United Therapeutics Corp (UTHR) 2024 Q3 法說會逐字稿

Good morning, and welcome to the United Therapeutics Corporation third quarter 2024 earnings webcast. My name is Dave, 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 2024 年第三季收益網路廣播。我叫戴夫，今天我將擔任你們的會議操作員。（操作員說明）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.

我現在想將網路廣播交給 United Therapeutics 投資者關係主管 Dewey Steadman。

Thank you, Dave, and good morning. It's my pleasure to welcome you to the United Therapeutics Corporation third quarter 2024 earnings webcast. Remarks today will include forward-looking statements representing our expectations or beliefs regarding future events, and these statements involve risks and uncertainties that may cause actual results to differ materially.

謝謝你，戴夫，早安。我很高興歡迎您觀看聯合治療公司 2024 年第三季收益網路廣播。今天的言論將包括代表我們對未來事件的期望或信念的前瞻性陳述，這些陳述涉及可能導致實際結果產生重大差異的風險和不確定性。

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. Today's remarks may discuss the progress and results of clinical trials or other developments with respect to our products, and 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 are available on our website.

我們最新的 SEC 文件（包括表格 10-K 和 10-Q）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聲明的義務。今天的言論可能會討論臨床試驗的進展和結果或與我們產品有關的其他發展，這些言論僅旨在教育投資者，無意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的用途都是安全有效的。我們的網站上提供了產品的完整處方資訊。

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 & Xenotransplantation; and Pat Poisson, our Executive Vice President of Technical Operations.

陪同我參加今天的電話會議的是我們的董事長兼執行長 Martine Rothblatt 博士； Michael Benkowitz，我們的總裁兼營運長； James Edgemond，我們的財務長兼財務主管； Leigh Peterson 博士，我們的產品開發和異種移植執行副總裁；以及我們的技術營運執行副總裁 Pat Poisson。

Note that Pat Poisson and I will participate in a fireside chat session and one-on-one meetings at the UBS Global Healthcare Conference outside of Los Angeles on November 12. Along with Harry Silvers from our Investor Relations team, I will be at the Oppenheimer Rare Disease Day in New York City on December 12. And finally, Martine Rothblatt will present at the 43rd Annual JPMorgan Healthcare Conference in San Francisco in January. Our scientific, commercial and medical affairs teams will present at the Phenomenal Hope 2024 on December 6th in Boston and at the Pulmonary Vascular Research Institute Annual Congress in Rio de Janeiro in late January.

請注意，Pat Poisson 和我將參加 11 月 12 日在洛杉磯郊外舉行的瑞銀全球醫療保健會議上的爐邊聊天會議和一對一會議。我將與投資者關係團隊的 Harry Silvers 一起參加 12 月 12 日在紐約市舉行的奧本海默罕見疾病日。最後，Martine Rothblatt 將於 1 月在舊金山舉行的第 43 屆摩根大通年度醫療保健會議上發表演講。我們的科學、商業和醫療事務團隊將出席 12 月 6 日在波士頓舉行的 Phenomenal Hope 2024 大會以及 1 月底在裡約熱內盧舉行的肺血管研究所年度大會。

Now I will turn the call -- the webcast over to Martine for an overview of our third quarter 2024 financial results and the business activities of United Therapeutics. Martine?

現在我將把電話轉接給 Martine，以概述我們 2024 年第三季的財務表現和 United Therapeutics 的業務活動。馬丁娜？

Thank you, Dewey, and good morning, everyone. We have slides available for reference, and I encourage you to review those at your leisure. I'm not going to speak directly to the slides. United Therapeutics is a momentum story. We continue to reach and exceed our goals quarter after quarter, year after year in all three waves of growth: foundation, innovation and revolution. For our foundation wave, driven by our current commercial business, United Therapeutics posted its sixth consecutive quarter of record revenue, led by double-digit growth for Tyvaso, both nebulized and DPI Orenitram and Unituxin. We also had a record number of patients on Tyvaso DPI, Orenitram and Remodulin.

謝謝杜威，大家早安。我們有可供參考的幻燈片，我鼓勵您在閒暇時查看這些幻燈片。我不會直接對著投影片講話。United Therapeutics 是一個充滿動力的故事。我們在基礎、創新和變革這三波成長浪潮中，季復一季、年復一年地繼續實現並超越我們的目標。對於我們的基礎浪潮，在我們當前商業業務的推動下，United Therapeutics 公佈了連續第六個季度創紀錄的收入，其中 Tyvaso、霧化劑以及 DPI Orenitram 和 Unituxin 實現了兩位數增長。我們使用 Tyvaso DPI、Orenitram 和 Remodulin 的患者數量也創下了紀錄。

We remain confident in the potential for our current commercial business to continue to drive double-digit revenue growth in the near and midterm as our innovation wave starts to reach the market. Our innovation wave is on the cusp of generating significant registration phase data with the TETON 2 study of nebulized Tyvaso in idiopathic pulmonary fibrosis expected to report top line data in the second half of 2025. As we progress toward full enrollment for TETON 1 by the end of this year, data for that study will not be far behind. In 2026, we expect to complete our ADVANCE OUTCOMES study of Ralinepag in PAH.

