Liquidia Corporation Full Year 2025 Earnings Call - YUTREPIA launch reached profitability and targets $1B franchise by 2027
Summary
Liquidia says its YUTREPIA launch moved from proof to profit faster than most imagined. The company reported $148.3 million in 2025 net product sales, including $90.1 million in Q4, and posted two consecutive quarters of improving profitability with Q4 adjusted EBITDA of $27.3 million and net income of $14.6 million. Management says commercial momentum continued into early 2026, with more than 3,600 referrals and over 2,900 patients shipped as of February 28, and it is targeting a billion-dollar franchise by 2027.
The story is part commercial execution and part product profile. Liquidia plans to fund multiple new trials and a next generation L-606 pivotal program from operating cash, expand the sales force by roughly a third, and press into PAH, PH-ILD and new indications such as systemic sclerosis associated Raynaud’s phenomenon and PH-COPD. Risks remain: ongoing patent litigation with no timetable for a decision, competitive device noise around soft mist inhalers, and modest gross-to-net pressure as coverage widens. Still, the company says the launch is cash-generating and scalable, and that YUTREPIA is already taking disproportionate share of new patient starts in the inhaled prostacyclin market.
Key Takeaways
- YUTREPIA generated $148.3 million in net product sales for full year 2025, including $90.1 million in Q4.
- Q4 marked Liquidia’s second consecutive quarter of improving profitability, with non-GAAP adjusted EBITDA of $27.3 million and net income of $14.6 million.
- The company ended 2025 with $190.7 million in cash and equivalents and produced $33 million of positive cash flow in Q4, calling the business a cash-generating growth engine.
- Commercial traction: more than 3,600 unique patient referrals and over 2,900 patients shipped since launch as of February 28, 2026.
- Patient mix and prescribing depth: roughly 75% of patients are prostacyclin-naive, 25% are transitions; about 860 prescribers and roughly 25% of physicians have referred 5 or more patients.
- Market share momentum: Liquidia estimates inhaled treprostinil revenue for Q4 was about $550 million, and Liquidia’s revenue share rose from ~10% in Q3 to ~17% in Q4, implying it captured a disproportionate share of new starts.
- Payer and access: company reports an 85% plus prescription-to-patient start conversion, coverage from major commercial payers, and expects modest gross-to-net increase as access widens but believes that will be offset by higher volume.
- Clinical program expansion: plans to start multiple studies in 2026 including transition studies from oral and inhaled prostacyclins, adjunctive combinations (eg tadalafil), sotatercept transition studies, and exploratory programs in systemic sclerosis-associated Raynaud’s phenomenon and PH-COPD.
- Next-generation program L-606 is moving toward a pivotal study across multiple territories with enrollment expected to begin in upcoming quarters; L-606 targets twice-daily liposomal delivery to reduce dosing burden and peak-to-trough variability.
- Competition and device dynamics: company downplayed risk from announced soft mist inhaler programs, arguing SMI offers portability but likely will not change clinical tolerability versus existing nebulized solutions and will not displace YUTREPIA’s differentiated particle engineering and dosing flexibility.
- Commercial execution plans include increasing the sales force by roughly one third to push deeper into the community and PH-ILD white space.
- Patent litigation remains unresolved: oral hearing occurred in June, post-trial briefs filed in August, the company expects an opinion but gives no timetable and says it is prepared for multiple outcomes.
- Inventory and refill trends: management says stocking has normalized nine months into launch, demand remains strong, and they see no seasonal slowdown through January and February 2026.
- Transition dynamics: of the transition cohort in PAH, management estimates about 30% of switches are from oral prostacyclins and the remainder from inhaled products, with some early movement from parenteral therapies as well.
Full Transcript
Operator: Good morning, and welcome to the Liquidia Corporation Full Year 2025 Financial Results and Corporate Update Conference Call. My name is Josh and I will be your operator today. All participants are currently in listen-only mode. Following the presentation, we will conduct a question-and-answer session. Instructions for joining the queue will be provided at that time. Please note that today’s call is being recorded. I’ll now turn the call over to Jason Adair, Chief Business Officer.
Jason Adair, Chief Business Officer, Liquidia Corporation: Thank you. Good morning, everyone. It’s my pleasure to welcome you to our full year 2025 financial results and corporate update call. Joining me today are Dr. Roger Jeffs, Chief Executive Officer, Michael Kaseta, Chief Operating Officer and Chief Financial Officer, Dr. Rajeev Saggar, Chief Medical Officer, Scott Moomaw, Chief Commercial Officer, and Rusty Schundler, our General Counsel. Before we begin, please note that today’s discussion will include forward-looking statements, including statements regarding future results, product performance, and ongoing clinical or commercial activities. These statements are subject to risks and uncertainties that may cause actual results to differ materially. For further information, please refer to our filings with the SEC, available on our website. Please also note that our earnings release and our commentary includes non-GAAP financial measures. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures can be found in our earnings release.
