United Therapeutics Corp (UTHR) 2025 Q3 法說會逐字稿

Good morning, everyone, and welcome to the United Therapeutics Corporation third quarter 2025 corporate update. My name is Jamie, and I will be your conference operator today. (Operator Instructions) Please also note today's event is being recorded.

各位早安，歡迎收聽聯合治療公司 2025 年第三季公司最新動態。我叫傑米，今天我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。

At this time, I'd like to turn the floor over to Harrison Silvers, Investor Relations Manager at United Therapeutics.

此時，我想把發言權交給聯合治療公司投資人關係經理哈里森‧西爾弗斯。

Thank you, Jamie. Good morning. It is my pleasure to welcome you to the United Therapeutics Corporation third quarter 2025 corporate update webcast.

謝謝你，傑米。早安.歡迎各位參加聯合治療公司 2025 年第三季企業最新動態網路直播。

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.

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 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 Xenotransplantation; 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 Benkowitz；財務長兼財務主管 James Edgemond；產品開發與異種移植執行副總裁 Leigh Peterson 博士；以及策略發展執行副總裁 Pat Poisson。

Note that Pat Poisson and I will participate in a fireside chat and one-on-one meetings at the UBS Global Healthcare Conference in Palm Beach on November 10. Additionally, James and I will be at the Jefferies Global Healthcare Conference in London on November 18 for a fireside chat and one-on-one meetings. And finally, Martine Rothblatt will present at the 44th Annual JPMorgan Healthcare Conference in San Francisco in January of next year.

請注意，我和 Pat Poisson 將於 11 月 10 日在棕櫚灘舉行的瑞銀全球醫療保健大會上參加爐邊談話和一對一會談。此外，我和詹姆斯將於 11 月 18 日在倫敦參加 Jefferies 全球醫療保健大會，屆時將舉行爐邊談話和一對一會談。最後，Martine Rothblatt 將於明年一月在舊金山舉行的第 44 屆摩根大通醫療保健年會上發表演講。

Our scientific, commercial and medical affairs teams will be present at PHenomenal Hope 2025 and on December 5 in Boston and at the Pulmonary Vascular Research Institute Annual Congress in Dublin in late January next year.

我們的科學、商業和醫療事務團隊將出席 2025 年 12 月 5 日在波士頓舉行的 PHenomenal Hope 大會，以及明年 1 月下旬在都柏林舉行的肺血管研究所年會。

Now I will turn the webcast over to Martine for an overview of our development pipeline and business activities. Martine?

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, and good morning, everyone. United Therapeutics had a great quarter, helping more patients and earning more revenues than ever before. In addition, this past quarter, our pipeline made more progress than ever before. We fully enrolled three Phase III trials, and we've shared the unblinded results for pulmonary fibrosis. In fact, the best results for that condition ever reported by anyone, anywhere, any time. We feel confident we'll be able to help tens (technical difficulty) of IPF patients live better lives.

謝謝你，哈里，大家早安。United Therapeutics 本季業績斐然，幫助了更多患者，並獲得了比以往任何時候都多的收入。此外，上個季度，我們的產品線取得了前所未有的進展。我們完成了三項 III 期試驗的全部受試者招募，並公佈了肺纖維化非盲試驗結果。事實上，這是迄今為止任何人、任何地方、任何時間所報告的針對該病症的最佳結果。我們有信心能夠幫助數十名（技術難度）特發性肺纖維化患者過上更好的生活。

United Therapeutics is a public benefit company, and I'm sometimes asked what exactly does that mean? Well, one thing that it means is to deploy the odds and invest millions of dollars over several years to develop a historically unmatched product portfolio for pulmonary fibrosis. Being a public benefit company means providing a framework of trust for patients, doctors, payers and employees. Being a public benefit company also means having shareholder interest as the hands on the helm.

United Therapeutics 是一家公益公司，我有時會被問到這到底是什麼意思？其中一項意義在於，要把握機遇，在未來幾年投入數百萬美元，開發出前所未有的肺纖維化產品組合。作為一家公益公司，意味著要為病人、醫生、付款人和員工提供一個信任的框架。作為一家公益公司，也意味著股東利益由公司掌舵。

For example, we've repurchased millions of our shares, including quite a few this quarter at a bargain price. For example, we are now guiding that we'll be at a $4 billion revenue run rate not later than 2027. And finally, I'll point out that we are actively engaged in all manner of business development.

例如，我們已經回購了數百萬股股票，其中不少是在本季以優惠價格回購的。例如，我們目前預計，最遲到 2027 年，我們的營收將達到 40 億美元。最後，我想指出，我們積極參與各種業務拓展活動。

In fact, I can predict the great companies such as Merck, J&J and Novartis with strong pulmonary disease franchises will be very keen to partner with us given our best-in-class data released for IPF this quarter with long-lived IP and also given the very near-term results of Ralinepag with its 2040 patent life. Indeed, I'd love to see a trial of Ralinepag, combined with [Winrevair] and I bet it would be super synergistic.

