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Apellis Pharmaceuticals, Inc. (APLS - Free Report) incurred second-quarter 2024 loss of 28 cents per share (excluding loss on extinguishment of development liability), narrower than the Zacks Consensus Estimate of a loss of 33 cents. The company had incurred a loss of $1.02 per share in the year-ago quarter.
Total revenues amounted to $199.7 million in the reported quarter, beating the Zacks Consensus Estimate of $189.5 million. In the year-ago quarter, the company had reported revenues of $95 million.
The top line skyrocketed 110% year over year, owing to higher sales of Syfovre (pegcetacoplan injection) in the second quarter.
Syfovre was approved for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration by the FDA in February 2023.
Year to date, shares of APLS have plunged 33.8% compared with the industry’s decline of 0.5%.
Image Source: Zacks Investment Research
Quarter in Detail
Revenues in the reported quarter included product sales of the marketed drugs — Empaveli (pegcetacoplan) and Syfovre — and licensing and other revenues under the collaboration agreement with Sobi.
Syfovre recorded sales of $154.6 million in the second quarter, which surged 130% year over year, owing to continued strong demand. Syfovre sales missed the Zacks Consensus Estimate of $158 million but beat our model estimate of $148 million for the reported quarter.
Apellis delivered more than 79,000 commercial vials and nearly 5,000 samples of Syfovre to doctors in the second quarter. As of Jun 30, 2024, the total number of doses of the drug delivered since launch was 330,000.
The potential approval and successful launch of Syfovre in additional geographies will add an incremental stream of revenues to APLS in the future.
Empaveli recorded sales of $24.5 million in the reported quarter, up 10% from the year-ago quarter’s figure, owing to continued high patient compliance rates of 97%. Empaveli sales, however, missed the Zacks Consensus Estimate of $26.5 million, as well as our model estimate of $27.6 million.
Empaveli is approved in the United States for the treatment of paroxysmal nocturnal hemoglobinuria. The drug is also approved in Europe under the brand name Aspaveli for the same indication.
Licensing and other revenues came in at $20.5 million, up significantly year over year.
Research and development expenses decreased 19% from the prior-year quarter’s level to $77.9 million. This was due to a decrease in program-specific external costs and other external costs.
General and administrative expenses totaled $128.1 million, up 15% year over year. This was due to higher employee-related costs, office costs and costs related to commercial and marketing activities. The uptick was partially offset by a decrease in professional and consulting fees.
As of Jun 30, 2024, Apellis had cash, cash equivalents and marketable securities worth $360.1 million compared with $325.9 million as of Mar 31, 2024. APLS expects its cash balance, combined with cash anticipated from sales of marketed products, to be enough to fund its operations in the foreseeable future.
Pipeline Update
Apellis’ phase III VALIANT study is currently evaluating systemic pegcetacoplan for treating primary immune complex membranoproliferative glomerulonephritis and C3 glomerulopathy. Top-line data from the study are anticipated in August 2024.
Regulatory Update
In late June, Apellis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a negative opinion for the second time on the marketing authorization application for intravitreal pegcetacoplan to treat GA in the EU. Despite this decision, there were several dissenting votes among CHMP members.
APLS has requested a re-examination of the opinion and anticipates a final decision in the fourth quarter of 2024. The negative opinion followed an Ad Hoc Expert Group meeting, where experts agreed that the size of GA lesions is an acceptable primary outcome measure for GA studies and that microperimetry is the best available functional measure for GA.
In the past 60 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has narrowed from $1.95 to $1.91. Year to date, shares of ANVS have plunged 50.2%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 60 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has narrowed from 44 cents to 43 cents. During the same time frame, the estimate for Anixa Biosciences’ 2024 loss per share has remained constant at 45 cents. Year to date, shares of ANIX have lost 14.4%.
ANIX beat estimates in three of the trailing four quarters and missed the mark once, delivering an average earnings surprise of 2.27%.
In the past 60 days, estimates for Akero Therapeutics’ 2024 loss per share have narrowed from $3.87 to $3.82. During the same period, loss per share estimates for 2025 have remained constant at $4.29. Year to date, shares of AKRO have gained 14.5%.
Akero’s earnings beat estimates in one of the trailing four quarters, missed twice and matched once, delivering an average negative surprise of 5.10%.
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Apellis (APLS) Q2 Earnings Beat, Syfovre Sales Drive Revenues
Apellis Pharmaceuticals, Inc. (APLS - Free Report) incurred second-quarter 2024 loss of 28 cents per share (excluding loss on extinguishment of development liability), narrower than the Zacks Consensus Estimate of a loss of 33 cents. The company had incurred a loss of $1.02 per share in the year-ago quarter.
