Medivation Reports First Quarter Financial Results and Provides Corporate Update

Medivation Reports First Quarter Financial Results and Provides Corporate Update 
$75.4 Million in First Quarter Net Sales; Conference Call Today at
4:30 p.m. Eastern Time 
SAN FRANCISCO, CA -- (Marketwired) -- 05/09/13 --  Medivation, Inc.
(NASDAQ: MDVN) today provided a corporate update and reported its
financial results for the first quarter ended March 31, 2013. Net
sales of XTANDI(R) (enzalutamide) capsules for the quarter, as
reported by Astellas Pharma Inc., were $75.4 million, an increase of
$18.0 million over the prior quarter. XTANDI was approved by the U.S.
Food and Drug Administration on August 31, 2012 and was available for
shipment on September 13, 2012. 
"We are pleased with the positive market response to XTANDI in the
first quarter of 2013, which provides a strong start to the year as
we look forward to the potential approval and launch of enzalutamide
in Europe and other markets for post-chemotherapy metastatic
castration-resistant prostate cancer patients, the results from the
planned interim analysis for the PREVAIL trial in pre-chemotherapy
metastatic castration-resistant prostate cancer patients, which if
positive, could potentially support a new indication for XTANDI, and
the initiation of a Phase 3 trial in non-metastatic patients with
castration-resistant prostate cancer," said David Hung, M.D.,
president and chief executive officer of Medivation, Inc. "The
expertise of our three new board members will be extremely valuable
as we further scale our organization to fully capture both existing
and future opportunities to transform the treatment of patients with
serious illness." 
Recent Developments  
XTANDI(R) (enzalutamide) capsules 


 
--  Net sales of XTANDI in the U.S. were $75.4 million in the first
    quarter of 2013, which included a favorable gross-to-net adjustment
    taken by Astellas of $4.4 million relating to prior quarters.
    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.
    
    
--  Received a positive opinion on April 25, 2013 from the European
    Medicines Agency's Committee for Medici
nal Products for Human Use,
    recommending European Commission approval for XTANDI (enzalutamide)
    capsules for the treatment of adult men with metastatic
    castration-resistant prostate cancer whose disease has progressed on
    or after docetaxel therapy. Marketing applications for XTANDI have
    also been submitted in Switzerland, South Korea, Canada and Brazil for
    the same indication.

  
Enzalutamide Clinical Development Program 


 
--  Exceeded the protocol-specified number of radiographic
    progression-free survival (PFS) events for the final analysis of the
    Phase 3 PREVAIL trial, and plan on conducting an interim overall
    survival (OS) analysis in 2013. The PREVAIL trial is evaluating
    enzalutamide versus placebo in 1,717 men with metastatic
    castration-resistant prostate cancer (mCRPC) who have not yet received
    chemotherapy. The co-primary endpoints in this trial are OS and PFS.
    Enrollment in this trial was completed in May 2012.
    
    
--  Presented data related to enzalutamide at the American Society of
    Clinical Oncology 2013 Genitourinary 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 OS
        (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 patient enrollment in two trials comparing enzalutamide's
    effects on PFS 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, Dawn Graham and Wendy L. Yarno to the
    Medivation Board of Directors. 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. Ms. Graham
    is the retired president of Europe and Canada at Merck & Co., Inc.
    Ms. Yarno is the retired chief marketing officer of Merck.

