United Therapeutics Corp (UTHR) 2025 Q1 法說會逐字稿

Good morning and welcome to the United Therapeutics Corporation first quarter 2025 corporate update. My name is Tobin and I will be your conference operator today. (Operator Instructions) Please note, this call is being recorded.

早安，歡迎收看聯合治療公司 2025 年第一季公司更新報告。我叫托賓，今天我將擔任您的會議主持人。（操作員指示）請注意，此通話正在錄音。

I would now like to turn the webcast over to Dewey Steadman, Head of Investor Relations at United Therapeutics. Please go ahead.

現在，我想將網路直播交給聯合治療公司投資者關係主管杜威·斯特德曼 (Dewey Steadman)。請繼續。

Thank you, Tobin, and good morning. It is my pleasure to welcome you to the United Therapeutics Corporation first quarter 2025 corporate update webcast. Remarks today will include forward-looking statements representing our expectations or beliefs regarding future events.

謝謝你，托賓，早安。我很高興歡迎您參加聯合治療公司 2025 年第一季公司更新網路廣播。今天的評論將包括前瞻性陳述，代表我們對未來事件的期望或信念。

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, and we assume no obligation to update these forward-looking statements.

這些聲明涉及風險和不確定性，可能導致實際結果大不相同。我們最新的 SEC 文件（包括 10-K 表和 10-Q 表）包含有關這些風險和不確定性的更多信息，我們不承擔更新這些前瞻性陳述的義務。

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 those products are available on our website.

今天的演講可能會討論臨床試驗的進展和結果或我們產品的其他發展。這些評論僅用於教育投資者，並不旨在作為醫療決策的依據或暗示任何產品對於任何未經批准或研究用途都是安全有效的。這些產品的完整處方資訊可在我們的網站上找到。

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; and Dr. Leigh Peterson, our Executive Vice President of Product Development and Xenotransplantation; and Pat Poisson, our Executive Vice President of Technical Operations. Our scientific commercial medical affairs team will present at the American Thoracic Society International Conference in San Francisco from May 16 to the 21.

陪同我參加今天電話會議的有我們的董事長兼執行長 Martine Rothblatt 博士；我們的總裁兼營運長 Michael Benkowitz； James Edgemond，我們的財務長兼財務主管；以及我們的產品開發和異種移植執行副總裁 Leigh Peterson 博士；以及我們的技術營運執行副總裁 Pat Poisson。我們的科學商業醫療事務團隊將於 5 月 16 日至 21 日在舊金山舉行的美國胸腔科學會國際會議上發表演講。

And now I will turn the webcast over for Martine for an overview of our development plan and business activities. Martine?

現在，我將把網路廣播交給 Martine，讓她概述我們的發展計畫和業務活動。馬丁？

Thank you, Dewey, and good morning, everyone. We have slides available for reference and I encourage you to review those at your leisure. However, Mike and I will not speak directly to the slides. How often can the CEO report to their investors and stakeholders that we've had a record revenue quarter for United Therapeutics, it has been 9 quarters out of the past 12. That reflects on the strong execution of our long-term vision to be a biotech leader with a relentless drive to deliver to patients with rare and underserved diseases, a broad array of solutions to help improve their lives.

謝謝你，杜威，大家早安。我們有投影片可供參考，我鼓勵您在閒暇時查看這些投影片。不過，麥克和我不會直接對著幻燈片講話。執行長多久會向投資者和利害關係人報告一次聯合治療公司創下了創紀錄的收入季度？在過去的 12 個季度中，已經有 9 個季度創下了創紀錄的收入。這體現了我們作為生物技術領導者的長期願景的強有力執行，我們堅持不懈地為患有罕見疾病和服務不足的疾病的患者提供廣泛的解決方案，以幫助改善他們的生活。

Our solid foundation built by Tyvaso, Orenitram, Remodulin and Unituxin continues to grow revenue by double digits now for 11 quarters in a row, we expect this momentum to continue, led by Tyvaso and Tyvaso DPI with continued solid performance by our other commercial products.

Tyvaso、Orenitram、Remodulin 和 Unituxin 為我們奠定了堅實的基礎，使我們的收入連續 11 個季度保持兩位數增長，我們預計這一勢頭將持續下去，由 Tyvaso 和 Tyvaso DPI 引領，我們的其他商業產品也將繼續保持穩健的表現。

Moving to our innovation and revolution waves. We believe our record revenue performance can continue for the foreseeable future as we have entered a sustained period of clinical and regulatory events poised to propel our business forward.

走向我們的創新和革命浪潮。我們相信，我們的創紀錄收入表現可以在可預見的未來持續下去，因為我們已經進入了持續的臨床和監管活動時期，並有望推動我們的業務向前發展。

We continue to grow our pipeline with five registration phase studies underway, a pending marketing application at the FDA and several new preclinical candidates including three xeno organs that should be ready for clinical trials within a year.

我們繼續擴大我們的產品線，目前有五個註冊階段研究正在進行中，一項行銷申請正在 FDA 等待審理，還有幾個新的臨床前候選產品，包括三種異種器官，應該可以在一年內準備好進行臨床試驗。

We also have other exciting innovations we will share later, and we expect we'll keep our product portfolio innovating for years to come. We're planning for the first transplant in our UKidney clinical study, which we're calling the EXPAND study in the middle of this year, this will be followed by investigational new drug applications for the EXTEND study, evaluating the UThymoKidney and the EXPRESS study evaluating the UHeart. Both of those INDs are expected to be submitted within the next year.

