Liquidia at Needham Conference: Strategic Insights on Eutropia Launch

On Wednesday, 09 April 2025, Liquidia Corporation (NASDAQ: LQDA) took center stage at the 24th Annual Needham Virtual Healthcare Conference. The company discussed its strategic plans for the upcoming launch of Eutropia, a treatment for Pulmonary Hypertension (PH) and Pulmonary Hypertension associated with Interstitial Lung Disease (PHILD). While the company is optimistic about the product's potential, challenges such as market competition and regulatory hurdles remain.

Key Takeaways

• Liquidia anticipates FDA approval for Eutropia by May 24, 2025.
• The company aims for profitability within three to four quarters post-launch.
• A significant market opportunity exists in both PAH and PHILD sectors.
• Liquidia ended Q4 with $176 million in cash and has access to additional capital.
• The L606 program is advancing with an anticipated global Phase 3 trial by year-end.

Financial Results

Liquidia reported a strong financial position with $176 million in cash at the end of Q4. The company has amended its agreement with health care royalties, allowing access to an additional $100 million. Of this, $25 million was drawn at signing, with further funds available post-Eutropia's commercial launch.

Operational Updates

The company emphasized its readiness for the Eutropia launch, highlighting a robust sales force and comprehensive patient support services. With 50 experienced sales representatives in place for 18 months, Liquidia is prepared to distribute the product within two to three weeks of approval. The company has engaged with payers to ensure broad access and anticipates minimal impact from tariffs due to US-based manufacturing.

Future Outlook

Liquidia's future looks promising with the anticipated FDA approval of Eutropia. The company plans a biphasic market approach, initially targeting new inhaled patient starts and later expanding to the oral market. The Ascent trial data for PHILD patients shows significant improvements, supporting Liquidia's confidence in Eutropia's market potential.

Market Opportunity

The PAH market presents a substantial opportunity, with approximately 100,000 prevalent patients and 45,000 treated patients. The PHILD market is similarly promising, with 60,000 prevalent patients and significant underpenetration. Liquidia aims to drive awareness and capture a larger market share.

L606 Program

The L606 program is progressing, with the FDA agreeing to a single Phase 3 study in PHILD that can support approval in both PH and PHILD. Liquidia plans to commence this global study by the end of the year, involving 350 patients across 100 centers, aiming for consistent overnight medication coverage.

Conclusion

For a detailed understanding, readers are encouraged to refer to the full transcript below.

Full transcript - 24th Annual Needham Virtual Healthcare Conference:

Serge Belanger, Health Care Analyst, Needham: Hi. Good morning. My name is Serge Belanger. I'm one of the health care analysts at Needham. Wanna welcome you to day three of our twenty fourth annual, health care conference.

And, happy to have for next fireside chat session here, we have Liquidia Corporation. And from the company, we have the CEO, Roger Jeffs, as well as the CFO and COO, Mike Caseta with us this morning. We're gonna be talking about, obviously, Eutropia and the impending near term potential approval and launch of the product in PH and PHILD. Before I hand it over to, the management team to give us a quick overview of the company, just wanna highlight to those listening in, that you do have the option to submit questions via the portal you're watching the presentation on. We'll take those as they come in.

So with that said, I'll hand it over to to Roger if you just wanna give us a a quick overview of the company for for those who aren't familiar with Liquidia or Eutropia.

Roger Jeffs, CEO, Liquidia Corporation: Yeah. Thank you, Serge. And it's a it's a delight to be here with you at the the Needham conference, virtually. And I'm pleased to have Mike Cassette, our CFO, with with me today. It's a really exciting time for Liquidia.

We're only forty five days from our PDUFA date of May 24 that we recently, were signed by the FDA. So excited employees, we think, to deliver a meaningful improvement in the standard of care for patients with PAH and PHILD, and with that, a meaningful return to our investors. Kinda wanna just I'll give you a a quick sort of overview of about how we are preparing to vigorously enter enter the market at full speed with particular focus on the readiness on the following five key area areas. One, we're develop continue to develop a best in class product profile. So as we've said before, the tolerability, titrate ability, the ease of use of the device, and the labeling that we will see receive that that speaks to the to all of these factors really is a differentiating product profile.

