Liquidia at Jefferies Conference: Strategic Moves in PAH Market

Published 04/06/2025, 19:48
Liquidia at Jefferies Conference: Strategic Moves in PAH Market

On Wednesday, 04 June 2025, Liquidia Technologies (NASDAQ:LQDA) presented at the Jefferies Global Healthcare Conference 2025, highlighting a major milestone with the FDA approval of Eutrebia for PAH and PHILD. The company showcased its strategic initiatives, balancing optimism about market opportunities with ongoing legal challenges.

Key Takeaways

  • Liquidia received FDA approval for Eutrebia, targeting PAH and PHILD.
  • The company plans to achieve profitability within three to four quarters.
  • A strong sales force is focused on reaching key prescribers.
  • The ASCENT study indicates better tolerability of Eutrebia compared to competitors.
  • Legal disputes with United Therapeutics continue, but Liquidia remains confident in its position.

Financial Results

  • Pricing: Eutrebia is priced at parity with Tyvaso DPI.
  • Cash Position: Liquidia ended Q1 with approximately $170 million in cash and access to an additional $50 million tranche from Health Care Royalties.
  • Profitability: Expected within three to four quarters post-launch.
  • COGS: Efficient due to PRINT technology and manufacturing process.
  • Market Opportunity: Targeting a $4 billion market with potential expansion into the underpenetrated PHILD sector.

Operational Updates

  • Approval and Shipping: Eutrebia was approved on May 23, with shipments beginning within five business days.
  • Patient Access: Scripts filled the day after the conference call, supported by a 28-day voucher program.
  • Commercial Supply: Confidence in supply through Plastiape inhalers.
  • Sales Force: 60 representatives targeting 6,500 critical prescribers.

Future Outlook

  • L-606 Development: A next-generation liposomal formulation, with Phase 3 studies expected by year-end.
  • PHILD Expansion: Strategies to penetrate the underdeveloped PHILD market.
  • Regulatory Strategy: Pursuing a 505(b)(2) pathway for L-606.
  • Data Presentation: Upcoming presentations on ASCENT study and L-606 safety study data.

Q&A Highlights

  • Salesforce Strategy: Confident in the 60-strong sales force’s ability to compete effectively.
  • ASCENT Study: Positive feedback on better tolerability compared to Tyvaso DPI.
  • Transitions: Expecting patient transitions from nebulized Tyvaso to Eutrebia.
  • Payer Access: Ongoing engagements with commercial payers for broader access.
  • Legal Challenges: Confidence in legal standing against United Therapeutics.

For more detailed insights, refer to the full transcript below.

Full transcript - Jefferies Global Healthcare Conference 2025:

Kombe Ziazi, Biotech Analyst, Jefferies: Welcome to the Jefferies Global Healthcare Conference. My name is Kombe Ziazi. I’m a biotech analyst here at Jefferies. Today, it’s my distinct honor and pleasure to welcome Liquidia Therapeutics CEO, Roger Jeffs, and CFO, Mike Caseta. Coming off a recent drug approval for Eutrebia.

Welcome gentlemen. Thank you, Combes. Roger, maybe I’ll allow you to have some open remarks because Eutrebia was so recently approved. We’d just love to hear your perspective, anything about the approval, the label and how launch is going because you’re already shipping.

Roger Jeffs, CEO, Liquidia Therapeutics: Correct. So first, pleasure to be here with you, Combis. Always enjoy coming to the Jefferies Conference. I’m here with Mike Acetra, our Chief Financial Officer and Chief Operating Officer and Jason O’Dare, who’s our Chief Business Officer and Head of IR. So if you have follow-up questions, I’d encourage you to talk to Jason after the meeting.

So as Combi said, on May 23, we got approval for Eutropia for both PAH and PHILD. So very excited that we can launch into both indications simultaneously with Eutropia, which is an inhaled treprostinil formulation. It’s enabled by a platform technology called PRINT. So print allows us to print in the lower end of the respirable range or manufacture dry particles in the one one micron say uniform size, shape, and form composition. The beauty of that is that print enables a product profile that it’s clearly differentiated on three critical elements, efficacy, safety, and convenience.

