On April 28, 2016 Alkermes plc (NASDAQ: ALKS) reported financial results for the first quarter of 2016 (Press release, Alkermes, APR 28, 2016, View Source;p=RssLanding&cat=news&id=2162613 [SID:1234511537]).
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"Our solid first quarter performance was highlighted by the robust growth in VIVITROL sales, the launch of ARISTADA, and continued strength of our base royalty and manufacturing business. The launch of ARISTADA continues to gain traction, and we are pleased with the progress that we are making with reimbursement discussions and physician awareness," commented James Frates, Chief Financial Officer of Alkermes. "With our strong financial position and growing commercial portfolio, we are well positioned to invest in our advancing pipeline, and today we are reiterating our financial expectations for 2016."
"We have built a differentiated and resilient business. Our portfolio of innovative products, including VIVITROL and ARISTADA, is growing rapidly and represents a significant opportunity in the years ahead," said Richard Pops, Chief Executive Officer of Alkermes. "Our pipeline has a number of exciting late-stage programs, and we are on the threshold of numerous development milestones. With three drug candidates in pivotal studies, each representing an important and differentiated treatment option in its therapeutic space, and two new candidates beginning clinical studies, the medical importance and potential economic value of our pipeline is substantial and growing."
Quarter Ended March 31, 2016 Highlights
Total revenues for the quarter were $156.8 million. This compared to $161.2 million for the same period in the prior year, or $142.0 million excluding $19.2 million of revenue from the products associated with the Gainesville manufacturing facility that was divested in April 2015 (the "Gainesville Divestiture").
Net loss according to generally accepted accounting principles in the U.S. (GAAP) was $77.4 million, or a basic and diluted GAAP loss per share of $0.51, for the quarter and reflected increased investment in the company’s advancing late-stage pipeline and commercial infrastructure. This compared to GAAP net loss of $30.7 million, or a basic and diluted GAAP loss per share of $0.21 for the same period in the prior year, or GAAP net loss of $34.9 million, or a basic and diluted loss per share of $0.24, excluding $4.2 million of GAAP net income related to the Gainesville Divestiture.
Non-GAAP net loss was $24.6 million, or a non-GAAP basic and diluted loss per share of $0.16 for the quarter. This compared to non-GAAP net income of $9.2 million, or a non-GAAP diluted earnings per share (EPS) of $0.06, for the same period in the prior year, or non-GAAP net income of $1.9 million, or basic and diluted EPS of $0.01, excluding $7.3 million of non-GAAP net income related to the Gainesville Divestiture.
Quarter Ended March 31, 2016 Financial Results
Revenues
Net sales of VIVITROL were $43.8 million, compared to $31.1 million for the same period in the prior year, representing an increase of approximately 41%.
Net sales of ARISTADA were $5.5 million, following its launch in October 2015.
Manufacturing and royalty revenues from RISPERDAL CONSTA and INVEGA SUSTENNA/XEPLION and INVEGA TRINZA were $54.7 million, compared to $46.9 million for the same period in the prior year.
Manufacturing and royalty revenues from AMPYRA/FAMPYRA1 were $28.2 million, compared to $36.5 million for the same period in the prior year, reflecting the timing of shipments.
Royalty revenue from BYDUREON was $10.5 million, compared to $9.8 million for the same period in the prior year.
Costs and Expenses
Operating expenses were $233.7 million, reflecting increased investment in the company’s development pipeline, the continued launch of ARISTADA and a $10.0 million upfront payment to Reset Therapeutics, Inc. related to a collaboration on their novel orexin modulators, which was recorded as research and development expense. Operating expenses for the quarter ended March 31, 2015 were $188.5 million, or $173.5 million excluding $15.0 million of operating expenses related to the Gainesville Divestiture.
Balance Sheet
At March 31, 2016, Alkermes had cash and total investments of $719.4 million, compared to $798.8 million at Dec. 31, 2015. At March 31, 2016, the company’s total debt outstanding was $348.5 million.
Financial Expectations
Alkermes reiterates all of its financial expectations for 2016 set forth in its press release dated Feb. 25, 2016.