— Revenues of
— VIVITROL® Net Sales Grew by 53%
Year-Over-Year to
— 2016 Revenues Expected to Grow by 15% to 20%, Driven by Continuing
Growth of VIVITROL and Launch of ARISTADA® Into
Rapidly Growing Long-Acting
Antipsychotic Market —
— Pivotal Clinical Programs Underway for Late-Stage CNS Pipeline for Schizophrenia, Multiple Sclerosis and Major Depressive Disorder —
“Alkermes has a diversified CNS business poised for significant growth
over the coming years. In 2015, we continued to successfully execute on
our business plan, highlighted by the robust revenue growth of VIVITROL®
and the launch of our novel, long-acting antipsychotic ARISTADA®
for the treatment of schizophrenia,” said Richard Pops, Chief Executive
Officer of
“Our financial results in 2015 were driven by the strong performance of
VIVITROL, the approval and launch of ARISTADA into a rapidly growing
long-acting antipsychotic market, and the continued strength of our base
business,” commented
Quarter Ended
-
Total revenues for the quarter were
$163.1 million . This compared to$175.2 million for the same period in the prior year, or$156.7 million excluding$18.5 million of revenues 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
$69.4 million , or a basic and diluted GAAP loss per share of$0.46 , for the quarter and reflected increased investment in the company’s advancing late-stage pipeline and commercial infrastructure. This compared to GAAP net income of$30.5 million , or a basic GAAP earnings per share (EPS) of$0.21 and a diluted GAAP EPS of$0.20 for the same period in the prior year, or GAAP net income of$25.2 million , or a basic EPS of$0.17 and a diluted EPS of$0.16 , excluding$5.3 million of GAAP net income related to the Gainesville Divestiture. -
Non-GAAP net loss was
$22.6 million , or a non-GAAP basic and diluted loss per share of$0.15 for the quarter. This compared to non-GAAP net income of$16.8 million , or a non-GAAP basic and diluted EPS of$0.11 for the same period in the prior year, or non-GAAP net income of$9.0 million , or a non-GAAP basic and diluted EPS of$0.06 , excluding$7.8 million of non-GAAP net income related to the Gainesville Divestiture.
Quarter Ended
Revenues
-
Net sales of VIVITROL were
$38.2 million , compared to$29.7 million for the same period in the prior year, representing an increase of 29%. On a unit basis, sales grew 43% compared to the same period in the prior year. Compared to the third quarter of 2015, VIVITROL grew 7% on a unit basis, driven by increased adoption by treatment systems, while net sales grew 1% as the company increased accruals forMedicaid rebates to reflect the increasing volume of VIVITROL units covered byMedicaid . -
Net sales of ARISTADAwere
$4.6 million , following its launch inOctober 2015 . -
Manufacturing and royalty revenues from RISPERDAL CONSTA®,
INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®
were
$75.1 million , compared to$70.3 million for the same period in the prior year. -
Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1
were
$19.1 million , compared to$24.3 million for the same period in the prior year, due primarily to the timing of shipments. -
Royalty revenue from BYDUREON® was
$12.2 million , compared to$9.8 million for the same period in the prior year.
Costs and Expenses
-
Operating expenses were
$230.2 million for the quarter endedDec. 31, 2015 , reflecting increased investment in the company’s development pipeline and the launch of ARISTADA. This compared to$190.8 million for the same period in the prior year, or$177.4 million excluding$13.4 million of operating expenses related to the Gainesville Divestiture.
Calendar Year 2015 Financial Highlights
-
Total revenues were
$628.3 million in calendar 2015, which included VIVITROL net sales of$144.4 million and ARISTADA net sales of$4.6 million . This compared to total revenues of$618.8 million for calendar 2014. Please see the tables at the end of this press release for a detailed breakdown of the revenues from our key commercial products. Excluding the Gainesville Divestiture, 2015 total revenues were$608.6 million in calendar 2015, compared to total revenues of$545.8 million in calendar 2014. -
GAAP net loss was
$227.2 million , or a basic and diluted GAAP loss per share of$1.52 , for calendar 2015 and reflected increased investment in the company’s advancing late-stage pipeline and the launch of ARISTADA inOctober 2015 . This compared to a GAAP net loss of$30.1 million , or a basic and diluted GAAP loss per share of$0.21 , for calendar 2014. Excluding the Gainesville Divestiture, GAAP net loss was$231.7 million , or a basic and diluted loss per share of$1.55 , in calendar 2015, compared to a GAAP net loss of$53.7 million , or a basic and diluted GAAP loss per share of$0.37 , in calendar 2014. -
Non-GAAP net loss was
$53.2 million , or a non-GAAP basic and diluted loss per share of$0.36 , for calendar 2015. This compared to non-GAAP net income of$54.6 million , or a non-GAAP basic EPS of$0.38 and a non-GAAP diluted EPS of$0.35 , for calendar 2014. Excluding the Gainesville Divestiture, non-GAAP net loss was$59.5 million , or a non-GAAP basic and diluted loss per share of$0.40 , in calendar 2015, compared to a non-GAAP net income of$19.4 million , or a basic and diluted EPS of$0.13 , in calendar 2014. -
At
Dec. 31, 2015 ,Alkermes recorded cash and total investments of$798.8 million , compared to$801.6 million atDec. 31, 2014 . AtDec. 31, 2015 , the company’s total debt outstanding was$349.9 million .