With that, I’ll turn the call over to Roger. Roger?
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Thanks, Jason. Good morning, everyone. As we look back on 2025 and forward into 2026, what stands out is the rapid establishment of our preferred product profile paired with precise execution. Last year demonstrated that Liquidia could launch, scale, and reach profitability quickly within only 120 days of launch, in fact. Most importantly, we demonstrated that physicians were willing to rapidly change prescribing behavior when presented with a new differentiated option in YUTREPIA. The benefits of its product profile, deep lung delivery, low effort device, and wide dose range, are taking hold in clinical practice and help place YUTREPIA as one of the top specialty drug launches over the past 5 years across all therapeutic categories.
This did not happen by chance, but with purpose, as the category defined in the SENSE study data clearly set a new data-driven standard for therapeutic success. The momentum of 2025 has clearly carried into 2026. As of February 28, we have received more than 3,600 unique patient referrals and shipped therapy for more than 2,900 patients since launch, maintaining our robust trajectory. While others have observed stagnation from supposed seasonality, that has not been our initial experience as we continue on the same tour trajectory without decline, which would suggest that our % market share is rising and that we are capturing a disproportionate number of new patient starts for inhaled prostacyclins as the best-in-class option. This steady forward momentum is being achieved across PAH and PH-ILD, with new patient prescriptions roughly equal now between the two indications.
Patient starts remain at 75% naive to 25% transitions from other prostacyclins. Breadth and depth are also improving in a measurable way. We have increased total prescribers to around 860 as centers gain confidence and usage expands in the community. A key indicator of that depth is that roughly 25% of physicians have already referred 5 or more patients, which is exactly the pattern you want to see when a therapy evolves in becoming the standard of choice rather than an initial trial. If 2025 was the start of the full commercial phase, 2026 begins the full clinical exploration of what may be possible with YUTREPIA and L-606. Our development strategy is built on principles we have understood for a long time with prostacyclin. Exposure drives efficacy, tolerability drives durability, and convenience drives compliance.
Each of these elements is critical to the totality of therapeutic experience and speaks to the high bar that YUTREPIA has quickly established around safety, efficacy, and convenience. This year, we will look to further cement this best-in-class product profile via the initiation of multiple new studies, including studies that will transition patients from oral and inhaled prostacyclin therapies and a study of new combinations, like adjunctive studies with tadalafil, that we hope will further advance the changing standard of care. Further, we will work to initiate new studies to support expansion into additional disease areas such as systemic sclerosis-associated Raynaud’s phenomenon and PH-COPD, where high unmet but addressable need remains.
Of course, we will look to move the therapeutic needle even further via the advancement of our next generation L-606 pivotal study, with a study initiated in multiple territories and enrollment expected to begin in the following quarters. Importantly, this disciplined expansion of clinical evidence will be funded by cash flow from operations and will help grow the value of the franchise and the company. With that, I will turn it over to Mike.
Jason Adair, Chief Business Officer, Liquidia Corporation: Thank you, Roger. Good morning, everyone. Our financial results are a direct reflection of two things: sustained patient growth and retention and disciplined execution. Over the last 9 months, as the referral and start curves have moved higher, so have revenue, margin contribution, and cash generation. For the full year 2025, YUTREPIA generated $148.3 million in net product sales, including $90.1 million in the fourth quarter, representing 74% growth in net product sales over the third quarter 2025. The fourth quarter also marked our second consecutive quarter of increasing profitability with not only non-GAAP adjusted EBITDA of $27.3 million, but also $14.6 million of net income.
Michael Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia Corporation: We ended the year with approximately $190.7 million in cash and cash equivalents, having generated $33 million of positive cash flow in the fourth quarter alone. Liquidia is now operating as a cash-generating growth engine. That is not aspirational. It is visible in the quarterly numbers and on the balance sheet. Roger, back to you.
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Thanks, Mike. We’re confident in 2026 and the years ahead as we focus on building a durable franchise with increasing patient preference and a clear path towards at least a billion-dollar franchise in 2027, with increasing growth in the years beyond. Operator, please open the line for questions.
