— Second Quarter Revenues Increase 29% Year-Over-Year to
— Company Improves Financial Expectations for 2016 Driven by Strong VIVITROL® Performance —
— ARISTADA® Revenues Grow as Launch Progresses —
“Our second quarter results demonstrate the power of our business model
to efficiently capture operating leverage as our topline grows. These
results reflect the growth of VIVITROL® and launch of ARISTADA®
as well as the continued strength of our royalty and manufacturing
business. VIVITROL’s robust growth continued as we expand access and
utilization in the large
“Our proprietary commercial products, VIVITROL and ARISTADA, represent
important growth opportunities at a time when substance abuse and mental
illness are significant public health priorities,” said Richard Pops,
Chief Executive Officer of
Quarter Ended
-
Total revenues for the quarter were
$195.2 million . This compared to$151.4 million for the same period in the prior year. -
Net loss according to generally accepted accounting principles in the
U.S. (GAAP) was
$47.2 million , or a basic and diluted GAAP loss per share of$0.31 , 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$46.1 million , or a basic and diluted GAAP loss per share of$0.31 , for the same period in the prior year. -
Non-GAAP net loss was
$1.6 million , or a non-GAAP basic and diluted loss per share of$0.01 , for the quarter. This compared to non-GAAP net loss of$18.7 million , or a non-GAAP basic and diluted loss per share of$0.13 , for the same period in the prior year.
Quarter Ended
Revenues
-
Net sales of VIVITROL were
$47.2 million , compared to$37.2 million for the same period in the prior year. -
Net sales of ARISTADA were
$10.3 million , up from$5.5 million in the first quarter of 2016. -
Manufacturing and royalty revenues from RISPERDAL CONSTA®,
INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA®
were
$69.6 million , compared to$60.8 million for the same period in the prior year. -
Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1
were
$40.8 million , compared to$26.9 million for the same period in the prior year, reflecting the timing of shipments. -
Royalty revenue from BYDUREON® was
$12.3 million , compared to$11.1 million for the same period in the prior year.
Costs and Expenses
-
Operating expenses were
$242.3 million , reflecting increased investment in the company’s development pipeline and the continued launch of ARISTADA. Operating expenses for the quarter endedJune 30, 2015 were$203.9 million .
Balance Sheet
At
Financial Expectations
-
Revenues: The company now expects total revenues to range from
$710 million to $760 million , up from the previous range of$700 million to $750 million .-
The company now expects VIVITROL net sales to range from
$190 million to $210 million , up from a previous range of$180 million to$200 million .
-
The company now expects VIVITROL net sales to range from
-
Cost of Goods Manufactured and Sold: The company continues to
expect cost of goods manufactured and sold to range from
$125 million to$135 million . -
Research and Development (R&D) Expenses: The company
continues to expect R&D expenses to range from
$370 million to $400 million . -
Selling, General and Administrative (SG&A) Expenses: The
company continues to expect SG&A expenses to range from
$360 million to$390 million . -
Amortization of Intangible Assets: The company continues to
expect amortization of intangible assets of approximately
$60 million . -
Net Interest Expense: The company continues to expect net
interest expense of approximately
$10 million . -
Net Income Tax Expense: The company continues to expect net
income tax expense to range from
$0 million to $10 million . -
GAAP Net Loss: The company now expects GAAP net loss to range
from
$215 million to $245 million , or a basic and diluted loss per share of$1.41 to $1.61 , based on weighted average basic and diluted share counts of approximately 152 million shares outstanding. This compares to previous expectations of GAAP net loss in the range of$225 million to $255 million , or a basic and diluted loss per share of approximately$1.48 to $1.68 , based on weighted average basic and diluted share counts of approximately 152 million shares outstanding. -
Non-GAAP Net Loss: The company now expects non-GAAP net loss to
range from
$5 million to $35 million , or a basic and diluted loss per share of$0.03 to $0.23 , based on weighted average basic and diluted share counts of approximately 152 million shares outstanding. This compares to previous expectations of non-GAAP net loss in the range of$25 million to $55 million , or a non-GAAP diluted loss per share of$0.16 to $0.36 , based on weighted average diluted share counts of approximately 152 million shares outstanding. -
Capital Expenditures: The company continues to expect capital
expenditures to be approximately
$45 million .
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.
