United Therapeutics Corp (UTHR) 2024 Q2 法說會逐字稿

Good morning, everyone, and welcome to the United Therapeutics Corporation second-quarter 2024 earnings webcast.

大家早安，歡迎收看聯合治療公司 2024 年第二季財報網路廣播。

My name is Cole, and I'll be your conference operator today.

我叫科爾，今天我將擔任你們的會議接線生。

(Operator Instructions) And please note that this call is being recorded.

（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。

Please go ahead.

請繼續。

Yes.

是的。

Thank you, Cole.

謝謝你，科爾。

Good morning.

早安.

It's my pleasure to welcome you to the United Therapeutics Corporation second-quarter 2024 earnings webcast.

我很高興歡迎您觀看聯合治療公司 2024 年第二季收益網路廣播。

Remarks we make today will include forward-looking statements representing our expectations or beliefs regarding future events.

我們今天發表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。

These statements involve risks and uncertainties that may cause actual results to differ materially.

這些陳述涉及風險和不確定性，可能導致實際結果有重大差異。

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.

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。

Remarks today may discuss the progress and results of clinical trials or other developments with respect to our products.

今天的發言可能會討論有關我們產品的臨床試驗或其他開發的進展和結果。

And these remarks are intended solely to educate investors and are not intended to serve as a basis for medical decision-making or to suggest that any products are safe and effective for any unapproved or investigational uses and full prescribing information for our products are available on our website.

這些言論僅旨在教育投資者，無意作為醫療決策的基礎，或表明任何產品對於任何未經批准或研究用途都是安全有效的，並且我們產品的完整處方信息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; Dr. Leigh Peterson, our Executive Vice President of Product Development in 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，我們的異種移植產品開發執行副總裁；以及我們的技術營運執行副總裁 Pat Poisson。

Note that Michael Benkowitz and I will participate in the fireside chat and one-on-one meetings at the Morgan Stanley 22nd Annual Global Healthcare Conference in New York on September 4, and James Edgemond and I will participate in a fireside chat and one-on-one meetings at the 2024 Wells Fargo Health Care Conference in Boston the next day, September 5.

請注意，Michael Benkowitz 和我將參加9 月4 日在紐約舉行的摩根士丹利第22 屆年度全球醫療保健會議上的爐邊聊天和一對一會議，James Edgemond 和我將參加爐邊聊天和一對一會議。

Our scientific, commercial and medical affairs team will be present at the Pulmonary Hypertension Association 2024 International PAH Conference and Scientific Sessions, August 15 to 18 in Indianapolis, the European Respiratory Society Congress in Vienna, September 7 to 11, and the American College of Chest Physicians, CHEST, 2024 Annual Meeting in Boston, October 6 through the 9.

我們的科學、商業和醫療事務團隊將出席8 月15 日至18 日在印第安納波利斯舉行的肺動脈高壓協會2024 年國際PAH 會議和科學會議、9 月7 日至11 日在維也納舉行的歐洲呼吸學會大會以及美國胸腔科學會醫生，CHEST，2024 年年會於 10 月 6 日至 9 日在波士頓舉行。

Now I will turn the webcast over to Dr. Rothblatt for an overview of our second quarter 2021 financial results and the business activities of United Therapeutics.

現在我將把網路廣播交給 Rothblatt 博士，概述我們 2021 年第二季度的財務業績和 United Therapeutics 的業務活動。

Dr. Rothblatt?

羅斯布拉特博士？

Thank you very Dewey, July.

非常感謝杜威，七月。

We at UT are very pleased and proud to present the results of another record quarter.

我們 UT 非常高興且自豪地呈現另一個創紀錄季度的業績。

As described in the press release, PowerPoint and the financials, we are doing very well across the board.

如新聞稿、PowerPoint 和財務報告中所述，我們的整體表現非常好。

Double-digit revenue growth is the norm.

兩位數的收入成長是常態。

In a moment, our President, Mike Benkowitz, will provide some deep insight into these numbers.

稍後，我們的總統邁克·本科維茨（Mike Benkowitz）將對這些數字提供一些深入的見解。

So let me start with the strategic overview.

讓我從戰略概述開始。

We see our business as three waves of success.

我們將我們的業務視為三波成功。

First, approved products that are market leaders for the mid-2020s.

首先，批准成為 2020 年代中期市場領導者的產品。

Second, next-generation products and new indications that can be market leaders in the late 2020s.

其次，下一代產品和新適應症可以在 2020 年代末期成為市場領導者。

Third, an organ manufacturing business that can transform the treatment of end-stage organ disease.

第三，器官製造業務可以改變末期器官疾病的治療。

Examples of the first wave are Remodulin, Tyvaso, Orenitram, and Unituxin.

第一波的例子有 Remodulin、Tyvaso、Orenitram 和 Unituxin。

Examples of the second wave are Ralinepag as a once-daily pill for pulmonary hypertension and our TETON trial aiming to show improvement in pulmonary fibrosis.