我們還有其他令人興奮的創新，稍後會分享，我們預計未來幾年我們的產品組合將繼續創新。我們計劃在今年年中在英國腎臟臨床研究中進行首次移植手術，我們將其稱為 EXPAND 研究，隨後將進行 EXTEND 研究的新藥研究申請，以評估 UThymoKidney 和評估 UHeart 的 EXPRESS 研究。預計這兩項 IND 都將在明年內提交。

We recently received positive feedback from the FDA on our UThymoKidney program that gives us confidence to file INDs for both the UThymoKidney and UHeart without conducting additional baboon clinical studies.

我們最近收到了 FDA 對我們的 UThymoKidney 計劃的積極反饋，這使我們有信心為 UThymoKidney 和 UHeart 提交 IND，而無需進行額外的狒狒臨床研究。

What makes United Therapeutics unlike any other biotech is that we've been able to accomplish this massive business growth and unparalleled pipeline productivity while maintaining strict financial discipline. We never spend more than 50% of prior year revenue on cash operating expenses. And as a result, we have an industry-leading productivity per employee. And more than $1 billion in annual operating cash flow, and we're deploying our capital thoughtfully and strategically to provide for a sustainable business in the years to come.

聯合治療公司與其他生技公司的不同之處在於，我們能夠在保持嚴格的財務紀律的同時實現如此巨大的業務成長和無與倫比的管道生產力。我們用於現金營運費用的金額絕不會超過上一年收入的 50%。因此，我們的每位員工的生產效率處於行業領先地位。每年的營運現金流超過 10 億美元，我們正在深思熟慮和策略性地部署我們的資本，以確保未來幾年業務的可持續發展。

In the past six quarters, we have touched on all three areas of our capital allocation philosophy across both our commercial and development portfolios. We've invested in CapEx to support our new Tyvaso DPI manufacturing facility and acquired additional real estate to support future commercial manufacturing needs. We also commissioned the world's first clinical scale designated pathogen-free facility in Virginia and plan to complete two others in short order.

在過去的六個季度中，我們在商業和開發投資組合中觸及了資本配置概念的所有三個領域。我們已投資資本支出來支持我們新的 Tyvaso DPI 製造工廠，並收購了額外的房地產來支持未來的商業製造需求。我們還在維吉尼亞州建立了世界上第一個臨床規模指定無病原體設施，並計劃在短期內完成另外兩個設施。

On corporate development, we acquired IVIVA and Miromatrix to enhance our organ alternative development expertise, and we've licensed in new technologies to support our small molecule business. And with all this, we still returned $1 billion to you, our shareholders, through an accelerated share repurchase program last year that was universally well received. We will continue to evaluate all three core areas of our capital allocation philosophy on an ongoing basis. And we plan to pursue multiple avenues of capital allocation in the future.

在企業發展方面，我們收購了 IVIVA 和 Miromatrix，以增強我們的器官替代開發專業知識，並且我們獲得了新技術的許可來支援我們的小分子業務。儘管如此，去年我們仍然透過受到普遍好評的加速股票回購計畫向我們的股東返還了 10 億美元。我們將繼續持續評估我們的資本配置理念的所有三個核心領域。我們計劃在未來尋求多種資本配置途徑。

Our commercial business is extremely strong and growing. That along with five registration studies underway, several important data reads in the next 18 months and revolutionary progress on revolutionary organ programs makes United Therapeutics, a truly unique and compelling story, and I thank you, our stakeholders and shareholders for joining us on this journey. We're only just beginning.

我們的商業業務極為強勁且不斷成長。加上正在進行的五項註冊研究、未來 18 個月的幾項重要數據讀取以及革命性器官計劃的革命性進展，使得聯合治療公司成為一個真正獨特且引人注目的故事，我感謝我們的利益相關者和股東與我們一起踏上這段旅程。我們才剛開始。

And with that, I'll now turn the call over to our President, Mike Benkowitz, who will give an overview of our spectacular commercial performance for the quarter. Mike?

現在，我將把電話轉給我們的總裁 Mike Benkowitz，他將概述我們本季出色的商業表現。麥克風？

Thank you, Martine, and good morning, everyone. Today, we are pleased to report a strong start to the year with another quarter of record revenue at $794 million, representing 17% growth from the first quarter of 2024 driven by robust results for each of our treprostinil products.

謝謝你，馬丁，大家早安。今天，我們很高興地報告今年開局強勁，本季營收再創紀錄，達到 7.94 億美元，較 2024 年第一季度增長 17%，這得益於我們每種曲前列尼爾產品的強勁業績。

This quarter's performance is reflective of consistent patient demand, where we continue to see very strong referrals, starts and patient shipments for all of our treprostinil products, Tyvaso, both DPI and nebulizer, Orenitram and Remodulin as well as Unituxin.

本季的表現反映了患者的一致需求，我們繼續看到所有曲前列尼爾產品、Tyvaso（DPI 和霧化器）、Orenitram 和 Remodulin 以及 Unituxin 的轉診、開機和患者出貨量都非常強勁。

We continue to see growth in the number of treprostinil prescribers and increases in the depth of prescribing within practices as measured by riders with three or more patients. Overall, we believe these results demonstrate that treprostinil continues to be an important part of the treatment armamentarium for pulmonary hypertension, even with new therapies reaching the market.

我們持續看到曲前列尼爾處方數量的增長以及診所內處方深度的增加（以三名或更多患者的附加條款來衡量）。總體而言，我們相信這些結果表明，即使有新的療法進入市場，曲前列尼爾仍然是肺動脈高壓治療藥物的重要組成部分。

Building on Martine's comments, we remain confident that Tyvaso DPI is positioned for sustained growth over the long term due to the convenience of the device, its unlimited dosing potential the thousands of prescribers and many, many thousands of patients experience with the product since launch as well as the fact that there are no payer incentives to prefer an alternative.