事實上，我可以預測，像默克、強生和諾華這樣在肺部疾病領域擁有強大實力的大公司，將會非常渴望與我們合作，因為我們本季度發布了針對特發性肺纖維化（IPF）的一流數據，並擁有長期有效的知識產權，而且Ralinepag的專利有效期至2040年，其近期業績也將非常可觀。確實，我很想看看 Ralinepag 與 [Winrevair] 的組合效果，我敢肯定它會產生超強的協同效應。

Let's now give Mike Benkowitz a chance of the microphone so he can give us a deep dive into our great and better than ever numbers this quarter. Michael?

現在讓我們把麥克風交給麥克·本科維茨，讓他深入分析我們本季比以往任何時候都更加出色的業績。麥可？

Thank you, Martine, and good morning, everyone. Today, we are pleased to report another quarter of record total revenues of $800 million, representing 7% growth from the third quarter of 2024. This quarter's performance was driven by continued year-over-year growth in total Tyvaso and Orenitram sales, reflecting patient demand and the resilience of our commercial strategy and execution. Continued double-digit revenue growth for total Tyvaso demonstrates that we are realizing no material impact from the launch of Yutrepia.

謝謝你，馬丁，大家早安。今天，我們很高興地宣布，本季總營收再次創下歷史新高，達到 8 億美元，比 2024 年第三季成長 7%。本季業績成長主要得益於 Tyvaso 和 Orenitram 總銷售額的持續同比成長，這反映了患者的需求以及我們商業策略和執行的韌性。Tyvaso 總營收持續兩位數成長，顯示 Yutrepia 的推出並未對我們產生實質影響。

Our continued revenue growth also reinforces our belief that competition drives additional disease awareness which in turn, increases the overall opportunity in the large addressable pulmonary hypertension market. We remain confident that Tyvaso DPI is the best positioned inhaled treprostinil product and can sustain long-term growth due to the convenience of our DPI device, its unlimited dosing potential, the thousands of prescribers and many thousands of patients who have experienced Tyvaso DPI since launch, and the fact that there are no payer incentives to prefer an alternative product.

我們持續的收入成長也強化了我們的信念，即競爭會提高人們對疾病的認識，進而增加在龐大的肺動脈高壓市場的整體機會。我們仍然相信，Tyvaso DPI 是目前市場上定位最好的吸入式曲前列尼爾產品，並且由於其 DPI 裝置的便利性、無限的劑量潛力、自上市以來成千上萬的處方醫生和成千上萬的患者體驗過 Tyvaso DPI，以及支付方沒有動機去選擇替代產品，因此能夠保持長期增長。

On dosing and convenience, our Tyvaso DPI platform is driving a meaningful shift in treprostinil dosing behavior. Historically, patients averaged 9 breadth per treatment using Nebulized Tyvaso delivery. With Tyvaso DPI that average has increased to a 12 breath equivalent or 64 micrograms. I'm pleased to announce that we will soon be launching Tyvaso DPI 80-microgram cartridges to provide added convenience for patients being treated at higher doses.

在劑量和便利性方面，我們的 Tyvaso DPI 平台正在推動曲前列尼爾給藥行為的重大轉變。從歷史資料來看，使用霧化Tyvaso治療的患者平均每次治療可達到9個呼吸道寬度。使用 Tyvaso DPI 後，該平均值增加到相當於 12 次呼吸或 64 微克。我很高興地宣布，我們很快就會推出 Tyvaso DPI 80 微克藥筒，為接受較高劑量治療的患者提供更多便利。

This new cartridge will allow patients to reach the equivalent of 15 nebulized breath with 1 single breath as compared to 4 breath for Yutrepia This is the highest dose ever delivered in 1 breath via 1 cartridge, offering a clear competitive edge and dosing flexibility and reinforcing the clinical and commercial value of higher dose treprostinil. This innovation positions us to provide greater patient benefit, capture greater market share and unlock new revenue potential in the growing pulmonary hypertension space.

與 Yutrepia 相比，這種新型藥筒可以讓患者透過一次吸入達到相當於 15 次霧化吸入的劑量，而 Yutrepia 則需要 4 次吸入。這是迄今為止透過單一藥筒一次吸入即可達到的最高劑量，提供了明顯的競爭優勢和劑量靈活性，並強化了高劑量曲前列尼爾的臨床和商業價值。這項創新使我們能夠為患者帶來更大的益處，獲得更大的市場份額，並在不斷增長的肺動脈高壓領域釋放新的收入潛力。

At the same time, we launched the 80-microgram cartridge, we will also be launching 96 and 112-microgram combination kits which we believe will facilitate access and affordability for patients requiring even higher doses of Tyvaso DPI. Our tolerability we're looking forward to sharing abstracts at the PVRI Annual Congress in January that compare a real-world data from United Therapeutics safety database to clinical trial evidence for Yutrepia's INSPIRE study. These analyses show, among other things, a lower incidence of costs in both Tyvaso and Tyvaso DPI.

