Operator
Good morning, and welcome, everyone, to the Liquidia Corporation First Quarter 2025 Financial Results and Corporate Update Conference Call. My name is Ari, and I will be your conference operator today. — Operator Instructions — I would like to remind everyone that this conference call is being recorded. I will now hand the call off to Jason Adair, Chief Business Officer.
Jason Adair
Thank you, operator. It is my pleasure to welcome everyone to the Liquidia Corporation First Quarter 2025 Financial Results and Corporate Update Call. Joining the call today are Chief Executive Officer, Dr. Roger Jeffs; Chief Medical Officer, Dr. Rajeev Saggar; Chief Operating Officer and CFO, Michael Kaseta; Chief Commercial Officer, Scott Moomaw; 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 forwardlooking financial information as well as the company’s future performance and/or achieve- ments. 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. 1 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.
Roger Jeffs
Good morning, everyone, and thank you for joining us today. In a little more than 2 weeks, May 24, to be precise, we will have reached the PDUFA goal date for Liquidia’s first internally developed commercial product, YUTREPIA, an investigational inhaled dry powder formulation of treprostinil for the treatment of pulmonary arterial hypertension, or PAH, and pulmonary hypertension associated with interstitial lung disease or PH-ILD. 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 YUTREPIA, which added the treatment of PH-ILD to YUTREPA’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 YUTREPIA’s potential final approval following the expiration of gating regulatory exclusivity on May 23, 2025. With this favorable ruling in hand, we are doubling down on our preparations for the potential launch of YUTREPIA with a laser focus on 5 key strategic areas. First, we’re developing what we believe is a best-in-class product profile for YUTREPIA. As we’ve said before, YUTREPIA’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 ASCENT study in PH-ILD patients. As communicated in this morning’s press release, Cohort A of the ASCENT study is now fully 2 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 8 weeks of treatment was consistent with observations made in the IN- SPIRE study of PAH patients. Thus far, PH-ILD patients in the ASCENT study have been able to titrate to doses that are 3x higher than the labeled target dose of nebulized TYVASO. These patients have also shown positive trends on exploratory measures of efficacy, including 6-minute walk distance. Additional data from the ASCENT study will be presented during 2 poster sessions at the American Thoracic Society’s International Conference in San Francisco on May 20. 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 TYVASO and TYVASO DPI and transition them to YUTREPIA. The goal of this study will be to directly compare the differences and potential benefits that YUTREPIA presents, both in PAH and PH-ILD 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 YUTREPIA’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 YUTREPIA, whether starting inhaled treprostinil 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 3 prepared to put product in the channel in only 2 to 3 weeks after YUTREPIA’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 YUTREPIA can offer to patients. We remain confident that patients will have access to YUTREPIA within a short time after launch. With all these in play, we feel well prepared to launch YUTREPIA into the marketplace once approved, and we look forward to fulfilling our promise to provide patients with PAH and PH-ILD 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?
Michael Kaseta
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 3 months ended March 31, 2025, compared to $3 million for the 3 months ended March 31, 2024, revenue related primarily to the promotion agreement. The increase of $0.1 million was primarily due to the impact of unfavorable gross 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 3 months ended March 31, 2025 and 2024, cost of revenue related to the promotion agreement as noted above. Research and development expenses were $7 million for the 3 months ended March 31, 2025, compared to $10.1 million for the 3 months ended March 31, 2024. The decrease of $3.1 million or 31% was primarily due to a $3.6 million decrease in personnel expenses, including stockbased compensation due to a shift from activities related to research and development to preparation for the potential commercialization of YUTREPIA. These decreases were 4 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 YUTREPIA research and development activities. General and administrative expenses were $30.1 million for the 3 months ended March 31, 2025, compared to $20.2 million for the 3 months ended March 31, 2024. The increase of $9.9 million or 48% was primarily due to an $8.1 million increase in person- nel 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 YUTREPIA, a $0.6 million increase in legal fees related to our ongoing YUTREPIA-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 $0.45 per basic and diluted share compared to a net loss of $30.1 million or $0.40 per basic and diluted share for the 3 months ended March 31, 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 noncash 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 8-K we filed this morning. I would now like to turn the call back over to Roger.
