ユナイテッド・セラピューティクス（UTHR）2026年第3四半期決算説明会：タイバソの売上高が過去最高、吸入器のNDA延期

主要ポイント

• ユナイテッド・セラピューティクス（NASDAQ: UTHR）が発表した2026年第3四半期の総売上高は、潜在的な需要と前四半期比での伸びに支えられ、過去最高の8億3,300万ドルとなり、タイバソ（Tyvaso）の売上高も過去最高の5億400万ドルを記録しました。
• 経営陣はタイバソの好業績について、紹介数および治療開始数の増加、投与量の拡大、医師とのエンゲージメント強化、そして安定した月次での事業推進によるものとしています。在庫や季節的要因は重要な要因ではありませんでした。
• 同社は10月にユナイテッド・セラピューティクス製品に対する紹介数が月次として過去最高の1,000件を超えました。経営陣は、拡大された営業部隊が2026年第4四半期および2027年にかけてより大きく貢献すると期待しています。
• ソフトミストインヘラーの新規医薬品承認申請（NDA）は、FDAとの協議後に追加データを取得する必要が生じたため、当初予定していた2026年末ではなく2027年に提出される見込みです。
• 肺動脈性肺高血圧症を対象とする経口ラリネパグは、現在もFDAによる審査が行われており、PDUFA期日は2027年6月24日となっています。原薬（API）供給元のコンプライアンス状況が規制上のリスクとなっていますが、是正措置および代替計画が進められています。
• ユナイテッド・セラピューティクスは14の開発プログラムを擁しており、特発性肺線維症（IPF）、進行性肺線維症（PPF）、および慢性閉塞性肺疾患に伴う肺高血圧症（PH-COPD）にわたる対象患者数は米国で合計約100万人に達すると述べています。

主要財務データ

事業・業績動向

タイバソが商業的成長の主な牽引役となりました。経営陣は、肺動脈性肺高血圧症および間質性肺疾患に伴う肺高血圧症（PH-ILD）全体において、治療開始、紹介、患者需要、投与量、医師のエンゲージメントが強化されたことを挙げました。

同社は、当四半期中に目立った在庫効果や季節的要因の恩恵はなかったと述べています。業績は月ごとのより一貫した営業活動を反映しています。拡大された営業部隊は9月中旬頃から紹介数の増加傾向を生み出し始めましたが、経営陣は第3四半期の売上貢献は限定的であり、第4四半期および2027年により明確になると説明しました。

高用量のタイバソDPI（ドライパウダー吸入器）カートリッジも売上高と患者維持率を支援しました。高用量キットの導入後にタイバソDPIを開始した患者の約3人に1人が高用量に達しており、これは以前の約2倍の割合であると経営陣は述べています。

Liquidiaとの和解を受けて、ユナイテッド・セラピューティクスはタイバソDPIへの既存患者の移行は穏やかなものになると予想しています。経営陣は、PH-ILDにおけるより大きな機会は医師の認知度向上、対象患者の特定、および新規処方の獲得にあると強調しました。同社は、この和解により競合製品のPH-ILDにおけるプロモーション活動が禁止され、適応外使用の推奨も禁止されると述べています。

タイバソにとどまらず、ユナイテッド・セラピューティクスはネブライザー吸入薬およびドライパウダー吸入薬、ソフトミストインヘラー、1日1回投与薬、配合剤の開発を進めています。経営陣は、規制当局の承認および商業化の成功を条件として、IPFにおけるネブライザー吸入タイバソおよびPAHにおけるラリネパグを潜在的な主要成長ドライバーとして位置づけました。

同社はまた、人工臓器代替物の開発も継続しており、経営陣はこれを独立した長期的な成長プラットフォームとみなしています。

経営陣の見通し

ユナイテッド・セラピューティクスは現在、ソフトミストインヘラーのNDA提出時期を、従来の2026年末までの計画から2027年に変更しています。経営陣は、FDAから新しいカテゴリーの作業を要求されたわけではないものの、追加データの取得に時間を要すると説明しました。申請スケジュールの改定については、開発パートナーと協議中です。