基於 Martine 的評論，我們仍然相信 Tyvaso DPI 將實現長期持續增長，因為該設備非常方便，其無限的劑量潛力、自推出以來成千上萬的處方醫生和成千上萬的患者對該產品的體驗，以及沒有付款人激勵措施來選擇替代品。

Moreover, if positive, the TETON data in idiopathic pulmonary fibrosis, which is expected soon, could shift Tyvaso use into a much larger market, where we will have orphan drug exclusivity and rapidly position Tyvaso for continued long-term growth.

此外，如果特發性肺纖維化的 TETON 數據呈陽性（預計很快就會公佈），則可能將 Tyvaso 的使用推向更大的市場，我們將在該市場中擁有孤兒藥專營權，並迅速使 Tyvaso 處於長期持續增長的有利位置。

To wrap up, we couldn't be prouder of the unwavering effort of our dedicated team to deliver this outstanding performance and to provide therapies to our patients in need. And we believe that we are set up well to continue to execute throughout the remainder of the year and beyond.

總而言之，我們為我們敬業的團隊的不懈努力感到無比自豪，他們表現出色，為有需要的患者提供治療。我們相信，我們已經做好了充分的準備，可以在今年剩餘時間及以後繼續執行。

With that, I'll turn things back to Martine to run the Q&A session.

說完這些，我會把事情交還給 Martine 來主持問答環節。

Thank you so much, Mike. That's an amazing report. Operator, can we have the first caller, please?

非常感謝，麥克。這是一份令人驚奇的報告。接線員，請問我們可以接聽第一個來電嗎？

(Operator Instructions)

（操作員指示）

Joseph Thome, TD Cowen.

約瑟夫·托米（Joseph Thome），考恩（Cowen）TD。

Hi there, good morning. Congrats on the quarter and thank you for taking my question. Maybe will the UThymoKidney program enrol the same target population of the 10-gene kidney program. And we saw the great progress, obviously, with Ms. Looney but then I did see that she did have to be explanted. So maybe if you could talk a little bit about what you learned from that experience and how you might apply that to the upcoming trial. That would be great. Thank you.

大家好，早安。恭喜本季取得佳績，感謝您回答我的問題。也許 UThymoKidney 計劃會招募與 10 基因腎臟計劃相同的目標人群。顯然，我們看到了 Looney 女士的巨大進步，但後來我確實看到她必須進行移植。所以也許您可以談談您從那次經歷中學到了什麼以及如何將其應用到即將到來的審判中。那太好了。謝謝。

Sure. Thank you for your question, Joe, and thank you for the congrats. I'm going to assign that question to Dr. Leigh Peterson. She's in charge of all of our xenotransplantation activities.

當然。謝謝你的提問，喬，也謝謝你的祝賀。我將把這個問題交給 Leigh Peterson 博士。她負責我們所有的異種移植活動。

Yeah, hi, thanks for the call. And yes, what we haven't completed our clinical protocol for our UThymoKidney study yet. But yes, we do plan on enrolling a very similar, if not identical patient population into that study as what we're enrolling into the 10-gene xenokidney study. And yeah, we learned an incredible amount. We're very, very grateful for Ms. Looney participation through the IND conducted by NYU.

是的，你好，謝謝你的來電。是的，我們還沒有完成 UThymoKidney 研究的臨床方案。但是的，我們確實計劃在該研究中招募與我們參與 10 基因異種腎臟研究的患者群體非常相似（如果不是完全相同）的患者群體。是的，我們學到了很多。我們非常非常感謝 Looney 女士透過紐約大學開展的 IND 參與。

And we learned a lot. We learned a little bit more about tweaking the immunosuppression, which is a little bit different than what's commonly done in auto transplantation. And we're looking forward to applying all of the learnings with regard to the immunosuppression and follow-up that we learned with her.

我們學到了很多。我們對調整免疫抑制有了更多的了解，這與自體移植中常用的方法略有不同。我們期待將從她身上學到的有關免疫抑制和後續治療的所有知識應用到實踐中。

So again, we're really, really grateful we consider it definitely a positive experience, and it's unfortunate that she did have the unrelated infection that required us to have to reduce the amount of immunosuppression that she was on, which ultimately resulted in rejection. But again, it was an unrelated infection. And so learning how to manage that without having to reduce the immunosuppression quite as much is going to be key in the study.

所以，我們真的非常感激，我們認為這絕對是一次積極的經歷，不幸的是，她確實患有不相關的感染，這需要我們減少她所服用的免疫抑制劑量，最終導致了排斥。但同樣，這是一種無關的感染。因此，學習如何在不大幅減少免疫抑制的情況下控制這種情況將成為研究的關鍵。

Thank you so much, Dr. Peterson. For all of that great color on the progress that we're making both with the 10-gene kidney and with the UThymoKidney and the -- and as we are now referring to the trials as the EXPAND trial for the 10-gene kidney, which is now enrolling. Thank you very much.

非常感謝您，彼得森博士。我們在 10 基因腎臟和 UThymoKidney 方面取得的巨大進展令人矚目——我們現在將這些試驗稱為 10 基因腎臟的 EXPAND 試驗，該試驗目前正在招募患者。非常感謝。

Operator, we're ready for the next question.

接線員，我們準備好回答下一個問題了。

Jessica Fye, JP Morgan.

傑西卡費伊 (Jessica Fye)，摩根大通 (JP Morgan)。

Hey guys, good morning. Congrats on the strong quarter. I was wondering if you could elaborate for Tyvaso on kind of the magnitude of year over year contribution to sales from the continued implementation of the Part D redesign, I think you guys had previously said that was kind of mostly realized in '24. So I'm just curious to the extent to which you're seeing that benefit again this year as the out-of-pocket cap is further reduced.