So if you look at safety, for example, because we’re in the low end of the respirable range and preferentially fly to the lower distal airway, we avoid upper airway deposition. So we avoid transient cough and throat irritation, which is dose limiting for the incumbent brand product. The benefit of that also allows us to dose to a better effect. So because we don’t have intolerance in the upper airway, we can drive to three or 4x the current historical therapeutic dose standard for the incumbent brand. And then we can do it conveniently through a device that is a low resistance device because again we don’t need energy from a device to de aggregate the product.

It comes as a mono dispersed formulation. So we think those are three critical and important levers. So if you can differentiate on safety, efficacy and convenience that will port significant share over time. And I don’t say that without precedent. So if you look back in the PAH landscape, the first drug approved was epiprostenol.

It was a short acting intravenous therapy for patients who were in extreme class IV condition. It required a central venous catheter. The risk of that drug, though, however, if that catheter was pulled or kinked during sleeping, for example, the patient could suffer rebound pulmonary hypertension and death. We developed Remodulin while I was at United Therapeutics. Longer half life gave us larger safety margin.

The Flolan market converted almost uniformly in about twelve to eighteen months. If you look at endothelin receptor antagonists, similar story. So Actilian developed their first drug was Traclir, a Bosantin. It had was it endothelin A and B antagonist? It had potential for liver toxicity and was given twice a day.

They then ported to a once a day formulation called Ambrosentin or Letteris was the brand name. It was an endothelin A selective antagonist so better on safety, better on convenience cause it was once a day. That market ported in twelve to eighteen months. Then look directly at inhaled prostacyclins. Actelion had a drug called Ventevas, twenty minute half life.

It was recommended to be given six to nine times a day, same efficacy as treprostinil. Treprostinil Tyvaso was developed as a four times a day, twelve to eighteen months. That market converted almost universally to Tyvaso. So there’s good precedent if you can attend to one or two of those critical elements that you will port significant share. We’ve actually as you heard attended to all three critical elements safety, efficacy and convenience and we think that will speak and bode well for the presence of Utopia and its product profile and uptake.

Kombe Ziazi, Biotech Analyst, Jefferies: Amazing. Maybe some other factors that will help Utopia adoption, maybe you could speak a little bit about parity pricing with Tyvaso DPI And how will your voucher program enable rapid utrepy adoption in addition to your suite of patient access services?

Roger Jeffs, CEO, Liquidia Therapeutics: Yes. I’d love to have Mike talk to that.

Mike Caseta, CFO & COO, Liquidia Therapeutics: Yes. Thanks, Combis. So as we mentioned at approval that we have priced the product at parity to Tyvaso DPI, one of the things that’s most important for us is patients to be able to have access. We’ve also released a significant amount of patient support services. These suite of services are what patients are used to in in their current treatment with some additions, one of those being the the twenty eight day voucher program that you that you mentioned.

What this simply does is it allows patients to to get on therapy immediately. It is available for, you know, for all eligible patients and and, you know, allows patients it does take time to go through process, adjudication process with with reimbursement, allows patients to get on the product, see if it’s something that they are able to tolerate, which we absolutely believe they will be able to, and then move straight into the commercial landscape. So it is what we feel and what we’re gonna differentiate ourselves on is is being able to provide services to patients to get access to to utrebia and then ultimately continue on therapy and support them through their entire patient journey.

Kombe Ziazi, Biotech Analyst, Jefferies: In terms of actually shipping product, we saw the press release that you have shipped some product. When will patients actually the first patients actually be receiving Eutrebia?

Roger Jeffs, CEO, Liquidia Therapeutics: Yes. So we were approved on May 23. Referrals began that day. Shipments occurred in five business days, which we think is record setting pace, and patient scripts were filled starting yesterday.

