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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

 

FORM 10-Q

 

 

(Mark One)

x	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2014

or

 

¨	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from              to             

COMMISSION FILE NUMBER: 001-32836

 

 

MEDIVATION, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware		13-3863260
(State or other jurisdiction of incorporation or organization)		(IRS Employer identification No.)

525 Market Street, 36th floor

San Francisco, California 94105

(Address of principal executive offices) (Zip Code)

(415) 543-3470

(Registrant’s telephone number, including area code)

 

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x    No  ¨

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  x    No  ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer		x		Accelerated filer		¨
Non-accelerated filer		¨  (Do not check if a smaller reporting company)		Smaller reporting company		¨

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes  ¨    No  x

As of October 31, 2014, 77,624,659 shares of the registrant’s Common Stock, $0.01 par value per share, were outstanding.

 

 

 

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PART I — FINANCIAL INFORMATION					3
ITEM 1.		FINANCIAL STATEMENTS.			3
		CONSOLIDATED BALANCE SHEETS (unaudited).			3
		CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited).			4
		CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (unaudited).			5
		CONSOLIDATED STATEMENTS OF CASH FLOWS (unaudited).			6
		NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (unaudited).			7
ITEM 2.		MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.			22
ITEM 3.		QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.			33
ITEM 4.		CONTROLS AND PROCEDURES.			33
PART II — OTHER INFORMATION					34
ITEM 1.		LEGAL PROCEEDINGS.			34
ITEM 1A.		RISK FACTORS.			35
ITEM 6.		EXHIBITS.			55

 

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PART I. FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

MEDIVATION, INC.

CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

(unaudited)

 

		September 30, 2014				December 31, 2013
ASSETS
Current assets:
Cash and cash equivalents		$	321,053			$	228,788
Receivable from collaboration partner			208,090				107,210
Prepaid expenses and other current assets			20,918				17,981
Restricted cash			410				—
Total current assets			550,471				353,979
Property and equipment, net			41,075				17,035
Restricted cash			11,562				9,899
Other non-current assets			15,076				11,737
Total assets		$	618,184			$	392,650
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable, accrued expenses and other current liabilities		$	109,060			$	78,758
Deferred revenue			4,233				16,931
Current portion of build-to-suit lease obligation			781				—
Total current liabilities			114,074				95,689
Convertible Notes, net of unamortized discount of $40,187 and $50,336 at September 30, 2014, and December 31, 2013, respectively			218,555				208,414
Build-to-suit lease obligation, excluding current portion			18,249				—
Other non-current liabilities			18,060				11,600
Total liabilities			368,938				315,703
Commitments and contingencies (Note 12)
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; 77,567,195 and 75,803,020 shares issued and outstanding at September 30, 2014, and December 31, 2013, respectively			776				758
Additional paid-in capital			470,384				410,350
Accumulated deficit			(221,914	)			(334,161	)
Total stockholders’ equity			249,246				76,947
Total liabilities and stockholders’ equity		$	618,184			$	392,650

The accompanying notes are an integral part of these unaudited consolidated financial statements.

 

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MEDIVATION, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

(unaudited)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
Collaboration revenue		$	200,478			$	60,027			$	435,757			$	176,330
Operating expenses:
Research and development expenses			45,430				28,737				131,693				81,850
Selling, general and administrative expenses			63,165				39,288				165,695				124,746
Total operating expenses			108,595				68,025				297,388				206,596
Income (loss) from operations			91,883				(7,998	)			138,369				(30,266	)
Other income (expense), net:
Interest expense			(5,535	)			(5,165	)			(16,101	)			(15,035	)
Interest income			9				40				26				166
Other income (expense), net			55				(132	)			(76	)			(123	)
Total other income (expense), net			(5,471	)			(5,257	)			(16,151	)			(14,992	)
Income (loss) before income tax expense			86,412				(13,255	)			122,218				(45,258	)
Income tax expense			(8,419	)			(58	)			(9,971	)			(123	)
Net income (loss)		$	77,993			$	(13,313	)		$	112,247			$	(45,381	)
Basic net income (loss) per common share		$	1.01			$	(0.18	)		$	1.46			$	(0.60	)
Diluted net income (loss) per common share		$	0.96			$	(0.18	)		$	1.39			$	(0.60	)
Weighted average common shares used in the calculation of basic net income (loss) per common share			77,056				75,255				76,629				75,032
Weighted average common shares used in the calculation of diluted net income (loss) per common share			81,223				75,255				80,724				75,032

The accompanying notes are an integral part of these unaudited consolidated financial statements.

 

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MEDIVATION, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(in thousands)

(unaudited)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
Net income (loss)		$	77,993			$	(13,313	)		$	112,247			$	(45,381	)
Other comprehensive income (loss):
Change in unrealized gain on available-for-sale securities, net			—				6				—				(15	)
Other comprehensive income (loss), net			—				6				—				(15	)
Comprehensive income (loss)		$	77,993			$	(13,307	)		$	112,247			$	(45,396	)

The accompanying notes are an integral part of these unaudited consolidated financial statements.

 

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MEDIVATION, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

		Nine Months Ended September 30,
		2014				2013
Cash flows from operating activities:
Net income (loss)		$	112,247			$	(45,381	)
Adjustments for non-cash operating items:
Stock-based compensation			32,799				25,628
Amortization of deferred revenue			(12,698	)			(21,163	)
Amortization of debt discount and debt issuance costs			11,007				9,941
Depreciation on property and equipment			3,603				2,474
Asset impairment and other charges			1,112				35
Excess tax benefits from stock-based compensation			(362	)			—
Accretion of discount on securities			—				(148	)
Changes in operating assets and liabilities:
Receivable from collaboration partner			(100,880	)			(32,126	)
Prepaid expenses and other current assets			3,599				(6,567	)
Other non-current assets			(4,289	)			(1,468	)
Accounts payable, accrued expenses and other current liabilities			28,460				14,484
Interest payable			1,698				1,698
Other non-current liabilities			16				(239	)
Net cash provided by (used in) operating activities			76,312				(52,832	)
Cash flows from investing activities:
Purchases of property and equipment			(9,223	)			(6,321	)
Change in restricted cash			(2,073	)			(713	)
Purchases of short-term investments			—				(144,926	)
Maturities of short-term investments			—				285,000
Net cash (used in) provided by investing activities			(11,296	)			133,040
Cash flows from financing activities:
Proceeds from issuance of common stock under equity incentive and stock purchase plans			26,891				6,459
Excess tax benefits from stock-based compensation			362				—
Repayment of Convertible Notes			(4	)			—
Net cash provided by financing activities			27,249				6,459
Net increase in cash and cash equivalents			92,265				86,667
Cash and cash equivalents at beginning of period			228,788				71,301
Cash and cash equivalents at end of period		$	321,053			$	157,968
Supplemental disclosures of cash flow information:
Non-cash investing and financing activities:
Amounts capitalized under build-to-suit lease transactions		$	18,085			$	—
Interest capitalized during construction period for build-to-suit lease transactions		$	945			$	—
Property and equipment expenditures incurred but not yet paid		$	355			$	23

The accompanying notes are an integral part of these unaudited consolidated financial statements.

 

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MEDIVATION, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

September 30, 2014

(unaudited)

NOTE 1 — DESCRIPTION OF BUSINESS

Medivation, Inc. (the “Company” or “Medivation”) is a biopharmaceutical company focused on the rapid development and commercialization of medically innovative therapies to treat serious diseases for which there are limited treatment options.

The Company’s most advanced program is XTANDI^® (enzalutamide) capsules, or XTANDI, which is partnered with Astellas Pharma Inc., or Astellas. On August 31, 2012, XTANDI received marketing approval from the U.S. Food and Drug Administration, or FDA, for the treatment of metastatic castration-resistant prostate cancer, or mCRPC, patients who previously received docetaxel, or post-chemotherapy mCRPC patients. The Company and Astellas began co-promoting XTANDI for that indication in the United States on September 13, 2012. On June 24, 2013, the Company and Astellas announced that XTANDI was granted marketing authorization in the European Union, or EU, for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel therapy. On March 24, 2014, the Company’s partner, Astellas, announced that it received approval to market XTANDI in Japan for the treatment of patients with castration-resistant prostate cancer, or CRPC, with the precaution that the efficacy and safety of the drug have not been established in patients with prostate cancer who have not received chemotherapy. XTANDI is approved in more than 45 countries for the post-docetaxel indication and marketing applications for this indication are under review in multiple countries worldwide.

On September 10, 2014, the FDA approved a new indication for the use of XTANDI to treat patients with mCRPC who have not received chemotherapy. This new approved use follows a priority review of the supplemental New Drug Application, or sNDA, submission to the FDA that was based on the results of the Company’s Phase 3 PREVAIL trial. In October 2014, in Japan, the item “Precautions relating to indications” of the package insert has been revised based on the results of the PREVAIL trial, which means the sentence, “The efficacy and safety of the drug have not been established in patients with prostate cancer who have not received chemotherapy,” has been deleted. The revision of this item of the XTANDI package insert in Japan triggers a $45.0 million milestone payment to the Company, which will be recognized as collaboration revenue in the fourth quarter of 2014. Then, on October 24, 2014, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending a variation to amend the European Marketing Authorisation for XTANDI. The positive opinion relates to the use of enzalutamide 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. If the European Medicines Agency amends the European Marketing Authorisation for XTANDI, the Company will earn the final development milestone payment from Astellas under the Astellas Collaboration Agreement, totaling $45.0 million.

Together with Astellas, the Company is also conducting multiple trials of enzalutamide to further develop enzalutamide in the prostate cancer disease continuum, and also in breast cancer.

In addition, the Company is investing in programs where there is an unmet medical need. The Company’s research and drug discovery projects focus on diseases, including cancer for which it believes new therapies can substantially improve the current standard of care.

On October 23, 2014, the Company announced that it licensed exclusive worldwide rights to CureTech, Ltd.’s late-stage clinical molecule pidilizumab (CT-011), an immune modulatory anti PD-1 monoclonal antibody, for potential applications, including in oncology. Additional information regarding the agreement with CureTech, Ltd. is included in Note 13, “Subsequent Event.”

NOTE 2 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

(a) Basis of Presentation and Principles of Consolidation

The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP, for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The unaudited consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements. In the opinion of management, all adjustments, consisting of normal recurring adjustments necessary for the fair statement of the Company’s financial condition, results of operations and cash flows for the periods presented, have been included. The results of operations of any interim period are not necessarily indicative of the results of operations for the full year or any other interim period.

 

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The unaudited consolidated financial statements and related disclosures have been prepared with the presumption that users of the interim unaudited consolidated financial statements have read or have access to the audited consolidated financial statements for the preceding year. Accordingly, these unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2013, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013, or the Annual Report, filed with the U.S. Securities and Exchange Commission, or SEC, on February 27, 2014. The consolidated balance sheet at December 31, 2013, has been derived from the audited consolidated financial statements at that date.

The unaudited consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. The Company operates in one business segment.

All tabular disclosures of dollar and share amounts are presented in thousands unless otherwise indicated. All per share amounts are presented at their actual amounts. The number of shares issuable under the Amended and Restated 2004 Equity Incentive Award Plan, or the Medivation Equity Incentive Plan, and the Medivation, Inc. 2013 Employee Stock Purchase Plan, or ESPP, disclosed in Note 9, “Stockholders’ Equity,” are presented at their actual amounts. Amounts presented herein may not calculate or sum precisely due to rounding.

(b) Use of Estimates

The preparation of unaudited consolidated financial statements in accordance with U.S. GAAP requires that management make estimates and assumptions in certain circumstances that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Management bases its estimates on historical experience and on assumptions believed to be reasonable under the circumstances. Although management believes that these estimates are reasonable, actual future results could differ materially from those estimates. In addition, had different estimates and assumptions been used, the consolidated financial statements could have differed materially from what is presented.

Estimates and assumptions used by management principally relate to: revenue recognition, reliance on third-party information, including estimates of the various deductions from gross sales used to calculate net sales of XTANDI, and the estimated performance periods of the Company’s deliverables under its agreements with current and former collaboration partners; services performed by third parties but not yet invoiced; the fair value and forfeiture rates of equity awards under the Medivation Equity Incentive Plan and the ESPP; the probability and potential magnitude of contingent liabilities; the 2.625% convertible senior notes due April 1, 2017, or the Convertible Notes, including the Company’s estimate of how the net proceeds thereof should be bifurcated between the debt component and the equity component; determination of whether the Company is the primary beneficiary of any variable interest entities; determination of whether leases are operating, capital, or build-to-suit; and deferred income taxes, income tax provisions and accruals for uncertain income tax positions.

(c) Significant Accounting Policies

Reference is made to Note 2, “Summary of Significant Accounting Policies,” included in the notes to the Company’s audited consolidated financial statements included in its Annual Report. As of the date of the filing of this Quarterly Report on Form 10-Q, or the Quarterly Report, there were no significant changes to the significant accounting policies described in the Company’s Annual Report, except those related to build-to-suit lease accounting described in the following section.

Build-To-Suit Lease Accounting

In certain lease arrangements, the Company is involved in the construction of the building. To the extent the Company is involved with the structural improvements of the construction project or takes construction risk prior to the commencement of a lease, Accounting Standards Codification, or ASC, 840-40, Leases – Sale-Leaseback Transactions (Subsection 05-5), requires the Company to be considered the owner for accounting purposes of these types of projects during the construction period. Therefore, the Company records an asset in property and equipment, net on the consolidated balance sheets, including capitalized interest costs, for the replacement cost of the Company’s portion of the pre-existing building plus the amount of estimated structural construction costs incurred by the landlord and the Company as of the balance sheet date. The Company records a corresponding build-to-suit lease obligation on its consolidated balance sheets representing the amounts paid by the lessor.

Once construction is complete, the Company considers the requirements for sale-leaseback accounting treatment, including evaluating whether all risks of ownership have been transferred back to the landlord, as evidenced by a lack of continuing involvement in the leased property. If the arrangement does not qualify for sale-leaseback accounting treatment, the building asset remains on the Company’s consolidated balance sheets at its historical cost, and such asset is depreciated over its estimated useful life. The Company bifurcates its lease payments into a portion allocated to the building and a portion allocated to the parcel of land on which the building

 

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has been built. The portion of the lease payments allocated to the land is treated for accounting purposes as operating lease payments, and therefore is recorded as rent expense in the consolidated statements of operations. The portion of the lease payments allocated to the building is further bifurcated into a portion allocated to interest expense and a portion allocated to reduce the build-to-suit lease obligation. The interest rate used for the build-to-suit lease obligation represents the Company’s estimated incremental borrowing rate, adjusted to reduce any built in loss.

The initial recording of these assets and liabilities is classified as non-cash investing and financing items, respectively, for purposes of the consolidated statements of cash flows.

(d) Recently Issued Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board, or FASB, issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606), a comprehensive new revenue recognition standard that will supersede the existing revenue recognition guidance. The new accounting guidance creates a framework by which an entity will allocate the transaction price to separate performance obligations and recognize revenue when (or as) each performance obligation is satisfied. Under the new standard, entities will be required to use judgment and make estimates, including identifying performance obligations in a contract, estimating the amount of variable consideration to include in the transaction price, allocating the transaction price to each separate performance obligation and determining when an entity satisfies its performance obligations. The standard allows for either “full retrospective” adoption, meaning that the standard is applied to all of the periods presented with a cumulative catch-up as of the earliest period presented, or “modified retrospective” adoption, meaning the standard is applied only to the most current period presented in the financial statements with a cumulative catch-up as of the current period. The accounting standard will be effective for reporting periods beginning after December 15, 2016. The Company is currently assessing the method of adoption and the impact the new standard will have on its consolidated financial statements.

(e) Out-of-Period Adjustment

In the first quarter of 2013, the Company recorded an out-of-period correcting adjustment that increased operating expenses and net loss by $3.6 million for the three months ended March 31, 2013. Management concluded that the adjustment was not material to the full year 2013 results or any previously reported financial statements.

NOTE 3 — COLLABORATION AGREEMENT

(a) Collaboration Agreement with Astellas

In October 2009, the Company entered into a collaboration agreement with Astellas, or the Astellas Collaboration Agreement. Under the agreement, decision making and economic participation differs between the U.S. market and the ex-U.S. market. In the United States, decisions are generally made by consensus, pre-tax profits and losses are shared equally and subject to certain exceptions, development and commercialization costs (including cost of goods sold and the royalty on net sales payable to The Regents of the University of California (“UCLA” or “the Regents”) under the Company’s license agreement with UCLA) are also shared equally. The primary exceptions to equal cost sharing in the U.S. market are that each party is responsible for its own commercial full-time equivalent, or FTE, costs, and that development costs supporting marketing approvals in both the United States and either Europe or Japan are borne one-third by the Company and two-thirds by Astellas. The Company and Astellas are co-promoting XTANDI in the U.S. market, with each company providing half of the sales and medical affairs effort in support of the product. Both the Company and Astellas are entitled to receive a fee for each qualifying detail made by its respective sales representatives. Outside the United States, decisions are generally made by Astellas and all development and commercialization costs (including cost of goods sold and the royalty on net sales payable to UCLA) are borne by Astellas. Astellas retains all ex-U.S. profits and losses, and pays the Company a tiered royalty ranging from the low teens to the low twenties on any aggregate net sales of XTANDI outside the United States, or ex-U.S. XTANDI sales. Astellas has sole responsibility for promoting XTANDI outside the United States and for recording all XTANDI sales both inside and outside the United States. Both the Company and Astellas have agreed not to commercialize certain other products having a similar mechanism of action (as defined by the Astellas Collaboration Agreement) as XTANDI for the treatment of prostate cancer for a specified time period, subject to certain exceptions.

Under the Astellas Collaboration Agreement, Astellas paid the Company a non-refundable, upfront cash payment of $110.0 million in the fourth quarter of 2009. The Company is also eligible to receive up to $335.0 million in development milestone payments and up to $320.0 million in sales milestone payments. As of September 30, 2014, the Company has earned an aggregate of $245.0 million in development milestone payments and $25.0 million in sales milestone payments under the Astellas Collaboration Agreement. The Company expects that any of the remaining $90.0 million in development milestone payments and the remaining $295.0 million in sales milestone payments that the Company may earn in future periods will be recognized as revenue in their entirety in the period in which the underlying milestone event is achieved. The Company earned $45.0 million of the remaining development milestone payments in October 2014 which will be recognized as collaboration revenue during the fourth quarter of 2014 as described in the following table.

 

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The triggering events for the remaining development milestone payments the Company is eligible to receive under the Astellas Collaboration Agreement as of September 30, 2014 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	)			(8	)			(8	)
The first major country in Europe			(5	)		$	15 million			$	30 million
Japan			(6	)		$	15 million	(9)		$	30 million	(9)

 

(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 payment has been received.

(5)	These milestones totaling $78.0 million were earned and recognized as collaboration revenue prior to 2014 and payments have been received.

(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.

(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.

(8)	These milestones totaling $90.0 million were earned and recognized as collaboration revenue during the third quarter of 2014 and are included in receivable from collaboration partner on the consolidated balance sheet at September 30, 2014.

(9)	These milestones totaling $45.0 million were earned in October 2014 and will be recognized as collaboration revenue during the fourth quarter of 2014.

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.

The Company and Astellas are each permitted to terminate the Astellas Collaboration Agreement for an uncured material breach by the other party or for the insolvency of the other party. Astellas has a right to terminate the Astellas Collaboration Agreement unilaterally by advance written notice to the Company. Following any termination of the Astellas Collaboration Agreement in its entirety, all rights to develop and commercialize XTANDI will revert to the Company, and Astellas will grant a license to the Company to enable it to continue such development and commercialization. In addition, except in the case of a termination by Astellas for the Company’s material breach, Astellas will supply XTANDI to the Company during a specified transition period.

 

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Unless terminated earlier by the Company or Astellas pursuant to the terms thereof, the Astellas Collaboration Agreement will remain in effect: (a) in the United States, until such time as Astellas notifies the Company that Astellas has permanently stopped selling products covered by the Astellas Collaboration Agreement in the United States; and (b) in each other country of the world, on a country-by-country basis, until such time as (i) products covered by the Astellas Collaboration Agreement cease to be protected by patents or regulatory exclusivity in such country and (ii) commercial sales of generic equivalent products have commenced in such country.

(b) Collaboration Revenue

Collaboration revenue consists of three components: (a) collaboration revenue related to U.S. XTANDI sales; (b) collaboration revenue related to ex-U.S. XTANDI sales; and (c) collaboration revenue related to upfront and milestone payments.

Collaboration revenue was as follows:

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
Collaboration revenue:
Related to U.S. XTANDI sales		$	90,723			$	54,244			$	224,814			$	133,134
Related to ex-U.S. XTANDI sales			15,522				1,551				31,245				2,033
Related to upfront and milestone payments			94,233				4,232				179,698				41,163
Total		$	200,478			$	60,027			$	435,757			$	176,330

The Company is required to pay UCLA ten percent of all Sublicensing Income, as defined in the Company’s license agreement with UCLA. The Company is currently involved in certain litigation matters with UCLA regarding certain terms of the license agreement and other matters, which are discussed in Note 12, “Commitments and Contingencies.”

Collaboration Revenue Related to U.S. XTANDI Sales

Under the Astellas Collaboration Agreement, Astellas records all U.S. XTANDI sales. The Company and Astellas share equally all pre-tax profits and losses from U.S. XTANDI sales. Subject to certain exceptions, the Company and Astellas also share equally all XTANDI development and commercialization costs related to the U.S. market, including cost of goods sold and the royalty on net sales payable to UCLA under the Company’s license agreement with UCLA. The primary exceptions to 50/50 cost sharing are that each party is responsible for its own commercial FTE costs and that development costs supporting marketing approvals in both the United States and either Europe or Japan are borne one-third by the Company and two-thirds by Astellas. The Company recognizes collaboration revenue related to U.S. XTANDI sales in the period in which such sales occur. Collaboration revenue related to U.S. XTANDI sales consists of the Company’s share of pre-tax profits and losses from U.S. sales, plus reimbursement of the Company’s share of reimbursable U.S. development and commercialization costs. The Company’s collaboration revenue related to U.S. XTANDI sales in any given period is equal to 50% of U.S. XTANDI net sales as reported by Astellas for the applicable period.

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

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
U.S. XTANDI sales (as reported by Astellas)		$	181,446			$	108,487			$	449,629			$	266,267
Shared U.S. development and commercialization costs			(69,616	)			(58,901	)			(217,866	)			(178,002	)
Pre-tax U.S. profit		$	111,830			$	49,586			$	231,763			$	88,265
Medivation’s share of pre-tax U.S. profit		$	55,915			$	24,793			$	115,881			$	44,133
Reimbursement of Medivation’s share of shared U.S. costs			34,808				29,451				108,933				89,001
Collaboration revenue related to U.S. XTANDI sales		$	90,723			$	54,244			$	224,814			$	133,134

 

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Collaboration Revenue Related to Ex-U.S. XTANDI Sales

Under the Astellas Collaboration Agreement, Astellas records all ex-U.S. XTANDI sales. Astellas is responsible for all development and commercialization costs for XTANDI outside the United States, including cost of goods sold and the royalty on net sales payable to UCLA under the Company’s license agreement with UCLA, and pays the Company a tiered royalty ranging from the low teens to the low twenties on net ex-U.S. XTANDI sales. The Company recognizes collaboration revenue related to ex-U.S. XTANDI sales in the period in which such sales occur. Collaboration revenue related to ex-U.S. XTANDI sales consists of royalties from Astellas on those sales.

