Medivation Reports First Quarter Financial Results and Provides Corporate Update

Medivation Reports First Quarter Financial Results and Provides Corporate Update 
Collaboration Revenue Increased 89 Percent Year-on-Year; XTANDI U.S.
Net Sales Increased 65 Percent Year-on-Year; Conference Call Today at
4:30 p.m. Eastern Time 
SAN FRANCISCO, CA -- (Marketwired) -- 05/08/14 --  Medivation, Inc.
(NASDAQ: MDVN) today provided a corporate update and reported its
financial results for the first quarter ended March 31, 2014. U.S.
net sales of XTANDI(R) (enzalutamide) capsules for the quarter, as
reported by Astellas, were $124.5 million. Ex-U.S. net sales of
XTANDI for the quarter, as reported by Astellas, were $47.8 million.  
"We continue to be pleased with the sales performance of XTANDI in
the United States and with Astellas' progress to expand access to
XTANDI worldwide. To date, XTANDI has been approved in more than 40
countries for the treatment of patients with mCRPC who have
previously received docetaxel," said David Hung, M.D., president and
chief executive officer of Medivation. "We remain committed to
identifying new therapies that will improve the current standard of
care. Oncology is an important area of focus for Medivation and our
license agreement with OncoFusion Therapeutics for BET bromodomain
inhibitors sets the stage for future innovation in this important
area of need." 
Recent Developments  
XTANDI(R) (enzalutamide) capsules 


 
--  U.S. net sales of XTANDI were $124.5 million in the first quarter of
    2014. XTANDI was approved by the U.S. Food and Drug Administration
    (FDA) for the treatment of patients with metastatic
    castration-resistant prostate cancer (mCRPC) who have previously
    received docetaxel on August 31, 2012 and was made available for
    shipment on September 13, 2012. Medivation and Astellas are jointly
    responsible for commercialization and development of XTANDI in the
    U.S. and share equally in the costs (subject to certain exceptions),
    profits and losses arising from U.S. development and commercialization
    of XTANDI.
    
    
--  Ex-U.S. net sales of XTANDI were $47.8 million in the first quarter of
    2014. XTANDI was granted marketing authorization in the European Union
    in June 2013. Outside of the U.S., Astellas has responsibility for
    developing and commercializing XTANDI and pays Medivation a tiered
    royalty ranging from the low teens to the low twenties on aggregate
    net sales of XTANDI.
    
    
--  XTANDI is approved in more than 40 countries for the treatment of
    patients with mCRPC who have previously received docetaxel. In March,
    Astellas obtained XTANDI marketing approval for the treatment of
    patients with castration-resistant prostate cancer in Japan with the
    precaution that the efficacy and safety of the drug have not been
    established in patients with prostate cancer who have not received
    chemotherapy. The Japanese marketing authorization triggered a $15
    million milestone payment to Medivation during the first quarter under
    its collaboration agreement with Astellas.
    
    
--  The FDA accepted the supplemental New Drug Application (sNDA) filling
    to extend the indication for XTANDI for the treatment of men with
    mCRPC who have not received chemotherapy and granted priority review
    designation. The Prescription Drug User Fee Act (PDUFA) date for the
    completion of the FDA's review for the sNDA is September 18, 2014. The
    FDA's acceptance for filing of the sNDA triggered a $25 million
    milestone payment to Medivation during the second quarter under its
    collaboration agreement with Astellas.
    
    
--  Astellas submitted a variation to amend the European Marketing
    Authorization Application for XTANDI for the treatment of adult men
    with mCRPC who are asymptomatic or mildly symptomatic after failure of
    androgen deprivation therapy and in whom chemotherapy is not yet
    clinically indicated. The European Medicines Agency validated
    Astellas' application for an amended European Marketing Authorization
    Application and accepted the filing in April 2014, which triggered a
    $15 million milestone payment to Medivation.

