Apellis(US:APLS) Globenewswireยท2025-10-30 11:05Core Insights - Apellis Pharmaceuticals reported strong third quarter 2025 results, highlighting significant progress in its commercial and development portfolio, including a new regulatory approval for EMPAVELI, a first-in-class C3 therapy for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) [2][5][12] Financial Performance - Total revenue for Q3 2025 was $458.6 million, a substantial increase from $196.8 million in Q3 2024, driven by product sales and a $275 million upfront payment from Sobi [8][12] - U.S. net product revenue for SYFOVRE was $150.9 million, while EMPAVELI generated $26.8 million in net product revenue [5][8] - Cash and cash equivalents stood at $479 million as of September 30, 2025, indicating a strong financial position to support future growth [14] Product Developments - EMPAVELI received FDA approval on July 28, 2025, as the first treatment for C3G and primary IC-MPGN, showing a 68% reduction in proteinuria in clinical trials [6][12] - The launch of EMPAVELI has seen 152 new patient start forms in the first two months, indicating strong early adoption [5][6] - SYFOVRE continues to lead the geographic atrophy market with a market share exceeding 60% and a 4% increase in total injection demand quarter-over-quarter [12][16] Research and Development - R&D expenses decreased to $68.2 million in Q3 2025 from $88.6 million in Q3 2024, reflecting cost management efforts [10] - The company plans to initiate pivotal studies for focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF) by the end of 2025 [6][12] Strategic Collaborations - Apellis and Sobi have a collaboration agreement for the global co-development of pegcetacoplan, with Sobi holding exclusive ex-U.S. commercialization rights [18][12] - The recent royalty purchase agreement with Sobi allows Apellis to receive up to $300 million in exchange for 90% of future ex-U.S. royalties for Aspaveli [12][8]