ALKS Alkermes PLC

— Second Quarter Revenues of $151.4 Million and Non-GAAP Diluted Loss Per Share of $0.09 —

— Alkermes Unveils ARISTADA™ as Proposed Brand Name for Aripiprazole Lauroxil;Final Launch Preparations Underway in Advance of Aug. 22, 2015 PDUFA Date —

— Company Improves Financial Expectations for 2015 Driven by Strong VIVITROL® Performance —

Alkermes plc (NASDAQ: ALKS) today reported financial results for the second quarter of 2015.

“With the PDUFA date for ARISTADA™, our proposed brand name for aripiprazole lauroxil, just a few weeks away, we are in the midst of final launch preparations for this important potential new treatment option for patients with schizophrenia. Our field sales force is in position, our comprehensive patient support services are ready and launch quantities have been manufactured,” said Richard Pops, Chief Executive Officer of Alkermes. “ARISTADA, our long-acting atypical antipsychotic product candidate for schizophrenia, is leading the next wave of Alkermes’ emerging blockbusters that offer innovative treatment options for chronic CNS diseases that affect millions of people. Our late-stage pipeline of product candidates, including ALKS 5461 in depression, ALKS 3831 in schizophrenia, and ALKS 8700 in multiple sclerosis, has been purposefully designed to address areas of major unmet medical need and to be responsive to today’s regulatory and payer environments.”

“Our second quarter financial results were driven by the strong revenues from our core portfolio of commercial products, important investments in the development of our late-stage CNS pipeline and the launch preparations for ARISTADA,” commented James Frates, Chief Financial Officer of Alkermes. “Today we are improving our financial expectations for the remainder of 2015, driven by the accelerating quarterly growth in net sales of VIVITROL®, our long-acting injectable medication for the treatment of opioid dependence and alcohol dependence.”

Quarter Ended June 30, 2015 Highlights

• Total revenues for the quarter were $151.4 million compared to $153.4 million for the same period in the prior year. The prior year period included $21.1 million of revenues from the products associated with the Gainesville manufacturing facility that was divested in April 2015.
• Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $46.1 million, or a basic and diluted GAAP loss per share of $0.31, for the quarter. This compared to GAAP net income of $3.7 million, or a basic GAAP earnings per share (EPS) of $0.03 and a diluted GAAP EPS of $0.02, for the same period in the prior year, which included GAAP net income of $7.3 million related to the Gainesville facility and associated products and $27.6 million of net income from two one-time transactions.
• Non-GAAP net loss was $13.6 million, or a non-GAAP diluted loss per share of $0.09 for the quarter. This compared to non-GAAP net income of $17.7 million, or a non-GAAP diluted EPS of $0.11, for the same period in the prior year, which included non-GAAP net income of $10.6 million related to the Gainesville facility and associated products.
• On April 10, 2015, Alkermes closed the transaction to divest its Gainesville, Ga. facility and associated products, as well as rights to IV/IM and parenteral forms of Meloxicam (Meloxicam), to Recro Pharma, Inc. (Recro) in exchange for gross proceeds of $54 million and future payments related to Meloxicam, including milestone payments of up to $120 million and low double-digit royalties on net sales. Alkermes recorded a gain on this transaction of $9.9 million during the second quarter, which was recorded as a component of other income, net.

Quarter Ended June 30, 2015 Financial Results

Revenues

• Manufacturing and royalty revenues from the company’s long-acting atypical antipsychotic franchise, RISPERDAL® CONSTA® and INVEGA® SUSTENNA®/XEPLION®, were $60.8 million, compared to $60.0 million for the same period in the prior year.
• Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1 were $26.9 million, compared to $19.5 million for the same period in the prior year.
• Net sales of VIVITROL were $37.2 million, compared to $21.6 million for the same period in the prior year, representing an increase of approximately 72%.
• Royalty revenue from BYDUREON® was $11.1 million, compared to $8.8 million for the same period in the prior year.