Collaboration revenue related to ex-U.S. XTANDI sales was $15.5 million and $31.2 million for the three and nine months ended September 30, 2014, respectively. Collaboration revenue related to ex-U.S. XTANDI sales was $1.6 million and $2.0 million for the three and nine months ended September 30, 2013, respectively.

Collaboration Revenue Related to Upfront and Milestone Payments

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

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
Development milestones earned		$	90,000			$	—			$	167,000			$	20,000
Amortization of deferred upfront and development milestones			4,233				4,232				12,698				21,163
Total		$	94,233			$	4,232			$	179,698			$	41,163

Deferred revenue under the Astellas Collaboration Agreement was $4.2 million and $16.9 million at September 30, 2014, and December 31, 2013, respectively.

(c) Cost-Sharing Payments

Under the Astellas Collaboration Agreement, the Company and Astellas share certain development and commercialization costs (including cost of goods sold and the royalty on net sales payable to UCLA under the Company’s license agreement with UCLA) in the United States. For the three and nine months ended September 30, 2014, development cost sharing payments from Astellas were $15.1 million and $48.5 million, respectively. For the three and nine months ended September 30, 2013, development cost sharing payments from Astellas were $13.1 million and $31.6 million, respectively. For the three and nine months ended September 30, 2014, commercialization cost-sharing payments to Astellas were $7.6 million and $17.8 million, respectively. For the three and nine months ended September 30, 2013, commercialization cost-sharing payments to Astellas were $1.8 million and $10.4 million, respectively. Development cost sharing payments from Astellas are recorded as reductions in research and development, or R&D, expenses. Commercialization cost sharing payments to Astellas are recorded as increases in selling, general, and administrative, or SG&A, expenses.

NOTE 4 — NET INCOME (LOSS) PER COMMON SHARE

The computation of basic net income (loss) per common share is based on the weighted-average number of common shares outstanding during each period. The computation of diluted net income (loss) per common share is based on the weighted-average number of common shares outstanding during the period plus, when their effect is dilutive, incremental shares consisting of shares subject to stock options, restricted stock units, stock appreciation rights, ESPP shares, warrants, and shares issuable upon conversion of convertible debt.

In periods in which the Company reports net income, the Company uses the “if-converted” method in calculating the diluted net income per common share effect of the assumed conversion of the Convertible Notes. Under the “if-converted” method, interest expense related to the Convertible Notes is added back to net income, and the Convertible Notes (see Note 5, “Convertible Senior Notes Due 2017”) are assumed to have been converted into common shares at the beginning of the period (or issuance date) in periods in which there would have been a dilutive effect. The Convertible Notes can be settled in common stock, cash, or a combination thereof, at the Company’s election. During periods of net income, the Company’s intent and ability to settle the Convertible Notes in cash could impact the computation of diluted net income per common share. For the three and nine months ended September 30, 2014, the impact of the Convertible Notes has been excluded from the calculation of diluted net income per common share because the effect of their inclusion would have been anti-dilutive (approximately 5.1 million potentially dilutive common shares have been excluded).

 

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In periods in which the Company reports a net loss, all common stock equivalents are deemed anti-dilutive such that basic net loss per common share and diluted net loss per common share are equal.

The following table reconciles the numerator and denominator used to calculate diluted net income (loss) per common share:

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
Numerator:
Net income (loss)		$	77,993			$	(13,313	)		$	112,247			$	(45,381	)
Denominator:
Weighted-average common shares, basic			77,056				75, 255				76,629				75,032
Dilutive effect of common stock equivalents			4,167				—				4,095				—
Weighted-average common shares, diluted			81,223				75,255				80,724				75,032
Net income (loss) per common share:
Basic net income (loss) per common share		$	1.01			$	(0.18	)		$	1.46			$	(0.60	)
Diluted net income (loss) per common share		$	0.96			$	(0.18	)		$	1.39			$	(0.60	)

Approximately 12.8 million potentially dilutive common shares have been excluded from the diluted net loss per common share computations for the three and nine months ended September 30, 2013, because such securities have an anti-dilutive effect on net loss per common share due to the Company’s net loss in each of these periods.

NOTE 5 — CONVERTIBLE SENIOR NOTES DUE 2017

On March 19, 2012, the Company issued $258.8 million aggregate principal amount of the Convertible Notes. The Company pays interest semi-annually in arrears on April 1 and October 1 of each year. The Convertible Notes mature on April 1, 2017, unless earlier converted, redeemed, or repurchased in accordance with their terms. The Convertible Notes are general senior unsecured obligations and rank (1) senior in right of payment to any of the Company’s future indebtedness that is expressly subordinated in right of payment to the Convertible Notes, (2) equal in right of payment to any of the Company’s future indebtedness and other liabilities of the Company that are not so subordinated, (3) junior in right of payment to any of the Company’s secured indebtedness to the extent of the value of the assets securing such indebtedness and (4) structurally junior to all future indebtedness incurred by the Company’s subsidiaries and their other liabilities (including trade payables).

Prior to April 6, 2015, the Convertible Notes are not redeemable. On or after April 6, 2015, the Company may redeem for cash all or a part of the Convertible Notes if the closing sale price of its common stock for 20 or more trading days in a period of 30 consecutive trading days ending on the trading day preceding the date it provides notice of the redemption exceeds 130% of the conversion price in effect on each such trading day, subject to certain conditions. The redemption price will equal 100% of the principal amount of the Convertible Notes to be redeemed plus accrued and unpaid interest, if any, to, but excluding the redemption date. If a fundamental change (as defined in the Indenture) occurs prior to the maturity date, holders may require the Company to purchase for cash all or any portion of the Convertible Notes at a purchase price equal to 100% of the principal amount of the Convertible Notes to be purchased plus accrued and unpaid interest, if any, to, but excluding, the fundamental change purchase date.

Holders may convert their Convertible Notes prior to the close of business on the business day immediately preceding January 1, 2017, only upon the occurrence of the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on June 30, 2012, if the closing sale price of the Company’s common stock, for at least 20 trading days (whether or not consecutive) in the period of 30 consecutive trading days ending on the last trading day of the calendar quarter immediately preceding the calendar quarter in which the conversion occurs, is more than 130% of the conversion price of the Convertible Notes in effect on each applicable trading day; (2) during the five consecutive trading-day period following any five consecutive trading-day period in which the trading price for the Convertible Notes for each such trading day is less than 98% of the closing sale price of the Company’s common stock on such date multiplied by the then-current conversion rate; (3) upon the occurrence of specified corporate events; or (4) if the Company calls any Convertible Notes for redemption, at any time until the close of business on the second business day preceding the redemption date. On or after January 1, 2017 until the close of business on the second business day immediately preceding the stated maturity date, holders may surrender their Convertible Notes for conversion at any time, regardless of the foregoing circumstances.

 

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At September 30, 2014, the Convertible Notes met a requirement of convertibility because the Company’s common stock price was in excess of the stated conversion premium for at least 20 trading days in the period of 30 consecutive trading days ending on September 30, 2014. The Convertible Notes remain convertible through December 31, 2014. Convertibility of the Convertible Notes based on the trading price of the Company’s common stock is assessed on a calendar-quarter basis. Upon a conversion of the Convertible Notes, the Company is required to pay or deliver, as the case may be, cash, shares of the Company’s common stock, or a combination of both, at the Company’s election. As of September 30, 2014, the conversion rate was 19.5172 shares of common stock per $1,000 principal amount of the Convertible Notes, equivalent to a conversion price of approximately $51.24 per share of common stock. The conversion rate is subject to adjustment in certain events, such as distribution of dividends and stock splits. In addition, upon a Make-Whole Adjustment Event (as defined in the Indenture), the Company will, under certain circumstances, increase the applicable conversion rate for a holder that elects to convert its Convertible Notes in connection with such Make-Whole Adjustment Event.

Interest expense on the Convertible Notes consisted of the following:

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
Coupon interest expense		$	1,698			$	1,698			$	5,094			$	5,094
Non-cash amortization of debt discount			3,538				3,197				10,149				9,166
Non-cash amortization of debt issuance costs			299				270				858				775
Total		$	5,535			$	5,165			$	16,101			$	15,035

NOTE 6 — BUILD-TO-SUIT LEASE OBLIGATION

In the fourth quarter of 2013, the Company entered into a long-term property lease for approximately 52,000 square feet of laboratory space located in San Francisco, California. The lease agreement expires in July 2024, and the Company has an option to extend the lease term for up to an additional five years.

The Company is deemed, for accounting purposes only, to be the owner of the entire project including the building shell, even though it is not the legal owner. In connection with the Company’s accounting for this transaction, the Company capitalized $14.5 million as a build-to-suit property within property and equipment, net, and recognized a corresponding build-to-suit lease obligation for the same amount. The Company also recognized, as an additional build-to-suit lease obligation, structural tenant improvements totaling $3.6 million for amounts paid by the landlord and $0.9 million for capitalized interest during the construction period.

A portion of the monthly lease payment will be allocated to land rent and recorded as an operating lease expense and the non-interest portion of the amortized lease payments to the landlord related to the rent of the building will be applied to reduce the build-to-suit lease obligation. At September 30, 2014, $0.8 million of the build-to-suit lease obligation representing the expected reduction in the liability over the next twelve months is classified as a current liability and the remaining $18.2 million is classified as a non-current liability on the consolidated balance sheet. Expected reductions (increases) in the build-to-suit lease obligation at September 30, 2014 were as follows:

 

		Build-To-Suit Lease Obligation
Years Ending December 31,
Remainder of 2014		$	135
2015			632
2016			(14	)
2017			64
2018			148
2019 and thereafter			18,065
Total		$	19,030

The amounts included in the table above represent the reductions (increases) in the build-to-suit lease obligation on the Company’s consolidated balance sheet in each of the periods presented. The amount in the terminal period includes the amount to derecognize the build-to-suit lease obligation at the end of the lease term. Actual expected lease payments under the build-to-suit lease obligation are included in Note 12, “Commitments and Contingencies.”

 

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NOTE 7 — PROPERTY AND EQUIPMENT, NET

Property and equipment, net, consisted of the following:

 

		September 30, 2014				December 31, 2013
Build-to-suit property		$	19,030			$	—
Leasehold improvements			14,849				12,034
Computer equipment and software			7,624				4,503
Furniture and fixtures			4,660				3,981
Construction in progress			2,631				1,177
Laboratory equipment			714				703
			49,508				22,398
Less: Accumulated depreciation			(8,433	)			(5,363	)
Total		$	41,075			$	17,035

NOTE 8 — ACCOUNTS PAYABLE, ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

Accounts payable, accrued expenses and other current liabilities consisted of the following:

 

		September 30, 2014				December 31, 2013
Clinical and preclinical activities		$	30,041			$	34,182
Royalties and milestones payable			24,773				6,377
Payroll and payroll-related			19,779				23,832
Accounts payable			12,356				3,290
Accrued professional services and other current liabilities			9,405				9,379
Taxes payable			9,310				—
Interest payable			3,396				1,698
Total		$	109,060			$	78,758

Accounts payable represents short-term liabilities for which the Company has received and processed a vendor invoice prior to the end of the reporting period. Accrued expenses and other current liabilities represent, among other things, compensation and related benefits to employees; royalties and milestone payments that are due to licensors of technologies; cash interest payable related to the Company’s Convertible Notes; estimated amounts due to third party vendors for services rendered prior to the end of the reporting period; invoices received from third party vendors that have not yet been processed; and taxes payable.

NOTE 9 — STOCKHOLDERS’ EQUITY

(a) Stock Purchase Rights

All shares of the Company’s common stock, if issued prior to the termination by the Company of its rights agreement, dated as of December 4, 2006, include stock purchase rights. The rights are exercisable only if a person or group acquires twenty percent or more of the Company’s common stock or announces a tender or exchange offer which would result in ownership of twenty percent or more of the Company’s common stock. Following the acquisition of twenty percent or more of the Company’s common stock, the holders of the rights, other than the acquiring person or group, may purchase Medivation common stock at half of its fair market value. In the event of a merger or other acquisition of the Company, the holders of the rights, other than the acquiring person or group, may purchase shares of the acquiring entity at half of their fair market value. The rights were not exercisable at September 30, 2014.

(b) Medivation Equity Incentive Plan

The Medivation Equity Incentive Plan provides for the issuance of options and other stock-based awards, including restricted stock units, performance share awards and stock appreciation rights. The vesting of all outstanding awards under the Medivation Equity Incentive Plan will accelerate, and all such share awards will become immediately exercisable, upon a “change of control” of Medivation, as defined in the Medivation Equity Incentive Plan. On June 27, 2014, the Company’s stockholders approved an amendment and restatement of the Medivation Equity Incentive Plan to increase the aggregate number of shares of common stock authorized for issuance under the Medivation Equity Incentive Plan from 19,150,000 to 21,150,000. As of September 30, 2014, approximately 2.8 million shares were available for issuance under the Medivation Equity Incentive Plan.

 

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Stock Options

The following table summarizes stock option activity for the nine months ended September 30, 2014:

 

		Number of Options				Weighted Average Exercise Price				Weighted Average Remaining Contractual Term (in years)				Aggregate Intrinsic Value (1)
Outstanding at December 31, 2013			6,614,534			$	22.12
Granted			851,213			$	75.57
Exercised			(1,593,563	)		$	13.87
Forfeited			(427,701	)		$	45.89
Expired			(243	)		$	48.18
Outstanding at September 30, 2014			5,444,240			$	31.02				6.49			$	369.4
Vested and exercisable at September 30, 2014			3,613,023			$	18.42				5.43			$	290.7

 

(1)

The aggregate intrinsic value is calculated as the pre-tax difference between the weighted average exercise price of the underlying awards and the closing price per share of $98.87 of the Company’s common stock on September 30, 2014. The calculation excludes any awards with an exercise price higher than the closing price of the Company’s common stock on September 30, 2014. The amounts are presented in millions.

The weighted-average grant-date fair value per share of options granted during the nine months ended September 30, 2014 was $41.54.

Restricted Stock Units

The following table summarizes restricted stock unit activity for the nine months ended September 30, 2014:

 

		Number of Shares				Weighted- Average Grant-Date Fair Value
Unvested at December 31, 2013			311,347			$	52.57
Granted			345,034			$	79.85
Vested			(37,952	)		$	53.11
Forfeited			(74,254	)		$	62.73
Unvested at September 30, 2014			544,175			$	68.64

Stock Appreciation Rights

The following table summarizes stock appreciation rights activity for the nine months ended September 30, 2014:

 

		Number of Rights				Weighted Average Exercise Price				Weighted Average Remaining Contractual Term (in years)				Aggregate Intrinsic Value (1)
Outstanding at December 31, 2013			806,116			$	23.98
Granted			—			$	—
Exercised			(58,850	)		$	23.71
Forfeited			(10,384	)		$	24.40
Outstanding at September 30, 2014			736,882			$	23.99				7.03			$	55.2
Vested and exercisable at September 30, 2014			494,136			$	24.01				6.94			$	37.0

 

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(1)

The aggregate intrinsic value is calculated as the pre-tax difference between the weighted average exercise price of the underlying awards and the closing price per share of $98.87 of the Company’s common stock on September 30, 2014. The calculation excludes any awards with an exercise price higher than the closing price of the Company’s common stock on September 30, 2014. The amounts are presented in millions.

(c) ESPP

The ESPP, which was approved by the Company’s stockholders on June 28, 2013, permits eligible employees to purchase shares of the Company’s common stock through payroll deductions at the lower of 85% of the fair market value of the common stock at the beginning or end of a purchase period. Eligible employee purchases are limited on an annual basis to $25,000 in accordance with Section 423 of the Internal Revenue Code. As of September 30, 2014, a total of 3,000,000 shares of the Company’s common stock were authorized for issuance under the ESPP, and 90,067 shares have been issued.

(d) Stock-Based Compensation

The Company estimates the fair value of stock options, stock appreciation rights, and ESPP shares using the Black-Scholes valuation model. The Black-Scholes assumptions used to estimate the fair value of stock options granted during the periods were as follows:

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
Risk-free interest rate			1.56-1.79	%			1.45	%			1.56-1.79	%			0.73-1.55	%
Estimated term (in years)			5.06				5.25				5.06-5.50				5.24-5.50
Estimated volatility			63	%			68	%			60-64	%			68-75	%
Estimated dividend yield			—				—				—				—

The Black-Scholes assumptions used to estimate the fair value of shares issued under the ESPP on the commencement date of the offering period were as follows. No offering periods commenced during the third quarter of 2014.

 

		Nine Months Ended September 30, 2014
Risk-free interest rate			0.06	%
Estimated term (in years)			0.50
Estimated volatility			53	%
Estimated dividend yield			—

Stock-based compensation expense was as follows:

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
Stock-based compensation expense recognized as:
R&D expense		$	4,611			$	3,765			$	13,236			$	11,202
SG&A expense			7,346				5,436				19,563				14,426
Total		$	11,957			$	9,201			$	32,799			$	25,628

Unrecognized stock-based compensation expense totaled $80.5 million at September 30, 2014, and is expected to be recognized over a weighted-average period of 2.40 years.

NOTE 10 — INCOME TAXES

The Company calculates its quarterly income tax provision in accordance with the guidance provided by ASC 740-270, Interim Income Tax Accounting, whereby the Company forecasts its estimated annual effective tax rate and then applies that rate to its year-to-date pre-tax book income (loss). The Company recorded an income tax provision of $8.4 million and $10.0 million for the three and nine months ended September 30, 2014, respectively. The provision for income taxes was lower than the tax computed at the U.S. federal statutory rate due primarily to utilization of net operating loss and tax credit carryforwards.

 

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The effective tax rate was 9.7% and 8.2% for the three and nine months ended September 30, 2014, respectively. The effective tax rate for the three and nine months ended September 30, 2013 was not significant. The increase in the effective tax rate for the three and nine months ended September 30, 2014 as compared to prior year periods was due to forecasted taxable income for 2014.

During the quarter ended September 30, 2014, the Company reduced its current state taxes payable by $0.4 million related to excess tax benefits from stock-based compensation, offsetting additional paid-in capital.

The Company records a valuation allowance to reduce deferred tax assets to the amount that is more likely than not to be realized. The Company considers all available positive and negative evidence in determining the need for a valuation allowance, including historical operating results, losses in recent periods, forecasted earnings, future taxable income, and feasible tax planning strategies. Based upon the weight of available evidence at September 30, 2014, the Company has established and continues to maintain a full valuation allowance against its deferred tax assets as the Company does not currently believe that realization of those assets is more likely than not. Considering the Company’s current assessment of potential future earnings, including the probability of increased revenue and earnings resulting from FDA approval to extend the indication of XTANDI and earning future contingent milestones under its collaboration agreement, there is a reasonable possibility that, within twelve months, sufficient positive evidence may become available to reach a conclusion that a significant portion of the valuation allowance will no longer be needed. A release of the valuation allowance would result in the recognition of certain deferred tax assets and a decrease to income tax expense in the period such release is recorded and would have a material effect to the Company’s financial results.

The future effective tax rate is subject to volatility and may be materially impacted by various internal and external factors. These factors may include, but are not limited to, the amount of income tax benefits and charges from: interpretations of existing tax laws; changes in tax laws and rates; future levels of research and development expenditures; changes in the mix of earnings in countries with differing statutory tax rates in which the Company may conduct business; changes in the valuation of deferred tax assets and liabilities; state income taxes; the tax impact of stock-based compensation; accounting for uncertain tax positions; closure of statute of limitations or settlement of tax audits; changes in estimates of prior years’ items; tax costs for acquisition-related items; changes in accounting standards; and overall levels of income before taxes.

NOTE 11 — FAIR VALUE DISCLOSURES

The following table presents the Company’s cash equivalents as well as the hierarchy for its financial instruments measured at fair value on a recurring basis:

 

						Fair value measurements using:
		Fair Value				Level 1				Level 2				Level 3
September 30, 2014:
Cash equivalents:
Money market funds		$	209,245			$	209,245				—				—
December 31, 2013:
Cash equivalents:
Money market funds		$	189,092			$	189,092				—				—

The following table presents the total balance of the Company’s other financial instruments that are not measured at fair value on a recurring basis:

 

						Fair value measurements using:
		Total Balance				Level 1				Level 2				Level 3
September 30, 2014:
Assets:
Bank deposits (included in “Cash and cash equivalents”)		$	111,808			$	111,808				—				—
Liabilities:
Convertible Notes		$	363,902				—			$	363,902				—
December 31, 2013:
Assets:
Bank deposits (included in “Cash and cash equivalents”)		$	39,696			$	39,696				—				—
Liabilities:
Convertible Notes		$	277,145				—			$	277,145				—

 

 

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Due to their short-term maturities, the Company believes that the fair value of its bank deposits, receivable from collaboration partner, accounts payable and accrued expenses and other current liabilities approximate their carrying value. The estimated fair value of the Company’s Convertible Notes, including the equity component, was $503.3 million and $383.3 million at September 30, 2014, and December 31, 2013, respectively, and was determined using recent trading prices of the Convertible Notes. The fair value of the Convertible Notes included in the table above represents only the liability component of the Convertible Notes, because the equity component is included in stockholders’ equity on the consolidated balance sheets. For the purposes of the table above, the fair value of the Convertible Notes was bifurcated between the debt and equity components in a ratio similar to the principal amounts of the Convertible Notes.

NOTE 12 — COMMITMENTS AND CONTINGENCIES

(a) Lease Obligations

In the first quarter of 2014, the Company entered into the Fifth Amendment to its headquarters lease agreement in San Francisco, California, pursuant to which it leased approximately 29,000 additional square feet of office space. The Company is entitled to approximately $0.9 million of tenant improvement allowances pursuant to the Fifth Amendment. In connection with the execution of the Fifth Amendment, the Company delivered to the lessor a letter of credit collateralized by restricted cash totaling $2.1 million. In total, at September 30, 2014, the Company leased approximately 127,000 square feet of office space pursuant to the agreement, as amended, which expires in June 2019. Lease commitments pursuant to the Fifth Amendment total approximately $9.6 million over the term of the lease. There were no other changes to the Company’s lease obligations from that disclosed in the Company’s Annual Report other than a reduction of 2014 lease obligations due to the payment of current year lease payments.

Future operating lease obligations as of September 30, 2014 are as follows:

 

		Operating Leases
Years Ending December 31,
Remainder of 2014		$	1,975
2015			8,008
2016			8,170
2017			8,334
2018			8,499
2019 and thereafter			4,405
Total minimum lease payments		$	39,391

The Company is considered the “accounting owner” for a build-to-suit property and has recorded a build-to-suit lease obligation on its September 30, 2014 consolidated balance sheet. Additional information regarding the build-to-suit lease obligation is included in Note 6, “Build-To-Suit Lease Obligation.”

Expected future lease payments under the build-to-suit lease as of September 30, 2014 are as follows:

 

		Expected Cash Payments Under Build- To-Suit Lease Obligation
Years Ending December 31,
Remainder of 2014		$	349
2015			2,435
2016			2,537
2017			2,614
2018			2,692
2019 and thereafter			16,935
Total minimum lease payments		$	27,562

(b) Restricted Cash

At September 30, 2014, the Company had outstanding letters of credit collateralized by restricted cash totaling $12.0 million to secure various operating leases, of which $0.4 million and $11.6 million were classified as current and long-term assets, respectively,

 

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on the consolidated balance sheets. At December 31, 2013, the Company had outstanding letters of credit collateralized by restricted cash totaling $9.9 million to secure various operating leases, which was classified as long-term assets on the consolidated balance sheets.

