Alkermes plc ALKS today reported financial results for the second quarter of 2014.
“These quarterly results reflect the strength of our commercial business and the progress we are making to advance Alkermes' pipeline of innovative CNS medicines. We expect this valuable, late-stage pipeline to fuel significant future growth, and we are in the strong position to drive new product development with robust and reliable revenue streams and significant cash on the balance sheet,” commented James Frates, Chief Financial Officer of Alkermes. “Today, we are updating our financial expectations for 2014 to reflect our results year-to-date and investment in R&D activities that have accelerated since we originally provided expectations in February.”
“At Alkermes, we are focused on the development of important new CNS medicines that are designed to benefit patients, providers, payers and society,” said Richard Pops, Chief Executive Officer of Alkermes. “With the upcoming NDA submission for aripiprazole lauroxil, the pivotal program well underway for ALKS 5461, and important new data expected for ALKS 3831, ALKS 8700 and ALKS 7106 in the next several months, we are executing on our strategy and making rapid progress to bring these new medicines to patients.”
Quarter Ended June 30, 2014 Financial Highlights
- Total revenues for the quarter were $153.4 million, compared to $138.6 million for the same period in the prior year.
- Non-GAAP net income was $17.7 million, or a non-GAAP diluted earnings per share (EPS) of $0.11, for the quarter. This compared to non-GAAP net income of $42.9 million, or a non-GAAP diluted EPS of $0.30, for the same period in the prior year.
- GAAP net income was $3.7 million, or a basic GAAP EPS of $0.03 and a diluted GAAP EPS of $0.02, for the quarter. These results included a gain of $15.3 million related to the sale of Alkermes' stake in Acceleron Pharma Inc. and a gain of $12.3 million related to the sale of property, plant and equipment. This compared to GAAP net income of $7.3 million, or a basic and diluted GAAP EPS of $0.05, for the same period in the prior year.
- Free cash flow was $12.0 million for the quarter, compared to $39.2 million for the same period in the prior year.
Quarter Ended June 30, 2014 Financial Results
Revenues
- Manufacturing and royalty revenues from the company's long-acting atypical antipsychotic franchise, RISPERDAL® CONSTA® and INVEGA® SUSTENNA®/XEPLION®, were $60.0 million, compared to $56.2 million for the same period in the prior year, representing an increase of approximately 7%.
- Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1 were $19.5 million, compared to $19.9 million for the same period in the prior year.
- Net sales of VIVITROL® were $21.6 million, compared to $17.4 million for the same period in the prior year, representing an increase of approximately 24%.
- Royalty revenue from BYDUREON® was $8.8 million, compared to $5.4 million for the same period in the prior year.
- Additionally, results for the quarter included RITALIN LA®/FOCALIN XR® revenues of $10.9 million, EMEND® revenues of $5.1 million and VERELAN® revenues of $6.6 million. This compared to RITALIN LA/FOCALIN XR revenues of $11.2 million, EMEND revenues of $3.3 million and VERELAN revenues of $6.5 million for the same period in the prior year.
Costs and Expenses
- Operating expenses were $176.2 million for the quarter, compared to $125.1 million for the same period in the prior year. This includes Research and Development (R&D) expense of $67.2 million, compared to $33.5 million for the same period in the prior year. This increase was driven by a substantial increase in the number of late-stage clinical studies that the company is conducting.
- The company reported an income tax benefit of $1.5 million for the quarter, compared to an income tax provision of $2.7 million for the same period in the prior year.
Balance Sheet
At June 30, 2014, Alkermes had cash and total investments of $713.9 million, compared to $701.8 million at March 31, 2014. At June 30, 2014, the company's total debt outstanding was $361.1 million.
Financial Expectations
Alkermes is updating its financial expectations to reflect increased investment in R&D for 2014, partially offset by the gain on the sale of its investment in Acceleron Pharma Inc. This change in R&D expense is expected to reduce non-GAAP net income by $35 million to a range of $30 million to $50 million. The following outlines Alkermes' financial expectations for the year ending Dec. 31, 2014.
- Revenues: Alkermes continues to expect total revenues to range from $580 million to $610 million.
- Cost of Goods Manufactured: The company continues to expect cost of goods manufactured to range from $165 million to $175 million.
- R&D Expenses: The company now expects R&D expenses to range from $260 million to $280 million, up from a range of $225 million to $245 million.
