— Third Quarter Revenues of
— Commercial Launch of ARISTADA™ Underway Following FDA Approval for
the Treatment of Schizophrenia on
— ALKS 3831 for Schizophrenia and ALKS 8700 for Multiple Sclerosis to Commence Registration Studies Before Year-End —
“Earlier this month, the
“We are pleased by our solid financial performance during the third
quarter and are on track with our financial expectations for the
remainder of 2015. The approval of ARISTADA further strengthens our
commercial portfolio and represents a major financial opportunity for
Alkermes,” commented
Quarter Ended
-
Total revenues for the quarter were
$152.7 million compared to$160.0 million for the same period in the prior year, or$143.2 million excluding$16.8 million of revenues from the products associated with the Gainesville manufacturing facility that was divested inApril 2015 . -
Net loss according to generally accepted accounting principles in the
U.S. (GAAP) was
$81.0 million , or a basic and diluted GAAP loss per share of$0.54 , for the quarter. This compared to GAAP net loss of$40.0 million , or a basic and diluted GAAP loss per share of$0.27 , for the same period in the prior year, or$34.5 million , or a basic and diluted loss per share of$0.24 , excluding$5.5 million of GAAP net income related to the Gainesville facility and associated products. -
Non-GAAP net loss was
$26.2 million , or a non-GAAP diluted loss per share of$0.18 for the quarter. This compared to non-GAAP net income of$3.9 million , or a non-GAAP diluted earnings per share of$0.03 , for the same period in the prior year, or a non-GAAP net loss of$3.5 million , or a non-GAAP basic and diluted loss per share of$0.02 , excluding$7.4 million of non-GAAP net income related to the Gainesville facility and associated products.
Quarter Ended
Revenues
-
Manufacturing and royalty revenues from RISPERDAL CONSTA®
and INVEGA SUSTENNA®/XEPLION® were
$67.6 million , compared to$68.5 million for the same period in the prior year. -
Net sales of VIVITROL were
$37.9 million , compared to$25.8 million for the same period in the prior year, representing an increase of approximately 47%. -
Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1
were
$22.1 million , compared to$16.5 million for the same period in the prior year. -
Royalty revenue from BYDUREON® was
$13.0 million , compared to$10.3 million for the same period in the prior year.
Costs and Expenses
-
Operating expenses were
$230.1 million , reflecting increased investment in the company’s rapidly advancing development pipeline and pre-launch activities for ARISTADA, and included$13.9 million of share-based compensation expense related to the partial vesting of a performance-based equity grant related to the approval of ARISTADA. This compared to$192.7 million for the same period in the prior year, or$180.0 million excluding$12.7 million of operating expenses related to the Gainesville facility and associated products. -
Income tax provision was
$3.0 million , compared to$3.5 million for the same period in the prior year.
Balance Sheet
At
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 or loss, non-GAAP diluted earnings or loss 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 or 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.
- Free cash flow represents non-GAAP net income or loss 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 or loss, non-GAAP diluted earnings or loss 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 the timing of the
commencement of the pivotal programs for ALKS 3831 and ALKS 8700 and the
receipt of data from the first core efficacy study of ALKS 5461. 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: the impact of litigation, including
litigation against regulatory authorities, in respect of our products;