We're further characterizing the benefits of Utopia in a study we call the Ascent trial, which is a prospective study in PH ILD patients. Yeah. And we've we'll talk about that in the in the q and a, and then we're gonna show some of that data at ATS. But we're also gonna begin a directed transition study where we take patients from the incumbent brand Tyvaso and Tyvaso DPI and begin to transition them to Eutrebia to show that the differentiate differentiated aspects that we speak about are real. The second thing we're we've been preparing is is around competitive share of voice.

We have 50 reps in the field. They've been on onboard for about eighteen months, all with deep rare disease experience and most with PH experience. So we've been surveilling the centers, and really preparing for this launch that will occur in in the early June time frame. The other thing that we need to be successful is a full suite of patient support services which we put in place so there will be a seamless transition when scripting Eutropia compared to the incumbent brand. The the the fourth thing would be product availability.

Mike and his team, at Liquidia have prepared to put product in the channel in only two to three short weeks, after approval. So that's a speed which not many people can match. And finally, with with regard to payer access, we've engaged in forward looking conversations around positioning and reimbursement with a target audience that is keen to provide value and choice to patients. So with all of those in play, we feel very ready to launch this product into the market marketplace and provide the benefits to patients that we so desperately want to do. And with that, Serge, I'll turn it over to to begin the q and a.

Serge Belanger, Health Care Analyst, Needham: Thanks, Roger. Maybe before we we jump to to questions, you know, one of the topic du jour or topic of the last couple weeks has has been tariffs. And, I know so far pharmaceutical products have been exempted, but I think it's only gonna be temporary. And looks like it's gonna be another issue. It's gonna be, the main focus of of the markets in next couple days.

So just curious, if you can talk about your potential exposure to to tariffs given the the manufacturing of Eutropia.

Roger Jeffs, CEO, Liquidia Corporation: Yeah. So may maybe Mike can speak to how we'll have a minimum we feel we'll have a minimum impact from tariffs.

Mike Caseta, CFO and COO, Liquidia Corporation: Yeah. Thanks, Serge. I I I guess what the way we would portray this is, as you know, we manufacture our product in The United States. We do our bulk powder manufacturing in North Carolina. We do our downstream packaging and kitting, elsewhere in The United States.

While we do source our API from Korea, and and inevitably that will have an impact, through tariffs, we do not believe overall that it will have a direct material impact on on Eutropia or on on or on liquidity as a whole.

Serge Belanger, Health Care Analyst, Needham: Okay. Good to know. So if we're getting close to to crunch time with the potential approval, Eutropia, kinda waiting on the expiration of the exclusivity on on Tyvaso in in late May. So maybe if you can walk us through the the last steps to get there and and the process with FDA.

Roger Jeffs, CEO, Liquidia Corporation: Yeah. So, we've actually already initiated the last step. So the the last step for us was to submit the request for the transition from tentative to final approval. The FDA took only four days to respond with the May 24 PDUFA date, so it seems that they too are keen to see this drug approved for both PAH and PH ILD patients. And, really, at this point, it's just it's waiting on that expiry to to actually expire.

So, there's really nothing else to do. We've we've talked about all the things with the agency that we needed to do ahead of that, submission, and, it looks like it's all systems go. We're we're clearly on the clock at this point.

Serge Belanger, Health Care Analyst, Needham: Okay. So the recent changes at the FDA over the last few weeks should should have minimal impact here given that, like, what you said, things have been discussed regarding the label and, there is no other steps to, for the review process? Yeah. Good question. So, we're fortunate that our our regulatory liaison, our project manager, it remains at the FDA.

So he has the the portfolio history with the with the, Eutropia application.

Roger Jeffs, CEO, Liquidia Corporation: We, there really is, in our view, no no impact when we're fortunate in that sort of the adjudication of the application had already been determined. So when you get tentative approval, in essence, they're saying the drug is is safe and effective and approvable except for. And the except for, in our instance, was the dry powder exclusivity that Tyvaso received. So that will expire on May 23. There's really nothing else that needs to happen.

There's no other impediment in our way. And come May 24, we should be free and clear to launch the drug in both indications.