経営陣は、増員された営業部隊とPH-ILDの和解による紹介の勢いが、今後数週間から2027年初頭にかけてより顕著になると見込んでいます。同社は、2026年開始時点よりも大幅に強い営業モメンタムを持って2027年に入ると予想しています。

吸入ラリネパグについて、同社はIND申請に向けた準備作業を進めており、健常被験者を対象とした第I相試験を計画しています。この試験は、まずはPH-ILD、それに続いてIPFおよびPPFを対象とした、その後の承認申請プログラムに情報を提供することが期待されています。

リスクおよび注視点

• ソフトミストインヘラーの申請は、FDA申請戦略プロセスの過程で要求された追加データを同社が作成する間、2027年に延期されました。
• 経口ラリネパグの原薬（API）供給元は、査察後に「OAI（Official Action Indicated）」のコンプライアンス状況となっています。ユナイテッド・セラピューティクスは、2027年6月24日のPDUFA期日に対する潜在的リスクを軽減するため、是正措置の支援と代替計画の策定を進めています。
• 提案されている経口3剤併用製品は、完了した生物学的同等性試験のみに基づいて申請することはできません。経営陣は、FDAに受け入れられ得る代替の開発ルートを評価しています。
• 和解条件によって既存患者の移行が要求されていないため、競合の吸入製品からタイバソDPIへの短期的な切り替えは穏やかなものになると予想されます。
• PH-COPD、PH-ILD、IPF、PPFにおける開発プログラムには、依然として臨床および規制上のリスクが伴います。経営陣は、計画されている吸入ラリネパグの適応症に対して、重要な安全性および有効性の主試験が必要になると述べました。

アナリスト質疑応答のハイライト

タイバソのモメンタム：経営陣は、Liquidiaとの和解前にもすでに紹介の勢いが改善していたと述べました。PH-ILDのさらなる転換点は2026年末から2027年初頭にかけて現れる可能性がありますが、最大の機会は強制的な患者の切り替えではなく、引き続き新規処方の獲得です。

ソフトミストインヘラーの延期：FDAとの協議により追加データが必要となりましたが、新しく設計された開発要件ではありません。経営陣はこの問題を主にリードタイムの問題として位置づけています。

ラリネパグの供給リスク：同社は、PDUFA期日前に原薬（API）供給元のコンプライアンス状況を解消することに引き続き集中しています。是正措置の情報はFDAに提出済みであり、対話は継続中で、代替計画も並行して進められています。

ラリネパグの経済性：ユナイテッド・セラピューティクスは、アリーナ社のロイヤリティ買い下げ決定について、経口ラリネパグおよび複数の肺疾患適応症向けに計画しているドライパウダー製剤に対する確信を反映したものだと述べました。同社はこの取引を機動的な資本活用と説明しましたが、電話会議中に詳細な評価額についての言及はありませんでした。

PH-COPDの開発：経営陣は、吸入トレプロスチニルがより換気されている肺領域を標的にすることで換気血流不均等を軽減する可能性があると述べました。第II相プログラムはINDの承認を得ており、同社は対象集団を最適化し開発リスクを減らすため治験適格基準を精査しました。

決算説明会トランスクリプト全文

決算説明会の完全なトランスクリプト

経営陣による説明

Operator

Good morning, and welcome to the United Therapeutics Corporation Third Quarter 2026 Corporate Update. My name is Christa, and I will be your conference operator today. [Operator Instructions] Please note that this call is being recorded. I will now turn the webcast over to Harrison Silvers, Investor Relations at United Therapeutics.

Harrison Silvers

Thank you, Christa. Good morning, everyone. It is my pleasure to welcome you to the United Therapeutics Corporation Third Quarter 2026 Corporate Update Webcast. Remarks today will include forward-looking statements representing our expectations or beliefs regarding future events. These statements involve risks and uncertainties that may cause actual results to differ materially. Our latest SEC filings, including Forms 10-K and 10-Q, contain additional information on these risks and uncertainties.

