LQDA - NASDAQ

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. 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. 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.

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 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 will open the call for your questions.

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 YUTREPIA’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 rolling in hand, we are doubling down on our preparations for the potential launch of YUTREPIA with a laser focus on five 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 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 INSPIRE study of PAH patients. Thus far, PH-ILD patients in the ASCENT study have been able to titrate to doses that are 3 times 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 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 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 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 filling 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?

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 stack-based compensation, due to a shift from activities related to research and development to preparation for the potential commercialization of YUTREPIA. 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 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 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 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 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 8-K we filed this morning. I would now like to turn the call back over to Roger.

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 be soon become the prostacyclin of first choice. I’d now like to open the call to questions. Operator, first question, please?

Thank you. At this time, we will conduct the question-and-answer session. [Operator Instructions] Our first question comes from the line of Julian Harrison of BTIG. Your line is now open.

Hi, congrats on all the progress and thank you for taking my questions. 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.

Good morning, Julian. Good to hear from you. Rusty, if you wouldn’t mind answering Julian’s two questions.

Sure. Julian, thanks for the question. So let me, I mean, go over a couple 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. That’s number one. Number two, the dismissal was without prejudice. Again, keep in mind, there was some 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 repassion the argument in the future, but I think what’s clear from the way in which he approached 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 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 today. We don’t know what lengths 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, whatever form they pursue something if they pursue anything from here on out, we’ll be ready to address it. Thanks.

Excellent. Very helpful. Thank you. And congrats again.

Thank you, Julian. Next question, please?

Thank you. Our next question comes from the line of Kambiz Yazdi of Jefferies. Your line is now open. Kambiz, do we have you here?

Sorry. Good morning, team. Thank you so much for the questions and 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, I’d love to get an update on L606 as well.

Great. So, both of those questions fall into Rajeev Saggar’s court. So, Rajeev, do you mind answering those?

Yeah. Hi, 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 nebulized 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 for NDA filing in the INSPIRE study, we already showed that we were able to successfully transition patients with Group 1 PAH from nebulized Tyvaso 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, [Technical Difficulty] majority of them are on dry powder inhaler. These patients will have PH-ILD and very similar to Cohort A as in part of the ASCENT study that we’re presenting at ATS. We’re going to be looking at safety. So can we safely transition number two? 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?

Yeah, just an update there.

Yeah, 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 this study by year’s end.

Thank you.

Thank you. Our next question comes from the line of Greg Harrison of Scotiabank. Your line is now open.

Hey, good morning, guys. Congrats on the progress, and thanks for taking the question. So, we’ve seen the competitors struggle to convert patients to their dry powder formulation, and their nebulized formulation has persisted longer than 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 a DPI formulation than we’ve seen with Tyvaso, and how do you think the ASCENT data will help with this argument?

Yeah. Good morning, 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’d be helpful. So, again, I think you’re all right, it’s surprising that there remain a residual nebulized Tyvaso patient base. I think it’s about 31% of the scripts today, when all thoughts, including the competitor’s thoughts initially were that all patients would transition to the DPI for portability reasons alone. So that hasn’t happened, and the question is why. We think it’s formulation driven and that their formulation is part of an aggregated polydisperse formulation on a FDKP backbone, really, and a high resistance device in 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 they can get there quickly. So those two 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, like, 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, 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 still not going to go after it in time. So Rajeev, do you have any thoughts?

Yeah. Thanks, Roger. I think, again, just highlighting, I think we believe in our scientific formulation and our hypothesis that the PRINT formulation with the low flow resistance devices, actually what these patients need. I think, from my perspective, I think what’s really unique is two 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, 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 two full 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 costs. 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 transition study, I think would be well received by the scientific community.

Great. Thank you, Rajeev. I think your comments speak to the snippets of why we’re so excited about the pending launch. Operator, next question, please?

Thank you. Our next question comes from the line of Cory Jubinville of LifeSci Capital. Your line is now open.

Thanks for taking our questions, and 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 for patients?

Yeah. Thanks for the question, Cory. So, we’re benefiting by having our Chief Commercial Officer, Scott Moomaw, on the call. So Scott, if you wouldn’t mind addressing the questions.

Yes. Sure. Good morning. So, the specifics, I think, we’ll sort of share as we get through and pass approval 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 especially 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.

Great. Thank you, Scott.

Thank you. Our next question comes from the line of Jason Gerberry of BofA. Your line is now open.

Hey, guys, this is Chi [ph] on for Jason. Thanks for taking our question. 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. Thanks so much.

Great. Since, Rajeev, you’re the leading architect of the Cohort A study, if you could talk to that question.

Yeah, 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 three posters. Two are 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 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 two 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 who had acutely worsened and was hospitalized, placed on intravenous treprostinil and transitioned to LIQ861 or YUTREPIA, and just highlighting that safety, that ability to transition patients from parental therapy back to LIQ861 in that study. So, all-in-all, we’re very excited to, again, showcase some of our product profiles at ATS.

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, next question?

Great. Thank you.

Thank you. Our next question comes from the line of Serge Belanger of Needham. Your line is now open.

Good morning. 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 in the group of physicians you’ll be targeting upon launch? And secondly, do you expect there could 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? Thanks.

Yeah. Thank you. Thanks for the question, Serge. Scott, maybe you could opine on that.

Sure. So, on the awareness question, obviously, prior to launch, we’re very limited in what we can’t communicate [Technical Difficulty] perspective, in fact, nothing. 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 the 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 PH, whether that be PH, PAH or PH-ILD, will be aware and will 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 that that’s not optimal from a convenience standpoint and the 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 will be going after first and foremost will be those patients that are new to prostacyclins.

Yeah, thanks. And I think, Serge, one way to look at this is that there’s been almost 3 phases of how we integrate YUTREPIA into the standard of care, and I do think we can change the paradigm that currently exists and become the process like on the 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 opportunities, 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 in growing. And I think, there’s an 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, make your time for one more question, if you have any?

Thank you. Our last question comes from the line of Ryan Deschner of Raymond James. Your line is now open.

Good morning. 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. Thank you.

Yeah. So, Scott, if you’ll answer the first part of that, and then, Rusty, you’ll talk about 494 litigation.

Yeah, from a payer ex 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.

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 has been in the very early stages, so we can’t really comment on timing, and typical with past practice won’t comment publicly on legal theories or legal strategies we’re going to pursue in the case.

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 and about actually matriculating our mission and vision of delivering a new treatment modality to patients with PAH and PH-ILD. And, hopefully, as May 24th approaches, we’ll be in touch and speaking with you all very soon. Thank you for your time this morning.