(c) License Agreement with UCLA

Under an August 2005 license agreement with UCLA, the Company’s subsidiary Medivation Prostate Therapeutics, Inc., or MPT, holds an exclusive worldwide license under several UCLA patents and patent applications covering XTANDI and related compounds. Under the Astellas Collaboration Agreement, the Company granted Astellas a sublicense under the patent rights licensed to it by UCLA.

The Company is required to pay UCLA (a) an annual maintenance fee, (b) $2.8 million in aggregate milestone payments upon achievement of certain development and regulatory milestone events with respect to XTANDI (all of which has been paid as of September 30, 2014), (c) ten percent of all Sublicensing Income, as defined in the agreement, which the Company earns under the Astellas Collaboration Agreement, and (d) a four percent royalty on global net sales of XTANDI, as defined. Under the terms of the Astellas Collaboration Agreement, the Company shares this royalty obligation equally with Astellas with respect to sales in the United States, and Astellas is responsible for this entire royalty obligation with respect to sales outside of the United States. The Company is currently involved in certain litigation matters with UCLA, which are discussed below.

UCLA may terminate the agreement if the Company does not meet a general obligation to diligently proceed with the development, manufacturing and sale of licensed products, or if it commits any other uncured material breach of the agreement. The Company may terminate the agreement at any time upon advance written notice to UCLA. If neither party terminates the agreement early, the agreement will continue in force until the expiration of the last-to-expire patent on a country by country basis.

(d) Research and License Agreement

In March 2014, the Company entered into a Research and License Agreement with OncoFusion Therapeutics, Inc., or OncoFusion. Under the terms of the agreement, the Company paid OncoFusion a $12.0 million license and research agreement fee during the second quarter of 2014, which was accrued at March 31, 2014. The Company could also be required to pay OncoFusion potential future development and sales milestone payments, subject to the achievement of defined clinical and commercial events, and royalties based on sales. Such future milestone and royalty payments are contingent upon future events that may or may not materialize.

(e) Litigation

The Company is party to legal proceedings, investigations, and claims in the ordinary course of its business, including the matters described below. The Company records accruals for outstanding legal matters when it believes that it is both probable that a liability has been incurred and the amount of such liability can be reasonably estimated. The Company evaluates, on a quarterly basis, developments in legal matters that could affect the amount of any accrual and developments that would make a loss contingency both probable and reasonably estimable. To the extent new information is obtained and the Company’s views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in the Company’s accrued liabilities would be recorded in the period in which such determination is made. In addition, in accordance with the relevant authoritative guidance, for matters for which the likelihood of material loss is at least reasonably possible, the Company provides disclosure of the possible loss or range of loss; however, if a reasonable estimate cannot be made, the Company will provide disclosure to that effect. Gain contingencies, if any, are recorded as a reduction of expense when they are realized.

In May 2011, the Company filed a lawsuit in San Francisco Superior Court against the Regents of the University of California, or the Regents, and one of its professors, alleging breach of contract and fraud claims, among others. The Company’s allegations in this lawsuit include that it has exclusive commercial rights to an investigational drug known as ARN-509, which is currently being developed by Aragon Pharmaceuticals, or Aragon. In August 2013, Johnson & Johnson and Aragon completed a transaction in which Johnson & Johnson acquired all ARN-509 assets owned by Aragon. ARN-509 is an investigational drug currently in development to treat the non-metastatic CRPC population. ARN-509 is a close structural analog of XTANDI, was developed contemporaneously with XTANDI in the same academic laboratories in which XTANDI was developed, and was purportedly licensed by the Regents to Aragon, a company co-founded by the heads of the academic laboratories in which XTANDI was developed. On February 9, 2012, the Company filed a Second Amended Complaint, adding as additional defendants a former Regents professor and Aragon. The Company seeks remedies including a declaration that it is the proper licensee of ARN-509, contractual remedies conferring to it exclusive patent license rights regarding ARN-509, and other equitable and monetary relief. On August 7, 2012, the Regents filed a cross-complaint against the Company seeking declaratory relief which, if granted, would require the Company to share with the Regents ten percent of any sales milestone payments it may receive under the Astellas Collaboration Agreement because such milestones constitute Sublicensing Income under the license agreement with UCLA. Under the Astellas Collaboration Agreement, the Company is eligible to receive up to $320.0 million in sales milestone payments. As of September 30, 2014,

 

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the Company has earned $25.0 million in sales milestones under the Astellas Collaboration Agreement. The Company recorded a $2.5 million accrued payment to UCLA at December 31, 2013, representing ten percent of the $25.0 million sales milestone payment, which was paid to UCLA during the first quarter of 2014. On September 18, 2012, the trial court approved a settlement agreement dismissing the former Regents professor who was added to the case on February 9, 2012. On December 20, 2012, and January 25, 2013, the Court granted summary judgment motions filed by defendants Regents and Aragon, resulting in dismissal of all claims against Regents and Aragon, but denied such motions filed by the remaining Regents professor. On April 15, 2013, the Company filed a Notice of Appeal seeking appeal of the judgment in favor of Aragon, which is now wholly-owned by Johnson & Johnson, and the briefing of that matter has been concluded. The bench trial of the Regent’s cross-complaint against the Company was conducted in July 2013, and on January 15, 2014, the Court entered a judgment in the cross-complaint in favor of Regents, which the Company appealed on February 13, 2014 along with the December 2012 summary judgment order in favor of Regents. The jury trial of the Company’s breach of contract and fraud claims against the remaining Regents professor was conducted in October and November 2013. On November 15, 2013, the jury rendered a verdict in the case, finding in favor of Medivation on the breach of contract claim, and in favor of the Regents professor on the fraud claims. On November 22, 2013, the Court entered judgment for the prevailing party Medivation on the contract claim, and entering judgment in favor of the Regents professor on the fraud claims. The Company’s notice of appeal of the judgment on the fraud claims was filed on February 13, 2014. On October 17, 2014, the briefing in Medivation’s appeal of the summary judgment order and cross-complaint order in favor of Regents, as well as its appeal of the judgment on the fraud claims against the Regents professor commenced. On October 24, 2014, the court of appeals issued an order consolidating all of these appeals for hearing and consideration purposes, so the appeals will be heard and considered together once the briefing is completed.

On April 11, 2014, UCLA filed a complaint against the Company in which UCLA alleges that Medivation and MPT have failed to pay UCLA ten percent of “Operating Profits” Medivation has received (and will continue to receive) from Astellas, as a result of the Astellas Collaboration Agreement, and that Medivation has breached its fiduciary duties to UCLA, as minority shareholder of MPT. On July 16, 2014, UCLA dismissed without prejudice its claim that Medivation breached its fiduciary duties to UCLA, as a minority shareholder of MPT. The Company denies UCLA’s allegations and intends to vigorously defend the litigation.

While the Company believes it has meritorious positions with respect to the claims asserted against it and intends to advance its positions in these lawsuits vigorously, including on appeal, the process of resolving matters through litigation or other means is inherently uncertain, and it is not possible to predict the ultimate resolution of any such proceeding. The actual costs of defending the Company’s position may be significant, and the Company may not prevail.

NOTE 13 — SUBSEQUENT EVENT

In October 2014, the Company entered into license agreement with CureTech, Ltd. in which it has licensed exclusive worldwide rights to CureTech’s late-stage clinical molecule pidilizumab (CT-011), an immune modulatory anti-PD-1 monoclonal antibody. Under the license agreement, the Company will be responsible for all development, regulatory, and commercialization activities for pidilizumab for all indications, including in oncology.

The Company also entered into a manufacturing and supply agreement with CureTech in October, 2014 under which CureTech will manufacture and supply the antibody to the Company over the next three years for clinical development purposes. In addition, the agreement contemplates a guaranty agreement between the Company and CureTech’s largest (53%) shareholder, Clal Biotechnology Industries Ltd. (CBI), with respect to certain obligations of CureTech. The guaranty is subject to approval by CBI shareholders. If approval for the guaranty is not obtained, the Company has the option to terminate both the license agreement and the manufacturing and supply agreement or proceed with such agreements on reduced economic terms (i.e., a reduction of $2.0 million in the upfront payment and 1% from each tier of royalties). The shareholder vote on the guaranty and, thereafter, the Company’s decision to exercise its option to continue to maintain the license are expected in December 2014.

Under the terms of the license agreement, and depending on whether the guaranty from CBI is obtained, CureTech would receive an upfront payment of up to $5.0 million from the Company and would also be entitled to payments upon attainment of certain development and regulatory milestones totaling $85.0 million. In addition, CureTech would be eligible to receive sales based milestone payments totaling up to $245.0 million, upon the achievement of certain annual worldwide net sales thresholds, and tiered royalties ranging from 4% to 11% on annual worldwide net sales.

 

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ITEM 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.

The following discussion and analysis should be read in conjunction with our audited consolidated financial statements and notes thereto for the year ended December 31, 2013, included in our Annual Report on Form 10-K for the year ended December 31, 2013, or Annual Report. The following discussion and analysis contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. We intend that these forward-looking statements be subject to the safe harbors created by those provisions. Forward-looking statements are generally written in the future tense and/or are preceded by words such as “may,” “should,” “could,” “expect,” “suggest,” “believe,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” or similar words, or negatives of such terms or variations on such terms of comparable terminology. These forward-looking statements include, but are not limited to, statements regarding the commercialization of XTANDI^® (enzalutamide) capsules, or XTANDI, the continuation and success of our collaboration with Astellas Pharma, Inc., or Astellas, the timing, progress and results of our clinical trials, and our future drug development activities. The forward-looking statements contained in this Quarterly Report on Form 10-Q, or Quarterly Report, involve a number of risks, uncertainties and assumptions, many of which are outside of our control. Factors that could cause actual results to differ materially from projected results include, but are not limited to, those discussed in “Risk Factors” in Item 1A of Part II below. Readers are expressly advised to review and consider those Risk Factors. Although we believe that the assumptions underlying the forward-looking statements contained in this Quarterly Report are reasonable, any of the assumptions could be inaccurate, and therefore there can be no assurance that the results anticipated by such statements will occur. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation by us or any other person that the results or conditions described in such statements or our objectives and plans will be achieved. Furthermore, past performance in operations, trading price of our common stock or of our 2.625% convertible senior notes due on April 1, 2017, or the Convertible Notes, is not necessarily indicative of future performance. We disclaim any intention or obligation to update, supplement or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Overview

We are a biopharmaceutical company focused on the rapid development and commercialization of medically innovative therapies to treat serious diseases for which there are limited treatment options.

Our most advanced program is XTANDI^® (enzalutamide) capsules, or XTANDI, which we have partnered with Astellas Pharma, Inc., or Astellas. On August 31, 2012, XTANDI received marketing approval from the U.S. Food and Drug Administration, or FDA, for the treatment of metastatic castration-resistant prostate cancer, or mCRPC, patients who previously received docetaxel, or post-chemotherapy mCRPC patients. We and Astellas began co-promoting XTANDI for that indication in the United States on September 13, 2012. On June 24, 2013, we and Astellas announced that XTANDI was granted marketing authorization in the European Union, or EU, for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel therapy. On March 24, 2014, our partner Astellas announced that it received approval to market XTANDI in Japan for the treatment of patients with castration-resistant prostate cancer, or CRPC, with the precaution that the efficacy and safety of the drug have not been established in patients with prostate cancer who have not received chemotherapy. XTANDI is approved in more than 45 countries for the post-docetaxel indication and marketing applications for this indication are under review in multiple countries worldwide.

On September 10, 2014, the FDA approved a new indication for the use of XTANDI to treat patients with mCRPC who have not received chemotherapy. This new approved use follows a priority review of the supplemental New Drug Application, or sNDA, submission to the FDA that was based on the results of our Phase 3 PREVAIL trial. In October 2014, in Japan, the item “Precautions relating to indications” of the package insert has been revised based on the results of the PREVAIL trial, which means the sentence, “The efficacy and safety of the drug have not been established in patients with prostate cancer who have not received chemotherapy,” has been deleted. The revision of this item of the XTANDI package insert in Japan triggers a $45.0 million milestone payment to us, which will be recognized as collaboration revenue in the fourth quarter of 2014. Then, on October 24, 2014, the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency adopted a positive opinion recommending a variation to amend the European Marketing Authorisation for XTANDI. The positive opinion relates to the use of enzalutamide 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. If the European Medicines Agency amends the European Marketing Authorisation for XTANDI, we will earn the final development milestone payment from Astellas under the Astellas Collaboration Agreement, totaling $45.0 million.

Together with Astellas, we are also conducting multiple trials of enzalutamide to further develop enzalutamide in the prostate cancer disease continuum, and also in breast cancer.

 

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In addition, we are investing in programs where there is an unmet medical need. Our research and drug discovery projects focus on diseases, including cancer for which we believe new therapies can substantially improve the current standard of care.

On October 23, 2014, we announced that we had licensed exclusive worldwide rights to CureTech, Ltd.’s late-stage clinical molecule pidilizumab (CT-011), an immune modulatory anti PD-1 monoclonal antibody, for potential applications, including in oncology. Additional information is included in the sections entitled “2014 Business Highlights” and “Liquidity and Capital Resources.”

2014 Business Highlights

XTANDI^® (enzalutamide) capsules

 

•

On March 18, 2014, we and Astellas announced the submission of a sNDA filing to extend the indication for XTANDI for the treatment of men with mCRPC who have not received chemotherapy. Subsequently, on May 6, 2014, we announced that the FDA accepted the sNDA filing and granted priority review designation and set a Prescription Drug User Fee Act (PDUFA) date for the completion of its review of the sNDA of September 18, 2014. The FDA’s acceptance for filing of the sNDA triggered a $25.0 million milestone payment from Astellas, which we earned and recognized as collaboration revenue during the second quarter of 2014. On September 10, 2014, we and Astellas announced that the FDA approved a new indication for the use of XTANDI to treat patients with mCRPC who have not received chemotherapy. The FDA approval triggered milestone payments from Astellas totaling $90.0 million, which we earned and recognized as collaboration revenue during the third quarter of 2014.

 

•

On March 24, 2014, our partner, Astellas, announced that they received approval to market XTANDI in Japan for the treatment of patients with CRPC, with the precaution that the efficacy and safety of the drug have not been established in patients with prostate cancer who have not received chemotherapy. This approval triggered a $15.0 million milestone payment from Astellas that we earned and recognized as collaboration revenue during the first quarter of 2014. During the second quarter of 2014, we earned and recognized as collaboration revenue an additional $15.0 million milestone payment related to Astellas’ plans to address the PREVAIL population in Japan. In October 2014, in Japan, the item “Precautions relating to indications” of the package insert has been revised based on the results of the PREVAIL trial, which means the sentence, “The efficacy and safety of the drug have not been established in patients with prostate cancer who have not received chemotherapy,” has been deleted. This revision triggered a milestone payment of $45.0 million, which we earned in October 2014 and will be recognized as collaboration revenue in the fourth quarter of 2014.

 

•

On April 3, 2014, we and Astellas announced the submission of a variation to amend the European Marketing Authorisation Application for XTANDI 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. The European Medicines Agency validated Astellas’ application for an amended European Marketing Authorisation Application and accepted the filing, triggering a $15.0 million milestone payment, which was recognized as collaboration revenue during the second quarter of 2014. On October 24, 2014, the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency adopted a positive opinion recommending a variation to amend the European Marketing Authorisation for XTANDI. The positive opinion relates to the use of enzalutamide for treatment of adult men with mCRPC who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy in whom chemotherapy is not yet clinically indicated. If the European Medicines Agency amends the European Marketing Authorisation for XTANDI, we will earn the final development milestone payment from Astellas under the Astellas Collaboration Agreement, totaling $45.0 million.

Enzalutamide Clinical Development Program

 

•

The Phase 3 PREVAIL trial results were published in the June 1, 2014 online issue and the July 31, 2014 print issue of the New England Journal of Medicine in a paper entitled “Enzalutamide in Metastatic Prostate Cancer Before Chemotherapy.”

 

•

We completed patient enrollment in the STRIVE trial in March 2014, which enrolled approximately 400 men with either metastatic or non-metastatic disease in the United States.

 

•

We initiated start-up activities with our partner Astellas for a Phase 2 trial evaluating the safety and efficacy of adding enzalutamide to trastuzumab in approximately 80 patients with metastatic or locally advanced breast cancer that is androgen-receptor positive (AR+), human epidermal growth factor receptor 2 (HER2) amplified, and estrogen-receptor negative (ER-) or progesterone receptor negative (PgR-) whose disease has previously progressed on trastuzumab. The primary endpoint of the trial is clinical benefit rate defined as complete response or partial response or stable disease at or before 24 weeks. The goal of the study is to determine whether enzalutamide will provide any incremental benefit for women who have progressed on trastuzumab.

 

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•

In July 2014, we completed patient enrollment in a Phase 2 clinical trial evaluating enzalutamide as a single agent for the treatment of advanced, AR+, triple-negative breast cancer, or TNBC. TNBC is a type of cancer which is not driven by the three most commonly targeted receptors in breast cancer: estrogen, progesterone, and HER2. The Phase 2 open label, single-arm, multicenter trial enrolled more than 100 patients with AR+, TNBC at sites in the United States, Canada, and Europe. The primary endpoint of the trial is clinical benefit rate, defined as the proportion of patients with a best response of complete response, partial response or stable disease at > 16 weeks.

 

•

We announced plans to initiate a global Phase 3 trial evaluating the safety and efficacy of enzalutamide in approximately 1,860 patients with high-risk, hormone sensitive, non-metastatic prostate cancer that has biochemically recurred (rising prostate-specific antigen, or PSA level) following surgery and/or radiation. This trial will determine if enzalutamide can delay or prevent the development of metastatic prostate cancer in high-risk men with a rapidly rising PSA. The primary endpoint of the trial is metastasis-free survival.

Corporate Developments

 

•

In March 2014, we entered into a Research and License Agreement with OncoFusion Therapeutics, Inc., or OncoFusion.

 

•

In October 2014, we entered into an agreement to license exclusive worldwide rights to CureTech, Ltd.’s late-stage clinical molecule pidilizumab (CT-011), an immune modulatory anti PD-1 monoclonal antibody. Under the license agreement, we will be responsible for all development, regulatory, and commercialization activities for pidilizumab for all indications, including in oncology.

2014 Financial Highlights

 

•

Net sales of XTANDI in the United States for the three months ended September 30, 2014, as reported by Astellas, were $181.4 million, an increase of $73.0 million, or 67%, from the three months ended September 30, 2013. Net sales of XTANDI in the United States for the nine months ended September 30, 2014, as reported by Astellas, were $449.6 million, an increase of $183.4 million, or 69%, from the nine months ended September 30, 2013.

 

•

Net sales of XTANDI outside of the United States for the three and nine months ended September 30, 2014, as reported by Astellas, were approximately $119.6 million and $255.5 million, respectively. Net sales of XTANDI outside of the United States for the three and nine months ended September 30, 2013, as reported by Astellas, were $13.0 million and $16.9 million, respectively.

 

•

Collaboration revenue for the three months ended September 30, 2014, was $200.5 million, an increase of $140.5 million, or 234%, from the three months ended September 30, 2013. Collaboration revenue for the nine months ended September 30, 2014 was $435.8 million, an increase of $259.4 million, or 147%, from the nine months ended September 30, 2013.

 

•

Worldwide net sales of XTANDI, as reported by Astellas, for the three and nine months ended September 30, 2014 were approximately $300.0 million and $700.0 million, respectively. Under the Astellas Collaboration Agreement, we are entitled to a $50.0 million sales milestone payment from Astellas upon the achievement of $800.0 million of annual worldwide net sales on this basis. Although uncertain, we currently anticipate that we will earn this sales milestone payment during the fourth quarter of 2014.

 

•

Development milestone payments earned under the Astellas Collaboration Agreement were $90.0 million and $167.0 million for the three and nine months ended September 30, 2014, respectively. At September 30, 2014, the remaining development and sales milestone payments that may potentially be earned under the Astellas Collaboration Agreement were $90.0 million and $295.0 million, respectively. We earned $45.0 million of the remaining development milestone payments in October 2014 as a result of the PREVAIL approval in Japan which will be recognized as collaboration revenue during the fourth quarter of 2014.

 

•

Total operating expenses for the three months ended September 30, 2014, were $108.6 million, an increase of $40.6 million, or 60%, from the three months ended September 30, 2013. Total operating expenses for the nine months ended September 30, 2014, were $297.4 million, an increase of $90.8 million, or 44%, from the nine months ended September 30, 2013. Operating expenses included non-cash stock-based compensation expense of $12.0 million and $9.2 million for the three months ended September 30, 2014 and 2013, respectively, and $32.8 million and $25.6 million for the nine months ended September 30, 2014 and 2013, respectively.

 

•

Cash and cash equivalents were $321.1 million at September 30, 2014, an increase of $92.3 million, or 40%, from $228.8 million at December 31, 2013. At September 30, 2014, the collaboration receivable from Astellas was $208.1 million, of which $90.0 million was received in October 2014 and the remainder is expected to be received in the fourth quarter of 2014.

 

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Critical Accounting Policies and the Use of Estimates

The preparation of our consolidated financial statements and related footnotes requires us to make estimates, assumptions and judgments in certain circumstances that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. We have based our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances. We have discussed the development, selection and disclosure of these estimates with the Audit Committee of our Board of Directors. Actual results could differ materially from these estimates under different assumptions or conditions. A detailed description of our significant accounting policies is included in the footnotes to our audited consolidated financial statements included in our Annual Report.

We have identified our most critical accounting policies and estimates upon which our financial statements depend as those relating to: revenue recognition, reliance on third party information, including estimates of the various deductions from gross sales used to calculate net sales of XTANDI, and the estimated performance periods of our deliverables under collaboration agreements; stock-based compensation; research and development expenses and accruals; litigation; leases; Convertible Notes, including our estimate of how the net proceeds thereof should be bifurcated between the debt component and the equity component; determination of whether we are the primary beneficiary of any variable interest entities, or VIEs; and income taxes. As of September 30, 2014, there have been no significant or material changes to our critical accounting policies or estimates from that disclosed in Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report, except for those related to build-to-suit leases described in the following section.

Build-to-Suit Lease Accounting

In certain lease arrangements, we are involved in the construction of the building. To the extent we are involved with structural improvements of the construction project or take construction risk prior to the commencement of a lease, Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, 840-40, Leases – Sale-Leaseback Transactions (Subsection 05-5), requires us to be considered the owner for accounting purposes of these types of projects during the construction period. Therefore, we record an asset in property and equipment, net on the consolidated balance sheets, including capitalized interest costs, for the replacement cost of our portion of the pre-existing building plus the amount of estimated structural construction costs incurred by the landlord and us as of the balance sheet date. We record a corresponding build-to-suit lease obligation on our consolidated balance sheets representing the amounts paid by the lessor.

Once construction is complete, we consider the requirements for sale-leaseback accounting treatment, including evaluating whether all risks of ownership have been transferred back to the landlord, as evidenced by a lack of continuing involvement in the leased property. If the arrangement does not qualify for sale-leaseback accounting treatment, the building asset remains on our consolidated balance sheets at its historical cost, and such asset is depreciated over its estimated useful life. We bifurcate our lease payments into a portion allocated to the building, and a portion allocated to the parcel of land on which the building has been built. The portion of the lease payments allocated to the land are treated for accounting purposes as operating lease payments, and therefore recorded as rent expense in the consolidated statements of operations. The portion of the lease payments allocated to the building is further bifurcated into a portion allocated to interest expense and a portion allocated to reduce the build-to-suit lease obligation.

