Liquidia at BofA Securities 2025: Strategic Launch Plans for Eutrebia

On Tuesday, 13 May 2025, Liquidia Technologies (NASDAQ:LQDA) presented at the BofA Securities 2025 Healthcare Conference, outlining strategic plans for their lead product, Eutrebia, ahead of its imminent PDUFA date. The presentation, led by COO & CFO Mike Kaseta and CMO Rajiv Sagar, highlighted both the potential market impact and the challenges faced, including ongoing legal disputes with United Therapeutics.

Key Takeaways

• Liquidia is preparing for the potential market launch of Eutrebia, focusing on five key strategies for success.
• The company faces legal challenges from United Therapeutics but remains committed to bringing Eutrebia to market.
• Liquidia’s ASCENT trial data will soon be presented, showcasing Eutrebia’s safety and efficacy.
• A Phase 3 study for L606, a new formulation of treprostinil, is planned for the end of the year.
• Liquidia aims to expand its reach in the PHILD market, which remains largely underserved.

Financial Results

• United Therapeutics’ sales are close to $2 billion annually, indicating a substantial market opportunity.
• The market is divided into Part D (approximately 50%), commercial (35-40%), and mandated channels (10-15%).
• There are about 18,000 patients on prostacyclin therapy, with 6,000 new prescriptions annually.

Operational Updates

• Eutrebia is nearing its PDUFA date, with a focus on establishing a strong product profile and salesforce.
• Manufacturing capabilities are robust, with a three-year shelf life and sufficient supply for launch.
• Liquidia plans to support patients through comprehensive services and ensure broad payer access.

Future Outlook

• Eutrebia is positioned to maximize benefits in the PHILD market, addressing unmet needs.
• The upcoming Phase 3 study for L606 aims to target the twice-daily prostacyclin market.
• Liquidia may expand its salesforce based on the commercial success of Eutrebia.

Q&A Highlights

• Legal challenges from United Therapeutics are ongoing, but Liquidia is defending its rights.
• Eutrebia’s label will be similar to Tyvaso, with specific dosing guidance.
• The PHILD market is largely untapped, with only 20% penetration by United Therapeutics.
• The ASCENT trial data will highlight Eutrebia’s safety, tolerability, and efficacy.

Readers are encouraged to refer to the full transcript for a detailed understanding of Liquidia’s strategic plans and market positioning.

Full transcript - BofA Securities 2025 Healthcare Conference:

Jason, Host: And we’re joined by, two members of the management team, Mike Kaseta, chief operating officer and chief financial officer operating in dual roles, and Rajiv, Sagar, chief medical officer. So, gentlemen, thanks so much for, joining us. And and, Mike, if you get a a few introductory remarks about Liquidia, you know, which is a precommercial for now, biotech company in the cardiopulmonary space, but maybe just the latest and greatest for investors, to orient themselves to the Liquidia story, and then we’ll go into more specific questions.

Mike Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia: Yeah. Jason, thanks so much for having us. Rajeev and I are are, you know, really happy to be here to tell our story. You know what I’ll say? It’s a it’s an exciting time right now.

We are exactly eleven days away from our PDUFA date where we, are hopefully going to get approval for our lead product, Eutrebia, for the treatment of of PAH and PHILD. Eutrebia is our lead product, which is a dry powdered formulation of treprostinil that utilizes our proprietary print technology that allows us to formulate particles of uniform size and shape, which allows us to these monodispersed particles are able to reach the deep achieve deep lung deposition. And And as a result, allows us to be able to, titrate to high doses and and have what we believe is a superior tolerability. You know, over the last eight months since we received tentative approval on Eutropia from the FDA, we’ve been working hard on our five launch strategies. Those five strategies are, you know, first, you know, really developing our product profile.

Rajiv and his team, have fully enrolled our ASCENT trial, which is a open label study treating PHILD patients, the first prospective study of a DPI to to study PHILD. He’s also about to launch a second cohort of of Ascent, which I’m I’m sure he’ll be happy to get into as we go through this chat. The second, launch strategy that we have is around our Salesforce. We are looking forward. We have a best in class Salesforce that we will be able to, launch upon approval, to make sure that we have a competitive share, share of voice in, in the market.

