— Record Revenues of
— VIVITROL® Net Sales Grew by 45%
Year-Over-Year to
— 2017 Total Revenues Expected to Grow by Approximately 20%, Driven by Continuing Volume Growth of VIVITROL and ARISTADA® —
— Company Plans to Submit New Drug Application for ALKS 5461 in 2017 —
“Our 2016 financial results reflect the strong growth of our proprietary
commercial products and demonstrate the power and breadth of the
“We have built
Quarter Ended
-
Total revenues for the quarter were
$213.5 million . This compared to$163.1 million for the same period in the prior year, representing an increase of 31%. -
Net loss according to generally accepted accounting principles in the
U.S. (GAAP) was
$21.1 million , or a basic and diluted GAAP loss per share of$0.14 . This compared to GAAP net loss of$69.4 million , or a basic and diluted GAAP loss per share of$0.46 for the same period in the prior year. -
Non-GAAP net income was
$23.3 million , or a non-GAAP basic and diluted earnings per share of$0.15 for the quarter. This compared to non-GAAP net loss of$21.0 million , or a non-GAAP basic and diluted loss per share of$0.14 for the same period in the prior year.
Quarter Ended
Revenues
-
Net sales of VIVITROL were
$62.1 million , compared to$38.2 million for the same period in the prior year, representing an increase of 62%. On a unit basis, sales grew 67% compared to the same period in the prior year. -
Net sales of ARISTADAwere
$17.3 million , up from$4.6 million in the fourth quarter of 2015, which was the quarter of launch. -
Manufacturing and royalty revenues from RISPERDAL CONSTA®,
INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA®
were
$74.0 million , compared to$75.1 million for the same period in the prior year. -
Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1
were
$32.3 million , representing a 69% increase compared to$19.1 million for the same period in the prior year. -
Royalty revenue from BYDUREON® was
$11.3 million , compared to$12.2 million for the same period in the prior year.
Costs and Expenses
-
Operating expenses were
$237.1 million for the quarter endedDec. 31, 2016 , compared to$230.2 million for the same period in the prior year.
Calendar Year 2016 Financial Highlights
-
Total revenues increased 19% to
$745.7 million in 2016, which included VIVITROL net sales of$209.0 million and ARISTADA net sales of$47.2 million . This compared to total revenues of$628.3 million for 2015. Please see the tables at the end of this press release for a detailed breakdown of the revenues from our key commercial products. -
GAAP net loss was
$208.4 million , or a basic and diluted GAAP loss per share of$1.38 , for 2016. This compared to a GAAP net loss of$227.2 million , or a basic and diluted GAAP loss per share of$1.52 , for 2015. -
Non-GAAP net loss was
$10.3 million , or a non-GAAP basic and diluted loss per share of$0.07 , for 2016. This compared to non-GAAP net loss of$56.8 million , or a non-GAAP basic and diluted loss per share of$0.38 , for 2015. -
At
Dec. 31, 2016 ,Alkermes recorded cash and total investments of$619.2 million , compared to$798.8 million atDec. 31, 2015 . AtDec. 31, 2016 , the company’s total debt outstanding was$283.7 million , compared to$349.9 million atDec. 31, 2015 .
Financial Expectations for 2017
The following outlines the company’s financial expectations for 2017, which include investments in commercial infrastructure in preparation for the expected launch of ALKS 5461 in 2018 and in Alkermes’ pipeline of late-stage development candidates. The following statements are forward-looking, and actual results may differ materially. Please see “Note Regarding Forward-Looking Statements” at the end of this press release for risks that could cause results to differ materially from these forward-looking statements.
