리퀴디아(LQDA) 2026년 2분기 실적 발표회: 유트레피아 매출 31% 증가

주요 핵심 내용

• 2026년 2분기 유트레피아(YUTREPIA) 제품 순매출은 1억 7,040만 달러에 달해 전 분기 대비 4,000만 달러 이상, 즉 31% 증가했습니다.
• 순이익은 약 7,470만 달러로 증가했으며, 비GAAP 조정 EBITDA는 약 9,630만 달러에 달했습니다.
• 분기 말 현금 및 현금성 자산은 2억 8,420만 달러로, 1분기 대비 6,140만 달러, 2026년 초 대비 약 9,350만 달러 증가했습니다.
• 7월 31일 기준, 리퀴디아(Liquidia)는 약 5,900건의 개별 환자 처방을 접수하고, 5,000명 이상의 환자에게 유트레피아 투여를 시작했으며, 1,100명 이상의 전문의로부터 처방을 확보했습니다.
• 경영진은 유트레피아가 순매출 기준 흡입용 프로스타사이클린 시장의 30%에 근접하고 있다고 밝혔으며, 2027년 10억 달러 이상의 순매출을 달성할 수 있다는 자신감을 재확인했습니다.
• 리퀴디아는 유트레피아 및 L606에 대한 임상 개발을 확대함에 따라 2026년 하반기 R&D 비용이 상반기 수준의 두 배에 달할 것으로 예상하고 있습니다.

주요 재무 데이터

사업 및 영업 실적

유트레피아는 리퀴디아의 핵심 성장 동력 자리를 유지했습니다. 경영진은 지난 3분기 동안 분기 매출이 3배 이상 증가했다고 밝혔습니다. 2분기 유트레피아의 성장은 흡입용 프로스타사이클린 전체 범주의 성장률을 상회했으며, 이는 시장 확대와 점유율 확대 모두에서 성과를 거두었음을 나타냅니다.

유트레피아 처방 의료진 1,100여 명 중 약 30%가 최소 5명 이상의 환자에게 처방을 작성했습니다. 리퀴디아는 출시 이후 환자 의뢰 및 투여 시작 건수가 전반적으로 우상향 추세를 유지해 왔다고 설명했습니다.

상업적 확장은 기존 폐동맥고혈압 센터, PH-ILD 센터 및 지역 병의원을 목표로 하고 있습니다. 경영진은 지역 병의원 환경에서 환자 발굴을 개선할 여지가 상당하다고 보고 있으나, 판매 인력 확대에 따른 환자 수 증가 가속화에 대해 확답하지는 않았습니다.

보험 등 지불자(Payer) 접근성은 전반적으로 안정적이며 경쟁 제품과 대등한 수준으로 설명되었습니다. 경영진은 이제 보험 적용 범위보다는 제품 선택 자체가 주요 상업적 요인이라고 밝혔습니다.

리퀴디아는 PH-ILD 환자를 대상으로 한 24주간의 ASCENT 임상 연구 결과도 강조했습니다. 기침 점수의 악화 없이 유트레피아 중간 용량이 단계적으로 증량됨에 따라 6분 보행 거리 중앙값은 8주차에 21.5미터, 16주차에 31.5미터, 24주차에 41미터 개선되었습니다.

회사는 1일 4회 투여하는 유트레피아 용법을 개선하기 위해 1일 2회 투여하는 L606 개발을 추진하고 있습니다. 경영진은 48주간의 오픈라벨 연구에서 광범위한 용량 증량 가능성, 낮은 이상반응 부담, 투여 간격 동안 최대 6분 보행 거리 개선 효과의 유지를 확인했다고 밝혔습니다. 회사에 따르면 3상 Re-Spire 임상시험은 환자 모집 중이며 예정대로 진행되고 있습니다.

리퀴디아는 유트레피아 및 L606 전반에 걸쳐 향후 12개월 동안 진행 중이거나 시작할 예정인 10개의 임상 연구를 보유하고 있습니다.

경영진 가이던스

경영진은 지금까지 관찰된 분기별 성장세와 일관된 속도로 매출 성장이 지속될 것으로 예상하고 있습니다. 회사는 2027년 10억 달러 이상의 순매출을 달성하겠다는 전망을 재확인했습니다.

리퀴디아가 상업화를 확대함에 따라 판매관리비(SG&A)가 증가할 것으로 예상되며, 일부 항목은 매출에 비례하여 증가할 전망입니다. 또한 Re-Spire 환자 등록 진행 및 추가 유트레피아 연구 시작에 따라 연구개발비 지출도 늘어날 예정입니다.