Serge Belanger, Health Care Analyst, Needham: Great. And, you know, you did go through the five zero five b two pathway here to to gain approval at Eutropia. So what should we expect in in terms of the label and how it could be different from Tyvaso?

Roger Jeffs, CEO, Liquidia Corporation: Yeah. Good question. So from from an indication claim standpoint, the the labeling will be very similar will be exactly the same as the brand. That's so that's the consequence of the five zero five b two labeling. What will be unique for us is the actual dosing and administration description as well as some of the clinical pharmacology section be because we did studies under the five zero five b two both to show the PK bioequivalence and to show the safety of the drug in patients with PAH in particular.

So what we what you'll see as a consequence of the studies that we did, the INSPIRE study, is that it the label will speak to the dosing, which will take it up to a maximum dose dose that's two to two to two or more times the labeled dose for the brand in terms of, peak dose. And we we've certainly evolved that, post submission, and we'll update that in time. But, again, it speaks to the clear and present advantage of the print enabled formulation that Dengue Trepia has where we can dose with greater tolerability and to greater, levels. So so that will be there. And then in the clinical pharmacology section, it will also talk about the the the the fact that we, one, started de novo patients and two, started tran did transition patients from Tyvasa to Utopia.

So we've we've already done that. And while, you know, as I said in the opening, we're gonna do a directed transition study in patients on on the DPI in particular to transition to utrepia. We've already shown that patients can transition from Tyvaso, prefer unanimously and universally that transition, and then can do well and are well managed on utrepia. So for us, it's really now the other the newer study will show we can also do that in PHLD because we've already shown it in PAH, but it does speak to the fact that, you know, this there's some low hanging fruit out there, particularly the nebulized patient population who all prefer a dry powder formulation and like Eutropia and and want to move in a different direction.

Serge Belanger, Health Care Analyst, Needham: Okay. And I believe you you look at pH and PHILD as kinda two distinct market opportunities that they are two different diseases. So that that wouldn't make sense. So maybe if we can start with pH, you can just talk about that specific market opportunity, what it looks like now, you know, maybe how it's changed with the arrival of Tyvaso DPI over the last couple of years?

Roger Jeffs, CEO, Liquidia Corporation: Yeah. And it's a little bit, happy. So I'll talk let me talk about the PAH marketplace and then the PHLD. And it's a little bit hard to talk about specific use of the dry powder formulation in particular because that's not divulged by the competitor. So but just in just as a topical overview, there's about and for PAH only, there's about a hundred thousand prevalent patients.

About forty five thousand patients are treated with one form of therapy or another. Within that, forty five thousand, eighteen thousand of those patients approximately use prostacyclines with orals taking up about ten thousand, IV and sub q or parental therapies taking up about four thousand, and the DPI nebulized formulations taking about four thousand. There is a so so that's eighteen thousand in total. The the inhaled pro prostacyclines have grown since the launch of DPI. I think previous to that launch, it was more in the three thousand patient range, so it's grown, you know, by a third since the launch of Tyvaso DPI in PAH.

But of the 18,000, there they there's about 6,000 annual new starts or what we like to call jump balls, and that's both patients that are new or coming to new to a process psychotherapy or patients, for one reason or another, who become intolerant or are failing on existing therapies. You know, certainly, I I think one thing that happens with us when people look at the mark the mark the addressable market, they try to confine us to the just to the DPI and nebulized formulation. But, really, what we wanna do, we do wanna go after those new patient starts initially to to sort of have physicians to see one, do one. You know, we'll teach and preach, and then they'll they'll see one, do one. Get confidence that Utopia provides all of the flexibility that we suggest that it does.

Have them do a, you know, a number of patients so that they get experience and comfort with Eutropia, and then we we would see if we could displace all new patient starts and start leaning those towards Eutropia versus the brand the incumbent brand. Secondarily to that as well, given that we can show titratability and effect without any off target effects to particularly to the GI tract with orals, we would we're then gonna broach the oral market and see if we can penetrate and and take share from the orals because, really, it's a matter of choice. You know, when when you need a prostacyclin, the current choices are, do you wanna take easier choices, earlier choices, or do you wanna take an oral, or do you wanna take an inhaled? And as you can see, there's more people typically taking an oral currently. But I think given the product profile that Yotrebia brings, there's a very good chance that we could infringe on that share significantly.

