Apellis Pharmaceuticals, Inc.

Good day, and thank you for standing by. Welcome to Appellus Pharmaceuticals' second quarter 2023 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Meredith Kaya. Please go ahead.

Good morning, and thank you for joining us today. Earlier this morning, we reported our second quarter 2023 financial results. We will be happy to take questions from you on these results in the Q&A session. However, we will be focusing our prepared remarks today on safe ovary, including feedback from the recent ASRS annual meeting and an update on our comprehensive review of the rare safety events. 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 Baumol, 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 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, Meredith, and thank you all for joining us today. As Meredith said, we are going to take a different approach on today's call and focus the discussion on the rare events of vasculitis we have seen with typhovary. We know you have questions and we will do our best to answer as many of them as we can. But before we do, let me provide some overarching comments. First, I have never been prouder to be part of the Aperis team. The past few weeks have been challenging, and once again, the team has shown incredible dedication and resilience. Second, we had a strong second quarter. We reported approximately $90 million in total product sales, including $67 million for Cyphovry, demonstrating the early strength of this launch. With more than 68,000 vials of syphovory now distributed to physicians, syphovory is having a positive impact on the lives of tens of thousands of patients across the United States. And third, syphovory continues to demonstrate increasing effects over time. Data from our Gale long-term extension study showed a reduction in non-subphovial GA lesion growth of up to 45%. between months 24 and 30 as compared to projected sham. These are incredible findings, further strengthening our understanding of syphilis as an important treatment for patients with GA. With that, let's get into the discussion. Patient safety is our top priority, and we care deeply for the physicians who rely on us. we are conducting a comprehensive investigation into the potential causes of the events of vasculitis working closely within the retina community. We do not know the cause yet, and realistically, we may never identify a singular cause. What we do know, however, is that these events have been very rare and sporadic, and that zero events were reported in our clinical studies. Cyphovir is a newly launched drug in a new disease with a new mechanism of action. It is not unexpected that events may emerge when bringing a drug into the real world, but it is expected that we take them very seriously. Now, let's get into some of your questions. First, what do we know so far about these events, and what are the visual outcomes for these patients? I will hand it over to Caroline to speak about this. Caroline?