리퀴디아는 2026년 하반기 R&D 비용이 상반기 금액의 두 배에 달하고, 2027년에도 추가로 증가할 것으로 예상합니다. 이러한 투자에도 불구하고 경영진은 수익성이 지속적으로 성장할 것으로 기대하고 있습니다.

진행성 폐섬유증(PPF) 및 특발성 폐섬유증(IPF) 환자를 대상으로 유트레피아의 안전성, 유효성 및 용량 조절 가능성을 평가하는 임상 연구가 2027년 상반기로 계획되어 있습니다.

리스크 및 주요 관전 포인트

계류 중인 '327 특허 재판 판결은 법적 불확실성으로 남아 있습니다. 경영진은 유리한 결과가 나올 경우 사업 운영이 차질 없이 계속될 수 있을 것이라고 밝혔습니다. 불리한 판결이 나올 경우 로열티 지불이나 일정 형태의 금지명령 구제로 이어질 수 있습니다. 회사는 판결이 언제든 나올 수 있지만 판사의 일정에 대해서는 파악할 수 없다고 설명했습니다.

리퀴디아는 아직 유트레피아에 대한 상세한 장기 투약 순응도나 투약 중단 데이터를 제공하지 않았습니다. 경영진은 우려할 만한 투약 중단율은 관찰되지 않았다고 밝히면서도, 더 구체적인 데이터를 제공하기 위해서는 시간이 더 필요하다고 언급했습니다.

또한 회사는 연구 간 환자군, 병용 요법 및 기저 특성의 차이로 인해 L606과 개발 단계의 경쟁 제품 간 직접적인 효능 비교를 자제할 것을 당부했습니다.

애널리스트 Q&A 주요 내용

• 유트레피아 성장: 경영진은 이러한 성장이 다른 흡입용 및 경구용 프로스타사이클린에서의 전환과 치료 단계 초기에서의 유트레피아 사용 모두를 반영한다고 설명했습니다. 또한 ILD 관련 폐고혈압 진단 개선이 범주 전체의 확대로 이어졌다고 덧붙였습니다.
• 지역 병의원 기회: 리퀴디아는 지역 병의원 환경에서 많은 잠재적 PH-ILD 환자가 여전히 진단되지 않은 상태로 남아 있다고 보고 있습니다. 영업 인력 확대는 교육, 진단 및 환자 의뢰를 개선하기 위한 목적이지만, 경영진은 환자 추가 성장 속도가 더 빨라질 것이라는 예측까지는 내놓지 않았습니다.
• RE-WARM 임상 연구: 환자 75명을 대상으로 한 이 연구는 전신 경화증 관련 레이노 현상에서 유트레피아를 평가할 예정입니다. 용량 내약성 및 임상적 반응은 향후 3상 임상시험의 설계 및 투여 방식 결정에 반영될 것입니다.
• L606 차별화: 경영진은 1일 2회 투여 용법, 내약성, 도달 가능한 약물 노출 및 투여 간격 전반에 걸친 효과 유지를 조합한 강점을 강조했습니다. 이어 제품의 임상적·경쟁적 우위를 입증하려면 3상 Re-Spire 결과가 필요할 것이라고 밝혔습니다.
• IPF 및 PPF 개발: 계획된 연구에서는 용량 최적화 및 경구용 항섬유화 치료제와 유트레피아의 병용 사용을 평가하여 향후 임상시험 설계 및 대상 선정 기준 결정에 활용할 예정입니다.

실적 발표 컨퍼런스 콜 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

Operator

Good morning, and welcome to the Liquidia Corporation Second Quarter 2026 Financial Results and Corporate Update Conference Call. My name is Daniel, and I will be your operator today. [Operator Instructions] Please note that today's call is being recorded.

I'll now turn the call over to Jason Adair, Liquidia's Chief Business Officer.

Jason Adair

Thank you, and good morning, everyone. It's my pleasure to welcome you to our second quarter 2026 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, 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, which are available on our website.

Please also note that our earnings release and our commentary include non-GAAP financial measures. Reconciliations of these non-GAAP financial measures to the most comparable GAAP measures can be found in our earnings press release.

With that, I'll turn the call over to Roger.

Roger Jeffs

Thanks, Jason, and good morning, everyone. We're delighted to share our business results and clinical progress with you today. One year ago, we launched YUTREPIA and believed the medical community would find value in our differentiated approach to inhaled treprostinil. One year later, we have the answer. Physicians are prescribing it; patients are starting to switch to it and referrals and starts continue to accrue at a robust and sustained pace.