大家好，早安。恭喜本季業績強勁。我想知道您是否可以向 Tyvaso 詳細說明繼續實施 D 部分重新設計對銷售額的逐年貢獻程度，我想你們之前曾說過，這在 24 年基本上已經實現。因此，我只是好奇，隨著自付上限進一步降低，今年您在多大程度上會再次看到這種好處。

Yeah, thank you so much for that question. It's so nice to hear your voice this morning. if it's okay with you, I think the best person to address that question would be Michael Benkowitz. Mike?

是的，非常感謝您的提問。今天早上聽到你的聲音真是太好了。如果您同意的話，我認為最適合回答這個問題的人是 Michael Benkowitz。麥克風？

Yeah. Thanks, Martine. Thanks, Jess, for the question. Yeah, so I think if you're looking year over year, so Q1 of this year to Q1 last year, I mean there's obviously a benefit, right? And I think we've talked about in the last quarter, we saw a step down in Q1 last year, continue to kind of step down into Q2 and Q3 and then kind of flatten out over the balance of the year.

是的。謝謝，馬丁。謝謝傑西提出這個問題。是的，所以我認為如果你逐年觀察，那麼今年第一季與去年第一季相比，顯然是有好處的，對吧？我想我們已經討論過上個季度的情況，我們看到去年第一季出現了下滑，在第二季和第三季繼續下滑，然後在全年餘額中趨於平穩。

If I look at Q1 versus Q4, I would say like a modest benefit, but then I think you also have to kind of count on the flip side of that is with the manufacturers having to start to pick up part of catastrophic on the back end of the Part D redesign, we had some obligations there.

如果我看第一季與第四季度，我會說這是一個適度的好處，但我認為你還必須考慮到另一面，那就是製造商必須在 D 部分重新設計的後端開始承擔部分災難性損失，我們在那裡承擔了一些義務。

Obviously, it was less because we have the phase in. So I think -- I mean I haven't looked at the math to see if those exactly canceled each other out, but I think, by and large, they probably do. So I think any benefit is really, I think, very, very modest when looking at the results this quarter.

顯然，由於我們已經進入這個階段，所以數量較少。所以我認為——我的意思是我還沒有通過數學計算來看看它們是否完全相互抵消，但我認為，總的來說，它們可能確實相互抵消了。因此，我認為從本季的業績來看，任何好處實際上都是非常非常微薄的。

Great answer, Mike. Fully nailed it, and that queue us up for our next questioner. Operator, you can open up the line.

回答得非常好，麥克。完全搞定了，然後我們就等待下一個提問者了。接線員，您可以開通線路了。

Roanna Ruiz, Leerink Partners

Roanna Ruiz，Leerink Partners

Great, good morning, everyone. So I was going to ask about Tyvaso DPI revenue growth specifically in 1Q. Could you help us understand just the general split of prescriber and patient demand driving growth versus a little bit of price increase? And are there any gross to net impacts that we should think about for the product in 1Q or going forward?

太好了，大家早安。所以我想問 Tyvaso DPI 在第一季的營收成長情況。您能否幫助我們了解推動成長的處方者和病患需求與價格小幅上漲的整體差異？我們是否應該考慮該產品在第一季或未來的總影響和淨影響？

Yeah. Thanks, Roanna. Michael, again, would be totally on top of all of those numbers. So Mike, can you take that call?

是的。謝謝，羅安娜。邁克爾再次完全掌控了所有這些數字。那麼麥克，你能接聽這通電話嗎？

Sure. Yeah. So I think in terms of split between DPI and nebulizer, I think it's settled in at about two-thirds, one-third in terms of new patient starts. We haven't really seen much variability from that really for several quarters now. So I think that mix persists and it's great that we have both options, right, because they're just have to be patients that tolerate and nebulize are better than they do a powder. And so we have an option for both patients. So that's, I think, really great that we're able to provide those options to the patients.

當然。是的。因此，我認為就 DPI 和霧化器之間的分配而言，我認為它已穩定在約三分之二，就新患者開始而言則為三分之一。幾個季度以來，我們並沒有真正看到太大的變化。所以我認為這種混合仍然存在，而且我們有兩種選擇，這很好，對吧，因為他們必須是能夠耐受霧化的患者，而且霧化效果比粉末更好。因此，我們為兩位患者都提供了一個選擇。所以，我認為我們能夠為患者提供這些選擇真是太好了。

We did do a price increase at the beginning of the year on both products. I think it was the same amount for both and in line with what we typically have done in the past. And then on the gross to net question, as we said on the call a couple of months ago, that largely played out the fourth quarter. But for the additional, I think it's 1% obligation we have under the Part D redesign of the IRA that I mentioned in the answer to Jess's question, really no additional impact there that we observed in Q1.

我們確實在年初對這兩種產品進行了提價。我認為兩者的金額是相同的，並且與我們過去通常的做法一致。關於毛利率與淨利率的問題，正如我們幾個月前在電話會議上所說的那樣，這個問題主要在第四季出現。但對於額外的，我認為這是我們根據 IRA D 部分重新設計所承擔的 1% 的義務，正如我在回答 Jess 的問題時所提到的，實際上我們在第一季度沒有觀察到額外的影響。

Perfect. Thank you so much, Michael. Operator, next question.

完美的。非常感謝，麥可。接線員，下一個問題。

Andreas Argyrides, Oppenheimer.

安德烈亞斯·阿吉里德斯，奧本海默。

Good morning and thanks for taking our questions. Let me also extend my congrats on a fantastic quarter. Martine, you alluded to capital allocation consideration in your opening remarks and I think last time we left James out on the earnings call. So I wanted to make sure you get the question here.

