United Therapeutics Corporation (UTHR) 2026 Q2 法說會逐字稿

Good morning, and welcome to the United Therapeutics Corporation second-quarter 2026 corporate update. My name is JL, and I'll be your conference operator today. (Operator Instructions) Please note that this call is being recorded.

早安，歡迎參加 United Therapeutics Corporation 2026 年第二季公司最新進展說明會。我是 JL，今天將擔任會議接線員。(接線員指示) 請注意，本次電話會議將被錄音。

I'll now turn the webcast over to Harry Silvers, Investor Relations at United Therapeutics.

現在我將把網路直播交給 United Therapeutics 投資人關係部的 Harry Silvers。

Thank you, JL. Good morning, everyone. It is my pleasure to welcome you to the United Therapeutics Corporation's second-quarter 2026 corporate update webcast. Remarks today will include forward-looking statements representing our expectations or beliefs regarding future events. These statements involve risks and uncertainties that may cause actual results to differ materially.

謝謝你，JL。各位早安。我很高興歡迎各位參加 United Therapeutics Corporation 2026 年第二季公司最新進展網路直播。今天的發言將包含前瞻性陳述，代表我們對未來事件的預期或信念。這些陳述涉及風險與不確定性，可能導致實際結果與所述內容出現重大差異。

Our latest SEC filings, including Forms 10-K and 10-Q, contain additional information on these risks and uncertainties. We assume no obligation to update forward-looking statements. Today's remarks may discuss the progress and results of clinical trials or other developments with respect to our products. These remarks are intended solely to educate investors and are not intended to serve as the basis for medical decision-making or to suggest that any products are safe and effective for any unapproved or investigational uses. Full prescribing information for the products is available on our website.

我們最新的 SEC 申報文件（包括 10-K 與 10-Q 表格）載有關於這些風險與不確定性的更多資訊。我們不承擔更新前瞻性陳述的任何義務。今天的發言可能會討論臨床試驗的進展與結果，或與我們產品相關的其他發展。這些發言僅旨在教育投資人，並非作為醫療決策的依據，也不意圖暗示任何產品對於任何未核准或研究用途是安全且有效的。產品的完整處方資訊可於我們的網站取得。

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.

今天與我一同參與電話會議的有：我們的董事長兼執行長 Martine Rothblatt 博士；總裁兼營運長 Michael Benkowitz；財務長兼司庫 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 Martine Rothblatt, James Edgemond and I will participate in a fireside chat and one-on-one meetings at the Wells Fargo Healthcare Conference, September 8 in Boston; the Cantor Fitzgerald Global Healthcare Conference in New York on September 9. Pat Poisson will join us for the Morgan Stanley Healthcare Conference in New York on September 14.

請注意，Martine Rothblatt、James Edgemond 與我將於 9 月 8 日在波士頓舉行的 Wells Fargo Healthcare Conference 參加爐邊談話與一對一會議；並於 9 月 9 日在紐約舉行的 Cantor Fitzgerald Global Healthcare Conference 參與相關活動。Pat Poisson 將與我們一同出席 9 月 14 日在紐約舉行的 Morgan Stanley Healthcare Conference。

And then lastly, the Bernstein Third Annual Healthcare Forum in New York on September 23. Our scientific, commercial and medical affairs teams will be present at the European Respiratory Society Congress in Barcelona, September 5 through 9, and the American College of Chest Physicians CHEST 2026 Annual Meeting in Phoenix, October 18 through 21.

最後，還有 9 月 23 日在紐約舉行的 Bernstein 第三屆年度 Healthcare Forum。我們的科學、商業與醫藥事務團隊將出席 9 月 5 日至 9 日在巴塞隆納舉行的 European Respiratory Society Congress，以及 10 月 18 日至 21 日在鳳凰城舉行的 American College of Chest Physicians CHEST 2026 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，請她概述我們的研發管線與業務活動。Martine？

We have slides available for reference, and I encourage you to review those at your leisure. I'm not going to speak directly to the slides. The first half of 2026 has been one of the most consequential periods in United Therapeutics' history. First, we delivered exceptional clinical results from our ADVANCE OUTCOMES study, demonstrating ralinepag's potential to become a major new oral therapy for patients with PAH. Then we unblinded TETON-1, which surpassed the impressive TETON-2 results we reported last September.

我們提供投影片供各位參考，並鼓勵各位在方便時自行檢視。我不會逐頁直接講解投影片。2026 年上半年是 United Therapeutics 歷史上最具關鍵影響的時期之一。首先，我們在 ADVANCE OUTCOMES 研究中取得卓越的臨床結果，顯示 ralinepag 有潛力成為 PAH 患者的重要新型口服治療。接著，我們揭盲了 TETON-1，其結果超越了我們去年 9 月公布的、已相當亮眼的 TETON-2 結果。

Together, these results put us in an extraordinary position, a new molecule advancing toward the PAH market and a potential new indication for nebulized Tyvaso in IPF, representing an opportunity meaningfully larger than our currently approved markets and a new option for patients.

綜合而言，這些結果使我們處於極為有利的位置：一個新分子正邁向 PAH 市場，以及霧化 Tyvaso 在 IPF 的潛在新適應症；這代表的機會規模顯著大於我們目前已核准的市場，並為患者提供新的選擇。

With these highly statistically significant clinical results, we recently submitted to the FDA what we believe are two of the most important new drug applications in rare pulmonary disease: the sNDA for nebulized Tyvaso in IPF and the NDA for ralinepag in PAH. And we are not stopping there with additional filings planned later this year, including an IND for ralinepag DPI and an NDA for treprostinil SMI. We are moving with urgency toward what we believe will be a pivotal change in our growth trajectory as we plan to bring pioneering advanced inhalation technologies to patients. We expect potential approvals in 2027 for nebulized Tyvaso in IPF, ralinepag in PAH and the SMI device in PAH and PH-ILD. These are not incremental opportunities.