So and maybe it's a bit biphasic. I think we'll focus on the new patient and, you know, the typical new patient inhaled market first

Serge Belanger, Health Care Analyst, Needham: Yep. Prove

Roger Jeffs, CEO, Liquidia Corporation: ourselves there, and then reach out to that same target audience and suggest that maybe this is a better proposition for the for your patients than an oral therapy start would be. So that's in PAH. So pretty robust business even in in PAH alone. So that's that, if if you have any questions there. But I'll talk about PHILD now if you allow me.

So in PHILD, it's our view, and then we've done this through triangulated datasets that we think there's about 60,000 or more prevalent. You know, there are rate people float ranges anywhere from 30,000 to a hundred thousand, but we're somewhere in the me medium there. So I think about 60,000 prevalence, a reasonable expectation. If you take the same and I think this is conservative. You just haircut that by the same number of treated versus prevalent as as in PAH, which is about half or forty five percent, you would then come up with about twenty seven thousand patients available for treatment, again, with a with a significant haircut, which may be conservative.

We feel now kind of backtracking on things. It looks like there's probably around 6,000 or more patients treated on either the DPI or nebulized formulation in PHILD. So a a fairly underpenetrated market with still huge new start opportunity, and we think Eutrebia as a second second brand coming into the market will help drive awareness, and and that there'll be a a rising tide phenomenon in terms of treatment. The good news here is we don't there's so much opportunity. We don't really need to take the share from the competitive brand to do well.

We just need to to get our own share. But, certainly, as we're seeing with our Ascent data in PHILD, we do seem to offer a different and better value proposition, and we'll continue to progress these types of studies in the future to to show that. And as I said, doing directed transitions from patients who may be intolerant to Tyvaso DPI because of the the way it's formulated and the high resistance device required to, de aggregate that formulation. So, lots and lots of opportunity. I think on the on the the incumbent has, therefore, about 10,000 patients.

They're doing about 10,000,000,000 in business. But as as I've just described, the opportunity is two to three x that. So lots of room for for us to do well here and and make significant share gain in in the near term as well as the long term.

Serge Belanger, Health Care Analyst, Needham: And you currently have a a Salesforce, out in the market mostly catering to the PAH, prescribing physicians with, one of the generic for, forgetting the name, but the injectable treprostinil product. So should we expect that there'll be an initial focus more on the the PAH segment, or there's enough overlap between PAH PAH and PHILD that you'll be able to to target both at the same time?

Roger Jeffs, CEO, Liquidia Corporation: Yeah. So we're gonna focus on both. So, you know, obviously, it's it's some the only approved therapy in PHILD that's competitive to would be the Tyvaso and Tyvaso DPI. So all of the other, vasodilator type vasodilator type therapies that work in PH don't haven't have been shown not to work actually or or or are unsafe in patients with PHILD because they cause VQ mismatching because they're systemically delivered. So, the PHILD opportunity is is veritable white space.

So I you know, we we have what we've been doing there, can't talk about Eutrepy in a branded format, but we have surveilled those centers. We've talked about disease awareness. We've talked about, you know, prostacyclines in general, you know, potentially helping helping the competitor in our prelaunch phase, but that's fine. And talked about print. We just can't talk about utrapia.

So in PAH, same thing. Although we do in PAH, we have the, as you pointed out, a generic brand for injection that that we promote. So lots of opportunity. You know, there's an overlap there's some overlap between PH and PH ILD physicians. Some do both.

We think that's about two and, again, I'll give you a rough estimate. It's about 2,000 patients. There's probably 2,000 prescribers. There's probably 2,000 or more key prescribers that do PH only and maybe another 2,000 or more prescribers that do PH ILD alone. So our target sort of calling space in the near term is about 6,000 physicians, mostly card pulmonologists, but also with PH, there's a lot of cardiologists as well that practice.