隨著我們的創新浪潮開始進入市場，我們對當前商業業務在近期和中期繼續推動兩位數收入成長的潛力充滿信心。我們的創新浪潮正處於產生重要登記階段數據的風口浪尖，霧化泰瓦索治療特發性肺纖維化的 TETON 2 研究預計將在 2025 年下半年報告頂線數據。隨著我們在今年年底實現 TETON 1 的全面註冊，該研究的數據也不會落後太多。2026 年，我們預計完成 Ralinepag 在 PAH 中的 ADVANCE OUTCOMES 研究。

And finally, in 2025, we expect FDA action on our recently submitted premarket approval application for our Centralized Lung Evaluation System, or CLES, Ex Vivo Lung Perfusion technology. Beyond our record-setting commercial performance, we expect a steady stream of clinical data reads and regulatory actions through the next 36 months, setting our company up well for continued growth through the balance of the decade. Our revolution wave is also making tangible progress toward reality with our Phase 1 study for miroliverELAP now underway, the first clinical study of a bioengineered organ alternative. We expect data from this initial safety study in 2025.

最後，我們預計 FDA 會在 2025 年對我們最近提交的集中肺評估系統（CLES，Ex Vivo Lung Perfusion 技術）的上市前批准申請採取行動。除了創紀錄的商業業績外，我們預計未來 36 個月內將有穩定的臨床數據讀取和監管行動，為我們公司在未來十年的持續成長奠定良好的基礎。我們的革命浪潮也正在朝著現實取得切實進展，我們的 miroliverELAP 第一階段研究正在進行中，這是生物工程器官替代品的第一個臨床研究。我們預計這項初步安全研究的數據將於 2025 年獲得。

Also within our revolution wave, we recently received feedback from the FDA regarding our IND for our UKidney 10-gene edited porcine xenokidney, and we expect to file our IND shortly for what will be the first clinical study of a xeno organ. We look forward to sharing more details on our clinical trial design and commercial opportunity in the future following acceptance of our IND.

同樣在我們的革命浪潮中，我們最近收到了FDA 關於我們的UKidney 10 基因編輯的豬異種腎的IND 的反饋，我們預計很快就會提交我們的IND，這將是第一個異種器官的臨床研究。我們期待在 IND 被接受後，在未來分享更多有關我們的臨床試驗設計和商業機會的細節。

To close, I want to reiterate that our momentum is strong and growing. We have double-digit revenue growth from our thriving commercial business. We have several important data reads and potential regulatory decisions over the next 36 months, and we're moving into the clinic with revolutionary organ alternative technologies. In short, there is no other biotech with the vision, grit and determination as United Therapeutics.

最後，我想重申，我們的勢頭強勁且不斷增長。我們蓬勃發展的商業業務實現了兩位數的收入成長。我們在未來 36 個月內有多項重要的數據讀取和潛在的監管決策，並且我們將帶著革命性的器官替代技術進入臨床。簡而言之，沒有其他生技公司像 United Therapeutics 那樣具有遠見、勇氣和決心。

I'll now turn the call over to Chief Financial Officer and Treasurer, James Edgemond, to give a summary of our recently completed accelerated share repurchase program and our capital allocation priorities. James?

現在，我將把電話轉交給財務長兼財務主管 James Edgemond，概述我們最近完成的加速股票回購計畫和我們的資本配置優先事項。詹姆斯？

Thank you, Martine. I'd like to provide an update on our capital allocation strategy, specifically regarding our accelerated share repurchase program, or ASR, that was announced in late March 2024 earlier this year. As you recall, we entered into an ASR agreement with Citi to repurchase $1 billion of UTHR common stock. During the third quarter, Citi successfully completed the overall ASR program having repurchased a total of approximately 3.5 million shares at an average repurchase price of approximately $282 which repurchase shares we are currently holding as treasury stock on our balance sheet.

謝謝你，馬丁娜。我想提供有關我們資本配置策略的最新信息，特別是有關今年早些時候於 2024 年 3 月下旬宣布的加速股票回購計劃 (ASR) 的信息。您還記得，我們​​與花旗簽訂了 ASR 協議，回購價值 10 億美元的 UTHR 普通股。第三季度，花旗成功完成了整體 ASR 計劃，以平均回購價格約 282 美元回購了總計約 350 萬股股票，這些股票是我們目前在資產負債表上作為庫存股持有的股票。

The approximately 3.5 million repurchase shares represent approximately 7% of our outstanding shares as of the program's initiation day. Despite this overall reduction in UT's outstanding share count, liquidity in our stock has increased as reflected by our average daily trading volume being at its highest level ever through the end of September.

截至該計劃啟動之日，約 350 萬股回購股份約占我們已發行股份的 7%。儘管 UT 流通股數量總體減少，但我們股票的流動性有所增加，這一點從截至 9 月底我們的日均交易量達到有史以來的最高水平就可以看出。

Since the program's announcement in late March 2024, our stock appreciated 47% through September 30. The completion of this ASR program demonstrates our commitment over the last 12 months to all of our capital allocation priorities. First, through our innovative clinical development pipeline, as well as CapEx to support our DPI manufacturing facility in North Carolina and our clinical scale xenotransplantation DPF facilities in Virginia and Minnesota.

自 2024 年 3 月下旬宣布該計劃以來，截至 9 月 30 日，我們的股票上漲了 47%。此 ASR 計劃的完成表明了我們在過去 12 個月中對所有資本配置優先事項的承諾。首先，透過我們的創新臨床開發管道以及資本支出來支持我們位於北卡羅來納州的 DPI 製造工廠以及我們位於維吉尼亞州和明尼蘇達州的臨床規模異種移植 DPF 工廠。

Second, through the acquisition of IVIVA and Miromatrix, as well as an in-licensing agreement to support our small molecule business. And finally, through successful completion of this ASR. Looking ahead, we remain committed to all three capital allocation priorities, which in order are, first, to invest in our commercial and R&D opportunities through P&L spend as well as capital outlays for our commercial and clinical facilities. Our second priority is to pursue intelligent business and corporate development opportunities that enhance our rare disease focus and complement our organ alternative initiatives like bolt-on M&A and in-license opportunities. And our third priority is to return capital to shareholders like share repurchases. And we'll continue to consider all three priorities when deploying our financial capital.