Our third, pillar here is around our, developing and finalizing a, full service of patient support services, which, again, upon launch, we will be able to to launch for patients to get everything that they’ve come to expect as as patients plus some additional benefits that we can we can talk about after launch. Fourth is around, product availability. We are, we’ve been manufacturing commercial product for the last three years. We look forward to having sufficient supply in order to support a successful launch, and that will enable us to have product in the channel within two or three, weeks after approval. And then the last, part and and arguably the most important is working with with payers to make sure that we achieve broad, access for patients, something that we hope to be able to achieve at or near launch.

Jason, Host: Great. So, Eutrebia is a five zero five b two filing, right, referencing, United Therapeutics Tyvaso brand. There’s a long backstory, and we don’t need to, like, go into all the nitty gritty, but there’s been various, you know, litigation matters, things to sort of potentially slow access to market. But where where do we stand? There was a recent suit.

Does that in any way surprise you at all? And and how would you kinda frame those efforts ahead of a near term PDUFA? Because I imagine that’s top of mind for investors.

Mike Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia: Yeah. So what I would say first and foremost is our legal team is monitoring United’s patent portfolio on a daily basis. We were aware, as you said, United filed suit against us last Friday on, an additional patent. We were aware of this patent when it was issued, nearly three years ago. Ironically, this patent was issued almost a year before the three two seven patent, which they asserted against us about eighteen months ago.

So, so we were aware when it when it, you know, we were aware of the patent, obviously, long before they asserted against us. But just to put things in perspective and put it in context, you know, since 02/2020 when we filed our NDA, United has asserted five patents against us in federal court. They have sued the FDA twice to prevent the approval of Utopia. They have filed a citizen’s petition to the, to the FDA against Utopia to prevent the approval. They’ve asked for two preliminary injunctions on the patent cases, and they’ve asked for two preliminary injunctions, against the FDA.

So if you’re not counting at home, that is 12 unique instances of them trying to prevent Eutrebia from getting to market. So to answer your question specifically, are we surprised that they brought this suit two weeks before our PDUFA date? We are absolutely not. The only thing and last thing I’ll say about this is our legal team has done an amazing job to even put us in a position to get to have a PDUFA date, to have an unencumbered launch of Eutrebia here in in eleven days. And what I’ll say is we will continue to defend the rights of patients who are seeking alternative treatments for PAH and PHILD.

This is a right that United Therapeutics, which is a public benefit corporation, has continued and will probably continue to try to deny. So we are working hard. We are excited for the opportunity. Most importantly, we’ve made a commitment to this patient population in PAH and PH ILD, and we look to deliver on that commitment here, hopefully, with an approval in eleven days.

Jason, Host: Okay. And so, eleven days and counting, maybe to the extent you’re comfortable sharing, what what what have been sort of the the FDA interactions? I know there’s a lot of focus externally with, headcount reductions at FDA, and this is a question we’re asking a lot of our companies that are, have situations, you know, with with FDA ongoing. So any anything you can share with, like, us as it pertains to the process and kinda what underpins maybe confidence that things are going in the right direction ahead of that?

Mike Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia: Yeah. So as I said earlier, we did get tentative approval in both PAH and PHILD last August. We filed for full approval, at the March. ’4 days after we applied, we did receive a class we were we were classified as a class one submission, which is a two month review. Our PDUFA date is Saturday, May 24.

All I’ll say is we’ve had good dialogue with the FDA. We feel very confident where the where the NDA sits, and we’re hopeful that we will get we will get approved here in the next, in the next, say, eleven days.

Jason, Host: Yeah. Are there any label variables in your view that matter to the commercial rollout of Utrechtia and and how you wanna promote the the product to clinicians?