As you saw in our numbers this morning, as of July 31, we have received approximately 5,900 unique patient prescriptions, started more than 5,000 patients on therapy and had more than 1,100 physicians write for the product. 30% of those physicians have prescribed to 5 or more patients. What's especially notable is where that growth is coming from.

The overall inhaled prostacyclin market grew again this quarter from $573 million in Q1 to $607 million in Q2 or approximately 6%. And YUTREPIA's growth alone was larger than the growth of the entire category, even as we saw flat to declining use of oral infused and competing inhaled formulations. That tells us something important. Not only are the numbers of new starts for inhaled treprostinil growing, YUTREPIA has taken an ever-growing share of the total market for inhaled treprostinil.

On a net revenue basis, YUTREPIA is approaching 30% of the entire inhaled market, a tremendous result just over a year into launch, especially as the market is growing in concert with YUTREPIA's growth. This implies the majority of new patient starts are coming to YUTREPIA.

What matters more than the numbers is the impact we're seeing in patient lives. I spent my career in this field and have watched the delivery of prostacyclin move from complex IV and subcutaneous infusion to cumbersome nebulized therapy to intolerable oral formulations and now to inhaled dry powder delivery.

Across that history, one simplistic but guiding principle has remained constant. Better tolerability enables higher dosing, higher dosing can drive greater efficacy and greater efficacy can support durable clinical benefit. The linchpin in this therapeutic chain is solving first and foremost for tolerability as the ability to drive dose and improve symptoms while minimizing both off and on-target adverse events is the holy grail.

That's the lesson I've learned from my 30-plus years in the field, and to me, explains why YUTREPIA has had such broad adoption and early commercial success to date as it offers all of these attributes. This critical link between tolerability, dose and efficacy was beautifully demonstrated in our 24-week ASCENT study in PH-ILD patients. Specifically, progressively higher median doses of YUTREPIA at weeks 8, 16 and 24 was accompanied by progressive improvements in 6-minute walk distance of 21.5, 31.5 and 41 meters, respectively, without worsening cough scores.

The only caveat is that YUTREPIA requires a 4 times daily dose regimen, which is why we are going from strength to strength and aggressively building on these same principles with twice daily L606, which we believe has the potential to raise the tolerability bar even further. As we've previously shown, in our 48-week open-label study, L606 patients titrated across a broad range while incurring a low burden of adverse events, most notably the lowest incidence of cough we are aware of in any study of an inhaled treprostinil formulation, and we were able to observe enduring clinical benefit as peak 6-minute walk improvements were preserved at trough, or said another way, throughout the dosing interval.

These results are especially impressive when you consider that patients enrolled reflected the prevalent population in the U.S. and were on combinatory background standard of care. We are not aware of any other product in clinical development that has matched the dose range, tolerability and durability that we have already seen with L606.

We believe YUTREPIA and L606 have significantly raised the bar that every current and future product in this space will be measured against. And it is with this confidence that we've stood up a thoughtful R&D plan to best elucidate the current and future uses of inhaled treprostinil across a wide array of indications. In fact, between YUTREPIA and L606, we now have 10 clinical studies either underway or planned to begin over the next 12 months. And as Mike will explain, we can confidently make these investments because of the cash flow that this business now generates.

With that, I'll turn it over to Mike.

Michael Kaseta

Thank you, Roger, and good morning, everyone. I'm pleased to say the second quarter financial performance continued to reflect the growth trajectory for YUTREPIA we've described to-date. Quarterly sales of YUTREPIA have more than tripled over the last 3 quarters, and we've gone from reporting a net loss in Q2 2025 to 4 consecutive quarters of increasing profitability.

Looking specifically at the second quarter of 2026, net product sales of YUTREPIA were $170.4 million, up over $40 million or 31% quarter-over-quarter. Net income increased to approximately $74.7 million and non-GAAP adjusted EBITDA increased to approximately $96.3 million.

Turning to cash. We ended the quarter with approximately $284.2 million in cash and cash equivalents, up $61.4 million from the first quarter and nearly $93.5 million since the start of the year, a clear sign how we are seeing the operating leverage inherent in our business flow through to the balance sheet.

I'd also like to note a few other financial metrics. As we had previously forecasted to you, R&D and SG&A expenses both increased this quarter to support continued investment in our pipeline and the ongoing commercialization of YUTREPIA, which includes the expanded sales team that hit the field in June and additional patient support services.

Going forward, I'd note these 2 lines will behave differently. SG&A will increase as we scale commercially with certain components moving in proportion to revenue. We also expect R&D to increase in the coming quarters as enrollment ramps up in Re-Spire and we initiate multiple studies to inform the current and future use of YUTREPIA. More specifically, we expect R&D expense in the second half of 2026 to be double the expense in the first half of the year and to increase again in 2027 as we build the best inhaled treprostinil products for future and current patients.

