Apellis Pharmaceuticals, Inc. (NASDAQ:APLS) Q3 2022 Earnings Conference Call November 7, 2022 4:30 PM ET

Company Participants

Adam Townsend - Chief Commercial Officer

Cedric Francois - Co-Founder, President & Chief Executive Officer

Federico Grossi - Co-Founder & Chief Medical Officer

Meredith Kaya - Senior Vice President, Investor Relations & Strategic Finance

Timothy Sullivan - Chief Financial Officer

Conference Call Participants

Tazeen Ahmad - BAML

Jon Miller - Evercore

Anupam Rama - JPMorgan

Philip Nadeau - Cowen

Steven Seedhouse - Raymond James

Chris Howerton - Jefferies

Colleen Kusy - Baird

Justin Kim - Oppenheimer

Yigal Nochomovitz - Citi

Ellie Merle - UBS

Annabel Samimy - Stifel

Douglas Tsao - H.C. Wainwright

Operator

Hello, and thank you for standing by. Welcome to the Q3 2022 Apellis Pharmaceuticals Earnings Conference Call. [Operator Instructions]

I would now like to hand the conference over to your speaker, Meredith Kaya, Senior Vice President of Investor Relations and Strategic Finance. Please go ahead.

Meredith Kaya

Good afternoon, and thank you for joining us to discuss Apellis’ third quarter 2020 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. Federico Grossi; and Chief Financial Officer, Tim Sullivan.

Before we begin, I would 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 detail.

Now I’ll turn the call over to Cedric.

Cedric Francois

Thank you, Meredith, and thank you all for joining us today. Let me start this call with what is on all of our minds right now, which is our decision to submit the 24-month efficacy data from the Phase III DERBY and OAKS Studies to the FDA. This submission will be considered a major amendment to the NDA, extending our revenue timeline by 3 months with a new PDUFA expected in February 2023. Let me just state upfront, as we have received so many questions about this that this decision was ours. This was not requested by the FDA. The reason why we decided to do this is because including these efficacy data gives us the opportunity to have the best product profile at launch with minimal impact to our launch timing.