So, you know, again, where we're fortunate, those 50 reps that we have, which we feel is is adequate and, almost at parity in terms of share of voice with our competitor. You know, the these are these are deep deeply experienced reps who have been in the space and have relationships with these physicians for for, you know, some ten to twenty years. So I think, you know, again, we're well positioned to to get you Eutropia into the marketplace in a significant way.

Serge Belanger, Health Care Analyst, Needham: Okay. And for for all high priced product like like Tyvaso and, imagine, Neutropia pay, you know, coverage and reimbursement is key here. So maybe you can just break down the, you know, the components between commercial, Medicare, and Medicaid, and how quickly do you expect to have coverage once you have an approval and you're launching the product?

Roger Jeffs, CEO, Liquidia Corporation: Yeah. Great question. Maybe, Mike, you'll take that one.

Mike Caseta, CFO and COO, Liquidia Corporation: Yeah. So if if you look historically, at the overall market, what we've seen is Medicare is is between somewhere between 4550% of the market. We believe the commercial segment is between 3540% of the market. And then we think the mandated markets like you mentioned, Medicaid, v o d o d, three forty b, are probably somewhere in the 10 to 15% range. So, as we talk about strategy, as Roger said in the beginning, it's one of our our our one of the key components of our launch strategy as payers.

We've been engaging payers for the last couple of years. We've been talking about the value proposition that Eutrebia will bring. We feel very confident in delivering that message. And, you know, one thing that, you know, we've we've a stalwart of ours is we wanna make sure that patients have an opportunity to choose. In order for patients to have a choose, have an opportunity to choose, we need to have access.

And we feel extremely confident based on those conversations across all all of those segments that we will be able to achieve access at or near launch. As you know, our competitor has started contracting. Yeah. That has happened in the last several months. You know, they've they've they've talked publicly about not wanting to be disadvantaged.

And, like like I said earlier, we are, focused on making sure patients have choice, and as a result, we feel very confident that we'll be able to achieve broad access. Now with that being said, this is a a segment, a therapeutic area that has not had historically a tremendous amount of of insurance payer coverage. So these doctors, these centers are used to the process of of exceptions and prior authorizations. As Roger said, we'll have a a full suite of services then on the front end to help through that process. But at the end of the day, we do not feel that we will be disadvantaged from a from a payer point of view, and that will be very important to allow patients to to, you know, have that choice.

Serge Belanger, Health Care Analyst, Needham: K. And, how do you your competitor, like you said, started contracting? You view that as a hurdle for coverage or it's just gonna be a a regular com competition aspect that you have to, to deal with?

Mike Caseta, CFO and COO, Liquidia Corporation: Yeah. I mean, I I I don't think we're surprised. Obviously, they know that we're coming. They would not have started contracting if they didn't think we were coming. In addition, they felt that it was important that they contract, in order to to, as they said, make sure that they are not disadvantaged.

So we're not surprised. We are prepared. Hasn't not affected any of the conversations that we've been having for payers, and we look forward to, as as Roger said, forty five days from today when that exclusivity expires, and, hopefully, we get approval and and we can hit the ground running and and make sure we get as much Eutropia and Patient Sands as possible.

Serge Belanger, Health Care Analyst, Needham: Yeah. I think one of the questions we often get from investors is, you know, how will Utopia compete against Tyvaso and United? So I don't think people under quite understand yet the differentiation be that Utopia offers. So, Roger, maybe just highlight you know, you talked a little bit about it earlier on on the dosing front, but some of the other aspects of differentiation for the product.

Roger Jeffs, CEO, Liquidia Corporation: Yeah. And it's really it's really, search driven by the formulation technology, the the print formulated technology where we can, discreetly manufacture particles in in the with uniform size, shape, and form in the lower end of the respirable range. And because they're uniform particles of of small size, we can also use a low resistance device with so the patients just have an ease of use in terms of applying the drug through two simple breaths. So what what that allows is lower lung selective penetration of treprostinil versus upper airway deposition. And what what we what we're seeing, for example, in the ASCENT study with PHILD is minimum effects of cough.