早安，感謝您回答我們的問題。我還要對本季取得的優異成績表示祝賀。馬丁，您在開場白中提到了資本配置考慮，我想上次我們在收益電話會議上沒有提到詹姆斯。所以我想確保你明白我的問題。

But a successful share repurchase that was taking place last year, you have $5 billion in cash. There are a lot of things that are going on in the PAH space on the competitive landscape perspective. How do you consider deploying capital days where you can elaborate deploying capital either in terms of acquisitions to grow the business that way or -- and also what are some of your thoughts around a repurchase going into a pretty significant catalyst from IPF and TETON.

但由於去年成功進行了股票回購，所以你擁有 50 億美元現金。從競爭格局的角度來看，PAH 領域正在發生很多事情。您如何考慮部署資本日，您可以詳細說明如何部署資本，無論是透過收購來發展業務，還是 - 以及您對回購的一些看法，這對於 IPF 和 TETON 來說是一個相當重要的催化劑。

Sure. Thanks for the question, Andreas, I'm going to refer the capital allocation, the bulk of the capital allocation question to James. And just giving him a few seconds here while I respond to one of the questions that you sliced in there about internal R&D and the competitiveness of the PAH space and whatnot.

當然。謝謝你的提問，安德烈亞斯，我將把資本配置，大部分資本配置問題提交給詹姆斯。我現在給他幾秒鐘時間，來回答您提出的一個問題，關於內部研發、PAH 領域的競爭力等等。

So we do, as I mentioned in my introductory remarks, we spend about 50% of cash on various forms of internal R&D as well as SG&A, of course. And a big part of that spending is, in fact, allocated to our core competencies in pulmonary hypertension and interstitial lung disease.

正如我在開場白中提到的那樣，我們將大約 50% 的現金用於各種形式的內部研發以及銷售、一般和行政費用。事實上，這些支出的很大一部分都用於我們在肺動脈高壓和間質性肺病方面的核心競爭力。

So in that regard, as you know, we have these registration effort going on in -- with ralinepag in the outcome study as well as a lot of effort going toward pulmonary fibrosis with TETON 1, TETON 2, PPF.

因此，在這方面，如您所知，我們正在進行這些註冊工作 - 使用 ralinepag 進行結果研究，同時在 TETON 1、TETON 2、PPF 方面投入大量精力進行肺纖維化研究。

Plus a lot of efforts that don't necessarily have any visibility because they are still in the lead product lead effort for the product and the preclinical. But we have alternative types of methods of dosing and variations on dosing. We have a one Tyvaso dosing in preclinical development. So all of these type of activities are continuing on our part. And as we've seen since the first competition came in to us with, say, something like the Liquidia Generic Parenteral.

另外，許多努力不一定具有任何可見性，因為它們仍然處於產品和臨床前的主導產品主導工作中。但我們有其他類型的給藥方法和劑量變化。我們在臨床前開發中有一個 Tyvaso 劑量。因此，我們仍在繼續進行所有這些類型的活動。正如我們在第一次競爭中看到的那樣，例如 Liquidia Generic Parenteral 之類的產品。

I guess it was like seven years ago or something. I really had no material effect whatsoever. There was quite a bit of concern about sotatercept. We did try to emphasize the fact that all signs for that, it was much more complementary than anything else. And in fact, in the year of rollout, it has proven to be exactly that, quite complementary.

我想那大概是七年前的事了。我確實沒有產生任何實質的影響。人們對索他西普 (sotatercept) 相當擔憂。我們確實試圖強調這樣一個事實，即所有跡像都表明，它比其他任何東西都更具互補性。事實上，在推出的這一年，事實證明它確實具有很好的互補性。

So we're constantly at UT, we are just relentless in improving our drugs, improving our drug delivery devices like another example of just drop there. Our Remunity device is now virtually used by 100% of the patients. So that's pretty amazing to swap out a parenteral delivery device that has had many, many years in the clinic and in patients' hands.

因此，我們一直在 UT，我們只是堅持不懈地改進我們的藥物，改進我們的藥物輸送裝置，就像另一個例子一樣。現在幾乎 100% 的患者都在使用我們的 Remunity 設備。因此，更換已經在臨床和患者手中使用了很多年的腸外給藥裝置是相當了不起的。

And in essentially about 24 months or so do virtually 100% swap out of that device. But now I'm preparing for yet a further upgrade of [VAP-1 to what we call Remunity D9]. You'll see similar types of evolution in our inhalation devices.

基本上在大約 24 個月左右的時間內，該設備幾乎 100% 都會被更換掉。但現在我正準備進一步升級[VAP-1 到我們所謂的 Remunity D9]。您會在我們的吸入裝置中看到類似的演變。

And as mentioned, some of those developments will also allow us to -- even though I think that our 4 times a day dosing now is the easiest, the simplest super effective as the data shows loved by physicians and patients as the data shows. I think even there, you'll be able to see in the next few years that we'll be able to come out with new products, that go for even once a day dosing.

正如所提到的，其中一些進展也將使我們能夠——儘管我認為我們現在每天四次的服藥方式是最簡單的，也是最有效的，正如數據顯示的那樣，深受醫生和患者的喜愛。我認為，即使如此，您也能夠在未來幾年內看到我們能夠推出每天只需服用一次的新產品。

So this is just endemic in the UT culture, what we call approved and then improve, approve and then improve and we're relentless about that. Everybody in the company get something approved, then improve it, get something approved, then improve it. And that's what we're doing on Tyvaso too.

