Apellis Announces Preliminary U.S. Net Revenues of Approximately $74 Million for SYFOVRE® (pegcetacoplan injection) in the Third Quarter of 2023

• Continued strong demand, with more than 100,000 vials (commercial and sample) distributed to date; growth in week-over-week demand returned starting in August
• Permanent J-code effective as of October 1, and more than 95% of all Medicare payers now covering SYFOVRE
• Up to 45% reduction of nonsubfoveal GA lesion growth observed between Months 24-30 compared to projected sham in the GALE extension study
• Estimated rate of retinal vasculitis continues to be rare at 0.01% per injection

WALTHAM, Mass., Oct. 05, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today provided an update on the launch of SYFOVRE® (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

“In only seven months, more than 100,000 vials have been shipped to physician practices, which we believe is a testament to the unmet need and the strength of SYFOVRE’s product profile. SYFOVRE offers increasing treatment effects over time with as few as six doses per year,” said Adam Townsend, chief commercial officer, Apellis. “It is very encouraging to see the return to weekly growth in demand as physicians and patients have learned more about the long-term efficacy from the GALE study and real-world safety of SYFOVRE. With our permanent J-code now in place, we look forward to building on these trends and continuing to bring SYFOVRE to people living with this chronic disease.”

Highlights from the launch to date include:

Strong growth in demand

• Apellis expects approximately $74 million in preliminary U.S. net product revenue for SYFOVRE in the third quarter and approximately $160 million in preliminary total U.S. net product revenue for SYFOVRE since launch in March 2023 through September 30, 2023.i
• Approximately 37,000 commercial vials and 10,000 samples were distributed to physician practices in the third quarter; more than 100,000 total vials have been delivered to date.
  • Continued strong demand; week-over-week growth returned starting in August, with weekly orders from both new and existing sites of care.

Positive reimbursement of SYFOVRE

• Permanent J-code effective as of October 1, which will help ensure accurate and efficient reimbursement of SYFOVRE.
• 93% of Medicare Advantage payers and 100% of Original Medicare (fee-for-service) payers are now covering SYFOVRE.
  • Apellis estimates that 94% of the U.S. GA population is covered by Medicare.

Long-term efficacy and visual function benefit

• In the GALE long-term extension study, which was reported in July 2023, SYFOVRE continued to slow GA progression between Months 24 and 30 compared to projected sham (all p-values nominal):
  • SYFOVRE reduced GA lesion growth with both monthly (39%; p