同時，我們推出了 80 微克裝藥筒，我們還將推出 96 微克和 112 微克組合套裝，我們相信這將方便需要更高劑量 Tyvaso DPI 的患者獲得治療並降低治療費用。我們期待在 1 月的 PVRI 年度大會上分享摘要，比較來自 United Therapeutics 安全資料庫的真實世界數據與 Yutrepia 的 INSPIRE 研究的臨床試驗證據。這些分析表明，Tyvaso 和 Tyvaso DPI 的成本發生率較低。

Finally, on access, we have secured multiple favorable coverage decisions with major payers supporting a clear validation that Tyvaso DPI is well positioned in the marketplace. Our confidence in the growth profile of Tyvaso is further supported by the recent TETON 2 study which, as Martine said, demonstrated an unprecedented treatment of benefit for inhaled treprostinil in patients with idiopathic pulmonary fibrosis. We are excited about the TETON 2 data, which have the potential to significantly broaden our therapeutic reach into respiratory disease and further accelerate our growth.

最後，在市場准入方面，我們已與多家主要支付方達成有利的核保決定，這清楚地證明了 Tyvaso DPI 在市場上的良好地位。我們對 Tyvaso 的成長前景充滿信心，最近的 TETON 2 研究進一步證實了這一點。正如 Martine 所說，該研究證明了吸入曲前列尼爾對特發性肺纖維化患者俱有前所未有的治療益處。我們對 TETON 2 的數據感到非常興奮，這些數據有可能顯著擴大我們在呼吸系統疾病領域的治療範圍，並進一步加速我們的成長。

Lastly, turning to Remodulin. We're pleased to have launched our new RemunityPRO pump during the third quarter, which we designed based on feedback from health care providers and patients to enhance the overall experience of our parenteral therapy. Our RemunityPRO pump is small and discrete and features a user-friendly remote with guided instructions, automated priming and easy filling. Additionally, it's lower flow rates may enable more patients to initiate Remodulin therapy at home instead of requiring a hospital stay.

最後，我們來看看Remodulin。我們很高興在第三季推出了新的 RemunityPRO 泵，該泵是根據醫療保健提供者和患者的反饋設計的，旨在增強我們腸外治療的整體體驗。我們的 RemunityPRO 幫浦體積小巧、外觀隱蔽，配備使用者友善的遙控器，提供指導說明、自動啟動和輕鬆加註功能。此外，其較低的流速可能使更多患者能夠在家中開始接受 Remodulin 治療，而無需住院治療。

In closing, we are extremely proud of our team's steadfast dedication which has driven these remarkable innovations and results and enables us to offer critical therapies to our patients who rely on them. We are confident that our strong foundation positions us to maintain our momentum and continue delivering success for many years to come.

最後，我們為團隊堅定不移的奉獻精神感到無比自豪，正是這種奉獻精神推動了這些卓越的創新和成果，並使我們能夠為依賴這些療法的患者提供關鍵的治療方案。我們相信，我們強大的基礎將使我們能夠保持發展勢頭，並在未來多年繼續取得成功。

With that, I'll turn things back to Martine.

這樣，我就把話題轉回給馬丁了。

Michael that was an amazing overview. Thank you so much for sharing all that information and for all of your leadership. Operator, you may now open the lines to any questions.

邁克爾，你的概述太精彩了。非常感謝您分享這些訊息，也感謝您的領導。操作員，現在可以開始接受提問了。

(Operator Instructions)

（操作說明）

Lisa Walter, RBC.

Lisa Walter，RBC。

Great. And congrats on the quarter. I'm just curious, given the TETON 2 results in IPF, are you perhaps seeing an uptick in diagnosis of IPF patients with PH? And if so, do you think this could positively impact Tyvaso sales over the next few quarters? Any color here would be helpful.

偉大的。恭喜你本季業績出色。我只是好奇，鑑於 TETON 2 在 IPF 中的結果，您是否發現 IPF 患者合併肺動脈高壓的診斷數量增加？如果是這樣，您認為這會對泰瓦索未來幾季的銷售額產生正面影響嗎？這裡用任何顏色都會有幫助。

Thanks for the question, Lisa. I'm going to refer that to Michael. Under his overall leadership includes all of the different parts of UT that are interacting with physicians and patients, such as global medical affairs and our commercialization teams are regional nurse specialists. So Mike would have a lot of input on that. Michael?

謝謝你的提問，麗莎。我會把這件事轉交給麥可處理。在他的全面領導下，UT 的所有部門都與醫生和患者互動，例如全球醫療事務部和我們的商業化團隊以及區域護理專家。所以麥克在這方面會有很多發言權。麥可？

Sure. Thanks for the question. Yeah, it's an interesting question. It's actually one the opportunity to attend both the European Respiratory Society, where we unblinded the TETON 2 data as well as the CHEST Conference last week in Chicago. And it's actually -- every physician I talked to, I asked them that exact question, just trying to get a sense of whether that data would maybe create an incentive or prompt and to be more aggressive in screening for pulling hypertension in their IPF patients.