Operator: Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One moment for questions. Our first question comes from Ryan Deschner with Raymond James. You may proceed.
Benjamin Burnett, Analyst, Wells Fargo0: Thanks for the question. Congratulations on the, you know, impressive continued launch so far for YUTREPIA. Curious, you know, given the greater than 2,900 patient starts you’re reporting today, where do you think this puts you in terms of current market share, and how are you thinking about continued growth in the first half of 2026? I have a follow-up.
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Yeah. Thanks, Ryan. Appreciate you joining the call this morning. It’s hard to give a, you know, an accurate % market share from a patient number standpoint, given the competitor doesn’t disclose their numbers. What we have done is we’ve done an analysis based on revenue, that maybe, Mike, if you don’t mind going through that speaks to this question.
Michael Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia Corporation: Yeah. Thanks, Roger, and thanks, Ryan, for the question. You know, so to give everyone an idea, you know, inhaled treprostinil revenue for Q4 was approximately $550 million. As Roger said, despite what our competitors have talked about with seasonality in Q4 in their business and their corresponding decrease in revenue from Q3, that’s still an increase of 5% revenue from Q3 of 2025. You know, the fact that we had an 80% increase in revenue quarter-over-quarter means that we’re accounting for more than 100% of market growth in Q4. Again, as Roger had said, that represents a disproportionate share of new patient starts, along with a fair share of switches from Tyvaso.
You know, in terms of what that share is, you know, in Q3, we had about, from a revenue point of view, 10% of market revenue. That increased to 17% in Q4. We’re seeing a significant increase quarter-over-quarter. As Roger mentioned, the 2,900 patient starts in just 9 months since launch, that is through February 28th. We’re seeing that continued momentum that we’ve seen in Q4, in the first two-thirds of Q1 of 2026 and feel very excited and, you know, bullish on our ability to continue a successful launch.
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Thanks, Mike. Ryan, just to add, you know, it’s been very consistent in terms of trajectory, and we don’t see any impediment going forward this year with regard to any change in that trajectory. You know, as we mentioned in the prepared remarks, you know, the depth of prescriptions is increasing. We’re working on improving, you know, the duration and durability so that scripts stack upon scripts so that the revenue growth remains. I believe you had another question, Ryan.
Benjamin Burnett, Analyst, Wells Fargo0: Yeah, thanks for that. With the new outcomes data from a competitor that came out recently, what’s your take on the potential impact of a new addition to the oral prostacyclin receptor agonist mix, on the YUTREPIA launch?
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Yeah, I mean, it’s a good question. You know, first of all, congratulate, you know, Therapeutics on a successful trial with a IP1 selective agonist. I think for us, it really doesn’t have any impact at all. If you look at it’s more like Uptravi than not. I mean, they’re both in the nanomolar range. I think potency-wise, they’re generally similar. Their target binding profile is highly selective just to the IP1 agonist. I think the results are similar. You’re seeing an effect long-term over years in clinical worsening with a very muted effect on symptomatology, which primarily, if you look at the six-minute walk distance, which they didn’t disclose, they said it was significant. My guess is it’s muted.
As you know, with Uptravi, they had no statistical significance or clinical significantly change in six-minute walk distance. You know, in these patients, when you’re talking about a first edition of prostacyclin, the patients are symptomatic and looking for improvement. You know, I don’t think like the oral therapies just aren’t gonna give that bang for the buck. What they are gonna bang is the GI. If you look at the AE profile that was shown, you could see, you know, a high degree of GI side effects, diarrhea, emesis, and nausea. You know, I think it’s more of the same. All the results that Mike just talked about in terms of our launch trajectory and success are in the presence of Uptravi being in the market.
To me, it’s really an interchange between how ralinepag will compete with Uptravi in the marketplace once it’s launched. You know, not that concerning. I think also if you look at their box and whisker plot, while they did have success across a lot of different subgroups, one thing that was not differentiated was dose. It doesn’t seem like there’s an ability to dose to better outcome there. What you get is what you see is what you get based on probability close to the initial start dose. Again, more of the same, and I don’t think it’ll be impactful in any way in terms of how we view our business. Thanks for the question.
Benjamin Burnett, Analyst, Wells Fargo0: Got it. Thanks.
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Operator.
Operator: Our next question comes from Julian Harrison with BTIG. You may proceed.
Julian Harrison, Analyst, BTIG: Hi. Congrats on the progress. Thank you for taking the questions. Roger, I’m sure you’re very familiar with soft mist inhalers. Can you help us better understand the differentiation potentially of YUTREPIA, maybe L-606 as well, relative to a soft mist inhaler that was recently announced by another company in the space? Then as a follow-up, regarding the PAH versus PH-ILD split of patients on YUTREPIA, should we still be thinking about that on approximately a 3-to-1 basis? How do you see that maybe evolving over time?
