Apellis Pharmaceuticals, Inc.

Good day, and thank you for standing by. Welcome to the Q1 2023 Appellate Pharmaceuticals Earnings Conference 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 this session, you'll need to press star 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I'd now like to hand the conference over to your speaker today, Meredith Kaya. Please go ahead.

Good afternoon, and thank you for joining us to discuss Appellus' first 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, I'd 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 details. Now, I'll turn the call over to Cedric.

Thank you, Meredith, and thank you all for joining us today. I know that the launch of Cyphovry is top of mind for everyone, so let me jump right in. We received FDA approval of Cyphovry for the treatment of geographic atrophy on February 17th. Cyphovry is the first and only treatment available for GA, a disease that affects more than 1 million patients in the US alone and that relentlessly and inevitably leads to vision loss. Prescribing label details Cyphovry's proven ability to slow GA progression with increasing effects over a 24-month period, flexible dosing, and a well-demonstrated safety profile following nearly 12,000 injections. This approval is the culmination of more than 20 years of hard work and dedication by our team, and we are incredibly proud to bring Cyphovry to patients who, until now, had no treatment options. Cyphovry was launched in the US on March 1st. In that first month, just over 6,000 commercial vials were shipped to physicians and Cyphovry generated US net product sales of $18.4 million for the first quarter. We are continuing to see the strong momentum in the second quarter so far and are really encouraged by this early market adoption. Initial demand by both eye care professionals as well as patients has exceeded our expectations and we view this strong start as a leading indicator of longer term demand. However, let me temper this by saying that GA is a new uncharted category. We have been in the market for two months and are just starting to learn about how various adoption trends may impact demand. So while we are pleased with our progress in March, We anticipate fluctuations in uptake throughout the temporary J-code period. Caroline and Adam will provide more color on what we are seeing in the market, some of the recent functional analyses presented at ARVO, and our progress with the commercial launch. We are also making important steps in our efforts to bring intravitreal pexitacoplan to patients globally, with applications now under review in the European Union, Australia, Switzerland, Canada, and the United Kingdom. Turning now to Empaveli. We are continuing to see strong momentum with Empaveli as we close out its second year on the market. US net product sales were $20.4 million in the first quarter. We were pleased with the approval of our supplemental NDA, which includes the Pegasus and Prince results, and look forward to the potential approval of the Empaveli injector. What really continues to stand out are the compliance rates for Empavedi, which remain around 98%. This is outstanding for a drug this far into its launch, and we view it as a clear testament to how much better patients feel when taking Empavedi. In ALS, we recently made the tough decision to discontinue treatment in the open-label portion of the Phase 2 study following a recommendation by an independent data monitoring committee. The committee's recommendation was not based on any unexpected safety signals. All patients in the study have completed the randomized treatment period, and we will analyze the data as planned. I would like to say thank you to the people living with ALS and their caregivers who participated in this study, and for the partnerships we have built within the ALS community. We continue to advance nearly a dozen clinical and preclinical programs, and you'll hear more about some of these today. Overall, we believe we have only just begun to unlock the potential of complement science and look forward to sharing our continued progress with you going forward. With that, I will turn it over to Adam. Thank you, Cedric.