Apellis sees Q3 U.S. net product revenue for SYFOVRE of $74M

Apellis Pharmaceuticals provided an update on the launch of SYFOVRE for geographic atrophy (GA) secondary to age-related macular degeneration. “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. 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 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: SYFOVRE reduced GA lesion growth with both monthly and every-other-month treatment. SYFOVRE reduced nonsubfoveal GA lesion growth with monthly and EOS treatment. New functional data from post-hoc microperimetry analysis demonstrating that SYFOVRE prolonged foveal sensitivity in the Phase 3 OAKS study will be presented as a late-breaking presentation at the EURETINA Congress on Friday, October 6 at 12:24 CEST. Long-term and real-world safety: In the GALE study at 30 Months, the safety profile of SYFOVRE continued to be consistent with previously reported Phase 3 data. The estimated real-world rate of retinal vasculitis remains rare, at 0.01% per injection. In total, there have been 10 confirmed events of retinal vasculitis and two suspected events. Since the last update on August 22, there was one new confirmed event that occurred in early August and two new suspected events, one that occurred in mid-August and one in September. Of the two events that were previously classified as suspected, one event has been confirmed and the other was adjudicated to not be retinal vasculitis. Of the confirmed retinal vasculitis events, six patients have recovered vision either fully or partially, three patients have severe vision impairment that is unlikely to be resolved, and one patient’s outcome is pending. Visual outcomes in both suspected events are pending. All suspected retinal vasculitis events reported to Apellis are independently evaluated and adjudicated by two external sources: a panel of four retina/uveitis experts and an independent reading center as well as Apellis’ internal safety and medical teams. Apellis submits all reported adverse events to the U.S. FDA consistent with reporting guidelines for drug manufacturers. Apellis and the American Society of Retina Specialists are in close communication regarding reported cases of retinal vasculitis.