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Yes, I’ll answer the. Maybe ask Scott to help me with the second question first. We’ve moved to pretty equal split now between PAH and PH-ILD. You know, there’s clearly more white space opportunity in PH-ILD, and I think one of the things we’re doing is we’re gonna grow our sales force significantly, like by a third. We’re gonna have a larger share of voice. The purpose of that larger share of voice is to get into the community, particularly into the PH-ILD space, to continue to penetrate that market, drive awareness and either drive starts or drive referrals. You know, I think over time, that should become an increasing value proposition.
In PAH, don’t forget, you know, we have not only the inhaled market opportunity, but we’re also going after the oral and parenteral opportunity. On aggregate revenue numbers, they may appear similar in terms of the business opportunity. In pure patient numbers, I think PHILD has the opportunity to be more successful. Scott, do you have any other questions or any other responses that you’d like to add?
Benjamin Burnett, Analyst, Wells Fargo1: No, I would, excuse me. I would completely just agree with everything Roger said. It’s been interesting to see PAH get off to a fast start. As we’ve mentioned, PH-ILD has come on strong and you know, about half. Where it’s gonna go from here, I, you know, I think PH-ILD, we know PH-ILD is definitely the bigger opportunity long term, as Roger called it, the white space. There’s still a load of opportunity in PAH. You know, where it’ll settle out, eventually, I think PH-ILD definitely will be bigger, but there’s a lot of growth in both buckets right now to continue in the near term.
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Yeah. Great. Thanks, Scott. Again, Julian, you know, there’s multibillion-dollar opportunities in each indication. We’re excited about the opportunity that YUTREPIA and then subsequently L-606 will have in these markets. With regard to the SMI, I know it’s a seminal question for everybody and sort of front of mind, because there were some pretty hyperbolic comments made about it. What I would say is I think their commentary in general was it sounded very much to me that it was validating of YUTREPIA because it sounds like they’re trying to develop a product that has the product profile of YUTREPIA. What is that? It’s an easy-to-use, low resistance device with high portability.
There’s mitigation of cough. For us, it’s specifically done due to the print formulation and of engineered particles in the lower end of the respiratory range. Dosing flexibility due to that tolerance and which then correlates, as we’ve clearly shown in the ASCENT study, that we can rapidly and aggressively dose patients to two or four times the past standard with absolutely no exacerbation of cough in a population of PH-ILD patients who have a baseline cough and a high predilection for exacerbation of cough when they take inhalation therapy. You know, YUTREPIA is porting an ideal product profile. What Mike described is we’re clearly getting a lot, if not most of the NRx share, and our TRX share is catching up over time. The SMI to me is just a, it’s a repurposed opportunity.
If you go back to the ’793 patent that has a priority date of 2006 and look at example one for, in particular. It talks about there a single-dose acute administration of treprostinil using an SMI. In that same patent, there’s a single acute dose with the ultrasonic nebulizers, that is Tyvaso as we know it today. What that, what that showed is that in PAH patients with a single dose, low dose, that cough was prevalent. It described the MMAD or the median diameter of those particles to be in the 4-5 micron range. Nothing different. You’re giving Tyvaso solution. You’re not doing anything to improve its tolerability or penetration to the lower airway. You’re just using a different way to present an aerosolized mist.
It doesn’t really matter if you use a soft mist inhaler. Yes, that’s probably better from a portability standpoint, but that will be it. It will still present itself clinically in terms of how it behaves as Tyvaso nebulized. You know, we don’t really view it as competitive. I think, you know, you’d have to ask the competitor to explain the comments they made around tolerability. They’ve said they still have to do bioequivalence, so whatever data they have, my guess is it’s just single-dose acute studies in normal volunteers, which is a very bad proxy for what may happen in patients with a high predilection of cough. The truth to that statement is, remember when they launched Tyvaso DPI, they had no data in patients. It was done on bioequivalence in PHILD.
You’ve seen the issues they’ve had through the National Jewish Health, in particular with the DPI and PH-ILD. Now it seems like they’ve capitulated and feel that DPIs are now not useful, at least their DPI, and they’re trying to pivot to another methodology. I don’t see that methodology as providing any forward-looking benefit. That’s, that’s kind of like my quick view on it. I know, Rajiv, you have some broader statements around perspective because this has been tried before in other markets. If I could, I’d ask you to speak to those instances, if you will.
