Apellis Pharmaceuticals, Inc.

Good morning, ladies and gentlemen. Thank you for standing by, and welcome to APILIS Pharmaceutical's second 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 this session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising you your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference 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 Appellus' second 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 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 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. We are in a unique position today with one and the potential for two blockbuster drugs in the market, Cyphovri and Mpavini, both of which are making a meaningful difference for patients. The past six months have been a period of continued progress and execution by the Apelis team, but we recognize that there are questions around the competitive landscape for Cyphovri. Given this, I wanted to share some of my thoughts. Cyphovir is the market leader in a category with only two available drugs, one and a half million highly motivated patients, and a long runway for continued growth. That said, there has been a lot of focus on near-term dynamics. Our competitor has recently had tailwinds driven by factors such as its new J-code. They had every incentive to drive the amount in new patient starts as much as possible, and yet we saw approximately half of new patients choose Cyphovry. Following last month's successful ASRS meeting, we believe Cyphovry's clinical profile is being viewed favorably by physicians and will drive more growth in new patient starts over time. The Cyphovry launch has been one of the best launches in recent history, generating over half a billion dollars in sales in its first six quarters and achieving double-digit percentage growth every single quarter. More than 330,000 Sifovir injections are estimated to have been administered to patients, and this strong growth is continuing into the second half of the year. The GA market is growing significantly, and Sifovir has only scratched the surface of its long-term potential. Importantly, the recent ASRS meeting was a strategic turning point for us where our focus and our discussions shifted to Cyphovry's strong and differentiated efficacy profile. We have multiple analyses supporting the efficacy of Cyphovry, and retina doctors are enthusiastic about the totality of these data. The favorable benefit-risk profile of Cyphovry is becoming clearer to physicians with some key takeaways. One, Both monthly and every other month's Cyphovry treatment showed a better efficacy profile than the competitor among patients with non-sub-povial GA at both 12 and 24 months, as detailed in the matching-adjusted indirect comparison post-hoc analysis presented. Note that no head-to-head clinical trials have been performed. Two, Cyphovry is clinically proven to offer flexible dosing from day one, Every other month's treatment with cyphobre provides an even safer and more cost-effective treatment while maintaining its strong efficacy. And three, regarding safety, vasculitis is rare and appears to be a first injection phenomenon. The estimated rate has remained stable at 1 in 4,000 per first injection. During the podium presentation at ASRS, the REST Committee confirmed this estimated rate and agreed that it appears to be only on the first injection. After this meeting, we continue to believe that we are well positioned to continue growth and further cement our market leadership in GA for many years to come. Our singular focus is to ensure that every GA patient who needs treatment has access to Cyphovri. This is how we expect Cyphovri to continue on its path of becoming a multi-billion dollar drug. As for the European GA opportunity, we are focused on the CHMP reexamination process and are encouraged by the progress we made throughout the initial review. This was not an unexpected outcome, given that the process was reset back to day 180 of the initial review and therefore led by the original rapporteurs. We were encouraged to learn that in this recent opinion, multiple CHMP members disagreed with the negative opinion. Additionally, the external advisory experts were aligned on micro-parametry as the best available functional measure of GA. We are humbled by the broad support shown by the European retina community, and while we remain conservative in our expectations for the reexamination, we believe we are well-positioned heading into the appeal. Two new rapporteurs were recently designated, and we continue to expect the final decision to be issued in the fourth quarter of 2024. Moving to Empaveli, which continues to elevate the standard of care for patients with PNH. Empaveli generated $24.5 million in product sales in the second quarter. We continue to believe that patients on Empaveli are experiencing substantial benefits as demonstrated by its 97% compliance rate. Importantly, we are exploring its potential to expand into new indications and become a best-in-class treatment option for additional high unmet need areas. The upcoming Phase III Valiant stop-line readout in C3G and primary ICMP-GN is the next milestone in this process, and we expect to present these data later this month. If the data are positive, we plan to submit a supplemental NDA to the FDA for approval. Regarding the pipeline, we are advancing multiple earlier stage development programs, leveraging our core expertise in complement science to fuel the next phase of value creation for attendees. We look forward to sharing our progress at an upcoming investor day towards the end of this year. And finally, from a financial perspective, we are benefiting from the growing product revenue generated by Cyphovry and Empavedi and have actively taken steps to strengthen our balance sheet. We now have a clear line of sight to positive cash flow, allowing us to invest in future growth without having to rely on the capital markets. Before I turn it over to Adam to discuss our commercial activities, I will close by saying thank you to the patients and physicians who motivate us to develop and bring important treatments to market, and to the Apedis team who have shown unbelievable commitment and perseverance in getting these important medicines to patients, and to our shareholders, many of whom have stood with us through these dynamic periods and provided unwavering support to us over the years. With that, I will now turn it over to Adam.