當然。謝謝你的提問。是的，這確實是個有趣的問題。實際上，這是一個難得的機會，可以同時參加歐洲呼吸學會（我們在那裡公佈了 TETON 2 數據）和上週在芝加哥舉行的 CHEST 會議。事實上，我問過的每一位醫生，我都問了他們這個問題，只是想了解這些數據是否會激勵他們更積極地篩選 IPF 患者的高血壓。

And so they all said, yes, yes. Whether that plays out yet. I think it's still too early because we only unblinded the data just a few weeks ago. So I can't point to an uptick directly towards that, directly towards the TETON 2 study. But it's certainly something, I think, that we're chatting with physicians about and monitoring very closely. So I think it's logical that this will play out over time. Whether it does, when it does, to what degree, I think, remains to be seen.

於是他們都說，是，是。事情最終會如何發展，目前還不得而知。我認為現在下結論還為時過早，因為我們幾週前才揭開數據的盲法。所以我不能直接指出成長是由 TETON 2 研究引起的。但我認為這肯定是我們正在與醫生討論並密切關注的事情。所以我認為隨著時間的推移，這件事會水落石出，這是合乎邏輯的。是否會發生、何時發生、發生到什麼程度，我認為還有待觀察。

Andreas Argyrides, Oppenheimer.

安德烈亞斯·阿吉里德斯，奧本海默。

Congrats on another solid quarter here. Martine, you mentioned in your remarks, Ralinepag and potential for combination. Can you just give us a sense of where you see the market opportunity for Ralinepag and expectations for advanced outcomes next year? Appreciate it.

恭喜你們又一個季度業績穩健。Martine，你在發言中提到了 Ralinepag 以及合併的可能性。您能否簡要介紹一下您對 Ralinepag 的市場機會的看法，以及您對明年取得的進展的預期？謝謝。

Sure. Absolutely. Ralinepag is just blowing the doors off of expectations in everywhere we look. It's, first of all, the enrollment of the outcomes trial, which is just not all just trial enrolled in pulmonary hypertension has gone extraordinarily well. And even the -- some of the open-label results have been announced by some doctors that for patients who have already exited the trial, and the 6-minute walk distances that are maintained even a year after these patients have left the trial are best-in-class, 6-minute walk distances.

當然。絕對地。Ralinepag 的表現簡直令人難以置信，無論從哪個角度來看都是如此。首先，肺動脈高壓試驗的結果招募工作進展得非常順利，這不僅僅是一項針對肺動脈高壓患者的試驗。甚至一些醫生宣布，一些開放標籤試驗的結果顯示，對於已經退出試驗的患者，即使在這些患者退出試驗一年後，他們仍然能夠保持 6 分鐘步行距離，這是同類最佳的 6 分鐘步行距離。

Then as I mentioned, the long patent life for Ralinepag is a very significant factor as well from a business standpoint. With the patent, I'm not on the expert on all the dates, but it's roughly 2040. So it has a very, very long patent life. As you know, it's a pill that you just take once a day. It seems to be the most potent prostacyclin type of drug that has been identified yet. So patients have an opportunity to just take 1 pill once a day and be able to get their pulmonary hypertension managed as well as it could be the case with any other prostacyclin type therapy.

正如我之前提到的，從商業角度來看，Ralinepag 的專利期限長也是一個非常重要的因素。關於專利，我雖然不是所有日期的專家，但大概是在 2040 年左右。所以它的專利保護期非常非常長。如你所知，這是一種每天只需服用一次的藥片。它似乎是目前已知的最有效的前列環素類藥物。因此，患者有機會每天只需服用 1 片藥，就能像使用任何其他前列環素類療法一樣有效地控制肺動脈高壓。

Now on top of all of that, we were very impressed with the synergy that was shown in the data released by Merck between sotatercept and treprostinil. And we've continued to see that synergy in the marketplace. Subsequent to the sotatercept launch, our sales have just continued to grow. So there seems to be like a really nice synergy between those 2 drugs. And if one could leverage that synergy with a once-a-day pill, wow, that would be like even better.

除此之外，默克公司公佈的數據也給我們留下了非常深刻的印象，數據顯示索他西普和曲前列尼爾之間存在著協同作用。我們在市場上持續看到了這種協同效應。自 sotatercept 上市以來，我們的銷售額持續成長。所以這兩種藥物之間似乎存在著很好的協同作用。如果能將這種協同作用轉化為每天一次的藥丸，哇，那就更好了。

In addition to that, it turns out to be a tremendous formulation flexibility with Ralinepag which opens up a number of opportunities that are more in our stealth catalog, things such as combination, oral treatment and so on. So well Ralinepag is -- while IPF is a disease is front and forward for us, as an NCE, our (technical difficulty) is our number 1 force.

除此之外，Ralinepag 還展現出極大的配方靈活性，這為我們提供了許多尚未公開的用途，例如組合療法、口服療法等等。所以 Ralinepag 非常好——雖然 IPF 對我們來說是一種需要優先解決的疾病，但作為 NCE，我們的（技術難題）是我們最大的優勢。

Next question, operator?