We assume no obligation to update forward-looking statements. Today's remarks may discuss the progress and results of clinical trials or other developments with respect to our products. These remarks are intended solely to educate investors and are not intended to serve as the basis for medical decision-making or to suggest that any products are safe and effective for any unapproved or investigational uses. Full prescribing information for the products is available on our website.

Accompanying me on today's call are Dr. Martine Rothblatt, our Chairperson and Chief Executive Officer; Michael Benkowitz, our President and Chief Operating Officer; James Edgemond, our Chief Financial Officer and Treasurer; Dr. Leigh Peterson, our Executive Vice President of Product Development and Zeno Transplantation; and Pat Poisson, our Executive Vice President of Strategic Development.

Note that James Edgemond and I will participate in a fireside chat and one-on-one sessions at the UBS Global Biopharma Conference and Jefferies Global Healthcare Conference in London on November 16 and 17, respectively. Additionally, members from our management team will participate in a fireside chat in one-on-one meetings at the 45th Annual JPMorgan Healthcare Conference in San Francisco in January of next year.

Our scientific commercial and medical affairs teams will be President present at phenomenal Hope 2026 on December 4 in Boston and at the Pulmonary Vascular Research Institute Annual Congress in Bangkok in late January of next year. Now I will turn the webcast over to Martine for an overview of our development pipeline and business activities. Martine?

Martine Rothblatt

Thank you, Harry, and good morning, everyone. We have slides available for reference, and I encourage you to review those at your leisure. I'm not going to speak directly to the slides. As we look back on the third quarter, I'm incredibly proud of what our teams have accomplished. .

We executed at a high level across our business and across our company, delivering for patients while advancing one of the most ambitious growth strategies in biotechnology. The significance of this quarter extends beyond any individual results or milestone. It reflects the broader transformation underway at United Therapeutics as we build a comprehensive cardiopulmonary and respiratory medicine franchise capable of reaching dramatically more patients than ever before.

For most of our history, UT has been known as a pulmonary hypertension company. Today, that legacy serves as the foundation for a much bigger UT. Over the next several years, we expect to introduce wave after wave of innovation across multiple therapeutic and device platforms. From nebulized and dry powder therapies to softness inhalers, once-daily medicines and combination products.

We have 14 programs in development. Together, these advances are intended to address some of the largest unmet needs in pulmonary fibrosis and pulmonary hypertension. We are building an integrated portfolio designed around the needs of individual patients.

Our strategy is to keep innovating, so we can offer more patients the right therapy in the right format at the right time. The scale of that opportunity extends far beyond our historic pulmonary hypertension market across IPS, PPS and PH-COPD alone, we are pursuing patient populations totaling approximately 1 million people in the United States. Supporting this strategy are significant and durable competitive advantages.

Our portfolio features extensive intellectual property protections, including fibrosis-related patents, device protections and composition of matter protection for ralinepag, many of which extend into the 2040s, just as important, our market advantages include decades of expertise, extensive engagement with physicians, specialized commercialization capabilities manufacturing investments and a proven ability to bring complex drug device combinations to market.

We are building on our strength through the philosophy that has guided us for years, approve, then improve. We first established a therapy as quickly as possible because our patients do not have time. Then we continue to enhance convenience, administration and treatment experience through new devices, formulations and next-generation medicines. This disciplined approach creates a pipeline in which every new product builds on the foundation established by the last and provides improvements for the next.

And as compelling as our cardiopulmonary and respiratory franchises are they represent only 1 pillar of our long-term vision. In parallel, we continue to advance our manufactured organ alternatives programs and build the infrastructure we need to address one of medicine's greatest unmet needs. We believe this platform has the potential to revolutionize transplantation over the next decade, just as our therapies have revolutionized pulmonary hypertension over the past 2 decades.

