6,793)
(8)
(20,257)
Other income (expense), net consists of coupon interest expense and non-cash interest expense, interest income earned and net gains (losses) on sales of our
short-term investments, and the impact of changes in foreign exchange rates on our foreign currency-denominated payables, which were not significant.
Other income (expense), net for the year ended December 31, 2015 also includes non-cash losses on extinguishment of Convertible Notes. Additional
information regarding the extinguishment of Convertible Notes is included in Note 10, “Debt,” in the accompanying notes to our consolidated financial statements.
Income
Tax
(Expense)
Benefit
Income tax (expense) benefit and the effective income tax rate were as follows (dollars in thousands):
Income tax (expense) benefit
Effective income tax rate
2015
$
years
Ended
december
31,
2014
(136,593) $
35.8%
16,258
$
(6.2%)
2013
(115)
(0.3%)
Income tax expense for the year ended December 31, 2015 was $136.6 million. The provision for income taxes in 2015 was higher than the tax computed at
the U.S. federal statutory rate due primarily to state income taxes and non-deductible stock-based compensation, net of Federal research and development credit.
Income tax benefit for the year ended December 31, 2014, was $16.3 million. The provision for income taxes for 2014 was lower than the tax computed at the U.S.
federal statutory rate due primarily to utilization of net operating loss and tax credit carryforwards and the release of the valuation allowance on a portion of our net
deferred tax assets. Income tax expense for the year ended December 31, 2013 was not significant, due to our net loss for this year for which no tax benefit was
recognized due to our valuation allowance.
Our effective tax rate was 35.8% for the year ended December 31, 2015. Our effective tax rate was (6.2%) for year ended December 31, 2014. Our effective
tax rate for the year ended December 31, 2013 was not significant. The increase in the effective tax rate for the year ended December 31, 2015 as compared to the
prior year was primarily due to the release of the valuation allowance against Federal and certain state deferred tax assets during the fourth quarter of 2014.
During the year ended December 31, 2015, we reduced our current Federal and state taxes payable by $100.2 million related to excess tax benefits from
stock-based compensation, offsetting additional paid-in capital. In addition, for the year ended December 31, 2015, we recorded a credit to additional paid-in
capital of $11.8 million related to certain tax impacts of the extinguishment of Convertible Notes.
We record a valuation allowance to reduce deferred tax assets to reflect the net amount that is more likely than not to be realized. Realization of our deferred
tax assets is dependent upon the generation of future taxable income, the amount and timing of which are uncertain. Based upon the weight of available evidence at
December 31, 2014, we determined that it was more likely than not that a portion of our deferred tax assets would be realizable and consequently we released our
valuation allowance against Federal and certain state net deferred tax assets and recorded a discrete tax benefit of $33.4 million during the fourth quarter of 2014.
The decision to reverse a portion of the valuation allowance was made after management considered all available evidence, both positive and negative, including
but not limited to our historical operating results, income or loss in recent periods, cumulative income in recent years, forecasted earnings, forecasted future taxable
income, and significant risk and uncertainty related to forecasts. The release of the valuation allowance resulted in the recognition of certain deferred tax assets and
a decrease to income tax expense.
We have fully utilized all of our Federal gross net operating losses and Federal tax credit carryforwards for tax return purposes as of December 31, 2015.
lIquIdITy
ANd
CAPITAl
RESOuRCES
Our principal source of liquidity is cash generated from our collaboration agreement with Astellas, which is described elsewhere in this Annual Report.
At December 31, 2015, we had cash and cash equivalents of $225.9 million, compared with $502.7 million at December 31, 2014. At December 31, 2015,
our collaboration receivable from Astellas was $391.6 million, compared with $184.7 million at December 31, 2014. In the fourth quarter of 2015, we utilized
$410.0 million of our cash balances to pay an upfront fee to BioMarin for the acquisition of MDV3800 as described elsewhere in this Annual Report. Based on our
current expectations, we believe our net current assets, amounts that are available under our Revolving Credit Facility, and our projected cash flows will be
sufficient to fund our currently planned operations for at least the next twelve months. This estimate is based on a number of assumptions that may prove to be
wrong. In addition, we may choose to raise additional funds in the form of equity, debt, or otherwise due to market conditions or strategic considerations even if we
believe we have sufficient funds for our current and future operating plans. For example, we may choose to raise additional capital to fund business development
activities, and for other general corporate purposes.
63
For a detailed discussion of the risks and uncertainties associated with our sources of liq uidity and access to capital, see Part I, Item 1A, “Risk Factors—Risks
Related to the Operation of Our Business.”
On October 23, 2015, we entered into an amendment and restatement of our Original Credit Agreements described elsewhere in this Annual Report. The
Credit Agreement provides for (i) a five-year $300.0 million Revolving Credit Facility; and (ii) an uncommitted accordion facility subject to the satisfaction of
certain conditions (collectively, the “Senior Secured Credit Facility”). The Revolving Credit Facility includes a $50.0 million multicurrency sub-facility, a $20.0
million letter of credit sub-facility, and a $10.0 million swing line loan sub-facility. On October 23, 2015, we borrowed $75.0 million under the Revolving Credit
Facility, which was used to repay the $75.0 million outstanding at September 30, 2015 under the Original Credit Agreement. On January 25, 2016, we repaid the
$75.0 million outstanding under the Revolving Credit Facility.
Cash
Flow
Analysis
The following table summarizes our cash flows (in thousands):
Net cash provided by (used in):
Operating activities
Investing activities
Financing activities
Net change in cash and cash equivalents
2015
$
$
years
Ended
december
31,
2014
219,939 $
(430,987)
(65,776)
(276,824) $
240,599 $
(17,410)
50,700
273,889 $
2013
(68,209)
216,826
8,870
157,487
Operating
Activities
Net cash provided by operating activities totaled $219.9 million for 2015, which consisted of our net income of $244.7 million, partially offset by negative
changes in our operating assets and liabilities of $24.4 million and non-cash items of $0.4 million. Net cash provided by operating activities was primarily driven
by collaboration revenue related to U.S. XTANDI sales, royalties on ex-U.S. XTANDI sales, and milestone payments received from Astellas during 2015, partially
offset by cash utilized in operations that arose in the ordinary course of business.
Net cash provided by operating activities totaled $240.6 million for 2014, which consisted of our net income of $276.5 million, partially offset by non-cash
items of $1.9 million and negative changes in our operating assets and liabilities of $34.0 million. Net cash provided by operating activities was primarily driven by
collaboration revenue related to U.S. XTANDI sales, royalties on ex-U.S. XTANDI sales, and milestone payments received from Astellas during 2014, partially
offset by cash utilized in operations that arose in the ordinary course of business.
Net cash used in operating activities totaled $68.2 million for 2013, which consisted of negative changes in our operating assets and liabilities of $54.2
million and our net loss of $42.6 million, partially offset by non-cash items of $28.6 million. Non-cash items consisted primarily of non-cash stock-based
compensation expense of $37.1 million, non-cash interest expense on the Convertible Notes of $13.5 million and depreciation expense on property and equipment
of $3.4 million, partially offset by non-cash amortization of deferred revenue of $25.4 million. The negative cash flow from changes in operating assets and
liabilities of $54.2 million arose in the ordinary course of business.
Investing
Activities
Net cash used in investing activities totaled $431.0 million for 2015, which consisted of a $410.0 million payment to BioMarin under the asset purchase
agreement, purchases of short-term investments of $90.4 million, capital expenditures of $19.5 million, and an increase in letters of credit collateralized by
restricted cash to secure various leases of $1.4 million, partially offset by sales and maturities of short-term investments of $90.2 million.
Net cash used in investing activities totaled $17.4 million for 2014, and consisted primarily of capital expenditures of $10.5 million, a $5.0 million payment
to CureTech, Ltd. under the License Agreement and an increase in letters of credit collateralized by restricted cash to secure various leases of $1.9 million.
Net cash provided by investing activities totaled $216.8 million for 2013, consisting of net maturities of short-term investments of $225.0 million, partially
offset by $7.5 million of capital expenditures and an increase of $0.7 million in letters of credit collateralized by restricted cash to secure operating leases.
64
Financing
Activities
Net cash used in financing activities totaled $65.8 million for 2015, and consisted primarily of repayment of Convertible Notes principal and conversion
premium of $259.9 million, repayment of our Revolving Credit Facility of $75.0 million and financing transaction costs of $1.7 million, partially offset by proceeds
from our Revolving Credit Facility of $150.0 million, excess tax benefits from stock-based compensation of $100.2 million and proceeds from the issuance of
common stock under equity incentive and stock purchase plans of $21.5 million.
Net cash provided by financing activities totaled $50.7 million for 2014, and consisted of primarily of $33.9 million of proceeds from the issuance of
common stock under the Medivation Equity Incentive Plan and ESPP and $17.0 million of excess tax benefits from stock-based compensation.
Net cash provided by financing activities totaled $8.9 million for 2013 and consisted entirely of proceeds from the issuance of common stock under the
Medivation Equity Incentive Plan.
Commitments
and
Contingencies
At December 31, 2015, our future minimum contractual commitments were as follows (in thousands):
Revolving Credit Facility (1)
Lease obligations (2)
Other (3)
Total
(1)
(2)
(3)
Payment
due
by
Period
Total
$
$
75,000
54,885
17,500
147,385
less
than
1
year
$
$
75,000
11,521
17,500
104,021
1-3
years
$
$
—
23,840
—
23,840
3-5
years
$
$
—
9,897
—
9,897
More
than
5
years $
$
—
9,627
—
9,627
See Note 10, “Debt,” to our audited consolidated financial statements included elsewhere in this Annual Report. We repaid the $75.0 million outstanding
under the Revolving Credit Facility on January 25, 2016.
See Note 15, “Commitments and Contingencies,” to our audited consolidated financial statements included elsewhere in this Annual Report.
The amount represents a payment made to UCLA in the first quarter of 2016. Additional information regarding this payment is included below.
Potential
Obligations
Not
Included
in
the
Table
Above
In addition to the contractual obligations disclosed in the table above, we have other potential obligations for which the timing and the extent of future
payments are not known. We have described these potential obligations in the following paragraphs.
License
Agreement
with
UCLA
Under our license agreement with UCLA, we may be required to make various future payments including (a) ten percent of all Sublicensing Income, as
defined in the agreement, and (b) a four percent royalty on sales of products falling within the scope of the patent rights licensed from UCLA. Under the terms of
our Astellas Collaboration Agreement, we share this royalty obligation with Astellas 50/50 with respect to sales in the United States, and Astellas is responsible for
this entire royalty obligation with respect to sales outside of the United States. In ongoing litigation initiated by us, UCLA filed a cross-complaint alleging that we
are required to pay it ten percent of the $320.0 million in sales milestone payments that we are eligible to earn under the Astellas Collaboration Agreement because
such milestones constitute Sublicensing Income under the Astellas Collaboration Agreement. As of December 31, 2015, we have paid UCLA $14.5 million,
representing ten percent of the $145.0 million sales milestone payments we earned from Astellas through September 30, 2015. At December 31, 2015, we have
recorded a $17.5 million accrued payment to UCLA, representing ten percent of the $175.0 million sales milestone payment we earned from Astellas during the
fourth quarter of 2015. This amount, which is included in the table above, was paid to UCLA during the first quarter of 2016. Other potential payments to UCLA
are not included in the contractual obligations table above because they are contingent on future events that may or may not materialize.
On April 11, 2014, the Regents filed a complaint against us in which UCLA alleges that the “Operating Profits” we have received (and will continue to
receive) from Astellas, as a result of the Astellas Collaboration Agreement, constitute Sublicensing Income under the license agreement between us and the
Regents and that we and our subsidiary, Medivation Prostate Therapeutics, Inc., have failed to pay the Regents ten percent of such Operating Profits. We deny the
Regents’ allegations and are vigorously defending the litigation. For more information about this litigation, see Part I, Item 3, “Legal Proceedings.”
65
Commitments
Related
to
Our
Collaboration
Agreement
with
Astellas
Under the Astellas Collaboration Agreement, we share with Astellas certain development and commercialization costs. The actual amounts that we pay
Astellas or that Astellas pays us will depend on numerous factors, some of which are outside of our control and some of which are contingent upon the success of
certain development and commercialization activities. Future development and commercialization payments to Astellas are not included in the table above as the
timing and amounts of such payments are not determinable.
Contingent
Consideration
Liabilities
In accordance with accounting for business combinations guidance, contingent cash payments are recorded as contingent consideration liabilities on our
consolidated balance sheets at fair value.
In the fourth quarter of 2015, we completed an acquisition of all rights to MDV3800 from BioMarin pursuant to an Asset Purchase Agreement, or the
Agreement. In connection with the Agreement, we recorded contingent consideration pertaining to amounts potentially payable to BioMarin by us. The aggregate
remaining, undiscounted amount of contingent consideration that we could be required to pay to BioMarin under the Agreement consists of a total of
$160.0 million upon the achievement of defined regulatory and sales-based milestones, and mid-single digit royalties on net sales of products that
contain MDV3800 during the royalty term specified in the Agreement.
In the fourth quarter of 2014, we entered into a License Agreement with CureTech, pursuant to which we have licensed exclusive worldwide rights to
MDV9300. In connection with the CureTech License Agreement, we recorded contingent consideration pertaining to amounts potentially payable to CureTech by
us. The aggregate remaining, undiscounted amount of contingent consideration that we could be required to pay to CureTech under the License Agreement consists
of a total of $85.0 million upon attainment of certain development and regulatory milestones, up to $245.0 million upon the achievement of certain annual
worldwide net sales thresholds, and tiered royalties ranging from 5% to 11% on annual worldwide net sales. CureTech is also entitled to a $ 5.0 million milestone
payment upon completion of the Manufacturing Technology Transfer discussed below.
Future potential payments to BioMarin and CureTech are not included in the contractual obligations table above because they are all contingent on various
future events that may or may not materialize. Additional information regarding each transaction is included in Note 4, “Business Acquisitions,” to our audited
consolidated financial statements included elsewhere in this Annual Report.
As of December 31, 2015, the contingent consideration liabilities that we could be required to pay are our only financial liabilities measured and recorded
using Level 3 inputs in accordance with accounting guidance for fair value measurements, and represent approximately 48% of our total liabilities. See Note 14,
“Fair Value Disclosures,” in the accompanying notes to our consolidated financial statements for additional information.
Manufacturing
Services
and
Supply
Agreement
with
CureTech,
Ltd.
Contemporaneous with the execution of our License Agreement with CureTech, we entered into a Manufacturing Services and Supply Agreement, or MSA,
with CureTech pursuant to which CureTech will provide clinical trial supply of MDV9300 over a three year period. In accordance with the terms of the MSA, as
amended, we paid CureTech upfront and setup fees of $3.0 million during the fourth quarter of 2014, $0.2 million during the second quarter of 2015 and $0.1
million during the fourth quarter of 2015. We are required to pay CureTech a one-time milestone payment of $5.0 million upon the completion of the
Manufacturing Technology Transfer, as defined. We are also responsible for providing Manufacturing Funding of up to $19.3 million for clinical trial materials of
MDV9300 over a three year period. The Manufacturing Funding is contingent upon the successful achievement of the requirements set forth in the Manufacturing
Plan, and any such amounts may be reduced or eliminated by us under the terms of the MSA, of which approximately $9.0 million has been paid through December
31, 2015. Future potential payments to CureTech pursuant to the MSA are not included in the contractual obligations table above because they are contingent upon
future events that may or may not materialize and the timing of such payments is not certain. Additional information regarding the Manufacturing Services and
Supply Agreement with CureTech is included in Note 15, “Commitments and Contingencies,” to our audited consolidated financial statements included elsewhere
in this Annual Report.
66
Development
and
Manufacturing
Services
Agreement
During the fourth quarter of 2014, we entered into a Development and Manufacturing Services Agreement with a third-party clinical manufacturing
organization. The term of the agreement is for the longer of (i) a period of five (5) years or (ii) through the completion of the Services, as defined. Under the current
statement of work under this agreement, as amended, we intend to transfer the current manufacturing process of MDV9300 from CureTech to this third party,
further scale up and production of Phase 3 clinical trial material of MDV9300 from this entity’s manufacturing facility. The estimated total consideration under the
current statement of work is up to approximately $15.2 million, of which approximately $5.1 million has been paid through December 31, 2015. Future potential
payments pursuant to this agreement are not included in the table above because the timing of such payments is not certain. Additional information regarding the
Development and Manufacturing Services Agreement is included in Note 15, “Commitments and Contingencies,” to our audited consolidated financial statements
included elsewhere in this Annual Report.
Clinical
Trials
As of December 31, 2015, we have several on-going studies in various clinical trial stages. Under agreements with various clinical research organizations
and clinical trial sites, we incur expenses related to clinical trials of enzalutamide, MDV3800, MDV9300, and potential other clinical candidates. The timing and
amounts of these disbursements are contingent upon the achievement of certain milestones, patient enrollment and services rendered or as expenses are incurred by
the contract research organizations, contract manufacturing organizations, or clinical trial sites. Therefore, we cannot estimate the potential timing and amount of
these payments and they have been excluded from the table above. Although our material contracts with contract research organizations and contract manufacturing
organizations are cancellable, we have generally not cancelled such contracts.
Unrecognized
Tax
Benefits
At December 31, 2015, we had $14.1 million of gross unrecognized tax benefits, excluding interest, of which approximately $7.7 million represents the
amount of unrecognized tax benefits that would impact the effective tax rate, if recognized. The ultimate resolution of our uncertain income tax positions is
dependent on uncontrollable factors such as law changes, new case law, and the willingness of the income tax authorities to settle, including the timing thereof, and
other factors. Although we do not anticipate significant changes to our uncertain income tax positions in the next twelve months, items outside of our control could
cause our uncertain income tax positions to change in the future. Such amounts have been included on our audited consolidated balance sheet at December 31,
2015, but have not been included in the table above.
OFF-BAlANCE
ShEET
ARRANgEMENTS
We are involved in a variable interest entity, or VIE, that performs contract research for us. We have not consolidated this entity because we do not have the
power to direct the activities that most significantly impact the VIE’s economic performance and, thus, we are not considered the primary beneficiary of the VIE.
Item
7A.
quantitative
and
qualitative
disclosures
About
Market
Risk.
Market risk is the exposure to loss resulting from changes in interest rates, foreign currency exchange rates, commodity prices and equity prices.
Interest
Rate
Risk
Our investment policy emphasizes the safety and preservation of principal while maximizing the income we receive from our investments without assuming
significant risk of loss. Specifically, our investment objectives in order of priority are (1) the safety and preservation of principal, (2) maintain liquidity sufficient to
meet the requirements of our operations and strategic initiatives, and (3) deliver competitive after-tax returns relative to stated objectives and market conditions.
The securities permitted under our investment policy may be subject to market risk related to changes in interest rates and other market factors. We manage our
sensitivity to these risks by investing in short term, investment grade marketable securities. We currently do not use derivative financial instruments to hedge
market risk exposures related to the investment portfolio.
Our cash equivalents are exposed to the impact of interest rate changes and our interest income fluctuates as interest rates change. Due to the short-term,
highly liquid nature of our cash equivalents, we do not believe that we are subject to any material market risk exposure related to interest rates.
Foreign
Currency
Exchange
Risk
Under the Astellas Collaboration Agreement, Astellas records all ex-U.S. XTANDI sales and pays us a tiered royalty ranging from the low teens to the low
twenties on ex-U.S. XTANDI sales. The royalties we receive from Astellas on net sales of XTANDI outside of the United States are calculated by converting the
respective countries’ XTANDI net sales in local currency to U.S. dollars. The royalties are paid to us in U.S. dollars on a quarterly basis. To date, a significant
portion of ex-U.S. sales of XTANDI have been
67
generated in the European Union and in Japan. Therefore, the royalties we receive f rom Astellas related to ex-U.S. sales of XTANDI are dependent on the value of
the U.S. dollar versus the Euro and Japanese Yen. A strengthening of the U.S. dollar compared to current exchange rates would likely result in lower collaboration
revenue related to ex-U.S. XTANDI sales. We conduct certain R&D activities outside of the United States, with expenses incurred in various currencies, including
the Euro and Japanese Yen. These expenses partially offset the currency exposure related to our collaboration revenue from royalties. In 2016, we intend to hedge a
portion of these net exposures to manage the volatility of foreign exchange risk. Foreign exchange gains and losses recorded in our audited consolidated statements
of operations for the years ended Dece mber 31, 2015, 2014, and 2013, were not significant.
Equity
Price
Risk
The market price and volatility of our common stock impacts our non-cash stock-based compensation expense. Further information is included in Note 11,
“Stockholders Equity,” to our audited consolidated financial statements included elsewhere in this Annual Report.
Item
8.
Financial
Statements
and
Supplementary
data.
All information required by this item is included in the financial statements which follow the signature page of this Annual Report on Form 10-K and is
incorporated into this item by reference.
Item
9.
Changes
in
and
disagreements
with
Accountants
on
Accounting
and
Financial
disclosure.
None.
Item
9A.
Controls
and
Procedures.
Evaluation
of
disclosure
Controls
and
Procedures
We maintain “disclosure controls and procedures,” as such term is defined in Rule 13a-15(e) under the Exchange Act, that are designed to ensure that
information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the
time periods specified in the SEC rules and forms and that such information is communicated to our management, including our Chief Executive Officer (principal
executive officer) and Chief Financial Officer (principal financial officer), as appropriate to allow timely decisions regarding required disclosure. In designing and
evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well designed and operated, can
provide only reasonable, but not absolute, assurance that the objectives of the disclosure controls and procedures are met. Our disclosure controls and procedures
have been designed to meet the reasonable assurance standards. Additionally, in designing disclosure controls and procedures, our management necessarily was
required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and
procedures is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in
achieving its stated goals under all potential future conditions.
As required by Rule 13a-15(b) or Rule 15d-15(b) of the Exchange Act, we carried out an evaluation, under the supervision and with the participation of our
management, including our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer), of the effectiveness of the
design and operation of our disclosure controls and procedures as of December 31, 2015. Based on the foregoing, our Chief Executive Officer (principal executive
officer) and Chief Financial Officer (principal financial officer) concluded that our disclosure controls and procedures were effective as of December 31, 2015 at
the reasonable assurance level.
Management’s
Report
on
Internal
Control
over
Financial
Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act
Rule 13a-15(f) and 15d-15(f). Management, with the participation of our principal executive officer and principal financial officer, has conducted an evaluation of
the effectiveness of our internal control over financial reporting based on the framework set forth in Internal
Control—Integrated
Framework
(2013)
issued by the
Committee of Sponsoring Organizations of the Treadway Commission. Based on our evaluation under the framework set forth in Internal
Control—Integrated
Framework
(2013)
, our management concluded that our internal control over financial reporting was effective as of December 31, 2015.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with
the policies or procedures may deteriorate.
The effectiveness of our internal control over financial reporting as of December 31, 2015, has been audited by PricewaterhouseCoopers LLP, an
independent registered public accounting firm, as stated in their report which appears elsewhere herein.
68
Changes
in
Internal
Control
Over
Financial
Reporting
There were no changes in internal control over financial reporting during the quarter ended December 31, 2015, that have materially affected, or are
reasonably likely to materially affect, our internal control over financial reporting.
Item
9B.
Other
Information.
None.
69
PART
III
The information required by Part III is omitted from this Annual Report on Form 10-K since we intend to file our definitive Proxy Statement for our 2016
Annual Meeting of Stockholders, pursuant to Regulation 14A of the Exchange Act, not later than 120 days after the end of the fiscal year covered by this Annual
Report on Form 10-K, and certain information to be included in the Proxy Statement is incorporated herein by reference.
Item
10.
directors,
Executive
Officers
and
Corporate
governance.
Information required by this item regarding directors and director nominees, executive officers, the board of directors and its committees, and certain
corporate governance matters is incorporated by reference to the information set forth under the captions “Election of Directors,” “Information Regarding the
Board of Directors and Corporate Governance” and “Executive Officers” in our Proxy Statement for the 2016 Annual Meeting of Stockholders. Information
required by this item regarding compliance with Section 16(a) of the Exchange Act is incorporated by reference to the information set forth under the caption
“Section 16(a) Beneficial Ownership Reporting Compliance” in our Proxy Statement for the 2016 Annual Meeting of Stockholders.
We have adopted a written code of business conduct and ethics that applies to our principal executive officer, principal financial officer, principal
accounting officer, or persons serving similar functions. The code of business conduct and ethics is available on our corporate website at www.medivation.com . If
we make any substantive amendments to our code of business conduct and ethics or grant to any of our directors or executive officers any waiver, including any
implicit waiver, from a provision of our code of business conduct and ethics, we will disclose the nature of the waiver or amendment on our website or in a Current
Report on Form 8-K.
Item
11.
Executive
Compensation.
Information required by this item regarding executive compensation is incorporated by reference to the information set forth under the captions “Executive
Compensation,” “Director Compensation” and “Information Regarding the Board of Directors and Corporate Governance” in our Proxy Statement for the 2016
Annual Meeting of Stockholders.
Item
12.
Security
Ownership
of
Certain
Beneficial
Owners
and
Management
and
Related
Stockholder
Matters.
Information required by this item regarding security ownership of certain beneficial owners and management is incorporated by reference to the information
set forth under the caption “Security Ownership of Certain Beneficial Owners and Management” in our Proxy Statement for the 2016 Annual Meeting of
Stockholders. Information required by this item regarding securities authorized for issuance under our equity compensation plans is incorporated by reference to the
information set forth under the caption “Equity Compensation Plan Information” in our Proxy Statement for the 2016 Annual Meeting of Stockholders.
Item
13.
Certain
Relationships
and
Related
Transactions,
and
director
Independence.
Information required by this item regarding certain relationships and related transactions is incorporated by reference to the information set forth under the
caption “Transactions with Related Persons” in our Proxy Statement for the 2016 Annual Meeting of Stockholders. Information required by this item regarding
director independence is incorporated by reference to the information set forth under the caption “Information Regarding the Board of Directors and Corporate
Governance” in our Proxy Statement for the 2016 Annual Meeting of Stockholders.
Item
14.
Principal
Accounting
Fees
and
Services.
Information required by this item regarding principal accounting fees and services is incorporated by reference to the information set forth under the caption
“Ratification of Selection of Independent Registered Public Accounting Firm” in our Proxy Statement for the 2016 Annual Meeting of Stockholders.
70
PART
Iv
Item
15.
Exhibits,
Financial
Statement
Schedules.
(a) The following documents are filed as part of this Annual Report on Form 10-K:
1. Financial
Statements
. Our audited consolidated financial statements and the Report of Independent Registered Public Accounting Firm, are included
herein on the pages indicated:
Page
Report of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm
Consolidated Balance Sheets as of December 31, 2015 and 2014
Consolidated Statements of Operations for the years ended December 31, 2015, 2014 and 2013
Consolidated Statements of Comprehensive Income (Loss) for the years ended December 31, 2015, 2014, and 2013
Consolidated Statements of Cash Flows for the years ended December 31, 2015, 2014 and 2013
Consolidated Statements of Stockholders’ Equity for the years ended December 31, 2015, 2014 and 2013
Notes to Consolidated Financial Statements
73
74
75
76
77
78
79
2. Financial Statement Schedules: None.
3. Exhibits: See the Exhibit List which follows the financial statements attached following the signature page of this Annual Report on Form 10-K, which is
incorporated here by reference.
71
SIgNAT
uRES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its
behalf by the undersigned, thereunto duly authorized.
MEDIVATION, INC.
/ S / R ICHARD A. B IERLY
Richard
A.
Bierly
Chief
Financial
Officer
(Principal
Financial
Officer)
Dated: February 26, 2016
POWER
OF
ATTORNEy
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Richard A. Bierly and Andrew
K. W. Powell, as his or her true and lawful attorneys-in-fact and agents, with full power of substitution and re-substitution, for him or her and in his or her name,
place, and stead, in any and all capacities, to sign any and all amendments to this Report, and to file the same, with all exhibits thereto, and other documents in
connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to
do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he or she might or
could do in person, hereby ratifying and confirming that all said attorneys-in-fact and agents, or any of them or their or his or her substitute or substitutes, may
lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant
and in the capacities and on the dates indicated:
/ S / DAVID T. HUNG , M.D.
david
T.
hung,
M.d.
President, Chief Executive Officer and
Director (Principal Executive Officer)
February 26, 2016
Chief Financial Officer
(Principal Financial Officer)
February 26, 2016
Vice President, Finance and Accounting
(Principal Accounting Officer)
February 26, 2016
/ S / KIM D. BLICKENSTAFF
kim
d.
Blickenstaff
Director
February 26, 2016
/ S / KATHRYN E. FALBERG
kathryn
E.
Falberg
Director
February 26, 2016
/ S/
MICHAEL L. KING
Michael
l.
king
Director
February 26, 2016
/ S / C. PATRICK MACHADO
C.
Patrick
Machado
Director
February 26, 2016
/ S / DAWN SVORONOS
dawn
Svoronos
Director
February 26, 2016
/ S / W. ANTHONY VERNON
W.
Anthony
vernon
Director
February 26, 2016
/ S / WENDY L. YARNO
Wendy
l.
yarno
Director
February 26, 2016
/ S / RICHARD A. BIERLY
Richard
A.
Bierly
/ S / TSELI LILY YANG
Tseli
lily
yang
72
Report
of
Independent
Regist
ered
Public
Accounting
Firm
To the Board of Directors and Shareholders of
Medivation, Inc.:
In our opinion, the consolidated financial statements listed in the index appearing under Item 15(a)(1) present fairly, in all material respects, the financial
position of Medivation, Inc. and its subsidiaries at December 31, 2015 and December 31, 2014, and the results of their operations and their cash flows for each of
the three years in the period ended December 31, 2015 in conformity with accounting principles generally accepted in the United States of America. Also in our
opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2015, based on criteria established
in Internal
Control—Integrated
Framework
(2013)
issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). The Company’s
management is responsible for these financial statements, for maintaining effective internal control over financial reporting and for its assessment of the
effectiveness of internal control over financial reporting, included in Management’s Report on Internal Control over Financial Reporting, appearing under Item 9A.
Our responsibility is to express opinions on these financial statements and on the Company’s internal control over financial reporting based on our integrated
audits. We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that
we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatement and whether effective
internal control over financial reporting was maintained in all material respects. Our audits of the financial statements included examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and
evaluating the overall financial statement presentation. Our audit of internal control over financial reporting included obtaining an understanding of internal control
over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control
based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits
provide a reasonable basis for our opinions.
As discussed in Note 2 to the consolidated financial statements, the Company changed the manner in which it classifies deferred taxes in 2015 due to the
adoption of Accounting Standards Update 2015-17, Balance Sheet Classification of Deferred Taxes.
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over
financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the
transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of
financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in
accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with
the policies or procedures may deteriorate.
/s/ PricewaterhouseCoopers LLP
San Jose, California
February 26, 2016
73
MEdIvATION,
INC.
CONSOlIdATEd
BAlANCE
ShEETS
(in
thousands,
except
share
and
per
share
data)
ASSETS
Current assets:
Cash and cash equivalents
Receivable from collaboration partner
Deferred income tax assets
Prepaid expenses and other current assets
Restricted cash
Total current assets
Property and equipment, net
Intangible assets
Deferred income tax assets, non-current
Restricted cash, net of current
Goodwill
Other non-current assets
Total assets
$
$
lIABIlITIES
ANd
STOCkhOldERS’
EquITy
Current liabilities:
Accounts payable, accrued expenses and other current liabilities
Borrowings under Revolving Credit Facility
Contingent consideration
Deferred revenue
Current portion of build-to-suit lease obligation
Current portion of Convertible Notes, net of unamortized discount of $— and $1 at
December 31, 2015 and 2014, respectively
Total current liabilities
Convertible Notes, net of unamortized discount of $— and $36,598 at
December 31, 2015 and 2014, respectively
Contingent consideration
Build-to-suit lease obligation, excluding current portion
Other non-current liabilities
Total liabilities
Commitments and contingencies (Note 15)
Stockholders’ equity:
Preferred stock, $0.01 par value per share; 1,000,000 shares authorized; no
shares issued and outstanding
Common stock, $0.01 par value per share; 340,000,000 shares authorized; 163,905,342 and 156,234,454
shares issued and outstanding at December 31, 2015
and 2014, respectively
Additional paid-in capital
Retained earnings (accumulated deficit)
Total stockholders’ equity
Total liabilities and stockholders’ equity
december
31,
2015
$
$
225,853
391,558
—
15,877
930
634,218
58,142
644,299
57,011
12,206
18,643
7,072
1,431,591
$
186,203
75,000
4,900
—
—
$
502,677
184,737
21,987
12,264
203
721,868
41,161
101,000
15,176
11,562
10,000
10,852
911,619
106,128
—
10,000
2,822
698
—
266,103
4
119,652
—
262,368
17,406
13,035
558,912
222,140
96,000
18,711
5,817
462,320
—
—
1,639
684,841
186,199
872,679
1,431,591
SEE
ACCOMPANyINg
NOTES
TO
CONSOlIdATEd
FINANCIAl
STATEMENTS
74
$
2014
$
1,562
505,446
(57,709)
449,299
911,619
MEdIvATION,
INC.
CONSOlIdATEd
STATEMENTS
OF
OPERATIONS
(in
thousands,
except
per
share
data)
years
ended
december
31,
2014
2015
Collaboration revenue
Operating expenses:
Research and development expenses
Selling, general and administrative expenses
Total operating expenses
Income (loss) from operations
Other income (expense), net:
Loss on extinguishment of Convertible Notes
Interest expense
Other, net
Total other income (expense), net
Income (loss) before income tax (expense) benefit
Income tax (expense) benefit
Net income (loss)
$
Basic net income (loss) per common share
$
1.53
$
1.80
Diluted net income (loss) per common share
$
1.47
$
1.71
$
943,258
$
710,487
2013
$
272,942
232,100
296,545
528,645
414,613
189,570
239,071
428,641
281,846
118,952
176,231
295,183
(22,241)
(21,087)
(12,483)
275
(33,295)
381,318
(136,593)
244,725
—
(21,690)
38
(21,652)
260,194
16,258
276,452
$
—
(20,249)
(8)
(20,257)
(42,498)
(115)
(42,613)
$
(0.28)
$
(0.28)
$
Weighted-average common shares used in the calculation of basic
net income (loss) per common share
160,345
153,859
150,331
Weighted-average common shares used in the calculation of diluted
net income (loss) per common share
169,324
170,001
150,331
SEE
ACCOMPANyINg
NOTES
TO
CONSOlIdATEd
FINANCIAl
STATEMENTS
75
MEdIvATION,
INC.
CONSOlIdATEd
STATEMENTS
OF
COMPREhENSIvE
INCOME
(lOSS)
(in
thousands)
Net income (loss)
Other comprehensive income (loss):
Change in unrealized loss on available-for-sale securities, net
Amounts reclassified into earnings related to investments
Other comprehensive income (loss), net
Comprehensive income (loss)
2015
years
ended
december
31,
2014
$
244,725
$
(10)
10
—
244,725
$
276,452
$
—
—
—
276,452
SEE
ACCOMPANyINg
NOTES
TO
CONSOlIdATEd
FINANCIAl
STATEMENTS
76
2013
$
(42,613)
$
(33)
—
(33)
(42,646)
MEdIvATION,
INC.
CONSOlIdATEd
STATEMENTS
OF
CASh
FlOWS
(in
thousands)
Cash flows from operating activities:
Net income (loss)
Adjustments for non-cash operating items:
Stock-based compensation
Impairment of intangible assets
Loss on extinguishment of Convertible Notes
Amortization of debt discount and debt issuance costs
Depreciation on property and equipment
Excess tax benefits from stock-based compensation
Changes in deferred income taxes
Change in fair value of contingent purchase consideration
Amortization of deferred revenue
Release of valuation allowance for deferred income taxes
Other non-cash items
Changes in operating assets and liabilities:
Receivable from collaboration partners
Prepaid expenses and other current assets
Other non-current assets
Accounts payable, accrued expenses and other current liabilities
Current taxes payable
Other non-current liabilities
Net cash provided by (used) in operating activities
Cash flows from investing activities:
Payments to BioMarin Pharmaceutical Inc. under Asset Purchase Agreement
Payments to CureTech, Ltd. under License Agreement
Purchases of short-term investments
Sales or maturities of short-term investments
Purchases of property and equipment
Change in restricted cash
Net cash (used in) provided by investing activities
Cash flows from financing activities:
Principal repayment of Convertible Notes
Cash settlement of Convertible Notes conversion premium
Proceeds from borrowings under Revolving Credit Facility
Principal repayment of borrowings under Revolving Credit Facility
Financing transaction costs
Excess tax benefits from stock-based compensation
Proceeds from issuance of common stock under equity incentive and stock purchase plans
Reduction of build-to-suit lease obligation
Net cash (used in) provided by financing activities
Net (decrease) increase in cash and cash equivalents
Cash and cash equivalents at beginning of year
Cash and cash equivalents at end of year
Supplemental
disclosures
of
cash
flow
information:
Cash payments (refunds) for:
Interest
Income taxes, net of refunds
Non-cash investing and financing activities:
Reacquisition of Convertible Notes equity component upon conversion
Fair value of common stock issued for conversion of Convertible Notes
Derecognition of build-to-suit lease asset
Derecognition of build-to-suit lease obligations
Property and equipment expenditures incurred but not yet paid
Interest capitalized during construction period for build-to-suit lease transactions
Accrued interest payable forfeited upon conversion of Convertible Notes
Amounts capitalized under build-to-suit lease transactions
years
ended
december
31,
2014
2015
$
$
244,725
$
$
(42,613)
54,862
30,000
21,087
8,613
7,023
(100,243)
(8,270)
(10,674)
(2,822)
—
52
45,134
—
—
14,898
5,239
(16,965)
(3,827)
—
(14,109)
(33,403)
1,124
37,078
—
—
13,456
3,449
—
—
—
(25,396)
—
(10)
(206,821)
(4,556)
3,279
145,997
30,459
7,228
219,939
(77,527)
301
(401)
41,965
1,970
(252)
240,599
(71,752)
(3,953)
(7,353)
27,852
37
996
(68,209)
(410,000)
—
(90,381)
90,224
(19,459)
(1,371)
(430,987)
—
(5,000)
—
—
(10,544)
(1,866)
(17,410)
—
—
(144,926)
370,000
(7,535)
(713)
216,826
(258,742)
(1,126)
150,000
(75,000)
(1,715)
100,243
21,459
(895)
(65,776)
(276,824)
502,677
225,853
$
(12)
—
—
—
—
16,965
33,882
(135)
50,700
273,889
228,788
502,677
$
—
—
—
—
—
—
8,870
—
8,870
157,487
71,301
228,788
$
$
6,792
1,525
$
$
$
$
3,577
2,122
$
$
$
$
$
$
$
$
324,177
312,990
3,241
3,176
5,828
2,024
1,686
44
$
$
$
SEE
ACCOMPANyINg
NOTES
TO
CONSOlIdATEd
FINANCIAl
STATEMENTS
77
276,452
2013
—
—
—
—
242
1,459
—
18,085
$
6,792
(127)
—
—
—
—
99
—
—
—
MEdIvATION,
INC.
CONSOlIdATEd
STATEMENTS
OF
STOCkhOldERS’
EquITy
(in
thousands,
except
share
amounts)
Balances
at
January
1,
2013
Common stock issued under equity incentive plan
Common stock issued for warrant exercises, net
of shares withheld for exercise price
Stock-based compensation expense
Change in comprehensive income
Net loss
Balances
at
december
31,
2013
Common stock issued under equity incentive and
employee stock purchase plans
Stock-based compensation expense
Excess tax benefits from stock-based compensation
Tax shortfalls from stock-based compensation
Repayment of Convertible Notes
Net income
Balances
at
december
31,
2014
Common stock issued under equity incentive and
employee stock purchase plans
Stock-based compensation expense
Excess tax benefits from stock-based compensation
Tax shortfalls from stock-based compensation
Common stock issued for conversion of
Convertible Notes
Tax impact of extinguishment of Convertible Notes
Reclassification of accrued interest on Convertible
Notes upon conversion
Stock dividend
Net income
Balances
at
december
31,
2015
Common
Stock
Shares
(1) Amount
(1) Accumulated
Retained
Additional
Other
Earnings
Total
Paid-In Comprehensive (Accumulated Stockholders’ Capital
(1) Income
(loss) deficit)
Equity
149,549,878
$
2,005,218
1,495
$
20
363,665
$
8,850
33
$
—
(291,548) $
—
73,645
8,870
50,944
—
—
—
151,606,040
1
—
—
—
1,516
(1)
37,078
—
—
409,592
—
—
(33)
—
—
—
—
—
(42,613)
(334,161) —
37,078
(33)
(42,613)
76,947
4,628,414
—
—
—
—
—
156,234,454
46
—
—
—
—
—
1,562
33,836
45,134
16,965
(77)
(4)
—
505,446
—
—
—
—
—
—
—
—
—
—
—
—
276,452
(57,709) 33,882
45,134
16,965
(77)
(4)
276,452
449,299
2,032,312
—
—
—
21
—
—
—
21,438
54,862
100,243
(259)
—
—
—
—
—
—
—
—
21,459
54,862
100,243
(259)
5,638,576
—
56
—
(11,239)
11,847
—
—
—
—
(11,183)
11,847
—
—
—
163,905,342
$
—
—
—
1,639
$
1,686
817
—
684,841
$
—
—
—
—
$
—
(817)
244,725
186,199
$
1,686
—
244,725
872,679
(1)
All share, par, and additional paid-in capital amounts have been retroactively adjusted to reflect the Company’s September 15, 2015, two-for-one forward
stock split effected through a stock dividend. This stock split resulted in the issuance of approximately 81.7 million shares of the Company’s common stock.
SEE
ACCOMPANyINg
NOTES
TO
CONSOlIdATEd
FINANCIAl
STATEMENTS
78
MEdIvATION,
INC.
NOTES
TO
CONSOlIdATEd
FINANCIAl
STATEMENTS
december
31,
2015
NOTE
1.
dESCRIPTION
OF
BuSINESS
Medivation, Inc. (the “Company” or “Medivation”) is a biopharmaceutical company focused on the development and commercialization of medically
innovative therapies to treat serious diseases for which there are limited treatment options. It has one commercial product, XTANDI® (enzalutamide) capsules, or
XTANDI, through the Company’s collaboration with Astellas Pharma, Inc., or Astellas. XTANDI has received marketing approval in the United States, Europe
and numerous other countries worldwide for the treatment of patients with metastatic castration-resistant prostate cancer, or mCRPC, and in Japan for the treatment
of patients with castration-resistant prostate cancer, or CRPC. The Company and Astellas are also conducting investigational studies of enzalutamide in prostate
cancer, advanced breast cancer, and hepatocellular carcinoma. Under the Company’s collaboration agreement with Astellas, it shares equally with Astellas all
profits (losses) related to U.S. net sales of XTANDI. The Company also receives royalties ranging from the low teens to the low twenties as a percentage of ex-U.S.