接線員，下一個問題是什麼？

Joseph Thome, TD Cowen.

Joseph Thome，TD Cowen。

Martine, in addition to that combination partnership potential, it sounds like you also mentioned some large pharma partnership related to -- or in light of the recent Tyvaso IPF data. So maybe if you could go a little bit more into maybe what you're thinking about there? What would an ideal kind of partner look like or partnership? And is this related to kind of European rights? Or just any additional clarity on that because that seemed like a little bit of an update from the prior quarter, obviously, given the recent data.

Martine，除了這種聯合合作的可能性之外，聽起來你還提到了一些與最近 Tyvaso IPF 數據相關的大型製藥公司合作。所以，您能不能再詳細說說您在想什麼？理想的合作夥伴或合作關係是什麼樣的？這和歐洲人權有關嗎？或者只是想進一步澄清一下，因為鑑於最近的數據，這顯然是對上一季情況的更新。

Yes. It was only -- it's so funny that you say that because before we release this data, I would say that I don't know, these are just heuristic numbers, but like 90% of people seems like they didn't really believe that our drug would work in pulmonary fibrosis, which seems odd to us. We have a computational biology lab, which has an extraordinary digital model of the lung and all of the key diseases that we focus on in the lung.

是的。只是——你說這話真有意思，因為在我們公佈這些數據之前，我會說，我不知道，這些只是經驗數字，但似乎有 90% 的人並不相信我們的藥物對肺纖維化有效，這讓我們覺得很奇怪。我們有一個計算生物學實驗室，其中擁有非凡的肺部數字模型，以及我們重點研究的所有肺部關鍵疾病。

We use a large learning model based on all of the previous studies that have been done in pulmonary fibrosis and pulmonary hypertension to develop this digital lung model. And then we are able to run new NCEs, new drugs through this model to get the results of standard endpoint measurements.

我們利用基於先前在肺纖維化和肺動脈高壓領域所做的所有研究的大型學習模型來開發這個數位肺模型。然後，我們可以透過這個模型運行新的NCE、新藥，以獲得標準終點測量的結果。

So for example, we ran the TETON 2 study the entire like 100 clinical trials modeled as the TETON 2 study, 100 clinical trials in 2 hours (technical difficulty). Compare that to the years and years that it takes like slugging around the world, enrolling these trials.

例如，我們執行了整個 TETON 2 研究，相當於模擬了 100 項臨床試驗，在 2 小時內完成了 100 項臨床試驗。（技術難題）相較之下，招募這些試驗參與者需要花費數年時間，奔波於世界各地。

And the results of that digital clinical trial were that by comparison to the roughly 95 millimeters improvement over baseline that we showed with the clinical trial we had estimated, our median estimate of these 100 trials was like 130 millimeters, which is fascinating because the difference between the digital trial and the physical trial, was closer than the effect size from the pirfenidone and [antennamide] trials.

這個數位臨床試驗的結果表明，與我們估計的臨床試驗中基線改善約 95 毫米相比，我們對這 100 次試驗的中位數估計約為 130 毫米，這令人著迷，因為數字試驗和物理試驗之間的差異比吡非尼酮和[antennaamide]試驗的效果大小更接近。

So what that tells you is that the digital trial very closely modeled the disease, like we know what we're doing here. And so I think that augers really, really well for some companies that might have been a bit skeptical about the antifibrotic effects of treprostinil in pulmonary fibrosis, kind of waking up and paying a little bit of attention.

這說明數位試驗非常接近地模擬了這種疾病，就像我們知道自己在做什麼一樣。所以我認為這對一些可能對曲前列尼爾在肺纖維化中的抗纖維化作用持懷疑態度的公司來說，是一個非常好的預兆，讓他們開始意識到這一點並給予一些關注。

Now United Therapeutics is very much of a United States company, it's not that we don't do things in other countries in the world, we do. In fact, the TETON 2 trial was enrolled throughout all of the rest of the world. But if you look at our financials, you'll see that the overwhelming portion of our revenues are derived from the United States. All of our medicines are manufactured in the United States. All of our devices for delivering our medicines are manufactured in the United States.

聯合治療公司現在是一家非常典型的美國公司，但這並不意味著我們不在世界其他國家開展業務，我們確實在其他國家開展業務。事實上，TETON 2 試驗的受試者遍布世界各地。但如果你查看我們的財務報表，你會發現我們絕大部分的收入都來自美國。我們所有的藥品都是在美國生產的。我們所有的給藥裝置均在美國製造。

So if there are partners in other parts of the world, that wanted to help bring the amazing benefits of Tyvaso to patients in those other parts of the world. I think that would be a good thing for everybody concerned. Thanks and great question.

因此，如果世界其他地區有合作夥伴，他們希望幫助將泰瓦索的驚人益處帶給世界其他地區的患者。我認為這對所有相關人員來說都是一件好事。謝謝，問得好。

Olivia Brayer, Cantor.

