Medivation Reports Third Quarter Financial Results and Provides

Medivation Reports Third Quarter Financial Results and Provides
Corporate Update 
$14.1 Million in Net Sales Reflect First 12 Business Days of XTANDI
Launch; Conference Call Today at 4:30 p.m. Eastern Time 
SAN FRANCISCO, CA -- (Marketwire) -- 11/09/12 --  Medivation, Inc.
(NASDAQ: MDVN) today provided a corporate update and reported its
financial results for the third quarter ended September 30, 2012. Net
sales of XTANDI(R) (enzalutamide) capsules for the quarter, as
reported by Astellas Pharma Inc., were $14.1 million, which
represents the first 12 business days of sales following availability
of XTANDI for shipment on September 13, 2012. 
"The rapid approval and subsequent U.S. launch of XTANDI in the third
quarter marked a transformative time for Medivation as we made our
transition into a commercial company," said David Hung, M.D.,
co-founder, president and chief executive officer of Medivation, Inc.
"With our partner Astellas, we look forward to reporting progress on
the future growth and use of XTANDI to treat patients with metastatic
castration-resistant prostate cancer who have received docetaxel,
while we continue to explore enzalutamide's potential utility in
earlier prostate cancer indications and in breast cancer." 
Recent Developments  
XTANDI(R) (enzalutamide) capsules 


 
--  Received approval from the U.S. Food and Drug Administration (FDA) for
    XTANDI on August 31, 2012, three months ahead of the goal date set by
    the Prescription Drug User Fee Act (PDUFA), for the treatment of
    patients with metastatic castration-resistant prostate cancer who have
    received docetaxel.
    
    
--  Announced availability of XTANDI in the U.S. on September 13, 2012 for
    patients with metastatic castration-resistant prostate cancer who have
    received docetaxel. 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.
    
    
--  European Medicines Agency (EMA) accepted for review the XTANDI
    Marketing Authorisation Application (MAA) seeking approval to market
    XTANDI in Europe for the treatment of men with metastatic
    castration-resistant prostate cancer who have received docetaxel.

  
Enzalutamide Clinical Development Program 


 
--  Publication of the Phase 3 AFFIRM trial results on August 15, 2012 in
    The New England Journal of Medicine in a paper entitled "Increased
    Survival with Enzalutamide in Prostate Cancer After Chemotherapy."
    
    
--  Presented data at the 2012 European Society of Medical Oncology Annual
    Meeting. The data are from the Phase 3 AFFIRM trial on the effect of
    enzalutamide on pain-related secondary endpoints and a post-hoc
    analysis of the survival impact of baseline corticosteroid use in men
    with metastatic castration-resistant prostate cancer who have received
    docetaxel.
    
    
--  Completed targeted enrollment of approximately 1,700 patients in the
    Phase 3 PREVAIL trial of enzalutamide in men with castration-resistant
    prostate cancer who have not yet received chemotherapy. The co-primary
    endpoints in this trial are overall survival and progression-free
    survival.
    
    
--  Continued patient enrollment in two trials 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 LHRH analog therapy or
    surgical castration. TERRAIN is enrolling approximately 370 men with
    metastatic disease primarily in Europe; STRIVE is enrolling
    approximately 400 men with either metastatic or non-metastatic disease
    primarily in the U.S.
    
    
--  Completed an open-label clinical trial designed to evaluate the effect
    of enzalutamide in 67 men with advanced prostate cancer who have not
    had any previous hormonal therapies. The primary endpoint in this
    trial is prostate specific antigen response. Study results will be
    reported at an upcoming medical meeting.
    
    
--  Continued patient enrollment in an open-label clinical trial
    evaluating enzalutamide as neoadjuvant therapy in approximately 50 men
    prior to prostatectomy. The primary endpoint in this trial is
    pathological complete response rate.
    
    
--  Completed patient enrollment in an open-label study evaluating the
    safety, tolerability and pharmacokinetics of enzalutamide when dosed
    in combination with docetaxel in 18 men with castration-resistant
    prostate cancer.
    
