SAN FRANCISCO, Nov. 5, 2010 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today provided a corporate update and reported its financial results for the third quarter ended September 30, 2010.
"In the third quarter, we began the expansion of our MDV3100 development program into earlier stage patients with the initiation of the Phase 3 PREVAIL trial, which is enrolling men with advanced prostate cancer who have not yet received chemotherapy. Additionally, we believe that the positive interim analysis of the abiraterone Phase 3 study is a net positive for MDV3100, as it provides further clinical validation for the importance of the androgen receptor signaling pathway in advanced prostate cancer," said David Hung, MD, president and chief executive officer of Medivation. "Together with our partner Pfizer, we continue to investigate dimebon's potential clinical benefit in the ongoing Phase 3 HORIZON trial in Huntington disease and the ongoing Phase 3 CONCERT trial in mild-to-moderate Alzheimer's disease patients who are taking donepezil. We remain on track to complete enrollment in the CONCERT trial this year and look forward to announcing top-line results from the HORIZON trial in the first half of 2011."
Recent Accomplishments and Anticipated Milestones
-- Initiated the Phase 3 PREVAIL trial evaluating MDV3100 in men with
advanced prostate cancer who have not yet received chemotherapy. This
randomized, double-blind, placebo-controlled, multi-national Phase 3
trial is expected to enroll approximately 1,700 patients globally.
-- Continued to enroll patients in the AFFIRM trial and expect to complete
patient accrual on November 15, 2010. This randomized, double-blind,
placebo-controlled Phase 3 trial is evaluating MDV3100 in men with
advanced prostate cancer who have been previously treated with
-- On track to initiate two new MDV3100 trials in earlier-stage prostate
cancer this year: a Phase 2 head-to-head trial comparing MDV3100 with
bicalutamide; and a Phase 2 trial in hormone-naive patients.
-- The Proceedings of the National Academy of Sciences (PNAS) published a
paper showing the preclinical efficacy of MDV3100 against splice
variants, which are mutated forms of the androgen receptor that may be
associated with the development of prostate cancer resistance to hormone
-- On track to report top-line data from HORIZON in the first half of 2011.
This six-month, randomized, double-blind, placebo-controlled Phase 3
trial is evaluating dimebon's potential benefits on cognition and global
function in patients with Huntington disease.
-- Continued to enroll patients in CONCERT and expect to complete patient
accrual on November 30, 2010. This 12-month randomized, double-blind,
placebo-controlled Phase 3 clinical trial in patients with
mild-to-moderate Alzheimer's disease is evaluating the potential
efficacy of dimebon when added to ongoing treatment with donepezil.
-- Were awarded a $733,000 research and development grant under the
Internal Revenue Service's Therapeutic Discovery Project Credit Program.
Third Quarter 2010 Financial Results
Revenue for the third quarter of 2010 was $14.4 million, consisting of partial recognition of the non-refundable up-front payments to date from the Company's corporate partners Pfizer and Astellas. These payments were recorded as deferred revenue upon receipt and are being recognized as revenue on a straight-line basis over the estimated performance period of the Company's obligations under the applicable collaboration agreement.
Total operating expenses for the third quarter of 2010 were $21.1 million, compared with $27.6 million for the same period in 2009. These figures are net of cost-sharing payments from the Company's corporate partners of $17.9 million and $4.2 million in the third quarters of 2010 and 2009, respectively, and include non-cash stock-based compensation expense of $3.3 million and $2.5 million, respectively.
For the nine months ended September 30, 2010, total operating expenses were $77.7 million, compared with $73.8 million for the same period in 2009. These figures are net of cost-sharing payments from the Company's corporate partners of $41.5 million and $16.2 million in the nine months ended September 30, 2010 and 2009, respectively, and include non-cash stock-based compensation expense of $10.0 million and $7.7 million, respectively.
Income tax benefit for the third quarter of 2010 was $1.5 million, compared with income tax expense of $2.8 million in the comparable period of 2009. For the nine months ended September 30, 2010, income tax benefit was $1.5 million, compared with income tax expense of $4.5 million in the prior year period.
Medivation reported a net loss for the quarter ended September 30, 2010, of $5.4 million, or $0.16 per share, compared with a net loss of $14.0 million, or $0.42 per share, for the same period in 2009. For the nine months ended September 30, 2010, the net loss was $30.1 million, or $0.88 per share, compared with a net loss of $28.5 million, or $0.90 per share, for the same period in 2009.