Kombe Ziazi, Biotech Analyst, Jefferies: Amazing. Yeah. Wow. For launch, I guess, robust is the supply of your DPI inhaler for utremia? And kind of what are kind of key KPIs you’re gonna be sharing, and how much transparency will you be providing the street into launch metrics?

Roger Jeffs, CEO, Liquidia Therapeutics: Mike?

Mike Caseta, CFO & COO, Liquidia Therapeutics: Yes. So as it relates to commercial supply, we’ve been building commercial supply for the last couple of years. As Roger said, we were able to ship product within five days. We are very confident in our ability to supply as it relates specifically to the inhalers. We use a device that’s manufactured by Plastiape.

It’s manufactured in the millions. We purchase a very small percentage of their overall output. So we have sufficient on hand in kits that are already sitting at specialty pharmacies, but then also in our inventory as we move forward. So we’re very confident in our supply, very confident in our ability to service all of these patients as we move through what we believe is going to be a very successful launch. Now as it relates to metrics, we will have access to a lot of information around our our launch.

And while especially as we are early in the launch phase where revenue may not be the direct indicator of success of launch given at the time of year that we are launching, we will be prepared to share other information, whether it’s new patient starts, unique prescribers, things like that, where we will have access to that information. And we do understand it’s important for us to convey our confidence in the launch and do that with certain metrics. And we will be prepared to do that starting with our first earnings call after launch in August.

Kombe Ziazi, Biotech Analyst, Jefferies: Great. And you know, one big question I get from investors is, you know, there may like, you know, perception of a discrepancy in Salesforce, how Liquidio will compete with incumbents. Of course, we have a very experienced management team sitting with us right here but would love to hear you go a little bit in more detail of how Scott and the work he’s going to do is going to really help Utrepy adoption.

Roger Jeffs, CEO, Liquidia Therapeutics: Yes. So we’ve done a number of sales force sizing exercises. So we have about a 60 odd strong sales force team. And there’s ancillary support with medical affairs and other groups as well. Maybe what I’ll talk about is the prescribing landscape a little bit.

So we think there’s about 6,500 upper tier critical prescribers for PAH and PHILD. About a third do PAH only, about a third do PHILD specifically and about a third do both. So we need to call on those 6,500 targets. Those 6,500 targets reside at about and again these are rough numbers about 150 key centers of excellence and about seven fifty community centers. So the sizing exercises around our ability to call on those doctors with a certain level of frequency, We feel that is equal to the competitive brand and remember we’re really detailing mostly just Trepia whereas they have multiple products that they have to detail.

So our share of voice we feel will be equal if not better.

Kombe Ziazi, Biotech Analyst, Jefferies: Excellent. And you know you’re kind of coming hot off of some great data you shared at ATS. I was there as well. What was kind of the reception there by doctors? Do doctors think that ASCENT Cohort A, the 20 patient data that’s available so far demonstrated a differentiated profile for Utruria and PHILD?

And what’s just the general reception there?

Roger Jeffs, CEO, Liquidia Therapeutics: Yes. So we weren’t approved when we were at ATS. So we had an ad board, we were able to share our first sample and we did have an abstract at ATS. What the ASCENT study is a prospective trial in patients with PH ILD and what we’re trying to look at is can we port the same tolerability and dosing profile that we’ve observed in PAH patients because it’s clear in the marketplace that Tyvaso DPI is having a struggle in terms of tolerance probably because they’re using a aggregated moiety on an FTKP backbone that requires a high resistance device and the energy of that to disaggregate that product. So those patients with inspiratory issues due to their interstitial lung disease as well as their PH are struggling with that therapy and are coming off as fast as forty days after starting.

So what we’ve seen with Ascent is a very, very different picture than that. So in the first twenty patients through eight weeks, we’re seeing only one dropout due to a respiratory infection. We’re seeing the ability to tolerate the drug with only mild cough. In fact, we did a sequential cough score. The cough is not changing from start up, from initiation of therapy to end of therapy, even though we’re escalating doses by two to three orders higher.