    
--  Continued patient enrollment in an open-label Phase 1 study in
    patients with breast cancer. The study is designed to evaluate the
    safety and tolerability of enzalutamide in breast cancer patients who
    have failed prior hormonal therapy.

  
Corporate Developments 


 
--  Effected a 2-for-1 forward split of all shares of Medivation common
    stock. Medivation's stock began trading on a post-split basis on the
    NASDAQ Global Market on September 24, 2012.

  
Third Quarter 2012 Financial Results 
XTANDI net sales for the third quarter of 2012, as reported by
Astellas, were $14.1 million, representing 12 business days of sales
following availability of XTANDI for shipment on September 13, 2012.
Medivation's collaboration revenue for the third quarter of 2012 was
$64.8 million, which consisted of two components: collaboration
revenue attributable to U.S. XTANDI sales ($7.1 million), and
collaboration revenue attributable to up-front and development
milestone payments from the Company's corporate partner Astellas and
former partner Pfizer ($57.7 million).  
Medivation received and recognized $45 million of development
milestone payments from Astellas during the third quarter of 2012,
which are included in collaboration revenue. These payments consisted
of $10 million upon the FDA's acceptance for review of the XTANDI New
Drug Application (NDA), $30 million upon the FDA's approval of the
XTANDI NDA, and $5 million upon the EMA acceptance of the XTANDI MAA
for review. Medivation is required to share ten percent of all
up-front and development milestone payments received from Astellas
with UCLA, the licensor of the enzalutamide technology.  
Total operating expenses for the third quarter were $64.4 million,
compared with total operating expenses of $26.4 million for the same
period in 2011. These figures include non-cash stock-based
compensation expense of $7.6 million in the quarter ended September
30, 2012, compared with $3.2 million for the same period in 2011. 
Medivation reported a net loss for the quarter ended September 30,
2012 of $4.5 million, or $0.06 per diluted share, compared with a net
loss of $10.0 million, or $0.14 per diluted share, for the same
period in 2011, adjusted on a post-split basis.  
Cash, cash equivalents and short-term investments at September 30,
2012 totaled $340.4 million, compared with $145.1 million at December
31, 2011.  
2012 Financial Outlook 
Medivation currently expects total operating expenses for 2012, net
of cost-sharing payments from Astellas, to be between $205 and $215
million, approximately $25 million of which consists of non-cash
stock-based compensation expense. This increase from prior guidance
of between $183 and $198 million is due primarily to increased
compensation and 
royalty expense in 2012 resulting from XTANDI's
approval in the U.S. approximately one quarter earlier than expected.
Medivation continues to expect to incur approximately $15 million in
capital expenditures in 2012, primarily related to leasehold
improvements at its new corporate and commercial headquarters
facilities. 
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
www.medivation.com and going to the Investor Relations section. A
replay of the webcast will be available on the Company's website for
30 days following the live event. 
About XTANDI 
 Please visit www.xtandihcp.com for full Prescribing
Information for XTANDI (enzalutamide) capsules, including
precautions, warnings, adverse reactions, and contraindications for
the treatment of patients with metastatic castration-resistant
prostate cancer who have received docetaxel. 
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 www.medivation.com. 
The statements in this press release under the caption "2012
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 September 30, 2012, filed today 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
or revise any forward-looking statements contained in this press
release. 


 
                                                                            
                                                                            
                              MEDIVATION, INC.                              
                    CONSOLIDATED STATEMENT OF OPERATIONS                    
                    (in thousands, except per share data)                   
                                 (unaudited)                                
                                                                            
                                                                            
                                Three Months Ended      Nine Months Ended   
                                   September 30,          September 30,     
                                                                            
                               --------------------   --------------------  
                                  2012       2011        2012       2011    
                                                                            
                               ---------  ---------   ---------  ---------  
Collaboration revenue          $  64,798  $  14,940   $ 144,535  $  45,448  
                                                                            
