— Second Quarter Revenues Increased 12% Year-Over-Year to
— Net Sales of Proprietary Commercial Products, VIVITROL® and ARISTADA®, Increased 54% Year-Over-Year —
— Rolling Submission of ALKS 5461 New Drug Application to Begin in August —
“Our solid results this quarter demonstrate the continued strength of
our business and commercial portfolio, driven by increasing demand for
our proprietary products, VIVITROL® and ARISTADA®,
which continue to grow robustly in their respective markets,” commented
“We are executing on our strategy and making rapid progress as we
continue to invest in our future growth drivers. Following a pre-NDA
meeting with
Quarter Ended
-
Total revenues for the quarter were
$218.8 million . This compared to$195.2 million for the same period in the prior year. -
Net loss according to generally accepted accounting principles in the
U.S. (GAAP) was
$43.0 million , or a basic and diluted GAAP loss per share of$0.28 , for the quarter and reflected increased investment in the company’s commercial infrastructure and higher cost of goods manufactured and sold reflecting increased manufacturing activity. This compared to GAAP net loss of$47.2 million , or a basic and diluted GAAP loss per share of$0.31 , for the same period in the prior year. -
Non-GAAP net income was
$1.2 million , or a non-GAAP basic and diluted earnings per share of$0.01 for the quarter. This compared to non-GAAP net loss of$1.6 million , or a non-GAAP basic and diluted loss per share of$0.01 , for the same period in the prior year.
Quarter Ended
Revenues
-
Net sales of VIVITROL were
$66.1 million , compared to$47.2 million for the same period in the prior year. -
Net sales of ARISTADA were
$22.7 million , compared to$10.3 million for the same period in the prior year. -
Manufacturing and royalty revenues from RISPERDAL CONSTA®,
INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA®
were
$82.2 million , compared to$69.6 million for the same period in the prior year. -
Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1
were
$25.3 million , compared to$40.8 million for the same period in the prior year. -
Royalty revenue from BYDUREON® was
$11.6 million , compared to$12.3 million for the same period in the prior year.
Costs and Expenses
-
Operating expenses were
$263.4 million , compared to$242.3 million for the same period in the prior year, reflecting increased investment in the company’s commercial infrastructure and higher cost of goods manufactured and sold reflecting increased manufacturing activity at our site inOhio .
Balance Sheet
At
Financial Expectations
Conference Call
About
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; certain other one-time or non-cash items; and the income tax effect of these reconciling items.
The company’s management and board of directors utilize these non-GAAP financial measures to evaluate the company’s performance. The company provides these non-GAAP measures of the company’s performance to investors because 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. 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. Further, non-GAAP net income (loss) and non-GAAP diluted earnings (loss) per share should not be considered measures of our liquidity.
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, including the growth of VIVITROL
and ARISTADA; the therapeutic and commercial value of the company’s
products, including the launch and commercialization of two-month
ARISTADA; and expectations concerning the timing and results of clinical
development activities, including the timing of the NDA submission for
ALKS 5461. You are cautioned 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 unfavorable outcome of
litigation, including so-called “Paragraph IV” litigation and other
patent litigation, related to any of our products, which may lead to
competition from generic drug manufacturers; data from clinical trials
may be interpreted by 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 | June 30, | June 30, | |||||||
(In thousands, except per share data) | 2017 | 2016 | |||||||
Revenues: | |||||||||
Manufacturing and royalty revenues | $ 129,252 | $ 137,034 | |||||||
Product sales, net | 88,756 | 57,519 | |||||||
Research and development revenues | 833 | 612 | |||||||
Total Revenues | 218,841 | 195,165 | |||||||
Expenses: | |||||||||
Cost of goods manufactured and sold | 39,775 | 33,998 | |||||||
Research and development | 99,153 | 97,007 | |||||||
Selling, general and administrative | 108,950 | 96,120 | |||||||
Amortization of acquired intangible assets | 15,472 | 15,157 | |||||||
Total Expenses | 263,350 | 242,282 | |||||||
Operating Loss | (44,509 | ) | (47,117 | ) | |||||
Other Expense, net: | |||||||||
Interest income | 1,171 | 994 | |||||||
Interest expense | (2,923 | ) | (3,323 | ) | |||||
Increase in the fair value of contingent consideration | 700 | 2,200 | |||||||
Other expense, net | (119 | ) | (467 | ) | |||||
Total Other Expense, net | (1,171 | ) | (596 | ) | |||||
Loss Before Income Taxes | (45,680 | ) | (47,713 | ) | |||||
