United Therapeutics Corp (UTHR) 2025 Q4 法說會逐字稿

Good morning, everyone and welcome to the United Therapeutics Corporation fourth-quarter 2025 corporate update conference call. My name is Jamie and I'll be your conference operator today. (Operator Instructions) Please also note today's event is being recorded. At this time, I'd like to turn the webcast over to Harry Silvers, Investor Relations Manager at United Therapeutics.

各位早安，歡迎參加聯合治療公司2025年第四季公司業績更新電話會議。我叫傑米，今天將擔任你們的會議接線生。（操作說明）也請注意，今天的活動正在錄製中。此時，我想把網路直播交給聯合治療公司投資人關係經理哈里·西爾弗斯。

Thank you, Jamie. Good morning. It is my pleasure to welcome you to the United Therapeutics Corporation fourth quarter 2025 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.

謝謝你，傑米。早安.歡迎各位參加聯合治療公司 2025 年第四季企業最新動態網路直播。今天的發言將包含一些前瞻性陳述，代表我們對未來事件的預期或觀點。這些聲明涉及風險和不確定性，可能導致實際結果與聲明有重大差異。我們最新的美國證券交易委員會文件，包括 10-K 表格和 10-Q 表格，包含有關這些風險和不確定性的更多資訊。我們不承擔更新前瞻性陳述的義務。

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.

今天的演講可能會談到臨床試驗的進展和結果，或與我們產品相關的其他進展。這些言論僅旨在教育投資者，並不旨在作為醫療決策的依據，也不暗示任何產品對於任何未經批准或研究性用途都是安全有效的。完整的產品處方資訊可在我們的網站上查閱。

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

今天陪同我參加電話會議的有：董事長兼執行長 Martine Rothblatt 博士；總裁兼營運長 Michael Benkiewicz；財務長兼財務主管 James Edgeman；產品開發與異種移植執行副總裁 Lee Peterson 博士；以及策略發展執行副總裁 Pat Poisson。

Note that Michael Benkiewicz, James Edgeman, and I will participate in a fireside chat and one-on-one meeting at the TD Cowen 46th Annual Healthcare Conference in Boston on March 2. Additionally, Martine Rothblatt, James, and I will be at the Lee Ring Global Healthcare Conference in Miami on March 9 for a fireside chat and one-on-one meetings.

請注意，Michael Benkiewicz、James Edgeman 和我將於 3 月 2 日在波士頓舉行的 TD Cowen 第 46 屆年度醫療保健大會上參加爐邊談話和一對一會議。此外，Martine Rothblatt、James 和我將於 3 月 9 日在邁阿密參加 Lee Ring 全球醫療保健大會，進行爐邊談話和一對一會談。

Finally, James and I will also participate in one-on-one meetings at the UBS Biotech Summit in Miami on March 10. Our scientific, commercial, and medical affairs teams will be present at the 21st Annual John Vane Memorial Symposia in London March 13 and 14, and at the International Society for Heart and Lung Transplantation in Toronto, April 22 to 25. Now I will turn the webcast over to Martine for an overview of our development pipeline and business activities. Martine?

最後，我和 James 還將於 3 月 10 日在邁阿密舉行的瑞銀生物技術高峰會上進行一對一會談。我們的科學、商業和醫療事務團隊將出席 3 月 13 日至 14 日在倫敦舉行的第 21 屆約翰·範紀念研討會，以及 4 月 22 日至 25 日在多倫多舉行的國際心臟和肺移植協會會議。現在我將把網路直播交給 Martine，讓她概述我們的開發流程和業務活動。瑪蒂娜？

Thank you, Harry. Good morning, everyone. Today I'm going to share with you news that transforms the fields of pulmonary hypertension and IPF. This news is our unsheathing of a category killer product called Tresmi, T-R-E-S-M-I. This product is a revolutionary, proprietary, drug device formulation of tryprosinol into a soft mist inhaler. It will reduce the number one side effect of dry powder inhalers, which is coughing, by up to 90% based on the human studies we've done so far. And we intend to file for its approval in PAH and ILD this year and commercially launch it next year.

謝謝你，哈里。各位早安。今天要跟大家分享一些改變肺動脈高壓和特發性肺纖維化領域的新聞。這則新聞是我們正式推出一款名為 Tresmi（T-R-E-S-M-I）的顛覆性產品。本產品是一種革命性的、專有的藥物裝置配方，將曲普瑞諾製成軟霧吸入器。根據我們目前進行的人體研究，它可以將乾粉吸入器的最大副作用——咳嗽——減少高達 90%。我們計劃今年提交該藥物在肺動脈高壓和間質性肺病治療中的批准申請，並於明年進行商業推廣。

The days of people discontinuing their PAH or ILD therapy due to cough will be over. Anyone would rather have soft mist than dry powder. Also transformative for our markets will be the unblinding of our outcome study next week. We are optimistic that this unblinding will usher in a new era of once-a-day treatments for pulmonary hypertension.