  
Enzalutamide Clinical Development Program 


 
--  Continued patient enrollment in the Phase 3 PROSPER trial evaluating
    the safety and efficacy of enzalutamide in approximately 1,500
    patients with non-metastatic CRPC. PROSPER will 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 primary endpoint of the
    trial is metastasis-free survival.
    
    
--  Advanced the prostate cancer development program comparing
    enzalutamide's effects on progression-free-survival when compared
    head-to-head versus bicalutamide, the most commonly used
    anti-androgen, in men who have progressed following medical castration
    with a luteinizing hormone releasing hormone (LHRH) analog therapy or
    surgical castration.
    
    
    --  Completed patient enrollment in the TERRAIN trial in July 2013,
        which enrolled approximately 370 men with mCRPC disease primarily
        in Europe; and
        
        
    --  Completed patient enrollment in the STRIVE trial in March 2014,
        which enrolled approximately 400 men with either metastatic or
        non-metastatic disease in the U.S.
        
        
--  Continued patient enrollment in the Phase 4 PLATO trial evaluating the
    efficacy and safety of continued treatment with enzalutamide plus
    abiraterone acetate and prednisone as compared to treatment with
    abiraterone acetate and prednisone alone in patients with
    pre-chemotherapy mCRPC whose disease has progressed following
    enzalutamide therapy. The purpose of the trial is to help determine
    the potential clinical benefit of continuing androgen receptor
    signaling inhibition with enzalutamide treatment and adding an
    additional therapy in patients with pre-chemotherapy mCRPC. The global
    randomized, double-blind, placebo-controlled trial is designed to
    enroll approximately 500 chemotherapy-naive patients with mCRPC.
    The primary endpoint of the trial is progression-free survival.

  
Enzalutamide in Breast Cancer 


 
--  Continued patient enrollment in the Phase 2 clinical trial evaluating
    enzalutamide in combination with exemestane in women with advanced
    breast cancer that is estrogen receptor positive (ER+) or progesterone
    receptor positive (PgR+) and human epidermal growth factor 2, or HER2
    normal. The Phase 2 randomized, double-blind, placebo controlled,
    multicenter trial plans to enroll approximately 240 patients in two
    parallel cohorts of 120 patients each. The first cohort will enroll
    patients who have not previously received hormonal treatment for
    advanced breast cancer. The second cohort will enroll patients who
    have previously progressed following one hormonal treatment for
    advanced disease. The primary endpoint of the trial is progression
    free survival in all patients and in the subset of patients whose
    tumor expresses the androgen receptor.
    
    
--  Continued patient enrollment in a Phase 2 clinical trial evaluating
    enzalutamide as a single agent for the treatment of advanced, androgen
    receptor positive (AR+), triple-negative breast cancer, or TNBC. TNBC
    is a type of cancer which is not driven by the three most commonly
    targeted receptors in breast cancer: estrogen, progesterone and HER2.
    The Phase 2 open label, single-arm, multicenter trial plans to enroll
    approximately 80 patients with AR+, TNBC at sites in the United
    States, Canada and Europe. The primary endpoint of the trial is
    clinical benefit rate, defined as the proportion of patients with a
    best response of complete response, partial response or stable disease
    at ≥ 16 weeks.

  
Corporate Developments 


 
--  Entered into a research and license agreement with OncoFusion
    Therapeutics, Inc., for certain compounds targeting Bromodomain and
    Extra-Terminal (BET) proteins for potential use in oncology and other
    disease areas. Medivation gained exclusive worldwide rights for the
    development and commercialization of these compounds. Under the terms
    of the agreement, Medivation will have access to OncoFusion's growing
    library of small molecule BET bromodomain inhibitor compounds from
    which Medivation may select compounds to move forward in its drug
    discovery and development efforts.
    
    
--  Appointed Rick Bierly chief financial officer in March 2014. Rick
    brings to Medivation over 30 years experience in finance roles at
    GlaxoSmithKline, Aventis, Centocor and Johnson & Johnson.
    