- Selling, General and Administrative (SG&A) Expenses: The company continues to expect SG&A expenses to range from $190 million to $200 million.
- Amortization of Intangible Assets: The company continues to expect amortization of intangibles of approximately $60 million.
- Net Interest Expense: The company continues to expect net interest expense to range from $10 million to $15 million.
- Other Income (Expense), Net: The company now expects net other income to range from $25 million to $30 million, up from a range of $10 million to $15 million.
- 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 the GAAP net loss to range from $90 million to $110 million, or a basic and diluted loss per share of approximately $0.62 to $0.76, based on weighted average basic and diluted share counts of approximately 145 million shares outstanding. This compares to previous expectations of a GAAP net loss in the range of $70 to $90 million, or a basic and diluted loss per share of approximately $0.48 to $0.61, based on weighted average basic and diluted share counts of approximately 147 million shares outstanding.
- Non-GAAP Net Income: The company now expects non-GAAP net income to range from $30 million to $50 million, and non-GAAP diluted EPS to range from $0.19 to $0.32, based on a weighted average diluted share count of approximately 155 million shares outstanding. This compares to previous expectations of non-GAAP net income in the range of $65 million to $85 million and non-GAAP diluted EPS in the range of $0.41 to $0.54, based on a weighted average diluted share count of approximately 157 million shares outstanding.
- Capital Expenditures: The company now expects capital expenditures to be approximately $30 million, down from an expectation of approximately $35 million.
- Free Cash Flow: The company now expects free cash flow of up to $20 million, down from a range of $30 million to $50 million.
Conference Call
Alkermes will host a conference call at 8:30 a.m. EDT (1:30 p.m. BST) on Thursday, July 31, 2014, 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 31, 2014, through 5:00 p.m. EDT (10:00 p.m. BST) on Thursday, August 7, 2014, 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 plc
Alkermes plc is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and manufacturing facilities in Gainesville, Georgia and 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:
- 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.
- Free cash flow represents non-GAAP net income less capital expenditures.
Management believes that these non-GAAP financial measures, when viewed with its 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 clinical development activities. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond the company's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements.
These risks and uncertainties include, among others: whether clinical development activities will be completed on time or at all and whether the results of such activities will 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; whether the company, and its partners, are able to continue to successfully commercialize its products; whether there will 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 possibility of adverse decisions by the U.S. Food and Drug Administration or regulatory authorities outside the U.S. regarding the company's products; the possibility that 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 Transition Report on Form 10-K, 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; TRICOR® is a registered trademark of Fournier Industrie et Sante Corporation; RITALIN LA® and FOCALIN XR® are registered trademarks of Novartis AG Corporation; EMEND® is a registered trademark of Merck Sharp & Dohme Corp.; and VERELAN® is a registered trademark of Alkermes Pharma Ireland Limited.
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 Idec, under a licensing agreement with Acorda Therapeutics, as FAMPYRA® (prolonged-release fampridine tablets).
| Alkermes plc and Subsidiaries | ||||||||