So we seem to be providing a product profile that’s quite different where the tolerability is there which allows us to port the efficacy and we’re doing it with this low resistance device which is easy and convenient for the patients particularly with PHILD to use. So there was a really enthusiastic reception to that data. There were comments and it’s a spectrum. I think some people want to see so we announced earlier that in March we had enrolled a full sample which is over 50 patients. Some docs want to see the full 50 patients through eight weeks.

I can tell you now that it’s looking very similar but we will present that data in the late summer early fall but we don’t think it will materially change from what we’re seeing already. And then after that then we’ll show the sixteen week data. So we have a number of sequential data sets and opportunities to again promote the benefits that we’re talking about on these three critical leavers safety, efficacy, and convenience. What caught me a little off guard frankly and even though I’ve been in this a long time is it has generated a lot of enthusiasm for transitions, particularly from nebulized Tyvaso. So the nebulized Tyvaso still enjoys about a 35% share, which is inexplicable, really, if you have a more convenient dry powder option.

But that alone tells you that the DPI is having issues, the Tyvaso DPI. So I think what I’m more encouraged about after hearing the doctors respond to that data was their eagerness to transition to nebulized patient base that’s captive and retained but looking for something different and better. So I think we had talked about doing of a biphasic launch combi is where we would look for new patient starts, compete with those, prove ourselves, get breadth and depth of prescriptions. But I think we’re going to pull forward the transitions as well. Think based on the data we’re showing and the clear differentiation there’s an opportunity to give those patients a potentially better option for them.

Kombe Ziazi, Biotech Analyst, Jefferies: Yeah. And ascent cohort a is only just starting to develop that kind of, important dataset. You’re also gonna be directly, you know, you’re gonna have another cohort, cohort b that’s gonna be directly studied in transition patients. Maybe can you tell us a little bit about that?

Roger Jeffs, CEO, Liquidia Therapeutics: So that’ll be a directed so we’ve we’ve in our original approval study, they called the INSPIRE, we had two two patient populations with PAH. One were naive or de novo and the other sample was transitions from nebulized Tyvaso. So we’ve already shown in PAH you can transition patients. You can do it rapidly and you can just do it on breath equivalence with ease so that the dose equivalence seem to help makes that quite simple. What we want to now do in PHILD particularly with nebulized anti vaso DPIs do a prospective study where we show directed transitions show that patients that were either under dosed and underperforming can be tuned up because now they get a dose a drug that’s better tolerated and we can get to a more efficacious dose.

So that study is going to start very very soon. It will be a similar size study in the 30 patient range or so. We don’t think we need much more than that and we’ll also have ongoing commercial data for transition patients that we’re going to collect as well from centers. So I think that’s going to be a growing data set that will again push us to the preferred prostacyclin or first choice because as some doctors are saying the way Tyvaso DPI got approved it was switches from nebulized so some practitioners are starting on nebulized and then switch to DPI but now they’re saying why ever start on a nebulized if you can use Eutrebia from day one. So I think again it’s paradigm shifting and really what we’re trying to do here is change standard of care.

I think Utopia has the real and true opportunity to become the prostacyclin of not only best in class for the inhaled, but prostacyclin of first choice and the next thing we’ll do is consider how do you take patients on oral prostacyclins who are having significant GI toxicity and move them to utremia where we can solve for any off target effect and give them the same dosing flexibility that they can get with oral if they tolerate it. So again a lot of opportunity. The oral market’s $2,000,000,000 in revenue currently in North America. Tyvaso, Tyvaso DPI is doing $2,000,000,000 So if you broaden out your lens we’re already going to go after what is a $4,000,000,000 today opportunity and PHILD still hasn’t been touched. It’s only marginally penetrated.

I think it’s only in the low double digits. So huge opportunity for us. We don’t have to necessarily displace competitive share. I think that will happen naturally, but just huge opportunity to do a lot of good things for these patients and our stakeholders.

Kombe Ziazi, Biotech Analyst, Jefferies: Yeah. And maybe just to dwell on that point a little bit longer, how do you counter detail those oral prostacyclines today and what are some like ideas you have long term? Is there any data you could generate to help your efforts on that front as well?