憑藉這些具高度統計顯著性的臨床結果，我們近期已向 FDA 提交我們認為在罕見肺部疾病領域最重要的兩項新藥申請：霧化 Tyvaso 用於 IPF 的補充新藥申請（sNDA），以及 ralinepag 用於 PAH 的新藥申請（NDA）。而且我們不會止步於此；今年稍晚還規劃提交其他申請，包括 ralinepag DPI 的 IND，以及 treprostinil SMI 的 NDA。我們正以緊迫感推進，我們相信這將成為我們成長軌跡的關鍵轉折，因為我們計畫把開創性的先進吸入技術帶給患者。我們預期在 2027 年可能取得核准：霧化 Tyvaso 用於 IPF、ralinepag 用於 PAH，以及 SMI 裝置用於 PAH 與 PH-ILD。這些並非小幅增量的機會。

We believe they are multibillion-dollar catalysts with the potential to redefine patient treatment paradigms, improve outcomes for patients and fundamentally transform our growth profile and competitive position. Looking further ahead, enrollment in our TETON-PPF trial is nearly complete, paving the way for another substantial Phase III readout in the back half of 2027.

我們相信，這些是具數十億美元規模的催化劑，有潛力重新定義患者治療典範、改善患者預後，並從根本上改變我們的成長輪廓與競爭地位。再往前看，我們的 TETON-PPF 試驗收案已接近完成，為 2027 年下半年另一項重要的第三期結果讀出鋪路。

Based on the successful TETON-1 and TETON-2 studies as well as the similarities in underlying fibrosis and disease progression between IPF and PPF, we have a high degree of confidence in our ability to report another positive outcome. If successful, TETON-TPF would open the door to an even larger opportunity, at least double that of IPF, and position nebulized Tyvaso to become a leading therapy for patients with pulmonary fibrosis.

基於 TETON-1 與 TETON-2 研究的成功，以及 IPF 與 PPF 在基礎纖維化與疾病進展方面的相似性，我們對於能再度報告正向結果具有高度信心。若成功，TETON-TPF 將開啟更大的機會，至少為 IPF 的兩倍，並使霧化 Tyvaso 有望成為肺纖維化患者的領先治療。

Turning to our organ pipeline, we continue to make strong progress toward our goal of expanding the availability of transplantable organs. The UKidney EXPAND study continues to make great progress with completion of the initial six-patient cohort expected later this year. In parallel, we soon anticipate initiating the UThymoKidney EXTEND registration-enabling study.

談到我們的器官管線，我們持續朝擴大可供移植器官的目標穩健推進。UKidney EXPAND 研究持續取得良好進展，預期今年稍晚完成最初的六名患者隊列。同時，我們也預期不久將啟動 UThymoKidney EXTEND 註冊申請支援性研究。

Lastly, with recent clearance from the FDA, we are working to commence our EXPRESS-UHeart study. Moreover, by the end of this year, we will complete construction of our two additional commercial-scale DPFs in Minnesota and Texas. With 3 authorized clinical trials, United Therapeutics is not just participating in the future of xenotransplantation; we are leading it. We believe this work can redefine organ transplantation, save countless lives and create one of the most significant growth opportunities in our company's history.

最後，隨著近期獲得 FDA 核准放行，我們正著手啟動 EXPRESS-UHeart 研究。此外，在今年年底前，我們將完成在明尼蘇達州與德州兩座新增商業規模 DPF 的建置。憑藉 3 項已獲授權的臨床試驗，United Therapeutics 不僅是在參與異種移植的未來；我們正在引領它。我們相信，這項工作能重新定義器官移植、拯救無數生命，並創造公司史上最重要的成長機會之一。

Our deep organ pipeline represents a bold and differentiated extension of United Therapeutics' mission with the potential to transform how patients access life-saving organs and how United Therapeutics will create substantial value over the long term. We will be sharing with you more details about these programs as each moves through their development timelines.

我們深厚的器官管線，是對 United Therapeutics 使命的一項大膽且差異化的延伸，具有改變患者取得救命器官方式的潛力，也將使 United Therapeutics 在長期創造可觀價值。隨著各項計畫依其研發時程推進，我們將與各位分享更多細節。

Our ability to pursue these opportunities is supported by a disciplined approach to capital allocation through our budget algorithm, which has positioned us near the top of our industry in operating efficiency. We have also been thoughtful in deploying capital toward internal growth objectives while remaining mindful of returning capital to shareholders.

我們能夠追求這些機會，仰賴透過預算演算法所支持的嚴謹資本配置方法，使我們在營運效率方面位居同業前段班。我們也審慎地將資本投入內生成長目標，同時兼顧回饋股東。

As an example, we recently deployed capital to acquire Thymmune Therapeutics, adding a promising thymus-based regenerative medicine platform that fits squarely within our mission. This acquisition broadens our organ alternative strategy and strengthens our ability to pursue therapies that could restore immune function for patients with serious diseases. We see tremendous potential ahead, and we're excited to welcome the Thymmune team to United Therapeutics.