Cash, cash equivalents and short-term investments at September 30, 2010, totaled $211.5 million, compared with $278.2 million at December 31, 2009 and $233.3 million at June 30, 2010.
Medivation expects that its existing cash resources are adequate to fund its currently budgeted operations beyond 2012. By the end of 2012, the Company expects to have reported top-line data from the Phase 3 CONCERT trial in mild-to-moderate Alzheimer's disease, the Phase 3 HORIZON trial in Huntington disease and the Phase 3 AFFIRM trial in advanced prostate cancer patients who have failed chemotherapy..
Conference Call Information
To participate by telephone in today's live call beginning at 4:30 p.m. Eastern Time, please call 877-303-2523 from the U.S. or +1-253-237-1755 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. Together with its corporate partners Pfizer and Astellas, Medivation currently has investigational drugs in Phase 3 development to treat advanced prostate cancer, mild-to-moderate Alzheimer's disease and Huntington disease. For more information, please visit us at www.medivation.com.
This press release contains forward-looking statements, including statements regarding the continued clinical development of Medivation's product candidates, the potential completion of patient enrollment in ongoing clinical trials, the potential initiation of new clinical trials and the potential conduct of an interim analysis in the AFFIRM study, the anticipated timing of announcement of top-line data from ongoing clinical trials and other statements with respect to future clinical trial results, the therapeutic and commercial potential of Medivation's product candidates, the continued effectiveness of, and continuing activities under, Medivation's collaboration agreements with Pfizer and Astellas and the potential sufficiency of Medivation's cash resources, 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, including the risk that adverse or inconclusive clinical trial results could alone or together with other factors result in the delay or discontinuation of some or all of Medivation's dimebon development activities and the risk that positive results seen in our prior clinical trials may not be predictive of the results of our ongoing clinical trials, difficulties or delays in enrolling and retaining patients in Medivation's current and planned clinical trials, including as a result of the availability of competing treatments or clinical trials of competing drugs for the same indication, partnering of Medivation's product candidates, including Medivation's dependence on the efforts of and funding by Pfizer and Astellas for the development of dimebon and MDV3100, respectively, including the risk that Pfizer could elect to unilaterally terminate the dimebon collaboration agreement with Medivation at its election at any time, the achievement of development, regulatory and commercial milestones under Medivation's collaboration agreements, the manufacturing of Medivation's product candidates, including Medivation's dependence on Pfizer for the manufacture of all clinical requirements of dimebon, 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 September 30, 2010, 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 follow~
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2010 2009 2010 2009
---- ---- ---- ----
revenue $14,350 $16,341 $45,876 $49,021
------- ------- ------- -------
development 15,633 21,530 59,470 54,851
administrative 5,454 6,034 18,267 18,950
expenses 21,087 27,564 77,737 73,801
------ ------ ------ ------
operations (6,737) (11,223) (31,861) (24,780)
net (174) 96 245 813
---- --- --- ---
income tax (6,911) (11,127) (31,616) (23,967)
(expense) 1,468 (2,846) 1,468 (4,538)
Net loss $(5,443) $(13,973) $(30,148) $(28,505)
======= ======== ======== ========
share $(0.16) $(0.42) $(0.88) $(0.90)
====== ====== ====== ======
per share 34,570 33,468 34,198 31,588
====== ====== ====== ======
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
Cash and cash equivalents $159,936 $57,463
Short-term investments 51,562 220,781
Receivable from collaboration partners 17,865 6,490
Prepaid expenses and other current
assets 12,256 9,343
Total current assets 241,619 294,077
Property and equipment, net 925 1,092
Restricted cash 843 843
Other non-current assets 918 678
Total assets $244,305 $296,690
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable $5,482 $4,840
Accrued expenses 22,612 12,054
Deferred revenue 57,225 86,570
Other current liabilities 158 800
Total current liabilities 85,477 104,264
Deferred revenue, net of current 150,067 166,598
Other non-current liabilities 978 554
Total liabilities 236,522 271,416
Preferred stock, $0.01 par value per
1,000,000 shares authorized; no shares
issued and outstanding - -
Common stock, $0.01 par value per
50,000,000 shares authorized; issued
and outstanding 34,571,329 shares
at September 30, 2010 and 33,823,062
at December 31, 2009 346 338
Additional paid-in capital 214,995 202,361
Accumulated other comprehensive gain
(loss) 3 (12)
Accumulated deficit (207,561) (177,413)
Total stockholders' equity 7,783 25,274
Total liabilities and stockholders'
equity $244,305 $296,690
SOURCE Medivation, Inc.