—First Quarter Revenues of
—VIVITROL® Net Sales Grew by 41%
Year-Over-Year to
—ARISTADA® Gaining Traction in Growing Long-Acting Antipsychotic Market —
“Our solid first quarter performance was highlighted by the robust
growth in VIVITROL® sales, the launch of ARISTADA®,
and continued strength of our base royalty and manufacturing business.
The launch of ARISTADA continues to gain traction, and we are pleased
with the progress that we are making with reimbursement discussions and
physician awareness,” commented
“We have built a differentiated and resilient business. Our portfolio of
innovative products, including VIVITROL and ARISTADA, is growing rapidly
and represents a significant opportunity in the years ahead,” said
Richard Pops, Chief Executive Officer of
Quarter Ended
-
Total revenues for the quarter were
$156.8 million . This compared to$161.2 million for the same period in the prior year, or$142.0 million excluding$19.2 million of revenue from the products associated with the Gainesville manufacturing facility that was divested inApril 2015 (the “Gainesville Divestiture”). -
Net loss according to generally accepted accounting principles in the
U.S. (GAAP) was
$77.4 million , or a basic and diluted GAAP loss per share of$0.51 , for the quarter and reflected increased investment in the company’s advancing late-stage pipeline and commercial infrastructure. This compared to GAAP net loss of$30.7 million , or a basic and diluted GAAP loss per share of$0.21 for the same period in the prior year, or GAAP net loss of$34.9 million , or a basic and diluted loss per share of$0.24 , excluding$4.2 million of GAAP net income related to the Gainesville Divestiture. -
Non-GAAP net loss was
$24.6 million , or a non-GAAP basic and diluted loss per share of$0.16 for the quarter. This compared to non-GAAP net income of$9.2 million , or a non-GAAP diluted earnings per share (EPS) of$0.06 , for the same period in the prior year, or non-GAAP net income of$1.9 million , or basic and diluted EPS of$0.01 , excluding$7.3 million of non-GAAP net income related to the Gainesville Divestiture.
Quarter Ended
Revenues
-
Net sales of VIVITROL were
$43.8 million , compared to$31.1 million for the same period in the prior year, representing an increase of approximately 41%. -
Net sales of ARISTADA were
$5.5 million , following its launch inOctober 2015 . -
Manufacturing and royalty revenues from RISPERDAL CONSTA®
and INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®
were
$54.7 million , compared to$46.9 million for the same period in the prior year. -
Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1
were
$28.2 million , compared to$36.5 million for the same period in the prior year, reflecting the timing of shipments. -
Royalty revenue from BYDUREON® was
$10.5 million , compared to$9.8 million for the same period in the prior year.
Costs and Expenses
-
Operating expenses were
$233.7 million , reflecting increased investment in the company’s development pipeline, the continued launch of ARISTADA and a$10.0 million upfront payment toReset Therapeutics, Inc. related to a collaboration on their novel orexin modulators, which was recorded as research and development expense. Operating expenses for the quarter endedMarch 31, 2015 were$188.5 million , or$173.5 million excluding$15.0 million of operating expenses related to the Gainesville Divestiture.
Balance Sheet
At
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 (loss) and non-GAAP diluted earnings (loss) per share. 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.
Non-GAAP net income (loss) 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.
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 (loss) and non-GAAP diluted earnings (loss) per share 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 in this press release 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.