人們因咳嗽而停止肺動脈高壓或間質性肺病治療的日子將一去不復返了。任何人都喜歡柔和的霧氣而不是乾燥的粉末。下周公布研究結果，也將對我們的市場產生變革性影響。我們樂觀地認為，此次揭盲將開啟肺動脈高壓每日一次治療的新時代。

The reason we can promise once-a-day treatment is because the new medicine is a super prostacyclin. It is a super prostacyclin because it lasts much longer and binds molecules much more efficiently than all other approved forms of prostacyclin. Hence, between our super prostacyclin once daily pill and our coughless soft mist inhaler, or SMI, we have solved the two biggest problems in our diseases, cough and dose frequency.

我們之所以能夠承諾每天一次的治療，是因為這種新藥是一種超級前列環素。它是一種超級前列環素，因為它的作用時間更長，並且比所有其他已批准的前列環素形式的結合效率更高。因此，憑藉我們的超級前列環素每日一次藥片和我們的無咳軟霧吸入器（SMI），我們解決了疾​​病治療中的兩大難題：咳嗽和給藥頻率。

Also very exciting is our unblinding next month of our second pivotal trial of Tyvaso for IPF. You'll recall from last quarter that our first pivotal trial showed Tyvaso to be much better than any other IPF drug the FDA has ever approved. With confirmation of those results next month, we'll quickly file for approval and commercially launch into IPF not later than June of 2027.

同樣令人興奮的是，我們下個月將揭盲 Tyvaso 治療 IPF 的第二個關鍵性試驗。您可能還記得上個季度我們的第一個關鍵性試驗表明，Tyvaso 比 FDA 批准的任何其他 IPF 藥物都要好得多。如果下個月能確認這些結果，我們將迅速提交審批申請，並最遲在 2027 年 6 月開始向 IPF 患者進行商業推廣。

In summary, for 2027, we should have three disease-transformative, paradigm-shattering commercial launches. One, a once-daily super prostacyclin for PAH; two, a category-crushing Tresmai coughless inhaler for ILD; and three, a better-than-everything new treatment for IPF. Hell yeah, we are pumped. Now, let me review some of the other major management areas that I track as CEO. We are religious about revenue growth at UT. And Mike Cain --

總而言之，到 2027 年，我們應該會有三款能夠改變疾病現況、顛覆傳統觀念的商業產品上市。一是用於治療肺動脈高壓的每日一次的超級前列環素；二是用於治療間質性肺病的顛覆性無咳吸入劑 Tresmai；三是用於治療特發性肺纖維化的比以往任何療法都更好的新療法。太棒了，我們興奮極了。現在，讓我回顧一下我作為執行長關注的其他一些主要管理領域。在德州大學，我們非常重視營收成長。還有麥克凱恩--

Thanks, Mark Cain, and good morning, everyone. 2025 marked another year of record-breaking revenue, driven by double-digit percent revenue growth from Tyvaso and Orenitram, leading to 11% total revenue growth over a full year of 2024, and surpassing $3 billion in total revenue for the first time in our history. For the fourth quarter, we recorded $790 million in total revenue, representing 7% growth from the fourth quarter of 2024. We have pointed out in the past and continue to remind investors of our historical seasonal revenue trends where the first quarter and fourth quarter tend to be lighter ordering quarters, while the second quarter and third quarter tend to be heavier ordering quarters.

謝謝馬克凱恩，大家早安。 2025年，公司營收再創新高，主要得益於Tyvaso和Orenitram兩位數的營收成長，使得公司2024年全年總營收成長11%，並首次突破30億美元大關。第四季度，我們的總營收為 7.9 億美元，比 2024 年第四季成長了 7%。我們過去曾指出，並將繼續提醒投資者，我們歷史上的季節性收入趨勢是，第一季和第四季往往是訂單較少的季度，而第二季和第三季往往是訂單較多的季度。

As such, sales in the short term can vary depending on the timing and magnitude of orders from our specialty pharmaceutical distributors and may not precisely reflect patient demand or changes in patient census.

因此，短期銷售額​​可能會因我們專業藥品分銷商的訂單時間和數量而有所不同，並且可能無法準確反映患者需求或患者數量的變化。

Turning to Tyvaso, total revenue for the fourth quarter was $464 million, a 12% increase over the previous year, underpinned by robust 24% year-over-year growth in Tyvaso DPI. This impressive trajectory reflects our strategic positioning in a large and growing addressable but uncaptured market in PAH and PHILD, where we are steadily increasing our share of voice and expect to continue delivering double-digit growth.

再來看 Tyvaso，第四季總營收為 4.64 億美元，比上年增長 12%，這主要得益於 Tyvaso DPI 年成長 24%。這一令人矚目的發展軌跡反映了我們在 PAH 和 PHILD 這一龐大且不斷增長的潛在但尚未開發的市場中的戰略定位，我們正在穩步提高市場份額，並有望繼續實現兩位數的增長。

Through mid-February of this year, our rate of referrals for total Tyvaso was at its highest level in two years. Notably, the referral rate in three of the last four months was at or above where we were heading into a competitive launch early summer of last year. This continued strength and the underlying fundamentals reflects the disciplined execution of our teams who continue to reinforce our message. And we expect this momentum to continue throughout the year as the many attributes of Tyvaso DPI position the device for sustainable long-term growth.