-
Revenues: The company expects total revenues to range from
$870 million to $920 million , a 17% to 23% increase from 2016, driven by continuing growth of VIVITROL and ARISTADA. Included in this total revenue expectation,Alkermes expects VIVITROL net sales to range from$280 million to $300 million . -
Cost of Goods Manufactured and Sold: The company expects cost
of goods manufactured and sold to range from
$150 million to $160 million . -
Research and Development (R&D) Expenses: The company expects
R&D expenses to range from
$405 million to $435 million . -
Selling, General and Administrative (SG&A) Expenses: The
company expects SG&A expenses to range from
$425 million to $455 million . -
Amortization of Intangible Assets: The company expects
amortization of intangibles to be approximately
$60 million . -
Net Interest Expense: The company expects net interest expense
to be approximately
$10 million . -
Income Tax Expense: The company expects income tax expense of
up to
$10 million . -
GAAP Net Loss: The company expects GAAP net loss to range from
$180 million to $210 million , or a basic and diluted loss per share of$1.17 to $1.36 , based on a weighted average basic and diluted share count of approximately 154 million shares outstanding. -
Non-GAAP Net Income (Loss): The company expects its non-GAAP
financial measure to be in the range of non-GAAP net loss of
$15 million to non-GAAP net income of$15 million . This equates to a non-GAAP basic loss per share of$0.10 to a non-GAAP basic income per share of$0.10 , based on a weighted average basic share count of approximately 154 million shares outstanding, and a non-GAAP diluted loss per share of$0.10 to a non-GAAP diluted income per share of$0.09 , based on a weighted average diluted share count of approximately 161 million shares outstanding. -
Capital Expenditures: The company expects capital expenditures
to range from
$70 million to $80 million .
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, including the launch of ALKS
5461; 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; and
expectations concerning the timing and results of clinical development
activities, including the timing of the NDA submission for 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 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 | December 31, | December 31, | ||||||
(In thousands, except per share data) | 2016 | 2015 | ||||||
Revenues: | ||||||||
Manufacturing and royalty revenues | $ 133,804 | $ 119,310 | ||||||
Product sales, net | 79,451 | 42,816 | ||||||
Research and development revenues | 259 | 972 | ||||||
Total Revenues | 213,514 | 163,098 | ||||||
Expenses: | ||||||||
Cost of goods manufactured and sold | 34,957 | 34,791 | ||||||
Research and development | 89,627 | 93,686 | ||||||
Selling, general and administrative | 97,145 | 87,472 | ||||||
Amortization of acquired intangible assets | 15,322 | 14,206 | ||||||
Total Expenses | 237,051 | 230,155 | ||||||
Operating Loss | (23,537 | ) | (67,057 | ) | ||||
Other Expense, net: | ||||||||
Interest income | 835 | 1,010 | ||||||
Interest expense | (4,896 | ) | (3,319 | ) | ||||
Loss on the Gainesville Transaction | - | (301 | ) | |||||
Change in the fair value of contingent consideration | 4,800 | (5,000 | ) | |||||
Other (expense) income, net | (1,515 | ) | 1,874 | |||||
Total Other Expense, net | (776 | ) | (5,736 | ) | ||||
Loss Before Income Taxes | (24,313 | ) | (72,793 | ) | ||||
Income Tax Benefit | (3,172 | ) | (3,411 | ) | ||||
Net Loss — GAAP | $ (21,141 | ) | $ (69,382 | ) | ||||
Net (Loss) Earnings Per Share: | ||||||||
GAAP net loss per share — basic and diluted | $ (0.14 | ) | $ (0.46 | ) | ||||
Non-GAAP net earnings (loss) per share — basic and diluted | $ 0.15 | $ (0.14 | ) | |||||
Weighted Average Number of Ordinary Shares Outstanding: | ||||||||
Basic and diluted — GAAP | 152,148 | 150,330 | ||||||
Basic — Non-GAAP | 152,148 | 150,330 | ||||||
Diluted — Non-GAAP | 159,212 | 150,330 | ||||||
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income (loss) is as follows: | ||||||||