Dr. Rajeev Saggar, Chief Medical Officer, Liquidia Corporation: Yeah, sure. Thanks, Roger. I think I just want to highlight some key point here. I think the signature of the SMI was primarily derived from the Spiriva Respimat, and that was done at a time when the CFC propellants were being removed, there was a patent issue from that company. They compared it to Spiriva HandiHaler, which is their dry powder formulation. At that time, the HandiHaler was the highest resistance device ever to be developed in patients with asthma and COPD, which you know is tens of millions of patients. The only device that has a higher resistance than the HandiHaler to date is actually the Tyvaso DPI device that’s used in PAH and PH-ILD.
What’s really interesting is, with all the studies done comparing the soft mist inhaler to a dry powder inhaler using the same formulation in disregard with tiotropium, the SMI has never been shown to change the clinical efficacy, the pharmacokinetics, and most importantly, has never been shown to improve or modify safety and/or tolerability inclusive of the concerns for cough. I just want to highlight as what Roger spoke to, that the SMI does not port any substantial benefit besides the portability itself.
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: All right. Thank you, Rajiv. Operator, next question, please.
Operator: Thank you. Our next question comes from Ami Fadia with Jefferies. You may proceed.
Ami Fadia, Analyst, Jefferies: Hey, thanks so much for taking your question and congrats on the momentum. When we look at your path to the $1 billion revenue target in 2027 that you laid out, our math suggests that implies sustained patient adds from here. Is that the right way to think about the trajectory? More importantly, what gives you confidence in maintaining your current pace in the next couple of years? How much visibility do you have into the patient funnel and where are the patients coming from? Are you still confident in that number in light of kind of the potential emerging competitive dynamics like SMI?
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: I’ll ask Mike to speak to some of that, how we get there, at least from a revenue calculation standpoint. As we just said, Amy, like we don’t see any influence from the SMI. I think it’s, again, it’s gonna be Tyvaso and perhaps a more portable format from a, you know, using jet nozzles to create aerosolized particles. As I said, they’re gonna be polydispersed, they’re gonna cause cough, they’re gonna have titration issues. I don’t really see that impacting us in any other way. As you’re noting in the competitors’ revenues, that the nebulized business is decreasing mostly because we’re beginning to take that share away. I think more of that will continue to happen.
Mike, do you want to talk about kind of how we see our sales continuing to climb the mountain towards a greater than at least $1 billion in revenue in 2027?
Michael Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia Corporation: Yeah, Ami, thanks for the question. I mean, if you just look at, you know, start with what I talked about earlier, you know, the market for the quarter was over $500 billion, which means The inhaled treprostinil market’s already a $2 billion market. You talk about, you know, our share of that revenue has increased considerably quarter-over-quarter. We believe that will continue as well. You look at the opportunity that we talked about in PAH with the $2 billion oral opportunity, where we believe that there will be significant opportunity for us to gain significant share from that. That’s another $2 billion opportunity just within PAH that we see. As Scott and Roger had said earlier, we’re just scratching the surface in PH-ILD.
We’re enhancing our sales force. We’re getting more penetration. We’re getting further into the community. When you look at the overall opportunity, a current $2 billion market opportunity in inhaled treprostinil, plus the oral opportunity, plus the enhanced white space in PH-ILD, we feel very bullish in our ability to continue on this trajectory and continue on this path to get us to what, you know, as Roger had said at JPM, a billion-dollar YUTREPIA being a billion-dollar product in 2027.
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: I think the other thing, Amy, too, great response, Mike, is, look, we’re doing directed studies that we’re gonna transition patients from the competitive agents, either oral or inhaled, and show the benefits of moving those patients to direct tolerability and efficacy. You know, all of these things just will continue to build a portfolio and a suite of evidence and data-driven proof that YUTREPIA is the best in class and first in choice product. Operator, next question, please.
Operator: Thank you. Our next question comes from Serge Belanger with Needham. You may proceed.
Dr. Rajeev Saggar, Chief Medical Officer, Liquidia Corporation: Hi, good morning. First question on the legal front. Any new updates or developments that you can share with us? Secondly, regarding payer access, I think you reported another 85% prescription to patient start conversion. Just curious how that number varies across the Medicare and commercial segment. I guess what additional Coverage work is required. I know you had coverage from 3 major commercial payers, but would additional payers need to come online over the remainder of 2026? Thank you.
