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Alkermes (ALKS) Reports Narrower-Than-Expected Loss in Q1
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Alkermes plc. (ALKS - Free Report) 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 (BIIB - Free Report) 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 Vumerity, which has been conditionally accepted by the FDA and would be confirmed upon approval. A regulatory action is expected in the fourth quarter of 2019.
In February 2019, the company initiated ARTISTRY-2, a new clinical study of ALKS 4230 administered subcutaneously as monotherapy and in combination with Merck’s (MRK - Free Report) PD-1 inhibitor, Keytruda (pembrolizumab), in patients with advanced solid tumors.
In April 2019, Alkermes announced positive top-line results from ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness), a six-month phase IIIb study evaluating the efficacy, safety and tolerability of its long-acting injectable Aristada and Johnson & Johnson's (JNJ - Free Report) monthly injectable Invega Sustenna in 200 patients experiencing acute exacerbations of schizophrenia
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-holds for the year?
Who wouldn't? Our annual Top 10s have beaten the market with amazing regularity. In 2018, while the market dropped -5.2%, the portfolio scored well into double-digits overall with individual stocks rising as high as +61.5%. And from 2012-2017, while the market boomed +126.3, Zacks' Top 10s reached an even more sensational +181.9%.
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Alkermes (ALKS) Reports Narrower-Than-Expected Loss in Q1
Alkermes plc. (ALKS - Free Report) 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 (BIIB - Free Report) 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 Vumerity, which has been conditionally accepted by the FDA and would be confirmed upon approval. A regulatory action is expected in the fourth quarter of 2019.
In February 2019, the company initiated ARTISTRY-2, a new clinical study of ALKS 4230 administered subcutaneously as monotherapy and in combination with Merck’s (MRK - Free Report) PD-1 inhibitor, Keytruda (pembrolizumab), in patients with advanced solid tumors.
In April 2019, Alkermes announced positive top-line results from ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness), a six-month phase IIIb study evaluating the efficacy, safety and tolerability of its long-acting injectable Aristada and Johnson & Johnson's (JNJ - Free Report) monthly injectable Invega Sustenna in 200 patients experiencing acute exacerbations of schizophrenia
Alkermes plc Price, Consensus and EPS Surprise
Alkermes plc Price, Consensus and EPS Surprise | Alkermes plc Quote
Zacks Rank
Alkermes currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks' Top 10 Stocks for 2019
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-holds for the year?
Who wouldn't? Our annual Top 10s have beaten the market with amazing regularity. In 2018, while the market dropped -5.2%, the portfolio scored well into double-digits overall with individual stocks rising as high as +61.5%. And from 2012-2017, while the market boomed +126.3, Zacks' Top 10s reached an even more sensational +181.9%.
See Latest Stocks Today >>