奧利維亞·布雷耶，坎托爾。

Can you talk through some of the commercial dynamics you're seeing for Tyvaso over these last few months and maybe even into October? Really, I'm curious whether most of the share gains for DPI are in PAH versus PH-ILD? And then I have to ask the obvious question, but whether you're seeing any competitive impacts in either indication or if you are, maybe it's made it weighted more towards one versus the other.

能否談談您在過去幾個月，甚至到十月份，觀察到的 Tyvaso 的一些商業動態？我很好奇，DPI 的大部分市佔率成長是否來自 PAH 而非 PH-ILD？然後我必須問一個顯而易見的問題，那就是你是否看到這兩種適應症之間存在任何競爭影響，或者如果存在，是否導致其中一種適應症比另一種適應症更具優勢。

And then sorry to sneak this in. But Martine, I did just want to ask for a quick point of clarification. You're now guiding to a $4 billion run rate by 2027, which I think is well ahead of where some numbers are today. Does that mean you expect to hit $1 billion in a quarter sometime in 2027, just to kind of clarify. And I assume that's in light of the very strong IPF results.

然後，很抱歉偷偷插。但馬丁，我只是想請教一個需要澄清的問題。你們現在預計到 2027 年年收入將達到 40 億美元，我認為這遠高於目前的一些預測數字。那是不是意味著你預計在 2027 年的某個季度達到 10 億美元的營收？我只是想確認一下。我推測這是基於非常強烈的IPF結果得出的結論。

Yeah. So we do expect to hit $1 billion in a quarter in 2027, and we're very happy for you poking around all the different lines and workflows of our revenue growth. So no problems there. And Michael will take it away on that question.

是的。因此，我們預計到 2027 年，季度營收將達到 10 億美元，我們很高興您能深入了解我們營收成長的各個面向和工作流程。所以這方面沒有問題。麥可將就這個問題發表看法。

Yes. So thanks for the question. So I think in terms of what we're seeing over the course of the third quarter and then even early into the fourth quarter, as I said, I think we're confident in that there's really no material impact from the launch of Yutrepia. And in fact, what we see, and we've seen this in the past with other competitors launches actually it really kind of grows the pie addressable patient population because you now have like another sales force out there talking about these diseases.

是的。感謝您的提問。所以我認為，就我們在第三季乃至第四季初期所看到的情況而言，正如我所說，我們有信心 Yutrepia 的推出不會產生實質影響。事實上，我們看到，而且我們過去也從其他競爭對手的產品發布中看到過這種情況，這實際上確實擴大了目標患者群體，因為現在又多了一支銷售隊伍在談論這些疾病。

So you've got doctors thinking about pulmonary (technical difficulty) hypertension Group 1 as well as PH-ILD in Group 3. And so that's a great thing for patients and then it's a great thing for the companies that are providing these drugs. And variably, what happens is I think we saw this even with the sotatercept launch, as Martine alluded to in her opening remarks, we continue to grow through that. And that's what we expect to happen here as we move into 2026 is continued growth in Tyvaso at both PAH and PH-ILD.

所以，醫生們正在考慮肺動脈高壓（技術難度）第 1 組以及肺動脈高壓-間質性肺病第 3 組。所以這對病人來說是件好事，對提供這些藥物的公司來說也是好事。而且，我認為我們在 Sotatercept 上市時也看到了這種情況，正如 Martine 在開場白中提到的那樣，我們繼續透過它實現成長。我們預計，隨著我們邁入 2026 年，Tyvaso 在 PAH 和 PH-ILD 領域將繼續成長。

And so when I look at really from let's say, beginning of September through halfway through October. And I think the things I look at, right, the underlying metrics, patient shipments, prescriber breadth and depth, referrals and starts. And I think on the patient shipments, super strong and really headed into October, like exceptionally strong so far, a couple of weeks in. Number of prescribers grew quarter-over-quarter, and we're still maintaining depth in those the three-plus writers, which is sort of our key metric on depth.

所以，當我真正觀察從九月初到十月中旬這段時間。而我認為我關注的是一些基本指標，例如病患出院量、處方醫師的廣度和深度、轉診量和啟動量。我覺得病人出貨量非常強勁，而且進入十月後，到目前為止，幾週以來都異常強勁。處方醫生的數量環比增長，而且我們仍然保持著三張以上處方醫生的深度，這可以說是我們衡量醫生深度的關鍵指標。

And then referrals and starts kind of bounced around a little bit in the quarter, but really, again, since September, a pretty consistent upward trend, and we're almost back at where we were for Yutrepia launch. So this is, I think, played out about like we expected. There has been some trialing with their products. We've had some patients transition. A lot of those have come back. And as I said in my mind, I think as we look out into 2026 and beyond, we think we're really positioned well for continued growth in both PAH and PH ILD.

然後，本季推薦量和啟動量略有波動，但實際上，自 9 月以來，一直保持著相當穩定的上升趨勢，我們幾乎回到了 Yutrepia 發佈時的水平。所以，我覺得事情的發展基本上跟我們預想的一樣。他們的產品已經進行了一些試驗。我們已經有一些患者轉院了。很多人已經回來了。正如我之前所說，我認為展望 2026 年及以後，我們已經為 PAH 和 PH ILD 的持續成長做好了充分準備。

Perfect, Michael. Thank you so much. Wow, that's a great covering of all 3 [associated] of that question.