Roger Jeffs, CEO, Liquidia Therapeutics: Yeah, so nobody’s like nobody’s counter detailed orals today because United Therapeutics has both an oral program and one in development and an inhaled program their pitch was choose what you want we can give you both. Our view is gonna be oral is potentially toxic and if you can’t tolerate the drug you then can’t titrate it well, you can’t get the best benefit and if your trachea is direct to the site of injury you’re gonna have a better outcome with potentially no GI toxicity so it’s paradigm shifting. So that’s a behavioral change that’s going to take more time, admittedly. And again, this is very terse and generic. Cardiologists tend to use orals.

Pulmonologists tend to use inhaled therapies. So we’ll have to change behavior in the cardiology practice that there’s now a prostacyclin that you can use for your patients who you before would have used either Orenitram or Optravi, J and J’s product. And what we’ll probably we’ll have to figure out how do you transition the dose. Does it require a dose titration off of the oral and an uptitration of inhaled? Or can we do it sort of boldly and full force where we just switch them?

So that’s the work that we need to do so we can inform the market how to do the oral switches. That will take more time than just penetrating the naive and transition markets in PAH and PHILD that it’s currently looking at inhaled.

Kombe Ziazi, Biotech Analyst, Jefferies: Great. And maybe a question for Mike. You guys have been very consistent in saying or relatively consistent that you may be able to become profitable within three or four quarters from launch. What kind of gives you that confidence? And is that kind of maintaining that kind of

Mike Caseta, CFO & COO, Liquidia Therapeutics: Yes. So everything Roger just said, we’re very confident in the launch. We’re very confident in the trajectory that we believe that we’re going to see. We have a very efficient process. Our P and L is already fully loaded from an SG and A point of view.

Through our print technology and our manufacturing process, we have very efficient COGS. So we are confident that within three or four quarters of launch that we can reach profitability. We ended Q1 with about $170,000,000 of cash. As part of our agreement with Health Care Royalties, we have access to an additional $50,000,000 tranche upon first commercial sale. So we have formally requested that.

So we think together with our ability to achieve profitability, the cash that we have on hand plus that $50,000,000 along with the revenue that we will earn from sales of Eutrebia, we actually feel confident that we can reach that profitability and actually reach cash flow positivity on our current cash.

Kombe Ziazi, Biotech Analyst, Jefferies: And in terms of, like, the blocking and tackling required to get patient access for payer for from payers to Eutrebia, what’s kinda required from now until three to four quarters from now to get full reimbursement?

Mike Caseta, CFO & COO, Liquidia Therapeutics: Yeah. So I think what’s important to understand is if you look at the diversification of patients, we believe about fifty percent of patients come through Part D, about thirty five percent come through commercial, and fifteen percent come through the government mandated channels. What’s important to understand is that the Part D market, there is no contracting in Part D. This is a patient based doctor. These doctors have the infrastructure to go through the medical exception process, the prior auth process.

As part of our suite of support services, we will have reimbursement specialists. So if you look barriers that are out there, Part D is, in effect, open now. We are not disadvantaged right now as no products are covered, and we’re prepared to penetrate that. As it relates on the commercial front, our competitor has contracted in commercial, what we believe are giving modest rebates. We’ve been spending the last two years engaging with payers, talking about the value proposition that Eutrebia is going to bring.

We feel that we’ve done a really good job in doing that, build good relationships. Ultimately, we needed to get full approval to accelerate those discussions. That obviously has happened. We are in the process of having those conversations, and we are confident that we can achieve broad access here in the coming months.

Kombe Ziazi, Biotech Analyst, Jefferies: Right. And then your pricing is is the parity pricing is flat across doses, and you’re thinking of doing also kind of multipack? Yeah.

