— Third Quarter Total Revenues Increased 21% Year-Over-Year to
— Sales of Proprietary Products Increased 34% Year-Over-Year —
— Portfolio of CNS Medicines Continues to
— Company Updates Financial Expectations for 2017 —
“Our third quarter results reflect solid year-over-year topline growth
of more than twenty percent and disciplined expense management. We
continue to focus on executing on our business strategy to grow our
commercial products and invest in the late-stage development programs
that we expect will be the growth drivers for the future,” commented
“VIVITROL and ARISTADA® both operate in markets where there
remains significant unmet patient need. With new health and economic
data being generated to support the long-term potential of these
important medicines, we continue to progress VIVITROL and ARISTADA and
work toward ensuring access for the patients that need these medicines,”
said Richard Pops, Chief Executive Officer of
Quarter Ended
-
Total revenues for the quarter were
$217.4 million . This compared to$180.2 million for the same period in the prior year. -
Net loss according to generally accepted accounting principles in the
U.S. (GAAP) was
$36.3 million , or a basic and diluted GAAP loss per share of$0.24 , for the quarter. This compared to GAAP net loss of$62.7 million , or a basic and diluted GAAP loss per share of$0.41 , for the same period in the prior year. -
Non-GAAP net income was
$4.2 million , or a non-GAAP basic and diluted earnings per share of$0.03 . This compared to non-GAAP net loss of$14.1 million , or a non-GAAP basic and diluted loss per share of$0.09 , for the same period in the prior year.
Quarter Ended
Revenues
-
Net sales of VIVITROL were
$69.2 million , compared to$55.8 million for the same period in the prior year. -
Net sales of ARISTADA were
$24.5 million , compared to$14.0 million for the same period in the prior year. -
Manufacturing and royalty revenues from RISPERDAL CONSTA®,
INVEGA SUSTENNA®/XEPLION® and INVEGA TRINZA®/TREVICTA®
were
$79.4 million , compared to$73.3 million for the same period in the prior year. -
Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1
were
$24.5 million , compared to$12.9 million for the same period in the prior year.
Costs and Expenses
-
Operating expenses were
$255.7 million , compared to$241.4 million for the same period in the prior year, reflecting increased investment in the company’s development pipeline and commercial organization.
Balance Sheet
At
Financial Expectations
-
Revenues: The company now expects total revenues to range from
$850 million to $880 million , reduced from a previous range of$870 million to $920 million . Included in this total revenue expectation, the company now expects VIVITROL net sales to range from$265 million to$275 million , reduced from a previous range of$280 million to $300 million . -
Cost of Goods Manufactured and Sold: The company continues to
expect cost of goods manufactured and sold to range from
$150 million to$160 million . -
Research and Development (R&D) Expenses: The company now
expects R&D expenses to range from
$400 million to $420 million , reduced from$405 million to $435 million , reflecting the timing of certain expenses related to various ongoing programs. -
Selling, General and Administrative (SG&A) Expenses: The
company now expects SG&A expenses to range from
$410 million to $430 million , reduced from$425 million to $455 million , reflecting disciplined expense management and the timing of certain commercial initiatives. -
Amortization of Intangible Assets: The company continues to
expect amortization of intangibles to be approximately
$60 million . -
Net Interest Expense: The company continues to expect net
interest expense to be approximately
$10 million . -
Other Income, Net: The company now expects net other income of
approximately
$10 million . -
Income Tax Benefit: The company now expects an income tax
benefit of approximately
$5 million , improved from an income tax expense of up to$10 million . -
GAAP Net Loss: The company now expects GAAP net loss to range
from
