- Third Quarter Revenues Grew to
- Third Quarter Adjusted EBITDA Grew to
- Company Increases Revenue and Adjusted EBITDA Guidance for Fiscal 2012 -
"These quarterly results demonstrate the powerful financial and operational entity
Third Quarter Fiscal 2012 Financial Results
Based on U.S. Generally Accepted Accounting Principles (GAAP), for the quarter ended
As a complement to GAAP results, the company is also providing a non-GAAP measure of Adjusted EBITDA, which the company believes better indicates underlying trends in ongoing operations. Adjusted EBITDA excludes from GAAP results the following: net interest expense, taxes, depreciation, amortization, share-based compensation expense and merger-related expenses.
For the third quarter of fiscal 2012, the company reported Adjusted EBITDA of
"Our third quarter results were driven by the strong performance of our key commercial products, with particularly robust growth from our long-acting atypical antipsychotic franchise and AMPYRA®, as well as strong contributions from a number of our mature products," commented
Revenues
Total revenues for the third quarter of fiscal 2012 were
- Manufacturing and royalty revenues from the company's long-acting atypical antipsychotic franchise, RISPERDAL CONSTA and INVEGA SUSTENNA/XEPLION, were
$47.6 million for the third quarter of fiscal 2012, compared to$35.2 million from RISPERDAL CONSTA alone for the same period of fiscal 2011. According toJohnson & Johnson , worldwide sales of RISPERDAL CONSTA and INVEGA SUSTENNA grew nearly 20% operationally during the quarter as compared to the same period in fiscal 2011 due to increased combined market share. - Manufacturing and royalty revenues from AMPYRA/FAMPYRA were
$10.2 million for the third quarter of fiscal 2012. For the quarter endedDec. 31, 2011 , U.S. unaudited net sales of AMPYRA reported byAcorda Therapeutics, Inc. (Acorda) were approximately$57 million .Alkermes, Inc. did not record any revenues for AMPYRA/FAMPYRA for the same period of fiscal 2011. For the calendar year endedDec. 31, 2011 , unaudited net sales of AMPYRA in the U.S. reported by Acorda were approximately$210 million . - Net sales for VIVITROL were
$10.6 million for the third quarter of fiscal 2012, compared to$7.7 million for the same period of fiscal 2011, representing a 38% increase year-over-year, and compared to$9.9 million for the second quarter of fiscal 2012, representing a 7% sequential quarterly increase. This marks the tenth consecutive quarter of growth for VIVITROL. - Royalty revenue from BYDUREON was
$0.3 million in the third quarter of fiscal 2012. BYDUREON was commercially launched in certain EU countries in the second half of calendar 2011. - Additionally, third quarter fiscal 2012 results included
TRICOR ® 145 revenues of$15.7 million , RITALIN LA®/FOCALIN XR® revenues of$11.6 million and VERELAN® revenues of$6.6 million . These products already face, or are expected to face in the near term, generic competition.
Costs and Expenses
Operating expenses for the third quarter of fiscal 2012 were
Balance Sheet
As of
Financial Expectations for Fiscal 2012
- Revenues:
Alkermes expects total revenues to range from$370 million to $400 million , up from a range of$350 million to $380 million . - Cost of Goods Manufactured: The company continues to expect cost of goods manufactured to range from
$120 million to $130 million . - R&D Expenses: The company continues to expect R&D expenses to range from
$135 million to $145 million . - SG&A Expenses: The company continues to expect SG&A expenses to range from
$130 million to $140 million . - Amortization of Intangible Assets: The company continues to expect amortization of intangibles to range from
$25 million to $30 million . - Net Interest Expense: The company continues to expect net interest expense to range from
$25 million to $27 million . - Net Income Tax Expense: The company continues to expect net income tax expense to range from
$5 million to $10 million . - GAAP Net Loss: The company expects a GAAP net loss in the range of
$70 million to $82 million , or a basic and diluted loss per share of approximately$0.61 to $0.71 , based on a weighted average basic and diluted share count of approximately 115 million shares outstanding. This compares to previous expectations of a GAAP net loss in the range of$90 million to $102 million , or a basic and diluted loss per share of approximately$0.78 to $0.89 . - Share-Based Compensation Expense: The company continues to expect share-based compensation expense, included in the operating expenses above, to range from
$30 million to $35 million . - Adjusted EBITDA: The company expects Adjusted EBITDA to range from
$65 million to $75 million , or a basic Adjusted EBITDA per share of$0.57 to $0.65 , based on a weighted average basic share count of approximately 115 million shares outstanding, or a diluted Adjusted EBITDA per share of$0.54 to $0.63 , based on a weighted average diluted share count of approximately 120 million shares outstanding. This compares to a prior expectation of Adjusted EBITDA in the range of$45 million to $55 million , or a basic Adjusted EBITDA per share of$0.39 to $0.48 , based on a weighted average basic share count of approximately 115 million shares outstanding, or a diluted Adjusted EBITDA per share of$0.38 to $0.46 , based on a weighted average diluted share count of approximately 120 million shares outstanding.