The interest rate used for the build-to-suit lease obligation represents our estimated incremental borrowing rate, adjusted to reduce any built in loss.

The initial recording of these assets and liabilities is classified as non-cash investing and financing items, respectively, for purposes of the consolidated statements of cash flows.

The most significant estimates used by management in accounting for build-to-suit leases and the impact of these estimates are as follows:

 

•

Expected lease term- Our expected lease term includes both contractual lease periods and cancelable option extension periods in which failure to exercise such options would result in an economic penalty. The expected lease term is used in determining the depreciable life of the asset or the straight-line rent recognition period for the portion of the lease payment allocable to the land component. Increasing the expected lease term to include cancelable optional extension periods would generally result in higher interest and depreciation expense for a build-to-suit lease recorded on our consolidated balance sheet.

 

•

Incremental borrowing rate- We estimate our incremental borrowing rate using treasury rates for debt with maturities comparable to the expected lease term and our credit spread. For build-to-suit leases recorded on our consolidated balance sheet with a related build-to-suit lease obligation, the incremental borrowing rate is used in allocating our rental payments between interest expense and a reduction of the outstanding build-to-suit lease obligation.

 

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•

Fair market value of leased asset- The fair market value of a build-to-suit lease property is based on replacement cost of the pre-construction shell and comparable market data. Fair market value is used in determining the amount of the property asset and related build-to-suit lease obligation to be recognized on our consolidated balance sheet for build-to-suit leases.

Recent Accounting Pronouncements

Information regarding recent accounting pronouncements applicable to us is included in Note 2, “Summary of Significant Accounting Policies,” to our unaudited consolidated financial statements included elsewhere in this Quarterly Report.

Results of Operations

Collaboration Revenue

Collaboration revenue consists of three components: (a) collaboration revenue related to U.S. XTANDI sales; (b) collaboration revenue related to ex-U.S. XTANDI sales; and (c) collaboration revenue related to upfront and milestone payments.

Collaboration revenue was as follows (in thousands):

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
Collaboration revenue:
Related to U.S. XTANDI sales		$	90,723			$	54,244			$	224,814			$	133,134
Related to ex-U.S. XTANDI sales			15,522				1,551				31,245				2,033
Related to upfront and milestone payments			94,233				4,232				179,698				41,163
Total		$	200,478			$	60,027			$	435,757			$	176,330

We are required to pay UCLA ten percent of all Sublicensing Income, as defined in our license agreement with UCLA. We are currently involved in certain litigation matters with UCLA regarding certain terms of the license agreement and other matters, which are discussed in Part II, Item 1, “Legal Proceedings.”

Collaboration Revenue Related to U.S. XTANDI Sales

In October 2009, we entered into a collaboration agreement with Astellas, or the Astellas Collaboration Agreement. Under the Astellas Collaboration Agreement, Astellas records all U.S. XTANDI sales. We and Astellas share equally all pre-tax profits and losses from U.S. XTANDI sales. Subject to certain exceptions, we and Astellas also share equally all XTANDI development and commercialization costs related to the U.S. market, including cost of goods sold and the royalty on net sales payable to UCLA under our XTANDI license agreement. The primary exceptions to 50/50 cost sharing are that each party is responsible for its own commercial full-time equivalent, or FTE, costs, and that development costs supporting marketing approvals in both the United States and either Europe or Japan are borne one-third by us and two-thirds by Astellas. Both we and Astellas are entitled to receive a fee for each qualifying detail made by our respective sales representatives. We recognize collaboration revenue related to U.S. XTANDI sales in the period in which such sales occur. Collaboration revenue related to U.S. XTANDI sales consists of our share of pre-tax profits and losses from U.S. XTANDI sales, plus reimbursement of our share of reimbursable U.S. development and commercialization costs. Our collaboration revenue related to U.S. XTANDI sales in any given period is equal to 50% of U.S. XTANDI net sales as reported by Astellas for the applicable period.

Under the Astellas Collaboration Agreement, the deductions from gross sales used to derive net sales of XTANDI are determined by Astellas in a manner consistent with GAAP, consistently applied. The largest component of the deductions used in deriving net sales is legally mandated discounts or rebates to Medicare and other government payors or programs. The estimates used in calculating gross-to-net deductions are reassessed periodically by Astellas and trued-up as appropriate based on actual deductions.

Collaboration revenue related to U.S. XTANDI sales was as follows (in thousands):

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
U.S. XTANDI net sales (as reported by Astellas)		$	181,446			$	108,487			$	449,629			$	266,267
Shared U.S. development and commercialization costs			(69,616	)			(58,901	)			(217,866	)			(178,002	)

 

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		Three Months Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
Pre-tax U.S. profit		$	111,830			$	49,586			$	231,763			$	88,265
Medivation’s share of pre-tax U.S. profit		$	55,915			$	24,793			$	115,881			$	44,133
Reimbursement of Medivation’s share of shared U.S. costs			34,808				29,451				108,933				89,001
Collaboration revenue related to U.S. XTANDI sales		$	90,723			$	54,244			$	224,814			$	133,134

Collaboration revenue related to U.S. XTANDI sales for the three months ended September 30, 2014 was $90.7 million, an increase of $36.5 million, or 67%, from $54.2 million for the prior year period. Collaboration revenue related to U.S. XTANDI sales for the nine months ended September 30, 2014 was $224.8 million, an increase of $91.7 million, or 69%, from $133.1 million for the prior year period. The increase in both periods resulted from an increase in our share of pre-tax U.S. profit in the collaboration with Astellas as well as an increase in the reimbursement of our share of shared U.S. costs. Net sales of XTANDI in the United States for the three months ended September 30, 2014, as reported by Astellas, were $181.4 million, an increase of $73.0 million, or 67%, from $108.5 million for the prior year period. Net sales of XTANDI in the United States for the nine months ended September 30, 2014, as reported by Astellas, were $449.6 million, an increase of $183.4 million, or 69%, from $266.3 million for the prior year period. The increase in U.S. XTANDI net sales, as reported by Astellas, for the three and nine month periods ended September 30, 2014 was primarily due to an increase in volume.

Collaboration Revenue Related to Ex-U.S. XTANDI Sales

Under the Astellas Collaboration Agreement, Astellas records all ex-U.S. XTANDI sales. Astellas is responsible for all development and commercialization costs for XTANDI outside the United States, including cost of goods sold and the royalty on net sales payable to UCLA under our license agreement with UCLA, and pays us a tiered royalty ranging from the low teens to the low twenties on net ex-U.S. XTANDI sales. We recognize collaboration revenue related to ex-U.S. XTANDI sales in the period in which such sales occur. Collaboration revenue related to ex-U.S. XTANDI sales consists of royalty payments from Astellas on those sales.

Net sales of XTANDI outside of the United States for the three and nine months ended September 30, 2014, as reported by Astellas, were approximately $119.6 million and $255.5 million, respectively. Net sales of XTANDI outside of the United States for the three and nine months ended September 30, 2013, as reported by Astellas, were $13.0 million and $16.9 million, respectively. XTANDI was first approved for sale outside of the United States in June 2013.

Collaboration Revenue Related to Upfront and Milestone Payments

Collaboration revenue related to upfront and milestone payments from Astellas was as follows (in thousands):

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
Development milestones earned		$	90,000			$	—			$	167,000			$	20,000
Amortization of deferred upfront and development milestones			4,233				4,232				12,698				21,163
Total		$	94,233			$	4,232			$	179,698			$	41,163

 

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The increase in collaboration revenue related to upfront and milestone payments from Astellas was due to the timing of the recognition of development milestone payments upon the achievement of certain defined events as well as a change in our estimated performance period under the Astellas Collaboration Agreement during the third quarter of 2013. Additional information regarding the milestones earned during 2014 is included in the section of Management’s Discussion and Analysis of Financial Condition and Results of Operations entitled, “2014 Business Highlights” and “2014 Financial Highlights.” At September 30, 2014, we estimated that our remaining performance obligations under the Astellas Collaboration Agreement are expected to be completed in the fourth quarter of 2014. Deferred revenue under the Astellas Collaboration Agreement was $4.2 million at September 30, 2014.

As indicated previously, we earned a $45.0 million development milestone payment from Astellas in October 2014 as a result of the Japan package insert revision, which will be recorded as collaboration revenue during the fourth quarter of 2014. In addition, as indicated previously, although uncertain, we currently anticipate that we will earn a $50.0 million sales milestone from Astellas during the fourth quarter of 2014 upon the achievement of $800.0 million of annual worldwide net sales of XTANDI.

Research and Development Expenses

Research and development, or R&D, expenses were as follows (in thousands):

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
Research and development expenses		$	45,430			$	28,737			$	131,693			$	81,850
Percentage change			58	%							61	%

R&D expenses increased by $16.7 million, or 58%, to $45.4 million for the three months ended September 30, 2014, from $28.7 million for the prior year period. The increase was primarily due to a $9.0 million development milestone-related payment due to UCLA, representing ten percent of the development milestone payments we earned from Astellas during the third quarter of 2014, a $5.0 million increase in personnel costs resulting from higher staffing levels, and a $0.5 million increase in third party clinical and preclinical development costs as a result of increased clinical and preclinical activities.

R&D expenses increased by $49.8 million, or 61%, to $131.7 million for the nine months ended September 30, 2014 from $81.9 million for the prior year period. The increase was primarily due to a $14.7 million increase in development milestone-related payments due to UCLA, representing ten percent of the development milestone payments we earned from Astellas, a $12.0 million license and research agreement fee to OncoFusion, a $9.9 million increase in third party clinical and preclinical development costs as a result of increased clinical and preclinical activities, and a $7.7 million increase in personnel costs resulting from higher staffing levels.

R&D expenses represented 42% and 44% of total operating expenses for the three and nine months ended September 30, 2014, respectively, compared with 42% and 40% of total operating expenses for the three and nine months ended September 30, 2013, respectively. R&D headcount increased to 207 full-time employees at September 30, 2014, from 157 full-time employees at September 30, 2013. The higher R&D headcount in 2014 was the result of increased clinical and preclinical activities.

Under the Astellas Collaboration Agreement, we and Astellas share certain development costs in the United States. Development cost-sharing payments from Astellas, and corresponding reductions in R&D expenses, were $15.1 million and $13.1 million for the three months ended September 30, 2014 and 2013, respectively. Development cost-sharing payments from Astellas, and corresponding reductions in R&D expenses, were $48.5 million and $31.6 million for the nine months ended September 30, 2014 and 2013, respectively.

We are currently engaged in two major R&D programs: (1) the development of enzalutamide for the treatment of prostate and breast cancer; and (2) multiple research and drug discovery projects. R&D costs are identified as either directly allocable to one of our R&D programs or indirect costs, with only direct costs being tracked by specific program. Direct costs consist primarily of clinical, preclinical, and drug discovery costs, cost of supplying drug substance and drug product for use in clinical and preclinical studies, upfront and milestone payments under license agreements, personnel costs (including both cash costs and non-cash stock-based compensation costs), contract research organization fees, and other contracted services pertaining to specific clinical and preclinical studies. Indirect costs consist of corporate overhead costs and other administrative and support costs. The following table summarizes the direct costs attributable to each program and total indirect costs (in thousands):

 

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		Three Months Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
Direct costs:
XTANDI (enzalutamide) program		$	27,120			$	15,434			$	72,243			$	50,848
Research and drug discovery			13,705				10,900				46,880				24,040
Total direct costs			40,825				26,334				119,123				74,888
Indirect costs			4,605				2,403				12,570				6,962
Total		$	45,430			$	28,737			$	131,693			$	81,850

Our R&D programs may change from time to time as we evaluate our priorities and available resources.

For a detailed discussion of the risks and uncertainties associated with the timing and cost of completing a product development plan, see Part II Item 1A, “Risk Factors—Risks Related to Our Future Product Development Candidates” of this Quarterly Report.

Selling, General and Administrative Expenses

Selling, general and administrative, or SG&A, expenses were as follows (in thousands):

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
Selling, general and administrative expenses		$	63,165			$	39,288			$	165,695			$	124,746
Percentage change			61	%							33	%

SG&A expenses increased by $23.9 million, or 61%, to $63.2 million for the three months ended September 30, 2014 from $39.3 million for the prior year period. The increase was primarily due to an $8.3 million increase in third-party sales and marketing expenses as a result of increased sales and marketing activities, including activities related to launch preparation for XTANDI in the pre-chemotherapy setting, a $7.4 million increase in personnel costs resulting from higher staffing levels, a $3.5 million increase in consulting and other professional fees, a $3.3 million increase in royalty and milestone expense to UCLA due to higher net sales of XTANDI in the 2014 period, and $1.1 million in asset impairment and other charges, partially offset by a $1.2 million decrease in legal fees. Additional information regarding significant litigation matters is included in Part II, Item 1, “Legal Proceedings.”

SG&A expenses increased by $41.0 million, or 33%, to $165.7 million for the nine months ended September 30, 2014 from $124.7 million for the prior year period. The increase was primarily due to a $14.6 million increase in personnel costs resulting from higher staffing levels, a $14.4 million increase in third-party sales and marketing expenses as a result of increased sales and marketing activities, including activities related to launch preparation for XTANDI in the pre-chemotherapy setting, a $7.9 million increase in royalty and milestone expense to UCLA due to higher net sales of XTANDI in the 2014 period, a $5.2 million increase in consulting and other professional fees, and $1.1 million in asset impairment and other charges, partially offset by a $4.1 million decrease in legal fees. Additional information regarding significant litigation matters is included in Part II, Item 1, “Legal Proceedings.”

SG&A expenses represented 58% and 56% of total operating expenses for the three and nine months ended September 30, 2014, respectively, compared to 58% and 60% for the three and nine months ended September 30, 2013, respectively. SG&A headcount increased to 261 full-time employees at September 30, 2014 from 190 full-time employees at September 30, 2013. The additional headcount was primarily the result of launch preparation for XTANDI in the pre-chemotherapy setting and other general and administrative support functions.

Under our collaboration with Astellas, we are responsible for fifty percent of the cost of goods sold and the royalty payable to UCLA on U.S. net sales of XTANDI. Our share of these items is included in SG&A expenses in our consolidated statements of operations. As such, those components of our reported SG&A expenses will fluctuate in correlation with net sales of XTANDI in the United States.

 

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Under the Astellas Collaboration Agreement, we and Astellas share certain commercialization costs in the United States. Commercialization cost-sharing payments to Astellas, and corresponding increases in SG&A expense, were $7.6 million and $1.8 million for the three months ended September 30, 2014 and 2013, respectively. Commercialization cost-sharing payments to Astellas, and corresponding increases in SG&A expense, were $17.8 million and $10.4 million for the nine months ended September 30, 2014 and 2013, respectively. Commercialization cost sharing payments to Astellas during the 2014 periods include $6.4 million resulting from additional expenses related to the Branded Prescription Drug Fee in the third quarter of 2014. The commercialization cost sharing payments to Astellas are included in the table above.

On July 28, 2014, the IRS issued final rules and regulations in the U.S. for the Branded Prescription Drug Fee, an annual non-tax-deductible fee payable to the federal government under the Affordable Care Act based on an allocation for a given year based upon a company’s market share for branded prescription drugs sold to certain government programs in the prior year. The final rules have the effect of accelerating the expense recognition criteria for the fee obligation from the year in which the fee is paid, to the year in which the market share used to allocate the fee is determined. This change requires us and other industry participants to recognize an additional year of Branded Prescription Drug Fee expense in 2014. We share this annual fee equally with Astellas with respect to U.S. XTANDI sales sold through these government programs. As a result, an additional expense of $6.4 million is recognized as commercialization cost-sharing payments to Astellas within SG&A during the third quarter of 2014, and is included in the table above.

Other Income (Expense), Net

The components of other income (expense), net were as follows:

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
Other income (expense):
Coupon interest expense on Convertible Notes		$	(1,698	)		$	(1,698	)		$	(5,094	)		$	(5,094	)
Non-cash amortization of debt discount and issuance costs on Convertible Notes			(3,837	)			(3,467	)			(11,007	)			(9,941	)
Interest income			9				40				26				166
Other income (expense), net			55				(132	)			(76	)			(123	)
Total		$	(5,471	)		$	(5,257	)		$	(16,151	)		$	(14,992	)

Other income (expense), net consists of coupon interest expense and non-cash interest expense on the Convertible Notes, interest income on our cash equivalents and short-term investment balances, and the impact of changes in foreign exchange rates on our foreign currency-denominated payables. The impact of foreign exchange rates on our results of operations fluctuates from period to period based upon our foreign currency exposures resulting from changes in applicable foreign exchange rates associated with our foreign currency denominated payables and was not significant during the periods presented.

Income Tax Expense

Income tax expense and the effective income tax rate were as follows:

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2014				2013				2014				2013
Income tax expense		$	8,419			$	58			$	9,971			$	123
Effective income tax rate			9.7	%			0.4	%			8.2	%			0.3	%

Income tax expense for the three and nine months ended September 30, 2014, was $8.4 million and $10.0 million, respectively. Our provision for income taxes was lower than the tax computed at the U.S. federal statutory rate due primarily to utilization of net operating loss and tax credit carryforwards. Income tax expense for the three and nine months ended September 30, 2013, was not significant.

Our effective tax rate was 9.7% and 8.2% for the three and nine months ended September 30, 2014, respectively. Our effective tax rate for the three and nine months ended September 30, 2013, was not significant. The increase in the effective tax rate for the three and nine months ended September 30, 2014, as compared to prior year periods was due to forecasted taxable income during 2014.

 

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During the three months ended September 30, 2014, we reduced our current state taxes payable by $0.4 million related to excess tax benefits from stock-based compensation, offsetting additional paid-in capital.

We record a valuation allowance to reduce deferred tax assets to the amount that is more likely than not to be realized. We consider all available positive and negative evidence in determining the need for a valuation allowance, including historical operating results, losses in recent periods, forecasted earnings, future taxable income, and feasible tax planning strategies. Based upon the weight of available evidence at September 30, 2014, we have established and continue to maintain a full valuation allowance against our deferred tax assets as we do not currently believe that realization of those assets is more likely than not. Considering our current assessment of potential future earnings, including the probability of increased revenues and earnings resulting from FDA approval to extend the indication for XTANDI and earning future contingent milestones under our collaboration agreement, there is a reasonable possibility that, within twelve months, sufficient positive evidence may become available to reach a conclusion that a significant portion of the valuation allowance will no longer be needed. A release of the valuation allowance would result in the recognition of certain deferred tax assets and a decrease to income tax expense in the period such release is recorded and would have a material effect to our financial results.

Liquidity and Capital Resources

Sources of Liquidity and Access to Capital

We have incurred significant annual net losses since our inception. We have funded our operations primarily through public offerings of our common stock, the issuance of the Convertible Notes, and from the upfront, milestone and cost-sharing payments under agreements with our current and former collaboration partners and, subsequent to September 13, 2012, from collaboration revenue related to XTANDI net sales. As of September 30, 2014, we had earned a total of $245.0 million in development milestone payments and $25.0 million in sales milestone payments under the Astellas Collaboration Agreement, and remained eligible to earn an additional $90.0 million in development milestone payments and $295.0 million in sales milestone payments under the Astellas Collaboration Agreement. We earned $45.0 of the remaining development milestone payments in October 2014 which will be recognized as collaboration revenue during the fourth quarter of 2014 as described in the section entitled, “2014 Business Highlights.” Although uncertain, we currently anticipate that we will earn a $50.0 million sales milestone payment from Astellas under the Astellas Collaboration Agreement in the fourth quarter of 2014 upon achieving $800.0 million of annual worldwide net sales of XTANDI. Under our license agreement with UCLA, we are required to pay UCLA ten percent of development milestone payments we earn from Astellas. UCLA has also asserted that we are required to pay UCLA ten percent of any sales milestone payments and “Operating Profits” that we receive from Astellas. We deny UCLA’s allegations and intend to vigorously defend the litigation. For more information about this litigation, see Part II, Item 1, “Legal Proceedings.”

At September 30, 2014, we had cash and cash equivalents of $321.1 million. At September 30, 2014, collaboration receivable from Astellas was $208.1 million, of which $90.0 million was received in October 2014 and the remainder is expected to be received in the fourth quarter of 2014. Based on our current expectations, we believe our capital resources at September 30, 2014, combined with our anticipated future cash flows, will be sufficient to fund our currently planned operations for at least the next 12 months. This estimate is based on a number of assumptions that may prove to be wrong. For a detailed discussion of the risks and uncertainties associated with our sources of liquidity and access to capital, see Part II, Item 1A, “Risk Factors—Risks Related to the Operation of Our Business.”

Cash Flow Analysis

The following table summarizes our cash flows:

 

		Nine Months Ended September 30,
		2014				2013
Net cash provided by (used in):
Operating activities		$	76,312			$	(52,832	)
Investing activities			(11,296	)			133,040
Financing activities			27,249				6,459
Net change in cash and cash equivalents		$	92,265			$	86,667

Net cash provided by operating activities totaled $76.3 million for the nine months ended September 30, 2014, which consisted of our net income of $112.2 million and non-cash items of $35.5 million, partially offset by negative changes in our operating assets and liabilities of $71.4 million. Non-cash items consisted of non-cash stock-based compensation expense of $32.8 million, non-cash interest expense on the Convertible Notes of $11.0 million, depreciation expense on property and equipment of $3.6 million and asset

 

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impairment and other charges of $1.1 million, partially offset by non-cash amortization of deferred revenue of $12.7 million and excess tax benefits from stock-based compensation of $0.4 million. The negative cash flow from changes in operating assets and liabilities of $71.4 million arose in the ordinary course of business.

Net cash used in operating activities totaled $52.8 million for the nine months ended September 30, 2013, which consisted of our net loss of $45.4 million and negative changes in our operating assets and liabilities of $24.2 million, partially offset by non-cash items of $16.8 million. Non-cash items consisted primarily of non-cash stock-based compensation expense of $25.6 million, non-cash interest expense on the Convertible Notes of $9.9 million and depreciation expense on property and equipment of $2.5 million, partially offset by non-cash amortization of deferred revenue of $21.2 million. The negative cash flow from changes in operating assets and liabilities of $24.2 million arose in the ordinary course of business.

Net cash used in investing activities totaled $11.3 million for the nine months ended September 30, 2014, and consisted of capital expenditures of $9.2 million and an increase in letters of credit collateralized by restricted cash to secure various operating leases of $2.1 million. Net cash provided by investing activities totaled $133.0 million for the nine months ended September 30, 2013, consisting of net maturities of short-term investments of $140.1 million, partially offset by $6.3 million of capital expenditures and $0.7 million in letters of credit collateralized by restricted cash to secure operating leases.

Net cash provided by financing activities totaled $27.2 million for the nine months ended September 30, 2014, and consisted of primarily of $26.9 million of proceeds from the issuance of common stock under the Medivation Equity Incentive Plan and ESPP and $0.4 million of excess tax benefits from stock-based compensation. Net cash provided by financing activities totaled $6.5 million for the nine months ended September 30, 2013, and consisted of proceeds from the issuance of common stock under the Medivation Equity Incentive Plan.

Non-cash investing and financing activities for the nine months ended September 30, 2014 included $19.0 million capitalized under build-to-suit lease transactions for which we are deemed the owner for accounting purposes and $0.4 million of property and equipment expenditures incurred but not paid.

Our U.S. federal cash taxes are anticipated to be lower than the 35% statutory rate due to approximately $230.0 million, at September 30, 2014, of federal gross unrealized tax deductions from excess tax benefits for stock-based compensation.