例如，我們近期投入資本收購 Thymmune Therapeutics，新增一個具前景、以胸腺為基礎的再生醫學平台，與我們的使命高度契合。此項收購擴大了我們的器官替代策略，並強化我們追求可能為重症患者恢復免疫功能之療法的能力。我們看見前方巨大的潛力，也很高興歡迎 Thymmune 團隊加入 United Therapeutics。

To close, we believe United Therapeutics is entering a defining era, one shaped by scientific ambition, innovative platforms and a pipeline with the potential to transform care across some of the most challenging areas of medicine. As these opportunities advance, we see a future in which our impact on patients, our industry and our growth trajectory can reach an entirely new level, making United Therapeutics a growth story unlike any other in biotech.

最後，我們相信 United Therapeutics 正進入一個定義性的時代——由科學雄心、創新平台，以及一條有潛力在醫學中若干最具挑戰領域改變照護方式的研發管線所塑造。隨著這些機會持續推進，我們看見一個未來：我們對患者、對產業以及對成長軌跡的影響力都能達到全新層級，使 United Therapeutics 成為生技領域獨一無二的成長故事。

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

接下來，我將把電話會議交給我們的總裁 Michael Benkowitz，他將概述我們本季的商業表現。Mike？

Thank you, Martine, and good morning, everyone. For the second quarter of 2026, we generated approximately $783 million in total revenue, essentially flat with the first quarter. While these results were below our expectations, they do not change our confidence in the strength of our business, the opportunities in front of us or our ability to create substantial value over the coming years.

謝謝你，Martine，各位早安。2026 年第二季，我們創造約 7.83 億美元的總營收，與第一季基本持平。雖然這些結果低於我們的預期，但不會改變我們對業務實力、眼前機會以及未來數年創造可觀價值能力的信心。

I want to start by acknowledging something directly. Over the last several quarters, we understand investors have been looking for a faster acceleration in growth, and we recognize that confidence is earned through execution, not projections. So our focus is on improving results. As we evaluate the current state of the business, we believe the underlying fundamentals are strong, and we believe we are positioned to deliver improved performance in the second half of the year.

我想先直接談一件事。過去幾個季度，我們理解投資人一直期待更快的成長加速，而我們也認知到，信心是靠執行贏得的，而不是靠預測。因此，我們的重點是改善成果。在評估目前業務狀況時，我們認為基本面依然強勁，並相信我們已具備條件在下半年交出更佳表現。

Simply put, we exited the second quarter with considerably more momentum than the reported revenue line alone would suggest. Based on the trends we're seeing today, we expect the second half of 2026 to be stronger than the first half of 2026, and we remain focused on accelerating revenue growth as we move through the balance of the year. That said, we are not reaffirming or updating any prior revenue growth expectations for 2026 today.

簡而言之，我們在第二季結束時的動能，遠比單看已公布的營收數字所呈現的要強。根據我們目前看到的趨勢，我們預期 2026 年下半年將強於 2026 年上半年，並將在今年剩餘時間持續聚焦加速營收成長。不過，我們今天不會重申或更新先前對 2026 年營收成長的任何預期。

Turning to Tyvaso, total revenue for the quarter was $453 million. Nebulized Tyvaso remained pressured by competitive dynamics within the inhaled prostacyclin category as patients and providers evaluate an increasing number of treatment options. We expected this market to become more competitive over time, and that's precisely what we are seeing today. Tyvaso DPI, meanwhile, continued to demonstrate growth and, more importantly, exited the quarter with what we view as significant underlying momentum.

談到 Tyvaso，本季總營收為 4.53 億美元。霧化 Tyvaso 仍受到吸入型前列環素（prostacyclin）類別內競爭態勢的壓力，因為病患與醫療提供者正在評估愈來愈多的治療選項。我們原本就預期這個市場會隨時間變得更具競爭性，而這正是我們今天所看到的情況。另一方面，Tyvaso DPI 持續展現成長，更重要的是，我們認為其在季末呈現出顯著的內在動能。

As we have discussed previously, quarterly sales are not always the best measure of underlying demand. Starts, referrals, total patients and commercial patients all reached record levels exiting the quarter. Those metrics give us confidence not only in the durability of the franchise but also in our ability to translate that momentum into stronger commercial performance over the second half of the year. So we remain confident in the strength and long-term value of our existing commercial portfolio.

如同我們先前討論過的，季度銷售額不一定是衡量內在需求的最佳指標。在季末，啟用（starts）、轉介（referrals）、總病患數以及商業保險病患數皆創下新高。這些指標讓我們對該產品線的持久性更有信心，也讓我們相信能把這股動能轉化為下半年更強的商業表現。因此，我們仍對現有商業產品組合的實力與長期價值充滿信心。

Our conviction is grounded in what we believe are highly differentiated therapies that offer meaningful advantages in efficacy, convenience, dosing and long-term tolerability. We continue to believe these characteristics matter deeply to patients and providers and position us well for sustained growth. Recognition of these benefits, particularly in a highly competitive environment, are taking time to crystallize with physicians.