Following compliance and disclosure interpretations published by the
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; 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) | |||||||||||||
Three Months | Three Months | ||||||||||||
Ended | Ended | ||||||||||||
Condensed Consolidated Statements of Operations - GAAP | June 30, | June 30, | |||||||||||
(In thousands, except per share data) | 2016 | 2015 | |||||||||||
Revenues: | |||||||||||||
Manufacturing and royalty revenues | $ | 137,034 | $ | 113,162 | |||||||||
Product sales, net | 57,519 | 37,172 | |||||||||||
Research and development revenues | 612 | 1,036 | |||||||||||
Total Revenues | 195,165 | 151,370 | |||||||||||
Expenses: | |||||||||||||
Cost of goods manufactured and sold | 33,998 | 30,418 | |||||||||||
Research and development | 97,007 | 87,882 | |||||||||||
Selling, general and administrative | 96,120 | 71,539 | |||||||||||
Amortization of acquired intangible assets | 15,157 | 14,052 | |||||||||||
Total Expenses | 242,282 | 203,891 | |||||||||||
Operating Loss | (47,117 | ) | (52,521 | ) | |||||||||
Other (Expense) Income, net: | |||||||||||||
Interest income | 994 | 795 | |||||||||||
Interest expense | (3,323 | ) | (3,315 | ) | |||||||||
Gain on Gainesville Transaction | - | 9,911 | |||||||||||
Increase in the fair value of contingent consideration | 2,200 | 1,500 | |||||||||||
Other (expense) income, net | (467 | ) | 585 | ||||||||||
Total Other (Expense) Income, net | (596 | ) | 9,476 | ||||||||||
Loss Before Income Taxes | (47,713 | ) | (43,045 | ) | |||||||||
Income Tax (Benefit) Provision | (520 | ) | 3,064 | ||||||||||
Net Loss — GAAP | $ | (47,193 | ) | $ | (46,109 | ) | |||||||
Net Loss Per Share: | |||||||||||||
GAAP net loss per share — basic and diluted | $ | (0.31 | ) | $ | (0.31 | ) | |||||||
Non-GAAP net loss per share — basic and diluted | $ | (0.01 | ) | $ | (0.13 | ) | |||||||
Weighted Average Number of Ordinary Shares Outstanding: | |||||||||||||
Basic and diluted — GAAP and Non-GAAP | 151,301 | 148,867 | |||||||||||
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net loss is as follows: | |||||||||||||
Net Loss — GAAP | $ | (47,193 | ) | $ | (46,109 | ) | |||||||
Adjustments: | |||||||||||||
Share-based compensation expense | 26,631 | 21,877 | |||||||||||
Amortization expense | 15,157 | 14,052 | |||||||||||
Depreciation expense | 7,927 | 6,584 | |||||||||||
Income tax effect related to reconciling items | (2,051 | ) | (2,531 | ) | |||||||||
Non-cash net interest expense | 231 | 235 | |||||||||||
Gain on warrants and equity method investments | (127 | ) | (1,273 | ) | |||||||||
Increase in the fair value of contingent consideration | (2,200 | ) | (1,500 | ) | |||||||||
Gain on Gainesville Transaction | - | (9,911 | ) | ||||||||||
Gain on sale of property, plant and equipment | - | (114 | ) | ||||||||||
Non-GAAP Net Loss | $ | (1,625 | ) | $ | (18,690 | ) |
Six Months | Six Months | ||||||||||||
Ended | Ended | ||||||||||||
Condensed Consolidated Statements of Operations - GAAP | June 30, | June 30, | |||||||||||
(In thousands, except per share data) | 2016 | 2015 | |||||||||||
Revenues: | |||||||||||||
Manufacturing and royalty revenues | $ | 243,194 | $ | 241,906 | |||||||||
Product sales, net | 106,893 | 68,309 | |||||||||||
Research and development revenues | 1,853 | 2,369 | |||||||||||
Total Revenues | 351,940 | 312,584 | |||||||||||
Expenses: | |||||||||||||
Cost of goods manufactured and sold | 61,709 | 70,392 | |||||||||||
Research and development | 198,079 | 158,160 | |||||||||||
Selling, general and administrative | 185,840 | 134,589 | |||||||||||
Amortization of acquired intangible assets | 30,313 | 29,272 | |||||||||||
Total Expenses | 475,941 | 392,413 | |||||||||||
Operating Loss | (124,001 | ) | (79,829 | ) | |||||||||
Other (Expense) Income, net: | |||||||||||||
Interest income | 2,005 | 1,455 | |||||||||||
Interest expense | (6,618 | ) | (6,603 | ) | |||||||||
Gain on Gainesville Transaction | - | 9,911 | |||||||||||
Increase in the fair value of contingent consideration | 4,100 | 1,500 | |||||||||||
Other (expense) income, net | (218 | ) | 374 | ||||||||||
Total Other (Expense) Income, net | (731 | ) | 6,637 | ||||||||||
Loss Before Income Taxes | (124,732 | ) | (73,192 | ) | |||||||||
Income Tax (Benefit) Provision | (116 | ) | 3,574 | ||||||||||
Net Loss — GAAP | $ | (124,616 | ) | $ | (76,766 | ) | |||||||
Net Loss Per Share: | |||||||||||||