Mike Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia: Yeah. So we can talk about product profile. I think when you talk about label, we did go through a five zero five, as you said earlier, a five zero five, b two path. By following that path, obviously, our label between us and and Tyvaso are very similar. So I think there will be nuances that are different from a label from a dosing point of view, but but by and large, the labels will be generally the same.

Rajeev, I don’t know if you have any demand to that.

Rajiv Sagar, Chief Medical Officer, Liquidia: Yeah. I mean, obviously, you know, it would highlight, our INSPIRE study, which which showcases our safety profile of the drug. It’ll also provide guidance to clinicians about what dose to initiate naive patients on and when they wanna transition patients from Tyvaso to Eutropia, what is the dose transitions that they should be looking for. So it does it does set up a really nice guideline for them. I think another key aspect is, you know, just to reiterate, we don’t we do not have a max dose ceiling with with Eutropia.

Jason, Host: Okay. So let’s talk market here. You know, the the reference brand, I believe sales are close to 2,000,000,000 ish run rate. Yep. Sort of I think if you listen to to United, maybe that characterization is, like, sort of a fifty fifty split of of ILD and PH.

You may have a different view on that. But, directionally, is there a more attractive segment of those markets? Do you see one as maybe more amenable to Switch, or or is this launch really about a lot of white space in ILD and sort of building and growing that space, which, since Tyvaso was launched there, I think estimates continue to maybe grow in terms of how big ILD could be

Mike Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia: as a market. Yeah. So I’ll start, and Rajiv can can add in. So, you know, PHILD, is of you know, Tyvaso and Tyvas DPI were the first products to, to be approved, in PHILD. So when you look at the white space that you referred to, you know, United has has said on multiple occasions that they’ve penetrated probably less than 20% of that market.

We’ve characterized that market to be at least 60,000 patients. So there is a tremendous amount of white space in PHILD. They’ve done a very nice job in their initial launch. As you said, they’re approaching a $2,000,000,000 run rate, but we’re very excited about the opportunities in PH ILD. At the same time, we’re also excited about the opportunity in PAH.

PAH is a obviously, it’s a very crowded, a very crowded market. You know, there are three forms of of prostacyclines in in, oral, inhaled, and parenteral. What our goal is to be the prostacyclin the first choice. Specifically, the parenterals and the oral have very difficult, you know, off target side effects. We believe our ability to be able to titrate to higher doses will be a, a, look at, current inhaled, patients, but then also looking at oral patients and parenteral patients, we think there’s a great opportunity there.

What we in our estimation, there’s about eighteen thousand patients on prostacyclin therapy. We think that turns over about every three years. So you’re talking about 6,000 new scripts every year, new patients coming in. And we feel that we will our offering of utremia are being able to titrate to higher doses, show the tolerability of of what we believe is the nebulized version will really attract all patients both new to therapy, but also transitions from from, you know, from current inhaled, but also oral and potentially parenteral.

Jason, Host: Remind me for pH at 18,000, all forms of prostacyclin, that’s against, like, a group three, four typical, like, TAM. Right? Like, what’s the penetration rate of all prostacyclins? I’m just wondering if that’s good analog to think about a steady state penetration in ILD, which sits at, like, twenty percent now and where that could go.

Rajiv Sagar, Chief Medical Officer, Liquidia: Yeah. So there’s roughly about forty five thousand patients in group one that are treated with medications at this point in time, you know, out of a potential about a hundred thousand. So, you know, about a forty five percent treatment rate. There we believe so. You know, roughly eighteen thousand patients are on a background of pauciclin.

I think I think one of the things that I think Mike is trying to allude to is we’re gonna be launching into both PAH and in PHLD with a very uniform message that is applicable not only to PAH patients but to PHLD. In other words, the story is very simplified. The drug is safe. It’s effective. It reduces off off target systemic side effects.

It’s customizable to the demands of the patient, whether you’re on background therapy in in group one PH on top of x y z medications, or you’re you’re you’re a newly diagnosed patient with PHLD. I think that message is gonna be well received in the commercial market.

