Patient access crisis
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Is Apellis Pharmaceuticals’ FDA Win Just the Beginning?
Yahoo Finance· 2026-01-17 10:36
Core Insights - Apellis Pharmaceuticals' stock has decreased by 31% over the past year despite receiving FDA approval for EMPAVELI, indicating a disconnect between regulatory success and commercial performance [2][7] Product Approval and Market Potential - EMPAVELI is the first and only approved treatment for C3 glomerulopathy and IC-MPGN, targeting approximately 5,000 patients in the U.S., with exclusive approval for about two-thirds of this population [3] - The positive opinion from the European CHMP in December 2025 enhances the global expansion potential and pricing power, typically associated with gross margins exceeding 90% [3] Patient Start Forms and Growth Expectations - Management has guided for 225 cumulative patient start forms by the end of 2025, having achieved 152 by the end of September, suggesting a slowdown to 24 forms per month in Q4 [4] - CEO Cedric Francois indicated that the company is moving past the initial wave of early adopters and anticipates steady growth moving into the next year [4] Revenue Challenges and Market Dynamics - SYFOVRE, which constitutes the majority of revenue, reported flat sales of $151 million in Q3 2025, with a mere 4% growth in injections, primarily driven by free goods costing the company $15 million [5] - The share of new patients for SYFOVRE has decreased to 52%, with management noting that retina specialists are adopting a cautious approach despite SYFOVRE's 60% market share [5] External Market Issues - The cessation of new co-pay assistance applications by Good Days Foundation has led to practices halting new patient enrollments, a challenge not unique to Apellis but reflective of broader issues in the geographic atrophy market [6]