Apellis Pharmaceuticals Inc
reported a second quarter (Q2) EPS loss of $1.02, beating the consensus of -$1.35.
Sales came in at $95 million, up from $16.3 million a year ago, beating the consensus of $71.72 million.
The sales included $22.3 million of the U.S. net product revenue of Empaveli and $67.3 million of the U.S. net product revenue of Syfovre.
Cash and cash equivalents of $616.3 million as of June 30, 2023; expected cash runway into Q1 2025.
Over 31,000 commercial vials and nearly 11,000 samples of SYFOVRE were delivered to physician practices in the second quarter. The total number of vials delivered since launch through July 29 is over 68,000.
Last week, the company provided an update on its review of rare events of retinal vasculitis reported in real-world treatment with Syfovre (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Apellis has been conducting a thorough evaluation following these reported events and noted no changes in the product formulation between Phase 3 trials and commercial supply.
Based on this review, there is no indication that drug product or manufacturing issues contributed to these events, and there were no new safety findings in the clinical trials upon secondary review.
No manufacturing-related issues impacting product quality were identified.
No quality issues and no contaminants were discovered. No single manufacturing lot was implicated.
No indication of drug-related immunogenicity was observed in the trial data.
Zero events of retinal vasculitis were reported by investigators or identified by an independent reading center in Phase 3 trials.
Since Syfovre's launch, Apellis has had seven confirmed events of retinal vasculitis (4 occlusive, three non-occlusive).
Additionally, Apellis announced data from the GALE extension study following 30 months of continuous treatment with Syfovre.
Syfovre reduced nonsubfoveal GA lesion growth by up to 45% between Months 24-30 compared to the projected sham in the GALE long-term extension study.
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