Jason, Host: Within ILD, are are orals or parenterals used at all? I know it’s not been studied or approved, but given the validation of prostacyclin and the idea of pushing dose, I just wonder, do do those forms of therapies get traction there?

Rajiv Sagar, Chief Medical Officer, Liquidia: Yeah. So I think, you know, prior to the approval of inhaled treprostinil, I mean, things were always tried off label. I think now with the approval, I I would be pretty I think it’s I think it’s safe to say that that the overwhelming majority, if not if not almost virtually all patients, are now treated with inhaled therapies only in PHLD. I don’t anticipate that to change. And so, again, you know, the opportunity in PHLD is quite tremendous investment.

It’s something that we’re extremely excited about.

Jason, Host: Okay. So it sounds like you view both segments as equally attractive within PAH, the opportunity to maybe penetrate into parenterals or orals, right, you know, gives you a nice kinda landscape of of new starts to penetrate into in a in a given year where versus ILD, it’s just a much more expansive landscape. Yeah. I mean,

Mike Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia: I think, undoubtedly, the PH ILD market, which, you know, we’ve we’ve read, we’ve seen, but this people think this market could grow to $3.04, $5,000,000,000. If if if United has only penetrated less than 20%, there’s a massive, massive opportunity. And, you know, we will help each other. You know, we will have boots on the ground, both companies, disease education, identifying patients, diagnosing patients, ultimately treat treating patients. So, you know, the focus we will be focused on new patients.

We will be focused in both PAH and PHILD. But I think the PHILD opportunity, when you look at the size of the market and and how relatively unpenetrated it is, we are we are really excited

Rajiv Sagar, Chief Medical Officer, Liquidia: about that. Maybe just a final piece on a great great analog for the p h PHLD market is if you just look at the IPF market

Jason, Host: I was thinking about that.

Rajiv Sagar, Chief Medical Officer, Liquidia: Yeah. Yeah. So, you know, the IPF market obviously has two drugs available. And if you look at so there’s roughly about a hundred thousand patients or so that have IPF. And the market penetration depending on what real world data set you use is anywhere from around 45% upwards of 70%.

So if we think if if, you know, we believe the market is 60,000 plus. We know that United Therapeutics has at least six thousand people on active therapy. So, you know, you’re in you’re you’re just in the first of 10 innings. I know that’s not correct in terms of baseball. I’m a cricket lover anyway.

So but just keep that in mind. Yeah.

Jason, Host: And and within PAH, I get the sense that if you talk about sort of this dynamic in play market of 6,000 patients, sort of the key is intercepting that patient before they go on to parenteral or, say, Abtravi, to to go on to utremia as opposed to trying to drive a switch. Is that a fair synopsis?

Mike Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia: Or

Rajiv Sagar, Chief Medical Officer, Liquidia: Yeah. I think I think, again, I think I think the way inhaled in group one has been, at least I think the incumbent what their what their view is is that it’s an intermediary, you know, in in the not so sick. Mhmm. I think our and and I think that’s because their tolerability profile and ability to titrate is is capped because of tolerability concerns. And now we we’re gonna go into the market and saying, we can customize it to the demands of the patient’s needs.

So if you’re really sick, we can rapidly escalate the therapy. If you’re if you’re hopefully in a more stable state, we can adapt the therapy accordingly.

Jason, Host: Yep. Okay. So you’ve had this 50 person sales force in place for about eighteen months, I believe. Maybe talk about, any unbranded promotional efforts that that that have occurred and and how you think that could maybe help, you know, as you you roll out the product presumably, sometime in late May, hopefully.

Mike Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia: Yeah. So we’re very excited about our Salesforce. It is a highly experienced Salesforce. The major vast majority of them have PAH experience, over ten years of experience in rare disease. They’ve really focused their last, you know, say, fifteen to eighteen months on building relationships both at p a at large centers, but also with the local community physicians, pulmonologists where we believe a lot of, a lot of PAH ILD patients sit.