Financial Expectations for 2016
The following outlines the company’s financial expectations for 2016, which include continued investment in the pipeline and a full year of expenses related to the ARISTADA commercial launch. 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
$700 million to $750 million , a 15% to 20% increase from 2015 excluding revenues derived from the Gainesville Divestiture, driven by continuing growth of VIVITROL and the ongoing launch of ARISTADA. Included in this total revenue expectation,Alkermes expects VIVITROL net sales to range from$180 million to $200 million . For ARISTADA, the company expects to provide net product revenue guidance during 2016 after gaining additional experience from the launch. -
Cost of Goods Manufactured and Sold: The company expects cost
of goods manufactured and sold to range from
$125 million to $135 million . -
Research and Development (R&D) Expenses: The company expects
R&D expenses to range from
$370 million to $400 million . -
Selling, General and Administrative (SG&A) Expenses: The
company expects SG&A expenses to range from
$360 million to $390 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 a GAAP net loss to be in the
range of
$225 million to $255 million , or a basic and diluted loss per share of$1.48 to $1.68 , based on a weighted average basic and diluted share count of approximately 152 million shares outstanding. -
Non-GAAP Net Loss: The company expects a non-GAAP net loss to
be in the range of
$25 million to $55 million , and non-GAAP basic and diluted loss per share to be between$0.16 and $0.36 . -
Capital Expenditures: The company expects capital expenditures
to be approximately
$45 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; 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) |
|||||||
Condensed Consolidated Statements of Operations - GAAP (In thousands, except per share data) |
Three Months Ended December 31, 2015 |
Three Months Ended December 31, 2014 |
|||||
Revenues: | |||||||
Manufacturing and royalty revenues | $ 119,310 | $ 143,202 | |||||
Product sales, net | 42,816 | 29,684 | |||||
Research and development revenues | 972 | 2,275 | |||||
Total Revenues | 163,098 | 175,161 | |||||
Expenses: | |||||||
Cost of goods manufactured and sold | 34,791 | 46,368 | |||||
Research and development | 93,686 | 74,433 | |||||
Selling, general and administrative | 87,472 | 54,804 | |||||
Amortization of acquired intangible assets | 14,206 | 15,244 | |||||
Total Expenses | 230,155 | 190,849 | |||||
Operating Loss | (67,057 | ) | (15,688 | ) | |||
Other (Expense) Income, net: | |||||||
Interest income | 1,010 | 592 | |||||
Interest expense | (3,319 | ) | (3,333 | ) | |||
Gain on the Gainesville Transaction | (301 | ) | - | ||||
Decrease in the fair value of contingent consideration | (5,000 | ) | - | ||||
Gain on sale of property, plant and equipment | 2,407 | 29,612 | |||||
Gain on sale of investment in Civitas Therapeutics, Inc. | - | 29,564 | |||||
Other (expense) income, net | (533 | ) | 33 | ||||
Total Other (Expense) Income, net | (5,736 | ) | 56,468 | ||||
(Loss) Income Before Income Taxes | (72,793 | ) | 40,780 | ||||
Income Tax (Benefit) Provision | (3,411 | ) | 10,266 | ||||
Net (Loss) Income — GAAP | $ (69,382 | ) | $ 30,514 | ||||
(Loss) Earnings Per Share: | |||||||
GAAP (loss) earnings per share — basic | $ (0.46 | ) | $ 0.21 | ||||
GAAP (loss) earnings per share — diluted | $ (0.46 | ) | $ 0.20 | ||||
Non-GAAP (loss) earnings per share — basic and diluted | $ (0.15 | ) | $ 0.11 | ||||
Weighted Average Number of Ordinary Shares Outstanding: | |||||||
Basic — GAAP | 150,330 | 146,882 | |||||
Diluted — GAAP | 150,330 | 155,527 | |||||
Basic — Non-GAAP | 150,330 | 146,882 | |||||