其次，透過收購 IVIVA 和 Miromatrix，以及簽訂授權協議來支援我們的小分子業務。最後，成功完成此 ASR。展望未來，我們仍然致力於所有三個資本配置優先事項，首先是透過損益支出以及商業和臨床設施的資本支出來投資我們的商業和研發機會。我們的第二優先事項是尋求明智的業務和企業發展機會，以加強我們對罕見疾病的關注，並補充我們的器官替代計劃，例如補強併購和許可機會。我們的第三個優先事項是向股東返還資本，例如股票回購。在部署我們的金融資本時，我們將繼續考慮所有三個優先事項。

Our healthy balance sheet and robust cash flow generation driven by our growing commercial portfolio, enable us to continue to pursue these capital allocation priorities in a thoughtful manner. Moreover, we remain in a strong position to meet our mid and long-term goals that set ourselves up for future growth across our innovative pipeline with Tyvaso in pulmonary fibrosis and Ralinepag in pulmonary hypertension, and our revolutionary organ alternative program.

在我們不斷增長的商業投資組合的推動下，我們健康的資產負債表和強勁的現金流產生使我們能夠繼續以深思熟慮的方式追求這些資本配置優先事項。此外，我們仍然處於實現中長期目標的有利地位，這些目標為我們在肺纖維化領域的 Tyvaso 和肺動脈高壓領域的 Ralinepag 創新產品線以及革命性的器官替代計劃的未來增長奠定了基礎。

On a separate note, in the third quarter, we recorded under selling, general and administrative expenses, a litigation accrual of $65.1 million in connection with a potential judgment in the Sandoz case. While this liability could be adjusted up or down in the future as the litigation progresses, it should not be considered a recurring expense.

另外，在第三季度，我們在銷售、一般和管理費用項下記錄了與 Sandoz 案的潛在判決相關的 6,510 萬美元的訴訟應計費用。雖然隨著訴訟的進展，這項負債將來可能會上下調整，但不應將其視為經常性費用。

I'll now turn the call over to our President, Michael Benkowitz, who will give an overview of our commercial performance. Michael?

現在我將把電話轉給我們的總裁 Michael Benkowitz，他將概述我們的商業表現。麥可？

Thank you, James, and good morning, everyone. Today, we are excited and pleased to report another quarter of record-breaking revenue, achieving a remarkable $749 million, which represents a 23% growth from the third quarter of 2023. Achieving this $3 billion revenue run rate just eight quarters after surpassing the $2 billion run rate mark is a significant milestone for our company, something we have been really focused on hitting since the beginning of the year. Before I provide the usual product performance overview, I want to express my thanks and congratulations to my fellow Unitarians for their incredible effort and success.

謝謝你，詹姆斯，大家早安。今天，我們很高興並高興地報告另一個季度的收入破紀錄，達到 7.49 億美元，較 2023 年第三季增長 23%。在突破20 億美元的運行率大關後僅八個季度就實現了30 億美元的收入運行率，這對我們公司來說是一個重要的里程碑，也是我們自今年年初以來一直致力於實現的目標。在提供通常的產品性能概述之前，我想對我的一神論者同胞們所付出的令人難以置信的努力和成功表示感謝和祝賀。

Total Tyvaso revenue for the third quarter was $434 million, marking a 33% increase over the previous year. This growth was driven by continued uptake of Tyvaso DPI, growth in utilization by PH-ILD patients, an increase in pricing and enhanced commercial utilization following the implementation of the Part D redesign provisions under the Inflation Reduction Act.

Tyvaso 第三季總營收為 4.34 億美元，較上年成長 33%。這一增長的推動因素包括 Tyvaso DPI 的持續使用、PH-ILD 患者使用量的增長、定價的上漲以及根據《通貨膨脹減少法案》實施 D 部分重新設計條款後商業利用率的提高。

Tyvaso has solidified its position as the number one prescribed prostacyclin treatment in the US across both nebulizer and dry powder inhaler delivery systems. Referral and start patterns remain very robust and the franchise saw record commercial and total patients, reinforcing our confidence in the durability of our growth profile. We're also seeing the benefit of the sales force expansion and realignment that went into effect at the beginning of this year.

Tyvaso 鞏固了其作為美國霧化器和乾粉吸入器輸送系統第一處方前列環素治療藥物的地位。轉診和啟動模式仍然非常強勁，特許經營業務的商業和患者總數創歷史新高，增強了我們對成長狀況持久性的信心。我們也看到了今年年初生效的銷售團隊擴張和重組的好處。

Through the third quarter, we have grown our prescriber base by almost 15%, while still maintaining prescribing depth, measured as those physicians with three or more Tyvaso patients. 40% of these new prescribers are ILD physicians which is important to grow the PH-ILD market and eventually the IPF and PPF markets if our clinical trials in those indications are successful.

截至第三季度，我們的處方者基礎增加了近 15%，同時仍保持處方深度（以治療三名或更多 Tyvaso 患者的醫生來衡量）。這些新處方者中有 40% 是 ILD 醫生，如果我們在這些適應症上的臨床試驗取得成功，這對於發展 PH-ILD 市場以及最終發展 IPF 和 PPF 市場非常重要。

We also reported record revenue for Orenitram at $113 million for the third quarter, representing a 23% growth from the same period last year. This increase was driven by increased demand, higher commercial utilization and pricing adjustments. As with Tyvaso, referral and start patterns remained strong, and we ended the quarter with a record number of commercial and total patients. We are seeing increased utilization of the expedite induction protocol where PAH patients initiate treprostinil therapy on Remodulin and then transition to Orenitram.