XTANDI net sales. The collaboration also involved certain milestone payments from Astellas to the Company upon the achievement of defined development,
regulatory and sales events, all of which have been achieved as of December 31, 2015.
The Company seeks to become a more fully-integrated biopharmaceutical company through the continued commercialization of XTANDI, the acquisition
or in-license and development and commercialization of other product opportunities, and through the advancement of its own proprietary research and development
programs. The Company expects that its future growth may come from both internal research efforts and third-party business development activities. In the fourth
quarter of 2015, the Company acquired all worldwide rights to talazoparib (which is referred to as MDV3800), an orally available poly-ADP ribose polymerase, or
PARP, inhibitor from BioMarin Pharmaceutical Inc., or BioMarin. MDV3800 is currently in a Phase 3 clinical trial for the treatment of patients with germline
BRCA, or gBRCA, mutated advanced breast cancer (i.e., advanced breast cancer in patients whose BRCA genes contain germline mutations). The Company is
targeting a number of other indications in which to investigate MDV3800, including breast cancer (beyond gBRCA mutations), prostate cancer, small cell lung
cancer, and ovarian cancer. In the fourth quarter of 2014, the Company licensed exclusive worldwide rights to pidilizumab (which is referred to as MDV9300), an
antibody with immune-mediated anti-tumor effects for all potential indications from CureTech, Ltd., or CureTech. Under the license agreement, the Company is
responsible for all development, regulatory, manufacturing, and commercialization activities for MDV9300. The Company initiated a Phase 2 clinical trial
evaluating MDV9300 in patients with relapsed or refractory diffuse large B-cell lymphoma in the fourth quarter of 2015, which is on partial clinical hold pending
its revision of certain investigator brochure, protocols and informed consent documents. The Company submitted the revised documents to the FDA in early
February 2016 and the FDA has 30 days thereafter to notify the Company if the partial hold is lifted. The Company also plans to develop MDV9300 in other
hematologic malignancies such as multiple myeloma.
In addition to the above activities, the Company has various internal research and discovery efforts focused in oncology, neurology and other areas.
NOTE
2.
SuMMARy
OF
SIgNIFICANT
ACCOuNTINg
POlICIES
(a)
Basis
of
Presentation
and
Principles
of
Consolidation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States,
or U.S. GAAP, and include the accounts of the Company and its subsidiaries. All intercompany transactions and balances have been eliminated in consolidation.
The Company operates in one business segment.
All tabular disclosures of dollar and share amounts are presented in thousands unless otherwise indicated. All per share amounts are presented at their actual
amounts. The number of shares issuable under the Amended and Restated 2004 Equity Incentive Award Plan, or the Medivation Equity Incentive Plan, and the
Medivation, Inc. 2013 Employee Stock Purchase Plan, or ESPP, disclosed in Note 11, “Stockholders’ Equity,” are presented at their actual amounts unless
otherwise indicated. Amounts presented herein may not calculate or sum precisely due to rounding.
Certain prior period amounts have been reclassified to conform to the current year presentation. There was no effect on net income (loss) or stockholders’
equity related to these reclassifications.
(b)
use
of
Estimates
The preparation of consolidated financial statements in accordance with U.S. GAAP requires that management make estimates and assumptions in certain
circumstances that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and
the reported amounts of revenues and expenses during the reporting period. Management bases its estimates on historical experience and on assumptions believed
to be reasonable under the circumstances.
79
Although management believes that these e stimates are reasonable, actual future results could differ materially from those estimates. In addition, had different
estimates and assumptions been used, the consolidated financial statements could have differed materially from what is presented.
Significant estimates and assumptions used by management principally relate to revenue recognition, including reliance on third-party information,
estimating the performance periods of the Company’s deliverables under collaboration agreements, and estimating the various deductions from gross sales to
calculate net sales of XTANDI. Additionally, significant estimates and assumptions used by management include those related to contingent purchase
consideration, intangible assets, goodwill, the Convertible Notes, determining whether the Company is the primary beneficiary of any variable interest entities,
leases, taxes, research and development and other accruals, share-based compensation, and the calculation of diluted net income per common share.
(c)
Capital
Structure
On June 15, 2015, the Company filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation, as amended, effecting an
increase in the total number of authorized shares of capital stock of the Company from 171,000,000 to 341,000,000 and an increase in the total number of
authorized shares of common stock of the Company from 170,000,000 to 340,000,000.
On September 15, 2015, the Company effected a two-for-one forward stock split of its common stock in the form of a stock dividend. Stockholders of
record as of August 13, 2015 received one additional share of the Company’s common stock, par value $0.01, for each share they held as of the record date. The
Company issued approximately 81.7 million shares of its common stock as a result of the stock dividend. The par value of the Company’s common stock remained
unchanged at $0.01 per share.
During the year ended December 31, 2015, the Company settled $258.8 million aggregate principal amount of its 2.625% convertible senior notes due April
1, 2017, or the Convertible Notes, through a combination of $259.9 million in cash and 5,638,576 shares of its common stock. Upon settlement, the Convertible
Notes were no longer outstanding, interest ceased to accrue thereon, and all rights of the holders of the Convertible Notes ceased to exist.
Information regarding shares of common stock (except par value per share), par, additional paid-in capital, and net income (loss) per common share for all
periods presented has been retroactively adjusted to reflect the effects of the stock split. The number of shares of the Company’s common stock issuable upon
exercise of outstanding stock options and stock appreciation rights and vesting of other stock-based awards was proportionally increased, and the exercise price per
share thereof, as applicable, was proportionally decreased, in accordance with the terms of the Medivation Equity Incentive Plan, as amended, and the ESPP.
(d)
Collaboration
Agreement
Payments
The Company accounts for the various payment flows under its collaboration agreement with Astellas, or the Astellas Collaboration Agreement, as follows:
Estimated
Performance
Periods
The Astellas Collaboration Agreement contains multiple elements and deliverables, and required evaluation pursuant to Financial Accounting Standards
Board, or FASB, Accounting Standards Codification, or ASC, 605-25, “Revenue Recognition—Multiple-Element Arrangements.” The Company concluded that it
had multiple deliverables under the Astellas Collaboration Agreement, including deliverables relating to grants of technology licenses, and performance of
manufacturing, regulatory and clinical development activities in the United States. The period in which the Company performed its deliverables began in the fourth
quarter of 2009 and concluded in the third quarter of 2015 upon substantial completion of the Company’s remaining performance obligations. The Company also
concluded that its deliverables under the Astellas Collaboration Agreement should be accounted for as a single unit under ASC 605-25.
Estimation of the performance periods of the Company’s deliverables requires the use of management’s judgment. Significant factors considered in
management’s evaluation of the estimated performance periods include, but are not limited to, the Company’s experience, along with its collaboration partners’
experience, in conducting manufacturing, clinical development and regulatory activities. The Company reviews the estimated duration of its performance periods
under its collaboration agreements on a quarterly basis and makes any appropriate adjustments on a prospective basis.
Upfront
Payments
The Company received a non-refundable, upfront cash payment of $110.0 million under the Astellas Collaboration Agreement. The Company recognized
the payment as collaboration revenue on a straight-line basis over the applicable estimated performance period. As of December 31, 2015, there was no deferred
revenue related to payments received under the Astellas Collaboration Agreement.
80
Milestone
Payments
The Company has been eligible to receive milestone payments under the Astellas Collaboration Agreement based on achievement of specified development,
regulatory and commercial events. Management evaluated the nature of the events triggering these contingent payments, and concluded that these events fall into
two categories: (a) events which involve the performance of the Company’s obligations under the Astellas Collaboration Agreement, and (b) events which do not
involve the performance of the Company’s obligations under the Astellas Collaboration Agreement.
The former category of milestone payments consist of those triggered by development and regulatory activities in the United States and by the acceptance
for review of marketing applications in Europe and Japan. Management concluded that each of these payments, with one exception, constitute substantive
milestone payments. This conclusion was based primarily on the facts that (i) each triggering event represented a specific outcome that could be achieved only
through successful performance by the Company of one or more of its deliverables, (ii) achievement of each triggering event was subject to inherent risk and
uncertainty and would result in additional payments becoming due to the Company, (iii) each of the milestone payments was non-refundable, (iv) substantial effort
was required to complete each milestone, (v) the amount of each milestone payment was reasonable in relation to the value created in achieving the milestone,
(vi) a substantial amount of time was expected to pass between the upfront payment and the potential milestone payments, and (vii) the milestone payments related
solely to past performance. Based on the foregoing, the Company recognized any revenue from these milestone payments in the period in which the underlying
triggering event occurs. The one exception is the milestone payment for initiation of the Phase 3 PREVAIL trial, an event which management deemed to be
reasonably assured at the inception of the Astellas collaboration. This milestone payment was triggered in the third quarter of 2010, and the Company recognized it
as collaboration revenue on a straight-line basis over the estimated remaining performance period of the Astellas Collaboration Agreement.
The latter category of milestone payments consist of those triggered by potential marketing approvals in Europe and Japan, and commercial activities
globally, all of which were areas in which the Company had no pertinent contractual responsibilities under the Astellas Collaboration Agreement. Management
concluded that these payments constitute contingent revenues and thus recognized them as revenue in the period in which the contingency was met.
As of December 31, 2015, the Company has earned all development and sales milestone payments under the Astellas Collaboration Agreement.
Royalties
and
Profit
(Loss)
Sharing
Payments
Under the Astellas Collaboration Agreement, the Company shares equally profits (losses) on sales of products in the United States and receives royalties on
sales of products outside the United States. The Company recognizes revenue from these events based on the revenue recognition criteria set forth in ASC 605-1025-1, “Revenue Recognition.” Based on those criteria, the Company considers these payments to be contingent revenues, and recognizes them as revenue in the
period in which the applicable contingency is resolved.
Cost-Sharing
Payments
Under the Astellas Collaboration Agreement, the Company and Astellas share certain development and commercialization costs in the United States,
including cost of goods sold and the royalty on net sales payable to The Regents of the University of California, or UCLA, under the Company’s license agreement
with UCLA. The Company and Astellas make quarterly cost-sharing payments to one another in amounts necessary to ensure that each party bears its contractual
share of the overall shared U.S. development and commercialization costs incurred. The Company’s policy is to account for cost-sharing payments to its
collaboration partners as increases in expense in its consolidated statements of operations, while cost-sharing payments from its collaboration partners to the
Company are accounted for as reductions in expense. Cost-sharing payments related to development activities and commercialization activities are recorded in
research and development expenses, or R&D expenses, and selling, general and administrative expenses, or SG&A expenses, respectively.
Reliance
on
Third-Party
Information
Under the Astellas Collaboration Agreement, Astellas records all XTANDI sales globally and has operational responsibility for certain development and
commercialization activities in the United States for which the Company shares costs. Thus, Astellas has control over certain XTANDI-related financial
information needed to prepare the Company’s financial statements and related disclosures, including information regarding gross sales, net sales, gross-to-net sales
deductions, including estimates of potential future product returns, and shared U.S. development and commercialization costs incurred by Astellas. The Company is
dependent on Astellas to provide it with such information in a timely and accurate manner for use in preparing the Company’s consolidated financial statements
and disclosures. Certain of this information provided by Astellas is subject to estimates, including estimates used in determining gross-to-net revenue deductions
such as payor mix, discounts (including legally mandated discounts to government entities), returns, chargebacks, rebates, and participation levels in patient
assistance programs, and estimates regarding accrued development and commercialization costs incurred by Astellas. Under the Astellas Collaboration Agreement,
the deductions from
81
gross sales used to derive net sales of XTANDI are determined in a manner consistent with GAAP, consistently applied. Should Astellas fail to provide the
Company with any such financial information in a timely manner, or should any such financial i nformation provided by Astellas, or any of the estimates upon
which such financial information was based, prove to be inaccurate, the Company could be required to record adjustments in future periods.
(e)
Research
and
development
Expenses
and
Accruals
R&D expenses are charged to expense as incurred unless there is an alternative future use in other research and development projects or otherwise. R&D
expenses are comprised of costs incurred in performing research and development activities, including personnel-related costs, share-based compensation, and
facilities-related overhead, outside contracted services including clinical trial costs, manufacturing and process development costs for both clinical and preclinical
materials, research costs, upfront and development milestone payments under license agreements and other consulting services. Non-refundable advance payment
for goods and services that will be used in future research and development activities are expensed when the activity has been performed or when the goods have
been received rather than when the payment is made. In instances where the Company enters into agreements with third parties to provide research and
development services, costs are expensed as services are performed. Amounts due under such arrangements may be either fixed fee or fee for service, and may
include upfront payments, monthly payments, and payments upon the completion of milestones or receipt of deliverables.
The Company’s accruals for clinical trials and other research and development activities are based on estimates of the services received and efforts
expended pursuant to contracts with numerous clinical trial centers, contract research organizations and clinical manufacturing organizations. In the normal course
of business the Company contracts with third parties to perform various research and development activities in the on-going development of its product candidates,
including, without limitation, third-party clinical trial centers and contract research organizations that perform and administer the Company’s clinical trials on its
behalf and clinical manufacturing organizations that manufacture clinical trial materials. The financial terms of these agreements are subject to negotiation and vary
from contract to contract and may result in uneven payment flows. Payments under these agreements depend on factors such as the achievement of certain events,
the successful enrollment of patients, and the completion of portions of the clinical trial or similar conditions. The objective of the Company’s accrual policy is to
match the recording of expenses in its consolidated financial statements to the actual services received and efforts expended. As such, expense accruals related to
clinical trials and other research and development activities are recognized based on the Company’s estimate of the degree of completion of the event or events
specified in the specific agreement.
The Company’s accrual estimates are dependent upon the timeliness and accuracy of data provided by third parties regarding the status and cost of studies,
and may not match the actual services performed by the organizations. During the course of a clinical trial, the Company adjusts its rate of clinical trial expense
recognition if actual results differ from its estimates. The Company makes estimates of its accrued clinical trial expenses as of each balance sheet date based on
facts and circumstances known at that time. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its
understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in the Company
reporting amounts that are too high or too low for any particular period. This could result in adjustment to the Company’s R&D expense in future periods. The
Company has had no significant adjustments to previously recorded research and development amounts.
(f)
Promotional
and
Advertising
Costs
Promotional and advertising costs are classified as SG&A expenses and are expensed as incurred. Promotional and advertising expenses consist primarily of
the costs of designing, producing and distributing materials promoting the Company and its products, including its corporate website. Under the Astellas
Collaboration Agreement, the Company and its collaboration partners share certain commercialization costs, including certain promotional and advertising costs, in
the United States. See Note 3, “Collaboration Agreement,” for additional information regarding cost-sharing with its collaboration partners.
(g)
Stock-Based
Compensation
The Company has outstanding stock options, restricted stock units, and stock appreciation rights pursuant to the terms of the Medivation Equity Incentive
Plan, and eligible employees may purchase shares pursuant to the ESPP. The Company accounts for stock-based compensation awards to employees and directors
and ESPP shares in accordance with ASC 718, “Stock Compensation,” and stock-based compensation awards to consultants in accordance with ASC 505-50,
“Equity-Based Payments to Non-Employees.”
Stock-based compensation expense associated with stock options is based on the estimated grant date fair value using the Black-Scholes valuation model,
which requires the use of subjective assumptions related to the expected stock price volatility, option term, risk-free interest rate and dividend yield. The Company
recognizes compensation expense over the vesting period of the awards that are ultimately expected to vest.
82
Stock-based compensation expense associated with restricted stock units is based on the fair value of the Company’s common stoc k on the grant date,
which equals the closing market price of the Company’s common stock on the grant date. For restricted stock units, the Company recognizes compensation expense
over the vesting period of the awards that are ultimately expected to vest.
The fair value of stock-settled and cash-settled stock appreciation rights is initially measured on the grant date using the Black-Scholes valuation model,
which requires the use of subjective assumptions related to the expected stock price volatility, term, risk-free interest rate and dividend yield. Similar to stock
options, compensation expense for stock-settled stock appreciation rights is recognized over the vesting period of the awards that are ultimately expected to vest
based on the grant-date fair value. Cash-settled stock appreciation rights are liability-classified awards for which compensation expense and the liability are
remeasured at each reporting date through the date of settlement based on the portion of the requisite service period rendered. Upon the conversion of cash-settled
stock appreciation rights to stock-settled stock appreciation rights, the awards are remeasured using the then-current Black-Scholes assumptions and the remeasured
liability is reclassified to additional paid-in capital.
The Company accounts for the ESPP as a compensatory plan. The fair value of each purchase under the Company’s ESPP is estimated on the date of the
beginning of the offering period using the Black-Scholes valuation model, which requires the use of subjective assumptions related to the expected stock price
volatility, term, risk-free interest rate and dividend yield. The Company recognizes compensation expense over the vesting period of the awards that are ultimately
expected to vest.
Equity awards to consultants are typically remeasured at fair value at each reporting date until the awards vest.
The Company applies a forfeiture rate when determining stock-based compensation expense to account for an estimate of the granted awards not expected
to vest. If actual forfeitures differ from the expected rate, the Company may be required to make additional adjustments to compensation expense in future periods.
The Black-Scholes valuation model was developed for use in estimating the fair value of traded options that have no vesting restrictions and are fully
transferable, characteristics not present in the Company’s stock options, stock appreciation rights, or ESPP shares. If the model permitted consideration of the
unique characteristics of employee stock options, stock appreciation rights, and ESPP shares, the resulting estimate of fair value of the stock options, stock
appreciation rights, and ESPP shares could be different. In addition, if the Company had made different assumptions and estimates for use in the Black-Scholes
valuation model, the amount of recognized and to be recognized stock-based compensation expense could have been different.
(h)
Cash
and
Cash
Equivalents
Cash and cash equivalents are stated at cost, which approximates fair market value. Cash and cash equivalents consist of cash on deposit with banks, money
market funds, and all highly liquid investments with a remaining maturity of three months or less at the time of purchase.
(i)
Short-Term
Investments
The Company considers all highly liquid investments with a remaining maturity at the time of acquisition of more than three months but no longer than 12
months to be short-term investments. The Company classifies its short-term investments as available-for-sale securities and reports them at fair value with related
unrealized gains and losses included as a component of stockholders’ equity. The amortized cost of debt securities in this category is adjusted for amortization of
premiums and accretion of discounts to maturity, which is included in other income (expense), net, on the consolidated statements of operations. Realized gains and
losses and declines in value judged to be other-than-temporary, if any, on available-for-sale securities are included in other income (expense), net. The cost of
securities sold is based on the specific identification method. Interest and dividends on securities classified as available-for-sale are included in other income
(expense), net.
For the year ended December 31, 2015, total realized gains and losses on sales of available-for-sale securities were not material. There were no realized
gains or losses from sales of available-for-sale securities for the years ended December 31, 2014 and 2013.
(j)
Concentration
of
Credit
Risk
The Company is subject to credit risk from its portfolio of cash, cash equivalents and short-term investments. The goals of the Company’s investment
policy, in order of priority, are (1) the safety and preservation of principal, (2) maintain liquidity sufficient to meet the requirements of the Company’s operations
and strategic initiatives, and (3) deliver competitive after-tax returns relative to stated objectives and market conditions. The Company’s investment policy limits
investments by credit rating, maturity, industry group, investment type and issuer, except for securities issued by the U.S. government. Given this investment
policy, the Company does not believe its exposure to credit risk with respect to the issuers of the securities in which it invests is material. The Company’s cash and
cash equivalents are primarily invested in deposits and money market accounts with one major financial institution in the United States. Deposits in this financial
institution may exceed the amount of insurance provided on such deposits.
83
(k)
Restricted
Cash
Restricted cash represents certificates of deposit held in the Company’s name with a major financial institution to secure the Company’s contingent
obligations under irrevocable letters of credit issued to certain of its lessors.
(l)
Property
and
Equipment
Property and equipment are recorded at cost, less accumulated depreciation and amortization. Repairs and maintenance costs are expensed in the period
incurred. Property and equipment is generally depreciated on a straight-line basis over the estimated useful lives of the assets as follows:
description
Estimated
useful
life
Furniture and fixtures
Computer equipment and software
Laboratory equipment
3-5 years
3-5 years
5 years
Leasehold improvements are amortized over their estimated useful life or the related lease term, whichever is shorter.
(m)
leases
At the inception of a lease, the Company evaluates the lease agreement to determine whether the lease is an operating, capital or build-to-suit lease using the
criteria in ASC 840, “Leases.”
Certain lease agreements also require the Company to make additional payments for taxes, insurance, and other operating expenses incurred during the lease
period, which are expensed as incurred.
Operating
Leases
For operating leases, the Company recognizes rent expense on a straight-line basis over the lease term and records the difference between cash rent
payments and the recognition of rent expense as a deferred liability. Where lease agreements contain rent escalation clauses, rent abatements and/or concessions,
such as rent holidays and tenant improvement allowances, the Company applies them in the determination of straight-line expense over the lease term.
Capital
Leases
Capital leases are recorded as an asset within property and equipment, net and as an obligation at an amount equal to the present value of the minimum lease
payments during the lease term. The asset is generally amortized over its estimated useful life or the related lease term, whichever is shorter. Lease payments under
capital leases are recognized as a reduction of the capital lease obligation and interest expense. The Company currently does not have any capital leases.
Build-to-Suit
Leases
In certain lease arrangements, the Company is involved in the construction of the building. To the extent the Company is involved with the structural
improvements of the construction project or takes construction risk prior to the commencement of a lease, ASC 840-40, “Leases – Sale-Leaseback Transactions
(Subsection 05-5),” requires the Company to be considered the owner for accounting purposes of these types of projects during the construction period. Therefore,
the Company records an asset in property and equipment, net on the consolidated balance sheets, including capitalized interest costs, for the replacement cost of the
Company’s portion of the pre-existing building plus the amount of estimated structural construction costs incurred by the landlord and the Company as of the
balance sheet date. The Company records a corresponding build-to-suit lease obligation on its consolidated balance sheets representing the amounts paid by the
lessor.
Once construction is complete, the Company considers the requirements for sale-leaseback accounting treatment, including evaluating whether all risks of
ownership have been transferred back to the landlord, as evidenced by a lack of continuing involvement in the leased property. If the arrangement does not qualify
for sale-leaseback accounting treatment, the building asset remains on the Company’s consolidated balance sheets at its historical cost, and such asset is depreciated
over its estimated useful life. The Company bifurcates its lease payments into a portion allocated to the building and a portion allocated to the parcel of land on
which the building has been built. The portion of the lease payments allocated to the land is treated for accounting purposes as operating lease payments, and
therefore is recorded as rent expense in the consolidated statements of operations. The portion of the lease payments allocated to the building is further bifurcated
into a portion allocated to interest expense and a portion allocated to reduce the build-to-suit lease obligation. The interest rate used for the build-to-suit lease
obligation represents the Company’s estimated incremental borrowing rate at inception of the lease, adjusted to reduce any built in loss. The initial recording of
these assets and liabilities is classified as non-cash investing and financing items, respectively, for purposes of the consolidated statements of cash flows.
84
(n)
Business
Combinations
Business combinations are accounted for under the acquisition method of accounting. The purchase price, including the fair value of any contingent
consideration, is allocated between tangible and intangible assets acquired and liabilities assumed from the acquired business based on their estimated fair values,
with the residual of the purchase price recorded as goodwill. Transaction costs are expensed as incurred.
Contingent
Consideration
The Company determines the fair value of contingent consideration payable at the acquisition date using a probability-based income approach utilizing an
appropriate discount rate. Each reporting period thereafter, the Company re-measures the contingent consideration and records increases or decreases in their fair
value as non-cash adjustments in the consolidated statements of operations. Changes in the fair value of contingent consideration payable can result from
adjustments to the estimated probability and assumed timing of achieving the underlying milestones, as well as from changes to the discount rates and periods.
In-Process
Research
and
Development
In-process research and development, or IPR&D, represents the fair value assigned to incomplete research projects that the Company acquires through
business combinations which, at the time of acquisition, have not reached technological feasibility. The amounts are capitalized and accounted for as indefinitelived intangible assets, subject to impairment testing until completion or abandonment of the projects. Upon successful completion of each project, the Company
will make a determination as to the then useful life of the intangible asset, generally determined by the period in which the substantial majority of the cash flows are
expected to be generated, and begin amortization over that period. The Company tests IPR&D for impairment at least annually, or more frequently if impairment
indicators exist, by first assessing qualitative factors to determine whether it is more likely than not that the fair value of the IPR&D is less than its carrying
amount. If the Company concludes it is more likely than not that the fair value is less than the carrying amount, a quantitative test that compares the fair value of
the IPR&D with its carrying value is performed. If the fair value is less than the carrying amount, a non-cash impairment change is recognized in the consolidated
statements of operations.
Goodwill
Goodwill represents the excess of the consideration transferred over the fair value of net assets of businesses acquired. Goodwill is assigned to reporting
units and tested at least annually for impairment or when events or changes in circumstances indicate that the carrying amount of such assets may not be
recoverable, on an enterprise level by assessing qualitative factors or performing a quantitative analysis in determining whether it is more likely than not that its fair
value exceeds the carrying value. Examples of qualitative factors include the Company’s share price, its financial performance compared to budgets, long-term
financial plans, macroeconomic, industry and market conditions as well as the substantial excess of fair value over the carrying value of net assets. If the carrying
value of goodwill exceeds its implied fair value, the excess is recorded as a non-cash impairment charge in the consolidated statement of operations.
(o)
Convertible
Notes
The debt and equity components of the Company’s Convertible Notes were bifurcated and accounted for separately based on the authoritative guidance in
ASC 470-20, “Debt with Conversion and Other Options.” The debt component of the Convertible Notes, which excluded the associated equity conversion feature,
was recorded at fair value on the issuance date. The equity component, representing the difference between the aggregate principal amount of the Convertible Notes
and the fair value of the debt component, was recorded in additional paid-in capital on the consolidated balance sheet. The discounted carrying value of the
Convertible Notes resulting from the bifurcation was subsequently accreted to its principal amount through the recognition of non-cash interest expense.
Costs related to the issuance of the Convertible Notes, consisting primarily of investment banking, legal and other professional fees were allocated to the
debt and equity components of the Company’s Convertible Notes in proportion to the allocation of the principal. Amounts allocated to the debt component were
capitalized and amortized as non-cash interest expense using the effective yield method over the five-year contract term of the Convertible Notes. Amounts
allocated to the equity component were recorded against additional paid-in capital.
During the year ended December 31, 2015, all of the Company’s Convertible Notes were settled.
(p)
Fair
value
of
Financial
Instruments
The estimated fair value of the Company’s cash equivalents is based on quoted market prices. The estimated fair value of contingent consideration is
determined utilizing a model that considers the probability of achieving each milestone and an appropriate discount rate. The estimated fair value of the Company’s
Convertible Notes was determined using recent trading prices of the Convertible Notes. Other financial instruments, including bank deposits, receivable from
collaboration partner, accounts payable,
85
accrued expenses, borrowings under the Revolving Credit Facility, and othe r current liabilities are carried at cost, which the Company believes approximates fair
value because of the short-term maturities of these instruments.
(q)
litigation
The Company is party to legal proceedings, investigations, and claims in the ordinary course of its business. The Company records accruals for outstanding
legal matters when it believes that it is both probable that a liability has been incurred and the amount of such liability can be reasonably estimated. The Company
evaluates, on a quarterly basis, developments in significant legal matters that could affect the amount of any accrual and developments that would make a loss
contingency both probable and reasonably estimable. To the extent new information is obtained and the Company’s views on the probable outcomes of claims,
suits, assessments, investigations or legal proceedings change, changes in the Company’s accrued liabilities would be recorded in the period in which such
determination is made. In addition, in accordance with the relevant authoritative guidance, for matters for which the likelihood of material loss is at least reasonably
possible, the Company provides disclosure of the possible loss or range of loss; however, if a reasonable estimate cannot be made, the Company will provide
disclosure to that effect. Gain contingencies, if any, are recorded when they are realized.
(r)
Income
Taxes
The Company accounts for income taxes using an asset and liability approach in accordance with the guidance provided by ASC 740-10, “Accounting for
Income Taxes.” ASC 740-10 requires the recognition of taxes payable or refundable for the current year and deferred tax assets and liabilities for the future tax
consequences of events that have been recognized in the consolidated financial statements or tax returns. The measurement of current and deferred tax assets and
liabilities is based on provisions of the enacted tax law; the effects of future changes in tax laws or rates are not anticipated. The measurement of deferred tax assets
is reduced, if necessary, by the amount of any tax benefits that, based on available evidence, is not expected to be realized.
The Company records a valuation allowance to reduce its deferred tax assets to reflect the net amount that it believes is more likely than not to be realized.
Realization of the deferred tax assets is dependent upon the generation of future taxable income, the amount and timing of which are uncertain. Based upon the
weight of available evidence at December 31, 2014, the Company determined that it was more likely than not that a portion of its deferred tax assets would be
realizable and consequently released the valuation allowance against Federal and certain state net deferred tax assets and recorded a discrete tax benefit of $33.4
million during the fourth quarter of 2014. The decision to reverse a portion of the valuation allowance was made after management considered all available
evidence, both positive and negative, including but not limited to the Company’s historical operating results, income or loss in recent periods, cumulative income in
recent years, forecasted earnings, forecasted future taxable income, and significant risk and uncertainty related to forecasts. The release of the valuation allowance
resulted in the recognition of certain deferred tax assets and a decrease to income tax expense.
Significant judgment in required in evaluating the Company’s uncertain income tax positions based on the guidance in ASC 740-10-25, “Accounting for
Uncertainty in Income Taxes.” The Company recognizes a tax benefit from an uncertain tax position only if it is more likely than not that the position will be
sustained upon examination by tax authorities. The tax benefit recognized in the financial statements on a particular tax position is measured on the largest benefit
that is more likely than not to be realized. The Company evaluates uncertain tax positions on a quarterly basis and adjusts the liability for changes in facts and
circumstances, such as new regulations or interpretations by the taxing authorities, new information obtained during a tax examination, significant amendment to an
existing tax law, or resolution of an examination. To the extent that the final tax outcome of these matters is different than the amounts recorded, such differences
will impact the income tax provision in the period in which such determination is made. The resolution of the Company’s uncertain income tax positions is
dependent on uncontrollable factors such as law changes, new case law, and the willingness of the income tax authorities to settle, including the timing thereof and
other factors. Although The Company does not anticipate significant changes to its uncertain income tax positions in the next twelve months, items outside of the
Company’s control could cause the uncertain income tax positions to change in the future, which would be recorded in the consolidated statements of operations.
Interest and/or penalties related to income tax matters are recognized as a component of income tax expense as incurred.
(s)
New
Accounting
Pronouncements
In November 2015, the FASB issued Accounting Standards Update, or ASU, 2015-17, “Income Taxes (Topic 740): Balance Sheet Classification of
Deferred Taxes.” ASU 2015-17 requires that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. The
amended guidance is effective for fiscal years beginning after December 15, 2016, including interim periods within that reporting period, and may be applied either
prospectively to all deferred tax liabilities and assets or retrospectively to all periods presented. Earlier application is permitted for all entities as of the beginning of
an interim or annual reporting period. The Company adopted the amended guidance prospectively as of October 1, 2015. Prior periods were not retrospectively
adjusted. The adoption of ASU 2015-17 resulted in a reclassification of current deferred tax assets to non-current on the Company’s consolidated balance sheet as
of December 31, 2015. See Note 13, “Income Taxes,” for additional information regarding the adoption of ASU 2015-17.
86
In September 2015, the FASB issued ASU 2015-16, “Business Combinations (Topic 805): Simplifying the Accounting for Measurement-Period
Adjustments.” ASU 2015-16 requires that the acquirer recognize adjustments to provisional amounts recognized in a business combination that are identified
during the measurement period in the reporting period in which the adjustment amounts are determined and record, in the same period’s financial statements, the
effect on earnings of changes in depreciation, amortization, or other income effects, if any, as a result of the change to the provisional amounts, calculated as if the
accounting had been completed at the acquisition date. The amended guidance eliminates the requirement to retrospectively account for adjustments made to
provisional amounts during the measurement period. The amended guidance is effective for fiscal years beginning after December 15, 2015, including interim
periods within that reporting period, and should be applied prospectively to provisional amounts that occur after the effective date. The Company does not currently
expect that the adoption of ASU 2015- 16 will have a material impact on its consolidated financial statements and related disclosures.
In August 2015, the FASB issued ASU 2015-15, “Interest – Imputation of Interest (Subtopic 835-30): Presentation and Subsequent Measurement of Debt
Issuance Costs Associated with Line of Credit Arrangements.” The amended guidance, which became effective immediately upon issuance, clarifies that entities
are permitted to defer and present such debt issuance costs as an asset to be amortized ratably over the term of the line of credit arrangement, regardless of whether
there are any outstanding borrowings on the line of credit arrangement. The adoption of ASU 2015-15 did not have a material impact on the Company’s
consolidated financial statements and related disclosures.
In April 2015, the FASB issued ASU 2015-03, “Interest – Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs,”
which requires that debt issuance costs related to a recognized debt liability be presented on the balance sheet as a direct deduction from the carrying amount of the
debt liability, consistent with debt discounts. The ASU requires retrospective adoption and is effective for fiscal years beginning after December 15, 2015,
including interim periods within that reporting period. Early adoption is permitted. The Company does not currently expect that the adoption of ASU 2015-03 will
have a material impact on its consolidated financial statements and related disclosures.
In February 2015, the FASB issued ASU 2015-02, “Consolidation (Topic 820): Amendments to the Consolidation Analysis.” The amended guidance
provides a revised consolidation model for all reporting entities to use in evaluating whether they should consolidate certain legal entities. All legal entities will be
subject to reevaluation under this revised consolidation model. The revised consolidation model, among other things, (i) modifies the evaluation of whether limited
partnerships and similar legal entities are voting interest entities, (ii) eliminates the presumption that a general partner should consolidate a limited partnership, and
(iii) modifies the consolidation analysis of reporting entities that are involved with voting interest entities through fee arrangements and related party relationships.
The amended guidance is effective for fiscal years beginning after December 15, 2015, including interim periods within that reporting period. The Company does
not currently expect that the adoption of ASU 2015-02 will have a material impact on its consolidated financial statements and related disclosures.
In May 2014, the FASB issued ASU 2014-09, “Revenue from Contracts with Customers” (Topic 606), a comprehensive new revenue recognition standard
that will supersede the existing revenue recognition guidance. The new accounting guidance creates a framework by which an entity will allocate the transaction
price to separate performance obligations and recognize revenue when (or as) each performance obligation is satisfied. Under the new standard, entities will be
required to use judgment and make estimates, including identifying performance obligations in a contract, estimating the amount of variable consideration to
include in the transaction price, allocating the transaction price to each separate performance obligation and determining when an entity satisfies its performance
obligations. The standard allows for either “full retrospective” adoption, meaning that the standard is applied to all of the periods presented with a cumulative
catch-up as of the earliest period presented, or “modified retrospective” adoption, meaning the standard is applied only to the most current period presented in the
financial statements with a cumulative catch-up as of the current period. In August 2015, the effective date of the new revenue standard was delayed by one year to
December 15, 2017 for annual reporting periods beginning after that date. The FASB also agreed to permit early adoption of the standard, but not before the
original effective date of December 15, 2016. The Company has not yet selected a transition method and is currently evaluating the effect that the updated standard
will have on its consolidated financial statements and related disclosures.
(t)
Out-of-Period
Adjustment
In the first quarter of 2013, the Company recorded an out-of-period correcting adjustment that increased operating expenses and net loss by $3.6 million for
the three months ended March 31, 2013. Management concluded that the adjustment is not material to the full year 2013 results or any previously reported financial
statements.
NOTE
3.
COllABORATION
AgREEMENT
(a)
Collaboration
Agreement
with
Astellas
In October 2009, the Company entered into the Astellas Collaboration Agreement, pursuant to which it is collaborating with Astellas to develop and
commercialize XTANDI globally for all indications, dosages and formulations of enzalutamide. Under the agreement, decision making and economic participation
differs between the U.S. market and the ex-U.S. market. In the United States,
87
decisions are generally made by consensus, pre-tax profits and losses are shared equally, and, subject to certain exceptions, development and commercializat ion
costs (including cost of goods sold and the royalty on net sales payable to UCLA under the Company’s license agreement with UCLA) are also shared equally. The
primary exceptions to equal cost sharing in the U.S. market are that each party is responsibl e for its own commercial full-time equivalent, or FTE, costs, and that
development costs supporting marketing approvals in both the United States and either Europe or Japan are borne one-third by the Company and two-thirds by
Astellas. The Company and Aste llas are co-promoting XTANDI in the U.S. market, with each company providing half of the sales and medical affairs effort in
support of the product. Both the Company and Astellas are entitled to receive a fee for each qualifying detail made by its respecti ve sales representatives. Outside
the United States, decisions are generally made by Astellas and all development and commercialization costs (including cost of goods sold and the royalty on net
sales payable to UCLA) are borne by Astellas. Astellas retain s all ex-U.S. profits and losses, and pays the Company a tiered royalty ranging from the low teens to
the low twenties as a percentage of the aggregate net sales of XTANDI outside the United States, or ex-U.S. XTANDI net sales. Astellas has sole responsibi lity for
promoting XTANDI outside the United States and for recording all XTANDI net sales both inside and outside the United States. Both the Company and Astellas
have agreed not to commercialize certain other products having a similar mechanism of action (as defined by the Astellas Collaboration Agreement) as XTANDI
for the treatment of prostate cancer for a specified time period, subject to certain exceptions.
Under the Astellas Collaboration Agreement, Astellas paid the Company a non-refundable, upfront cash payment of $110.0 million in the fourth quarter of
2009. The Company was also eligible to receive up to $335.0 million in development milestone payments and up to $320.0 million in sales milestone payments. As
of December 31, 2015, the Company has earned all development and sales milestone payments under the Astellas Collaboration Agreement.
The Company and Astellas are each permitted to terminate the Astellas Collaboration Agreement for an uncured material breach by the other party or for the
insolvency of the other party. Astellas has a right to terminate the Astellas Collaboration Agreement unilaterally by advance written notice to the Company.
Following any termination of the Astellas Collaboration Agreement in its entirety, all rights to develop and commercialize XTANDI will revert to the Company,
and Astellas will grant a license to the Company to enable it to continue such development and commercialization. In addition, except in the case of a termination
by Astellas for the Company’s material breach, Astellas will supply XTANDI to the Company during a specified transition period.
Unless terminated earlier by the Company or Astellas pursuant to the terms thereof, the Astellas Collaboration Agreement will remain in effect: (a) in the
United States, until such time as Astellas notifies the Company that Astellas has permanently stopped selling products covered by the Astellas Collaboration
Agreement in the United States; and (b) in each other country of the world, on a country-by-country basis, until such time as (i) products covered by the Astellas
Collaboration Agreement cease to be protected by patents or regulatory exclusivity in such country and (ii) commercial sales of generic equivalent products have
commenced in such country.
(b)
Collaboration
Revenue
Collaboration revenue was as follows:
Collaboration revenue:
Related to U.S. XTANDI net sales
Related to ex-U.S. XTANDI net sales
Related to upfront and milestone payments
Total
2015
$
$
years
Ended
december
31,
2014
575,658
119,778
247,822
943,258
$
$
339,902
49,476
321,109
710,487
$
$
2013
196,208
6,338
70,396
272,942
The Company is required to pay UCLA ten percent of all Sublicensing Income, as defined in its license agreement with UCLA. The Company is currently
involved in litigation with UCLA regarding certain terms of the license agreement and other matters, which are discussed in Note 15, “Commitments and
Contingencies.”
Collaboration
Revenue
Related
to
U.S.
XTANDI
Net
Sales
Under the Astellas Collaboration Agreement, Astellas records all U.S. XTANDI net sales. The Company and Astellas share equally all pre-tax profits and
losses from U.S. XTANDI net sales. Subject to certain exceptions, the Company and Astellas also share equally all XTANDI development and commercialization
costs attributable to the U.S. market, including cost of goods sold and the royalty on net sales payable to UCLA under the Company’s license agreement with
UCLA. The primary exceptions to the 50/50 cost sharing are that each party is responsible for its own commercial FTE costs and that development costs supporting
marketing approvals in both the United States and either Europe or Japan are borne one-third by the Company and two-thirds by Astellas. The Company recognizes
collaboration revenue related to U.S. XTANDI net sales in the period in which such sales occur. Collaboration revenue related to U.S. XTANDI net sales consists
of the Company’s share of pre-tax profits and losses from U.S. XTANDI net sales,
88
plus reimbursement of the Company’s share of reimbursable U.S. development and commercialization costs. The Company’ s collaboration revenue related to U.S.
XTANDI net sales in any given period is equal to 50% of U.S. XTANDI net sales as reported by Astellas for the applicable period.
Collaboration revenue related to U.S. XTANDI net sales was as follows:
2015
U.S. XTANDI net sales (as reported by Astellas)
Shared U.S. development and commercialization costs
Pre-tax U.S. profit
$
Medivation’s share of pre-tax U.S. profit
Reimbursement of Medivation’s share of shared U.S. costs
Collaboration revenue related to U.S. XTANDI net sales
$
$
$
years
Ended
december
31,
2014
1,151,317 $
(375,008)
776,309 $
388,154
187,504
575,658
$
$
679,805 $
(323,730)
356,075 $
178,037
161,865
339,902
$
$
2013
392,415
(241,106)
151,309
75,655
120,553
196,208
Collaboration
Revenue
Related
to
Ex-U.S.
XTANDI
Net
Sales
Under the Astellas Collaboration Agreement, Astellas records all ex-U.S. XTANDI net sales. Astellas is responsible for all development and
commercialization costs for XTANDI outside the United States, including cost of goods sold and the royalty on net sales payable to UCLA under the Company’s
license agreement with UCLA, and pays the Company a tiered royalty ranging from the low teens to the low twenties on net ex-U.S. XTANDI net sales. The
Company recognizes collaboration revenue related to ex-U.S. XTANDI net sales in the period in which such sales occur. Collaboration revenue related to ex-U.S.
XTANDI net sales consists of royalties from Astellas on those sales.
Collaboration
Revenue
Related
to
Upfront
and
Milestone
Payments
Collaboration revenue related to upfront and milestone payments from Astellas was as follows:
Sales milestones earned
Development milestones earned
Amortization of deferred upfront and development
milestones
Total
2015
$
$
years
Ended
december
31,
2014
245,000
—
2,822
247,822
$
$
50,000
257,000
14,109
321,109
$
$
2013
25,000
20,000
25,396
70,396
As of December 31, 2015, the Company has earned all development and sales milestone payments under the Astellas Collaboration Agreement,
including $245.0 million, $307.0 million, and $45.0 million in the years ended December 31, 2015, 2014, and 2013, respectively.