So what we hear and what we've seen through from, for example, the National Jewish Center with Tyvaso DPI is that cough is significant. It leads to an inability to to, dose titrate, which leads to the patient's clinical worsening. So in that National Jewish study, patients you know, over sixty percent of patients who started on Tyvaso DPI came off within a a median of as early as forty days. So, and most of that was due to cough or clinical worsening, which I view those two things as interrelated. If you cough, you can't get dose.

You if you can't get dose, you you worsen. So and then it's not it's not drug specific issue. It's actually formulation specific because those patients were then sandwiched by to nebulized formulation, which is a the lowest resistance device because you just do it with with your regular breathing pattern. So it it is an absolute the competitor is struggling with an absolute issue of, intolerance to the formulation, and they're having to by using that high resistance, low flow device, it's it's, in our view, sticking in the upper airway and causing discomfort. What we've seen in Ascent is a completely one eighty to that.

We've seen patients all tolerate the the drug. There is mild cough, but it's not dose limiting. We're able to titrate the dose to levels above the therapeutic target that they suggest, and we're able to do that quickly. So I think it's not just the amount of drug that we can give. It's the pace at which we can give the drug.

Because if you think about it, the patients are coming to their physician because they they are having exacerbating symptoms like shortness of breath, and they wanna feel better, and they wanna feel better soon. So the way to do that is to have a therapy like Eutropia with the print enabled technology we just talked about where they can rapidly get to therapeutic dose. And then, really, you can you can tweak to taste in terms of tuning them up based on their individual response to the drug. So that's the flexibility that Utrapia is gonna bring to this marketplace, which is a completely new paradigm. And as I said in the opening, you know, we think can change the standard of care for patients both with PAH and PHILD.

Serge Belanger, Health Care Analyst, Needham: K. And you are conducting, the open label ascent trial currently in in PHILD patients to to kinda highlight these differentiating attributes. So maybe just give us an update on on where that that study currently is and when we could start seeing data more data, I guess.

Roger Jeffs, CEO, Liquidia Corporation: Yeah. So we you recently, in our earnings call, we talked about the efficacy correlation with with those first with the first twenty patients at eight weeks, and we saw a positive 26.4 meter change as a as a mean change. So what you'll we're gonna next present data at ATS. So our our chief medical officer, doctor Rajiv Sargil, has a poster presentation at ATS. And in that study, we'll we'll show, more mature data both from that patient subset and from other patients.

And we'll talk about some things like we've done, large longitudinal assessment of cough through a through a validated cough score. So you know, I'd ask I'd ask people to tune in to the ATS poster that Rajeev's gonna present. We announced also that we have completed enrollment in that trial, so we concluded that study with over 50 patients. And then it's a it's a forty eight week study, so patients are running running through the year, and we we'll continue to develop and mature data in that in that sample. But, again, everything that we hope to achieve, at least in the early sub subset of patients that we've been able to to see the data from, looks very promising.

And

Serge Belanger, Health Care Analyst, Needham: would the ASCENT data ever find itself in the the label Utopia? Is that something you could submit to FDA to augment the the label at some point?

Roger Jeffs, CEO, Liquidia Corporation: Yeah. Great question. So it's, it's an open label study. And because there's no control group, it it won't be part of an indication claim. But where we will you'll we definitely will have to add it to the safety summary.

Yep. And we could potentially add it to the clinical pharmacology section because it certainly describes experience with eutrophic in patients with PHILD, which I think the FDA will be keen to add to the label in the ClinPharm section, but not not in the indication section.

Serge Belanger, Health Care Analyst, Needham: Okay. And how would you describe the the level of awareness of of Eutropia and its differentiation, versus Tyvaso within I imagine patients still aren't aware of it just because it hasn't been approved unless they're they're part of the Ascent trial. But, you know, from a physician and patient perspective, just a level of awareness of of the product at this point.

Roger Jeffs, CEO, Liquidia Corporation: Yeah. Great question. So so clearly, we haven't been able to promote. And I think the audience that you mentioned that's done the clinical work with the drug certainly is aware of the attributes and and advantages of Utopia. In PAH, that's a very tight knit community that's been using prostacyclins since the early nineties, and they they understand that prostacyclins are a hallmark of of treatment and and a mainstay.