Costs and Expenses

• Operating expenses were $203.9 million, reflecting increased investment in the company’s rapidly advancing central nervous system (CNS) development pipeline and pre-launch activities for ARISTADA. This compared to $176.2 million for the same period in the prior year, which included $13.2 million related to the Gainesville facility and associated products.
• Income tax provision was $3.1 million, compared to an income tax benefit of $1.5 million for the same period in the prior year.

Balance Sheet

At June 30, 2015, Alkermes had cash and total investments of $832.4 million, compared to $801.6 million at Dec. 31, 2014. At June 30, 2015, the company’s total debt outstanding was $354.8 million.

Financial Expectations

Alkermes is updating its financial expectations for 2015 as a result of accelerating growth trends for VIVITROL, which are driving a $10 million increase in expected revenues and $8 million improvement in expected non-GAAP net loss. The following outlines Alkermes’ updated financial expectations for 2015.

• Revenues: Alkermes now expects total revenues to range from $610 million to $640 million, up from the previous range of $600 million to $630 million.
  • Alkermes now expects VIVITROL net sales to range from $135 million to $145 million, up from a previous range of $125 million to $135 million.
  • The company continues to expect net sales from the anticipated launch of ARISTADA to range from $5 million to $10 million.
• Cost of Goods Manufactured and Sold: The company continues to expect cost of goods manufactured and sold to range from $130 million to $140 million.
• R&D Expenses: The company continues to expect R&D expenses to range from $345 million to $365 million.
• Selling, General and Administrative (SG&A) Expenses: The company continues to expect SG&A expenses to range from $310 million to $330 million.
• Amortization of Intangible Assets: The company now expects amortization of intangible assets of approximately $60 million, reduced from the previous expectation of approximately $65 million.
• Net Interest Expense: The company continues to expect net interest expense to range from $10 million to $15 million.
• Other Income, Net: The company now expects other income, net to range from $10 million to $15 million, driven primarily by the gain on the sale of the Gainesville facility and associated products during the second quarter and changes in the fair value of the contingent consideration and warrants received as part of the transaction.
• Net Income Tax Expense: The company continues to expect net income tax expense to range from $10 million to $15 million.
• GAAP Net Loss: The company now expects GAAP net loss to range from $245 million to $270 million, or a basic and diluted loss per share of $1.63 to $1.80, based on weighted average basic and diluted share counts of approximately 150 million shares outstanding. This compares to previous expectations of GAAP net loss in the range of $270 million to $300 million, or a basic and diluted loss per share of approximately $1.80 to $2.00, based on weighted average basic and diluted share counts of approximately 150 million shares outstanding.
• Non-GAAP Net Loss: The company now expects non-GAAP net loss to range from $47 million to $67 million, or a basic and diluted loss per share of $0.31 to $0.45, based on weighted average basic and diluted share counts of approximately 150 million shares outstanding. This compares to previous expectations of non-GAAP net loss in the range of $55 million to $75 million, or a non-GAAP diluted loss per share of $0.37 to $0.50, based on a weighted average diluted share count of approximately 150 million shares outstanding.
• Capital Expenditures: The company continues to expect capital expenditures to be approximately $50 million.
• Free Cash Outflow: The company now expects free cash outflow to range from $97 million to $117 million. This compares to previous expectations of free cash outflow in the range of $105 million to $125 million.

Conference Call

Alkermes will host a conference call at 8:30 a.m. EDT (1:30 p.m. BST) on Thursday, July 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, July 30, 2015, through 5:00 p.m. EDT (10:00 p.m. BST) on Thursday, August 6, 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 or loss, non-GAAP diluted earnings or loss 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:

• Non-GAAP net income or loss 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.
• Free cash flow represents non-GAAP net income or loss 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 or loss, non-GAAP diluted earnings or loss 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 ARISTADA (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 “Item 1A. Risk Factors” in the company’s Annual Report on Form 10-K for the fiscal year ended Dec. 31, 2014, under the heading “Item 1A. Risk Factors” in the company’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2015, and in any other subsequent filings made by the company with the Securities and Exchange Commission (“SEC”), 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.

