Apellis (APLS) Provides Syfovre Q3 Preliminary Revenues Guidance
Apellis Pharmaceuticals APLS provided third-quarter 2023 preliminary revenues guidance for its recently launched drug, Syfovre (pegcetacoplan injection), for the treatment of geographic atrophy secondary to age-related macular degeneration. Shares of the company were up 5.4% on Oct 5, following the development.
The company expects U.S. net product revenues for Syfovre to be $74 million and $160 million for third-quarter 2023 and March-September (since launch), respectively. The drug has been witnessing a robust initial uptake since its launch. In just seven months, Apellis has shipped more than 100,000 vials of Syfovre for both commercial use and administration in clinical studies.
Furthermore, the demand for the drug has been steadily increasing on a week-over-week basis since August, with orders coming in from both new and existing sites of care.
A significant development for Syfovre is the implementation of a permanent J-code, effective as of Oct 1. J-codes are permanent reimbursement codes used by government payers and commercial insurers to facilitate billing of Medicare Part B treatments, which must be administered by a healthcare professional. These simplify and streamline the billing and reimbursement procedures, allowing for efficient claim processing.
APLS’ shares have lost 23.4% year to date compared with the industry's 17.0% decline.
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However, Syfovre is facing some safety concerns. The company received reports of retinal vasculitis (or inflammation) following treatment with the injection in July.
Apellis, along with the American Society of Retina Specialists' Research and Safety in Therapeutics (ReST), examined the reported cases. These events occurred between seven and 13 days after the initial administration of the drug, with no specific lot implicated.
APLS partnered with ReST and has been closely monitoring and investigating the occurrences of retinal vasculitis. It updated the number of confirmed adverse events and suspected events to 10 (seven occlusive and three non-occlusive) and two, respectively. All these events occurred after the initial administration of Syfovre.
Per the company, the events of retinal vasculitis remain extremely rare, occurring at an estimated rate of 0.01% per injection.
On a positive note, APLS is seeking to launch Syfovre in additional geographies. A regulatory application seeking approval of pegcetacoplan for the same indication as in the United States is currently under review in Europe and several other countries. A decision regarding the same from the European Medicines Agency is expected in early 2024, while those from regulatory bodies in other countries are anticipated in the first half of 2024.
The successful approval and launch 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 stocks in the same industry are Anika Therapeutics ANIK, Annovis Bio ANVS and Corcept Therapeutics CORT, 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 90 days, the Zacks Consensus Estimate forAnika Therapeutics has narrowed from a loss of $1.41 per share to a loss of $1.24 for 2023. The bottom-line estimate has widened from a loss of 79 cents to a loss of 82 cents for 2024 during the same time frame. Shares of the company have lost 36.8% year to date.
ANIK’s earnings beat estimates in one of the trailing four quarters and missed the mark in the remaining three, delivering an average negative surprise of 32.12%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to a loss of $2.77 for 2024 during the same time frame. Shares of the company have lost 32.2% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.
In the past 90 days, the Zacks Consensus Estimate for Corcept’s earnings has gone up from 62 cents per share to 78 cents for 2023. The bottom-line estimate has also improved from 61 cents to 83 cents for 2024 during the same time frame. Shares of the company have rallied 29.4% year to date.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
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