第二波的例子包括每日一次治療肺動脈高壓的 Ralinepag 以及旨在改善肺纖維化的 TETON 試驗。

Examples of our third wave of success are our Xenotransplantation products that offer tremendous potential for the thousands of patients on dialysis.

我們第三次成功的例子是我們的異種移植產品，它為成千上萬的透析患者提供了巨大的潛力。

Now I'm sometimes asked with all of this success, Martine, what keeps you up at night.

現在，我有時會被問到，為什麼我能取得如此巨大的成功，馬丁娜，是什麼讓你徹夜難眠。

Well, let me start with what does not keep me up.

好吧，讓我從那些讓我無法堅持下去的事情開始。

What does not keep me up is our foundational business because I do not see any threats to the vitality of our Remodulin, Tyvaso or Orenitram products.

讓我無法繼續前進的是我們的基礎業務，因為我沒有看到我們的 Remodulin、Tyvaso 或 Orenitram 產品的生命力受到任何威脅。

For Remodulin and Tyvaso, my confidence is borne of the uniqueness and clinical efficacy of our drug device combination technology.

對於 Remodulin 和 Tyvaso，我的信心來自於我們藥物器材組合技術的獨特性和臨床功效。

For Remodulin, there is no other parenteral drug delivery device that is as small, accurate and easy to use as our Remunity Pump.

對於 Remodulin，沒有任何其他腸外給藥裝置能夠像我們的 Remunity Pump 那樣小巧、準確且易於使用。

It's patented acoustic volume sensing technology is more than 10 times more accurate than legacy pumps and has fewer moving parts.

其專利的聲學體積感測技術比傳統幫浦精確 10 倍以上，且移動部件更少。

For Tyvaso, there is no other dry powder inhaler so well matched to deep lung delivery of our drug as the Mankind DPI.

對於泰瓦索 (Tyvaso) 來說，沒有任何其他乾粉吸入器能夠像 Mankind DPI 那樣與我們的藥物的深肺輸送如此匹配。

The proof is really in the pudding in record time, thousands of patients have begun using our patented device in both old and new pulmonary indications such as pulmonary arterial hypertension and interstitial lung disease.

證據確實在創紀錄的時間裡，成千上萬的患者已經開始使用我們的專利設備治療新舊肺部適應症，如肺動脈高壓和間質性肺部疾病。

Competition in our current foundational business doesn't really keep me up either, because they are mostly used in combination with our drugs or if not used drug delivery devices that are not as elegant as our Remunity and our DPI devices.

我們目前的基礎業務中的競爭也並沒有真正讓我保持動力，因為它們大多與我們的藥物結合使用，或者如果不使用藥物輸送設備，這些設備不如我們的 Remunity 和 DPI 設備那麼優雅。

Now let me jump ahead to the organ business.

現在讓我跳到器官業務。

That also doesn't keep me up because in the last year, we have obtained multiple times scientific proof that our Xeno kidney function well in human bodies with no more immunosuppression than an allograft.

這也沒有讓我失望，因為在去年，我們獲得了許多科學證明，證明我們的異種腎在人體中功能良好，並且不需要比同種異體移植更多的免疫抑制。

Folks, that cannot happen by accident.

夥計們，這不可能是偶然發生的。

Of course, there's much more work to do to get these Xeno kidney FDA approved and even more work to do to get them into quantity production, but I see no showstoppers, and we have achieved proof of concept.

當然，要讓這些異種腎獲得 FDA 批准還有很多工作要做，要讓它們投入大量生產還有更多工作要做，但我認為沒有什麼阻礙，而且我們已經實現了概念驗證。

It is only in our second wave of success, Tyvaso for pulmonary fibrosis and Ralinepag for PAH that I find myself kept up at night.

只是在我們的第二波成功中，Tyvaso 治療肺纖維化和 Ralinepag 治療肺動脈高壓，我才發現自己徹夜難眠。

The reason is that the results of a clinical trial cannot be known until it is unblinded.

原因是臨床試驗的結果只有在揭盲前才能得知。

And even a study that is 90% powered for success by definition, still has a 10% chance of missing.

即使一項研究的成功率高達 90%，仍有 10% 的失敗機會。

Of course, we are doing everything we can to ensure the credibility and approvability of our IPF and Ralinepag clinical trials.

當然，我們正在盡一切努力確保我們的 IPF 和 Ralinepag 臨床試驗的可信度和可批准性。

But because these two products have the potential to more than double our current $3 billion revenue run rate, the stakes are extremely high.

但由於這兩種產品有可能使我們目前 30 億美元的營收運行率增加一倍以上，因此風險非常高。

In conclusion, UT is a rock-solid bet on its current foundational business.

總之，UT 對其當前的基礎業務下了堅定的賭注。

UT is a very, very good bet and a highly rewarding one at that in its next stage generation products that are now in late-stage clinical trials.

UT 是一個非常非常好的選擇，對於目前正處於後期臨床試驗的下一代產品來說，這是一個非常有價值的選擇。

And UT is a once-in-a-lifetime biotechnology opportunity in manufactured organs.