And, you know, I think there's general awareness in the PAH community about Eutropia as an alternative to Tyvaso and Tyvaso DPI. Certainly, there's more to do, there because we have not been able to talk about it in a promotional way. Probably less awareness in the PHILD community other than what's in Ascend. The good news about Ascend is because we're presenting it at, major congresses like ATS, there's massive physician bases there that get the abstract book and and can attend the abstract talk that that Rajiv will give. So there's there's growing awareness there, but, certainly, we have more work to do, and that's gonna be the primary focus of our field sales force and medical affairs team is to help drive that awareness in the near term.

Serge Belanger, Health Care Analyst, Needham: Okay. So like like you said, we'll see more data at ATS. Imagine you'll be active with publications. Do you also plan on, you know, having a a sampling program at launch so that patients and physicians can can trial Eutropia as they think about transitioning or, just get more experience with the product?

Roger Jeffs, CEO, Liquidia Corporation: Yeah. So, we'll talk today about our full suite suite of services. In in forty five days, we'll go live with with sort of the game plan. I think you'll find that we've considered every, available option and are are looking to to bring this therapy at full speed and full force to the marketplace.

Serge Belanger, Health Care Analyst, Needham: Got it. Maybe just to to wrap up our conversation on Eutropia, we can just get a overview of the IP around the product.

Roger Jeffs, CEO, Liquidia Corporation: Yeah. So the IP extends into the late two thousand and thirties. A lot of that's around the print formulation technology. And, it's a it's a, there's some trademark know how and show how that, we have as well. So we have a very long runway for Utopia to continue to have a protective, landscape.

Serge Belanger, Health Care Analyst, Needham: Okay. And, maybe we should talk about the l six zero six program. I know most of the, most of the focus is on Eutropia, but you do have a pipeline, and I feel this program is is pretty exciting for for both PAH and PHILD. So maybe just give us an overview and how it differs from, current inhalables.

Roger Jeffs, CEO, Liquidia Corporation: Yeah. Absolutely. So so in a way, like, the way we look at l six zero six is moving from strength to strength, and that l six zero six has the potential to deliver on all the advantages that Eutropia ports, but it's gonna do it in a twice daily format via the sustained release liposomal formulation. So l six zero six is an in license with our partner, Pharmosa, and it basically creates liposomal droplets of treprostinil that are that depot in the lung and are released over time when they hit the a certain salinity and control its radio release. What what happens because of that sustained release is we take the Cmax down, and we sustain the duration of therapy.

And we can do it in a manner so that we're we're as best we can trying to mimic parenteral delivery delivery where you get to steady state. So why we're doing twice a day is because we want to provide overnight coverage. So because it's important that the peak and trough performance of the drug be similar. So if you were on a parenteral therapy, a pump therapy where you're getting continuous infusion, obviously, the kinetics don't change. They only change with dose.

So once you're at steady state, there is no peak or trough performance change difference. So we're trying to get as as close to a no difference in in that, kinetic profile so that the peak and trough performance can be the same so that when a patient wakes up in the morning, they don't wake up short of breath because with current therapies, they're basically off drug during the overnight period. And so here's here's what you here's the the beauty of l six zero six. So you try to solve for tolerability because of print, titratability because of print, portability with a DPI, but the regimen is the same as Tyvaso in the sense that it's still four times a day. So there there was the the one thing we didn't improve.

What we're trying to improve on with l six zero six is also the regimen and move it to a twice a day. It will be tolerable and titratable because it's in a liposome with a sustained release, so we can give you a twelve hours of drug in just one session because we're dropping the Cmax and continuing to cover the AUC over that twelve hour period that you would normally take, you know, two other sessions to to complete. So all of the advantages that Utopia brings in a different way, not with print, but with liposomes, but now in a twice a day format. And the reason I wanna stress that that peak and trough need to be similar is because we could've we could've we chosen to do l six zero six once a day. And you would have seen a very good peak effect but a lower trough effect because the drug would have its its exposure would have abated over the twenty four hour period.

But that's not what you wanna do, And so we we're trying to get it more smoothed out closer to a parenteral like steady state. So we're getting a pseudo steady state, if you will, with a twice a day formulation. Because, again, therapeutically, the goal is to manage those patients for the twenty four hours, not just for their twelve for twelve hours, for example. So there's other people in development that are doing a once a day

Serge Belanger, Health Care Analyst, Needham: Yep.