Commitments and Contingencies

There have been no significant changes in our contractual cash obligations, commercial commitments and contingencies since December 31, 2013, except for the items disclosed below.

Leases

In the first quarter of 2014, we entered into the Fifth Amendment to our headquarters lease agreement in San Francisco, California, pursuant to which we leased approximately 29,000 additional square feet of office space. In total, at September 30, 2014, we leased approximately 127,000 square feet of office space pursuant to the lease agreement, as amended, which expires in June 2019. Lease commitments pursuant to the Fifth Amendment total approximately $9.6 million over the term of the lease. There were no other changes to our lease obligations from that disclosed in our Annual Report other than a reduction of 2014 lease obligations due to the payment of current year rent payments.

Research and License Agreement with OncoFusion Therapeutics, Inc.

In March 2014, we entered into a Research and License Agreement with OncoFusion Therapeutics, Inc., or OncoFusion. Under the terms of the agreement, we paid OncoFusion a $12.0 million license and research agreement fee during the second quarter of 2014. We could also be required to pay OncoFusion potential future development and sales milestone payments, subject to the achievement of defined clinical and commercial events, and royalties based on sales. Such future milestone and royalty payments are contingent upon future events that may or may not materialize.

License Agreement and Manufacturing and Supply Agreement with CureTech, Ltd.

In October 2014, we entered into a license agreement with CureTech, Ltd. in which we have licensed exclusive worldwide rights to CureTech’s late-stage clinical molecule pidilizumab (CT-011), an immune modulatory anti-PD-1 monoclonal antibody. Under the license agreement, we will be responsible for all development, regulatory, and commercialization activities for pidilizumab for all indications, including in oncology.

We also entered into a manufacturing and supply agreement with CureTech in October, 2014 under which CureTech will manufacture and supply the antibody to us over the next three years for clinical development purposes. In addition, the agreement contemplates a guaranty agreement between us and CureTech’s largest (53%) shareholder, Clal Biotechnology Industries Ltd. (CBI), with respect to certain obligations of CureTech. The guaranty is subject to approval by CBI shareholders. If approval for the guaranty

 

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is not obtained, we have the option to terminate both the license agreement and the manufacturing and supply agreement or proceed with such agreements on reduced economic terms (i.e., a reduction of $2.0 million in the upfront payment and 1% from each tier of royalties). The shareholder vote on the guaranty and, thereafter, our decision to exercise our option to continue to maintain the license are expected in December 2014.

Under the terms of the license agreement, and depending on whether the guaranty from CBI is obtained, CureTech would receive an upfront payment of up to $5.0 million from us and would also be entitled to payments upon attainment of certain development and regulatory milestones totaling $85.0 million. In addition, CureTech would be eligible to receive sales based milestone payments totaling up to $245.0 million, upon the achievement of certain annual worldwide net sales thresholds, and tiered royalties ranging from 4% to 11% on annual worldwide net sales.

License Agreement with UCLA

On April 11, 2014, UCLA filed a complaint against us in which UCLA alleges that Medivation and Medivation Prostate Therapeutics, Inc., or MPT, have failed to pay UCLA ten percent of “Operating Profits” Medivation has received (and will continue to receive) from Astellas, as a result of the Astellas Collaboration Agreement, and that Medivation has breached its fiduciary duties to UCLA, as minority shareholder of MPT. On July 16, 2014, UCLA dismissed without prejudice its claim that Medivation breached its fiduciary duties to UCLA, as a minority shareholder of MPT. We deny UCLA’s allegations and intend to defend the litigation. For more information about this litigation, see Part II, Item 1, “Legal Proceedings.”

Convertible Senior Notes Due 2017

We have outstanding $258.8 million aggregate principal amounts of the Convertible Notes. Prior to April 6, 2015, the Convertible Notes are not redeemable. On or after April 6, 2015, we may redeem for cash all or part of the Convertible Notes if the closing price of our common stock for 20 or more trading days in a period of 30 consecutive trading days ending on the trading day preceding the date we provide notice of redemption exceeds 130% of the conversion price in effect on each such trading day, subject to certain conditions. At this time, we have not made a determination whether or not we will redeem all or part of the Convertible Notes for cash if they meet the technical requirements of redemption beginning April 6, 2015. If we choose to redeem all or part of the Convertible Notes for cash, we may need to raise additional funds through public or private financing or other arrangements. At September 30, 2014, the estimated fair value of the Convertible Notes, including the equity component, was $503.3 million and was determined using recent trading prices of the Convertible Notes.

Off-Balance Sheet Arrangements

We are involved in a variable interest entity, or VIE, but have not consolidated this entity because we do not have the power to direct the activities that most significantly impact the VIE’s economic performance and thus we are not considered the primary beneficiary of the VIE.

 

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.

Market risk is the exposure to loss resulting from changes in interest rates, foreign currency exchange rates, commodity prices and equity prices. Our exposure to market risk has been limited. We currently do not use derivative financial instruments to hedge our market risk exposures. Our investment policy emphasizes liquidity and the preservation of capital over other portfolio considerations. There were no material changes to our market risk from those disclosed in Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk,” of our Annual Report.

 

ITEM 4.

CONTROLS AND PROCEDURES.

Evaluation of Disclosure Controls and Procedures

We maintain “disclosure controls and procedures,” as such term is defined in Rule 13a-15(e) under the Exchange Act, that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC rules and forms and that such information is communicated to our management, including our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer), as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well designed and operated, can provide only reasonable, but not absolute, assurance that the objectives of the disclosure controls and procedures are met. Our disclosure controls and procedures have been designed to meet the reasonable assurance standards. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

 

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As required by Rule 13a-15(b) or Rule 15d-15(b) of the Exchange Act, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer), of the effectiveness of the design and operation of our disclosure controls and procedures as of September 30, 2014. Based on the foregoing, our Chief Executive Officer (principal executive officer) and Chief Financial Officer (principal financial officer) concluded that our disclosure controls and procedures were effective as of September 30, 2014, at the reasonable assurance level.

Changes in Internal Controls

There were no changes in our internal control over financial reporting during the three months ended September 30, 2014, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

 

ITEM 1.

LEGAL PROCEEDINGS

We are involved in legal proceedings, investigations, and claims in the ordinary course of our business, including the matters described below.

In May 2011, we filed a lawsuit in San Francisco Superior Court against the Regents of the University of California, or the Regents, and one of its professors, alleging breach of contract and fraud claims, among others. Our allegations in this lawsuit include that we have exclusive commercial rights to an investigational drug known as ARN-509, which is currently being developed by Aragon Pharmaceuticals, or Aragon. In August 2013, Johnson & Johnson and Aragon completed a transaction in which Johnson & Johnson acquired all ARN-509 assets owned by Aragon. ARN-509 is an investigational drug currently in development to treat non-metastatic CRPC population. ARN-509 is a close structural analog of XTANDI, was developed contemporaneously with XTANDI in the same academic laboratories in which XTANDI was developed, and was purportedly licensed by the Regents to Aragon, a company co-founded by the heads of the academic laboratories in which XTANDI was developed. On February 9, 2012, we filed a Second Amended Complaint, adding as additional defendants a former Regents professor and Aragon. We seek remedies including a declaration that we are the proper licensee of ARN-509, contractual remedies conferring to us exclusive patent license rights regarding ARN-509, and other equitable and monetary relief. On August 7, 2012, the Regents filed a cross-complaint against us seeking declaratory relief which, if granted, would require us to share with the Regents ten percent of any sales milestone payments we may receive under the Astellas Collaboration Agreement because such milestones constitute Sublicensing Income under the license agreement with UCLA. Under the Astellas Collaboration Agreement, we are eligible to receive up to $320.0 million in sales milestone payments. As of September 30, 2014, we have earned $25.0 million in sales milestone payments under the Astellas Collaboration Agreement. On September 18, 2012, the trial court approved a settlement agreement dismissing the former Regents professor who was added to the case on February 9, 2012. On December 20, 2012, and January 25, 2013, the Court granted summary judgment motions filed by defendants Regents and Aragon, resulting in dismissal of all claims against Regents and Aragon, but denied such motions filed by the remaining Regents professor. On April 15, 2013, we filed a Notice of Appeal seeking appeal of the judgment in favor of Aragon, which is now wholly-owned by Johnson & Johnson, and the briefing of that matter has been concluded. The bench trial of the Regent’s cross-complaint against us was conducted in July 2013, and on January 15, 2014, the Court entered a judgment in the cross-complaint in favor of Regents, which we appealed on February 13, 2014, along with the December 2012 summary judgment order in favor of Regents. The jury trial of our breach of contract and fraud claims against the remaining Regents professor was conducted in October and November 2013. On November 15, 2013, the jury rendered a verdict in the case, finding in favor of Medivation on the breach of contract claim, and in favor of the Regents professor on the fraud claims. On November 22, 2013, the Court entered judgment for the prevailing party Medivation on the contract claim, and entering judgment in favor of the Regents professor on the fraud claims. Our notice of appeal of the judgment on the fraud claims was filed on February 13, 2014. On October 17, 2014, the briefing in Medivation’s appeal of the summary judgment order and cross-complaint order in favor of Regents, as well as its appeal of the judgment on the fraud claims against the Regents professor commenced. On October 24, 2014, the court of appeals issued an order consolidating all of these appeals for hearing and consideration purposes, so the appeals will be heard and considered together once the briefing is completed.

On April 11, 2014, UCLA filed a complaint against us in which UCLA alleges that Medivation and MPT have failed to pay UCLA ten percent of “Operating Profits” Medivation has received (and will continue to receive) from Astellas, as a result of the Astellas Collaboration Agreement, and that Medivation has breached its fiduciary duties to UCLA, as minority shareholder of MPT. On July 16, 2014, UCLA dismissed without prejudice its claim that Medivation breached its fiduciary duties to UCLA, as a minority shareholder of MPT. We deny UCLA’s allegations and intend to vigorously defend the litigation.

Our management believes that we have meritorious positions with respect to the claims we have asserted and the claims asserted against us, and we intend to advance our positions in these lawsuits vigorously, including on appeal. However, the lawsuits are subject to inherent uncertainties, the actual costs may be significant, and we may not prevail.

 

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ITEM 1A.

RISK FACTORS

Risks facing our business have not changed substantively from those discussed in our Annual Report on Form 10-K for the year ended December 31, 2013, except for those risk factors below designated by an asterisk (*) and the removal of the risk factor regarding the purported securities class action lawsuit previously filed against us, which has been dismissed with prejudice and so is formally concluded. Our business faces significant risks, some of which are set forth below to enable readers to assess, and be appropriately apprised of, many of the risks and uncertainties applicable to the forward-looking statements made in this Quarterly Report. You should carefully consider these risk factors as each of these risks could adversely affect our business, operating results, cash flows and financial condition. If any of the events or circumstances described in the following risk factors actually occurs, our business may suffer, the trading price of our common stock and our 2.625% convertible senior notes due April 1, 2017, or the Convertible Notes, could decline and our financial condition or results of operations could be harmed. Given these risks and uncertainties, you are cautioned not to place undue reliance on forward-looking statements. These risks should be read in conjunction with the other information set forth in this Quarterly Report. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties not currently known to us, or that we currently believe to be immaterial, may also adversely affect our business.

Risks Related to XTANDI ^® (enzalutamide) capsules

We may not be able to further commercialize XTANDI in the United States, and may fail to continue to generate significant revenue from the sale of XTANDI in the United States.*

We only have one commercial product, XTANDI, which is now approved in the United States, as of September 10, 2014, to treat men with metastatic castration-resistant prostate cancer, or mCRPC, in both the pre- and post-chemotherapy settings. However, the further commercialization of XTANDI in the United States for the treatment of mCRPC or any other patient populations for which XTANDI is being developed and may subsequently be approved, may not be successful for a number of reasons, including:

 

•

we and our collaboration partner, Astellas Pharma, Inc., or Astellas, may not be able to establish or demonstrate in the medical community the safety and efficacy of XTANDI and its potential advantages over, and side effects compared to, competing therapeutics and products currently in clinical development for each applicable patient population;

 

•

our limited experience in marketing XTANDI for the pre-chemotherapy mCRPC or other patient populations;

 

•

reimbursement and coverage policies of government and private payors such as Medicare, Medicaid, insurance companies, health maintenance organizations and other plan administrators;

 

•

the relative price of XTANDI as compared to alternative treatment options;

 

•

changes or increases in regulatory restrictions;

 

•

changes to the label for XTANDI that further restrict how we and Astellas market XTANDI, including as a result of data collected from the safety study in patients with known risk factor(s) for seizure that the FDA required us to undertake as a post-marketing requirement or from any other ongoing or future studies;

 

•

we and Astellas may not have adequate financial or other resources to successfully commercialize XTANDI; and

 

•

we and Astellas may not be able to obtain adequate commercial supplies of XTANDI to meet demand or at an acceptable cost.

If the further commercialization of XTANDI is unsuccessful, our ability to generate revenue from product sales and achieve profitability would be adversely affected and our business could fail.

XTANDI may fail to obtain regulatory approval, be successfully commercialized and generate significant revenue outside the United States.*

XTANDI is approved in more than 45 countries for the post-chemotherapy indication and in the United States and Japan for the pre-chemotherapy mCRPC indication. XTANDI was approved in Japan for patients with mCRPC, who have not received docetaxel, on October 22, 2014. Additional marketing applications for the pre-chemotherapy indication are under review in multiple countries worldwide. Unless we and Astellas can obtain additional regulatory approval and reimbursement of XTANDI outside the United States and Japan to treat mCRPC patients both pre- and post-chemotherapy, and for additional patient populations for which XTANDI is in development and may be approved, Astellas’ ability to successfully commercialize XTANDI further and our ability to generate additional revenue from XTANDI worldwide, and fund our operations could be significantly limited.

 

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If XTANDI fails to obtain regulatory approval for mCRPC patients who have not received chemotherapy outside of the United States and Japan, the commercial potential of XTANDI will be harmed.*

Other than the United States, XTANDI has only been approved in Japan for the treatment of mCRPC patients who have not received chemotherapy. We believe that the commercial opportunity represented by mCRPC patients who have not received chemotherapy is substantially larger than that represented by post-chemotherapy mCRPC patients, and thus any failure to successfully obtain approval of XTANDI for the treatment of mCRPC patients who have not received chemotherapy in other countries outside of the United States and Japan would have a negative impact on our business and future prospects. If approved in other countries outside of the United States and Japan, the new label for XTANDI for pre-chemotherapy patients may have new safety risks, monitoring requirements, or warnings and precautions that may limit the commercial uptake of the product in this patient population. In January 2014, the results of the PREVAIL trial, the Phase 3 trial of XTANDI for mCRPC patients who have not received chemotherapy, were presented at the American Society of Clinical Oncology 2014 Genitourinary Cancers Symposium. Subsequently, we announced the submission of a variation to amend the European Marketing Authorisation Application for XTANDI to the European Medicines Agency (which the European Medicines Agency accepted) 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, but we do not know if the results of the PREVAIL trial are robust enough to support regulatory approval by the European Medicines Agency, although on October 24, 2014, the Committee for Medicinal Products for Human Use, or CHMP, adopted a positive opinion regarding XTANDI’s potential approval for the treatment of mCRPC patients who have not received chemotherapy.

In order to successfully commercialize XTANDI in the United States to treat mCRPC patients who have not received chemotherapy, we will need to expand our sales and marketing efforts to include urologists, and if we are not successful in marketing to urologists, the commercial potential of XTANDI will be harmed.*

On September 10, 2014, we and Astellas announced that the FDA approved a new indication for XTANDI to treat men with mCRPC who have not received chemotherapy. Our commercialization of XTANDI for such indication in the United States will require marketing and sales efforts directed to urologists, who may have different prostate cancer treatment perspectives and require different sales and marketing efforts from oncologists, who have been the largest physician specialty prescribing XTANDI to date. Failure to successfully commercialize XTANDI for the treatment of mCRPC patients who have not received chemotherapy with urologists would have a negative impact on our business and future prospects.

XTANDI may fail to compete effectively commercially with other approved products and other products in development.*

Companies are currently marketing, or expected to be marketing in the near future, products that may compete directly with XTANDI. These companies include some of the world’s largest and most experienced pharmaceutical companies, such as Johnson & Johnson, Sanofi, and Bayer Pharma AG, which have considerably more financial, development and commercialization resources and experience than we have to develop and commercialize their products. We are competing, and expect to continue to compete, against these companies and against multiple drugs that currently exist, e.g., the approved hormonal agent, Zytiga^® (abiraterone acetate), as well as against additional drugs currently in development, to treat mCRPC, including both pre- and post-chemotherapy indications, and for upstream prostate cancer indications, e.g., ARN-509, in non-metastatic CRPC. Some competitive drugs already have acquired substantial shares in these markets or are generic, e.g., Casodex, which may make it more difficult for us to compete successfully in these markets notwithstanding any positive results that we may generate from our clinical trials. Also, intense competition from products and compounds in development could impact our ability to successfully conduct upstream clinical trials, as trials may become more difficult to enroll, or complete successfully, as patients may have more treatment options with demonstrated efficacy and safety. Bases upon which XTANDI would have to compete successfully include efficacy, safety, price and cost effectiveness. We cannot guarantee that we and Astellas will be able to compete successfully in the context of any of these factors.

Price pressure from third party payors and price competition from approved competitors could substantially impact our ability to generate revenue from XTANDI and negatively impact our business.*

The realized price of XTANDI could be subject to downward pressure from aggressive competitive pricing activity and managed care organizations and institutional purchasers, who use cost considerations to restrict the sale of preferred drugs that their physicians may prescribe. To the extent, that payors think the price for XTANDI is too high, and/or prefer similar lower-priced, branded or generic competitors due to cost considerations, we and our partner Astellas may be forced either to reduce the price of XTANDI or be subject to formulary restrictions, which could result in a loss of sales revenue and/or market share. Additionally, XTANDI currently competes against products and could compete in the future with products marketed by some of the world’s largest and most experienced pharmaceutical companies, such as Johnson & Johnson, who have more resources and greater flexibility to engage in aggressive price competition in order to gain revenues and market share. It is uncertain whether we and Astellas could compete with such competition, and our failure to compete or decision to reduce the price of XTANDI in order to compete could severely impact our business.

 

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Competition from other approved products, including those that operate similarly to XTANDI, could negatively impact the expected use or duration of therapy of XTANDI, and impact our ability to generate revenue.

We are competing and will continue to compete against drugs that operate similarly to XTANDI. To the extent XTANDI is used after drugs like Zytiga and/or potentially ARN-509, which operate on the same molecular signaling pathway or have the same mechanism of action as XTANDI, patients may not have as good a response on XTANDI as would patients who are naïve of such drugs. If XTANDI is unable to successfully compete for a position in the prostate cancer treatment paradigm ahead of drugs like Zytiga and/or potentially ARN-509, which are now being investigated in Phase 3 clinical studies in earlier stage prostate cancer, sales of XTANDI would be negatively impacted, due to decreased use or shorter duration of XTANDI therapy. In addition, the availability of multiple other approved agents to treat the same patients being treated with XTANDI could cause the treating physicians to switch patients off of XTANDI and onto competing therapies more quickly than would otherwise be the case, which would also negatively impact XTANDI sales due to shorter duration of use.

Competition from generic products could potentially harm our business.

Competition from manufacturers of generic drugs could be a major challenge for us, like other branded pharmaceutical companies, and the loss or expiration of intellectual property rights on enzalutamide or a competitor product, e.g., Zytiga, could adversely affect on our business, and could put downward pressure on the price and market share of XTANDI. Generic products that have already been approved by the FDA, e.g., Casodex, are generally sold at a reduced price from branded drugs. Additionally, for new generic products, the FDA approval process exempts them from costly and time-consuming clinical trials to demonstrate their safety and efficacy, allowing generic manufacturers to rely on the safety and efficacy data of the branded product. Generic products need only demonstrate a drug level availability in the body equivalent to that of the branded product.

XTANDI may not be commercially successful if not widely-covered and appropriately reimbursed by third-party payors, and we are dependent upon Astellas for the execution of third-party payor access and reimbursement strategies for XTANDI.

Our ability to successfully commercialize XTANDI for its approved indications depends, in part, on the extent to which adequate coverage and reimbursement for XTANDI is available from government and health administration authorities, private health insurers, managed care programs and other third-party payors, both domestically and globally. Significant uncertainty exists as to the coverage and reimbursement of newly approved prescription drug products.

In addition, even if third-party payors ultimately elect to cover and reimburse for XTANDI, most payors will not reimburse 100% of the cost, but rather require patients to pay a portion of the cost through a co-payment. Thus, even if reimbursement is available, the percentage of drug cost required to be borne by the patients may make use of XTANDI financially difficult or impossible for certain patients, which would have a negative impact on sales of XTANDI. For example, in the United States there exists a coverage gap, or “donut hole”, in the Medicare Part D coverage for prescription medications for participants, which renews annually each January 1st. While in the donut hole, Medicare Part D participants, including many patients in XTANDI’s approved indication, may have to pay out of pocket a substantial portion of their prescription drug costs, which may discourage physicians from prescribing or patients from accessing XTANDI. It is increasingly difficult to obtain coverage and adequate reimbursement levels from third-party payors, and we may be unable to achieve these objectives. Moreover, our commercial prospects would be further weakened if payors approve coverage for XTANDI only as second- or later-line treatments, or if they place XTANDI in tiers requiring unacceptably high patient co-payments. Since launch, several third-party payors and at least one government payor have approved coverage for XTANDI only after patient treatment on Zytiga plus prednisone. These coverage decisions may persist even with expanded indications for XTANDI. Because XTANDI works via the same molecular signaling pathway as Zytiga does, patients who have already failed treatment with Zytiga may not have as good a response on XTANDI as would patients who are Zytiga-naïve. Failure to overturn these coverage decisions or stop additional such coverage decisions could materially harm our or our partner’s ability to successfully market XTANDI in the United States. Achieving coverage and acceptable reimbursement levels typically involves negotiating with individual payors and is a time-consuming and costly process. We are dependent upon Astellas globally for the achievement of such coverage and acceptable reimbursement, and negotiation with individual payors.

Federal healthcare laws and regulations may substantially impact our ability to generate revenue from XTANDI.

In March 2010, the President of the United States signed the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, collectively, PPACA, which has the potential to substantially change health care delivery and financing by both governmental and private insurers, and to significantly impact the pharmaceutical industry. The provisions of PPACA most relevant to the pharmaceutical industry include the following:

 

•

an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs, not including orphan drug sales;

 

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•

an increase in the rebates a manufacturer must pay under the Medicaid Drug Rebate Program to 23.1% and 13% of the average manufacturer price for branded and generic drugs, respectively;

 

•

a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts to negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;

 

•

extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

 

•

expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for certain individuals with income at or below 133% of the Federal Poverty Level beginning in 2014, thereby potentially increasing manufacturers’ Medicaid rebate liability;

 

•

expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;

 

•

new requirements to report certain financial arrangements with physicians and teaching hospitals, as defined in PPACA and its implementing regulations, including reporting any payment or “transfers of value” made or distributed to prescribers and teaching hospitals, and reporting any ownership and investment interests held by physicians and their immediate family members and applicable group purchasing organizations during the preceding calendar year, with data collection that commenced on August 1, 2013, annual reporting beginning in the second quarter of 2014, and publication by CMS on a searchable website beginning September 30, 2014;

 

•

expansion of health care fraud and abuse laws, including the federal false claims act and anti-kickback statute, new government investigative powers, and enhanced penalties for noncompliance;

 

•

a licensure framework for follow-on biologic products; and

 

•

a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.