UT 是人造器官中千載難逢的生物技術機會。

With that strategic overview, I'd like to now turn the call over to our President, Michael Benkowitz.

有了這個策略概述，我現在想將電話轉給我們的總裁 Michael Benkowitz。

Mike?

麥克風？

Thanks, Martine, and good morning, everyone.

謝謝，馬丁娜，大家早安。

As Martine noted, today, we reported yet another quarter of record revenue at $715 million and 20% growth from the second quarter of 2023.

正如 Martine 指出的那樣，今天我們公佈的季度營收再創新高，達到 7.15 億美元，較 2023 年第二季成長 20%。

We saw meaningful worldwide revenue growth for all of our key products, Tyvaso, Orenitram, Remodulin and Unituxin.

我們所有的關鍵產品 Tyvaso、Orenitram、Remodulin 和 Unituxin 都實現了顯著的全球營收成長。

First, I want to touch on Tyvaso, which when viewing the nebulizer and dry powder inhaler delivery systems together, remains the number one prescribed prostacyclin treatment in the U.S. Total Tyvaso revenue for the second quarter was $398 million, up 25% over last year with growth led by continued uptake of Tyvaso DPI increase in pricing and increased commercial utilization following the implementation of the Part D redesign provisions under the Inflation Reduction Act, or IRA.

首先，我想談談Tyvaso，當綜合考慮霧化器和乾粉吸入器輸送系統時，它仍然是美國排名第一的處方前列環素治療藥物。成長25%，成長的推動因素是 Tyvaso DPI 的持續採用、定價的提高以及根據《通貨膨脹減少法案》（IRA）實施 D 部分重新設計條款後商業利用率的提高。

For the franchise, we saw record referrals and starts during the quarter, leading us to have confidence in the durability of our growth profile, as Martine mentioned.

對於特許經營權，我們在本季度看到了創紀錄的推薦和啟動，這使我們對我們的成長狀況的持久性充滿信心，正如馬丁所提到的那樣。

The percentage of Tyvaso DPI patients using our patient access programs continues to tick down following the implementation of the first provisions of the IRA earlier this year.

自今年稍早實施 IRA 第一項條款以來，使用我們的患者訪問計劃的 Tyvaso DPI 患者的比例繼續下降。

Albeit, not at the same rate we saw between the fourth quarter of 2023 and the first quarter of 2024.

儘管如此，我們在 2023 年第四季至 2024 年第一季之間看到的成長率並不相同。

We could continue to see a modest decline in patient access program utilization through the remainder of the year as new patients on therapy are less likely to need patient assistance, having met their copay obligations on another product before starting Tyvaso DPI.

在今年剩餘時間內，我們可能會繼續看到患者訪問計劃的利用率略有下降，因為新接受治療的患者在開始Tyvaso DPI 之前已經履行了另一種產品的自付費用，因此需要患者幫助的可能性較小。

The benefit from this could be offset by modest rebates from our initial contracting efforts to ensure [ period of ] access in the future for Tyvaso DPI.

由此帶來的好處可能會被我們為確保 Tyvaso DPI 未來 [一段時間] 的訪問權限而進行的初始承包工作中獲得的適度回扣所抵消。

As an aside, we understand that CMS will soon publish the negotiated prices for the first 10 drugs selected under the IRAs drug price negotiation provision.

順便說一句，我們了解到 CMS 將很快公佈根據 IRA 藥品價格談判條款選出的前 10 種藥物的談判價格。

I want to remind investors that our drugs are not on this list.

我想提醒投資者，我們的藥品不在這個名單上。

In addition, based on our current understanding of the IRA statute and guidance issued by CMS thus far, we expect our treprostinil products will not be subject to price negotiation under the IRA because there is at least one marketed generic version of treprostinil.

此外，根據我們目前對IRA 法規和CMS 迄今為止發布的指南的理解，我們預計我們的曲前列環素產品將不會受到IRA 下價格談判的影響，因為至少有一種已上市的曲前列環素仿製藥。

Moving to Orenitram.

搬到奧雷尼特蘭。

We reported getting another quarter of record revenue at $107 million, representing 13% growth from the second quarter of 2023.

我們報告稱，第四季營收再創新高，達到 1.07 億美元，較 2023 年第二季成長 13%。

Like the first quarter, this was driven by a combination of increased commercial utilization, pricing and a modest increase in average dose from prior quarter levels.

與第一季一樣，這是由商業利用率增加、定價以及平均劑量較上一季適度增加共同推動的。

Recall that Orenitram and Remodulin are priced on a per milligram basis.

回想一下，奧瑞尼曲和瑞莫杜林是按每毫克定價的。

Like with Tyvaso DPI, we saw a modest decrease in patient access program used for Orenitram in the second quarter, driven by the same dynamics.

與 Tyvaso DPI 一樣，我們看到第二季度用於 Orenitram 的患者准入計劃略有減少，原因是相同的動態。

Likewise, we expect a modest decline in patient access program used through the remainder of the year.