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Sure. Hey, good morning, Serge. Thanks for the question. I’ll take the legal, and then I’ll pass it to Mike for payer. Really nothing new from what we said at J.P. Morgan, Serge. You know, just a reminder for those who may be newer to the story that the oral hearing was in June. Post-trial briefings were completed in August. We’re now approaching nine months from trial and seven months from the post-trial briefing. We do think we’re in the sweet spot for when an opinion should and could be rendered, but obviously it’s been taking longer than we all expected, can’t really probabilitize on when it actually will come down.
What I would say is, you know, we remain very confident in the arguments that we made, and we strongly believe that we should win the case and the case should read out favorably to us. We acknowledge there’s a lot of potential options here or outcomes, but regardless of what happens, we’re prepared for any and all outcomes. Really nothing new to state today other than we remain confident in our position and look forward to hearing from the judge in due time. Mike, if you’ll talk to payer access, please.
Michael Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia Corporation: Yeah. Serge, great to hear from you. I think, you know, where we are with payer and pull-through is just another example of how we’ve executed on this launch. You know, Scott and his team have done a masterful job. The fact that we’ve maintained 85% plus of pull-through from really the very early stages of the launch is simply staggering. We continue on that pace. We’ve also said from the beginning of the launch was our goal was to make sure that patients have a choice if they want to use YUTREPIA. What we can say is we’ve achieved that, and we continue to work through our pull-through, making sure that we provide a suite of services to patients to make sure that if they want YUTREPIA, they can get it.
I think that’s evident in that pull-through percentage, and we don’t see any, you know, any change in that coming, and our goal will always be to improve that as we move forward. I really think we’re already in a best-in-class state, being at 85+% pull-through percentage.
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Great. Thanks, Mike. Operator, next question.
Operator: Thank you. Our next question comes from Benjamin Burnett with Wells Fargo. You may proceed.
Benjamin Burnett, Analyst, Wells Fargo: Hey, thanks very much. Congrats on all the progress. I just wanted to see if I could get a little bit of color on some of the launch dynamics into the first quarter. Anything you can say kind of around inventory, stocking trends or kind of the refill rate that you’re seeing?
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Yeah. Mike, if you wouldn’t mind commenting on that.
Michael Kaseta, Chief Operating Officer and Chief Financial Officer, Liquidia Corporation: Yeah. Ben, thanks for the question. You know, as we said in our press release, Roger reiterated already, we’ve already had a strong, you know, January and February when it comes to both new patient starts and referrals. We’re staying on the exact same trajectory we were on in Q4. You know, we’ve often gotten questions from analysts and from comments from our competitors about seasonality. We’ve seen nothing but increases across the board and as we showed today, we continue to see those increases. You know, as we’ve always said, you know, as Roger had said, we are still very confident as we move through the rest of Q1 into Q2 and are on our path to be a billion-dollar product in 2027.
As it relates to inventory and stocking, you know, I think we’re now at the point of the launch nine months in where we’ve really normalized and I don’t expect there to be any significant swings. You know, specialty distributors can make decisions at end of quarters that, you know, don’t have influence over. At the end of the day, we are tracking well, our demand is extremely strong, and as a result, we feel very confident in the revenue, as we move forward.
Benjamin Burnett, Analyst, Wells Fargo: Okay. That’s extremely helpful. Thank you. I guess just also regarding the systemic sclerosis RP program, I thought that was interesting. Could you maybe walk us through kind of the evidence in support of treprostinil and kind of what your path forward is there?
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Yeah, I’d love to. Rajiv, if you wouldn’t mind talking about the Raynaud’s program.
Dr. Rajeev Saggar, Chief Medical Officer, Liquidia Corporation: Yeah, sure. Thanks. Thanks for the question. Obviously, you know, systemic sclerosis is a rare condition overall. Obviously, by the nature of their the actual topic of systemic means they have multiple disorders affecting multiple organ dysfunctions, inclusive of the most deadly, which is PAH and PHLD. Despite that, their single most complaints of what drives their quality of life is the problem that occurs with Raynaud’s phenomenon, which occurs in at least, you know, and it’s debatable, but somewhere between 90% to 95% of all patients with systemic sclerosis or scleroderma.
The reason why we think we have good rationale is that actually many, many of the drugs that have been approved for pulmonary hypertension have been studied specifically on the end complication of Raynaud’s phenomenon, which is known as digital ulcers, inclusive of prostacyclins. In fact, in the European and the U.S. guidelines for the management of Raynaud’s phenomenon, iloprost and/or Flolan is used as salvage therapy in the event that patients are recalcitrant to treatments such as calcium channel blockers, and/or even PDE5 inhibitors, which is used off-label.