Deferred revenue related to payments received under the Astellas Collaboration Agreement was $2.8 million at December 31, 2014. There was no deferred
revenue related to payments received under the Astellas Collaboration Agreement at December 31, 2015.
(c)
Cost-Sharing
Payments
Under the Astellas Collaboration Agreement, the Company and Astellas share certain development and commercialization costs (including cost of goods
sold and the royalty on net sales payable to UCLA under the Company’s license agreement with UCLA) in the United States. Development cost-sharing payments
from Astellas were $60.8 million, $63.5 million and $46.6 million for the years ended December 31, 2015, 2014 and 2013, respectively. Commercialization costsharing payments to Astellas were $37.5 million, $36.1 million and $12.0 million for the years ended December 31, 2015, 2014 and 2013, respectively.
Development cost-sharing payments from Astellas are recorded as reductions in R&D expenses. Commercialization cost-sharing payments to Astellas are recorded
as increases in SG&A expenses.
(d)
Collaboration
Receivable
At December 31, 2015 and 2014, collaboration receivable from Astellas was $391.6 million and $184.7 million, respectively. The amounts receivable at
December 31, 2015 and 2014 were received in the first quarter of 2016 and 2015, respectively.
89
NOTE
4.
BuSINESS
ACquISITIONS
(a)
Acquisition
of
Mdv3800
from
BioMarin
In the fourth quarter of 2015, the Company completed an acquisition of all rights to MDV3800, a PARP inhibitor, from BioMarin pursuant to an Asset
Purchase Agreement. The acquired MDV3800 assets include all patents, data, know-how, third-party agreements, regulatory materials and pre-commercial
inventories. The Company also assumed certain costs for ongoing clinical trials of MDV3800, and commitments under certain agreements previously entered into
or assumed by BioMarin and assigned to the Company. The parties entered into a Transition Services Agreement at the closing of the transaction to facilitate the
transition of the research and development activities relating to MDV3800 from BioMarin to the Company, including responsibility for the ongoing clinical studies.
The Company has concluded that the acquisition of MDV3800 from BioMarin is an acquisition of a business and will account for it in accordance with ASC
805-10, “Business Combinations.” The acquisition was completed on October 6, 2015, and results of operations related to MDV3800 since that date have been
included in the consolidated statement of operations and were not significant.
In connection with the acquisition, the Company paid BioMarin an upfront cash payment of $410.0 million during the fourth quarter of 2015. In addition,
BioMarin is entitled to contingent payments totaling up to $160.0 million upon the achievement of defined regulatory and sales-based milestones, and mid-single
digit royalties on net sales of products that contain MDV3800 during the royalty term specified in the Asset Purchase Agreement . The acquisition-date fair value
of the contingent consideration payments totaled $171.9 million and was estimated by applying a probability-based income model using a discounted cash flow
analysis for contingent regulatory and royalty payments and a Monte Carlo simulation model for the contingent sales milestone payments . The estimation was
based on significant inputs that are not observable in the market, referred to as Level 3 inputs, as described in more detail in Note 14, “Fair Value Disclosures.”
The following table presents the final allocation of the purchase consideration for the MDV3800 acquisition, including the contingent consideration payable,
based on fair value:
Purchase consideration:
Cash
Acquisition-date fair value of contingent consideration
Total purchase consideration
Allocation of the purchase consideration:
Assets:
Identifiable intangible assets- IPR&D
Net identifiable assets acquired
Goodwill
Net assets acquired
$
$
$
$
410,000
171,942
581,942
573,299
573,299
8,643
581,942
Identifiable intangible assets totaled $573.3 million and consist entirely of IPR&D for MDV3800. As of the valuation date, the Company determined that
MDV3800 was the only R&D project with substance, such that the project had undergone conceptual stages, and research, development, and preproduction had
been started for the project. As such, no other intangible assets were identified in the transaction other than MDV3800 as separate and apart from goodwill. The
Company utilized the multi-period excess earnings model of the “income method” to determine the fair value of the IPR&D as of the acquisition date. The excess
of the consideration over the fair values assigned to the net assets acquired was $8.6 million, which represents the amount of goodwill resulting from the
acquisition. The Company believes that the goodwill primarily represents benefits to it, such as the potential to diversify its product portfolio in the area of
oncology, that do not qualify for separate recognition as acquired intangible assets. The amount of goodwill that is expected to be deductible for income tax
purposes is $8.6 million. The Company recorded the goodwill on its consolidated balance sheet as of the acquisition date.
90
Pro
forma
Financial
Information
The following unaudited pro forma financial information presents the combined results of operations of Medivation and MDV3800 as if the acquisition of
MDV3800 had been completed on January 1, 2014, with adjustments to give effect to pro forma events that are directly attributable to the acquisition. The
unaudited pro forma results do not reflect any operating efficiencies or potential cost savings which may result from the consolidation of the operations of
Medivation and MDV3800. Accordingly, these unaudited pro forma results are presented for informational purposes only and are not necessarily indicative of what
the actual results of operations of the combined company would have been if the acquisition had occurred at the beginning of the period presented, nor are they
indicative of future results of operations:
Total revenues
Net income
year
Ended
december
31,
2015
2014
$
$
943,258
201,161
$
$
710,487
230,271
(b)
Acquisition
of
Mdv9300
from
CureTech
In the fourth quarter of 2014, the Company entered into a License Agreement with Israel-based CureTech, pursuant to which it licensed exclusive
worldwide rights to CureTech’s late-stage clinical molecule MDV9300, an antibody with immune-mediated anti-tumor effects. Under the License Agreement, the
Company is responsible for all development, regulatory, manufacturing, and commercialization activities for MDV9300 for all indications, including oncology.
The Company has concluded that the in-license transaction is an acquisition of a business and will account for it in accordance with ASC 805-10, “Business
Combinations.”
In connection with the acquisition, the Company made upfront cash payments to CureTech totaling $5.0 million during the fourth quarter of 2014. In
addition, CureTech is entitled to contingent payments totaling up to $85.0 million upon attainment of certain development and regulatory milestones, up to $245.0
million upon the achievement of certain annual worldwide net sales thresholds, and tiered royalties ranging from 5% to 11% on annual worldwide net sales.
CureTech is also entitled to a $5.0 million milestone payment upon completion of the Manufacturing Technology Transfer as described in Note 15, “Commitments
and Contingencies.” The acquisition-date fair value of the contingent consideration payments totaled $106.0 million and was estimated by applying a probabilitybased income approach using an appropriate discount rate. The estimation was based on significant inputs that are not observable in the market, referred to as Level
3 inputs, as described in more detail in Note 14, “Fair Value Disclosures.”
The following table presents the final allocation of the purchase consideration for the MDV9300 acquisition, including the contingent consideration payable,
based on fair value:
Purchase consideration:
Cash
Acquisition-date fair value of contingent consideration
Total purchase consideration
Allocation of the purchase consideration:
Assets:
Identifiable intangible assets- IPR&D
Net identifiable assets acquired
Goodwill
Net assets acquired
$
$
$
$
5,000
106,000
111,000
101,000
101,000
10,000
111,000
Identifiable intangible assets totaled $101.0 million and consist entirely of IPR&D for MDV9300. As of the valuation date, the Company determined that
MDV9300 was the only R&D project with substance, such that the project had undergone conceptual stages, and research, development, and preproduction had
been started for the project. As such, no other intangible assets were identified in the transaction other than MDV9300 as separate and apart from goodwill. The
Company utilized the multi-period excess earnings model of the “income method” to determine the fair value of the IPR&D as of the acquisition date. The excess
of the consideration over the fair values assigned to the net assets acquired was $10.0 million, which represents the amount of goodwill resulting from the
acquisition. The Company believes that the goodwill primarily represents benefits to it, such as the potential to diversify its product portfolio in the area of
oncology, that do not qualify for separate recognition as acquired intangible assets. The amount of goodwill that is expected to be deductible for income tax
purposes is $10.0 million. The Company recorded the goodwill on its consolidated balance sheet as of the acquisition date.
Pro
forma
Financial
Information
The following unaudited pro forma financial information presents the combined results of operations of Medivation and MDV9300 as if the acquisition of
MDV9300 had been completed on January 1, 2013, with adjustments to give effect to pro forma
91
events that are directly attributable to the acquisition. The unaudited pro f orma results do not reflect any operating efficiencies or potential cost savings which may
result from the consolidation of the operations of Medivation and MDV9300. Accordingly, these unaudited pro forma results are presented for informational
purposes on ly and are not necessarily indicative of what the actual results of operations of the combined company would have been if the acquisition had occurred
at the beginning of the period presented, nor are they indicative of future results of operations:
Total revenues
Net income (loss)
year
Ended
december
31,
2014
2013
$
$
710,487
274,626
$
$
272,942
(45,685)
NOTE
5.
INTANgIBlE
ASSETS
ANd
gOOdWIll
Intangible assets consist of IPR&D acquired from business acquisitions. The Company accounts for IPR&D as indefinite-lived intangible assets until
regulatory approval or discontinuation of the related R&D efforts. Upon obtaining regulatory approval, the Company reclassifies the IPR&D as a definite-lived
intangible asset and determines the economic life for amortization purposes. The Company assesses the impairment of indefinite-lived intangible assets and
goodwill on an annual basis or more frequently whenever events or changes in circumstances may indicate that the carrying value might not be recoverable.
During the fourth quarter of 2015, the Company recorded a $30.0 million impairment charge related to its IPR&D asset for MDV9300 as a result of an
extended clinical development timeline and other factors. In the fourth quarter, the Company concluded its testing that revealed MDV9300 is not an anti-PD-1
antibody and, after advising the FDA of this conclusion in early-January 2016, its IND was placed on partial clinical hold pending revision of all related study
documentation characterizing MDV9300 as an anti-PD-1 antibody. While the Company believes the partial clinical hold does not relate to concerns regarding the
safety or previously-observed efficacy of MDV9300, the Company extended its clinical study timelines which, in turn, gave rise to changes to the significant inputs
to its IPR&D valuation including forecasted revenues and probabilities of success. The quantitative assessment resulted in a net impairment charge, which the
Company recorded as a reduction in the IPR&D asset and an increase to R&D expense in the fourth quarter of 2015.
The following table summarizes the Company’s indefinite-lived intangible assets:
Indefinite-lived intangible asset – MDV3800
Indefinite-lived intangible asset – MDV9300
Total
2015
$
$
december
31,
2014
573,299
71,000
644,299
$
—
101,000
101,000
The following table summarizes the changes in the carrying amount of goodwill:
year
Ended
december
31,
2015 Goodwill:
Balance at beginning of period
Goodwill at acquisition date – MDV3800
Balance at end of period
$
$
10,000
8,643
18,643
NOTE
6.
NET
INCOME
(lOSS)
PER
COMMON
ShARE
The computation of basic net income (loss) per common share is based on the weighted-average number of common shares outstanding during each
period. The computation of diluted net income (loss) per common share is based on the weighted-average number of common shares outstanding during the period
plus, when their effect is dilutive, incremental shares consisting of shares subject to stock options, restricted stock units, stock appreciation rights, ESPP shares,
warrants, and shares issuable upon conversion of convertible debt.
92
During the second quarter of 2015, the Company asserted its intent and ability to settle the outstanding Convertible Notes for a combination of cash and
common stock. Under the “cash settlement” method, interest is not added back to the numerator, and only the contingently issuable shares related to the convers ion
spread are included in the denominator, if dilutive. Under such method, the settlement of the conversion spread has a dilutive effect when the average share price of
the Company’s common stock during the period exceeds the conversion price. The computa tion of diluted net income per share for the year ended December 31,
2015 reflects the application of the “if-converted” method for the first quarter of 2015 and the “cash settlement” method for the second and third quarters of 2015
given the demonstrated and asserted redemption of the outstanding debt. The Company completed the settlement of all of its Convertible Notes during the third
quarter of 2015 as described in Note 10, “Debt.” The calculation of diluted net income per common share for the year ende d December 31, 2015 includes
approximately 3.9 million contingently issuable shares related to the Convertible Notes.
The Company used the “if-converted” method to compute the dilutive effect of the Convertible Notes for the calculation of diluted net income per common
share for the year ended December 31, 2014. Under the “if-converted” method, interest expense, net of tax, related to the Convertible Notes is added back to net
income, and the Convertible Notes are assumed to have been converted into common shares at the beginning of the period in periods in which there would have
been a dilutive effect. The calculation of diluted net income per common share for the year ended December 31, 2014 includes approximately 10.1 million
contingently issuable shares related to the Convertible Notes.
In periods in which the Company reports a net loss, all common stock equivalents are deemed anti-dilutive such that basic net loss per common share and
diluted net loss per common share are equal.
For the years ended December 31, 2015 and 2014, employee stock-based awards to purchase approximately 1.4 million and 1.3 million shares of the
Company’s common stock, respectively, were excluded from the computation of diluted net income per common share because their effect would have been antidilutive. For the year ended December 31, 2013, approximately 25.1 million potentially dilutive common shares were excluded from the diluted net loss per
common share computation because such securities had an anti-dilutive effect on net loss per common share due to the Company’s net loss for that year.
The following table reconciles the numerator and denominator used to calculate diluted net income (loss) per common share:
Numerator:
Net income (loss)
Interest expense on convertible notes, net of tax
Numerator for diluted net income (loss) per common
share calculation
Denominator:
Weighted-average common shares, basic
Dilutive effect of common stock equivalents
Weighted-average common shares, diluted
2015
years
Ended
december
31,
2014
2013
$
244,725
3,629
$
276,452
14,030
$
(42,613)
—
$
248,354
$
290,482
$
(42,613)
160,345
8,979
169,324
153,859
16,142
170,001
150,331
—
150,331
NOTE
7.
BuIld-TO-SuIT
lEASE
OBlIgATION
In the fourth quarter of 2013, the Company entered into a property lease for approximately 52,000 square feet of space located in San Francisco, California.
In the second quarter of 2015, the Company entered into an amended lease agreement to reduce the amount of leased space at this property to approximately 44,000
square feet. The lease agreement expires in August 2024, and the Company has an option to extend the lease term for up to an additional five years.
The Company is deemed, for accounting purposes only, to be the owner of the entire project including the building shell, even though it is not the legal
owner. In connection with the Company’s accounting for this transaction, the Company capitalized $14.5 million as a build-to-suit property within property and
equipment, net, and recognized a corresponding build-to-suit lease obligation for the same amount. The Company has also recognized, as an additional build-to-suit
lease property and obligation, structural tenant improvements totaling $3.6 million for amounts paid by the landlord and $3.5 million for capitalized interest during
the construction period through December 31, 2015.
As a result of the amended agreement, the Company surrendered a portion of the property totaling approximately 8,000 square feet to the lessor. The
Company has no continuing involvement with the portion of the property surrendered to the lessor. Accordingly, the Company derecognized a portion of the buildto-suit asset totaling $3.2 million and a portion of the build-to-suit lease obligation totaling $3.2 million during 2015 related to the portion of the property that was
surrendered to the lessor.
93
A portion of the monthly lease payment is allocated to land rent and recorded as an operating lease expense and the non-interest portion of the amortized
lease payments to the landlord related to the rent of the building is app lied to reduce the build-to-suit lease obligation. At December 31, 2015, the build-to-suit
lease obligation totaling $17.4 million was classified as a non-current liability on the consolidated balance sheet. Expected reductions (increases) in the build-tosuit lease obligation are as follows:
Build-To-Suit
lease
Obligation years
Ending
december
31,
2016
2017
2018
2019
2020
2021 and thereafter
Total
$
(8)
58
130
208
292
16,726
17,406
$
The amounts included in the table above represent the reductions (increases) in the build-to-suit lease obligation included on the Company’s consolidated
balance sheet at December 31, 2015 related to each of the periods presented. The amount in the terminal period includes the amount to derecognize the build-to-suit
lease obligation at the end of the lease term. The expected reductions (increases) in the build-to-suit lease obligation presented in the table above are impacted by
the timing of the completion of the construction project. Actual expected lease payments under the build-to-suit lease obligation are included in Note 15,
“Commitments and Contingencies.”
NOTE
8.
PROPERTy
ANd
EquIPMENT,
NET
Property and equipment, net, consisted of the following:
Build-to-suit property
Leasehold improvements
Computer equipment and software
Furniture and fixtures
Construction in progress
Laboratory equipment
2015
$
Less: Accumulated depreciation
Total
$
december
31,
2014
18,371 $
19,074
16,083
5,714
14,440
748
74,430
(16,288)
58,142 $
19,544
15,051
9,499
4,667
1,360
735
50,856
(9,695)
41,161
NOTE
9.
ACCOuNTS
PAyABlE,
ACCRuEd
EXPENSES
ANd
OThER
CuRRENT
lIABIlITIES
Accounts payable, accrued expenses and other current liabilities consisted of the following:
Clinical and preclinical
Taxes payable
Payroll and payroll-related
Accounts payable
Royalties payable
Other payable to licensor
Accrued professional services and other current liabilities
Interest payable
Total
2015
$
$
december
31,
2014
48,975
32,565
29,215
22,696
20,665
17,500
14,282
305
186,203
$
$
31,069
2,106
33,272
10,492
13,582
5,000
8,909
1,698
106,128
Accounts payable represents short-term liabilities for which the Company has received and processed a vendor invoice prior to the end of the reporting
period. Accrued expenses and other current liabilities represent, among other things, compensation and related benefits to employees, royalties due to licensors of
technologies, interest payable related to the Company’s Convertible Notes and Revolving Credit Facility, estimated amounts due to third-party vendors for services
rendered prior to the end of the reporting period, invoices received from third-party vendors that have not yet been processed, taxes payable, and other accrued
items.
94
NOTE
10.
dEBT
(a)
Revolving
Credit
Facility
On September 4, 2015, the Company, as borrower, entered into a credit agreement (the “Original Credit Agreement”) with JPMorgan Chase Bank, N.A., as
administrative agent, and the lenders from time to time party thereto providing for (i) a one-year $75.0 million revolving loan facility and (ii) an uncommitted
accordion facility subject to the satisfaction of certain conditions. The revolving loan facility included a $20.0 million multicurrency sub-facility, a $10.0 million
letter of credit sub-facility and a $100,000 swing line loan sub-facility. On September 17, 2015, the Company executed a borrowing of $75.0 million under this
revolving credit facility. The interest rate for this borrowing was 2.3125% and was applied on an actual/360 day basis.
On October 23, 2015, the Company entered into an amendment and restatement of the Original Credit Agreement (the “Credit Agreement”) with JPMorgan
Chase Bank, N.A., as administrative agent, and the lenders from time to time party thereto (the “Lenders”), providing for (i) a five-year $300 million revolving loan
facility (the “Revolving Credit Facility”); and (ii) an uncommitted accordion facility subject to the satisfaction of certain conditions (collectively, the “Senior
Secured Credit Facility”). The Revolving Credit Facility includes a $50 million multicurrency sub-facility, a $20 million letter of credit sub-facility and a $10
million swing line loan sub-facility.
Loans under the Revolving Credit Facility bear interest, at the Company’s option, at a rate equal to either (a) the LIBOR rate, plus an applicable margin
ranging from 1.75% to 2.50% per annum, based upon the secured leverage ratio (as defined in the Credit Agreement) or (b) the prime lending rate, plus an
applicable margin ranging from 0.75% to 1.50% per annum, based upon the senior secured net leverage ratio (as defined in the Credit Agreement). On October 23,
2015, the Company borrowed $75.0 million under the Revolving Credit Facility, which was used to repay the $75.0 million outstanding at September 30, 2015
under the Original Credit Agreement. The interest rate for this borrowing was 2.1250% and was applied on an actual/360 day basis. On January 25, 2016, the
Company repaid the $75.0 million outstanding under the Revolving Credit Facility.
The obligations under the Credit Agreement and any swap obligations and banking services obligations owing to a lender (or an affiliate of a lender)
thereunder are and will be guaranteed by the Company and each of the Company’s existing and subsequently acquired or organized direct and indirect domestic
subsidiaries (other than certain immaterial domestic subsidiaries, certain Domestic Foreign Holding Companies, and certain domestic subsidiaries whose equity
interests are owned directly or indirectly by certain foreign subsidiaries) (collectively, the “Loan Parties”). The obligations under the Credit Agreement and any
such swap and banking services obligations are secured, subject to customary permitted liens and other agreed upon exceptions, by a perfected security interest in
(i) all tangible and intangible assets of the Loan Parties, except for certain customary excluded assets, and (ii) all of the capital stock owned by the Loan Parties
thereunder (limited, in the case of the stock of certain non-U.S. subsidiaries of the Company and Domestic Foreign Holding Companies, to 65% of the capital stock
of such subsidiaries).
The Credit Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among other things,
restrictions on indebtedness, liens, investments, mergers, dispositions, prepayment of other indebtedness and dividends and other distributions. Under the terms of
the Credit Agreement, the Company is required to comply with a maximum senior secured net leverage ratio and minimum interest coverage ratio covenants. At
December 31, 2015, the Company was in compliance with these covenants.
In accordance with ASU 2015-15, the Company deferred $1.7 million of debt issuance costs associated with the Revolving Credit Facility, including
underwriting, legal and accounting fees, and will amortize this amount ratably over the five-year access period of the facility. Amortization of the debt issuance
costs will be recorded as non-cash interest expense on the consolidated statement of operations.
(b)
Convertible
Notes
due
2017
On March 19, 2012, the Company issued $258.8 million aggregate principal amount of the Convertible Notes. The Company was required to pay interest
semi-annually in arrears on April 1 and October 1 of each year, at a rate of 2.625% per annum . The Convertible Notes were convertible upon the occurrence of
certain conditions into shares of the Company’s common stock at a conversion rate of 39.0344 shares of common stock per $1,000 principal amount of the
Convertible Notes, equivalent to a conversion price of approximately $25.62 per share of common stock . The Convertible Notes were scheduled to mature on
April 1, 2017, unless earlier converted, redeemed or repurchased in accordance with their terms. Upon a conversion of the Convertible Notes, the Company was
required to pay or deliver, as the case may be, cash, shares of the Company’s common stock, or a combination of both, at the Company’s election.
The debt and equity components of the Convertible Notes were bifurcated and accounted for separately based on the authoritative accounting guidance in
ASC 470-20. The $258.8 million aggregate principal amount of Convertible Notes was bifurcated between the debt component ($187.1 million) and the equity
component ($71.7 million). The amount allocated to the debt component was estimated based on the fair value of similar debt instruments that did not include an
equity conversion feature. The Convertible
95
Notes were recorded at an initial car rying value of $187.1 million, net of $71.7 million in debt discount, which was being accreted to the carrying value of the
Convertible Notes as non-cash interest expense over the life of the Convertible Notes .
During the year ended December 31, 2015, the Company settled $258.8 million aggregate principal amount of the Convertible Notes through a combination
of $259.9 million in cash and 5,638,576 shares of its common stock. The Company recorded a non-cash loss on extinguishment of the Convertible Notes of $21.1
million for the year ended December 31, 2015, which was included in other income (expense), net, on the consolidated statements of operations. Forfeited accrued
interest payable of $1.7 million was reclassified to additional paid-in capital during the year ended December 31, 2015. Upon settlement, the Convertible Notes
were no longer outstanding, interest ceased to accrue thereon, and all rights of the holders of the Convertible Notes ceased to exist.
NOTE
11.
STOCkhOldERS’
EquITy
(a)
Stock
Purchase
Rights
All shares of the Company’s common stock, if issued prior to the termination by the Company of its rights agreement, dated as of December 4, 2006,
include stock purchase rights. The rights are exercisable only if a person or group acquires twenty percent or more of the Company’s common stock or announces a
tender or exchange offer which would result in ownership of twenty percent or more of the Company’s common stock. Following the acquisition of twenty percent
or more of the Company’s common stock, the holders of the rights, other than the acquiring person or group, may purchase Medivation common stock at half of its
fair market value. In the event of a merger or other acquisition of the Company, the holders of the rights, other than the acquiring person or group, may purchase
shares of the acquiring entity at half of their fair market value. The rights were not exercisable at December 31, 2015.
(b)
Medivation
Equity
Incentive
Plan
The Medivation Equity Incentive Plan, which is stockholder-approved, provides for the issuance of options and other stock-based awards, including
restricted stock units and stock appreciation rights. The vesting of all outstanding awards under the Medivation Equity Incentive Plan will accelerate, and all such
awards will become immediately exercisable, upon a “change of control” of Medivation, as defined in the Medivation Equity Incentive Plan.
On June 16, 2015, the Company’s stockholders approved an amendment and restatement of the Medivation Equity Incentive Plan to increase the aggregate
number of shares of common stock authorized for issuance under the Medivation Equity Incentive Plan from 21,150,000 to 23,850,000. As a result of the two-forone stock split effected through a stock dividend described in Note 2, “Summary of Significant Accounting Policies,” the number of shares of common stock
authorized for issuance under the Medivation Equity Incentive Plan was increased to 47,700,000 effective on September 15, 2015. As a result of the stock dividend,
the number of shares of the Company’s common stock issuable upon exercise of outstanding stock options and vesting of other stock-based awards was
proportionally increased, and the exercise price per share as applicable for options and stock appreciation rights was proportionally decreased, in accordance with
the terms of the Medivation Equity Incentive Plan.
As of December 31, 2015, approximately 8.7 million shares were available for issuance under the Medivation Equity Incentive Plan.
Stock
Options
The terms of stock options granted under the Medivation Equity Incentive Plan cannot exceed ten years. Stock options generally have an exercise price
equal to the fair market value of the Company’s common stock on the grant date, and generally vest over a period of four years, except for annual stock option
grants to non-employee directors, which vest over a period of one year.
The following table summarizes stock option activity for the year ended December 31, 2015, as adjusted to reflect the two-for-one forward stock split
effected through a stock dividend on September 15, 2015:
Outstanding at December 31, 2014
Granted
Exercised
Forfeited/expired
Outstanding at December 31, 2015
Vested and exercisable at December 31, 2015
96
Number
of
Options
WeightedAverage
Exercise
Price WeightedAverage
Remaining
Contractual
Term
(in
years)
Aggregate
Intrinsic
value(1)
(in
millions)
10,135,914
1,822,724
(1,446,047)
(404,422)
10,108,169
$
$
$
$
$
16.76
52.66
11.24
41.20
23.05
6.01
$
266.4
7,043,757
$
13.88
4.84
$
242.9
(1)
The aggregate intrinsic value is calculated as the pre-tax difference between the weighted-average exercise price of the underlying awards and the closing
price per share of $48.34 of the Company’s common stock on December 31, 2015. The calculation excludes any awards with an exercise price higher than
the closing price of the Company’s common stock on December 31, 2015.
Additional information regarding stock options is set forth below (in thousands, except per share data):
Intrinsic value of options exercised
Grant-date fair value of options vested
Weighted-average grant-date fair value per share of
options granted (split-adjusted)
years
Ended
december
31,
2014
2015
2013
$
$
63,550
26,542
$
$
145,842
38,147
$
$
35,155
22,278
$
25.08
$
21.68
$
15.20
Restricted
Stock
Units
A restricted stock unit is an agreement to issue shares of the Company’s common stock at the time of vesting. Restricted stock units generally vest in three
equal installments on approximately the first, second and third anniversaries of the grant date, except for annual restricted stock unit grants to non-employee
directors, which vest on approximately the first anniversary of the grant date.
The following table summarizes restricted stock unit activity for the year ended December 31, 2015, as adjusted to reflect the two-for-one forward stock
split effected through a stock dividend on September 15, 2015:
Number
of
Shares
Unvested at December 31, 2014
Granted
Vested
Forfeited
Unvested at December 31, 2015
WeightedAverage
grant-date
Fair
value
967,160
670,244
(404,906)
(143,452)
1,089,046
$
$
$
$
$
38.10
52.34
34.92
45.45
47.08
The total fair value of restricted stock units that vested during the years ended December 31, 2015, 2014, and 2013 was $14.1 million, $7.0 million, and
$11.8 million, respectively.
Stock
Appreciation
Rights
Stock appreciation rights give the holder the right, upon exercise, to receive the difference between the market price per share of the Company’s common
stock at the time of exercise and the exercise price of the stock appreciation right. The exercise price of the stock appreciation right is equal to the market price of
the Company’s common stock at the date of the grant.
The following table summarizes stock appreciation rights activity for the year ended December 31, 2015, as adjusted to reflect the two-for-one forward
stock split effected through a stock dividend on September 15, 2015:
(1)
Number
of
Rights
WeightedAverage
Exercise
Price Outstanding at December 31, 2014
Granted
Exercised
Forfeited
Outstanding at December 31, 2015
1,376,456
—
(61,172)
(17,156)
1,298,128
$
Vested and exercisable at December 31, 2015
1,290,720
WeightedAverage
Remaining
Contractual
Term
(in
years)
Aggregate
Intrinsic
value
(1)
(in
millions)
$
$
$
12.03
—
11.60
11.60
12.05
5.96
$
47.1
$
12.05
5.96
$
46.8
The aggregate intrinsic value is calculated as the pre-tax difference between the weighted-average exercise price of the underlying awards and the closing
price per share of $48.34 of the Company’s common stock on December 31, 2015. The calculation excludes any awards with an exercise price higher than
the closing price of the Company’s common stock on December 31, 2015.
97
Additional information regarding stock appreciation rights is set forth below:
Intrinsic value of stock appreciation rights exercised
Fair value of stock appreciation rights vested (based on
remeasurement-date fair value)
2015
years
Ended
december
31,
2014
2013
$
3,034
$
7,024
$
1,090
$
5,730
$
6,834
$
9,955
No stock appreciation rights were granted during the years ended December 31, 2015, 2014 and 2013.
(c)
Medivation
Employee
Stock
Purchase
Plan
The ESPP, which is stockholder approved, permits eligible employees to purchase shares of the Company’s common stock through payroll deductions at the
lower of 85% of the fair market value of the common stock at the beginning or end of a purchase period. Eligible employee purchases are limited on an annual
basis to $25,000 in accordance with Section 423 of the Internal Revenue Code. As a result of the stock dividend described in Note 2, “ Summary of Significant
Accounting Policies,” the number of shares of common stock authorized for issuance under the ESPP increased from 3,000,000 shares to 6,000,000 shares effective
September 15, 2015. As of December 31, 2015, approximately 97,662 shares are reserved for issuance under the current purchase period and 312,086 shares have
been issued. At December 31, 2015, total employee withholdings for ESPP shares of $1.7 million were recorded in “accounts payable, accrued expenses and other
current liabilities” on the consolidated balance sheet.
(d)
Stock-Based
Compensation
The Company estimates the fair value of stock options, stock appreciation rights, and ESPP shares using the Black-Scholes valuation model. The Company
estimates expected volatility based on the historical price volatility of its common stock and implied volatility of its common stock inherent in the market price of
publicly traded options in its common stock. The Company estimates the expected term of stock options and stock appreciation rights based on actual exercise
experience and an assumption that unexercised options will remain outstanding for a period equal to the midpoint between the date the option vests in full and the
contractual option termination date. The Company estimates the expected term of ESPP shares based on the duration of the applicable purchase period. The riskfree interest rate is based on the U.S. Treasury yield for a term consistent with the expected term of the awards at the time of grant. The Company uses a dividend
yield of zero as it has no history or expectation of paying cash dividends on its common stock.
The Black-Scholes assumptions used to estimate the fair value of stock options granted were as follows:
2015
Expected volatility
Expected term (in years)
Risk-free interest rate
Expected dividend yield
years
Ended
december
31,
2014
50-64%
4.98-7.17
1.33-1.77%
—
60-65%
5.0-5.5
1.56-1.79%
—
2013
64-75%
5.2-5.5
0.73-1.64%
—
No significant stock options were granted to consultants during the periods presented above.
The Black-Scholes assumptions used to estimate the fair value of shares issued under the ESPP on the commencement date of the offering period were as
follows:
2015
Expected volatility
Expected term (in years)
Risk-free interest rate
Expected dividend yield
years
Ended
december
31,
2014
37-48%
0.5
0.08-0.12%
—
2013
43-53%
0.5
0.04-0.06%
—
45%
0.5
0.04%
—
Stock-based compensation expense was as follows:
2015
Stock-based compensation expense recognized as:
R&D expenses
SG&A expenses
Total
$
$
98
years
Ended
december
31,
2014
24,368
30,494
54,862
$
$
17,913
27,221
45,134
$
$
2013
16,503
20,575
37,078
Unrecognized stock-based compensation expense was approximately $87.2 million at December 31, 2015, and is expected to be recognized over a
weighted-average period of approximately 2.5 years.
(e)
Warrants
At December 31, 2015, an aggregate of 40,000 warrants to purchase shares of Medivation common stock at an exercise price of $3.47 per share were
outstanding. These outstanding warrants expire in 2017. During the year ended December 31, 2013, an aggregate of 51,616 warrants to purchase shares of
Medivation common stock at an exercise price of $0.39 per share were exercised.
NOTE
12.
RETIREMENT
PlAN
The Company has a defined contribution savings plan, which qualifies as a deferred salary arrangement under Section 401(k) of the Internal Revenue Code,
or IRC. The 401(k) Plan is for the benefit of all participating employees and permits voluntary contributions by employees up to 100% of their annual pre-tax
compensation limited by the Internal Revenue Service, or the IRS, imposed maximum contribution. The Company matches 100% of the first 3% of employee
contributions and 50% of the next 2% of employee contributions. The Company’s contributions and the employee contributions are fully vested when contributed.
The plan assets are held in trust and invested as directed by the plan participants. Employer matching contributions to the plan were $3.5 million, $2.7 million, and
$1.9 million for the years ended December 31, 2015, 2014, and 2013, respectively.
NOTE
13.
INCOME
TAXES
The Company’s income before income tax (expense) benefit was $381.3 million and $260.2 million for the years ended December 31, 2015 and 2014,
respectively. The Company’s loss before income tax expense was $42.5 million for the year ended December 31, 2013. Since inception, the Company has only
generated pre-tax income (losses) in the United States and has not generated any pre-tax income (losses) outside the United States. Income tax (expense) benefit for
the periods presented consisted of the following:
years
Ended
december
31,
2014
2015
Current:
Federal
State
Total current
Deferred:
Federal
State
Total deferred
Total income tax (expense) benefit
$
(140,987) $
(3,875)
(144,862)
(19,476) $
(1,496)
(20,972)
8,179
90
8,269
(136,593) $
$
36,917
313
37,230
16,258
2013
(7)
(108)
(115)
—
—
—
(115)
$
During 2015 and 2014, the Company reduced its current Federal and state taxes payable by $100.2 million and $17.0 million, respectively, related to excess
tax benefits from stock-based compensation, offsetting additional paid-in capital. In addition, for the year ended December 31, 2015, the Company recorded a
credit to additional paid-in capital of $11.8 million related to certain tax impacts of the extinguishment of Convertible Notes. The Company had unrecorded state
excess stock-based compensation tax benefits of $3.4 million (tax-effected) as of December 31, 2015. These amounts will be credited to additional paid-in capital
when such amounts reduce cash taxes payable.
A reconciliation of the statutory Federal income tax rate of 35% to the Company’s effective income tax rates is as follows:
years
Ended
december
31,
2015
Federal tax provision at statutory rate
State taxes (net of Federal benefit)
Stock-based compensation
Non-deductible officer compensation
Change in valuation allowance
Research and development credits
Other
Effective income tax rate
35.0%
0.6%
0.1%
0.2%
—
(0.2%)
0.1%
35.8%
99
2014
35.0%
0.4%
0.1%
0.1%
(40.5%)
(1.5%)
0.2%
(6.2%)
2013
35.0%
1.4%
(0.2%)
(1.8%)
(52.1%)
17.1%
0.3%
(0.3%)
The Company recorded income tax expense of $136.6 million for the year ended December 31, 2015. The Company recorded an income tax benefit of
$16.3 million for the year ended December 31, 2014. For the year ended Dec ember 31, 2015, the provision for income taxes was higher than the tax computed at
the U.S. Federal statutory rate primarily due to state income taxes and non-deductible stock-based compensation, net of Federal research and development credit.
For the year ended December 31, 2014, the provision for income taxes was lower than the tax computed at the U.S. Federal statutory rate due primarily to
utilization of net operating loss and tax credit carryforwards and the release of the valuation allowance on a port ion of the Company’s net deferred tax assets. The
income tax expense for the year ended December 31, 2013 was not significant. The increase in the effective tax rate for the year ended December 31, 2015 as
compared to the year ended December 31, 2014 was p rimarily due to the release of the valuation allowance against federal and certain state deferred tax assets
during the fourth quarter of 2014.
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting
purposes and the tax basis of assets and liabilities. Significant components of the Company’s deferred tax assets for Federal and state income taxes are follows:
2015
Deferred tax assets:
Deferred revenue
Net operating loss carryforward
Stock-based compensation
Tax credits
Intangible assets
Accruals and reserves
Total deferred tax assets
Less: valuation allowance
Total net deferred tax assets
Deferred tax liabilities
Depreciation
Convertible Notes
Contingent consideration
Total deferred tax liabilities
Net deferred tax assets
$
$
Recorded as:
Net current deferred tax assets
Net non-current deferred tax assets
Net non-current deferred tax liabilities (included in “Other
non-current liabilities”)
Net deferred tax assets
$
$
december
31,
2014
— $
8,257
35,482
8,076
9,833
19,156
80,804
(16,827)
63,977
1,005
9,100
26,000
12,098
5,259
15,247
68,709
(16,023)
52,686
(3,168)
—
(3,798)
(6,966)
57,011 $
(2,741)
(12,792)
—
(15,533)
37,153
—
57,011
—
57,011
$
$
21,987
15,176
(10)
37,153
As of December 31, 2015, all deferred tax assets and liabilities are classified as non-current on the Company’s balance sheet in accordance with the early
adoption of ASU 2015-17. See additional discussion in Note 2, “Summary of Significant Accounting Policies”.
As of December 31, 2015, the Company had no Federal net operating loss carryforwards for tax return purposes as the Company fully utilized all of its tax
attributes during 2015. Also, as of December 31, 2015, the Company had state net operating loss carryforwards for tax return purposes of approximately $216.3
million, which will expire at various dates between the years 2017 and 2033, if not utilized.
The Company has fully utilized all of its Federal research and development credit and Orphan Drug credit carryforwards and alternative minimum tax
credits as of December 31, 2015 for tax return purposes. In addition, the Company has California research and development credit carryforwards for tax purposes
of approximately $16.6 million as of December 31, 2015. The California research credits do not expire. On December 18, 2015, the Consolidated Appropriations
Act of 2016 was signed, permanently renewing the Federal research and development tax credit retroactive to January 1, 2015. ASC 740-10-45-15, “Income
Taxes,” requires that the effects of a change in tax laws or rates be recognized in the period that includes the enactment date; consequently, the Company
recognized the benefit of the Federal research and development credit during the fourth quarter of 2015.
Federal and state tax laws impose substantial restrictions on the utilization of net operating loss and credit carryforwards in the event of an “ownership
change” for tax purposes, as defined in IRC Section 382. The Company completed Section 382 studies through September 30, 2015, and concluded that ownership
changes occurred in 2004, 2007 and 2010. The ownership changes did not
100
result in a reduction of its net operating loss or in its research and development credits expiring unused. If additiona l ownership changes occur, the utilization of
net operating loss and credit carryforwards could be significantly reduced.
The valuation allowance increased by $0.8 million in 2015, decreased by $104.8 million in 2014 and increased by $22.1 million in 2013.
The Company records a valuation allowance to reduce deferred tax assets to reflect the net amount that is more likely than not to be realized. Based upon the
weight of available evidence at December 31, 2014, the Company determined that it was more likely than not that a portion of its deferred tax assets would be
realizable and consequently released the valuation allowance against Federal and certain state net deferred tax assets and recorded a discrete tax benefit of $33.4
million during the fourth quarter of 2014. The decision to reverse a portion of the valuation allowance was made after management considered all available
evidence, both positive and negative, including but not limited to the historical operating results, income or loss in recent periods, cumulative income in recent
years, forecasted earnings, forecasted future taxable income, and significant risk and uncertainty related to forecasts. The release of the valuation allowance resulted
in the recognition of certain deferred net tax assets and a decrease to income tax expense.
The following table summarizes activity related to the Company’s gross unrecognized tax positions:
Balance as of beginning of year
Additions based on tax positions related to the current year
Additions based on tax position related to prior year
Decreases based on tax positions related to prior year
Balance as of end of year
2015
$
$
12,367 $
2,898
135
(1,324)
14,076 $
december
31,
2014
5,955 $
6,439
—
(27)
12,367 $
2013
4,602
702
660
(9)
5,955
Approximately $7.7 million of the total gross unrecognized tax benefits at December 31, 2015, if recognized, would affect the effective tax rate. The
Company does not anticipate a material change in unrecognized tax benefits during the next twelve months.
Interest and/or penalties related to income tax matters are recognized as a component of income tax expense as incurred. The interest expense related to
uncertain tax positions in the income tax expense line of the Company’s consolidated statements of operations was not significant during 2015, 2014, and 2013.
Interest related to income tax matters accrued as of December 31, 2015 and 2014 was not significant.
As a result of the Company’s net operating loss and tax credit carryforwards, all of its tax years are subject to Federal and state examination. The
Company’s Federal income tax returns were audited by the Internal Revenue Service for tax years 2008 and 2012 and resulted in no material adjustments. The
Company’s 2009 and 2010 California income tax returns are currently under audit by the California tax authorities. The Company believes that it has adequately
provided for any reasonable foreseeable outcomes related to its Federal and California income tax returns.
The future effective tax rate is subject to volatility and may be materially impacted by various internal and external factors. These factors may include, but
are not limited to, the amount of income tax benefits and charges from: interpretations of existing tax laws; changes in tax laws and rates; future levels of research
and development expenditures; changes in the mix of earnings in countries with differing statutory tax rates in which the Company may conduct business; changes
in the valuation of deferred tax assets and liabilities; state income taxes; the tax impact of stock-based compensation; accounting for uncertain tax positions; closure
of statute of limitations or settlement of tax audits; changes in estimates of prior years’ items; tax costs for acquisition-related items; changes in accounting
standards; non-deductible officers’ compensation; limitations on the utilization of net operating losses and tax credits due to changes in ownership; and overall
levels of income before taxes.
NOTE
14.
FAIR
vAluE
dISClOSuRES
The Company follows ASC 820-10, “Fair Value Measurements and Disclosures,” which among other things, defines fair value, establishes a consistent
framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring
basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between
market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in
pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in
measuring fair value as follows:
·
Level 1—Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.
·
Level 2—Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation
with market data at the measurement date and for the duration of the instrument’s anticipated life.
