Apellis Pharmaceuticals, Inc.

Hello, and welcome to Appellate's Pharmaceuticals' first quarter 2022 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 1 on your telephone. If you require any further assistance, please press star 0. It is now my pleasure to introduce Senior Vice President of Investor Relations and Strategic Finance, Meredith Kaya.

Good afternoon, and thank you for joining us to discuss Appellus' first 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 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 off to an extraordinary start at APELIS, as we continue to execute across each of our key priorities. Starting with Intravitreal Plexi-TACO Plan for Geographic Atrophy, or GA, We've made important progress as we prepare for the NDA submission later this quarter. We completed the pre-NDA meeting in January. And then in March, we shared 18-month data from our Phase III Derby and Oaks studies demonstrating that longer-term treatment with Bexita Copeland resulted in an increasing benefit to patients with greater amounts of retinal tissue saved over time and a favorable safety profile. Additionally, these data showed improving effects in derby that were comparable with OAKS starting at month six. Just this week at ARVO, we shared additional 18-month data analyses that showed that texetacoplan reduced lesion growth in patients with extra fovea lesions and in patients with fovea lesions, further supporting texetacoplan's benefits for a diverse population of patients across the GA disease spectrum. Collectively, these data reinforce the potential for Pexetacoplan to become the first-ever treatment for the millions of patients living with GA, a relentless disease that is a leading cause of blindness worldwide. Turning to EmpaVeti and PNH, the launch is off to a strong start in 2022 with approximately $12 million in U.S. net sales, despite the initial headwinds due to the Omicron variant. We remain focused on further establishing MPaVedi as a first-line treatment for patients living with PNH. Our aim is to ensure that all patients with PNH, regardless of their baseline hemoglobin levels, have the potential to benefit from MPaVedi. The leading indicators for the launch remain strong, with positive physician and patient feedback, a favorable patient mix, high levels of compliance, and positive recognition by payers. Globally, we are thrilled to see our partner SOBI begin to bring mPavetti, known also as Aspavetti in certain countries outside the U.S., to patients worldwide. Beyond PNH, we are seeking to advance mPavetti as a transformative therapy for rare, complement-driven diseases. In the first quarter, we completed enrollment in our potentially registrational Phase II study in amyotrophic lateral sclerosis, or ALS. top-line results expected in mid-2023. Additionally, SOBE dosed its first patient in a Phase II study in hematopoietic stem cell transplant-associated thrombotic microangiopathy, or HSCT, TMA. Together with SOBE, we now have two late-stage clinical programs underway and remain on track to initiate two additional programs in the second quarter. Combined, these opportunities could address the needs of as many as 35,000 patients per year in the U.S. alone, significantly expanding the opportunity for EmpaVedi. We are also advancing complement inhibition as a novel approach to enabling adeno-associated viruses, or AAVs. In collaboration with Spark Therapeutics, we look forward to sharing in vitro data with APL9 at the upcoming annual meeting of the American Society of Gene and Cell Therapy later this month. While early, with additional clinical investigation warranted, these in vitro data further support our hypothesis that complement, and specifically C3, plays an important role in anti-AAV responses, and that targeting C3 has the potential to help mitigate the safety and tolerability concerns associated with AAV delivery. Finally, we are continuing to progress our early stage pipeline with three IMDs expected over the next 18 months, including APL2006, APL1030, and our siRNA program, and continue to make great progress in our partnership with Beam Therapeutics. On the finance side, we ended the first quarter with close to a billion dollars in cash, providing runway into the first quarter of 2024. This strong financial position allows us to head into our NDA submission and potential launch from a position of strength in otherwise challenging market conditions. We look forward to building on our momentum as we further cement our position as a leader in complement across multiple therapeutic areas. And let me now turn the call over to Adam for a commercial update. Adam?