截至今年 2 月中旬，我們 Tyvaso 的總轉診率達到了兩年來的最高水準。值得注意的是，在過去四個月的三個月裡，推薦率達到或超過了去年夏天初我們即將迎來競爭激烈的市場推廣時的標準。這種持續的強勁勢頭和基本面反映了我們團隊嚴謹的執行力，他們不斷強化我們的理念。我們預計這種勢頭將在今年持續下去，因為 Tyvaso DPI 的許多特性使其能夠實現可持續的長期成長。

We are constantly striving to enhance our Tyvaso DPI platform, which we believe will help us solidify and grow our position as the preferred inhaled prostacyclin therapy. We recently introduced 80-microgram cartridges, which enable delivery of the equivalent of 15 nebulized troposomal breaths in a single DPI breath, as well as 96 and 112-microgram combination kits. This advancement strengthens Tyvaso DPI's differentiation in the pulmonary hypertension market by improving convenience and expanding dosing flexibility, which we believe can support broader adoption and longer-term growth while streamlining access and affordability for patients with more advanced dosing needs.

我們不斷努力改進我們的 Tyvaso DPI 平台，我們相信這將有助於我們鞏固和擴大我們作為首選吸入式前列環素療法的地位。我們最近推出了 80 微克藥盒，一次吸入即可輸送相當於 15 次霧化吸入的藥物，此外還有 96 微克和 112 微克組合套裝。這項進步透過提高便利性和擴大給藥靈活性，增強了 Tyvaso DPI 在肺動脈高壓市場的差異化優勢，我們相信這可以支持更廣泛的採用和長期增長，同時簡化有更高級給藥需求的患者的獲取途徑和降低其負擔能力。

Moreover, we believe that consistency of flow rate and delivery with our DPI device and its low inspiratory flow requirements further differentiates our platform. Turning to Orenitram and Remodulin, last month at the Pulmonary Vascular Research Institute Annual Congress in Dublin, Our medical affairs teams presented data from the ongoing artisan study examining the effect of early and rapid tryprosomal therapy on mean pulmonary arterial pressure, or MPAP, and the reduction to improve right ventricular function in PAH. Preliminary data suggests that early initiation of high-dose tryprosomal therapy represents a feasible strategy for reducing MPAP and improving right ventricular structure and function.

此外，我們相信，我們的 DPI 設備在流量和輸送方面的一致性以及其較低的吸氣流量要求，進一步使我們的平台脫穎而出。上個月在都柏林舉行的肺血管研究所年會上，我們的醫療事務團隊介紹了 Orenitram 和 Remodulin，並展示了正在進行的工匠研究的數據，該研究旨在檢驗早期快速的胰蛋白酶體療法對平均肺動脈壓 (MPAP) 的影響，以及降低 MPAP 以改善 PAH 患者右心室功能的效果。初步數據顯示，早期開始高劑量胰蛋白酶體療法是降低平均肺動脈壓、改善右心室結構和功能的可行策略。

These data further reinforce the significant benefits that can be achieved from Orenitram and Remodulin, which remain backbones to proprostinol-based therapy in treating pulmonary hypertension and are strong foundational pieces to our commercial business.

這些數據進一步強化了 Orenitram 和 Remodulin 所能帶來的顯著益處，它們仍然是治療肺動脈高壓的前列腺素療法的支柱，也是我們商業業務的堅實基礎。

To close, we are proud of the exceptional drive and relentless focus of our teams who remain deeply committed to making a real difference for the patients we serve. Building on the strength of this past year, we expect this foundation will continue to support durable double-digit growth and ongoing success over the long term. With that, I'll turn things back to Martin to run the Q&A.

最後，我們為我們團隊展現出的卓越動力和不懈專注感到自豪，他們始終致力於為我們服務的患者帶來真正的改變。在過去一年強勁成長的基礎上，我們預計這一基礎將繼續支撐兩位數的持續成長，並在長期內取得持續成功。接下來，我將把問答環節交還給馬丁。

Michael, thanks so much for that great review of our religious, dedication to strong revenue growth operator, maybe.

邁克爾，非常感謝你對我們這家致力於強勁營收成長的宗教經營者的精彩評價。

We could go to, the first question in the queue. And ladies and gentlemen, at this time, we'll start the question and answer session. Operator.

我們可以去問隊列中的第一個問題。女士們、先生們，現在我們將開始問答環節。操作員。

(Operator Instructions) Ash Varma, UBS.

（操作說明）Ash Varma，瑞銀集團。

Oh yeah, hi, good morning. Thanks for taking our question. So just on TETON 1 data coming up, wanted to understand your level of confidence here in a positive study for IPF. I know you're very confident ahead of the TETON 2 study, but just in terms of how you're thinking about for this second study, would love to get your thoughts. And then secondly, seems like this question keeps coming up, just the impact from eutropia. I know previously we talked about that this is, there was a give it a try dynamic, but just what are you seeing latest in terms of the patient ads for DPI or nebulizer, and if there is any impact from the competitor? Thanks.

