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): April 30, 2015
ALKERMES PUBLIC LIMITED COMPANY
(Exact name of registrant as specified in its charter)
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Ireland
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001-35299
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98-1007018
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(State or other jurisdiction
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(Commission
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(IRS Employer
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of incorporation)
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File Number)
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Identification No.)
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Connaught House, 1 Burlington Road
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Dublin 4, Ireland
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(Address of principal executive offices)
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(Zip Code)
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(Registrant's telephone number, including area code): + 353-1-772-8000
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 (see General Instruction A.2. below):
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☐
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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TABLE OF CONTENTS
Item 2.02 Results of Operations and Financial Condition
On April 30, 2015, Alkermes plc announced financial results for the three months ended March 31, 2015. A copy of the press release is attached hereto as Exhibit 99.1. This information, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Exchange Act, or incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
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Exhibit
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No.
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Description
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99.1
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Press release issued by Alkermes plc dated April 30, 2015 announcing financial results for the three months ended March 31, 2015.
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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.
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ALKERMES PLC
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Date: April 30, 2015
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By:
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/s/ James M. Frates
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James M. Frates
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Senior Vice President and Chief Financial Officer (Principal Financial and Accounting Officer)
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EXHIBIT INDEX
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Exhibit
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No.
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Description
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99.1
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Press release issued by Alkermes plc dated April 30, 2015 announcing financial results for the three months ended March 31, 2015.
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Alkermes Contacts:
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For Investors: Rebecca Peterson, +1 781 609 6378
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For Media: Jennifer Snyder, +1 781 609 6166
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ALKERMES PLC REPORTS FIRST QUARTER 2015 FINANCIAL RESULTS
— First Quarter Revenues of $161.2 Million and Non-GAAP Diluted EPS of $0.06 —
— Late-Stage Pipeline Advancing Rapidly as Company Progresses Pivotal Programs for ALKS 5461 in Depression, ALKS 3831 in Schizophrenia and ALKS 8700 in Multiple Sclerosis —
— Preparing for Launch of Aripiprazole Lauroxil for Schizophrenia —
— 2015 Financial Expectations Reiterated —
DUBLIN, Ireland, April 30, 2015 — Alkermes plc (NASDAQ: ALKS) today reported financial results for the first quarter of 2015.
“Our results this quarter reflect strong revenues from our portfolio of key commercial products and focused investment in our promising late-stage pipeline of CNS product candidates that will drive our future growth,” commented James Frates, Chief Financial Officer of Alkermes. “Our business continues to perform as planned, and today we are reiterating the financial expectations that we provided in March.”
“Alkermes is on the threshold of our next phase of growth and is in the midst of an extremely active time at the company as we advance one of the most exciting late-stage pipelines of CNS medicines in the industry. Aripiprazole lauroxil, our long-acting atypical antipsychotic for schizophrenia, is moving toward FDA approval and launch later this year, and significant progress is being made across our pipeline of emerging blockbusters that offer innovative treatment options for chronic CNS diseases that affect millions of people,” said Richard Pops, Chief Executive Officer of Alkermes. “The ALKS 5461 FORWARD pivotal program in depression continues to enroll well, and, based on exciting new clinical data obtained in the first quarter, we plan to initiate pivotal development for ALKS 3831 in schizophrenia and ALKS 8700 in multiple sclerosis toward the end of 2015.”
Quarter Ended March 31, 2015 Highlights
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Total revenues for the quarter were $161.2 million compared to $130.2 million for the same period in the prior year. |
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Non-GAAP net income was $9.2 million, or a non-GAAP diluted earnings per share (EPS) of $0.06 for the quarter. This compared to non-GAAP net income of $16.2 million, or a non-GAAP diluted EPS of $0.11, for the same period in the prior year. |
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GAAP net loss was $30.7 million, or a basic and diluted GAAP loss per share of $0.21, for the quarter. This compared to GAAP net loss of $24.4 million, or a basic and diluted GAAP loss per share of $0.17, for the same period in the prior year. |
Quarter Ended March 31, 2015 Financial Results
Revenues
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Manufacturing and royalty revenues from the company’s long-acting atypical antipsychotic franchise, RISPERDAL® CONSTA® and INVEGA® SUSTENNA®/XEPLION®, were $46.9 million, compared to $49.6 million for the same period in the prior year. |
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Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1 were $36.5 million, compared to $20.6 million for the same period in the prior year. |
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Net sales of VIVITROL® were $31.1 million, compared to $17.1 million for the same period in the prior year, representing an increase of approximately 82%. |
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Royalty revenue from BYDUREON® was $9.8 million, compared to $7.7 million for the same period in the prior year. |
Costs and Expenses
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Operating expenses were $188.5 million, reflecting increased investment in the company’s rapidly advancing central nervous system (CNS) development pipeline and pre-launch activities for aripiprazole lauroxil. This compared to $146.1 million for the same period in the prior year. |
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Income tax provision was $0.5 million, compared to $3.8 million for the same period in the prior year. |
Balance Sheet
At March 31, 2015, Alkermes had cash and total investments of $805.7 million, compared to $801.6 million at Dec. 31, 2014. At March 31, 2015, the company’s total debt outstanding was $356.4 million.