Diluted — Non-GAAP | 150,330 | 155,527 | |||||
An itemized reconciliation between net (loss) income on a GAAP basis and non-GAAP net (loss) income is as follows: | |||||||
Net (Loss) Income — GAAP | $ (69,382 | ) | $ 30,514 | ||||
Adjustments: | |||||||
Share-based compensation expense | 22,869 | 13,341 | |||||
Amortization expense | 14,206 | 15,244 | |||||
Depreciation expense | 7,575 | 10,124 | |||||
Non-cash taxes | (2,790 | ) | 7,324 | ||||
Non-cash net interest expense | 233 | 237 | |||||
Deferred revenue | 542 | (390 | ) | ||||
Decrease in the fair value of contingent consideration | 5,000 | - | |||||
Decrease in the fair value of common stock warrants | 860 | - | |||||
Gain on the Gainesville Transaction | 301 | - | |||||
Net gain on transactions with equity method investee | (397 | ) | (29,961 | ) | |||
Gain on sale of property, plant and equipment | (1,646 | ) | (29,612 | ) | |||
Non-GAAP Net (Loss) Income | $ (22,629 | ) | $ 16,821 |
Condensed Consolidated Statements of Operations - GAAP (In thousands, except per share data) |
Year Ended |
Year Ended |
|||||
Revenues: | |||||||
Manufacturing and royalty revenues | $ 475,288 | $ 516,876 | |||||
Product sales, net | 149,028 | 94,160 | |||||
Research and development revenues | 4,019 | 7,753 | |||||
Total Revenues | 628,335 | 618,789 | |||||
Expenses: | |||||||
Cost of goods manufactured and sold | 138,989 | 175,832 | |||||
Research and development | 344,404 | 272,043 | |||||
Selling, general and administrative | 311,558 | 199,905 | |||||
Amortization of acquired intangible assets | 57,685 | 58,153 | |||||
Total Expenses | 852,636 | 705,933 | |||||
Operating Loss | (224,301 | ) | (87,144 | ) | |||
Other Income, net: | |||||||
Interest income | 3,330 | 1,972 | |||||
Interest expense | (13,247 | ) | (13,430 | ) | |||
Gain on the Gainesville Transaction | 9,636 | - | |||||
Decrease in the fair value of contingent consideration | (2,300 | ) | - | ||||
Gain on sale of property, plant and equipment | 2,862 | 41,933 | |||||
Gain on sale of investment in Civitas Therapeutics, Inc. | - | 29,564 | |||||
Gain on sale of investment in Acceleron Pharma Inc. | - | 15,296 | |||||
Other income (expense), net | 15 | (2,220 | ) | ||||
Total Other Income, net | 296 | 73,115 | |||||
Loss Before Income Taxes | (224,005 | ) | (14,029 | ) | |||
Income Tax Provision | 3,158 | 16,032 | |||||
Net Loss — GAAP | $ (227,163 | ) | $ (30,061 | ) | |||
(Loss) Earnings Per Share: | |||||||
GAAP loss per share — basic and diluted | $ (1.52 | ) | $ (0.21 | ) | |||
Non-GAAP (loss) earnings per share — basic | $ (0.36 | ) | $ 0.38 | ||||
Non-GAAP (loss) earnings per share — diluted | $ (0.36 | ) | $ 0.35 | ||||
Weighted Average Number of Ordinary Shares Outstanding: | |||||||
Basic and Diluted — GAAP | 149,206 | 145,274 | |||||
Basic — Non-GAAP | 149,206 | 145,274 | |||||
Diluted — Non-GAAP | 149,206 | 154,415 | |||||
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net (loss) income is as follows: | |||||||
Net Loss — GAAP | $ (227,163 | ) | $ (30,061 | ) | |||
Adjustments: | |||||||
Share-based compensation expense | 97,342 | 59,579 | |||||
Amortization expense | 57,685 | 58,153 | |||||
Depreciation expense | 27,911 | 39,934 | |||||
Non-cash taxes | 1,409 | 12,379 | |||||
Non-cash net interest expense | 938 | 954 | |||||
Deferred revenue | (630 | ) | (997 | ) | |||
Gain on the Gainesville Transaction | (9,636 | ) | - | ||||
Decrease in the fair value of contingent consideration | 2,300 | - | |||||
Decrease in the fair value of common stock warrants | 302 | - | |||||
Net gain on transactions with equity method investee | (1,588 | ) | (28,119 | ) | |||
Gain on sale of property, plant and equipment | (2,101 | ) | (41,933 | ) | |||
