Alkermes plc today reported financial results for the first quarter of 2015.
“Our results this quarter reflect strong revenues from our portfolio of key commercial products and focused investment in our promising late-stage pipeline of CNS product candidates that will drive our future growth,” commented James Frates, Chief Financial Officer of Alkermes. “Our business continues to perform as planned, and today we are reiterating the financial expectations that we provided in March.”
“Alkermes is on the threshold of our next phase of growth and is in the midst of an extremely active time at the company as we advance one of the most exciting late-stage pipelines of CNS medicines in the industry. Aripiprazole lauroxil, our long-acting atypical antipsychotic for schizophrenia, is moving toward FDA approval and launch later this year, and significant progress is being made across our pipeline of emerging blockbusters that offer innovative treatment options for chronic CNS diseases that affect millions of people,” said Richard Pops, Chief Executive Officer of Alkermes. “The ALKS 5461 FORWARD pivotal program in depression continues to enroll well, and, based on exciting new clinical data obtained in the first quarter, we plan to initiate pivotal development for ALKS 3831 in schizophrenia and ALKS 8700 in multiple sclerosis toward the end of 2015.”
Quarter Ended March 31, 2015 Highlights
- Total revenues for the quarter were $161.2 million compared to $130.2 million for the same period in the prior year.
- Non-GAAP net income was $9.2 million, or a non-GAAP diluted earnings per share (EPS) of $0.06 for the quarter. This compared to non-GAAP net income of $16.2 million, or a non-GAAP diluted EPS of $0.11, for the same period in the prior year.
- GAAP net loss was $30.7 million, or a basic and diluted GAAP loss per share of $0.21, for the quarter. This compared to GAAP net loss of $24.4 million, or a basic and diluted GAAP loss per share of $0.17, for the same period in the prior year.
Quarter Ended March 31, 2015 Financial Results
- Manufacturing and royalty revenues from the company’s long-acting atypical antipsychotic franchise, RISPERDAL, CONSTA, and INVEGA, SUSTENNA/XEPLION, were $46.9 million, compared to $49.6 million for the same period in the prior year.
- Manufacturing and royalty revenues from AMPYRA/FAMPYRA were $36.5 million, compared to $20.6 million for the same period in the prior year.
- Net sales of VIVITROL were $31.1 million, compared to $17.1 million for the same period in the prior year, representing an increase of approximately 82%.
- Royalty revenue from BYDUREON was $9.8 million, compared to $7.7 million for the same period in the prior year.
Costs and Expenses
- Operating expenses were $188.5 million, reflecting increased investment in the company’s rapidly advancing central nervous system (CNS) development pipeline and pre-launch activities for aripiprazole lauroxil. This compared to $146.1 million for the same period in the prior year.
- Income tax provision was $0.5 million, compared to $3.8 million for the same period in the prior year.
At March 31, 2015, Alkermes had cash and total investments of $805.7 million, compared to $801.6 million at Dec. 31, 2014. At March 31, 2015, the company’s total debt outstanding was $356.4 million.
On April 10, 2015, Alkermes closed the transaction to divest its Gainesville, GA manufacturing facility and associated products, as well as IV/IM and parenteral forms of Meloxicam, to Recro Pharma, Inc. in exchange for gross proceeds of $50 million and future payments related to IV/IM and parenteral forms of Meloxicam, including milestone payments of up to $120 million and low double-digit royalties on net sales. During the first quarter, the Gainesville facility and products included in the transaction generated $19.2 million of revenue and $7.3 million of non-GAAP net income.