Mike Caseta, CFO & COO, Liquidia Therapeutics: So as as we stated, our our pricing, we have four SKUs of product at twenty six point five micrograms, fifty three micrograms, seventy nine point five micrograms, and one hundred and six micrograms. One of the things Roger talked about, our point of differentiation is being able to titrate to doses. Part of what we’re gonna do is create NDC additional NDCs of combining combining capsules, will be very important from a patient affordability point of view. That’s something that we could not trigger until we got full approval. So we’ve already been working through that to to get that in place and our plan is to have that, you know, hopefully have that place in place in the coming months.

Kombe Ziazi, Biotech Analyst, Jefferies: Excellent. Roger, maybe any kind of important points that we haven’t hit on yet on Eutropia?

Roger Jeffs, CEO, Liquidia Therapeutics: No. I think one thing to also when you look at at liquidity and what value we can bring, we’re building strength upon strength. So we have a next generation program called l six zero six. It’s a liposomal formulation suspension that we’ll use through a next gen nebulizer because we’re trying to create, again, incrementally better options for patients. So instead of a four times a day therapy, that will be a twice a day therapy.

And we think that can be market changing as well and it just gives us long extended terminal value. So excited about what we’re bringing to not only PH and PHLD patients and communities but also what we’re bringing to shareholders like yourselves.

Kombe Ziazi, Biotech Analyst, Jefferies: Yeah. And maybe building upon, you know, kind of the L606, how it increases your inhaled treprostinil franchise, how many patients have achieved greater than three hundred microgram twice daily dose in the open label label safety study and how have the adverse events been in that study? Has it been consistent with prior ones?

Roger Jeffs, CEO, Liquidia Therapeutics: Yeah, so what Kameez is referring to is there was an open label safety study. It’s ongoing now. We’ve completed enrollment at 28 patients. I won’t talk specifically about doses other than to say we’re getting to upwards of again three to 4x equivalents to traditional forms of inhaled treprostinil. Those patients have generally most the majority have been on the therapy between one and three years.

We will start presenting that patient data set in the fall. Again, it’s open label, but what you’ll what you should expect to see there is because they’re on the therapy and it’s durable, good tolerability is porting clinical benefit and they’re doing it easily with a twice a day regimen and the beauty of the what the reason it’s twice a day is we’re trying to mimic the steady state that you get with a parenteral therapy. So everybody knows if somebody comes into the hospital class four sick on death’s door, you hit them

Kombe Ziazi, Biotech Analyst, Jefferies: with

Roger Jeffs, CEO, Liquidia Therapeutics: intravenous prostacyclin. The reason is you can get them to a steady state dose, and then you can turn it up until you get them to a therapeutic benefit and stabilize them. What we’re trying to now do with L-six zero six is instead of peaks and valleys where we give it four times a day currently, smooth it out and then we can dose escalate. The beauty of the liposome is it brings down the Cmax because it’s sustained release. So you’re going to get a really attractive safety profile because usually AEs are Cmax driven.

But we’re getting the AUC that is in a pseudo steady state. And it’s important, you know, there are other people trying to develop next generation formulations, long acting formulations doing it as a single bolus dose but what they’re seeing is they’re getting a PK like this, it goes way up and it comes down and while it is there at twenty four hours it’s not really appreciably there. So and the consequence of that at least in some early data I’ve seen is that they lost treatment effect at the twenty four hours. That’s not what you want to do with a sustained release drug. You want sustained activity.

Just the fact that you can detect minimal levels in the plasma is pointless. You wanna show that you have sustained effect at the twenty four hour period. Otherwise, just use eutropia. So you need to improve on the current standard and that should be the goal of these studies that are next gen is can you develop a sustained action drug so that when patients sleep and wake up they still have drug in the system and they still are benefiting even though they went to sleep and currently are basically withdrawing from the drug each night.

Kombe Ziazi, Biotech Analyst, Jefferies: Now for L-six zero six, can you give us a lay of the Phase three registrational studies? What are the kind of the key features for that study design? When is it slated to start? Yeah.

