Apellis Pharmaceuticals, Inc.

Good day and welcome to the second quarter 2025 Appellus Pharmaceuticals, Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker, Tracy Bennis, Vice President of Communications. Please go ahead.

Good morning, and thank you for joining us to discuss Appellus' second quarter 2025 financial results. With me on the call are co-founder and Chief Executive Officer, Dr. Cedric Francois, Chief Financial Officer, Tim Sullivan, Chief Medical Officer, Dr. Caroline Baumel, and Executive Vice President of Commercial, David Acheson. 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. As many of you know, Apelis is a pioneering biopharmaceutical company with two approved C3 targeting medicines, Cyfovir and Empatheli, both with blockbuster potential and a pipeline of innovative therapies. We are focused on treating diseases with high unmet needs by targeting C3, the central protein in the complement cascade, and the only target that addresses all three activation pathways that can initiate and drive disease. Earlier this week, the FDA approved a label extension for Empaveli for the treatment of patients 12 years and older with C3 glomerulopathy or primary immune complex membranoproliferative glomerulonephritis. This marks our third FDA approval in just four years, a significant milestone that reflects the strength of our science and our ability to deliver for patients. Importantly, This approval represents a breakthrough for patients as for the first time they can be treated with a C3 targeting therapy and one that achieves the trifecta of outcomes across all three key markers of these diseases, including proteinuria reduction, EGFR stabilization, and substantial clearance of C3 deposits. It also advances care for several underserved populations that previously had no approved treatments. including pediatric patients with T3G, primary ICMP-GEM patients 12 years and older, and patients with post-transplant T3G disease recurrence. The launch is now underway, and we are excited to make this transformative medicine available to patients as we expand into rare nephrology. Moving then to SIFO re-performance. We continued to see steady demand growth in the second quarter. Total injections, including commercial and free goods, grew by 6% quarter over quarter, delivering SIFO-V revenues of $151 million. SIFO-V remains the clear market leader in GA, with 55% of new patient starts during the quarter and total market share exceeding 60%. Commensurate with the headwinds we saw in the first quarter, we do continue to see high levels of free goods usage in connection with the funding shortage at the co-pay assistance programs. The market opportunity in GA is significant. With SIFOBRI's market leadership, strong patent life, meaningful potential for growth, and a low likelihood of new market entrants in the next few years, we have confidence in the long-term potential of SIFOBRI. During the second quarter, we also gained significant operational flexibility through our Astaveli capped royalty purchase agreement with SOVI. This transaction reflects our shared confidence in the meaningful growth potential in rare kidney diseases. With a strong cash position, a substantial growth opportunity for Empaveli, Cyphovri's continued market leadership, and a maturing pipeline, we are well positioned for success going forward. With that, I will now turn over the call to Tim to provide a review of the financials from the second quarter. Tim?