    
--  Appointed Patrick Machado to Medivation's board of directors. After
    nearly 10 years at Medivation, Pat retired from his role as chief
    financial officer in March 2014 and chief business officer in April
    2014.

  
First Quarter Financial Results 
Medivation's collaboration revenue was $87.2 million for the first
quarter of 2014, consisting of three components: collaboration
revenue attributable to U.S. XTANDI net sales, collaboration revenue
attributable to ex-U.S. XTANDI net sales and collaboration revenue
attributable to upfront and milestone payments.  


 
--  U.S. net sales of XTANDI for the first quarter of 2014 were $124.5
    million, an increase of 65%, compared with $75.4 million for the same
    period in 2013. Collaboration revenue attributable to U.S. net sales
    of XTANDI for the first quarter of 2014 was $62.2 million compared to
    $37.7 million in 2013.
    
    
--  Ex-U.S. net sales of XTANDI for the first quarter were $47.8 million,
    compared with $0.3 million for the same period in 2013. XTANDI was
    granted marketing authorization in the European Union in June 2013.
    Collaboration revenue attributable to ex-U.S. net sales of XTANDI for
    the first quarter of 2014 was $5.7 million.
    
    
--  Collaboration revenue attributable to upfront and milestone payments
    for the first quarter of 2014 was $19.2 million.