同樣，我們預計今年剩餘時間內使用的患者訪問計劃將略有下降。

Our medical teams continue to have scientific discussions based on recent scientific publications, with health care providers on the EXPEDITE induction protocol where PAH patients initiate on Remodulin and then transition to Orenitram as an option for appropriate patients who may not want or need to go on long-term parenteral therapy.

我們的醫療團隊繼續根據最近的科學出版物與醫療保健提供者就 EXPEDITE 誘導方案進行科學討論，其中 PAH 患者開始使用 Remodulin，然後過渡到 Orenitram，作為可能不希望或需要長期治療的適當患者的選擇長期腸外治療。

Moving to Remodulin.

轉向雷莫杜林。

Worldwide revenue of $147 million was up 16% from last year with very strong performance across all of our underlying demand metrics.

全球營收為 1.47 億美元，比去年成長 16%，我們所有基本需求指標都表現強勁。

And this comes 5 years after the first launch of generic Remodulin, reflecting our continued commitment to our patients and Remodulin.

這是在首次推出仿製藥 Remodulin 五年後，體現了我們對患者和 Remodulin 的持續承諾。

Remodulin, both intravenous and subcutaneous remains the most prescribed parental prostacyclin in the U.S. Our Remunity Pump remains the only option for new subcutaneous patient starts.

Remodulin（靜脈注射和皮下注射）仍然是美國最常使用的父母前列環素。

Last quarter, we heard through the channel that specialty pharmacy distributors are going to start proactively converting all subcu treprostinil use, to Remodulin and our Remunity Pump given the discontinuation of support for the CAD MS3 system by its manufacturer.

上個季度，我們透過通路得知，由於製造商停止了對 CAD MS3 系統的支持，專業藥品分銷商將開始主動將所有 subcu 曲前列環素使用轉換為 Remodulin 和我們的 Remunity Pump。

We've seen this trend continue through the second quarter.

我們看到這種趨勢在第二季度持續存在。

Finally, Unituxin.

最後，尤尼圖辛。

Worldwide revenue of $52 million, was up 17% from the prior year quarter and U.S. Unituxin revenue of $47 million was up 18%.

全球營收為 5,200 萬美元，比去年同期成長 17%，美國 Unituxin 營收為 4,700 萬美元，成長 18%。

U.S. growth was driven by price and volume.

美國的成長是由價格和數量所推動的。

To wrap up with our fifth quarter in a row of record revenue, our commercial products clearly have the innovation, interest momentum and muscle to continue to grow and serve our patients.

為了結束我們連續第五個季度創紀錄的收入，我們的商業產品顯然具有創新、興趣動力和力量來繼續增長和服務我們的患者。

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

這樣，我會將電話轉回給 Martine 進行問答。

Michael, that was just such a perfect overview of everything.

邁克爾，這真是對一切的完美概述。

Thanks so much, and thanks for all of your leadership in all of those areas.

非常感謝，並感謝您在所有這些領域的領導。

Operator, you may now bring forward the first call.

接線員，您現在可以轉接第一個通話。

(Operator Instructions) Roanna Ruiz, Leerink Partners.

（操作員說明）Roanna Ruiz，Leerink Partners。

So I was curious, could you elaborate a bit on the different drivers you saw in the quarter for Tyvaso DPI versus Nebulized Tyvaso.

所以我很好奇，您能否詳細說明您在本季度看到的 Tyvaso DPI 與霧化 Tyvaso 的不同驅動因素。

And were there any changes or reasons for greater confidence coming through, like I think you mentioned increased number of referrals and possibly ramping the new field force that we should keep in mind going into 3Q this year?

是否有任何變化或理由增強信心，就像我認為您提到的推薦數量增加以及可能增加新的現場人員，我們應該牢記今年第三季度的情況？

Thank you for that question, Roanna.

謝謝你提出這個問題，羅安娜。

That type of commercialization question would be best handled by Michael.

這種類型的商業化問題最好由麥可來處理。

Sure.

當然。

Thanks for the question.

謝謝你的提問。

So I think the underlying demand metrics, just kind of -- we continue to just, I think, plug along or tug-along like we have the past few quarters with the referrals and with the starts and continues to come from both Group 1 PAH as well as Group III PH-ILD.

因此，我認為潛在的需求指標，我認為，我們將繼續堅持或拖拉，就像過去幾季的轉介和開始一樣，並且繼續來自第一組 PAH以及第 III 組 PH-ILD。

The second part of your question about the sales force, I think we're starting to see some of the impact of that sales force expansion in the second quarter.

關於銷售隊伍的問題的第二部分，我認為我們開始看到第二季銷售隊伍擴張的一些影響。

As you recall, we started that ramp-up in the last fall, really fully deployed that team January 1.

您還記得，我們​​在去年秋天開始了這項準備工作，並在 1 月 1 日真正全面部署了團隊。

And of course, it takes a little bit of time for the reps to get out in the field and get in front of those physicians and have the opportunity to educate them on the benefits of our products.

當然，銷售代表需要一點時間才能到現場並站在這些醫生面前，並有機會向他們介紹我們產品的好處。

But what's been really nice to see so far in the first six months is the increase in the number of ILD prescribers actually writing Tyvaso.

