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Medivation, Inc MEDIVATION, INC. FORM 10-K (Annual Report) Filed 02/26/16 for the Period Ending 12/31/15 Address 525 MARKET STREET 36TH FLOOR SAN FRANCISCO, CA 94105 Telephone 415-543-3470 CIK 0001011835 Symbol MDVN SIC Code 2834 - Pharmaceutical Preparations Industry Biotechnology & Drugs Sector Healthcare Fiscal Year 12/31 http://www.edgar-online.com © Copyright 2016, EDGAR Online, Inc. All Rights Reserved. Distribution and use of this document restricted under EDGAR Online, Inc. Terms of Use. uNITEd STATES SECuRITIES ANd EXChANgE COMMISSION Washington, d.C. 20549 Form 10-k x ANNuAl REPORT PuRSuANT TO SECTION 13 OR 15(d) OF ThE SECuRITIES EXChANgE ACT OF 1934 For the Fiscal Year Ended December 31, 2015 OR o 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) (I.R.S. Employer Identification No.) 525 Market Street, 36th Floor San Francisco, California 94105 (Address of principal executive offices) (Zip Code) Registrant’s telephone number, including area code: (415) 543-3470 Securities registered pursuant to Section 12(b) of the Act: Title of Each Class Name of Each Exchange on Which Registered Common Stock, par value $0.01 per share The NASDAQ Stock Market LLC Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES o NO x Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. YES o NO x 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 o 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 (§229.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). YES x NO o Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. x 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 o Non-accelerated filer o (Do not check if a smaller reporting company) Smaller reporting company o Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act.). YES o NO x The aggregate market value of the voting stock held by non-affiliates of the registrant was approximately $7.7 billion as of June 30, 2015, based upon the closing sale price on The NASDAQ Global Market reported on June 30, 2015. Excludes an aggregate of 24,807,840 shares of the registrant’s common stock (on a post-split basis) held by officers, directors and affiliated stockholders. For purposes of determining whether a stockholder was an affiliate of the registrant at June 30, 2015, the registrant assumed that a stockholder was an affiliate of the registrant at June 30, 2015 if such stockholder (i) beneficially owned 10% or more of the registrant’s common stock, as determined based on public filings, and/or (ii) was an executive officer or director or was affiliated with an executive officer or director of the registrant at June 30, 2015. Exclusion of such shares should not be construed to indicate that any such person possesses the power, direct or indirect, to direct or cause the direction of the management or policies of the registrant or that such person is controlled by or under common control with the registrant. There were 164,233,527 shares of Registrant’s Common Stock, par value $0.01 per share, outstanding as of February 16, 2016. dOCuMENTS INCORPORATEd By REFERENCE Portions of the registrant’s definitive Proxy Statement for the 2016 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission pursuant to Regulation 14A not later than 120 days after the end of the fiscal year covered by this Form 10-K are incorporated by reference in Part III, Items 10-14 of this Form 10-K. MEDIVATION, INC. 2015 ANNUAL REPORT ON FORM 10-K TABLE OF CONTENTS Page PART I Item 1. BUSINESS 2 Item 1A. RISK FACTORS 21 Item 1B. UNRESOLVED STAFF COMMENTS 44 Item 2. PROPERTIES 45 Item 3. LEGAL PROCEEDINGS 45 Item 4. MINE SAFETY DISCLOSURES 45 PART II Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES 46 Item 6. SELECTED FINANCIAL DATA 48 Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 49 Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 67 Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 68 Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 68 Item 9A. CONTROLS AND PROCEDURES 68 Item 9B. OTHER INFORMATION 69 PART III Item 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 70 Item 11. EXECUTIVE COMPENSATION 70 Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS 70 Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 70 Item 14. PRINCIPAL ACCOUNTING FEES AND SERVICES 70 PART IV Item 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES 71 S IGNATURES 72 FINANCIAL STATEMENTS REPORT OF PRICEWATERHOUSECOOPERS LLP, INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM 73 CONSOLIDATED BALANCE SHEETS 74 CONSOLIDATED STATEMENTS OF OPERATIONS 75 CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) 76 CONSOLIDATED STATEMENTS OF CASH FLOWS 77 CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY 78 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS 79 i FORWARd-lOOkINg STATEMENTS This Annual Report on Form 10-K, or Annual Report, includes “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 other 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, including those with respect to talazoparib (which is referred to as MDV3800) and pidilizumab (which is referred to as MDV9300). The forward-looking statements contained in this Annual 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” included elsewhere in this Annual Report. 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 Annual 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 financial or operations performance 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. 1 PART I Item 1. Business. OvERvIEW We are a biopharmaceutical company focused on the development and commercialization of medically innovative therapies to treat serious diseases for which there are limited treatment options. We have one commercial product, XTANDI ® (enzalutamide) capsules, or XTANDI, through our collaboration with Astellas Pharma, Inc., or Astellas. XTANDI has received marketing approval in the United States, Europe and numerous other countries worldwide for the treatment of patients with metastatic castration-resistant prostate cancer, or mCRPC, and in Japan for the treatment of patients with castration-resistant prostate cancer, or CRPC. We and Astellas are also conducting investigational studies of enzalutamide in prostate cancer, advanced breast cancer, and hepatocellular carcinoma. Under our collaboration agreement with Astellas, we share equally with Astellas all profits (losses) related to U.S.
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