XML 59 R24.htm IDEA: XBRL DOCUMENT v2.4.0.8
Collaboration Agreements (Tables)
12 Months Ended
Dec. 31, 2013
Organization Consolidation And Presentation Of Financial Statements [Abstract]  
Substantive Development Milestone Payments Eligible to Receive under Astellas Collaboration Agreement

The triggering events for 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 December 31, 2013.
Schedule of Milestone Payments in Sales

The triggering events for the remaining $295.0 million in sales milestone payments the Company is eligible to receive are as follows:

 

Annual Global Net Sales in a Calendar Year

  

Milestone Payment(1)

$800 million

   $50 million

$1.2 billion

   $70 million

$1.6 billion

   $175 million

 

(1) Each milestone shall only be paid once during the term of the Astellas Collaboration Agreement.
Schedule of Collaboration Revenue

Collaboration revenue was as follows:

 

     Years Ended December 31,  
     2013      2012      2011  

Collaboration revenue:

        

Attributable to U.S. XTANDI sales

   $ 196,208       $ 35,752      $ —    

Attributable to ex-U.S. XTANDI sales

     6,338        —          —    

Attributable to up-front and milestone payments

     70,396         145,944         60,389   
  

 

 

    

 

 

    

 

 

 

Total

   $ 272,942       $ 181,696       $ 60,389   
  

 

 

    

 

 

    

 

 

Schedule of Collaboration Revenue Attributable to Sales

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

 

     Years Ended
December 31,
 
     2013     2012  

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

   $ 392,415      $ 71,504   

Shared U.S. development and commercialization costs

     (241,106     (88,908
  

 

 

   

 

 

 

Pre-tax U.S. profit (loss)

   $ 151,309      $ (17,404
  

 

 

   

 

 

 

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

   $ 75,655      $ (8,702

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

     120,553        44,454   
  

 

 

   

 

 

 

Collaboration revenue attributable to U.S. XTANDI sales

   $ 196,208      $ 35,752   
  

 

 

   

 

 

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

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

 

     Years Ended December 31,  
     2013      2012      2011  

Collaboration revenue attributable to up-front and milestone payments:

        

From Astellas

   $ 70,396       $ 73,914       $ 24,374   

From Pfizer

     —           72,030         36,015   
  

 

 

    

 

 

    

 

 

 

Total

   $ 70,396       $ 145,944       $ 60,389   
  

 

 

    

 

 

    

 

 

Deferred Revenue

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

 

     December 31,  
     2013      2012  

Current

   $ 16,931       $ 33,862   

Long-term

     —          8,465   
  

 

 

    

 

 

 

Total

   $ 16,931       $ 42,327   
  

 

 

    

 

 

 
Development and Commercialization Cost-Sharing Payments

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

 

     Years Ended December 31,  
     2013      2012      2011  

Development cost-sharing payments from Astellas

   $ 46,594       $ 47,473       $ 44,285   

Development cost-sharing payments from Pfizer

     —          1,740         12,365   
  

 

 

    

 

 

    

 

 

 

Total

   $ 46,594       $ 49,213       $ 56,650   
  

 

 

    

 

 

    

 

 

 

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

 

     Years Ended December 31,  
     2013     2012     2011  

Commercialization cost-sharing payments to Astellas

   $ (11,973   $ (3,437   $ (472

Commercialization cost-sharing payments from Pfizer

     —         9        32   
  

 

 

   

 

 

   

 

 

 

Total

   $ (11,973   $ (3,428   $ (440