Is Apellis Pharmaceuticals' FDA Win Just the Beginning?

"EMPAVELI is the first and only approved treatment for C3G and IC-MPGN across pediatric patients 12+, adults, and post-transplant recurrence. That's roughly 5,000 patients in the U.S., with EMPAVELI holding exclusive approval for about two-thirds. Add the European CHMP positive opinion in December 2025, and you have a rare disease franchise with global expansion potential and pricing power that typically commands gross margins north of 90%."

"Management guided for 225 cumulative patient start forms by year-end 2025. They hit 152 by September's close. The math: that's 76 forms per month in July-August, implying just 24 per month in Q4 if they hit guidance. CEO Cedric Francois framed this as working through "the onetime wave of early adopters," expecting "steady, consistent growth going into next year." The bolus is over, and the ramp will be gradual."

"The bear case centers on SYFOVRE, which accounts for the bulk of revenue. Q3 2025 brought $151 million in sales, flat versus Q2's $161 million. Injection growth was just 4%, "driven predominantly by free goods" that cost the company $15 million in the quarter. New patient share ticked down to 52%, and management openly acknowledged retina specialists are taking a "wait-and-see approach" despite SYFOVRE's 60% market share."

Apellis stock declined about 31% over the past year despite FDA approval for EMPAVELI in C3G and IC-MPGN. EMPAVELI is the first and only approved treatment for those indications across 12+ pediatric, adult, and post-transplant recurrence populations, representing roughly 5,000 U.S. patients with exclusive approval for about two-thirds and potential European expansion. Management guided 225 cumulative patient start forms by year-end 2025 but reached 152 by September. SYFOVRE remains the main revenue driver with Q3 sales of $151 million; injection growth was 4%, partly due to $15 million in free goods, and new patient share slipped to 52%.

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