我們也報告了 Orenitram 第三季的創紀錄收入為 1.13 億美元，較去年同期成長 23%。這一增長是由需求增加、商業利用率提高和價格調整所推動的。與 Tyvaso 一樣，轉診和啟動模式仍然強勁，本季結束時，我們的商業患者數量和患者總數均創歷史新高。我們看到快速誘導方案的使用增加，其中 PAH 患者開始使用瑞莫杜林進行曲前列環素治療，然後過渡到奧瑞尼曲。

Over time, we could see the average Orenitram dose per patient increase as patients are able to reach a therapeutic dose more quickly with this approach. Worldwide revenue for Remodulin was $128 million, a slight decline of 2% from last year due to international order timing. However, US revenue grew by 3% year-over-year, setting a new record for total US patients on therapy. And for the first nine months of the year, US Remodulin revenue was up about 12% from the same period in 2023 reflecting the continued strength of the brand despite competition on multiple fronts.

隨著時間的推移，我們可以看到每位患者的平均奧瑞尼曲劑量增加，因為患者能夠透過這種方法更快達到治療劑量。Remodulin 的全球收入為 1.28 億美元，由於國際訂單時間安排，比去年小幅下降 2%。然而，美國收入年增 3%，創下美國接受治療患者總數的新紀錄。今年前 9 個月，美國 Remodulin 營收較 2023 年同期成長約 12%，反映出該品牌儘管面臨多條戰線的競爭，但仍保持強勁實力。

Looking deeper, US Remodulin referral and start patterns remain very strong. Remodulin remains the most prescribed parental prostacyclin in the US with sustained demand for both intravenous and subcutaneous administration. And this comes five years after the first launch of a generic version of Remodulin.

更深入地看，美國 Remodulin 推薦和啟動模式仍然非常強大。瑞莫杜林仍然是美國處方最多的親用前列環素，靜脈和皮下給藥的需求持續成長。這是在 Remodulin 仿製藥首次推出五年後。

Finally, Unituxin also achieved record revenue of $61 million for the third quarter, up 19% from the prior year quarter. US revenue for Unituxin was $58 million, driven by both price and volume increases. This growth demonstrates the product's strong market presence and the effectiveness of our commercial strategies. To wrap up, we are extremely proud of our achievements this quarter driven by strong performance from each of our commercial products. We are well positioned to continue providing these important medicines to our patients and delivering value to our shareholders.

最後，Unituxin 第三季營收也創下了 6,100 萬美元的紀錄，比去年同期成長 19%。由於價格和銷售量的成長，Unituxin 在美國的收入為 5,800 萬美元。這一成長證明了該產品強大的市場影響力和我們商業策略的有效性。總而言之，我們對本季所取得的成就感到非常自豪，這得益於我們每個商業產品的強勁表現。我們有能力繼續為我們的患者提供這些重要的藥物，並為我們的股東創造價值。

Martine, I'll turn things back to you to run the Q&A. Martine, do we still have you?

馬丁，我會把事情轉回給你來進行問答。馬丁，我們還有你嗎？

We have lost connection with Martine.

我們與馬丁失去了聯繫。

Yeah, I'll run the Q&A. Operator, can we have our first question, please?

是的，我會進行問答。接線員，我們可以問第一個問題嗎？

(Operator Instruction)

（操作員說明）

Joseph Thome, TD Cowen.

約瑟夫·托姆，TD·考恩。

Hi there. Good morning and congrats on the progress. Maybe a little bit of a follow-up to the expedite question. We have heard since (technical difficulty) launch that some patients are able to deescalate from Remodulin down to oral Orenitram. I guess, is this something that you were seeing? Obviously, Orenitram was strong in the quarter. And patients that do kind of titrate off of Remodulin onto the Orenitram, are they going to higher doses like what we were seeing in expedite? Maybe how would you expect this to impact the revenue line maybe going forward? Thank you.

你好呀。早上好，祝賀取得的進展。也許是對加急問題的一些後續行動。自從（技術困難）推出以來，我們聽說一些患者能夠從瑞莫杜林降級為口服奧瑞尼曲。我想，這是你所看到的嗎？顯然，奧瑞尼曲本季表現強勁。那些確實將瑞莫杜林滴定到奧瑞尼曲的患者，他們是否會像我們在加急中看到的那樣接受更高的劑量？也許您預計這將如何影響未來的收入線？謝謝。

Michael, go ahead. Can you take that?

邁克爾，繼續吧。你能接受嗎？

Yeah, I'll go ahead and take that one. Yeah. So I think two parts to that question, Joe. Thanks for the question. I think on the first part in terms of the -- I guess, the down titration off of Remodulin to Orenitram, I wouldn't say this is a trend yet or I guess, a widely used practice. I mean, we have heard at the margins that there -- some patients are able to do that.

是的，我會繼續接受那個。是的。所以我認為這個問題有兩個部分，喬。謝謝你的提問。我認為，在第一部分中，我想，Remodulin 滴定為 Orenitram，我不會說這是一種趨勢，或者我猜，這是一種廣泛使用的做法。我的意思是，我們聽說有些患者能夠做到這一點。

But I think the jury is still out on whether that's going to become like a widespread trend. We did kind of point back to kind of how -- to Remodulin performance during the quarter which is certainly showing that brand is continuing to grow, and there's certainly still a place for Remodulin and parental prostacyclin therapy in PAH.

