Liquidia Corporation

Chief Medical Officer, Dr. Rajiv Sagar, Chief Operating Officer and CFO, Michael Cassetta, 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 statements regarding future results, unaudited and forward-looking financial information, as well as the company's future performance and or achievement. 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 will open the call for your questions.

Good morning, everyone, and thank you for joining us today. In a little more than two weeks, May 24th to be precise, we will have reached the PDUFA goal date for Liquidia's first internally developed commercial product, Utrepia. an investigational inhaled dry powder formulation of tropostinil for the treatment of pulmonary arterial hypertension, or PAH, and pulmonary hypertension associated with interstitial lung disease, or PHILD. With all eyes on the future, we are going to keep our prepared remarks focused on a few key areas. First, I'd like to take a moment to highlight last week's news regarding the decision rendered by the District Court dismissing United Therapeutics' cross-claim that sought to challenge our amendment to the new drug application for eutropia. which added the treatment of PHILD to Utrecht's proposed label. While United Therapeutics has the right to appeal the court's ruling, we are pleased with the court's decision to dismiss this cross-claim, specifically holding that United Therapeutics failed to establish standing. We are proud to say there continue to be no legal barriers barring Utrecht's potential final approval following the expiration of gating regulatory exclusivity on May 23rd, 2025. With this favorable ruling in hand, we are doubling down on our preparations for the potential launch of Utrepia, with a laser focus on five key strategic areas. First, we're developing what we believe is a best-in-class product profile for Utrepia. As we've said before, Utrepia's tolerability, titratability, ease of use, and future labeling speaks to the fact that it offers a differentiated product profile. We continue to further characterize these clear benefits in the company's open-label assent study in PHILD patients. As communicated in this morning's press release, cohort A of the assent study is now fully enrolled with more than 50 patients. The interim data has shown us that the dosing and tolerability profile in the first 20 patients to complete eight weeks of treatment was consistent with observations made in the INSPIRE study of PAH patients. Thus far, PHILD patients in the assent study have been able to titrate to doses that are three times higher than the labeled target dose of nebulized tibiasis. These patients have also shown positive trends on exploratory measures of efficacy, including six-minute walk distance. Additional data from the ASCENT study will be presented during two poster sessions at the American Thoracic Society's International Conference in San Francisco on May 20th. As part of the ASCENT study, we will begin cohort B, a directed transition study in the coming months where we will take patients unsatisfied with the clinical attributes of Tyveso and Tyveso-DPI and transition them to Eutrevia. The goal of this study will be to directly compare the differences and potential benefits that Eutrevia presents, both in PAH and PHILD patients. You'll hear more regarding this study in the months ahead. Next, we are fully prepared to go to market with a competitive share of voice. We have 50 sales reps in the field who have been on board for about 18 months and a companion medical affairs team, all with an impressive level of rare disease experience and most with pH experience. These groups have been actively surveilling both the major centers of excellence as well as the community prescriber base in preparation for Utrecht's potential launch. Our third strategic area of focus is our preparation to launch a full suite of patient support services, which we have meticulously put into place. Physicians and patients should expect no differences in support with Eutrepia, whether starting inhaled Trapasil for the first time or transitioning from incumbent inhaled products. Fourth, we've continued to focus on ensuring robust product availability. Mike and his team at Liquidia have prepared to put product in the channel in only two to three weeks after Eutrepia's potential approval. And finally, the fifth strategic area of focus that will help us ensure success is broad payer access. Over the last several years, we have developed strong relationships with payers who understand the differentiated product profile that Eutrepia can offer to patients. We remain confident that patients will have access to Eutrepia within a short time after launch. With all these in play, we feel well prepared to launch Eutrepia into the marketplace once approved, and we look forward to fulfilling our promise to provide patients with PAH and PHILD, a much-needed and potentially best-in-class therapeutic alternative. I'll now turn the call over to Mike to provide an overview of our first quarter 2025 financials. Mike?

Thank you, Roger, and good morning, everyone. Turning to our first quarter 2025 financial results, which can be found in the press release, you will see that revenue was $3.1 million for the three months ended March 31, 2025. compared to $3 million for the three months ended March 31st, 2024, revenue related primarily to the promotion agreement. The increase of $0.1 million was primarily due to the impact of unfavorable growth to net returns adjustments recorded in the prior year, offset by lower sales volumes in the current year. Cost of revenue was $1.5 million for each of the three months ended March 31st, 2025 and 2024. Cost of revenue related to the promotion agreement as noted above. Research and development expenses were $7 million for the three months ended March 31st, 2025, compared to $10.1 million for the three months ended March 31st, 2024. The decrease of $3.1 million, or 31%, was primarily due to a $3.6 million decrease in personnel expenses, including stock-based compensation, due to a shift from activities related to research and development to preparation for the potential commercialization of EUTREPIA. These decreases were offset by a $1.7 million increase in clinical expenses related to our L606 program and a $0.4 million decrease in expenses related to our EUTREPIA research and development activities. General and administrative expenses were $30.1 million for the three months ended March 31, 2025, compared to $20.2 million for the three months ended March 31, 2024. The increase of $9.9 million, or 48%, was primarily due to an $8.1 million increase in personnel expenses, including stock-based compensation, driven by higher headcount and a shift from activities related to research and development to preparation for the potential commercialization of EUTREPIA, a $0.6 million increase in legal fees related to our ongoing EUTREPIA-related litigation, and a $0.6 million increase in facilities and infrastructure expenses. We incurred a net loss for the quarter-ended March 31, 2025, of $38.4 million. or 45 cents per basic and diluted share, compared to a net loss of $30.1 million, or 40 cents per basic and diluted share, for the three months ended March 31st, 2024. Included in the comparative results we have presented is an immaterial revision of other income, as previously reported for fiscal year 2024. This revision is a technical, non-cash accounting adjustment related to gain and loss recognized when we made amendments to our HCR facility made in 2024. Additional details are included in the Form 8K we filed this morning. I would now like to turn the call back over to Roger.