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The Company And Summary Of Significant Accounting Policies
9 Months Ended
Sep. 30, 2011
The Company And Summary Of Significant Accounting Policies [Abstract] 
The Company And Summary Of Significant Accounting Policies

NOTE 1 — THE COMPANY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The Company

Medivation, Inc. (the "Company") is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. The Company's product candidates in clinical development are MDV3100, which is in Phase 3 development for the treatment of advanced prostate cancer, and dimebon (latrepirdine), which is in Phase 3 development for the treatment of mild-to-moderate Alzheimer's disease. The Company's MDV3100 program is partnered with Astellas Pharma Inc., or Astellas, and its dimebon program is partnered with Pfizer Inc., or Pfizer.

In October 2009, the Company entered into a collaboration agreement with Astellas. Under the terms of the agreement, the Company and Astellas agreed to develop and commercialize MDV3100 for the treatment of prostate cancer. The Company and Astellas share equally the costs and expenses of developing and commercializing MDV3100 for the United States market, except that (a) development costs for studies useful in both the United States market and either Europe or Japan are shared two-thirds by Astellas and one-third by the Company, and (b) both the Company and Astellas will be responsible for all commercialization costs incurred in fielding and supporting its respective MDV3100 sales forces, and each of Astellas and the Company will be entitled to receive a fee for each detail made by its respective sales forces. The Company and Astellas will share equally profits (or losses) resulting from commercialization of MDV3100 in the United States. Outside the United States, Astellas will bear all development and commercialization costs and will pay the Company tiered double-digit royalties on aggregate net sales of MDV3100.

In November 2011, the Company reported positive results from a planned interim analysis of its Phase 3 AFFIRM trial in advanced prostate cancer patients previously treated with docetaxel-based chemotherapy. The independent data monitoring committee, or IDMC, overseeing the AFFIRM study determined that MDV3100 demonstrated a clinically meaningful and statistically significant (p<0.0001) improvement in overall survival compared to placebo, and as a result recommended that the study be stopped early and men who received placebo be offered MDV3100. The IDMC informed the Company that (a) MDV3100 produced a 4.8-month advantage in median survival compared to placebo; (b) the estimated median survival for men treated with MDV3100 was 18.4 months compared to 13.6 months for men treated with placebo; and (c) MDV3100 provided a 37% reduction in risk of death compared to placebo (hazard ratio = 0.631). The IDMC further determined, considering the observed safety profile, that MDV3100 demonstrated a favorable risk-to-benefit ratio sufficient to stop the study. Because the AFFIRM trial remains blinded, the IDMC did not provide the Company with any efficacy or safety data other than that described above.

Based on the positive interim analysis results from the AFFIRM trial, the Company has elected to exercise its right under the Astellas Collaboration Agreement to co-promote MDV3100 in the U.S. market. Should MDV3100 receive marketing approval, the Company will provide 50% of the sales and medical affairs field forces supporting MDV3100 in the U.S. market.

In September 2008, the Company announced a collaboration agreement with Pfizer, which became effective in October 2008. Under the terms of the agreement, the Company and Pfizer agreed to develop and commercialize dimebon for the treatment of Alzheimer's disease and Huntington disease. The Company and Pfizer share the costs and expenses of developing and commercializing dimebon for the United States market on a 60% Pfizer/40% Medivation basis, and will share profits (or losses) resulting from commercialization of dimebon in the United States in the same proportions. Outside the United States, Pfizer will bear all development and commercialization costs and will pay the Company tiered royalties on aggregate net sales of dimebon.

The first two Phase 3 clinical studies of dimebon that the Company completed under its collaboration agreement with Pfizer were both negative. In March 2010, the Company reported negative top-line results from its 598-patient Phase 3 CONNECTION trial of dimebon in patients with mild-to-moderate Alzheimer's disease, and in April 2011, the Company reported negative top-line results from its 403-patient Phase 3 HORIZON trial of dimebon in patients with Huntington disease. Dimebon failed to show a statistically significant benefit over placebo on any of the primary or secondary endpoints in both the CONNECTION and HORIZON trials, and thus did not meet any of either study's efficacy endpoints. Due to the negative results in the CONNECTION trial, Pfizer has the right to terminate the collaboration agreement with the Company at any time. Due to the negative results in the HORIZON trial, the Company and Pfizer discontinued development of dimebon for Huntington disease in April 2011.

The Company has funded its operations primarily through private and public offerings of its common stock, and from the up-front, development milestone and cost-sharing payments from its collaboration agreements with Astellas and Pfizer. As of September 30, 2011, the Company had an accumulated deficit of $239.4 million and it expects to incur substantial additional losses for the foreseeable future as it pursues regulatory approval for, and, if approved, commercial launch of MDV3100 and continues to finance clinical and preclinical studies of its existing and potential future product candidates and its corporate overhead costs.

Basis of Presentation

The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the U.S., 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 presentation 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.

The preparation of unaudited consolidated financial statements requires management to make estimates and assumptions that affect the recorded amounts reported therein. A change in facts or circumstances surrounding the estimates could result in a change to estimates and impact future operating results.

The balance sheet at December 31, 2010 has been derived from the audited financial statements at that date.

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 fiscal year. Accordingly, these unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the fiscal year ended December 31, 2010 included in the Company's Annual Report on Form 10-K for the year ended December 31, 2010, or the Annual Report, filed with the Securities and Exchange Commission, on March 16, 2011.

The unaudited consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Medivation Neurology, Inc., Medivation Prostate Therapeutics, Inc. and Medivation Technologies, Inc. and reflect the elimination of intercompany accounts and transactions.

Reference is made to Note 2, "Summary of Significant Accounting Policies," in the notes to the audited consolidated financial statements included in the Annual Report. As of the date of the filing of this Quarterly Report on Form 10-Q, there were no significant changes to the significant accounting policies discussed in its Annual Report.

Recently Issued Accounting Pronouncements Impacting the Company

In June 2011, the Financial Accounting Standards Board, or FASB, amended Accounting Standards Codification, or ASC 220, "Presentation of Comprehensive Income." This amendment will require companies to present the components of net income and other comprehensive income either as one continuous statement or as two consecutive statements. It eliminates the option to present components of other comprehensive income as part of the statement of changes in stockholders' equity. The amended guidance, which must be applied retroactively, will be effective for the Company in the first quarter of fiscal year 2012. The adoption of this amendment concerns disclosure only and the Company does not expect it to have an impact on its consolidated financial position, results of operations or cash flows.

In May 2011, the FASB amended ASC 820, "Fair Value Measurement." This amendment is intended to result in convergence between U.S. GAAP and International Financial Reporting Standards requirements for measurement of and disclosures about fair value. This guidance clarifies the application of existing fair value measurements and disclosures, and changes certain principles or requirements for fair value measurements and disclosures. The amendment will be effective for the Company in the second quarter of fiscal year 2012. The Company is currently assessing the potential impact, if any, this amendment may have on its consolidated financial position, results of operations and cash flows.