Apellis Pharmaceuticals Reports Third Quarter 2024 Financial Results

Financial Performance - Generated $196.8 million in total revenue for Q3 2024, including$152.0 million from SYFOVRE U.S. net product sales and $24.6 million from EMPAVELI U.S. net product sales [1][8] - SYFOVRE U.S. net product revenue grew to$152.0 million in Q3 2024, up from $75.3 million in Q3 2023 [8] - Total revenue increased by 78$110.4 million in Q3 2023 to $196.8 million in Q3 2024 [8] - Net loss decreased to$57.4 million in Q3 2024, compared to a net loss of $140.2 million in Q3 2023 [12] SYFOVRE Performance and Market Position - SYFOVRE demand grew by 7$152.0 million in Q3 2024 [1][3] - More than 88,500 SYFOVRE doses were delivered to physician practices in Q3 2024, including approximately 84,500 commercial vials and 4,000 samples [3] - SYFOVRE remains the market leader in geographic atrophy (GA), with over 420,000 injections administered through September 2024, including clinical trials [3] - A large Medicare Advantage plan will make SYFOVRE the only preferred product on its formulary starting January 1, 2025 [3] R&D and Regulatory Updates - On track to file a supplemental new drug application (sNDA) for pegcetacoplan in C3G and IC-MPGN in early 2025, based on positive 6-month Phase 3 VALIANT results [1][5] - Detailed results from the Phase 3 VALIANT study were presented at Kidney Week 2024, highlighting strong treatment effects in patients with C3G and primary IC-MPGN [5] - Sobi plans to submit a marketing application with the European Medicines Agency in early 2025 and with Japanese Health Authorities in 2025 [6] Cash Position and Financial Outlook - Cash and cash equivalents stood at $396.9 million as of September 30, 2024, up from$351.2 million as of December 31, 2023 [1][13] - The company anticipates that its cash, combined with expected product revenues, will be sufficient to fund operations to positive cash flow [1][13] EMPAVELI Performance - EMPAVELI generated $24.6 million in U.S. net product revenue in Q3 2024, with a high patient compliance rate of 97% [4] - EMPAVELI is approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in the U.S., European Union, and other countries globally [16] Pipeline and Future Milestones - Enrollment completed in the Phase 2 study evaluating systemic pegcetacoplan in patients with HSCT-TMA, with topline data expected in mid-2025 [6] - Topline data from the Phase 1 dose escalation study of APL-3007 (small interfering RNA silencing C3) is expected in Q1 2025 [6]