— Fiscal 2012 Revenues Grew 109% Year-Over-Year to
— Fiscal 2012 Adjusted EBITDA Grew to
— For Fiscal 2013 Company Expects Non-GAAP Diluted EPS to Grow to a Range of
Fourth Quarter Fiscal 2012 Highlights
- Total revenues for the fourth quarter increased more than 155% to
$130.5 million , compared to$51.1 million for the same period in the prior fiscal year forAlkermes, Inc. , reflecting expansion of the company’s commercial product portfolio as a result of the merger. - Based on accounting principles generally accepted in the U.S. (GAAP),
Alkermes reported a net loss of$63.4 million , which included a non-cash charge of$45.8 million related to the one-time write-off of in-process research and development (IPR&D) intangible assets acquired in the merger. The company reported basic and diluted GAAP net loss per share of$0.49 , or$0.14 excluding the IPR&D charge. This compared to a GAAP net loss of$13.1 million , or a basic and diluted loss per share of$0.14 , for the same period in the prior fiscal year. - The company reported Adjusted EBITDA of
$24.4 million , or a basic and diluted Adjusted EBITDA per share of$0.19 and$0.18 , respectively. This compared to an Adjusted EBITDA loss of$6.6 million , or a basic and diluted Adjusted EBITDA loss per share of$0.07 , for the same period in the prior fiscal year. - At
March 31, 2012 ,Alkermes recorded cash and total investments of$246.1 million reflecting an increase of$12.1 million from$234.0 million atDec. 31, 2011 .
Fiscal 2012 Highlights
- Total revenues increased 109% to
$390.0 million , compared to$186.6 million for the prior fiscal year forAlkermes, Inc. , reflecting expansion of the company’s commercial product portfolio as a result of the merger. Alkermes reported a GAAP net loss of$113.7 million , which included the non-cash$45.8 million IPR&D charge. The company reported basic and diluted GAAP net loss per share of$0.99 , or$0.59 excluding the IPR&D write-off. This compared to a GAAP net loss of$45.5 million , or a basic and diluted loss per share of$0.48 , for the prior fiscal year.- The company reported Adjusted EBITDA for fiscal 2012 of
$70.2 million , or a basic and diluted Adjusted EBITDA per share of$0.61 and$0.59 , respectively. This compared to an Adjusted EBITDA loss of$15.4 million , or a basic and diluted Adjusted EBITDA loss per share of$0.16 , for fiscal 2011.
“During fiscal 2012, we laid the groundwork to build a major biotech company and are now in a position that few biotech companies ever achieve: we have a financial engine that is generating cash, a pipeline of several promising late-stage candidates and an efficient corporate structure,” commented Richard Pops, Chief Executive Officer of
Fiscal 2012 Financial Results
Revenues
- Manufacturing and royalty revenues from the company’s long-acting atypical antipsychotic franchise, RISPERDAL® CONSTA® and INVEGA® SUSTENNA®/XEPLION®, were
$186.3 million for fiscal 2012. This compared to$154.3 million in manufacturing and royalty revenues from RISPERDAL CONSTA alone for fiscal 2011. - Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1 were
$24.6 million for fiscal 2012.Alkermes, Inc. did not record any revenues for AMPYRA/FAMPYRA for fiscal 2011. - Net sales of VIVITROL® were
$41.2 million for fiscal 2012, compared to$28.9 million for fiscal 2011, representing an increase of more than 42% year-over-year and the 11th consecutive quarter of growth. - Revenue from BYDUREON™ was
$15.6 million for fiscal 2012, including$14.0 million in milestone payments fromAmylin Pharmaceuticals, Inc. in connection with the launch of BYDUREON in the EU and U.S., which were recorded as research and development (R&D) revenues. This compared to$0.6 million related to BYDUREON R&D revenues for fiscal 2011. - Additionally, fiscal 2012 results included
TRICOR ® 145 revenues of$27.8 million , RITALIN LA®/FOCALIN XR® revenues of$23.1 million and VERELAN® revenues of$14.2 million .Alkermes, Inc. did not record any revenues for these products for fiscal 2011.
Costs and Expenses
- Operating expenses for fiscal 2012 were
$478.3 million . This compared to operating expenses of$232.3 million for fiscal 2011 forAlkermes, Inc. The increase was primarily related to the inclusion of expenses associated with the former EDT business, the advancement of pipeline candidates into later-stage development and$74.9 million in one-time charges associated with merger-related costs and the write-off of IPR&D. - Net interest expense for fiscal 2012 was
$26.6 million , including$28.1 million of interest expense on the$450 million of term loans secured to fund the acquisition.
