Apellis Pharmaceuticals Inc (NASDAQ: APLS) reported a second quarter (Q2) EPS loss of $1.02, beating the consensus of -$1.35. Apellis Pharmaceuticals Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced its second quarter 2023 financial results and business highlights.
“We made important progress in the second quarter, highlighted by strong commercial execution of the SYFOVRE launch, continued momentum in PNH, and the advancement of APL-3007 into a Phase 1 study. With more than 68,000 SYFOVRE vials distributed through July, we continue to work with the retina community to bring the first and only approved treatment for GA to patients. Following the rare events of retinal vasculitis with SYFOVRE in the real world, we began conducting a comprehensive investigation into the potential causes of these events and have found no indication of drug product or manufacturing issues. Patient safety is our top priority, and we are continuing our ongoing review with external experts,” said Cedric Francois, M.D., Ph.D., co-founder and chief executive officer of Apellis according to Yahoo Finance.
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.
“We also continue to strengthen our understanding of the long-term safety and efficacy of SYFOVRE. Results from our GALE extension study showed that SYFOVRE continues to demonstrate increasing effects over time, with a reduction in nonsubfoveal GA lesion growth of up to 45% between months 24 and 30. Additionally, the safety profile continued to be consistent with previously reported clinical data. We are committed to making a difference for people living with GA, PNH, and other serious complement-driven diseases, and I’d like to thank our team for their incredible dedication and for always putting patients first.” said Cedric Francois as reported on the Yahoo Finance website.
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.
APLS shares are down more than 10.2% today, hovering at around $28.75 on the last check Monday.
Produced in association with Benzinga
Edited by Eunice Anyango Oyule and Judy J. Rotich