When I step back, I see a United Therapeutics stronger than at any point in our history with a growing commercial business, late-stage assets of significant potential multiple upcoming launches and a clear strategy for creating value over the long term. In closing, thank you to our fellow Unitarians, patients, physicians, shareholders and our other stakeholders for helping us fulfill our purpose. And with that, I'll turn the call over to our President, Michael Benkowitz, for an overview of our commercial performance for the quarter. Mike?

Michael Benkowitz

Thanks, Martine, and good morning, everybody. For the third quarter of 2026, we delivered record total revenue of $833 million and record Tyvaso revenue of $504 million. Highlighted by strong sequential growth and underlying demand. 3 months ago, I said confidence is earned through execution, not projections.

This quarter's results are best quarter ever demonstrate that execution and reinforce our conviction that our business has regained meaningful momentum. A huge shout out to all of our commercial, commercial operations and medical teams for their hard work, persistence and performance.

Tyvaso's performance was driven by strong underlying demand as the patient metrics we highlighted last quarter translated into commercial results. Starts, referrals, patient demand, increased dosing and physician engagement all continue to support growth and emphasize the value of differentiated products, disciplined execution, a clear understanding of physician and patient needs and our expertise and support in the field of pulmonary hypertension.

Most importantly, we see meaningful room to grow from here. The investments we made earlier this year in resources and sharpening our messaging are working as intended by expanding our reach deepening physician engagement, increasing disease awareness and driving greater penetration across PAH and PH ILD. We have greater conviction in our strategy than ever. Elsewhere, the recent court decision upholding our intellectual property, together with the settlement we reach, provide important clarity and reinforce the long-term durability of our base business.

The terms of our settlement were highly favorable for United Therapeutics, ultimately removing PH-ILD from the tropo label, preventing its promotion and marketing into that indication and prohibiting Liquidia from encouraging off-label usage, which we will be monitoring very closely. With no direct branded competition on the horizon, we can remain focused on growing the large underpenetrated PH-ILD market.

Based upon the provisions contemplated in the settlement and damages structure, near-term expectations for transitions from UTP to Tyvaso should be moderate. The larger opportunity in PH-ILD continues to remain focused on expanding physician awareness, identifying more eligible patients and growing new prescriptions.

That gives Tyvaso a long runway for largely uncontested growth. Step back, our story is not about stabilizing our business. It is about building on renewed momentum from our durable commercial foundation with 2 of the most important potential launches in our street still ahead. Once approved, we expect nebulized Tyvaso and IPF and ralinepag in PAH will each address significant unmet need. Both are supported by compelling clinical data and both have the potential to become multibillion-dollar growth drivers for United Therapeutics.

These opportunities do not replace our current growth story, they accelerate it. In closing, our base business is performing. Our commercial strategy is working. Our competitive position is strong and we expect to enter 2027 with substantially more momentum than we had entering 2026.

To highlight this continued momentum, we received over 1,000 referrals for a UT product in October, the most ever received in a single month. We remain focused, accountable and committed to continue delivering compelling results. And as proud as we are of this quarter, we believe we are just getting the full scale of what we are determined to achieve. And with that, I'll pass the call back to Harry to run the Q&A.

Harrison Silvers

Thanks, Michael. Thanks, Martine. Great updates from both of you. [Operator Instructions] Operator, you can start.

Operator

[Operator Instructions] Your first question comes from Joseph Thome with TD Hain.

質疑応答

Joseph Thome

Maybe could you talk a little bit more about the patient switch dynamic now that PHLD will be off-label for you [indiscernible] , what are sort of your expectations of current patients switching over? And maybe for new start markets, you mentioned that you are monitoring their off-label use potential. Can you just kind of go into how you're doing that in the field. .

Unknown Executive

Thanks for the question, Joe. I'm going to pass this 1 to Michael.

