Medivation Reports Fourth Quarter and Year-End 2013 Financial Results and Provides Corporate Update

Medivation Reports Fourth Quarter and Year-End 2013 Financial Results and 
Provides Corporate Update 
$126.1 Million in Fourth Quarter U.S. Net Sales of XTANDI; $392.4
Million in 2013 Full-Year U.S. Net Sales of XTANDI; Conference Call
Today at 4:30 p.m. Eastern Time 
SAN FRANCISCO, CA -- (Marketwired) -- 02/27/14 --  Medivation, Inc.
(NASDAQ: MDVN) today provided a corporate update and reported its
financial results for the fourth quarter and year ended December 31,
2013. U.S. net sales of XTANDI(R) (enzalutamide) capsules for the
quarter, as reported by Astellas Pharma Inc., were $126.1 million.
U.S. net sales for the full year 2013, as reported by Astellas, were
$392.4 million. Ex-U.S. net sales of XTANDI for the quarter, as
reported by Astellas, were $35.8 million. Ex-U.S. net sales, as
reported by Astellas, for the full year 2013 were $52.8 million.  
"2013 was an extremely productive year for Medivation. In addition to
the excellent commercial performance from XTANDI in mCRPC patients
post chemotherapy, the year was highlighted by the statistically
significant results from the Phase 3 PREVAIL study as well as the
initiation and continued enrollment in numerous ongoing clinical
studies evaluating enzalutamide in pre-chemotherapy CRPC patients,
including both metastatic and non-metastatic disease, and also in
breast cancer," said David Hung, M.D., president and chief executive
officer of Medivation. "Looking ahead, we remain focused on continued
value creation for our shareholders, driving meaningful innovation
and rapidly pursuing the most attractive business opportunities
strategically and cost-effectively." 
Recent Developments  
XTANDI(R) (enzalutamide) capsules 


 
--  U.S. net sales of XTANDI were $126.1 million in the fourth quarter and
    $392.4 million for the full year 2013. XTANDI was approved by the U.S.
    Food and Drug Administration 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 $35.8 million in the fourth quarter
    and $52.8 million for the full year 2013. 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 35 countries for the treatment of
    patients with mCRPC who have previously received docetaxel.

  
PREVAIL 


 
--  Reported positive top-line results in October 2013 from the PREVAIL
    trial, a randomized, double-blind Phase 3 trial evaluating
    enzalutamide as compared to placebo in more than 1,700
    pre-chemotherapy mCRPC patients. Given the overall survival benefit
    and the observed safety profile, the Independent Data Monitoring
    Committee considered the overall benefit-risk ratio to favor the
    enzalutamide arm and recommended unequivocally that patients receiving
    placebo be offered treatment with enzalutamide.
    
    
    Compared to placebo, enzalutamide demonstrated statistically
    significant reductions in both the risk of death (29% risk reduction;
    HR=0.71; p less than 0.0001) and the risk of radiographic progression
    or death (81% risk reduction; HR=0.19; p less than 0.0001). Benefit in
    overall survival was observed despite greater use of subsequent
    life-extending therapies in the placebo group (70%) compared to the
    enzalutamide group (40%).
    
    
--  Additional results from the PREVAIL trial were shared in a
    late-breaking oral presentation at the American Society of Clinical
    Oncology 2014 Genitourinary Cancers Symposium (ASCO GU) in January
    2014. Enzalutamide achieved all of PREVAIL's key secondary endpoints
    with strong statistical significance.
    
    
    --  Men taking enzalutamide experienced a 17-month delay in the time
        to initiation of chemotherapy compared with placebo (28.0 months
        versus 10.8 months; HR=0.35; p less than 0.0001).
        
        
    --  The majority of men (58.8%) with soft tissue metastatic disease
        treated with enzalutamide versus 5% of patients treated with
        placebo had objective responses (complete responses or partial
        responses) including complete responses in 19.7% of enzalutamide
        patients compared with 1% of placebo patients.
        
        
    --  Enzalutamide extended the median time to PSA progression from 2.8
        months (placebo) to 11.2 months (HR=0.169; p less than 0.0001).
        
        
    --  Nearly 4 out of 5 patients in the enzalutamide group experienced a
        PSA decline of 50% or more, compared to less than 4% in the
        placebo group (78% vs. 3.5%; p less than 0.0001).
        