$160 million to $190 million , or a basic and diluted loss per share of$1.04 to $1.23 , based on a weighted average basic and diluted share count of approximately 154 million shares outstanding. This compares to previous expectations of GAAP net loss in the range of$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 continues to expect 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 now expects capital
expenditures to range from
$50 million to $60 million , reduced 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, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income (loss) and non-GAAP basic and 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 basic and 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
marketed and development products and patient access to such products;
and expectations concerning the timing and results of clinical
development activities, including the phase 3 data readout for ALKS
3831, phase 1 data readout for ALKS 4230, the timing of the submission
of the NDA for ALKS 8700, and the timing of the submission and
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) | 2017 | 2016 | ||||||||
| Revenues: | ||||||||||
| Manufacturing and royalty revenues | $ 122,677 | $ 110,250 | ||||||||
| Product sales, net | 93,681 | 69,802 | ||||||||
| Research and development revenues | 1,027 | 189 | ||||||||
| Total Revenues | 217,385 | 180,241 | ||||||||
| Expenses: | ||||||||||
| Cost of goods manufactured and sold | 36,054 | 35,456 | ||||||||
| Research and development | 104,411 | 99,444 | ||||||||
| Selling, general and administrative | 99,633 | 91,145 | ||||||||
| Amortization of acquired intangible assets | 15,643 | 15,323 | ||||||||
| Total Expenses | 255,741 | 241,368 | ||||||||
| Operating Loss | (38,356 | ) | (61,127 | ) | ||||||
| Other Income (Expense), net: | ||||||||||
| Interest income | 1,173 | 912 | ||||||||
| Interest expense | (3,129 | ) | (3,375 | ) | ||||||
| Change in the fair value of contingent consideration | 13,600 | (1,000 | ) | |||||||
| Other expense, net | (9,078 | ) | (752 | ) | ||||||
| Total Other Income (Expense), net | 2,566 | (4,215 | ) | |||||||
| Loss Before Income Taxes | (35,790 | ) | (65,342 | ) | ||||||
| Provision (Benefit) for Income Taxes | 486 | (2,655 | ) | |||||||
| Net Loss — GAAP | $ (36,276 | ) | $ (62,687 | ) | ||||||
| Net (Loss) Earnings Per Share: | ||||||||||
| GAAP net loss per share — basic and diluted | $ (0.24 | ) | $ (0.41 | ) | ||||||
| Non-GAAP earnings (loss) per share — basic and diluted | $ 0.03 | $ (0.09 | ) | |||||||
| Weighted Average Number of Ordinary Shares Outstanding: | ||||||||||
| Basic and diluted — GAAP | 153,684 | 151,652 | ||||||||
| Basic — Non-GAAP | 153,684 | 151,652 | ||||||||
| Diluted — Non-GAAP | 159,989 | 151,652 | ||||||||
| An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income (loss) is as follows: | ||||||||||
| Net Loss — GAAP | $ (36,276 | ) | $ (62,687 | ) | ||||||
| Adjustments: | ||||||||||
| Share-based compensation expense | 19,487 | 23,726 | ||||||||
| Amortization expense | 15,643 | 15,323 | ||||||||
| Depreciation expense | 9,394 | 8,497 | ||||||||
| Non-cash net interest expense | 192 | 231 | ||||||||
| Other-than-temporary impairment of equity method investment | 10,471 | - | ||||||||
| Change in the fair value of warrants and equity method investments | (303 | ) | 521 | |||||||
| Change in the fair value of contingent consideration | (13,600 | ) | 1,000 | |||||||
| Income tax effect related to reconciling items | (844 | ) | (673 | ) | ||||||
| Non-GAAP Net Income (Loss) | $ 4,164 | $ (14,062 | ) | |||||||
| Nine Months | Nine Months | |||||||||
| Ended | Ended | |||||||||
| Condensed Consolidated Statements of Operations - GAAP | September 30, | September 30, | ||||||||
| (In thousands, except per share data) | 2017 | 2016 | ||||||||
| Revenues: | ||||||||||
| Manufacturing and royalty revenues | $ 366,608 | $ 353,444 | ||||||||
| Product sales, net | 258,893 | 176,695 | ||||||||
| Research and development revenues | 2,503 | 2,042 | ||||||||
| Total Revenues | 628,004 | 532,181 | ||||||||
| Expenses: | ||||||||||
| Cost of goods manufactured and sold | 116,241 | 97,165 | ||||||||
| Research and development | 308,399 | 297,523 | ||||||||
| Selling, general and administrative | 310,682 | 276,985 | ||||||||
| Amortization of acquired intangible assets | 46,417 | 45,636 | ||||||||