Roger Jeffs
Thank you, Mike. In summary, we continue to drive forward the right set of strategies to support the successful potential launch of YUTREPIA in the coming weeks, and we look forward to providing both physicians and patients with what we believe could soon become the prostacyclin of first choice. I would now like to open the call to questions. Operator, first question, please. 5
Operator
— Operator Instructions — Our first question comes from the line of Julian Harrison of BTIG.
Julian Harrison
Congrats on all the progress. I’m wondering if you believe United has any injunctive value left on the cross claim that was dismissed last week. Also curious if you had any reaction to the dismissal without prejudice versus with prejudice given the judge’s expressed views on standing in the opinion memorandum.
Roger Jeffs
Julian, good to hear from you. Rusty, if you wouldn’t mind answering Julian’s 2 questions.
Russell Schundler
Sure. Julian, thanks for the question. So let me – I mean, cover a couple of things. I mean, one, what’s absolutely clear is that there’s currently no proceeding actively ongoing in which United Therapeutics is seeking to enjoin either the FDA from giving us approval for YUTREPIA or seeking any sort of temporary restraining order or preliminary injunction to prevent our launch of YUTREPIA upon approval. So that’s number one. Number two, the dismissal was without prejudice. Again, keep in mind, it was a motion to dismiss. So the judge was not addressing the full merits of the case. This was a question of whether their complaint had even set forth grounds upon which the court could even entertain their lawsuit. What that does mean is they can try to repurpose or refashion the argument in the future. But I think what’s clear from the way in which we approach the opinion is – they can’t come back with the exact same argument they did before. I think they still have significant standing issues trying to link the bundling guidance to a 6 30-month stay. And keep in mind, again, this is all just at the motion to dismiss phase. They still would have to then show that they’re correct on the merits as well. As far as other things that United Therapeutics might do, which I think your question alluded to, that’s really not for us to say. We don’t know what length they’re going to go to try to deny PAH and PH-ILD patients access to an alternative therapy. What I can say though is we’ll be ready in whatever form they pursue something, if they pursue anything from here on out, we’ll be ready to address it.
Operator
Our next question comes from the line of Kambiz Yazdi of Jefferies.
Kambiz Yazdi
Very exciting times for the company. Maybe a little bit on the forward-looking transition studies. Any kind of thoughts on what may be interesting patient baseline characteristics that you may be looking to enroll in that study? And then would love to get an update on L606 as well.
Roger Jeffs
Great. So both of those questions fall into Rajeev Saggar’s court. So Rajeev, mind answering those.
Rajeev Saggar
Kambiz, thanks for the question. So the first question was regarding the upcoming transition study. This study is specifically evaluating the transition from TYVASO, either neb- ulized and preferably dry powder inhaler to YUTREPIA. These patients will be specifically in the category of PH-ILD. And that’s very purposeful. As you know, in our – for our NDA filing in the INSPIRE study, we already showed that we were able to successfully transition patients with Group 1 PAH from nebulized TYVASO 7 directly to YUTREPIA. And now we’re trying to do the same thing in the PH-ILD population. So first of all, these patients will be on background TYVASO with majority of them are on dry powder inhaler. These patients will have PH-ILD. And very similar to Cohort A in part of the ASCENT study that we’re presenting at ATS, we’re going to be looking for the ability to – we’re going to be looking at safety. So can we safely transition #2, can we transition them and then continue to showcase our product profile, which we believe is going to be beneficial in terms of our ability to up-titrate that patient, maintain their clinical stability or even improve them. So we’ll be looking at exploratory efficacy modalities, inclusive of, of course, 6-minute walk and other quality of life indicators. So we look forward to showcasing that study and initiating that in the next few months. And your second question, Kambiz, is that on L606?
Kambiz Yazdi
Yes, just an update there.