Gain on sale of investment in Acceleron Pharma Inc. | - | (15,296 | ) | ||||
Non-GAAP Net (Loss) Income | $ (53,231 | ) | $ 54,593 | ||||
Condensed Consolidated Balance Sheets (In thousands) |
December 31, 2015 |
December 31, 2014 |
|||
Cash, cash equivalents and total investments | $ 798,849 | $ 801,646 | |||
Receivables | 155,487 | 151,551 | |||
Inventory | 38,411 | 51,357 | |||
Prepaid expenses and other current assets | 26,286 | 42,719 | |||
Property, plant and equipment, net | 254,819 | 265,740 | |||
Intangible assets, net and goodwill | 472,059 | 573,624 | |||
Other assets | 109,833 | 32,421 | |||
Total Assets | $ 1,855,744 | $ 1,919,058 | |||
Long-term debt — current portion | $ 65,737 | $ 6,750 | |||
Other current liabilities | 170,470 | 123,832 | |||
Long-term debt | 284,207 | 349,006 | |||
Deferred revenue — long-term | 7,975 | 11,801 | |||
Other long-term liabilities | 13,080 | 30,832 | |||
Total shareholders' equity | 1,314,275 | 1,396,837 | |||
Total Liabilities and Shareholders' Equity | $ 1,855,744 | $ 1,919,058 | |||
Ordinary shares outstanding (in thousands) | 150,701 | 147,539 |
This selected financial information should be read in conjunction with
the consolidated financial statements and notes thereto included in
Revenues for Calendar Year 2015 and 2014 | |||||||||||
(In thousands) |
Three Months Ended March 31, 2015 |
Three Months Ended June 30, 2015 |
Three Months Ended September 30, 2015 |
Three Months Ended December 31, 2015 |
Year Ended December 31, 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 | ||||||
Three Months Ended March 31, 2014 |
Three Months Ended June 30, 2014 |
Three Months Ended September 30, 2014 |
Three Months Ended December 31, 2014 |
Year Ended December 31, 2014 |
|||||||
Revenues: | |||||||||||
PARTNERED LONG-ACTING ANTIPSYCHOTICS (1) | $ 49,608 | $ 60,001 | $ 68,472 | $ 70,311 | $ 248,392 | ||||||
AMPYRA/FAMPYRA | 20,631 | 19,518 | 16,503 | 24,273 | 80,925 | ||||||
BYDUREON | 7,700 | 8,784 | 10,254 | 9,849 | 36,587 | ||||||
VIVITROL | 17,079 | 21,595 | 25,802 | 29,684 | 94,160 | ||||||
Key Commercial Product Revenues | 95,018 | 109,898 | 121,031 | 134,117 | 460,064 | ||||||
Legacy Product Revenues (2) | 16,952 | 21,396 | 21,203 | 21,058 | 80,609 | ||||||
Gainesville Revenues | 16,623 | 21,067 | 16,833 | 18,448 | 72,971 | ||||||
Research and Development Revenues | 1,619 | 1,063 | 925 | 1,538 | 5,145 | ||||||
Total Revenues | $ 130,212 | $ 153,424 | $ 159,992 | $ 175,161 | $ 618,789 | ||||||
Total Revenues excluding Gainesville Revenues |
$ 113,589 | $ 132,357 | $ 143,159 | $ 156,713 | $ 545,818 | ||||||
(1) - Includes RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA.
(2) - Includes legacy product revenues excluding product revenues sold as part of the Gainesville transaction.
2016 Guidance — GAAP to Non-GAAP Adjustments | |||||||||
An itemized reconciliation between projected loss per share on a GAAP basis and projected loss per share | |||||||||
on a non-GAAP basis is as follows: | |||||||||
(In millions, except per share data) | Amount | Shares |
(Loss)/Earnings Per Share |
||||||
Projected Net Loss — GAAP | $ (240.0 | ) | 152 | $ (1.58 | ) | ||||
Adjustments: | |||||||||
Non-cash net interest expense | 1.0 | ||||||||
Non-cash taxes | (5.0 | ) | |||||||
Depreciation expense | 32.5 | ||||||||
Amortization expense | 60.0 | ||||||||
Share-based compensation expense | 112.5 | ||||||||
Deferred revenue | (1.0 | ) | |||||||
Projected Non-GAAP Net Loss | $ (40.0 | ) | 152 | $ (0.26 | ) | ||||
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/20160225005294/en/
Source:
Alkermes plc
For Investors:
Eva Stroynowski, +1 781-609-6823
or
For
Media:
Jennifer Snyder, +1 781-609-6166