Conference Call
About
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, 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 five key commercial products; the timing, funding and feasibility of development activities for its product candidates; and the therapeutic value of the company's products. 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; the company's business is subject to significant risk and uncertainties, and there can be no assurance that its actual results will not differ materially from its expectations.
These risks and uncertainties include, among others: the commercial markets and demand for our products may not be as large as the company anticipates; reimbursement for our products may change; the possibility that the anticipated benefits from the recently completed merger of
Acorda is developing and marketing AMPYRA in the U.S. under a licensing agreement with
VIVITROL® is a registered trademark of
| Alkermes plc and Subsidiaries | ||||
| Selected Financial Information (Unaudited) | ||||
| Three Months | Three Months | |||
| Ended | Ended | |||
| Condensed Consolidated Statements of Operations - GAAP | December 31, | December 31, | ||
| (In thousands, except per share data) | 2011 | 2010 | ||
| Revenues: | ||||
| Manufacturing and royalty revenues | $ 112,780 | $ 35,932 | ||
| Product sales, net | 10,597 | 7,729 | ||
| Research and development revenue | 2,266 | 314 | ||
| Total Revenues | 125,643 | 43,975 | ||
| Expenses: | ||||
| Cost of goods manufactured and sold | 42,752 | 12,860 | ||
| Research and development | 40,493 | 22,503 | ||
| Selling, general and administrative | 35,469 | 20,521 | ||
| Amortization of acquired intangible assets | 11,896 | - | ||
| Total Expenses | 130,610 | 55,884 | ||
| Operating Loss | (4,967) | (11,909) | ||
| Other (Expense) Income, net: | ||||
| Interest income | 350 | 650 | ||
| Interest expense | (10,458) | - | ||
| Other income (expense), net | 345 | (83) | ||
| Total Other (Expense) Income, net | (9,763) | 567 | ||
| Loss Before Income Taxes | (14,730) | (11,342) | ||
| Income Tax Provision | 98 | 41 | ||
| Net Loss - GAAP | $ (14,828) | $ (11,383) | ||
| (Loss) Earnings Per Share: | ||||
| GAAP loss per share - basic and diluted | $ (0.11) | $ (0.12) | ||
| Adjusted EBITDA per share - basic (Non-GAAP) | $ 0.23 | $ (0.04) | ||
| Adjusted EBITDA per share - diluted (Non-GAAP) | $ 0.22 | $ (0.04) | ||
| Weighted Average Number of Common Shares Outstanding - GAAP: | ||||
| Basic and diluted | 129,670 | 95,667 | ||
| Weighted Average Number of Common Shares Outstanding - Adjusted EBITDA (Non-GAAP) | ||||
| Basic | 129,670 | 95,667 | ||
| Diluted | 133,617 | 95,667 | ||
| An itemized reconciliation between net loss on a GAAP basis and Adjusted EBITDA is as follows: | ||||
| Net Loss - GAAP | $ (14,828) | $ (11,383) | ||
| Adjustments: | ||||
| Share-based compensation included in cost of goods manufactured and sold | 801 | 385 | ||
| Share-based compensation included in R&D | 2,470 | 1,573 | ||
| Share-based compensation included in SG&A | 5,760 | 3,834 | ||
| Depreciation included in cost of goods manufactured and sold | 6,926 | 1,066 | ||
| Depreciation included in R&D | 1,675 | 757 | ||
| Depreciation included in SG&A | 380 | 325 | ||
| Amortization of acquired intangible assets | 11,896 | - | ||
| Net interest expense (income) | 10,108 | (650) | ||
| Income tax provision | 98 | 41 | ||
| Costs incurred related to the merger with Elan Drug Technologies, included in SG&A | 4,447 | - | ||
| Adjusted EBITDA - Non-GAAP | $ 29,733 | $ (4,052) | ||
| Use of Non-GAAP Financial Measures | ||||
| We use "Adjusted EBITDA" as a key indicator of financial operating performance without regard to financing methods, capital structures, taxes or historical cost basis. Adjusted EBITDA is not a GAAP measure of performance and is defined as net income or loss plus or minus interest expense, provision for or benefit from income taxes, depreciation and amortization of costs, share-based compensation expense and other noncash or nonrecurring items, such as merger-related expenses. We feel that Adjusted EBITDA provides management and investors with a better representation of the ongoing economics of the business and reflects how we manage the business internally. | ||||
