Liquidia Q1 2025 Earnings Report

Liquidia EPS Results

• Actual EPS: -$0.45
• Consensus EPS: -$0.42
• Beat/Miss: Missed by -$0.03
• One Year Ago EPS: N/A

Liquidia Revenue Results

• Actual Revenue: $3.12 million
• Expected Revenue: $3.23 million
• Beat/Miss: Missed by -$105.00 thousand
• YoY Revenue Growth: N/A

Liquidia Announcement Details

• Quarter: Q1 2025
• Date: 5/8/2025
• Time: Before Market Opens
• Conference Call Date: Thursday, May 8, 2025
• Conference Call Time: 8:30AM ET

Liquidia (NASDAQ:LQDA), a biopharmaceutical company, develops, manufactures, and commercializes various products for unmet patient needs in the United States. Its lead product candidates include YUTREPIA, an inhaled dry powder formulation of treprostinil for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company also offers Remodulin, a treprostinil administered through continuous intravenous and subcutaneous infusion. The company also a license agreement with Pharmosa Biopharm Inc to develop and commercialize L606, an inhaled sustained-release formulation of Treprostinil for the treatment of PAH and PH-ILD. Liquidia Corporation was founded in 2004 and is headquartered in Morrisville, North Carolina.

Liquidia Q1 2025 Earnings Call Transcript

Key Takeaways

• On May 24, 2025, Liquidia expects a PDUFA decision for Eutrevia, its inhaled dry powder treprostinil product targeting pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
• The U.S. District Court dismissed United Therapeutics’ challenge to Eutrevia’s PH-ILD label addition, leaving no legal obstacles to approval after exclusivity expires on May 23, 2025.
• The open-label ASCENT trial in PH-ILD has fully enrolled Cohort A (>50 patients), demonstrating tolerability at doses three times higher than nebulized Tyvaso and positive trends in six-minute walk distance, with Cohort B transition study launching soon.
• Liquidia is fully prepared for commercialization with 50 experienced sales representatives, a comprehensive patient support program, product channel stocking within two to three weeks post-approval, and established payer relationships.
• In Q1 2025, revenue was $3.1 million (vs. $3.0 M Y/Y), R&D expenses declined 31% to $7.0 M, G&A expenses rose 48% to $30.1 M, and net loss was $38.4 M ($0.45 per share).

Presentation

[Operator]

Good morning, and welcome everyone to the Liquidia Corporation First Quarter twenty twenty five 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. Intra instructions will be provided at that time for you to queue up for questions.

[Operator]

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, Chief Business Officer at Liquidia Corp]

Thank you, operator. It is my pleasure to welcome everyone to the Liquidia Corporation first quarter twenty twenty five financial results and corporate update call. Joining the call today are Chief Executive Officer, Doctor. Roger Jeffs Chief Medical Officer, Doctor. Rajeev Sagar Chief Operating Officer and CFO, Michael Cassetta Chief Commercial Officer, Scott Mumaw and General Counsel, Rusty Schundler.

[Jason Adair, Chief Business Officer at Liquidia Corp]

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.

[Roger Jeffs, CEO at Liquidia Corp]

Good morning, everyone, and thank you for joining us today. In a little more than two weeks, May twenty fourth to be precise, we will have reached the PDUFA goal date for Liquidia's first internally developed commercial product, Eutrebia, 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 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 Eutrebia, which added the treatment of PHILD to Eutrebia'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.

[Roger Jeffs, CEO at Liquidia Corp]

We are proud to say there continue to be no legal barriers barring Utrechtia's potential final approval following the expiration of gating regulatory exclusivity on 05/23/2025. With this favorable ruling in hand, we are doubling down on our preparations for the potential launch of Utruria with a laser focus on five key strategic areas. First, we're developing what we believe is a best in class product profile for Eutropia. As we've said before, Eutropia'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.

[Roger Jeffs, CEO at Liquidia Corp]

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 twenty patients to complete eight 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 three times higher than the labeled target dose of nebulized Tyvaso. 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 20.