哦，對了，你好，早安。感謝您回答我們的問題。關於即將公佈的 TETON 1 數據，我想了解您對這項針對 IPF 的積極研究的信心程度。我知道你對 TETON 2 研究非常有信心，但就你對這項第二項研究的看法而言，我很想聽聽你的想法。其次，這個問題似乎一直被提及，那就是正常化帶來的影響。我知道我們之前討論過，這是一種嘗試的趨勢，但就乾粉吸入器或霧化器的患者廣告而言，您最近看到了什麼？競爭對手是否產生了任何影響？謝謝。

Yeah, I'll go ahead. This is Lee Peterson, and I will go ahead and answer the first question about expectations for TETON 1. And yeah, just to reinforce that we're extremely encouraged by the TETON 2 results, and we're really optimistic that we can show a treatment effect in the TETON 1 study as well, particularly sense, we did see such a robust effect in TETON 2, and that the TETON 1 and TETON 2 study population are relatively similar with regards to the baseline characteristics. So we're confident that the TETON 2 results will translate to a second successful study.

好的，我去。我是李彼得森，我將回答關於 TETON 1 的期望的第一個問題。是的，再次強調，我們對 TETON 2 的結果感到非常鼓舞，並且非常樂觀地認為我們也能在 TETON 1 研究中顯示出治療效果，特別是考慮到我們在 TETON 2 中看到瞭如此顯著的效果，而且 TETON 1 和 TETON 2 研究人群在基線特徵方面相對相似。因此，我們有信心 TETON 2 的結果將轉化為第二次研究的成功。

Martin, this is the conference operator. We're going into the live conference. Your line just dropped here recently. We've rejoined you back in. Your line is live.

馬丁，我是會議接線生。我們要進入直播會議了。您的線路最近才開通。我們已經重新連結到你們了。您的線路已開通。

Okay. I'm sorry, everybody, the conference operator messed up the conference call. And I think, Mike, were you able to get your entire presentation through before you got dropped?

好的。對不起，各位，電話會議接線員把電話會議搞砸了。麥克，我想問一下，在你被淘汰之前，你的整個演講都完成了嗎？

I think so. I'm not sure if anybody heard me, though.

我也這麼認為。不過我不確定有沒有人聽到我說話。

OK, well, why don't we start back up? We'll go over 9.30. And why don't we go start back up around the time I think I was dropped. And then, Mike, if you don't mind redoing your presentation after I continue. Is that OK?

好吧，那我們重新開始吧？我們會超過9點30分。不如我們從我覺得自己被淘汰的那個時間點重新開始。然後，麥克，如果你不介意的話，在我繼續講完之後重新做一遍你的演講。這樣可以嗎？

OK. Yeah, well, I just think, Martin, I think we just confirmed that everybody heard my presentation.

好的。嗯，馬丁，我覺得我們剛才已經確認大家都聽到我的演講了。

Oh, OK, good. Well, I'll pick up from when I was dropped then. Thanks. So everyone has just heard Mike's presentation, and I think it confirms what we've been saying to everybody is our commitment to double-digit revenue growth. I'm going to continue from the point that I got dropped by the call to say, in addition to all of the fantastic success that Mike and his team have delivered in terms of revenues, that we at UT are also fanatical about new product development because we never like to rest on laurels. And Dr. Peterson, who is also on this call, is doing a superb job of product development. including the amazing new superprostacyclin and IPF medicines that I mentioned at the start. Before I dive into these new products, let me just take a moment due to the conference call earlier just to double check with Harry and Michael that my remarks are coming through. Are they coming through?

哦，好的。那我就從我被踢出局的地方繼續吧。謝謝。大家剛才都聽了麥克的演講，我認為這證實了我們一直以來向大家所說的，那就是我們致力於實現兩位數的收入成長。我將繼續剛才被掛斷電話時說的話，除了麥克和他的團隊在收入方面取得的巨大成功之外，我們UT也對新產品開發充滿熱情，因為我們從不喜歡固步自封。還有彼得森博士，他也參加了這次電話會議，他在產品開發方面做得非常出色，包括我一開始提到的令人驚嘆的新型超級前列環素和特發性肺纖維化藥物。在我深入介紹這些新產品之前，請允許我花一點時間，因為之前有個電話會議，我想和哈里和邁克爾再次確認我的發言是否傳達出去了。他們能過來嗎？

Yep, we got you, Martin.

是的，我們懂你，馬丁。

Okay. Sorry for the interruption, but, you know, trust but verify kind of thing. All righty, so other areas that I focus on in addition to new product development are investor relations and business development. With regard to business development, we are now in fruitful discussions with three great pharmaceutical companies. And this is really driven by their keen interest in the proven predictive power of our AI-enabled digital lung model. Our model can run hundreds of accurate in silico phase three trials in way less time than it takes for a single in vivo trial.

好的。抱歉打斷一下，但是，你知道，就是那種信任但要核實的事情。好的，除了新產品開發之外，我關注的其他領域還有投資者關係和業務拓展。在業務拓展方面，我們目前正與三家大型製藥公司進行富有成效的洽談。這實際上是由他們對我們人工智慧驅動的數位肺部模型的成熟預測能力的濃厚興趣所驅動的。我們的模型可以在比單次體內試驗所需時間少得多的時間內運行數百次準確的電腦模擬三期試驗。

No one else has this advanced and lung-specific computational biology technology. It is great to know that the outcome of a pulmonary trial can be known before spending hundreds of millions of dollars to run it. not to mention the many years saved or gained. Transplantation is another major management focus for me, and it too is firing on all thrusters. I'm just going to, before I go into transplantation, just let me take a moment to check again with Harry and Mike and make sure the line remains active.