| Nine Months | Nine Months | |||
| Ended | Ended | |||
| Condensed Consolidated Statements of Operations - GAAP | December 31, | December 31, | ||
| (In thousands, except per share data) | 2011 | 2010 | ||
| Revenues: | ||||
| Manufacturing and royalty revenues | $ 215,759 | $ 114,363 | ||
| Product sales, net | 30,170 | 20,402 | ||
| Research and development revenue | 13,575 | 737 | ||
| Total Revenues | 259,504 | 135,502 | ||
| Expenses: | ||||
| Cost of goods manufactured and sold | 76,501 | 39,436 | ||
| Research and development | 96,703 | 69,412 | ||
| Selling, general and administrative | 103,200 | 58,683 | ||
| Amortization of acquired intangible assets | 13,713 | - | ||
| Total Expenses | 290,117 | 167,531 | ||
| Operating Loss | (30,613) | (32,029) | ||
| Other (Expense), net: | ||||
| Interest income | 1,235 | 2,175 | ||
| Interest expense | (18,019) | (3,298) | ||
| Other income (expense), net | 770 | (266) | ||
| Total Other (Expense), net | (16,014) | (1,389) | ||
| Loss Before Income Taxes | (46,627) | (33,418) | ||
| Income Tax Provision (Benefit) | 3,694 | (960) | ||
| Net Loss - GAAP | $ (50,321) | $ (32,458) | ||
| (Loss) Earnings Per Share: | ||||
| GAAP loss per share - basic and diluted | $ (0.46) | $ (0.34) | ||
| Adjusted EBITDA per share - basic (Non-GAAP) | $ 0.42 | $ (0.09) | ||
| Adjusted EBITDA per share - diluted (Non-GAAP) | $ 0.40 | $ (0.09) | ||
| Weighted Average Number of Common Shares Outstanding - GAAP: | ||||
| Basic and diluted | 109,645 | 95,502 | ||
| Weighted Average Number of Common Shares Outstanding - Adjusted EBITDA (Non-GAAP) | ||||
| Basic | 109,645 | 95,502 | ||
| Diluted | 113,727 | 95,502 | ||
| An itemized reconciliation between net loss on a GAAP basis and Adjusted EBITDA is as follows: | ||||
| Net Loss - GAAP | $ (50,321) | $ (32,458) | ||
| Adjustments: | ||||
| Share-based compensation included in cost of goods manufactured and sold | 1,886 | 1,271 | ||
| Share-based compensation included in R&D | 6,714 | 4,726 | ||
| Share-based compensation included in SG&A | 13,143 | 9,199 | ||
| Depreciation included in cost of goods manufactured and sold | 9,325 | 3,111 | ||
| Depreciation included in R&D | 3,252 | 2,121 | ||
| Depreciation included in SG&A | 961 | 978 | ||
| Amortization of acquired intangible assets | 13,713 | - | ||
| Net interest expense | 16,784 | 1,123 | ||
| Income tax provision (benefit) | 3,694 | (960) | ||
| Costs incurred related to the merger with Elan Drug Technologies, included in SG&A | 26,718 | - | ||
| Costs related to the redemption of the non-recourse 7% Notes | - | 2,168 | ||
| Adjusted EBITDA - Non-GAAP | $ 45,869 | $ (8,721) | ||
| Condensed Consolidated Balance Sheets | December 31, | March 31, | ||
| (In thousands) | 2011 | 2011 | ||
| Cash, cash equivalents and total investments | $ 233,952 | $ 294,730 | ||
| Receivables | 104,684 | 22,969 | ||
| Inventory | 46,109 | 20,425 | ||
| Prepaid expenses and other current assets | 10,916 | 8,244 | ||
| Property, plant and equipment, net | 302,612 | 95,020 | ||
| Intangible assets, net and goodwill | 780,987 | - | ||
| Other assets | 26,567 | 11,060 | ||
| Total Assets | $ 1,505,827 | $ 452,448 | ||
| Long-term debt - current portion | $ 3,100 | $ - | ||
| Other current liabilities | 94,096 | 48,057 | ||
| Deferred revenue - long-term | 4,697 | 4,837 | ||
| Long-term debt | 441,668 | - | ||
| Other long-term liabilities | 57,413 | 7,536 | ||
| Total shareholders' equity | 904,853 | 392,018 | ||
| Total Liabilities and Shareholders' Equity | $ 1,505,827 | $ 452,448 | ||
| Common shares outstanding (in thousands) | 129,747 | 95,702 | ||
| This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in Alkermes, Inc.'s Annual Report on Form 10-K for the year ended March 31, 2011, the company's Registration Statement on Form S-4 and the company's Quarterly Report on Form 10-Q for the nine months ended December 31, 2011, which the company intends to file in February 2012. | ||||
Source:
Alkermes Contacts:
For Investors:
Rebecca Peterson, +1 781 609 6378
For Media:
Jennifer Snyder, +1 781 609 6166