Apellis Pharmaceuticals (APLS) Q3 2025 earnings summary

Executive summary

• Achieved FDA approval for EMPAVELI in C3G and primary IC-MPGN, expanding the addressable market and marking a significant milestone in rare kidney disease treatment.

• SYFOVRE maintained market leadership in geographic atrophy (GA) with over 60% market share and 52% of new patient starts, despite only 10% of GA patients currently treated.

• EMPAVELI launch in C3G and IC-MPGN saw strong early adoption, with 152 patient start forms received by end of September 2025.

• Entered a royalty purchase agreement with Sobi, resulting in a $275 million upfront payment and up to $25 million in milestones.

• Net income reached $215.7 million in Q3 2025, reversing a net loss of $57.4 million in Q3 2024, primarily due to the Sobi agreement.

Financial highlights

• Total Q3 2025 revenue was $459 million, up from $196.8 million year-over-year, including $275 million from Sobi for EMPAVELI royalties.

• SYFOVRE U.S. net product revenue was $150.9 million, with 101,000 doses delivered (86,000 commercial, 15,000 free goods).

• EMPAVELI U.S. net product revenue was $26.8 million, up from $24.6 million year-over-year.

• Operating expenses decreased to $235.4 million from $244.1 million year-over-year.

• Ended the quarter with $479 million in cash and cash equivalents.

Outlook and guidance

• Cash and cash equivalents of $479 million expected to fund operations to profitability.

• Modest SYFOVRE injection growth expected in Q4, with revenue broadly in line with Q3.

• Two pivotal studies in FSGS and DGF planned to initiate by year-end 2025 to expand EMPAVELI's indications.

• Gross-to-net adjustments for SYFOVRE expected to trend slightly above prior range in Q4.

• Full-year operating expenses projected to remain consistent with 2024 levels.