Business
Apellis Pharmaceuticals Reports Second Quarter 2025 Financial Results
Received U.S. FDA approval for EMPAVELI® (pegcetacoplan) for treatment of patients 12 years and older with C3G and primary IC-MPGNAnnounced capped royalty
About this update from Apellis Pharmaceuticals, Inc.
[{"type":"text","content":"Received U.S. FDA approval for EMPAVELI® (pegcetacoplan) for treatment of patients 12 years and older with C3G and primary IC-MPGNAnnounced capped royalty purchase agreement with Sobi under which Apellis receives up to $300 million for 90% of ex-U.S. royalties of Aspaveli® (pegcetacoplan)Generated $178 million in 2Q 2025 revenues, including $171 million in U.S. net product salesSYFOVRE® (pegcetacoplan injection) injection demand grew 6% quarter-over-quarter, with U.S. net product revenue of $151 millionCash and cash equivalents of $370 million as of June 30, 2025; existing cash, $275 million payment from Sobi, and future product sales expected to be sufficient to fund business to sustainable profitability.Management to host conference call today at 8:30 a.m. ET WALTHAM, Mass., July 31, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), today announced its second quarter 2025 financial results and business highlights. “We are incredibly proud of the recent FDA approval of EMPAVELI in C3G and primary IC-MPGN and are now focused on bringing this transformational therapy to patients. With two C3-targeting medicines approved across four serious diseases, we have further cemented our position as a leader in complement,” said Cedric Francois, M.D., Ph.D., chief executive officer at Apellis. “On top of our regulatory success, we were encouraged to see SYFOVRE’s continued market leadership in GA.” Second Quarter 2025 Business Highlights and Upcoming Milestones Maximizing EMPAVELI’s impact in rare diseases C3 glomerulopathy (C3G) and primary immune complex glomerulonephritis (IC-MPGN): EMPAVELI was approved by the U.S. Food and Drug Administration (FDA) as the first treatment for C3G and primary IC-MPGN for patients 12 and older. The approval was based on the Phase 3 VALIANT study results, which demonstrated an unprecedented 68% reduction in proteinuria, stabilization of kidney function, and substantial clearance of C3 deposits as measured by C3 staining, compared to placebo. EMPAVELI is the first and only U.S. FDA approved treatment for primary IC-MPGN, adolescent patients with C3G, and post-transplant C3G disease recurrenceNew 52-week data from the VALIANT study, presented at the European Renal Association (ERA) Congress in June, demonstrated sustained efficacy, including robust proteinuria reduction and stable kidne...