You know, obviously, they’ve not been able to detail utrebia, but they’ve been able to do a couple things. One is we’ve they’ve been able to talk about and educate doctors on print technology. And the print technology that I I talked about earlier is what we feel is one of the differentiating factors that utrebia is going to bring. In addition, there’s a lot of disease state education where a lot of these doctors there there hadn’t been any treatment options for these patients until 02/2021, especially in local communities. Doing that education, building those relationships with these doctors and these doctors’ offices, I think, is really gonna pay off once we do get approval, and and we’ll be able to to detail Utrechtia.

Won’t be our first time in the office. We spent, you know, countless times in offices already. And, ultimately, we feel we’ll accelerate our launch curve here.

Jason, Host: And how does that Salesforce maybe compare in size to some of the others, you know, that have been stand alone sort of cardiopulmonary plays in the past, like Tilian or Yeah. Or even United? Would there be any a need to rightsize it for any further? It was commercial success and adoption.

Mike Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia: Yeah. So, you know, we we have always been financially disciplined, but we also want to invest into an opportunity. And we’ve done a detailed sizing exercise multiple times to to make sure that we are targeting the right doctors. And we feel that the Salesforce that we have right now is appropriately sized to, you know, to go to large centers. Also, like I said, these local community physicians.

As we get into the launch and and through the initial phase of the launch, if we feel an expansion of the of the Salesforce is appropriate, we will not hesitate to do so. But we feel very confident that our our share of voice that we have will be competitive. The one advantage we have is, you know, a lot of these sales reps for these other companies have multiple products in their bags, have different messaging. We can be very focused. As Rajiv said, the the the the message we can give to for PAH and PHILD is very similar, and we feel will be very effective.

Jason, Host: Okay. So let’s see. Manufacturing has been something that has been, you know, maybe a legacy issue with others in the space, and DPI is they’re not the the cheapest or the easiest thing to scale up. So how have you approached that? Like, you know, do you have a what is your product shelf life and, you know, have have you kinda built up inventory ahead of the launch?

Mike Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia: Yeah. So one of the advantages of having tentative approval, we’ve been preparing for launch for for several years, is we’ve been able to to manufacture commercial supply. We feel very confident in the levels of supply that we’ll have at launch. Our our product has three years dating, so that is also very helpful. I think what’s important to understand is we have a very proprietary process to manufacture our bulk powder, but our excipients are off the shelf.

Our devices are off the shelf. Our DPI is manufactured in the millions by Plastiappe, is familiar to doctors all across the world. And, you know, we we purchase a very small percentage of their overall output. So we are very confident in our continuity of supply and our level of supply and ultimately in our ability to to supply this market through our you know, as we as we approach launch.

Jason, Host: Okay. I know I know, obviously, you guys have had discussions with with payers and, you know, maybe help us think about this space in terms of channel mix, how much is Medicare Part D, you know, when you roll out your your thoughts on on access. I think historically, Tyvaso or I guess United didn’t contract that much, but still had brought a general access. And so as you kind of roll out, thoughts on, you know, would this be parity access with with the other brand and, you know, how to think that about that rollout?

Mike Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia: Yeah. So what I would say historically, this is a field, especially with Tyvaso, that generally did not contract. So why where that is important is these doctors’ offices, these these physicians are used to going through process of of getting, claims adjudicated. So that’s very important. As you said, United has, in the last several months, started to to contract.

We believe they’re contracting in the commercial space. So to get back to your first question, when you look at the market, we believe that Part d is probably about 50% of the market. We think commercial is somewhere in the 35 to 40% market. And then if you look at the mandated channels like, like Medicaid, VA DOD, three forty b, things like that, are somewhere between 1015% of the market. So our goal, as I said at the beginning, is to to to make sure that we have broad access.

It’s important that if patients want to be able to choose utrapia, that they have the ability to choose utrapia. We’ve worked exceedingly hard over the last couple of years to build relationships with payers both in the commercial space and the Part D space. And, we’ve we’ve we’ve accelerated those conversations as far as we can until we get full approval. And our goal is that we will have broad access across commercial and part d at or near launch, and we’re we’re confident that we’ll be able to achieve that.

