Apellis Pharmaceuticals Inc (NASDAQ:APLS) shares are trading lower amid safety concerns regarding the company’s newly launched Syfovre (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Raymond James analyst notes that the ASRS Research and Safety in Therapeutics (ReST) Committee distributed a notification to its members on Saturday indicating:
- Six cases of occlusive retinal vasculitis have been observed since Syfovre’s launch in March this year.
- All events observed after the first injection, 7-13 days post-injection.
- No specific product lots were implicated.
Moreover, the communication indicates that ~60,000 vials of Syfovre have been distributed since FDA approval.
The analyst spoke with Apellis, who confirmed the details.
The 60k vials distributed since launch exceeds the already Street-high 2Q23 estimate by ~15k vials, implying 2Q23 Syfovre revenue could be over $80 million (vs. Raymond James’s estimate of $54 million and Street consensus $34 million).
In Q1 FY23, Apellis reported $18.4 million in Syfovre U.S. net product revenue.
Price Action: APLS shares are down 22.80% at $65.25 on the last check Monday.