所以這只是 UT 文化中普遍存在的現象，我們稱之為批准然後改進，批准然後改進，我們對此堅持不懈。公司裡的每個人都會對某件事進行批准，然後對其進行改進，對某件事進行批准，然後對其進行改進。這也是我們在泰瓦索所做的。

Well, with that, I'll lead in, James, can you answer some of the more econometric financial aspects of the capital allocation question?

好吧，那麼，我先說說，詹姆斯，你能回答一些有關資本配置問題的計量經濟學財務方面的問題嗎？

Yes. Thank you, Martine. Andreas, thank you for the question, and thank you for remembering the last call. As you know, we are committed to allocating capital wisely and we spend a lot of time internally talking about it. We want to do it in the best interest of our shareholders.

是的。謝謝你，馬丁。安德烈亞斯，感謝您的提問，也感謝您還記得上次的通話。如您所知，我們致力於明智地分配資本，並且我們花費大量時間在內部討論此事。我們希望這樣做符合股東的最大利益。

And as you know, the first priority is deploying our internal -- our capital for internal research and development and commercial initiatives. As Martine just explained -- there is a lot of -- and the highest priority around spending for research and development. And if you look at the P&L this quarter, you'll see there was a milestone payment we made in research and development and outsized increased R&D kind of outsized for the quarter relative to prior quarters.

如您所知，首要任務是部署我們的內部資本，用於內部研發和商業計劃。正如馬丁剛才解釋的那樣，有很多事情需要做，最優先考慮的是研發支出。如果你看一下本季的損益表，你會發現我們在研發方面取得了里程碑式的付款，而且與前幾季相比，本季的研發支出成長幅度很大。

Just as we move along and push along these initiatives that Martine talked about. And we also spend in our first pillar a lot of capital on our manufacturing facilities. And as you know, we're building a new DPI manufacturing facility in Research Triangle Park, North Carolina that is well on its way.

正如我們繼續前進並推動馬丁談到的這些舉措一樣。我們還在第一個支柱上投入了大量資金用於製造設施。如您所知，我們正在北卡羅來納州三角研究園區建設一個新的 DPI 製造工廠，目前進展順利。

The second priority insistent priority that we spend capital on is for our external corporate development. So we look for new opportunities for potential acquisitions and license opportunities, et cetera.

我們投入資金的第二個優先重點是企業外部發展。因此，我們尋找新的機會，包括潛在的收購和授權機會等等。

And as Martine lined in her opening remarks over the last 1.5 years or so, we've actually touched on all these priorities or touch on these priorities relative to business and corporate development. So it's an area that's very active and we look for products that are complementary to our product -- existing products and platforms and tend to focus on rare diseases, things in cardiovascular and things where there are corridors have been different. So we want to look for opportunities where we can have a big impact and there's little products or competition at this point.

正如 Martine 在過去一年半左右的開場白中所說的那樣，我們實際上已經觸及了所有這些優先事項，或者觸及了與商業和企業發展相關的這些優先事項。因此，這是一個非常活躍的領域，我們尋找與我們現有產品和平台互補的產品，並且傾向於關注罕見疾病、心血管疾病以及存在不同管道的疾病。因此，我們希望尋找能夠產生重大影響的機會，而目前產品或競爭很少。

And third, we do look, as Martine outlined, to return cash to shareholders. And as Martine talked about, for 2024, we did the $1 billion share repurchase that was well received. So our capital allocation priorities and kind of waterfall is still the same. But as you can see, we've been very active in allocating capital across all three in the recent months and years. So thank you very much for remembering. Thank you for the question. And Martine, I'll turn it back to you.

第三，正如馬丁所概述的，我們確實希望向股東返還現金。正如馬丁所說，我們在 2024 年進行了 10 億美元的股票回購，並獲得了廣泛好評。因此，我們的資本配置優先順序和瀑布類型仍然相同。但正如您所看到的，近幾個月和幾年來，我們一直非常積極地在這三個領域配置資本。非常感謝你的記憶。謝謝你的提問。馬丁，我會把它還給你。

Thank you, James. Thanks for such a great 360 degree coverage of that topic. Operator, next question.

謝謝你，詹姆斯。感謝您對主題進行如此精彩的全方位報道。接線員，下一個問題。

Roger Song, Jefferies.

傑富瑞 (Jefferies) 的羅傑宋 (Roger Song)。

Great. Congrats for the strong quarter and thank you for taking all questions. I think Martine, you mentioned a couple of things related to the competitive landscape for PAH. Maybe just can you just qualitatively comment on the potential growth trajectory this year, next given we have a couple of emerging competitor net dynamic, if you can kind of understand you don't provide the revenue guidance, but just qualitative the revenue growth trajectory. What the rest of the year and the next will be helpful. Thank you.

偉大的。恭喜本季業績強勁，感謝您回答所有問題。我認為 Martine，您提到了一些與 PAH 競爭格局相關的事情。也許您只能定性地評論一下今年的潛在成長軌跡，接下來考慮到我們有幾個新興的競爭對手網絡動態，如果您能理解您不提供收入指導，而只是定性地提供收入成長軌跡。今年剩餘時間和明年的情況將會有所幫助。謝謝。

Of course, Roger. Thank you for the question. But right with you, I'm going to assign that question to Michael because he oversees so many of the core competencies that we have within UT relevant to the growth trajectory question for a complex disease like PAH and like ILD, of course, it's very, very important to have a strong commercialization team, sales and marketing personnel, so called specialized sales reps throughout the country.

