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Medivation Reports First Quarter 2011 Financial Results and Provides Corporate Update

May 6, 2011 - SAN FRANCISCO, CA

Medivation, Inc. (NASDAQ: MDVN) todayprovided a corporate update and reported its financial results for thefirst quarter ended March 31, 2011.

"We and our partner Astellas continue to make substantial progress with ourMDV3100 program. We now have multiple MDV3100 trials ongoing evaluating abroad spectrum of advanced Prostate cancer patients, and we have jointlyreached a decision to conduct an interim analysis of our Phase 3 AFFIRMtrial in the post-chemotherapy patient population," said David Hung, M.D.,president and chief executive officer of Medivation. "On the corporateside, we reiterate our financial guidance for 2011 and continue to believethat our existing cash is adequate to fund our operations beyond the end of2012, which we expect to be more than sufficient time to complete andreport data from our ongoing Phase 3 trials in post-chemotherapy advancedprostate cancer and in Alzheimer's disease."

Recent Accomplishments and Anticipated Milestones


  • Confirmed intent to conduct an interim analysis of the Phase 3 AFFIRMtrial, which is evaluating the effect of MDV3100 on overall survival in1,199 men with advanced Prostate cancer who have previously been treatedwith docetaxel-based chemotherapy. Depending on the survival rates ofpatients in the AFFIRM trial, data from the interim analysis couldpotentially be available in 2011.
  • Continued to enroll patients in the Phase 3 PREVAIL trial, which isevaluating the effect of MDV3100 on overall survival and progression-freesurvival in men with advanced Prostate cancer who have not yet receivedchemotherapy. This trial is expected to enroll approximately 1,700chemotherapy-naïve patients globally.
  • Initiated the Phase 2 TERRAIN trial, which is comparing the effect ofMDV3100 versus bicalutamide, the most commonly used anti-androgen, onprogression-free survival in approximately 370 patients with advancedProstate cancer who have progressed following medical castration with LHRHanalog therapy or surgical castration.
  • On track to initiate a Phase 2 trial in the second quarter of 2011 inpatients who have not yet received any hormonal therapy. This will be thefirst trial to evaluate MDV3100 in advanced prostate patients who have notyet undergone medical or surgical castration.

Dimebon (latrepirdine)

  • Announced top-line results from the Phase 3 placebo-controlled HORIZONtrial in patients with Huntington disease showing that dimebon wasgenerally well tolerated but did not achieve statistical significance onany of the co-primary or secondary efficacy endpoints. Based on theseresults, we have discontinued the dimebon program in Huntingtondisease.
  • On track to report top-line results from the Phase 3 CONCERT trial inthe first half of 2012. This 12-month clinical trial in 1,003 patients withmild-to-moderate Alzheimer's disease is evaluating the potential efficacyof dimebon when added to ongoing treatment with donepezil, the leadingapproved treatment for mild-to-moderate Alzheimer's disease.

First Quarter 2011 Financial Results

Revenue for the first quarter of 2011 was $14.7 million, consisting ofpartial recognition of the non-refundable up-front and developmentmilestone payments to date from the Company's corporate partners Pfizer andAstellas. These payments were recorded as deferred revenue upon receipt andare being recognized as revenue on a straight-line basis over the estimatedperformance period of the Company's obligations under the applicablecollaboration agreement.

For the three months ended March 31, 2011, total operating expenses were$23.8 million, compared with total operating expenses of $33.4 million forthe same period in 2010. These figures include non-cash stock-basedcompensation expense of $3.6 million in the quarter ended March 31, 2011,compared with $3.5 million for the same period in 2010.

Medivation reported a net loss for the quarter ended March 31, 2011, of$8.5 million, or $0.24 per share, compared with a net loss of $17.5million, or $0.51 per share, for the same period in 2010.

Cash, cash equivalents and short-term investments at March 31, 2011,totaled $195.0 million, compared with $207.8 million at December 31, 2010.

2011 Financial Outlook

Medivation reaffirms its guidance that total operating expenses for 2011,net of cost-sharing payments from Astellas and Pfizer, will be between$100.0 and $110.0 million. This forecast includes approximately $12.0million of non-cash stock-based compensation expense.

