Liquidia Corporation

Good morning and welcome everyone to the Liquidia Corporation second quarter 2025 financial results and corporate update conference call. My name is Nadia and I will be your conference operator today. Currently all participants are in 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 for up for questions. I would like to remind everyone that this conference call is being recorded. I will now hand the conference call over to Jason Adair, Chief Business Officer. Please go ahead, sir.

Thank you, operator, and good morning, everyone. It's my pleasure to welcome you to the Liquidia Corporation second quarter 2025 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 Medical Officer, Dr. Rajiv Sagar, Chief Commercial Officer, Scott Mumaw, and General Counsel Rusty Schoenler. Before we begin, please note that today's conference call will contain forward-looking statements, including those regarding future results, unaudited and forward-looking financial information, and 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 differ materially. For more information, please refer to the documents filed with the SEC available on our website. With that, I'd like to turn the call over to Roger for our prepared remarks. Roger?

Thanks, Jason, and good morning, everyone. We are very pleased and excited to share our first commercial data for eutropia with everyone this morning. It's been a spectacular beginning. Just over 11 weeks ago, we were proud to introduce eutropia for the treatment of patients with pulmonary arterial hypertension, PAH, and pulmonary hypertension associated with interstitial lung disease, PHILD. Within one week of approval, we were live and in the market, shipping product, supporting physicians, and most importantly, delivering therapy to patients. This wasn't simply a product introduction. It was a launch executed with purpose and precision, and one that has been extremely well received by the physician and patient communities that we now serve. Today, we will share data and, as promised, provide additional granularity around key metrics to improve transparency regarding this early launch period. Since May, specialty pharmacies have reported over 900 unique patient prescriptions, leading to more than 550 patient starts on Eutrepia. That pace of adoption is unprecedented in the tryprostenol space and underscores the power of our print-enabled prostacyclin product. We had no doubt about the key attributes of Eutrepia's profile to enhance deep lung delivery with an easy-to-use, low-effort device, enabling a wide range of doses. I can honestly say in all my years of launching drugs in this space, this has truly outpaced all expectations, even mine, which were very, very high. Not only does this signal the value of what we have developed, but also that existing products fall short in addressing the needs of many patients. In conversations with prescribers and in communications from patients, the ease of use, tolerability, especially with regard to cough, and ability to escalate dose to clinical effect represents a market and meaningful improvement in the quality of care. Utopia's differentiated product profile, paired with the commercial success in driving brand awareness, has led to an early and enthusiastic uptake, as you have seen in the prescription and start numbers. In fact, it's been an unabated sprint since day one of launch. We've seen broad demand from cardiologists and pulmonologists with prescriptions occurring at both specialty centers and community practices. and they are treating a broad group of patients across both diseases who are prostacyclin-naive, transitioning from Tyveso and Tyveso-DPI, and even moving from oral prostacyclins. Eutrapia is truly off to a strong start and quickly positioning itself as potentially the best-in-class and first-in-choice option for patients in need of a prostacyclin therapy. Anticipating the strong interest. Our market access team prepared premium white glove services and reimbursement support to allow patients to gain early access to Eutropia. Healthcare providers have responded positively to the program's copay assistance and 28-day free vouchers, a first for an inhaled prostacyclin therapy. As a way of providing some insight, prescriptions received during the first six weeks of launch had a 75% script-to-start conversion rate. It's especially noteworthy that this early momentum has been achieved in spite of the customary period of new-to-market blocks and non-formulary positioning. We see the potential for accelerating growth and possibly higher conversion rates as we continue to expand market access during the third and fourth quarters. While the commercial team has been driving EUTREPIA's robust update, our clinical team has been analyzing maturing data from the ongoing open-label assent study, which was fully enrolled with 54 PHILD patients in March. This analysis includes the safety and observational exploratory efficacy data up to week 16. The ASCENT study was intentionally designed to include a real-world PHILD population treated with eutrapia. In particular, we treated patients ranging from mild pulmonary hypertension to those with more advanced hemodynamic and forced vital capacity impairments, and even patients listed for lung transplantation. The observations at week eight and week 16 are indeed impressive. The tolerability remains very favorable, as evidenced by the fact that only 18.5% of patients discontinued the study at week 16, with no discontinuations for serious or drug-related adverse events, including cough. For context, this favorable tolerability is juxtaposed by prospective data of Tyveso DPI from the National Jewish Health Center, a preeminent pulmonary care center where 69% of treatment-naive patients discontinued Tyveso DPI in a median time of only 40 days, with the primary reasons for discontinuation being cough and clinical worsening. Taking a slightly deeper look at the favorable tolerability that we are observing in the ASCENT study of those patients that reported a treatment-related cough, the vast majority, or 24 of 26 patients, reported mild cough, and only two patients reported a moderate cough. It should also be noted that in the longitudinal analysis, the mean daytime simplified cough scores remained essentially unchanged from baseline through week 16, suggesting the cough overall tended to be transient in nature and not worsened with the addition of eutrefia, even with escalating doses, and therefore likely similar to these patients' historical cough that is associated with their underlying interstitial lung disease. This tolerability is helping patients escalate to higher doses. The median dose at week 8 was 132.5 micrograms, or approximately 15 breath equivalents to Tyveso, and 159 micrograms at week 16, approximately 18 breath equivalents to Tyveso, with the highest exposure of 318 micrograms, comparable to approximately 36 breaths, four times per day at Tyveso nebulizers. The net result of greater tolerability and higher achieved doses also correlates with a robust efficacy result, with the observed median improvements in six-minute walk distance of 21.5 meters at week 8 that increased further to 31.5 meters at week 16. Overall, this data set continues to highlight the robust tolerability, titratability, efficacy, and durability of eutrapia in a real-world population of PHLD patients. We look forward to sharing the detailed data with the medical community, targeting the PH Professional Network Symposium Conference in mid-September and a major respiratory conference in October. Now, I will pass the call to Mike, who continues to guide the company with a firm hand on the financials and with an eye towards supporting continued growth.