SAN FRANCISCO, Aug. 11 /PRNewswire-FirstCall/ -- Medivation, Inc. today reported on its corporate progress and financial results for the quarter ended June 30, 2008.
“Based on the significant findings of the Dimebon 12-month pivotal trial in Alzheimer’s disease recently published in The Lancet, as well as the promising results from our Phase 2 study in Huntington’s disease announced last month, we believe Dimebon is among the most promising drug candidates being investigated today to treat patients with debilitating, and ultimately fatal, neurodegenerative diseases,” said David Hung, M.D., president and chief executive officer of Medivation. “We are making excellent progress opening U.S. sites and enrolling patients in our confirmatory Phase 3 trial of Dimebon in Alzheimer’s disease, and remain on target to complete the study in time to file for U.S. marketing approval for Alzheimer’s disease in 2010. In addition, we continue to increase the dose and enroll patients in our ongoing Phase 1-2 study of MDV3100 for castration-resistant prostate cancer. We remain on track for completing that study later this year, after which we intend to seek FDA approval to enter Phase 3 in 2009.”
Second Quarter 2008 Financial Results
Medivation reported a net loss for the quarter ended June 30, 2008 of $18.5 million, or $0.64 per share, compared to a net loss of $7.2 million, or $0.26 per share, for the same period in 2007. For the six months ended June 30, 2008, the net loss was $34.1 million, or $1.18 per share, compared to a net loss of $12.8 million, or $0.46 per share, for the same period in 2007.
Total operating expenses for the three months ended June 30, 2008 were $18.7 million, compared to $7.7 million for the same period in 2007. The increase in operating expenses for the second quarter of 2008 compared to the same period in 2007 is primarily due to increased development costs associated with the Company’s lead investigational products, Dimebon and MDV3100, currently in clinical trials.
For the six months ended June 30, 2008, total operating expenses were $34.6 million, compared to total operating expenses of $13.9 million for the same period in 2007. These figures include non-cash stock-based compensation expense of $4.2 million in the six months ended June 30, 2008 compared to $2.6 million for the same period in 2007. Medivation expects that total operating expenses in 2008 will be in the range of $65 million to $75 million, excluding stock-based compensation expense. The increase from prior guidance is due primarily to increased manufacturing and clinical development costs to support the expansion of the Company’s ongoing and upcoming clinical trials.
Cash and cash equivalents at June 30, 2008 totaled $33.4 million, compared to $43.3 million at December 31, 2007 and $32.9 million at March 31, 2008. During the second quarter of 2008, the Company raised approximately $15 million in net proceeds from the sale of shares to existing institutional investors. At June 30, 2008 the remaining capacity under Medivation’s committed equity line of credit with Azimuth Opportunity, Ltd. was $78.8 million. The Company may draw on that remaining capacity at its discretion during the term of the facility, which expires on April 1, 2009.
Conference Call Information
To participate in today’s live call beginning at 4:30 p.m. Eastern Time by telephone, please call 877-397-0286 from the U.S. or +1-719-325-4901 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. 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/
