APLS — Apellis Pharmaceuticals, Inc.

Summary of Apellis Pharmaceuticals Q3 2025 Earnings Call

1. Key Financial Results and Metrics

• Total Revenue: $459 million, boosted by a $275 million upfront payment from Sobi related to a royalty purchase agreement.
• SYFOVRE Revenue: $151 million, with approximately 101,000 doses delivered (86,000 commercial and 15,000 free goods).
• EMPAVELI Revenue: $27 million across indications (PNH, C3G, and primary IC-MPGN).
• Operating Expenses: $235 million, down from $244 million year-over-year.
• Cash Position: $475 million, supported by the Sobi transaction, allowing for the discontinuation of factoring and expected annual cost savings of $5 million.

2. Strategic Updates and Business Highlights

• FDA Approval: EMPAVELI received approval for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis, expanding the addressable market by approximately 5,000 patients.
• Launch Progress: Positive feedback from the nephrology community regarding EMPAVELI, with 152 patient start forms received, including 50 from an expanded access program.
• SYFOVRE Market Leadership: Maintained a leading position with 52% of new patient starts and over 60% of the overall market, despite only 10% of diagnosed geographic atrophy patients currently being treated.
• Pipeline Expansion: Plans to initiate pivotal trials for EMPAVELI in focal segmental glomerulosclerosis and delayed graft function by year-end.

3. Forward Guidance and Outlook

• SYFOVRE Growth: Expected modest total injection growth in the low to mid-single-digit range for Q4, with potential for renewed growth driven by new initiatives and tools over the next 12-18 months.
• EMPAVELI Adoption: Anticipated steady growth as awareness increases and patient access expands, with a target of 225 cumulative start forms by year-end.

4. Bad News, Challenges, or Points of Concern

• Headwinds from Free Goods: Elevated use of free goods has negatively impacted revenue, with an estimated $40 million headwind for SYFOVRE revenue over the first three quarters of the year.
• Market Dynamics: The adoption of SYFOVRE has been slow, attributed to a wait-and-see approach by retina specialists and challenges in patient access due to co-pay issues.
• Competitive Pressures: Concerns regarding the competitive landscape, particularly with the recent downward revision of IZERVAY sales guidance, indicating potential challenges in the geographic atrophy market.

5. Notable Q&A Insights

• Launch Dynamics: There is cautious optimism regarding the EMPAVELI launch, with expectations for steady growth post-initial patient bolus.
• Sampling and Access: Discussions highlighted the importance of patient access programs and the challenges faced by practices in navigating co-pay assistance and prior authorization processes.
• Market Penetration: Insights into prescriber habits revealed that physicians are more motivated to diagnose and treat C3G and IC-MPGN due to the availability of EMPAVELI, which may lead to increased biopsies.
• Prefilled Syringe Development: The prefilled syringe for SYFOVRE is in development and expected to enhance convenience for physicians, potentially driving market growth once launched.

Overall, Apellis Pharmaceuticals is making significant strides with its product offerings and market positioning, though it faces challenges related to patient access and competitive pressures in the therapeutic landscape.