101
·
Level 3—Inputs reflect management’s best estimate of wh at market participants would use in pricing the asset or liability at the measurement date.
Unobservable inputs are used when little or no market data are available. Consideration is given to the risk inherent in the valuation technique and
the risk inhere nt in the inputs to the model.
The following table presents the Company’s financial assets and liabilities that are measured at fair value on a recurring basis:
Fair
value
december
31,
2015:
Current liabilities:
Contingent consideration
Long-term liabilities:
Contingent consideration
december
31,
2014:
Cash equivalents:
Money market funds
Current liabilities:
Contingent consideration
Long-term liabilities:
Contingent consideration
level
1
Fair
value
measurements
using:
level
2
level
3
$
4,900
—
—
$
4,900
$
262,368
—
—
$
262,368
$
189,031
189,031
—
$
10,000
—
—
$
10,000
$
96,000
—
—
$
96,000
$
—
The Company classifies money market funds, which are based on quoted market prices in active markets with no valuation adjustments, as Level 1 assets
within the valuation hierarchy.
The Company estimates the fair values of Level 2 assets by taking into consideration valuations obtained from third-party pricing sources. These pricing
sources utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either
directly, or indirectly, to estimate fair value. These inputs include market pricing based on real-time trade data for the same or similar assets, issuer credit spreads,
benchmark yields, and other observable inputs. The Company validates the prices provided by its third-party pricing sources by understanding the models used,
obtaining market values from other pricing sources, and/or analyzing pricing data in certain instances.
In connection with the acquisitions of MDV9300 and MDV3800 , the Company recorded contingent consideration liabilities pertaining to amounts
potentially payable to CureTech and BioMarin, respectively. The fair value of contingent consideration is considered a Level 3 liability and was estimated utilizing
a model with key assumptions that included estimated revenues or completion of certain development, regulatory and sales milestone targets during the earn-out
period, volatility, and estimated discount rates corresponding to the periods of expected payments. The estimated fair value of the contingent consideration liability
is measured at each reporting date based on significant inputs not observable in the market. The Company assesses these estimates on an ongoing basis as
additional data impacting the assumptions is obtained. Changes in the estimated fair value of contingent consideration are reflected as non-cash adjustments to
operating expenses in the consolidated statements of operations.
During the year ended December 31, 2015, the Company recorded fair value adjustments of $2.6 million and $7.7 million as a decrease to R&D expenses
and SG&A expenses, respectively, related to the CureTech contingent consideration liability. Since the date of the fourth quarter acquisition of MDV3800 , the
Company also recorded nominal fair value adjustments to the related contingent consideration liability. Such adjustments were primarily due to the time value of
money.
The aggregate remaining, undiscounted amount of contingent consideration that the Company could potentially be required to pay to CureTech and
BioMarin under each respective transaction is included in Note 4, “Business Acquisitions.”
Contingent consideration may change significantly as development progresses and additional data is obtained that will affect the Company’s assumptions
regarding probabilities of successful achievement of related milestones used to estimate the fair value of the liability and the timing in which they are expected to
be achieved. Updates to these assumptions could have a significant impact on our results of operations. For example, a significant increase in the probability of
achieving a milestone would result in a significantly higher fair value measurement, while a significant increase in the expected timing of achieving the milestone
would result in a significantly lower fair value measurement. Considerable judgment is required to interpret the market data used to develop the assumptions. The
estimates of fair value may not be indicative of amounts that could be realized in a current market exchange. Accordingly, the use of different market assumptions
and/or different valuation techniques could result in materially different fair value estimates.
102
There were no transfers between Level 1 and Level 2 financial instruments during the year ended December 31, 2015. The following table includes a rollforward of the fair value of Level 3 financial instruments for the year ended December 31, 2015:
year
Ended
december
31,
2015 Contingent consideration (current and long-term):
Balance at beginning of period
Amounts acquired or issued
Net change in fair value
Settlements
Transfers in and/or out of Level 3
Balance at end of period
$
106,000
171,942
(10,674)
—
—
267,268
$
The following table presents the total balance of the Company’s other financial instruments that are not measured at fair value on a recurring basis.
Total
Balance december
31,
2015:
Assets:
Bank deposits (included in “Cash and cash
equivalents”)
liabilities:
Borrowings under Revolving Credit Facility
december
31,
2014:
Assets:
Bank deposits (included in “Cash and cash
equivalents”)
liabilities:
Convertible Notes
level
1
Fair
value
measurements
using:
level
2
level
3
$
225,853
$
225,853
—
—
$
75,000
$
75,000
—
—
$
313,646
$
313,646
—
—
$
359,219
359,219
—
—
$
Due to their short-term maturities, the Company believes that the fair value of its bank deposits, receivable from collaboration partner, accounts payable and
accrued expenses, short-term borrowings under the Revolving Credit Facility, and other current assets and liabilities approximate their carrying value.
The estimated fair value of the Company’s Convertible Notes, including the equity component, was $496.8 million at December 31, 2014 and was
determined using recent trading prices of the Convertible Notes. The fair value of the Convertible Notes included in the table above at December 31, 2014
represents only the liability component of the Convertible Notes, because the equity component is included in stockholders’ equity on the consolidated balance
sheet. The Company settled its remaining Convertible Notes in the third quarter of 2015 as discussed further in Note 10, “Debt.”
NOTE
15.
COMMITMENTS
ANd
CONTINgENCIES
(a)
leases
The Company leases approximately 158,000 square feet of office space, including 143,000 square feet of office space at its corporate headquarters, pursuant
to operating lease agreements expiring at various dates through December 2019. The Company has the option to extend the lease term of its corporate headquarters
for an additional five years.
Future operating lease obligations as of December 31, 2015, are as follows:
years
Ending
december
31,
Operating
leases
2016
2017
2018
2019
2020
2021 and thereafter
Total
$
$
103
9,343
9,542
9,743
5,065
—
—
33,693
The Company is considered the “accounting owner” for a build-to-suit property and has recorded a build-to-suit lease obligation on its consolidated balance
sheets. Additional information regarding the build-to-suit lease obligation is included in Note 7 , “ Build-To-Suit Lease Obligation.”
Expected future lease payments under the build-to-suit lease as of December 31, 2015 are as follows:
years
Ending
december
31,
Expected
Cash
Payments
under
Build-To-Suit
lease
Obligation
2016
2017
2018
2019
2020
2021 and thereafter
Total minimum lease payments
$
$
2,178
2,244
2,311
2,380
2,452
9,627
21,192
Rent expense for the years ended December 31, 2015, 2014, and 2013 was $10.3 million, $8.1 million, and $5.2 million, respectively. In addition to the
amounts included in the tables above, certain lease agreements also require the Company to make additional payments during the lease term for taxes, insurance,
and other operating expenses.
(b)
license
Agreement
with
uClA
Under an August 2005 license agreement with UCLA, the Company’s subsidiary Medivation Prostate Therapeutics, Inc., or MPT, holds an exclusive
worldwide license under several UCLA patents and patent applications covering XTANDI and related compounds. Under the Astellas Collaboration Agreement,
the Company granted Astellas a sublicense under the patent rights licensed to it by UCLA.
The Company is required to pay UCLA (a) an annual maintenance fee, (b) $2.8 million in aggregate milestone payments upon achievement of certain
development and regulatory milestone events with respect to XTANDI (all of which has been paid as of December 31, 2015), (c) ten percent of all Sublicensing
Income, as defined in the agreement, which the Company earns under the Astellas Collaboration Agreement, and (d) a four percent royalty on global net sales of
XTANDI, as defined. Under the terms of the Astellas Collaboration Agreement, the Company shares this royalty obligation equally with Astellas with respect to
sales in the United States, and Astellas is responsible for this entire royalty obligation with respect to sales outside of the United States. The Company is currently
involved in litigation with UCLA, which are discussed in the section titled “Litigation” below.
UCLA may terminate the agreement if the Company does not meet a general obligation to diligently proceed with the development, manufacturing and sale
of licensed products, or if it commits any other uncured material breach of the agreement. The Company may terminate the agreement at any time upon advance
written notice to UCLA. If neither party terminates the agreement early, the agreement will continue in force until the expiration of the last-to-expire patent on a
country-by-country basis.
(c)
Clinical
Manufacturing
Agreements
Manufacturing
Services
and
Supply
Agreements
Contemporaneous with the execution of the License Agreement with CureTech, the Company entered into a Manufacturing Services and Supply
Agreement, or MSA, with CureTech pursuant to which CureTech will provide clinical trial supply of MDV9300 over a three-year period. In accordance with the
terms of the MSA, as amended, the Company paid CureTech upfront and setup fees of $3.0 million during the fourth quarter of 2014, $0.2 million during the
second quarter of 2015 and $0.1 million during the third quarter of 2015. The Company is required to pay CureTech a one-time milestone payment of $5.0 million
upon the completion of the Manufacturing Technology Transfer, as defined. In accordance with the terms of the MSA, the Company is also responsible for
providing Manufacturing Funding totaling up to $19.3 million for clinical trial materials of MDV9300 over the three-year term of the MSA, of which $9.0 million
has been paid through December 31, 2015. The Manufacturing Funding is contingent upon the successful achievement of the requirements set forth in the
Manufacturing Plan, and any such amounts may be reduced or eliminated by the Company under the terms of the MSA.
104
Development
and
Manufacturing
Services
Agreement
During the fourth quarter of 2014, the Company entered into a Development and Manufacturing Services Agreement with a third party clinical
manufacturing organization. The term of the agreement is for the longer of (i) a period of five (5) years or (ii) through the completion of the Services, as defined.
Under the current statement of work under this agreement, as amended, the Company intends to transfer the current manufacturing process of MDV9300 from
CureTech to this third party, further scale up and production of Phase 3 clinical trial material of MDV9300 from this entity’s manufacturing facility. The estimated
total consideration payable under the current statement of work, as amended, is approximately $15.2 million, of which approximately $5.1 million has been paid
through December 31, 2015.
(f)
litigation
The Company is party to legal proceedings, investigations, and claims in the ordinary course of its business, including the matters described below. The
Company records accruals for outstanding legal matters when it believes that it is both probable that a liability has been incurred and the amount of such liability
can be reasonably estimated. The Company evaluates, on a quarterly basis, developments in significant legal matters that could affect the amount of any accrual
and developments that would make a loss contingency both probable and reasonably estimable. To the extent new information is obtained and the Company’s
views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in the Company’s accrued liabilities would be
recorded in the period in which such determination is made. In addition, in accordance with the relevant authoritative guidance, for matters for which the likelihood
of material loss is at least reasonably possible, the Company provides disclosure of the possible loss or range of loss; however, if a reasonable estimate cannot be
made, the Company will provide disclosure to that effect. Gain contingencies, if any, are recorded when they are realized.
In May 2011, the Company filed a lawsuit in San Francisco Superior Court against the Regents of the University of California, or the Regents, and one of its
professors, alleging breach of contract and fraud claims, among others. The Company’s allegations in this lawsuit include that it has exclusive commercial rights to
apalutamide, an investigational drug originally known as ARN-509 (previously also referred to as JNJ-56021927, or JNJ-927), which is currently being developed
by Aragon Pharmaceuticals, or Aragon. In August 2013, Johnson & Johnson and Aragon completed a transaction in which Johnson & Johnson acquired all
apalutamide assets owned by Aragon. The Company sought remedies including a declaration that it is the proper licensee of apalutamide, contractual remedies
conferring to it exclusive patent license rights regarding apalutamide, and other equitable and monetary relief. On August 7, 2012, the Regents filed a crosscomplaint against the Company seeking declaratory relief that the Regents are entitled to ten percent of any sales milestone payments under the Astellas
Collaboration Agreement.
On December 20, 2012, and January 25, 2013, the Court granted summary judgment motions filed by defendants Regents and Aragon, resulting in dismissal
of all claims against Regents and Aragon, but denied such motions filed by the remaining Regents professor. On April 15, 2013, the Company filed a Notice of
Appeal seeking appeal of the judgment in favor of Aragon, which is now wholly-owned by Johnson & Johnson. The bench trial of the Regent’s cross-complaint
against the Company was conducted in July 2013, and on January 15, 2014, the Court entered a judgment in the cross-complaint in favor of Regents. The Company
appealed this judgment on February 13, 2014 along with the December 2012 summary judgment order in favor of Regents. The jury trial of the Company’s breach
of contract and fraud claims against the remaining Regents professor was conducted in October and November 2013. On November 15, 2013, the jury rendered a
verdict in the case, finding in favor of Medivation on one of the breach of contract claims, and in favor of the Regents professor on the fraud claims. The Company
appealed the resulting judgment on the fraud claims. All appeals from this matter were consolidated, and oral arguments were heard on February 23, 2016. A
decision of the appellate court is required to be rendered within 90 days of the oral argument.
On April 11, 2014, the Regents filed a complaint against the Company in which UCLA alleges that the “Operating Profits” Medivation has received (and
will continue to receive) from Astellas, as a result of the Astellas Collaboration Agreement, constitute Sublicensing Income under the license agreement between
Medivation and the Regents and that Medivation and its subsidiary, MPT, have failed to pay the Regents ten percent of such Operating Profits. The Company
denies the Regents’ allegations and is vigorously defending the litigation. The Company is currently awaiting a trial date to be set by the Courts.
While the Company believes it has meritorious positions with respect to the claims above and intends to advance its positions in these lawsuits vigorously,
including on appeal, the process of resolving matters through litigation or other means is inherently uncertain, and it is not possible to predict the ultimate
resolution of any such proceeding. The actual costs of defending the Company’s position may be significant, and the Company may not prevail.
105
NOTE
16.
SElECTEd
quARTERly
FINANCIAl
dATA
(uNAudITEd)
The following table presents the unaudited quarterly results of operations of the Company for the years ended December 31, 2015 and 2014, respectively.
The unaudited financial information is prepared on the same basis as the audited consolidated financial statements. The Company’s operating results for any quarter
are not necessarily indicative of results for any future quarters or for a full year. All share and per share amounts have been retroactively adjusted to reflect the
Company’s September 15, 2015, two-for-one forward stock split effected through a stock dividend.
2015:
Collaboration revenue
Operating expenses
Income from operations
Net income (loss)
Basic net income (loss) per common share
Diluted net income (loss) per common share
Weighted-average common shares used in the calculation
of basic net income (loss) per common share
Weighted-average common shares used in the calculation
of diluted net income (loss) per common share
2014:
Collaboration revenue
Operating expenses
Income (loss) from operations
Net income (loss)
Basic net income (loss) per common share
Diluted net income (loss) per common share
Weighted-average common shares used in the calculation
of basic net income (loss) per common share
Weighted-average common shares used in the calculation
of diluted net income (loss) per common share
March
31,
$
$
$
$
$
$
$
$
$
$
$
$
quarters
Ended
June
30,
September
30, 129,188
(128,615)
573
(3,118)
(0.02)
(0.02)
$
$
$
$
$
$
175,657
(122,002)
53,655
25,826
0.16
0.15
$
$
$
$
$
$
260,665
(121,680)
138,985
79,510
0.49
0.47
december
31, $
$
$
$
$
$
377,748
(156,348)
221,400
142,507
0.87
0.85
156,637
158,505
162,390
163,746
156,637
168,690
168,070
168,368
87,189
(95,654)
(8,465)
(13,665)
(0.09)
(0.09)
$
$
$
$
$
$
148,090
(93,139)
54,951
47,919
0.31
0.30
$
$
$
$
$
$
200,478
(108,595)
91,883
77,993
0.51
0.48
$
$
$
$
$
$
274,730
(131,253)
143,477
164,205
1.06
0.98
152,489
153,153
154,112
155,644
152,489
160,983
162,446
171,513
Net income (loss) per common share amounts for the 2015 and 2014 quarters and full years have been computed separately. Accordingly, quarterly amounts
may not add to the annual amounts because of differences in the weighted average shares outstanding during each quarter due to the effect of potentially dilutive
securities only in the periods in which such effect would be dilutive.
106
Exhibit
Index
Exhibit
Number
2.1**
Exhibit
description
Form
File
No.
Incorporated
By
Reference
Exhibit
Filing
date
Asset Purchase Agreement, dated August 21, 2015, by and between
Medivation, Inc. and BioMarin Pharmaceutical, Inc.
8-K
001-32836
2.1
10/07/2015
License Agreement between Medivation, Inc. and CureTech Ltd.,
dated as of October 23, 2014
8-K
001-32836
2.1
11/06/2015
3.1
Restated Certificate of Incorporation.
8-K
001-32836
3.4
10/17/2013
3.2
Certificate of Amendment to Amended and Restated Certificate of
Designation of Series C Junior Participating Preferred Stock of
Medivation, Inc.
8-K
001-32836
3.1
2/13/2015
3.3
Certificate of Amendment of Restated Certificate of Incorporation
8-K
001-32836
3.1
6/19/2015
3.4
Amended and Restated Bylaws of Medivation, Inc.
8-K
001-32836
3.2
2/13/2015
4.1
Common Stock Certificate.
10-Q
001-32836
4.1
5/9/2012
4.2
Rights Agreement, dated as of December 4, 2006, between
Medivation, Inc. and American Stock Transfer & Trust Company, as
Rights Agent, which includes the form of Certificate of Designations
of the Series C Junior Participating Preferred Stock of Medivation,
Inc. as Exhibit A, the form of Right Certificate as Exhibit B and the
Summary of Rights to Purchase Preferred Shares as Exhibit C.
8-K
001-32836
4.1
12/4/2006
2.2**
10.1*
Amended and Restated 2004 Equity Incentive Award Plan.
DEF14A
001-32836
Annex A
4/30/2015
10.2*
Form of Stock Option Agreement for Early Exercisable Options under
the Amended and Restated 2004 Equity Incentive Award Plan.
10-KSB
000-20837
10.7(c)
2/11/2005
Form of Stock Option Agreement under the 2004 Equity Incentive
Award Plan (for use from July 1, 2004 through October 6, 2013).
10-KSB
000-20837
10.7(b)
2/11/2005
10-K
001-32836
10.39
2/25/2015
001-32836
10.22
3/16/2011
10.3*
10.4*
10.5*
10.6*
10.7*
Form of Stock Option Grant Notice and Non-Qualified Stock Option
Agreement under the Amended and Restated 2004 Equity Incentive
Award Plan (for use after October 6, 2013).
Form of Restricted Stock Unit Grant Notice and Agreement under the
2004 Amended and Restated Equity Incentive Award Plan (for use
from December 10, 2010 through October 6, 2013).
10-K
Form of Restricted Stock Unit Grant Notice and Agreement under the
Amended and Restated 2004 Equity Incentive Plan (for use from
October 7, 2013 through December 11, 2014).
10-K
001-32836
10.40
2/25/2015
Form of Restricted Stock Unit Grant Notice and Agreement under the
Amended and Restated 2004 Equity Incentive Award Plan (for use
after December 11, 2014 through December 31, 2015).
10-K
001-32836
10.41
2/25/2015
107
Filed
herewith
Exhibit
Number
10.8*
10.9*
Exhibit
description
Form
File
No.
Incorporated
By
Reference
Exhibit
Filing
date
X
Form of Restricted Stock Grant Notice and Agreement for NonEmployee Directors under the Amended and Restated 2004 Equity
Incentive Plan and Joint Escrow Instructions (for use after January 1,
2016).
X
The Medivation, Inc. Employee Stock Purchase Plan.
8-K
001-32836
10.1
7/1/2013
10.11**
The Exclusive License Agreement, by and among Medivation, Inc.,
the Regents of the University of California, and Medivation Prostate
Therapeutics, Inc., dated as of August 12, 2005.
10-Q
001-32836
10.1
11/12/2013
10.13
10.14
10.15
10.16
10.17**
10.18**
10.19**
10.20
10.21
10.22
Filed
herewith
Form of Restricted Stock Unit Grant Notice and Agreement under the
Amended and Restated 2004 Equity Incentive Award Plan (for use
after January 1, 2016).
10.10*
10.12
First Amendment to Exclusive License Agreement by and among
Medivation, Inc., the Regents of the University of California, and
Medivation Prostate Therapeutics, Inc., dated as of November 4,
2005.
X
Second Amendment to Exclusive License Agreement by and among
Medivation, Inc., the Regents of the University of California, and
Medivation Prostate Therapeutics, Inc., dated as of May 8, 2006.
X
Third Amendment to Exclusive License Agreement by and among
Medivation, Inc., the Regents of the University of California, and
Medivation Prostate Therapeutics, Inc., dated as of June 12, 2006.
X
Fourth Amendment to Exclusive License Agreement by and among
Medivation, Inc., the Regents of the University of California, and
Medivation Prostate Therapeutics, Inc., dated as of July 17, 2007.
X
Fifth Amendment to Exclusive License Agreement by and among
Medivation, Inc., the Regents of the University of California, and
Medivation Prostate Therapeutics, Inc., dated as of October 21, 2009.
Collaboration Agreement, dated as of October 26, 2009, by and
between Medivation, Inc. and Astellas US LLC.
X
10-K/A
001-32836
10.15
3/24/2014
10-Q
001-32836
10.1
8/9/2011
10-Q/A
001-32836
10.2
3/24/2014
Amendment No. 3 to Collaboration Agreement, dated April 1, 2013,
by and among Medivation, Inc., Astellas Pharma Inc., and Astellas
US LLC.
10-K
001-32836
10.15
2/25/2015
Amendment No. 4 to Collaboration Agreement, dated October 29,
2013, by and among Medivation, Inc., Astellas Pharma Inc., and
Astellas US LLC.
10-K
001-32836
10.16
2/25/2015
Amendment No. 5 to Collaboration Agreement, dated May 6, 2014,
by and among Medivation, Inc., Astellas Pharma Inc., and Astellas
US LLC.
10-K
001-32836
10.17
2/25/2015
Amendment No. 1 to Collaboration Agreement, dated January 1,
2010, by and among Medivation, Inc., Astellas Pharma Inc. and
Astellas US LLC.
Amendment No. 2 to Collaboration Agreement, dated May 13, 2011,
by and among Medivation, Inc., Astellas Pharma Inc. and Astellas US
LLC.
108
Exhibit
Number
10.23**
10.24
10.25
10.26
10.27
10.28
10.29
10.30
10.31
10.32
10.33
10.34*
Exhibit
description
Form
File
No.
Incorporated
By
Reference
Exhibit
Filing
date
Amendment No. 6 to Collaboration Agreement dated January 6, 2016,
by and among Medivation, Inc., Astellas Pharma Inc., and Astellas
US LLC.
Office Lease, dated as of December 28, 2011, by and between
Knickerbocker Properties, Inc. XXXIII and Medivation, Inc.
10-K
001-32836
10.27
2/29/2012
001-32836
10.32
2/25/2015
Second Amendment to Lease, dated as of July 6, 2012, by and
between Knickerbocker Properties, Inc. XXXIII and Medivation, Inc.
10-Q
001-32836
10.2
11/9/2012
Third Amendment to Lease, dated as of September 27, 2012, by and
between Knickerbocker Properties, Inc. XXXIII and Medivation, Inc.
10-Q
001-32836
10.3
11/9/2012
Fourth Amendment to Lease, dated as of June 26, 2013, by and
between Knickerbocker Properties, Inc. XXXIII and Medivation, Inc.
10-Q
001-32836
10.2
8/8/2013
Fifth Amendment to Lease, dated as of February 12, 2014, by and
between Knickerbocker Properties, Inc. XXXIII and Medivation, Inc.
10-Q
001-32836
10.2
8/7/2014
10-Q
001-32836
10.3
5/7/2015
8-K
001-32836
10.1
9/9/2015
8-K
001-32836
10.1
10/26/2015
Sixth Amendment to Lease, dated as of January 12, 2015, by and
between Knickerbocker Properties, Inc. XXXIII and Medivation, Inc.
Credit Agreement, dated as of September 4, 2015, among Medivation,
Inc., the lenders party thereto and JPMorgan Chase Bank, N.A., as
Administrative Agent.
Amended and Restated Credit Agreement, dated as of October 23,
2015, by and among Medivation, Inc., the lenders party thereto and
JPMorgan Chase Bank, N.A., as Administrative Agent
Amendment No. 1 dated as of November 13, 2015 to Amended and
Restated Credit Agreement, dated as of October 23, 2015, by and
among Medivation, Inc., the lenders party thereto and JPMorgan
Chase Bank, N.A., as Administrative Agent
X
Change of Control Severance Benefits Agreement, dated as of
February 2, 2009, between Medivation, Inc. and David Hung, M.D.
10-K
001-32836
10.11
3/16/2009
Form of Medivation, Inc. Change of Control Severance Benefits
Agreement.
10-K
001-32836
10.13
3/16/2009
10.36*
Form of Indemnification Agreement for directors and officers.
10-K
001-32836
10.25
2/29/2012
10.37
Compensation Information for Non-Employee Directors.
10-Q
001-32836
10.2
5/7/2015
10.38*
The Medivation, Inc. 2013 Cash Performance Incentive Plan.
8-K
001-32836
10.3
7/1/2013
10.39*
2014 Bonuses, 2015 Base Salaries and Equity Awards for Certain
Executive Officers.
001-32836
Item 5.02
2/13/2015
10.35*
109
Filed
herewith
X
10-K
First Amendment to Office Lease, dated as of December 28, 2011, by
and between Knickerbocker Properties, Inc. XXXIII and Medivation,
Inc.
8-K
Exhibit
Number
10.40*
10.41*
10.42*
10.43*
10.44*
10.45*
10.46*
10.47*
10.48*
10.49*
10.50*
Exhibit
description
2015 Bonuses, 2016 Base Salaries and Bonus Plan, and Equity
Awards for Certain Executive Officers.
Form
File
No.
Incorporated
By
Reference
Exhibit
Filing
date
Filed
herewith
1/11/2015;
2/23/2015
8-K
001-32836
Item 5.02
Offer Letter, dated February 28, 2014, by and between Medivation,
Inc. and Rick Bierly, as amended March 3, 2014.
10-Q
001-32836
10.3
5/8/2014
Consulting Agreement, dated July 14, 2014, by and between
Medivation, Inc. and Dawn Svoronos.
10-Q
001-32836
10.2
11/6/2014
Amendment to Consulting Agreement, dated October 14, 2014, by
and between Medivation, Inc., and Dawn Svoronos.
10-K
001-32836
10.29
2/25/2015
Offer Letter, dated November 10, 2014 by and between Medivation
Field Solutions, Inc. and Joseph Lobacki.
10-K
001-32836
10.27
2/25/2015
10-Q
001-32836
10.2
8/6/2015
10-Q
001-32836
10.2
11/6/2015
Offer Letter between Medivation, Inc. and Thomas Templeman,
Ph.D., dated July 1, 2015.
10-Q
001-32836
10.3
11/6/2015
Offer Letter between Medivation, Inc. and Mohammad Hirmand,
M.D., dated September 30, 2015.
10-Q
001-32836
10.4
11/6/2015
Separation Agreement between Medivation, Inc. and Lynn Seely,
M.D., dated September 23, 2015
10-Q
001-32836
10.5
11/6/2015
Offer Letter, dated May 13, 2015, by and between Medivation, Inc.
and Andrew Powell.
Separation Agreement between Medivation, Inc. and Jennifer J.
Rhodes, dated August 3, 2015.
Offer Letter, dated January 6, 2016, by and between Medivation, Inc.
and Marion McCourt
X
Form of Performance Share Unit Grant Notice and Agreement under
the Amended and Restated 2004 Equity Incentive Award Plan (for
use from February 18, 2016)
X
21.1
Subsidiaries of Medivation, Inc.
X
23.1
Consent of Independent Registered Public Accounting Firm.
X
24.1
Power of Attorney (contained on signature page).
X
31.1
Certification pursuant to Rule 13a-14(a)/15d-14(a).
X
31.2
Certification pursuant to Rule 13a-14(a)/15d-14(a).
X
32.1†
Certifications of Chief Executive Officer and Chief Financial Officer.
X
101.INS
XBRL Instance Document.
X
101.SCH
XBRL Taxonomy Extension Schema Document.
X
101.CAL
XBRL Taxonomy Extension Calculation Linkbase Document.
X
101.DEF
XBRL Taxonomy Extension Definition Linkbase Document.
X
101.LAB
XBRL Taxonomy Extension Labels Linkbase Document.
X
10.51*
110
Exhibit
Number
101.PRE
*
**
†
Exhibit
description
XBRL Taxonomy Extension Presentation Linkbase Document.
Form
File
No.
Incorporated
By
Reference
Exhibit Filing
date
Filed
herewith
X
Indicates management contract or compensatory plan or arrangement.
Confidential treatment has been granted with respect to certain portions of this exhibit.
The certifications attached as Exhibit 32.1 accompanying this Annual Report on Form 10-K are not deemed filed with the Securities and Exchange
Commission and are not to be incorporated by reference into any filing of Medivation, Inc., under the Securities Act of 1933, as amended, or the Securities
Exchange Act of 1934, as amended, whether made before or after the date of this Annual Report on Form 10-K, irrespective of any general incorporation
language contained in such filing.
111
Exhibit
10.8
MEdIvATION,
INC.
AMENdEd
ANd
RESTATEd
2004
EquITy
INCENTIvE
AWARd
PlAN
RESTRICTEd
STOCk
uNIT
gRANT
NOTICE
Medivation, Inc. (the “ Company
”), pursuant to its Amended and Restated 2004 Equity Incentive Award Plan, as amended from time
to time (the “ Plan
”), hereby awards to Participant a Restricted Stock Unit award for the number of stock units (“ Stock
Units
”) set forth
below (the “ Award
”). The Award is subject to all of the terms and conditions as set forth in this Restricted Stock Unit Grant Notice (the “
Grant
Notice
”) and in the Plan and the Restricted Stock Unit Agreement (which is attached hereto as Attachment I), both of which are
incorporated herein in their entirety. Capitalized terms not otherwise defined herein shall have the meanings set forth in the Plan or the
Restricted Stock Unit Agreement.
Participant:
Date of Grant:
Number of Stock Units Subject to Award:
vesting
Schedule
:
The Stock Units subject to the Award shall vest in three substantially equal installments on each of t he first,
second and third anniversaries of (i) the fourth day of the month of the Date of Grant, if the Date of Grant occurs between the first and the
fourth day of the month of the Date of Grant, or (ii) the fourth day of the month following the month of the Date of Grant, if the Date of Grant
occurs on or after the fifth day of the month of the Date of Grant. Notwithstanding the foregoing, vesting shall terminate upon Participant’s
Termination of Service.
Issuance
Schedule
:
Subject to any adjustments pu rsuant to Section 11.1 of the Plan, one share of Stock will be issued for each Stock
Unit that vests in accordance with the schedule set forth in Section 6 of the Restricted Stock Unit Agreement.
definitions
:
For purposes of the Grant Notice and the Restri cted Stock Unit Agreement, “ Termination
of
Service
” means that
Participant’s service with the Company or a Subsidiary in all capacities, whether as an employee, director and/or consultant, has been
materially interrupted or terminated. A change in the capacity in which Participant renders service to the Company or a Subsidiary as an
employee, director and/or consultant, or a change in the entity for which Participant renders such service, provided that there is no material
interruption or termination of Participant’s service with the Company or a Subsidiary, shall not be a Termination of Service; provided,
however
, that if the only entity for which Participant is rendering services ceases to qualify as a Subsidiary, as determined by the Board, in its
sole discretion, Participant shall be considered to have a Termination of Service on the date such entity ceases to qualify as a Subsidiary. To
the extent permitted by law and subject to the Plan, the Board or the chief executive officer of the Company, in that party’s sole discretion,
may determine whether service shall be considered materially interrupted or terminated in the case of (i) any leave of absence approved by the
Board or chief executive officer, including sick leave, military leave or any other personal leave, or (ii) transfers between the Company, a
Subsidiary, or their successors. Any such determination shall be made in compliance with Section 422 of the Code.
Notwithstanding any other provision of the Plan or the Grant Notice or the Restricted Stock Unit Agreement, the Company or any Subsidiary
has an absolute and unrestricted right to terminate Participant’s employment and/or services at any time for any reason whatsoever, with or
without Cause, except to the extent expressly provided otherwise in a written agreement between the Company or a Subsidiary and
Participant.
For purposes of the Grant Notice and the Restricted Stock Unit Agreement, “ Cause
” will have the meaning ascribed to such term in any
written employment or severance agreement between Participant and the Company or any Subsidiary defining such term and, in the absence
of such agreement, such term means, with respect to Participant, the occurrence of any of the following events: (i) Participant’s commission
of any felony or any crime involving fraud, dishonesty or moral turpitude under the laws of the United States or any state thereof; (ii )
Participant’s attempted commission of, or participation in, a fraud or act of dishonesty against the Company or any of its Subsidiaries; (ii i)
Participant’s intentional, material violation of any contract or agreement between Participant and the Company or any of its Subsidiaries or of
any statutory duty owed to the Company or any of its Subsidiaries; (iv) Participant’s unauthorized use or dis closure of the confidential
information or trade secrets of the Company or any of its Subsidiaries; or (v) Participant’s gross misconduct. The determination that
Participant’s Termination of Service is either for Cause or without Cause will be made by the Company, in its sole discretion. Any
determination by the Company that Participant’s Termination of Service was for Cause or without Cause for the purposes of outstanding
Stock Units held by Participant will have no effect upon any determination of the r ights or obligations of the Company or Participant for any
other purpose.
Sale
to
Cover
Withholding
Taxes
: Unless Participant qualifies to make a payment election (“ Payment
Election
”) under the Company’s
Policy regarding the Payment of Withholding Taxes Due and Payable upon vesting of Awards of Restricted Stock or Restricted Stock
Units
(the “ Withholding
Policy
”) and duly makes such Payment Election in accordance with such Withholding Policy, by acceptance of this
Award Participant agrees that any Withholding Taxes will be satisfied, to the fullest extent permitted under the Plan and applicable law,
through the sale of a number of the shares subject to the Award as determined in accordance with Section 10 of the Restricted Stock Unit
Agreement and the remittance of the cash proceeds to the Company. Under the Restricted Stock Unit Agreement , the Company is authorized
and directed by Participant to make payment from the cash proceeds of this sale directly to the appropriate taxing authorities in an amount
equal to the taxes required to be withheld.
Additional
Terms/Acknowledgements
: Participant acknowledges receipt of, and understands and agrees to the terms of the Grant Notice,
the Restricted Stock Unit Agreement and the Plan (together, the “ Award
Documents
”). Participant further acknowledges that as of the Date
of Grant, the Award Documents set forth the entire understanding between Participant and the Company regarding the Award and supersede
all prior oral and written agreements on that subject, with the exception, if applicable, of (i) any employment or severance arrangement that
would provide for vesting acceleration of the Award upon the terms and conditions set forth therein, and (ii) any compensation recovery
policy that is adopted by the Company or is otherwise required by applicable law.
By accepting the Award, Participant acknowledges having received and read the Award Documents and agrees to all of the terms and
conditions set forth in such documents. Participant consents to receive Award Documents by electronic delivery and to participate in the Plan
through an on-line or electronic system established and maintained by the Company or another third party designated by the
Company. Participant may designate receipt and acceptance of the Award and the terms of the Award Documents via electronic confirmation
in accordance with instructions that accompany delivery of the Grant Notice and Restricted Stock Unit Agreement by the Company or an
authorized representative of the Company to Participant.
Attachment
I
MEdIvATION,
INC.
AMENdEd
ANd
RESTATEd
2004
EquITy
INCENTIvE
AWARd
PlAN
RESTRICTEd
STOCk
uNIT
AgREEMENT
Pursuant to the Restricted Stock Unit Grant Notice and this Restricted Stock Unit Agreement and in consideration of your services,
Medivation, Inc. (the “ Company
”) has awarded you a Restricted Stock Unit award (the “ Award
”) under its Amended and Restated 2004
Equity Incentive Award Plan (the “ Plan
”). Your Award is granted to you effective as of the Date of Grant set forth in the Grant Notice for
this Award. You agree that your electronic acceptance of the Award in the manner set forth in the Grant Notice will constitute your
agreement and acceptance of the terms of the Award. Capitalized terms not explicitly defined in this Restricted Stock Unit Agreement shall
have the same meanings given to them in the Plan or the Grant Notice, as applicable. The details of your Award, in addition to those set forth
in the Grant Notice and the Plan, are as follows.
1.
gRANT
OF
ThE
AWARd. The Award represents the right to be issued on a future date the number of shares of the
Company’s Stock that is equal to the number of stock units indicated in the Grant Notice (the “ Stock
Units
”). As of the Date of Grant, the
Company will credit to a bookkeeping account maintained by the Company for your benefit (the “ Account
”) the number of Stock Units
subject to the Award. The Award was granted in consideration of your services to the Company or its Subsidiaries. Except as otherwise
provided herein, you will not be required to make any payment to the Company (other than past and future services to the Company or its
Subsidiaries) with respect to your receipt of the Award, the vesting of the Stock Units or the delivery of the Stock to be issued in respect of
the Award.
2.
vESTINg
.
Subject to the limitations contained herein, your Award will vest, if at all, in accordance with the vesting
schedule set forth in the Grant Notice, provided that vesting will cease upon your Termination of Service. Upon such Termination of Service,
the Stock Units credited to the Account that were not vested on the date of such termination will be forfeited at no cost to the Company, and
you will have no further right, title or interest in the Stock Units or the shares of Stock to be issued in respect of the Award.
3.
NuMBER
OF
STOCk
uNITS
ANd
ShARES
.
(a)
The number of Stock Units subject to your Award may be adjusted from time to time for capitalization
adjustments, as provided in Section 11.1 of the Plan.
(b)
Any additional Stock Units that become subject to the Award pursuant to this Section 3 and Section 7, if
any, shall be subject, in a manner determined by the Board, to the same forfeiture restrictions, restrictions on transferability, and time and
manner of delivery as applicable to the other Stock Units covered by your Award.
(c)
Notwithstanding the provisions of this Section 3, no fractional shares or rights for fractional shares of Stock
shall be created pursuant to this Section 3. The Board shall, in its discretion, determine an equivalent benefit for any fractional shares that
might be created by the adjustments referred to in this Section 3.
4.
SECuRITIES
lAW
COMPlIANCE
.
You may not be issued any shares in respect of your Award unless either (i) the shares
are registered under the Securities Act of 1933, as amended (the “ Securities
Act
”) ; or (ii) the Company has determined that such issuance
would be exempt from the registration requirements of the Securities Act. Your Award also must comply with other applicable laws and
regulations governing the Award, and you will not receive such shares if the Company determines that such receipt would not be in material
compliance with such laws and regulations. 5.
TRANSFER
RESTRICTIONS.
Your Award is not transferable, except by will or by the laws of descent and distribution. In
addition to any other limitation on transfer created by applicable securities laws, you agree not to assign, hypothecate, donate, encumber or
otherwise dispose of any interest in any of the shares of Stock subject to the Award until the shares are issued to you in accordance with
Section 6 of this Restricted Stock Unit Agreement. After the shares have been issued to you, you are free to assign, hypothecate, donate,
encumber or otherwise dispose of any interest in such shares, provided that any such actions are in compliance with the provisions herein and
applicable securities laws. Notwithstanding the foregoing, by delivering written notice to the Company, in a form satisfactory to the
Company, you may designate a third party who, in the event of your death, shall thereafter be entitled to receive any distribution of Stock to
which you were entitled at the time of your death pursuant to this Restricted Stock Unit Agreement.
6.
dATE
OF
ISSuANCE.
(a)
If the Award is exempt from application of Section 409A of the Code and any state law of similar effect
(collectively “ Section
409A
”), the Company will deliver to you a number of shares of the Company’s Stock equal to the number of vested
Stock Units subject to your Award, including any additional Stock Units received pursuant to Section 3 above that relate to those vested Stock
Units on the applicable vesting date(s). However, if a scheduled delivery date falls on a date that is not a business day, such delivery date
shall instead fall on the next following business day. Notwithstanding the foregoing, in the event that any shares covered by your Award are
scheduled to be delivered on a day (the “ Original
Distribution
Date
”) on which you are prohibited from selling shares of the Company’s
Stock on the open market, as a result of any Company policy regarding trading windows (the “ Policy
”) or otherwise, and (i) your Award is
subject to Withholding Taxes, (ii) you have not entered into a written plan that meets the requirements of Rule 10b5-1 under the Exchange
Act, as determined by the Company in accordance with the Policy, (iii) the Company elects not to satisfy the Withholding Taxes by
withholding shares from your distribution, and (iv) you are not qualified to make a Payment Election under the Withholding Policy or you
have not satisfied the Withholding Taxes by duly making such Payment Election in accordance with such Withholding Policy, then such
shares shall not be delivered on such Original Distribution Date and shall instead be delivered on the first business day on which you are no
longer prohibited from selling shares of the Company’s Stock in the open market, but in no event later than the fifteenth (15th) day of the
third calendar month of the calendar year following the calendar year in which the shares covered by the Award vest. Delivery of the shares
pursuant to the provisions of this Section 6(a) is intended to comply with the requirements for the short-term deferral exemption available
under Treasury Regulations Section 1.409A-1(b)(4) and shall be construed and administered in such manner. The form of such delivery of
the shares ( e.g.
, a stock certificate or electronic entry evidencing such shares) shall be determined by the Company.
(b)
The provisions of this Section 6(b) are intended to apply if the Award is subject to Section 409A because of
the terms of a severance arrangement or other agreement between you and the Company, if any, that provide for acceleration of vesting of the
Award upon your separation from service (as such term is defined in Section 409A(a)(2)(A)(i) of the Code (“ Separation
from
Service
”) and
such severance benefit does not satisfy the requirements for an exemption from application of Section 409A provided under Treasury
Regulations Section 1.409A-1(b)(4) or 1.409A-1(b)(9) (“ Non-Exempt
2.
Severance
Arrangement
”). If the Award is subject to and not exempt from application of Section 409A due to application of a Non-Exempt
Severance Arrangement, the f ollowing provisions in this Section 6(b) shall supersede anything to the contrary in Section 6(a). (i)
If the Award vests in the ordinary course prior to your Termination of Service in accordance with
the vesting schedule set forth in the Grant Notice, without accelerated vesting under the terms of a Non-Exempt Severance Arrangement, in
no event will the shares to be issued in respect of your Award be issued any later than the later of: (i) December 31 st of the calendar year that
includes the applicable vesting date and (ii) the 60 th day that follows the applicable vesting date.
(ii)
If vesting of the Award accelerates under the terms of a Non-Exempt Severance Arrangement in
connection with your Separation from Service, and such vesting acceleration provisions were in effect as of the date of grant of the Award
and, therefore, are part of the terms of the Award as of the date of grant, then the shares will be earlier issued in respect of your Award upon
your Separation from Service in accordance with the terms of the Non-Exempt Severance Arrangement, but in no event later than the 60 th
day that follows the date of your Separation from Service. However, if at the time the shares would otherwise be issued you are subject to the
distribution limitations contained in Section 409A applicable to “specified employees,” as defined in Section 409A(a)(2)(B)(i) of the Code,
such shares shall not be issued before the date that is six (6) months following the date of your Separation from Service, or, if earlier, the date
of your death that occurs within such six month period.
