SAN FRANCISCO, Nov. 10 /PRNewswire-FirstCall/ -- Medivation, Inc. today reported on its corporate progress and financial results for the quarter ended September 30, 2008.
"The third quarter represented another quarter of significant achievement and progress and was capped with the signing of our partnering agreement with Pfizer for Dimebon. This collaboration not only gives us access to a world-class partner capable of maximizing global commercialization, but also provides significant funding allowing us to invest in all of our clinical programs and actively pursue other drug candidates," said David Hung, M.D., president and chief executive officer of Medivation. "We are working with Pfizer on an extensive program to support a broad label for Dimebon in Alzheimer's disease beyond our original plan to pursue the treatment of mild-to-moderate Alzheimer's, and to achieve comprehensive and expeditious regulatory submissions and market acceptance. Accordingly, together we intend to expand development of Dimebon to include new Phase 3 trials in addition to the CONNECTION study. We expect to begin the new trials in 2009 and to file a New Drug Application (NDA) for a broader Alzheimer's disease label in 2011."
Third Quarter 2008 Financial Results
Medivation reported a net loss for the quarter ended September 30, 2008 of $20.5 million, or $0.68 per share, compared with a net loss of $9.4 million, or $0.34 per share, for the same period in 2007. For the nine months ended September 30, 2008, the net loss was $54.5 million, or $1.86 per share, compared with a net loss of $22.2 million, or $0.80 per share, for the same period in 2007.
Total operating expenses for the nine months ended September 30, 2008 were $20.6 million, compared with $9.8 million for the same period in 2007. The increase in operating expenses for the third quarter of 2008 compared with the same period in 2007 is primarily due to increased development costs associated with Dimebon and MDV3100.
For the nine months ended September 30, 2008, total operating expenses were $55.3 million, compared with total operating expenses of $23.7 million for the same period in 2007. These figures include non-cash stock-based compensation expense of $6.4 million in the nine months ended September 30, 2008 compared with $4.3 million for the same period in 2007. Pfizer will fund 60 percent of U.S. Dimebon-related development expenses incurred on or after October 21, 2008, the closing date of our collaboration agreement, and 100 percent of ex-U.S. Dimebon-related development expenses. Thus, we expect that Dimebon-related operating expenses after cost sharing payments from Pfizer will decrease in the fourth quarter of 2008 compared with the third quarter. We intend to provide full-year 2009 financial guidance in the first quarter of 2009.
Cash and cash equivalents at September 30, 2008 totaled $20.4 million, compared with $43.3 million at December 31, 2007. On October 27, 2008, Medivation received its $225 million up-front payment from Pfizer pursuant to the Dimebon collaboration agreement. Even after taking into account the expanded Dimebon development being undertaken with Pfizer, the upfront payment and development milestone payments Medivation is eligible to receive under the Pfizer agreement significantly exceed the Company's share of presently budgeted development and pre-launch commercialization costs for Dimebon.
Conference Call Information
To participate in today's live call beginning at 4:30 p.m. Eastern Time by telephone, please call 877-340-7912 from the U.S. or +719-325-4872 internationally. In addition, the live conference call is being webcast and can be accessed on the "Events and Presentations" page of the "Investor Relations" section of the Company's website at http://www.medivation.com. A replay also will be available for 30 days following the live call.
About Medivation
Medivation, Inc. 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. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. The Company's current clinical development program includes a pivotal and confirmatory Phase 3 trial of Dimebon in Alzheimer's disease and a Phase 1-2 clinical trial of MDV3100 in patients with castration-resistant (also known as hormone-refractory) prostate cancer. Medivation recently announced that it plans to continue further development of Dimebon in patients with mild-to-moderate Huntington's disease based on the positive results seen in its Phase 2 trial. In September 2008, Medivation entered into a global agreement with Pfizer Inc to develop and commercialize Dimebon for the treatment of Alzheimer's and Huntington's diseases. For more information, please visit us at http://www.medivation.com.
This press release contains forward-looking statements, including statements regarding future clinical development plans and milestones, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Medivation's actual results to differ significantly from those projected, including, without limitation, risks related to progress, timing and results of Medivation's clinical trials, difficulties or delays in obtaining regulatory approval, enrollment of patients in Medivation's clinical trials, partnering of Medivation's product candidates, manufacturing of Medivation's product candidates, competition with Medivation's product candidates should they receive marketing approval, the adequacy of Medivation's financial resources, unanticipated expenditures or liabilities, intellectual property matters, and other risks detailed in Medivation's filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q filed today with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Medivation disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
CONTACT: Patrick Machado, Chief Financial Officer of Medivation, Inc.,
+1-415-829-4101; or Daryl Messinger of WeissComm Partners, +1-415-946-1062,
for Medivation, Inc.
Web site: http://www.medivation.com/