Balance Sheet
As of
“The merger with EDT has put
Financial Expectations for Fiscal 2013
The following outlines Alkermes’ financial expectations for the fiscal year ending
- Revenues:
Alkermes expects total revenues to range from$490 million to $530 million . - Cost of Goods Manufactured: The company expects cost of goods manufactured to range from
$170 million to $180 million . - R&D Expenses: The company expects R&D expenses to range from
$155 million to $165 million . - SG&A Expenses: The company expects selling, general and administrative (SG&A) expenses to range from
$120 million to $130 million . - Amortization of Intangible Assets: The company expects amortization of intangibles to range from
$40 million to $45 million . - Net Interest Expense: The company expects net interest expense to range from
$35 million to $40 million . - Net Income Tax Expense: The company expects to have a nominal tax charge in fiscal 2013.
- GAAP Net Loss: The company expects a GAAP net loss in the range of
$20 million to $40 million , or a basic and diluted loss per share of approximately$0.15 to $0.30 , based on a weighted average basic share count of approximately 132 million shares outstanding. - Share-Based Compensation Expense: The company expects share-based compensation expense, included in the operating expenses above, to range from
$35 million to $40 million . - Capital Expenditures: The company expects capital expenditures to be approximately
$25 million .
Non-GAAP Performance
As a complement to GAAP results, the company is providing a new non-GAAP measure. Going forward, the company will provide reported, and expectations for, non-GAAP net income and non-GAAP diluted EPS, 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.
- Non-GAAP Net Income: The company expects non-GAAP net income to range from
$85 million to $105 million , and non-GAAP diluted EPS to range from$0.62 to $0.77 , based on a weighted average diluted share count of approximately 137 million shares outstanding. This compares to non-GAAP net income of$40.0 million , or non-GAAP diluted EPS of$0.34 , for fiscal 2012.
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 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
1AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg is developed and marketed in the U.S. by
(tables follow)
| Alkermes plc and Subsidiaries | ||||||||
| Selected Financial Information (Unaudited) | ||||||||
| Year | Year | |||||||
| Ended | Ended | |||||||
| Condensed Consolidated Statements of Operations - GAAP | March 31, | March 31 | ||||||
| (In thousands, except per share data) | 2012 | 2011 | ||||||
| Revenues: | ||||||||
| Manufacturing and royalty revenues | $ | 326,444 | $ | 156,840 | ||||
| Product sales, net | 41,184 | 28,920 | ||||||
| Research and development revenue | 22,349 | 880 | ||||||
| Total Revenues | 389,977 | 186,640 | ||||||
| Expenses: | ||||||||
| Cost of goods manufactured and sold | 127,578 | 52,185 | ||||||
| Research and development | 141,893 | 97,239 | ||||||
| Selling, general and administrative | 137,632 | 82,847 | ||||||
| Amortization and impairment of acquired intangible assets | 71,155 | - | ||||||
| Total Expenses | 478,258 | 232,271 | ||||||
| Operating Loss | (88,281 | ) | (45,631 | ) | ||||
| Other (Expense) Income, net: | ||||||||
| Interest income | 1,516 | 2,728 | ||||||
| Interest expense | (28,111 | ) | (3,298 | ) | ||||
| Other income (expense), net | 484 | (290 | ) | |||||
| Total Other (Expense), net | (26,111 | ) | (860 | ) | ||||
| Loss Before Income Taxes | (114,392 | ) | (46,491 | ) | ||||
| Income Tax (Benefit) | (714 | ) | (951 | ) | ||||
| Net Loss — GAAP | $ | (113,678 | ) | $ | (45,540 | ) | ||
| (Loss) Earnings Per Share: | ||||||||
| GAAP loss per share — basic and diluted | $ | (0.99 | ) | $ | (0.48 | ) | ||
