Apellis Pharmaceuticals, Inc.

Good afternoon. My name is Sarah, and I will be your conference operator today. At this time, I would like to welcome everyone to the Appellate Pharmaceuticals first quarter 2021 financial results conference call. Today's call is being recorded, and a replay will be available at appellates.com. I would now like to turn the call over to Tracy Benise, Vice President of Communications at Appellate.

Good afternoon, and thank you for joining us to discuss Appellus' first quarter 2021 financial results. With me on the call are co-founder and chief executive officer, Dr. Cedric Francois, chief medical officer, Dr. Federico Grossi, chief commercial officer, Adam Townsend, and chief financial officer, Timothy Sullivan. Before we begin, I would like to 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 our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. Now, I'm pleased to turn the call over to Cedric.

Thank you, Tracy, and good afternoon to everyone joining us today for our conference call. It is an exciting time at APELIS with the potential U.S. approval of texetacoplan and paroxysmal nocturnal hemoglobinuria, or PNH, just a couple of weeks away. We are fully prepared for our PDUFA date of May 14th and ready to launch Bexita Co-Plan shortly after approval. Our Chief Commercial Officer, Adam Townsend, will provide the latest updates on our efforts to ensure a successful launch in P&H. As this slide shows, we are focused on advancing our global leadership in continent, and our potential approval in P&H is just the start to what will be a transformational year for Apedis. With PNH as our lead indication, we aim to establish systemic texetacotin, our targeted C3 therapy, as a disruptive treatment across rare complement-driven diseases. We plan to become number one in the retina with the first treatment for geographic atrophy, and we continue to advance innovative technologies to control complement with a focus on complement factor C3. Last month, we were thrilled to see results from our programs in PNH and Geographic Atrophy, or GA, published in three leading medical journals. In PNH, results from our Phase III Pegasus study were published in the prestigious New England Journal of Medicine. The recognition by NEJM underscores the importance of the Pegasus data to the PNH community and the high caliber of science that we are advancing at Abelis. Additionally, Two separate analyses of our Philly study in GA were published in the American Journal of Ophthalmology and Ophthalmology. Our chief medical officer, Dr. Federico Grossi, will provide additional details later, but together, these publications showcase the broad platform potential of our targeted C3 therapy for complement-driven diseases. The GA publications also reinforce our confidence in our upcoming phase three readouts, which we continue to expect in the third quarter of this year. Top line results from our Derby and Oaks studies will be an important event for Abilis and for the more than 5 million people worldwide living with this relentless and disabling disease. Geographic atrophy is a leading cause of blindness and the most significant remaining unmet need in the retina. We believe that targeting C3 has the potential to control the excessive complement activation responsible for the growth of GA lesions, and all of us at Apedis are committed to advancing the first potential treatment for people living with GA. Finally, our world-class researchers continue to develop new technologies to control complement. On June 30th, we will host an R&D day, that will include the new product candidates that we plan to advance into clinical development by the end of next year. These programs are focused on three key areas. Less frequent dosing while maintaining the strong clinical benefit seen in multiple studies of Pexetacoplan. Secondly, treating all forms of AMD. And thirdly, exploring new indications in neurology. We look forward to sharing more details as we get closer to the event. As I mentioned earlier, 2021 is a transformational year for Aperis. We have spent the past decade building the foundation for our leadership in complement, and we look forward to seeing the results of those efforts come together over the next several months. And now I'd like to turn the call over to our Chief Medical Officer, Dr. Federico Grossi, for a review of our pipeline updates. beginning with our work to establish systemic pexetacoplan as a disruptive therapy across rare, confidence-driven diseases. Philippe?