2/24/2026

speaker
Operator
Conference Operator

Good morning, ladies and gentlemen. Thank you for standing by and welcome to the Appellus Pharmaceuticals fourth quarter and full year 2025 earnings conference call. Please be advised that today's call is being recorded. I will now turn the call over to Eva Stronowski, head of investor relations. Please go ahead.

speaker
Eva Stronowski
Head of Investor Relations

Good morning, and thank you for joining us to discuss Appellus' fourth quarter and full year 2025 financial results. With me on the call are co-founder and chief executive officer Dr. Cedric Francois, executive vice president of commercial David Atchison, chief medical officer Dr. Caroline Baumel, and chief financial officer Tim Sullivan. Before we begin, let me point out that we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. Now, I'll turn the call over to Cedric.

speaker
Dr. Cedric Francois
Co-Founder & Chief Executive Officer

Thank you, Eva, and thank you all for joining us this morning. Before turning to our fourth quarter results, I'd like to briefly reflect on the progress APELIS made over the course of 2025. It was a year of disciplined execution and foundation building for our company. We strengthened our commercial franchises, advanced key programs across our pipeline, and continued to demonstrate the value of our differentiated C3 approach, all while maintaining a strong balance sheet and a clear focus on long-term value creation. These foundations position us well as we move ahead with clear priorities centered on execution growth, and unlocking the next set of value-creating inflection points for Apelis. At our core, Apelis is a company focused on complement biology, specifically targeting C3, the central hub of the complement cascade. By intervening at this central point where all complement pathways converge, we take a fundamentally different approach that enables comprehensive disease control at the root cause while preserving essential immune function. This strategy continues to differentiate us scientifically and commercially and positions us to address a broad range of serious, complement-driven diseases. Our 2026 focus remains anchored in our three strategic pillars. strengthening Cyphovry's leadership in geographic atrophy. Second, driving growth with Empaveli across rare kidney diseases. And third, advancing an innovative pipeline that underpins our next wave of growth. Starting with Cyphovry, Cyphovry continues to be a resilient and durable business. In 2025, we delivered steady growth in total injections, and we expect SIFO-V to remain a stable and meaningful revenue stream through 2026. Last month, co-pay assistance programs at third-party organizations began reopening to new patients. While we do not have visibility into how activity may ramp over time, we are encouraged that patients may be able to gain access to treatment. Looking ahead, We are advancing key initiatives to lay the foundation for accelerated growth in 2027, including a best-in-class pre-filled syringe and OCTF, our AI-enabled approach to visualize the functional benefits Cyphorb can provide for patients. Together, these initiatives are designed to make treatment more tangible, improve workflow, and support broader adoption over time. Turning now to our second pillar, Empaveli. Empaveli is our near-term growth engine, and its launch trajectory reinforces our confidence in its long-term value. Following FDA approval in July for patients with C3G and primary ICMPGN, the launch has progressed fully in line with our internal expectations, reflecting strong execution and early market receptivity. After its first full quarter on the market, Empaveli achieved more than 5% market penetration, significantly outpacing other rare nephrology launches. We continue to receive outstanding feedback from the community, with growing appreciation of Empaveli's value proposition following the publication of our data in the New England Journal of Medicine. We believe Empaveli's strong efficacy and safety profile will continue to drive adoption and that over time it has the potential to be used by up to 50% of the estimated 5,000 U.S. patient population. Lastly, our third pillar, which is our innovative pipeline. In nephrology, we are building on the momentum of Empaveli and expanding the franchise into new indications. with pivotal trials now underway in focal segmental glomerulosclerosis and delayed graft function. In geographic atrophy, we are further bolstering Sifovri's leadership through our next generation strategy, combining Sifovri with APL3007, designed to enhance efficacy, patient experience, and further differentiate our offerings. We are also excited to advance APL 9099, our category-defining FCRN program. This first-in-class base editing approach has the potential to disrupt a multi-billion dollar market and enable a one-and-done treatment paradigm across multiple indications. These programs reflect the breadth, strategic depth, and long-term ambition of our pipeline. With a strong balance sheet and a growing commercial revenue base, we are well positioned to self-fund our pipeline and drive long-term value through disciplined financial execution. And with that, I will now turn the call over to David for an update on our commercial performance.

Disclaimer

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