Apellis Pharmaceuticals, Inc.

Hello, everyone, and welcome to the Q1 2025 Appellate Pharmaceuticals, Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. After the presentation, there will be a question and answer session. To participate, you will need to press star 11 on your telephone. You will then hear a message advising your hand is raised. To withdraw your question, simply press star 11 again. Please be advised that today's conference is being recorded. Now it's my pleasure to turn the call over to the Vice President of Communications, Tracey Veniz. The floor is yours.

Good morning, and thank you for joining us to discuss Appellus' first quarter 2025 financial results. With me on the call, our co-founder and chief executive officer, Dr. Cedric Francois. Chief Financial Officer Tim Sullivan, Executive Vice President of Commercial David Acheson, and Chief Medical Officer Dr. Caroline Baumol is on the line for Q&A. 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.

Thank you, Tracy, and thank you all for joining us this morning. As many of you know, Apelids is a commercial stage biopharmaceutical company with two approved C3 targeting therapies, Cyfovri and Empaveli, and a growing pipeline of novel therapeutic compounds. Our focus is on addressing diseases with significant unmet need through targeted inhibition of the complement system. The first quarter of 2025 presented a combination of challenges and progress. Despite growth in injection demand, we faced a unique set of market dynamics that impacted Cyphovri revenue performance. Meanwhile, we advanced Empa-Vedi closer to its second approval with the FDA granting priority review designation for C3G and ICMP-GN and a PDUFA date that is now less than three months away. Let's begin with Cyphovri. While first quarter syphovry injection demands grew 4% quarter over quarter, revenue came in below expectations. We believe that this shortfall was primarily driven by two factors. As mentioned already in our Q4 earnings call, there were funding shortages at third party co-pay assistance programs. There was also a larger than expected drawdown of total channel inventory during the first quarter, including in physician offices. Tim and David will share more details on these dynamics shortly. Competitively, we continue to strengthen our market leadership within geographic atrophy. Cyphovry maintains more than 60% of the overall market and new patient starts continue to grow, exceeding 50% during the first quarter and already reaching 55% by late April. GA represents a significant unmet need, and GA therapies are only in the early stages of adoption. We expect continued but modest market growth in the near term, and are confident that our efforts in the field will translate into meaningful growth for Cyphovry over time. Shifting now to M-Pavetti, where we are gearing up for a major launch of our second potential blockbuster opportunity. We have made significant strides towards our goal of bringing Empaveli to more patients in the first quarter. Supplemental NDA for C3G and ICMPGN was accepted by the FDA and granted priority review designation with a PDUFA date of July 28. The Phase III Valiant results demonstrated Empaveli's potential for disease modification across all patient subgroups, achieving the trifecta of glomerular disease endpoints. First, an unprecedented 68% reduction in proteinuria. Second, stabilization of kidney function as measured by EGFR. And finally, substantial clearing of C3C staining. We look forward to presenting the VALIANT 52-week data at the European Renal Association Congress in early June. U.S. approval and launch of Empaveli in C3G and ICMP-GEN will represent Apelis' third new product launch in just four years. We are carrying this momentum forward and looking to build on the success of Empaveli in rare nephrology indications. We remain on track to initiate pivotal studies in focal segmental glomerulosclerosis and delays graft function in the second half of this year. I will now turn the call over to Tim to provide a review of the financials from the first quarter.