Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) Q3 2023 Earnings Call Transcript
Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) Q3 2023 Earnings Call Transcript November 1, 2023
Apellis Pharmaceuticals, Inc. misses on earnings expectations. Reported EPS is $-1.17 EPS, expectations were $-0.86.
Operator: Good morning ladies and gentlemen. Thank you for standing by and welcome to the Apellis Pharmaceuticals Third Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please note that today’s conference is being recorded. I will now hand the conference over to your speaker host, Meredith Kaya, Senior Vice President of Investor Relations and Strategic Finance. Please go ahead.
Meredith Kaya: Good morning and thank you for joining us to discuss Apellis' third 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 Baumal; 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.
A pharmacist holding a vial of a pharmaceutical product manufactured by West Pharmaceuticals.
Cedric Francois: Thank you, Meredith, and thank you all for joining us this morning. It has been a busy few months here at Apellis and the period is not without its share of ups and downs. That said, I am thrilled with where our company is today and then more confident than ever in the opportunities that we have in front of us. Importantly we are delivering on our goals of bringing EMPAVELI and SYFOVRE to patients with nearly $100 million in total of the U.S. net product revenue generated in the third quarter and continuing to be [indiscernible] potentially transformative new treatments. I'll begin with SYFOVRE. We reported $75 million in SYFOVRE U.S. net product revenue in the third quarter, up about 12% quarter-over-quarter resulting in more than $160 million in U.S. net product revenue generated in the first seven months since launch.
A few key highlights include more than 100,000 vials of SYFOVRE have been distributed since launch through our last update on October 5th which we believe underscores the positive impact it is having on the lives of thousands of patients across the U.S. The permanent J-code effective on October 1st, driving even stronger demand to date with some of our largest weeks ever in October. The long-term data emerging from our GALE extension study continues to show increasing effects over time. [Indiscernible] feature of SYFOVRE's efficacy profile and additional analyses have been presented this fall demonstrating the visual function benefits of SYFOVRE in GA patients. And finally, the estimated rate of retinal vasculitis with SYFOVRE continues to be rare at 0.01%.
Visual outcomes in these cases are really important and the rate of events that that resulted in this year irreversible vision loss is substantially less than 0.01%. Given the continuous stability in the rates, we plan to continue provide the estimated rate of events which we will no longer discuss in the visual cases. The success of SYFOVRE reinforces the unmet need in GA and the strength of our product profile. We faced unexpected challenges with the rare events of vasculitis emerging this summer, but we have worked hard to build trust with the retina community through continued transparency and sharing the learnings from our investigation. In doing so, we have provided retina specialists with the information they need to make the right treatment decisions for their patients.
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