On June 28, 2012, the United States Supreme Court upheld the constitutionality of PPACA, excepting certain provisions that would have required states to expand their Medicaid programs or risk losing all of the state’s Medicaid funding, as noted above. At this time, it remains unclear whether there will be any further changes made to PPACA, whether in part or in its entirety. Moreover, other state and federal legislative and regulatory proposals aimed at reforming the health care system in the United States are periodically proposed, the effect of which, if enacted, could adversely impact our product sales and results of operations.

Federal and state budget control legislation and spending reductions could substantially impact our ability to generate revenue from XTANDI.

On August 2, 2011, the Budget Control Act of 2011 created, among other things, the Joint Select Committee on Deficit Reduction, to recommend to Congress proposals in spending reductions. The Joint Select Committee did not achieve a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, which triggered the legislation’s automatic reduction to several government programs. This includes aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, beginning on March 1, 2013. Further, President Obama’s proposed budget for fiscal year 2015, if enacted, would require drug manufacturers to pay to the Medicare program new rebates for certain outpatient drugs covered under Medicare Part D. These proposals would allow the Medicare program to benefit from the same, relatively higher, rebates that Medicaid receives for brand name and generic drugs provided to beneficiaries who receive the low-income subsidies under the Medicare Part D program and “dual eligible” beneficiaries (i.e., those who are eligible for both the Medicare and Medicaid programs.)

We expect that there will continue to be a number of federal and state proposals to implement spending reductions in government healthcare programs, e.g., Medicare or government controls over drug product pricing. We are currently unable to predict what additional legislation or regulations, if any, relating to the pharmaceutical industry or third-party payor coverage and reimbursement may be enacted in the future, or what effect PPACA or any such additional legislation or regulation will or would have on our business. However, spending reductions in government healthcare programs or additional government controls over drug product pricing would likely negatively impact our business. In addition, we would face competition in such negotiations from other approved drugs against which we compete, and the marketers of such other drugs are likely to be significantly larger than us and therefore enjoy significantly more negotiating leverage with respect to the individual payors than we may have.

 

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We are dependent upon our collaborative relationship with Astellas to further develop, fund, manufacture and commercialize XTANDI, and if such relationship is unsuccessful, or if Astellas terminates our Collaboration Agreement with them, it could negatively impact our ability to conduct our business and generate revenue from XTANDI.

Under our collaboration agreement with Astellas, Astellas is responsible for developing, seeking regulatory approval for, and commercializing XTANDI outside the United States and is responsible globally for all manufacture of product for both clinical and commercial purposes. We and Astellas are jointly responsible for commercializing XTANDI in the United States. We and Astellas share equally the costs (subject to certain exceptions), profits and losses arising from development and commercialization of XTANDI in the United States. For clinical trials useful both in the United States and in Europe or Japan, we are responsible for one-third of the total costs and Astellas is responsible for the remaining two-thirds. We are subject to a number of risks associated with our dependence on our collaborative relationship with Astellas, including:

 

•

Astellas’ right to terminate the collaboration agreement with us on limited notice for convenience (subject to certain limitations), or for other reasons specified in the collaboration agreement;

 

•

the need for us to identify and secure on commercially reasonable terms the services of third parties to perform key activities currently performed by Astellas in the event that Astellas were to terminate its collaboration with us, including development and commercialization activities outside of the United States and manufacturing activities globally;

 

•

adverse decisions by Astellas regarding the amount and timing of resource expenditures for the commercialization of XTANDI;

 

•

decisions by Astellas to prioritize other of its present or future products more highly than XTANDI for either development and/or commercial purposes;

 

•

possible disagreements with Astellas as to the timing, nature and extent of our development plans, including clinical trials or regulatory approval strategy, which if we disagree could significantly delay or halt development of XTANDI;

 

•

the financial returns to us, if any, under our collaboration agreement with Astellas, depend in large part on the achievement of development and sales milestones and the generation of product sales, and if Astellas fails to perform or satisfy its obligations to us, the development or commercialization of XTANDI would be delayed or may not occur and our business and prospects could be materially and adversely affected; and

 

•

changes in key management personnel that are members of the collaboration’s various committees.

Due to these factors and other possible disagreements with Astellas, we may be delayed or prevented from further developing, manufacturing or commercializing XTANDI or we may become involved in litigation or arbitration, which would be time consuming and expensive.

If Astellas were to terminate our collaborative relationship unilaterally, we would need to undertake development and commercialization activities for XTANDI solely at our own expense and/or seek one or more other partners for some or all of these activities, worldwide. If we pursued these activities on our own, it would significantly increase our capital and infrastructure requirements, might limit the indications we are able to pursue for XTANDI, and could prevent us from effectively commercializing XTANDI. If we sought to find one or more other pharmaceutical company partners for some or all of these activities, we may not be successful in such efforts, or they may result in collaborations that have us expending greater funds and efforts than our current relationship with Astellas.

We are dependent on third party manufacturers for commercial supply of XTANDI and for clinical study materials and if we fail to receive such adequate supplies, global sales of XTANDI could be limited and clinical trials could be delayed.

We require adequate supplies of enzalutamide for commercial supply of XTANDI, and for use in clinical trials. Under our collaboration agreement, Astellas has the responsibility to manufacture commercial supplies of XTANDI for all markets and provide material for clinical studies. Astellas fulfills its manufacturing and supply obligations largely through third-party contract manufacturers. Consequently, we are, and expect to remain, dependent on Astellas and its contract manufacturers for commercial and clinical materials. If Astellas cannot provide the materials on a timely basis due to, for example, raw materials availability, quality issues or failure of the contracting facilities to perform, it could result in decreased sales or put at risk on-going clinical studies. If Astellas or its contract manufacturers do not perform, we may be forced to incur additional expenses, delays, or both, to arrange or take responsibility for contract manufacturers to manufacture or package XTANDI or enzalutamide on our behalf, as we do not have any internal manufacturing or packaging capabilities.

We also rely on our own third-party vendors for clinical supplies. If clinical supplies cannot be provided on a timely basis it could put at risk our sponsored clinical studies.

 

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We are dependent on Astellas to distribute and sell XTANDI, and if Astellas fails to adequately perform, our business would be negatively impacted.

Under our collaboration agreement with Astellas, we and Astellas have the right to jointly promote XTANDI to customers in the United States. However, Astellas has the sole right to distribute and sell XTANDI to customers in the United States and the sole right to promote, distribute and sell XTANDI to customers outside the United States. We are thus partially dependent on Astellas to successfully promote XTANDI in the United States, and solely dependent on Astellas to successfully distribute and sell XTANDI in the United States and to promote, distribute and sell XTANDI outside of the United States. In the United States, we depend on customer support from specialty pharmaceutical distributors and wholesalers in Astellas’ network. Astellas has contracted with a limited number of specialty pharmaceutical distributors and wholesalers to deliver XTANDI to end users. The use of specialty pharmacies and wholesalers requires significant coordination with Astellas’ sales and marketing, medical affairs, regulatory affairs, legal and finance organizations and involves risks, including but not limited to risks that these specialty pharmacies and wholesalers will:

 

•

not provide Astellas accurate or timely information regarding their inventories, patient- or account-level data or safety complaints regarding XTANDI;

 

•

not effectively sell or support XTANDI;

 

•

not devote the resources necessary to sell XTANDI in the volumes and within the timeframes that we expect; or

 

•

cease operations.

We generally do not have control over the resource or degree of effort that any of the specialty pharmacies and distributors may devote to XTANDI, and if their performance is substandard, this will adversely affect sales of XTANDI. If Astellas’ network of specialty pharmacies and distributors fails to adequately perform, it could negatively impact sales of XTANDI, which would negatively impact our business, results of our operations, cash flows and liquidity.

We and Astellas are required to undertake certain studies to comply with post-marketing requirements or commitments in the European Union and the United States, which could result in adverse modifications to XTANDI’s existing labeling, and risk XTANDI’s ability to obtain additional regulatory approvals for additional patient populations.*

In the European Union, we and Astellas are required to collect efficacy data on mCRPC patients previously treated with Zytiga to determine XTANDI’s efficacy response in such patients, which we do not expect to be as good as in patients naïve to Zytiga. In the United States, we and Astellas are required to conduct an open-label safety study of XTANDI in patients with known risk factor(s) for seizure and to report the results of that study to the FDA in 2019. If the results of this study reveal unacceptable safety risks, this could result in decreased commercial utilization of XTANDI for mCRPC patients in the U.S. and in the EU (if approved for pre-chemotherapy mCRPC), failure to obtain approval in other indications (including breast cancer), and modifications to the existing label for XTANDI , including potentially a boxed warning, or additional clinical testing. Any one or more of these outcomes would seriously harm our business. Additionally, we could receive additional post-marketing requirements as we seek approval of XTANDI in additional patient populations. Failure to conduct the post-marketing requirements or commitments in a timely manner may result in withdrawal of approval for XTANDI and substantial civil and/or criminal penalties.

Even though we have obtained approval to market XTANDI in the United States, we are subject to ongoing regulatory obligations and review, including post-approval requirements, which may result in the withdrawal of XTANDI from the market. Further, we are seeking approval in additional patient populations through the submission of clinical trial data in such populations that could result in negative changes to XTANDI’s product labeling and additional post-approval requirements.*

Even though we have obtained approval to market XTANDI in the United States, we are seeking approval in additional patient populations through the submission of clinical trial data in such populations, and we are subject to extensive ongoing obligations and continued regulatory review from the FDA and other applicable regulatory agencies, including continued adverse event reporting requirements and expensive post-marketing requirements for clinical and non-clinical studies. Regulatory review of filings seeking approval for additional patient populations, and the required post-marketing clinical and non-clinical studies may result in negative changes to XTANDI’s product labeling that may limit our ability to commercialize XTANDI in the United States or potentially other jurisdictions.

We and the manufacturers of XTANDI are also required to comply with current good manufacturing practices, or cGMP, regulations which include requirements relating to quality control and quality assurance as well as the corresponding maintenance of records and documentation. In addition, regulatory agencies subject an approved product, its manufacturer and the manufacturer’s facilities to continual review and inspections. The subsequent discovery of previously unknown problems with XTANDI, or problems with the facilities where XTANDI is manufactured, may result in restrictions on the marketing of XTANDI, up to and including

 

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withdrawal of XTANDI from the market. If our manufacturing facilities or those of our suppliers fail to comply with applicable regulatory requirements, such noncompliance could result in regulatory action and additional costs to us. Failure to comply with applicable FDA and other regulatory requirements may subject us to administrative or judicially imposed sanctions, including:

 

•

issuance of Form 483 notices or Warning Letters by the FDA or other regulatory agencies;

 

•

imposition of fines and other civil penalties;

 

•

criminal prosecutions;

 

•

injunctions, suspensions or revocations of regulatory approvals;

 

•

suspension of any ongoing clinical trials;

 

•

total or partial suspension of manufacturing;

 

•

delays in commercialization;

 

•

refusal by the FDA to approve pending applications or supplements to approved applications filed by us or Astellas;

 

•

refusals to permit drugs to be imported into or exported from the United States;

 

•

restrictions on operations, including costly new manufacturing requirements; and

 

•

product recalls or seizures.

The policies of the FDA and other regulatory agencies may change and additional government regulations may be enacted that could prevent or delay regulatory approval of XTANDI in other indications or further restrict or regulate post-approval activities. We cannot predict the likelihood, nature or extent of adverse government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are not able to maintain regulatory compliance, we or Astellas might not be permitted to market XTANDI and our business would suffer.

Risks Related to Our Future Product Development Candidates

Our business strategy depends on our ability to identify and acquire additional product candidates which we may never acquire or identify for reasons that may not be in our control, or are otherwise unforeseen or unforeseeable to us.

A key component of our business strategy is to diversify our product development risk by identifying and acquiring new product opportunities for development. However, we may not be able to identify promising new technologies. In addition, the competition to acquire promising biomedical technologies is fierce, and many of our competitors are large, multinational pharmaceutical, biotechnology and medical device companies with considerably more financial, development and commercialization resources and experience than we have. Thus, even if we succeed in identifying promising technologies, we may not be able to acquire rights to them on acceptable terms or at all. If we are unable to identify and acquire new technologies, we will be unable to diversify our product risk. We believe that any such failure would have a significant negative impact on our prospects.

Because we depend on our management to oversee the execution of commercialization plans for XTANDI and continued development activities for enzalutamide, and to identify and acquire promising new product candidates, the loss of any of our executive officers could harm our business.

Our future success depends upon the continued services of our executive officers. We are particularly dependent on the continued services of David Hung, M.D., our president and chief executive officer and a member of our board of directors. Dr. Hung identified enzalutamide for acquisition and has primary responsibility for identifying and evaluating other potential product candidates. We believe that Dr. Hung’s services in this capacity would be difficult to replace. None of our executive officers is bound by an employment agreement for any specific term, and they may terminate their employment at any time. In addition, we do not have “key person” life insurance policies covering any of our executive officers. The loss of the services of any of our executive officers could delay the commercialization of XTANDI and continued development activities for enzalutamide and adversely affect or preclude the identification and acquisition of new product candidates, either of which events could harm our business.

Pharmaceutical product candidates require extensive, time-consuming and expensive preclinical and clinical testing to establish safety and efficacy, and regulatory approval. If we are unable to successfully develop and test our product candidates, we will not be successful.

The research and development of pharmaceuticals is an extremely risky industry. Only a small percentage of product candidates that enter the development process ever receive regulatory approval. The process of conducting the preclinical and clinical testing required to establish safety and efficacy and obtain regulatory approval is expensive and uncertain and takes many years. If we are unable to complete preclinical or clinical trials of current or future product candidates, due to safety concerns with a product

 

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candidate, or if the results of these trials are not satisfactory to convince regulatory authorities of their safety or efficacy, we will not be able to obtain regulatory approval for commercialization. We cannot be certain if any of our product candidates will be approved by regulatory authorities. Furthermore, even if we are able to obtain regulatory approvals for any of our product candidates, those approvals may be for indications that are not as broad as desired or may contain other limitations that would adversely affect our ability to generate revenue from sales of those products. If this occurs, our business would be materially harmed and our ability to generate revenue would be severely impaired.

Enrollment and retention of patients in clinical trials is an expensive and time-consuming process, could be made more difficult or rendered impossible by competing treatments or clinical trials of competing drugs in the same or other indications, and could result in significant delays, cost overruns, or both, in our product development activities, or in the failure of such activities.

We may encounter delays in enrolling, or be unable to enroll, a sufficient number of patients to complete any of our clinical trials, and even once enrolled we may be unable to retain a sufficient number of patients to complete any of our trials. Patient enrollment and retention in clinical trials depends on many factors, including the size of the patient population, the nature of the trial protocol, the existing body of safety and efficacy data with respect to the study drug, the number and nature of competing treatments and ongoing clinical trials of competing drugs for the same indication, the proximity of patients to clinical sites and the eligibility criteria for the study. Furthermore, any negative results we may report in clinical trials of enzalutamide or any potential future product candidates may make it difficult or impossible to recruit and retain patients in other clinical studies of that same product candidate. Delays or failures in planned patient enrollment and/or retention may result in increased costs, program delays or both, which could have a harmful effect on our ability to develop enzalutamide or any product candidates, or could render further development impossible.

Our reliance on third parties for the operation of our business may result in material delays, cost overruns and/or quality deficiencies in our development programs.

We rely on third party vendors to perform key product development tasks, such as conducting preclinical and clinical studies and manufacturing our product candidates at appropriate scale for preclinical and clinical trials and, in situations where we are unable to transfer those responsibilities to a corporate partner, for commercial use as well. To manage our business successfully, we will need to identify, engage and properly manage qualified third party vendors that will perform these development activities. For example, we need to monitor the activities of our vendors closely to ensure that they are performing their tasks correctly, on time, on budget and in compliance with strictly enforced regulatory standards. Our ability to identify and retain key vendors with the requisite knowledge is critical to our business and the failure to do so could negatively impact our business. Because all of our key vendors perform services for other clients in addition to us, we also need to ensure that they are appropriately prioritizing our projects. If we fail to manage our key vendors well, we could incur material delays, cost overruns or quality deficiencies in our development and commercialization programs, as well as other material disruptions to our business.

Risks Related to our License and Manufacturing and Supply Agreement with CureTech, Ltd.*

A negative vote of Clal Biotechnology Industries (“CBI”) shareholders on the guaranty may result in the termination of the License and Manufacturing and Supply Agreements with CureTech.*

In October 2014, we entered into an agreement with CureTech, Ltd., or CureTech, in which we have licensed exclusive worldwide rights to CureTech’s late-stage clinical molecule pidilizumab (CT-011), an immune modulatory anti-PD-1 monoclonal antibody. The arrangement with CureTech also includes a manufacturing and supply agreement, under which CureTech will manufacture and supply the antibody to us over the next three years for clinical development purposes. In addition, the arrangement contemplates a guaranty agreement between us and CureTech’s largest shareholder, Clal Biotechnology Industries Ltd. (CBI), with respect to certain obligations of CureTech. The guaranty is subject to approval by CBI shareholders. If approval for the guaranty is not obtained, we have the option to terminate both the license agreement and the manufacturing and supply agreement or proceed with such agreements on reduced economic terms. The shareholder vote on the guaranty and, thereafter, our decision to exercise our option to continue to maintain the license are expected in December 2014. If we do not maintain the license agreement, we will not be able to develop or potentially commercialize the CureTech technology to generate shareholder value.

The clinical molecule pidilizumab licensed from CureTech is a biologic molecule, and we do not have experience or expertise in the development, manufacture, or commercialization of biologic molecules.*

Under the license agreement, we will be responsible for all development, manufacturing, and commercialization activities for pidilizumab for all indications, including in oncology. While we have some experience developing and in certain aspects of the commercialization of small molecule products, we have no experience or expertise in the development, manufacturing and

 

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commercialization, including regulatory interactions, commercial manufacturing, and distribution of biologic molecules, like pidilizumab. Biologic molecules can involve processes and procedures often more complex than those for small molecule products. In general, biologic molecules are manufactured in a living system such as a microorganism, or plant or animal cells, are very large, complex molecules or mixtures of molecules, and often are produced using recombinant DNA technology. Also, biologic molecules are subject to different regulatory requirements and procedures worldwide. Our failure to successfully develop, manufacture, or commercialize pidilizumab could significantly impact our ability to generate value from the agreements with CureTech.

The development and commercialization of pidilizumab will face strong competition from other anti-PD-1 antibodies, which are being developed quickly and by larger companies with experience developing, manufacturing, and commercializing biologic molecules.*

The immune-oncology field is competitively crowded with biologics molecules, including anti-PD-1 antibodies like pidilizumab, in development for various tumor types and patient populations by larger more experienced companies than ours, such as Bristol Myers Squibb, Roche, and Merck, Inc. This competitive environment could compromise our ability to develop pidilizumab by limiting the availability of clinical trial investigators, sites, and/or appropriate clinical patients, which could slow, delay or limit the progress of pidilizumab’s development. In addition, if we are able to successfully develop pidilizumab and obtain regulatory approval for it in an oncology indication, it will be likely face competition from already approved anti-PD-1 molecules in the same or similar oncology indications. This could significantly limit our ability to generate revenue with pidilizumab.

Risks Related to the Pharmaceutical Industry, Including the Activities of Medivation, Inc.

Our industry is highly regulated by the FDA and comparable foreign regulatory agencies. We must comply with extensive, strictly enforced regulatory requirements to develop and obtain marketing approval for any of our product candidates.

Before we, Astellas or any potential future partners can obtain regulatory approval for the sale of our product candidates, our product candidates must be subjected to extensive preclinical and clinical testing to demonstrate their safety and efficacy for humans.

The preclinical and clinical trials of any product candidates that we develop must comply with regulation by numerous federal, state and local government authorities in the United States, principally the FDA, and by similar agencies in other countries. We are required to obtain and maintain an effective investigational new drug application to commence human clinical trials in the United States and must obtain and maintain additional regulatory approvals before proceeding to successive phases of our clinical trials. Securing FDA approval requires the submission of extensive preclinical and clinical data and supporting information for each therapeutic indication to establish the product candidate’s safety and efficacy for its intended use. It takes years to complete the testing of a new drug or medical device and development delays and/or failure can occur at any stage of testing. Any of our present and future clinical trials may be delayed, halted or approval of any of our products may be delayed or may not be obtained due to any of the following:

 

•

any preclinical test or clinical trial may fail to produce safety and efficacy results satisfactory to the FDA or foreign regulatory authorities;

 

•

preclinical and clinical data can be interpreted in different ways, which could delay, limit or prevent regulatory approval;

 

•

negative or inconclusive results from a preclinical test or clinical trial or adverse medical events during a clinical trial could cause a preclinical study or clinical trial to be repeated or a program to be terminated, even if other studies or trials relating to the program are ongoing or have been completed and were successful;

 

•

the FDA or foreign regulatory authorities can place a clinical hold on a trial if, among other reasons, it finds that patients enrolled in the trial are or would be exposed to an unreasonable and significant risk of illness or injury;

 

•

the facilities that we utilize, or the processes or facilities of our consultants, including without limitation the contract manufacturers who will be manufacturing drug substance and drug product for us or any potential collaborators, may not complete successful inspections by the FDA or foreign regulatory authorities; and

 

•

we may encounter delays or rejections based on changes in FDA policies or the policies of foreign regulatory authorities during the period in which we develop a product candidate or the period required for review of any final regulatory approval before we are able to market any product candidate.

In addition, information generated during the clinical trial process is susceptible to varying interpretations that could delay, limit, or prevent regulatory approval at any stage of the approval process. Moreover, early positive preclinical or clinical trial results may not be replicated in later clinical trials. Failure to demonstrate adequately the quality, safety and efficacy of any of our product candidates would delay or prevent regulatory approval of the applicable product candidate. There can be no assurance that if clinical trials are completed, either we or our collaborative partners will submit applications for required authorizations to manufacture or market potential products or that any such application will be reviewed and approved by appropriate regulatory authorities in a timely manner, if at all. Moreover, any regulatory approval we, Astellas or any potential future collaborators ultimately obtain may be limited or subject to restrictions or post-approval commitments that render the product not commercially viable.

 

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If XTANDI or any potential future product candidates cannot be manufactured in a cost-effective manner and in compliance with cGMP and other applicable regulatory standards, they will not be commercially successful.

All pharmaceutical and medical device products in the United States, Europe and other countries must be manufactured in strict compliance with cGMP and other applicable regulatory standards. Establishing a cGMP-compliant process to manufacture pharmaceutical products involves significant time, cost and uncertainty. Furthermore, to be commercially viable, any such process would have to yield product on a cost-effective basis, using raw materials that are commercially available on acceptable terms. We face the risk that our contract manufacturers may have interruptions in raw material supplies, be unable to comply with strictly enforced regulatory requirements, or, for other reasons beyond their or our control, be unable to complete their manufacturing responsibilities on time, on budget, or at all. This risk could adversely affect our commercial sales and delay our clinical trials. Under our Collaboration Agreement with Astellas, Astellas is responsible for all manufacture of XTANDI for commercial purposes, but we cannot guarantee that Astellas will be able to supply XTANDI in a timely manner or at all, or that continued commercial-scale cGMP manufacture of XTANDI using a validated manufacturing process will be possible on a cost-effective basis, which would materially and adversely affect the value of our XTANDI program.