That just shows that the prostacyclin class in and of itself is able to prevent worsening ischemic episodes, therefore potentially leading to avoiding issues of gangrene and/or amputation of these digits that’s affecting these patients. One of the challenges, oral treprostinil was studied in this in condition, again, to try to modify the digital ulcers. The problem with that was the trial was fraught with tolerability issues and patients coming off because of the intolerability of oral treprostinil. Again, highlighting that if we can provide YUTREPIA for these patients, we know that the tolerability profile of inhaled treprostinil is significantly improved. We also know from our data that we can dose to a significantly high level, ensuring that we obtain appropriate pharmacokinetic profile to modify the disease.
You know, we’re we look forward to initiating, you know, our phase 2A program in systemic sclerosis RP, here in the near the end of the year.
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Great. Thank you, Rajesh. Next question, operator.
Operator: Thank you. Our next question comes from Jason Gerberry with Bank of America. You may proceed.
Jason Gerberry, Analyst, Bank of America: Hey, guys. Thanks for taking my question. Two for me. Just first on PAH. Wanted to just get your view on sort of the role for an inhaled treprostinil in the PAH setting. It’s a bit confusing. You know, on the one hand, you know, your competitor flagged that maybe inhalation approaches are gonna see a diminished role in PAH. When we talk to KOLs, what they’re saying is they’re not putting new starts on Uptravi. Yet when we look at IQVIA data, the Uptravi NRx look pretty stable. There’s a lot of conflicting data points in this, and it’s a dynamic space. You know, Winrevair is now getting used more in newly diagnosed PAH.
How do you see this dynamic where the role of, say, oral versus an inhaled prostacyclins in PAH? Then my second question for Mike, just when I look at fourth quarter numbers, it looks like really good revenue recognition per patient to take the average, the 3Q number versus the 4Q number, over sales or under sales, I should say. When we look ahead to 2026, it doesn’t seem like that there’s gonna be a huge gross to net adjustment in the numbers relative to the patients and the revenue capture, but wanted to get your perspective there. Thanks.
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Thanks for the question, Jason. I’ll speak to the PAH issue in terms of oral versus inhaled. I think the field is moving, the paradigm shifting to where patients aren’t gonna be willing to accept off-target effects any longer. Because the burden of those off-target effects can be as bad as the burden of the disease in terms of impact on daily living. So the orals, clearly, if you look at the frequency of AEs related to the GI toxicities, they’re significant, and they occur daily. They occur over hours in the day. If you then pair that with minimal symptomatic benefit to the disease, that benefit to risk exchange is not a good negotiation for the patient.
I think going forward, particularly as we continue to evolve data around the ability of YUTREPIA to dose titrate, drive effect, and really eradicate off-target effects to the GI or from parenteral issues related to septicemia and subcutaneous site pain and irritation. There really nobody would be willing to make a trade-off because now you can get the symptomatic benefit without sacrificing your daily living through these off-target effects. You know, I do think, and our competitor said it when they spoke about their SMIs, you know, like they’re, you know, people are tired now of off-target effects and, you know, people. What you wanna see is a better benefit to risk profile, which YUTREPIA provides.
It is a four times a day therapy, so that would be the only sort of negative there. We’re gonna negate that negative with L-606. The importance of that study is it will achieve in a different way through liposomal encapsulation all the benefits of YUTREPIA, but then now it will do it in a twice-a-day format, and it will also minimize peak-to-trough excursions so that trough benefit is steady to the peak benefit. You know, what we’re trying to do is at this company is really improve patient outcome, have patients feel better, remove these off-target effects, and then get them to a point in time where the, you know, they can take an easy portable therapy without risk. I think we’re well on our way to doing that.
I think clearly YUTREPIA has become the preferred inhaled, and as we continue to sort of, cannibalize share from orals, you’ll see more and more of that. Again, very excited across the board and, I think that’s it for the PH to oral. Maybe, Mike, if you’ll talk about the fourth quarter dynamics.
Dr. Rajeev Saggar, Chief Medical Officer, Liquidia Corporation: Yeah. Jason, thanks for the questions. As we look at our gross to net from 2025 to 2026, as we had said in previous quarters, working on access in the back half of the year, we had some new to market blocks that had existed on the commercial front. Those were slowly removed. The result of that is going to be twofold. One, we will pay more rebates on more of our business as we move forward in 2026, but that will be offset by having more patients having access. What I would say is, as we have kept saying, we are extremely confident in our trajectory as we move into 26 and into 27.