[Roger Jeffs, CEO at Liquidia Corp]

As part of the ASCEND 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 Utruria. The goal of this study will be to directly compare the differences and potential benefits that Utruria 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 eighteen months, and a companion medical affairs team, all with an impressive level of rare disease experience, and most with PH experience.

[Roger Jeffs, CEO at Liquidia Corp]

These groups have been actively surveilling both the major centers of excellence, as well as the community prescriber base in preparation for Eutropia'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 utrebia, 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 two to three weeks after Eutrebia's potential approval.

[Roger Jeffs, CEO at Liquidia Corp]

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 Eutremia within a short time after launch. With all these in play, we feel well prepared to launch Eutremia 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 twenty twenty five financials.

[Roger Jeffs, CEO at Liquidia Corp]

Mike?

[Michael Kaseta, COO & CFO at Liquidia Corp]

Thank you, Roger, and good morning, everyone. Turning to our first quarter twenty twenty five financial results, which can be found in the press release, you will see that revenue was $3,100,000 for the three months ended 03/31/2025, compared to $3,000,000 for the three months ended 03/31/2024. Revenue related primarily to the promotion agreement. The increase of $100,000 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 $1,500,000 for each of the three months ended March 2024.

[Michael Kaseta, COO & CFO at Liquidia Corp]

Cost of revenue related to the promotion agreement as noted above. Research and development expenses were $7,000,000 for the three months ended 03/31/2025, compared to $10,100,000 for the three months ended 03/31/2024. The decrease of $3,100,000 or 31% was primarily due to a $3,600,000 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 Eutrebia. These decreases were offset by a $1,700,000 increase in clinical expenses related to our L606 program and a $400,000 decrease in expenses related to our Eutremia research and development activities. General and administrative expenses were $30,100,000 for the three months ended 03/31/2025 compared to $20,200,000 for the three months ended 03/31/2024.

[Michael Kaseta, COO & CFO at Liquidia Corp]

The increase of $9,900,000 or 48% was primarily due to an $8,100,000 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 Eutremia, a $600,000 increase in legal fees related to our ongoing Eutremia related litigation, and a $600,000 increase in facilities and infrastructure expenses. We incurred a net loss for the quarter ended March thirty one, twenty twenty five of thirty eight point four million dollars or $0.45 per basic and diluted share compared to a net loss of $30,100,000 or $0.40 per basic and diluted share for the three months ended 03/31/2024. 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 eight ks we filed this morning.

[Michael Kaseta, COO & CFO at Liquidia Corp]

I would now like to turn the call back over to Roger.

[Roger Jeffs, CEO at Liquidia Corp]

Thank you, Mike. In summary, we continue to drive forward the right set of strategies to support the successful potential launch of Utopia 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.

[Operator]

Thank you. At this time, we will conduct a question and answer session. As a reminder, to ask a question, you will need to press 11 on your telephone and wait for your name to be announced. To withdraw your question, please press 11 again. Our first question comes from the line of Julian Harrison of BTIG.

[Operator]

Your line is now open.

[Julian Harrison, Managing Director at BTIG]

Hi. Congrats on all the progress,

[Julian Harrison, Managing Director at BTIG]

and thank you for taking my 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, CEO at Liquidia Corp]

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

[Rusty Schundler, General Counsel at Liquidia Corp]

Sure. Julian, thanks for the question. So let me, I mean, go over 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 utreptia or seeking, any sort of, temporary restraining order preliminary injunction to prevent our launch of utreptia upon Number two, the dismissal was without prejudice.

[Rusty Schundler, General Counsel at Liquidia Corp]

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 You know 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 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 thirty 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.

[Rusty Schundler, General Counsel at Liquidia Corp]

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 gonna go to try to deny PAH and PHLD patients access to an alternative therapy. What I can say, though, is, you know, we'll be ready, you know, whatever form they they pursue something. If they pursue anything from here on out, we'll be we'll be ready to address it. Thanks.

