Liquidia Corporation

Good morning, and welcome everyone to the Liquidia Corporation third quarter 2022 financial results and corporate update conference call. My name is Abby, 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. Instructions will be provided at that time for you to queue up for questions. If anyone has any difficulties hearing the conference, please press star zero for operator assistance at any time. I would like to remind everyone that this conference call is being recorded. I will now hand the call over to Jason Adair, Senior Vice President, Corporate Development and Strategy.

Thank you, Abby. It's my pleasure to welcome everyone to Liquidia's third quarter 2022 Financial Results and Corporate Update conference call. Joining the call today are Chief Executive Officer Roger Jeffs, Chief Financial Officer, Mike Cassetta, General Counsel, Rusty Schundler, and other members of the Liquidia management team. 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 actual results or performance to be materially different from any future results or performance expressed or implied on the call. For additional information, including a detailed discussion of our risk factors, please refer to the company's documents filed with the Security and Exchange Commission, which can be accessed on our website. I'd now like to turn the call over to Roger for our prepared remarks, after which he will open the call up for your questions. Roger?

Thank you, Jason. Good morning, everyone, and thank you for joining us. I firmly believe we will look back at the third quarter as a seminal point in our mission to bring Utopia to patients. Notably, and as Rusty will expand upon shortly, we achieve outcomes in our legal proceedings that if simply affirmed on appeal will allow us to launch Utopia, as all of the asserted patent claims have been found in at least one proceeding to be invalid or not infringed. Our primary goal is to obtain the affirmations of these favorable decisions as quickly as possible so that Utopia can become an important treatment choice for patients, physicians, and payers. Our drive to get to the market is greatly strengthened by robust patient and physician feedback, even after the launch of Taveso DPI. The two primary unique product pillars that resonate firmly with patients and physicians are, one, the high degree of tolerability and associated dose flexibility enabled by our print formulation, and two, the ease of use of the low-resistance device. Firstly, with regard to the high degree of tolerability and dose flexibility, We have observed in our open-label extension study exposures up to 238.5 micrograms of eutropia, which equates to greater than or equal to 27 breaths of Tyveso, which, as you may know, has a labeled therapeutic target of only 9 to 12 breaths per session due to tolerability limitations. Eutropia is a radically different dose profile. significantly transforms the therapeutic utility of inhaled tryprosinol delivery. Specifically, the ability to modulate eutropia dose over a wide range makes it customizable for a broader spectrum of PAH patients, from patients naive to therapy, in place of oral prostacyclin therapy, or for patients intolerant to oral prostacyclin therapies, for transitions from other less flexible inhaled therapies, and even patients improved on parenteral therapies, given patients will now be able to achieve parenteral-like dose exposures. With this broad and customizable dose profile, it is easy to envision that eutropia can quickly assert itself as the highest utility for our testing health, obviating the need to endure the route-specific side effects of oral and parenteral therapy. These dosing benefits are further augmented by the second product pillar of eutropia, the ease of use of the low-resistance dry powder inhaler, a device that is robust to patient misuse scenarios and without specific orientation requirements. either of which could result in poor drug delivery or even spillage from the competitor's high-resistance device. Eutrepia's device-specific advantages will further strengthen the position of eutrepia as the dominant choice. It is important to note that the benefit of a low-resistance device to deliver eutrepia also means that the therapy is highly agnostic to the presence of comorbid lung dysfunction. This advantage will be especially relevant in PHILD patients who may not have the inspiratory capacity to use a high-resistance device and should further enhance patient uptake of Eutrepia as a preferred choice in this rapidly expanding market opportunity. With these product attributes and benefits, it is easy to envision that Eutrepia can quickly become the best-in-class and first-in-choice process vitamin, both in PAH and PHILD populations. I would now like to turn the call over to Rusty for an update on the legal proceedings. Rusty?