當然，羅傑。謝謝你的提問。但是，我馬上要把這個問題交給邁克爾，因為他負責監督我們 UT 內部的許多核心能力，這些能力與 PAH 和 ILD 等複雜疾病的增長軌跡問題有關，當然，擁有一支強大的商業化團隊、銷售和營銷人員，即遍布全國的所謂專業銷售代表，非常非常重要。

But actually, it's just the foundation. And on top of that, there's like a superstructure that extends into global medical affairs and many other core competencies. And all of these -- we have regional nurse specialists. Our drugs are complex and require almost always a drug device combination and there has to be training and how to use these things, working with the nurses, not to mention the entire payer universe.

但實際上，這只是基礎。除此之外，還有一個延伸到全球醫療事務和許多其他核心競爭力的上層建築。所有這些——我們都有區域護理專家。我們的藥物很複雜，幾乎總是需要藥物設備組合，而且必須進行培訓並學習如何使用這些東西，與護士合作，更不用說整個付款人群體了。

So all of these things are relevant, Roger, and Mike is like a virtuoso conductor who's got all these different actions of the orchestra, all with the goal of providing a growth trajectory for our products that is second to none. And with that lead in, Mike, can you provide some kind of deeper color on all of that?

所以，羅傑，所有這些事情都是相關的，而麥克就像一位技藝精湛的指揮家，掌控著管弦樂團的所有不同動作，所有這些都是為了為我們的產品提供無與倫比的成長軌跡。那麼，麥克，您能否對這一切提供更深入的解釋呢？

Thanks, Martine, and thanks for that introduction. I feel like I just won some kind of award.

謝謝，馬丁，謝謝你的介紹。我感覺就像剛剛贏得了某種獎勵。

Yeah, well, you win award [for Q2]. Yeah, absolutely.

是的，你獲獎了[針對第二季]。是的，絕對是如此。

Yeah. I think what we've been named, I think for the last couple of years and even as recently as the last call and Martine's comments on this call is we expect to continue to grow revenues at double-digit growth with our existing portfolio heading into this year and next year. And then, as I said in my opening remarks, if we have TETON if that's positive, that gets us into an entirely new market where we have orphan exclusivity.

是的。我認為，在過去的幾年裡，甚至在最近的最後一次電話會議上，以及馬丁對這次電話會議的評論中，我們預計，憑藉我們現有的投資組合，今年和明年的收入將繼續以兩位數的速度增長。然後，正如我在開場白中所說的那樣，如果我們擁有 TETON，如果這是積極的，那將使我們進入一個全新的市場，我們擁有孤兒藥專營權。

I didn't even touch on ralinepag, which we're would be commercialized around the same time frame and give us a best-in-class product within PAH. So despite the fact that it is become of PAH in particular is becoming an increased lead competitive market, we still feel like we're extremely well positioned to grow in PAH.

我什至沒有提到 ralinepag，我們將在同一時間段內將其商業化，並為我們提供 PAH 領域一流的產品。因此，儘管 PAH 已成為一個競爭日益激烈的市場，但我們仍然覺得我們在 PAH 領域擁有極佳的發展條件。

As I said on prior calls, yeah, it's still only about 40% of PAH patients are on any kind of prostacyclin. So I think there's plenty of room for us to grow. There's plenty of room for -- I mean even the competitive products within that class. So I think still prostacyclin, I think, are still woefully under prescribed within PAH. And with all of our efforts and all the teams that Martine mentioned, we're continuing to make progress there.

正如我在之前的電話中所說的那樣，是的，仍然只有大約 40% 的 PAH 患者服用任何類型的前列環素。所以我認為我們還有足夠的成長空間。有足夠的空間——我的意思是，即使是同一類別中的競爭產品也是如此。因此我認為前列環素在 PAH 治療中仍然嚴重不足。在我們所有人的努力下以及馬丁提到的所有團隊的幫助下，我們正在繼續取得進展。

It wasn't too long ago that we were saying it was only about 20% of patients PAH on process like the -- but I think through the efforts of our company, other companies, bringing new easier products to market such as Tyvaso DPI, we've been able to really expand the utilization of prostacyclin within PAH in PH-ILD, obviously, I still feel like we're just scratching the surface in terms of what the potential is there.

不久前我們還在說，只有大約 20% 的 PAH 患者會經歷類似的治療過程 - 但我認為，透過我們公司和其他公司的努力，將 Tyvaso DPI 等更簡單的新產品推向市場，我們已經能夠真正擴大前列環素在 PH-ILD 患者 PAH 中的應用，顯然，我仍然覺得我們只是觸及了其潛力的表面。

I think with the expansion that we rolled out last year. I think we -- the team has done an amazing job in increasing our prescriber base as well as the depth of ILD physicians prescribing Tyvaso for public hypertension associated with ILD. I expect that to continue as we move into the balance of this year and even heading into next year and beyond.

我認為這是我們去年推出的擴張計劃。我認為我們——團隊在擴大我們的處方基礎以及 ILD 醫生為與 ILD 相關的公共高血壓開具 Tyvaso 處方的深度方面做得非常出色。我預計，隨著我們進入今年年底，甚至進入明年及以後，這種勢頭將持續下去。

So I think we still have a lot of opportunity there. So we were very confident that we're going to meet these expectations of continuing to grow revenues at a double-digit clip with our existing portfolio.

所以我認為我們仍然有很多機會。因此，我們非常有信心，憑藉我們現有的產品組合，我們將能夠滿足繼續以兩位數速度成長收入的預期。

Thank you so much, Mike. Operator, we're actually at the bottom of the hour, but we'll take one last question.

非常感謝，麥克。接線員，實際上現在已經到了最後一個小時，但我們還要回答最後一個問題。

Ash Verma, UBS.

瑞銀的 Ash Verma。

Hi, congrats on the quarter. I have two questions. Just can you give us a sense of how much patient adds there have been in the last few quarters for Tyvaso? So is it more in line with the roughly [500-ish] that you have had historically or more or less? I just wanted to understand like the volume growth dynamic for PH and PH-ILD. And then secondly for instruments upcoming data on TPIP just what are you expecting this trial can show? And how do you think Tyvaso is competitively positioned against TPIP? Thanks.