Rajeev Saggar
Yes. Thank you. So we’re working diligently to initiate this global study. Just to recap, this is the liposomal sustained release formulation of treprostinil that we’re going to be delivering twice a day. Just to recap, this is a global study with more than 300 patients and more than 20 companies, and we anticipate that we’ll be initiating the study by year’s end.
Operator
Our next question comes from the line of Greg Harrison of Scotiabank.
Gregory Harrison
Congrats on the progress. So we’ve seen the competitors struggle to convert patients to their dry powder formulation and their nebulized formulation has persisted longer than 8 thought initially. Could you speak to the patient perspective on switching to dry powder formulation and whether you think YUTREPIA will have a stronger case for keeping patients on the DPI formulation than we’ve seen with TYVASO? And how do you think the ASCENT data will help with this argument?
Roger Jeffs
Greg, thanks for the question. So I’ll start with an answer and then Rajeev, if you’ll give your thoughts as well. I think that would be helpful. So again, I think you are right. It’s surprising that there remain residual nebulized TYVASO patient base. I think it’s about 31% of the scripts to date. When all thoughts, including the competitors’ thoughts initially were that all patients would transition to the DPI for portability reasons. So that hasn’t happened. And the question is why. We think it’s formulation-driven and that their formulation as part of an aggregated polydispersed formulation on a FTKP backbone really and a high resistance device and low flow really doesn’t deliver the drug to the lower airway, which is the site of action. So that’s completely the opposite of what a PRINT enabled YUTREPIA is going to achieve, and which is what we’ve shown in the ASCENT study that patients can tolerate the drug well. They can get to very high doses and then they can get there quickly. So those 2 points are important in the sense that patients want to feel better. They want to do it on convenient and portable therapeutic modality. And we think YUTREPIA is clearly defined as a differentiated and a better opportunity to do just that. So I think what we’ll do in the marketplace first is go after new patient starts to let physicians experience the benefits of YUTREPIA firsthand. And then once they’re comfortable with that, then we’ll see if they will transition, particularly their nebulized patients who are going to be looking for an alternative, more portable therapy. And then also, I think it becomes a question of would you even start TYVASO DPI or if you’re on TYVASO DPI, 9 would you want to transition? And as Rajeev just said in the previous question, we’re going to have data directing to the specifics of how you transition and the benefits of doing the same. So we’re really excited about all of the market opportunity, but I do agree that the nebulized TYVASO retained commercial share is at risk, and we’re going to go after that in time. So Rajeev, do you have any thoughts?
Rajeev Saggar
Yes. Thanks, Roger. I think, again, just highlighting, I think we believe in our scientific formulation and our hypothesis that the PRINT formulation with a low flow resistance device is actually what these patients need. I think from my perspective, I think what’s really unique is 2 things. In – back when we did the INSPIRE study in Group 1 PAH, it took a while for patients to titrate up YUTREPIA to get to doses of therapeutic zones. I think what we’re seeing now a few years later now that we did the first cohort study that we now have fully enrolled, and we’re going to showcase that data at ATS is that not only can we titrate doses to above the sort of traditional 9 to 12 breaths, we’re dosing these to at least twofold levels higher than what traditionally is given by TYVASO, but we can do it in a matter of just several weeks, not over a course of a year. And I think that’s very important because these patients are extremely sick. They are susceptible to clinical worsening. And finally, inherently, they just have terrible costs. And one thing, I think, to your question is that the current incumbent dry powder formulation, I think one of its major limitations is its inability to titrate to the appropriate doses to match the clinical severity of the patient in part due to cost. And I think one of the things that we are going to continue to highlight, especially at ATS is just the tolerability profile of YUTREPIA seems to be well received by the patients and the practitioners that are participating in the study. So I think using that signal and reshowing that in the 10 transition study, I think, would be well received by the scientific community.
Roger Jeffs
Great. Thank you, Rajeev. I think your comments speak to the snippets of why we’re so excited about the pending launch.
Operator
Our next question comes from the line of Cory Jubinville of LifeSci Capital.
