Liquidia Corporation (NASDAQ:LQDA) Q4 2023 Earnings Conference Call March 13, 2024 8:30 AM ET

Company Participants

Roger Jeffs - CEO

Scott Moomaw - CCO

Michael Kaseta - COO & CFO

Rajeev Saggar - CMO

Jason Adair - CBO

Rusty Schundler - General Counsel

Conference Call Participants

Mary Kate Davis - Bank of America

Julian Harrison - BTIG

Serge Belanger - Needham & Company

Matt Kaplan - Ladenburg Thalmann

Kambiz Yazdi - Jefferies

Operator

Good morning, and welcome everyone to the Liquidia Corporation Full-Year 2023 Financial Results and Corporate Update Conference Call. My name is Michelle, and I will be your conference operator today. [Operator instructions]. I would like to remind everyone that this conference call is being recorded.

I would now like to hand the conference call over to Jason Adair, Chief Business Officer.

Jason Adair

Thank you, Michelle. It's my pleasure to welcome everyone to Liquidia's full-year quarter 2023 financial results and corporate update call. Joining the call today are Chief Executive Officer, Dr. Roger Jeffs; Chief Operating Officer and CFO, Michael Kaseta; Chief Commercial Officer, Scott Moomaw, Chief Medical Officer, Dr. Rajeev Saggar, and General Counsel, Rusty Schundler.

Before we begin, please note that today's conference call will contain forward-looking statements, including those statements regarding future results, unaudited, and forward-looking financial information, as well as the company's future performance and/or achievements. These statements are subject to known and unknown risks and uncertainties, which may cause our actual results or performance to be materially different from any future results or performance expressed or implied on this call. For additional information, including a detailed discussion of our risk factors, please refer to the company's documents filed with the Securities and Exchange Commission, which can be accessed on our website.

I would now like to turn the call over to Roger for our prepared remarks, after which, he’ll open-up the call up for your questions. Roger?

Roger Jeffs

Thank you, Jason. Good morning, everyone, and thank you for joining us today. While today's call is intended to review the company's accomplishments in the last year, we know that physicians, patients, and our investors are solely focused on one thing, the potential FDA approval in the coming weeks of YUTREPIA, our novel dry-powder formulation of Treprostinil. I'll ask Rusty to address the legal and regulatory path to approval in more detail shortly, but to put it simply, with the recent decisions by the federal circuit affirming the invalidity of the sole patent that is blocking our approval, the FDA should be able to grant approval for YUTREPIA after March 31, when regulatory exclusivity to treat PH-ILD with Tyvaso expires. A precise final approval date is hard to forecast, but we view the remaining steps as largely procedural. Final FDA approval has always been the goal, and we have never been closer or better prepared than today. Our commercial teams are in place and ready for launch. Our expanded field force has been raising the profile of Liquidia in their territories over the last three months. Our manufacturing team is preparing inventory in anticipation of a potential launch in both PAH and PH-ILD. Our R&D team continues to build clinical knowledge by studying YUTREPIA and PH-ILD patients in the open-label ASCENT trial, and our finance team has positioned the company with the resources and discipline required to execute a successful launch.