In closing, we expect to continue to grow revenue, consistent with quarterly growth we've observed to date, increase our investment in our pipeline and even with that investment, continue to grow profitability at the same time. We have a commercial product that generates significant cash flow and a clear set of priorities for where we will invest it.

With that, Roger, back to you.

Roger Jeffs

Thanks, Mike, for that summary. These results give us confidence that we're well on our way to more than $1 billion in net revenue in 2027. And just as importantly, confidence that we're building the right foundation for the next decade of this franchise. We look forward to updating you on our progress in the quarters ahead.

With that, operator, please open the line for questions.

Operator

[Operator Instructions] And our first question comes from Amy Li with Jefferies.

질의응답

Amy Li

Congrats on all the continued momentum. I just wanted to start with 2 non-launch-related questions. The first one, on your 75-patient RE-WARM Raynaud's study, what efficacy signal would you need to see to move this directly into a registrational trial? And how should we think about the design in that context? Was the low-dose arm primarily driven by tolerability considerations in this population? Or is there a reason to believe that the efficacy threshold in Raynaud's maybe below the dose needed than PAH and PH-ILD?

And then finally, on L606, you suggested that the competitive advantage isn't just the BID dosing, but also the combination of exposure and tolerability. So what evidence have you seen that higher achievable exposure and 24-hour coverage could translate to a clinically meaningful advantage compared to other long-acting inhaled treprostinil approaches? And what should we look for in the Phase III to validate that thesis?

Roger Jeffs

Thank you very much for the question. For the RE-WARM study on efficacy and dose, I'll ask Rajeev to answer that, and then I'll answer the question around L606 and more how we're thinking about that from a dose comparison versus anything else. So Rajeev, if you could talk about the RE-WARM study, please?

Rajeev Saggar

Sure. Thanks, Roger, and thanks, Amy, for the question. So maybe just to step back, the RE-WARM study is going to be evaluating patients with systemic sclerosis associated with Raynaud's phenomenon. Just for many that don't know, systemic sclerosis, of course, is a very rare autoimmune disease in which Raynaud's phenomenon effectively manifests in around 90% of those patients.

And consistent with other conditions that affect arteriopathy and systemic sclerosis such as PAH and PH-LD, Raynaud's is also a vasculopathy of the small digits, usually of the bilateral hands in nature. What's really interesting about this condition is that there's no FDA-approved therapies. However, there is plenty decades of experience with prostacyclin and prostacyclin analogs that have been studied in this condition, including treprostinil.

And many of those are actually used off-label to treat the moderate and severe complications of Raynaud's that manifest. So these are life-saving therapies. One of the challenges with studies that have used prostacyclins is the tolerability of those varied medications, including parenteral and oral prostacyclins, which in those studies have been limited by dose tolerability issues.

So the purpose of RE-WARM, first and foremost, is to evaluate the typical doses that we use in YUTREPIA in both PAH and in PH-LD and to assess the tolerability profile. At the same time, we compare it against the lowest dose versus maximizing the dose titration of YUTREPIA in the study and seeing what is the clinical response to those doses, that will inform us of how to appropriately lead into the Phase III study, depending on the results that we see. But we have a high, strong clinical suspicion that -- we anticipate that a very similar dosing profile will be used eventually in the management of symptoms associated with Raynaud's phenomenon.

Roger Jeffs

Thank you, Rajeev, on that. So Amy, maybe what I'll do is kind of go back to the script a little bit when we make comparisons to TPIP and that it's -- again, it's tolerability drives [indiscernible] drives durability and the linchpin being tolerability. And the only way to kind of make comparisons is to sort of match on dose equivalents. And typically, that's been done to date through labeling with YUTREPIA, for example, through breath equivalent to Tyvaso and Tyvaso DPI.

So -- maybe just to clarify because I think there might be some confusion in the field around TPIP. [Audio Gap] So, if you look at TPIP, if you took the 640-microgram dose, really only 64% of that is treprostinil mass because the 16 chain palmitoyl -- lipophilic carbon chain contributes about 35% of the mass.

And then there's about an 85% admitted dose from the capsule. So you have to subtract that as well. So when you look at the 640, and we know that 1 breath of Tyvaso is 6 micrograms, so 15 breaths would be 90 micrograms. The 640 essentially, if you do 640 times 0.64 times 0.85 you get to just [indiscernible] 90 micrograms or 15 breath equivalents. So, that's what they're delivering with the 640 and then the 1,280 obviously will be twice that of 30 breath equivalents.