Cory Jubinville
Congrats on the progress. So you mentioned earlier in the prepared remarks that you’re building out this prescriber support team. And as we speak to KOLs in addition to efficacy and tolerability, it seems that ease of prescribing also appears to be a major component to their prescription habits. Could you just provide a little bit more detail as to what that support team might look like in their activities? And specifically, what might you be doing that improves the prescriber experience over what’s out there presently and how that compares to potential competitors? And I guess on the patient side, in terms of early patient access, do you have any details about what a potential bridging program might look like if that’s in the plans of the patients?
Roger Jeffs
Yes. Thanks for the question, Cory. So we’re benefited by having our Chief Commercial Officer, Scott Moomaw, on the call. So Scott, if you wouldn’t mind addressing the questions.
Scott Moomaw
Yes, sure. So the specifics, I think we’ll sort of share as we get through and past approval 11 around the patient support program. But what I would say is our team has over a decade – most folks have over a decade of experience with treprostinil in the various forms, working with the specialty pharmacies, working with this patient population. And we have a very good understanding of what the needs of the HCPs and the patients are. So we’ve built out a program that we think in all respects will be as good as or better than what’s on the market right now in terms of the way that these patients have been cared for. We completely understand the point that you raised around being able to start these patients is what’s very important to early success, and we’re going to make sure that we have everything in place to make sure that happens. And we look forward to sharing that with you, hopefully, after the end of May.
Operator
Our next question comes from the line of Jason Gerberry of BofA.
Chi Meng Fong
This is Chi on for Jason. So you have some data presentation at the ATS meeting in a couple of weeks. I’m curious if you can give us an early flavor of these presentations, what’s your expectations? And when might we get the full 48-week data from the ASCENT study?
Roger Jeffs
Great. Since Rajeev, you’re the leading architect of the Cohort A study, if you could talk to that question.
Rajeev Saggar
Yes. Thanks for that question. I think at this point, obviously, we’re under embargo to go into the actual details of the study. But essentially, we’re going to be presenting 3 posters tumor specifically related to the ASCENT study, which we will showcase the first 20 patients that were treated for 8 weeks. Remember, these are patients with newly 12 diagnosed PH-ILD that are now taking YUTREPIA. So we’ll showcase a few things, the baseline demographics. We will detail out the tolerability profile of these patients as well as the dosing characteristics that we’re seeing. So that’s the first thing. The second thing is that we’ll finally showcase some exploratory endpoints within the first 2 posters. The first one being, of course, what happens to their exercise tolerability, which is defined by 6-minute walk distance compared to baseline through 8 weeks. And the other thing is we’re going to showcase a novel endpoint that’s known as cardiac effort, and that will be presented by Dr. Dan Lachant at the University of Rochester, again, sort of understanding why potentially these patients are showing improvements in their exercise capacity and what are the potential reasons for that and how YUTREPIA is modifying its performance on the right ventricle. The third poster will be presented looking at transitioning a patient that was participating in the INSPIRE study from – who had acutely worsened, was hospitalized, placed on intravenous treprostinil and transitioned to LIQ861 or YUTREPIA and just highlighting that safety, that ability to transition patients from parenteral therapy back to LIQ861 in that study. So all in all, we’re very excited to again showcase some of these – our product profiles of ATS.
Roger Jeffs
Thank you, Rajeev. Obviously, the timing of that data is quite exciting and the fact that it will be presented literally within a week of potential approval.
Operator
Our next question comes from the line of Serge Belanger of Needham. 13
Serge Belanger
A couple of commercial questions. The first one, maybe for Roger and Scott, can you just describe the level of awareness of YUTREPIA and its differentiating attributes and the group of physicians you’ll be targeting upon launch? And secondly, do you expect there to be some warehouse demand for this product? Or this is a group of physicians that will likely want to run their own internal evaluation before really ramping up usage of YUTREPIA?
Roger Jeffs
Yes. Thanks for the question, Serge. Scott, maybe you could opine on those.