(iii)
If vesting of the Award accelerates under the terms of a Non-Exempt Severance Arrangement in
connection with your Separation from Service, and such vesting acceleration provisions were not in effect as of the date of grant of the Award
and, therefore, are not a part of the terms of the Award on the date of grant, then such acceleration of vesting of the Award shall not accelerate
the issuance date of the shares, but the shares shall instead be issued on the same schedule as set forth in the Grant Notice as if they had vested
in the ordinary course prior to your Termination of Service, notwithstanding the vesting acceleration of the Award. Such issuance schedule is
intended to satisfy the requirements of payment on a specified date or pursuant to a fixed schedule, as provided under Treasury Regulations
Section 1.409A-3(a)(4).
(c)
If the Award is subject to Section 409A due to the application of a Non-Exempt Severance Arrangement or a
provision for deferral of the delivery of shares in respect of the Award (a “ Non-Exempt
Award
”), then the following provisions in this
Section shall apply and shall supersede anything to the contrary that may be set forth in the Plan that would provide for accelerated issuance
of the shares in respect of your Award in connection with a Change of Control that is not also a 409A Change of Control (a “ Non-Qualifying
Transaction
”). For such purposes, a “ 409A
Change
of
Control
” is a change in the ownership or effective control of the Company, or in the
ownership of a substantial portion of the Company’s assets, as provided in Section 409A(a)(2)(A)(v) of the Code. In the event of a NonQualifying Transaction, then with respect to a Non-Exempt Award, the surviving or acquiring corporation (or its parent company) (the “
Acquiring
Entity
”) must either assume, continue or substitute your Non-Exempt Award, and shares to be issued in respect of your NonExempt Award, to the extent vested, shall be issued to you by the Acquiring Entity on the same schedule that the shares would have been
issued to you if the Non-Qualifying Transaction had not occurred.
(d)
Notwithstanding anything to the contrary set forth herein, the Company explicitly reserves the right to
earlier issue the shares in respect of any Non-Exempt Award to the extent permitted and in compliance with the requirements of Section
409A, including pursuant to any of the exemptions available in Treasury Regulations Section 1.409A-3(j)(4)(ix).
3.
(e)
The provisions in this Restricted Stock Unit Agreeme nt for delivery of the shares in respect of the Award
are intended either to comply with the requirements of Section 409A or to provide a basis for exemption from such requirements so that the
delivery of the shares will not trigger the additional tax impo sed under Section 409A, and any ambiguities herein will be so interpreted. 7.
dIvIdENdS.
You shall receive no benefit or adjustment to your Award with respect to any cash dividend, stock
dividend or other distribution that does not result from an adjustment as provided in Section 11.1 of the Plan; provided,
however,
that the
foregoing limitation shall cease to apply with respect to shares issued in respect of your Award.
8.
RESTRICTIvE
lEgENdS.
determined by the Company.
The shares issued in respect of your Award shall be endorsed with appropriate legends
9.
AWARd
NOT
A
SERvICE
CONTRACT
.
(a)
Your employment and/or service with the Company or a Subsidiary is not for any specified term and may be
terminated by you or by the Company or a Subsidiary at any time, for any reason, with or without Cause and with or without notice. Nothing
in this Restricted Stock Unit Agreement (including, but not limited to, the vesting of your Award pursuant to the schedule referenced in
Section 2 herein or the issuance of the shares in respect of your Award), the Plan or any covenant of good faith and fair dealing that may be
found implicit in this Restricted Stock Unit Agreement or the Plan shall: (i) confer upon you any right to continue in the employ or service of,
or affiliation with, the Company or a Subsidiary; (ii) constitute any promise or commitment by the Company or a Subsidiary regarding the
fact or nature of future positions, future work assignments, future compensation or any other term or condition of employment, service or
affiliation; (iii) confer any right or benefit under this Restricted Stock Unit Agreement or the Plan unless such right or benefit has specifically
accrued under the terms of this Restricted Stock Unit Agreement or Plan; or (iv) deprive the Company of the right to terminate you at will and
without regard to any future vesting opportunity that you may have.
(b)
By accepting this Award, you acknowledge and agree that the right to continue vesting in the Award
pursuant to the schedule referenced in Section 2 is earned only by continuing as an employee, director or consultant of the Company or a
Subsidiary at the will of the Company or a Subsidiary (not through the act of being hired, being granted this Award or any other award or
benefit) and that the Company has the right to reorganize, sell, spin-out or otherwise restructure one or more of its businesses or Subsidiaries
at any time or from time to time, as it deems appropriate (a “reorganization”). You further acknowledge and agree that such a reorganization
could result in your Termination of Service, or the termination of Subsidiary status of your employer and the loss of benefits available to you
under this Restricted Stock Unit Agreement, including but not limited to, the termination of the right to continue vesting in the Award. You
further acknowledge and agree that this Restricted Stock Unit Agreement, the Plan, the transactions contemplated hereunder and the vesting
schedule set forth herein or any covenant of good faith and fair dealing that may be found implicit in any of them do not constitute an express
or implied promise of continued engagement as an employee, director or consultant of the Company or a Subsidiary for the term of this
Restricted Stock Unit Agreement, for any period, or at all, and shall not interfere in any way with your right or the Company’s right to
terminate your employment and/or service at any time, with or without Cause and with or without notice.
4.
10.
WIThhOldINg
OBlIgATIONS.
(a)
On each vesting date, and on or before the time you receive a distribution of the shares underlying your
Stock Units, and at any other time as reasonably requested by the Company in accordance with applicable tax laws, you agree to make
adequate provision for any sums required to satisfy the federal, state, local and foreign tax withholding obligations of the Company or any
Subsidiary that arise in connection with your Award (the “ Withholding
Taxes
”). Specifically, pursuant to Section 10(d), unless (i) your
Award is not subject to Withholding Taxes or (ii) you qualify to make a Payment Election under the Withholding Policy and duly make such
Payment Election in accordance with such Withholding Policy, you agree to a “same day sale” commitment with a broker-dealer that is a
member of the Financial Industry Regulatory Authority (a “ FINRA
Dealer
”) whereby you irrevocably agree to sell a portion of the shares to
be delivered in connection with your Stock Units to satisfy the Withholding Taxes and whereby the FINRA Dealer commits to forward the
proceeds necessary to satisfy the Withholding Taxes directly to the Company and/or its Subsidiaries . If, for any reason, this “same day sale”
commitment does not result in sufficient proceeds to satisfy the Withholding Taxes or if, for any reason, this “same day sale” commitment
cannot be effected, the Company or a Subsidiary may, in its sole discretion, satisfy all or any portion of the Withholding Taxes relating to
your Award by any of the following means or by a combination of such means: (i) withholding from any compensation otherwise payable to
you by the Company or a Subsidiary ; (ii) causing you to tender a cash payment (which may be in the form of a check, electronic wire transfer
or other method permitted by the Company); or (iii) subject to the approval of the independent members of the Board, withholding shares of
Stock from the shares of Stock issued or otherwise issuable to you in connection with your Stock Units with a Fair Market Value (measured
as of the date shares of Stock are issued to you) equal to the amount of such Withholding Taxes; provided,
however
, that the number of such
shares of Stock so withheld will not exceed the amount necessary to satisfy the Company’s required tax withholding obligations using the
minimum statutory withholding rates for federal, state, local and foreign tax purposes, including payroll taxes, that are applicable to
supplemental taxable income.
(b)
Unless the tax withholding obligations of the Company and/or any Subsidiary are satisfied, the Company
shall have no obligation to deliver to you any Stock.
(c)
In the event the Company’s obligation to withhold arises prior to the delivery to you of Stock or it is
determined after the delivery of Stock to you that the amount of the Company’s withholding obligation was greater than the amount withheld
by the Company, you agree to indemnify and hold the Company harmless from any failure by the Company to withhold the proper amount.
(d)
Unless you qualify to make a Payment Election under the Withholding Policy and have duly made such
Payment Election in accordance with such Withholding Policy, you hereby acknowledge and agree to the following:
(i)
I hereby appoint such firm or broker as the Company shall designate from time to time as my agent (the “
Agent
”), and authorize the Agent, to:
1.
Sell on the open market at the then prevailing market price(s), on my behalf, as soon as practicable on
or after each date on which Withholding Taxes arise in connection with the Award, the number
(rounded up to the next whole number) of the shares of Stock to be delivered to me sufficient to
generate proceeds to cover (1) the Withholding Taxes that I am required to pay pursuant to the Plan and
this Restricted Stock Unit Agreement as a result of the Stock Units vesting (or shares of Stock being
issued, as applicable)
5.
and (2) all applicable fees and commissions due to, or required to be collected by, the Agent with
respect thereto; and
2.
Remit any remaining funds to me.
(ii) I hereby authorize the Company and the Agent to cooperate and communicate with one another to determine
the number of shares of Stock that must be sold pursuant to this Section 10(d).
(iii) I understand that the Agent may effect sales as provided in this Section 10(d) in one or more sales and that
the average price for executions resulting from bunched orders will be assigned to my account. In addition, I
acknowledge that it may not be possible to sell shares of Stock as provided by this Section 10(d) due to (i) a
legal or contractual restriction applicable to me or the Agent, (ii) a market disruption, or (iii) rules governing
order execution priority on the national exchange where the Stock may be traded. In the event of the Agent’s
inability to sell shares of Stock, I will continue to be responsible for the timely payment to the Company of
all federal, state, local and foreign taxes that are required by applicable laws and regulations to be withheld,
including but not limited to those amounts specified in this Section 10(d).
(iv) I acknowledge that regardless of any other term or condition of this Section 10(d), the Agent will not be
liable to me for (a) special, indirect, punitive, exemplary, or consequential damages, or incidental losses or
damages of any kind, or (b) any failure to perform or for any delay in performance that results from a cause
or circumstance that is beyond its reasonable control.
(v) I hereby agree to execute and deliver to the Agent any other agreements or documents as the Agent
reasonably deems necessary or appropriate to carry out the purposes and intent of this Section 10(d). The
Agent is a third-party beneficiary of this Section 10(d).
(vi) I hereby agree that if I have signed the Grant Notice at a time that I am in possession of material non-public
information, unless I inform the Company in writing within five business days following the date I cease to
be in possession of material non-public information that I am not in agreement with the provisions of this
Section 10(d), my not providing such written determination shall be a determination and agreement that I
have agreed to the provisions set forth in this Section 10(d) on such date as I have ceased to be in possession
of material non-public information.
This Section 10(d) shall terminate not later than the date on which all Withholding Taxes arising in connection
with the Award have been satisfied.
11.
uNSECuREd
OBlIgATION.
Your Award is unfunded, and as a holder of a vested Award, you shall be considered an
unsecured creditor of the Company with respect to the Company’s obligation, if any, to issue shares pursuant to this Restricted Stock Unit
Agreement. You shall not have voting or any other rights as a stockholder of the Company with respect to the shares to be issued pursuant to
this Restricted Stock Unit Agreement until such shares are issued to you pursuant to Section 6 of this Restricted Stock Unit Agreement. Upon
such issuance, you will obtain full voting and other rights as a stockholder of the Company. Nothing contained in this Restricted Stock Unit
Agreement, and no action
6.
taken pursuant to its provisions, shall create or be construed to create a trust of any kind or a fiduciary relationship between you and the
Company or any other person. 12.
OThER
dOCuMENTS.
You hereby acknowledge receipt or the right to receive a document providing the information
required by Rule 428(b)(1) promulgated under the Securities Act, which includes the Plan prospectus. In addition, you acknowledge receipt
of the Company’s policy permitting directors, officers at the level of vice president and above and other designated employees to sell shares
only during certain “window” periods and the Company’s insider trading policy, in effect from time to time.
13.
NOTICES
.
Any notices provided for in your Award or the Plan shall be given in writing and shall be deemed
effectively given upon receipt or, in the case of notices delivered by the Company to you, five (5) days after deposit in the United States mail,
postage prepaid, addressed to you at the last address you provided to the Company. Notwithstanding the foregoing, the Company may, in its
sole discretion, decide to deliver any documents related to participation in the Plan and this Award by electronic means or to request your
consent to participate in the Plan by electronic means. You hereby consent to receive such documents by electronic delivery and, if requested,
to agree to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party
designated by the Company.
14.
MISCEllANEOuS
.
(a)
The rights and obligations of the Company under your Award shall be transferable to any one or more
persons or entities, and all covenants and agreements hereunder shall inure to the benefit of, and be enforceable by the Company’s successors
and assigns. Your rights and obligations under your Award may only be assigned with the prior written consent of the Company.
(b)
You agree upon request to execute any further documents or instruments necessary or desirable in the sole
determination of the Company to carry out the purposes or intent of your Award.
(c)
You acknowledge and agree that you have reviewed your Award in its entirety, have had an opportunity to
obtain the advice of counsel prior to executing and accepting your Award, and fully understand all provisions of your Award.
(d)
This Restricted Stock Unit Agreement shall be subject to all applicable laws, rules, and regulations, and to
such approvals by any governmental agencies or national securities exchanges as may be required.
(e)
All obligations of the Company under the Plan and this Restricted Stock Unit Agreement shall be binding on
any successor to the Company, whether the existence of such successor is the result of a direct or indirect purchase, merger, consolidation, or
otherwise, of all or substantially all of the business and/or assets of the Company.
15.
gOvERNINg
PlAN
dOCuMENT
.
Your Award is subject to all the provisions of the Plan, the provisions of which are
hereby made a part of your Award, and is further subject to all interpretations, amendments, rules and regulations which may from time to
time be promulgated and adopted pursuant to the Plan. Except as otherwise expressly provided in the Grant Notice or this Restricted Stock
Unit Agreement, in the event of any conflict between the provisions in the Grant Notice or this Restricted Stock Unit Agreement and those of
the Plan, the provisions of the Plan shall control.
7.
16.
SEvERABIlITy.
If all or any part of this Restricted Stock Unit Agreement or the Plan is declared by any court or
governmental authority to be unlawful or invalid, such unlawfulness or invalidity shal l not invalidate any portion of this Restricted Stock
Unit Agreement or the Plan not declared to be unlawful or invalid. Any Section of this Restricted Stock Unit Agreement (or part of such a
Section) so declared to be unlawful or invalid shall, if possib le, be construed in a manner which will give effect to the terms of such Section
or part of a Section to the fullest extent possible while remaining lawful and valid. 17.
EFFECT
ON
OThER
EMPlOyEE
BENEFIT
PlANS.
The value of the Award subject to this Restricted Stock Unit
Agreement shall not be included as compensation, earnings, salaries, or other similar terms used when calculating your benefits under any
employee benefit plan sponsored by the Company or any Subsidiary, except as such plan otherwise expressly provides. The Company
expressly reserves its rights to amend, modify, or terminate any of the Company’s or any Subsidiary’s employee benefit plans.
18.
AMENdMENT.
This Restricted Stock Unit Agreement may not be modified, amended or terminated except by an
instrument in writing, signed or otherwise validly authorized by you and by a duly authorized representative of the
Company. Notwithstanding the foregoing, this Restricted Stock Unit Agreement may be amended solely by the Board by a writing which
specifically states that it is amending this Restricted Stock Unit Agreement, so long as a copy of such amendment is delivered to you, and
provided that no such amendment adversely affecting your rights hereunder may be made without your written consent. Without limiting the
foregoing, the Board reserves the right to change, by written notice to you, the provisions of this Restricted Stock Unit Agreement in any way
it may deem necessary or advisable to carry out the purpose of the grant as a result of any change in applicable laws or regulations or any
future law, regulation, ruling, or judicial decision, provided that any such change shall be applicable only to rights relating to that portion of
the Award which is then subject to restrictions as provided herein.
8.
Exhibit
10.9
MEdIvATION,
INC.
AMENdEd
ANd
RESTATEd
2004
EquITy
INCENTIvE
AWARd
PlAN
RESTRICTEd
STOCk
gRANT
NOTICE
Medivation, Inc. (the “ Company
”), pursuant to its Amended and Restated 2004 Equity Incentive Award Plan, as amended from time to time
(the “ Plan
”), hereby awards to Participant a Restricted Stock award for the number of shares of Stock set forth below (the “ Award
”). The
Award is subject to all of the terms and conditions as set forth in this Restricted Stock Grant Notice (the “ Grant
Notice
”) and in the Plan, the
Restricted Stock Agreement (which is attached hereto as Attachment I), the form of Joint Escrow Instructions (which is attached hereto as
Attachment II) and the form of Assignment Separate from Certificate (which is attached hereto as Attachment III), all of which are
incorporated herein in their entirety. Capitalized terms not otherwise defined herein shall have the meanings set forth in the Plan or the
Restricted Stock Agreement.
Participant:
Date of Grant:
Number of Shares Subject to Award:
vesting
Schedule
:
The shares of Stock subject to the Award shall vest in three substantially equal installments on each of the first,
second and third anniversaries of (i) the fourth day of the month of the Date of Grant, if the Date of Grant occurs between the first and the
fourth day of the month of the Date of Grant, or (ii) the fourth day of the month following the month of the Date of Grant, if the Date of Grant
occurs on or after the fifth day of the month of the Date of Grant. Notwithstanding the foregoing, vesting shall terminate upon Participant’s
Termination of Service.
definitions
:
For purposes of the Grant Notice and the Restricted Stock Agreement, “ Termination of Service
” means that
Participant’s service with the Company or a Subsidiary in all capacities, whether as an employee, director and/or consultant, has been
materially interrupted or terminated. A change in the capacity in which Participant renders service to the Company or a Subsidiary as an
employee, director and/or consultant, or a change in the entity for which Participant renders such service, provided that there is no material
interruption or termination of Participant’s service with the Company or a Subsidiary, shall not be a Termination of Service; provided,
however
, that if the only entity for which Participant is rendering services ceases to qualify as a Subsidiary, as determined by the Board, in its
sole discretion, Participant shall be considered to have a Termination of Service on the date such entity ceases to qualify as a Subsidiary. To
the extent permitted by law and subject to the Plan, the Board or the chief executive officer of the Company, in that party’s sole discretion,
may determine whether service shall be considered materially interrupted or terminated in the case of (i) any leave of absence approved by the
Board or chief executive officer, including sick leave, military leave or any other personal leave, or (ii) transfers between the Company, a
Subsidiary, or their successors. Any such determination shall be made in compliance with Section 422 of the Code.
Notwithstanding any other provision of the Plan or the Grant Notice or the Restricted Stock Agreement, the Company or any Subsidiary has
an absolute and unrestricted right to terminate Participant’s employment and/or services at any time for any reason whatsoever, with or
without Cause, except to the extent expressly provided otherwise in a written agreement between the Company or a Subsidiary and
Participant.
For purposes of the Grant Notice and the Restricted Stock Agreement, “ Cause
” will have the meaning ascribed to such term in any written
employment or severance agreement between Participant and the Company or any Subs idiary defining such term and, in the absence of such
agreement, such term means, with respect to Participant, the occurrence of any of the following events: (i) Participant’s commission of any
felony or any crime involving fraud, dishonesty or moral turp itude under the laws of the United States or any state thereof; (ii ) Participant’s
attempted commission of, or participation in, a fraud or act of dishonesty against the Company or any of its Subsidiaries; (iii) Participant’s
intentional, material violatio n of any contract or agreement between Participant and the Company or any of its Subsidiaries or of any
statutory duty owed to the Company or any of its Subsidiaries; (iv) Participant’s unauthorized use or disclosure of the confidential
information or trad e secrets of the Company or any of its Subsidiaries; or (v) Participant’s gross misconduct. The determination that
Participant’s Termination of Service is either for Cause or without Cause will be made by the Company, in its sole discretion. Any determin
ation by the Company that Participant’s Termination of Service was for Cause or without Cause for the purposes of the Award will have no
effect upon any determination of the rights or obligations of the Company or Participant for any other purpose.
Sale
to
Cover
Withholding
Taxes
: Unless Participant qualifies to make a payment election (“ Payment
Election
”) under the Company’s
Policy regarding the Payment of Withholding Taxes Due and Payable upon vesting of Awards of Restricted Stock or Restricted Stock
Units
(the “ Withholding
Policy
”) and duly makes such Payment Election in accordance with such Withholding Policy, by acceptance of this
Award Participant agrees that any Withholding Taxes will be satisfied, to the fullest extent permitted under the Plan and applicable law,
through the sale of a number of the shares subject to the Award as determined in accordance with Section 9 of the Restricted Stock
Agreement and the remittance of the cash proceeds to the Company. Under the Restricted Stock Agreement , the Company is authorized and
directed by Participant to make payment from the cash proceeds of this sale directly to the appropriate taxing authorities in an amount equal to
the taxes required to be withheld.
Additional
Terms/Acknowledgements
: Participant acknowledges receipt of, and understands and agrees to the terms of the Grant Notice,
the Restricted Stock Agreement and the Plan (together, the “ Award
Documents
”). Participant further acknowledges that as of the Date of
Grant, the Award Documents set forth the entire understanding between Participant and the Company regarding the Award and supersede all
prior oral and written agreements on that subject, with the exception, if applicable, of (i) any employment or severance arrangement that
would provide for vesting acceleration of the Award upon the terms and conditions set forth therein, and (ii) any compensation recovery
policy that is adopted by the Company or is otherwise required by applicable law.
By accepting the Award, Participant acknowledges having received and read the Award Documents and agrees to all of the terms and
conditions set forth in such documents. Participant consents to receive Award Documents by electronic delivery and to participate in the Plan
through an on-line or electronic system established and maintained by the Company or another third party designated by the
Company. Participant may designate receipt and acceptance of the Award and the terms of the Award Documents via electronic confirmation
in accordance with instructions that accompany delivery of the Grant Notice and Restricted Stock Agreement by the Company or an
authorized representative of the Company to Participant.
Attachment
I
MEdIvATION,
INC.
AMENdEd
ANd
RESTATEd
2004
EquITy
INCENTIvE
AWARd
PlAN
RESTRICTEd
STOCk
AgREEMENT
Pursuant to the Restricted Stock Grant Notice and this Restricted Stock Agreement and in consideration of your services,
Medivation, Inc. (the “ Company
”) has awarded you a Restricted Stock award (the “ Award
”) under its Amended and Restated 2004 Equity
Incentive Award Plan (the “ Plan
”). Your Award is granted to you effective as of the Date of Grant set forth in the Grant Notice for this
Award. You agree that your electronic acceptance of the Award in the manner set forth in the Grant Notice will constitute your agreement
and acceptance of the terms of the Award. Capitalized terms not explicitly defined in this Restricted Stock Agreement shall have the same
meanings given to them in the Plan or the Grant Notice, as applicable. The details of your Award, in addition to those set forth in the Grant
Notice and the Plan, are as follows.
1.
gRANT
OF
ThE
AWARd. The Award was granted in consideration of your services to the Company or its
Subsidiaries. Except as otherwise provided herein, you will not be required to make any payment to the Company (other than past and future
services to the Company or its Subsidiaries) with respect to your receipt of the Award or the vesting of the shares of Stock subject to the
Award.
2.
vESTINg
.
Subject to the limitations contained herein, your Award will vest, if at all, in accordance with the vesting
schedule set forth in the Grant Notice, provided that vesting will cease upon your Termination of Service.
Notwithstanding the foregoing, in the event that any shares covered by your Award are scheduled to vest on a day (the “ Original
Vesting
Date
”) on which you are prohibited from selling shares of the Company’s Stock on the open market, as a result of any Company
policy regarding trading windows (the “ Policy
”) or otherwise, and (i) your Award is subject to Withholding Taxes, (ii) you have not entered
into a written plan that meets the requirements of Rule 10b5-1 under the Exchange Act, as determined by the Company in accordance with the
Policy, (iii) the Company elects not to satisfy the Withholding Taxes by withholding shares from the shares issued or otherwise issuable to
you or released from escrow , and (iv) you are not qualified to make a Payment Election under the Withholding Policy or you have not
satisfied the Withholding Taxes by duly making such Payment Election in accordance with such Withholding Policy, then such shares shall
not vest on such Original Vesting Date and shall instead vest on the first business day on which you are no longer prohibited from selling
shares of the Company’s Stock in the open market.
3.
NuMBER
OF
ShARES
. The number of shares of Stock subject to the Award may be adjusted from time to time for
capitalization adjustments, as provided in Section 11.1 of the Plan.
4.
SECuRITIES
lAW
COMPlIANCE
.
You may not be issued any shares in respect of your Award unless either (i) the shares
are registered under the Securities Act of 1933, as amended (the “ Securities
Act
”) ; or (ii) the Company has determined that such issuance
would be exempt from the registration requirements of the Securities Act. Your Award also must comply with other applicable laws and
regulations governing the Award, and you will not receive such shares if the Company determines that such receipt would not be in material
compliance with such laws and regulations.
5.
TRANSFER
RESTRICTIONS.
Your Award is not transferable, except by will or by the laws of descent and distribution. In
addition to any other limitation on transfer created by applicable securities laws, you agree not to assign, hypothecate, donate, encumber or
otherwise dispose of any interest in any of the shares of Stock subject to the Award until the shares are vested and released from any escrow
provided for herein . After the shares are vested and released from any escrow provided for herein, you are free to assign, hypothe cate,
donate, encumber or otherwise dispose of any interest in such shares, provided that any such actions are in compliance with the provisions
herein and applicable securities laws. Notwithstanding the foregoing, by delivering written notice to the Comp any, in a form satisfactory to
the Company, you may designate a third party who, in the event of your death, shall thereafter be entitled to receive any shares that have
vested and been released from any escrow provided for herein as of the time of your de ath pursuant to this Restricted Stock Agreement. 6.
RIghT
OF
REACquISITION
OF
uNvESTEd
ShARES.
(a)
The Company will have a right to reacquire all or any part of the shares of Stock received pursuant to your
Award (a “ Reacquisition
Right
”) that have not as yet vested in accordance with the vesting schedule provided in the Grant Notice (the “
Unvested
Shares
”) on the following terms and conditions:
(i)
The Company will simultaneously with your Termination of Service automatically reacquire for
no consideration all of the Unvested Shares, unless the Company agrees to waive its Reacquisition Right as to some or all of the Unvested
Shares. Any such waiver will be exercised by the Company by written notice to you or your representative (with a copy to the escrow agent
party to the Joint Escrow Instructions attached to the Grant Notice (the “ Escrow
Agent
”)) within ninety (90) days after your Termination of
Service , and the Escrow Agent may then release to you the number of Unvested Shares not being reacquired by the Company. If the
Company does not waive its Reacquisition Right as to all of the Unvested Shares, then upon your Termination of Service , the Escrow Agent
will transfer to the Company the number of Unvested Shares the Company is reacquiring.
(ii)
The shares issued under your Award will be held in escrow pursuant to the terms of the Joint
Escrow Instructions attached to the Grant Notice as Attachment II. You agree to execute two (2) Assignment Separate From Certificate forms
(with date and number of shares blank) substantially in the form attached to the Grant Notice as Attachment III and deliver the same, along
with the certificate or certificates evidencing the shares, for use by the Escrow Agent pursuant to the terms of the Joint Escrow Instructions.
(iii)
Subject to the provisions of your Award, you will, during the term of your Award, exercise all
rights and privileges of a stockholder of the Company with respect to the shares deposited in escrow. You will be deemed to be the holder of
the shares for purposes of receiving any dividends which may be paid with respect to such shares and for purposes of exercising any voting
rights relating to such shares, even if some or all of such shares have not yet vested and been released from the Reacquisition Right; provided,
however
, that any such dividends will be immediately subject to the same forfeiture restrictions, restrictions on transferability and any other
restrictions applicable to such shares .
(iv)
If, from time to time, there is any stock dividend, stock split or other change in the character or
amount of any of the outstanding Stock which is subject to the provisions of your Award, then in such event any and all new, substituted or
additional securities to which you are entitled by reason of your ownership of the shares acquired under your Award will be immediately
subject to the Reacquisition Right with the same force and effect as the shares subject to this Reacquisition Right immediately before such
event.
7.
RESTRICTIvE
lEgENdS.
determined by the Company. The shares issued in re spect of your Award shall be endorsed with appropriate legends
8.
AWARd
NOT
A
SERvICE
CONTRACT
.
(a)
Your employment and/or service with the Company or a Subsidiary is not for any specified term and may be
terminated by you or by the Company or a Subsidiary at any time, for any reason, with or without Cause and with or without notice. Nothing
in this Restricted Stock Agreement (including, but not limited to, the vesting of your Award pursuant to the schedule referenced in Section 2
herein or the issuance of the shares in respect of your Award), the Plan or any covenant of good faith and fair dealing that may be found
implicit in this Restricted Stock Agreement or the Plan shall: (i) confer upon you any right to continue in the employ or service of, or
affiliation with, the Company or a Subsidiary; (ii) constitute any promise or commitment by the Company or a Subsidiary regarding the fact
or nature of future positions, future work assignments, future compensation or any other term or condition of employment, service or
affiliation; (iii) confer any right or benefit under this Restricted Stock Agreement or the Plan unless such right or benefit has specifically
accrued under the terms of this Restricted Stock Agreement or Plan; or (iv) deprive the Company of the right to terminate you at will and
without regard to any future vesting opportunity that you may have.
(b)
By accepting this Award, you acknowledge and agree that the right to continue vesting in the Award
pursuant to the schedule referenced in Section 2 is earned only by continuing as an employee, director or consultant of the Company or a
Subsidiary at the will of the Company or a Subsidiary (not through the act of being hired, being granted this Award or any other award or
benefit) and that the Company has the right to reorganize, sell, spin-out or otherwise restructure one or more of its businesses or Subsidiaries
at any time or from time to time, as it deems appropriate (a “reorganization”). You further acknowledge and agree that such a reorganization
could result in your Termination of Service, or the termination of Subsidiary status of your employer and the loss of benefits available to you
under this Restricted Stock Agreement, including but not limited to, the termination of the right to continue vesting in the Award. You further
acknowledge and agree that this Restricted Stock Agreement, the Plan, the transactions contemplated hereunder and the vesting schedule set
forth herein or any covenant of good faith and fair dealing that may be found implicit in any of them do not constitute an express or implied
promise of continued engagement as an employee, director or consultant of the Company or a Subsidiary for the term of this Restricted Stock
Agreement, for any period, or at all, and shall not interfere in any way with your right or the Company’s right to terminate your employment
and/or service at any time, with or without Cause and with or without notice.
9.
WIThhOldINg
OBlIgATIONS.
(a)
On each vesting date and at any other time as reasonably requested by the Company in accordance with
applicable tax laws, you agree to make adequate provision for any sums required to satisfy the federal, state, local and foreign tax withholding
obligations of the Company or any Subsidiary that arise in connection with your Award (the “ Withholding
Taxes
”). Specifically, pursuant
to Section 9(d), unless (i) your Award is not subject to Withholding Taxes or (ii) you qualify to make a Payment Election under the
Withholding Policy and duly make such Payment Election in accordance with such Withholding Policy, you agree to a “same day sale”
commitment with a broker-dealer that is a member of the Financial Industry Regulatory Authority (a “ FINRA Dealer
”) whereby you
irrevocably agree to sell a portion of the shares to be delivered or released from escrow in connection with your Award to satisfy the
Withholding Taxes and whereby the FINRA Dealer commits to forward the proceeds necessary to satisfy the Withholding Taxes directly to
the Company and/or its Subsidiaries . If, for any reason, this “same day sale” commitment does not result in sufficient proceeds to satisfy the
Withholding Taxes or if, for any reason, this “same day sale” commitment cannot be effected, the Company or a Subsidiary may, in its sole
discretion, satisfy all or any portion of the Withholding Taxes relating to your
Award by any of the following means or by a combination of such means: (i) withholding from any compensation otherwise payable to you
by the Company or a Subsidiary ; (ii) causing yo u to tender a cash payment (which may be in the form of a check, electronic wire transfer or
other method permitted by the Company); or (iii) subject to the approval of the independent members of the Board, withholding shares of
Stock from the shares of St ock issued or otherwise issuable to you or released from escrow in connection with your Award with a Fair
Market Value (measured as of the applicable date) equal to the amount of such Withholding Taxes; provided,
however
, that the number of
such shares of Stock so withheld will not exceed the amount necessary to satisfy the Company’s required tax withholding obligations using
the minimum statutory withholding rates for federal, state, local and foreign tax purposes, including payroll taxes, that are applica ble to
supplemental taxable income. (b)
Unless the tax withholding obligations of the Company and/or any Subsidiary are satisfied, the Company
shall have no obligation to deliver to you any Stock or release such Stock from any escrow provided for herein.
(c)
In the event the Company’s obligation to withhold arises prior to the delivery to you of Stock or release of
such Stock from any escrow provided for herein, or it is determined after the delivery or release of Stock to you that the amount of the
Company’s withholding obligation was greater than the amount withheld by the Company, you agree to indemnify and hold the Company
harmless from any failure by the Company to withhold the proper amount.
(d)
Unless you qualify to make a Payment Election under the Withholding Policy and have duly made such
Payment Election in accordance with such Withholding Policy, you hereby acknowledge and agree to the following:
(i)
I hereby appoint such firm or broker as the Company shall designate from time to time as my agent (the “
Agent
”), and authorize the Agent, to:
1.
Sell on the open market at the then prevailing market price(s), on my behalf, as soon as practicable on
or after each date on which the shares of Stock subject to the Award vest, the number (rounded up to the
next whole number) of the shares of Stock to be delivered or released to me in connection with the
vesting of those shares sufficient to generate proceeds to cover (1) the Withholding Taxes that I am
required to pay pursuant to the Plan and this Restricted Stock Agreement as a result of the shares of
Stock subject to the Award vesting and (2) all applicable fees and commissions due to, or required to be
collected by, the Agent with respect thereto; and
2.
Remit any remaining funds to me.
(ii) I hereby authorize the Company and the Agent to cooperate and communicate with one another to determine
the number of shares of Stock that must be sold pursuant to this Section 9(d).
(iii) I understand that the Agent may effect sales as provided in this Section 9(d) in one or more sales and that the
average price for executions resulting from bunched orders will be assigned to my account. In addition, I
acknowledge that it may not be possible to sell shares of Stock as provided by this Section 9(d) due to (i) a
legal or contractual restriction applicable to me or the Agent, (ii) a market disruption, or (iii) rules governing
order execution priority on the national exchange where the Stock may be traded. In the event of the Agent’s
inability to sell shares of Stock, I will continue to be responsible for the timely payment to
the Company of all federal, state, local and foreign taxes that are required by applicable laws and regulations
to be withheld, including but not limited to those amounts specified in this Section 9(d).
(iv) I acknowledge that regardless of any other term or condition of this Section 9(d), the Agent will not be liable
to me for (a) special, indirect, punitive, exemplary, or consequential damages, or incidental losses or damages
of any kind, or (b) any failure to perform or for any delay in performance that results from a cause or
circumstance that is beyond its reasonable control.
(v) I hereby agree to execute and deliver to the Agent any other agreements or documents as the Agent
reasonably deems necessary or appropriate to carry out the purposes and intent of this Section 9(d). The
Agent is a third-party beneficiary of this Section 9(d).
(vi) I hereby agree that if I have signed the Grant Notice at a time that I am in possession of material non-public
information, unless I inform the Company in writing within five business days following the date I cease to
be in possession of material non-public information that I am not in agreement with the provisions of this
Section 9(d), my not providing such written determination shall be a determination and agreement that I have
agreed to the provisions set forth in this Section 9(d) on such date as I have ceased to be in possession of
material non-public information.
This Section 9(d) shall terminate not later than the date on which all Withholding Taxes arising in connection with
the Award have been satisfied.
10.
OThER
dOCuMENTS.
You hereby acknowledge receipt or the right to receive a document providing the information
required by Rule 428(b)(1) promulgated under the Securities Act, which includes the Plan prospectus. In addition, you acknowledge receipt
of the Company’s policy permitting directors, officers at the level of vice president and above and other designated employees to sell shares
only during certain “window” periods and the Company’s insider trading policy, in effect from time to time.
11.
NOTICES
.
Any notices provided for in your Award or the Plan shall be given in writing and shall be deemed
effectively given upon receipt or, in the case of notices delivered by the Company to you, five (5) days after deposit in the United States mail,
postage prepaid, addressed to you at the last address you provided to the Company. Notwithstanding the foregoing, the Company may, in its
sole discretion, decide to deliver any documents related to participation in the Plan and this Award by electronic means or to request your
consent to participate in the Plan by electronic means. You hereby consent to receive such documents by electronic delivery and, if requested,
to agree to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party
designated by the Company.
12.
MISCEllANEOuS
.
(a)
The rights and obligations of the Company under your Award shall be transferable to any one or more
persons or entities, and all covenants and agreements hereunder shall inure to the benefit of, and be enforceable by the Company’s successors
and assigns. Your rights and obligations under your Award may only be assigned with the prior written consent of the Company.
(b)
You agree upon request to execute any further documents or instruments necessary or desirable in the sole
determination of the Company to carry out the purposes or intent of your Award. (c)
You acknowledge and agree that you have reviewed your Award in its entirety, have had an opportunity to
obtain the advice of counsel prior to executing and accepting your Award, and fully understand all provisions of your Award.
(d)
This Restricted Stock Agreement shall be subject to all applicable laws, rules, and regulations, and to such
approvals by any governmental agencies or national securities exchanges as may be required.
(e)
All obligations of the Company under the Plan and this Restricted Stock Agreement shall be binding on any
successor to the Company, whether the existence of such successor is the result of a direct or indirect purchase, merger, consolidation, or
otherwise, of all or substantially all of the business and/or assets of the Company.
13.
gOvERNINg
PlAN
dOCuMENT
.
Your Award is subject to all the provisions of the Plan, the provisions of which are
hereby made a part of your Award, and is further subject to all interpretations, amendments, rules and regulations which may from time to
time be promulgated and adopted pursuant to the Plan. Except as otherwise expressly provided in the Grant Notice or this Restricted Stock
Agreement, in the event of any conflict between the provisions in the Grant Notice or this Restricted Stock Agreement and those of the Plan,
the provisions of the Plan shall control.
14.
SEvERABIlITy.
If all or any part of this Restricted Stock Agreement or the Plan is declared by any court or
governmental authority to be unlawful or invalid, such unlawfulness or invalidity shall not invalidate any portion of this Restricted Stock
Agreement or the Plan not declared to be unlawful or invalid. Any Section of this Restricted Stock Agreement (or part of such a Section) so
declared to be unlawful or invalid shall, if possible, be construed in a manner which will give effect to the terms of such Section or part of a
Section to the fullest extent possible while remaining lawful and valid.
15.
EFFECT
ON
OThER
EMPlOyEE
BENEFIT
PlANS.
The value of the Award subject to this Restricted Stock Agreement
shall not be included as compensation, earnings, salaries, or other similar terms used when calculating your benefits under any employee
benefit plan sponsored by the Company or any Subsidiary, except as such plan otherwise expressly provides. The Company expressly
reserves its rights to amend, modify, or terminate any of the Company’s or any Subsidiary’s employee benefit plans.
16.
AMENdMENT.
This Restricted Stock Agreement may not be modified, amended or terminated except by an instrument
in writing, signed or otherwise validly authorized by you and by a duly authorized representative of the Company. Notwithstanding the
foregoing, this Restricted Stock Agreement may be amended solely by the Board by a writing which specifically states that it is amending this
Restricted Stock Agreement, so long as a copy of such amendment is delivered to you, and provided that no such amendment adversely
affecting your rights hereunder may be made without your written consent. Without limiting the foregoing, the Board reserves the right to
change, by written notice to you, the provisions of this Restricted Stock Agreement in any way it may deem necessary or advisable to carry
out the purpose of the grant as a result of any change in applicable laws or regulations or any future law, regulation, ruling, or judicial
decision, provided that any such change shall be applicable only to rights relating to that portion of the Award which is then subject to
restrictions as provided herein.
Attachment
II
JOINT
ESCROW
INSTRuCTIONS
[DATE]
Corporate Secretary
Medivation, Inc.
525 Market Street, 36th Floor
San Francisco, CA 94105
Dear Sir/Madam:
As Escrow Agent for both Medivation, Inc. (the “ Company
”) and the undersigned recipient of stock of the Company (“ Recipient
”), you are hereby authorized and directed to hold the documents delivered to you pursuant to the terms of that certain Restricted Stock Grant
Notice (the “ Grant
Notice
”), dated _______________, to which a copy of these Joint Escrow Instructions is attached as Attachment II, and
pursuant to the terms of that certain Restricted Stock Agreement (“ Agreement
”), which is Attachment I to the Grant Notice, in accordance
with the following instructions:
1.
In the event Recipient ceases to render services to the Company or a Subsidiary (as defined in the Company’s Amended
and Restated 2004 Equity Incentive Award Plan) during the vesting period set forth in the Grant Notice, the Company or its assignee will give
to Recipient and you a written notice specifying that the shares of stock shall be transferred to the Company. Recipient and the Company
hereby irrevocably authorize and direct you to close the transaction contemplated by such notice in accordance with the terms of said notice.
2.
At the closing, you are directed (a) to date any stock assignments necessary for the transfer in question, (b) to fill in the
number of shares being transferred, and (c) to deliver same, together with the certificate evidencing the shares of stock to be transferred, to the
Company.
3.
Recipient irrevocably authorizes the Company to deposit with you any certificates evidencing shares of stock to be held
by you hereunder and any additions and substitutions to said shares as specified in the Grant Notice or Agreement. Recipient does hereby
irrevocably constitute and appoint you as Recipient’s attorney‑in‑fact and agent for the term of this escrow to execute with respect to such
securities and other property all documents of assignment and/or transfer and all stock certificates necessary or appropriate to make all
securities negotiable and complete any transaction herein contemplated.
4.
This escrow shall terminate upon vesting of the shares or upon the earlier return of the shares to the Company.
5.
If, at the time of termination of this escrow, you should have in your possession any documents, securities, or other
property belonging to Recipient, you shall deliver all of same to any pledgee entitled thereto or, if none, to Recipient and shall be discharged
of all further obligations hereunder.
6.
Your duties hereunder may be altered, amended, modified or revoked only by a writing signed by all of the parties
hereto.
7.
You shall be obliga ted only for the performance of such duties as are specifically set forth herein and may rely and shall
be protected in relying or refraining from acting on any instrument reasonably believed by you to be genuine and to have been signed or
presented by the proper party or parties or their assignees. You shall not be personally liable for any act you may do or omit to do hereunder
as Escrow Agent or as attorney ‑in ‑fact for Recipient while acting in good faith and any act done or omitted by you pursuant to t he advice of
your own attorneys shall be conclusive evidence of such good faith. 8.
