Core Insights - Apellis Pharmaceuticals reported Q3 2025 earnings of $1.67 per share, exceeding the Zacks Consensus Estimate of $1.03 per share, compared to a loss of 46 cents in the same quarter last year [1][7] - Total revenues for the quarter reached $458.6 million, surpassing the Zacks Consensus Estimate of $366 million and more than doubling from $196.8 million in the prior year, largely due to a $275 million upfront payment from Sobi related to a royalty purchase agreement [2][7] Financial Performance - The revenue growth was primarily driven by the one-time payment from Sobi, raising concerns about the sustainability of core performance, as Syfovre sales declined year-over-year [3][6] - Syfovre sales were reported at $150.9 million, down 1% year-over-year, missing both the Zacks Consensus Estimate of $156.6 million and the internal estimate of $160.4 million [5][7] - Empaveli generated sales of $26.8 million, reflecting a 9% increase from the previous year, and exceeded the Zacks Consensus Estimate of $22.1 million [8] Expenses and Cash Position - Research and development expenses decreased by 23% year-over-year to $68.2 million, attributed to lower external costs and personnel expenses [9] - Selling, general, and administrative expenses rose 17% year-over-year to $142.7 million due to increased commercial activities and personnel costs [9] - As of September 30, 2025, Apellis had cash and marketable securities totaling $479.2 million, up from $370 million as of June 30, 2025, indicating sufficient liquidity to fund operations towards profitability [10] Product Pipeline and Market Position - Syfovre is the market leader in geographic atrophy with over 60% market share, and new patient starts increased by over 52% in Q3 [6] - Empaveli is approved for treating paroxysmal nocturnal hemoglobinuria in the U.S. and Europe, with ongoing regulatory filings for expanded indications [11][12] - Apellis plans to initiate two pivotal phase III studies for Empaveli in rare kidney diseases by the end of 2025 [14] Strategic Developments - A capped royalty purchase agreement with Sobi allows Apellis to receive up to $300 million, with $275 million paid upfront for 90% of ex-U.S. Aspaveli royalties [16]

Core Insights - Apellis Pharmaceuticals (APLS) shares increased by 3.2% following a capped royalty agreement with Sobi, allowing Apellis to receive up to $300 million for 90% of its future ex-U.S. royalties from Aspaveli [1][5] - The deal significantly enhances Apellis' financial position, providing operational flexibility with cash and marketable securities totaling $358.4 million as of the end of Q1 2025 [2] - The agreement includes a $275 million upfront payment and potential milestone payments of up to $25 million upon EU approval for Aspaveli in two severe kidney diseases [3][5] Financial Impact - The capped royalty deal will allow Sobi to receive 90% of ex-U.S. royalties until performance-based caps are met, after which all royalties will revert to Apellis [4] - Year-to-date, APLS shares have decreased by 44%, contrasting with a 3.4% decline in the industry [4] Regulatory Developments - Apellis and Sobi are seeking label expansion for Empaveli, with FDA and EU reviews currently underway for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis [7] - A decision from the FDA is anticipated on July 28, 2025, while the EU decision is expected by year-end [7] Clinical Study Results - The phase III VALIANT study demonstrated a statistically significant 68% reduction in proteinuria for patients treated with Empaveli compared to placebo, indicating its effectiveness in C3G and IC-MPGN [9] - The study also showed that patients experienced stabilized kidney function, with 71% achieving complete clearance of C3c staining intensity [10][12]