Scott Moomaw
Sure. So on the awareness question, obviously, prior to launch, we’re very limited in what we can communicate from a perspective, in fact, nothing. So – but we’re looking forward to the launch, and I can guarantee you that we will be loud. The awareness will go up extremely quickly. There is background awareness due to medical information we’ve shared, et cetera. But once the sales team gets out there, we have a full suite of marketing activities, electronic activities. Our goal is that every HCP who is involved in PAH, whether that be PAH or PH-ILD will be aware, and we’ll be able to try it very soon after launch. The second question was about warehousing. I think there might be some of that due to the tolerability issues in the conversation that came up earlier around the nebulized patients. Certainly, as Roger has said, I think even earlier in this call, we’ll be focused on new patients because those are the patients that give the physician really the best opportunity to try the drug in sort of a clean way. Having said that, we have heard from a number of physicians that they have patients that have transitioned back to the nebulized version of TYVASO. And I think we all understand 14 that that’s not optimal from a convenience standpoint and a dosing standpoint. And so we will get some of those. We will work with those physicians to make sure that those are successes. But strategically, the patients that we’ll be going after, first and foremost, will be those patients that are new to prostacyclin.
Roger Jeffs
Yes. Thanks. And I think, Serge, one way to look at this is there’s the almost 3 phases of how we integrate YUTREPA into the standard of care. And I do think we can change the paradigm that currently exists and become the prostacyclin of first and best choice. So I think we’ll do the new patient starts, then we’ll do the transitions. And then if you just said what’s the current inhaled treprostinil market, that’s a $2 billion market opportunity and growing significantly still with the sort of white space that remains in PH-ILD. But then the other $2 billion today market opportunity is the oral prostacyclins both Uptravi and Orenitram enjoy. And I don’t think there’s been any counter detailing against those products to date, and we certainly are going to do that because they have significant off-target effects. There’s quite some duress that the patients have to undergo to get to therapeutic doses and be maintained on those therapies that we think we can solve for because now for the first time, there’s a readily titratable and durable inhaled prostacyclin called YUTREPIA. So those different promotional cadences will happen at different paces. But I think collectively, we’re going to integrate ourselves across all of that. So when you look at what’s the current market opportunity, it’s really $4 billion and growing. And I think there’s opportunity for us to be very successful. We don’t necessarily need to take incumbent share, but I think over time, that will happen. Operator, time for one more question, if you have any. 15
Operator
Our last question comes from the line of Ryan Deschner of Raymond James.
Ryan Deschner
Curious on what you’re anticipating in terms of the split between commercial and public payers in PAH and PH-ILD. And I was wondering if you could just quickly walk us through the important points of the 494 patent infringement suit that you recently filed.
Roger Jeffs
Yes. So Scott, if you’ll answer the first part of that and then rest of you talk about the ’494 litigation.
Scott Moomaw
Yes. From a payer mix standpoint, looking at the prostacyclin market and TYVASO specifically, we think we’ll probably have about 50% Medicare, about 35% commercial, maybe 10% Medicaid and then 5% other, whether that be TRICARE, DoD, et cetera. So we’ll see when we get out there, but that seems to be what we’re expecting.
Russell Schundler
And Ryan, thanks for the question on the 494 lawsuit. So we’re not really going to comment much on that. I mean, obviously, we filed the lawsuit. I think the complaint sets forth pretty clearly our thoughts as to the grounds on which we’re proceeding with an infringement lawsuit. That case is in the very early stages. So again, I can’t really comment on timing and typical with best practice, we won’t comment publicly on legal theories or legal strategies we’re going to pursue in the case.
Roger Jeffs
Great. Thank you, Scott. Thank you, Ryan, for the question. So with that, we’ll close. And as you can see, we’re very excited about actually matriculating our mission and vision of 16 delivering a new treatment modality to patients with PAH and PH-ILD. And hopefully, as May 24 approaches, we’ll be in touch and speaking with you all very soon. Thank you for your time this morning.
Operator
Thank you for your participation in today’s conference. This does conclude the program. You may now disconnect. Copyright © 2025, S&P Global Market Intelligence. All rights reserved 17