Subsequent Event
On April 10, 2015, Alkermes closed the transaction to divest its Gainesville, GA manufacturing facility and associated products, as well as IV/IM and parenteral forms of Meloxicam, to Recro Pharma, Inc. in exchange for gross proceeds of $50 million and future payments related to IV/IM and parenteral forms of Meloxicam, including milestone payments of up to $120 million and low double-digit royalties on net sales. During the first quarter, the Gainesville facility and products included in the transaction generated $19.2 million of revenue and $7.3 million of non-GAAP net income.
Financial Expectations
Alkermes reiterates all of its financial expectations for 2015 set forth in its press release dated March 9, 2015.
Conference Call
Alkermes will host a conference call at 8:30 a.m. EDT (1:30 p.m. BST) on Thursday, April 30, 2015, 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 U.S. 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 11:00 a.m. EDT (4:00 p.m. BST) on Thursday, April 30, 2015, through 5:00 p.m. EDT (10:00 p.m. BST) on Thursday, May 7, 2015, and may be accessed by visiting Alkermes’ website or by dialing +1 888 843 7419 for U.S. callers and +1 630 652 3042 for international callers. The replay access code is 6037988.
About Alkermes
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.
Non-GAAP Financial Measures
This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (GAAP), including non-GAAP net income, non-GAAP diluted earnings per share and free cash flow. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies.
Management defines its non-GAAP financial measures as follows:
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Non-GAAP net income adjusts for one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; non-cash tax expense; deferred revenue; and certain other one-time or non-cash items. |
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Free cash flow represents non-GAAP net income less capital expenditures. |
The company’s management believes that these non-GAAP financial measures, when viewed with the company’s results under GAAP and the accompanying reconciliations, better indicate underlying trends in ongoing operations and cash flows. However, non-GAAP net income, non-GAAP diluted earnings per share and free cash flow are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance.
A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release.
Note Regarding Forward-Looking Statements
Certain statements set forth above may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to: statements concerning future financial and operating performance, business plans or prospects; the likelihood of continued revenue growth from the company’s commercial products; the therapeutic and commercial value of the company’s products; and expectations concerning the timing and results of development activities, including regulatory approval of aripiprazole lauroxil and advancement of the company’s product candidates. The company cautions 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 expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: clinical development activities may not be completed on time or at all and the results of such activities may not be predictive of real-world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company, and its partners, may not be able to continue to successfully commercialize its products; there may be a reduction in payment rate or reimbursement for the company’s products or an increase in the company’s financial obligations to governmental payers; the U.S. Food and Drug Administration or regulatory authorities outside the U.S. may make adverse decisions regarding the company’s products; the company’s products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the fiscal year ended Dec. 31, 2014, and in any other subsequent filings made by the company with the Securities and Exchange Commission (“SEC”) and which are available on the SEC’s website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. 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 or revising any forward-looking information contained in this press release.
VIVITROL® is a registered trademark of Alkermes, Inc.; RISPERDAL® CONSTA®, INVEGA® SUSTENNA® and XEPLION® are registered trademarks of Johnson & Johnson Corporation; AMPYRA® and FAMPYRA® are registered trademarks of Acorda Therapeutics, Inc.; BYDUREON® is a registered trademark of Amylin Pharmaceuticals, LLC.
1AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg is developed and marketed in the U.S. by Acorda Therapeutics, Inc. and outside the U.S. by Biogen, under a licensing agreement with Acorda Therapeutics, as FAMPYRA® (prolonged-release fampridine tablets).
(tables follow)