我們的信念建立在我們認為高度差異化的療法之上，這些療法在療效、便利性、劑量設計與長期耐受性方面提供了有意義的優勢。我們持續相信，這些特性對病患與醫療提供者都非常重要，並使我們具備持續成長的良好定位。在高度競爭的環境中，醫師對這些效益的認知，尤其需要一些時間才能更明確地形成。

However, we believe our commercial strategy has us well positioned to accelerate that process, and the underlying trends we are seeing reinforce our belief that we are moving in the right direction. As we discussed last quarter, we significantly expanded, that is roughly doubled, our sales force. Those representatives entered the field in early July and are already increasing our reach and frequency of engagement with physicians across both PAH and PH-ILD. We recruited an exceptionally strong team with deep, relevant experience, and we expect their efforts to meaningfully enhance awareness of our therapies, accelerate adoption and support stronger commercial performance over time.

然而，我們相信我們的商業策略讓我們具備加速這一進程的良好條件，而我們目前看到的內在趨勢也強化了我們正朝正確方向前進的信念。如同我們上季所提到的，我們大幅擴編——也就是約增加一倍——我們的銷售團隊。這些代表在 7 月初進入市場，已開始提升我們在 PAH 與 PH-ILD 兩個領域對醫師的覆蓋範圍與互動頻率。我們招募到一支非常強的團隊，具備深厚且高度相關的經驗，我們預期他們的努力將顯著提升對我們療法的認知、加速採用，並隨時間推進支持更強的商業表現。

To round out this section, we believe the combination of record patient metrics, increased commercial reach, the strength of our differentiated portfolio and growing physician awareness positions us well to accelerate performance in the second half of the year. At the same time, it's important to recognize that our story is not solely about the next quarter or the next year. We continue to believe that we have 2 potentially transformative opportunities in front of us.

總結這一部分，我們相信：創紀錄的病患指標、提升的商業覆蓋、差異化產品組合的實力，以及醫師認知的提升，這些因素的結合，使我們具備在下半年加速表現的良好條件。同時，也必須認知到，我們的故事不僅僅關乎下一季或下一年。我們仍相信眼前有兩個可能帶來變革的機會。

First, nebulized Tyvaso and IPF; second, ralinepag in PAH. Both represent areas of substantial unmet need, both have the potential to become multibillion-dollar opportunities and both have the potential to further strengthen our leadership position in respiratory and cardiopulmonary disease. For Tyvaso in IPF, we continue to see strong interest from physicians following the TETON results, and we remain excited about the potential impact this therapy could have for patients with limited treatment options today. For ralinepag, we believe the opportunity to introduce the first once-daily oral prostacyclin could represent a meaningful advancement for patients and providers seeking a differentiated treatment option.

第一，霧化 Tyvaso 與 IPF；第二，ralinepag 用於 PAH。兩者都代表龐大的未被滿足需求，兩者都有潛力成為數十億美元級的機會，並且兩者都有潛力進一步強化我們在呼吸與心肺疾病領域的領導地位。就 Tyvaso 在 IPF 的應用而言，在 TETON 結果公布後，我們持續看到醫師的高度興趣，也仍對這項療法可能為目前治療選擇有限的病患帶來的影響感到振奮。就 ralinepag 而言，我們相信推出第一個每日一次口服前列環素（prostacyclin）的機會，可能為尋求差異化治療選項的病患與醫療提供者帶來有意義的進展。

We have previously projected a $4 billion revenue run rate by the end of 2027 with our existing commercial portfolio. We still see a path to achieve this, although it has certainly narrowed. Factoring in some of the revenue from our anticipated IPF and ralinepag launches next year should get us there and beyond.

我們先前曾預估，僅憑現有商業產品組合，到 2027 年底可達到 40 億美元的營收年化運行率（revenue run rate）。我們仍看到達成此目標的路徑，儘管這條路徑確實變得更窄。若將我們預期明年 IPF 與 ralinepag 上市所帶來的部分營收納入考量，應可讓我們達到並超越該目標。

Our strategy is straightforward. We are focused on executing and growing the business we have today while simultaneously preparing the organization for what we believe could be two important future launches. We do not view these future opportunities as replacing our current growth story. Rather, we view our current commercial portfolio as providing a strong, durable and growing foundation, while Tyvaso and IPF and ralinepag offer meaningful upside beyond that foundation. That combination gives us confidence not only in the long-term potential of United Therapeutics but also in our ability to accelerate growth in the near term and create value across multiple time horizons.

我們的策略很直接。我們專注於執行並成長我們今天既有的業務，同時也在為我們認為可能是兩項重要的未來上市做組織準備。我們不認為這些未來機會是在取代我們目前的成長故事。相反地，我們將現有商業產品組合視為提供強勁、持久且成長中的基礎，而 Tyvaso 在 IPF 的機會與 ralinepag 則在此基礎之上提供有意義的上行空間。這樣的組合不僅讓我們對 United Therapeutics 的長期潛力更有信心，也讓我們相信能在短期內加速成長，並在多個時間維度上創造價值。

Before I close, I want to share with our investors something that is an important part of our culture and how we work. Across the company, we have a rallying cry called LTFI, which stands for Lock The F In. While there are certainly exciting opportunities on the horizon in 2027 and beyond, LTFI is a reminder that our responsibility is not to focus on future possibilities at the expense of present execution. We have patients, providers, shareholders and fellow Unitherians counting on us today.

在我結束之前，我想與投資人分享一件對我們文化與工作方式很重要的事。在全公司，我們有一句凝聚人心的口號叫 LTFI，代表 Lock The F In。雖然 2027 年及更遠的未來確實有令人振奮的機會，但 LTFI 提醒我們：我們的責任不是為了未來的可能性而犧牲當下的執行。今天就有病患、醫療提供者、股東以及我們的 Unitherians 仰賴著我們。

LTFI is our commitment to all of those stakeholders. It's a reminder that, while we are excited about what may come next, our focus remains on what we must deliver now. And we believe the trends we are seeing today position us to do exactly that. We are focused; we are accountable. We are committed to accelerating performance in the second half of the year. And we will continue to be LTFI as we deliver for patients, providers, our colleagues and our shareholders.