Roger Jeffs, CEO, Liquidia Corporation: Formulation long longer acting formulation. But what they've recently shown is they don't have a twenty four hour effect on on six minute walk distance. That's not what you want. You definitely want to see a walk effect at trough that is as close to peak as possible. Even with Tyvaso in its studies in PAH, there was about there was only about a 35% diminution from peak to trough.

So we're trying to, like, get rid of that diminution in peak to trough effect. And it's important when you think about developing a next gen therapy that that is improving the regimen that you met you manage the trough effect as best you can.

Serge Belanger, Health Care Analyst, Needham: Okay. And I I believe there was a an ongoing phase two trial with l six zero six, and you had plans to initiate a phase three in relatively near term?

Roger Jeffs, CEO, Liquidia Corporation: Yeah. So so l six zero six, there's there was an open label study. There's 28 patients in that that we're not enrolling for other patients, but there's all of those patients, I believe, have now gone over a year. And the the perform the therapy is performing again exactly as we'd wanted. There those patients are clinically well managed on a twice a day treatment regimen.

We we were we've been in negotiations with the FDA and e n EMA about IND enabling work and and phase three registration studies. The FDA has agreed that a single study in PH ILD will subserve for approval in both PH and PH ILD, and it's our we're working hard to get that study started at the end of the year. That's a global phase three study in over a hundred centers. Around 350 patients will be studied. Again, it will look very similar to the original TAVESO, nebulized PHILD study in terms of, how it's constructed.

So it's just a matter of doing that same study and showing that same result, showing it with l six zero six.

Serge Belanger, Health Care Analyst, Needham: Got it. We only have a few minutes left, so maybe I'll ask Mike to give us an overview of financials in terms of where cash balance is. I think that's important as the current environment and, what you're looking at in terms of operating runway. And I think you even started talking about maybe profitability timelines that are on the horizon.

Mike Caseta, CFO and COO, Liquidia Corporation: Yeah. So, you know, as you know, we ended q four with about a hundred and $76,000,000 in cash. We also, in the last month, entered into an amendment with health care royalties to add up to a hundred million dollars of additional capital. As you know, we've already drawn $100,000,000 on our current facility from health care royalties. As part of the amendment, we drew an additional $25,000,000 at the time of signing.

We will then have an, access to $50,000,000 after the first commercial sale of Eutrebia in PAH and PHILD, and then a final $25,000,000 will be available at mutual option once Eutrebia reaches a hundred billion dollars of net sales no later than 06/30/2026. So as you know, since Roger's been here, we've really focused on fortifying the balance sheet, having strength on our balance sheet while also being disciplined in our investing. What it allows us to to do now is and what we said is what you're referring to is, you know, we feel assuming that we assuming that we are able to launch in the time period that we talked about here at the by the end in in q two and we reach our targets, we actually feel that our current capital along with what we have access to, in the future with health care royalties could bridge us to profitability, and we could be profitable as a company within three or four quarters after launch. So I think that's very important, especially given the current environment, also allows us to fully invest into the launch, fully fund the l six zero six pivotal phase three trial, while also, you know, putting Eutrepy on a launch trajectory that would allow us to to be profitable with the capital that we have on hand.

Serge Belanger, Health Care Analyst, Needham: Got it. Okay. Maybe just to to finish off, is there anything, you believe remains underappreciated or or misunderstood by investors as we head into the the home stretch for the approval and launch of Eutropia here?

Roger Jeffs, CEO, Liquidia Corporation: No. And I think you you've hit hit all the seminal points today, Serge, and we appreciate your your time and attention to Liquidia and our emerging story. You know, we're just as you've heard, we're very keen and passionate about the opportunity to launch this drug and provide choice to patients.

Serge Belanger, Health Care Analyst, Needham: Great. Well, Roger and Mike, thanks for joining us today. We appreciate learning more about, Liquidia and the Eutropia story.

Mike Caseta, CFO and COO, Liquidia Corporation: Thanks, Serge.

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