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
ARISTADA™ is a 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 | September 30, | September 30, | ||||||||||
(In thousands, except per share data) | 2015 | 2014 | ||||||||||
Revenues: | ||||||||||||
Manufacturing and royalty revenues | $ | 114,072 | $ | 132,028 | ||||||||
Product sales, net | 37,903 | 25,802 | ||||||||||
Research and development revenues | 678 | 2,162 | ||||||||||
Total Revenues | 152,653 | 159,992 | ||||||||||
Expenses: | ||||||||||||
Cost of goods manufactured and sold | 33,806 | 47,335 | ||||||||||
Research and development | 92,558 | 78,263 | ||||||||||
Selling, general and administrative | 89,497 | 51,888 | ||||||||||
Amortization of acquired intangible assets | 14,207 | 15,244 | ||||||||||
Total Expenses | 230,068 | 192,730 | ||||||||||
Operating Loss | (77,415 | ) | (32,738 | ) | ||||||||
Other Expense, net: | ||||||||||||
Interest income | 865 | 546 | ||||||||||
Interest expense | (3,325 | ) | (3,356 | ) | ||||||||
Gain on the Gainesville Transaction | 26 | - | ||||||||||
Increase in the fair value of contingent consideration | 1,200 | - | ||||||||||
Gain on sale of property, plant and equipment | - | 36 | ||||||||||
Other income (expense), net | 629 | (921 | ) | |||||||||
Total Other Expense, net | (605 | ) | (3,695 | ) | ||||||||
Loss Before Income Taxes | (78,020 | ) | (36,433 | ) | ||||||||
Income Tax Provision | 2,995 | 3,523 | ||||||||||
Net Loss — GAAP | $ | (81,015 | ) | $ | (39,956 | ) | ||||||
(Loss) Earnings Per Share: | ||||||||||||
GAAP loss per share — basic and diluted | $ | (0.54 | ) | $ | (0.27 | ) | ||||||
Non-GAAP (loss) earnings per share — basic and diluted | $ | (0.18 | ) | $ | 0.03 | |||||||
Weighted Average Number of Ordinary Shares Outstanding: | ||||||||||||
Basic and diluted — GAAP | 149,512 | 145,896 | ||||||||||
Basic — Non-GAAP | 149,512 | 145,896 | ||||||||||
Diluted — Non-GAAP | 149,512 | 154,399 | ||||||||||
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net (loss) income is as follows: | ||||||||||||
Net Loss — GAAP | $ | (81,015 | ) | $ | (39,956 | ) | ||||||
Adjustments: | ||||||||||||
Share-based compensation expense | 35,267 | 13,481 | ||||||||||
Amortization expense | 14,207 | 15,244 | ||||||||||
Depreciation expense | 6,486 | 9,989 | ||||||||||
Non-cash taxes | 677 | 3,640 | ||||||||||
Non-cash net interest expense | 234 | 238 | ||||||||||
Deferred revenue | (725 | ) | 696 | |||||||||
Net (gain) loss on transactions with equity method investee | (397 | ) | 603 | |||||||||
Gain on the Gainesville Transaction | (26 | ) | - | |||||||||
Increase in the fair value of contingent consideration | (1,200 | ) | - | |||||||||
Change in the fair value of common stock warrants | 318 | - | ||||||||||
Gain on sale of property, plant and equipment | - | (36 | ) | |||||||||
Non-GAAP Net (Loss) Income | $ | (26,174 | ) | $ | 3,899 | |||||||
Capital expenditures | 11,974 | 8,888 | ||||||||||
Free Cash Outflow | $ | (38,148 | ) | $ | (4,989 | ) | ||||||
Nine Months | Nine Months | |||||||||||
Ended | Ended | |||||||||||
Condensed Consolidated Statements of Operations - GAAP | September 30, | September 30, | ||||||||||
(In thousands, except per share data) | 2015 | 2014 | ||||||||||
Revenues: | ||||||||||||
Manufacturing and royalty revenues | $ | 355,978 | $ | 373,674 | ||||||||
Product sales, net | 106,212 | 64,476 | ||||||||||
Research and development revenues | 3,047 | 5,478 | ||||||||||
Total Revenues | 465,237 | 443,628 | ||||||||||
Expenses: | ||||||||||||
Cost of goods manufactured and sold | 104,198 | 129,464 | ||||||||||
Research and development | 250,718 | 197,610 | ||||||||||
Selling, general and administrative | 224,086 | 145,101 | ||||||||||
Amortization of acquired intangible assets | 43,479 | 42,909 | ||||||||||
Total Expenses | 622,481 | 515,084 | ||||||||||