You are hereby expressly authorized to disregard any and all warnings given by any of the parties hereto or by any other
person or corporation, excepting only orders or process of courts of law, and are hereby expressly authorized to comply with and obey orders,
judgments or decrees of any court. In case you obey or comply with any such order, judgment or decree of any court, you shall not be liable
to any of the parties hereto or to any other person, firm or corporation by reason of such compliance, notwithstanding any such order,
judgment or decree being subsequently reversed, modified, annulled, set aside, vacated or found to have been entered without jurisdiction.
9.
You shall not be liable in any respect on account of the identity, authority or rights of the parties executing or delivering
or purporting to execute or deliver the Grant Notice or any documents or papers deposited or called for hereunder.
10.
You shall not be liable for the outlawing of any rights under any statute of limitations with respect to these Joint
Escrow Instructions or any documents deposited with you.
11.
You shall be entitled to employ such legal counsel, including but not limited to Cooley LLP, and other experts as you
may deem necessary properly to advise you in connection with your obligations hereunder, may rely upon the advice of such counsel, and
may pay such counsel reasonable compensation therefor.
12.
Your responsibilities as Escrow Agent hereunder shall terminate if you shall cease to be Corporate Secretary of the
Company or if you shall resign by written notice to each party. In the event of any such termination, the Company may appoint any officer or
assistant officer of the Company as successor Escrow Agent and Recipient hereby confirms the appointment of such successor or successors
as his attorney‑in‑fact and agent to the full extent of your appointment.
13.
If you reasonably require other or further instruments in connection with these Joint Escrow Instructions or obligations
in respect hereto, the necessary parties hereto shall join in furnishing such instruments.
14.
It is understood and agreed that should any dispute arise with respect to the delivery and/or ownership or right of
possession of the securities, you may (but are not obligated to) retain in your possession without liability to anyone all or any part of said
securities until such dispute shall have been settled either by mutual written agreement of the parties concerned or by a final order, decree or
judgment of a court of competent jurisdiction after the time for appeal has expired and no appeal has been perfected, but you shall be under no
duty whatsoever to institute or defend any such proceedings.
15.
Any notice required or permitted hereunder s hall be given in writing and shall be deemed effectively given upon
personal delivery or upon deposit in any United States Post Box, by registered or certified mail with postage and fees prepaid, addressed to
each of the other parties hereunto entitled at the following addresses, or at such other addresses as a party may designate by ten (10) days’
written notice to each of the other parties hereto: COMPANy:
Medivation, Inc.
525 Market Street, 36th Floor
San Francisco, CA 94105
Attn: General Counsel
RECIPIENT:
ESCROW
AgENT:
Medivation, Inc.
525 Market Street, 36th Floor
San Francisco, CA 94105
Attn: Corporate Secretary
16.
By signing these Joint Escrow Instructions you become a party hereto only for the purpose of said Joint Escrow
Instructions; you do not become a party to the Grant Notice.
17.
This instrument shall be binding upon and inure to the benefit of the parties hereto, and their respective successors and
permitted assigns. It is understood and agreed that references to “you” or “your” herein refer to the original Escrow Agent and to any and all
successor Escrow Agents. It is understood and agreed that the Company may at any time or from time to time assign its rights under the
Grant Notice and these Joint Escrow Instructions in whole or in part.
Very truly yours,
MEdIvATION,
INC.
By:
RECIPIENT
Name:
ESCROW
AgENT:
Attachment
III
ASSIgNMENT
SEPARATE
FROM
CERTIFICATE
FOR
vAluE
RECEIvEd
and pursuant to that certain Restricted Stock Grant Notice and Restricted Stock Agreement (the “ Award
”),
________________________ hereby assigns and transfers unto Medivation, Inc. (“ Assignee
” or “ Company
”)
________________________ (__________) shares of the common stock of the Assignee, standing in the undersigned’s name on the books of
the Company represented by Certificate No. _____ herewith and does hereby irrevocably constitute and appoint
________________________ as attorney-in-fact to transfer the said stock on the books of the Company with full power of substitution in the
premises. This Assignment may be used only in accordance with and subject to the terms and conditions of the Award, in connection with
the reacquisition of shares of common stock of the Company issued to the undersigned pursuant to the Award, and only to the extent that such
shares remain subject to the Company’s Reacquisition Right under the Award.
Dated:
Signature:
[
__________________ ],
Recipient
[INSTRuCTION:
Please do not fill in any blanks other than the signature line. The purpose of this Assignment is to enable the Company to
exercise its Reacquisition Right set forth in the Award without requiring additional signatures on your part. ]
Exhibit
10.12
FIRST
AMENdMENT
TO
EXCluSIvE
lICENSE
AgREEMENT
uC
Agreement
Control
No.
2006-04-0085
This First Amendment to Exclusive License Agreement (this “ Amendment
”), dated as of November 4, 2005, is made by
and among The Regents of the University of California, a California corporation (“ The
Regents
”), Medivation, Inc., a Delaware
corporation (“ Medivation
”), and Medivation Prostate Therapeutics, Inc., a Delaware corporation and subsidiary of Medivation (“
MPT
”)
WHEREAS, the Regents, Medivation and MPT are parties to an Exclusive License Agreement, dated as of August 12,
2005 (the “ Exclusive
license
Agreement
”);
WHEREAS, The Regents, Medivation and MPT wish to strengthen the patent protection of certain members of the family
of compounds covered in UC Case Nos. 2004-129 and 2005-438 by the filing of a patent application to cover additional selected
diarylthiohydantoin compounds, which are disclosed in UC Case No. 2006-260 entitled “Selected Diarylthiohydantoin Compounds,”
by Samedy Ouk, Michael E. Jung, Derek Welsbie and Charlie D. Chen, employees of The Regents, and Charles L. Sawyers, an
employee of HHMI and a member of the faculty of the University of California, Los Angeles;
WHEREAS, Medivation as the parent corporation of MPI will benefit directly from the agreements made herein;
WHEREAS, the parties mutually intend to enter into this First Amendment to amend the terms of the Exclusive license
Agreement, as specified below.
THEREFORE, the parties hereby agree as follows:
1.
Paragraph 1.1 (“Regents’ Patent Rights”) is deleted and replaced with the following, which is amended to include “ UC
Case
No.
2006-260
” in the parenthetical at the end of the paragraph:
1.1
“ Regents’ Patent Rights
” means The Regents interest in the claims of the United States patents and patent
applications, corresponding foreign patents and patent applications (requested under Paragraph 7.3 herein), and
any reissues, extensions, substitutions, continuations, divisions, and continuation-in-part applications (but only
those claims in the continuation-in-part applications that are entirely supported in the specification and entitled
to the priority date of the parent application) based on the patent applications listed in Appendix A (UC Case
Nos. 2004-129, 2005-438 and 2006-260).
1
2.
Appendix A (Regents’ Patent Rights) is deleted and replaced with the Appendix A attached to this First Amendment,
which is amended to include the patent application to be filed under UC Case No. 2006-260.
3.
Paragraph 2.1 is deleted and replaced with the following, which is amended to delete “Licensee” and replace it with
“MPT.” The effect of this Amendment is that MPI is the sole recipient of the license granted pursuant to Paragraph
2.1. Notwithstanding this amendment, it is expressly understood that all other references to “Licensee” in the Exclusive
License Agreement, including without limitation in Article 18 thereof (Indemnification), shall refer to Medivation and MPI
collectively.
2.1
4.
Subject to the limitations set forth in this Agreement, including the licenses granted to the United States
Government and those reserved by HHMI set forth in the recitals and in Paragraph 2.2 and the rights reserved by
The Regents in Paragraph 2.3, The Regents hereby grants to MPI an exclusive license (the “License”) under
Regents’ Patent Rights, in jurisdictions where Regents’ Patent Rights exist, to make, have made, use, sell, offer
for sale and import Licensed Products and to practice Licensed Methods in the Field of Use to the extent
permitted by law.
Except for the amendments specifically referenced above, all other terms of the Exclusive License Agreement shall remain
unchanged and in full force and effect.
The Regents, Medivation and MPI have executed this Amendment in duplicate originals by their authorized officers on the dates
written below:
MEdIvATION,
INC.
By
Name
Title
Date
/s/
C.
Patrick
Machado
C. Patrick Machado
Senior Vice President and CFO
4 Nov. 05
ThE
REgENTS
OF
ThE
uNIvERSITy
OF
CAlIFORNIA
By
Name
Title
Date
MEdIvATION
PROSTATE
ThERAPEuTICS,
INC.
By
Name
Title
Date
/s/
C.
Patrick
Machado
C. Patrick Machado
Senior Vice President and CFO
4 Nov. 05
2
/s/
Claire
T.
Wake
Claire T. Wake, Ph.D.
Assistant Director, Licensing
November 4, 2005
APPENdIX
A
(First
Amendment)
REgENTS’
PATENT
RIghTS
uC
Case
No.
2004-129
PCT Patent Application No. US05/05529 “Methods and Materials for Assessing Prostate Cancer Therapies and Compounds,” filed
February 23, 2005, based on US Provisional Patent Application No. 60/547,101 filed February 24, 2004. The inventors are Michael
E. Jung, Samedy Ouk, Charlie D. Chen and Derek Welsbie, employees of The Regents, and Charles L. Sawyers, an employee of the
Howard Hughes Medical Institute (“HHMI”) and a member of the faculty of The Regents.
uC
Case
No.
2005-438
US Provisional Patent Application No. 60/680,835 “Novel Androgen Receptor Inhibitors with Minimal Agonistic Activities,” filed
May 11, 2005. The inventors rue Michael E. Jung, Samedy Ouk, Charlie D. Chen and Derek Welsbie, employees of The Regents,
and Charles L. Sawyers, an employee of the Howard Hughes Medical Institute (“HHMI”) and a member of the faculty of The
Regents. This application, together with the patent application pertaining to UC Case No. 2004-129, cover the compounds
identified as RD1 through RD138, inclusive, on Exhibit A attached hereto.
uC
Case
No.
2006-260
US Provisional Patent Application to be filed on “Selected Diarylthiohydantoin Compounds” based on UC Case No. 2006260. The inventors are Michael E. Jung, Samedy Ouk, Charlie D. Chen and Derek Welsbie, employees of The Regents, and
Charles L. Sawyers, an employee of the Howard Hughes Medical Institute (“HHMI”) and a member of the faculty of The
Regents. This application will cover only the following diarylthiohydantoin compounds developed in the laboratory of Michael E.
Jung, the structures of which are set forth on Exhibit A attached hereto:
RD139 through RD142
·
RD145 through RD163
·
RD168
·
3
EXhIBIT
A
To
Appendix
A
[begins
on
Page
5)
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
Exhibit
10.13
SECONd
AMENdMENT
TO
EXCluSIvE
lICENSE
AgREEMENT
uC
Agreement
Control
No.
2006-04-0085
This Second Amendment to Exclusive License Agreement ( “Second
Amendment”
), dated as of
May 8
, 2006, is made by and among The Regents of the University of California, a California corporation ( “The
Regents”
), Medivation, Inc., a Delaware corporation ( “Medivation”
), and Medivation Prostate Therapeutics, Inc., a Delaware
corporation and subsidiary of Medivation ( “MPT”
).
WHEREAS, The Regents, Medivation and MPT are parties to an Exclusive License Agreement, dated as of August 12, 2005 (the
“Exclusive
license
Agreement”
);
WHEREAS, Medivation has been supporting research in Dr. Michael E. Jung’s laboratory at UCLA under a Sponsored Research
Agreement with an Effective Date of August 12, 2005 (the “Sponsored
Research
Agreement”
);
WHEREAS, an invention has been developed at UCLA in the performance of the Sponsored Research Agreement, which is
disclosed in UC Case No 2006-537 entitled “ New
Thiohydantoin
Androgen
Receptor
Antagonists
for
Treatment
of
Prostate
Cancer
,” by Michael E. Jung and Dongwon Yoo, employees of The Regents, Charles L. Sawyers, an employee of Howard Hughes Medical
Institute ( “hhMI”
) and a member of the faculty of the University of California, Los Angeles, and Chris Tran, an employee of
HHMI;
WHEREAS, the Sponsored Research Agreement grants Medivation the first right to negotiate for a license to inventions made by
The Regents in the performance of the Sponsored Research Agreement, and Medivation has exercised its right and wishes to obtain
an exclusive license to the invention noted in the preceding WHEREAS clause;
WHEREAS, Medivation as the parent corporation of MPT will benefit directly from the agreements made herein; and
WHEREAS, the parties mutually intend to enter into this Second Amendment to amend the terms of the Exclusive License
Agreement, as specified below.
THEREFORE, the parties hereby agree as follows:
1.
Paragraph 1.1 (“Regents’ Patent Rights”) is deleted and replaced with the following, which is amended to include “UC
Case
No.
2006-537”
in the parenthetical at the end of the paragraph:
1.1
“Regents’ Patent Rights”
means The Regents interest in the claims of the United States patents and patent
applications, corresponding foreign patents and patent applications (requested under Paragraph 7.3 herein), and
any reissues, extensions, substitutions, continuations, divisions, and continuation-in-part applications (but only
those claims in the continuation-in-part applications that are entirely
1
supported in the specification and entitled to the priority date of the parent application) based on the patent
applications listed in Appendix A (UC Case Nos. 2004 -129, 2005-438, 2006-260 and 2006-537)
2.
Appendix A (Regents’ Patent Rights) is deleted and replaced with the Appendix A attached to this First Amendment,
which is amended to include the patent application filed under UC Case No. 2006-537.
3.
In consideration for the addition of UC Case No. 2006-537 to the Exclusive License Agreement, Medivation will pay to
The Regents a fee of five hundred dollars ($500) within thirty (30) days of the Effective Date of this Second Amendment.
4.
Except for the amendments specifically referenced above, all other terms of the Exclusive License Agreement shall remain
unchanged and in full force and effect.
The Regents, Medivation and MPT have executed this Amendment in duplicate originals by their authorized officers on the dates
written below:
MEdIvATION,
INC.
ThE
REgENTS
OF
ThE
uNIvERSITy
OF
CAlIFORNIA
By
By
/s/ C. Patrick Machado
Claire T. Wake, Ph.D.
Name C. Patrick Machado
Title Senior Vice President and CFO
Name Claire T. Wake, Ph.D.
Title Assistant Director, Licensing
Date 8 May 06
Date
MEdIvATION
PROSTATE
ThERAPEuTICS,
INC.
By
/s/ C. Patrick Machado
Name C. Patrick Machado
Title Senior Vice President and CFO
Date 8 May 06
2
May 16, 2006
APPENdIX
A
(Second
Amendment)
REgENTS’
PATENT
RIghTS
uC
Case
No.
2004-129
PCT Patent Application No. uS05/05529
“Methods and Materials for Assessing Prostate Cancer Therapies and Compounds,”
filed February 23, 2005, based on uS
Provisional
Patent
Application
No.
60/547,101
filed February 24, 2004. The inventors are
Michael E Jung, Samedy Ouk, Charlie D. Chen and Derek Welsbie, employees of The Regents, and Charles L. Sawyers, an
employee of the Howard Hughes Medical Institute (“HHMI”) and a member of the faculty of The Regents.
uC
Case
No.
2005-438
uS
Provisional
Patent
Application
No.
60/680,835
“Novel
Androgen
Receptor
Inhibitors
with
Minimal
Agonistic
Activities,”
filed
May 13, 2005. The inventors are Michael E. Jung, Samedy Ouk, Charlie D. Chen and Derek Welsbie, employees of The Regents,
and Charles L. Sawyers, an employee of the Howard Hughes Medical Institute (“HHMI”) and a member of the faculty of The
Regents. This application, together with the patent application pertaining to UC Case No. 2004-129, cover the compounds identified
as RD1 through RD138, inclusive, on Exhibit A attached to the First Amendment.
PCT
Patent
Application
No.
PCT/uS06/11417
(also
includes
uC
Case
Nos.
2006-260
&
2006-537)
titled “Diarylthiohydantoin
Compounds”
was filed March 29, 2006. The inventors are Michael E. Jung, Samedy Ouk, Charlie D. Chen, Derek Welsbie and
Dongwon Yoo, employees of The Regents, and Charles L. Sawyers, an employee of Howard Hughes Medical Institute ( “hhMI”
)
and a member of the faculty of the University of California, Los Angeles, and John Wongvipat and Chris Tran, employees of HHMI.
uC
Case
No.
2006-260
uS Provisional Patent Application No. 60/750,351
filed December 15, 2005 and uS Provisional Patent Application No.
60/756,552
filed January 6, 2006, both titled “Selected Diarylthiohydantoin Compounds,”
filed January 6, 2006 (both were
subsequently rolled into PCT Patent Application No. PCT/US06/11417). The inventors are Michael E. Jung, Samedy Ouk and
Charlie D. Chen, employees of The Regents, and Charles L. Sawyers, an employee of the Howard Hughes Medical Institute
(“HHMI”) and a member of the faculty of The Regents, and John Wongvipat and Chris Tran, employees of HHMI. This application
will cover only the following diarylthiohydantoin compounds developed in the laboratory of Michael E. Jung, the structures of which
are set forth on Exhibit A attached hereto:
RD139 through RD142
·
RD145 through RD163
·
RD168
·
3
uC
Case
No.
2006-537
uS
Provisional Patent Application No.
TBd
“Diarylthiohydantoin
Compounds”
filed March 29, 2006 (This invention was also
filed as part of PCT Patent Application No. PCT/US06/11417, listed under UC Case No. 2005-438 above). The inventors are
Michael E. Jung and Dongwon Yoo, employees of The Regents, and Charles L. Sawyers, an employee of Howard Hughes Medical
Institute (“ hhMI
”) and a member of the faculty of the University of California, Los Angeles, and Chris Tran, an employee of
HHMI. This application covers the following compounds: RD162’, RD162’’, RD169 and RD170 (analogues of earlier compounds
RD162 and RD131).
4
Exhibit
10.14
ThIRd
AMENdMENT
TO
EXCluSIvE
lICENSE
AgREEMENT
uC
Agreement
Control
No.
2006-04-0085
This Third Amendment to Exclusive License Agreement ( “Third
Amendment”
), dated as of June 12, 2006, is made by and among
The Regents of the University of California, a California corporation ( “The
Regents”
), Medivation, Inc., a Delaware corporation (
“Medivation”
), and Medivation Prostate Therapeutics, Inc., a Delaware corporation and subsidiary of Medivation ( “MPT”
)
(Medivation and MPT together “licensee”
).
BACkgROuNd
A.
The Regents, Medivation and MPT are parties to an Exclusive License Agreement, dated as of August 12, 2005 (the
“Exclusive
license
Agreement”
), as amended on November 4, 2005 and May 8, 2006.
B.
The Regents and MPT are parties to a Nonexclusive Bailment and License Agreement dated October 27, 2005 (the
“Nonexclusive Bailment”
) that grants to MPT limited rights in a certain Field of Use to patent rights generally
characterized as “Methods
and
Materials
for
Assessing
Prostate
Cancer
Therapies”
(UCLA Case No. 2003-279), which
was made in the course of research at the University of California, Los Angeles by Charles L. Sawyers, Charlie D. Chen
and Derek S. Welsbie, employees of The Regents. MPT now wishes to obtain broader nonexclusive rights to these patent
rights in the United States and exclusive rights to these patent rights in certain countries and regions outside the United
States in a different field of use. The Regents is willing to grant such rights. This Third Amendment is not intended to
change the scope of rights granted under the Nonexclusive Bailment.
C.
Medivation as the parent corporation of MPT will benefit directly from the agreements made herein.
D.
The parties mutually intend to enter into this Third Amendment to amend the terms of the Exclusive License Agreement,
as specified below.
1
THEREFORE, the parties hereby agree as follows:
1.
Paragraph 1.1 (“Regents’ Patent Rights”) is deleted and replaced with the following, which is amended to include “UC
Case
No.
2003-279-2”
in the parenthetical at the end of the paragraph:
1.1
2.
“Regents’ Patent Rights”
means The Regents’ interest in the claims of the United States patents and patent
applications, corresponding foreign patents and patent applications (requested under Paragraph 7.3 herein), and
any reissues, extensions, substitutions, continuations, divisions, and continuation-in-part applications (but only
those claims in the continuation-in-part applications that are entirely supported in the specification and entitled
to the priority date of the parent application) based on the patent applications listed in Appendix A (UC Case
Nos. 2003-279-2, 2004-129, 2005-438, 2006-260 and 2006-537).
Paragraph 2.1 is deleted and replaced with the following, which is amended to grant nonexclusive rights in the United
States and exclusive rights outside the United States to the patent rights covered by UC Case No 2003-279-2:
2.1
Subject to the limitations set forth in this Agreement, including the licenses granted to the United States
Government and those reserved by HHMI set forth in the recitals and in Paragraph 2.2 and the rights reserved by
The Regents in Paragraph 2.3, The Regents hereby grants to MPT an exclusive license (the “license”
) under
Regents’ Patent Rights, in jurisdictions where Regents’ Patent Rights exist, to make, have made, use, sell, offer
for sale and import Licensed Products and to practice Licensed Methods in the Field of Use to the extent
permitted by law; provided, however, that as to UC Case No 2003-279-2 only, the License shall be exclusive
only in Australia, Canada, the European Union, Japan and New Zealand, and shall be non-exclusive in the
United States.
3.
Appendix A (Regents’ Patent Rights) is deleted and replaced with the Appendix A attached to this Third Amendment,
which is amended to include the patent applications to be filed under UC Case No. 2003-279-2 in Australia, Canada, the
European Union, Japan, New Zealand and the United States.
4.
In consideration for the addition of the patent rights of UC Case No. 2003-279-2 to the Exclusive License Agreement,
Licensee will pay to The Regents a fee of two thousand five hundred dollars ($2,500) within thirty (30) days of the
Effective Date of this Third Amendment. In addition, Licensee will pay a one-time milestone fee of twenty-five thousand
dollars ($25,000) upon issuance of the first patent under UC Case No. 2003-279-2 in Australia, Canada, the European
Union, Japan or New Zealand that would cover a Licensed Product.
2
5.
Article 7 (Patent Filing, Prosecution and Maintenance) is amended to include a new Paragraph 7.7:
7.7
6.
Notwithstanding the foregoing provisions in this Article 7, Licensee is not obligated to reimburse costs incurred
prior to and during the term of this Agreement in the preparation, filing, prosecution and maintenance of patent
applications and patents pertaining to the United States patent rights of UC Case No. 2003-279-2 within
Regents’ Patent Rights. Further, The Regents has no obligation to prosecute or maintain the United States patent
rights of UC Case No. 2003-279-2 within Regents’ Patent Rights. If The Regents elects to abandon the United
States patent rights of UC Case No. 2003-279-2 within Regents’ Patent Rights, then the consideration due to The
Regents under this Agreement shall remain the same.
Except for the amendments specifically referenced above, all other terms of the Exclusive License Agreement shall remain
unchanged and in full force and effect.
The Regents, Medivation and MPT have executed this Amendment in duplicate originals by their authorized officers on the dates
written below:
MEdIvATION,
INC.
ThE
REgENTS
OF
ThE
uNIvERSITy
OF
CAlIFORNIA
By
By
/s/ C. Patrick Machado
/s/ Claire T. Wake
Name C. Patrick Machado
Title Senior Vice President and CFO
Name Claire T. Wake, Ph.D.
Title Assistant Director, Licensing
Date
Date
10 Jul 106
MEdIvATION
PROSTATE
ThERAPEuTICS,
INC
By
/s/ C. Patrick Machado
Name
Title
C. Patrick Machado
Senior Vice President and CFO
Date
10 Jul 106
3
June 13, 2006
APPENdIX
A
(Third
Amendment)
REgENTS’
PATENT
RIghTS
uC
Case
No.
2003-279-2
Australian Patent Application No. [TBD] to be filed
Canadian Patent Application No. [TBD] to be filed
European Patent Application No. [TBD] to be filed
Japanese Patent Application No. [TBD] to be filed
New Zealand Patent Application No. [TBD] to be filed
United States Patent Application No. [TBD] to be filed
All of the above based on PCT Patent Application No. uS04/42221
“Method and Materials for Assessing Prostate Cancer
Therapies,”
filed December 16, 2004 and assigned to The Regents. The inventors are Charles L. Sawyers, an employee of the
Howard Hughes Medical Institute (“HHMI”) and a member of the faculty of The Regents, and Charlie D. Chen and Derek S.
Welsbie, employees of The Regents.
uC
Case
No.
2004-129
PCT Patent Application No. uS05/05529
“Methods and Materials for Assessing Prostate Cancer Therapies and Compounds,”
filed February 23, 2005, based on uS
Provisional
Patent
Application
No.
60/547,101
filed February 24, 2004 and assigned to The
Regents. The inventors are Michael E. Jung, Samedy Ouk, Charlie D. Chen and Derek Welsbie, employees of The Regents, and
Charles L. Sawyers, an employee of the Howard Hughes Medical Institute (“HHMI”) and a member of the faculty of The Regents.
uC
Case
No.
2005-438
uS
Provisional
Patent
Application
No.
60/680,835
“Novel
Androgen
Receptor
Inhibitors
with
Minimal
Agonistic
Activities,”
filed
May 13, 2005 and assigned to The Regents. The inventors are Michael E. Jung, Samedy Ouk, Charlie D. Chen and Derek Welsbie,
employees of The Regents, and Charles L. Sawyers, an employee of the Howard Hughes Medical Institute (“HHMI”) and a member
of the faculty of The Regents. This application, together with the patent application pertaining to UC Case No. 2004-129, cover the
compounds identified as RD1 through RD138, inclusive, on Exhibit A attached to the First Amendment.
4
PCT
Patent
Application
No.
PCT/uS06/11417
(also
includes
uC
Case
Nos.
2006-260
&
2006-537)
titled “Diarylthiohydantoin
Compounds”
was filed March 29, 2006 and assigned to The Regents. The inventors are Michael E. Jung, Samedy Ouk, Charlie D.
Chen, Derek Welsbie and Dongwon Yoo, employees of The Regents, and Cha rles L. Sawyers, an employee of Howard Hughes
Medical Institute (“HHMI”) and a member of the faculty of the University of California, Los Angeles, and John Wongvipat and
Chris Tran, employees of HHMI.
uC
Case
No.
2006-260
uS Provisional Patent Application No. 60/750,351
filed December 15, 2005 and uS Provisional Patent Application No.
60/756,552
filed January 6, 2006, both titled “Selected Diarylthiohydantoin Compounds,”
filed January 6, 2006 (both were
subsequently rolled into PCT Patent Application No. PCT/US06/11417), and both assigned to The Regents. The inventors are
Michael E. Jung, Samedy Ouk and Charlie D. Chen, employees of The Regents, and Charles L. Sawyers, an employee of the Howard
Hughes Medical Institute (“HHMI”) and a member of the faculty of The Regents, and John Wongvipat and Chris Tran, employees of
HHMI.
uC
Case
No.
2006-537
uS
Provisional
Patent
Application
No.
60/786,837
“ Diarylthiohydantoin
Compounds”
filed March 29, 2006 and assigned to The
Regents. (This invention was also filed as part of PCT Patent Application No. PCT/US06/11417, listed under UC Case No. 2005-438
above). The inventors are Michael E. Jung and Dongwon Yoo, employees of The Regents, and Charles L. Sawyers, an employee of
Howard Hughes Medical Institute (“HHMI”) and a member of the faculty of the University of California, Los Angeles, and Chris
Tran, an employee of HHMI.
5
Exhibit
10.15
Fourth
Amendment
To
Exclusive
license
Agreement
Between
The
Regents
of
the
university
of
California
and
Medivation,
Inc
and
Medivation
Prostate
Therapeutics,
Inc
For
uC
Agreement
Control
No.
2006-04-0085
FOuRTh
AMENdMENT
TO
EXCluSIvE
lICENSE
AgREEMENT
uC
Agreement
Control
No.
2006-04-0085
This Fourth Amendment to Exclusive License Agreement (“ Fourth
Amendment
”), dated as of July 17, 2007, is made by and
among The Regents of the University of California, a California corporation (“ The Regents
”), Medivation, Inc., a Delaware
corporation (“ Medivation
”), and Medivation Prostate Therapeutics, Inc., a Delaware corporation and subsidiary of Medivation (“
MPT
”) (Medivation and MPT together “ licensee
”).
BACkgROuNd
A.
The Regents, Medivation and MPT are parties to an Exclusive License Agreement, dated as of August 12, 2005 (the “
Exclusive
license
Agreement
”), as amended on November 4, 2005, May 8, 2006 and June 12, 2007.
B.
Medivation has supported research in Dr. Michael E. Jung’s laboratory at UCLA under a Sponsored Research Agreement
with an Effective Date of August 12, 2005 (the “ Sponsored
Research
Agreement
”).
C.
An invention has been developed at UCLA in the performance of the Sponsored Research Agreement, which is disclosed
in UC Case No 2007-139 entitled “ Additional Thiohydantoin Androgen Receptor Antagonists for Prostate Cancer
Treatment,
” by Michael E. Jung and Dongwon Yoo, employees of The Regents, Charles L. Sawyers, an employee of
Howard Hughes Medical Institute (“ hhMI
”) and a member of the faculty of the University of California, Los Angeles at
the time the invention was made, and Chris Tran, an employee of HHMI at the time the invention was made.
D.
The Sponsored Research Agreement grants Medivation the first right to negotiate for a license to inventions made by The
Regents in the performance of the Sponsored Research Agreement, and Medivation has exercised its right and wishes to
obtain an exclusive license to the invention noted in the preceding clause.
E.
Medivation as the parent corporation of MPT will benefit directly from the agreements made herein.
F.
The parties mutually intend to enter into this Fourth Amendment to amend the terms of the Exclusive License Agreement,
as specified below.
THEREFORE, the parties hereby agree as follows:
1.
Paragraph 1.1 (“ Regents’
Patent
Rights
”) is deleted and replaced with the following, which is amended to include “ UC
Case
No.
2007-139
” in the parenthetical at the end of the paragraph:
1.1
“ Regents’
Patent
Rights
” means The Regents’ interest in the claims of the United States patents and patent
applications, corresponding foreign patents and patent applications (requested under Paragraph 7.3 herein), and
any reissues, extensions, substitutions, continuations, divisions, and continuation-in-part
1
applications (but only those claims in the continuation-in-part applications that are entirely supported in the
specification and entitled to the priority date of the parent application) based on the patent applications list ed in
Appendix A (UC Case Nos. 2003-279-2, 2004-129, 2005-438, 2006-260, 2006-537 and 2007-139).
2.
Appendix A (Regents’ Patent Rights) is deleted and replaced with the Appendix A attached to this Fourth Amendment,
which is amended to include the patent applications to be filed under UC Case No. 2007-139.
3.
In consideration for the addition of the patent rights of UC Case No. 2007-139 to the Exclusive License Agreement,
Licensee will pay to The Regents a fee of two thousand five hundred dollars ($2,500) within thirty (30) days of the
Effective Date of this Fourth Amendment. In addition, Licensee will pay a one-time milestone fee of twenty-five thousand
dollars ($25,000) upon issuance of the first patent under UC Case No 2007-139 that would cover a Licensed Product.
4.
Except for the amendments specifically referenced above, all other terms of the Exclusive License Agreement shall remain
unchanged and in full force and effect.
The Regents, Medivation and MPT have executed this Amendment in duplicate originals by their authorized officers on the dates
written below:
MEdIvATION,
INC.
By
Name
Title
Date
ThE
REgENTS
OF
ThE
uNIvERSITy
OF
CAlIFORNIA
/s/
CP
Machado
By
C. Patrick Machado
Senior Vice President and CFO
Name
Title
8 Aug 07
Date
MEdIvATION
PROSTATE
ThERAPEuTICS,
INC
By
/s/
CP
Machado
Name
Title
C. Patrick Machado
Senior Vice President and CFO
Date
8 Aug 07
2
/s/
Claire
T.
Wake
Claire T. Wake, Ph.D.
Assistant Director, Licensing
July 19, 2007
APPENdIX
A
(Fourth
Amendment)
REgENTS’
PATENT
RIghTS
uC
Case
No.
2003-279-2
United States Patent Application No. 10/583,280 filed December 16, 2004
Australian Patent Application No, 2004-305075 filed December 16, 2004
Canadian Patent Application No 2550447 filed December 16, 2004
European Patent Application No. 04814409.1 filed December 16, 2004
Hong Kong Patent Application No. 7103115.7 filed December 16, 2004
Japanese Patent Application No. 2006-545417 filed December 16, 2004
New Zealand Patent Application No. 548209 filed December 16, 2004
All of the above based on PCT Patent Application No. uS04/42221
“ Method and Materials for Assessing Prostate Cancer
Therapies,
” filed December 16, 2004, based on uS
Provisional
Patent
Application
No.
60/531,091
filed on December 19, 2003
and assigned to The Regents. The inventors are Charles L, Sawyers, an employee of the Howard Hughes Medical Institute
(“HHMI”) and a member of the faculty of The Regents, and Charlie D. Chen and Derek S. Welsbie, employees of The Regents.
uC
Case
No.
2004-129
United States Patent Application No., 10/590,445 filed February 23, 2005
Australian Patent Application No. 2005-232526 filed February 23, 2005
New Zealand Patent Application No. 550102 filed February 23, 2005
All of the above based on PCT Patent Application No. uS05/05529
“ Methods and Materials for Assessing Prostate Cancer
Therapies
and
Compounds,
” filed February 23, 2005, based on uS
Provisional
Patent
Application
No.
60/547,101
filed February
24, 2004 and assigned to The Regents. The inventors are Michael E. Jung, Samedy Ouk, Charlie D. Chen and Derek Welsbie,
employees of The Regents, and Charles L. Sawyers, an employee of the Howard Hughes Medical Institute (“HHMI”) and a member
of the faculty of The Regents.
3
uC
Case
N
o.
2005-438
United States Patent Application No. 11/433,829 filed March 29, 2006
The above based on PCT
Patent
Application
No.
PCT/uS06/11417
“ Novel
Androgen
Receptor
Inhibitors
with
Minimal
Agonistic
Activities
,” filed on March 29, 2006, based on uS
Provisional
Patent
Application
No.
60/680,835
filed May 13, 2005 and assigned
to The Regents. The inventors are Michael E. Jung, Samedy Ouk, Charlie D. Chen and Derek Welsbie, employees of The Regents,
and Charles L. Sawyers, an employee of the Howard Hughes Medical Institute (“HHMI”) and a member of the faculty of The
Regents. This application, together with the patent application pertaining to UC Case No. 2004-129, cover the compounds identified
as RD1 through RD138, inclusive, on Exhibit A attached to the First Amendment.
PCT
Patent
Application
No.
PCT/uS06/11417
(also
includes
uC
Case
Nos.
2006-260
&
2006-537)
titled “ Diarylthiohydantoin
Compounds
” was filed March 29, 2006 and assigned to The Regents. The inventors are Michael E. Jung, Samedy Ouk, Charlie D.
Chen, Derek Welsbie and Dongwon Yoo, employees of The Regents, and Charles L. Sawyers, an employee of Howard Hughes
Medical Institute (“ hhMI
”) and a member of the faculty of the University of California, Los Angeles, and John Wongvipat and
Chris Iran, employees of HHMI.
uC
Case
No.
2006-260
uS Provisional Patent Application No. 60/750,351 filed december 15, 2005 and uS Provisional Patent Application No.
60/756,552
filed January 6, 2006, both titled “ Selected Diarylthiohydantoin Compounds,
” filed January 6, 2006 (both were
subsequently rolled into PCT Patent Application No PCT/US06/11417), and both assigned to The Regents. The inventors are
Michael E Jung, Samedy Ouk and Charlie D. Chen, employees of The Regents, and Charles L. Sawyers, an employee of the Howard
Hughes Medical Institute (“HHMI”) and a member of the faculty of The Regents, and John Wongvipat and Chris Tian, employees of
HHMI.
uC
Case
No.
2006-537
United States Patent Application No. 11/730,168 filed March 29, 2007
The above based on PCT
Patent
Application
No.
PCT/uS07/07854
“ Diarylthiohydantoin
Compounds
” filed on March 29, 2007,
based on uS
Provisional
Patent
Application
No.
60/786,837
filed March 29, 2006 and assigned to The Regents. (This invention
was also filed as part of PCT Patent Application No. PCT/US06/11417, listed under UC Case No 2005-438 above). The inventors
are Michael E .Jung and Dongwon Yoo, employees of The Regents, and Charles L. Sawyers, an employee of Howard Hughes
Medical Institute (“HHMI”) and a member of the faculty of the University of California, Los Angeles, and Chris Tran, an employee
of HHMI.
uC
Case
No.
2007-139
uS Provisional Patent No. [TBd] to be filed
“ Additional Thiohydantoin Androgen Receptor Antagonists for Prostate Cancer
Treatment
.” The inventors are Michael E. Jung and Dongwon Yoo, employees of The Regents, and Charles L. Sawyers, an
employee of HHMI and a member of the faculty of the University of California, Los Angeles, and Chris Iran, employee of HHMI.
4
E
xhibit
10.16
FIFTh
AMENdMENT
TO
EXCluSIvE
lICENSE
AgREEMENT
uC
Agreement
Control
No.
2006-04-0085
This Fifth Amendment to Exclusive License Agreement (“ Fifth
Amendment
”), dated as of October 21, 2009, is made by and
among The Regents of the University of California, a California corporation (“ The Regents
”), Medivation, Inc., a Delaware
corporation (“ Medivation
”), and Medivation Prostate Therapeutics, Inc., a Delaware corporation and subsidiary of Medivation (“
MPT
”) (Medivation and MPT together “ licensee
”).
BACkgROuNd
A.
The Regents, Medivation and MPT are parties to an Exclusive License Agreement, dated as of August 12, 2005 (the “
Exclusive
license
Agreement
”), as amended on November 4, 2005, May 8, 2006, June 12, 2006 and July 17, 2007.
B.
Medivation intends to grant an exclusive sublicense under the Exclusive License Agreement to the Designated Sublicensee
(as defined in the Exclusive License Agreement as amended below).
C.
The parties mutually intend to enter into this Fifth Amendment to amend the terms of the Exclusive License Agreement, as
specified below.
THEREFORE, the parties hereby agree as follows:
1.
2.
Article 1 is amended by the addition of the following new Paragraphs 1.15, 1.16 and 1.17:
1.15
“ designated
Sublicense
” means the Sublicense granted by Licensee to the Designated Sublicensee.
1.16
“ designated
Sublicense
Agreement
” means the agreement entered into by Licensee and the
Designated Sublicensee pursuant to which the Designated Sublicense is granted.
1.17
“ designated
Sublicensee
” means any Sublicensee that Licensee and The Regents agree in writing is
a Designated Sublicensee for the purposes of this Agreement.
Article 3 (Sublicenses) is amended to include a new Paragraph 3.6:
3 .6
If this Agreement is terminated for any reason other than (a) a termination by The Regents pursuant to
Article 12 due to a material breach by Licensee of any material term or covenant of this Agreement,
which material breach is caused by a material breach of a material term or covenant of the Designated
Sublicense Agreement by the Designated Sublicensee, or (b) a termination by
1
The Regents pursuant to Paragraph 6.3 for a failure by Licensee to perform any of the terms of such
Paragraph, in all cases exce pt (a) and (b), Paragraph 3.5 will not apply, and instead this Paragraph 3.6
will apply: For as long as the Designated Sublicensee Agreement remains in effect, the Designated
Sublicense will survive and remain in full force and effect on an exclusive basis , and from and after
the effective date of such termination with respect to Licensee, the Designated Sublicensee will be
deemed to have the rights of Licensee under this Agreement and will become responsible for fulfilling
all of Licensee’s obligations and covenants under this Agreement that arise as a result of the exercise
by the Designated Sublicensee of such Sublicense, including all financial terms.
3.
4.
Paragraphs 6.3d and 6.3e are deleted and replaced with the following:
6.3d
First application to market a Licensed Product to be filed in the U.S. or EU by the eleventh (11th)
anniversary of the date of this Agreement.
6.3e
First Commercial Sale of a Licensed Product by the thirteenth (13th) anniversary of the date of this
Agreement.
Article 7 (Patent Filing, Prosecution and Maintenance) is amended to include the following new Paragraph 7.8:
7.8
5.
The Regents represents that as of October 21, 2009, except as requested by Medivation in a notice
provided pursuant to Paragraph 7.3, The Regents has not filed patent applications claiming or covering
the Invention or corresponding with the Regents’ Patent Rights in any foreign country, and that all of
the foreign patents and patent applications claiming or covering the Invention or corresponding with
the Regents’ Patent Rights are subject to this Agreement (and are within the scope of the licenses and
rights granted in Paragraphs 2.1 and 3.1). Notwithstanding the foregoing, no representation is made
pursuant to this Section 7.8 with respect Patent No. 10/590,445, which The Regents is prosecuting in
the United States without funding by Medivation.
The second sentence of Paragraph 8.1 is amended to include the following at the end of such sentence:
. . . except that Licensee may notify a Sublicensee or Affiliate thereof of such infringement without
consent of The Regents.
6.
Paragraph 8.2 is renumbered as Paragraph 8.2a. The third sentence of such Paragraph is deleted and replaced with the
following:
If joinder of The Regents is required by applicable law to perfect or maintain jurisdiction with respect
to any such suit, then subject to approval of the Board of Regents of the University of California, The
Regents will join such suit, will consent to the jurisdiction of federal or state courts with respect to
2
such suit, and will not oppose joinder in such suit, including on grounds of sovereign immunity. In the
event of such required joinder, Licensee will pay any costs incurred by The Regents arising out of
such suit, including but not limited to, any legal fees of counsel that The Regents selects and retains to
represent it in the suit.
7.