[Julian Harrison, Managing Director at BTIG]

Excellent. Very helpful. Thank you, and congrats again.

[Roger Jeffs, CEO at Liquidia Corp]

Thank

[Roger Jeffs, CEO at Liquidia Corp]

you, Julian. Next question, please.

[Operator]

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

[Kambiz Yazdi, Vice President - Equity Research at Jefferies Financial Group]

Hi. 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 would love to get an update on L606 as well.

[Roger Jeffs, CEO at Liquidia Corp]

Great, so both of

[Roger Jeffs, CEO at Liquidia Corp]

those

[Roger Jeffs, CEO at Liquidia Corp]

questions fall into Rajeev's cyber support. So Rajeev, do you mind answering those?

[Rajeev Saggar, CMO at Liquidia Corp]

Yeah, hi, Kenvi, thanks for the question. So the first question was regarding the upcoming transition study. This study is specifically evaluating transition from Tyvaso either nebulized and preferably dry powder inhaler to Eutropia. These patients will be specifically in a 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 one PAH from nebulized Tyvaso directly to Eutropia. And now we're trying to do the same thing in the PHLD population.

[Rajeev Saggar, CMO at Liquidia Corp]

So first of all, these patients will be on background Tyvasyl, majority of them are on Threat Powder Inhaler. These patients will have PHLD and very similar to cohort A as in part of the SENSE 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 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 uptitrate that patient, maintain their clinical stability or even improve them. We'll be looking at exploratory efficacy modalities inclusive of of course, six minute walk and other quality of life indicators.

[Rajeev Saggar, CMO at Liquidia Corp]

So we look forward to showcasing that study and initiating that in the next few months. And your second question, Coffey, is that on L-six zero six?

[Kambiz Yazdi, Vice President - Equity Research at Jefferies Financial Group]

Yeah, just an update there.

[Rajeev Saggar, CMO at Liquidia Corp]

Yeah, thank you. So, you know, 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.

[Kambiz Yazdi, Vice President - Equity Research at Jefferies Financial Group]

Thank you.

[Operator]

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

[Greg Harrison, Director - Biotechnology at Scotiabank]

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 whether you think you Trepia 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?

[Roger Jeffs, CEO at Liquidia Corp]

Yeah. Good morning, Greg.

[Roger Jeffs, CEO at Liquidia Corp]

Thanks for the question. So I'll I'll start with an answer, then, Rajeev, if you'll give your thoughts as well, I think that'd be helpful. So, you know, again, I think 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 today, when all thoughts, including the competitor's thoughts initially, were that all patients would trans transition to the DPI for portability alone.

[Roger Jeffs, CEO at Liquidia Corp]

So that hasn't happened, and the the question is why. We think it's it's formulation driven and that their formulation, you know, is part of a aggregated polydispersed formulation on a FTKP backbone, really, and 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 TREPIA 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.

[Roger Jeffs, CEO at Liquidia Corp]

And we think utrebia 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 utrebia firsthand. And then once they're comfortable with that, then then we'll see if 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?

[Roger Jeffs, CEO at Liquidia Corp]

And as Rajeev just said in the previous question, we're gonna have data directed directing to the specifics of how you transition and the benefits of doing the same. So I we're really excited about all of the market opportunity, but I I do agree that the nebulized Tyvaso retained commercial share is is at risk, and we're still not gonna go after it in time. So Rajeev, do you have any thoughts?

[Rajeev Saggar, CMO at Liquidia Corp]

Yeah, 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 two things. Back when we did the INSPIRE study in group one PAH, it took a while for patients to titrate up utrebia 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 nine to twelve breaths.

[Rajeev Saggar, CMO at Liquidia Corp]

We're dosing these to at least two fold levels higher than what traditionally is given by Tyvaso but we can do it in a matter of just several weeks, 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. Finally, inherently they just have terrible costs. And one thing I think to your question is that the current incumbents dry powder formulation, I think one of its major limitations is inability to titrate to the appropriate doses to match the clinical severity of the patient in part due to cost.

