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SEC Filing: Alkermes Provides Outlook
Posted July 19, 2011
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WALTHAM, Mass., - Alkermes, Inc. (NASDAQ: ALKS) today will host its Analyst and Investor Day from 3:00-5:00 p.m. Eastern Time at the Boston Harbor Hotel in Boston.
Alkermes will discuss the business strategy and financial outlook related to the merger of Alkermes with Elan Drug Technologies (EDT) to create Alkermes plc, which was announced in May 2011 and is expected to close, subject to approval of Alkermes' stockholders and the satisfaction of customary closing conditions and regulatory approvals, during the third quarter of calendar 2011. The merger transaction accelerates Alkermes' strategy to build a sustainably profitable biopharmaceutical company with expertise in developing treatments for central nervous system (CNS) diseases and a broad, diversified portfolio of products and pipeline candidates. The company will also provide an update on its financial outlook for Alkermes plc, including revenues and Adjusted EBITDA1 margin expansion, as well as report VIVITROL® (naltrexone for extended-release injectable suspension) net sales for the first quarter of fiscal 2012 and the launch of BYDUREONTM (exenatide extended-release for injectable suspension) in Europe.
Richard Pops, Chief Executive Officer, will discuss the rationale and vision for the merger creating Alkermes plc. Elliot Ehrich, M.D., Chief Medical Officer, will highlight recent advances of Alkermes' products and late-stage pipeline candidates. Shane Cooke, Head of EDT, will discuss the contribution of EDT's product innovation and manufacturing capabilities to Alkermes plc. James Frates, Chief Financial Officer, will discuss the growth outlook and financial expectations for Alkermes plc.
"The creation of Alkermes plc is a significant inflection point in the transformation of Alkermes into a sustainably profitable biopharmaceutical company with growing revenues and margins," commented Richard Pops. "It will be a dramatically different company, with a broad portfolio of diverse and significant commercial products and pipeline candidates to drive growth and profitability."
Analyst and Investor Day Highlights
• Financial Updates: Alkermes will provide expanded financial expectations for Alkermes plc.
- Revenues: In fiscal year 2012, the company expects pro forma revenues to grow at a single-digit rate to a range of $460 million to $480 million. Pro forma revenues of the combined companies on a trailing 12-month basis as of March 31, 2011 were approximately $450 million. Revenue growth for Alkermes plc will be driven by sales from five commercial products, each in their product growth phase and with long patent lives: RISPERDAL® CONSTA® (risperidone long-acting injection); INVEGA® SUSTENNA® (paliperidone palmitate); AMPYRA® (dalfampridine); VIVITROL and BYDUREON.
- Adjusted EBITDA: In fiscal year 2012, the company expects Adjusted EBITDA margins in the 15% to 20% range yielding pro forma Adjusted EBITDA in the range of $70 million to $90 million. In fiscal year 2013 and beyond, Adjusted EBITDA margins are expected to expand to 30% to 35%.
- VIVITROL: Alkermes will announce that VIVITROL had net sales of $9.7 million for the first quarter of fiscal 2012, an increase of 14% over the previous quarter.
- BYDUREON: Alkermes will announce today that BYDUREON has been launched in Europe, with the first commercial sale in the U.K. This triggers a $7 million milestone payment to Alkermes, expected in the second quarter of fiscal year 2012.
• Clinical Pipeline Updates: Alkermes will report several key advances of promising products in its pipeline, including the following:
- ALKS 9070 to enter pivotal clinical program in schizophrenia: Alkermes will provide details on the recently completed phase 1b study of ALKS 9070, a proprietary molecule for the treatment of schizophrenia. ALKS 9070 is designed to provide once-monthly dosing of a medication that converts in vivo into aripiprazole, a molecule that is commercially available under the name ABILIFY®. Alkermes will describe plans to advance ALKS 9070 into pivotal clinical development by the end of calendar 2011.
- ALKS 37 advances into a phase 2b definitive, dose-ranging study for the treatment of opioid-induced constipation (OIC): Alkermes will announce the initiation of a phase 2b study of ALKS 37, an orally-active, peripherally restricted opioid antagonist for the treatment of OIC. The multi-center, randomized, double-blind, placebo-controlled, repeat-dose study is designed to assess the safety, tolerability, efficacy and pharmacokinetic profile of ALKS 37 in approximately 150 patients. According to IMS Health, an estimated 266 million prescriptions were written for opioids in the United States during 2010, and many studies indicate that a high percentage of patients receiving opioids are likely to experience side effects affecting gastrointestinal motility. Alkermes expects to provide topline results from the study mid-year calendar 2012.
- ALKS 5461 phase 1b topline results in treatment-resistant depression (TRD) expected in 2011: Alkermes will provide details on the recently initiated phase 1b study of ALKS 5461 in TRD, with the topline results of this study expected by the end of calendar 2011. The company will describe ALKS 5461's mechanism of action as a non-addictive antagonist of kappa opioid receptors, a promising approach for the treatment of depression.
- Initiation of the VICTORY study: Alkermes will announce the initiation of the VICTORY study (VIVITROL's Cost and Treatment Outcomes RegistrY), an observational, open-label, multi-center registry of approximately 500 opioid dependent patients treated with VIVITROL. The study is designed to evaluate and describe characteristics of patients receiving VIVITROL in real-world clinical practice; assess clinical, health economic and health-related quality of life outcomes and provide additional data to inform future research on VIVITROL. Data readouts from the study will be reported on an ongoing basis.
Webcast
A live webcast of the company's Analyst and Investor Day will begin today at 3:00 p.m. ET and will run until approximately 5:00 p.m. ET. The webcast will be available on the investor relations section of the company's website at www.alkermes.com. To ensure a timely connection to the webcast, it is recommended that users register 15 minutes prior to the scheduled webcast. This webcast will be archived on the Alkermes website.
About Alkermes
Alkermes, Inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients' lives. Alkermes developed, manufactures and commercializes VIVITROL® for alcohol and opioid dependence and manufactures RISPERDAL® CONSTA® for schizophrenia and bipolar I disorder. Alkermes' robust pipeline includes extended-release injectable and oral products for the treatment of prevalent, chronic diseases, such as central nervous system disorders, addiction and diabetes. Headquartered in Waltham, Massachusetts, Alkermes has a research facility in Massachusetts and a commercial manufacturing facility in Ohio.
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