UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 6, 2011
MEDIVATION, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-32836 | 13-3863260 | ||
(State or other jurisdiction of incorporation) |
(Commission File No.) |
(IRS Employer Identification No.) |
201 Spear Street, 3rd Floor
San Francisco, California 94105
(Address of principal executive offices and zip code)
Registrants telephone number, including area code: (415) 543-3470
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02. | Results of Operations and Financial Condition. |
On May 6, 2011, Medivation, Inc. (the Company) announced its financial results for the first quarter ended March 31, 2011. A copy of the Companys press release, entitled Medivation Reports First Quarter 2011 Financial Results and Provides Corporate Update, is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto.
The information in this report, including the exhibit hereto, shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in such filing.
Item 9.01. | Financial Statements and Exhibits. |
(d) | Exhibits. |
99.1 |
Press release, dated May 6, 2011, entitled Medivation Reports First Quarter 2011 Financial Results and Provides Corporate Update. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
MEDIVATION, INC. | ||||||
Dated: May 6, 2011 | By: | /s/ C. Patrick Machado | ||||
C. Patrick Machado | ||||||
Chief Business Officer and Chief Financial Officer |
EXHIBIT INDEX
99.1 | Press release, dated May 6, 2011, entitled Medivation Reports First Quarter 2011 Financial Results and Provides Corporate Update. |
Exhibit 99.1
Contacts: | ||
Medivation, Inc. | WCG | |
Patrick Machado, Chief Business Officer | Nicole Foderaro | |
(415) 829-4101 | (415) 946-1058 |
MEDIVATION REPORTS FIRST QUARTER 2011 FINANCIAL RESULTS AND PROVIDES
CORPORATE UPDATE
Company Announces It Will Conduct Interim Analysis of Phase 3 MDV3100 AFFIRM Trial in
Post-Chemotherapy Prostate Cancer Patients
Conference Call Today at 4:30 p.m. Eastern Time
San Francisco (May 6, 2011) Medivation, Inc. (Nasdaq: MDVN) today provided a corporate update and reported its financial results for the first quarter ended March 31, 2011.
We and our partner Astellas continue to make substantial progress with our MDV3100 program. We now have multiple MDV3100 trials ongoing evaluating a broad spectrum of advanced prostate cancer patients, and we have jointly reached a decision to conduct an interim analysis of our Phase 3 AFFIRM trial in the post-chemotherapy patient population, said David Hung, M.D., president and chief executive officer of Medivation. On the corporate side, we reiterate our financial guidance for 2011 and continue to believe that our existing cash is adequate to fund our operations beyond the end of 2012, which we expect to be more than sufficient time to complete and report data from our ongoing Phase 3 trials in post-chemotherapy advanced prostate cancer and in Alzheimers disease.
Recent Accomplishments and Anticipated Milestones
MDV3100
| Confirmed intent to conduct an interim analysis of the Phase 3 AFFIRM trial, which is evaluating the effect of MDV3100 on overall survival in 1,199 men with advanced prostate cancer who have previously been treated with docetaxel-based chemotherapy. Depending on the survival rates of patients in the AFFIRM trial, data from the interim analysis could potentially be available in 2011. |
| Continued to enroll patients in the Phase 3 PREVAIL trial, which is evaluating the effect of MDV3100 on overall survival and progression-free survival in men with advanced prostate cancer who have not yet received chemotherapy. This trial is expected to enroll approximately 1,700 chemotherapy-naïve patients globally. |
| Initiated the Phase 2 TERRAIN trial, which is comparing the effect of MDV3100 versus bicalutamide, the most commonly used anti-androgen, on progression-free survival in approximately 370 patients with advanced prostate cancer who have progressed following medical castration with LHRH analog therapy or surgical castration. |
| On track to initiate a Phase 2 trial in the second quarter of 2011 in patients who have not yet received any hormonal therapy. This will be the first trial to evaluate MDV3100 in advanced prostate patients who have not yet undergone medical or surgical castration. |
Dimebon (latrepirdine)
| Announced top-line results from the Phase 3 placebo-controlled HORIZON trial in patients with Huntington disease showing that dimebon was generally well tolerated but did not achieve statistical significance on any of the co-primary or secondary efficacy endpoints. Based on these results, we have discontinued the dimebon program in Huntington disease. |
| On track to report top-line results from the Phase 3 CONCERT trial in the first half of 2012. This 12-month clinical trial in 1,003 patients with mild-to-moderate Alzheimers disease is evaluating the potential efficacy of dimebon when added to ongoing treatment with donepezil, the leading approved treatment for mild-to-moderate Alzheimers disease. |
First Quarter 2011 Financial Results
Revenue for the first quarter of 2011 was $14.7 million, consisting of partial recognition of the non-refundable up-front and development milestone payments to date from the Companys 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 Companys obligations under the applicable collaboration 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 for the same period in 2010. These figures include non-cash stock-based compensation 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 $17.5 million, 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 $12.0 million of non-cash stock-based compensation expense.
Conference Call Information
To participate by telephone in todays 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 Companys website at www.medivation.com. A replay also will be available for 30 days following the live call.
About Medivation
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 Astellas and Pfizer, Medivation currently has investigational drugs in Phase 3 development to treat advanced prostate cancer and mild-to-moderate Alzheimers 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 Medivations product candidates and potential future progress related thereto, the therapeutic potential of Medivations product candidates, the potential completion of patient enrollment in ongoing clinical trials, the planned initiation of additional clinical trials, the planned 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 events or results, the continued effectiveness of, and continuing collaborative activities and benefits under, Medivations collaboration agreements with Pfizer and Astellas, and Medivations anticipated future financial results, including the potential sufficiency of Medivations 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 Medivations actual results to differ significantly from those projected, including, without limitation, risks related to progress, timing and results of Medivations clinical trials, including the risk that adverse clinical trial results could alone or together with other factors result in the delay or discontinuation of some or all of Medivations product development activities and the risk that positive results seen in our prior clinical trials may not be predictive of the results of our ongoing or planned clinical trials, difficulties or delays in enrolling and retaining patients in Medivations clinical trials, including as a result of the availability of competing treatments or clinical trials of competing drugs for the same indication, partnering of Medivations product candidates, including Medivations dependence on the efforts of and funding by Astellas and Pfizer for the development of MDV3100 and dimebon, respectively, the achievement of development, regulatory and commercial milestones under Medivations collaboration agreements, the manufacturing of Medivations product candidates, the adequacy of Medivations financial resources, unanticipated expenditures or liabilities, intellectual property matters, and other risks detailed in Medivations filings with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended March 31, 2011, 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~
MEDIVATION, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(unaudited)
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 | ) | ||
Basic and diluted net loss per common share |
$ | (0.24 | ) | $ | (0.51 | ) | ||
Weighted average common shares used in the calculation of basic and diluted net loss per share |
34,663 | 33,953 | ||||||
MEDIVATION, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
(unaudited)
March 31, 2011 |
December 31, 2010 |
|||||||
ASSETS |
||||||||
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 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
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 | ||||||
Total liabilities |
214,399 | 231,919 | ||||||
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 | ||||