ARISTADA™ is a trademark of Alkermes Pharma Ireland Limited; 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 International GmbH, under a licensing agreement with Acorda Therapeutics, Inc., as FAMPYRA® (prolonged-release fampridine tablets).

 

Alkermes plc and SubsidiariesSelected Financial Information (Unaudited)

 

         

Three Months

Three Months Ended Ended Condensed Consolidated Statements of Operations - GAAP June 30, June 30, (In thousands, except per share data) 2015 2014 Revenues: Manufacturing and royalty revenues $ 113,162 $ 130,366 Product sales, net 37,172 21,595 Research and development revenues 1,036   1,463   Total Revenues 151,370   153,424   Expenses: Cost of goods manufactured and sold 30,418 43,290 Research and development 87,882 67,207 Selling, general and administrative 71,539 50,663 Amortization of acquired intangible assets 14,052   15,089   Total Expenses 203,891   176,249   Operating Loss (52,521 ) (22,825 ) Other Income, net: Interest income 795 323 Interest expense (3,315 ) (3,385 ) Gain on Gainesville Transaction 9,911 - Increase in the fair value of contingent consideration 1,500 - Gain on sale of property, plant and equipment - 12,285 Other income, net 585 518 Gain on sale of investment in Acceleron Pharma Inc. -   15,296   Total Other Income, net 9,476   25,037   (Loss) Income Before Income Taxes (43,045 ) 2,212   Income Tax Provision (Benefit) 3,064   (1,523 ) Net (Loss) Income — GAAP $ (46,109 ) $ 3,735     (Loss) Earnings Per Share: GAAP (loss) earnings per share — basic $ (0.31 ) $ 0.03   GAAP (loss) earnings per share — diluted $ (0.31 ) $ 0.02   Non-GAAP (loss) earnings per share — basic $ (0.09 ) $ 0.12   Non-GAAP (loss) earnings per share — diluted $ (0.09 ) $ 0.11     Weighted Average Number of Ordinary Shares Outstanding: Basic — GAAP 148,867   144,913   Diluted — GAAP 148,867   154,300   Basic — Non-GAAP 148,867   144,140   Diluted — Non-GAAP 148,867   153,833     An itemized reconciliation between net (loss) income on a GAAP basis and non-GAAP net (loss) income is as follows: Net (Loss) Income — GAAP $ (46,109 ) $ 3,735 Adjustments: Share-based compensation expense 21,877 19,337 Amortization expense 14,052 15,089 Depreciation expense 6,584 9,844 Non-cash net interest expense 235 239 Non-cash taxes 3,034 (2,207 ) Deferred revenue (574 ) (338 ) Net loss on transactions with equity method investee (397 ) (396 ) Gain on Gainesville Transaction (9,911 ) - Increase in the fair value of contingent consideration (1,500 ) - Change in the fair value of common stock warrants (876 ) - Gain on sale of investment in Acceleron Pharma Inc. - (15,296 ) Gain on sale of property, plant and equipment -   (12,285 ) Non-GAAP Net (Loss) Income $ (13,585 ) $ 17,722 Capital expenditures 14,046   5,753   Free Cash (Outflow) Inflow $ (27,631 ) $ 11,969            

