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WALTHAM, Mass., May 18, 2011 (BUSINESS WIRE) -- Alkermes, Inc. (NASDAQ: ALKS) today reported financial results for the fiscal year ended March 31, 2011, and provided financial expectations for its fiscal year 2012, on a standalone basis.
Other recent highlights:
"We enter fiscal 2012 stronger than ever and poised to build a major new biopharmaceutical company, with global scale and positioned for faster, more diversified and more amplified growth," commented Richard Pops, Chief Executive Officer of Alkermes. "Our plan is to grow Alkermes into a much larger company that will reap the financial benefits of our key marketed products and the novel and proprietary products that are now in clinical development."
Key operating results for fiscal 2011 include the following:
Alkermes is providing pro forma results as a complement to GAAP results. The pro forma measure excludes certain noncash or nonrecurring items, and Alkermes' management believes these pro forma measures help to indicate underlying trends in the company's ongoing operations. The reconciliation between pro forma diluted loss and reported diluted loss per share for fiscal 2011 and 2010 is provided in the following table:
Charges Related to
Costs Related to the
Costs and Expenses
At March 31, 2011, Alkermes had cash and total investments of $294.7 million, compared to $285.0 million at December 31, 2010, and $350.2 million at March 31, 2010. During fiscal 2011, Alkermes reported a net cash outflow from operations of $5.9 million. In addition, in fiscal 2011, Alkermes made principal and interest payments of $46.4 million related to the redemption in full of Alkermes' non-recourse RISPERDAL CONSTA secured 7% Notes.
"During fiscal 2011, we maintained our financial discipline and achieved objectives set out at the beginning of the year, which left us in a position of financial strength," stated James Frates, Chief Financial Officer of Alkermes. "In addition, the merger with EDT will immediately make the company profitable on a cash basis and diversify our revenues. We will have the ability to grow earnings while also laying the foundation for growth by investing prudently in our promising pipeline."
Financial Expectations for Fiscal 2012
The following outlines Alkermes' financial expectations for the fiscal year ending March 31, 2012. These financial expectations do not include any impact of the proposed merger with EDT. Financial expectations for the combined Alkermes/EDT business will be provided upon completion of the transaction. These financial expectations do include the impact of share-based compensation expense. The following statements are forward-looking, and actual results may differ materially. Please see "Note Regarding Forward-Looking Statements" at the end of this release and Alkermes' annual and quarterly reports on file with the U.S. Securities and Exchange Commission (SEC) for a description of risks that could cause results to differ materially from these forward-looking statements.
Alkermes will host a conference call at 4:30 p.m. ET on Wednesday, May 18, 2011, to discuss these financial results and provide an update on the company. The conference call may be accessed by dialing 1-888-424-8151 for domestic callers and 1-847-585-4422 for international callers. The conference call ID number is 6037988. In addition, a replay of the conference call will be available from 7:30 p.m. ET on Wednesday, May 18, 2011, through 5:00 p.m. ET on Wednesday, May 25, 2011, and may be accessed by visiting Alkermes' website or by dialing 1-888-843-7419 for domestic callers and 1-630-652-3042 for international callers. The replay access code is 6037988.
Alkermes, Inc. is a fully integrated biotechnology company committed to developing innovative medicines to improve patients' lives. Alkermes developed, manufactures and commercializes VIVITROL® or 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. For more information, please visit Alkermes' website at www.alkermes.com.
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute "forward-looking statements" as defined by the SEC. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "project," "intend," "plan," "believe," "target," "forecast" and other words and terms of similar meaning or use future dates. Such forward-looking statements include, but are not limited to: statements concerning future financial and operating performance, business plans or prospects; the successful manufacture and commercialization of VIVITROL and RISPERDAL CONSTA, including continued revenue growth from VIVITROL and RISPERDAL CONSTA; statements by Amylin concerning the expected commencement date and duration of the tQT study and timing around the submission of such study results to the FDA; the timing and approval of BYDUREON for the treatment of type 2 diabetes; the likelihood that the merger with EDT is consummated and the timing of such consummation; the financial and operational impact of the Alkermes and EDT merger; the timing, funding and feasibility of clinical trials for our products; and the therapeutic value of the company's products. You are cautioned that forward-looking statements are inherently uncertain.
Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: the company's ability to manufacture RISPERDAL CONSTA and VIVITROL on a commercial scale, economically or in sufficient quantities to supply the market; the company's ability to successfully commercialize VIVITROL in the U.S.; Janssen's ability to successfully commercialize RISPERDAL CONSTA and VIVITROL in Russia; the company's ability to successfully conduct clinical trials in a timely and cost-effective manner; the possibility that the merger with EDT will not be completed because of the failure of one or more conditions, including but not limited to the failure to obtain the required regulatory approval and the failure of Alkermes shareholders to approve the merger; the possibility that the anticipated benefits from the proposed merger with EDT cannot or will not be fully realized; the possibility that costs or difficulties related to integration of the two companies will be greater than expected; whether clinical trial results for the company's products will be predictive of real-world results or of results in subsequent clinical trials; whether advancement of BYDUREON will be delayed due to actions or decisions by Amylin with regard to development and regulatory strategy, timing and funding which are out of the company's control; whether the tQT study will be completed on time or at all; whether the results of the tQT study will demonstrate that exenatide causes an effect on heart rhythm; decisions by foreign regulatory authorities or the FDA regarding the company's products, including the FDA's decision regarding Amylin's New Drug Application submission for BYDUREON; whether the company's products may have unintended side effects, adverse reactions or incidents of misuse that could cause the FDA or other health authorities to require post-approval studies or require removal of the company's products from the market; and those risks described in Part 1, Item 1A, "Risk Factors" of our Annual Report on Form 10-K for the year ended March 31, 2010. The information contained in this press release is provided by the company as of the date hereof, and, except as required by law, the company disclaims any intention or responsibility for updating any forward-looking information contained in this press release.