        
    --  The median times to deterioration in a measure of prostate
        cancer-specific quality of life, the Functional Assessment of
        Cancer Therapy-Prostate or FACT-P, were 11.3 months for the
        enzalutamide-treated patients and 5.6 months for the placebo
        patients (HR=0.625, p less than 0.0001).
        
        
    --  The median treatment duration for enzalutamide was more than 3
        times longer than for placebo (16.6 versus 4.6 months).
        
        
    --  Common side effects occurring during treatment and more common in
        the enzalutamide treated men included fatigue, back pain,
        constipation and arthralgia. Hypertension was observed in 13.4% of
        enzalutamide versus 4.1% of placebo-treated patients. Grade 3 or
        greater adverse events were observed in 42.9% of
        enzalutamide-treated versus 37.1% of placebo-treated patients.
        Investigators reported zero seizures in the enzalutamide-treated
        group and one in the placebo group prior to the data cutoff date.
        One seizure was reported in the enzalutamide group after the data
        cutoff date.
        
        
    --  Regulatory applications are expected to be submitted to the U.S.
        Food and Drug Administration and European Medicines Agency in
        early 2014.

  
Enzalutamide Clinical Development Program  


 
--  Initiated the Phase 3 PROSPER trial in December 2013 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 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 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
        
        
    --  Continued patient enrollment in the STRIVE trial, which is
        enrolling approximately 400 men with either metastatic or
        non-metastatic disease primarily in the U.S.
        
        
--  Initiated the Phase 4 PLATO trial in November 2013 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 


 
--  Initiated a Phase 2 clinical trial in December 2013 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 greater than or equal to 16 weeks.

  
Fourth Quarter and Year-End 2013 Financial Results 
XTANDI U.S. net sales for the fourth quarter and year end 2013, as
reported by Astellas, were $126.1 million and $392.4 million,
respectively, compared to $57.4 million and $71.5 million,
respectively, in the prior year periods. U.S. net sales of XTANDI for
the year ended December 31, 2012, represented sales during the period
from commercial launch on September 13, 2012 through December 31,
2012. 
Ex-U.S. net sales of XTANDI for the fourth quarter and full year
2013, as reported by Astellas, were $35.8 million and $52.8 million,
respectively. XTANDI was granted marketing authorization in the
European Union in June 2013.  
Medivation's collaboration revenue was $96.6 million for the fourth
quarter and $272.9 million for the full year 2013, compared to $37.2
million and $181.7 million, respectively, for the same periods in
2012. Medivation's collaboration revenue consists 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 up-front and development
milestone payments.  
Total operating expenses for the quarter and year ended December 31,
2013, were $88.6 million, and $295.2 million, respectively, compared
with total operating expenses of $63.9 million and $207.9 million,
respectively, for the same periods in 2012. These figures include
non-cash stock-based compensation expense of $11.5 million and $37.1
million for the quarter and year ended December 31, 2013,
respectively, compared with $6.2 million and $23.7 million,
respectively, for the same periods in 2012.  
Medivation reported net income of $2.8 million, or $0.03 per diluted
share, for the quarter ended December 31, 2013, compared with a net
loss of $31.7 million, or $0.43 per diluted share, for the same
period in 2012. Medivation reported a net loss of $42.6 million, or
$0.57 per diluted share, for the full year 2013, compared to a net
loss of $41.3 million, or $0.56 per diluted share, for the full year
2012  
At December 31, 2013, cash, cash equivalents and short-term
investments totaled $228.8 million, compared with $296.2 million at
December 31, 2012.  
2014 Financial Outlook 
For the full year 2014, Medivation expects U.S. net sales of XTANDI
to be between $500 million and $535 million and expects to receive
approximately $212 million in development milestone payments from
Astellas. Medivation expects 2014 total operating expenses, net of
cost-sharing payments from Astellas, to be between $460 million and
$485 million, approximately $57 million of which consists of non-cash
stock-based compensation expense and excludes the cost of any
in-licensing opportunities we may elect to pursue. 
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 will have 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 annual report on Form 10-K
for the year ended December 31, 2013, which was filed on February 27,
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)              
                                                                            
                                                                            
                                                          December 31,      
                                                     ---------------------- 
                                                        2013        2012    
                                                     ----------  ---------- 
ASSETS                                                                      
Current assets:                                                             
  Cash and cash equivalents                          $  228,788  $   71,301 
  Short-term investments                                      -     224,939 
  Receivable from collaboration partner                 107,210      35,458 
  Restricted cash                                             -         343 
  Prepaid expenses and other current assets              17,981      12,175 
                                                     ----------  ---------- 
                                                                            