Jason, Host: Okay. And and how would you compare the sort of ease of use profile of Vitrepia, Tyvaso on the DPI side specifically? Now there’s some, you know, debate out there, you know, with investors that, you know, is one a bigger or a Clint one require cleaning, just different things that, like, will play into the patient, you know, ease of use experience.

Mike Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia: Yeah. I’ll let Rajiv get into details. I mean, I think we we will offer a product that is easy to use, is going to be tolerable, and an ability to titrate to higher doses. And, you know, we do not require refrigeration. Our for a a patient to use the device, they can inhale their utremia within seconds, four times a day, can fit it in their in their front pocket, their full day’s worth of dose in their front pocket along with their DPI, and we feel very confident from an ease of use that we will we we believe it will be part of what differentiates us versus Tyvaso.

But, again, until we get out on the playing field, we’ll have to, you know, we’ll have to prove that, and and we believe when given the opportunity that that that patients and doctors alike will will agree with that.

Rajiv Sagar, Chief Medical Officer, Liquidia: Yeah. What what I would add is just to reiterate that the the device the low effort device and low resist device we’re using has been in the hands of pulmonologist, I mean, since I was since I was practicing, you know, over fifteen years ago. The capsule technology is very familiar with pulmonologists who treat simple diseases not simple, but, you know, common diseases like COPD and asthma. So they’re gonna it’s it’s gonna be very familiar when they when they when they instruct their patients on how to use this. In terms of in terms of cleaning and and and those processes, very simple, won’t affect really any sort of meaningful time for the patient.

Right? Within seconds, this is really done, and the capsule is discharged and is clean, and you’re done. I would finally state that one thing that I find quite interesting is that the penetrance of DPI in the market is only reached around, let’s say, 70%. What and this is this means that 30% of the market share still is is is dependent on the nebulizer. And for the comparison of a nebulizer, which is not portable, it’s very large, it’s cumbersome, not to not to be limited to maybe less than 10%, to me suggests that the dry powder form of Tyvaso has real limitations in real life.

And the reason we feel this way and what what we know is that dose matters. And we keep talking about our titrate ability and tolerability profile, is because that Tyvaso has been shown that it’s most effective when you get to 10 to 12 breaths. What we’re gonna showcase in our upcoming American Threats Society meeting here just actually next week is that our median dose for patients with PHLD that’s in our ASCENT study is at one hundred and thirty two point five micrograms, which is 15 breath equivalents or higher. So the construct is that we have a very low resistance, low effort, very well familiar device that will be in the hands of practitioners and and patients, and that we’re gonna back that up with data in the only study, to be done, to showcase that we can get to the levels where clinicians want us to be and even higher if needed for those patients that that need to advance to higher doses.

Jason, Host: So that’s a good segue. So when we think about your data generation, and and specifically upcoming ATS medical meeting, I think it’s gonna be 20 patients, eight weeks. If you can maybe preview that a little bit, what what investors could expect there in terms of exploratory endpoints and and other measures to focus in on?

Rajiv Sagar, Chief Medical Officer, Liquidia: Yeah. So, you know, we we we took upon our to initiate the first, you know, study in in newly diagnosed patients with PHLD to be treated with with with utropia. This study fully enrolled at the end of first quarter. The study is actually one year long, so we want to we’re gonna show at the next week, we’re gonna highlight the first eight weeks in the first twenty patients that are enrolled. It is open label, so we’ll we’ll present more data cuts as time goes on.

The first thing we wanted to showcase is what is the safety, how safe is the drug, what its its its tolerability profile, and most importantly, what people wanna see as well as the drug effective. So we’re gonna highlight what what happens in terms of change from baseline in terms of six minute walk. We’re also gonna showcase patient reported outcomes with with certain quality of life indicators, which are we’re very excited about. And most importantly, we’re also gonna show how the interaction between dose and walk effects are seen at a very early time point, which is eight weeks. Remember, the signatory study that got Tyvaso approved in PHLD was at sixteen weeks.