[Rajeev Saggar, CMO at Liquidia Corp]

I think one of the things that we are going to continue to highlight especially at ATS is just the tolerability profile of utropia seems

[Rajeev Saggar, CMO at Liquidia Corp]

to be

[Rajeev Saggar, CMO at Liquidia Corp]

well received by the patients and the practitioners that are participating in the study. I think using that signal and re showing that in the transition study I think be well received by the scientific community.

[Roger Jeffs, CEO at Liquidia Corp]

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

[Operator]

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

[Cory Jubinville, Managing Director & Research Analyst at LifeSci Capital, LLC]

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. As we speak to KOLs, in addition to efficacy and tolerability, 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?

[Roger Jeffs, CEO at Liquidia Corp]

Yeah, thanks for the question, Corey. So we're benefited by having our Chief Commercial Officer Scott Luma on the call. So Scott, if you wouldn't mind addressing questions.

[Scott Moomaw, Chief Commercial Officer at Liquidia Corp]

Yes, sure. Good morning. So, you know, the specifics, I think we'll we'll sort of, share as we get, through and pass approval around the patient support program. But what I would say is, you know, 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 these this patient population. And we have a very good understanding of what the needs of the HCPs and the patients are.

[Scott Moomaw, Chief Commercial Officer at Liquidia Corp]

So we 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, you know, being able to start these patients is what's very important to early success. And we're going 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 May.

[Roger Jeffs, CEO at Liquidia Corp]

Great. Thank you, Scott.

[Operator]

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

[Chi Fong, VP - Equity Research at Bank of America Merrill Lynch]

Hey, guys, this is Chi 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?

[Chi Fong, VP - Equity Research at Bank of America Merrill Lynch]

And when might we get the full forty eight week data from the ASCEND study? Thanks so much.

[Roger Jeffs, CEO at Liquidia Corp]

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

[Rajeev Saggar, CMO at Liquidia Corp]

Yeah. Thanks. Thanks for that question. I I think at this point, you know, obviously, we're under embargo, to to go into the actual details of the study. Essentially we're going to be presenting three posters.

[Rajeev Saggar, CMO at Liquidia Corp]

Two are specifically related to the SENSE study which we will showcase the first twenty patients that were treated for eight weeks. Remember, these are patients with newly diagnosed PHLD that are now taking utrebia. 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.

[Rajeev Saggar, CMO at Liquidia Corp]

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 six minute walk distance compared to baseline through eight 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 Doctor. Dan LeChant at University of Rochester. Again, sort of understanding why potentially these patients are showing improvements in their exercise capacity and are the potential reasons for that and how Utopia is modifying its performance on the right ventricle.

[Rajeev Saggar, CMO at Liquidia Corp]

The third poster will 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 utrebia and just highlighting that safety, that ability to transition patients from parental therapy back LIQ861 in that study. So all in all, we're very excited to again showcase some of these, our product profiles at ATS.

[Roger Jeffs, CEO at Liquidia Corp]

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.

[Chi Fong, VP - Equity Research at Bank of America Merrill Lynch]

Great, thank you.

[Operator]

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

[Serge Belanger, Senior Analyst at Needham & Company]

Hi, good morning. A couple of commercial questions. The first one maybe for Roger and Scott. Can you just describe the level of awareness of Vutropia 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 Eutropia?

[Serge Belanger, Senior Analyst at Needham & Company]

Thanks.

[Roger Jeffs, CEO at Liquidia Corp]

Yeah, thank you. Thanks for the question, Serge. Scott, maybe if you could opine on those.

[Scott Moomaw, Chief Commercial Officer at Liquidia Corp]

Sure. So on the awareness question, obviously, you know, prior to launch, we're very limited, in, you know, what we can communicate from perspective, in fact, nothing. So but we're looking forward to the the launch, and I can guarantee you that we will be loud. The awareness will go up extremely quickly. There is background awareness, you know, due to the medical information we've shared, etcetera.