Total revenues amounted to $199.7 million in the reported quarter, beating the Zacks Consensus Estimate of $189.5 million. In the year-ago quarter, the company had reported revenues of $95 million.
The top line skyrocketed 110% year over year, owing to higher sales of Syfovre (pegcetacoplan injection) in the second quarter.
Syfovre was approved for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration by the FDA in February 2023.
Year to date, shares of APLS have plunged 33.8% compared with the industry’s decline of 0.5%.
Image Source: Zacks Investment Research
Quarter in Detail
Revenues in the reported quarter included product sales of the marketed drugs — Empaveli (pegcetacoplan) and Syfovre — and licensing and other revenues under the collaboration agreement with Sobi.
Syfovre recorded sales of $154.6 million in the second quarter, which surged 130% year over year, owing to continued strong demand. Syfovre sales missed the Zacks Consensus Estimate of $158 million but beat our model estimate of $148 million for the reported quarter.
Apellis delivered more than 79,000 commercial vials and nearly 5,000 samples of Syfovre to doctors in the second quarter. As of Jun 30, 2024, the total number of doses of the drug delivered since launch was 330,000.
The potential approval and successful launch of Syfovre in additional geographies will add an incremental stream of revenues to APLS in the future.
Empaveli recorded sales of $24.5 million in the reported quarter, up 10% from the year-ago quarter’s figure, owing to continued high patient compliance rates of 97%. Empaveli sales, however, missed the Zacks Consensus Estimate of $26.5 million, as well as our model estimate of $27.6 million.
Empaveli is approved in the United States for the treatment of paroxysmal nocturnal hemoglobinuria. The drug is also approved in Europe under the brand name Aspaveli for the same indication.
Licensing and other revenues came in at $20.5 million, up significantly year over year.
Research and development expenses decreased 19% from the prior-year quarter’s level to $77.9 million. This was due to a decrease in program-specific external costs and other external costs.
General and administrative expenses totaled $128.1 million, up 15% year over year. This was due to higher employee-related costs, office costs and costs related to commercial and marketing activities. The uptick was partially offset by a decrease in professional and consulting fees.
As of Jun 30, 2024, Apellis had cash, cash equivalents and marketable securities worth $360.1 million compared with $325.9 million as of Mar 31, 2024. APLS expects its cash balance, combined with cash anticipated from sales of marketed products, to be enough to fund its operations in the foreseeable future.
Pipeline Update
Apellis’ phase III VALIANT study is currently evaluating systemic pegcetacoplan for treating primary immune complex membranoproliferative glomerulonephritis and C3 glomerulopathy. Top-line data from the study are anticipated in August 2024.
Regulatory Update
In late June, Apellis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a negative opinion for the second time on the marketing authorization application for intravitreal pegcetacoplan to treat GA in the EU. Despite this decision, there were several dissenting votes among CHMP members.
APLS has requested a re-examination of the opinion and anticipates a final decision in the fourth quarter of 2024. The negative opinion followed an Ad Hoc Expert Group meeting, where experts agreed that the size of GA lesions is an acceptable primary outcome measure for GA studies and that microperimetry is the best available functional measure for GA.
Apellis Pharmaceuticals, Inc. Price and Consensus
Apellis Pharmaceuticals, Inc. price-consensus-chart | Apellis Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Apellis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Annovis Bio (ANVS - Free Report) , Anixa Biosciences (ANIX - Free Report) and Akero Therapeutics (AKRO - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has remained constant at $2.46. During the same period, the consensus estimate for 2025 loss per share has narrowed from $1.95 to $1.91. Year to date, shares of ANVS have plunged 50.2%.
ANVS beat estimates in three of the trailing four quarters and missed once, delivering an average negative surprise of 1.39%.
In the past 60 days, the Zacks Consensus Estimate for Anixa Biosciences’ 2023 loss per share has narrowed from 44 cents to 43 cents. During the same time frame, the estimate for Anixa Biosciences’ 2024 loss per share has remained constant at 45 cents. Year to date, shares of ANIX have lost 14.4%.
ANIX beat estimates in three of the trailing four quarters and missed the mark once, delivering an average earnings surprise of 2.27%.
In the past 60 days, estimates for Akero Therapeutics’ 2024 loss per share have narrowed from $3.87 to $3.82. During the same period, loss per share estimates for 2025 have remained constant at $4.29. Year to date, shares of AKRO have gained 14.5%.
Akero’s earnings beat estimates in one of the trailing four quarters, missed twice and matched once, delivering an average negative surprise of 5.10%.