Medivation Reports Fourth Quarter and Year-End 2012 Financial Results and Provides Corporate Update

Medivation Reports Fourth Quarter and Year-End 2012 Financial Results and 
Provides Corporate Update 
$57.4 Million in Fourth Quarter Net Sales Reflect First Full Quarter
of XTANDI Sales; Conference Call Today at 4:30 p.m. Eastern Time 
SAN FRANCISCO, CA -- (Marketwire) -- 02/28/13 --  Medivation, Inc.
(NASDAQ: MDVN) today provided a corporate update and reported its
financial results for the fourth quarter and year ended December 31,
2012. Net sales of XTANDI(R) (enzalutamide) capsules for the quarter,
as reported by Astellas Pharma Inc., were $57.4 million, which
represents the first full quarter of sales following availability of
XTANDI for shipment. Net sales for the full year 2012 were $71.5
million, as a result of XTANDI's approval by the U.S. Food and Drug
Administration on August 31, 2012 and the availability of XTANDI for
shipment on September 13, 2012. 
"We are extremely pleased with the strong initial sales of XTANDI,
which marks the culmination of months of hard work, prioritization
and disciplined decision making following XTANDI's early approval in
August," said David Hung, M.D., co-founder, president and chief
executive officer of Medivation, Inc. "2013 is a pivotal year of both
execution and growth for Medivation as we continue the commercial
expansion of XTANDI and advance enzalutamide's development in earlier
prostate cancer indications and in new areas where the medical need
remains high." 
Recent Developments  
XTANDI(R) (enzalutamide) capsules 


 
--  Net sales of XTANDI in the U.S. were $57.4 million in the fourth
    quarter and $71.5 million for the full year 2012, following the
    availability of XTANDI 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.
    
    
--  The U.S. Food and Drug Administration approved XTANDI on August 31,
    2012 for patients with metastatic castration-resistant prostate cancer
    who have previously received docetaxel. Marketing applications for
    XTANDI have also been submitted in Europe, South Korea, Canada and
    Brazil for the same indicati
on.

  
Enzalutamide Clinical Development Program 


 
--  Presented data related to enzalutamide at the American Society of
    Clinical Oncology (ASCO) 2013 Genitourinary (GU) Cancers Symposium in
    February 2013. Selected abstracts included:
    
    
    --  Post-hoc analysis of the Phase 3 AFFIRM trial evaluating the
        survival impact of baseline corticosteroid (CS) use in men, which
        showed that concomitant CS use was associated with reduced overall
        survival (median of 12.8 months in the CS group vs. median not met
        in the no CS group) and higher rates of grade 3-4 adverse events
        (63.3% in the CS group vs. 34.4% in the no CS group) in this
        population. The three most common side effects observed more
        frequently in XTANDI-treated patients as compared with
        placebo-treated patients were fatigue, diarrhea and hot flush.
        
        
    --  Results from a Phase 2 trial in 67 men with advanced prostate
        cancer who had not received any previous hormonal therapies. The
        primary endpoint was PSA (prostate specific antigen) response,
        defined as a reduction in PSA levels of at least 80%, after 25
        weeks of treatment. In this study, 93% of men experienced a PSA
        response, with the median response being a PSA reduction of 99.6%.
        Frequent treatment-emergent adverse events were mostly Grade 1 or
        2 and included gynecomastia (36%), fatigue (34%), nipple pain
        (19%), and hot flush (18%).
        
        
--  Continued to follow patients in the Phase 3 PREVAIL trial of
    enzalutamide evaluating approximately 1,700 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. Enrollment in this trial was
    completed in May 2012.
    
    
--  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.
    
    
--  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 


 
--  Elected Kathryn E. Falberg to the Medivation Board of Directors. She
    will also serve as the chair of the Audit Committee. Ms. Falberg
    currently serves as the executive vice president and chief financial
    officer of Jazz Pharmaceuticals, plc. and was formerly the senior vice
    president, finance, strategy and chief financial officer at Amgen Inc.

  
Fourth Quarter and Year-End 2012 Financial Results 
XTANDI net sales for the fourth quarter and year-end 2012, as
reported by Astellas, were $57.4 million, and $71.5 million
respectively. Medivation's collaboration revenue was $37.2 million
for the fourth quarter of 2012 and $181.7 million for the full year
2012, which consisted of two components: collaboration revenue
attributable to U.S. XTANDI net sales ($28.7 million and $35.8
million for the quarter and year respectively), and collaboration
revenue attributable to up-front and development milestone payments
($8.5 million and $145.9 million respectively).  
Total operating expenses for the quarter and year ended December 31,
2012 were $63.9 million and $207.9 million, respectively, compared
with total operating expenses of $26.9 million and $103.3 million for
the same period in 2011. The full year figures include non-cash
stock-based compensation expense of $23.7 million in 2012, compared
with $13.9 million in 2011. 
Medivation reported a net loss of $31.7 million, or $0.43 per diluted
share for the quarter ended December 31, 2012, compared with a net
loss of $10.9 million, or $0.15 per diluted share, for the same
period in 2011 on a post-split basis. Medivation reported a net loss
of $41.3 million, or $0.56 per diluted share for the full year 2012,
compared to $38.8 million or $0.56 per diluted share for the full
year 2011 on a post-split basis. 
At December 31, 2012, cash, cash equivalents and short-term
investments totaled $296.2 million, compared with $145.1 million at
December 31, 2011.  
2013 Financial Outlook 
Medivation currently expects total operating expenses for 2013, net
of cost-sharing payments from Astellas, to be between $285 million
and $300 million, approximately $29 million of which consists of
non-cash stock-based compensation expense. Medivation continues to
expect to incur approximately $7 million in capital expenditures in
2013, primarily related to leasehold improvements at its corporate
headquarters. 
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(R) (enzalutamide) capsules, including
precautions, warnings, adverse reactions, and contraindications for
the treatment of patients with metastatic castration resistant
prostate cancer who have previously 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 "2013
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 annual report on Form 10-K
for the year ended December 31, 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,
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)                                 
                                                                            