Now when you look at [Audio Gap] 15 breath equivalents and then -- and above that would be more. So when you then make a comparison for R-210, 15 breath equivalents in our open-label study, 21% of patients had a -- I'm sorry, 71% of patients had a 15 breath equivalents or more and 21% of patients had 30 breath equivalents or more or more.

So how does that compare to TPIP? Well, they only had 21% above 640 or 15 breath equivalents and only 8% reached 1,280 or 30% (sic) [ 30 breath ] equivalent. So significantly lower dose attainment on a percentage basis between the 2 trials. Now I'm making cross-study comparisons, and it's difficult. And I think it's probably inappropriate in particular, to talk about efficacy comparisons because the efficacy is going to be driven by the sample that you're studying and what the selection bias is. And obviously, as we said, ours was a prevalent population in the U.S. who had transitioned essentially from Tyvaso or Tyvaso DPI versus theirs, which was ex U.S. studies, perhaps not on background therapy and with a lower baseline walk.

So those comparisons get complicated. But I think if you believe the paradigm that tolerability drives dose, then what you can see with L606 is that we've already shown a favorable profile vis-a-vis TPIP and the rest will sort itself out because as you achieve dose, you will get effect and as you achieve effect, you will get durability. So we feel very confident that L606 is extremely well positioned in our Phase III Re-Spire trial to be successful and actually be incrementally [Audio Gap] in development.

So that's kind of how we look at [Audio Gap] standpoint, at least today. And certainly, I don't want to make any performative statements around kind of how we'll share market or not until we get the Phase III results. But I think, again, we feel very confident about what we're building and very happy that the Phase III Re-Spire study is already enrolling patients and on target to meet its time line.

Operator

Our next question comes from Julian Harrison with BTIG.

Julian Harrison

Congrats on the progress. I have 3, and I'll just ask them all at once. First, considering your recently expanded sales force, I'm wondering how you're thinking about the balance between deepening relationships with existing prescribers of YUTREPIA versus expanding your prescriber base going forward.

Second, with a little more than a year into YUTREPIA's launch, can you give us an update on where payer coverage stands? Wondering if you're satisfied where access is today and if there are any remaining gaps or hurdles that when resolved could maybe even accelerate growth further?

Third, can you -- maybe a refresher type of question, but can you walk us through the range of outcomes you're prepared for in the [ 327 ] trial? And do you have any updated expectations in the timing of decisions there?

Roger Jeffs

Great. Good to hear from you, Julian. So Scott, if you wouldn't mind asking kind of your view on the sales force expansion and where we currently are with payer coverage and then Rusty, if you'll update on the legal.

Scott Moomaw

Julian, so on the sales force expansion, I think the good news is, we have a lot of opportunity both on the existing customer front as well as the expanding front as you phrased it, Julian. So we will be able to get more visits, more frequency, if you will, on the current customers, and we will be able to get deeper in the community, which is sort of our stated intent of doing the expansion.

So when you look at PAH centers, we still feel like we have an amazing amount of opportunity there to get in front of the oral prostacyclins and the inhaled prostacyclins to be the first PAH prostacyclin of choice. In the PH-ILD centers, there's both opportunity to get in front of the other inhaled prostacyclins and also patient identification. We still feel like those -- even the academic PH-ILD centers can do a better job of diagnosing the patients.

And then finally is the community, which was, as I mentioned, one of the main reasons we did the expansion, and this enables us to get further out into the community deeper where we know many of these 60,000 patients are, they just need to be identified and usually referred, but if they will diagnose them and treat them in that venue, then that's great as well. So I think the answer is, it's nice, which is that we have opportunities on both fronts.

From the payer perspective, I think we feel good where we are. I think we've reached sort of a stasis. We have, I would say, very good availability across the board. I would say we are generally at parity across the board. And therefore, it just comes down to product choice. And as you can see from our numbers and the revenue growth, we feel like folks are taking advantage of that product choice and choosing YUTREPIA. So thanks, Julian.

Operator

Our next question comes from Ben Burnett with Wells Fargo.

Unknown Analyst

This is [ TianQi ] calling in for Ben. Congratulations on the quarter. So I have a question regarding the new patient adds. So based on our back of the envelope math, new patient add during this period is still showing about middle-single-digit acceleration versus last period. So just thinking about for the remainder of the year, how should that growth trend for the rest of the year? And where do you see it kind of lands over the long term?

Roger Jeffs

Yes. I appreciate the question. Maybe first, Rusty, if you could answer Julian's question around the 327 update. And then, Mike, if you'll talk about patient numbers going forward.