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; the results of such clinical
development activities may not be positive, or 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) | 2016 | 2015 | ||||||||
Revenues: | ||||||||||
Manufacturing and royalty revenues | $ | 106,159 | $ | 128,744 | ||||||
Product sales, net | 49,374 | 31,137 | ||||||||
Research and development revenues | 1,241 | 1,333 | ||||||||
Total Revenues | 156,774 | 161,214 | ||||||||
Expenses: | ||||||||||
Cost of goods manufactured and sold | 27,711 | 39,974 | ||||||||
Research and development | 101,072 | 70,278 | ||||||||
Selling, general and administrative | 89,719 | 63,050 | ||||||||
Amortization of acquired intangible assets | 15,156 | 15,220 | ||||||||
Total Expenses | 233,658 | 188,522 | ||||||||
Operating Loss | (76,884 | ) | (27,308 | ) | ||||||
Other Expense, net: | ||||||||||
Interest income | 1,011 | 660 | ||||||||
Interest expense | (3,295 | ) | (3,288 | ) | ||||||
Increase in the fair value of contingent consideration | 1,900 | - | ||||||||
Other income (expense), net | 249 | (211 | ) | |||||||
Total Other Expense, net | (135 | ) | (2,839 | ) | ||||||
Loss Before Income Taxes | (77,019 | ) | (30,147 | ) | ||||||
Income Tax Provision | 404 | 510 | ||||||||
Net Loss — GAAP | $ | (77,423 | ) | $ | (30,657 | ) | ||||
(Loss) Earnings Per Share: | ||||||||||
GAAP loss per share — basic and diluted | $ | (0.51 | ) | $ | (0.21 | ) | ||||
Non-GAAP (loss) earnings per share — basic and diluted | $ | (0.16 | ) | $ | 0.06 | |||||
Weighted Average Number of Ordinary Shares Outstanding: | ||||||||||
Basic and Diluted — GAAP | 150,825 | 148,089 | ||||||||
Basic — Non-GAAP | 150,825 | 148,089 | ||||||||
Diluted — Non-GAAP | 150,825 | 157,416 | ||||||||
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net (loss) income is as follows: | ||||||||||
Net Loss — GAAP | $ | (77,423 | ) | $ | (30,657 | ) | ||||
Adjustments: | ||||||||||
Share-based compensation expense | 24,256 | 17,329 | ||||||||
Amortization expense | 15,156 | 15,220 | ||||||||
Depreciation expense | 7,548 | 7,266 | ||||||||
Decrease in the fair value of common stock warrants | 870 | - | ||||||||
Non-cash net interest expense | 232 | 236 | ||||||||
Deferred revenue | (442 | ) | (328 | ) | ||||||
Increase in the fair value of contingent consideration | (1,900 | ) | - | |||||||
Non-cash taxes | (2,863 | ) | 488 | |||||||
Upfront license option payment to Reset Therapeutics, Inc. charged to R&D expense | 10,000 | - | ||||||||
Net gain on transactions with equity method investee | - | (397 | ) | |||||||
Non-GAAP Net (Loss) Income | $ | (24,566 | ) | $ | 9,157 | |||||
|
Condensed Consolidated Balance Sheets | March 31, | December 31, | ||||||
(In thousands) | 2016 | 2015 | ||||||
Cash, cash equivalents and total investments | $ | 719,380 | $ | 798,849 | ||||
Receivables | 139,814 | 155,487 | ||||||
Inventory | 44,817 | 38,411 | ||||||
Prepaid expenses and other current assets | 28,539 | 26,286 | ||||||
Property, plant and equipment, net | 256,326 | 254,819 | ||||||
Intangible assets, net and goodwill | 456,903 | 472,059 | ||||||
Other assets | 149,108 | 109,833 | ||||||
Total Assets | $ | 1,794,887 | $ | 1,855,744 | ||||
Long-term debt — current portion | $ | 64,825 | $ |
65,737 |
||||
Other current liabilities | 159,306 | 170,470 | ||||||
Long-term debt | 283,664 | 284,207 | ||||||
Deferred revenue — long-term | 7,442 | 7,975 | ||||||
Other long-term liabilities | 14,572 | 13,080 | ||||||
Total shareholders' equity | 1,265,078 | 1,314,275 | ||||||
Total Liabilities and Shareholders' Equity | $ | 1,794,887 | $ | 1,855,744 | ||||
Ordinary shares outstanding (in thousands) | 151,082 | 150,701 | ||||||
|
This selected financial information should be read in conjunction with
the consolidated financial statements and notes thereto included in
View source version on businesswire.com: http://www.businesswire.com/news/home/20160428005348/en/
Source:
Alkermes
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or
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