Alkermes plc (NASDAQ:ALKS) today reported financial results for the third quarter of 2016.
“Our third quarter results demonstrate the value of our highly-diversified commercial portfolio, and were driven by the strong growth of our proprietary products, VIVITROL® and ARISTADA®,” commented James Frates, Chief Financial Officer of Alkermes. “As we approach year-end, we remain well-positioned to execute on our business strategy and are reiterating our 2016 financial expectations provided in July.”
“We are at an unprecedented place in Alkermes’ evolution, with two proprietary products growing in their markets, ALKS 5461 advancing at full speed, and two additional late-stage candidates well into their pivotal programs,” stated Richard Pops, Chief Executive Officer of Alkermes. “VIVITROL for opioid and alcohol dependence and ARISTADA for schizophrenia are important, distinctive medicines in their disease areas and are the foundation of our future growth. With the positive results of FORWARD-5 for ALKS 5461 for major depressive disorder in hand, Alkermes’ next potential growth driver is coming more clearly into focus.”
Quarter Ended Sept. 30, 2016 Highlights
- Total revenues for the quarter were $180.2 million. This compared to $152.7 million for the same period in the prior year.
- Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $62.7 million, or a basic and diluted GAAP loss per share of $0.41, 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 $81.0 million, or a basic and diluted GAAP loss per share of $0.54, for the same period in the prior year.
- Non-GAAP net loss was $14.1 million, or a non-GAAP basic and diluted loss per share of $0.09, for the quarter. This compared to non-GAAP net loss of $28.8 million, or a non-GAAP basic and diluted loss per share of $0.19, for the same period in the prior year.
Quarter Ended Sept. 30, 2016 Financial Results
- Net sales of VIVITROL were $55.8 million, compared to $37.9 million for the same period in the prior year, representing an increase of approximately 47%.
- Net sales of ARISTADA were $14.0 million, up from $10.3 million in the second quarter of 2016.
- Manufacturing revenues from RISPERDAL CONSTA® (risperidone) and royalty revenues from RISPERDAL CONSTA, INVEGA SUSTENNA®/XEPLION® (paliperidone palmitate) and INVEGA TRINZA®/TREVICTA® (paliperidone palmitate) were $73.3 million, compared to $67.6 million for the same period in the prior year.
- Manufacturing and royalty revenues from AMPYRA®/FAMPYRA®1 were $12.9 million, compared to $22.1 million for the same period in the prior year, primarily due to the timing of manufacturing shipments.
- Royalty revenue from BYDUREON® was $11.6 million, compared to $13.0 million for the same period in the prior year.
Costs and Expenses
- Operating expenses were $241.4 million, reflecting increased investment in the company’s development pipeline, the continued launch of ARISTADA and growth of VIVITROL. Operating expenses for the quarter ended Sept. 30, 2015 were $230.1 million.
At Sept. 30, 2016, Alkermes had cash and total investments of $624.6 million, compared to $798.8 million at Dec. 31, 2015. On Sept. 26, 2016 the company retired $60 million of maturing debt. In October 2016, the company extended the maturity date of the approximately $286 million outstanding term loan by two years to Sept. 25, 2021.
Alkermes reiterates its Financial Expectations for 2016 set forth in its press release dated July 28, 2016.
Alkermes will host a conference call at 8:30 a.m. ET (12:30 p.m. GMT) on Wednesday, Nov. 2, 2016, to discuss these financial results and provide an update on the company. The conference call may be accessed by dialing +1 888 424 8151 for U.S. callers and +1 847 585 4422 for international callers. The conference call ID number is 6037988. In addition, a replay of the conference call will be available from 11:00 a.m. ET (3:00 p.m. GMT) on Wednesday, Nov. 2, 2016, through 5:00 p.m. ET (10:00 p.m. GMT) on Wednesday, Nov. 9, 2016, and may be accessed by visiting Alkermes’ website or by dialing +1 888 843 7419 for U.S. callers and +1 630 652 3042 for international callers. The replay access code is 6037988.
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.