| Total Expenses | 781,739 | 717,309 | ||||||||
| Operating Loss | (153,735 | ) | (185,128 | ) | ||||||
| Other Expense, net: | ||||||||||
| Interest income | 3,287 | 2,917 | ||||||||
| Interest expense | (8,816 | ) | (9,993 | ) | ||||||
| Change in the fair value of contingent consideration | 15,900 | 3,100 | ||||||||
| Other expense, net | (10,696 | ) | (970 | ) | ||||||
| Total Other Expense, net | (325 | ) | (4,946 | ) | ||||||
| Loss Before Income Taxes | (154,060 | ) | (190,074 | ) | ||||||
| Income Tax Benefit | (5,904 | ) | (2,771 | ) | ||||||
| Net Loss — GAAP | $ (148,156 | ) | $ (187,303 | ) | ||||||
| Net Loss Per Share: | ||||||||||
| GAAP net loss per share — basic and diluted | $ (0.97 | ) | $ (1.24 | ) | ||||||
| Non-GAAP net loss per share — basic and diluted | $ (0.15 | ) | $ (0.22 | ) | ||||||
| Weighted Average Number of Ordinary Shares Outstanding: | ||||||||||
| Basic and diluted — GAAP and Non-GAAP | 153,263 | 151,261 | ||||||||
| An itemized reconciliation between net loss on a GAAP basis and non-GAAP net loss is as follows: | ||||||||||
| Net Loss — GAAP | $ (148,156 | ) | $ (187,303 | ) | ||||||
| Adjustments: | ||||||||||
| Share-based compensation expense | 63,336 | 74,613 | ||||||||
| Amortization expense | 46,417 | 45,636 | ||||||||
| Depreciation expense | 26,889 | 23,972 | ||||||||
| Change in the fair value of warrants and equity method investments | 2,760 | 1,264 | ||||||||
| Non-cash net interest expense | 578 | 694 | ||||||||
| Other-than-temporary impairment of equity method investment | 10,471 | - | ||||||||
| Increase in the fair value of contingent consideration | (15,900 | ) | (3,100 | ) | ||||||
| Income tax effect related to reconciling items | (8,896 | ) | 616 | |||||||
| Upfront license option payment to Reset Therapeutics, Inc. charged to R&D expense | - | 10,000 | ||||||||
| Non-GAAP Net Loss | $ (22,501 | ) | $ (33,608 | ) | ||||||
| Condensed Consolidated Balance Sheets | September 30, | December 31, | ||||||||
| (In thousands) | 2017 | 2016 | ||||||||
| Cash, cash equivalents and total investments | $ 568,850 | $ 619,165 | ||||||||
| Receivables | 207,537 | 191,102 | ||||||||
| Inventory | 85,027 | 62,998 | ||||||||
| Prepaid expenses and other current assets | 38,888 | 39,344 | ||||||||
| Property, plant and equipment, net | 270,666 | 264,785 | ||||||||
| Intangible assets, net and goodwill | 364,683 | 411,100 | ||||||||
| Other assets | 212,675 | 137,929 | ||||||||
| Total Assets | $ 1,748,326 | $ 1,726,423 | ||||||||
| Long-term debt — current portion | $ 3,000 | $ 3,000 | ||||||||
| Other current liabilities | 253,014 | 208,993 | ||||||||
| Long-term debt | 278,994 | 280,666 | ||||||||
| Deferred revenue — long-term | 6,132 | 7,122 | ||||||||
| Other long-term liabilities | 19,906 | 17,161 | ||||||||
| Total shareholders' equity | 1,187,280 | 1,209,481 | ||||||||
| Total Liabilities and Shareholders' Equity | $ 1,748,326 | $ 1,726,423 | ||||||||
| Ordinary shares outstanding (in thousands) | 153,746 | 152,431 | ||||||||
|
|
||||||||||
This selected financial information should be read in conjunction with
the consolidated financial statements and notes thereto included in
| Alkermes plc and Subsidiaries | |||||||||||||||||
| 2017 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: | |||||||||||||||||
| (Loss)/Earnings | |||||||||||||||||
| (In millions, except per share data) | Amount | Shares | Per Share | ||||||||||||||
| Projected Net Loss — GAAP | $ (175.0 | ) | 154 | $ (1.14 | ) | ||||||||||||
| Adjustments: | |||||||||||||||||
| Share-based compensation expense | 85.0 | ||||||||||||||||
| Amortization expense | 60.0 | ||||||||||||||||
| Depreciation expense | 37.5 | ||||||||||||||||
| Other-than-temporary impairment of equity method investment | 10.5 | ||||||||||||||||
| Change in the fair value of warrants and equity method investments | 2.0 | ||||||||||||||||
| Non-cash net interest expense | 1.0 | ||||||||||||||||
| Increase in the fair value of contingent consideration | (16.0 | ) | |||||||||||||||
| Income tax effect related to reconciling items | (5.0 | ) | |||||||||||||||
|
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/20171026005707/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