但我認為，對於這是否會成為一種普遍趨勢，目前還沒有定論。我們確實回顧了 Remodulin 在本季度的表現，這無疑表明該品牌正在持續成長，並且 Remodulin 和親代前列環素治療在 PAH 中肯定仍然有一席之地。

Regarding expedite and the transition from Remodulin to Orenitram, and the short answer to that is, yes, we do expect higher doses with Orenitram as a result of the expedite protocol. We're seeing, I'd say, higher average dose, right? Because the idea is that you start patients on Remodulin, you titrate them up to a range of a dose and then you're able to transition them over to Orenitram and you're able to get them up to a therapeutic dose, in some cases as soon as a month, but I would say, in kind of a one to two range, which would normally take -- if you're starting de novo, it could take up to six months. And then from there, depending on the patients to how the patient is doing, you can continue to titrate up. So as a result of that, as we see more patients coming to Orenitram from Remodulin, we're going to see that average dose for Orenitram to continue to tick up over time.

關於加速和從瑞莫杜林到奧雷尼曲的過渡，簡短的回答是，是的，我們確實預計由於加速方案，奧雷尼曲的劑量會更高。我想說，我們看到平均劑量更高，對吧？因為這個想法是，你開始給患者服用瑞莫杜林，你將他們調整到一定的劑量範圍，然後你可以將他們過渡到奧瑞尼曲，在某些情況下，你可以讓他們達到治療劑量最快一個月，但我想說，在一到兩個月的範圍內，這通常需要——如果你從頭開始，可能需要長達六個月的時間。然後從那裡開始，根據患者的情況，您可以繼續滴定。因此，當我們看到越來越多的患者從瑞莫杜林轉向奧瑞尼曲時，我們將看到奧瑞尼曲的平均劑量隨著時間的推移繼續增加。

Thank you, Michael. Great answer. Next question, please.

謝謝你，麥可。很好的答案。請下一個問題。

Roanna Ruiz, Leerink Partners.

羅安娜·魯伊斯 (Roanna Ruiz)，Leerink 合夥人。

Morning, everyone. So I noticed that the nebulized Tyvaso had pretty robust growth in the quarter along with DPI. I was just curious if you could elaborate on some of the drivers behind that? Did that include some new patient starts? And was there a piece of that where if you're observing, are there more patients transitioning from nebulizer to DPI eventually?

早安，大家。因此，我注意到霧化 Tyvaso 在本季度與 DPI 一起出現了相當強勁的成長。我只是很好奇您能否詳細說明背後的一些驅動因素？這是否包括一些新患者的開始？如果您觀察，是否有更多患者最終從霧化器過渡到 DPI？

Thanks, Roanna. Michael, you definitely have the most knowledge of us on that. So if you could answer?

謝謝，羅安娜。邁克爾，在這方面你絕對是我們最了解的。那你能回答嗎？

Sure. I think some of the growth -- some of the year-over-year growth in the nebulized Tyvaso was a function of some of the destocking that we saw last year. And so that may be explain some of the delta. But I would say generally, from a trending standpoint, I think we've reached kind of a really nice kind of steady state in terms of the mix of DPI and nebulizer.

當然。我認為霧化泰瓦索的一些增長——一些同比增長是我們去年看到的一些去庫存的結果。這也許可以解釋一些三角洲。但我想說的是，從趨勢的角度來看，我認為我們在 DPI 和霧化器的組合方面已經達到了非常好的穩定狀態。

It's roughly 2/3, 1/3 in favor of DPI. And we're starting to see really both of those growing. I would say, transitions back and forth between the products, nebulizer to DPI or DPI to nebulizer, it's pretty marginal at this point. I mean, we are seeing some of that, but not a lot.

大約是 2/3，1/3 有利於 DPI。我們開始看到這兩者都在增長。我想說的是，在產品、霧化器到 DPI 或 DPI 到霧化器之間來回轉換，在這一點上是相當微不足道的。我的意思是，我們看到了其中一些，但不是很多。

I mean, I think we saw -- when we launched in the DPI, we did see, obviously, a significant number of nebulizer patients transition over to DPI. But that's largely played out. So it's really, I think, more case by case, how is the patient doing on one delivery system versus the other. And then the nice thing about our portfolio is the doctors can toggle back and forth as they need to, depending on how the patient is doing. Martine?

我的意思是，我認為我們看到——當我們推出 DPI 時，我們確實看到，顯然，大量霧化器患者過渡到 DPI。但這基本上已經結束了。所以，我認為，更多的是根據具體情況，患者在一種輸送系統上與另一種輸送系統上的表現如何。我們的產品組合的好處是醫生可以根據需要來回切換，這取決於患者的情況。馬丁娜？

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

完美的。非常感謝邁克爾。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 your questions and congrats on another solid quarter. We have some couple of capital allocation questions, just one or two parts here. But can you talk about Tyvaso and Tyvaso DPI manufacturing capacity needs to support IPF? Will additional investment need to take place? And then along the share repurchase program, how are you thinking about the potential to run another program, especially given the lead up into the IPF?

早安，感謝您提出問題，並祝賀又一個堅實的季度。我們有一些資本配置問題，這裡只是一兩個部分。但您能談談支援 IPF 的 Tyvaso 和 Tyvaso DPI 製造能力需求嗎？是否需要進行額外投資？然後，在股票回購計劃中，您如何考慮運行另一個計劃的潛力，特別是考慮到 IPF 的啟動？

Okay. Thanks for those questions. And by the way, thanks to Oppenheimer as well for continuing a Rare Disease Day that we'll be very proud to present at. Our whole community appreciates that. Those two questions are best addressed by James. So James, can you take it from here?

