Apellis Pharmaceuticals, Inc. Q2 FY2025 earnings call

• Product Updates: FDA approved label expansion for EMPAVELI for patients 12 years and older with C3 myelopathy or primary IC-MPGN. SYFOVRE had steady demand growth. The Aspaveli capped royalty purchase agreement with Sobi provided $275 million upfront and potential milestones.
• Medical Activities: EMPAVELI launch in rare kidney diseases, with expansion into delayed graft function (DGF) and primary focal segmental glomerulosclerosis (FSGS) planned. Initiated Phase II study of SYFOVRE and ATL-3007 combination.
• Commercial Strategies: For EMPAVELI, focus on raising awareness, establishing as treatment of choice, and securing broad access. For SYFOVRE, continued market leadership, educating retina offices, expanding clinical community engagement, and leveraging DTC campaigns.

SYFOVRE: Total injections (commercial + free goods) grew 6% quarter-over-quarter, with revenue at $151 million. It remains the clear market leader in geographic atrophy (GA) with 55% of new patient starts and over 60% total market share, but high free goods usage persists due to co-pay assistance program funding shortages. EMPAVELI: Revenue was $21 million, up 5% quarter-over-quarter. Patient compliance rates were 97%, and launch is underway in C3G and primary immune complex membranoproliferative glomerulonephritis (primary IC-MPGN), with expected meaningful revenue in the fourth quarter of 2025.

• SYFOVRE injection growth expected to be low to mid-single digits quarter-over-quarter for the rest of 2025.
• EMPAVELI expected to generate meaningful revenue in Q4 2025 from C3G and primary IC-MPGN.
• Cash position of $370 million plus $275 million from the royalty deal sufficient to fund the business to sustainable profitability.

• High free goods usage due to co-pay assistance program funding shortages.
• Uncertainties in patient reimbursement and access.
• Competitive dynamics and market penetration challenges.

Q: Jon Miller asked about the discrepancy between Apellis' mid-single-digit growth and a competitor's 20%-plus growth in the GA market.

A: Cedric Francois highlighted Apellis' clear leadership on all metrics, long-term data, and larger database sets compared to the competitor.

Q: Anupam Rama inquired about sampling trends in the quarter.

A: David Acheson stated continued growth due to foundation funding and demand, with similar trends expected for the rest of the year.

Q: Yigal Nochomovitz asked about endpoints for the FSGS trial.

A: Cedric Francois mentioned being influenced by the PARASOL group's work and excitement about the trial, with enrollment planned for the second half of the year.

Q: Colleen Kusy asked about ongoing disruption of third-party co-pay assistance and VALE data for EMPAVELI.

A: Cedric Francois noted support for patient foundations, and Caroline Baumal discussed EMPAVELI's trifecta of outcomes and positive feedback from physicians on VALE data.

Q: Akash Tewari asked about SYFOVRE's trajectory and when it might reach profitability.

A: David Acheson and Tim Sullivan discussed stable growth, long-term market opportunity, and SYFOVRE being a profitable business line.