GAAP net loss per share — basic and diluted | $ | (0.82 | ) | $ | (0.52 | ) | |||||||
Non-GAAP net loss per share — basic and diluted | $ | (0.13 | ) | $ | (0.05 | ) | |||||||
Weighted Average Number of Ordinary Shares Outstanding: | |||||||||||||
Basic and diluted — GAAP and Non-GAAP | 151,063 | 148,480 | |||||||||||
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net loss is as follows: | |||||||||||||
Net Loss — GAAP | $ | (124,616 | ) | $ | (76,766 | ) | |||||||
Adjustments: | |||||||||||||
Share-based compensation expense | 50,887 | 39,206 | |||||||||||
Amortization expense | 30,313 | 29,272 | |||||||||||
Depreciation expense | 15,475 | 13,850 | |||||||||||
Income tax effect related to reconciling items | 1,289 | 140 | |||||||||||
Loss (gain) on warrants and equity method investments | 743 | (1,670 | ) | ||||||||||
Non-cash net interest expense | 463 | 471 | |||||||||||
Upfront license option payment to Reset Therapeutics, Inc. charged to R&D expense | 10,000 | - | |||||||||||
Increase in the fair value of contingent consideration | (4,100 | ) | (1,500 | ) | |||||||||
Gain on Gainesville Transaction | - | (9,911 | ) | ||||||||||
Gain on sale of property, plant and equipment | - | (114 | ) | ||||||||||
Non-GAAP Net Loss | $ | (19,546 | ) | $ | (7,022 | ) | |||||||
|
Pursuant to compliance and disclosure interpretations published by the
Condensed Consolidated Balance Sheets | June 30, | December 31, | |||||||||
(In thousands) | 2016 | 2015 | |||||||||
Cash, cash equivalents and total investments | $ | 677,671 | $ | 798,849 | |||||||
Receivables | 185,008 | 155,487 | |||||||||
Inventory | 49,896 | 38,411 | |||||||||
Prepaid expenses and other current assets | 38,369 | 26,286 | |||||||||
Property, plant and equipment, net | 258,354 | 254,819 | |||||||||
Intangible assets, net and goodwill | 441,746 | 472,059 | |||||||||
Other assets | 134,242 | 109,833 | |||||||||
Total Assets | $ | 1,785,286 | $ | 1,855,744 | |||||||
Long-term debt — current portion | $ | 63,913 | $ | 65,737 | |||||||
Other current liabilities | 172,350 | 170,470 | |||||||||
Long-term debt | 283,120 | 284,207 | |||||||||
Deferred revenue — long-term | 6,943 | 7,975 | |||||||||
Other long-term liabilities | 15,434 | 13,080 | |||||||||
Total shareholders' equity | 1,243,526 | 1,314,275 | |||||||||
Total Liabilities and Shareholders' Equity | $ | 1,785,286 | $ | 1,855,744 | |||||||
Ordinary shares outstanding (in thousands) | 151,503 | 150,701 | |||||||||
This selected financial information should be read in conjunction with
the consolidated financial statements and notes thereto included in
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 Per Share | |||||||||||||
Projected Net Loss — GAAP | $ | (230.0 | ) | 152 | $ | (1.51 | ) | |||||||||
Adjustments: | ||||||||||||||||
Non-cash net interest expense | 1.0 | |||||||||||||||
Income taxes | 5.0 | |||||||||||||||
Depreciation expense | 32.5 | |||||||||||||||
Amortization expense | 60.0 | |||||||||||||||
Share-based compensation expense | 101.5 | |||||||||||||||
Upfront license option payment to Reset Therapeutics, Inc. charged to R&D expense | 10.0 | |||||||||||||||
Projected Non-GAAP Net Loss | $ | (20.0 | ) | 152 | $ | (0.13 | ) | |||||||||
|
||||||||||||||||
|
Projected GAAP and non-GAAP measures reflect mid-points within ranges of estimated guidance.
Pursuant to compliance and disclosure interpretations published by the
Non-GAAP Reconciliation from Prior to Current Presentation | |||||||||||||||||||||||||||||||
Pursuant to compliance and disclosure interpretations published by the SEC in May 2016, the Company made certain changes to how it presents non-GAAP net loss. The Company no longer adjusts the deferred revenue recognized in the period and now reflects the tax effect of the reconciling items, as opposed to the non-cash taxes, as was previously the case. The Company revised its prior period presentation to reflect its current period presentation. The following reconciliation shows the effect of this change in presentation of non-GAAP net income (loss) for each of the quarters in the year ended December 31, 2015, the year ended December 31, 2015 and the quarter ended March 31, 2016: | |||||||||||||||||||||||||||||||
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/20160728005241/en/
Source:
Alkermes Contacts:
For Investors:
Sandy
Coombs, +1 781-609-6377
or
Eva Stroynowski, +1 781-609-6823
or
For
Media:
Jennifer Snyder, +1 781-609-6166