Operating expenses:                                                         
  Research and development        32,045     18,706      73,625     55,463  
  Selling, general and                                                      
   administrative                 32,345      7,724      70,369     20,916  
                               ---------  ---------   ---------  ---------  
    Total operating expenses      64,390     26,430     143,994     76,379  
                               ---------  ---------   ---------  ---------  
Income (loss) from operations        408    (11,490)        541    (30,931) 
Other income (expense):                                                     
  Interest expense                (4,840)        --     (10,113)        --  
  Interest income                     57         19         140         69  
  Other income (expense), net       (154)        62        (169)      (370) 
                               ---------  ---------   ---------  ---------  
    Total other income                                                      
     (expense), net               (4,937)        81     (10,142)      (301) 
                               ---------  ---------   ---------  ---------  
Net loss before income tax                                                  
 (expense) benefit                (4,529)   (11,409)     (9,601)   (31,232) 
Income tax (expense) benefit          (8)     1,365           4      3,262  
                               ---------  ---------   ---------  ---------  
Net loss                       $  (4,537) $ (10,044)  $  (9,597) $ (27,970) 
                               =========  =========   =========  =========  
Basic and diluted net loss per                                              
 common share                  $   (0.06) $   (0.14)* $   (0.13) $   (0.40)*
                               =========  =========   =========  =========  
                                                                            
Weighted average common shares                                              
 used in the calculation of                                                 
 basic and diluted net loss                                                 
 per common share                 73,697     69,818 *    72,794     69,642 *
                               =========  =========   =========  =========  
                                                                            
 *Adjusted to reflect 2-for-1 forward split of Medivation common stock, 
  which took effect on September 21, 2012.                        
                                                                                
                                                                                
                                                
                                                                            
                                                                                
                                                
                              MEDIVATION, INC.                              
                         CONSOLIDATED BALANCE SHEET                         
              (in thousands, except share and per share data)               
                                (unaudited)                                 
              
                                                              
                                                                            
                                                September 30,  December 31, 
                                                     2012          2011     
                                                                            
                                                -------------  ------------ 
ASSETS                                                                      
Current assets:                                                             
  Cash and cash equivalents                     $     115,557  $     70,136 
  Short-term investments                              224,854        74,996 
  Receivables from collaboration partners              17,082        12,545 
  Restricted cash                                         843            -- 
  Prepaid expenses and other current assets            13,015        10,512 
                                                -------------  ------------ 
    Total current assets                              371,351       168,189 
Property and equipment, net                            13,585           720 
Restricted cash, net of current                         8,843         5,489 
Other non-current assets                                5,206           719 
                                                -------------  ------------ 
Total assets                                    $     398,985  $    175,117 
                                                =============  ============ 
LIABILITIES AND STOCKHOLDERS' EQUITY                                        
Current liabilities:                                                        
  Accounts payable                              $       4,320  $      5,588 
  Accrued expenses                                     50,165        24,014 
  Deferred revenue                                     29,024        59,762 
  Other current liabilities                               513           270 
                                                -------------  ------------ 
    Total current liabilities                          84,022        89,634 
Convertible Notes, net of unamortized discount                              
 of $65,670 at September 30, 2012                     193,080            -- 
                                                                            
Deferred revenue, net of current                       21,768        83,509 
Other non-current liabilities                           4,938           653 
                                                -------------  ------------ 
    Total liabilities                                 303,808       173,796 
                                                -------------  ------------ 
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; 74,148,795                                
   and 71,463,676 shares issued and outstanding                             
   at September 30, 2012 and December 31, 2011,                             
   respectively                                           742           357 
  Additional paid-in capital                          354,329       251,242 
  Accumulated other comprehensive (loss) gain              (6)           13 
  Accumulated deficit                                (259,888)     (250,291)
                                                -------------  ------------ 
    Total stockholders' equity                         95,177         1,321 
                                                -------------  ------------ 
Total liabilities and stockholders' equity      $     398,985  $    175,117 
                                                =============  ============ 

  
Contacts:
Patrick Machado 
Chief Business & Financial Officer 
(415) 829-4101  
Anne Bowdidge
Sr. Director, Investor Relations
(650) 218-6900 
 
 
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