嗨，恭喜本季。我有兩個問題。您能否告訴我們過去幾季 Tyvaso 新增了多少位患者？那麼，它是否與您歷史上所擁有的大約 [500 左右] 的數字更一致，還是更多或更少？我只是想了解 PH 和 PH-ILD 的數量增長動態。其次，對於即將發布的 TPIP 工具數據，您預期這次試驗能顯示什麼？您認為 Tyvaso 與 TPIP 相比具有怎樣的競爭優勢？謝謝。

Okay. Mike, do you want to continue to roll on that same topic.

好的。麥克，你想繼續討論同一話題嗎？

Sure. Yeah. I think with -- I think your first question was around patient adds for Tyvaso. So is that right? So yeah, so going back about 1 year, 1.5 years, we really kind of moved away from the patient ad metric due to, I think, just competitive confidentiality reasons.

當然。是的。我認為——我認為您的第一個問題是關於 Tyvaso 的病人補充。那麼這是對的嗎？是的，回顧大約 1 年或 1.5 年前，我們確實有點放棄了病患廣告指標，我認為，這只是出於競爭保密的原因。

I think what we've said about 1.5 years ago is if you look at the revenue, we've got to a point where I think the revenues are tracking pretty well with underlying demand. And so I think you can kind of look at how the revenues are trending and really get a good sense of what's happening at the underlying demand level.

我認為我們大約一年半前就說過，如果你看一下收入，你會發現我們已經達到了一個點，我認為收入與潛在需求跟踪得相當好。因此，我認為您可以看看收入趨勢，並真正了解潛在需求水平的情況。

In terms of the Insmed product, we'll see here in a few weeks when they unwind. And so it's hard for me to sort of speculate on what the impact is going to be relative to do without actually seeing any data. But I think we're all going to find out here pretty quick.

就 Insmed 產品而言，我們將在幾週後看到他們解散的情況。因此，如果沒有實際看到任何數據，我很難推測其影響會是如何的。但我想我們很快就會找到答案。

And then as Martine said in her answer to a prior question, we have some things that we're looking at in the preclinical setting and in our pipeline to potentially bring a once daily inhaled product market.

正如 Martine 在回答先前的問題時所說，我們正在臨床前環境和研發過程中研究一些事情，以期有可能開拓每日一次吸入的產品市場。

Yeah. Thank you, Mike, and thank you, Ash. I'm very skeptical that just copying treprostinil in a kind of a once daily formulation is going to really provide comparably effective control of pulmonary hypertension. However, as Mike and I referred to earlier, we do have a once daily [NCE] in our early development and the nature of our clinical development team and process, as such that can actually move very, very rapidly from preclinical to registration case.

是的。謝謝你，麥克，謝謝你，阿什。我非常懷疑僅僅複製曲前列尼爾的每日一次的配方是否真的能夠提供同樣有效的肺動脈高壓控制效果。然而，正如 Mike 和我之前提到的，我們在早期開發中確實有每日一次的 [NCE]，而且我們的臨床開發團隊和流程的性質使得它實際上可以非常非常迅速地從臨床前轉向註冊案例。

So not that I think it's necessary, but I think all of you know that another big mantra at United Therapeutics is multiple shots on goal. That's why we have so many products for pulmonary hypertension as you saw from the data today, all of them are growing. I mean that's super, super cool, oral, parenteral, inhaled, nebulized DPI, I mean, it's just like across the board. So we are constantly developing new products.

所以我認為這並不是必要的，但我想大家都知道，聯合治療公司的另一個重要口號是多次射門。這就是為什麼我們有這麼多針對肺動脈高壓的產品，正如您從今天的數據中看到的那樣，它們都在增長。我的意思是這非常非常酷，口服、腸胃外、吸入、霧化 DPI，我的意思是，它就像全面的一樣。因此我們不斷開發新產品。

And finally, I have not seen anything in -- since the company has begun developing products, whereas some new ones comes in and kind of steal the market, it actually has never happened. And the reason why is that when a product when a patient has a life-threatening illness, is well managed on a medicine as the patients are well managed on United Therapeutics medicines in overwhelming numbers.

最後，自從公司開始開發產品以來，我還沒有看到任何新產品進入市場並搶佔市場的情況，但這種情況實際上從未發生過。原因在於，當患者患有危及生命的疾病時，使用一種藥物可以得到很好的控制，就像絕大多數患者使用聯合治療公司的藥物可以得到很好的控制一樣。

It is a very flat and cautious and slow process to move those patients to some like newbie on the block that has not really been well proven in the clinic. And these are the reasons, the core reasons why Mike and I and the rest of the team can be so confident that United Therapeutics will continue to deliver the type of double-digit revenue growth year after year, the kind of record revenue growth that I reported in my introductory remarks for many years to come.

將這些患者轉移到一些尚未在臨床上得到充分證實的新手患者是一個非常平穩、謹慎和緩慢的過程。這些就是麥克、我和團隊其他成員如此有信心聯合治療公司將在未來許多年繼續實現兩位數的收入增長，實現我在開場白中報告的創紀錄的收入增長的核心原因。

Operator, you can wrap up the call now.

接線員，您現在可以結束通話了。

Certainly. Thank you. 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 that is ir.unither.com.

當然。謝謝。感謝您參加今天的聯合治療公司收益網路廣播。您可以透過造訪 United Therapeutics 投資者關係網站 ir.unither.com 的活動和演示部分（即 ir.unither.com）重播該網路廣播一週。