Second Quarter Revenues Increase to $304.6 Million, Driven by License Revenues and 24% Year-Over-Year Growth of Proprietary Product Net Sales
|
DUBLIN, July 26, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the second quarter of 2018. "Our strong second quarter results were driven by the solid growth of our proprietary commercial products, the continued strength of our royalty and manufacturing business, as well as the receipt of a $50 million payment related to our collaboration with Biogen for BIIB098," commented James Frates, Chief Financial Officer of Alkermes. "The business is performing as planned and today we are reiterating our financial expectations for 2018. As we head into a catalyst-rich second half of the year, we are well-positioned financially to drive value, grow our portfolio of commercial products and advance our late-stage pipeline." Quarter Ended June 30, 2018 Financial Highlights
"VIVITROL and ARISTADA continue to demonstrate solid growth and perform in-line with our expectations. Our proprietary commercial portfolio is a key growth driver for Alkermes, and we are confident about the prospects ahead for these important products," stated Jim Robinson, President and Chief Operating Officer of Alkermes. "In particular, the launch of ARISTADA INITIO™ is an important opportunity to support continuity of care and address a critical unmet need for patients, as ARISTADA is now the first and only long-acting atypical antipsychotic that can be fully dosed on day one for up to two months. ARISTADA INITIO represents a key addition to the treatment paradigm for schizophrenia and provides a platform to further expand utilization of ARISTADA." Quarter Ended June 30, 2018 Financial Results Revenues
Costs and Expenses
"With a growing proprietary commercial portfolio and partnered royalty and manufacturing business approaching $1 billion in revenue in 2018, Alkermes is in a strong position to create significant long-term value. As we head into the second half of 2018, we are on the threshold of important value inflections across our development portfolio," said Richard Pops, Chief Executive Officer of Alkermes. "For ALKS 5461 for major depressive disorder, the regulatory review is underway and we are preparing for an Advisory Committee meeting in the fourth quarter. For ALKS 3831 for schizophrenia, enrollment of the ENLIGHTEN-2 pivotal study is complete and we expect topline data in the fourth quarter of 2018. In addition, we are on track to submit the NDA for BIIB098 toward year-end, and we look forward to presenting initial data from the ALKS 4230 phase 1 study and expanding into combination therapy later this year." Recent Events:
Financial Expectations for 2018 Conference Call About Alkermes plc Non-GAAP Financial Measures 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 VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA® is a registered trademark and ARISTADA INITIO™ is a trademark of Alkermes Pharma Ireland Limited; RISPERDAL CONSTA®, INVEGA SUSTENNA®, XEPLION®, INVEGA TRINZA® and TREVICTA® are registered trademarks of Johnson & Johnson; AMPYRA® and FAMPYRA® are registered trademarks of Acorda Therapeutics, Inc. 1AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg is developed and marketed in the U.S. by Acorda Therapeutics, Inc. and outside the U.S. by Biogen Idec, under a licensing agreement with Acorda Therapeutics, as FAMPYRA® (prolonged-release fampridine tablets). 2ARISTADA INITIO was approved by the FDA for the initiation of ARISTADA, a long-acting injectable atypical antipsychotic for the treatment of schizophrenia in adults. The ARISTADA INITIO regimen consists of ARISTADA INITIO plus a single 30 mg dose of oral aripiprazole. (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) 2018 2017
---- ----
Revenues:
Manufacturing and royalty revenues $128,241 $129,252
Product sales, net 109,807 88,756
License revenues 48,250 -
Research and development revenues 18,344 833
Total Revenues 304,642 218,841
-------------- ------- -------
Expenses:
Cost of goods manufactured and sold 43,417 39,775
Research and development 106,823 99,153
Selling, general and administrative 138,257 108,950
Amortization of acquired intangible assets 16,247 15,472
Total Expenses 304,744 263,350
-------------- ------- -------
Operating Loss (102) (44,509)
-------------- ---- -------
Other Expense, net:
Interest income 1,900 1,171
Interest expense (3,126) (2,923)
Change in the fair value of contingent consideration (19,600) 700
Other expense, net (3,517) (119)
Total Other Expense, net (24,343) (1,171)
------------------------ ------- ------
Loss Before Income Taxes (24,445) (45,680)
------------------------ ------- -------
Income Tax Provision (Benefit) 8,204 (2,681)
-----------------------------
Net Loss - GAAP $(32,649) $(42,999)