We are subject to certain healthcare laws, regulation and enforcement that may impact the commercialization of XTANDI and our product candidates. Failure to comply with such laws, regulations and enforcement could subject us to significant fines and penalties and result in a material adverse effect on our results of operations and financial conditions.*

We are subject to several healthcare regulations and enforcement by the federal government and the states in which we conduct our business. These laws may impact our business activities, including, among other things, the sales, marketing and education programs for XTANDI or any of our potential future product candidates that may be approved for commercial sale:

 

•

the federal Health Insurance Portability and Accountability Act of 1996, (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) which governs the conduct of certain electronic healthcare transactions and protects the security and privacy of protected health information;

 

•

the federal healthcare programs’ Anti-Kickback Law, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;

 

•

federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent;

 

•

the Federal Food, Drug, and Cosmetic Act, which, among other things, strictly regulates drug product marketing, prohibits manufacturers from marketing drug products for off-label use, and regulates the distribution of drug samples;

 

•

federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; and

 

•

state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers.

Additionally, the compliance environment is changing, with more states, such as California, Massachusetts, Vermont, and Minnesota, mandating implementation of compliance programs, compliance with industry ethics codes, and implementation of gift bans and spending limits, and/or gifts, compensation, and other remuneration to healthcare professionals. Moreover, Section 6002 of PPACA included new requirements for pharmaceuticals manufacturers, among others, to report certain payments or “transfers of value” made or distributed to physicians and teaching hospitals, and to report any ownership and investment interests held by physicians and their immediate family members during the preceding calendar year. Section 6002 of PPACA includes in its reporting requirements a broad range of transfers of value, including, but not limited to consulting fees, charitable contributions, payments for research, and grants. The Centers for Medicare & Medicaid Services, or CMS, issued its final rule implementing Section 6002 of PPACA in February 2013, and required data collection commenced as of August 1, 2013. Manufacturers were required to report unaggregated data for August through December of 2013 to CMS by June 30, 2014. CMS released the data on a public website in September 2014. Failure to so report could subject companies to significant financial penalties. Several states currently have similar laws and more states may enact similar legislation. Reporting and public disclosure of these payments and transfers of value may make it more difficult to recruit physicians for assistance with activities that would be helpful to our business. Tracking and reporting the required payments and transfers of value may result in considerable expense and additional resources.

 

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If our operations are found to be in violation of any of the laws described above or any other healthcare laws that apply to us, we may be subject to penalties, including, but limited to, civil, criminal penalties, and administrative penalties, damages, fines, the curtailment or restructuring of our operations, and the exclusion from participation in federal and state healthcare programs and imprisonment, any of which could adversely affect our ability to operate our business and our financial results.

If any promotional activities that we undertake fail to comply with the regulations and guidelines of the FDA and applicable foreign regulatory agencies, we may be subject to warnings or enforcement actions that could harm our business.

Physicians may prescribe drugs for uses that are not described in the drug’s labeling or for uses that differ from those tested in clinical studies and approved by the FDA or foreign regulatory authorities. Regulatory authorities generally do not regulate the behavior of physicians in their choice of treatments. Regulatory authorities do, however, restrict communications on the subject of uses outside of the approved labeling, or “off-label” uses. Companies cannot actively promote approved drugs for off-label uses. If our promotional activities for XTANDI and any other potential future product candidate for which we may receive regulatory approval fail to comply with applicable regulations or guidelines, we may be subject to warnings from, or enforcement by, these authorities, including potentially civil and criminal penalties.

We could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act and other worldwide anti-bribery laws.

We are subject to the U.S. Foreign Corrupt Practices Act, or FCPA, which generally prohibits companies and their intermediaries from making payments to non-U.S. government officials for purpose of obtaining or retaining business or securing any other improper advantage. We are also subject to similar anti-bribery laws in the jurisdictions in which we operate. Failure to comply with the FCPA or related laws governing the conduct of business with foreign government entities could disrupt our business and lead to severe criminal and civil penalties, including criminal and civil fines, denial of government reimbursement for our products and exclusion from participation in government healthcare programs. Other remedial measures could include further changes or enhancements to our procedures, policies, and controls and potential personnel changes and/or disciplinary actions, any of which could have a material adverse impact on our business, financial condition, results of operations and liquidity. We could also be affected by any allegation that we violated such laws.

We may be subject to product liability or other litigation, which could harm our ability to efficiently and effectively conduct our business, and, if successful, could materially and adversely harm our business and financial condition as a result of the costs of liabilities that may be imposed thereby.*

Our business exposes us to the risk of product liability claims that is inherent in the development, manufacturing, distribution and sale of pharmaceutical products. If XTANDI or any potential future product candidate harms people, or is alleged to be harmful, we may be subject to costly and damaging product liability claims brought against us by clinical trial participants, consumers, health care providers, corporate partners or others. We have product liability insurance covering commercial sales of XTANDI and our ongoing clinical trials. However, the amount of insurance we maintain may not be adequate to cover all liabilities that we may incur. If we are unable to obtain insurance at an acceptable cost or otherwise protect against potential product liability claims, we may be exposed to significant litigation costs and liabilities, which may materially and adversely affect our business and financial position. If we are sued for injuries allegedly caused by XTANDI or any of our current or future product candidates, our litigation costs and liability could exceed our total assets and our ability to pay. Regardless of merit or eventual outcome, liability claims may result in:

 

•

decreased demand for XTANDI and any potential future product candidate that we may develop;

 

•

injury to our reputation;

 

•

withdrawal of clinical trial participants;

 

•

significant costs to defend the related litigation;

 

•

substantial monetary awards to trial participants or patients;

 

•

loss of revenue; and

 

•

the inability to commercialize any other products that we may develop.

In addition, we may from time to time become involved in various lawsuits and legal proceedings which arise in the ordinary course of our business, such as our litigation with the Regents of the University of California. On April 11, 2014, The Regents of the University of California, or UCLA, filed a complaint against us and one of our subsidiaries in the Superior Court of the State of California, County of San Francisco. The complaint arises from the parties’ 2005 Exclusive License Agreement, or ELA, which grants our subsidiary rights in certain UCLA patents, including the UCLA patents covering XTANDI. The complaint centers on two allegations. The first allegation is that we and our subsidiary have failed to pay UCLA ten percent of “Operating Profits” we received (and will continue to receive) from Astellas Pharma, Inc. as a result of the 2009 Collaboration Agreement between us and Astellas.

 

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UCLA alleges that such Operating Profits are “Sublicensing Income” under the ELA and that UCLA is entitled to ten percent of such payments. The second allegation is that we breached our fiduciary duties to UCLA, as a minority shareholder of our subsidiary. UCLA owns a fraction of one percent of the outstanding shares of our subsidiary. The complaint seeks a declaration and judgment for breach of contract related to the allegation that “Operating Profits” payments received from Astellas are “Sublicensing Income” under the ELA, a judgment that we have breached our fiduciary duties and an injunction requiring us to comply with our fiduciary duties. At the time of this filing, UCLA’s second allegation that we breached our fiduciary duties to UCLA, as a minority shareholder of MPT, had been dismissed without prejudice. Although the UCLA complaint does not seek termination of the ELA, if we are not successful in this litigation we may be required to pay UCLA ten percent of the “Operating Profits” and be subject to other liabilities, any of which could have a material adverse effect on our financial condition and results of operations. See Part II, Item 1, “Legal Proceedings” for additional information on this litigation. Any litigation to which we are subject could require significant involvement of our senior management and may divert management’s attention from our business and operations. Litigation costs or an adverse result in any litigation that may arise from time to time may adversely impact our operating results or financial condition.

We may be subject to damages or injunctions resulting from qui tam or “whistleblower” actions that individuals may bring against us.

Although we have developed, implemented, and continue to improve a program for compliance with all federal and state laws, we cannot guarantee that our compliance program will be sufficient or effective, that our employees will comply with our policies, that our employees will notify us of any violation of our policies, that we will have the ability to take appropriate and timely corrective action in response to any such violation, or that we will make decisions and take actions that will necessarily limit or avoid liability for qui tam or “whistleblower” claims that individuals, such as employees or former employees, may bring against us or that governmental authorities may prosecute against us based on information provided by individuals. Qui tam or “whistleblower” claims against a defendant are brought by individuals or governmental authorities based on information from individuals have increased substantially in recent years. In any qui tam or “whistleblower” action that results in the payment of a fine imposed by a court or a settlement, the individual who brought the claim or furnished information allowing the governmental authority to prosecute the claim is rewarded with a percentage of the fine or settlement amount collected from the defendant. The prospect of sharing in the proceeds of any fine collected from the defendant motivates individuals to bring qui tam or “whistleblower” claims or to furnish information to a governmental authority for the prosecution of such claims. In addition, the enactment of new federal and state laws, the amendment of existing federal and state laws, and the interpretation of existing or future laws by court decision could further expand the grounds on which individuals may pursue qui tam or “whistleblower” claims. If one or more of individuals bring a qui tam or “whistleblower” claim against us or if a governmental authority prosecutes a claim against us on the basis of information provided by one or more individuals, and if we are found liable and a fine and/or an injunction is imposed on us or we agree to pay a fine and/or accept an injunction in settlement of the claim, the payment of the fine and/or the curtailment of our activities consequent to the injunction could have a material adverse effect on our financial condition and impair or prevent us from continuing our business. In addition, the costs and fees associated with defending a qui tam or “whistleblower” claim would be significant.

Risks Related to the Operation of our Business

We have a history of net losses and we may incur substantial losses in the foreseeable future as we continue our development and commercialization activities and may never achieve, maintain, or increase profitability on a quarterly or annual basis.*

We have incurred significant losses since our inception and as of September 30, 2014, we have an accumulated deficit of $221.9 million. We have incurred these losses principally from costs incurred in funding our research and development activities, from general and administrative expenses and from our XTANDI commercialization activities. We may incur substantial costs in the future as we continue to finance the commercialization of XTANDI in the U.S. market, clinical and preclinical studies of enzalutamide and our research and drug discovery projects, potential business development activities, and our corporate overhead costs, which could impact our ability to achieve, maintain, or increase profitability on a quarterly or annual basis. Our ability to generate revenue to achieve, maintain, or increase profitability on a quarterly or annual basis is dependent on our ability, alone or with collaboration partners, to successfully commercialize products for which we have received marketing approval.

Our significant level of indebtedness and lease obligations could adversely affect our financial condition. In addition, we may not have sufficient funds to service our indebtedness and lease obligations when payments are due.

At September 30, 2014, we had outstanding $258.7 million of the Convertible Notes, and approximately $67.0 million of minimum lease commitments. We may also incur additional indebtedness to meet future financing needs, including in connection with any licensing or acquisition transactions that we may elect to assume to diversify our product risk. Our substantial indebtedness could have significant effects on our business, results of operations and financial condition. For example, it could:

 

•

make it more difficult for us to satisfy our financial obligations, including with respect to the Convertible Notes and leases;

 

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•

increase our vulnerability to general adverse economic, industry and competitive conditions;

 

•

reduce the availability of our cash resources to fund our operations because we will be required to dedicate a substantial portion of our cash resources to the payment of principal and interest on our indebtedness and lease payments;

 

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limit our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate;

 

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prevent us from raising funds necessary to repurchase the Convertible Notes following a fundamental change, which includes a non-stock takeover of our company and certain other merger and business combination transactions;

 

•

place us at a competitive disadvantage compared to our competitors that are less highly leveraged and that, therefore, may be able to take advantage of opportunities that our leverage prevents us from exploring; and

 

•

limit our ability to obtain additional financing.

Each of these factors may have a material and adverse effect on our financial condition and viability.

We have funded our operations primarily through public offerings of our common stock, proceeds from the issuance of the Convertible Notes, from upfront, milestone and cost-sharing payments received under agreements with current and former collaboration partners, and subsequent to September 13, 2012, from collaboration revenue related to XTANDI sales. At September 30, 2014, we had cash and cash equivalents totaling $321.1 million available to fund our operations. We expect to continue to spend substantial amounts of capital for our operations in the future. Our ability to generate a sufficient amount of profit and positive cash flows from sales of XTANDI could impact our ability to make payments on the Convertible Notes and our leases when they become due and to satisfy our other cash requirements and will depend on our existing cash resources and future financing activity, if any.

We may need additional funds to support our operations, and such funding may not be available to us on acceptable terms, or at all, which would force us to delay, scale back or eliminate some or all of our development programs and other operations, restructure or refinance our indebtedness, or any combination of the foregoing. Raising additional capital may subject us to unfavorable terms, cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our product candidates and technologies.*

We have a history of net losses and we may incur additional losses in the future. Our future capital requirements will depend on many factors, including without limitation:

 

•

costs associated with commercialization of XTANDI for mCRPC, including post-chemotherapy mCRPC patients and mCRPC patients who have not received chemotherapy in the United States;

 

•

the timing and magnitude of sales of XTANDI for post-chemotherapy mCRPC patients globally and mCRPC patients who have not received chemotherapy in the United States and Japan;

 

•

whether any changes are made to the scope of our ongoing clinical development activities;

 

•

the scope and results of our and our collaboration partner’s preclinical programs and clinical studies;

 

•

whether we experience delays in our preclinical and clinical development programs;

 

•

whether opportunities to acquire additional product candidates arise and the timing and costs of acquiring and developing those product candidates;

 

•

whether we are able to enter into additional third-party collaborative partnerships to develop and/or commercialize potential future product candidates on terms, including development and commercialization cost share terms, that are acceptable to us;

 

•

the timing and requirements of, and the costs involved in, conducting studies required to obtain regulatory approvals for XTANDI or potential future product candidates from the FDA and comparable foreign regulatory agencies;

 

•

the availability of third parties to perform the key development tasks for XTANDI and potential future product candidates, including conducting preclinical and clinical studies and manufacturing our product candidates to be tested in those studies, and the associated costs of those services;

 

•

expenses associated with, and the outcome of, ongoing litigation;

 

•

the costs involved in preparing, filing, prosecuting, maintaining, defending the validity of and enforcing patent claims and other costs related to patent rights and other intellectual property rights, including litigation costs and the results of such litigation; and

 

•

interest payments and potential cash settlement of the Convertible Notes and lease payments.

 

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Based on our current expectations, we believe our capital resources at September 30, 2014, combined with our anticipated future cash flows, will be sufficient to fund our currently planned operations for at least the next 12 months. This estimate is based on a number of assumptions that may prove to be wrong, including assumptions regarding net sales of XTANDI, potential XTANDI approvals in new markets and for other indications, and potential receipt of profit sharing, royalty, and milestone payments under our Astellas Collaboration Agreement, and we could exhaust our available cash and cash equivalents earlier than presently anticipated. For example, we may be required or choose to seek additional capital to fund the costs of commercialization of XTANDI in the United States, to expand our preclinical and clinical development activities for XTANDI and other existing or potential future product candidates, or to license additional product, product candidates or companies, if we face challenges or delays in connection with our clinical trials, to maintain minimum cash balances that we deem reasonable and prudent, or in the event a fundamental change occurs under the terms of the Convertible Notes, which would give the holders of the Convertible Notes the right to require us to purchase their Convertible Notes in cash or if we elect to redeem all or part of the Convertible Notes for cash if they meet the technical requirements of redemption beginning April 6, 2015. Our ability to raise additional funds on acceptable terms will be dependent on the climate of worldwide capital markets, which could be challenging.

Our failure to raise capital when needed may harm our business and operating results. If we are unable to raise additional funds when needed, we could be required to delay, scale back or eliminate some or all of our development programs and other operations, restructure or refinance our indebtedness, or any combination of the foregoing. We may seek to raise additional funds through public or private financing or other arrangements. We cannot assure you that any of these actions could be effected on satisfactory terms, if at all, or that they would yield sufficient funds to make required payments on the Convertible Notes or to fund our other liquidity needs. We cannot assure you that our business will have access to sufficient cash resources to enable us to pay our indebtedness, including the Convertible Notes, or to fund our other liquidity needs.

The proposed changes to financial accounting standards, if adopted, could require our operating leases to be recognized on our consolidated balance sheet.

In addition to our significant level of indebtedness, we have significant obligations relating to our leases. At September 30, 2014, we had minimum lease commitments of approximately $67.0 million. Leases that are classified as operating leases are disclosed in the footnotes to our consolidated financial statements, but are not reflected as liabilities on our consolidated balance sheets.

The Financial Accounting Standards Board, or FASB, and the International Accounting Standards Board, or IASB, have been in deliberation on their conveyed lease project regarding proposed changes to financial accounting standards for leases. Currently, Accounting Standards Codification, or ASC, 840, Leases, requires that operating leases are classified as off-balance sheet transactions and only operating lease expense is included in the consolidated statements of operations. The proposed changes to lease accounting could potentially require recognition of our operating leases as assets and liabilities on our consolidated balance sheets. The right to use the leased property would be capitalized as an asset and the present value of future lease payments would be accounted for as a liability. A retroactive adoption may be required when the changes become effective. We have not quantified the impact of this proposed standard on our consolidated financial statements. If our operating leases are recognized on our consolidated financial statements, it could likely result in a significant increase in the liabilities reflected on our consolidated balance sheets and an increase in the interest expense and depreciation and amortization expense reflected in our consolidated statements of operations.

We may have additional tax liabilities.*

We are subject to income taxes in various jurisdictions. Significant judgment is required in determining our provision for income taxes and other tax liabilities. Our effective income tax rate in the future is subject to volatility and could be adversely affected by a number of factors, including: interpretations of existing tax laws; changes in tax laws and rates; future levels of research and development expenditures; changes in the mix of earnings in countries with differing statutory tax rates in which we may conduct business, changes in the valuation of deferred tax assets and liabilities; state income taxes; the tax impact of stock-based compensation; changes in estimates of prior years’ items; tax costs for acquisition-related items; changes in accounting standards; and overall levels of income before taxes. The impact of our income tax provision resulting from these items may be significant and could have a negative impact on our net income.

We are also subject to non-income based taxes, such as payroll, sales, use, net worth, property, and goods and services taxes in the United States. We may have additional exposure to non-income based tax liabilities.

We are regularly subject to audits by tax authorities in the jurisdictions in which we conduct business. Although we believe our tax positions are reasonable, the final outcome of tax audits and related litigation could be materially different than that reflected in our historical income tax provisions and accruals, and we could be subject to assessments of additional taxes and/or substantial fines or penalties. The resolution of any audits or litigation could have an adverse effect on our financial position and results of operations.

We and our subsidiaries are engaged in a number of intercompany transactions. Although we believe that these transactions reflect arm’s length terms and that proper transfer pricing documentation is in place, which should be respected for tax purposes, the transfer prices and terms and conditions of such transactions may be scrutinized by tax authorities, which could result in additional tax and/or penalties becoming due.

 

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Intellectual property protection for our product candidates is crucial to our business, and is subject to a significant degree of legal risk, particularly in the life sciences industry.*

The success of our business will depend in part on our ability to maintain and obtain intellectual property protection, primarily patent protection for the XTANDI product and any potential future product candidates, as well as successfully asserting and defending these patents against third-party challenges. We and our collaborators will only be able to protect the XTANDI product and our potential future product candidates from unauthorized commercialization by third parties to the extent that valid and enforceable patents or trade secrets cover them. Furthermore, future protection of our proprietary rights is uncertain because legal means may afford only limited protection and may not adequately protect our rights or permit us or our potential future collaborators to gain or keep our competitive advantage.

The patent positions of life sciences companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. Further, changes in either the patent laws or in interpretations of patent laws in the United States or other countries may diminish the value of our intellectual property rights. Accordingly, we cannot predict the breadth of claims that may be granted or enforced for our patents or for third-party patents that we have licensed. For example:

 

•

we or our licensors might not have been the first to make the inventions covered by each of our pending patent applications and issued patents;

 

•

we or our licensors might not have been the first to file patent applications for these inventions;

 

•

others may independently develop similar or alternative technologies or duplicate any of our technologies;

 

•

it is possible that none of our pending patent applications or the pending patent applications of our licensors will result in issued patents;

 

•

our issued patents and future issued patents, or those of our licensors, may not provide a basis for protecting commercially viable products, may not provide us with any competitive advantages, or may be challenged by third parties and invalidated or rendered unenforceable; and

 

•

we may not develop additional proprietary technologies or product candidates that are patentable.

Further, even if we can obtain protection for and defend the intellectual property position of the XTANDI product or any potential future product candidates, we or any of our potential future collaborators still may not be able to exclude competitors from developing or marketing competing drugs. Should this occur, we and our potential future collaborators may not generate any revenues or profits from the XTANDI product or any potential future product candidates or our revenue or profits would be significantly decreased.

We could become subject to litigation or other challenges regarding intellectual property rights, which could divert management attention, cause us to incur significant costs, prevent us from selling or using the challenged technology and/or subject us to competition by lower priced generic products.

Generic and other pharmaceutical manufacturers are and have been very aggressive in challenging the validity of patents held by proprietary pharmaceutical companies, especially if these patents are commercially significant. We are facing a patent opposition in Europe and two pre-grant oppositions in India, and we may face additional challenges to our existing or future patents covering the XTANDI product or any potential future product candidates. If a generic pharmaceutical company or other third party were able to successfully invalidate any of our present or future patents, the XTANDI product and any potential future product candidates that may ultimately receive marketing approval could face additional competition from lower-priced generic products that would result in significant price and revenue erosion and have a significantly negative impact on the commercial viability of the affected product candidate(s).

In the future, we may be a party to litigation to protect our intellectual property or to defend our activities in response to alleged infringement of a third party’s intellectual property. These claims and any resulting lawsuit, if successful, could subject us to significant liability for damages and invalidation, or a narrowing of the scope, of our proprietary rights. These lawsuits, regardless of their success, would likely be time-consuming and expensive to litigate and resolve and would divert management time and attention. Any potential intellectual property litigation also could force us or our licensees to do one or more of the following:

 

•

discontinue our products that use or are covered by the challenged intellectual property; or

 

•

obtain from the owner of the allegedly infringed intellectual property right a license to sell or use the relevant technology, which license may not be available on reasonable terms, or at all.

 

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If we or our licensees are forced to take any of these actions, our business may be seriously harmed. Although we carry general liability insurance, our insurance does not cover potential claims of this type.

In addition, our patents and patent applications, or those of our licensors, could face other challenges, such as interference proceedings, opposition proceedings, re-examination proceedings, inter parties review, post-grant review, derivation proceedings and pre-grant submissions. Any such challenge, if successful, could result in the invalidation of, or in a narrowing of the scope of, any of our patents and patent applications subject to the challenge. Any such challenges, regardless of their success, would likely be time-consuming and expensive to defend and resolve and would divert our management’s time and attention.

We may in the future initiate claims or litigation against third parties for infringement to protect our proprietary rights or to determine the scope and validity of our proprietary rights or the proprietary rights of competitors. These claims could result in costly litigation and the diversion of our technical and management personnel and we may not prevail in making these claims.

We rely on license agreements for certain aspects of our product candidates and our technology, and failure to meet our obligations under those agreements could severely negatively impact our business, and ability to generate revenue.

We have entered into agreements with third-party commercial and academic institutions to license intellectual property rights and technology. For example, we have a license agreement with UCLA pursuant to which we were granted exclusive worldwide rights to certain UCLA patents related to XTANDI and a family of related compounds. Some of these license agreements, including our license agreement with UCLA, contain diligence and milestone-based termination provisions, in which case our failure to meet any agreed upon diligence requirements or milestones may allow the licensor to terminate the agreement. If our licensors terminate our license agreements or if we are unable to maintain the exclusivity of our exclusive license agreements, we may be unable to continue to develop and commercialize XTANDI or any potential future product candidates based on licensed intellectual property rights and technology.