Russell Schundler

Sure, happy to. And thanks for the question, Julian. So as for the 2 questions you asked me. First is the range of outcomes, no change there. It's the same things we've been talking about for over a year now. Obviously, in the upside scenario where we win on all claims, we continue forward as is, unimpeded. If the ruling goes against us, it's the full range of outcomes we've been talking about in the past. It could be a royalty, it could be some form of adjunctive relief. So again, no change on that front.

We don't know -- we don't have any visibility into what the judge's workload is, where he is in sort of his process. I think looking at past data as to how long it typically has taken Judge Andrews to get to decisions following a bench trial, I'd say our expectation is we could see a decision any day now. But again, it's hard for us to provide much more color than that just because we don't have visibility into this process.

Roger Jeffs

Yes. And I would add that nothing has changed in our confidence based on the probability of success and the arguments that we made in court. So, Mike, if you want to talk about kind of how we look at patient adds going forward and the implications that may have for down the road?

Michael Kaseta

Yes. Thanks, Roger, and thanks for the question. What we've seen since launch is really a linear trajectory of referrals and new patient starts really since the beginning of the launch last June. So we're very confident in what we're doing, as Scott had spoken earlier, increasing our -- the size of our sales force, looking to increase our patient support services. We feel very confident that we can stay on the same trajectory that we're on right now. Roger has said in the prepared statements that we believe we'll be more than $1 billion in sales in 2027. And we say that with confidence and believe that we will stay on the same trajectory and see significant increases as we move forward.

Operator

Our next question comes from Ryan Deschner with Raymond James.

Ryan Deschner

Congrats on the impressive results this quarter. Two for me. Where are you seeing the biggest areas of script growth in terms of specific patient subpopulations in both PAH and PH-ILD at this point? And then also, in one of your PAH posters this year, you cite the diverse responsibilities of the pharmacists, the diverse responsibilities that they have in supporting PAH patients, including assistance with transitioning patients across different prostacyclins. How have those findings change your commercial strategy with respect to pharmacist interactions?

Roger Jeffs

Yes. Great. So Scott, I think both of those are directed in your field.

Scott Moomaw

Yes. So in terms of the growth, I think there's kind of a short- and long-term aspect to this. The short term is, we still have loads of opportunity in the centers where these patients are coming in today and tomorrow. And I think the flywheel of YUTREPIA is turning only more strongly as time goes along and more prescribers get a chance to try it. And so we have many examples of when one prescriber who's tried it and really found it to be satisfying has talked to better -- has talked to another prescriber and said, "Look, it's not the same. You really need to try this."

And so as that flywheel turns more in the short term, those physicians who are using prostacyclins and treating PAH, whether that's PAH or PH-ILD, there's a lot of opportunity there. And of course, those patients, as I said, are coming in right now. And so therefore, the prescriber has the opportunity to make that decision today or tomorrow.

Longer term is what I referenced earlier, which is the patients out in the community and that tide will raise as the education around that takes place and as we get deeper out. It is rising right now. I mean a lot of the PH-ILD academic centers are being overwhelmed by the number of patients that are coming in from the community because it's becoming more -- there's more awareness around this. So it's starting. It's happening right now, but it's going to continue to happen.

On the pharmacist question, Ryan, I wasn't quite sure I understood it. I mean we have a very expansive care model. We work with the specialty pharmacies who are high touch with the patients and in touch with the patients all the time. One of the things we found is early on, I think they were almost -- despite our -- trying to convince them, I think they were almost sort of stuck in the old paradigm of tolerability and dosing. And as those folks have experienced the new paradigm where the dosing and the tolerability are better leading to, as Roger mentioned, the efficacy, I think the lights have gone on there a little bit as well. And so they've become believers as well. But feel free to elaborate, Ryan, on the question if I didn't get it.

Rajeev Saggar

Scott, it's Rajeev. Maybe I can just add in something. Ryan, on that particular poster. So first of all, what we recognize in the market is that the care team that provides care to patients with Group 1 PH and PH-ILD is multifactorial from the physician to the nurse practitioner and to the pharmacist and the PH coordinators.

So I think one of the key things that we're doing on the ground is heavy education about the benefits of YUTREPIA, the ease of prescribability and titratability of the drug respective to both conditions. So the pharmacists are, I think, critical in many of the larger programs. They help coordinate the care of the patient. They manage the side effect profile, and they also support how to titrate those patients. So it's a key target for us. And I think the results have spoken is what you see here today at the earnings call.