好的。謝謝你提出這些問題。順便說一句，也要感謝奧本海默繼續舉辦罕見疾病日活動，我們將非常自豪地出席這項活動。我們整個社區對此表示讚賞。詹姆斯最好地回答了這兩個問題。那麼詹姆斯，你能從這裡拿走嗎？

Yeah. Thanks, Martine. So Andreas, good to hear your voice this morning. On your first question, which I think was capital allocation, but really related to production of DPI relative to an approval in IPF. And we do not expect to have -- or let me say it differently, we expect to be able to support and approval of IPF with DPI. So our production facility in North Carolina, which we talked about previously, a $500 million investment in a new manufacturing facility for Tyvaso DPI and the thinking of expanding that manufacturing capacity was not only to continue serving the existing patient population but be in a strong position to support new indications that would use DPI going forward. So we don't expect any -- we expect to be able to support that and don't expect any shortages or anything like that going forward at all.

是的。謝謝，馬丁娜。安德烈亞斯，很高興今天早上聽到你的聲音。關於你的第一個問題，我認為是資本配置，但實際上與 DPI 的生產相關，並與 IPF 的批准相關。我們不希望——或者換句話說，我們希望能夠透過 DPI 支援和批准 IPF。因此，我們在北卡羅來納州的生產設施（我們之前談過）投資5 億美元為Tyvaso DPI 建造新的生產設施，以及擴大生產能力的想法不僅是為了繼續為現有患者群體服務，而且要處於有利地位支持未來將使用 DPI 的新適應症。所以我們不期望任何——我們期望能夠支持這一點，並且不期望未來出現任何短缺或類似的情況。

The second question with respect to the share repurchase. As I mentioned in my opening remarks, we did do the $1 billion ASR in 2024, which was completed in September. And as I also mentioned, over the last 12 months, we've actually demonstrated our commitment to all three capital allocation priorities through various opportunities. And going forward, we're going to continue to thoughtfully evaluate the deployment of capital in all our capital allocation priorities going forward. So investing in ourselves, in our facilities through a thoughtful corporate development, but also through potentially ASRs. But again, at this point, we're not calling specifically out in ASR going forward, but it's going to be in our catalyst going forward as we look at all our capital deployment. So Martine, back to you.

第二個問題，關於股份回購。正如我在開場白中提到的，我們確實在 2024 年完成了 10 億美元的 ASR，並在 9 月完成。正如我還提到的，在過去 12 個月中，我們實際上透過各種機會展示了我們對所有三個資本配置優先事項的承諾。展望未來，我們將繼續認真評估未來所有資本配置優先事項中的資本部署。因此，透過深思熟慮的企業發展以及潛在的 ASR 來投資我們自己、投資我們的設施。但同樣，在這一點上，我們並沒有特別呼籲 ASR 向前發展，但當我們審視我們所有的資本部署時，它將成為我們向前發展的催化劑。馬丁娜，回到你身邊。

Okay. Thank you, James. That's -- I love how you covered all 360 degrees of that question, excellent. Operator, next question.

好的。謝謝你，詹姆斯。那是——我喜歡你 360 度全方位涵蓋這個問題的方式，太棒了。接線員，下一個問題。

Roger Song, Jefferies.

羅傑·宋，杰弗里斯。

Great. Congrats for the quarter. Maybe a question relates to the margin. And since your sales is reaching a pretty good kind of steady state with a slight growth just curious about the nuance between IV versus subcu against the generics? And then should we see some regrowth from here?

偉大的。恭喜本季。也許有一個問題與保證金有關。既然你們的銷售額達到了相當好的穩定狀態，並且略有增長，只是對 IV 與 subcu 與仿製藥之間的細微差別感到好奇？然後我們應該會看到這裡有一些再生嗎？

Okay, Roger. Thank you for your question and the complement on the (technical difficulty) order. Yes, and thank you also for recognizing the growth in the Remodulin patients. I think Mike would have all of the answers at his fingertips to the questions you asked. Mike?

好吧，羅傑。感謝您的提問以及對（技術難度）訂單的補充。是的，也感謝您認可 Remodulin 患者的成長。我認為麥克對你提出的問題的所有答案都唾手可得。麥克風？

Thanks, Martine. Thanks for the question, Roger. So with respect to Remodulin, I mean -- I think we have -- ever since we were on the cusp of a generic launch, been very confident about the durability and resilience of the brand through generic competition and then even through the introduction of other medicines in PAH. I think if you talk to doctors today, they still think that, that is one of the go-to drugs, one of the best drugs that we have at our disposal to treat pulmonary hypertension patients.

謝謝，馬丁娜。謝謝你的提問，羅傑。因此，就Remodulin 而言，我的意思是——我認為我們——自從我們正處於仿製藥上市的風口浪尖以來，我們就通過仿製藥競爭，甚至通過引入其他藥物，對該品牌的耐用性和彈性非常有信心。我想如果你今天與醫生交談，他們仍然認為這是首選藥物之一，是我們可以使用的治療肺動脈高壓患者的最佳藥物之一。

I think the limitation of it being more widely used is one is patients are a little bit reluctant to go on a pump before they have to. And there are other options available. So naturally, we're going to want to try and experiment or use these less invasive options before moving to Remodulin.

