Alkermes plc. (NASDAQ:ALKS) reported a loss of 17 cents per share in the first quarter of 2019, narrower than the Zacks Consensus Estimate of a loss of 19 cents. The loss was, however, wider than the year-ago quarter’s loss of 9 cents.
The company’s revenues of $223.1 million in the quarter declined 0.9% from the year-ago quarter. The top line, however, beat the Zacks Consensus Estimate of $221.2 million. The company’s proprietary products — Vivitrol and Aristada — drove revenues. However, this was offset by declining sales of Ampyra, following its generic entry into the market in 2018.
Alkermes’ shares have increased 2.7% year to date compared with the industry’s growth of 3.3%.
Factors Impacting Q1
Manufacturing and royalty revenues from Risperdal Consta, InvegaSustenna/Xeplion and InvegaTrinza/Trevicta were $75.6 million, up 9.9% year over year. The same from Ampyra/Fampyra were down 56.9% year over year to $12.2 million due to generic competition. Research and development revenues from the collaboration with Biogen (NASDAQ:BIIB) for diroximel fumarate (BIIB098) were $13.9 million, down 20.6% year over year.
Vivitrol sales improved about 10% year over year to $69.2 million.
Aristada sales came in at $30.3 million, up 4% year over year.
Research and development (R&D) expenses were $102.5 million, down 5.3% year over year.
Selling, general and administrative (SG&A) expenses were $141.2 million, up 19.3% year over year.
2019 Outlook
Alkermes reiterated its guidance for 2019. The company expects total revenues of $1.14-$1.19 billion, driven by anticipated growth of its proprietary products and an expected $150-million milestone payment from Biogen in the fourth quarter of 2019 related to the potential FDA approval of diroximel fumarate (BIIB098).
The Zacks Consensus Estimate for 2019 revenues is $1.17 billion.
Alkermes expects Vivitrol sales to be $330-$350 million, while Aristada sales are anticipated to be $210-$230 million. The company expects R&D expenses to be $450-$480 million. Alkermes’ guidance for SG&A expenses is $590-$620 million.
The company expects earnings per share to be 25-43 cents. The Zacks Consensus Estimate for 2019 earnings is pegged at 36 cents.
Pipeline Update
In February 2019, the FDA accepted for review the new drug application (NDA) for diroximel fumarate to treat multiple sclerosis. If approved, Biogen intends to market diroximel fumarate under the brand name V