目前還沒有其他機構擁有這種先進的、專門針對肺部的計算生物學技術。令人欣慰的是，肺部疾病試驗的結果可以在花費數億美元之前就得知，更不用說還能節省或延長患者的許多年壽命了。移植是我管理工作的另一個重點，它也正在全力進行中。在進行移植手術之前，我先花點時間再和哈里和麥克確認一下，確保線路仍然暢通。

Yes, we have it.

是的，我們有。

Okay, great. The first thruster is Zeno, which has now two patients transplanted and doing well in our FDA-approved phased-less clinical trial. We are on schedule to fully enroll the full six-patient cohort by this summer. Then we'll enroll the full balance of the trial needed for registration as decided by the FDA in 2027. At this rate, We should have a commercial Xeno product on the market in 2030. The second transplant thruster is Mural Matrix. We've now fully enrolled and successfully completed the first manufactured liver clinical trial ever.

好的，太好了。第一款推進器是 Zeno，目前已有兩名患者接受了移植手術，在我們獲得 FDA 批准的非分階段臨床試驗中，患者情況良好。我們正按計畫推進，將於今年夏季完成全部六名患者的招募工作。然後，我們將按照 FDA 在 2027 年的決定，完成註冊所需的全部剩餘試驗受試者招募工作。照此速度，我們應該在 2030 年就能將 Xeno 商業產品推向市場。第二個移植推進器是壁基質。我們現在已經完成了首個人工肝臟臨床試驗的全部招募工作，並且取得了圓滿成功。

We expect FDA guidance on how to take this liver failure recovery product and also our mural kidney implanted product to regulatory approval during the course of this year. Instead of me going through all of our multiple other transplant thrusters, such as, for example, 3D bioprinting of kidneys and lungs, let me simply say that I felt honored to be chosen by Forbes' team of experts and AIs as the eighth most innovative person in America. I feel an obligation to live up to that, and there is no company in the world manufacturing as many transplantable organs in as many different ways with as many, or for that matter, any in the human clinical trials as my teams at United Therapeutics. This is life-saving innovation writ very, very large. A final area of major management focus for me is our strategic clinical development group, also known as our scum works or stealth divisions. It is in this group that the revolutionary new TRES-My product was birthed as described at the start of the call.

我們預計 FDA 將在今年內就如何將這款肝衰竭恢復產品以及我們的壁內腎植入產品獲得監管批准提供指導。與其讓我詳細介紹我們其他的移植推進項目，例如腎臟和肺臟的 3D 生物列印，不如讓我簡單地說，我很榮幸被《福布斯》的專家和人工智慧團隊評選為美國第八位最具創新精神的人。我覺得我有義務不辜負這份期望，而且世界上沒有任何一家公司能像我在聯合治療公司的團隊那樣，以如此多種不同的方式生產如此多的可移植器官，並進行如此多的（或者說，正在進行任何）人體臨床試驗。這是一項意義極為重大的救命創新。對我來說，最後一個需要重點關注的管理領域是我們的策略性臨床開發團隊，也稱為我們的秘密部門或隱形部門。正如電話會議開始時所描述的那樣，革命性的新產品 TRES-My 正是在這個團隊中誕生的。

This is the product that will totally transform our markets by all but eliminating Triprostanil's number one reason for patient discontinuation, harsh coughing. We are unsheathing this product today because it will be filed this year for commercial launch next year. The immense power of this product is summarized in its name. Few will want to continue inhaling a dry powder when instead they can breathe a soft mist. Other products that you'll soon see emerging from our Skunk Works division include a once-daily inhaler, PRN inhalers, even better pills than the once-daily Relenopeg, and more IPF and pH products than I can really discuss in a mass call like this because they are deeper in stealth mode. But all of these products have long IP. In summary, UT is committed to using relentless innovation and our AI-enabled digital lung model to keep producing the best, most convenient, most effective, and safest products in the PAH and IPF space. Operator, you can now open up the line for additional questions.

這款產品將徹底改變我們的市場，幾乎完全消除了患者停用曲普司他尼的首要原因——劇烈咳嗽。我們今天發布這款產品，是因為它將於今年提交備案，明年正式上市。這款產品強大的威力在其名稱中就已體現。很少人願意繼續吸入乾燥的粉末，而寧願呼吸柔和的霧氣。您很快就會看到我們臭鼬工廠部門推出的其他產品包括每日一次吸入器、按需吸入器、比每日一次的 Relenopeg 更好的藥片，以及更多 IPF 和 pH 產品，我無法在這種大規模電話會議上真正討論這些產品，因為它們目前處於更深層次的保密狀態。但所有這些產品都擁有長期知識產權。總而言之，UT 致力於運用不懈的創新和我們人工智慧驅動的數位肺模型，不斷生產 PAH 和 IPF 領域最好、最方便、最有效、最安全的產品。操作員，現在可以接通線路，接受其他問題。

Ash Verma, UBS

阿什維爾馬，瑞銀集團

Oh, great. Yeah, thanks. Sorry about what happened earlier. Just on, like, the TETON 1 data coming up, I wanted to get an understanding of the level of confidence you have in the IPF study outcome. versus how you're feeling about TETON 2. And secondly, we just wanted to get the latest on impact from you, Trepia, if you're starting to see any type of patient add or competitive dynamic on the DPI or the nebulizer.