完美，邁克爾。太感謝了。哇，這真是對這個問題的所有三個相關方面都回答得很好。

Roger Song, Jefferies.

Roger Song，傑富瑞集團。

Great. Congrats for the record quarter again. Quick ones, one is on the PPF. So just curious about the data timing on the enrollment. And then more interesting question could be the given the TETON 2 data, how is the [resue], should IPF any new updated thoughts from physicians and scientists regarding the MOA?

偉大的。再次恭喜你們創下季度業績新高。簡單問幾個問題，一個是關於PPF的。所以，我只是好奇報名資料的具體時間安排。那麼，更有趣的問題可能是，根據 TETON 2 數據，IPF 的結果如何？醫生和科學家對於作用機制有什麼新的更新想法嗎？

And then also quickly on IPF and the Phase II meeting, I believe you are having a meeting with the FDA around year-end. And then just curious about the potential outcome scenario, any upside case you can have earlier approval.

另外，關於特發性肺纖維化 (IPF) 和 II 期會議，我相信您將在年底前後與 FDA 舉行會議。然後，我只是好奇可能的結果狀況，有沒有什麼好的結果，例如可以事先獲得批准。

Okay. So that's a whole thinking stack of questions you got there. So basically, I'm going to refer all three of those questions, and hopefully, she's been taking notes to Dr. Peterson who would be the best person to opine in the [specification] on the enrollment progress with the PPF or maybe we could call it TETON 3 trial.

好的。所以你這裡有很多問題要思考。所以基本上，我要把這三個問題都轉交給彼得森博士，希望她已經把筆記記下來了，彼得森博士是就PPF（或者我們可以稱之為TETON 3試驗）的入組進展情況發表意見的最佳人選。

And then walk through the mechanism of action that's increasingly being understood as she's attended all of the major [Jeff] Pulmonary Respiratory conferences and she's talked with all of the major KOLs. She's also right in the loop on the major top tier -- top of the top tier type of pub reviewed publication that's about to come out, and there's a lot of interest in the MOA question there.

然後，她詳細闡述了隨著她參加所有主要的[Jeff]肺呼吸會議並與所有主要KOL交談，人們對這種作用機制的理解也越來越深入。她也對即將出版的頂級期刊——頂級期刊中的頂級期刊——瞭如指掌，而且該期刊對作用機制問題非常感興趣。

And then finally, she works very closely with our regulatory group and give you some insight on the kind of cadence of what we can expect in terms of filing. So Dr. Peterson, could you take all those questions away, and that will probably make you the last answer because that was a lot of questions.

最後，她與我們的監管團隊密切合作，並向我們介紹了我們在文件提交方面可以預期的節奏。所以彼得森博士，您能回答所有這些問題嗎？這可能意味著您將是最後一個回答這個問題的人，因為問題真的很多。

Thank you. Yes, I did take notes. For regarding TETON PPF, we're about halfway through enrollment a little bit more. And that study in design, as you well know, is very similar to those for the TETON 1 and TETON 2 in that there's a 52-week follow-up period. And so again, we can't really speak in detail about when we would expect unblinding, but that gives you an idea. And you all know that, that's being run in basically US, Canada as well as rest of the world.

謝謝。是的，我做了筆記。關於 TETON PPF 項目，我們的招生工作已經進行到一半左右了。如您所知，這項研究的設計與 TETON 1 和 TETON 2 非常相似，都採用了 52 週的追蹤期。所以，我們無法詳細說明何時可以解除盲化，但這可以給你一個大致的概念。你們都知道，這種情況基本上在美國、加拿大以及世界其他地區都在發生。

So and again, most importantly, really, based on the similarities of the underlying fibrosis and disease progression between IPF and PPF, we -- I mean, these results suggest that inhaled treprostinil would potentially offer a treatment option for these patients with PPF.

所以，最重要的是，基於 IPF 和 PPF 之間潛在的纖維化和疾病進展的相似性，我們——我的意思是，這些結果表明吸入曲前列尼爾可能為這些 PPF 患者提供一種治療選擇。

With regard to the mechanism of action, the specific mechanism of action, again, with the similarities in the underlying fibrosis and as we've discussed, the both the in vitro results, the preclinical results demonstrating an antifibrotic effect of treprostinil as its as it works through the various receptors, the [IP receptor 2 DP] all of that, in addition to having a vasodilation effect. We expect that to play out in both of these indications.

關於作用機制，具體作用機制，同樣，鑑於潛在的纖維化具有相似性，正如我們所討論的，體外結果和臨床前結果都表明曲前列尼爾具有抗纖維化作用，因為它通過各種受體發揮作用，包括[IP受體2DP]，此外還具有血管舒張作用。我們預計這兩項指標都會反映出這一點。

And as far as the regulatory path, so we had agreed with FDA that we will -- we're using both the data from TETON 2 and TETON 1, and you all know that we are expected to have the TETON 1 results report those at the first half of 2026. And -- so in fact, we are meeting with the FDA before the end of this year and to discuss ways to potentially expedite that regulatory review process when the TETON 1 results are available. So all of that is really positive, really, really exciting and definitely pointing in the right direction of consistent results among these various TETON trials.

