- Conference Call Today at 4:30 p.m. Eastern Time -
SAN FRANCISCO, March 16 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today reported on its corporate progress and financial results for the fourth quarter and year ended December 31, 2008.
"We had a very productive 2008 and are looking forward to an equally exciting 2009. We have made excellent progress across our pipeline and are on track to be in Phase 3 testing in all of our programs in 2009 -- Dimebon in both Alzheimer's and Huntington's diseases and MDV3100 for castration-resistant prostate cancer," said David Hung, M.D., president and chief executive officer of Medivation. "We and Pfizer are jointly executing a comprehensive Phase 3 development program for Dimebon in Alzheimer's disease and are already well on our way with the ongoing CONNECTION study, the recent initiation of a large safety trial designed to support a potential earlier NDA filing date, and the soon-to-be-initiated CONCERT study of Dimebon in combination with Aricept. In addition, with Pfizer, we had a successful end-of-Phase 2 meeting with the FDA for Dimebon in Huntington's disease."
Mechanism of Action (MOA)
Fourth Quarter and Year-End 2008 Financial Results
Revenue for the fourth quarter and full year of 2008 was $12.6 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 twelve months ended December 31, 2008, total operating expenses were $76.8 million, compared with total operating expenses of $33.8 million for the same period in 2007. These figures include non-cash stock-based compensation expense of $8.5 million in the year ended December 31, 2008, compared with $5.9 million for the same period in 2007.
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 will make quarterly true-up payments as necessary to ensure that each bears its applicable share of costs. For the fourth quarter of 2008, the true-up payment payable to Medivation was $3.5 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 December 31, 2008, of $7.9 million, or $0.26 per share, compared with a net loss of $9.6 million, or $0.34 per share, for the same period in 2007. For the twelve months ended December 31, 2008, the net loss was $62.5 million, or $2.12 per share, compared with a net loss of $31.7 million, or $1.14 per share, for the same period in 2007.
Cash, cash equivalents and short-term investments at December 31, 2008, totaled $221.4 million, compared with $43.3 million at December 31, 2007.
2009 Financial Outlook
We expect 2009 revenue from our collaboration with Pfizer to be approximately $65 million, representing partial recognition of our $225 million up-front payment received. We do not expect to recognize any Dimebon related milestone payments in 2009. We expect that total operating expenses for 2009, net of cost-sharing payments from Pfizer, will be between $130 and $140 million, which includes non-cash stock-based compensation expense of approximately $10 million.
Conference Call Information
To participate in today's live call beginning at 4:30 p.m. Eastern Time by telephone, please call 877-718-5104 from the U.S. or +1-719-325-4794 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 Phase 3 trials planned to begin this year in both Alzheimer's disease and 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: initiation of clinical studies, filing of an NDA for Dimebon, seeking approval to commence a Phase 3 trial of MDV3100, the presentation of data with respect to Dimebon and MDV3100 and the receipt of milestone payments as well as the extent of future expected financial results, 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 annual report on Form 10-K for the year ended December 31, 2008 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.
~financial statements to follow~
MEDIVATION, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share data) Year ended December 31, 2008 2007 2006 Collaboration revenue $12,578 $- $- Operating expenses: Research and development 54,895 23,399 11,825 Selling, general and administrative 21,865 10,364 4,321 Total operating expenses 76,760 33,763 16,146 Loss from operations (64,182) (33,763) (16,146) Other income (expense): Interest income, net 1,206 2,020 785 Other income (expense), net 516 - (2) Total other income (expense) 1,722 2,020 783 Net loss $(62,460) $(31,743) $(15,363) Basic and diluted net loss per share $(2.12) $(1.14) $(0.63) Weighted average common shares used in the calculation of basic and diluted net loss per share 29,478 27,932 24,248
MEDIVATION, INC. CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share data) December 31, 2008 2007 ASSETS Current assets: Cash and cash equivalents $71,454 $43,258 Short-term investments 149,968 - Receivable from collaboration partner 3,522 - Prepaid expenses and other current assets 1,957 991 Total current assets 226,901 44,249 Property and equipment, net 768 689 Restricted cash 843 500 Intellectual property, net 54 58 Other non-current assets 706 100 Total assets $229,272 $45,596 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $7,166 $1,747 Accrued expenses 5,772 2,218 Deferred revenue 64,286 - Other current liabilities 93 70 Total current liabilities 77,317 4,035 Deferred revenue, net of current 148,137 - Other non-current liabilities 399 492 Series A redeemable preferred stock 11 11 Total liabilities 225,864 4,538 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 30,088,390 shares at December 31, 2008 and 28,837,290 at December 31, 2007 301 288 Additional paid-in capital 125,074 100,970 Accumulated other comprehensive income 693 - Accumulated deficit (122,660) (60,200) Total stockholders' equity 3,408 41,058 Total liabilities and stockholders' equity $229,272 $45,596
|SOURCE Medivation, Inc.|
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