Net Loss — GAAP | $ (21,141 | ) | $ (69,382 | ) | ||||
Adjustments: | ||||||||
Share-based compensation expense | 19,783 | 22,869 | ||||||
Amortization expense | 15,322 | 14,206 | ||||||
Depreciation expense | 9,326 | 7,575 | ||||||
Income tax effect related to reconciling items | 1,636 | (618 | ) | |||||
Non-cash net interest expense | 194 | 233 | ||||||
Loss on warrants and equity method investments | 866 | 463 | ||||||
Loss on debt refinancing | 2,075 | - | ||||||
Change in the fair value of contingent consideration | (4,800 | ) | 5,000 | |||||
Loss on the Gainesville Transaction | - | 301 | ||||||
Gain on sale of property, plant and equipment | - | (1,646 | ) | |||||
Non-GAAP Net Income (Loss) | $ 23,261 | $ (20,999 | ) |
Year Ended | Year Ended | |||||||
Condensed Consolidated Statements of Operations - GAAP | December 31, | December 31, | ||||||
(In thousands, except per share data) | 2016 | 2015 | ||||||
Revenues: | ||||||||
Manufacturing and royalty revenues | $ 487,247 | $ 475,288 | ||||||
Product sales, net | 256,146 | 149,028 | ||||||
Research and development revenues | 2,301 | 4,019 | ||||||
Total Revenues | 745,694 | 628,335 | ||||||
Expenses: | ||||||||
Cost of goods manufactured and sold | 132,122 | 138,989 | ||||||
Research and development | 387,148 | 344,404 | ||||||
Selling, general and administrative | 374,130 | 311,558 | ||||||
Amortization of acquired intangible assets | 60,959 | 57,685 | ||||||
Total Expenses | 954,359 | 852,636 | ||||||
Operating Loss | (208,665 | ) | (224,301 | ) | ||||
Other (Expense) Income, net: | ||||||||
Interest income | 3,752 | 3,330 | ||||||
Interest expense | (14,889 | ) | (13,247 | ) | ||||
Gain on the Gainesville Transaction | - | 9,636 | ||||||
Change in the fair value of contingent consideration | 7,900 | (2,300 | ) | |||||
Other (expense) income, net | (2,485 | ) | 2,877 | |||||
Total Other (Expense) Income, net | (5,722 | ) | 296 | |||||
Loss Before Income Taxes | (214,387 | ) | (224,005 | ) | ||||
Income Tax (Benefit) Provision | (5,943 | ) | 3,158 | |||||
Net Loss — GAAP | $ (208,444 | ) | $ (227,163 | ) | ||||
Net Loss Per Share: | ||||||||
GAAP net loss per share — basic and diluted | $ (1.38 | ) | $ (1.52 | ) | ||||
Non-GAAP net loss per share — basic and diluted | $ (0.07 | ) | $ (0.38 | ) | ||||
Weighted Average Number of Ordinary Shares Outstanding: | ||||||||
Basic and diluted — GAAP and Non-GAAP | 151,484 | 149,206 | ||||||
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net loss is as follows: | ||||||||
Net Loss — GAAP | $ (208,444 | ) | $ (227,163 | ) | ||||
Adjustments: | ||||||||
Share-based compensation expense | 94,396 | 97,342 | ||||||
Amortization expense | 60,958 | 57,685 | ||||||
Depreciation expense | 33,298 | 27,911 | ||||||
Income tax effect related to reconciling items | 2,252 | (2,822 | ) | |||||
Loss (gain) on warrants and equity method investments | 2,130 | (1,286 | ) | |||||
Non-cash net interest expense | 888 | 938 | ||||||
Upfront license option payment to Reset Therapeutics, Inc. charged to R&D expense | 10,000 | - | ||||||
Loss on debt refinancing | 2,075 | |||||||
Change in the fair value of contingent consideration | (7,900 | ) | 2,300 | |||||
Gain on the Gainesville Transaction | - | (9,636 | ) | |||||
Gain on sale of property, plant and equipment | - | (2,101 | ) | |||||
Non-GAAP Net Loss | $ (10,347 | ) | $ (56,832 | ) | ||||
Pursuant to compliance and disclosure interpretations published by the
Condensed Consolidated Balance Sheets | December 31, | December 31, | ||||
(In thousands) | 2016 | 2015 | ||||
Cash, cash equivalents and total investments | $ 619,164 | $ 798,849 | ||||
Receivables | 191,102 | 155,487 | ||||
Inventory | 62,998 | 38,411 | ||||
Prepaid expenses and other current assets | 39,345 | 26,286 | ||||
Property, plant and equipment, net | 264,785 | 254,819 | ||||
Intangible assets, net and goodwill | 411,100 | 472,059 | ||||
Other assets | 137,929 | 109,833 | ||||
Total Assets | $ 1,726,423 | $ 1,855,744 | ||||