| Selected 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) | 2014 | 2013 | ||||||
| Revenues: | ||||||||
| Manufacturing and royalty revenues | $ 130,366 | $ 119,788 | ||||||
| Product sales, net | 21,595 | 17,379 | ||||||
| Research and development revenues | 1,463 | 1,464 | ||||||
| Total Revenues | 153,424 | 138,631 | ||||||
| Expenses: | ||||||||
| Cost of goods manufactured and sold | 43,290 | 45,991 | ||||||
| Research and development | 67,207 | 33,462 | ||||||
| Selling, general and administrative | 50,663 | 32,933 | ||||||
| Amortization of acquired intangible assets | 15,089 | 12,716 | ||||||
| Total Expenses | 176,249 | 125,102 | ||||||
| Operating (Loss) Income | (22,825 | ) | 13,529 | |||||
| Other Income (Expense), net: | ||||||||
| Interest income | 323 | 161 | ||||||
| Interest expense | (3,385 | ) | (3,468 | ) | ||||
| Gain on sale of investment in Acceleron Pharma Inc. | 15,296 | - | ||||||
| Gain on sale of property, plant and equipment | 12,285 | - | ||||||
| Other income (expense), net | 518 | (170 | ) | |||||
| Total Other Income (Expense), net | 25,037 | (3,477 | ) | |||||
| Income Before Income Taxes | 2,212 | 10,052 | ||||||
| Income Tax (Benefit) Provision | (1,523 | ) | 2,718 | |||||
| Net Income — GAAP | $ 3,735 | $ 7,334 | ||||||
| Earnings Per Share: | ||||||||
| GAAP earnings per share — basic | $ 0.03 | $ 0.05 | ||||||
| GAAP earnings per share — diluted | $ 0.02 | $ 0.05 | ||||||
| Non-GAAP earnings per share — basic | $ 0.12 | $ 0.32 | ||||||
| Non-GAAP earnings per share — diluted | $ 0.11 | $ 0.30 | ||||||
| Weighted Average Number of Ordinary Shares Outstanding: | ||||||||
| Basic — GAAP and Non-GAAP | 144,913 | 134,602 | ||||||
| Diluted — GAAP and Non-GAAP | 154,300 | 143,369 | ||||||
| An itemized reconciliation between net income on a GAAP basis and non-GAAP net income is as follows: | ||||||||
| Net Income — GAAP | $ 3,735 | $ 7,334 | ||||||
| Adjustments: | ||||||||
| Share-based compensation expense | 19,337 | 8,809 | ||||||
| Amortization expense | 15,089 | 12,716 | ||||||
| Depreciation expense | 9,844 | 11,011 | ||||||
| Non-cash net interest expense | 239 | 268 | ||||||
| Non-cash taxes | (2,207 | ) | 2,814 | |||||
| Deferred revenue | (338 | ) | (97 | ) | ||||
| Net loss on transactions with equity method investee | (396 | ) | - | |||||
| Gain on sale of investment in Acceleron Pharma Inc. | (15,296 | ) | - | |||||
| Gain on sale of property, plant and equipment | (12,285 | ) | - | |||||
| Non-GAAP Net Income | $ 17,722 | $ 42,855 | ||||||
| Capital expenditures | 5,753 | 3,625 | ||||||
| Free Cash Flow | $ 11,969 | $ 39,230 | ||||||
| Six Months | Six Months | |||||||
| Ended | Ended | |||||||
| Condensed Consolidated Statements of Operations - GAAP | June 30, | June 30, | ||||||
| (In thousands, except per share data) | 2014 | 2013 | ||||||
| Revenues: | ||||||||
| Manufacturing and royalty revenues | $ 241,646 | $ 266,707 | ||||||
| Product sales, net | 38,674 | 32,005 | ||||||
| Research and development revenues | 3,316 | 3,341 | ||||||
| Total Revenues | 283,636 | 302,053 | ||||||
| Expenses: | ||||||||
| Cost of goods manufactured and sold | 82,129 | 93,982 | ||||||
| Research and development | 119,347 | 69,262 | ||||||
| Selling, general and administrative | 93,213 | 67,612 | ||||||
| Amortization of acquired intangible assets | 27,665 | 23,038 | ||||||
| Restructuring | - | 12,300 | ||||||
| Impairment of long-lived assets | - | 3,346 | ||||||
| Total Expenses | 322,354 | 269,540 | ||||||
| Operating (Loss) Income | (38,718 | ) | 32,513 | |||||
| Other Income (Expense), net: | ||||||||
| Interest income | 834 | 332 | ||||||
| Interest expense | (6,741 | ) | (14,941 | ) | ||||
| Gain on sale of investment in Acceleron Pharma Inc. | 15,296 | - | ||||||
| Gain on sale of property, plant and equipment | 12,285 | - | ||||||
| Other (expense) income, net | (1,332 | ) | 14 | |||||
| Total Other Income (Expense), net | 20,342 | (14,595 | ) | |||||
| (Loss) Income Before Income Taxes | (18,376 | ) | 17,918 | |||||
| Income Tax Provision | 2,243 | 7,585 | ||||||