  
First Quarter Financial Results 
XTANDI net sales for the first quarter of 2013, as reported by
Astellas, were $75.4 million, which included a favorable gross-to-net
adjustment of $4.4 million taken by Astellas relating to prior
quarters. Medivation's collaboration revenue was $46.2 million for
the first quarter of 2013, which consisted of two components:
collaboration revenue attributable to U.S. XTANDI net sales ($37.7
million), and collaboration revenue attributable to up-front and
development milestone payments ($8.5 million).  
Total operating expenses for the quarter ended March 31, 2013 were
$68.5 million, compared with total operating expenses of $35.7
million for the same period in 2012. These figures include non-cash
stock-based compensation expense of $8.3 million in the quarter ended
March 31, 2013, compared with $4.3 million for the same period in
2012. 
Medivation reported a net loss of $27.2 million, or $0.36 per diluted
share, for the quarter ended March 31, 2013, compared with a net
income of $0.4 million, or $0.01 per diluted share, for the same
period in 2012. The net income in the first quarter of 2012 resulted
from the acceleration of unamortized revenue from the Company's
former collaboration with Pfizer. 
At March 31, 2013, cash, cash equivalents and short-term investments
totaled $271.5 million, compared with $296.2 million at December 31,
2012.  
2013 Financial Outlook 
Medivation continues to expect 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.  
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  
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 XTANDI(R) (enzalutamide) capsules  
XTANDI is indicated for the treatment of patients with metastatic
castration-resistant prostate cancer (mCRPC) who have previously
received docetaxel. 
Important Safety Information for XTANDI
 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. 
For Full Prescribing Information, please visit www.XtandiHCP.com. 
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" as well as statements regarding the potential
approval and launch of enzalutamide in Europe and other markets and
the expected benefits resulting from the addition of Medivation's
directors 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, 2013, which will be filed on May
10, 2013 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, 
                                                     2013          2012     
                                                 ------------  ------------ 
ASSETS                                                                      
Current assets:                                                             
  Cash and cash equivalents                      $    111,524  $     71,301 
  Short-term investments                              159,957       224,939 
  Receivable from collaboration partner                40,142        35,458 
  Restricted cash                                         343           343 
  Prepaid expenses and other current assets            13,069        12,175 
                                                 ------------  ------------ 
    Total current assets                         
     325,035       344,216 
Property and equipment, net                            16,472        13,262 
Restricted cash, net of current                         8,843         8,843 
Other non-current assets                                5,443         5,545 
                                                 ------------  ------------ 
Total assets                                     $    355,793  $    371,866 
                                                 ============  ============ 
LIABILITIES AND STOCKHOLDERS' EQUITY                                        
Current liabilities:                                                        
  Accounts payable                               $      3,157  $      2,073 
  Accrued expenses and other current liabilities       54,927        48,951 
  Deferred revenue                                     33,862        33,862 
                                                 ------------  ------------ 
    Total current liabilities                          91,946        84,886 
Convertible Notes, net of unamortized discount                              
 of $59,802 and $62,743 at March 31, 2013 and                               
 December 31, 2012, respectively                      198,948       196,007 
Deferred revenue, net of current                           --         8,465 
Other non-current liabilities                           8,323         8,863 
                                                 ------------  ------------ 
    Total liabilities                                 299,217       298,221 
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; 74,957,571 and                            
   74,774,939 shares issued and outstanding at                              
   March 31, 2013 and December 31, 2012,                                    
   respectively                                           750           748 
  Additional paid-in capital                          374,528       364,412 
  Accumulated other comprehensive income                   16            33 
  Accumulated deficit                                (318,718)     (291,548)
                                                 ------------  ------------ 
    Total stockholders' equity                         56,576        73,645 
                                                 ------------  ------------ 
Total liabilities and stockholders' equity       $    355,793  $    371,866 
                                                 ============  ============ 
                                                                            
                                                                            
                                                                            
                              MEDIVATION, INC.                              
                   CONSOLIDATED STATEMENTS OF OPERATIONS                    
                   (in thousands, except per share data)                    
                                (unaudited)                                 
                                                                            
                                                     Three Months Ended     
                                                          March 31,         
                                                 -------------------------- 
                                                     2013          2012     
                                                                            
                                                 ------------  ------------ 
Collaboration revenue                            $     46,154  $     36,825 
Operating expenses:                                                         
  Research and development expenses                    24,908        20,030 
  Selling, general and administrative expenses         43,568        15,687 
                                                 ------------  ------------ 
    Total operating expenses                           68,476        35,717 
                                                 ------------  ------------ 
(Loss) income from operations                         (22,322)        1,108 
Other income (expense), net:                                                
  Interest expense                                     (4,888)         (585)
  Interest income                                          74            27 
  Other income (expense), net                              (1)          (98)
                                                 ------------  ------------ 
    Total other income (expense), net                  (4,815)         (656)
                                                 ------------  ------------ 
Net (loss) income before income tax expense           (27,137)          452 
Income tax expense                                        (33)          (12)
                                                 ------------  ------------ 
Net (loss) income                                $    (27,170) $        440 
                                                 ============  ============ 
Basic net (loss) income per common share         $      (0.36) $       0.01 
                                                 ============  ============ 
Diluted net (loss) income per common share       $      (0.36) $       0.01 
                                                 ============  ============ 
Weighted-average common shares used in the                                  
 calculation of basic net (loss) income per                                 
 common share                                          74,824        71,907 
                                                 ============  ============ 
Weighted-average common shares used in the                                  
 calculation of diluted net (loss) income per                               
 common share                                          74,824        77,299 
                                                 ============  ============ 

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