— Third Quarter Revenues Increased 18% Year-Over-Year to
GAAP Loss per Share of
— VIVITROL® Net Sales Grew 47% Year-Over-Year
to
— ARISTADA® Launch Progressing; Revenues Grow In Line With Expectations —
“Our third quarter results demonstrate the value of our
highly-diversified commercial portfolio, and were driven by the strong
growth of our proprietary products, VIVITROL® and ARISTADA®,”
commented
“We are at an unprecedented place in Alkermes’ evolution, with two
proprietary products growing in their markets, ALKS 5461 advancing at
full speed, and two additional late-stage candidates well into their
pivotal programs,” stated Richard Pops, Chief Executive Officer of
Quarter Ended
-
Total revenues for the quarter were
$180.2 million . This compared to$152.7 million for the same period in the prior year. -
Net loss according to generally accepted accounting principles in the
U.S. (GAAP) was
$62.7 million , or a basic and diluted GAAP loss per share of$0.41 , for the quarter, which reflected increased investment in the company’s advancing late-stage pipeline and commercial infrastructure. This compared to GAAP net loss of$81.0 million , or a basic and diluted GAAP loss per share of$0.54 , for the same period in the prior year. -
Non-GAAP net loss was
$14.1 million , or a non-GAAP basic and diluted loss per share of$0.09 , for the quarter. This compared to non-GAAP net loss of$28.8 million , or a non-GAAP basic and diluted loss per share of$0.19 , for the same period in the prior year.
Quarter Ended
Revenues
-
Net sales of VIVITROL were
$55.8 million , compared to$37.9 million for the same period in the prior year, representing an increase of approximately 47%. -
Net sales of ARISTADA were
$14.0 million , up from$10.3 million in the second quarter of 2016. -
Manufacturing revenues from RISPERDAL CONSTA® (risperidone)
and royalty revenues from RISPERDAL CONSTA, INVEGA SUSTENNA®/XEPLION®
(paliperidone palmitate) and INVEGA TRINZA®/TREVICTA®
(paliperidone palmitate) were
$73.3 million , compared to$67.6 million for the same period in the prior year. -
Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1
were
$12.9 million , compared to$22.1 million for the same period in the prior year, primarily due to the timing of manufacturing shipments. -
Royalty revenue from BYDUREON® was
$11.6 million , compared to$13.0 million for the same period in the prior year.
Costs and Expenses
-
Operating expenses were
$241.4 million , reflecting increased investment in the company’s development pipeline, the continued launch of ARISTADA and growth of VIVITROL. Operating expenses for the quarter endedSept. 30, 2015 were$230.1 million .
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 loss in the three and nine months ended
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 revenue growth from the
company’s marketed products; the therapeutic and commercial value of the
company’s marketed and development products; and expectations concerning
the timing and results of clinical development activities and regulatory
authority interactions. 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 unfavorable outcome
of litigation, including so-called “Paragraph IV” litigation and other
patent litigation, related to any of our products; 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 |
September 30, | September 30, | |||||||
(In thousands, except per share data) |
2016 | 2015 | |||||||
Revenues: | |||||||||
Manufacturing and royalty revenues | $ 110,250 | $ 114,072 | |||||||
Product sales, net | 69,802 | 37,903 | |||||||
Research and development revenues | 189 | 678 | |||||||
Total Revenues | 180,241 | 152,653 | |||||||
Expenses: | |||||||||
Cost of goods manufactured and sold | 35,456 | 33,806 | |||||||
