Apellis Pharmaceuticals, Inc.

Good morning, ladies and gentlemen. Thank you for standing by and welcome to the Appellus Pharmaceuticals third quarter 2024 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 the session, you will need to press star 11 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 would now like to turn the call over to Meredith Kaya, Senior Vice President, Investor Relations and Strategic Finance. Please go ahead.

Good morning, and thank you for joining us to discuss Pellis' third quarter 2024 financial results. With me on the call are co-founder and Chief Executive Officer, Dr. Cedric Francois, Chief Operating Officer, Adam Townsend, Chief Medical Officer, Dr. Caroline Bommel, 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 filings for additional detail. Now, I'll turn the call over to Cedric.

Thank you, Meredith, and thank you all for joining us this morning. Over the past few months, we have made meaningful progress towards our long-term goals. reaching key milestones such as generating continued growth in vial demand for Sifovir and presenting the groundbreaking Phase III valiant results with mPavetti and C3G and ICMPGN. These data underscore the power of C3 and reinforce our belief that targeting C3 is the optimal way to treat complement-mediated diseases. During the third quarter, commercial vial demand for Sifovir grew by 7% quarter over quarter, and Saifovri maintained its market leadership with 84,500 commercial vials shipped to physicians. Third quarter Saifovri net product revenue of $152 million were more than double the same period last year. However, we recognized that revenue fell short of expectations, declining by 1.7% relative to the last quarter. This was partially due to higher gross to net adjustments which Adam and Tim will speak to shortly. Importantly, we expect growth to net to be stable going forward with more modest quarterly adjustments typical of a buy and build model. Also affecting our performance this quarter was an overall slowing within the GA market. Total file demand did grow quarter over quarter, but at a slower pace than in previous quarters. Market growth is now being driven by the next group of retina specialists, who often need more time to appreciate the benefit-risk profile of complement treatments and therefore take longer to decide to treat their GA patients. To support meaningful growth going forward, we need to continue building awareness of CyphorBree's strong clinical profile. We have launched several key initiatives aimed at increasing our share of new patient starts, strengthening our market leadership, and accelerating growth in the overall GA markets. Early science suggests that these efforts are delivering positive results, but their impact on the GA market and safe-over-demand will take time. Considering this, we remain conservative in our near-term expectations for growth, anticipating low single-digit percentage value growth for the remainder of 2024, with flat to modest net revenue growth in the fourth quarter. We plan to provide further insight into the GAA market dynamics and our growth expectations for 2025 and the coming months as we gain visibility into the impact of our new commercial initiatives. It is important to remember that we are still in the early stages of the launch. We estimate that only about half of all GAA patients are diagnosed and seen by an eye care professional, and of those, An estimated 15% are currently being treated. GA patients are on an irreversible path to blindness, and Cyphovry has a significant impact on slowing disease progression and potentially preserving patient's vision for longer. We see tremendous opportunity over the long term, but expect the sales ramp to be more gradual going forward. Importantly, we continue to believe Cyphovry remains on track to become a blockbuster drug. Quickly touching on Europe, we were disappointed with the negative CHMP opinion, despite multiple analyses showing that FEMA would say for preserved visual function. We do not have plans to pursue EU approval further at this time. And then moving to Mpavelli, we were extremely pleased to share the full results from the phase 3 valiant study in C3G and primary ICMPGN at kidney week last month. I will let Caroline discuss these results further, but we believe Mpavedi has the potential to become a best-in-class treatment for these rare kidney diseases, redefining the current treatment paradigm for patients with C3G and ICMPGN. At Apenis, we have spent the last two decades investigating C3 as a therapeutic target because we believe in the significant benefit of targeting C3 as compared to other targets within complement. These positive valiant results suggest once again that abelicis C3 targeted therapies are particularly effective across multiple therapeutic areas, now including PNH, geographic atrophy, and C3G and ICMPGN. We received feedback from the FDA last week that our submission proposal has been accepted, which means that we remain on track to file our supplemental NDA early next year in both C3G and ICMPGN based on our positive six-month data. Importantly, the FDA did not require us to file with the full 52-week data. Our ex-US partner, SOBI, expects to file a regulatory submission in the EU in early 2025, followed by a submission with the Japanese health authorities later in 2025. The VALIANT data also unlock additional opportunities within nephrology that we are evaluating and plans to provide detail on soon. On the commercial front, Embavedi generated $24.6 million in U.S. product revenue in P&H in the third quarter, up 3% as compared to the same period last year. The 97% compliance rate supports the substantial benefit that these patients are receiving. In closing, our strong fundamentals position us well for the future. Apedis has two commercial products, each with blockbuster potential, which are already making a meaningful difference in patients' lives. Our emerging pipeline holds exciting products, and we look forward to sharing more on this soon. We are on a clear path to profitability and continue to believe we can independently fund our core business. And with that, I will now turn it over to Adam to discuss our commercial activities.