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Medivation Reports First Quarter Financial Results and Provides Corporate Update

Medivation Reports First Quarter Financial Results and Provides Corporate Update  Collaboration Revenue Increased 89 Percent Year-on-Year; XTANDI U.S. Net Sales Increased 65 Percent Year-on-Year; Conference Call Today at 4:30 p.m. Eastern Time  SAN FRANCISCO, CA -- (Marketwired) -- 05/08/14 --  Medivation, Inc. (NASDAQ: MDVN) today provided a corporate update and reported its financial results for the first quarter ended March 31, 2014. U.S. net sales of XTANDI(R) (enzalutamide) capsules for the quarter, as reported by Astellas, were $124.5 million. Ex-U.S. net sales of XTANDI for the quarter, as reported by Astellas, were $47.8 million.   "We continue to be pleased with the sales performance of XTANDI in the United States and with Astellas' progress to expand access to XTANDI worldwide. To date, XTANDI has been approved in more than 40 countries for the treatment of patients with mCRPC who have previously received docetaxel," said David Hung, M.D., president and chief executive officer of Medivation. "We remain committed to identifying new therapies that will improve the current standard of care. Oncology is an important area of focus for Medivation and our license agreement with OncoFusion Therapeutics for BET bromodomain inhibitors sets the stage for future innovation in this important area of need."  Recent Developments   XTANDI(R) (enzalutamide) capsules      --  U.S. net sales of XTANDI were $124.5 million in the first quarter of     2014. XTANDI was approved by the U.S. Food and Drug Administration     (FDA) for the treatment of patients with metastatic     castration-resistant prostate cancer (mCRPC) who have previously     received docetaxel on August 31, 2012 and was made available for     shipment on September 13, 2012. Medivation and Astellas are jointly     responsible for commercialization and development of XTANDI in the     U.S. and share equally in the costs (subject to certain exceptions),     profits and losses arising from U.S. development and commercialization     of XTANDI.           --  Ex-U.S. net sales of XTANDI were $47.8 million in the first quarter of     2014. XTANDI was granted marketing authorization in the European Union     in June 2013. Outside of the U.S., Astellas has responsibility for     developing and commercializing XTANDI and pays Medivation a tiered     royalty ranging from the low teens to the low twenties on aggregate     net sales of XTANDI.           --  XTANDI is approved in more than 40 countries for the treatment of     patients with mCRPC who have previously received docetaxel. In March,     Astellas obtained XTANDI marketing approval for the treatment of     patients with castration-resistant prostate cancer in Japan with the     precaution that the efficacy and safety of the drug have not been     established in patients with prostate cancer who have not received     chemotherapy. The Japanese marketing authorization triggered a $15     million milestone payment to Medivation during the first quarter under     its collaboration agreement with Astellas.           --  The FDA accepted the supplemental New Drug Application (sNDA) filling     to extend the indication for XTANDI for the treatment of men with     mCRPC who have not received chemotherapy and granted priority review     designation. The Prescription Drug User Fee Act (PDUFA) date for the     completion of the FDA's review for the sNDA is September 18, 2014. The     FDA's acceptance for filing of the sNDA triggered a $25 million     milestone payment to Medivation during the second quarter under its     collaboration agreement with Astellas.           --  Astellas submitted a variation to amend the European Marketing     Authorization Application for XTANDI for the treatment of adult men     with mCRPC who are asymptomatic or mildly symptomatic after failure of     androgen deprivation therapy and in whom chemotherapy is not yet     clinically indicated. The European Medicines Agency validated     Astellas' application for an amended European Marketing Authorization     Application and accepted the filing in April 2014, which triggered a     $15 million milestone payment to Medivation.     Enzalutamide Clinical Development Program      --  Continued patient enrollment in the Phase 3 PROSPER trial evaluating     the safety and efficacy of enzalutamide in approximately 1,500     patients with non-metastatic CRPC. PROSPER will enroll a high-risk     subgroup of patients with prostate cancer who are progressing despite     androgen deprivation therapy, but who are asymptomatic with no prior     or present evidence of metastatic disease. The primary endpoint of the     trial is metastasis-free survival.           --  Advanced the prostate cancer development program comparing     enzalutamide's effects on progression-free-survival when compared     head-to-head versus bicalutamide, the most commonly used     anti-androgen, in men who have progressed following medical castration     with a luteinizing hormone releasing hormone (LHRH) analog therapy or     surgical castration.               --  Completed patient enrollment in the TERRAIN trial in July 2013,         which enrolled approximately 370 men with mCRPC disease primarily         in Europe; and                       --  Completed patient enrollment in the STRIVE trial in March 2014,         which enrolled approximately 400 men with either metastatic or         non-metastatic disease in the U.S.                   --  Continued patient enrollment in the Phase 4 PLATO trial evaluating the     efficacy and safety of continued treatment with enzalutamide plus     abiraterone acetate and prednisone as compared to treatment with     abiraterone acetate and prednisone alone in patients with     pre-chemotherapy mCRPC whose disease has progressed following     enzalutamide therapy. The purpose of the trial is to help determine     the potential clinical benefit of continuing androgen receptor     signaling inhibition with enzalutamide treatment and adding an     additional therapy in patients with pre-chemotherapy mCRPC. The global     randomized, double-blind, placebo-controlled trial is designed to     enroll approximately 500 chemotherapy-naive patients with mCRPC.     