但到目前為止，在前六個月中真正令人高興的是，實際服用 Tyvaso 的 ILD 處方者數量有所增加。

So when we first launched in the PH-ILD a couple of years ago, our efforts are really focused on educating around the need to screen for pulmonary hypertension.

因此，當我們幾年前首次推出 PH-ILD 時，我們的工作重點是圍繞著篩檢肺動脈高壓的必要性來開展教育。

And then once they started to do that [indiscernible] that the patients had, pulmonary hypertension associated with ILD, then they can make the decision whether we refer that patient into the PAH clinic or trying to treat it themselves.

然後，一旦他們開始[音訊不清晰]發現患者患有與間質性肺病相關的肺動脈高壓，那麼他們就可以決定是將該患者轉診至肺動脈高壓診所還是嘗試自行治療。

I would say, the vast majority of doctors at that time started referring to the PAH clinic.

我想說，當時絕大多數醫師開始提到肺動脈高壓診所。

So -- but we knew really -- for us to I think, realize the full opportunity that we have in PH-ILD, these physicians are going to have to start treating just because of the number of patients that are out there and the bandwidth constraints on the physicians in the PAH clinic.

所以，但我們確實知道，我認為，要認識到我們在 PH-ILD 方面擁有的全部機會，這些醫生將不得不開始治療，因為那裡的患者數量和頻寬PAH 診所醫生的限制。

So it's been really nice to see that over the last six months, we really started to increase the breadth of ILD prescribers as well as the depth and recall the depth metric we always look at is physicians with three-plus patients.

因此，很高興看到在過去六個月中，我們確實開始增加 ILD 處方者的廣度和深度，回想一下，我們一直關注的深度指標是醫生與三名以上患者的情況。

And so we're seeing really positive momentum and growth on both of those key metrics.

因此，我們在這兩個關鍵指標上看到了真正積極的勢頭和成長。

Thank you so much, Mike, and thank you, Roanna, for your question.

非常感謝你，麥克，也謝謝你，羅安娜，提出你的問題。

Operator, you can bring forward the next question.

接線員，您可以提出下一個問題。

Jessica Fye, JPMorgan.

潔西卡法耶，摩根大通。

Curious if you could talk a little bit about what you're seeing in the PAH marketplace as it relates to the initial WINREVAIR launch.

我想知道您能否談談您在 PAH 市場中看到的情況，因為它與最初的 WINREVAIR 發布有關。

Do your observations line up with Merck's commentary yesterday.

您的觀察結果與默克公司昨天的評論相符嗎？

Have you noticed any changes in referrals or starts in PAH?

您是否注意到 PAH 的轉介或起始有任何變化？

Thanks, Jess.

謝謝，傑西。

Nice to hear your voice this morning.

很高興今天早上聽到你的聲音。

Again, I think it's a market dynamic question that Michael is the best person to answer.

同樣，我認為這是一個市場動態問題，而麥可是回答的最佳人選。

Yeah, sure.

好，當然。

Thanks for the question, Jess.

謝謝你的提問，傑西。

Yeah, I mean, I'm not going to really comment too much on Merck's product.

是的，我的意思是，我不會對默克的產品發表太多評論。

I mean they're plenty capable of speaking to sell.

我的意思是他們有足夠的能力去推銷。

I would say with respect to our business, and specifically in the PAH, I think the business remains very solid, very strong, really strong referral growth, really, really strong start growth, patient shipments, all of the underlying demand metrics continue to be in line with what we expect and where we think we need to be, and that's obviously being reflected in the revenue line on our financial statement.

我想說的是，就我們的業務而言，特別是在PAH 方面，我認為業務仍然非常穩固、非常強勁、非常強勁的轉介增長、非常非常強勁的啟動增長、患者出貨量、所有基本需求指標都持續保持在符合我們的預期和我們認為需要達到的目標，這顯然反映在我們財務報表的收入項目中。

So yes, so at this point, in the first quarter, no surprises there.

所以是的，所以在這一點上，在第一季度，沒有什麼意外的。

I think as Martine said in the opening remarks, if you look at -- you look at the Merck's clinical trial, most of those patients were using sotatercept in combination with prostacyclins and that certainly at least seems to be how that's playing out so far.

我認為，正如 Martine 在開場白中所說，如果你看看默克的臨床試驗，大多數患者都將 sotatercept 與前列環素聯合使用，至少到目前為止似乎是這樣的。

Perfect.

完美的。

Thanks so much, Mike.

非常感謝，麥克。

Ash Verma, UBS.

阿什‧維爾瑪，瑞銀集團。

Great.

偉大的。

So my question just wanted to understand.

所以我的問題只是想了解一下。

So look, I mean, I think the stock has reacted pretty favorably to the ASR.

所以，我的意思是，我認為該股票對 ASR 的反應非常有利。

And I know from a cash outflow, you mentioned last quarter that you have now a more specific understanding of what's required for Xeno.