--------------- -------- --------
Net (Loss) Earnings Per Share:
GAAP net loss per share - basic and diluted $(0.21) $(0.28)
====== ======
Non-GAAP earnings per share - basic and diluted $0.29 $0.01
===== =====
Weighted Average Number of Ordinary Shares Outstanding:
Basic and diluted - GAAP 155,176 153,392
======= =======
Basic - Non-GAAP 155,176 153,392
======= =======
Diluted - Non-GAAP 159,761 160,307
======= =======
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income is as follows:
Net Loss - GAAP $(32,649) $(42,999)
Adjustments:
Share-based compensation expense 30,933 22,680
Amortization expense 16,247 15,472
Depreciation expense 9,521 9,034
Change in the fair value of warrants and equity method investments 1,269 1,611
Non-cash net interest expense 170 193
Change in the fair value of contingent consideration 19,600 (700)
Income tax effect related to reconciling items 512 (4,102)
Non-GAAP Net Income $45,603 $1,189
======= ======
Six Months Six Months
Ended Ended
Condensed Consolidated Statements of Operations - GAAP June 30, June 30,
(In thousands, except per share data) 2018 2017
---- ----
Revenues:
Manufacturing and royalty revenues $242,842 $243,931
Product sales, net 201,649 165,212
License revenues 48,250 -
Research and development revenues 37,051 1,476
Total Revenues 529,792 410,619
-------------- ------- -------
Expenses:
Cost of goods manufactured and sold 87,893 80,187
Research and development 215,169 203,988
Selling, general and administrative 256,404 211,049
Amortization of acquired intangible assets 32,316 30,774
Total Expenses 591,782 525,998
-------------- ------- -------
Operating Loss (61,990) (115,379)
-------------- ------- --------
Other Expense, net:
Interest income 3,385 2,114
Interest expense (8,613) (5,687)
Change in the fair value of contingent consideration (21,500) 2,300
Other expense, net (2,725) (1,618)
Total Other Expense, net (29,453) (2,891)
------------------------ ------- ------
Loss Before Income Taxes (91,443) (118,270)
------------------------ ------- --------
Income Tax Provision (Benefit) 3,711 (6,390)
-----------------------------
Net Loss - GAAP $(95,154) $(111,880)
--------------- -------- ---------
Net (Loss) Earnings Per Share:
GAAP net loss per share - basic and diluted $(0.61) $(0.73)
====== ======
Non-GAAP earnings (loss) per share - basic and diluted $0.20 $(0.17)
===== ======
Weighted Average Number of Ordinary Shares Outstanding:
Basic and diluted - GAAP 154,802 153,050
======= =======
Basic - Non-GAAP 154,802 153,050
======= =======
Diluted - Non-GAAP 160,472 153,050
======= =======
An itemized reconciliation between net loss on a GAAP basis and non-GAAP net income (loss) is as follows:
Net Loss - GAAP $(95,154) $(111,880)
Adjustments:
Share-based compensation expense 50,975 43,849
Amortization expense 32,316 30,774
Depreciation expense 19,174 17,495
Change in the fair value of warrants and equity method investments 967 3,063
Non-cash net interest expense 361 386
Change in the fair value of contingent consideration 21,500 (2,300)
Income tax effect related to reconciling items (4,666) (8,052)
Restructuring expense 3,598 -
Debt refinacing charge 2,298 -
Non-GAAP Net Income (Loss) $31,369 $(26,665)
======= ========
Condensed Consolidated Balance Sheets June 30, December 31,
(In thousands) 2018 2017
------------- ---- ----
Cash, cash equivalents and total investments $560,519 $590,716
Receivables 255,230 233,590
Contract assets 14,582 -
Inventory 87,165 93,275
Prepaid expenses and other current assets 49,639 48,475
Property, plant and equipment, net 296,635 284,736
Intangible assets, net and goodwill 316,725 349,041
Other assets 170,991 197,394
Total Assets $1,751,486 $1,797,227
------------ ---------- ----------
Long-term debt - current portion $2,843 $3,000
Other current liabilities 284,630 288,122
Long-term debt 277,548 278,436
Deferred revenue - long-term 5,857 5,657
Other long-term liabilities 22,453 19,204
Total shareholders' equity 1,158,155 1,202,808
Total Liabilities and Shareholders' Equity $1,751,486 $1,797,227
------------------------------------------ ---------- ----------
Ordinary shares outstanding (in thousands) 155,303 154,009
This selected financial information should be read in conjunction with the consolidated financial statements and notes thereto included in
Alkermes plc's Quarterly Report on Form 10-Q for the three and six months ended June 30, 2018, which the company intends to file in July 2018.
Alkermes Contacts:
------------------
For Investors: Sandy Coombs +1 781 609 6377
Eva Stroynowski +1 781 609 6823
For Media: Jennifer Snyder +1 781 609 6166
View original content with multimedia:http://www.prnewswire.com/news-releases/alkermes-plc-reports-second-quarter-2018-financial-results-300686668.html SOURCE Alkermes plc |
||
Company Codes: NASDAQ-NMS:ALKS |
