Apellis (APLS) Up on Strong Q4 Preliminary Syfovre U.S. Revenues
Apellis Pharmaceuticals APLS reported net product sales of approximately $138 million in the United States for the fourth quarter of 2023, up significantly year over year. The company generates product revenues from the sale of its two marketed drugs, Empaveli (pegcetacoplan) and Syfovre (pegcetacoplan injection). Its top line also comprises of licensing and other revenues.
The 39% sequential increase in product revenues (from $99.2 million) was driven by strong Syfovre sales. Syfovre recorded sales of $114 million in fourth-quarter 2023, up 51.4% sequentially, while Empaveli recorded the remaining $24 million in sales, up 21.8% year over year.
Syfovre sales beat our model estimate of $78.5 million. Apellis reported distributing approximately 62,000 doses of Syfovre to doctors in the to-be-reported quarter.
The company recorded preliminary total U.S. product revenues (unaudited) of approximately $366 million for full-year 2023.
Preliminary net revenues generated from the sale of Syfovre in the United States amounted to approximately $275 million in 2023, which beat our model estimate of $239.5 million. The company distributed approximately 160,000 total doses (commercial and sample vials) of the drug in 2023.
For the full year of 2023, preliminary net revenues generated from the sale of Empaveli in the United States were approximately $91 million.
The company’s shares rose 14.7% on Monday as investors were impressed by the robust sales growth of Syfovre in the fourth quarter of 2023.
Over the past year, shares of Apellis have risen 39.4% against the industry’s 12.9% decline.
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Apellis received FDA approval for its targeted C3 therapy, Empaveli, as a monotherapy treatment for adult patients suffering from Paroxysmal Nocturnal Hemoglobinuria (PNH) in 2021. This marked the first FDA nod to the company for any of its products.
APLS has seen a strong uptake of Empaveli in recent quarters. Empaveli is also currently approved in the EU under the brand name Aspaveli (pegcetacoplan) for the treatment of adult patients with PNH who are anemic after treatment with a C5 inhibitor for at least three months.
In October 2023, the FDA approved the company’s single-use, on-body device, Empaveli Injector, to enhance self-administration for the treatment of PNH. Following this approval, more than 50% of existing patients and over 90% of new patients currently use the Empaveli Injector.
Empaveli therapy is also being evaluated for several other rare diseases across hematology and nephrology.
Apellis received FDA approval for its second drug, Syfovre (pegcetacoplan injection), in February 2023. Syfovre is the first and only treatment for geographic atrophy (GA) secondary to age-related macular degeneration. Syfovre has the potential to be a best-in-class treatment for patients with GA,a disease that affects more than one million people in the United States and five million people worldwide. The company reported that approximately 95% of treated GA patients are estimated to be using this drug.
The drug has been witnessing robust uptake since its commercial launch in March 2023, a trend that is expected to continue in the upcoming quarters.
A marketing authorization application seeking approval for intravitreal pegcetacoplan for the treatment of GA is currently under review in the EU and several other countries. A decision regarding the same from the European Medicines Agency is expected in early 2024. Approvals from regulatory bodies in other countries are expected in the first half of 2024.
Approval for the drug in additional geographies will add an incremental stream of revenues to Apellis.
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 drug/biotech stocks worth mentioning are Puma Biotechnology, Inc. PBYI, ADMA Biologics ADMA and Acadia Pharmaceuticals ACAD. While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA and ACAD carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has increased from 72 cents to 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 64 cents to 69 cents. Over the past year, shares of PBYI have risen 1.3%.
PBYI's earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 3 cents to 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 18 cents. Over the past year, shares of ADMA have risen 31.5%.
ADMA's earnings beat estimates in three of the trailing four quarters and met in one, delivering an average surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Acadia’s 2023 loss per share has remained constant at 33 cents. During the same time frame, the consensus estimate for Acadia’s 2024 EPS is pegged at $1.04. Over the past year, shares of ACAD have rallied 74.3%.
ACAD's earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 20.69%.
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