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"Based on the significant findings of the Dimebon 12-month pivotal trialin Alzheimer's disease recently published in The Lancet, as well as thepromising results from our Phase 2 study in Huntington's disease announcedlast month, we believe Dimebon is among the most promising drug candidatesbeing investigated today to treat patients with debilitating, and ultimatelyfatal, neurodegenerative diseases," said David Hung, M.D., president and chiefexecutive officer of Medivation. "We are making excellent progress openingU.S. sites and enrolling patients in our confirmatory Phase 3 trial of Dimebonin Alzheimer's disease, and remain on target to complete the study in time tofile for U.S. marketing approval for Alzheimer's disease in 2010. Inaddition, we continue to increase the dose and enroll patients in our ongoingPhase 1-2 study of MDV3100 for castration-resistant prostate cancer. Weremain on track for completing that study later this year, after which weintend to seek FDA approval to enter Phase 3 in 2009."
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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 endedJune 30, 2008, the net loss was $34.1 million, or $1.18 per share, compared toa 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. Theincrease in operating expenses for the second quarter of 2008 compared to thesame period in 2007 is primarily due to increased development costs associatedwith 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 thesame period in 2007. These figures include non-cash stock-based compensationexpense 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 totaloperating expenses in 2008 will be in the range of $65 million to $75 million,excluding stock-based compensation expense. The increase from prior guidanceis due primarily to increased manufacturing and clinical development costs tosupport the expansion of the Company's ongoing and upcoming clinical trials.
Cash and cash equivalents at June 30, 2008 totaled $33.4 million, comparedto $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 institutionalinvestors. At June 30, 2008 the remaining capacity under Medivation'scommitted equity line of credit with Azimuth Opportunity, Ltd. was$78.8 million. The Company may draw on that remaining capacity at itsdiscretion 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 bytelephone, please call 877-397-0286 from the U.S. or +1-719-325-4901internationally. In addition, the live conference call is being webcast andcan be accessed on the "Events and Presentations" page of the "InvestorRelations" section of the Company's website at http://www.medivation.com. Areplay also will be available for 30 days following the live call.
About Medivation
Medivation, Inc. is a biopharmaceutical company focused on the rapiddevelopment of novel small molecule drugs to treat serious diseases for whic
