XML 83 R20.htm IDEA: XBRL DOCUMENT v2.4.0.8
Collaboration Agreement (Tables)
6 Months Ended
Jun. 30, 2014
Organization Consolidation And Presentation Of Financial Statements [Abstract]  
Schedule of Potential Development Milestone Payments

The triggering events for the remaining 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)           (7)           (7) 

The first major country in Europe

          (5)           (7)           (7) 

Japan

          (5)           (7)           (7) 

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

          (6)    $ 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. This milestone payment was earned and recognized as collaboration revenue during the second quarter of 2014 and has been received as of June 30, 2014.
(5) These milestones totaling $78.0 million were earned and recognized as collaboration revenue prior to 2014 and payments have been received as of June 30, 2014.
(6) This milestone of $15.0 million was earned and recognized as collaboration revenue during the first quarter of 2014 and payment has been received as of June 30, 2014.
(7) These milestones totaling $55.0 million were earned and recognized as collaboration revenue during the second quarter of 2014 and payments have been received as of June 30, 2014.
Schedule of Potential Sales Milestone Payments

The triggering events for the remaining 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:

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
     2014      2013      2014      2013  

Collaboration revenue:

           

Related to U.S. XTANDI sales

   $ 71,866       $ 41,201       $ 134,091       $ 78,890   

Related to ex-U.S. XTANDI sales

     9,992         482         15,723         482   

Related to upfront and milestone payments

     66,232         28,466         85,465         36,931   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 148,090       $ 70,149       $ 235,279       $ 116,303   
  

 

 

    

 

 

    

 

 

    

 

 

Schedule of Collaboration Revenue Related to U.S. XTANDI Sales

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

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2014     2013     2014     2013  

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

   $ 143,732      $ 82,402      $ 268,183      $ 157,780   

Shared U.S. development and commercialization costs

     (70,543     (61,431     (148,250     (119,101
  

 

 

   

 

 

   

 

 

   

 

 

 

Pre-tax U.S. profit

   $ 73,189      $ 20,971      $ 119,933      $ 38,679   
  

 

 

   

 

 

   

 

 

   

 

 

 

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

   $ 36,594      $ 10,486      $ 59,966      $ 19,340   

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

     35,272        30,715        74,125        59,550   
  

 

 

   

 

 

   

 

 

   

 

 

 

Collaboration revenue related to U.S. XTANDI sales

   $ 71,866      $ 41,201      $ 134,091      $ 78,890   
  

 

 

   

 

 

   

 

 

   

 

 

Schedule of Collaboration Revenue Related to Upfront and Milestone Payments

Collaboration revenue related to upfront and milestone payments from Astellas was as follows:

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
     2014      2013      2014      2013  

Development milestones earned

   $ 62,000       $ 20,000       $ 77,000       $ 20,000   

Amortization of deferred upfront and development milestones

     4,232         8,466         8,465         16,931   
  

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 66,232       $ 28,466       $ 85,465       $ 36,931