LTFI 是我們對所有這些利害關係人的承諾。它提醒我們：即使我們對接下來可能發生的事感到興奮，我們的重點仍是我們現在必須交付的成果。而我們相信，今天看到的趨勢讓我們具備做到這一點的良好條件。我們專注；我們負責。我們致力於在下半年加速表現。而在為病患、醫療提供者、同仁與股東交付成果的同時，我們也將持續秉持 LTFI。

With that, I'll pass the call back to Harry to start our Q&A session. Harry?

接下來，我把電話會議交回給 Harry，開始我們的問答環節。Harry？

Great. Thank you, Michael, and thank you, Martine, for the excellent overviews this morning. Before I give this over to JL to start the Q&A session, I would just like to remind those on the call asking questions, please try to limit yourselves to one question with respect to the long queue that we have.

好的。謝謝你，Michael，也謝謝你，Martine，今天早上提供非常出色的概述。在我把會議交給 JL 開始問答之前，我想提醒在電話會議上提問的各位，考量到我們有很長的排隊序列，請盡量將問題限制為一個。

(Operator Instructions)

（接線員指示）

Joseph Thome, TD Cowen.

Joseph Thome，TD Cowen。

Hi, there. Good morning and thank you for taking my question. Maybe just as we're thinking about some of the other offerings, either ralinepag in PAH or the Tresmi in PAH and PH-ILD, I guess, how much do you think you're going to be able to kind of recapture maybe some of the momentum that you did lose by increased competition in the space? Yeah, just kind of your thoughts around that.

嗨，你好。早安，謝謝讓我提問。也許在我們思考其他產品時，無論是 ralinepag 用於 PAH，或是 Tresmi 用於 PAH 與 PH-ILD，我想問的是，在該領域競爭加劇、導致你們失去一些動能之後，你們認為自己能在多大程度上重新奪回部分動能？是的，想聽聽你們對此的看法。

Thanks, Joe. I'm going to pass it to Michael to answer that question.

謝謝，Joe。我把這個問題交給 Michael 來回答。

Yeah. So I think in terms of ralinepag, as I think both Martine and I said in our opening remarks, we look at that as a multibillion-dollar opportunity. We've talked about the notion that this is a super-prostacyclin. We think the data that we saw in the ADVANCE OUTCOMES study certainly support that. I think the initial reactions and feedback we're getting from physicians is very positive.

是的。所以我認為就 ralinepag 而言，正如 Martine 和我在開場致詞中都提到的，我們把它視為一個數十億美元規模的機會。我們談過這是一種「超級前列環素（super-prostacyclin）」的概念。我們認為在 ADVANCE OUTCOMES 研究中看到的數據確實支持這一點。我覺得我們從醫師那裡得到的初步反應與回饋非常正面。

And I think the combination of -- it's not just it being a once-daily oral prostacyclin, which we think is differentiated in and of itself. But more importantly, actually, the clinical benefit that we saw in the trial, I think, is really going to position us well for an exciting launch and, like we said, a multibillion-dollar opportunity.

而且我認為其組合優勢在於——不僅僅是它作為每日一次口服前列環素（prostacyclin），我們認為這本身就具有差異化。但更重要的是，我們在試驗中看到的臨床效益，我認為將使我們在令人振奮的上市推進上具備很好的定位，並且如我們所說，是一個數十億美元規模的機會。

I think -- similarly with SMI, I think we look at SMI as really being a really differentiated way to deliver inhaled therapies across eventually all of our indications. And so I think when -- we believe that it's going to be, I think, very well received by both the physicians and the patients. We think there could be potentially some tolerability benefits. And so we look at that as really being, again, another way to kind of differentiate ourselves relative to competition.

我認為——同樣地，對於 SMI，我們把 SMI 視為一種非常具差異化的方式，能夠在最終涵蓋我們所有適應症的範圍內，提供吸入式治療。因此我認為——我們相信它將會受到醫師與病患的高度接受。我們認為在耐受性方面可能會有一些潛在的優勢。因此我們也把它視為再次讓我們相對於競爭對手形成差異化的另一種方式。

Roger Song, Jefferies.

Roger Song，Jefferies。

Great. Thanks for taking the question. Also, along the line, in terms of those new product launch, appreciating the 2027 guidance reaffirmation. How should we think about the launch ramp-up for those new products, including the nebulized IPF, Tyvaso IPF and then ralinepag and Tresmi? Thank you.

很好。謝謝讓我提問。同樣沿著這個方向，關於這些新產品上市，在你們重申 2027 年指引的前提下，我們應該如何看待這些新產品的上市爬坡（ramp-up），包括霧化 IPF、Tyvaso IPF，以及 ralinepag 和 Tresmi？謝謝。

Thanks, Roger. Michael will answer that question for you.

謝謝你，Roger。Michael 會為你回答這個問題。

Sure, Roger. Thanks for the question. I think we're going to have more information to share on launch trajectory or launch ramps as we get to the back half of the year or early 2027. I think we're working through that now. As we said, I think we certainly look at both as being multibillion-dollar opportunities.

