Apellis Pharmaceuticals, Inc.

Good morning, ladies and gentlemen. Thank you for standing by. And welcome to the Pell's Pharmaceuticals third quarter 2023 earnings conference call. At this time, all participants are on 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'll need to press star 11 on your telephone. You will then hear an automatic message advising your hand is raised. Please note that today's conference is being recorded. I will now hand the conference over to your speaker host, Meredith Kaya, Senior Vice President, Investillations and Specific Finance. Please go ahead.

Good morning, and thank you for joining us to discuss the Pellis' third quarter 2023 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. 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 filing for additional detail. Now, I'll turn the call over to Cedric.

Thank you, Meredith, and thank you all for joining us this morning. It has been a busy few months here at Apiris, and a period not without its share of ups and downs. That said, I am thrilled with where our company is today, and I'm more confident than ever in the opportunities that we have in front of us. Importantly, we are delivering on our goals of bringing Empatherian Cyphovry to patients with nearly $100 million in total U.S. net product revenue generated in the third quarter and continuing to develop a pipeline of potentially transformative new treatments. I'll begin with Cyphovry. We reported $75 million in SIFOBRI U.S. net product revenue in the third quarter, up about 12% quarter over quarter, resulting in more than $160 million in U.S. net product revenue generated in the first seven months since launch. A few key highlights include more than 100,000 vials of SIFOBRI have been distributed since launch through our last update on October 5th. which we believe underscores the positive impact it is having on the lives of thousands of patients across the U.S. The permanent JCODE became effective on October 1st, driving even stronger demands to date with some of our largest tweaks ever in October. The long-term data emerging from our GALE extension study continues to show increasing effects over time, a seminal feature of SafeCODE's efficacy profile. And additional analyses have been presented this fall demonstrating the visual function benefits of cyphovry in GA patients. And finally, the estimated rate of retinal vasculitis with cyphovry continues to be rare at 0.01%. Visual outcomes in these cases are really important. and the rate of events that resulted in CVR irreversible vision loss is substantially less than 0.01%. Given the continued stability in the rates, we plan to continue to provide the estimated rate of events, but will no longer discuss individual cases. The success of Steyr FOBRI reinforces the unmet need in GA and the strength of our product profile. We faced unexpected challenges with the rare events of vasculitis emerging this summer, but we have worked hard to build trust with the retina community through continuous transparency and sharing the learnings from our investigation. In doing so, we have provided retina specialists with the information they need to make the right treatment decisions for their patients. I had the privilege of spending time with some of our key opinion leaders this fall at both U Retina and Retina Society. It was encouraging to hear the discussions shifting back to what this product can do for patients. After a challenging few months, we have turned the corner and believe we are now back to the demand growth trajectory that we were on in July. Globally, we are looking forward to the decision on our MAA submission for the European Medicines Agency, which is on track for early 2024. At Euretina, I was impressed with the incredible amount of work our European team has been doing to prepare for the launch. There was also a lot of enthusiasm from the European physicians about the possibility of finally having a treatment for their GAA patients. Turning to Empazeri. We generated $24 million in third quarter U.S. net product revenue and $67 million year-to-date. With Empaveri, we now have over 1,300 patient years and compliance rates at 97%, and still not a single case of meningococcal infection. One of the key highlights for Empaveri during the quarter was receiving FDA approval for the Empaveri injector. an innovative and first-of-its-kind high-tech volume injector. With this approval, we are further enhancing the patient's experience by offering greater mobility and simplifying administration. We also announced top-line data from our Phase II novel study with systemic pexetacroplam in ICMPGN and C3G, which will be presented this Saturday at the American Society of Nephrology. The strength of these data is driven by the speed and magnitude of effect that pexetacoblan had in the kidney, which is unprecedented in these diseases. We believe that we have an opportunity to significantly expand the number of patients who are benefiting from pexetacoblan, as ICMPGN and C3G affect more than three times the treated PNH population. We look forward to the top-line results from our Phase III Valium study expected in the third quarter of 2024. Before I turn it over to Adam, I would like to comment on our recent corporate restructuring. In late August, we took actions to streamline our organization, prioritizing the growth of Sypho Re and Mpavedi and positioning the company for continued long-term success. This was a difficult decision, and we are grateful for the commitment and contributions of all of our colleagues. As a reminder, key elements of our reprioritization include maximizing SIFO-B's global leadership in GA, streamlining the empathy business focused on the commercialization in P&H and development in ICMP-GEN-T3G, prioritizing certain CNS and retina research initiatives, and continuing our collaboration with BEAM, and finally, improving operational efficiencies. We anticipate total cost savings of up to $300 million through 2024 as a result of this restructuring. And as Tim will speak to later, we expect our cash runway to now extend into at least the second quarter of 2025. As a more focused organization, we believe we are in a stronger position to create value for shareholders and deliver on our mission for patients now and in the future. With that, I will now turn it over to Adam to discuss our commercial activity.