至於監管途徑，我們已經與 FDA 達成一致，我們將使用 TETON 2 和 TETON 1 的數據，大家都知道，我們預計將在 2026 年上半年公佈 TETON 1 的結果。因此，事實上，我們將在今年年底前與 FDA 會面，討論在 TETON 1 結果公佈後，如何加快監管審查流程。所以所有這些都非常積極，非常令人興奮，並且肯定朝著正確的方向發展，在這些不同的 TETON 試驗中取得一致的結果。

Thank you so much, Dr. Peterson. Great responses, and you collapse them. So elegantly that we have time for one last question, operator.

非常感謝您，彼得森博士。回覆很棒，但你卻把它們合併了。如此優雅，我們還有時間問最後一個問題，操作員。

Roanna Ruiz, Leerink.

羅安娜·魯伊斯，利林克。

So I wanted to ask about the 80-microgram cartridge for DPI. Could you give a little bit more color on the launch plans for that? Any strategies to drive more durable patient use possible switching from the prior cartridge, et cetera?

所以我想問一下關於DPI的80微克墨盒的情況。能否詳細介紹一下該產品的發布計畫？是否有任何策略可以提高患者使用新藥盒的持久性，例如從先前的藥盒更換到新藥盒等等？

Sure. Let me turn that question initially and perhaps comprehensively to Pat Poisson, who's our Executive Vice President for technical operations and has been key in the design of that incredible Tyvaso product from the very beginning. Pat?

當然。首先，我想把這個問題，或許也應該更全面地，交給我們的技術營運執行副總裁 Pat Poisson 來回答。從一開始，他就在 Tyvaso 這款令人驚嘆的產品的設計中發揮了關鍵作用。拍？

Yes, happy to. Thanks, Martine. I didn't catch the whole question. Could you just repeat it for me just to make sure I answer it correctly?

是的，我很樂意。謝謝你，馬丁。我沒聽清楚問題的全部內容。您能再重複一遍嗎？這樣我就能確保回答正確了。

Sure. So for the new 80-microgram cartridge, just curious about launch plans for that strategies to drive patient use switching, et cetera.

當然。所以對於新的 80 微克藥筒，我很好奇該藥筒的上市計劃，以及推動患者改用其他藥物的策略等等。

Sure. So with DPI, we've seen patients able to titrate higher. And really for their convenience, we've developed this 80-microgram cartridge to allow them to take 15 breaths in 1 single dose. So that will be added convenience where as to get there before they had to combine 2 cartridges. So we're anticipating launching that very soon, certainly in the next, say, 30 to 60 days that will be out there. And so we're really just looking to add convenience and easier dosing for patients.

當然。因此，使用 DPI 的患者能夠逐漸增加劑量。為了方便他們使用，我們開發了這款 80 微克裝的藥盒，讓他們一次服用即可吸入 15 次。這樣就方便多了，以前他們需要合併兩個墨水匣才能達到目的。所以我們預計很快就會推出，肯定會在接下來的30到60天內推出。因此，我們真正想要做的只是為患者增加便利性和更簡單的用藥方式。

Excellent. Pat, thank you so much. I'm going to wrap up the call now. We've reached our a lot of time, but I want to thank everybody for the congratulations that they've offered us on this best quarter that we've ever had, commercially, clinically, really across the board.

出色的。帕特，非常感謝你。我這就結束通話。我們已經花了很多時間，但我還是要感謝大家對我們這個季度取得的商業、臨床等各方面成績最好的一個季度的祝賀。

We're super excited about the UT product portfolio, [just also] there's some newbies on the call, just to remember, that the opportunity in pulmonary fibrosis is more than twice the size of the opportunity in pulmonary hypertension, and we're still continuing to go and grow like gangbusters in pulmonary hypertension itself. So it's truly best of times at United Therapeutics. Thank you for your interest. And operator, you can wrap up the call.

我們對 UT 產品組合感到非常興奮，[另外]電話會議上也有一些新人，需要記住的是，肺纖維化領域的機會是肺動脈高壓領域的兩倍多，而且我們在肺動脈高壓領域本身也仍在快速發展。所以，現在正是聯合治療公司最好的時代。感謝您的關注。接線員，您可以結束通話了。

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 Presentations section of the United Therapeutics Investor Relations website at ir.unither.com. again, that's ir.unither.com.

感謝您參加今天聯合治療公司財報網路直播。本次網路直播的重播將在一周內提供，您可以透過造訪 United Therapeutics 投資者關係網站 ir.unither.com 的「活動與演示」部分進行回放。再次強調，網址是 ir.unither.com。

We thank you for participating. You may now disconnect your lines.

感謝您的參與。現在您可以斷開線路了。