Collaboration Agreement (Tables)

3 Months Ended

Mar. 31, 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

4^th line prostate cancer
patients⁽¹⁾

3^rd line prostate cancer
patients⁽²⁾

2 ^nd line prostate cancer
patients^{(3)
(4)}

First acceptance for filing of a marketing application in:

The U.S.

⁽⁵

⁾

10 million

⁽⁷⁾

15 million

⁽⁷⁾

The first major country in Europe

⁽⁵

⁾

5 million

⁽⁸⁾

10 million

⁽⁸⁾

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

⁽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 2^nd line prostate cancer patients; (b) first approval of a marketing application in the first major country in Europe with a label encompassing 2^nd line prostate cancer patients; (c) first approval of a marketing application in Japan with a label encompassing 2^nd 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 2^nd line patients. This milestone has been earned in the second quarter of 2014 and will be recognized as collaboration revenue during the second quarter of 2014.

(5)	These milestone payments totaling $78.0 million were earned and recognized as collaboration revenue prior to 2014. Payments totaling $78.0 million have been received as of March 31, 2014.

(6)

In March 2014, the Company’s partner, Astellas, obtained XTANDI marketing approval for the treatment of patients with castration-resistant prostate cancer, or CRPC, in Japan with the precaution that the efficacy and safety of XTANDI have not been established in patients with prostate cancer who have not received chemotherapy. The Japanese marketing approval triggered a $15.0 million milestone payment, which has been recognized as collaboration revenue during the first quarter of 2014. The milestone payment, which was included in “receivable from collaboration partner” on the accompanying unaudited consolidated balance sheet at March 31, 2014, was received during the second quarter of 2014.

(7)

These milestones totaling $25.0 million have been earned in May 2014 as a result of the FDA’s acceptance for filing of the sNDA to extend the indication of XTANDI for the treatment of men with mCRPC who have not received chemotherapy and will be recognized as collaboration revenue during the second quarter of 2014.

(8)

These milestones totaling $15.0 million have been earned in April 2014 as a result of the European Medicines Agency’s validation of Astellas’ application for an amended European Marketing Authorization Application and acceptance of the filing for the treatment of adult men with mCRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated and will be recognized as collaboration revenue during the second quarter of 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 March 31,
	2014		2013
Collaboration revenue:
Attributable to U.S. XTANDI sales	$	62,225	$	37,689
Attributable to ex-U.S. XTANDI sales		5,731		—
Attributable to up-front and milestone payments		19,233		8,465

Total	$	87,189	$	46,154

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

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


	Three Months Ended March 31,
	2014			2013
Net U.S. sales (as reported by Astellas)	$	124,451		$	75,378
Shared U.S. development and commercialization costs		(77,707	)		(57,670	)

Pre-tax U.S. profit	$	46,744		$	17,708

Medivation’s share of pre-tax U.S. profit	$	23,372		$	8,854
Reimbursement of Medivation’s share of shared U.S. costs		38,853			28,835

Collaboration revenue attributable to U.S. XTANDI sales	$	62,225		$	37,689