APLS - Apellis Announces Preliminary Fourth Quarter and Full Year 2023 U.S. Net Product Revenues | Benzinga
- Approximately $114 million in preliminary fourth quarter SYFOVRE® revenue as strong launch continues
- Approximately $24 million in preliminary fourth quarter EMPAVELI® revenue
WALTHAM, Mass., Jan. 08, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) today announced preliminary U.S. net product revenues of approximately $138 million for the fourth quarter and approximately $366 million for the full year 2023 for SYFOVRE® (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration and for EMPAVELI® (pegcetacoplan) for adults with paroxysmal nocturnal hemoglobinuria (PNH).
Strong SYFOVRE launch continues:
- Approximately $114 million and $275 million expected in preliminary U.S. net product revenues in the fourth quarter and full year 2023, respectively.i
- Approximately 62,000 doses (commercial and sample vials) distributed to physician practices in the fourth quarter; approximately 160,000 total doses have been distributed in 2023.
- Approximately 95% of treated GA patients are estimated to be using SYFOVRE.ii
Continued momentum with EMPAVELI:
- Approximately $24 million and $91 million expected in preliminary U.S. net product revenues in the fourth quarter and full year 2023, respectively.i
- High patient compliance rate of 97%.iii
- More than 50% of existing patients and more than 90% of new patients now use the EMPAVELI Injector, an on-body device designed to streamline self-administration, since the October Injector approval.iii
"SYFOVRE is the market-leading treatment for GA, with approximately 160,000 doses distributed since launch. More patients than ever are benefiting from SYFOVRE, including the increasing treatment effects over time and flexible dosing, and we look forward to building on the momentum this year," said Cedric Francois, M.D., Ph.D., co-founder and chief executive officer, Apellis. "Additionally, the high compliance observed with EMPAVELI speaks to the important impact of this medicine on patients' lives. In addition to advancing our pipeline, we believe the tremendous commercial progress made in the past year has positioned us for an even stronger 2024."
J.P. Morgan Healthcare Conference Presentation and Webcast
Dr. Francois will discuss these updates in a corporate presentation at the 42nd Annual J.P. Morgan Healthcare Conference today, Monday, January 8, 2024, at 9:45 a.m. PT. The event will be available via a live webcast from the "Events and Presentations" page of the "Investors and Media" section of the company's website. A replay of the webcast will be available for approximately 30 days following the event.
About SYFOVRE® (pegcetacoplan injection)
SYFOVRE® (pegcetacoplan injection) is the first and only approved therapy for geographic atrophy (GA). By targeting C3, SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body's immune system. SYFOVRE is approved in the United States for the treatment of GA secondary to age-related macular degeneration.
About EMPAVELI®/Aspaveli® (pegcetacoplan)
EMPAVELI®/Aspaveli® (pegcetacoplan) is a targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body's immune system, which can lead to the onset and progression of many serious diseases. It is approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in the United States, European Union, and other countries globally. The therapy is also under investigation for several other rare diseases across hematology and nephrology.
U.S. Important Safety Information for SYFOVRE® (pegcetacoplan injection)
CONTRAINDICATIONS
- SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation
WARNINGS AND PRECAUTIONS
- Endophthalmitis and Retinal Detachments
- Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering SYFOVRE to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.
- Retinal Vasculitis and/or Retinal Vascular Occlusion
- Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have ...