Research and development | 99,444 | 92,558 | |||||||
Selling, general and administrative | 91,145 | 89,497 | |||||||
Amortization of acquired intangible assets | 15,323 | 14,207 | |||||||
Total Expenses | 241,368 | 230,068 | |||||||
Operating Loss | (61,127 | ) | (77,415 | ) | |||||
Other Expense, net: | |||||||||
Interest income | 912 | 865 | |||||||
Interest expense | (3,375 | ) | (3,325 | ) | |||||
Gain on Gainesville Transaction | - | 26 | |||||||
Change in the fair value of contingent consideration | (1,000 | ) | 1,200 | ||||||
Other (expense) income, net | (752 | ) | 629 | ||||||
Total Other Expense, net | (4,215 | ) | (605 | ) | |||||
Loss Before Income Taxes | (65,342 | ) | (78,020 | ) | |||||
Income Tax (Benefit) Provision | (2,655 | ) | 2,995 | ||||||
Net Loss — GAAP | $ (62,687 | ) | $ (81,015 | ) | |||||
Net Loss Per Share: | |||||||||
GAAP net loss per share — basic and diluted | $ (0.41 | ) | $ (0.54 | ) | |||||
Non-GAAP net loss per share — basic and diluted | $ (0.09 | ) | $ (0.19 | ) | |||||
Weighted Average Number of Ordinary Shares Outstanding: | |||||||||
Basic and diluted — GAAP and Non-GAAP | 151,652 | 149,512 | |||||||
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net loss is as follows: | |||||||||
Net Loss — GAAP | $ (62,687 | ) | $ (81,015 | ) | |||||
Adjustments: | |||||||||
Share-based compensation expense | 23,726 | 35,267 | |||||||
Amortization expense | 15,323 | 14,207 | |||||||
Depreciation expense | 8,497 | 6,486 | |||||||
Income tax effect related to reconciling items | (673 | ) | (2,344 | ) | |||||
Non-cash net interest expense | 231 | 234 | |||||||
Loss (gain) on warrants and equity method investments | 521 | (79 | ) | ||||||
Change in the fair value of contingent consideration | 1,000 | (1,200 | ) | ||||||
Gain on Gainesville Transaction | - | (26 | ) | ||||||
Gain on sale of property, plant and equipment | - | (341 | ) | ||||||
Non-GAAP Net Loss | $ (14,062 | ) | $ (28,811 | ) | |||||
Nine Months | Nine Months | ||||||||
Ended | Ended | ||||||||
Condensed Consolidated Statements of Operations - GAAP | September 30, | September 30, | |||||||
(In thousands, except per share data) | 2016 | 2015 | |||||||
Revenues: | |||||||||
Manufacturing and royalty revenues | $ 353,444 | $ 355,978 | |||||||
Product sales, net | 176,695 | 106,212 | |||||||
Research and development revenues | 2,042 | 3,047 | |||||||
Total Revenues | 532,181 | 465,237 | |||||||
Expenses: | |||||||||
Cost of goods manufactured and sold | 97,165 | 104,198 | |||||||
Research and development | 297,523 | 250,718 | |||||||
Selling, general and administrative | 276,985 | 224,086 | |||||||
Amortization of acquired intangible assets | 45,636 | 43,479 | |||||||
Total Expenses | 717,309 | 622,481 | |||||||
Operating Loss | (185,128 | ) | (157,244 | ) | |||||
Other (Expense) Income, net: | |||||||||
Interest income | 2,917 | 2,320 | |||||||
Interest expense | (9,993 | ) | (9,928 | ) | |||||
Gain on Gainesville Transaction | - | 9,937 | |||||||
Change in the fair value of contingent consideration | 3,100 | 2,700 | |||||||
Other (expense) income, net | (970 | ) | 1,003 | ||||||
Total Other (Expense) Income, net | (4,946 | ) | 6,032 | ||||||
Loss Before Income Taxes | (190,074 | ) | (151,212 | ) | |||||
Income Tax (Benefit) Provision | (2,771 | ) | 6,569 | ||||||
Net Loss — GAAP |
$ (187,303 | ) | $ (157,781 | ) | |||||
Net Loss Per Share: | |||||||||
GAAP net loss per share — basic and diluted | $ (1.24 | ) | $ (1.06 | ) | |||||
Non-GAAP net loss per share — basic and diluted | $ (0.22 | ) | $ (0.24 | ) | |||||
Weighted Average Number of Ordinary Shares Outstanding: | |||||||||
Basic and diluted — GAAP and Non-GAAP | 151,261 | 148,828 | |||||||