Article 8 (Patent Infringement) is amended to include the following new Paragraph 8.2b:
8.2b
3
Notwithstanding anything contained in this Article 8 to the contrary, if the Infringement Notice is
predicated on the receipt of a notice of certification sent or filed pursuant to the U.S. “Drug Price
Competition and Patent Term Restoration Act” of 1984, including pursuant to 21 U.S.C. 355(b)(2)(A)
(iv) or (j)(2)(A)(vii)(IV), or any equivalent or similar notice or certification in any foreign jurisdiction,
claiming that the patent is invalid or unenforceable or claiming that the patent will not be infringed by
the Manufacture, use, marketing or sale of a product for which an application under the act is filed,
then the Licensee may institute suit within the applicable timeframe required by law and may, if
required to perfect or maintain jurisdiction with respect to such suit, name The Regents as a coplaintiff in such suit, subject to approval of the Board of Regents of the University of California. In
such circumstance, The Regents will use best efforts to obtain the approval of the Board of Regents of
the University of California within 30 days of the Infringement Notice, and will notify Licensee no
later than such 30th day whether the Board of the Regents of the University of California will grant
such approval. Prior to initiating the suit, the Licensee will consult with The Regents to obtain its input
with respect to the proposed suit, and will consider such input in good faith. Without limitation to the
foregoing and subject to approval of the Board of Regents of the University of California, The Regents
agree to cooperate with respect to such suit if named as a co-plaintiff, including by participating as a
party plaintiff in any such suit, joining in such suit, consenting to the jurisdiction of federal or state
courts, and not opposing joinder, including on grounds of sovereign immunity. The Regents may
voluntarily join any such suit initiated solely by the Licensee at the Regents’ own expense, but may
not thereafter commence suit against the infringer for the acts of infringement that are the subject of
the Licensee’s suit or any judgment rendered in the suit. If The Regents is named by the Licensee as a
co-plaintiff in such a suit pursuant to the first sentence of this Paragraph 8.2b, then the Licensee will
pay any costs incurred by The Regents arising out of such suit, including but not limited to, any legal
fees of counsel that The Regents selects and retains to represent it in the suit. The Regents hereby
acknowledges that the rights conferred on the Licensee pursuant to Paragraphs 8.1 and 8.2 may be
exercised by a Sublicensee designated by the Licensee (including the Designated Sublicensee).
8.
Article 30 is amended by the addition of the following new Paragraph 30.2:
30.2
9.
The Designated Sublicensee is an intended third-party beneficiary of this Agreement and certain of its
provisions, including Paragraph 3.6, are for the benefit of the Designated Sublicensee and are
enforceable by the Designated Sublicensee in its own name.
Except for the amendments specifically referenced above, all other terms of the Exclusive License Agreement remain
unchanged and in full force and effect.
The Regents, Medivation and MPT have executed this Amendment in duplicate originals by their authorized officers on the dates
written below:
ThE
REgENTS
OF
ThE
uNIvERSITy
OF
CAlIFORNIA
By
/s/Claire T. Wake
Name:
Title:
Claire T. Wake
Assistant Director, Licensing
Date:
October 21, 2009
MEdIvATION,
INC.
By
/s/ C. Patrick Machado
Name:
Title:
C. Patrick Machado
CFO
Date:
21 Oct 09
MEdIvATION
PROSTATE
ThERAPEuTICS,
INC.
By
/s/ C. Patrick Machado
Name:
Title:
C. Patrick Machado
CFO
Date:
21 Oct 09
4
9.
Except for the amendments specifically referenced above, all other terms of the Exclusive License Agreement remain
unchanged and in full force and effect.
The Regents, Medivation and MPT have executed this Amendment in duplicate originals by their authorized officers on the dates
written below:
ThE
REgENTS
OF
ThE
uNIvERSITy
OF
CAlIFORNIA
By
Name:
Title:
Date:
MEdIvATION,
INC.
By
/s/ C. Patrick Machado
Name:
Title:
C. Patrick Machado
CFO
Date:
21 Oct 09
MEdIvATION
PROSTATE
ThERAPEuTICS,
INC.
By
/s/ C. Patrick Machado
Name:
Title:
C. Patrick Machado
CFO
Date:
21 Oct 09
4
Exhibit
10.23
SuPPlEMENTAl
AgREEMENT
REgARdINg
CdX
AgREEMENT
ANd
COllABORATION
AgREEMENT
ANd
SIXTh
AMENdMENT
TO
COllABORATION
AgREEMENT
ThIS
SuPPlEMENTAl
AgREEMENT
Regarding
Cdx
Agreement
and
Collaboration
Agreement
ANd
SIXTh
AMENdMENT
TO
COllABORATION
AgREEMENT
(this “ Supplemental
Agreement
”) is entered into as of January 6, 2016 (the “ Effective
date
”) by
and among MEdIvATION,
INC.
, a Delaware corporation having offices located at 525 Market Street, 36th Floor, San Francisco, CA
94105, United States, its wholly owned subsidiary Medivation Prostate Therapeutics, Inc., a Delaware corporation having offices
located at [the same location] (such entities, collectively, “Medivation”
), ASTEllAS
PhARMA
INC.
, a Japanese corporation having
offices located at 2-5-1, Nihonbashi Honcho, Chuo Ku, Tokyo 103- 8411, Japan (“ API
”) and its indirect wholly owned subsidiary
Astellas US LLC, a Delaware limited liability company having office located at 1 Astellas Way, Northbrook, Illinois 60062, United
States (collectively with API, “Astellas”
). Medivation and Astellas are sometimes referred to herein individually as a “Party”
and
collectively as the “Parties”
.
BACkgROuNd
Medivation and Astellas entered into a Collaboration Agreement dated October 26, 2009, as amended January 1, 2010,
May 13, 2011, April 1, 2013, October 29, 2013, and May 6, 2014 (the “ Collaboration
Agreement
”).
NanoString Technologies, Inc. ( “NanoString”
), Medivation, Inc. and its Affiliates (as defined in the CDx Agreement;
collectively with Medivation, Inc., “Mdv”
), and API entered into a Collaboration Agreement effective as of January 6, 2016 (the “
Cdx
Agreement
”).
Medivation and Astellas desire to provide for certain supplemental terms with respect to their rights and obligations
pursuant to the CDx Agreement and the Collaboration Agreement, and to clarify the intended interplay of certain terms of the CDx
Agreement and the Collaboration Agreement.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants contained in this Supplemental
Agreement, the Parties hereby agree as follows:
ARTIClE
1
dEFINITIONS
As used in this Supplemental Agreement, the following initially capitalized terms, whether used in the singular or plural
form, shall have the meanings set forth in this Article 1. Unless otherwise provided herein, any capitalized term used but not defined
herein shall have the meaning provided in the Collaboration Agreement. In addition, the terms “includes,” “including,” “include”
and derivative forms of them shall be deemed followed by the phrase
1
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
“without limitation” (regardless of whether it is actually written there (and drawing no implication from the actual inclusion of such
phrase in some instances afte r such terms but not others)) and the term “or” has the inclusive meaning represented by the phrase
“and/or” (regardless of whether it is actually written (and drawing no implication from the actual use of the phrase “and/or” in some
instances but not in o thers)). Unless otherwise stated, dollar amounts set forth herein are U.S. dollars.
1.1
“API Cdx IP”
means (a) Background IP (as defined in the CDx Agreement) of API or its Affiliates,
and (b) API’s interest in and to (i) Joint Project IP (as defined in the CDx Agreement), (ii) Medivation/Astellas Project IP (as defined
in the CDx Agreement), and (iii) Medivation/Astellas Project Data (as defined in the CDx Agreement).
1.2
“Cdx”
has the meaning ascribed to such term in the CDx Agreement.
1.3
“Cdx
Joint
Patent”
has the meaning ascribed to the term “Joint Patent” in the CDx Agreement.
1.4
“Cdx
JSC”
has the meaning ascribed to the term “JSC” in the CDx Agreement.
1.5
“Inventions”
has the meaning ascribed to such term in the CDx Agreement.
1.6
“Ivd”
has the meaning ascribed to such term in the CDx Agreement.
1.7
“Joint
Project
IP”
has the meaning ascribed to such term in the CDx Agreement.
1.8
“losses”
has the meaning ascribed to such term in the CDx Agreement.
1.9
“Mdv Cdx IP”
means (a) Background IP (as defined in the CDx Agreement of MDV or its Affiliates,
and (b) MDV’s interest in and to (i) Joint Project IP (as defined in the CDx Agreement), (ii) Medivation/Astellas Project IP (as
defined in the CDx Agreement), and (iii) Medivation/Astellas Project Data (as defined in the CDx Agreement).
1.10
“Medivation/Astellas
Project
IP”
has the meaning ascribed to such term in the CDx Agreement.
ARTIClE
2
gOvERNANCE
2.1
Cdx JSC voting.
In light of the fact that Medivation and Astellas [*] at the CDx JSC, Medivation and
Astellas agree that [*] shall be cast in accordance with the following principles:
(a)
If the Parties agree in writing [*], then both Parties shall cast [*] at the CDx JSC in
accordance with such agreement. If the Parties do not agree in writing [*], [*].
2
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(b)
If the Parties do not agree in writing [*], and the vote pertains solely to the Licensed
Territory [*], including the Development or Commercialization of the CDx solely for the Licensed Territory, then [*].
(c)
If the Parties do not agree in writing [*], and the vote pertains to a matter other than an
[*], then the JSC shall promptly attempt to resolve such disagreement in accordance with Section 2.7 of the Collaboration Agreement
(including the rights of the Parties to determine such matter, if applicable, under Sections 2.7(b)(i) and (ii) and referral to Executive
Officers set forth in Section 2.7(c)), in each case taking account of the timing of such decision as may be required to comply with the
CDx Agreement. For so long as the Parties remain deadlocked with respect to any decision within the jurisdiction of the CDx JSC
after compliance with the foregoing procedures, [*], and the [*] procedures set forth in [*] and [*] of the CDx Agreement shall apply
as to the decision to be made by the CDx JSC.
2.2
Regulatory Matters.
The Parties agree that, as between Medivation and Astellas, all decisions in
respect of regulatory strategy in relation to any Product (including Regulatory Issues) shall be governed by Articles 2 and 4 and the
other terms and conditions of the Collaboration Agreement, notwithstanding anything to the contrary set forth in the CDx
Agreement, including Section 4.1(b) of the CDx Agreement. In exercising any rights or approvals of Medivation or Astellas
pursuant to the CDx Agreement, each Party shall exercise such right or grant such approval consistent with the foregoing.
2.3
Other Joint decisions, Rights and Actions.
Except as otherwise provided in this Article 2 or in
Article 3 or 9 of this Supplemental Agreement, wherever the CDx Agreement provides for a decision to be made, a right to be
exercised (including a consent right) or an action to be taken, in each case by Medivation and Astellas collectively (excluding any
decision, right or action to be taken by “each of” Medivation and Astellas), and the Parties do not agree on such decision, the
exercise of such right or the taking of such action, then such decision, right or action shall be made, exercised or taken in accordance
with the principles set forth in Section 2.1, except that (i) the concept of casting of the [*] vote at the JSC shall be replaced with the
concept of making such decision, exercising such right or taking such action and (ii) the statement in the last sentence of Section
2.1(c) of this Supplemental Agreement that the “[*] procedures set forth in [*] … of the CDx Agreement shall apply” shall be
disregarded. If the Parties agree in writing on such decision, the exercise of such right or the taking of such action, either Party may
make such decision, exercise such right or take such action for purposes of the CDx Agreement.
2.4
Joint Obligations.
For clarity, when the phrases “Medivation or Astellas” (other than at the end of a
list or as part of any defined term) or “Medivation and Astellas” are used in the CDx Agreement in the context of an obligation to be
performed under the CDx Agreement, and such obligation does not reasonably pertain to only one such Party in the context in which
it is used, both Medivation and Astellas shall be obligated to the other to comply with such obligation.
3
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
2.5
Coordination.
The Parties shall cooperate with each other to implement reasonable procedures to
streamline [*] decisions, actions, rights and obligations under the CDx Agreement in accordance with this Article 2.
ARTIClE
3
AllOCATION
OF
COSTS
3.1
Cost Sharing of Compensation.
As between Medivation and Astellas, all amounts to be paid by
Medivation or Astellas to NanoString under the CDx Agreement (other than Article 14 thereof or for breach thereof), including the
Technology Access Fee (as defined in the CDx Agreement), development costs (including Development Costs (as defined in the
CDx Agreement)), and milestone payments (for purposes of this Supplemental Agreement, any such amounts due to NanoString may
be referred to as “ Compensation
”), shall be paid by Medivation or Astellas to NanoString as provided in this Section 3.1:
(a)
with respect to Compensation consisting of the Technology Access Fee due pursuant
to Section 8.1 of the CDx Agreement and the [*] pursuant to Section 11.1(c) of the CDx Agreement, such amounts shall be paid by
[*] and [*] of such amounts shall be reimbursed by [*];
(b)
with respect to Compensation consisting of Development Costs due pursuant to
Section 8.2 of the CDx Agreement or any additional amounts which may be due pursuant to Section 3.3(b)(ii) of the CDx
Agreement, such amounts shall be paid by [*] and [*] of such amounts shall be reimbursed by [*];
(c)
with respect to Compensation consisting of the milestone payment due pursuant to
Sections 8.3[*] of the CDx Agreement, such amounts shall be paid by [*] and [*] of such amounts shall be reimbursed by Astellas;
(d)
with respect to Compensation consisting of the milestone
Sections 8.3[*] of the CDx Agreement, such amounts shall be paid by [*] and shall [*];
payment
due
pursuant
to
(e)
with respect to Compensation consisting of (i) any milestone payment due pursuant to
the penultimate sentence of Section 8.3 of the CDx Agreement based on [*], and (ii) as set forth in Section 8.6 of the CDx
Agreement, any amounts due to NanoString pursuant to Section 3.7 of the CDx Agreement as reimbursement for costs and expenses
incurred with respect to [*], such amounts shall be paid by [*] and shall [*];
(f)
with respect to Compensation consisting of the [*] due pursuant to Section 12.2 of the
CDx Agreement based on the [*] of the CDx Agreement in the United States as a result of [*] pursuant to Section 9.1 of this
Supplemental Agreement, such amount shall be paid by [*] and [*] of such amount shall be reimbursed by [*];
4
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(g)
with respect to Compensation consist ing of other amounts due to NanoString from
Medivation and Astellas pursuant to the CDx Agreement (excluding for purposes of this Section 3.1(g) (i) any amounts due as
damages or other liability (including an arbitration award) for breach of the CDx Agreem ent by Medivation or Astellas and (ii) any
amounts due pursuant to Section 14.2 or 14.3 of the CDx Agreement), such amounts shall be (A) paid by [*] and [*] shall be
reimbursed by [*] if such amounts that relate to the [*], (B) paid by [*] and [*] shall b e reimbursed by [*] if such amounts relate to
the [*], (C) [*] shall be paid by [*] and [*] if such amounts relate [*], or (D) as the Parties may otherwise agree in writing.
3.2
Right of Payment to NanoString and Related Reimbursement.
Each of Medivation and Astellas
will endeavor to timely pay each Compensation payment due and owing under the CDx Agreement in accordance with the foregoing
cost sharing. However, on account of the joint liability for Compensation set forth in Section 8.6 of the CDx Agreement, each of
Medivation and Astellas may pay any Compensation to NanoString that is due and owing by the other Party to the extent such other
Party has not paid its portion of such Compensation in a timely fashion. In such event, the Party that failed to pay the full amount of
its portion of the Compensation due and owing to NanoString shall promptly reimburse the other Party for any amount paid by such
other Party on the non-paying Party’s behalf or, at the option of such other Party upon notice to the non-paying Party, such other
Party shall have the right to offset any amount that was paid by such other Party on the non-paying Party’s behalf pursuant to this
Section 3.2 against any payments owned by such other Party to the non-paying Party under the Collaboration Agreement or this
Supplemental Agreement.
3.3
Interest. Each of Medivation and Astellas shall bear the full amount of any interest due on any late
payment under Section 8.7 of the CDx Agreement to the extent arising from the portion of the Compensation for which it is
responsible under the Collaboration Agreement.
3.4
Relationship of Section 8.5 of the Cdx Agreement to the Collaboration Agreement. Notwithstanding anything contained in Section 8.5 of the CDx Agreement, as between Astellas and Medivation, with respect to costs
and expenses incurred by such Party in the performance of its obligations under the CDx Agreement in connection with the Project,
if and to the extent such costs and expenses would constitute Joint Commercialization Costs, Joint Development Costs, Joint Medical
Affairs Costs or Manufacturing Costs pursuant to the Collaboration Agreement if incurred by such Party thereunder, such amounts
shall constitute Joint Commercialization Costs, Joint Development Costs, Joint Medical Affairs Costs or Manufacturing Costs, as
applicable, under the Collaboration Agreement and be subject to the terms and conditions thereof.
3.5
Amounts Not Recharacterizable under Collaboration Agreement
. In the case of any costs
identified in Section 3.1 of this Supplemental Agreement, neither Party shall have any right to charge, characterize or recharacterize
such amounts as Joint Development Costs, Joint Medical Affairs Costs or Joint Commercialization Costs under the Collaboration
Agreement.
5
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
ARTIClE
4
INTEllECTuAl
PROPERTy
4.1
Sole
Project
IP
and
Joint
Project
IP.
Subject to Section 4.2:
(a)
Ownership.
The Parties agree that as between MDV and API:
(i)
all Medivation/Astellas Project IP or Joint Project IP that is jointly
conceived, discovered, developed or otherwise made, as necessary to establish authorship, inventorship or ownership under
Applicable Law (hereinafter “ Conceived
”) by either Medivation or Astellas (but not both) and NanoString shall constitute (or be
deemed to constitute) Sole Inventions of the Party that Conceived such Medivation/Astellas Project IP or Joint Project IP;
(ii)
except
as
set
forth
in
section
4.1(a)(i),
all
Medivation/Astellas
Project IP shall constitute (or be deemed to constitute) Joint Inventions of the Parties under the Collaboration Agreement; and
(iii)
ownership
of
all
other
Inventions
Conceived
under
the
CDx
Agreement shall be determined pursuant to Section 10.1 of the Collaboration Agreement as though such other Inventions were
inventions Conceived under the Collaboration Agreement.
(b)
Prosecution of Joint Project IP First Controlled by NanoString. The Parties agree
that, as between MDV and API, with respect to Joint Project IP in which (i) both Medivation and Astellas have a joint interest under
the CDx Agreement and (ii) NanoString has the first right to prepare patent applications covering such Joint Project IP and to file and
Prosecute and Maintain (as defined in the CDx Agreement) such patent applications, and any resulting CDx Joint Patents in any
jurisdiction, if NanoString provides written notice to MDV and API of NanoString’s intent to abandon, cease prosecution or
otherwise not file or maintain any such CDx Joint Patent in any jurisdiction worldwide, MDV’s and API’s rights and obligations to
each other with respect to prosecution and maintenance of such CDx Joint Patent shall be subject to the terms and conditions of the
Collaboration Agreement, including Sections 10.3 and 10.5 thereof, with such CDx Joint Patent treated as a Joint Patent under the
Collaboration Agreement. The rights and obligations between MDV or API, on the one hand, and NanoString, on the other hand,
with respect to such CDx Joint Patents shall continue to be governed by the CDx Agreement.
(c)
Enforcement of Cdx Joint Patents First Controlled by NanoString. The Parties
agree that, as between MDV and API, with respect to CDx Joint Patents in which (i) both Medivation and Astellas have a joint
interest under the CDx Agreement and (ii) NanoString has the first right to bring an appropriate suit or other action to enforce such
CDx Joint Patents against any person or entity allegedly engaged in infringement of such CDx Joint Patents, if NanoString notifies
MDV and API of NanoString’s intent to not so elect (or settle or otherwise secure the abatement of such infringement), then MDV’s
and API’s rights and obligations to
6
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
each other with respect to enforcement of such CDx Joint Patent shall be subject to the terms and conditions of the Collaboration
Agreement, including Sections 10.4 and 10.5 thereof, with such CDx Joint Patent treated as a Joint Patent under the Collaboration
Agreement. The rights and obligations between MDV or API, on the one hand, and NanoString, on the other hand, with respect to
such CDx Joint Patents shall continue to be governed by the CDx Agreement.
4.2
Medivation/Astellas Project data. Notwithstanding anything to the contrary in the Collaboration
Agreement, the Parties agree that as between MDV and API, all Medivation/Astellas Project Data under the CDx Agreement shall
constitute (or be deemed to constitute) a Joint Invention of the Parties under the Collaboration Agreement (whether or not
NanoString also jointly conceived, discovered, developed or otherwise made such Medivation/Astellas Project Data).
4.3
Confirmatory Assignment.
Each Party shall, and does hereby, assign, and shall cause its Affiliates to
so assign, to the other Party, without additional compensation, such right, title and interest in and to any Joint Project IP,
Medivation/Astellas Project IP and Medivation/Astellas Project Data as well as any intellectual property rights with respect thereto,
as is necessary to fully effect any rights of joint ownership provided for in Section 4.1(a) or Section 4.2 of this Supplemental
Agreement. Subject to the licenses and rights of reference granted by a Party to the other Party in the Collaboration Agreement, this
Supplemental Agreement or the CDx Agreement, each Party shall have the right to Exploit any jointly-owned Joint Project IP,
Medivation/Astellas Project IP and Medivation/Astellas Project Data without a duty of seeking consent or accounting to the other
Party.
ARTIClE
5
lICENSES
5.1
licenses to Astellas. Without limitation to the rights and licenses granted by Medivation to Astellas in
the Collaboration Agreement:
(a)
MDV
hereby
grants
to
API
a
non-exclusive,
worldwide,
paid-up,
royalty-free,
sublicensable (through multiple tiers) license under the MDV CDx IP to the extent reasonably necessary or useful for API to perform
its obligations under the CDx Agreement.
(b)
MDV hereby grants to API
a non-exclusive, worldwide, paid-up, royalty-free,
sublicensable (through multiple tiers) license under the MDV CDx IP to the extent reasonably necessary or useful for API to Exploit
any IVD, including any CDx, for use with any Product. The licenses granted in this Section 5.1(b) and in Section 8.1 of the
Collaboration Agreement, include a license for Astellas to Exploit Products with reference to or in conjunction with any IVD,
including the CDx.
(c)
MDV hereby grants to API a perpetual, non-exclusive, worldwide, paid-up, royaltyfree, sublicenseable (through multiple tiers) license and “right of reference” in and to, including the right to cross-reference, file or
incorporate by reference, any regulatory
7
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
documentation or any Regulatory Approvals (as defined in the CDx Agreement) Controlled by MDV with respect to any IVD,
including any CDx, intended for use with any Product, for purposes of the Exploitation of any Product with reference to or in
conjunction with any IVD, including any CDx, and the Exploitation of any IVD, including any CDx, for use with any Product.
5.2
licenses to Medivation.
Medivation in the Collaboration Agreement:
Without limitation to the rights and licenses granted by Astellas to
(a)
API
hereby
grants
to
MDV
a
non-exclusive,
worldwide,
paid-up,
royalty-free,
sublicensable (through multiple tiers) license under the API CDx IP to the extent reasonably necessary or useful for MDV to perform
its obligations under the CDx Agreement.
(b)
API hereby grants to MDV a non-exclusive, paid-up, royalty-free, sublicensable
(through multiple tiers) license, in the Shared Territory, under the API CDx IP to the extent reasonably necessary or useful for MDV
to Exploit any IVD, including any CDx, for use with any Product.
ARTIClE
6
CONFIdENTIAlITy
6.1
Collaboration Agreement governs Confidentiality Obligations.
The Parties hereby agree that this
Section 6.1 shall govern MDV’s and API’s rights and obligations (if any) to each other with respect to any information or materials
that (in the absence of this Section 6.1) qualify as Confidential Information of MDV or API under the CDx Agreement, and that this
Section 6.1 shall apply in lieu of any rights or obligations that Medivation or Astellas would otherwise have to the other pursuant to
Sections 9.1 through 9.4 of the CDx Agreement (Confidentiality) or other terms and conditions of the CDx Agreement that provide
for rights and obligations of Medivation or Astellas in relation to the other, with respect to Confidential Information of MDV or API
under the CDx Agreement. In the case of any information or materials that (in the absence of this Section 6.1) qualify as
“Confidential Information” of Medivation or Astellas pursuant to the CDx Agreement, as between Medivation and Astellas, such
information and material shall constitute (or be deemed to constitute) “Confidential Information” of the applicable Party under the
Collaboration Agreement only if and to the extent such information or materials would qualify as Confidential Information under the
Collaboration Agreement if disclosed by Medivation or Astellas to the other under the Collaboration Agreement. Any such
information or material that so qualifies shall be subject to Article 13 of the Collaboration Agreement. The rights and obligations
between MDV or API, on the one hand, and NanoString, on the other hand, with respect to Confidential Information (as defined in
the CDx Agreement) shall continue to be governed by the CDx Agreement.
6.2
Medivation/Astellas Project data. Without limiting Section 4.2, as between the Parties, all
Medivation/Astellas Project Data under the CDx Agreement is hereby deemed Product Information under the Collaboration
Agreement, regardless of whether or not such
8
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Medivation/Astellas Project Data relates specifically to Collaboration Molecules or Products, or the Exploitation thereof. MDV’s
and API’s rights and obligations to each other with respect to such Medivation/Astellas Project Data shall be subject to the terms and
conditions of the Collaboration Agreement, to the same extent as if such Medivation/Astellas Project Data were Product Information
under the Collaboration Agreement. The rights and obligations between MDV or API, on the one hand, and NanoString, on the
other hand, with respect to Medivation/Astellas Project Data shall continue to be governed by the CDx Agreement.
ARTIClE
7
INdEMNIFICATION
ANd
lIMITATION
OF
lIABIlITy
7.1
Indemnification of NanoString by Medivation and Astellas.
obligated to indemnify NanoString under Article 14 of the CDx Agreement:
If either Medivation or Astellas are
(a)
to the extent the Losses under the CDx Agreement for which such indemnification is
owing (or has been provided) constitute Shared Program Damages under the Collaboration Agreement, such Losses shall be borne
equally by each of Medivation and Astellas to the extent provided by Section 12.4 of the Collaboration Agreement;
(b)
to the extent the Losses under the CDx Agreement for which such indemnification is
owing (or has been provided) would constitute Astellas Damages resulting from Astellas Claims subject to indemnification by
Medivation under Section 12.1 of the Collaboration Agreement, such Losses shall be borne by Medivation to the extent provided in
Article 12 of the Collaboration Agreement; and
(c)
to the extent the Losses under the CDx Agreement for which such indemnification is
owing (or has been provided) would constitute Medivation Damages resulting from Medivation Claims subject to indemnification by
Astellas under Section 12.2 of the Collaboration Agreement, such Losses shall be borne by Astellas to the extent provided in Article
12 of the Collaboration Agreement.
7.2
Indemnification of Medivation by Astellas.
In order to provide for indemnification of Medivation
Indemnitees by Astellas for certain matters in relation to the CDx Agreement:
(a)
Article 1 of the Collaboration Agreement shall be amended to add to the following
defined term: “ NanoString Agreement
” means the Collaboration Agreement dated as of January 6, 2016, by and among
NanoString Technologies, Inc., Medivation and Astellas.”;
(b)
Section 12.2(b) of the Collaboration Agreement is hereby
following, before the semicolon and after “this Agreement”: “or under the NanoString Agreement”;
amended
to
add
the
9
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(c)
Section 12.2(c) of the Collaboration Agreement is hereby amended to add the
following, before the semicolon and after “Sublicensees”: “in performing its obligations or exercising its rights under this
Agreement or the NanoString Agreement”; and
(d)
Section 12.2(d) of the Collaboration Agreement is hereby amended to add the
following, before the semicolon and after “Sublicensees”: “in performing its obligations or exercising its rights under this
Agreement or the NanoString Agreement”.
7.3
Indemnification of Astellas by Medivation.
In order to provide for indemnification of Astellas
Indemnitees by Medivation for certain matters in relation to the CDx Agreement:
(a)
Section 12.1(a)(i) is hereby amended
after “this Agreement”: “or under the NanoString Agreement”;
to
add
the
following,
before
the
semicolon
and
(b)
Section 12.1(a)(ii) of the Collaboration Agreement is hereby amended to add the
following, before the semicolon and after “sublicensees”: “in performing its obligations or exercising its rights under this Agreement
or the NanoString Agreement”; and
(c)
Section 12.2(a)(iv) of the Collaboration Agreement is hereby amended to add the
following, before the semicolon and after “sublicensees”: “in performing its obligations or exercising its rights under this Agreement
or the NanoString Agreement”.
7.4
Shared Program Activities / Shared Program damages.
For purposes of this Supplemental
Agreement and the Collaboration Agreement, “Shared Program Activities” shall have the meaning set forth in the Collaboration
Agreement, provided
that activities with respect to a Collaboration Molecule or Product shall be understood to include activities with
respect to a Product that consist of activities directed to the development or commercialization of (i) the CDx for use with the
Product or (ii) the Product for use in conjunction with the CDx.
7.5
Other Claims Between the Parties.
As between Medivation and Astellas, the [*] contained in Section
14.8 of the CDx Agreement (including [*] set forth therein) shall not apply to any claim, suit, proceeding or cause of action between
Astellas and Medivation arising under or in connection with the Collaboration Agreement and/or the CDx Agreement, it being
agreed that that Astellas and Medivation shall be subject only to the limitations on liability set forth in the Collaboration Agreement
(including Section 16.11 thereof) with respect to any claim, suit, proceeding or cause of action between the Parties arising under or in
connection with the CDx Agreement and/or the Collaboration Agreement.
ARTIClE
8
dISPuTE
RESOluTION
8.1
Coordination.
To the extent there are related disputes under the Collaboration Agreement and the CDx
Agreement that in each case have been referred to [*], the Parties will
10
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
endeavor to coordinate the resolution of all such disputes, including to the extent practicable by having the same [*] determine the
disputed matters in similar timeframes.
8.2
Resolution of disputes.
Each of Medivation and Astellas agree that, except to the extent relating to
the CDx, involving NanoString, or arising from a breach of the CDx Agreement, disputes between Medivation and Astellas
(including in respect of Clinical Trials) shall to the extent practicable be resolved in accordance with the Collaboration Agreement
rather than the CDx Agreement.
ARTIClE
9
TERMINATION
MATTERS
9.1
Exercise of Right of
[*] under the Cdx Agreement. The Parties acknowledge that, pursuant to
Section 12.2 of the CDx Agreement, Medivation and Astellas jointly have the right to [*] the CDx Agreement with respect to [*]
upon [*] written notice to NanoString. Notwithstanding the joint nature of this right, in the event that [*] notifies [*] in writing that
[*] desires to [*] the CDx Agreement [*], [*] shall cooperate with [*] and deliver to NanoString the notice required pursuant to
Section 12.2 of the CDx Agreement to effect [*]. [*] shall provide such notice to NanoString jointly with [*] no more than [*] after
receipt of notice from [*] requesting same.
ARTIClE
10
MISCEllANEOuS
10.1
Ownership of nCounter Systems.
The Parties agree that they shall jointly own (in equal shares) and
hold title to the nCounter systems purchased under Section 8.2(a)(iii)(A) of the CDx Agreement.
10.2
Coordination of Audits.
The Parties agree that they shall use good faith efforts to coordinate audits
under Section 6.2 of the CDx Agreement, including to take account of audits required in support of Exploitation of the CDx in
conjunction with the Product in the United States and the Licensed Territory. Furthermore, the [*] permitted under Section 6.2(b) of
the CDx Agreement shall be allocated as follows: (a) during the Initial Clinical Trial, Medivation shall have the right to appoint [*]
and Astellas shall have the right to appoint [*]; and (b) upon Commercialization and thereafter, Medivation shall have the right to
appoint [*] and Astellas shall have the right to appoint [*].
10.3
Medivation Affiliates. Medivation, Inc. shall cause its Affiliates (as defined in the CDx Agreement
as parties to the CDx Agreement) to be bound by the terms and conditions of this Supplemental Agreement.
10.4
Entire Agreement; Amendment
.
This Supplemental Agreement, together with the terms and
conditions of the CDx Agreement that contain rights and obligations of MDV and
11
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
API in relation to one another, and the Collaboration Agreement, sets forth the complete, final and exclusive agreement and all th e
covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto with respect
to the subject matter hereof and supersede all prior agreements and understandings between the Parties existing as of the Effective
Date with respect to the subject matter hereof. Notwithstanding the preceding sentence, the Parties intend for the CDx Agreement
and the Collaboration Agreement to remain in full force and effect, subject to the terms and conditions of this Supp lemental
Agreement. No subsequent alteration, amendment, change or addition to this Supplemental Agreement shall be binding upon the
Parties unless reduced to writing and signed by an authorized officer of each Party.
10.5
Assignment. Neither Party may assign or transfer this Supplemental Agreement or any rights or
obligations hereunder without the prior written consent of the other, except that a Party may make such an assignment without the
other Party’s consent to Affiliates or to a successor to which such Party assigns its rights and obligations under the Collaboration
Agreement in accordance with the terms and conditions thereof. Any permitted successor or assignee of rights and/or obligations
hereunder shall, in a writing to the other Party, expressly assume such rights and/or obligations (and in any event, any Party
assigning this Supplemental Agreement to an Affiliate shall remain bound by the terms and conditions hereof). Any permitted
assignment shall be binding on the successors of the assigning Party. Any assignment or attempted assignment by either Party in
violation of the terms of this Section 10.5 shall be null, void and of no legal effect.
10.6
Other Provisions. Sections 16.2 (Force Majeure), 16.3 (Notices), 16.4 (No Strict Construction;
Headings), 16.8 (Performance by Affiliates), 16.9 (Further Actions), 16.12 (Severability), 16.13 (No Waiver), 16.14 (Independent
Contractors) and 16.15 (Counterparts), of the Collaboration Agreement, and Article 15 (Dispute Resolution) of the Collaboration
Agreement, shall apply to this Supplemental Agreement on a mutatis
mutandis
basis.
[Signature
Page
Follows]
12
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
IN
WITNESS
WhEREOF,
the Parties have executed this Supplemental Agreement in duplicate originals by their duly authorized officers
as of the Effective Date.
MEdIvATION,
INC.
(ON
BEhAlF
OF
ITSElF
ANd
ITS
AFFIlIATES
(AS
dEFINEd
IN
ThE
CdX
AgREEMENT))
/s/ Andrew Powell
By:
ASTEllAS
PhARMA
INC.
By:
Name:
Andrew Powell
Name:
Title:
Secretary
Title:
MEdIvATION
PROSTATE
ThERAPEuTICS,
INC.
/s/ Andrew Powell
By:
ASTEllAS
uS
llC
By:
Name:
Andrew Powell
Name:
Title:
Secretary
Title:
SUPPLEMENTAL AGREEMENT
IN
WITNESS
WhEREOF,
the Parties have executed this Supplemental Agreement in duplicate originals by their duly authorized officers
as of the Effective Date.
MEdIvATION,
INC.
(ON
BEhAlF
OF
ITSElF
ANd
ITS
AFFIlIATES
(AS
dEFINEd
IN
ThE
CdX
AgREEMENT))
By:
ASTEllAS
PhARMA
INC.
By:
/s/ Chihiro Yokota
Name:
Name:
Chihiro Yokota
Title:
Title:
Executive Vice President
MEdIvATION
PROSTATE
ThERAPEuTICS,
INC.
By:
ASTEllAS
uS
llC
By:
Name:
Name:
Title:
Title:
SUPPLEMENTAL AGREEMENT
IN
WITNESS
WhEREOF,
the Parties have executed this Supplemental Agreement in duplicate originals by their duly authorized officers
as of the Effective Date.
MEdIvATION,
INC.
(ON
BEhAlF
OF
ITSElF
ANd
ITS
AFFIlIATES
(AS
dEFINEd
IN
ThE
CdX
AgREEMENT))
By:
ASTEllAS
PhARMA
INC.
By:
Name:
Name:
Title:
Title:
MEdIvATION
PROSTATE
ThERAPEuTICS,
INC.
By:
ASTEllAS
uS
llC
By:
/s/ Masao Yoshida
Name:
Name:
Masao Yoshida
Title:
Title:
President and CEO
SUPPLEMENTAL AGREEMENT
Exhibit
10.33
EXECuTION
COPy
AMENDMENT NO. 1
Dated as of November 13, 2015
to
AMENDED AND RESTATED CREDIT AGREEMENT
Dated as of October 23, 2015
THIS AMENDMENT NO. 1 (this “ Amendment ”) is made as of November 13, 2015 by and among Medivation, Inc., a
Delaware corporation (the “ Borrower ”), the financial institutions listed on the signature pages hereof and JPMorgan Chase Bank, N.A., as
Administrative Agent (the “ Administrative Agent ”), under that certain Amended and Restated Credit Agreement dated as of October 23,
2015 by and among the Borrower, the Lenders and the Administrative Agent (as amended, restated, supplemented or otherwise modified from
time to time, the “ Credit Agreement ”). Capitalized terms used herein and not otherwise defined herein shall have the respective meanings
given to them in the Credit Agreement.
WHEREAS, the Borrower has requested that the requisite Lenders and the Administrative Agent agree to certain
amendments to the Credit Agreement;
WHEREAS, the Borrower, the Lenders party hereto and the Administrative Agent have so agreed on the terms and
conditions set forth herein;
NOW, THEREFORE, in consideration of the premises set forth above, the terms and conditions contained herein, and
other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Borrower, the Lenders party hereto
and the Administrative Agent hereby agree to enter into this Amendment.
1. Amendments to the Credit Agreement . Effective as of the date of satisfaction of the conditions precedent set forth in
Section 2 below, the parties hereto agree that the Credit Agreement is hereby amended as follows:
(a) Section 1.01 of the Credit Agreement is amended to add the following definition thereto in the appropriate
alphabetical order:
“ Specified Prepayment ” means those certain payments in respect of the 2.625% convertible senior notes due
April 1, 2017 made by the Borrower on or about July 24, 2015 in the principal amount of $167,800,000.
(b) The definition of “ Excess Cash Flow ” appearing in Section 1.01 of the Credit Agreement is hereby restated in its
entirety as follows:
“ Excess Cash Flow ” means, for any period, the excess, if any, of (a) the sum, without duplication, of (i)
Consolidated Net Income for such period, (ii) the amount of all non-
cash charges (including depreciation and amortization) deducted in determining such Consolidated Net Income, and (iii) the
aggregate net amount of non-cash loss on the disposition of pr operty by the Borrower and its Subsidiaries during such period
(other than sales of inventory in the ordinary course of business), to the extent deducted in arriving at such Consolidated Net
Income, minus (b) the sum, without duplication, of (i) the amount of all non-cash credits included in determining such
Consolidated Net Income, (ii) the aggregate amount paid by the Borrower and its Subsidiaries during such period on account of
Consolidated Capital Expenditures, excluding any amount funded with proceeds from the issuance of Funded Indebtedness (other
than Revolving Loans or intercompany loans), (iii) the aggregate amount of all principal payments of Indebtedness of the Borrower
and its Subsidiaries (including the principal component of Capital Lease Obli gations, but excluding (x) any such Indebtedness to
the extent refinanced with, converted into or exchanged for, Funded Indebtedness (other than Revolving Loans or intercompany
loans) and/or Equity Interests of the Borrower, (y) all prepayments of Revolvin g Loans made during such period and (z) all
prepayments under any other revolving credit facility, except in the case of this clause (z), to the extent there is not an equivalent
permanent reduction in commitments thereunder) made during such period, excep t to the extent financed with the proceeds of an
incurrence or issuance of other Indebtedness (other than Revolving Loans) of the Borrower or its Subsidiaries and (iv) the
aggregate net amount of non-cash gain on the disposition of property by the Borrower and its Subsidiaries during such period
(other than sales of inventory in the ordinary course of business), to the extent included in determining such Consolidated Net
Income. Notwithstanding the foregoing, it is hereby understood and agreed that Excess Cash Flow shall be calculated without
giving effect to the Specified Prepayment.
2. Conditions of Effectiveness . The effectiveness of this Amendment is subject to the conditions precedent that the
Administrative Agent shall have received (i) counterparts of this Amendment duly executed by the Borrower, the Required Lenders and the
Administrative Agent, (ii) counterparts of the Consent and Reaffirmation attached as Exhibit A hereto duly executed by the Subsidiary
Guarantors and (iii) payment and/or reimbursement of the Administrative Agent’s and its affiliates’ reasonable and documented out-of-pocket
expenses (including, to the extent invoiced, reasonable and documented fees and expenses of counsel for the Administrative Agent) in
connection with the Loan Documents.
3. Representations and Warranties of the Borrower . The Borrower hereby represents and warrants as follows:
(a) This Amendment and the Credit Agreement as modified hereby constitute legal, valid and binding obligations of the
Borrower and are enforceable in accordance with their terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium or
other laws affecting creditors’ rights generally and subject to general principles of equity, regardless of whether considered in a proceeding in
equity or at law.
(b) As of the date hereof and after giving effect to the terms of this Amendment, (i) no Default or Event of Default has
occurred and is continuing and (ii) the representations and warranties of the Borrower set forth in the Credit Agreement, as amended hereby,
are true and correct in all material respects (or, if qualified by materiality or “Material Adverse Effect”, in all respects), except to the extent
that such representations and warranties specifically refer to an earlier date, in which case they are true and correct in all material respects (or,
in the case of any representation or warranty qualified by materiality or Material Adverse Effect, in all respects) as of such earlier date.
4. Reference to and Effect on the Credit Agreement .
2
(a) Upon the effectiveness hereof, each reference to the Credit Agreement in the Credit Agreement or any other Loan
Document shall mean and be a reference to the Credit Agreement as amended hereby.
(b) Each Loan Document and all other documents, instruments and agreements executed and/or delivered in connection
therewith shall remain in full force and effect and are hereby ratified and confirmed.
(c) Except with respect to the subject matter hereof, the execution, delivery and effectiveness of this Amendment shall
not operate as a waiver of any right, power or remedy of the Administrative Agent or the Lenders, nor constitute a waiver of any provision of
the Credit Agreement, the Loan Documents or any other documents, instruments and agreements executed and/or delivered in connection
therewith.
(d) This Amendment is a Loan Document under (and as defined in) the Credit Agreement.
5. Governing Law . This Amendment shall be construed in accordance with and governed by the law of the State of
New York.
6. Headings . Section headings in this Amendment are included herein for convenience of reference only and shall not
constitute a part of this Amendment for any other purpose.
7. Counterparts . This Amendment may be executed by one or more of the parties hereto on any number of separate
counterparts, and all of said counterparts taken together shall be deemed to constitute one and the same instrument. Delivery of an executed
counterpart of a signature page of this Amendment by telecopy, e-mailed.pdf or any other electronic means that reproduces an image of the
actual executed signature page shall be effective as delivery of a manually executed counterpart of this Amendment.
[Signature Pages Follow]
3
IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed and delivered by their
respective authorized officers as of the day and year first above written.
MEDIVATION, INC.,
as the Borrower
By:
/s/
Richard
A.
Bierly
Name: Richard a. Bierly
Title: CFO
Signature Page to Amendment No. 1 to
Amended and Restated Credit Agreement dated as of October 23, 2015
Medivation, Inc.
JPMORGAN CHASE BANK, N.A.,
individually as a Lender and as Administrative Agent
By:
/s/ Alex Rogin
Name: Alex Rogin
Title: Vice President
Signature Page to Amendment No. 1 to
Amended and Restated Credit Agreement dated as of October 23, 2015
Medivation, Inc.
CITIBANK, N.A.,
as a Lender
By:
/s/ Marni McManus
Name: Marni McManus
Title: Vice President
Signature Page to Amendment No. 1 to
Amended and Restated Credit Agreement dated as of October 23, 2015
Medivation, Inc.