Long-term debt — current portion | $ 3,000 | $ 65,737 | ||||
Other current liabilities | 208,993 | 170,470 | ||||
Long-term debt | 280,666 | 284,207 | ||||
Deferred revenue — long-term | 7,122 | 7,975 | ||||
Other long-term liabilities | 17,161 | 13,080 | ||||
Total shareholders' equity | 1,209,481 | 1,314,275 | ||||
Total Liabilities and Shareholders' Equity | $ 1,726,423 | $ 1,855,744 | ||||
Ordinary shares outstanding (in thousands) | 152,431 | 150,701 | ||||
This selected financial information should be read in conjunction with
the consolidated financial statements and notes thereto included in
Revenues for Calendar Year 2016 and 2015 | |||||||||||||||
Three Months | Three Months | Three Months | Three Months | Year | |||||||||||
Ended | Ended | Ended | Ended | Ended | |||||||||||
March 31, | June 30, | September 30, | December 31, | December 31, | |||||||||||
(In thousands) | 2016 | 2016 | 2016 | 2016 | 2016 | ||||||||||
Revenues: | |||||||||||||||
PARTNERED LONG-ACTING ANTIPSYCHOTICS (1) | $ 54,667 | $ 69,578 | $ 73,251 | $ 73,967 | $ 271,463 | ||||||||||
AMPYRA/FAMPYRA | 28,194 | 40,848 | 12,897 | 32,254 | 114,193 | ||||||||||
BYDUREON | 10,533 | 12,303 | 11,554 | 11,256 | 45,646 | ||||||||||
VIVITROL | 43,827 | 47,242 | 55,804 | 62,109 | 208,982 | ||||||||||
ARISTADA | 5,547 | 10,277 | 13,998 | 17,342 | 47,164 | ||||||||||
Key Commercial Product Revenues | 142,768 | 180,248 | 167,504 | 196,928 | 687,448 | ||||||||||
Legacy Product Revenues (2) | 12,765 | 14,305 | 12,548 | 16,327 | 55,945 | ||||||||||
Research and Development Revenues | 1,241 | 612 | 189 | 259 | 2,301 | ||||||||||
Total Revenues | $ 156,774 | $ 195,165 | $ 180,241 | $ 213,514 | $ 745,694 | ||||||||||
Three Months | Three Months | Three Months | Three Months | Year | |||||||||||
Ended | Ended | Ended | Ended | Ended | |||||||||||
March 31, | June 30, | September 30, | December 31, | December 31, | |||||||||||
(In thousands) | 2015 | 2015 | 2015 | 2015 | 2015 | ||||||||||
Revenues: | |||||||||||||||
PARTNERED LONG-ACTING ANTIPSYCHOTICS (1) | $ 46,864 | $ 60,841 | $ 67,606 | $ 75,074 | $ 250,385 | ||||||||||
AMPYRA/FAMPYRA | 36,549 | 26,939 | 22,132 | 19,116 | 104,736 | ||||||||||
BYDUREON | 9,800 | 11,081 | 13,039 | 12,195 | 46,115 | ||||||||||
VIVITROL | 31,137 | 37,172 | 37,903 | 38,227 | 144,439 | ||||||||||
ARISTADA | - | - | - | 4,589 | 4,589 | ||||||||||
Key Commercial Product Revenues | 124,350 | 136,033 | 140,680 | 149,201 | 550,264 | ||||||||||
Legacy Product Revenues (2) | 17,314 | 13,737 | 11,295 | 12,925 | 55,271 | ||||||||||
Gainesville Revenues | 19,167 | 565 | - | - | 19,732 | ||||||||||
Research and Development Revenues | 383 | 1,035 | 678 | 972 | 3,068 | ||||||||||
Total Revenues | $ 161,214 | $ 151,370 | $ 152,653 | $ 163,098 | $ 628,335 | ||||||||||
Total Revenues excluding Gainesville Revenues | $ 142,047 | $ 150,805 | $ 152,653 | $ 163,098 | $ 608,603 | ||||||||||
(1) - Includes RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA.
(2) - Includes legacy product revenues, excluding product revenues sold as part of the Gainesville transaction.
2017 Guidance — GAAP to Non-GAAP Adjustments |
An itemized reconciliation between projected loss per share on a GAAP basis and projected earnings (loss) per share |
on a non-GAAP basis is as follows: |
|
|||||||||||
|
|||||||||||
(Loss)/Earnings | |||||||||||
(In millions, except per share data) | Amount | Shares | Per Share | ||||||||
Projected Net Loss — GAAP | $ (195.0 | ) | 154 | $ (1.27 | ) | ||||||
Adjustments: | |||||||||||
Non-cash net interest expense | 1.0 | ||||||||||
Income tax effect related to reconciling items | 1.5 | ||||||||||
Depreciation expense | 37.5 | ||||||||||
Amortization expense | 60.0 | ||||||||||
Share-based compensation expense | 95.0 | ||||||||||
Projected Non-GAAP Net Income (Loss) | $ - | 161 | $ - | ||||||||
Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170215005205/en/
Source:
Alkermes plc
For Investors:
Sandy Coombs, +1 781-609-6377
or
Eva
Stroynowski, +1 781-609-6823
or
For Media:
Jennifer
Snyder, +1 781-609-6166