我認為它被更廣泛使用的限制之一是患者在必須之前有點不願意使用泵。還有其他可用選項。因此，在轉向 Remodulin 之前，我們自然會想要嘗試和實驗或使用這些侵入性較小的選擇。

But PAH is a progressive disease. There is no cure. And so we believe that really almost all patients, at some point, are going to need parental prostacyclin. So that's really why, over time, we've been very, I think, confident in the durability of the Remodulin product. And we continue to feel that, that will be the case going forward.

但 PAH 是一種進行性疾病。沒有治癒方法。因此，我們相信幾乎所有患者在某個時候都需要父母使用前列環素。因此，我認為，這就是為什麼隨著時間的推移，我們對 Remodulin 產品的耐用性非常有信心。我們仍然認為，未來的情況將會如此。

And so as we look out into the future, we continue to believe that it will continue to perform at current levels. As we talked about with I think Joe's question, I mean, there could be some toggling back and forth between Remodulin and Orenitram, starting on Remodulin, going to Orenitram, moving up to Orenitram. But even those patients, at some point, may need to go on Remodulin. So you may see some variability there over the next few years as the expedite approach continues to take hold.

因此，當我們展望未來時，我們仍然相信它將繼續保持當前水平。當我們討論喬的問題時，我的意思是，Remodulin 和 Orenitram 之間可能會有一些來回切換，從 Remodulin 開始，到 Orenitram，再到 Orenitram。但即使是這些患者，在某些時候也可能需要繼續服用瑞莫杜林。因此，隨著加急方法的繼續流行，您可能會在接下來的幾年中看到一些變化。

We have another trial that is about to complete called the ARTISAN study where it's similar to expedite and that we're starting the patient on Remodulin. We're actually keeping them on for a longer period of time and the idea is that we're able to return the hemodynamics to a normal level and then transition those patients over to Orenitram as a maintenance drug. So we continue to feel very strongly that there will be a place for Remodulin in the PAH armamentarium now and in the future.

我們還有另一個試驗即將完成，稱為 ARTISAN 研究，它與 expedite 類似，我們開始讓患者服用 Remodulin。實際上，我們將它們保留更長的時間，我們的想法是，我們能夠將血流動力學恢復到正常水平，然後將這些患者過渡到奧瑞尼曲作為維持藥物。因此，我們仍然強烈感覺到 Remodulin 現在和將來都會在 PAH 軍備庫中佔有一席之地。

Excellent, Mike. I'd love when you used the word armamentarium. That describes us -- yeah. Well, it's like hits UT (inaudible) perfect. Operator, next question.

太棒了，麥克。我很高興你使用“armamentarium”這個詞。這描述了我們——是的。嗯，就像 UT（聽不清楚）完美一樣。接線員，下一個問題。

Jessica Fye, JPMorgan.

潔西卡法耶，摩根大通。

Great. Good morning guys, and thanks for taking my question and congrats on what sounds like some favorable pre-IND feedback for the 10-gene edit kidney. Can you elaborate on some of that pre-IND feedback you got from FDA? And maybe talk about how we should think about the design and goals for initial clinical trial?

偉大的。大家早安，感謝您提出我的問題，並祝賀您獲得了 10 基因編輯腎臟的一些有利的 IND 前反饋。您能否詳細說明一下您從 FDA 獲得的 IND 前回饋？或許可以談談我們應該如何思考初步臨床試驗的設計和目標？

Sure, Jessica, and it's so nice to hear your voice this morning as well. We have on our call, Dr. Leigh Peterson. She is in charge of all xenotransplantation. So Leigh, could you address Jessica's question.

當然，傑西卡，今天早上聽到你的聲音也很高興。我們請來的是 Leigh Peterson 博士。她負責所有異種移植工作。Leigh，你能回答一下潔西卡的問題嗎？

Yeah, sure. Thanks for the question. Thanks for the question. You're right. We did receive some pre-IND feedback from the FDA on our UKidney, which is the 10-gene edited porcine xenokidney, and we're working very hard to submit that IND shortly. We did propose the clinical study design. We had a few proposals there. But unfortunately, we haven't -- I mean, we really don't want to share all of the details until it's officially cleared by FDA, which is IND clearance. So we're really looking forward to sharing that design with you later, but we need to get that IND cleared first.

是的，當然。謝謝你的提問。謝謝你的提問。你說得對。我們確實收到了 FDA 關於我們的 UKidney（10 基因編輯的豬異種腎）的一些預 IND 反饋，我們正在非常努力地盡快提交該 IND。我們確實提出了臨床研究設計。我們在那裡提出了一些建議。但不幸的是，我們還沒有——我的意思是，在 FDA 正式批准（即 IND 批准）之前，我們真的不想分享所有細節。因此，我們非常期待稍後與您分享設計，但我們需要先獲得 IND 批准。

Thank you so much, Leigh. Great answer. Operator, next question please.

非常感謝你，利。很好的答案。接線員，請下一個問題。

Ash Verma with UBS.

阿什‧維爾瑪 (Ash Verma)，來自瑞銀集團。

Okay, Thanks for taking my question. Just good to see you get to the $3 billion annualized revenue run rate. I know you had previously outlined this goal of reaching $4 billion run rate actually in 2025. Are you still on track to get there? And then secondly, in the last quarter, you made a mention a potential rebating contracting, I know the competitor launch has since then been pushed out to May next year, but have you already rebated some book of your business preemptively?

