Apellis(APLS) - 2025 Q4 - Annual Results

Financial Performance - Preliminary U.S. net product revenues for full-year 2025 were approximately $689 million, with Q4 revenues of about $155 million[5][13]. - Cash and cash equivalents as of December 31, 2025, were approximately $466 million, expected to fund operations to profitability[10]. Product Demand and Market Penetration - SYFOVRE total injection demand grew 17% year-over-year, maintaining a market share of approximately 60% in geographic atrophy[5][6]. - EMPAVELI achieved more than 5% market penetration in C3G and primary IC-MPGN, with 267 new patient start forms in 2025[3][12]. Regulatory and Clinical Developments - Regulatory submission for a prefilled syringe of SYFOVRE is planned in the first half of 2026[5][6]. - Pivotal trials for EMPAVELI have been initiated in two additional nephrology indications: FSGS and DGF[5][12]. - APL-90993, a potential one-time treatment using base editing technology, is advancing with an IND submission planned in the second half of 2026[8]. - The Phase 2 study of SYFOVRE + APL-3007 is ongoing, with topline data expected in 2027[12]. - Sobi received a positive opinion from the EMA for Aspaveli's indication extension in C3G and primary IC-MPGN[12]. - The New England Journal of Medicine published positive Phase 3 VALIANT results for EMPAVELI in C3G and primary IC-MPGN[12]. Product Innovations - Apellis Pharmaceuticals has developed two C3-targeting medicines approved for treating four serious diseases, marking the first new class of complement medicine in 15 years[38]. - The company has introduced the first-ever therapy for geographic atrophy, a leading cause of blindness, and the first treatment for patients aged 12 and older with C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis[38]. Safety and Monitoring - EMPAVELI treatment requires monitoring for signs of hemolysis after discontinuation, with a recommended observation period of at least 8 weeks[33]. - Common adverse reactions for adult patients with PNH include injection site reactions, infections, and fatigue, with an incidence of ≥10%[35]. - For patients aged 12 and older with C3G or primary IC-MPGN, common adverse reactions include injection-site reactions and pyrexia, also with an incidence of ≥10%[36]. - The company emphasizes the importance of pregnancy testing for females of reproductive potential before starting EMPAVELI, advising effective contraception during treatment and for 40 days post-treatment[37]. Forward-Looking Statements and Company Focus - Apellis warns that actual results may differ from forward-looking statements due to various factors, including adjustments to revenue figures and regulatory approvals[39]. - The company is focused on unlocking the potential of targeting C3 across various serious diseases, indicating a commitment to ongoing research and development[38]. - Apellis has established media and investor contact channels for further inquiries, enhancing transparency and communication with stakeholders[40].