當然，Roger。謝謝你的提問。我想我們會在今年下半年或 2027 年初，分享更多關於上市軌跡或上市爬坡的資訊。我想我們目前正在推進相關工作。如我們所說，我們確實把這兩項都視為數十億美元規模的機會。

I don't think that's really in question. How quickly we get there? I think we're kind of working through that. And then obviously, a lot of that's going to depend on when we're able to launch. Do we get priority review or not?

我認為這點其實沒有疑問。至於我們能多快達到？我想我們正在梳理與評估。而且很明顯，其中很大一部分將取決於我們何時能夠上市。我們是否能獲得優先審查（priority review）？

So I think as we get a little bit more information on the status of our regulatory filings and the timing of when we could see an approval and just kind of continue doing kind of our work on the commercial side to prepare our launch trajectory, we'll have more information to share later this year, as I said.

所以我認為，隨著我們對監管申報狀態、可能看到核准的時間點有更多資訊，以及我們在商業端持續推進準備上市軌跡的工作，我們會在今年稍晚如我所說，分享更多資訊。

Jessica Fye, JPMorgan.

Jessica Fye，JPMorgan。

Hey, guys, good morning. Thanks for taking my question. I guess this one is for Michael, and I appreciate the comments on how you see the business set up for a stronger back half than first half. I guess just in the interest of getting consensus numbers in the right place for this sort of period prior to the IPF launch, I think back half Tyvaso consensus is for about $1.047 billion of revenue. Is that achievable based on kind of the larger sales force and the other dynamics you mentioned? Or should the Street be thinking about that number a little bit differently? Just want to make sure expectations are in the right place for the next couple of quarters.

嗨，各位，早安。謝謝讓我提問。我想這題是問 Michael 的，也謝謝你提到你如何看待下半年相較上半年會有更強的業務表現。我想為了讓在 IPF 上市前這段期間的市場一致預期數字更到位，目前市場對下半年 Tyvaso 的一致預期約為 10.47 億美元營收。基於你提到的更大的銷售團隊與其他動態，這個數字可達成嗎？還是華爾街應該用不同方式來看待這個數字？只是想確保未來幾個季度的預期放在正確的位置。

Thanks for the question, Jess. Good to hear from you this morning. We got Michael to answer that.

謝謝你的提問，Jess。今天早上很高興聽到你的聲音。我們請 Michael 來回答。

Yeah. So Jess, as we said, we're not really kind of reaffirming or updating anything at this point. As I said in my opening remarks, we expect it to be -- we expect the second half to be stronger than the first half. And I think we're just going to kind of leave it at that for right now.

是的。所以 Jess，如我們所說，我們目前不會在這個時間點重申或更新任何內容。正如我在開場致詞中提到的，我們預期——我們預期下半年會比上半年更強。我想我們目前就先說到這裡。

Roanna Ruiz, Leerink Partners.

Roanna Ruiz，Leerink Partners。

Hey, guys. You have Ryan on for Roanna. Thanks for taking the question. Maybe pivoting over to IPF. Coming out of ATS and your conversations with physicians, can you kind of talk about your expectations for where you think Tyvaso is going to be positioned in the IPF treatment landscape? And between nebulizer, DPI and SMI, what do you think is really the main driver of future prescribing for this franchise? Thanks.

嗨，各位。我是代 Roanna 上線的 Ryan。謝謝讓我提問。也許把話題轉到 IPF。在 ATS 會議之後以及你們與醫師的交流中，你們能否談談你們預期 Tyvaso 在 IPF 治療版圖中會如何定位？另外在霧化器、DPI 與 SMI 之間，你認為未來這個產品線（franchise）處方成長的主要驅動因素是什麼？謝謝。

Hey, Ryan, good morning. Thanks for the question. We got Michael again for you.

嗨，Ryan，早安。謝謝你的提問。我們再請 Michael 來回答。

Yeah. So just to make sure everybody is clear, when we launch into IPF next year, we're just not launching with the nebulized Tyvaso -- we still have -- have some engagement to do with the FDA to understand exactly what we're going to need to do to get an approval in that indication for both DPI and SMI. So the launch next year will solely be nebulized in IPF.

是的。先確認大家都清楚，明年我們進入 IPF 上市時，我們不會只推出霧化 Tyvaso——我們仍需要與 FDA 進一步互動，以了解在 DPI 與 SMI 這兩種劑型要取得該適應症核准，究竟需要做哪些工作。因此明年的 IPF 上市將僅限於霧化劑型。

And I think it's -- the feedback we're getting is, as I said in my remarks, really, I think, a lot of excitement around IPF, around the data, around the treatment option. And so I think as we've kind of talked to some of the top KOLs, they said whether they use it first line or whether they add it on, it's really going to be patient-dependent.

而且我認為——我們收到的回饋是，如我在發言中提到的，大家對 IPF、對數據、對這個治療選項都非常興奮。因此我認為，當我們與一些頂尖 KOL 交流時，他們表示不論是作為一線使用，或是加用（add-on），都會取決於病患狀況。

But I think they all said ultimately, it doesn't -- it probably doesn't really even matter because I think what they're saying is IPF is moving towards what we're seeing in PAH in terms of a polytherapy approach to treating these patients. And so I think the vast, vast majority of the docs we're talking about have said they're going to use Tyvaso in combination with other products. And so whether it's sequenced first or second, it kind of doesn't matter, but they're going to quickly get to polytherapy.