In connection with the proposed merger, Alkermes plc will file with the SEC a registration statement that will include a preliminary prospectus regarding the proposed merger and Alkermes, Inc. will file with the SEC a proxy statement in respect of the proposed merger. The definitive proxy statement/prospectus will be mailed to the stockholders of Alkermes, Inc. INVESTORS ARE URGED TO CAREFULLY READ THE REGISTRATION STATEMENT AND THE PROXY STATEMENT/PROSPECTUS AND OTHER MATERIALS REGARDING THE PROPOSED MERGER WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT ALKERMES, INC. AND EDT AND THE PROPOSED TRANSACTION. Investors may obtain a free copy of the registration statement and the proxy statement/prospectus when they are available and other documents containing information about EDT and Alkermes, Inc., without charge, at the SEC's website at www.sec.gov. Copies of the proxy statement/prospectus and the filings with the SEC that will be incorporated by reference in the proxy statement/prospectus can also be obtained, when available, without charge, from Elan's website www.elan.com or Alkermes, Inc.'s website at www.alkermes.com.
This communication does not constitute an offer to sell, or the solicitation of an offer to sell, or the solicitation of an offer to subscribe for, or buy, any securities, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
Participants in Solicitation
This communication is not a solicitation of a proxy from any Alkermes shareholder. Alkermes, Inc. and its directors, officers and certain other members of management may, however, be deemed to be participants in the solicitation of proxies from Alkermes, Inc.'s shareholders in respect of the proposed merger. Information about these persons can be found in Alkermes, Inc.'s Annual Report on Form 10-K for the year ended March 31, 2010, as filed with the SEC on May 21, 2010. Additional information about the interests of such persons in the solicitation of proxies in respect of the merger will be included in the registration statement and the proxy statement/prospectus to be filed with the SEC in connection with the proposed merger. Investors can obtain free copies of these documents as described above.
VIVITROL® is a trademark of Alkermes, Inc. RISPERDAL® CONSTA® is a trademark of Janssen-Cilag group of companies. BYDUREON(TM) is a trademark of Amylin Pharmaceuticals, Inc.
Alkermes, Inc. and Subsidiaries
Selected Financial Information (Unaudited)
|Consolidated Statements of Operations||March 31,||March 31,|
|(In thousands, except per share data)||2011||2010|
|Product sales, net||28,920||20,245|
|Research and development revenue under collaborative arrangements||880||3,117|
|Net collaborative profit||-||5,002|
|Cost of goods manufactured and sold||52,185||49,438|
|Research and development||97,239||95,363|
|Selling, general and administrative||82,847||76,514|
|Other Expense, net:|
|Other expense, net||(290)||(360)|
|Total Other Expense, net||(860)||(1,667)|
|Loss Before Income Taxes||(46,491)||(44,701)|
|Income Tax Benefit||(951)||(5,075)|
|Loss per Common Share:|
|Basic and Diluted||$||(0.48)||$||(0.42)|
Weighted Average Number of Common Shares
|Basic and Diluted||95,610||94,839|
|Pro Forma Reconciliation:|
|Net Loss - GAAP||$||(45,540)||$||(39,626)|
|Share-based compensation and severance expense||19,832||15,327|
|Costs related to the redemption of the non-recourse 7% Notes||2,168||-|
Costs incurred related to the
|Net Loss - Pro Forma||$||(23,540)||$||(5,350)|
|Pro Forma Loss per Common Share:|
|Basic and Diluted||$||(0.25)||$||(0.06)|
|Consolidated Balance Sheets||March 31,||March 31,|
|Cash, cash equivalents and total investments||$||294,730||$||350,193|
|Prepaid expenses and other current assets||8,244||10,936|
|Property, plant and equipment, net||95,020||96,905|
|Non-recourse RISPERDAL CONSTA secured 7% notes - current||$||-||$||51,043|
|Other current liabilities||48,057||40,101|
|Deferred revenue - long-term||4,837||5,105|
|Other long-term liabilities||7,536||6,735|
|Total shareholders' equity||392,018||412,616|
|Total Liabilities and Shareholders' Equity||$||452,448||$||515,600|
This selected financial information should be read in conjunction with the consolidated financial
Alkermes Inc. and Subsidiaries
Quarterly Financial Data (Unaudited)
|Three Months Ended||Year Ended|
|June 30,||September 30,||December 31,||March 31,||March 31,|
|(In thousands, except per share data)|
|Product sales, net||6,204||6,469||7,729||8,518||28,920|
|Research and development revenue under collaborative arrangements||268||155||314||143||880|
|Cost of goods manufactured and sold||12,665||13,911||12,860||12,749||52,185|
|Research and development||22,977||23,932||22,503||27,827||97,239|
|Selling, general and administrative||19,726||18,436||20,521||24,164||82,847|
|Total Other Expense (Income), net||(379)||(1,577)||567||529||(860)|
|Loss Before Income Taxes||(13,467)||(8,609)||(11,342)||(13,073)||(46,491)|
|Income Tax (Benefit) Provision||(58)||(943)||41||9||(951)|
|Loss Per Common Share:|
|Basic and diluted||$||(0.14)||$||(0.08)||$||(0.12)||$||(0.14)||$||(0.48)|
|Weighted Average Number of Common Shares Outstanding:|
|Basic and diluted||95,326||95,511||95,667||95,939||95,610|
SOURCE: Alkermes, Inc.
Rebecca Peterson, 781-609-6378
Jennifer Snyder, 781-609-6166