In the future, we may need to obtain additional licenses of third-party technology that may not be available to us or are available only on commercially unreasonable terms, and which may cause us to operate our business in a more costly or otherwise adverse manner that was not anticipated.

From time to time we may be required to license technology from additional third parties to further develop XTANDI and any future product candidates. Should we be required to obtain licenses to any third-party technology, including any such patents based on biological activities or required to manufacture our product candidates, such licenses may not be available to us on commercially reasonable terms, or at all. The inability to obtain any third-party license required to develop any of our product candidates could cause us to abandon any related development efforts, which could seriously harm our business and operations.

We may become involved in disputes with Astellas or any potential future collaborators over intellectual property ownership, and publications by our research collaborators and scientific advisors could impair our ability to obtain patent protection or protect our proprietary information, which, in either case, could have a significant impact on our business.

Inventions discovered under research, material transfer or other such collaboration agreements, including the Astellas Collaboration Agreement, may become jointly owned by us and the other party to such agreements in some cases and the exclusive property of either party in other cases. Under some circumstances, it may be difficult to determine who owns a particular invention, or whether it is jointly owned, and disputes could arise regarding ownership of those inventions. These disputes could be costly and time consuming and an unfavorable outcome could have a significant adverse effect on our business if we were not able to protect or license rights to these inventions. In addition, our research collaborators and scientific advisors generally have contractual rights to publish our data and other proprietary information, subject to our prior review. Publications by our research collaborators and scientific advisors containing such information, either with our permission or in contravention of the terms of their agreements with us, may impair our ability to obtain patent protection or protect our proprietary information, which could significantly harm our business.

Trade secrets may not provide adequate protection for our business and technology.

We also rely on trade secrets to protect our technology, especially where we believe patent protection is not appropriate or obtainable. However, trade secrets are difficult to protect. While we use reasonable efforts to protect our trade secrets, our or any potential collaborators’ employees, consultants, contractors or scientific and other advisors may unintentionally or willfully disclose our information to competitors. If we were to enforce a claim that a third party had illegally obtained and was using our trade secrets, our enforcement efforts would be expensive and time consuming, and the outcome would be unpredictable. In addition, courts outside the United States are sometimes less willing to protect trade secrets. Moreover, if our competitors independently develop equivalent knowledge, methods or know-how, it will be more difficult or impossible for us to enforce our rights and our business could be harmed.

 

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Significant disruptions of information technology systems or breaches of data security could adversely affect our business.

Our business is increasingly dependent on critical, complex and interdependent information technology systems to support business processes as well as internal and external communications. The size and complexity of our computer systems make them vulnerable to breakdown, malicious intrusion and computer viruses. We have experienced at least one successful intrusion into our computer systems, and although it did not have a material adverse effect on our operations, there can be no assurance of a similar result in the future. We have developed systems and processes that are designed to protect our information and prevent data loss and other security breaches, including systems and processes designed to reduce the impact of a security breach; however, such measures cannot provide absolute security, and we have taken and are continually taking additional security measures to protect against any future intrusion, including employee training. Any failure to protect against breakdowns, malicious intrusions and computer viruses may result in the impairment of production and key business processes. In addition, our systems are potentially vulnerable to data security breaches, whether by employees or others, which may expose sensitive data to unauthorized persons. Such data security breaches could lead to the loss of trade secrets or other intellectual property, or could lead to the public exposure of personal information of our employees, clinical trial patients, customers, and others. Such disruptions and breaches of security could expose us to liability and have a material adverse effect on the operating results and financial condition of our business.

Risks Related to Ownership of Our Common Stock and Convertible Notes

Our operating results are unpredictable and may fluctuate. If our operating results are below the expectations of securities analysts or investors, the market value of our common stock and the trading price of the Convertible Notes could decline.

Our operating results are difficult to predict and will likely fluctuate from quarter to quarter and year to year. Due to the competitive market for mCRPC therapies, XTANDI sales will be difficult to predict from period to period. As a result, you should not rely on XTANDI sales results in any period as being indicative of future performance and sales of XTANDI may be below the expectation of securities analysts or investors in the future. Additionally, you should not place undue reliance on the forward looking statements about expectations for future XTANDI sales from our partner Astellas, as we may not agree with such statements, or from us, as XTANDI sales results are difficult to predict. We believe that our quarterly and annual results of operations may be affected by a variety of factors, including:

 

•

the level of demand for XTANDI;

 

•

the extent to which coverage and reimbursement for XTANDI is available from government and health administration authorities, private health insurers, managed care programs and other third-party payors;

 

•

the timing, cost and level of investment in our and Astellas’ sales and marketing efforts to support XTANDI sales;

 

•

the timing, cost and level of investment in our research and development activities involving XTANDI and our product candidates;

 

•

the cost of manufacturing XTANDI, and the amount of legally mandated discounts to government entities, other discounts and rebates, product returns and other gross-to-net deductions;

 

•

the risk/benefit profile, cost and reimbursement of existing and potential future drugs which compete with XTANDI;

 

•

the timeliness and accuracy of financial information we receive from Astellas regarding XTANDI net sales globally, and shared U.S. development and commercialization costs for XTANDI incurred by Astellas, including the accuracy of the estimates Astellas uses in calculating any such financial information including for gross to net revenue adjustments; and

 

•

expenditures that we will or may incur to acquire or develop additional technologies, product candidates and products.

In addition, our revenues will also depend on the achievement of development and sales milestones that trigger milestone payments under our existing collaboration with Astellas, as well as any upfront and milestone payments under potential future collaboration and license agreements. These upfront and milestone payments may vary significantly from quarter to quarter and any such variance could cause a significant fluctuation in our operating results from one quarter to the next. Further, we measure compensation cost for stock-based awards made to employees at the grant date of the award, based on the fair value of the award, and recognize the cost as an expense over the employee’s requisite service period. As the variables that we use as a basis for valuing these awards change over time, including our underlying stock price and stock price volatility, the magnitude of the expense that we must recognize may vary significantly.

For these and other reasons, it is difficult for us to accurately forecast future profits or losses. As a result, it is possible that in some quarters our operating results could be below the expectations of securities analysts or investors.

 

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Sales fluctuations of XTANDI as a result of inventory levels at pharmaceutical wholesalers and distributors may cause our revenue to fluctuate, which could adversely affect our financial results, the market value of our common stock and the trading price of our Convertible Notes.

The pharmaceutical wholesalers and distributors with whom Astellas has entered into inventory management agreements make estimates to determine end user demand and may not be completely effective in matching their inventory levels to actual end user demand. As a result, changes in inventory levels held by those wholesalers and distributors can cause our operating results to fluctuate unexpectedly if sales of XTANDI to these wholesalers do not match end user demand. Adverse changes in economic conditions or other factors may cause wholesalers and distributors to reduce their inventories of XTANDI. As inventory of XTANDI in the distribution channel fluctuates from quarter to quarter, we may see fluctuations in collaboration revenue from XTANDI sales.

If our operating results are below the expectations of securities analysts, our stock price may decline.

Various securities analysts follow our financial results and issue reports on us. These reports include information about our historical financial results as well as the analysts’ estimates of our future performance. The analysts’ estimates are based upon their own opinions and are often different from our estimates or expectations. If our operating results are below the expectations of securities analysts, the market value of our common stock and the trading price of the Convertible Notes could decline, perhaps substantially.

Our stock price has been and may continue to be volatile, and our stockholders’ investment in our stock could decline in value.

The market prices for our securities and those of other life sciences companies have been highly volatile and often unrelated or disproportionate to the operating performance of those companies, and may continue to be highly volatile in the future. There has been particular volatility in the market prices of securities of life sciences companies because of problems or successes in a given market segment or because investor interest has shifted to other segments. These broad market and industry factors may cause the market price of our common stock to decline, regardless of our operating performance. We have no control over this volatility and can only focus our efforts on our own operations, and even these may be affected due to the state of the capital markets.

In the past, following periods of large price declines in the public market price of a company’s securities, securities class action litigation has often been initiated against that company. New litigation of this type could result in substantial costs and diversion of management’s attention and resources, which would hurt our business. Any adverse determination in litigation could also subject us to significant liabilities.

The following factors, in addition to other risk factors described herein, may have a significant impact on the market price of our common stock:

 

•

our ability to meet the expectations of investors related to the commercialization of XTANDI;

 

•

inaccurate sales forecasting of XTANDI;

 

•

the timing and amount of revenues generated from sales of XTANDI;

 

•

actual or anticipated variations in quarterly operating results;

 

•

legislation or regulatory actions or decisions affecting XTANDI or product candidates, including those of our competitors;

 

•

changes in laws or regulations applicable to XTANDI;

 

•

the receipt or failure to receive the additional funding necessary to conduct our business;

 

•

the progress and results of preclinical studies and clinical trials of our product candidates conducted by us, Astellas or any future collaborative partners or licensees, if any, and any delays in enrolling a sufficient number of patients to complete clinical trials of our product candidates;

 

•

the announcement by our competitors of results from clinical trials of their products or product candidates;

 

•

selling by existing stockholders and short-sellers;

 

•

announcements of technological innovations or new commercial products by our competitors or us;

 

•

developments concerning proprietary rights, including patents;

 

•

developments concerning our collaboration with Astellas or any future collaborations;

 

•

publicity regarding us, our product candidates or those of our competitors, including research reports published by securities analysts;

 

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•

regulatory developments in the United States and foreign countries;

 

•

litigation;

 

•

hedging or arbitrage trading activity involving our common stock, including in connection with arbitrage strategies employed or that may be employed by investors in the Convertible Notes;

 

•

economic and other external factors or other disaster or crisis; and

 

•

period-to-period fluctuations in financial results.

These factors and fluctuations, as well as political and other market conditions, may adversely affect the market price of our common stock. Securities-related class action litigation is often brought against a company following periods of volatility in the market price of its securities. Securities-related litigation, whether with or without merit, could result in substantial costs and divert management’s attention and financial resources, which could harm our business and financial condition, as well as the market price of our common stock. Additionally, volatility or lack of positive performance in our stock price may adversely affect our ability to retain or recruit key employees, all of whom have been or will be granted stock options as a part of their compensation.

A decrease in the market price of our common stock would also likely adversely impact the trading price of the Convertible Notes. The market price of our common stock could also be affected by possible sales of our common stock by investors who view the Convertible Notes as a more attractive means of equity participation in us and by hedging or arbitrage trading activity that we expect to develop involving our common stock. This trading activity could, in turn, affect the trading prices of the notes. This may result in greater volatility in the trading price of the Convertible Notes than would be expected for non-convertible debt securities.

We rely on Astellas to timely deliver important financial information relating to net sales of XTANDI. In the event that this information is inaccurate, incomplete, or not timely, we will not be able to meet our financial reporting obligations as required by the SEC.

Under the Astellas Collaboration Agreement, Astellas has exclusive control over the flow of information relating to net sales of XTANDI that we are dependent upon to meet our SEC reporting obligations. Astellas is required under the Astellas Collaboration Agreement to provide us with timely and accurate financial data related to net sales of XTANDI so that we may meet our reporting requirements under federal securities laws. In the event that Astellas fails to provide us with timely and accurate information, we may incur significant liability with respect to federal securities laws, our internal controls and procedures under the Sarbanes-Oxley Act of 2002, or Sarbanes-Oxley, may be inadequate, and we may be required to restate our financial statements, any of which could adversely affect the market price of our common stock and Convertible Notes and subject us to securities litigation.

To the extent that we create any joint ventures or have any variable interest entities for which we are required to consolidate, we would need to rely on those entities to timely deliver important financial information to us. In the event that the financial information is inaccurate, incomplete, or not timely, we would not be able to meet our financial reporting obligations as required by the SEC.*

To the extent we create joint ventures or have any variable interest entities that we are required to consolidate and the financial statements of such entities are not prepared by us, we will not have direct control over their financial statement preparation. As a result, we will, for our financial reporting, depend on what these entities report to us, which could result in us adding monitoring and audit processes, which could increase the difficulty of implementing and maintaining adequate controls over our financial processes and reporting in the future. This may be particularly true when such entities do not have sophisticated financial accounting processes in place, or where we are entering into new relationships at a rapid pace, straining our integration capacity. Additionally, if we do not receive the information from the joint venture or variable interest entity on a timely basis, this could cause delays in our external reporting obligations as required by the SEC.

Failure to maintain effective internal control over financial reporting in accordance with Sarbanes-Oxley could have a material adverse effect on our stock price and the trading price of the Convertible Notes.

Section 404 of Sarbanes-Oxley and the related rules and regulations of the SEC require an annual management assessment of the effectiveness of our internal control over financial reporting and a report by our independent registered public accounting firm attesting to the effectiveness of our internal control over financial reporting at the end of the fiscal year. If we fail to maintain the adequacy of our internal control over financial reporting, as such standards are modified, supplemented or amended from time to time, we may not be able to ensure that we can conclude on an ongoing basis that we have effective control over financial reporting in accordance with Sarbanes-Oxley and the related rules and regulations of the SEC. If we cannot in the future favorably assess, or our independent registered public accounting firm is unable to provide an unqualified attestation report on, the effectiveness of our internal control over financial reporting, investor confidence in the reliability of our financial reports may be adversely affected, which could have a material adverse effect on our stock price and the trading price of our outstanding Convertible Notes.

 

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We do not intend to pay dividends on our common stock for the foreseeable future.

We do not expect for the foreseeable future to pay dividends on our common stock. Any future determination to pay dividends on or repurchase shares of our common stock will be at the discretion of our board of directors and will depend upon, among other factors, our success in completing sales or partnerships of our programs, our results of operations, financial condition, capital requirements, contractual restrictions and applicable law.

Provisions of our charter documents, our stockholder rights plan and Delaware law could make it more difficult for a third party to acquire us, even if the offer may be considered beneficial by our stockholders.

Provisions of the Delaware General Corporation Law could discourage potential acquisition proposals and could delay, deter or prevent a change in control. The anti-takeover provisions of the Delaware General Corporation Law impose various impediments to the ability of a third party to acquire control of us, even if a change in control would be beneficial to our existing stockholders. Specifically, Section 203 of the Delaware General Corporation Law, unless its application has been waived, provides certain default anti-takeover protections in connection with transactions between us and an “interested stockholder.” Generally, Section 203 prohibits stockholders who, alone or together with their affiliates and associates, own more than 15% of the subject company from engaging in certain business combinations for a period of three years following the date that the stockholder became an interested stockholder of such subject company without approval of the board or the vote of two-thirds of the shares held by the independent stockholders. Our board of directors has also adopted a stockholder rights plan, or “poison pill,” which would significantly dilute the ownership of a hostile acquirer. Additionally, provisions of our amended and restated certificate of incorporation and bylaws could deter, delay or prevent a third party from acquiring us, even if doing so would benefit our stockholders, including without limitation, the authority of the board of directors to issue, without stockholder approval, preferred stock with such terms as the board of directors may determine.

We may issue additional shares of our common stock or instruments convertible into shares of our common stock, including additional shares associated with the potential conversion of the Convertible Notes, which could cause our stock price to fall and cause dilution to existing stockholders.

We may from time to time issue additional shares of common stock or other instruments convertible into, or exchangeable or exercisable for, shares of our common stock, including in connection with potential in-licensing and acquisition transactions entered into to diversify our product risk. In addition, we may elect to satisfy all or a portion of our conversion obligations under the Convertible Notes with shares of our common stock. The issuance of additional shares of our common stock, including upon conversion of some or all of the Convertible Notes, would dilute the ownership interests of existing holders of our common stock. Dilution will be greater if the conversion rate of the Convertible Notes is adjusted upon the occurrence of certain events specified in the indenture to the Convertible Notes.

The issuance of a substantial number of shares of our common stock, the sale of a substantial number of shares of our common stock that were previously restricted from sale in the public market, or the perception that these issuances or sales might occur, could depress the market price of our common stock and in turn adversely impact the trading price of the Convertible Notes. In addition, holders of the Convertible Notes may hedge their investment in the Convertible Notes by short selling our common stock, which could depress the price of our common stock. As a result, investors may not be able to sell their shares of our securities at a price equal to or above the price they paid to acquire them.

Furthermore, the issuance of additional shares of our common stock, or the perception that such issuances might occur, could impair our ability to raise capital through the sale of additional equity securities.

Provisions in the indenture for the Convertible Notes may deter or prevent a business combination.

Under the terms of the indenture governing the Convertible Notes, the occurrence of a fundamental change would require us to repurchase all or a portion of the Convertible Notes in cash, or, in some circumstances, increase the conversion rate applicable to the Convertible Notes. In addition, the indenture for the Convertible Notes prohibits us from engaging in certain mergers or business combination transactions unless, among other things, the surviving entity assumes our obligations under the Convertible Notes. These and other provisions could prevent or deter a third party from acquiring us even where the acquisition could be beneficial to our stockholders.

Any adverse rating of the Convertible Notes may negatively affect the price of our common stock.

We do not intend to seek a rating on the Convertible Notes. However, if a rating service were to rate the Convertible Notes and if such rating service were to assign the Convertible Notes a rating lower than the rating expected by investors or were to lower its rating on the Convertible Notes below the rating initially assigned to the Convertible Notes or otherwise announce its intention to put the Convertible Notes on credit watch, the price of our common stock could decline.

 

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The conditional conversion feature of the Convertible Notes may adversely affect our financial condition and operating results.*

Holders of the Convertible Notes are entitled to convert their notes at any time during specified periods at their option. If one or more holders elect to convert their Convertible Notes, unless we satisfy our conversion obligation by delivering solely shares of our common stock (other than cash in lieu of any fractional share), we would be required to settle all or a portion of our conversion obligation through the payment of cash, which could adversely affect our liquidity. We may, at any time prior to the final settlement method election date, irrevocably elect to satisfy our conversion obligation with respect to each subsequent conversion date in a combination of cash and shares of our common stock, if any, with a specified dollar amount of $1,000, in which case we will no longer be permitted to settle the principal portion of any converted Convertible Notes in shares of our common stock. In addition, even if holders do not elect to convert their Convertible Notes, we could be required under applicable accounting rules to reclassify all or a portion of the outstanding principal of the notes as a current rather than long-term liability, which would result in a material reduction of our net working capital.

The accounting method for convertible debt securities that may be settled in cash, such as the Convertible Notes, could have a material effect on our reported financial results.

Under ASC 470-20, Debt with Conversion and Other Options, or ASC 470-20, an entity must separately account for the liability and equity components of convertible debt instruments (such as the Convertible Notes) that may be settled entirely or partially in cash upon conversion in a manner that reflects the issuer’s economic interest cost. The effect of ASC 470-20 on the accounting for the Convertible Notes is that the equity component is required to be included in the additional paid-in capital section of stockholders’ equity on our consolidated balance sheet and the value of the equity component would be treated as original issue discount for purposes of accounting for the debt component of the Convertible Notes. As a result, we are required to record a greater amount of non-cash interest expense as a result of the amortization of the discounted carrying value of the Convertible Notes to their face amount over the term of the Convertible Notes. We report lower net income in our financial results because ASC 470-20 requires interest to include both the current period’s amortization of the debt discount and the instrument’s coupon interest, which could adversely affect our reported or future financial results, the market price of our common stock and the trading price of the Convertible Notes.

The repurchase rights and events of default features of the Convertible Notes, if triggered, may adversely affect our financial condition and operating results.

Following a fundamental change under the indenture governing the Convertible Notes, dated as of March 19, 2012 between us and Wells Fargo Bank, National Association as Trustee, as supplemented by the first supplemental indenture dated as of March 19, 2012, or the Indenture, holders of the Convertible Notes will have the right to require us to purchase their Convertible Notes for cash. In addition, if an event of default under the Convertible Notes is triggered, the trustee or the holders of the Convertible Notes may declare the principal amount of the Convertible Notes, plus accrued and unpaid interest thereon, to be immediately due and payable. In either event, we would be required to make cash payments to satisfy our obligations, which could adversely affect our liquidity. In addition, even if the repurchase rights are not exercised or the payment of principal and interest of Convertible Notes is not accelerated, we could be required under applicable accounting rules to reclassify all or a portion of the outstanding principal of the Convertible Notes as a current rather than long-term liability, which could result in a material reduction of our net working capital.

Changes in, or interpretations of, accounting principles could have a significant impact on our financial position and results of operations.*

We prepare our consolidated financial statements in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP. These principles are subject to interpretation by the SEC and various other bodies formed to interpret and create appropriate accounting principles. A change in these principles can have a significant effect on our reported results and may even retroactively affect previously reported transactions.

For example, the FASB is currently working together with the IASB on several projects to further align accounting principles and facilitate more comparable financial reporting between companies who are required to follow U.S. GAAP under SEC regulations and those who are required to follow International Financial Reporting Standards outside of the United States. These efforts by the FASB and the IASB may result in different accounting principles under U.S. GAAP that may result in materially different financial results for us in areas including, but not limited to, principles for recognizing revenue and lease accounting.

 

ITEM 6.

EXHIBITS.

See the Exhibit List which follows the signature page of this Quarterly Report on Form 10Q, which is incorporated by reference.

 

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Table of Contents

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Date: November 6, 2014				MEDIVATION, INC.
				By:		/s/ Richard A. Bierly
				Name:		Richard A. Bierly
				Title:		Chief Financial Officer
						(Duly Authorized Officer and Principal Financial Officer)

 

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Table of Contents

Incorporated By Reference

Exhibit Number

Exhibit Description

Form

File No.

Exhibit

Filing Date

Filed Herewith

3.1

Restated Certificate of Incorporation.

8-K

000-20837

3.4

10/17/2013

3.2

Amended and Restated Bylaws of Medivation, Inc.

10-K

001-32836

3.2

3/16/2009

4.1

Common Stock Certificate

10-Q

001-32836

4.1

5/9/2012

4.2

Rights Agreement, dated as of December 4, 2006, between Medivation, Inc. and American Stock Transfer & Trust Company, as Rights Agent, which includes the form of Certificate of Designations of the Series C Junior Participating Preferred Stock of Medivation, Inc. as Exhibit A, the form of Right Certificate as Exhibit B and the Summary of Rights to Purchase Preferred Shares as Exhibit C.

8-K

001-32836

4.1

12/4/2006

4.3

Indenture, dated March 19, 2012, between Medivation, Inc. and Wells Fargo Bank, National Association, as Trustee.

8-K

001-32836

4.1

3/19/2012

4.4

First Supplemental Indenture, dated March 19, 2012, between Medivation, Inc. and Wells Fargo Bank, National Association, as Trustee (including the form of 2.625% convertible senior notes due 2017).

8-K

001-32836

4.2

3/19/2012

10.1

Cheryl Cohen Separation Agreement

X

10.2

Consulting Agreement with Dawn Svoronos

X

12.1

Computation of Ratio of Earnings to Fixed Charges

X

31.1

Certification pursuant to Rule 13a-14(a)/15d-14(a).

X

31.2

Certification pursuant to Rule 13a-14(a)/15d-14(a).

X

32.1†

Certifications of Chief Executive Officer and Chief Financial Officer.

X

101.INS

XBRL Instance Document.

X

101.SCH

XBRL Taxonomy Extension Schema Document.

X

101.CAL

XBRL Taxonomy Extension Calculation Linkbase Document.

X

101.DEF

XBRL Taxonomy Extension Definition Linkbase Document.

X

101.LAB

XBRL Taxonomy Extension Labels Linkbase Document.

X

101.PRE

XBRL Taxonomy Extension Presentation Linkbase Document.

X

 

†

The certifications attached as Exhibit 32.1 accompanying this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Medivation, Inc., under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing.

 

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