哦，太好了。嗯，謝謝。很抱歉之前發生的事。關於即將公佈的TETON 1數據，我想了解您對IPF研究結果的信心程度，以及您對TETON 2的看法。其次，Trepia，我們想了解最新的影響情況，看看您是否開始看到DPI或霧化器方面出現任何類型的患者增加或競爭動態。

Thanks. Okay, thank you, Ash. Thanks for the question. So the first part of your question about TETON 1 We will have answered by Dr. Lee Peterson. She's in charge of product development and in charge of the team that's running the Teton Trials. And then after she finishes answering your question, then the second part of your question will be answered by Mike Bankowitz relating to marketplace dynamics between us and EUTREPIA. Dr. Peterson, could you please start?

謝謝。好的，謝謝你，阿什。謝謝你的提問。所以關於 TETON 1 的問題的第一部分，我們將由 Lee Peterson 博士來解答。她負責產品開發，也負責管理負責 Teton Trials 專案的團隊。然後，在她回答完您的問題後，您的問題的第二部分將由 Mike Bankowitz 回答，這與我們和 EUTREPIA 之間的市場動態有關。彼得森博士，請您開始吧？

Yeah, sure. So I don't know if y'all heard me the first time I said this, but I'll add a little bit more detail this time. So just to reiterate, we're extremely enthusiastic about the TETON 2 results. And we have great confidence that these results are going to be translated to a second successful study, in particular TETON 1. The baseline characteristics of both studies are similar, relatively similar. So the possibility of the translation is really high. And again, the robust results that we saw in TETON 2 also give us confidence. I mean, we not only saw a very good, very positive, statistically significant, basically primary endpoint with regard to FBC, we saw, as everyone knows, we saw an improvement in absolute force biocapacity of 95.6 milliliters. And we also saw significant improvements in our secondary endpoints. And so, again, given these really good results, we expect similar results from TETON 1.

當然可以。我不知道你們第一次有沒有聽到我說的話，但這次我會補充一些細節。所以再次重申一下，我們對 TETON 2 的結果感到非常興奮。我們非常有信心，這些結果將轉化為第二項成功的研究，特別是 TETON 1 研究。兩項研究的基線特徵相似，相對相似。所以翻譯成功的可能性很高。此外，我們在 TETON 2 中看到的強勁成果也給了我們信心。我的意思是，我們不僅看到了 FBC 方面非常好的、非常積極的、具有統計意義的、基本上是主要終點的結果，而且正如大家所知，我們還看到了絕對力生物容量提高了 95.6 毫升。此外，我們的次要終點指標也得到了顯著改善。因此，鑑於這些非常好的結果，我們預計 TETON 1 也將取得類似的結果。

Perfect, Dr. Peterson. Thank you so much. Mike, I'm not sure how much they heard of your earlier discussion, so if you could just respond to Ash's question as you think best.

太好了，彼得森博士。太感謝了。麥克，我不確定他們對你們之前的討論了解多少，所以如果你能根據自己的判斷回答阿什的問題就太好了。

Yeah, so to Ash, I think you were asking about just kind of the competitive dynamics between us and Liquidia. And so, what I would say is TIDESA remains the well-entrenched market leader for inhaled therapy and pulmonary hypertension. The healthcare providers consistently affirm UT's leadership position in this space. As we said, there was initial curiosity to evaluate a new market entrant, but the doctors are recognizing that the advantages of Tyvaso DPI's easy and, importantly, consistent delivery in just one breath is important. Our primary market research insights and underlying demand trends support this. What we're hearing and seeing is that the belief in liquidity is unsubstantiated claims of higher dosing, less cough, better lung deposition, lower effort is definitely waning.

是的，Ash，我想你是在問我們和Liquidia之間的競爭動態。因此，我認為 TIDESA 仍然是吸入療法和肺動脈高壓領域根深蒂固的市場領導者。醫療服務提供者一致肯定了德州大學在該領域的領導地位。正如我們所說，最初大家對評估新進入市場的藥物感到好奇，但醫生們逐漸認識到，Tyvaso DPI 只需一口氣即可輕鬆且穩定地輸送藥物的優勢非常重要。我們的主要市場調查結果和潛在需求趨勢都支持這一觀點。我們現在聽到和看到的是，人們對流動性的信念，以及關於更高劑量、更少咳嗽、更好的肺部沉積、更低努力程度等未經證實的說法，正在逐漸減弱。

Our referrals have been at pre-Liquidia launch levels in three of the last four months. Our prescriber breadth and depth and patient retention is at or better to where it was before Liquidia launched. Now, what we have seen is the patient starts have lagged these trends a little bit. I think that's primarily due to the typical Q4 seasonality we see. as well as just kind of the cross-country severe weather we experienced in January. However, that logjam really seems to have broken in February based on what we've seen in the last three or four weeks. And I would say if these trends continue, you'd expect to see us return to sequential revenue growth no later than Q2.