| Non-GAAP net income (loss) per share — basic | $ | 0.35 | $ | (0.15 | ) | |||
| Non-GAAP net income (loss) per share — diluted | $ | 0.34 | $ | (0.15 | ) | |||
| Adjusted EBITDA per share — basic (Non-GAAP) | $ | 0.61 | $ | (0.16 | ) | |||
| Adjusted EBITDA per share — diluted (Non-GAAP) | $ | 0.59 | $ | (0.16 | ) | |||
| Weighted Average Number of Common Shares Outstanding — GAAP: | ||||||||
| Basic and diluted | 114,702 | 95,610 | ||||||
| Weighted Average Number of Common Shares Outstanding — Non-GAAP Net Income (Loss) and Adjusted EBITDA: | ||||||||
| Basic | 114,702 | 95,610 | ||||||
| Diluted | 119,069 | 95,610 | ||||||
| An itemized reconciliation between net loss on a GAAP basis, non-GAAP net income (loss) and Adjusted EBITDA is as follows: | ||||||||
| Net Loss — GAAP | $ | (113,678 | ) | $ | (45,540 | ) | ||
| Adjustments: | ||||||||
| Non-cash net interest expense | 6,453 | 1,614 | ||||||
| Non-cash taxes | (10,782 | ) | (1,011 | ) | ||||
| Depreciation expense | 22,529 | 8,652 | ||||||
| Amortization and impairment expense | 71,155 | - | ||||||
| Share-based compensation | 28,826 | 19,832 | ||||||
| Deferred revenue | 4,784 | (146 | ) | |||||
| Merger-related costs | 29,073 | - | ||||||
| Severance costs | 1,624 | - | ||||||
| Costs related to the redemption of the non-recourse 7% Notes | - | 2,168 | ||||||
| Non-GAAP Net Income (Loss) | $ | 39,984 | $ | (14,431 | ) | |||
| Cash net interest expense | 20,142 | (1,044 | ) | |||||
| Cash taxes | 10,068 | 60 | ||||||
| Adjusted EBITDA — Non-GAAP | $ | 70,194 | $ | (15,415 | ) | |||
| Three Months | Three Months | |||||||
| Ended | Ended | |||||||
| Condensed Consolidated Statements of Operations - GAAP | March 31, | March 31, | ||||||
| (In thousands, except per share data) | 2012 | 2011 | ||||||
| Revenues: | ||||||||
| Manufacturing and royalty revenues | $ | 110,685 | $ | 42,477 | ||||
| Product sales, net | 11,014 | 8,518 | ||||||
| Research and development revenue | 8,774 | 143 | ||||||
| Total Revenues | 130,473 | 51,138 | ||||||
| Expenses: | ||||||||
| Cost of goods manufactured and sold | 51,077 | 12,749 | ||||||
| Research and development | 45,190 | 27,827 | ||||||
| Selling, general and administrative | 34,432 | 24,164 | ||||||
| Amortization and impairment of acquired intangible assets | 57,442 | - | ||||||
| Total Expenses | 188,141 | 64,740 | ||||||
| Operating Loss | (57,668 | ) | (13,602 | ) | ||||
| Other (Expense) Income, net: | ||||||||
| Interest income | 281 | 553 | ||||||
| Interest expense | (10,092 | ) | - | |||||
| Other (expense), net | (286 | ) | (24 | ) | ||||
| Total Other (Expense) Income, net | (10,097 | ) | 529 | |||||
| Loss Before Income Taxes | (67,765 | ) | (13,073 | ) | ||||
| Income Tax (Benefit) Provision | (4,408 | ) | 9 | |||||
| Net Loss — GAAP | $ | (63,357 | ) | $ | (13,082 | ) | ||
| (Loss) Earnings Per Share: | ||||||||
| GAAP loss per share — basic and diluted | $ | (0.49 | ) | $ | (0.14 | ) | ||
| Non-GAAP net income (loss) per share — basic | $ | 0.13 | $ | (0.06 | ) | |||
| Non-GAAP net income (loss) per share — diluted | $ | 0.12 | $ | (0.06 | ) | |||
| Adjusted EBITDA per share — basic (Non-GAAP) | $ | 0.19 | $ | (0.07 | ) | |||
| Adjusted EBITDA per share — diluted (Non-GAAP) | $ | 0.18 | $ | (0.07 | ) | |||
| Weighted Average Number of Common Shares Outstanding — GAAP: | ||||||||
| Basic and diluted | 129,986 | 95,939 | ||||||
| Weighted Average Number of Common Shares Outstanding — non-GAAP Net Income (Loss) and Adjusted EBITDA: | ||||||||
| Basic | 129,986 | 95,939 | ||||||
| Diluted | 135,143 | 95,939 | ||||||
| An itemized reconciliation between net loss on a GAAP basis, non-GAAP net income (loss) and Adjusted EBITDA is as follows: | ||||||||
| Net Loss — GAAP | $ | (63,357 | ) | $ | (13,082 | ) | ||
| Adjustments: | ||||||||
| Non-cash net interest expense | 1,916 | - | ||||||