So one of the things we’re excited to show is sort of that ramp up of dose and the dose response to the effect in terms of walk.

Jason, Host: Okay. I guess as the market’s priming for more data in this space, I think there’s sort of a focus in smaller studies on hemodynamics over a six minute walk. And so when you kind of measure those and and and weight the importance of what you’ll see on the hemodynamics versus six minute walk. Is it fair to say that maybe the focus should be on on the hemodynamics, or do you maybe disagree with that?

Rajiv Sagar, Chief Medical Officer, Liquidia: Well, I mean, I I think I think everything’s important in this condition, but what is what is most important is you can have I mean, there’s drugs that I can give you acutely that drop your pulmonary pressures but have no absolute effect on your ability to function. So I personally think what is most important is what is the response to the patient to the drug in terms of how it changes their their lifestyle. PHLD patients, unlike group one PH, the majority around seventy to eighty percent are dependent on oxygen twenty four hours, seven days a week. They are short of breath when walking from the stage to the end of that doorway. So to be able to give a patient utropia and to say that they can walk that distance and walk back and be less short of breath or do more activities with with with less use of energy, I think that is the most important thing.

And that’s actually when they sit down with their clinician, the clinician is not gonna brag their hemodynamics are going gone down. They’re going to have that discussion saying, how does this affect your daily life? And if they could show the patient’s walking significantly farther and the patient, has that positive affirmation on their daily life, that’s where I think it’s gonna be most important.

Jason, Host: Yep. Okay. So we focused a lot on the near term. Right? For the long term, which will be kind of an investor focus as well, maybe just how are you thinking about l six zero six, TPIP, and then I think United on their most recent earnings call talked about a preclinical once daily NCE that could maybe be a replacement product for Tyvaso.

I don’t know if you if there’s much out there that we can discern as to what what that might be, but maybe, obviously, l six zero six sounds like a very easy to use nebulized bid offering. And, you know, any any drug that gets developed in the space has a pretty long lead time to get developed in phase three. But, yeah, how do you think you’re positioned for the long term with with what you got?

Rajiv Sagar, Chief Medical Officer, Liquidia: Yeah. I I think we’re we’re single singularly fixed on, maximizing the benefit of inhaled treprostinil. We think Eutrebia is here for to to take advantage of the present time. The thing we haven’t solved is the four times a day. L six zero six is our liposomal sustained release formulation that’s delivered twice a day, so we solve for daily amounts to twice a day.

We specifically because of the suspension formula, I picked a nebulizer. That nebulizer, we believe, has to be portable. It has to be next generation. It has to be quick and effective. This is a five zero five b two pathway, so we’re gonna run our phase three study initiating at the end of the end of the year and specifically in p patients with PHLD because the background is placebo, true placebo.

When that study reads out and if it’s positive, that singular study can be used for approval for both group one PAH and the PHLD because of the b two pathway. So we think that we are we’re we’re charged, we’re ready, and we’re ready to initiate that study. And I think, you know, we we we believe that we’re primed to be first in that in that next generation of products.

Jason, Host: Okay. And then, I guess, lastly, about a minute here. Just on the legal front, I think there’s the District Court of Columbia case throughout a cross claim from your competitor that would have looked to, I guess, challenge the nature of the amendment, and we have to get into the technical details of that. But, you know, how key was that if the stock really reacted favorably on that news that, you know, that would might be but what else is, you know, out there in terms of litigation? Yeah.

Mike Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia: I mean, as general counsel says, you can have an infinite number of bad arguments and only a finite number of good arguments. And I think what you’ve seen the track record. You’ve seen what’s happened. We’re anticipating what they can do. We’re expecting.

They clearly don’t want us on the market. We have a PDUFA in eleven days. We look forward to full approval. We look forward to fulfilling our commitment to this patient population to provide an alternative treatment option, for this for these debilitating diseases, and we feel very confident in our ability to get there.

Jason, Host: Well, great. We’re out of time. So, gentlemen, thank you for joining us.

Mike Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia: Thanks, Jason.

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