我從現金流出中了解到，您在上個季度提到您現在對 Xeno 的需求有了更具體的了解。

So given where we are right now, like what's your appetite for another significant share buyback or another ASR?

那麼，考慮到我們現在的處境，您對另一次重大股票回購或另一次 ASR 有何興趣？

Thank you for your question, Ash.

謝謝你的提問，阿什。

That being basically a kind of a capital allocation question.

這基本上是一種資本配置問題。

I think the best person on the call to answer that would be our Chief Financial Officer, James Edgemond.

我認為在電話會議上回答這個問題的最佳人選是我們的財務長詹姆斯·埃奇蒙德 (James Edgemond)。

James?

詹姆士？

Great.

偉大的。

Thanks, Martine.

謝謝，馬丁娜。

Ash, good to hear your voice.

阿什，很高興聽到你的聲音。

Thank you for the question.

感謝你的提問。

Two kind of responses to your question.

對你的問題有兩種答案。

One is, our current ASR is still in process, right?

一是，我們目前的 ASR 仍在進行中，對嗎？

The existing or the second tranche as we've described in our disclosure, the $700 million still is in process through the end of September of this year.

正如我們在披露中所描述的，現有的或第二期的 7 億美元仍在進行中，截至今年 9 月底。

So we're going to first focus on executing the existing ASR and share repurchase program.

因此，我們將首先專注於執行現有的 ASR 和股票回購計劃。

A second kind of consideration is we are still committed to allocating capital wisely.

第二個考慮因素是我們仍然致力於明智地配置資本。

And in the best interest of stakeholders by first deploying it, as we've said historically, Ash, internally for our R&D initiatives, including manufacturing facilities and included in those manufacturing facilities certainly is our consideration of future commercial DPF capital requirements.

為了利害關係人的最大利益，首先部署它，正如我們歷史上所說，Ash 在內部為我們的研發計劃（包括製造設施）而納入這些製造設施，當然是我們對未來商業 DPF 資本要求的考慮。

Second is we're going to still focus on corporate development to find those opportunities where we think can bring value to shareholders and value to patients.

其次，我們仍將專注於企業發展，尋找那些我們認為能為股東和病患帶來價值的機會。

And third, kind of what we've said to [indiscernible] said at the beginning, our current share repurchase program.

第三，我們在開始時[音訊不清楚]所說的，我們目前的股票回購計畫。

So our capital allocation program will continue to be the same.

因此我們的資本配置計劃將繼續保持不變。

We'll continue to evaluate and get more knowledgeable about construction of the DPF facilities.

我們將繼續評估並進一步了解 DPF 設施的建設。

But right now, we're just going to continue to focus on the ASR that's in place and then continue to use that capital allocation waterfall to evaluate any future opportunities, whether it's share repurchase or otherwise.

但現在，我們將繼續關注現有的 ASR，然後繼續使用資本配置瀑布來評估任何未來的機會，無論是股票回購還是其他機會。

But thank you for the question.

但謝謝你的提問。

Martine, back to you.

瑪蒂娜，回到你身邊。

James, that was a 360-degree comprehensive answer to Ash.

詹姆斯，這是對阿什的360度全面回答。

So greatly appreciated.

非常感謝。

Operator, next question, please.

接線員，請下一個問題。

Joseph Thome, TD Cowen.

約瑟夫·托姆，TD·考恩。

Maybe just one on the filing strategy for IPF, assuming success.

如果成功的話，也許只是 IPF 的申請策略之一。

I guess, both of the ongoing IPF studies need to be successful in order to pursue a filing?

我想，兩項正在進行的 IPF 研究都需要成功才能申請備案？

Or do you think there is a P-value level or a level of benefit that you could see in one where you maybe would only need one of these studies to work -- and any feedback from the FDA on that point would be helpful, if you have it.

或者您認為在一項研究中您可能只需要其中一項研究就可以發揮作用，您是否認為存在 P 值水平或一定程度的益處，並且 FDA 在這一點上的任何反饋都會有所幫助，如果您擁有了它。

Thank you, Joe, for that question.

謝謝喬提出這個問題。

Fortunately, we have on our call the person who's in charge of that entire program, Dr. Leigh Peterson.

幸運的是，我們接到了整個計畫的負責人 Leigh Peterson 博士的電話。

So Dr. Peterson, could you kindly respond to Joe?

Peterson 博士，您能回覆一下 Joe 嗎？

Yes, sure.

是的，當然。

We haven't recently discussed this with FDA.

我們最近沒有與 FDA 討論過這個問題。

I mean this was really early, early discussions with the IND.

我的意思是，這確實是與 IND 的早期討論。

They really just gave us the boilerplate language that they always do, which is typically, we require two studies for like two positive studies for registration.

他們實際上只是給了我們他們總是做的樣板語言，通常情況下，我們需要兩項研究來進行註冊，就像兩項積極的研究一樣。

But of course, I mean, if we see, we'll likely see the TETON 2 results coming out before TETON 1, at least the top line results because as you know, we completed the TETON 2 enrollment period early.