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 +1-253-237-1755internationally. 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 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 forwhich there are limited treatment options. Medivation aims to transform thetreatment of these diseases and offer hope to critically ill patients andtheir caregivers. Together with its corporate partners Astellas and Pfizer,Medivation currently has investigational drugs in Phase 3 development totreat advanced Prostate cancer and mild-to-moderate Alzheimer's disease.For more information, please visit us at

This press release contains forward-looking statements, includingstatements regarding the continued clinical development of Medivation'sproduct candidates and potential future progress related thereto, thetherapeutic potential of Medivation's product candidates, the potentialcompletion of patient enrollment in ongoing clinical trials, the plannedinitiation of additional clinical trials, the planned interim analysis inthe AFFIRM study, the anticipated timing of announcement of top-line datafrom ongoing clinical trials and other statements with respect to futureclinical trial events or results, the continued effectiveness of, andcontinuing collaborative activities and benefits under, Medivation'scollaboration agreements with Pfizer and Astellas, and Medivation'santicipated future financial results, including the potential sufficiencyof Medivation's cash resources, which are made pursuant to the safe harborprovisions of the Private Securities Litigation Reform Act of 1995. Anystatements contained in this press release that are not statements ofhistorical fact may be deemed to be forward-looking statements.Forward-looking statements involve risks and uncertainties that could causeMedivation's actual results to differ significantly from those projected,including, without limitation, risks related to progress, timing andresults of Medivation's clinical trials, including the risk that adverseclinical trial results could alone or together with other factors result inthe delay or discontinuation of some or all of Medivation's productdevelopment activities and the risk that positive results seen in our priorclinical trials may not be predictive of the results of our ongoing orplanned clinical trials, difficulties or delays in enrolling and retainingpatients in Medivation's clinical trials, including as a result of theavailability of competing treatments or clinical trials of competing drugsfor the same indication, partnering of Medivation's product candidates,including Medivation's dependence on the efforts of and funding by Astellasand Pfizer for the development of MDV3100 and dimebon, respectively, theachievement of development, regulatory and commercial milestones underMedivation's collaboration agreements, the manufacturing of Medivation'sproduct candidates, 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 andExchange Commission, including its quarterly report on Form 10-Q for thequarter ended March 31, 2011, filed today with the SEC. You are cautionednot to place undue reliance on the forward-looking statements, which speakonly as of the date of this release. Medivation disclaims any obligation orundertaking to update or revise any forward-looking statements contained inthis press release.

~financial statements follow~

(In thousands, except per share data)

Three Months Ended
March 31,
2011 2010
--------- ---------

Collaboration revenue $ 14,709 $ 15,734
--------- ---------

Operating expenses:
Research and development 17,618 25,582
Selling, general and administrative 6,156 7,839

--------- ---------
Total operating expenses 23,774 33,421
--------- ---------

Loss from operations (9,065) (17,687)
Other income (expense):
Interest income 41 113
Other income (expense), net (333) 109
--------- ---------
Total other income (expense) (292) 222
--------- ---------
Net loss before income tax (9,357) (17,465)
Income tax expense (benefit) (905) -
--------- ---------
Net loss $ (8,452) $ (17,465)
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Basic and diluted net loss per common share $ (0.24) $ (0.51)
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Weighted average common shares used in the
calculation of basic and diluted net loss per share 34,663 33,953
========= =========

(In thousands, except share and per share data)

March 31, December 31,
2011 2010
----------- -----------
Current assets:
Cash and cash equivalents $ 94,885 $ 107,717
Short-term investments 100,074 100,039
Receivable from collaboration partners 14,747 21,188
Prepaid expenses and other current assets 7,979 8,067
----------- -----------
Total current assets 217,685 237,011
Property and equipment, net 754 862
Restricted cash 843 843
Other non-current assets 1,785 887
----------- -----------
Total assets $ 221,067 $ 239,603
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Current liabilities:
Accounts payable $ 4,879 $ 3,229
Accrued expenses 21,704 21,399
Deferred revenue 59,216 59,153
Other current liabilities 453 5,193
----------- -----------
Total current liabilities 86,252 88,974

Deferred revenue, net of current 126,735 141,507
Other non-current liabilities 1,412 1,438
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Total liabilities 214,399 231,919
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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 34,777,729 shares at
March 31, 2011 and 34,573,829 shares at
December 31, 2010 348 346
Additional paid-in capital 226,220 218,786
Accumulated other comprehensive gain 2 2
Accumulated deficit (219,902) (211,450)
----------- -----------
Total stockholders' equity 6,668 7,684
----------- -----------
Total liabilities and stockholders' equity $ 221,067 $ 239,603
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