What I would say is maybe there’ll be a very small incremental increase in our gross to net, but that is.
Benjamin Burnett, Analyst, Wells Fargo1: You know, it goes to our goal of making sure patients have choice and patients have access. We will have achieved that goal, and I think we will sit at a place where we’re very comfortable and can still achieve our goals in 2026 and as we’ve said, this being a billion-dollar product in 2027.
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Thanks, Mike.
Benjamin Burnett, Analyst, Wells Fargo1: Great.
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Operator, I think we have time for one more question.
Operator: Thank you. Our next question comes from Gaurav Mani with LifeSci Capital. You may proceed.
Gaurav Mani, Analyst, LifeSci Capital: Hey, good morning, everyone. Congrats on a great print and continued strong launch of YUTREPIA. Just two for me, if that’s okay. Can the team give some color on that, you know, one in four prostacyclin transition patients and kinda what bucket of prostacyclin therapy, i.e., oral versus inhaled, these patients are coming from? Then secondly, on the new exploratory YUTREPIA trials, can you just describe how these are expected, or if they are, I guess, to be, label-enhancing?
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Yeah. Maybe I’ll ask Scott to talk about sort of how the transition market, kind of the demographics of that, and then Rajiv, you can speak to the benefits of the trials that we’re doing. Scott?
Benjamin Burnett, Analyst, Wells Fargo1: Sure. As we’ve said, you alluded to, we’ve said that 75% of the patients are new to prostacyclin, and then 25% are switched. Obviously in PH-ILD, that’s, you know, there aren’t other options, those are switches are coming from inhaled. In PAH, what we’ve said is that about 30% of the 25% in PAH are coming from the orals, and then the bulk of those are coming the rest of those are coming from inhaled. We are starting to see more patients transition off of parenterals onto YUTREPIA. I don’t think that’s going to necessarily become material in terms of the switches, but it is interesting and shows that in the future we’ll probably kind of encroach on the parenteral space.
You know, when I’m out there in the market, I can tell you that the enthusiasm around using YUTREPIA instead of the oral prostacyclins for all the reasons Roger elucidated earlier, is only growing. We think that, you know, whether they’re switching the patient off of an oral prostacyclin or they’re using it instead, using YUTREPIA instead of an oral prostacyclin, I think, you know, again, I think there’s a big opportunity there for us.
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Great. Thank you, Scott. Rajiv, if you’ll speak to the trials, please.
Dr. Rajeev Saggar, Chief Medical Officer, Liquidia Corporation: Yeah, thanks for the question. You know, listen, I firmly believe we’re entering into a decade and beyond of an inhaled renaissance here in PAH and in PH-ILD. I think YUTREPIA is leading the charge today, and L-606 is gonna definitely lead it tomorrow. In that regard, the trials that we are purposely conducting is defining how to switch from the oral prostanoid to YUTREPIA. I think we highlighted a few things on this call. Number 1, it is very clear that practitioners across the board are very interested in delivering the most tolerable drug. I think this has been highlighted by the addition of sotatercept to the armamentarium, which has, I think, completely negated and limited the utility of parenteral therapies at this time.
We have several large anecdotal cases of YUTREPIA being used acutely in the hospital, and to combine that also with sotatercept to maximize the benefit of that combination. In regards to oral prostanoids, we plan to switch studies from selexipag to YUTREPIA. It would detail to the practitioners how to do that effectively and safely. And also, again, the advantage of YUTREPIA is that we can dose 2 to 4 times that typically what is used traditionally by Tyvaso. In those studies, we’ll also highlight some of the hemodynamic capacity of YUTREPIA, which I think would be very exciting. In regards to label-enhancing, I think we reserve the right to always present our data to the agency for consideration for label discussions in that regard.
Finally, I think we’ve highlighted just to highlight again the sotatercept study. The purpose of this study is to transition patients that are on sotatercept in combination with either forms of prostanoid inclusive of parenteral and/or oral, and transition those off those therapies safely and effectively to YUTREPIA. Those are the studies that we are keenly and working across to initiate this year.
Dr. Roger Jeffs, Chief Executive Officer, Liquidia Corporation: Thank you, Rajiv. Very well said, both from you and Scott. I’ll close by just saying, as you can hear, Liquidia Corporation is all in for our patients and trying to provide better and better opportunities both now and in the future. We look forward to speaking with everyone again in May when we update you on our Q1 outcome. Thank you, everyone.
Operator: Thank you. This concludes the conference. Thank you for your participation. You may now disconnect.