Liquidia Corporation

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. Currently, all participants are in a listen-only mode. Following the presentation, we will conduct a question and answer session. The instructions will be provided at the time for you to queue up for a question. I would like to remind everyone that this conference is being recorded. I would now like to hand the conference over to Jason Adair, Chief Business Officer.

Thank you, Michelle. It's my pleasure to welcome everyone to Liquidia's full year 2023 financial results and corporate update call. Joining the call today are Chief Executive Officer Dr. Roger Jeffs, Chief Operating Officer and CFO Michael Cassetta, Chief Commercial Officer Scott Mumaw, Chief Medical Officer Dr. Rajiv Sagar, 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 for your questions.

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 Eutrepia, our novel dry powder formulation of Trapacinib. I will 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 Eutrepia after March 31st, when regulatory exclusivity to treat PHLD with type A so 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 liquidity in their territories over the last three months, Our manufacturing team is preparing inventory in anticipation of a potential launch in both PAH and PHILD. Our R&D team continues to build clinical knowledge by studying eutrophia in PHILD patients in the open-label assent trial. And our finance team has positioned the company with the resources and discipline required to execute a successful launch. We entered 2024 at a full sprint due to the resolve and execution of our team in 2023. Last year, everything grew in the right direction. Our confidence grew with legal wins. Our balance sheet grew with key transactions by marquee investors and insiders. And our pipeline grew with the in-license of L606, the most clinically advanced next-generation sustained release inhaled through ProSino program. Given the proximity of a potential launch, I'd like to spend a little time framing the potential market opportunity for Utopia as we see it, both in PHILD and PAH. With regard to PHILD, patients. However, these estimates likely undervalue the total addressable population since those calculations rely on historical publications before the field had effective tools to treat the disease and therefore reasons to diagnose the disease. With inhaled tryprosinol as the only approved mechanism to treat PHILD, the market penetration is still in its infancy. we believe there is significant growth in this market. Total inhaled tryprosinol revenues currently sit at about a 1.3 billion annual run rate in the U.S. alone. With regard to PAH, we also believe that eutrefia has potential for significant uptake. We view eutrefia as having the potential to not only be the best-in-class inhaled tryprosinol, given its dosing flexibility and ease of use, but also the first-in-choice process I Specifically, patients who previously considered the oral prostacyclines as their starting choice can now avoid the significant and limiting off-target GI toxicities associated with these drugs while still achieving therapeutic doses. Thus, combining current sales of oral prostacyclines of approximately $1.6 billion in pH with the recently reported sales from inhaled ripostidol of $1.3 billion, the market opportunity for eutrepia could be approaching $3 billion and growing incrementally as the PHLD patients still remain largely untreated. With its unique and differentiated approach, it's exciting to think about the potential for eutropia and rapture value in both of these markets. At this time, I would like to ask Rusty to summarize the next steps towards final.