— First Quarter Revenues of
— Late-Stage Pipeline Advancing Rapidly as Company Progresses Pivotal Programs for ALKS 5461 in Depression, ALKS 3831 in Schizophrenia and ALKS 8700 in Multiple Sclerosis —
— Preparing for Launch of Aripiprazole Lauroxil for Schizophrenia —
— 2015 Financial Expectations Reiterated —
“Our results this quarter reflect strong revenues from our portfolio of
key commercial products and focused investment in our promising
late-stage pipeline of CNS product candidates that will drive our future
growth,” commented
“Alkermes is on the threshold of our next phase of growth and is in the
midst of an extremely active time at the company as we advance one of
the most exciting late-stage pipelines of CNS medicines in the industry.
Aripiprazole lauroxil, our long-acting atypical antipsychotic for
schizophrenia, is moving toward
Quarter Ended
-
Total revenues for the quarter were
$161.2 million compared to$130.2 million for the same period in the prior year. -
Non-GAAP net income was
$9.2 million , or a non-GAAP diluted earnings per share (EPS) of$0.06 for the quarter. This compared to non-GAAP net income of$16.2 million , or a non-GAAP diluted EPS of$0.11 , for the same period in the prior year. -
GAAP net loss was
$30.7 million , or a basic and diluted GAAP loss per share of$0.21 , for the quarter. This compared to GAAP net loss of$24.4 million , or a basic and diluted GAAP loss per share of$0.17 , for the same period in the prior year.
Quarter Ended
Revenues
-
Manufacturing and royalty revenues from the company’s long-acting
atypical antipsychotic franchise, RISPERDAL® CONSTA®
and INVEGA® SUSTENNA®/XEPLION®, were
$46.9 million , compared to$49.6 million for the same period in the prior year. -
Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1
were
$36.5 million , compared to$20.6 million for the same period in the prior year. -
Net sales of VIVITROL® were
$31.1 million , compared to$17.1 million for the same period in the prior year, representing an increase of approximately 82%. -
Royalty revenue from BYDUREON® was
$9.8 million , compared to$7.7 million for the same period in the prior year.
Costs and Expenses
-
Operating expenses were
$188.5 million , reflecting increased investment in the company’s rapidly advancing central nervous system (CNS) development pipeline and pre-launch activities for aripiprazole lauroxil. This compared to$146.1 million for the same period in the prior year. -
Income tax provision was
$0.5 million , compared to$3.8 million for the same period in the prior year.
Balance Sheet
At
Subsequent Event
On
Financial Expectations
Conference Call
About Alkermes
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.
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, 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 development activities, including regulatory approval of
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
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) | ||||||
Three Months | Three Months | |||||
Ended | Ended | |||||
Condensed Consolidated Statements of Operations - GAAP | March 31, | March 31, | ||||
(In thousands, except per share data) | 2015 | 2014 | ||||
Revenues: | ||||||
Manufacturing and royalty revenues | $ 128,744 | $ 111,280 | ||||
Product sales, net | 31,137 | 17,079 | ||||
Research and development revenues | 1,333 | 1,853 | ||||
Total Revenues | 161,214 | 130,212 | ||||
Expenses: | ||||||
Cost of goods manufactured and sold | 39,974 | 38,839 | ||||
Research and development | 70,278 | 52,140 | ||||
Selling, general and administrative | 63,050 | 42,550 | ||||
Amortization of acquired intangible assets | 15,220 | 12,576 | ||||
Total Expenses | 188,522 | 146,105 | ||||
Operating Loss | (27,308 | ) | (15,893 | ) | ||
Other Expense, net: | ||||||
Interest income | 660 | 511 | ||||
Interest expense | (3,288 | ) | (3,356 | ) | ||
Other expense, net | (211 | ) | (1,850 | ) | ||
Total Other Expense, net | (2,839 | ) | (4,695 | ) | ||
Loss Before Income Taxes | (30,147 | ) | (20,588 | ) | ||
Income Tax Provision | 510 | 3,766 | ||||
Net Loss — GAAP | $ (30,657 | ) | $ (24,354 | ) | ||
(Loss) Earnings Per Share: | ||||||
GAAP loss per share — basic and diluted | $ (0.21 | ) | $ (0.17 | ) | ||
Non-GAAP earnings per share — basic and diluted | $ 0.06 | $ 0.11 | ||||
Weighted Average Number of Ordinary Shares Outstanding: | ||||||
Basic and Diluted — GAAP | 148,089 | 143,358 | ||||
Basic — Non-GAAP | 148,089 | 143,358 | ||||
Diluted — Non-GAAP | 157,416 | 153,583 | ||||
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income is as follows: | ||||||
Net Loss — GAAP | $ (30,657 | ) | $ (24,354 | ) | ||
Adjustments: | ||||||
Share-based compensation expense | 17,329 | 13,420 | ||||
Amortization expense | 15,220 | 12,576 | ||||
Depreciation expense | 7,266 | 9,977 | ||||
Non-cash taxes | 488 | 3,622 | ||||
Non-cash net interest expense | 236 | 240 | ||||
Deferred revenue | (328 | ) | (965 | ) | ||
Net (gain) loss on transactions with equity method investee | (397 | ) | 1,635 | |||
Non-GAAP Net Income | $ 9,157 | $ 16,151 | ||||
Capital expenditures | (10,710 | ) | (5,685 | ) | ||
Free Cash Flow | $ (1,553 | ) | $ 10,466 |
Condensed Consolidated Balance Sheets | March 31, | December 31, | |||
(In thousands) | 2015 | 2014 | |||
Cash, cash equivalents and total investments | $ 805,713 | $ 801,646 | |||
Receivables | 141,978 | 151,551 | |||
Inventory | 49,139 | 51,357 | |||
Prepaid expenses and other current assets | 64,967 | 42,719 | |||
Property, plant and equipment, net | 268,760 | 265,740 | |||
Intangible assets, net and goodwill | 558,404 | 573,624 | |||
Other assets | 35,813 | 34,635 | |||
Total Assets (includes $105.2 million of assets held for sale at March 31, 2015) | $ 1,924,774 | $ 1,921,272 | |||
Long-term debt — current portion | $ 6,750 | $ 6,750 | |||
Other current liabilities | 107,467 | 123,832 | |||
Long-term debt | 349,638 | 351,220 | |||
Deferred revenue — long-term | 11,577 | 11,801 | |||
Other long-term liabilities | 28,923 | 30,832 | |||
Total shareholders' equity | 1,420,419 | 1,396,837 | |||
Total Liabilities and Shareholders' Equity (includes $6.6 million of liabilities held for sale at March 31, 2015) | $ 1,924,774 | $ 1,921,272 | |||
Ordinary shares outstanding (in thousands) | 148,480 | 147,539 | |||
|
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