Michael Benkowitz

Sure. Yes. So Joe, thanks for the question. On the patient switch is the -- per the terms of the settlement agreement, we sort of contemplated -- we didn't -- there was no requirement or expectation that patients would have to switch from [indiscernible] to Tyvaso DPI and so we kind of contemplated that in the damage structure, as I mentioned.

And so I think, obviously, we're going to continue to talk about the benefits the differentiation of DP relative to Trebia, but it's really going to be, I think, a physician patencies to whether or not they want to transition existing patients over to Titaso-DPI. But that's not something that's going to be required for the terms of the settlement.

So like I said, I think what you're going to see is if you've got patients on Metropia that for are having issues, obviously, Tyvaso remains an option, you can switch, but there's not -- I think if a patient's doing well on. There's not really going to be, I think, a push on the part of doctors to switch patients over. So as I said, the real opportunity here is with new prescriptions and continuing to penetrate the pH ILD market, which we're starting to see with the benefit of the expanded sales force.

In terms of monitoring that, I mean, look, we kind of -- I'm not going to really get into kind of sources and methods of how we're going to do that. But I think we have pretty good visibility into how things are playing out in terms of prescriptions and indications, and we're just going to continue to kind of keep an eye on that and see how that plays out along with what we're hearing in the market through our interactions with physicians.

Harrison Silvers

Thanks, Michael. Operator next question.

Operator

Your next question comes from the line of Olivia Brayer with Cantor.

Olivia Brayer

Michael, I just quickly wanted to follow-up on PHLD. Are you guys actually seeing any acceleration in new starts on Tyvaso in the fourth quarter just on the back of that settlement? Or do you really expect that to become more meaningful as patients come up for reauthorization in January? Just trying to kind of reconcile your comments around October trends. And then I'm sorry, Harry, -- but my real question is on the softness inhaler program, where are you guys in the submission process at this point? And is a filing still on track for the end of the year? And then as you think about softness kind of looking ahead to PH-COPD, what have you guys actually seen in the SMI product profile that's giving you so much confidence that it could succeed in this patient population, just given some of the challenges that we've already -- or that others have experienced, right, with prior approaches?

Harrison Silvers

Sound more like 3. I'll give Michael the first question. And then if you could pass it to Pat on the NDA expectations for SMI and then perhaps we can close it off with expectations in PH COP.

Michael Benkowitz

Yes. Olivia, you never disappoint with your multi question. So on PLD, so if you kind of think about the time line of everything, as I said, I think even before the settlement, right, going back to like mid-September, I think we saw this inflection in the referrals coming in. Really across both cations, PAH and PLD for Tyvaso that has persisted through the end of October into November, in terms of working out the litigation decision, the settlement, I mean, all of that stuff really didn't really get worked out until, I guess, what was that second, third week of October.

So still a little early to see I think another sort of inflection in terms of PH ILD. I would expect that we're going to start to see that here over the next couple of weeks. And into December than obviously the first part of the year. So that's kind of where things are right now. I mean we do expect to see that I've seen -- I kind of monitor the daily referral trends. We have a couple of days where we spiked, but I expect us to see kind of a new baseline in terms of referrals here over the next few weeks. Pat, do you want to take the other question?

Patrick Poisson

We recently met with the FDA to discuss our NDA filing strategy, and that was preplanned. And following that discussion, we've now determined that additional work is going to be needed to support the application. So as a result of that, we now expect to submit the NDA in 2027 and not at the end of this year. We are actively working with our development partner to complete the necessary activities and establish an updated filing time line. Leigh pass it on to you.

Leigh Peterson

Yes. As far as PH-COPD, goes, our Phase II trial, as you know, we have IND clearance for that study. And in terms of the biological rationale for COPD, mean the pharmacology of inhaled treprostinil is really well characterized with our commercially approved treatments for PH and PH-ILD.

And as you know, in these patients with [indiscernible] with group through PH, such as ILD and COPD, the inhaled treprostinil directly targets more ventilated portions of the lungs. And so that can minimize the VQ mismatch that's with the concern with more systemic therapies that are also vasodilators.