Operating Loss | (157,244 | ) | (71,456 | ) | ||||||||
Other Income, net: | ||||||||||||
Interest income | 2,320 | 1,380 | ||||||||||
Interest expense | (9,928 | ) | (10,097 | ) | ||||||||
Gain on the Gainesville Transaction | 9,937 | - | ||||||||||
Increase in the fair value of contingent consideration | 2,700 | - | ||||||||||
Gain on sale of investment in Acceleron Pharma Inc. | - | 15,296 | ||||||||||
Gain on sale of property, plant and equipment | - | 12,321 | ||||||||||
Other income (expense), net | 1,003 | (2,253 | ) | |||||||||
Total Other Income, net | 6,032 | 16,647 | ||||||||||
Loss Before Income Taxes | (151,212 | ) | (54,809 | ) | ||||||||
Income Tax Provision | 6,569 | 5,766 | ||||||||||
Net Loss — GAAP | $ | (157,781 | ) | $ | (60,575 | ) | ||||||
(Loss) Earnings Per Share: | ||||||||||||
GAAP loss per share — basic and diluted | $ | (1.06 | ) | $ | (0.42 | ) | ||||||
Non-GAAP (loss) earnings per share — basic | $ | (0.21 | ) | $ | 0.26 | |||||||
Non-GAAP (loss) earnings per share — diluted | $ | (0.21 | ) | $ | 0.25 | |||||||
Weighted Average Number of Ordinary Shares Outstanding: | ||||||||||||
Basic and diluted — GAAP | 148,828 | 144,732 | ||||||||||
Basic — Non-GAAP | 148,828 | 144,732 | ||||||||||
Diluted — Non-GAAP | 148,828 | 154,017 | ||||||||||
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net (loss) income is as follows: | ||||||||||||
Net Loss — GAAP | $ | (157,781 | ) | $ | (60,575 | ) | ||||||
Adjustments: | ||||||||||||
Share-based compensation expense | 74,473 | 46,238 | ||||||||||
Amortization expense | 43,479 | 42,909 | ||||||||||
Depreciation expense | 20,336 | 29,810 | ||||||||||
Non-cash taxes | 4,199 | 5,055 | ||||||||||
Non-cash net interest expense | 705 | 717 | ||||||||||
Deferred revenue | (1,627 | ) | (607 | ) | ||||||||
Net (gain) loss on transactions with equity method investee | (1,191 | ) | 1,842 | |||||||||
Gain on the Gainesville Transaction | (9,937 | ) | - | |||||||||
Increase in the fair value of contingent consideration | (2,700 | ) | - | |||||||||
Change in the fair value of common stock warrants | (558 | ) | - | |||||||||
Gain on sale of investment in Acceleron Pharma Inc. | - | (15,296 | ) | |||||||||
Gain on sale of property, plant and equipment | - | (12,321 | ) | |||||||||
Non-GAAP Net (Loss) Income | $ | (30,602 | ) | $ | 37,772 | |||||||
Capital expenditures | 36,730 | 20,326 | ||||||||||
Free Cash (Outflow) Inflow | $ | (67,332 | ) | $ | 17,446 | |||||||
Condensed Consolidated Balance Sheets | September 30, | December 31, | ||||||||||
(In thousands) | 2015 | 2014 | ||||||||||
Cash, cash equivalents and total investments | $ | 815,499 | $ | 801,646 | ||||||||
Receivables | 140,987 | 151,551 | ||||||||||
Inventory | 36,783 | 51,357 | ||||||||||
Prepaid expenses and other current assets | 50,893 | 42,719 | ||||||||||
Property, plant and equipment, net | 242,675 | 265,740 | ||||||||||
Intangible assets, net and goodwill | 486,266 | 573,624 | ||||||||||
Contingent consideration | 60,300 | - | ||||||||||
Other assets | 47,552 | 34,635 | ||||||||||
Total Assets | $ | 1,880,955 | $ | 1,921,272 | ||||||||
Long-term debt — current portion | $ | 66,712 | $ | 6,750 | ||||||||
Other current liabilities | 133,690 | 123,832 | ||||||||||
Long-term debt | 286,512 | 351,220 | ||||||||||
Deferred revenue — long-term | 7,477 | 11,801 | ||||||||||
Other long-term liabilities | 19,759 | 30,832 | ||||||||||
Total shareholders' equity | 1,366,805 | 1,396,837 | ||||||||||
Total Liabilities and Shareholders' Equity | $ | 1,880,955 | $ | 1,921,272 | ||||||||
Ordinary shares outstanding (in thousands) | 149,854 | 147,539 | ||||||||||
|
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/20151029005359/en/
Source:
Alkermes
For Investors:
Sandy
Coombs, +1-781-609-6377
or
For Media:
Jennifer Snyder,
+1-781-609-6166