The primary endpoint of the trial is progression-free survival.     Enzalutamide in Breast Cancer      --  Continued patient enrollment in the Phase 2 clinical trial evaluating     enzalutamide in combination with exemestane in women with advanced     breast cancer that is estrogen receptor positive (ER+) or progesterone     receptor positive (PgR+) and human epidermal growth factor 2, or HER2     normal. The Phase 2 randomized, double-blind, placebo controlled,     multicenter trial plans to enroll approximately 240 patients in two     parallel cohorts of 120 patients each. The first cohort will enroll     patients who have not previously received hormonal treatment for     advanced breast cancer. The second cohort will enroll patients who     have previously progressed following one hormonal treatment for     advanced disease. The primary endpoint of the trial is progression     free survival in all patients and in the subset of patients whose     tumor expresses the androgen receptor.           --  Continued patient enrollment in a Phase 2 clinical trial evaluating     enzalutamide as a single agent for the treatment of advanced, androgen     receptor positive (AR+), triple-negative breast cancer, or TNBC. TNBC     is a type of cancer which is not driven by the three most commonly     targeted receptors in breast cancer: estrogen, progesterone and HER2.     The Phase 2 open label, single-arm, multicenter trial plans to enroll     approximately 80 patients with AR+, TNBC at sites in the United     States, Canada and Europe. The primary endpoint of the trial is     clinical benefit rate, defined as the proportion of patients with a     best response of complete response, partial response or stable disease     at ≥ 16 weeks.     Corporate Developments      --  Entered into a research and license agreement with OncoFusion     Therapeutics, Inc., for certain compounds targeting Bromodomain and     Extra-Terminal (BET) proteins for potential use in oncology and other     disease areas. Medivation gained exclusive worldwide rights for the     development and commercialization of these compounds. Under the terms     of the agreement, Medivation will have access to OncoFusion's growing     library of small molecule BET bromodomain inhibitor compounds from     which Medivation may select compounds to move forward in its drug     discovery and development efforts.           --  Appointed Rick Bierly chief financial officer in March 2014. Rick     brings to Medivation over 30 years experience in finance roles at     GlaxoSmithKline, Aventis, Centocor and Johnson & Johnson.           --  Appointed Patrick Machado to Medivation's board of directors. After     nearly 10 years at Medivation, Pat retired from his role as chief     financial officer in March 2014 and chief business officer in April     2014.     First Quarter Financial Results  Medivation's collaboration revenue was $87.2 million for the first quarter of 2014, consisting of three components: collaboration revenue attributable to U.S. XTANDI net sales, collaboration revenue attributable to ex-U.S. XTANDI net sales and collaboration revenue attributable to upfront and milestone payments.       --  U.S. net sales of XTANDI for the first quarter of 2014 were $124.5     million, an increase of 65%, compared with $75.4 million for the same     period in 2013. Collaboration revenue attributable to U.S. net sales     of XTANDI for the first quarter of 2014 was $62.2 million compared to     $37.7 million in 2013.           --  Ex-U.S. net sales of XTANDI for the first quarter were $47.8 million,     compared with $0.3 million for the same period in 2013. XTANDI was     granted marketing authorization in the European Union in June 2013.     Collaboration revenue attributable to ex-U.S. net sales of XTANDI for     the first quarter of 2014 was $5.7 million.           --  Collaboration revenue attributable to upfront and milestone payments     for the first quarter of 2014 was $19.2 million.     Total operating expenses for the quarter ended March 31, 2014 were $95.7 million, compared with total operating expenses of $68.5 million for the same period in 2013. These figures include non-cash stock-based compensation expense of $9.7 million in the quarter ended March 31, 2014, compared with $8.3 million for the same period in 2013.  Medivation reported a net loss of $13.7 million, or $0.18 per diluted share, for the quarter ended March 31, 2014, compared with a net loss of $27.2 million, or $0.36 per diluted share, for the same period in 2013.   At March 31, 2014, cash, cash equivalents and short-term investments totaled $241.5 million, compared with $228.8 million at December 31, 2013.   2014 Financial Outlook  For the full year 2014, Medivation expects U.S. net sales of XTANDI to be between $540 million and $575 million. Medivation expects 2014 total operating expenses, net of cost-sharing payments from Astellas, to be between $400 million and $430 million, approximately $45 million to $50 million of which consists of non-cash stock-based compensation expense and excludes the cost of future in-licensing opportunities we may elect to pursue, if any.   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. Individuals may access the live audio webcast by visiting http://investors.medivation.com/events.cfm. A replay of the webcast will be available on the Company's website for a limited time following the live event.  About XTANDI(R) (enzalutamide) capsules   XTANDI was approved by the FDA on August 31, 2012 and is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received docetaxel.  Important Safety Information for XTANDI from the Approved Prescribing Information   Contraindications- XTANDI can cause fetal harm when administered to a pregnant woman based on its mechanism of action. XTANDI is not indicated for use in women. XTANDI is contraindicated in women who are or may become pregnant.   