Apellis Pharmaceuticals NASDAQ: APLS used its fourth-quarter and full-year 2025 earnings call to highlight what management described as a year of “disciplined execution and foundation building,” led by continued demand for its geographic atrophy (GA) therapy Syfovre and an early launch ramp for Empaveli in rare complement-mediated kidney diseases.
2025 revenue and product performance
Chief Financial Officer Timothy Sullivan said total revenue was $200 million for the fourth quarter and $1.0 billion for the full year 2025. He noted that full-year revenue included a one-time $275 million upfront payment tied to the Sobi royalty repurchase agreement.
Syfovre net product revenue was $155 million in the fourth quarter and $587 million for the full year. Sullivan said Apellis delivered approximately 102,000 Syfovre doses to physician offices in the quarter, including about 89,000 commercial doses and 13,000 free goods doses. Management reiterated that reported revenue in 2025 was “meaningfully impacted” by elevated free goods utilization.
Empaveli generated $35 million in U.S. net product revenue in the fourth quarter and $102 million for the full year 2025. The company emphasized that the July FDA approval for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) has positioned Empaveli as what management called its “near-term growth engine.”
Syfovre: demand trends, access dynamics, and 5-year GALE data
Executive Vice President of Commercial David Acheson said Syfovre’s full-year revenue was “modestly down” versus 2024, largely due to free goods, but that underlying demand remained strong, with total injections up approximately 17% year-over-year. He also said Syfovre continues to lead the GA market and that payer coverage remains strong, including preferred status across a broad range of plans.
Management discussed recent changes in co-pay assistance availability. CEO Cedric Francois said third-party co-pay assistance programs began reopening to new patients and that the company was encouraged by the potential for improved access, though it did not have visibility into how quickly activity might ramp. In Q&A, Sullivan said the reopening is “an important advance” for patients who have been unable to pay, but Apellis could not yet quantify the impact on free goods trends.
On gross-to-net, Sullivan said Syfovre adjustments in the fourth quarter trended just above the mid-20% range, while the company expects gross-to-net in the “high 20%” range in 2026, reflecting what he called the typical evolution of the buy-and-bill market. He added that the company expects net price to remain relatively stable through 2026 under its current pricing strategy.
Chief Medical Officer Dr. Caroline Baumal highlighted new five-year data from a post-hoc analysis of the GALE extension study. She said Syfovre delayed GA progression by approximately 1.5 years in patients with non-subfoveal GA compared with sham or projected sham, and the company planned to present the full five-year dataset at The Macula Society. Both Francois and Baumal emphasized that the long-term dataset showed increasing effects over time and could support earlier treatment decisions.
Syfovre initiatives: prefilled syringe and “Functional OCT”
Apellis outlined two near-term development initiatives aimed at improving practice workflow and demonstrating patient benefit more tangibly.
- Prefilled syringe (PFS): Baumal said the clinical study for the prefilled syringe is complete and Apellis is working toward a regulatory submission in the first half of 2026. She described it as a “practice-enabling innovation” designed to improve convenience and efficiency in retina clinics, noting that retina physicians provided input on the packaging and refrigerator fit.
- Functional OCT (OCTF): Management described OCTF as an AI-enabled tool intended to visualize functional benefit in GA by translating OCT images into a functional mapping of retinal sensitivity. Baumal said Apellis plans to make the tool available for research use in retina practices in the second half of 2026.
In Q&A, Francois said the prefilled syringe could support share gains by better fitting retina practice workflows and lowering friction for physicians to try the product. He also described OCTF as a way to reframe GA as a “pan-retinal neurodegenerative condition” and to help physicians and families better understand disease impact and treatment benefit over time.
Empaveli launch: penetration, start forms, and 2026 priorities
Apellis said the Empaveli launch in C3G and primary IC-MPGN is tracking in line with internal expectations. Francois stated that after its first full quarter on the market, Empaveli achieved more than 5% market penetration, which management characterized as outpacing other rare nephrology launches. Acheson added that, as of year-end 2025, the company had received 267 cumulative patient start forms.
Management attributed early demand to physician engagement, payer access, and published clinical evidence, including data in The New England Journal of Medicine. Acheson said 95% of published payer policies reimburse to label or with minimal restrictions, and he highlighted physician feedback on Empaveli’s efficacy as well as the convenience of the on-body injector and twice-weekly dosing.
Looking to 2026, Acheson outlined three launch priorities:
- Strengthening patient identification and diagnosis through targeted medical education and earlier-treatment urgency
- Expanding engagement beyond initial focus on top 20 accounts (which he said represent more than 30% of the market and accounted for about one-third of start forms)
- Deepening adoption across patient segments, including pediatric, post-transplant, and adult populations
On the pace of adoption, Francois said Apellis expects a steady ramp typical of rare disease launches, and Acheson noted that quarter-to-quarter variability can occur given the ultra-rare nature of the diseases. When asked about future disclosure, Acheson said the company expects to continue reporting revenues and start forms but does not plan to provide additional start-form guidance beyond what it had discussed from the third to fourth quarter.
Pipeline updates and financial position
Apellis said it has initiated pivotal trials with Empaveli in focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF), which management described as high unmet need kidney indications with no FDA-approved therapies. Francois said it was too early to provide projections on enrollment.
The company also discussed two earlier-stage programs:
- Syfovre + APL-3007: A Phase 2 combination study is ongoing, with top-line data expected in 2027. Francois said the approach aims to enable longer dosing intervals and potentially increase efficacy, though he did not quantify a specific target.
- APL-9099 (FcRn): Baumal said the company expects to submit an IND in the second half of 2026 for a “first-in-class base editing approach” designed to reduce IgG levels while preserving albumin.
On expenses and liquidity, Sullivan said operating expenses were $251 million in the fourth quarter, compared with $239 million a year earlier, and full-year 2025 operating expenses were consistent with 2024. Apellis ended 2025 with $466 million in cash and cash equivalents, which management said provides flexibility to fund the business to profitability.
Sullivan also noted that Sobi received European Commission approval for Aspaveli in C3G and primary IC-MPGN, triggering a $25 million milestone payment to Apellis during the first quarter of 2026. Separately, he said the company had approximately $94 million of convertible debt outstanding that matures in September and that Apellis is evaluating alternatives to address the obligation.
About Apellis Pharmaceuticals NASDAQ: APLS
Apellis Pharmaceuticals, Inc, traded as NASDAQ:APLS, is a clinical-stage biopharmaceutical company focused on the development of novel therapies targeting the complement cascade for the treatment of rare and debilitating diseases. The company's research and development efforts center on modulating complement proteins to address a range of ophthalmologic, hematologic and renal conditions. Apellis leverages its proprietary compstatin technology platform to design targeted inhibitors intended to improve patient outcomes and quality of life.
The company's lead marketed product, Syfovre (pegcetacoplan), is an intravitreal complement C3 inhibitor approved for geographic atrophy secondary to age-related macular degeneration, with ongoing investigations in other retinal disorders.
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