                                                                            
                                                         December 31,       
                                                      2012          2011    
                                                   -----------  ----------- 
ASSETS                                                                      
Current assets:                                                             
  Cash and cash equivalents                        $    71,301  $    70,136 
  Short-term investments                               224,939       74,996 
  Receivables from collaboration partners               35,458       12,545 
  Restricted cash                                          343          500 
  Prepaid expenses and other current assets             12,175       10,012 
                                                   -----------  ----------- 
    Total current assets                               344,216      168,189 
Property and equipment, net                             13,262          720 
Restricted cash, net of current                          8,843        5,489 
Other non-current assets                                 5,545          719 
                                                   -----------  ----------- 
Total assets                                       $   371,866  $   175,117 
                                                   ===========  =========== 
                                                                            
LIABILITIES AND STOCKHOLDERS' EQUITY                                        
Current liabilities:                                                        
  Accounts payable                                 $     2,073  $     5,588 
  Accrued expenses and other current liabilities        48,951       24,284 
  Deferred revenue                                      33,862       59,762 
                                                   -----------  ----------- 
    Total current liabilities                           84,886       89,634 
Convertible Notes, net of unamortized discount of                           
 $62,743 at December 31, 2012                          196,007           -- 
Deferred revenue, net of current                         8,465       83,509 
Other non-current liabilities                            8,863          653 
                                                   -----------  ----------- 
  Total liabilities                                    298,221      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; 74,774,939 and                            
   71,463,676* shares issued and outstanding at                             
   December 31, 2012 and 2011, respectively                748         714* 
  Additional paid-in capital                           364,412     250,885* 
  Accumulated other comprehensive income                    33           13 
  Accumulated deficit                                 (291,548)    (250,291)
                                                   -----------  ----------- 
    Total stockholders' equity                          73,645        1,321 
                                                   -----------  ----------- 
Total liabilities and stockholders' equity         $   371,866  $   175,117 
                                                   ===========  =========== 
                                                                            
  *Adjusted to reflect 2-for-1 forward split of Medivation common stock,    
  which took effect on September 21, 2012.                                  
                                                                            
                                                                            
                                                                            
                             MEDIVATION, INC.                               
                   CONSOLIDATED STATEMENTS OF OPERATIONS                    
                   (in thousands, except per share data)                    
                                (unaudited)                                 
                                                                            
                                                                            
                               Three Months Ended     Twelve Months Ended   
                                  December 31,            December 31,      
                              --------------------   ---------------------  
                                 2012       2011        2012        2011    
                              ---------  ---------   ---------   ---------  
Collaboration revenue         $  37,161  $  14,941   $ 181,696   $  60,389  
Operating expenses:                                                         
  Research and development       22,003     17,969      95,628      73,432  
  Selling, general and                                                      
   administrative                41,913      8,971     112,282      29,887  
         
                     ---------  ---------   ---------   ---------  
    Total operating expenses     63,916     26,940     207,910     103,319  
                              ---------  ---------   ---------   ---------  
Loss from operations            (26,755)   (11,999)    (26,214)    (42,930) 
Other income (expense), net:                                                
  Interest expense               (4,872)        --     (14,985)         --  
  Interest income                    89         25         229          94  
  Other income (expense), net      (111)        34        (280)       (336) 
                              ---------  ---------   ---------   ---------  
    Total other income                                                      
     (expense), net              (4,894)        59     (15,036)       (242) 
                              ---------  ---------   ---------   ---------  
Net loss before income tax                                                  
 (expense) benefit              (31,649)   (11,940)    (41,250)    (43,172) 
Income tax (expense) benefit        (11)     1,069          (7)      4,331  
                              ---------  ---------   ---------   ---------  
Net loss                      $ (31,660) $ (10,871)  $ (41,257)  $ (38,841) 
                              =========  =========   =========   =========  
                                                                            
                                                                            
Basic and diluted net loss                                                  
 per common share             $   (0.43) $   (0.15)* $   (0.56)* $   (0.56)*
                              =========  =========   =========   =========  
Weighted average common                                                     
 shares used in the                                                         
 calculation of basic and                                                   
 diluted net loss per common                                                
 share                           74,489     70,749*     73,480*     69,921* 
                              =========  =========   =========   =========  
                                                                            
  *Adjusted to reflect 2-for-1 forward split of Medivation common stock,    
  which took effect on September 21, 2012.                                  

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