Warnings and Precautions- In the randomized clinical trial, seizure occurred in 0.9% of patients on XTANDI. No patients on the placebo arm experienced seizure. Patients experiencing a seizure were permanently discontinued from therapy. All seizures resolved. Patients with a history of seizure, taking medications known to decrease the seizure threshold, or with other risk factors for seizure were excluded from the clinical trial. Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others.   Adverse Reactions- The most common adverse drug reactions (≥ 5%) reported in patients receiving XTANDI in the randomized clinical trial were asthenia/fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal pain, headache, upper respiratory infection, muscular weakness, dizziness, insomnia, lower respiratory infection, spinal cord compression and cauda equina syndrome, hematuria, paresthesia, anxiety, and hypertension. Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and in 6% on placebo (no Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients and 2% on placebo. One percent of XTANDI patients compared to 0.3% on placebo died from infections or sepsis. Falls or injuries related to falls occurred in 4.6% of XTANDI patients vs 1.3% on placebo. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients and included non-pathologic fractures, joint injuries, and hematomas. Grade 1 or 2 hallucinations occurred in 1.6% of XTANDI patients and 0.3% on placebo, with the majority on opioid-containing medications at the time of the event.   Drug Interactions- Effect of Other Drugs on XTANDI: Administration of strong CYP2C8 inhibitors can increase the plasma exposure to XTANDI. Co-administration of XTANDI with strong CYP2C8 inhibitors should be avoided if possible. If co-administration of XTANDI cannot be avoided, reduce the dose of XTANDI. Co-administration of XTANDI with strong or moderate CYP3A4 and CYP2C8 inducers can alter the plasma exposure of XTANDI and should be avoided if possible.   Effect of XTANDI on Other Drugs: XTANDI is a strong CYP3A4 inducer and a moderate CYP2C9 and CYP2C19 inducer in humans. Avoid CYP3A4, CYP2C9 and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.   Please visit www.XtandiHCP.com for full Prescribing Information for XTANDI(R) (enzalutamide) capsules.   About the Medivation/Astellas Collaboration   In October 2009, Medivation and Astellas entered into a global agreement to jointly develop and commercialize enzalutamide. The companies are collaborating on a comprehensive development program that includes studies to develop enzalutamide across the full spectrum of advanced prostate cancer as well as advanced breast cancer. The companies jointly commercialize XTANDI in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.   About Medivation  Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel therapies 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 families. For more information, please visit us at http://www.medivation.com.  Forward-Looking Statements  The statements in this press release under the caption "2014 Financial Outlook" are forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws. 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 the timing, progress and results of Medivation's clinical trials, including the risk that adverse clinical trial results could alone or together with other factors result in the delay or discontinuation of the commercialization of XTANDI or some or all of Medivation's product development activities; Medivation's dependence on the efforts of and funding by Astellas for the commercialization of XTANDI; the risk of unanticipated expenditures or liabilities; and other risks detailed in Medivation's filings with the Securities and Exchange Commission, or SEC, including its quarterly report on Form 10-Q for the quarter ended March 31, 2014, which is expected to be filed on May 8, 2014 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, supplement or revise any forward-looking statements contained in this press release.                                                                                                                  MEDIVATION, INC.                                                       CONSOLIDATED BALANCE SHEETS                                        (in thousands, except share and per share data)                                                (unaudited)                                                                                                                                                                                                                                               March 31,   December 31,                                                       2014          2013                                                       ------------  ------------  ASSETS                                                                       Current assets:                                                                Cash and cash equivalents                      $    241,469  $    228,788    Receivable from collaboration partner                93,251       107,210    Prepaid expenses and other current assets            17,129        17,981                                                   ------------  ------------                                                                                   Total current assets                              351,849       353,979  Property and equipment, net                            18,001        17,035  Restricted cash                                        11,972         9,899  Other non-current assets                               16,238        11,737                                                   ------------  ------------                                                                               Total assets                                     $    398,060  $    392,650                                                   ============  ============                                                                               LIABILITIES AND STOCKHOLDERS' EQUITY                                         