XML 71 R20.htm IDEA: XBRL DOCUMENT v2.4.0.8
Collaboration Agreements (Tables)
9 Months Ended
Sep. 30, 2013
Organization Consolidation And Presentation Of Financial Statements [Abstract]  
Substantive Development Milestone Payments Eligible to Receive under Astellas Collaboration Agreement

The remaining $257.0 million in development milestone payments the Company is eligible to receive under the Astellas Collaboration Agreement are as follows:

 

Milestone Event

   4th line prostate cancer
patients (1)
     3rd line prostate cancer
patients (2)
     2nd line prostate cancer
patients (3) (4)
 

First acceptance for filing of a marketing application in:

        

The U.S.

     (5 )     $  10 million       $  15 million   

The first major country in Europe

     (5 )     $ 5 million       $ 10 million   

Japan

     (5 )     $ 5 million       $ 10 million   

First approval of a marketing application in:

        

The U.S.

     (5 )     $ 30 million       $ 60 million   

The first major country in Europe

     (5 )     $ 15 million       $ 30 million   

Japan

   $  15 million       $ 15 million       $ 30 million   

 

(1)  Defined as prostate cancer patients who meet each of the following three criteria: (a) prior treatment failure on either (i) one or more luteinizing hormone-releasing hormone, or LHRH, analog drugs or (ii) surgical castration; (b) prior treatment failure on one or more androgen receptor antagonist drugs; and (c) prior treatment failure on chemotherapy.
(2)  Defined as prostate cancer patients who meet each of the following three criteria: (a) prior treatment failure on either (i) one or more LHRH analog drugs or (ii) surgical castration; (b) prior treatment failure on one or more androgen receptor antagonist drugs; and (c) no prior exposure to chemotherapy for prostate cancer.
(3)  Defined as prostate cancer patients who meet each of the following two criteria: (a) prior treatment failure on either (i) one or more LHRH analog drugs or (ii) surgical castration; and (b) no prior treatment failure on one or more androgen receptor antagonist drugs.
(4) 

An additional milestone payment of $7.0 million is payable upon the first to occur of: (a) first approval of a marketing application in the United States with a label encompassing 2nd line prostate cancer patients; (b) first approval of a marketing application in the first major country in Europe with a label encompassing 2nd line prostate cancer patients; (c) first approval of a marketing application in Japan with a label encompassing 2nd line prostate cancer patients; or (d) first patient dosed in a Phase 3 clinical trial other than the PREVAIL trial that is designed specifically to support receipt of marketing approval in 2nd line patients.

(5)  These milestone payments totaling $78.0 million have been received as of September 30, 2013.
Schedule of Collaboration Revenue

Collaboration revenue was as follows:

 

     Three Months Ended
September 30,
     Nine Months Ended
September 30,
 
     2013      2012      2013      2012  

Collaboration revenue:

           

Attributable to U.S. XTANDI sales

   $ 54,244       $ 7,056      $ 133,134       $ 7,056  

Attributable to ex-U.S. XTANDI sales

     1,551         —           2,033         —     

Attributable to up-front and milestone payments

     4,232         57,742         41,163         137,479   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 60,027       $ 64,798       $ 176,330       $ 144,535   
  

 

 

    

 

 

    

 

 

    

 

 

 
Schedule of Collaboration Revenue Attributable to Sales

Collaboration revenue attributable to U.S. XTANDI sales was as follows:

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2013     2012     2013     2012  

Net U.S. sales (as reported by Astellas)

   $ 108,487      $ 14,112      $ 266,267      $ 14,112   

Shared U.S. development and commercialization costs

     (58,901     (41,928     (178,002     (41,928
  

 

 

   

 

 

   

 

 

   

 

 

 

Pre-tax U.S. profit (loss)

   $ 49,586      $ (27,816   $ 88,265      $ (27,816
  

 

 

   

 

 

   

 

 

   

 

 

 

Medivation’s share of pre-tax U.S. profit (loss)

   $ 24,793      $ (13,908   $ 44,133      $ (13,908

Reimbursement of Medivation’s share of shared U.S. costs

     29,451        20,964        89,001        20,964   
  

 

 

   

 

 

   

 

 

   

 

 

 

Collaboration revenue attributable to U.S. XTANDI sales

   $ 54,244      $ 7,056      $ 133,134      $ 7,056   
  

 

 

   

 

 

   

 

 

   

 

 

 
Schedule of Collaboration Revenue Attributable to Up-Front and Milestone Payments

Collaboration revenue attributable to up-front and milestone payments were as follows:

 

     Three Months Ended
September 30,
     Nine Months Ended
September 30,
 
     2013      2012      2013      2012  

Collaboration revenue attributable to up-front and milestone payments:

           

From Astellas

   $ 4,232       $ 52,256       $ 41,163       $ 65,449   

From Pfizer

     —           5,486         —           72,030   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 4,232       $ 57,742       $ 41,163       $ 137,479   
  

 

 

    

 

 

    

 

 

    

 

 

 
Deferred Revenue

Deferred revenue under the Astellas Collaboration Agreement consisted of the following:

 

     September 30,
2013
     December 31,
2012
 

Current

   $ 16,931       $ 33,862   

Long-term

     4,233         8,465   
  

 

 

    

 

 

 

Total

   $ 21,164       $ 42,327   
  

 

 

    

 

 

 
Development and Commercialization Cost-Sharing Payments

The following table summarizes the reductions in R&D expenses related to development cost-sharing payments:

 

     Three Months Ended
September 30,
     Nine Months Ended
September 30,
 
     2013      2012      2013      2012  

Development cost-sharing payments from Astellas

   $ 13,070       $ 11,003       $ 31,617       $ 39,131   

Development cost-sharing payments from Pfizer

     —           51         —           1,740   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 13,070       $ 11,054       $ 31,617       $ 40,871   
  

 

 

    

 

 

    

 

 

    

 

 

 

The following table summarizes the (increases) reductions in SG&A expenses related to commercialization cost-sharing payments:

 

     Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
     2013     2012     2013     2012  

Commercialization cost-sharing payments to Astellas

   $ (1,812   $ (1,187   $ (10,388   $ (1,857

Commercialization cost-sharing payments from Pfizer

     —          —          —          9   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total

   $ (1,812   $ (1,187   $ (10,388   $ (1,848