  
Total operating expenses for the quarter ended March 31, 2014 were
$95.7 million, compared with total operating expenses of $68.5
million for the same period in 2013. These figures include non-cash
stock-based compensation expense of $9.7 million in the quarter ended
March 31, 2014, compared with $8.3 million for the same period in
2013. 
Medivation reported a net loss of $13.7 million, or $0.18 per diluted
share, for the quarter ended March 31, 2014, compared with a net loss
of $27.2 million, or $0.36 per diluted share, for the same period in
2013.  
At March 31, 2014, cash, cash equivalents and short-term investments
totaled $241.5 million, compared with $228.8 million at December 31,
2013.  
2014 Financial Outlook 
For the full year 2014, Medivation expects U.S. net sales of XTANDI
to be between $540 million and $575 million. Medivation expects 2014
total operating expenses, net of cost-sharing payments from Astellas,
to be between $400 million and $430 million, approximately $45
million to $50 million of which consists of non-cash stock-based
compensation expense and excludes the cost of future in-licensing
opportunities we may elect to pursue, if any.  
Conference Call Information 
To participate by telephone in today's live call beginning at 4:30
p.m. Eastern Time, please call 877-303-2523 from the U.S. or
+1-253-237-1755 internationally. Individuals may access the live
audio webcast by visiting http://investors.medivation.com/events.cfm.
A replay of the webcast will be available on the Company's website
for a limited time following the live event. 
About XTANDI(R) (enzalutamide) capsules  
XTANDI was approved by the FDA on August 31, 2012 and is indicated
for the treatment of patients with metastatic castration-resistant
prostate cancer (mCRPC) who have previously received docetaxel. 
Important Safety Information for XTANDI from the Approved Prescribing
Information  
Contraindications- XTANDI can cause fetal harm when administered to a
pregnant woman based on its mechanism of action. XTANDI is not
indicated for use in women. XTANDI is contraindicated in women who
are or may become pregnant.  
Warnings and Precautions- In the randomized clinical trial, seizure
occurred in 0.9% of patients on XTANDI. No patients on the placebo
arm experienced seizure. Patients experiencing a seizure were
permanently discontinued from therapy. All seizures resolved.
Patients with a history of seizure, taking medications known to
decrease the seizure threshold, or with other risk factors for
seizure were excluded from the clinical trial. Because of the risk of
seizure associated with XTANDI use, patients should be advised of the
risk of engaging in any activity where sudden loss of consciousness
could cause serious harm to themselves or others.  
Adverse Reactions- The most common adverse drug reactions (≥
5%) reported in patients receiving XTANDI in the randomized clinical
trial were asthenia/fatigue, back pain, diarrhea, arthralgia, hot
flush, peripheral edema, musculoskeletal pain, headache, upper
respiratory infection, muscular weakness, dizziness, insomnia, lower
respiratory infection, spinal cord compression and cauda equina
syndrome, hematuria, paresthesia, anxiety, and hypertension. Grade
1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and
in 6% on placebo (no Grade 3-4). Grade 1-4 elevations in bilirubin
occurred in 3% of XTANDI patients and 2% on placebo. One percent of
XTANDI patients compared to 0.3% on placebo died from infections or
sepsis. Falls or injuries related to falls occurred in 4.6% of XTANDI
patients vs 1.3% on placebo. Falls were not associated with loss of
consciousness or seizure. Fall-related injuries were more severe in
XTANDI patients and included non-pathologic fractures, joint
injuries, and hematomas. Grade 1 or 2 hallucinations occurred in 1.6%
of XTANDI patients and 0.3% on placebo, with the majority on
opioid-containing medications at the time of the event.  
Drug Interactions- Effect of Other Drugs on XTANDI: Administration of
strong CYP2C8 inhibitors can increase the plasma exposure to XTANDI.
Co-administration of XTANDI with strong CYP2C8 inhibitors should be
avoided if possible. If co-administration of XTANDI cannot be
avoided, reduce the dose of XTANDI. Co-administration of XTANDI with
strong or moderate CYP3A4 and CYP2C8 inducers can alter the plasma
exposure of XTANDI and should be avoided if possible.  
Effect of XTANDI on Other Drugs: XTANDI is a strong CYP3A4 inducer
and a moderate CYP2C9 and CYP2C19 inducer in humans. Avoid CYP3A4,
CYP2C9 and CYP2C19 substrates with a narrow therapeutic index, as
XTANDI may decrease the plasma exposures of these drugs. If XTANDI is
co-administered with warfarin (CYP2C9 substrate), conduct additional
INR monitoring.  
Please visit www.XtandiHCP.com for full Prescribing Information for
XTANDI(R) (enzalutamide) capsules.  
About the Medivation/Astellas Collaboration  
In October 2009, Medivation and Astellas entered into a global
agreement to jointly develop and commercialize enzalutamide. The
companies are collaborating on a comprehensive development program
that includes studies to develop enzalutamide across the full
spectrum of advanced prostate cancer as well as advanced breast
cancer. The companies jointly commercialize XTANDI in the United
States and Astellas has responsibility for manufacturing and all
additional regulatory filings globally, as well as commercializing
XTANDI outside the United States.  
About Medivation 
Medivation, Inc. is a biopharmaceutical company focused on the rapid
development of novel therapies to treat serious diseases for which
there are limited treatment options. Medivation aims to transform the
treatment of these diseases and offer hope to critically ill patients
and their families. For more information, please visit us at
http://www.medivation.com. 
Forward-Looking Statements 
The statements in this press release under the caption "2014
Financial Outlook" are forward-looking statements that are made
pursuant to the safe harbor provisions of the federal securities
laws. Forward-looking statements involve risks and uncertainties that
could cause Medivation's actual results to differ significantly from
those projected, including, without limitation: risks related to the
timing, progress and results of Medivation's clinical trials,
including the risk that adverse clinical trial results could alone or
together with other factors result in the delay or discontinuation of
the commercialization of XTANDI or some or all of Medivation's
product development activities; Medivation's dependence on the
efforts of and funding by Astellas for the commercialization of
XTANDI; the risk of unanticipated expenditures or liabilities; and
other risks detailed in Medivation's filings with the Securities and
Exchange Commission, or SEC, including its quarterly report on Form
10-Q for the quarter ended March 31, 2014, which is expected to be
filed on May 8, 2014 with the SEC. You are cautioned not to place
undue reliance on the forward-looking statements, which speak only as
of the date of this release. Medivation disclaims any obligation or
undertaking to update, supplement or revise any forward-looking
statements contained in this press release.  