| Net (Loss) Income — GAAP | $ (20,619 | ) | $ 10,333 | |||||
| (Loss) Earnings Per Share: | ||||||||
| GAAP (loss) earnings per share — basic | $ (0.14 | ) | $ 0.08 | |||||
| GAAP (loss) earnings per share — diluted | $ (0.14 | ) | $ 0.07 | |||||
| Non-GAAP earnings per share — basic | $ 0.24 | $ 0.74 | ||||||
| Non-GAAP earnings per share — diluted | $ 0.22 | $ 0.70 | ||||||
| Weighted Average Number of Ordinary Shares Outstanding: | ||||||||
| Basic — GAAP | 144,140 | 133,941 | ||||||
| Diluted — GAAP | 144,140 | 141,822 | ||||||
| Basic — Non-GAAP | 144,140 | 133,941 | ||||||
| Diluted — Non-GAAP | 153,833 | 141,822 | ||||||
| An itemized reconciliation between net (loss) income on a GAAP basis and non-GAAP net income is as follows: | ||||||||
| Net (Loss) Income — GAAP | $ (20,619 | ) | $ 10,333 | |||||
| Adjustments: | ||||||||
| Share-based compensation expense | 32,757 | 16,690 | ||||||
| Amortization expense | 27,665 | 23,038 | ||||||
| Depreciation expense | 19,821 | 19,010 | ||||||
| Non-cash net interest expense | 479 | 568 | ||||||
| Non-cash taxes | 1,415 | 7,257 | ||||||
| Deferred revenue | (1,303 | ) | (975 | ) | ||||
| Net loss on transactions with equity method investee | 1,239 | - | ||||||
| Gain on sale of investment in Acceleron Pharma Inc. | (15,296 | ) | - | |||||
| Gain on sale of property, plant and equipment | (12,285 | ) | - | |||||
| Restructuring | - | 12,300 | ||||||
| Loss on debt repricing | - | 7,541 | ||||||
| Impairment of long-lived assets | - | 3,346 | ||||||
| Non-GAAP Net Income | $ 33,873 | $ 99,108 | ||||||
| Capital expenditures | 11,438 | 11,884 | ||||||
| Free Cash Flow | $ 22,435 | $ 87,224 | ||||||
| Condensed Consolidated Balance Sheets | June 30, | December 31, | ||||
| (In thousands) | 2014 | 2013 | ||||
| Cash, cash equivalents and total investments | $ 713,894 | $ 449,995 | ||||
| Receivables | 139,316 | 134,154 | ||||
| Inventory | 57,066 | 46,218 | ||||
| Prepaid expenses and other current assets | 52,048 | 27,535 | ||||
| Property, plant and equipment, net | 264,247 | 274,490 | ||||
| Intangible assets, net and goodwill | 602,640 | 630,305 | ||||
| Other assets | 28,381 | 14,891 | ||||
| Total Assets | $ 1,857,592 | $ 1,577,588 | ||||
| Long-term debt — current portion | $ 6,750 | $ 6,750 | ||||
| Other current liabilities | 95,410 | 94,147 | ||||
| Long-term debt | 354,382 | 357,543 | ||||
| Deferred revenue — long-term | 11,507 | 12,213 | ||||
| Other long-term liabilities | 37,718 | 41,749 | ||||
| Total shareholders' equity | 1,351,825 | 1,065,186 | ||||
| Total Liabilities and Shareholders' Equity | $ 1,857,592 | $ 1,577,588 | ||||
| Ordinary shares outstanding (in thousands) | 145,664 | 137,793 | ||||
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, 2014, which the company intends to file in July 2014.
| Alkermes plc and Subsidiaries | |||||||||||
| Guidance — GAAP to Non-GAAP Adjustments | |||||||||||
|
An itemized reconciliation between projected loss per share on a GAAP basis and projected earnings per share on a non-GAAP basis is as follows: |
|||||||||||
| (Loss)/Earnings | |||||||||||
| (In millions, except per share data) | Amount | Shares | Per Share | ||||||||
| Projected Net Loss — GAAP | $ (100.0 | ) | 145 | $ (0.69 | ) | ||||||
| Adjustments: | |||||||||||
| Non-cash net interest expense | 1.0 | ||||||||||
| Non-cash taxes | 10.0 | ||||||||||
| Depreciation expense | 40.0 | ||||||||||
| Amortization expense | 60.0 | ||||||||||
| Share-based compensation expense | 58.0 | ||||||||||
| Gain on sale of investment in Acceleron Pharma Inc. | (15.0 | ) | |||||||||
| Gain on sale of property, plant and equipment | (12.0 | ) | |||||||||
| Deferred revenue | (2.0 | ) | |||||||||
| Projected Non-GAAP Net Income | $ 40.0 | 155 | $ 0.26 | ||||||||
| Capital expenditures | (30.0 | ) | |||||||||
| Projected Free Cash Flow | $ 10.0 | ||||||||||
| Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance. | |||||||||||
Alkermes Contacts:
For Investors:
Rebecca
Peterson, +1 781-609-6378
or
For Media:
Jennifer Snyder,
+1 781-609-6166
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