| Non-cash taxes | (4,406 | ) | (4 | ) | ||||
| Depreciation expense | 8,991 | 2,442 | ||||||
| Amortization and impairment expense | 57,442 | - | ||||||
| Share-based compensation | 7,083 | 4,636 | ||||||
| Deferred revenue | 4,843 | (31 | ) | |||||
| Merger-related costs | 2,355 | - | ||||||
| Severance costs | 1,624 | - | ||||||
| Non-GAAP Net Income (Loss) | $ | 16,491 | $ | (6,039 | ) | |||
| Cash net interest expense | 7,895 | (553 | ) | |||||
| Cash taxes | (2 | ) | 13 | |||||
| Adjusted EBITDA — Non-GAAP | $ | 24,384 | $ | (6,579 | ) | |||
Use of Non-GAAP Financial Measures
We use "non-GAAP net income (loss)" and "Adjusted EBITDA" as key indicators of the underlying financial operating performance of
| Three Months Ended | Year Ended | |||||||||||||||||||
| June 30, | September 30, | December 31, | March 31, | March 31, | ||||||||||||||||
| 2011 | 2011 | 2011 | 2012 | 2012 | ||||||||||||||||
| (In thousands, except per share data) | ||||||||||||||||||||
| Revenues: | ||||||||||||||||||||
| Manufacturing and royalty revenues | $ | 48,940 | $ | 54,039 | $ | 112,780 | $ | 110,685 | $ | 326,444 | ||||||||||
| Product sales, net | 9,686 | 9,887 | 10,597 | 11,014 | 41,184 | |||||||||||||||
| Research and development revenue | 3,257 | 8,052 | 2,266 | 8,774 | 22,349 | |||||||||||||||
| Total revenues | 61,883 | 71,978 | 125,643 | 130,473 | 389,977 | |||||||||||||||
| Expenses: | ||||||||||||||||||||
| Cost of goods manufactured and sold | 16,219 | 17,530 | 42,752 | 51,077 | 127,578 | |||||||||||||||
| Research and development | 28,050 | 28,160 | 40,493 | 45,190 | 141,893 | |||||||||||||||
| Selling, general and administrative | 31,497 | 36,234 | 35,469 | 34,432 | 137,632 | |||||||||||||||
| Amortization and impairment of acquired intangible assets | - | 1,817 | 11,896 | 57,442 | 71,155 | |||||||||||||||
| Total expenses | 75,766 | 83,741 | 130,610 | 188,141 | 478,258 | |||||||||||||||
| Operating Loss | (13,883 | ) | (11,763 | ) | (4,967 | ) | (57,668 | ) | (88,281 | ) | ||||||||||
| Other Income (Expense), Net | 591 | (6,842 | ) | (9,763 | ) | (10,097 | ) | (26,111 | ) | |||||||||||
| Loss Before Income Taxes | (13,292 | ) | (18,605 | ) | (14,730 | ) | (67,765 | ) | (114,392 | ) | ||||||||||
| Income Tax (Benefit) Provision | (54 | ) | 3,650 | 98 | (4,408 | ) | (714 | ) | ||||||||||||
| Net Loss - GAAP | $ | (13,238 | ) | $ | (22,255 | ) | $ | (14,828 | ) | $ | (63,357 | ) | $ | (113,678 | ) | |||||
| Basic and Diluted Net Loss per Share | $ | (0.14 | ) | $ | (0.22 | ) | $ | (0.11 | ) | $ | (0.49 | ) | $ | (0.99 | ) | |||||
|
Weighted Average Number of Common Shares Outstanding |
96,649 | 102,474 | 129,670 | 129,986 | 114,702 | |||||||||||||||
| Condensed Consolidated Balance Sheets | March 31, | March 31, | ||||
| (In thousands) | 2012 | 2011 | ||||
| Cash, cash equivalents and total investments | $ | 246,138 | $ | 294,730 | ||
| Receivables | 96,381 | 22,969 | ||||
| Inventory | 39,759 | 20,425 | ||||
| Prepaid expenses and other current assets | 12,566 | 8,244 | ||||
| Property, plant and equipment, net | 302,995 | 95,020 | ||||
| Intangible assets, net and goodwill | 710,585 | - | ||||
| Other assets | 26,793 | 11,060 | ||||
| Total Assets | $ | 1,435,217 | $ | 452,448 | ||
| Long-term debt — current portion | $ | 3,100 | $ | - | ||
| Other current liabilities | 86,064 | 48,057 | ||||
| Long-term debt | 441,360 | - | ||||
| Deferred revenue - long-term | 7,578 | 4,837 | ||||
| Other long-term liabilities | 43,263 | 7,536 | ||||
| Total shareholders' equity | 853,852 | 392,018 | ||||
| Total Liabilities and Shareholders' Equity | $ | 1,435,217 | $ | 452,448 | ||
| Common shares outstanding (in thousands) | 130,177 | 95,702 | ||||
This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in
Source:
Alkermes plc
For Investors:
Rebecca Peterson, +1 781-609-6378
or
For Media:
Jennifer Snyder, +1 781-609-6166