So it's really important to note that not only do we have a more robust design in our study. But we've really, really looked very carefully at the patient population that was enrolled into the prior study, COPD study and really worked hard with our steering committees to enrich this current population through the inclusion exclusion criteria to improve the chances of success as well as just decrease the risk of this program.

Harrison Silvers

Thanks, Lee. That was a great overview by all 3 of you.

Operator

Your next question comes from the line of Ash Verma with UBS.

Ashwani Verma

So on ralinepag, I wanted to ask about this open action indicated that you have mentioned in the Q about this API manufacturer. Can you talk about what is the contingency plan ahead of the potential regulatory approval for this?

Harrison Silvers

Thanks for the question, Ash. Pat, we'll kick that over to you.

Patrick Poisson

Yes. Thanks, Ash. So as you saw in the Q, our API supplier has an OAI compliance status as the result of an inspection earlier this year. We're actively working with them to remediate their compliance status so that it doesn't impact our PDUFA date. So that's kind of priority one.

We do have some alternative plans that are progressing in parallel. But on a positive note, they've recently provided FDA updated information on their corrective actions. And there's open dialogue between the parties. So we remain hopeful that this will get resolved fairly quickly, but we do have contingency plans in place.

Harrison Silvers

Great. Thanks, Pat. .

Operator

Your next question comes from the line of Roger Song with Jefferies.

Jiale Song

Great. Maybe related to the triplet oral pill, since the bioequivalent study is not sufficient for filing. So what is the current plan for development and funding plan for the [indiscernible]

Harrison Silvers

Thanks for your question, Roger. Pat, can I ask you to answer this 1 again?

Patrick Poisson

Yes. So we had a discussion with FDA and they share that, that was their feedback to us. And so right now, we're looking at what our options are really, if there's an alternate path that they would accept that's going to take us a little while. So -- but right now, we're just treading water. And while we work on different options that we can present to them. .

Operator

Your next question comes from the line of Rowan Ruiz with Leerink Partners. .

Unknown Analyst

A quick question. Could you elaborate on the -- what you saw as the biggest drivers behind the Tevas strength in the quarter? And if any could increase into year-end? I'm specifically focused on if there is more traction from the upsized field force or any inventory or seasonal dynamics that we should consider in addition to underlying demand growth?

Harrison Silvers

For your question. This 1 will go to Michael.

Michael Benkowitz

Sure. Yes, thanks for the question. So no inventory or seasonal dynamics really, I think, played into the quarter. I think it's really kind of a multifactorial thing. One is just honestly, just great execution by the sales team. I think we've like we talked about in the last quarter came out of the quarter with really strong momentum. .

We've been able to maintain that through -- even through October, as I talked about earlier. I think as we've talked about on prior calls, I think some of the challenges we faced in the prior quarters are we'd have 2 really good months and 1 soft month and the 2 good months weren't enough to offset the soft mine. So we've been kind of flat for several quarters. But now we've got, I think, really consistent performance month to month to month. And so we're stocking good months on top of good months. And so that's really just, I think, plays into really strong execution by our commercial teams.

I think the other thing that we've seen is at the beginning of the year, we -- we introduced a 80-microgram cartridge. So one breath gives you the equivalent of 15 nebulized breath and then some higher dose kits. I think there's been this misinformation out there that you can't get to higher doses on Tyvaso DPI. I think we've effectively debunk that for patients that have started on Tyvaso DPI since we introduced those cartrids.

We introduced those higher strength kids, like 1 in 3 patients are, have achieved these higher doses which is twice what it was beforehand. So that certainly, I think, played into the performance is that we're getting patients to higher dose which helps from a revenue standpoint, but also helps from a retention standpoint because patients are obviously benefiting from the product.