Current liabilities:                                                           Accounts payable, accrued expenses and other                                  current liabilities                           $     78,154  $     78,758    Deferred revenue                                     12,698        16,931                                                   ------------  ------------                                                                                   Total current liabilities                          90,852        95,689  Convertible Notes, net of unamortized discount of                             $47,079 and $50,336 at March 31, 2014 and                                    December 31, 2013, respectively                      211,671       208,414  Other non-current liabilities                          13,584        11,600                                                   ------------  ------------                                                                                   Total liabilities                                 316,107       315,703  Commitments and contingencies                                                                                                                             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;                                      170,000,000 shares authorized; 76,513,737 and                                75,803,020 shares issued and outstanding at                                  March 31, 2014 and December 31, 2013,                                        respectively                                           765           758    Additional paid-in capital                          429,014       410,350    Accumulated deficit                                (347,826)     (334,161)                                                  ------------  ------------                                                                                   Total stockholders' equity                         81,953        76,947                                                   ------------  ------------                                                                               Total liabilities and stockholders' equity       $    398,060  $    392,650                                                   ============  ============                                                                                                                                                                                                                                                                       MEDIVATION, INC.                                                  CONSOLIDATED STATEMENTS OF OPERATIONS                                        (in thousands, except per share data)                                                     (unaudited)                                                                                                                                                                                                                                                 Three Months Ended                                                                March 31,                                                           --------------------------                                                       2014          2013                                                       ------------  ------------  Collaboration revenue                            $     87,189  $     46,154  Operating expenses:                                                            Research and development expenses                    45,919        24,908    Selling, general and administrative expenses         49,735        43,568                                                   ------------  ------------                                                                                   Total operating expenses                           95,654        68,476                                                   ------------  ------------                                                                               Loss from operations                                   (8,465)      (22,322) Other income (expense), net:                                                   Interest expense                                     (5,230)       (4,888)   Interest income                                           9            74    Other expense, net                                      (38)           (1)                                                  ------------  ------------                                                                                   Total other income (expense), net                  (5,259)       (4,815)                                                  ------------  ------------                                                                               Net loss before income tax benefit (expense)          (13,724)      (27,137) Income tax benefit (expense)                               59           (33)                                                  ------------  ------------                                                                               Net loss                                         $    (13,665) $    (27,170)                                                  ============  ============                                                                               Basic and diluted net loss per common share      $      (0.18) $      (0.36)                                                  ============  ============                                                                               Weighted average common shares used in the                                    calculation of basic and diluted net loss per                                common share                                          76,245        74,824                                                   ============  ============      Contacts: Rick Bierly Chief Financial Officer (415) 543-3470  Anne Bowdidge Sr. Director, Investor Relations (650) 218-6900     
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