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Management characterizes 2025 as a foundational year of disciplined execution, focusing on the central role of C3 inhibition to address complement-driven diseases across ophthalmology and nephrology.
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SYFOVRE performance in geographic atrophy (GA) is described as resilient, with 17% year-over-year growth in total injections despite revenue being impacted by elevated free goods utilization.
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The EMPAVELI launch in C3G and primary IC-MPGN is cited as a primary near-term growth engine, achieving over 5% market penetration in its first full quarter, which management claims outpaces other rare nephrology launches.
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Strategic positioning for SYFOVRE is shifting toward ‘renewed growth’ in 2027, supported by the introduction of a prefilled syringe and AI-enabled functional imaging (OCT-F) to improve practice workflow and patient visualization of benefits.
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The company emphasizes a transition toward self-funding its pipeline, supported by a growing commercial revenue base and a disciplined approach to operating expenses.
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Management attributes the strong EMPAVELI uptake to its status as the only approved therapy for approximately 2/3 of the targeted patient population, including pediatric and post-transplant segments.
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2026 guidance for SYFOVRE assumes stable net pricing and gross-to-net adjustments in the high 20% range, with revenue growth expected to be modest and subject to typical Q1 seasonal dynamics.
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Management expects EMPAVELI to reach ‘blockbuster status’ over time, targeting up to 50% penetration of the estimated 5,000 U.S. patient population in C3G and IC-MPGN.
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The regulatory submission for the SYFOVRE prefilled syringe is planned for the first half of 2026, with the OCT-F tool expected to be available for research use in the second half of the year.
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Operating expenses are projected to be modestly higher in 2026 due to pivotal trial investments in FSGS and DGF, though partially offset by SG&A efficiencies.
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The company is actively evaluating alternatives to address $94 million in convertible debt maturing in September 2026 to maintain a prudent capital structure.
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Free goods utilization for SYFOVRE reached 12% to 14% in 2025; while third-party co-pay programs are reopening, management lacks visibility into the speed of the transition back to commercial units.
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A one-time $275 million upfront payment from the Sobi royalty repurchase significantly bolstered 2025 total revenue but does not reflect recurring product sales.
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Q1 2026 revenue is expected to face headwinds from typical seasonal Medicare reverifications and a modest reduction in channel inventory following 2025 year-end management.
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The APL-9099 FcRn program represents a strategic pivot toward base editing, with an IND submission targeted for the second half of 2026 to address limitations of existing therapies.
