- Conference Call Today at 4:30 p.m. Eastern Time -
SAN FRANCISCO, May 11 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today reported on its corporate progress and financial results for the first quarter ended March 31, 2009.
"We continue to make significant progress with both of our product candidates -- Dimebon in patients with Alzheimer's and Huntington's diseases and MDV3100 in patients with prostate cancer. Having received written permission from the FDA to initiate a pivotal Phase 3 trial of MDV3100 in castration-resistant prostate cancer, we are on track to be in Phase 3 testing in all of our clinical programs this year," said David Hung, M.D., president and chief executive officer of Medivation. "We expect to achieve a significant milestone in June - completion of enrollment in our six-month, confirmatory, pivotal Phase 3 CONNECTION trial in mild-to-moderate Alzheimer's disease. And as part of our plan to support a broad and differentiated label for Dimebon in Alzheimer's disease, we are pleased to have initiated the Phase 3 CONCERT trial of Dimebon in combination with donepezil (Aricept(R)), and intend to begin two additional Phase 3 trials in moderate-to-severe Alzheimer's disease patients this year."
Recent Highlights and Accomplishments
First Quarter 2009 Financial Results
Revenue for the first quarter of 2009 was $16.3 million, consisting of partial recognition of the non-refundable up-front payment of $225.0 million received from Pfizer in October 2008. The up-front payment was recorded as deferred revenue upon receipt and is being recognized on a straight-line basis over the estimated performance period of the Company's obligations under its collaboration agreement with Pfizer, which the Company presently expects to complete in the first quarter of 2012.
For the three months ended March 31, 2009, total operating expenses were $22.1 million, compared with total operating expenses of $15.9 million for the same period in 2008. These figures include non-cash stock-based compensation expense of $2.6 million in the quarter ended March 31, 2009, compared with $2.1 million for the same period in 2008.
Beginning October 21, 2008, Pfizer became responsible for 60 percent of all Dimebon-related development and commercialization costs in the U.S., and 100 percent of such costs outside the U.S. The parties are making quarterly true-up payments as necessary to ensure that each bears its applicable share of costs. For the first quarter of 2009, the true-up payment payable to Medivation was $5.8 million. Medivation presents these cost-sharing true-up payments in the applicable expense line of its statement of operations.
Medivation reported a net loss for the quarter ended March 31, 2009, of $5.6 million, or $0.19 per share, compared with a net loss of $15.5 million, or $0.54 per share, for the same period in 2008.
Cash, cash equivalents and short-term investments at March 31, 2009, totaled $200.7 million, compared with $221.4 million at December 31, 2008.
Conference Call Information
To participate in today's live call beginning at 4:30 p.m. Eastern Time by telephone, please call 877-681-3376 from the U.S. or +1-719-325-4757 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 www.medivation.com. A replay also will be available for 30 days following the live call.
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. In September 2008, Medivation announced a global agreement with Pfizer Inc to develop and commercialize Dimebon for the treatment of Alzheimer's and Huntington's diseases. With Pfizer, the Company is conducting a broad Dimebon clinical development program, including a pivotal and confirmatory Phase 3 trial, known as the CONNECTION study, in patients with mild-to-moderate Alzheimer's disease. The program also includes additional trials planned to begin this year in Alzheimer's disease, as well as further development of Dimebon in patients with mild-to-moderate Huntington's disease. In addition, a Phase 1-2 clinical trial of MDV3100 in patients with castration-resistant (also known as hormone-refractory) prostate cancer is ongoing. For more information, please visit us at http://www.medivation.com.
This press release contains forward-looking statements, including statements regarding the timing of clinical trial initiation and enrollment, 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 for the quarter ended March 31, 2009 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.
MEDIVATION, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share data) (unaudited) Three Months Ended March 31, 2009 2008 Collaboration revenue $16,340 $- Operating expenses: Research and development 15,776 11,956 Selling, General and administrative 6,305 3,953 Total operating expenses 22,081 15,909 Loss from operations (5,741) (15,909) Other income (expense): Interest income, net 509 382 Other income (expense), net 51 (1) Total other income (expense) 560 381 Loss before provision for income taxes (5,181) (15,528) Provision for income taxes 428 2 Net loss $(5,609) $(15,530) Basic and diluted net loss per share $(0.19) $(0.54) Weighted average common shares used in the calculation of basic and diluted net loss per share 30,105 28,847
MEDIVATION, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share data) (unaudited) March 31, December 31, 2009 2008 ASSETS Current assets: Cash and cash equivalents $50,718 $71,454 Short-term investments 149,970 149,968 Receivable from collaboration partner 5,766 3,522 Prepaid expenses and other current assets 3,127 1,957 Total current assets 209,581 226,901 Property and equipment, net 801 768 Restricted cash 843 843 Intellectual property, net 53 54 Other non-current assets 664 706 Total assets $211,942 $229,272 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $5,044 $7,166 Accrued expenses 10,241 5,772 Deferred revenue 65,361 64,286 Other current liabilities 103 93 Total current liabilities 80,749 77,317 Deferred revenue, net of current 130,722 148,137 Other non-current liabilities 425 399 Series A redeemable preferred stock 11 11 Total liabilities 211,907 225,864 Stockholders' equity: Preferred stock, $0.01 par value per share; 1,000,000 shares authorized; no shares issued and outstanding - - Common stock, $0.01 par value per share; 50,000,000 shares authorized; issued and outstanding 30,125,556 shares at March 31, 2009 and 30,088,390 at December 31, 2008 301 301 Additional paid-in capital 127,800 125,074 Accumulated other comprehensive income 203 693 Accumulated deficit (128,269) (122,660) Total stockholders' equity 35 3,408 Total liabilities and stockholders' equity $211,942 $229,272
|SOURCE Medivation, Inc.|
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