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® (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."
XTANDI® (enzalutamide) capsules
Enzalutamide Clinical Development Program
Enzalutamide in Breast Cancer
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.
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® (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® (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.
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.
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 ============ ============