在過去四個月中，有三個月我們的建議量都達到了 Liquidia 上線前的水平。我們的處方醫生數量和水平以及患者留存率都達到了或超過了 Liquidia 推出之前的水平。現在我們看到的情況是，患者數量比這些趨勢稍微落後了一些。我認為這主要是由於第四季度的典型季節性因素造成的，以及一月份席捲全國的極端天氣事件的影響。然而，根據我們在過去三四周看到的情況來看，這種僵局似乎在二月真正得到了打破。如果這些趨勢持續下去，我認為最晚在第二季度，我們將恢復營收季增。

Thank you, Mike. Operator, next question.

謝謝你，麥克。操作員，下一個問題。

Our next question comes from [LeRank] Partners. Please go ahead with your question.

我們的下一個問題來自 [LeRank] Partners。請繼續提問。

Great. Morning, everyone. So I thought it was a really interesting update on the soft mist inhaler product and was curious if you could talk a bit more about the human-based studies you've done so far and what additional features you've been optimizing for this product and how you think physicians will react in terms of prescribing it if it's fully available and commercialized.

偉大的。大家早安。所以我認為這是關於軟霧吸入器產品的非常有趣的更新，我很好奇您是否可以多談談您迄今為止進行的人體研究，以及您為該產品優化的其他功能，以及如果該產品完全上市並實現商業化，您認為醫生在開處方方面會有什麼反應。

Yeah, thanks for your question. I think physicians will be super happy about it. It is, as it says right in the name, it's soft mist versus dry powder. So I think physicians will be happy about it because patients will be happy about it. I think it will be equivalently effective, so why not have something that works just as good but is, you know, easier for the patient to tolerate. We have just brought this out of self mode today on this call. So this is totally really exciting news. And so many of the details we are not going to share openly. But I did want everybody to know that it was going to be filed for approval this year and then launched next year. So given the proximity, of all of that. It was important for us to unsheath the product, but all of the various competitive advantages of this product will remain undisclosed until we end up seeing the FDA approval.

謝謝你的提問。我認為醫生們會非常高興的。如其名，它是柔和的霧狀噴霧，而不是乾粉狀噴霧。所以我認為醫生們會為此感到高興，因為病人也會為此感到高興。我認為它的效果應該是一樣的，所以為什麼不選擇一種效果一樣好，但患者更容易耐受的藥物呢？今天我們透過這次電話會議才把這個問題從自我模式中提了出來。這真是個令人振奮的消息。還有很多細節我們不會公開。但我希望大家都知道，該專案將於今年提交審批，然後明年推出。考慮到所有這些因素，以及它們之間的密切聯繫。對我們來說，揭開產品的神秘面紗很重要，但該產品的各種競爭優勢在獲得 FDA 批准之前仍將保密。

Next question, operator.

下一個問題，操作員。

Roger Song, Jefferies.

Roger Song，傑富瑞集團。

Please go ahead with your question. Great. Congrats for the progress and exciting to see those three launches. Maybe the team, so I think you confirmed the double-digit growth this year. I think, Martin, you mentioned the $4 billion run rate by 2027, the end of 2027. Can you also comment on that kind of soft guidance? And also, given those three new product launch, next year. So how much contribution from those launches will contribute to the long-term growth, including the $4 billion run rate? Thank you.

請繼續提問。偉大的。祝賀取得的進展，很高興看到這三次發射成功。或許是團隊，所以我認為你已經證實了今年兩位數的成長。馬丁，我想你提到過到 2027 年底，年收入將達到 40 億美元。您能否也談談這種溫和的指導方式？此外，考慮到明年將推出三款新產品。那麼，這些新項目的推出將對長期成長（包括40億美元的年化收入）做出多大貢獻呢？謝謝。

Yeah, it's a really insightful question. So first of all, we can clearly double down on our commitment to hit that $4 billion revenue run rate next year. So it will be in the back half of the year. But if you just take our double-digit revenue growth and you roll it forward from the levels that we are at right now, you'll see that we would be hitting that billion-dollar quarter by the tail end of next year. So we're doubling down on that. It does not require the contribution of these three new product launches. So all of that is, you could say, you know, gravy, whipped cream, whatever is your favorite metaphor.

是的，這真是一個很有見地的問題。首先，我們可以明確地加倍努力，確保明年實現 40 億美元的營收目標。所以會在下半年進行。但如果你只看我們兩位數的營收成長，並從我們目前的水平向前推算，你會發現到明年年底，我們將實現10億美元的季度營收目標。所以我們要加倍投入。它不需要這三款新產品的推出。所以，你可以說這一切都是錦上添花，就像肉汁、鮮奶油，或是任何你喜歡的比喻。

But definitely these three product launches are going to bend the curve upwards in terms of our revenue levels beyond the $4 billion annualized rate because we were growing double-digit with the great products that we currently have, the Tyvaso DPI, Orenatram, Romodulin, you know, all of these, Unitoxin, all of these products. So above and beyond that, we've now got three more products, and these aren't just, like, Me Too products.