BANK OF AMERICA, N.A.,
as a Lender
By:
Name:
Title:
/s/ John C. Plecque
John C. Plecque
Senior Vice President
Signature Page to Amendment No. 1 to
Amended and Restated Credit Agreement dated as of October 23, 2015
Medivation, Inc.
BARCLAYS BANK PLC,
as a Lender
By:
Name:
Title:
/s/ Mathew Cybul
Mathew Cybul
Assistant Vice President
Signature Page to Amendment No. 1 to
Amended and Restated Credit Agreement dated as of October 23, 2015
Medivation, Inc.
MUFG UNION BANK, N.A.,
as a Lender
By:
Name:
Title:
/s/ Pierre Bury
Pierre Bury
Director
Signature Page to Amendment No. 1 to
Amended and Restated Credit Agreement dated as of October 23, 2015
Medivation, Inc.
ROYAL BANK OF CANADA,
as a Lender
By:
Name:
Title:
/s/ Dean Sas
Dean Sas
Authorized Signatory
Signature Page to Amendment No. 1 to
Amended and Restated Credit Agreement dated as of October 23, 2015
Medivation, Inc.
SILICON VALLEY BANK,
as a Lender
By:
Name:
Title:
/s/ Jackie Spencer
Jackie Spencer
Director
Signature Page to Amendment No. 1 to
Amended and Restated Credit Agreement dated as of October 23, 2015
Medivation, Inc.
EXhIBIT
A
Consent and Reaffirmation
Each of the undersigned hereby acknowledges receipt of a copy of the foregoing Amendment No. 1 to the Amended and
Restated Credit Agreement (as the same may be amended, restated, supplemented or otherwise modified from time to time, the “ Credit
Agreement ”), dated as of October 23, 2015, by and among Medivation, Inc., a Delaware corporation (the “ Borrower ”), the Lenders and
JPMorgan Chase Bank, N.A., as Administrative Agent (the “ Administrative Agent ”), which Amendment No. 1 is dated as of November 13,
2015 and is by and among the Borrower, the financial institutions listed on the signature pages thereof and the Administrative Agent (the “
Amendment ”). Capitalized terms used in this Consent and Reaffirmation and not defined herein shall have the meanings given to them in the
Credit Agreement. Without in any way establishing a course of dealing by the Administrative Agent or any Lender, each of the undersigned
consents to the Amendment and reaffirms the terms and conditions of the Subsidiary Guaranty and any other Loan Document executed by it
and acknowledges and agrees that the Subsidiary Guaranty and each and every such Loan Document executed by the undersigned in
connection with the Credit Agreement remains in full force and effect and is hereby reaffirmed, ratified and confirmed. All references to the
Credit Agreement contained in the above‑referenced documents shall be a reference to the Credit Agreement as so modified by the
Amendment and as the same may from time to time hereafter be amended, modified or restated.
Dated November 13, 2015
[Signature Page Follows]
IN WITNESS WHEREOF, this Consent and Reaffirmation has been duly executed and delivered as of the day and year
above written .
MEDIVATION FIELD SOLUTIONS, INC.
By:
/s/ Richard A. Bierly
Name: Richard A. Bierly
Title: CFO
MEDIVATION NEUROLOGY, INC.
By:
/s/ Richard A. Bierly
Name: Richard A. Bierly
Title: CFO
MEDIVATION PROSTATE THERAPEUTICS, INC.
By:
/s/ Richard A. Bierly
Name: Richard A. Bierly
Title: CFO
MEDIVATION SERVICES, INC.
By:
/s/ Richard A. Bierly
Name: Richard A. Bierly
Title: CFO
MEDIVATION TECHNOLOGIES, INC.
By:
/s/ Richard A. Bierly
Name: Richard A. Bierly
Title: CFO
Signature Page to Consent and Reaffirmation to Amendment No. 1 to
Amended and Restated Credit Agreement dated as of October 23, 2015
Medivation, Inc.
Exhibit
10.50
January 6, 2016
Marion E. McCourt
[Address]
Dear Marion:
It is my great pleasure to offer you the position of Chief Operating Officer, reporting to David Hung, President, and Chief Executive Officer.
We are very excited about the possibility of you joining our team, and we look forward to the prospect of working with you in our innovative
company!
As an employee of Medivation Inc., (the Company) you will be eligible to participate in our benefits and compensation programs. The
following outlines the terms of our offer:
Your annualized base salary will be $575,000 payable on the 15 th and last day of each month.
Medivation will pay you up to a $200,000 signing bonus within thirty days of your employment start date, to make up for any shortfall from
$392,000 in the event that you do not receive your full anticipated 2015 bonus from your current employer. If you voluntarily terminate your
employment with us before the first anniversary of your employment start date, you agree to repay this signing bonus to Medivation on or
before your termination date.
Employees who join the Company between January 1 and September 30 th will be eligible for a prorated bonus for their first year of
employment. Bonuses are generally paid in the first quarter, following year that the bonus was earned. As such, you will be eligible for the
2016 corporate bonus paid out in the first quarter of 2017. The target bonus opportunity for your position is 60% of your base salary. The
actual payout can vary based on your individual and company performance. The Board of Directors makes an assessment of company
achievement against goals for purposes of annual bonus payouts generally in the first quarter of the following year. You will be a participant
in any 2016 162M Bonus Program for Section 16 Officers that may be adopted by the Board of Directors.
We will recommend to Medivation’s Board of Directors or their designee that you be granted an option to purchase 80,905 shares of
Medivation common stock and 40,453 restricted stock units (RSU’s). Upon vesting, each RSU will entitle you to receive one share of
Medivation common stock.
Your options will have an exercise price equal to the fair market value of the shares, on the date the option is granted (as determined in
accordance with Medivation’s Stock Option Grant Date Policy). The terms of your options will be governed in all respects by the terms of our
2004 Equity Incentive Award Plan and the stock option agreements. Your options will vest over a four-year period – 25% at the end of the
first year, then 1/48 th monthly thereafter over the ensuing three years. Your RSUs will vest over a three year period – one third on each of
approximately the first, second and third anniversaries of the grant date. In the event there is a change of control of Medivation, your options
would fully vest and become exercisable, and your RSUs would fully vest, automatically upon the occurrence of that event.
525
Market
Street,
36th
floor
San
Francisco,
CA
94105
(415)
543-3470
Fax
(415)
543-3411
www.medivation.com
The Board of Directors or their designee generally con siders and approves new hire grants according to Medivation, Inc. policy. Your
options and RSUs will be submitted for Board approval following your first date of employment. A stock option agreement will be provided
to you, after the Board of Directors has approved your grant. In addition, you may be eligible for future annual equity grants under the Plan
based on the level of your position and your performance. Annual grants are typically made in the first quarter, of the year following a
performance evalu ation. Employees must be on board by September 30 th , in order to be eligible for an annual grant.
Upon your decision to relocate to the San Francisco Bay Area, you will be eligible for the Medivation Relocation Program. Relocation
benefits under this Plan are tailored to meet the needs of the relocating employee, within the guidelines of our Policy. The attached Relocation
document outlines the benefits that will be provided to you. All payments are grossed up for state and Federal taxes. If you voluntarily
terminate your employment with us before the second anniversary of your employment start date, you agree to repay the relocation costs to
Medivation on or before your termination date. You are required to use the relocation package, within one year of your start date.
In addition, to assist you in your relocation to the Bay Area, the company will provide you with a relocation allowance of $25,000 net;
meaning this amount will be grossed up for State and Federal taxes.
As an employee of the Company you will be eligible to enroll in our comprehensive benefits program that includes health, dental, vision,
basic life and basic personal accident insurance. Details of our benefits plans will be provided during your onboarding process and in the new
hire orientation. I am also pleased to respond to any questions you may have regarding Medivation benefits as you consider our offer. All
Medivation benefits are re-evaluated on an annual basis and are subject to change.
Paid Time Off (PTO) is an important benefit for all of our employees. For your position and subject to the timely completion of your job
responsibilities, PTO may be utilized at your discretion, with supervisory approval.
The Company offers a 401(k) plan with an employer match that provides you with the opportunity for pre- or post-tax, long-term savings.
You may contribute up to the federal maximum, which is currently $18,000.
In addition, the Company offers an Employee Stock Purchase Plan (ESPP) - ESPP is a voluntary benefit that allows eligible employees to
purchase shares of Medivation common stock at a discount through after tax payroll deductions. Eligible employees must enroll during the
designated enrollment period. Additional information including a Prospectus and online enrollment instructions will be provided after your
date of employment.
As a result of the 1986 Immigration Reform and Control Act, we are required to verify the identity and work authorization of all new
employees. You will therefore be required to sign the Employment Eligibility Verification (Form I-9). We will need to examine original
documents that satisfy these verification requirements, within 24 hours of your employment start date. This offer of employment is contingent
upon your providing the necessary documentation within that period.
You will abide by the Company’s strict policy that prohibits any new employee from using or bringing with him/her all prior employers’
proprietary information, trade secrets, proprietary materials, and/or processes. Upon starting employment with Medivation Inc., you will be
required to
sign an Employee Confidentiality and Invention Assignment Agreement indicating, among other things, your agreement wit h this policy.
Employees are expected to devote all professional work time to the Company. If you would like to request an exception for special
circumstances, you will need to obtain written permission from your manager.
By signing below you are indicating your understanding that should you accept a position at Medivation the employment relationship is based
on the mutual consent of the employee and the Company. Accordingly, either you or the Company can terminate the employment relationship
at will, at any time, with or without cause or advance notice.
This offer of employment is effective for 3 business days from the date of this letter and is contingent upon satisfactory completion of
references and a background check. If all of the foregoing is satisfactory, please sign, date, and return the letter, within 3 business days. Please
label the envelope attention Human Resources and mail it to Medivation, 525 Market Street 36 th Floor, and San Francisco, CA 94105. If you
prefer, you may scan and email your signed offer letter to [email protected]
Marion, we are all enthusiastic about welcoming you to the Company and look forward to you joining our team.
Sincerely,
/s/ Sandy Cooper
Sandy Cooper
Senior Vice President, Human Resources
I accept employment with the Company on the foregoing terms.
/s/ Marion McCourt
Marion McCourt
1/7/16
Date Signed
2/1/16
Anticipated Start Date
E
xhibit
10.51
MEdIvATION,
INC.
AMENdEd
ANd
RESTATEd
2004
EquITy
INCENTIvE
AWARd
PlAN
PERFORMANCE
ShARE
uNIT
gRANT
NOTICE
Medivation, Inc. (the “ Company
”), pursuant to its Amended and Restated 2004 Equity Incentive Award Plan, as amended from time
to time (the “ Plan
”), hereby awards to Participant a Performance Share Unit award for the number of performance share units (“ Share
Units
”) set forth below (the “ Award
”). The Award is subject to all of the terms and conditions as set forth in this Performance Share Unit
Grant Notice (the “ Grant
Notice
”) and in the Plan and the Performance Share Unit Agreement (which is attached hereto as Attachment I),
both of which are incorporated herein in their entirety. Capitalized terms not otherwise defined herein shall have the meanings set forth in the
Plan or the Performance Share Unit Agreement.
Participant:
Date of Grant:
Maximum Number of Share Units
Subject to Award:
Performance Period:
As set forth below.
Performance
Metrics,
Performance
Period
and
vesting
Terms
:
described below:
Share Units subject to the Award shall be earned and vested as
[insert
performance
vesting
metrics
and
terms
or
state
“See
Exhibit
A”;
may
include
minimum,
target
and
maximum
levels
of
achievement
triggering
the
vesting
of
different
numbers
of
Share
Units]
In order for the goals above to be considered to have been met and for the related Share Units to be vested, the Committee must have certified
the achievement of such goals. The certification date shall be considered the vesting date with respect to the Share Units to which such
certification relates. Such certification shall occur in a manner that is in compliance with the requirements of Section 162(m) of the Code to
the extent necessary to comply with Section 162(m) of the Code. Subject to the terms of this Grant Notice and the Performance Share Unit
Agreement, settlement of the Share Units is contingent upon the Participant remaining in the service of the Company or a Subsidiary through
the settlement date. Share Units not earned during the relevant performance period set forth above will be forfeited.
Issuance
Schedule
:
Subject to any adjustments pursuant to Section 11.1 of the Plan, one share of Stock will be issued for each Share
Unit that ve sts in accordance with the schedule set forth in Section 6 of the Performance Share Unit Agreement.
definitions
:
For purposes of the Grant Notice and the Performance Share Unit Agreement, “ Termination
of
Service
” means that
Participant’s service with the Company or a Subsidiary in all capacities, whether as an employee, director and/or consultant, has been
materially interrupted or terminated. A change in the capacity in which Participant renders service to the Company or a Subsidiary as an
employee, director and/or consultant, or a change in the entity for which Participant renders such service, provided that there is no material
interruption or termination of Participant’s service with the Company or a Subsidiary, shall not be a Termination of Service; provided,
however
, that if the only entity for which Participant is rendering services ceases to qualify as a Subsidiary, as determined by the Board, in its
sole discretion, Participant shall be considered to have a Termination of Service on the date such entity ceases to qualify as a Subsidiary. To
the extent permitted by law and subject to the Plan, the Board or the chief executive officer of the Company, in that party’s sole discretion,
may determine whether service shall be considered materially interrupted or terminated in the case of (i) any leave of absence
approved by the Board or chief executive officer, including sick leave, military leave or any other personal leave, or (ii) transfers between the
Company, a Subsidiary, or their successors. Any suc h determination shall be made in compliance with Section 422 of the Code. Notwithstanding any other provision of the Plan or the Grant Notice or the Performance Share Unit Agreement, the Company or any
Subsidiary has an absolute and unrestricted right to terminate Participant’s employment and/or services at any time for any reason
whatsoever, with or without Cause, except to the extent expressly provided otherwise in a written agreement between the Company or a
Subsidiary and Participant.
For purposes of the Grant Notice and the Performance Share Unit Agreement, “ Cause
” will have the meaning ascribed to such term in any
written employment or severance agreement between Participant and the Company or any Subsidiary defining such term and, in the absence
of such agreement, such term means, with respect to Participant, the occurrence of any of the following events: (i) Participant’s commission
of any felony or any crime involving fraud, dishonesty or moral turpitude under the laws of the United States or any st ate thereof; (ii)
Participant’s attempted commission of, or participation in, a fraud or act of dishonesty against the Company or any of its Subsidiaries; (iii)
Participant’s intentional, material violation of any contract or agreement between Participant and the Company or any of its Subsidiaries or of
any statutory duty owed to the Company or any of its Subsidiaries; (iv) Participant’s unauthorized use or disclosure of the confidential
information or trade secrets of the Company or any of its Subsidiaries; or (v) Participant’s gross misconduct. The determination that
Participant’s Termination of Service is either for Cause or without Cause will be made by the Company, in its sole discretion. Any
determination by the Company that Participant’s Termination of Service was for Cause or without Cause for the purposes of outstanding
Share Units held by Participant will have no effect upon any determination of the rights or obligations of the Company or Participant for any
other purpose.
Sale
to
Cover
Withholding
Taxes
: Unless Participant qualifies to make a payment election (“ Payment
Election
”) under the Company’s
Policy regarding the Payment of Withholding Taxes Due and Payable upon vesting of Awards of Restricted Stock or Restricted Stock
Units
(the “ Withholding
Policy
”) and duly makes such Payment Election in accordance with such Withholding Policy, by acceptance of this
Award Participant agrees that any Withholding Taxes will be satisfied, to the fullest extent permitted under the Plan and applicable law,
through the sale of a number of the shares subject to the Award as determined in accordance with Section 10 of the Performance Share Unit
Agreement and the remittance of the cash proceeds to the Company. Under the Performance Share Unit Agreement , the Company is
authorized and directed by Participant to make payment from the cash proceeds of this sale directly to the appropriate taxing authorities in an
amount equal to the taxes required to be withheld.
Additional
Terms/Acknowledgements
: Participant acknowledges receipt of, and understands and agrees to the terms of the Grant Notice,
the Performance Share Unit Agreement and the Plan (together, the “ Award
Documents
”). Participant further acknowledges that as of the
Date of Grant, the Award Documents set forth the entire understanding between Participant and the Company regarding the Award and
supersede all prior oral and written agreements on that subject, with the exception, if applicable, of (i) any employment or severance
arrangement that would provide for vesting acceleration of the Award upon the terms and conditions set forth therein, and (ii) any
compensation recovery policy that is adopted by the Company or is otherwise required by applicable law.
By accepting the Award, Participant acknowledges having received and read the Award Documents and agrees to all of the terms and
conditions set forth in such documents. Participant consents to receive Award Documents by electronic delivery and to participate in the Plan
through an on-line or electronic system established and maintained by the Company or another third party designated by the
Company. Participant may designate receipt and acceptance of the Award and the terms of the Award Documents via electronic confirmation
in accordance with instructions that accompany delivery of the Grant Notice and Performance Share Unit Agreement by the Company or an
authorized representative of the Company to Participant.
Attachment
I
MEdIvATION,
INC.
AMENdEd
ANd
RESTATEd
2004
EquITy
INCENTIvE
AWARd
PlAN
PERFORMANCE
ShARE
uNIT
AgREEMENT
Pursuant to the Performance Share Unit Grant Notice and this Performance Share Unit Agreement and in consideration of your
services, Medivation, Inc. (the “ Company
”) has awarded you a Performance Share Unit award (the “ Award
”) under its Amended and
Restated 2004 Equity Incentive Award Plan (the “ Plan
”). Your Award is granted to you effective as of the Date of Grant set forth in the
Grant Notice for this Award. You agree that your electronic acceptance of the Award in the manner set forth in the Grant Notice will
constitute your agreement and acceptance of the terms of the Award. Capitalized terms not explicitly defined in this Performance Share Unit
Agreement shall have the same meanings given to them in the Plan or the Grant Notice, as applicable. The details of your Award, in addition
to those set forth in the Grant Notice and the Plan, are as follows.
1.
gRANT
OF
ThE
AWARd. The Award represents the right to be issued on a future date the number of shares of
the Company’s Stock that is equal to the number of performance share units indicated in the Grant Notice (the “ Share
Units
”). As of the
Date of Grant, the Company will credit to a bookkeeping account maintained by the Company for your benefit (the “ Account
”) the number
of Share Units subject to the Award. The Award was granted in consideration of your services to the Company or its Subsidiaries. Except as
otherwise provided herein, you will not be required to make any payment to the Company (other than past and future services to the Company
or its Subsidiaries) with respect to your receipt of the Award, the vesting of the Share Units or the delivery of the Stock to be issued in respect
of the Award.
2.
vESTINg
.
Subject to the limitations contained herein, your Award will vest, if at all, in accordance with the vesting
schedule set forth in the Grant Notice, provided that vesting will cease upon your Termination of Service. Upon such Termination of Service,
the Share Units credited to the Account that were not vested on the date of such termination will be forfeited at no cost to the Company, and
you will have no further right, title or interest in the Share Units or the shares of Stock to be issued in respect of the Award.
3.
NuMBER
OF
ShARE
uNITS
ANd
ShARES
.
(a)
The number of Share Units subject to your Award may be adjusted from time to time for
capitalization adjustments, as provided in Section 11.1 of the Plan.
(b)
Any additional Share Units that become subject to the Award pursuant to this Section 3 and
Section 7, if any, shall be subject, in a manner determined by the Board, to the same forfeiture restrictions, restrictions on transferability, and
time and manner of delivery as applicable to the other Share Units covered by your Award.
(c)
Notwithstanding the provisions of this Section 3, no fractional shares or rights for fractional
shares of Stock shall be created pursuant to this Section 3. The Board shall, in its discretion, determine an equivalent benefit for any
fractional shares that might be created by the adjustments referred to in this Section 3.
4.
SECuRITIES
lAW
COMPlIANCE
.
You may not be issued any shares in respect o f your Award unless either (i)
the shares are registered under the Securities Act of 1933, as amended (the “ Securities
Act
”) ; or (ii) the Company has determined that such
issuance would be exempt from the registration requirements of the Securities Act. Y our Award also must comply with other applicable laws
and regulations governing the Award, and you will not receive such shares if the Company determines that such receipt would not be in
material compliance with such laws and regulations. 5.
TRANSFER
RESTRICTIONS.
Your Award is not transferable, except by will or by the laws of descent and
distribution. In addition to any other limitation on transfer created by applicable securities laws, you agree not to assign, hypothecate, donate,
encumber or otherwise dispose of any interest in any of the shares of Stock subject to the Award until the shares are issued to you in
accordance with Section 6 of this Performance Share Unit Agreement. After the shares have been issued to you, you are free to assign,
hypothecate, donate, encumber or otherwise dispose of any interest in such shares, provided that any such actions are in compliance with the
provisions herein and applicable securities laws. Notwithstanding the foregoing, by delivering written notice to the Company, in a form
satisfactory to the Company, you may designate a third party who, in the event of your death, shall thereafter be entitled to receive any
distribution of Stock to which you were entitled at the time of your death pursuant to this Performance Share Unit Agreement.
6.
dATE
OF
ISSuANCE.
(a)
If the Award is exempt from application of Section 409A of the Code and any state law of
similar effect (collectively “ Section
409A
”), the Company will deliver to you a number of shares of the Company’s Stock equal to the
number of vested Share Units subject to your Award, including any additional Share Units received pursuant to Section 3 above that relate to
those vested Share Units on the applicable vesting date(s). However, if a scheduled delivery date falls on a date that is not a business day,
such delivery date shall instead fall on the next following business day. Notwithstanding the foregoing, in the event that any shares covered
by your Award are scheduled to be delivered on a day (the “ Original
Distribution
Date
”) on which you are prohibited from selling shares of
the Company’s Stock on the open market, as a result of any Company policy regarding trading windows (the “ Policy
”) or otherwise, and (i)
your Award is subject to Withholding Taxes, (ii) you have not entered into a written plan that meets the requirements of Rule 10b5-1 under
the Exchange Act, as determined by the Company in accordance with the Policy, (iii) the Company elects not to satisfy the Withholding
Taxes by withholding shares from your distribution, and (iv) you are not qualified to make a Payment Election under the Withholding Policy
or you have not satisfied the Withholding Taxes by duly making such Payment Election in accordance with such Withholding Policy, then
such shares shall not be delivered on such Original Distribution Date and shall instead be delivered on the first business day on which you are
no longer prohibited from selling shares of the Company’s Stock in the open market, but in no event later than the fifteenth (15th) day of the
third calendar month of the calendar year following the calendar year in which the shares covered by the Award vest. Delivery of the shares
pursuant to the provisions of this Section 6(a) is intended to comply with the requirements for the short-term deferral exemption available
under Treasury Regulations Section 1.409A-1(b)(4) and shall be construed and administered in such manner. The form of such delivery of
the shares ( e.g.
, a stock certificate or electronic entry evidencing such shares) shall be determined by the Company.
(b)
The provisions of this Section 6(b) are intended to apply if the Award is subject to Section
409A because of the terms of a severance arrangement or other agreement between you and the Company, if any, that provide for acceleration
of vesting of the Award upon your separation from service (as such term is defined in Section 409A(a)(2)(A)(i) of the Code (“ Separation
from
Service
”) and such severance benefit does not satisfy the requirements for an exemption from application of Section 409A provided
under Treasury Regulations Section 1.409A-1(b)(4) or 1.409A-1(b)(9) (“ Non-Exempt
2
Severance
Arrangement
”). If the Award is subject to and not exempt from application of Section 409A due to application of a Non-Exempt
Severance Arrangement, the following provisions in this Section 6(b) shall supersede anything to the contrary in Section 6(a). (i)
If the Award vests in the ordinary course prior to your Termination of
Service in accordance with the vesting schedule set forth in the Grant Notice, without accelerated vesting under the terms of a Non-Exempt
Severance Arrangement, in no event will the shares to be issued in respect of your Award be issued any later than the later of: (i) December
31 st of the calendar year that includes the applicable vesting date and (ii) the 60 th day that follows the applicable vesting date.
(ii)
If vesting of the Award accelerates under the terms of a Non-Exempt
Severance Arrangement in connection with your Separation from Service, and such vesting acceleration provisions were in effect as of the
date of grant of the Award and, therefore, are part of the terms of the Award as of the date of grant, then the shares will be earlier issued in
respect of your Award upon your Separation from Service in accordance with the terms of the Non-Exempt Severance Arrangement, but in no
event later than the 60 th day that follows the date of your Separation from Service. However, if at the time the shares would otherwise be
issued you are subject to the distribution limitations contained in Section 409A applicable to “specified employees,” as defined in Section
409A(a)(2)(B)(i) of the Code, such shares shall not be issued before the date that is six (6) months following the date of your Separation from
Service, or, if earlier, the date of your death that occurs within such six month period.
(iii)
If vesting of the Award accelerates under the terms of a Non-Exempt
Severance Arrangement in connection with your Separation from Service, and such vesting acceleration provisions were not in effect as of the
date of grant of the Award and, therefore, are not a part of the terms of the Award on the date of grant, then such acceleration of vesting of the
Award shall not accelerate the issuance date of the shares, but the shares shall instead be issued on the same schedule as set forth in the Grant
Notice as if they had vested in the ordinary course prior to your Termination of Service, notwithstanding the vesting acceleration of the
Award. Such issuance schedule is intended to satisfy the requirements of payment on a specified date or pursuant to a fixed schedule, as
provided under Treasury Regulations Section 1.409A-3(a)(4).
(c)
If the Award is subject to Section 409A due to the application of a Non-Exempt Severance
Arrangement or a provision for deferral of the delivery of shares in respect of the Award (a “ Non-Exempt
Award
”), then the following
provisions in this Section shall apply and shall supersede anything to the contrary that may be set forth in the Plan that would provide for
accelerated issuance of the shares in respect of your Award in connection with a Change of Control that is not also a 409A Change of Control
(a “ Non-Qualifying
Transaction
”). For such purposes, a “ 409A
Change
of
Control
” is a change in the ownership or effective control of
the Company, or in the ownership of a substantial portion of the Company’s assets, as provided in Section 409A(a)(2)(A)(v) of the Code. In
the event of a Non-Qualifying Transaction, then with respect to a Non-Exempt Award, the surviving or acquiring corporation (or its parent
company) (the “ Acquiring
Entity
”) must either assume, continue or substitute your Non-Exempt Award, and shares to be issued in respect
of your Non-Exempt Award, to the extent vested, shall be issued to you by the Acquiring Entity on the same schedule that the shares would
have been issued to you if the Non-Qualifying Transaction had not occurred.
(d)
Notwithstanding anything to the contrary set forth herein, the Company explicitly reserves
the right to earlier issue the shares in respect of any Non-Exempt Award to the extent permitted and in compliance with the requirements of
Section 409A, including pursuant to any of the exemptions available in Treasury Regulations Section 1.409A-3(j)(4)(ix).
3
(e)
The provisions in this Performance Share Unit Agreem ent for delivery of the shares in
respect of the Award are intended either to comply with the requirements of Section 409A or to provide a basis for exemption from such
requirements so that the delivery of the shares will not trigger the additional tax imp osed under Section 409A, and any ambiguities herein
will be so interpreted. 7.
dIvIdENdS.
You shall receive no benefit or adjustment to your Award with respect to any cash dividend, stock
dividend or other distribution that does not result from an adjustment as provided in Section 11.1 of the Plan; provided,
however,
that the
foregoing limitation shall cease to apply with respect to shares issued in respect of your Award.
8.
RESTRICTIvE
lEgENdS.
determined by the Company.
The shares issued in respect of your Award shall be endorsed with appropriate legends
9.
AWARd
NOT
A
SERvICE
CONTRACT
.
(a)
Your employment and/or service with the Company or a Subsidiary is not for any specified
term and may be terminated by you or by the Company or a Subsidiary at any time, for any reason, with or without Cause and with or without
notice. Nothing in this Performance Share Unit Agreement (including, but not limited to, the vesting of your Award pursuant to the schedule
referenced in Section 2 herein or the issuance of the shares in respect of your Award), the Plan or any covenant of good faith and fair dealing
that may be found implicit in this Performance Share Unit Agreement or the Plan shall: (i) confer upon you any right to continue in the
employ or service of, or affiliation with, the Company or a Subsidiary; (ii) constitute any promise or commitment by the Company or a
Subsidiary regarding the fact or nature of future positions, future work assignments, future compensation or any other term or condition of
employment, service or affiliation; (iii) confer any right or benefit under this Performance Share Unit Agreement or the Plan unless such right
or benefit has specifically accrued under the terms of this Performance Share Unit Agreement or Plan; or (iv) deprive the Company of the
right to terminate you at will and without regard to any future vesting opportunity that you may have.
(b)
By accepting this Award, you acknowledge and agree that the right to continue vesting in
the Award pursuant to the schedule referenced in Section 2 is earned only by continuing as an employee, director or consultant of the
Company or a Subsidiary at the will of the Company or a Subsidiary (not through the act of being hired, being granted this Award or any
other award or benefit) and that the Company has the right to reorganize, sell, spin-out or otherwise restructure one or more of its businesses
or Subsidiaries at any time or from time to time, as it deems appropriate (a “reorganization”). You further acknowledge and agree that such a
reorganization could result in your Termination of Service, or the termination of Subsidiary status of your employer and the loss of benefits
available to you under this Performance Share Unit Agreement, including but not limited to, the termination of the right to continue vesting in
the Award. You further acknowledge and agree that this Performance Share Unit Agreement, the Plan, the transactions contemplated
hereunder and the vesting schedule set forth herein or any covenant of good faith and fair dealing that may be found implicit in any of them
do not constitute an express or implied promise of continued engagement as an employee, director or consultant of the Company or a
Subsidiary for the term of this Performance Share Unit Agreement, for any period, or at all, and shall not interfere in any way with your right
or the Company’s right to terminate your employment and/or service at any time, with or without Cause and with or without notice.
4
10.
WIThhOldINg
OBlIgATIONS.
(a)
On each vesting date, and on or before the time you receive a distribution of the shares
underlying your Share Units, and at any other time as reasonably requested by the Company in accordance with applicable tax laws, you
agree to make adequate provision for any sums required to satisfy the federal, state, local and foreign tax withholding obligations of the
Company or any Subsidiary that arise in connection with your Award (the “ Withholding
Taxes
”). Specifically, pursuant to Section 10(d),
unless (i) your Award is not subject to Withholding Taxes or (ii) you qualify to make a Payment Election under the Withholding Policy and
duly make such Payment Election in accordance with such Withholding Policy, you agree to a “same day sale” commitment with a brokerdealer that is a member of the Financial Industry Regulatory Authority (a “ FINRA
Dealer
”) whereby you irrevocably agree to sell a portion
of the shares to be delivered in connection with your Share Units to satisfy the Withholding Taxes and whereby the FINRA Dealer commits
to forward the proceeds necessary to satisfy the Withholding Taxes directly to the Company and/or its Subsidiaries . If, for any reason, this
“same day sale” commitment does not result in sufficient proceeds to satisfy the Withholding Taxes or if, for any reason, this “same day sale”
commitment cannot be effected, the Company or a Subsidiary may, in its sole discretion, satisfy all or any portion of the Withholding Taxes
relating to your Award by any of the following means or by a combination of such means: (i) withholding from any compensation otherwise
payable to you by the Company or a Subsidiary ; (ii) causing you to tender a cash payment (which may be in the form of a check, electronic
wire transfer or other method permitted by the Company); or (iii) subject to the approval of the independent members of the Board,
withholding shares of Stock from the shares of Stock issued or otherwise issuable to you in connection with your Share Units with a Fair
Market Value (measured as of the date shares of Stock are issued to you) equal to the amount of such Withholding Taxes; provided,
however
,
that the number of such shares of Stock so withheld will not exceed the amount necessary to satisfy the Company’s required tax withholding
obligations using the minimum statutory withholding rates for federal, state, local and foreign tax purposes, including payroll taxes, that are
applicable to supplemental taxable income.
(b)
Unless the tax withholding obligations
the Company shall have no obligation to deliver to you any Stock.
of
the
Company
and/or
any
Subsidiary are satisfied,
(c)
In the event the Company’s obligation to withhold arises prior to the delivery to you of
Stock or it is determined after the delivery of Stock to you that the amount of the Company’s withholding obligation was greater than the
amount withheld by the Company, you agree to indemnify and hold the Company harmless from any failure by the Company to withhold the
proper amount.
5
(d)
Unless you qualify to make a Payment Election under the Withholding Policy and have duly
made such Payment Election i n accordance with such Withholding Policy, you hereby acknowledge and agree to the following: (i)
I hereby appoint such firm or broker as the Company shall designate from time to time as my agent (the “
Agent
”), and authorize the Agent, to:
1.
Sell on the open market at the then prevailing market price(s), on my behalf, as soon as practicable on
or after each date on which Withholding Taxes arise in connection with the Award, the number
(rounded up to the next whole number) of the shares of Stock to be delivered to me sufficient to
generate proceeds to cover (1) the Withholding Taxes that I am required to pay pursuant to the Plan and
this Performance Share Unit Agreement as a result of the Share Unit s vesting (or shares of Stock being
issued, as applicable) and (2) all applicable fees and commissions due to, or required to be collected by,
the Agent with respect thereto; and
2.
Remit any remaining funds to me.
(ii) I hereby authorize the Company and the Agent to cooperate and communicate with one another to determine
the number of shares of Stock that must be sold pursuant to this Section 10(d).
(iii) I understand that the Agent may effect sales as provided in this Section 10(d) in one or more sales and that
the average price for executions resulting from bunched orders will be assigned to my account. In addition, I
acknowledge that it may not be possible to sell shares of Stock as provided by this Section 10(d) due to (i) a
legal or contractual restriction applicable to me or the Agent, (ii) a market disruption, or (iii) rules governing
order execution priority on the national exchange where the Stock may be traded. In the event of the Agent’s
inability to sell shares of Stock, I will continue to be responsible for the timely payment to the Company of
all federal, state, local and foreign taxes that are required by applicable laws and regulations to be withheld,
including but not limited to those amounts specified in this Section 10(d).
(iv) I acknowledge that regardless of any other term or condition of this Section 10(d), the Agent will not be
liable to me for (a) special, indirect, punitive, exemplary, or consequential damages, or incidental losses or
damages of any kind, or (b) any failure to perform or for any delay in performance that results from a cause
or circumstance that is beyond its reasonable control.
(v) I hereby agree to execute and deliver to the Agent any other agreements or documents as the Agent
reasonably deems necessary or appropriate to carry out the purposes and intent of this Section 10(d). The
Agent is a third-party beneficiary of this Section 10(d).
6
(vi) I hereby agree that if I have signed the Grant Notice at a time that I am in possession of material non-public
information, unless I inform the Company in writing within five business days following the date I cease to
be in possession of material non-public information that I am not in agreement with the provisions of this
Section 10(d), my not providing such written determination shall be a determination and agreement that I
have agreed to the provisions set forth i n this Section 10(d) on such date as I have ceased to be in possession
of material non-public information.
This Section 10(d) shall terminate not later than the date on which all Withholding Taxes arising in connection
with the Award have been satisfied.
11.
uNSECuREd
OBlIgATION.
Your Award is unfunded, and as a holder of a vested Award, you shall be considered an
unsecured creditor of the Company with respect to the Company’s obligation, if any, to issue shares pursuant to this Performance Share Unit
Agreement. You shall not have voting or any other rights as a stockholder of the Company with respect to the shares to be issued pursuant to
this Performance Share Unit Agreement until such shares are issued to you pursuant to Section 6 of this Performance Share Unit
Agreement. Upon such issuance, you will obtain full voting and other rights as a stockholder of the Company. Nothing contained in this
Performance Share Unit Agreement, and no action taken pursuant to its provisions, shall create or be construed to create a trust of any kind or
a fiduciary relationship between you and the Company or any other person.
12.
OThER
dOCuMENTS.
You hereby acknowledge receipt or the right to receive a document providing the information
required by Rule 428(b)(1) promulgated under the Securities Act, which includes the Plan prospectus. In addition, you acknowledge receipt
of the Company’s policy permitting directors, officers at the level of vice president and above and other designated employees to sell shares
only during certain “window” periods and the Company’s insider trading policy, in effect from time to time.
13.
NOTICES
.
Any notices provided for in your Award or the Plan shall be given in writing and shall be deemed
effectively given upon receipt or, in the case of notices delivered by the Company to you, five (5) days after deposit in the United States mail,
postage prepaid, addressed to you at the last address you provided to the Company. Notwithstanding the foregoing, the Company may, in its
sole discretion, decide to deliver any documents related to participation in the Plan and this Award by electronic means or to request your
consent to participate in the Plan by electronic means. You hereby consent to receive such documents by electronic delivery and, if requested,
to agree to participate in the Plan through an on-line or electronic system established and maintained by the Company or another third party
designated by the Company.
14.
MISCEllANEOuS
.
(a)
The rights and obligations of the Company under your Award shall be transferable to any one or more
persons or entities, and all covenants and agreements hereunder shall inure to the benefit of, and be enforceable by the Company’s successors
and assigns. Your rights and obligations under your Award may only be assigned with the prior written consent of the Company.
(b)
You agree upon request to execute any further documents or instruments necessary or desirable in the sole
determination of the Company to carry out the purposes or intent of your Award.
7
(c)
You acknowledge and agree th at you have reviewed your Award in its entirety, have had an opportunity to
obtain the advice of counsel prior to executing and accepting your Award, and fully understand all provisions of your Award. (d)
This Performance Share Unit Agreement shall be subject to all applicable laws, rules, and regulations, and to
such approvals by any governmental agencies or national securities exchanges as may be required.
(e)
All obligations of the Company under the Plan and this Performance Share Unit Agreement shall be binding
on any successor to the Company, whether the existence of such successor is the result of a direct or indirect purchase, merger, consolidation,
or otherwise, of all or substantially all of the business and/or assets of the Company.
15.
gOvERNINg
PlAN
dOCuMENT
.
Your Award is subject to all the provisions of the Plan, the provisions of which are
hereby made a part of your Award, and is further subject to all interpretations, amendments, rules and regulations which may from time to
time be promulgated and adopted pursuant to the Plan. Except as otherwise expressly provided in the Grant Notice or this Performance Share
Unit Agreement, in the event of any conflict between the provisions in the Grant Notice or this Performance Share Unit Agreement and those
of the Plan, the provisions of the Plan shall control.
16.
SEvERABIlITy.
If all or any part of this Performance Share Unit Agreement or the Plan is declared by any court or
governmental authority to be unlawful or invalid, such unlawfulness or invalidity shall not invalidate any portion of this Performance Share
Unit Agreement or the Plan not declared to be unlawful or invalid. Any Section of this Performance Share Unit Agreement (or part of such a
Section) so declared to be unlawful or invalid shall, if possible, be construed in a manner which will give effect to the terms of such Section
or part of a Section to the fullest extent possible while remaining lawful and valid.
17.
EFFECT
ON
OThER
EMPlOyEE
BENEFIT
PlANS.
The value of the Award subject to this Performance Share Unit
Agreement shall not be included as compensation, earnings, salaries, or other similar terms used when calculating your benefits under any
employee benefit plan sponsored by the Company or any Subsidiary, except as such plan otherwise expressly provides. The Company
expressly reserves its rights to amend, modify, or terminate any of the Company’s or any Subsidiary’s employee benefit plans.
18.
AMENdMENT.
This Performance Share Unit Agreement may not be modified, amended or terminated except by an
instrument in writing, signed or otherwise validly authorized by you and by a duly authorized representative of the
Company. Notwithstanding the foregoing, this Performance Share Unit Agreement may be amended solely by the Board by a writing which
specifically states that it is amending this Performance Share Unit Agreement, so long as a copy of such amendment is delivered to you, and
provided that no such amendment adversely affecting your rights hereunder may be made without your written consent. Without limiting the
foregoing, the Board reserves the right to change, by written notice to you, the provisions of this Performance Share Unit Agreement in any
way it may deem necessary or advisable to carry out the purpose of the grant as a result of any change in applicable laws or regulations or any
future law, regulation, ruling, or judicial decision, provided that any such change shall be applicable only to rights relating to that portion of
the Award which is then subject to restrictions as provided herein.
8
Subsidiaries
of
Medivation,
Inc.
1.
Medivation Neurology, Inc. (Delaware)
2.
Medivation Prostate Therapeutics, Inc. (Delaware)
3.
Medivation Technologies, Inc. (Delaware)
4.
Medivation Field Solutions, Inc. (Delaware)
5.
Medivation Services, Inc. (Delaware)
Exhibit
21.1
Exhibit
23.1
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (No. 333-132983, No. 333-190842, No. 333-187203, No. 333157051, and No. 333-199946) of Medivation, Inc. of our report dated February 26, 2016 relating to the consolidated financial statements and the effectiveness of
internal control over financial reporting, which appears in this Form 10-K.
/s/ PricewaterhouseCoopers LLP
San Jose, California
February 26, 2016
Exhibit
31.1
CERTIFICATIONS
I, David T. Hung, M.D., certify that:
1. I have reviewed this Form 10-K of Medivation, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that
material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the
period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with
generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal
quarter (the registrant’s fourth fiscal quarter in the case of an Annual Report) that has materially affected, or is reasonably likely to materially affect, the registrant’s
internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to
adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over
financial reporting.
Date: February 26, 2016
/s/ David T. Hung
David T. Hung, M.D.
President and Chief Executive Officer
(Principal Executive Officer)
Exhibit
31.2
CERTIFICATIONS
I, Richard A. Bierly, certify that:
1. I have reviewed this Form 10-K of Medivation, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the
registrant and have:
a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that
material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the
period in which this report is being prepared;
b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with
generally accepted accounting principles;
c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of
the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal
quarter (the registrant’s fourth fiscal quarter in the case of an Annual Report) that has materially affected, or is reasonably likely to materially affect, the registrant’s
internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to
adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over
financial reporting.
Date: February 26, 2016
/s/ Richard A. Bierly
Richard A. Bierly
Chief Financial Officer
(Principal Financial Officer)
Exhibit
32.1
CERTIFICATION
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of
Chapter 63 of Title 18 of the United States Code (18 U.S.C. § 1350), David T. Hung, M.D., President and Chief Executive Officer of Medivation, Inc. (the
“Company”), and Richard A. Bierly, Chief Financial Officer of the Company, each hereby certifies that, to the best of his knowledge:
1.
The Company’s Annual Report on Form 10-K for the period ended December 31, 2015, to which this Certification is attached as Exhibit 32.1 (the “Annual
Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act, as amended; and
2.
The information contained in the Annual Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
In Witness Whereof, the undersigned have set their hands hereto as of the 26th day of February, 2016.
/s/ David T. Hung
David T. Hung, M.D.
President and Chief Executive Officer
/s/ Richard A. Bierly
Richard A. Bierly
Chief Financial Officer
This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated
by reference into any filing of Medivation, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made
before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.