但我認為他們也都說，最終這可能甚至不太重要，因為他們的意思是，IPF 正朝向我們在 PAH 看到的方向發展，也就是以多重治療（polytherapy）的方式來治療這些病患。因此我認為，我們談到的絕大多數醫師都表示，他們會把 Tyvaso 與其他產品合併使用。所以不論是先用或後用，某種程度上並不重要，因為他們會很快走向多重治療。

Ben Burnett, Wells Fargo.

Ben Burnett，Wells Fargo。

Hi. Thanks very much. I just wanted to follow up just on IPF. And just what's your expectation for the type of data that you would need to generate to get the DPI and the SMI into IPF? Like would this just be bridging data? Or would you anticipate you need to generate any more efficacy data?

嗨。非常感謝。我想就 IPF 再追問一下。你們預期需要產生什麼類型的數據，才能讓 DPI 與 SMI 進入 IPF 適應症？例如這會只是橋接（bridging）數據嗎？還是你們預期需要再產生更多療效（efficacy）數據？

Hey, Ben, thanks. I think for part of the question with the SMI, perhaps Pat can address that. And maybe, Leigh, if you want to add any commentary on bridging to the Tyvaso DPI.

嗨，Ben，謝謝。我想關於 SMI 的部分，也許 Pat 可以回應。另外 Leigh，如果你想補充關於銜接到 Tyvaso DPI 的橋接（bridging）說明，也歡迎。

Yeah, you want me to start, Harry?

是的，你要我先開始嗎，Harry？

Yes.

是。

Yeah. I mean we're engaged with FDA to have those discussions to understand what they need to see for Tyvaso DPI. So it's yet to be determined. And I'll pass it over to Leigh to maybe add some color to the clinical approach.

是的。我的意思是，我們正與 FDA 進行溝通，以便展開這些討論，了解他們希望在 Tyvaso DPI 方面看到哪些資料。所以目前仍有待確定。我把時間交給 Leigh，請她或許補充一些臨床策略方面的說明。

Yeah. So as Pat said, we're engaging with FDA. We have some good ideas for bridging, and with regard to our current population that's enrolled as far as potentially new starts, we have a proposed strategy that we'll be presenting to them, and we look forward to seeing what they have to say, similar to what we've done in the past with regard to bridging. So -- and that goes for both SMI and DPI.

是的。如 Pat 所說，我們正在與 FDA 接洽。我們對於橋接（bridging）有一些不錯的想法；就目前已入組的人群而言，針對可能的新起始用藥者，我們有一個擬定的策略，將向他們提出，我們也期待聽取他們的意見，這與我們過去在橋接方面所做的做法類似。所以——而且這同樣適用於 SMI 與 DPI。

Ashwani Verma, UBS.

Ashwani Verma，瑞銀（UBS）。

Hi. Thanks for the opportunity. Can you talk about the sales force expansion heading into the IPF and ralinepag potential approval? How much of the sales force is already deployed? And I'm assuming the physician calling point is a little bit different. So how much does that help with the current Tyvaso indications? Thanks.

嗨。謝謝給我提問的機會。你們能談談在 IPF 與 ralinepag 可能獲批之前的銷售團隊擴編嗎？目前已有多少銷售人員部署到位？我猜醫師拜訪的目標點可能也有些不同。那麼這對目前 Tyvaso 的既有適應症有多大幫助？謝謝。

Thanks for the question, Ash. Good to hear from you this morning. Michael can take that one for you.

謝謝你的問題，Ash。今天早上很高興聽到你的聲音。Michael 可以為你回答這題。

Sure, Ash. Yeah. So we -- what we've talked about in the past and what I mentioned in my opening remarks is our plan has always been to roughly double the size of the sales force to support both the IPF and ralinepag indications. And we've done that. So we accelerated that process, made that decision earlier this year to accelerate that process and get those sales reps out in the field by July 1, which we've essentially done.

當然，Ash。是的。所以——我們過去談過、而我在開場致詞也提到，我們的計畫一直是將銷售團隊規模大致加倍，以支援 IPF 與 ralinepag 兩個適應症。而我們已經做到了。因此我們加速了這個流程，今年稍早就決定加快推進，並在 7 月 1 日前讓這些業務代表到第一線，基本上我們已經完成了。

I mean we still got maybe one or two openings that we have to fill. But essentially, we've expanded the sales force. Now of course, ralinepag and IPF are not approved indications. So they're not out detailing those two products or indications, but we're using them, I think, to really kind of get a little bit more leverage and a little bit greater reach and frequency to providers in our approved indications of PAH and PH-ILD.

我的意思是，我們可能還有一兩個缺額需要補上。但基本上，我們已擴編銷售團隊。當然，ralinepag 和 IPF 目前都還不是核准適應症。所以他們不會去推廣（detail）這兩個產品或適應症，但我認為我們正在利用這支團隊，讓我們在已核准的 PAH 與 PH-ILD 適應症上，能取得更多槓桿、並提升對醫療提供者的覆蓋範圍與拜訪頻率。

And so that -- like I said, we have them out in early July, and so they're out and starting to call on those physicians. I think the -- your point on the call point is it's a little bit different in the sense that with IPF, those patients are much more in the community than the academic centers, and that was really sort of the rationale behind expanding the sales force in IPF is because we knew we were going to have to go deeper into the community than we previously have had to because that's where those patients reside. So it's not necessarily a different physician. It's just a question of getting deeper into the community than we currently have.