但可以肯定的是，這三款產品的推出將使我們的營收水準超過 40 億美元的年化成長率，因為我們目前擁有的優秀產品，如 Tyvaso DPI、Orenatram、Romodulin、Unitoxin 等，都實現了兩位數的成長。所以除此之外，我們現在還有三款產品，而且這些產品不只是「我也是」運動相關的產品。

These are frickin' category crusher products. I mean, the first one that can, like, you know, slash way down the cough, a coughless inhaler, that's amazing. A once-a-day super prostacyclin, that's amazing. And an IPF treatment that's better than anything the FDA has ever approved for IPFs since the beginning of IPF. It does not get better than that. So like I said, we're super pumped, and I think the 4 billion revenue run rate, it's just to be the point at which the revenue curve bends even more sharply upwards.

這些產品簡直是顛覆品類的神器。我的意思是，第一款能夠大幅減少咳嗽的吸入器，一款無咳嗽吸入器，那真是太棒了。每天一次的超級前列環素，真是太神奇了。而且，這種 IPF 治療方法比 FDA 自 IPF 出現以來批准的任何 IPF 治療方法都要好。沒有比這更好的了。就像我說的，我們非常興奮，我認為 40 億美元的營收年化率，將標誌著營收曲線將更加急劇地向上彎曲。

Next question.

下一個問題。

Joseph Tomei, TD Cowen and Company.

Joseph Tomei，TD Cowen and Company。

Please go ahead with your question. Hi there, good morning. Thank you for taking my question and congrats on the progress. Maybe, given your excitement for Rolinapag, what are the most important outcomes that we should be looking at when we see those data? Is it on PBR, six-minute walk, time to worsening event? Kind of what do you think will resonate most with physicians in addition to the dosing benefit to drive adoption there?Thank you.

請繼續提問。您好，早安。感謝您回答我的問題，並祝賀您的進展。鑑於您對羅利那帕格的熱情，當我們看到這些數據時，我們應該關注哪些最重要的結果？是否在 PBR 範圍內，步行六分鐘，何時會出現病情惡化？除了劑量優勢之外，您認為還有哪些因素最能引起醫師的共鳴，進而推動其採用？謝謝。你。

Thank you. Yeah, we love these kind of scientific questions. Dr. Peterson, the head of product development, she has lived this trial for seven years because this trial started before COVID and persevered through COVID. So I don't think anybody knows the whole panorama of positive therapeutic benefits from this superprostacyclin than she does. Lee, if you could, you know, give kind of your stream of consciousness on what we can expect from this super-processed cyclin and what you think physicians will appreciate.

謝謝。是的，我們很喜歡這類科學問題。彼得森博士是產品開發負責人，她已經經歷了七年的試驗，因為這項試驗在新冠疫情之前就開始了，並在新冠疫情期間堅持了下來。所以我認為沒有人比她更了解這種超級前列環素的全部積極治療益處。李，如果你可以的話，請你暢所欲言地談談我們可以對這種超加工細胞週期蛋白抱有什麼樣的期待，以及你認為醫生們會欣賞它的哪些方面。

Yeah, sure, happy to. So, obviously, what Martin said is the most important with regard to this being a very, very potent drug. It binds the receptors, the IP receptor, very tightly and has a really long half-life. And so this translates to the once-a-day dosing and potentially more tolerability. So that's definitely a bonus. But also, we're looking to see the statistically significant and clinical meaningful benefit on top of that. in clinical worsening versus placebo. And as you all know from our other studies, as well as this one, clinical worsening is defined with specific parameters, and seeing a benefit in the number of hospitalizations as well as mortality would be a super advantage. No pun. A super fact to see in this product. So as Martin says, we are unblinding next week, and we are really, really looking forward to that and happy to put those results out there.

好的，當然可以，我很樂意。所以，很顯然，馬丁所說的才是最重要的，因為這是一種非常非常有效的藥物。它與受體（IP受體）結合非常緊密，且半衰期很長。因此，這意味著每天只需服用一次，而且可能具有更高的耐受性。所以這絕對是一個額外的好處。此外，我們還希望看到在統計學上顯著且具有臨床意義的益處，即在臨床惡化方面與安慰劑相比。正如大家從我們先前的研究以及這項研究中所了解的，臨床惡化是由特定的參數定義的，如果在住院人數和死亡率方面都能看到益處，那將是一個巨大的優勢。不開玩笑。這款產品的一個非常棒的特點。正如馬丁所說，我們下週將揭開盲法，我們非常非常期待，也很高興能把結果公佈出來。

Thank you so much, Leigh. Really appreciate it. Operator, I'm getting input that other people are being dropped on the call, so we can close the call at this time.

非常感謝你，莉。非常感謝。接線員，我收到訊息說其他人正在斷線，所以我們現在可以結束通話了。

Ladies and gentlemen, at this time, we will close today's conference call. We thank you for participating in today's United Therapeutics Corporation earnings webcast. A rebroadcast of this webcast will be available for replay for one week by visiting the events and presentation section of the United Therapeutics Investor Relations website at ir.unither.com. That's ir.unither.com. We thank you for joining. You may now disconnect your lines.

女士們、先生們，今天的電話會議到此結束。感謝您參加今天聯合治療公司（United Therapeutics Corporation）的財報網絡直播。本次網路直播的重播將在一週內提供，您可造訪United Therapeutics投資者關係網站ir.unither.com的「活動與演示」版塊觀看。網址是ir.unither.com。感謝您的參與。現在您可以斷開線路了。