Income Tax Benefit | (2,681 | ) | (520 | ) | |||||
Net Loss — GAAP | $ (42,999 | ) | $ (47,193 | ) | |||||
Net (Loss) Earnings Per Share: | |||||||||
GAAP net loss per share — basic and diluted | $ (0.28 | ) | $ (0.31 | ) | |||||
Non-GAAP earnings (loss) per share — basic and diluted | $ 0.01 | $ (0.01 | ) | ||||||
Weighted Average Number of Ordinary Shares Outstanding: | |||||||||
Basic and diluted — GAAP | 153,392 | 151,301 | |||||||
Basic — Non-GAAP | 153,392 | 151,301 | |||||||
Diluted — Non-GAAP | 160,307 | 151,301 | |||||||
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income (loss) is as follows: | |||||||||
Net Loss — GAAP | $ (42,999 | ) | $ (47,193 | ) | |||||
Adjustments: | |||||||||
Share-based compensation expense | 22,680 | 26,631 | |||||||
Amortization expense | 15,472 | 15,157 | |||||||
Depreciation expense | 9,034 | 7,927 | |||||||
Change in the fair value of warrants and equity method investments | 1,611 | (127 | ) | ||||||
Non-cash net interest expense | 193 | 231 | |||||||
Increase in the fair value of contingent consideration | (700 | ) | (2,200 | ) | |||||
Income tax effect related to reconciling items | (4,102 | ) | (2,051 | ) | |||||
Non-GAAP Net Income (Loss) | $ 1,189 | $ (1,625 | ) | ||||||
Six Months | Six Months | ||||||||
Ended | Ended | ||||||||
Condensed Consolidated Statements of Operations - GAAP | June 30, | June 30, | |||||||
(In thousands, except per share data) | 2017 | 2016 | |||||||
Revenues: | |||||||||
Manufacturing and royalty revenues | $ 243,931 | $ 243,194 | |||||||
Product sales, net | 165,212 | 106,893 | |||||||
Research and development revenues | 1,476 | 1,853 | |||||||
Total Revenues | 410,619 | 351,940 | |||||||
Expenses: | |||||||||
Cost of goods manufactured and sold | 80,187 | 61,709 | |||||||
Research and development | 203,988 | 198,079 | |||||||
Selling, general and administrative | 211,049 | 185,840 | |||||||
Amortization of acquired intangible assets | 30,774 | 30,313 | |||||||
Total Expenses | 525,998 | 475,941 | |||||||
Operating Loss | (115,379 | ) | (124,001 | ) | |||||
Other Expense, net: | |||||||||
Interest income | 2,114 | 2,005 | |||||||
Interest expense | (5,687 | ) | (6,618 | ) | |||||
Increase in the fair value of contingent consideration | 2,300 | 4,100 | |||||||
Other expense, net | (1,618 | ) | (218 | ) | |||||
Total Other Expense, net | (2,891 | ) | (731 | ) | |||||
Loss Before Income Taxes | (118,270 | ) | (124,732 | ) | |||||
Income Tax Benefit | (6,390 | ) | (116 | ) | |||||
Net Loss — GAAP | $ (111,880 | ) | $ (124,616 | ) | |||||
Net Loss Per Share: | |||||||||
GAAP net loss per share — basic and diluted | $ (0.73 | ) | $ (0.82 | ) | |||||
Non-GAAP net loss per share — basic and diluted | $ (0.17 | ) | $ (0.13 | ) | |||||
Weighted Average Number of Ordinary Shares Outstanding: | |||||||||
Basic and diluted — GAAP and Non-GAAP | 153,050 | 151,063 | |||||||
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net loss is as follows: | |||||||||
Net Loss — GAAP | $ (111,880 | ) | $ (124,616 | ) | |||||
Adjustments: | |||||||||
Share-based compensation expense | 43,849 | 50,887 | |||||||
Amortization expense | 30,774 | 30,313 | |||||||
Depreciation expense | 17,495 | 15,475 | |||||||
Change in the fair value of warrants and equity method investments | 3,063 | 743 | |||||||
Non-cash net interest expense | 386 | 463 | |||||||
Increase in the fair value of contingent consideration | (2,300 | ) | (4,100 | ) | |||||
Income tax effect related to reconciling items | (8,052 | ) | 1,289 | ||||||
Upfront license option payment to Reset Therapeutics, Inc. charged to R&D expense | - | 10,000 | |||||||
Non-GAAP Net Loss | $ (26,665 | ) | $ (19,546 | ) | |||||
Pursuant to compliance and disclosure interpretations published by the
Condensed Consolidated Balance Sheets | June 30, | December 31, | |||||
(In thousands) | 2017 | 2016 | |||||
Cash, cash equivalents and total investments | $ 560,831 | $ 619,165 | |||||
Receivables | 199,709 | 191,102 | |||||
Inventory | 77,352 | 62,998 | |||||
Prepaid expenses and other current assets | 43,457 | 39,344 | |||||
Property, plant and equipment, net | 266,484 | 264,785 | |||||
Intangible assets, net and goodwill | 380,326 | 411,100 | |||||
Other assets | 203,184 | 137,929 | |||||
Total Assets | $ 1,731,343 | $1,726,423 | |||||
Long-term debt — current portion | $ 3,000 | $ 3,000 | |||||
Other current liabilities | 221,644 | 208,993 | |||||
Long-term debt | 279,552 | 280,666 | |||||
Deferred revenue — long-term | 6,782 | 7,122 | |||||
Other long-term liabilities | 18,278 | 17,161 | |||||
Total shareholders' equity | 1,202,087 | 1,209,481 | |||||
Total Liabilities and Shareholders' Equity | $ 1,731,343 | $1,726,423 | |||||
Ordinary shares outstanding (in thousands) | 153,650 | 152,431 | |||||
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/20170727005239/en/
Source:
Alkermes
For Investors:
Sandy
Coombs, +1 781-609-6377
or
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or
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