Apellis Pharmaceuticals, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the second quarter 2022 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you need to press star 1-1 on your telephone. I would now like to turn the call over to your host, Meredith Kai. You may begin.

Good afternoon, and thank you for joining us to discuss Appellus' second quarter 2022 financial results. With me on the call are co-founder and chief executive officer, Dr. Cedric Francois, chief commercial officer, Adam Townsend, chief medical officer, Dr. Federico Grossi, and chief financial officer, Tim Sullivan. Before we begin, I would like to point out on slide three 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 our 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 all for joining us today. 2022 is a transformational year at ATHELIS, and we are making great progress across each of our key priorities. I'll start with geographic atrophy, or GA. A few weeks ago, we were thrilled to announce that our NDA for Intravitreal Tax Data Co-Plan was accepted by the FDA with a priority review designation and the PDUFA date of November 26, 2022. The FDA also stated that it is not planning to hold an advisory committee meeting to discuss the application. This is the best outcome we could have hoped for, and I am so proud of the Afghani's team for their efforts in getting us to this pivotal point. The NDA includes all available data from our Jerby and Oakes studies out to 18 months. and in the case of some patients, even longer, as well as the 12-month data from our Philly study. Collectively, these data reinforce the potential for Vexita Copeland to meaningfully slow disease progression and become the first-ever treatment for the millions of patients living with GA, a relentless disease that is a leading cause of blindness worldwide. We continue to work with the agency in our efforts to bring this therapy to patients who currently have no approved treatments. In parallel, we are also ramping up our commercial preparations so that we are well-positioned to bring intravitreal pexetacroplan to patients immediately upon potential approval. In Europe, we are on track to submit our application to the EMEA by the end of this year. We will include the 24-month data from Derby and Oaks in our submission, which we plan to report in September. J.D. will speak to this a bit more in a few minutes. Turning to PNH, we remain focused on further establishing Empavedi as a first-line treatment for patients living with PNH. We are seeing continued strength across a number of key indicators, translating to $15.7 million in U.S. net revenues for the second quarter. Globally, our partner Sobe is also making progress in bringing Empaveli to patients with PNH outside of the U.S. Beyond PNH, we continue to advance Empaveli as a transformative therapy for rare, complement-driven diseases. Together with Sobe, we now have four later-stage clinical programs underway. We are also continuing to progress our early stage pipeline with IND's plan for APL2006 and our siRNA program in the first half of next year. We have made great progress in our partnership with BEAM and with our efforts to advance complement inhibition as a novel approach to enhancing adeno-associated viruses or AAZ-based gene therapy products. We are also continuing to advance our preclinical work with APL 1030 for potential use in neurodegenerative diseases, but no longer expect to submit the IND by the end of 2022. On the finance side, we ended the second quarter with approximately $850 million in cash, providing runway into the first quarter of 2024. This puts us in a uniquely strong position in this challenging market environment as we head into a potential launch later this year. We look forward to building on our momentum as we further cement our position as a leader in complements across multiple therapeutic areas. And with that, I will turn it over to Adam.