Roger Jeffs

Yes. I think maybe I'll just add to both of the comments. So again, I think we're taking a fulsome approach to the centers, not just the physicians, the pharmacists, but also the nurse practitioners who are critical to the therapeutic success in this category. I think one thing on the numbers, we're starting to see a shift. If you just look, and we said a little bit about this in the prepared remarks. So inhaled category is now about, on a run rate of $600 million. The total prostacyclin pathway is about $1.2 billion, so in the quarter in total.

So you're getting into like a $5 billion market and half of that is in inhaled segment, which is growing. So that inhaled starting to infringe on the oral and parenteral category. So if you look at the oral categories between Uptravi and Orenitram, it's about [ $500 million ]. And if you look at Remodulin, it's about $100 million. So -- and those are shrinking or flat.

So the only growth that you're seeing is in the inhaled category. And the only reason for that growth is YUTREPIA launch. So what we're starting to do is broadly take share, not only from the competitive inhaled brand, but also from oral and parenteral as people figure out that, again, this paradigm of tolerability is key and the linchpin to success for these patients. This is where the field is moving.

So a very attractive opportunity in PAH and PH-ILD, as Scott said, which is virtual white space still. So lots of upside. And I think just in the current indications that are approved, there's opportunity to grow beyond the $5 billion that's here today. So a very attractive market, especially when you have a very attractive molecule like YUTREPIA.

Operator

Our next question comes from Serge Belanger with Needham.

Serge Belanger

I guess just one for -- probably for Rajeev. What is the current thinking for the development and regulatory path to potentially expand YUTREPIA usage to PPF and IPF?

Rajeev Saggar

Yes. Thanks for the question. So, obviously, just to remember, the safety profile of YUTREPIA has been studied in patients with pulmonary hypertension associated with a broad range of underlying interstitial lung disease, inclusive of IPF, autoimmune disease and most likely progressive chronic fibrosis as well given the definition of that condition. So I think there's a lot of confidence in the safety profile of YUTREPIA in these patients.

I think as you see in the slides, we are going to be advancing a study in the first half of 2027, evaluating the safety, efficacy and dose titratability of YUTREPIA. I think this is really critical to really highlight the fact that every study that's been done to date with inhaled treprostinil continues to highlight that dose absolutely matters. And if you extrapolate what we saw in the INCREASE study as well as in the TETON study, there is at least a minimally acceptable dose and anything above that still needs to be studied. This is where we believe we can shine.

So, evaluating how high of a dose that we should use to treat those patients is going to be critical in that assessment. Also, we do acknowledge that the antifibrotic world with oral therapies has advanced with the new therapy in the mix, and we do want to see what our -- how YUTREPIA will respond on top of some of these therapies so that we can adequately power future studies as well and modify inclusion/exclusion criteria. So we're taking it, I think, in a very sophisticated approach, and we have a lot of support through KOLs throughout the United States and the rest of the world to help guide us to the best trial design.

Operator

Our next question comes from Jason Gerberry with Bank of America.

Jason Gerberry

Congrats on the quarter. I got a few. So just thinking about the growth here, is it fair to say that most of the growth is coming from category expansion and limited more on the switch from inhaled competitor agents? And then as we think about the expanded pool of patients, do you have any anecdotes, any commentary to what extent patients with comorbid IPF are seeking treatment with inhaled options and that might be expanding the pie?

And then lastly, just a question around thinking about like drug adherence. You have 5,000 patients treated roughly since the launch. If we think about 10% free drug, about maybe 10% drop off. It gets you into that sort of patient number that could support the sales number for the quarter. So are those the right ways to maybe think about patient adherence for some of those early patients who started drug at the early point of the launch?

Roger Jeffs

Yes. So maybe I'll pick on the adherence and then maybe Scott and Mike, you guys can talk about the growth in the pool of patients. I will say, though, I don't think IPF is yet sort of expanding the market. I think what we're seeing is on-label expansion. So nothing there from an IPF standpoint, although certainly in the future, I think there will be more interest and seeing what the value of YUTREPIA could be in that indication by physicians.

In terms of drug adherence, really don't -- aren't talking about it much. Obviously, we've said it over and over again that the tolerability to our therapy is best-in-class. And I think because of that, that the adherence to the drug will be best-in-class. So we would expect that would be underneath sort of the typical discontinuation rate of competitive inhaled agents for sure. But we need more time to think about it.

What we do know is that AEs they manifest at first exposure. And if somebody is going to be intolerant to the drug, it's usually somewhat in the first 1 to 3 months that they become intolerant and we'll move off of the therapy if it's because of intolerance. Again, let's remind ourselves, this is a life-threatening disease. These patients are severely ill. And with ILD, they have comorbid disease. So patients do die and clip off at a pace just due to other comorbidities.