I think in terms of the effect of the sales force expansion. I think in terms of region frequency, that played a role in some of the consistent performance month-to-month. But in terms of like what we've seen in terms of increase in referrals increase in starts. I think we -- as I said, we start to see kind of this inflection point, probably mid-September. As a result of that. So that didn't really you can't really -- I don't think you can draw a straight line through to the revenue line for Q3. I think we'll start to see the benefit of that here in Q4 and then into next year. But it's clear that the expansion is working, and we're seeing the benefit of that. But probably limited revenue impact of that in Q3, but we certainly expect to see that, like I said, this quarter and heading into next year.

Harrison Silvers

Great color.

Operator

Our next question comes from the line of Jessica Fye with JPMorgan.

Jessica Fye

Congrats on the quarter. a quick follow-up. I think it was 1 of Olivia's questions. Pat, can you just expand on what was new that's needed for the softness filing?

Patrick Poisson

Yes. It's not necessarily anything new. It's just additional data in some areas that we need to provide. So really -- it's really just that. It wasn't anything you've asked us to do in addition to what we had already planned.

Jessica Fye

So [indiscernible] versus generating more data.

Patrick Poisson

It's just generating additional data. And I don't think we're particularly worried about it. It's just a lead time to do it. .

Harrison Silvers

Great. Thanks, Jess, for the question and Pat for the answer.

Operator

Your next question comes from the line of Ben Burnett with Wells Fargo.

Benjamin Burnett

I want to ask about ralinepag and just what was behind the decision to buy out Arena's economics to ralinepag. And I guess how did you value that transaction?

Harrison Silvers

Thanks for the question, Ben. I'm going to pass this 1 to James. .

James Edgemond

Yes. Thanks, Harry. Ben, overall, this transaction to buy down the royalty demonstrates really our confidence in the revenue opportunity for oral ralinepag which, as you know, has a pending new drug application under review by the FDA for pulmonary arterial hypertension, which you know is a PDUFA date of June 24 of next year. .

But in addition, the reason why we pursue this opportunity is we have conviction in the new dry powder inhalation formulations that we're developing for a variety of pulmonary indications going forward. And I would say the price was the result of really extensive negotiations, and we're not going to get into the details regarding that. But we looked at this more as an opportunistic use of capital kind of in our overall capital allocation waterfall. So thanks for the question.

Harrison Silvers

Thanks for that, James. Operator, we have time for 1 more question. Go ahead.

Operator

And that question is going to come from the line of Lisa Walter at RBC.

Lisa Walter

Congrats on a strong quarter. Maybe another 1 on ralinepag, DPI. Curious as plans have changed around developing this for PAA -- or is PH still part of the plan, along with PH-ILD, IPS and PPS? And how are you thinking about the clinical development plan for ralinepag DPI in these indications? Any color here would be helpful.

Harrison Silvers

Yes, absolutely. Good to hear your voice, Lisa. I'm going to pass this 1 over to Leigh to provide some color.

Leigh Peterson

Yes. Thanks for the question. So we are in the process, as you know, of conducting the IND-enabling studies as well as planning for the Phase I study in healthy volunteers. Now that Phase I study prestudy safety. That will actually inform any other registrational study that we want to do. So we're initially planning on doing a PH-ILD study and they're very, very soon thereafter or essentially at the same time, seeking approval for IPF, PPF, all of those will require some pivotal studies assessing the safety and efficacy.

But again, we're confident that the mechanism, both of the very, very potent drug, self the ralinepag being a very, very potent IP receptor agonist as well as the inhaled route for these indications where there's either some fibrosis or later for COPD, but that's not in the immediate plan. But anyway, this inhaled route to minimize VQ mismatch is really probably will make what we're calling route pie, a very transformative product in these larger indications.

Harrison Silvers

Excellent overview, Lee, and that will conclude the Q&A. So I'll pass it back to the operator to close this out. .

Operator

Thank you for participating in today's United Therapeutics Corporation's earnings webcast. A rebroadcast of this webcast will be available for replay for 1 week by visiting the Events and Presentations section of the United Therapeutics Investor Relations our website at ir.unither.com. This now concludes today's call, and you may now disconnect.