Roger Jeffs, CEO, Liquidia Therapeutics: Yeah, so we’re you know it’s actually pretty simple. We just need to replicate the original nebulized Tyvaso PHILD study. We have agreement with the FDA that a single study in PHILD patients will subserve for approval in both PAH and PHILD. It’s a five zero five(two) paradigm that we’re going to pursue from a regulatory standard. Our goal is to start by the end of the year.

It’s about three fifty patients that we are looking to enroll globally. A lot of the enrollment will be ex U. S, Europe, Latin America, Asia, etcetera. We think again wet finger in the air it’s from start to approved you should think about four to five years. So you know we have that full phase three development program to do but we only have one study to do.

I think the INS MEDS program will require two studies as NCE so both in PH and PHLD so my expectation is they’ll take a few additional years to do both of those efforts. If they’re successful, they’re a 2,030 plus reality. So nothing to worry about in the near term and a lot of work for both of us to do frankly.

Kombe Ziazi, Biotech Analyst, Jefferies: Maybe quickly, because there’s been a lot of litigation around Utopia, what are the kind of key legal cases for Liquidia and how they can how can they impact Utopia’s freedom to operate from your perspective today?

Roger Jeffs, CEO, Liquidia Therapeutics: I’ll let Michael Michael answer, I think there’s a little bit left. There’s been a lot of litigation.

Kombe Ziazi, Biotech Analyst, Jefferies: So, Mike. Yeah.

Mike Caseta, CFO & COO, Liquidia Therapeutics: So just to give everyone some background. So UT has sued us on five patents. They’ve sued the FDA twice. They’ve filed a citizen’s petition against our NDA. They’ve asked for four preliminary injunctions, and we got approval on May 23.

So what can affect launch? At this point, we are launched. We are we are do we are dispensing to patients, so we feel very comfortable with where we are. We’ve been successful in every lawsuit that they’ve brought against us. There are two lawsuits that are outstanding.

One is the three twenty seven patent, which is in PHILD. Our trial is scheduled in Delaware on June 23. It should be a three day bench trial. We’re very confident. We feel very strongly.

It is a very weak patent. We feel very confident that we will be able to invalidate that patent. And we should get clarity in that towards the end of this year. The second patent is the seven eighty two patent that they asserted against us two weeks before our NDA. It was a patent that was issued to them three years prior to that.

They waited until two weeks prior to our NDA to assert it against us. They requested a temporary restraining order and a preliminary injunction. Last Friday, the judge in North Carolina where they filed suit just outright rejected the PI and the TRO on grounds of irreparable harm and, most importantly, on the merits of the case. So that will go through the normal process. I guess what I’ll say is we’ve been ready.

We have been successful. We will continue to be ready to support patients’ rights to have an alternative option in in treatment of PAH and PH ILD. And you also have asserted a patent on

Kombe Ziazi, Biotech Analyst, Jefferies: the higher dosing against United as well. Correct?

Mike Caseta, CFO & COO, Liquidia Therapeutics: Yeah. We have. We have a we have a patent that for treatment of one hundred to three hundred micrograms that we believe clearly United Therapeutics is now infringing based on some additional NDCs that they have added to their label, which infringe that dosing regimen. That is a process that will be playing out as well in parallel with the other two.

Kombe Ziazi, Biotech Analyst, Jefferies: Well, Roger, I just wanted to say congratulations on the approval of utremia. It was a long time coming, we’re happy to see it. And that’s going to be used by patients sooner. It’s already been used by patients perhaps. Any final words for the investor audience today?

Roger Jeffs, CEO, Liquidia Therapeutics: No. Again, for those of you who have been with us for the duration of this, we appreciate your persistence. And I think what you’re going to see is the tactical precision at which we come at this market. We’ve talked about the breadth of how we’re looking at it, both from a clinical profile, from a payer landscape, from patient support services and having product in hand at such a rapid pace. Think while we’re a new entrant, we’re not newbies.

I think we’re going to come at this fast and furious.

Kombe Ziazi, Biotech Analyst, Jefferies: Thank you so much. Thank you.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers
© 2007-2025 - Fusion Media Limited. All Rights Reserved.