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net loss is as follows: | |||||||||
Net Loss — GAAP | $ (187,303 | ) | $ (157,781 | ) | |||||
Adjustments: | |||||||||
Share-based compensation expense | 74,613 | 74,473 | |||||||
Amortization expense | 45,636 | 43,479 | |||||||
Depreciation expense | 23,972 | 20,336 | |||||||
Income tax effect related to reconciling items | 616 | (2,204 | ) | ||||||
Loss (gain) on warrants and equity method investments | 1,264 | (1,749 | ) | ||||||
Non-cash net interest expense | 694 | 705 | |||||||
Upfront license option payment to Reset Therapeutics, Inc. charged to R&D expense | 10,000 | - | |||||||
Change in the fair value of contingent consideration | (3,100 | ) | (2,700 | ) | |||||
Gain on Gainesville Transaction | - | (9,937 | ) | ||||||
Gain on sale of property, plant and equipment | - | (455 | ) | ||||||
Non-GAAP Net Loss | $ (33,608 | ) | $ (35,833 | ) | |||||
|
Pursuant to compliance and disclosure interpretations published by the
Condensed Consolidated Balance Sheets | September 30, | December 31, | |||||
(In thousands) | 2016 | 2015 | |||||
Cash, cash equivalents and total investments | $ 624,605 | $ 798,849 | |||||
Receivables | 177,446 | 155,487 | |||||
Inventory | 54,155 | 38,411 | |||||
Prepaid expenses and other current assets | 26,204 | 26,286 | |||||
Property, plant and equipment, net | 262,181 | 254,819 | |||||
Intangible assets, net and goodwill | 426,423 | 472,059 | |||||
Other assets | 136,362 | 109,833 | |||||
Total Assets | $ 1,707,376 | $ 1,855,744 | |||||
Long-term debt — current portion | $ 3,000 | $ 65,737 | |||||
Other current liabilities | 187,240 | 170,470 | |||||
Long-term debt | 282,576 | 284,207 | |||||
Deferred revenue — long-term | 7,660 | 7,975 | |||||
Other long-term liabilities | 17,206 | 13,080 | |||||
Total shareholders' equity | 1,209,694 | 1,314,275 | |||||
Total Liabilities and Shareholders' Equity | $ 1,707,376 | $ 1,855,744 | |||||
Ordinary shares outstanding (in thousands) | 151,805 | 150,701 | |||||
|
This selected financial information should be read in conjunction with
the consolidated financial statements and notes thereto included in
Non-GAAP Reconciliation from Prior to Current Presentation
Pursuant to compliance and disclosure interpretations published by the
Three Months | Three Months | Three Months | Three Months | Year | Three Months | ||||||||||||||||||||
Ended | Ended | Ended | Ended | Ended | Ended | ||||||||||||||||||||
March 31, | June 30, | September 30, | December 31, | December 31, | March 31, | ||||||||||||||||||||
2015 | 2015 | 2015 | 2015 | 2015 | 2016 | ||||||||||||||||||||
Non-GAAP Net Income (Loss) — as previously reported | $ 9,157 | $ (13,585 | ) | $ (26,174 | ) | $ (22,629 | ) | $ (53,231 | ) | $ (24,566 | ) | ||||||||||||||
Removal of the adjustment for deferred revenue |
|
328 | 460 | 384 | (542 | ) | 630 | 442 | |||||||||||||||||
Removal of the adjustment for non-cash taxes |
|
(488 | ) | (3,034 | ) | (677 | ) | 2,790 | (1,409 | ) | 2,863 | ||||||||||||||
Adjustment for the income tax effect of other non-GAAP adjustments |
|
2,671 | (2,531 | ) | (2,344 | ) | (618 | ) | (2,822 | ) | 3,340 | ||||||||||||||
Non-GAAP Net Income (Loss) — revised | $ 11,668 | $ (18,690 | ) | $ (28,811 | ) | $ (20,999 | ) | $ (56,832 | ) | $ (17,921 | ) | ||||||||||||||
Net Increase (Decrease) From Previously Reported Non-GAAP Net Income (Loss) | $ 2,511 | $ (5,105 | ) | $ (2,637 | ) | $ 1,630 | $ (3,601 | ) | $ 6,645 |
View source version on businesswire.com: http://www.businesswire.com/news/home/20161102005243/en/
Source:
Alkermes plc
For Investors:
Sandy Coombs, +1 781-609-6377
or
Eva
Stroynowski, +1 781-609-6823
or
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Snyder, +1 781-609-6166