So we're still looking at that. And I don't think you can do the kind of parallel match that you're trying to assign here in terms of what you were doing. So, again, we'll -- as we get more and more information, we'll get a little bit more granular about that as we move forward. But nothing is concerning in terms of our DC rate.

And again, it all because of our PRINT-enabled formulation we're not getting discontinuation because of AEs at the rate that the competitive agents are. So again, all good news there. And I think one way that we can grow the revenues is to stack on patients quarter-over-quarter, and that's what you're seeing. So that's why it looks to be quite linear.

And then maybe, Scott, you want to talk about the growth specifically that Jason was asking about.

Scott Moomaw

Yes. Jason, so I'll handle the switch part of that question first, and then I'll come back to the kind of market expansion, although obviously, they're related. I mean I think we absolutely are still seeing switches. We're seeing switches from other inhaled therapies for the reasons we've been outlining since before launch. And we are seeing switches from the oral prostacyclins as well. I think generally because of the rough tolerability of those drugs and the inability to titrate to effect, but also with the decreased promotion in that sector coming from J&J backing away as well. I think that's kind of propelling that.

In terms of market expansion, I think if you walk through the math that Roger walked through earlier, I think you have to say that we are expanding the market just globally from a revenue standpoint. However, when I'm in the market, when I'm talking to folks, I think the dynamic is, yes, there are some switches when patients -- for the reasons I mentioned earlier. But more often than not, what happens is, it's a prescriber who used to use one of the other inhaled first or oral prostacyclin first. And they've come around to the fact that this is a better therapy to use first. And so now they are putting us ahead of those therapies and that's how we are gaining share.

So the good news is both are happening and as sort of a student of the market, having been in it 16 years, I'm fascinated to watch it happen. But I think the answer is both are happening. You can't argue with the math that the market is expanding, and I'm seeing it every day in terms of us gaining share within the market.

Rajeev Saggar

Maybe I can just step in, just last comment. I think it's important, Jason, to recognize that the hemodynamic definition has just changed, and it's been slightly under 2 years since the hemodynamic profile of the definition of pulmonary hypertension has been modified. So, that education, I think, is starting to become a lot more universal across both the centers and the community itself. And I think we can learn a lot from that by a study designed by one of our -- another company called PHINDER, which essentially was looking at what is actually the prevalence of pulmonary hypertension in the setting of ILD, just highlighting the market growth potential here.

And these proactively performed right heart catheterization, suggesting that actually the diagnosis of pulmonary hypertension was on the order of over 70% of which pre-capillary pulmonary hypertension using the new definition was around 55%. I think that just highlights that the demand and the amount of pulmonary hypertension, especially in Group III is actually acutely being understood by the market. There's -- and because of the safety profile of YUTREPIA and the ability to titrate higher titer doses and modify this condition, I think, is being well received in the marketplace, and we continue to focus on that exclusive growth.

Operator

Our next question comes from Gaurav Maini with LifeSci Capital.

Gaurav Maini

Congrats on another great quarter, guys. So just a quick one for me here. As we think about YUTREPIA growth moving forward, can you just give us a refresher on sort of the patient setting plan as we think about targets, right? So do you see the community setting as still relatively underpenetrated? And is this going to be a key area of growth moving forward? And then put another way, could we potentially see acceleration in patient adds as community penetration increases, especially with the recent sales force expansion?

Roger Jeffs

Yes. Scott, if you wouldn't mind talking about that?

Scott Moomaw

Yes. There is absolutely a lot of room for growth in the community. I mean, we know those patients are out there. Rajeev talks about the prevalence of PH-ILD being whatever it is, 30% to 60% in ILD patients. And so clearly, in all of those patients that are out there, there's an opportunity to better identify, diagnose and refer or treat those patients.

And so it's a little bit of a -- I don't want to say a slow burn because it's going to happen this year and next year. But there's definitely some work there to penetrate, which we're doing with the expansion. In terms of patient numbers, I don't think we're ready to say that that's going to -- the pace is going to increase as a result of that. But clearly, there is a lot of room in that 60,000 patients that are -- a lot of those are out there in the community that just haven't been identified yet.

Operator

I'm showing no further questions at this time. I would now like to turn it back to Dr. Roger Jeffs for closing remarks.

Roger Jeffs

Great. Thank you, everyone, for joining the call. We're very excited about the results and clinical update that we could provide today and look forward to updating you again in the near future. Bye-bye.

Operator

This concludes today's conference call. Thank you for participating. You may now disconnect.