好的，謝謝你回答我的問題。很高興看到您的年收入達到 30 億美元。我知道您之前曾概述過 2025 年運行率實際達到 40 億美元的目標。您仍然有望到達那裡嗎？其次，在上個季度，您提到了潛在的回扣合同，我知道競爭對手的推出已被推遲到明年五月，但您是否已經預先回扣了您業務的某些書籍？

Thanks

謝謝

Okay. So maybe best would be to have Mike talk about the competitor environment. And with regard to the revenue run rate, it is actually quite amazing that we have doubled from $1.5 billion to $3 billion revenue run rate so rapidly. As we've mentioned throughout the call and in the earnings release, and actually, as we've been forecasting for the past several quarters, we feel very comfortable continuing our double-digit annual revenue growth based on all of the products that we have in our portfolio and already approved and then in the pipeline and then with the three waves that we talk about.

好的。因此，也許最好讓麥克談論競爭對手的環境。至於收入運行率，我們的收入運行率如此迅速地從 15 億美元翻倍到 30 億美元，實際上是相當令人驚訝的。正如我們在整個電話會議和收益發布中提到的那樣，實際上，正如我們在過去幾個季度中所預測的那樣，我們對基於我們擁有的所有產品繼續保持兩位數的年收入增長感到非常滿意在我們的投資組合中，已經獲得批准，然後在管道中，然後是我們談論的三波浪潮。

So if you just do the math, you take $3 billion revenue run rate and you keep growing it at a double-digit rate, very quickly, you will be able to get to a $4 billion or $5 billion, $6 billion and beyond revenue run rates, and that's what we're targeting. Mike, can you talk about the competitor environment question?

因此，如果你算一下，你的營收運行率為30 億美元，並且繼續以兩位數的速度成長，很快，你將能夠達到40 億美元或50 億美元、60 億美元甚至更多的收入運行率，這就是我們的目標。麥克，您能談談競爭對手環境問題嗎？

Sure. And I think your question was specifically around some of the payer contracts we've entered into or in the process that we entered into. So we did have some that started. This is mainly on the Part D side where we haven't with the Part D payers where we historically have not contracted. So we had a couple that went effective July 1. We have a couple, I think, that kicked on October 1. And then I think one that kicks on January 1. So by January 1, they will all be in place. So we did see a little bit higher gross to net, particularly on DPI in Q3. But as you can see, we're clearly able to kind of grow through that.

當然。我認為你的問題特別圍繞著我們已經簽訂的或正在簽訂的過程中的一些付款人合約。所以我們確實有一些開始了。這主要是在 D 部分方面，我們過去沒有與 D 部分付款人簽訂合約。因此，我們有一些計劃於 7 月 1 日生效。我想，我們有幾個是在 10 月 1 日開始的。然後我認為將於 1 月 1 日開始。所以到 1 月 1 日，它們都會就位。因此，我們確實看到毛淨值有所上升，特別是在第三季的 DPI 方面。但正如你所看到的，我們顯然能夠透過這一點成長。

We think entering into these contracts now positions us very favorably for when a competitor comes to the market because we will, at that point, have rebate dollars already flowing through the payers, and we have parity and non-disadvantaged language. So I think they're going to be reluctant to just turn those off overnight. And so we thought it was important to kind of get those contracts in place, and I just have to give really a big shout out to our market access team. They did a phenomenal job in negotiating these contracts and really, I think, negotiating them on terms are very favorable to United Therapeutics.

我們認為，現在簽訂這些合約使我們在競爭對手進入市場時處於非常有利的地位，因為那時我們將擁有已經流經付款人的回扣資金，並且我們擁有平等和非劣勢的語言。所以我認為他們將不願意在一夜之間關閉它們。因此，我們認為簽訂這些合約很重要，我必須向我們的市場准入團隊大聲疾呼。他們在談判這些合約方面做得非常出色，我認為，實際上，談判條款對聯合治療公司非常有利。

Perfect. Thanks, Michael. Operator, we have time for one last question.

完美的。謝謝，麥可。接線員，我們還有時間回答最後一個問題。

We are not showing any further questions at this time.

目前我們不會提出任何進一步的問題。

Excellent. We've blow them away. Fantastic. Well, just to wrap up here, as we mentioned at the beginning, United Therapeutics is a very strong momentum story. As a bit of a science nerd, I've got to point out that momentum is mass times velocity. And our mass is truly formidable. We have a huge fault of intellectual property. We've got over 1,000 top of their game science, marketing and allied health professionals among our employee base and others have pointed out that we have a fortress balance sheet. So all of that is really, as Michael would say, an armamentarium of math.

出色的。我們已經把他們吹走了。極好的。好吧，總結一下，正如我們在開頭提到的，United Therapeutics 是一個勢頭非常強勁的故事。身為一個科學呆子，我必須指出動量是質量乘以速度。我們的群眾確實很強大。我們在知識產權方面存在巨大的缺陷。我們的員工中有超過 1,000 名頂尖的遊戲科學、行銷和聯合健康專業人士，其他人也指出我們擁有堡壘般的資產負債表。因此，正如邁克爾所說，所有這些實際上都是數學的武器庫。

And then in terms of velocity, UT really prides itself at moving at an entrepreneurial speed and the speed that we're moving in is in the direction of ever greater evasion and then, ultimately, a revolution in manufactured organ and organ alternative products.

然後就速度而言，UT 確實以創業速度而自豪，而我們前進的速度是朝著更大的逃避方向，然後最終是製造器官和器官替代產品的革命。

Thank you so much for participating in the call today, and I'll turn it back to the operator to wrap it up.

非常感謝您今天參與通話，我會將其轉回給接線生以結束通話。

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 & Presentations section of the United Therapeutics Investor Relations website at ir.unither.com.

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