所以——如我所說，我們在 7 月初就讓他們上線，因此他們已經開始拜訪那些醫師。我想——你提到的拜訪目標點確實有些不同，因為在 IPF 方面，患者更多是在社區端，而不是在學術醫學中心；這也是我們擴編 IPF 銷售團隊的主要理由，因為我們知道必須比以往更深入社區，因為患者就在那裡。所以不一定是不同的醫師。只是要比我們目前更深入社區而已。

Olivia Saunders, Cantor.

Olivia Saunders，Cantor。

Hi. Good morning, guys. Thanks for taking the questions. Are you able to put some numbers around how big of a revenue opportunity you see IPF being, maybe, kind of, overall franchise at peak? And just given how impressive JASCAYD's uptake has been so far, how does that impact the way that you guys are thinking about your own launch just given some of the differences between JASCAYD and Tyvaso?

嗨。各位早安。謝謝回答問題。你們是否能用一些數字來說明，你們認為 IPF 的營收機會有多大——例如整體產品線在高峰期的規模？另外，考量到 JASCAYD 目前的採用速度非常亮眼，這會如何影響你們對自身上市推進的思考，尤其是考量 JASCAYD 與 Tyvaso 之間的一些差異？

I also did want to see if there's anything you can say around baseline characteristics of the TETON PPF patients enrolled so far, just given that you're hitting that 95%-plus and whether you guys plan to publish those details after enrollment wraps. Thank you.

我也想了解，關於目前已入組的 TETON PPF 患者，你們是否能談談其基線特徵；畢竟你們入組已達 95% 以上，而且你們是否計畫在入組完成後發表這些細節。謝謝。

Thanks, Olivia, for your questions. I think Michael will address the commercial expectations side of it, and then maybe Leigh can answer the part on PPF patient characteristics.

謝謝你，Olivia，提出問題。我想 Michael 會回應商業預期的部分，然後也許 Leigh 可以回答 PPF 患者特徵的部分。

Yeah. So I think, Olivia, on your first question in terms of opportunity, as I said, I think to an earlier question, I think we'll start to provide more information on kind of all of that peak potential and ramp and trajectory and all of that as we get to the second half -- deeper into the second half of the year.

是的。所以我想，Olivia，關於你第一個問題、也就是機會規模方面，如我先前回覆較早的問題時所說，我們會在下半年——更深入進入下半年時——開始提供更多資訊，包含高峰潛力、爬坡與成長軌跡等。

The -- yeah, JASCAYD has had, I think, a very strong launch. I mean there's no question. And so we're certainly -- we're certainly looking at that. We're looking at what OFEV and Esbriet and all those things factor into kind of how we're thinking about the Tyvaso trajectory. But like I said, we'll have more details to share on that as we get to kind of later part of this year, early 2027.

至於——是的，JASCAYD 我認為上市表現非常強勁。這點毫無疑問。因此我們當然——我們當然也在關注。我們也在評估 OFEV、Esbriet 以及所有這些因素，如何納入我們對 Tyvaso 成長軌跡的思考。但如我所說，我們會在今年稍晚、以及 2027 年初分享更多細節。

Leigh, do you want to take the PPF question?

Leigh，你要回答 PPF 的問題嗎？

Yeah. So as we mentioned, our PPF study enrollment is actually quite a bit ahead of schedule, finishing up very, very shortly. And yeah, we will present the baseline characteristics of those -- that patient population in upcoming conferences. And so basically, that's your answer. Yeah, you will be seeing those. We look forward to sharing. Thank you.

好的。如我們提到的，我們的 PPF 研究入組進度其實大幅超前，將在非常、非常短期內完成。是的，我們會在接下來的會議上呈現該患者族群的基線特徵。所以基本上，答案就是這樣。是的，你們會看到那些資料。我們也期待與大家分享。謝謝。

Lisa Walter, RBC Capital Markets.

Lisa Walter，RBC Capital Markets。

Morning. Thanks for taking our question. Just a quick one on the IPF sNDA filing. Wonder if you could share the date when it was filed and when we could hear about acceptance of the filing and whether you think there is potential for priority review? Any color here would be helpful. Thanks so much.

早安。謝謝回答我們的問題。關於 IPF 的 sNDA 申請送件，我有個簡短問題。想請問你們能否分享送件日期，以及我們何時能得知申請是否被受理，另外你們是否認為有機會獲得優先審查？任何補充說明都會很有幫助。非常感謝。

Thanks, Lisa. Always happy to take your questions. I think Leigh can answer that one.

謝謝你，Lisa。一向很樂意回答你的問題。我想 Leigh 可以回答這題。

Yeah. So we submitted late June, and we will be learning shortly if we're able to receive priority review, probably -- well, I can't really give a specific date on that. But again, that would be a six-month review period if that is received and 10 months otherwise. So that's basically what I can say right now.

好的。我們在 6 月下旬提交，且我們將在不久後得知是否能獲得優先審查；大概——嗯，我無法提供一個具體日期。但再次說明，若獲得優先審查，審查期為 6 個月；否則為 10 個月。所以目前我能說的大致就是這些。

I think that was perfect, Leigh. Operator, you can go ahead and wrap up the call.

我覺得這回答很到位，Leigh。接線員，你可以開始結束本次電話會議。

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 -- sorry, that is at ir.unither.com. You may now disconnect.

感謝您參與今日 United Therapeutics Corporation 的財報網路直播。本次網路直播的重播將提供一週回放，請造訪 United Therapeutics 投資人關係網站 ir.unither.com 的「Events and Presentations」區域——也就是——抱歉，是在 ir.unither.com。您現在可以掛線。