但當然，我的意思是，如果我們看到的話，我們很可能會看到 TETON 2 結果在 TETON 1 之前出來，至少是頂線結果，因為如您所知，我們提前完成了 TETON 2 註冊期。

And so we'll see those, and we will certainly continue discussions with FDA.

所以我們會看到這些，我們肯定會繼續與 FDA 進行討論。

I mean assuming a really significant, highly positive, clinically significant results, then we will certainly have a discussion with them about that.

我的意思是假設有一個非常顯著的、非常積極的、具有臨床意義的結果，那麼我們肯定會與他們就此進行討論。

Thank you so much, Dr. Peterson.

非常感謝你，彼得森博士。

And -- just to -- because she's too modest to really toot your own horn, but I just want to remind everybody that Dr. Peterson and Dr. Smith, her right-hand clinical trial leader.

而且——只是因為——因為她太謙虛了，不會自吹自擂，但我只是想提醒大家，彼得森博士和史密斯博士，她的得力臨床試驗領導者。

They're the same team that executed so successfully or interstitial lung disease trial that resulted in the -- in really much of what we are celebrating today the explosive growth in Group III PAH and the entry into that space of the DPI.

他們是成功執行間質性肺部疾病試驗的同一個團隊，該試驗導致了 III 類 PAH 的爆炸性增長以及 DPI 進入該領域，這在我們今天慶祝的大部分內容中都是如此。

So this team, I can -- I know for sure, because I see them often, they, too, they sweat this trial day and night -- and we are -- this is our -- if somebody said like, what is your number one priority, it is the success of the TETON trial and the indication to achieve an indication in pulmonary fibrosis, a market that is probably 3x the size of the pulmonary hypertension market.

所以這支球隊，我可以——我確信，因為我經常見到他們，他們也日夜為這場考驗而努力——我們是——這是我們的——如果有人說，你的是什麼？首要任務是TETON 試驗的成功，以及達到肺纖維化適應症的指徵，肺纖維化市場的規模可能是肺動脈高壓市場的3 倍。

And again, our trial design is in combination with already approved background therapies.

同樣，我們的試驗設計與已經批准的背景療法相結合。

So there's no real kind of having to like take a patient off a drug to start them on an inhaled treprostinil.

因此，並不需要讓患者停止服藥才能開始吸入曲前列環素。

And similarly, there's no need to put a patient on another drug to start them because we have both types of patients in the trial.

同樣，沒有必要讓患者服用另一種藥物來開始治療，因為我們有兩種類型的患者都在試驗中。

So we would hope for all of that to be in the label.

所以我們希望所有這些都出現在標籤中。

Anyway, sorry to ramble on there a bit, Dr.

無論如何，抱歉在這裡閒扯了一會兒，Dr.

Peterson, but great answer to Joe.

彼得森，但對喬的回答很好。

And operator, due to the time we have time for just one more question.

接線員，由於時間關係，我們還有時間再問一個問題。

Andreas Argyrides, Oppenheimer.

安德烈亞斯·阿吉里德斯，奧本海默。

And continuing on the topic of TETON.

繼續討論 TETON 的話題。

What kind of bridging study might the FDA require to approve evasive DPI in addition to the nebulize if TETON is successful?

如果 TETON 成功，FDA 可能需要什麼樣的橋接研究來批准霧化以外的規避 DPI？

And then how are you thinking about presenting data.

然後你如何考慮呈現數據。

I mean, is there a chance for maybe like an interim readout of sorts or anything like that?

我的意思是，是否有機會進行某種臨時讀數或類似的東西？

Okay.

好的。

Yes.

是的。

Thanks for those two questions.

謝謝你提出這兩個問題。

Again, I think Dr. Peterson would be the best person on the call to answer.

再次強調，我認為彼得森博士是這次電話會議中回答問題的最佳人選。

Once again, just for your recollection, she and her team did the bridging study from the Tyvaso nebulizer into the DPI for PAH.

再次提醒您，她和她的團隊進行了從 Tyvaso 霧化器到 DPI 的 PAH 橋接研究。

So she's very, very familiar with how to do that.

所以她非常非常熟悉如何做到這一點。

She also was the lead author in a publication on those results in the New England Journal of Medicine.

她也是《新英格蘭醫學雜誌》上有關這些結果的出版物的主要作者。

So very much on top of getting the word out in the most credible and respected way.

因此，最重要的是以最可信和最受尊重的方式傳播訊息。

So with that little to toot of your horn, Dr. Peterson, can you answer the questions?

彼得森博士，你能用你的小喇叭來回答這些問題嗎？

Thank you.

謝謝。

Yes, Sure.

是的，當然。

So for the bridging study, again, we will -- well, let me answer the second question first for interim results.

因此，對於橋接研究，我們將—好吧，讓我先回答第二個問題以獲得中期結果。

We will not do an interim analysis or an interim look.

我們不會進行中期分析或中期考察。

We have, for TETON 2, as I just said, we have completed enrollment.

我們對於TETON 2，正如我剛才所說，我們已經完成了註冊。

So we're in the final follow-up period, and we will have the actual final results within a year, just shortly after the year follow-up is up.