[Scott Moomaw, Chief Commercial Officer at Liquidia Corp]

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 PHLD we'll be aware and we'll be able to try it very soon after launch. The second question was about warehousing. I think, you know, 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 option opportunity to try the drug in sort of a clean way.

[Scott Moomaw, Chief Commercial Officer at Liquidia Corp]

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 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, you know, the patients that we'll be going after first and foremost will be those patients that are new to prostacyclines.

[Roger Jeffs, CEO at Liquidia Corp]

Yeah, thanks. And I think Serge, one way to look at this is that there's the almost three phases of how we integrate Butrepe 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.

[Roger Jeffs, CEO at Liquidia Corp]

So I think we'll do the

[Roger Jeffs, CEO at Liquidia Corp]

new patient starts, then we'll do the transitions. And then, you know, if you just said what's the current inhaled treprostinil market, that's a 2,000,000,000 market opportunity and growing significantly still with the sort of white space that remains in PH ILD. But then the other 2,000,000,000 today market opportunities, the oral prostacyclines, both of Travy 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.

[Roger Jeffs, CEO at Liquidia Corp]

Because now, for the first time, there's a readily titratable and durable inhaled prostacyclin called Utrechtia. So, you know, those different promotional cadences will happen at different paces. But I think collectively, we're going to integrate ourselves across all of that. When you look at what's the current market opportunity, it's really $4,000,000,000 and growing. And I think there's opportunity for us to be very successful.

[Roger Jeffs, CEO at Liquidia Corp]

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.

[Operator]

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

[Ryan Deschner, Vice President - Equity Research at Raymond James Financial]

Good morning. Curious on what you're anticipating in terms of the split between commercial and public payers in PAH and PILD, and was wondering if you could just quickly walk us through the important points of the four ninety four patent infringement suit that you recently filed. Thank you.

[Roger Jeffs, CEO at Liquidia Corp]

Yeah, so Scott, if you'll answer the first part of that, and then Rusty, you'll talk about the four ninety four litigation.

[Scott Moomaw, Chief Commercial Officer at Liquidia Corp]

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, you know, DoD, etc. So, we'll see when we get out there, but that seems to be what we're expecting.

[Rusty Schundler, General Counsel at Liquidia Corp]

Ryan, thanks for the question on the four ninety four lawsuit. So, we're not really gonna comment much on that. I mean, obviously, filed You know, I think the complaint sets forth pretty clearly, you know, our thoughts as to the grounds on which we're proceeding with an infringement lawsuit. You know, that case is in the very early stages.

[Rusty Schundler, General Counsel at Liquidia Corp]

So again, can't really comment on timing and, typical with best practice won't comment publicly on legal theories or legal strategies we're going pursue in the case.

[Roger Jeffs, CEO at Liquidia Corp]

Great. Thank you, Scott. Thank you, Ryan, the question. So with that, we'll close. And, you know, 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 PH and PH ILD.

[Roger Jeffs, CEO at Liquidia Corp]

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.

Participants

Executives

• Jason Adair, Chief Business Officer
• Roger Jeffs, CEO
• Michael Kaseta, COO & CFO
• Rusty Schundler, General Counsel
• Rajeev Saggar, CMO
• Scott Moomaw, Chief Commercial Officer

Analysts

• Julian Harrison, Managing Director at BTIG
• Kambiz Yazdi, Vice President - Equity Research at Jefferies Financial Group
• Greg Harrison, Director - Biotechnology at Scotiabank
• Cory Jubinville, Managing Director & Research Analyst at LifeSci Capital, LLC
• Chi Fong, VP - Equity Research at Bank of America Merrill Lynch
• Serge Belanger, Senior Analyst at Needham & Company
• Ryan Deschner, Vice President - Equity Research at Raymond James Financial