Apellis(APLS)2025-01-13 14:08SYFOVRE Performance and Market Position - SYFOVRE achieved 167 million in Q4 2024[5][19] - Over 510,000 SYFOVRE injections administered through December 2024, including clinical trials[3][6] - Distributed approximately 94,000 SYFOVRE doses (commercial and sample vials) to physician practices in Q4 2024[6] - SYFOVRE demonstrated more than 120% year-over-year net sales growth, solidifying its position as the market-leading treatment for GA[3] EMPAVELI Revenue and Development - EMPAVELI generated 23 million in Q4 2024[5][19] - Apellis plans to submit EMPAVELI sNDA for C3G and primary IC-MPGN in early 2025, with a U.S. launch anticipated in 2H 2025 if approved[5][15] - EMPAVELI may cause embryo-fetal harm, requiring pregnancy testing and effective contraception for females of reproductive potential[34] Financial Position and Strategic Focus - Apellis ended 2024 with approximately 351.2 million in 2023[18] - Apellis plans to reduce ex-U.S. footprint by approximately 40 employees as part of prioritizing U.S. commercial efforts[6] - The company's cash resources are expected to fund operations for a certain period, subject to adjustments and financial closing procedures[37] Clinical Trials and Future Plans - Phase 3 studies of pegcetacoplan in two additional nephrology indications planned for initiation in 2H 2025[5][15] - Phase 1b/2 multi-dose study of APL-3007 (siRNA) + SYFOVRE expected to initiate in Q2 2025[6] - The company plans to initiate Phase 3 studies of pegcetacoplan in FSGS and DGF[37] - Apellis expects to achieve profitability, with timing dependent on various factors including clinical trial results and regulatory approvals[37] Product Portfolio and Innovation - Apellis Pharmaceuticals has two approved medicines targeting C3, including the first-ever therapy for geographic atrophy[36]