    Total current assets                                353,979     344,216 
Property and equipment, net                              17,035      13,262 
Restricted cash, net of current                           9,899       8,843 
Other non-current assets                                 11,737       5,545 
                                                     ----------  ---------- 
                                                                            
Total assets                                         $  392,650  $  371,866 
                                                     ==========  ========== 
                                                                            
LIABILITIES AND STOCKHOLDERS' EQUITY                                        
Current liabilities:                                                        
  Accounts payable, accrued expenses and other                              
   current liabilities                               $   78,758  $   51,024 
  Deferred revenue                                       16,931      33,862 
                                                     ----------  ---------- 
                                                                            
    Total current liabilities                            95,689      84,886 
Convertible Notes, net of unamortized discount of                           
 $50,336 and $62,743 at December 31, 2013 and 2012,                         
 respectively                                           208,414     196,007 
Deferred revenue, net of current                              -       8,465 
Other non-current liabilities                            11,600       8,863 
                                                     ----------  ---------- 
                                                                            
    Total liabilities                                   315,703     298,221 
                                                                            
Stockholders' equity:                                                       
  Preferred stock, $0.01 par val
ue 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; 75,803,020 and                            
   74,774,939 shares issued and outstanding at                              
   December 31, 2013 and 2012, respectively                 758         748 
  Additional paid-in capital                            410,350     364,412 
  Accumulated other comprehensive income                      -          33 
  Accumulated deficit                                  (334,161)   (291,548)
                                                     ----------  ---------- 
                                                                            
    Total stockholders' equity                           76,947      73,645 
                                                     ----------  ---------- 
                                                                            
Total liabilities and stockholders' equity           $  392,650  $  371,866 
                                                     ==========  ========== 
                                                                            
                                                                            
                                                                          
                                                                          
                              MEDIVATION, INC.                            
                   CONSOLIDATED STATEMENTS OF OPERATIONS                  
                   (in thousands, except per share data)                  
                                (unaudited)                               
                                                                          
                                                                          
                                Three Months Ended    Twelve Months Ended 
                                   December 31,          December 31,     
                               --------------------  -------------------- 
                                  2013       2012       2013       2012   
                               ---------  ---------  ---------  --------- 
  Collaboration revenue        $  96,612  $  37,161  $ 272,942  $ 181,696 
  Operating expenses:                                                     
    Research and development                                              
     expenses                     37,102     22,003    118,952     95,628 
    Selling, general and                                                  
     administrative expenses      51,485     41,913    176,231    112,282 
                               ---------  ---------  ---------  --------- 
      Total operating expenses    88,587     63,916    295,183    207,910 
                               ---------  ---------  ---------  --------- 
                                                                          
  Income (loss) from                                                      
   operations                      8,025    (26,755)   (22,241)   (26,214)
  Other income (expense), net:                                            
    Interest expense              (5,214)    (4,872)   (20,249)   (14,985)
    Interest income                   27         89        193        229 
    Other expense, net               (78)      (111)      (201)      (280)
                               ---------  ---------  ---------  --------- 
      Total other income                                                  
       (expense), net             (5,265)    (4,894)   (20,257)   (15,036)
                               ---------  ---------  ---------  --------- 
                                                                          
  Net income (loss) before                                                
   income tax benefit                                                     
   (expense)                       2,760    (31,649)   (42,498)   (41,250)
  Income tax benefit (expense)         8        (11)      (115)        (7)
                               ---------  ---------  ---------  --------- 
  Net income (loss)            $   2,768  $ (31,660) $ (42,613) $ (41,257)
                               =========  =========  =========  ========= 
  Basic net income (loss) per                                             
   common share                $    0.04  $   (0.43) $   (0.57) $   (0.56)
                               =========  =========  =========  ========= 
  Diluted net income (loss)                                               
   per common share            $    0.03  $   (0.43) $   (0.57) $   (0.56)
                               =========  =========  =========  ========= 
  Weighted average common                                                 
   shares used in the                                                     
   calculation of basic net                                               
   income (loss) per common                                               
   share                          75,560     74,489     75,165     73,480 
                               =========  =========  =========  ========= 
  Weighted average common                                                 
   shares used in the                                                     
   calculation of diluted net                                             
   income (loss) per common                                               
   share                          79,912     74,489     75,165     73,480 
                               =========  =========  =========  ========= 

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