Six Months

Six Months Ended Ended Condensed Consolidated Statements of Operations - GAAP June 30, June 30, (In thousands, except per share data) 2015 2014 Revenues: Manufacturing and royalty revenues $ 241,906 $ 241,646 Product sales, net 68,309 38,674 Research and development revenues 2,369   3,316   Total Revenues 312,584   283,636   Expenses: Cost of goods manufactured and sold 70,392 82,129 Research and development 158,160 119,347 Selling, general and administrative 134,589 93,213 Amortization of acquired intangible assets 29,272   27,665   Total Expenses 392,413     322,354   Operating Loss (79,829 )   (38,718 ) Other Income, net: Interest income 1,455 834 Interest expense (6,603 ) (6,741 ) Gain on Gainesville Transaction 9,911 - Increase in the fair value of contingent consideration 1,500 - Gain on sale of property, plant and equipment - 12,285 Other income (expense), net 374 (1,332 ) Gain on sale of investment in Acceleron Pharma Inc. -   15,296   Total Other Income, net 6,637   20,342   Loss Before Income Taxes (73,192 ) (18,376 ) Income Tax Provision 3,574   2,243   Net Loss — GAAP $ (76,766 ) $ (20,619 )   (Loss) Earnings Per Share: GAAP loss per share — basic $ (0.52 ) $ (0.14 ) GAAP loss per share — diluted $ (0.52 ) $ (0.14 ) Non-GAAP (loss) earnings per share — basic $ (0.03 ) $ 0.24   Non-GAAP (loss) earnings per share — diluted $ (0.03 ) $ 0.22     Weighted Average Number of Ordinary Shares Outstanding: Basic — GAAP 148,480   144,140   Diluted — GAAP 148,480   144,140   Basic — Non-GAAP 148,480   144,140   Diluted — Non-GAAP 148,480   153,833     An itemized reconciliation between net loss on a GAAP basis and non-GAAP net (loss) income is as follows: Net Loss — GAAP $ (76,766 ) $ (20,619 ) Adjustments: Share-based compensation expense 39,206 32,757 Amortization expense 29,272 27,665 Depreciation expense 13,850 19,821 Non-cash net interest expense 471 479 Non-cash taxes 3,522 1,415 Deferred revenue (902 ) (1,303 ) Net loss on transactions with equity method investee (794 ) 1,239 Gain on Gainesville Transaction (9,911 ) - Increase in the fair value of contingent consideration (1,500 ) - Change in the fair value of common stock warrants (876 ) - Gain on sale of investment in Acceleron Pharma Inc. - (15,296 ) Gain on sale of property, plant and equipment -   (12,285 ) Non-GAAP Net (Loss) Income $ (4,428 ) $ 33,873 Capital expenditures 24,756   11,438   Free Cash (Outflow) Inflow $ (29,184 ) $ 22,435               Condensed Consolidated Balance Sheets June 30, December 31, (In thousands) 2015 2014 Cash, cash equivalents and total investments $ 832,358 $ 801,646 Receivables 135,783 151,551 Inventory 38,801 51,357 Prepaid expenses and other current assets 65,279 42,719 Property, plant and equipment, net 239,258 265,740 Intangible assets, net and goodwill 500,472 573,624 Contingent consideration 59,100 - Other assets 43,460 34,635 Total Assets $ 1,914,511 $ 1,921,272 Long-term debt — current portion $ 6,750 $ 6,750 Other current liabilities 127,468 123,832 Long-term debt 348,056 351,220 Deferred revenue — long-term 7,805 11,801 Other long-term liabilities 25,441 30,832 Total shareholders' equity 1,398,991 1,396,837 Total Liabilities and Shareholders' Equity $ 1,914,511 $ 1,921,272   Ordinary shares outstanding (in thousands) 149,304 147,539                 This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in Alkermes plc's Quarterly Report on Form 10-Q for the three and six months ended June 30, 2015, which the company intends to file in July 2015.    

Alkermes plc and Subsidiaries2015 Guidance — GAAP to Non-GAAP Adjustments

 

                An itemized reconciliation between projected loss per share on a GAAP basis and projected loss per share on a non-GAAP basis is as follows:       (In millions, except per share data)       Amount     Shares     Loss Per Share Projected Net Loss — GAAP $ (257.5 ) 150 $ (1.72 ) Adjustments: Non-cash net interest expense 1.0 Non-cash taxes 10.0 Depreciation expense 35.0 Amortization expense 60.0 Share-based compensation expense 110.0 Gain on Gainesville Transaction (10.0 ) Change in fair value of contingent consideration and warrants (2.5 ) Deferred revenue (3.0 )   Projected Non-GAAP Net Loss $ (57.0 ) 150 $ (0.38 )   Capital expenditures 50.0   Projected Free Cash Outflow $ (107.0 )     Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance.

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Alkermes Contacts:For Investors:Rebecca Peterson, +1-781-609-6378orFor Media:Jennifer Snyder, +1-781-609-6166