 
                                                                            
                              MEDIVATION, INC.                              
                        CONSOLIDATED BALANCE SHEETS                         
              (in thousands, except share and per share data)               
                                (unaudited)                                 
                                                                            
                                                                            
                                                   March 31,   December 31, 
                                                     2014          2013     
                                                 ------------  ------------ 
ASSETS                                                                      
Current assets:                                                             
  Cash and cash equivalents                      $    241,469  $    228,788 
  Receivable from collaboration partner                93,251       107,210 
  Prepaid expenses and other current assets            17,129        17,981 
                                                 ------------  ------------ 
                                                                            
    Total current assets                              351,849       353,979 
Property and equipment, net                            18,001        17,035 
Restricted cash                                        11,972         9,899 
Other non-current assets                               16,238        11,737 
                                                 ------------  ------------ 
                                                                            
Total assets                                     $    398,060  $    392,650 
                                                 ============  ============ 
                                                                            
LIABILITIES AND STOCKHOLDERS' EQUITY                                        
Current liabilities:                                                        
  Accounts payable, accrued expenses and other                              
   current liabilities                           $     78,154  $     78,758 
  Deferred revenue                                     12,698        16,931 
                                                 ------------  ------------ 
                                                                            
    Total current liabilities                          90,852        95,689 
Convertible Notes, net of unamortized discount of                           
 $47,079 and $50,336 at March 31, 2014 and                                  
 December 31, 2013, respectively                      211,671       208,414 
Other non-current liabilities                          13,584        11,600 
                                                 ------------  ------------ 
                                                                            
    Total liabilities                                 316,107       315,703 
Commitments and contingencies                                               
                                                                            
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;                                  
   170,000,000 shares authorized; 76,513,737 and                            
   75,803,020 shares issued and outstanding at                              
   March 31, 2014 and December 31, 2013,                                    
   respectively                                           765           758 
  Additional paid-in capital                          429,014       410,350 
  Accumulated deficit                                (347,826)     (334,161)
                                                 ------------  ------------ 
                                                                            
    Total stockholders' equity                         81,953        76,947 
                                                 ------------  ------------ 
                                                                            
Total liabilities and stockholders' equity       $    398,060  $    392,650 
                                                 ============  ============ 
                                                                            
                                                                            
                                                                            
                              MEDIVATION, INC.                              
                   CONSOLIDATED STATEMENTS OF OPERATIONS                    
                   (in thousands, except per share data)                    
                                (unaudited)                                 
                                                                            
                                                                            
                                                     Three Months Ended     
                                                          March 31,         
                                                 -------------------------- 
                                                     2014          2013     
                                                 ------------  ------------ 
Collaboration revenue                            $     87,189  $     46,154 
Operating expenses:                                                         
  Research and development expenses                    45,919        24,908 
  Selling, general and administrative expenses         49,735        43,568 
                                                 ------------  ------------ 
                                                                            
    Total operating expenses                           95,654        68,476 
                                                 ------------  ------------ 
                                                                            
Loss from operations                                   (8,465)      (22,322)
Other income (expense), net:                                                
  Interest expense                                     (5,230)       (4,888)
  Interest income                                           9            74 
  Other expense, net                                      (38)           (1)
                                                 ------------  ------------ 
                                                                            
    Total other income (expense), net                  (5,259)       (4,815)
                                                 ------------  ------------ 
                                                                            
Net loss before income tax benefit (expense)          (13,724)      (27,137)
Income tax benefit (expense)                               59           (33)
                                                 ------------  ------------ 
                                                                            
Net loss                                         $    (13,665) $    (27,170)
                                                 ============  ============ 
                                                                            
Basic and diluted net loss per common share      $      (0.18) $      (0.36)
                                                 ============  ============ 
                                                                            
Weighted average common shares used in the                                  
 calculation of basic and diluted net loss per                              
 common share                                          76,245        74,824 
                                                 ============  ============ 

  
Contacts:
Rick Bierly
Chief Financial Officer
(415) 543-3470 
Anne Bowdidge
Sr. Director, Investor Relations
(650) 218-6900 
 
 
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