- First Quarter Revenues Grew to
- First Quarter Non-GAAP Diluted EPS Grew to
"Our first quarter results highlight Alkermes' transformation to a business generating growing revenues and earnings. These results also demonstrate the strength of our business model with revenues coming from a diversified portfolio of important medications," commented Richard Pops, Chief Executive Officer of
First Quarter Fiscal 2013 Highlights
- Total revenues for the first quarter increased 146% to
$152.2 million , which reflected the expansion of the company's commercial product portfolio as a result of the merger and the inclusion of$20.0 million of intellectual property license revenue unrelated to our key clinical development programs. This compared to total revenues of$61.9 million for the same period in the prior fiscal year forAlkermes, Inc. - Based on accounting principles generally accepted in the U.S. (GAAP),
Alkermes reported net income of$22.4 million , or a basic and diluted earnings per share (EPS) of$0.17 , for the quarter. This compared to a GAAP net loss of$13.2 million , or a basic and diluted loss per share of$0.14 , for the same period in the prior fiscal year forAlkermes, Inc. - The company reported non-GAAP1 net income of
$53.0 million , or a non-GAAP diluted EPS of$0.39 . This compared to non-GAAP net income of$3.6 million , or a non-GAAP diluted EPS of$0.04 , for the same period in the prior fiscal year forAlkermes, Inc.
"The business is performing as we expected with growing revenue streams from our key commercial products and continued contributions from the legacy portfolio during the quarter. For the remainder of the fiscal year, we expect to see growing contributions from the key products while contributions from the legacy products become less significant," commented
First Quarter Fiscal 2013 Financial Results
Revenues
- Manufacturing and royalty revenues from the company's long-acting atypical antipsychotic franchise, RISPERDAL® CONSTA® and INVEGA® SUSTENNA®/XEPLION®, were
$47.9 million for the first quarter of fiscal 2013. This compared to$48.5 million in manufacturing and royalty revenues from RISPERDAL CONSTA alone for the same period of fiscal 2012, which were driven by unusually high manufacturing revenues due to the timing of shipments. Worldwide end-market sales of RISPERDAL CONSTA and INVEGA SUSTENNA/XEPLIONfor the first quarter of fiscal 2013 were approximately$550 million and grew more than 14% year-over-year. - Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®2 were
$17.1 million for the first quarter of fiscal 2013.Alkermes, Inc. did not record anyrevenues from AMPYRA/FAMPYRA for the same period of fiscal 2012. - Net sales of VIVITROL® were
$12.4 million for the first quarter of fiscal 2013, compared to$9.7 million for the same period of fiscal 2012, representing an increase of approximately 28% year-over-year and the 12th consecutive quarter of growth. - Royalty revenue from BYDUREON™ was
$3.0 million for the firstquarter of fiscal 2013.Alkermes did not record any royalty revenues from BYDUREON for the same period of fiscal 2012. - Additionally, first quarter fiscal 2013 results included
TRICOR ® 145 revenues of$12.0 million , RITALIN LA®/FOCALIN XR® revenues of$10.9 million and VERELAN® revenues of$6.0 million .Alkermes, Inc. did not record any revenues from these products for the same period of fiscal 2012. - Manufacturing and royalty revenues in the first quarter of fiscal 2013 also included
$20.0 million of intellectual property license revenue unrelated to our key development programs.
Costs and Expenses
- Operating expenses for the first quarter of fiscal 2013 were
$120.1 million . This compared to operating expenses of$75.8 million for the same period of fiscal 2012 forAlkermes, Inc. The increase was primarily related to the inclusion of expenses associated with the former EDT business and the advancement of pipeline candidates into later stages of development. - Net interest expense for the first quarter of fiscal 2013 was
$9.9 million , including$10.2 million of interest expense on the term loans secured to fund the merger.
Balance Sheet
- At
June 30, 2012 ,Alkermes recorded cash and total investments of$231.9 million , compared to$246.1 million atMarch 31, 2012 . The decrease was primarily driven by changes in working capital, notably the increase in receivables due to the timing of receipts from collaborative partners, including the$20.0 million of license revenue.
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; 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 the company's products may not be as large as the company anticipates; reimbursement for the company's products may change; the company may not fully realize the anticipated benefits from the merger of
VIVITROL® is a registered trademark of
1As a complement to GAAP results, the company is providing non-GAAP net income (loss) and non-GAAP diluted earnings (loss) per share, which the company believes better indicate underlying trends in ongoing operations and cash flows. Non-GAAP net income (loss) adjusts for one-time and non-cash charges by excluding from GAAP results: share-based compensation; amortization; depreciation; non-cash net interest expense; non-cash tax expense; deferred revenue; and certain other one-time items.
2AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg is developed and marketed in the U.S. by
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) | 2012 | 2011 | ||||||||||
Revenues: | ||||||||||||
Manufacturing and royalty revenues | $ 138,380 | $ 48,940 | ||||||||||
Product sales, net | 12,372 | 9,686 | ||||||||||
Research and development revenue | 1,487 | 3,257 | ||||||||||
Total Revenues | 152,239 | 61,883 | ||||||||||
Expenses: | ||||||||||||
Cost of goods manufactured and sold | 42,070 | 16,219 | ||||||||||
Research and development | 37,806 | 28,050 | ||||||||||
Selling, general and administrative | 29,784 | 31,497 | ||||||||||
Amortization of acquired intangible assets | 10,434 | - | ||||||||||
Total Expenses | 120,094 | 75,766 | ||||||||||
Operating Income (Loss) | 32,145 | (13,883 | ) | |||||||||
Other (Expense) Income, net: | ||||||||||||
Interest income | 299 | 502 | ||||||||||
Interest expense | (10,170 | ) | - | |||||||||
Other income (expense), net | 923 | 89 | ||||||||||
Total Other (Expense) Income, net | (8,948 | ) | 591 | |||||||||
Income (Loss) Before Income Taxes | 23,197 | (13,292 | ) | |||||||||
Income Tax Provision (Benefit) | 764 | (54 | ) | |||||||||
Net Income (Loss) - GAAP | $ 22,433 | $ (13,238 | ) | |||||||||
Earnings (Loss) Per Share: | ||||||||||||
GAAP earnings (loss) per share - basic and diluted | $ 0.17 | $ (0.14 | ) | |||||||||
Non-GAAP earnings per share - basic | $ 0.41 | $ 0.04 | ||||||||||
Non-GAAP earnings per share - diluted | $ 0.39 | $ 0.04 | ||||||||||
Weighted Average Number of Ordinary Shares Outstanding: | ||||||||||||
Basic - GAAP | 130,434 | 96,649 | ||||||||||
Diluted - GAAP | 134,945 | 96,649 | ||||||||||
Basic - Non-GAAP | 130,434 | 96,649 | ||||||||||
Diluted - Non-GAAP | 134,945 | 100,736 | ||||||||||
An itemized reconciliation between net income (loss) on a GAAP basis and non-GAAP net income is as follows: | ||||||||||||
Net Income (Loss) - GAAP | $ 22,433 | $ (13,238 | ) | |||||||||
Adjustments: | ||||||||||||
Non-cash net interest expense | 1,528 | - | ||||||||||
Non-cash taxes | (145 | ) | (65 | ) | ||||||||
Depreciation expense | 7,584 | 1,908 | ||||||||||
Amortization expense | 10,434 | - | ||||||||||
Share-based compensation | 8,162 | 5,660 | ||||||||||
Deferred revenue | 2,970 | (197 | ) | |||||||||
Merger-related costs | - | 9,487 | ||||||||||
Non-GAAP Net Income | $ 52,966 | $ 3,555 | ||||||||||
|
||||||||||||
Use of Non-GAAP Financial Measures
We use "non-GAAP net income" as a key indicator of the underlying financial operating performance of
Condensed Consolidated Balance Sheets | June 30, | March 31, | ||||||||
(In thousands) | 2012 | 2012 | ||||||||
Cash, cash equivalents and total investments | $ 231,930 | $ 246,138 | ||||||||
Receivables | 135,656 | 96,381 | ||||||||
Inventory | 41,442 | 39,759 | ||||||||
Prepaid expenses and other current assets | 10,939 | 12,566 | ||||||||
Property, plant and equipment, net | 299,536 | 302,995 | ||||||||
Intangible assets, net and goodwill | 700,151 | 710,585 | ||||||||
Other assets | 26,013 | 26,793 | ||||||||
Total Assets | $ 1,445,667 | $ 1,435,217 | ||||||||
Long-term debt - current portion | $ 3,100 | $ 3,100 | ||||||||
Other current liabilities | 68,139 | 86,064 | ||||||||
Long-term debt | 441,083 | 441,360 | ||||||||
Deferred revenue - long-term | 8,146 | 7,578 | ||||||||
Other long-term liabilities | 42,713 | 43,263 | ||||||||
Total shareholders' equity | 882,486 | 853,852 | ||||||||
Total Liabilities and Shareholders' Equity | $ 1,445,667 | $ 1,435,217 | ||||||||
Ordinary shares outstanding (in thousands) | 130,730 | 130,177 | ||||||||
|
This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in
Source:
Alkermes Contacts:
For Investors:
Rebecca Peterson, +1 781-609-6378
or
For Media:
Jennifer Snyder, +1 781-609-6166