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"The third quarter represented another quarter of significant achievementand progress and was capped with the signing of our partnering agreement withPfizer for Dimebon. This collaboration not only gives us access to aworld-class partner capable of maximizing global commercialization, but alsoprovides significant funding allowing us to invest in all of our clinicalprograms and actively pursue other drug candidates," said David Hung, M.D.,president and chief executive officer of Medivation. "We are working withPfizer on an extensive program to support a broad label for Dimebon inAlzheimer's disease beyond our original plan to pursue the treatment ofmild-to-moderate Alzheimer's, and to achieve comprehensive and expeditiousregulatory submissions and market acceptance. Accordingly, together we intendto expand development of Dimebon to include new Phase 3 trials in addition tothe CONNECTION study. We expect to begin the new trials in 2009 and to file aNew Drug Application (NDA) for a broader Alzheimer's disease label in 2011."
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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 endedSeptember 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 sameperiod 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. Theincrease in operating expenses for the third quarter of 2008 compared with thesame period in 2007 is primarily due to increased development costs associatedwith Dimebon and MDV3100.
For the nine months ended September 30, 2008, total operating expenseswere $55.3 million, compared with total operating expenses of $23.7 millionfor the same period in 2007. These figures include non-cash stock-basedcompensation 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 fund60 percent of U.S. Dimebon-related development expenses incurred on or afterOctober 21, 2008, the closing date of our collaboration agreement, and 100percent of ex-U.S. Dimebon-related development expenses. Thus, we expect thatDimebon-related operating expenses after cost sharing payments from Pfizerwill 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 of2009.
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 tothe Dimebon collaboration agreement. Even after taking into account theexpanded Dimebon development being undertaken with Pfizer, the upfront paymentand development milestone payments Medivation is eligible to receive under thePfizer agreement significantly exceed the Company's share of presentlybudgeted 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 bytelephone, please call 877-340-7912 from the U.S. or +719-325-4872internationally. 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 whichthere are limited treatment options. Medivation aims to transform thetreatment of these diseases and offer hope to critically ill patients andtheir caregivers. The Company's current clinical development program includesa pivotal and confirmatory Phase 3 trial of Dimebon in Alzheimer's disease anda Phase 1-2 clinical trial of MDV3100 in patients with castration-resistant(also known as hormone-refractory) prostate cancer. Medivation recentlyannounced that it plans to continue further development of Dimebon in patientswith mild-to-moderate Huntington's disease based on the positive results seenin its Phase 2 trial. In September 2008, Medivation entered into a globalagreement with Pfizer Inc to develop and commercialize Dimebon for thetreatment 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, includingstatements regarding future clinical development plans and milestones, whichare made pursuant to the safe harbor provisions of the Private SecuritiesLitigation Reform Act of 1995. Any statements contained in this press releasethat are not statements of historical fact may be deemed to be forward-lookingstatements. Forward-looking statements involve risks and uncertainties thatcould cause Medivation's actual results to differ significantly from thoseprojected, including, without limitation, risks related to progress, timingand results of Medivation's clinical trials, difficulties or delays inobtaining regulatory approval, enrollment of patients in Medivation's clinicaltrials, partnering of Medivation's product candidates, manufacturing ofMedivation's product candidates, competition with Medivation's productcandidates should they receive marketing approval, the adequacy ofMedivation's financial resources, unanticipated expenditures or liabilities,intellectual property matters, and other risks detailed in Medivation'sfilings with the Securities and Exchange Commission, including its quarterlyreport on Form 10-Q filed today with the SEC. You are cautioned not to placeundue reliance on the forward-looking statements, which speak only as of thedate of this release. Medivation disclaims any obligation or undertaking toupdate or revise any forward-looking statements contained in this pressrelease.Corporate Update Dimebon: Drug candidate to treat Alzheimer's and Huntington's diseases -- Entered into an agreement with Pfizer Inc. to jointly develop and commercialize Dimebon for the treatment of Alzheimer's and Huntington's diseases. Under the terms of the agreement, Medivation has received an up-front cash payment of $225 million and is eligible to receive payments of up to $500 million upon the attainment of development and regulatory milestones, plus additional undisclosed commercial milestone payments. -- Enrollment in CONNECTION, our confirmatory Phase 3 trial in mild-to-moderate Alzheimer's disease, continues on track. All 30 of our U.S. sites have been opened, and we expect the majority of our ex-U.S. sites to be opened by the end of November. We expect to complete enrollment of this trial in 2009. -- Completed a randomized, double-blind safety and tolerability study of combination therapy with Dimebon and donepezil (Aricept(R)) in patients with Alzheimer's disease, which found the combination to be well tolerated with no serious adverse events. -- Plan to initiate new Phase 3 studies in 2009 to seek further differentiation of Dimebon to include moderate-to-severe Alzheimer's disease, adjunctive use with cholinesterase inhibitors, and twelve-month efficacy. -- Received a Corporate Achievement Award from the Huntington's Disease Society of America (HDSA) for exemplifying leadership in the fight against Huntington's disease and other neurodegenerative diseases. -- Plan to initiate the next Huntington's disease efficacy study in 2009. MDV3100: Drug candidate to treat castration-resistant prostate cancer -- Presented data at the 20th EORTC-NCI-AACR Symposium on "Molecular Targets and Cancer Therapeutics" from an ongoing open-label, dose-escalation, U.S.-based Phase 1-2 clinical trial in prostate cancer patients who have failed standard hormonal therapies. Results showed encouraging and durable anti-tumor activity in the three expanded dose groups tested thus far, as measured by prostate specific antigen (PSA) declines, radiographic findings, circulating tumor cell (CTC) changes, and time on treatment. MDV3100 has been generally well tolerated, with no reports of serious adverse events deemed related to the drug. -- Approximately 120 patients have been enrolled in the trial with enrollment completed at doses up to 360 mg/day. A total of 73 patients in the three lowest expanded dose groups (60, 150, and 240 mg/day) have been followed for more than 24 weeks. Of these 73 patients, 31 patients (42 percent) have received MDV3100 for greater than 24 weeks. Dose escalation in the trial is continuing; the 360 mg/day expansion group is completely enrolled, dose escalation is in progress at 480 mg/day, and initial dosing at 600 mg/day has started. Thus far a maximum tolerated dose (MTD) has not been reached. -- Medivation expects to seek FDA agreement to begin a pivotal Phase 3 registration study in castration-resistant prostate cancer patients in 2009.
SOURCE Medivation, Inc.