所以我們正處於最後的追蹤期，我們將在一年內得到實際的最終結果，就在當年的追蹤結束後不久。

So we completed in July, so that would be July plus some time to clean those data just for the top line results.

所以我們在 7 月份完成了，所以這將是 7 月份，再加上一些時間來清理這些數據，以獲取最重要的結果。

So that will be the next time we -- that will be the first time we see the actual results from these -- one of these studies.

因此，這將是我們下一次——這將是我們第一次看到這些研究的實際結果。

And as far as bridging into DPI.

至於橋接 DPI。

Now as you know, the -- so what we did for in our BREEZE study, we looked at PAH patients.

如您所知，我們在 BREEZE 研究中所做的就是觀察 PAH 患者。

We transitioned from Nebulized Tyvaso to Tyvaso DPI and that was actually sufficient to get approval for both PAH patients and PH-ILD patients for the Tyvaso DPI.

我們從霧化 Tyvaso 過渡到 Tyvaso DPI，這實際上足以獲得 PAH 患者和 PH-ILD 患者使用 Tyvaso DPI 的批准。

Now for the IPF studies, we still have some ongoing discussions with FDA.

現在對於 IPF 研究，我們仍在與 FDA 進行一些持續的討論。

We will be discussing as soon as -- I mean, really, when we get further into the follow-up period or when we get top line results, we're going to have a discussion because it's a different group.

我們將盡快進行討論——我的意思是，真的，當我們進一步進入後續階段或當我們得到頂線結果時，我們將進行討論，因為這是一個不同的小組。

It's the pulmonary division for IPF versus the cardiorenal division for PAH and PH-ILD.

這是 IPF 的肺科與 PAH 和 PH-ILD 的心腎科。

So different group, different people, sometimes just slightly different requirements.

所以不同的群體，不同的人，有時只是要求略有不同。

So we need to just confirm what we need to do for the bridging.

所以我們只需要確認我們需要為橋接做什麼。

It might be a matter of a small sub-study in our TETON OLE program.

這可能是我們 TETON OLE 計畫中的一個小型子研究的問題。

It -- so we need to sort that out.

所以我們需要解決這個問題。

But again, it shouldn't delay.

但話又說回來，不該拖延。

We'll get the results of the TETON studies.

我們將得到 TETON 研究的結果。

We will pursue the approval based on the TETON 1, TETON 2.

我們將根據TETON 1、TETON 2尋求批准。

And then while that is occurring, we'll do what we need to do for bridging.

然後，當這種情況發生時，我們將做我們需要做的橋接工作。

Excellent.

出色的。

Excellent answer.

很好的答案。

Thank you so much, Dr. Peterson.

非常感謝你，彼得森博士。

Thank you, everybody, for being on the call today.

謝謝大家今天接電話。

I'd like to just wrap up with drawing everybody's attention to the terrific PowerPoint that Dewey Steadman and his team released, I think it's not only aesthetically beautiful, which it is.

最後，我想提請大家注意杜威·斯特德曼 (Dewey Steadman) 和他的團隊發布的精彩 PowerPoint，我認為它不僅美觀，確實如此。

It's just rich in content, graphs, charts, numbers, kind of strategic overview kind of things.

它的內容非常豐富，包括圖形、圖表、數字、策略概述之類的東西。

So please study that PowerPoint at depth, if you really want to understand the beauty of the United Therapeutics story.

因此，如果您真的想了解 United Therapeutics 故事的美妙之處，請深入研究該 PowerPoint。

And then finally, I'd like to just do a shout out to everybody that is part of our United Therapeutics family, what we call Unitherians.

最後，我想向所有屬於我們 United Therapeutics 大家庭（我們稱之為 Unitherians）的人大聲喊叫。

We're now bumping up on 1,500 people.

我們現在增加了 1,500 名員工。

And it's in line with the metric that Michael, James and I have long adopted a QT to grow our headcount in accordance with a revenue per head metric of approximately $2 million per head and that's on par with the absolute best, not only of biotech, but of really American corporations in general.

這與邁克爾、詹姆斯和我長期以來採用的QT 來增加我們的員工人數的指標是一致的，按照每人約200 萬美元的人均收入指標，這與絕對最好的水平不相上下，不僅是生物技術領域，但實際上是美國公司的整體情況。

So now that we're knocking on the door of a $3 billion revenue run rate, that's $2 million per head for our knocking on the door of 1,500 people.

因此，現在我們正在敲開 30 億美元收入運行率的大門，對於我們敲開 1,500 人的大門來說，這相當於每人 200 萬美元。

And it's just another tremendous testament to the success of United Therapeutics and to the fact that the leaders of this company, Michael, James, myself, Pat Poisson, Dr.

這只是聯合治療公司成功的另一個巨大證明，也證明了該公司的領導者邁克爾、詹姆斯、我、帕特·泊松、博士。

Peterson, others -- for all of us, our number one goal is to make sure that everybody working at our company is having the absolute best career development experience of their dreams.

彼得森和其他人——對我們所有人來說，我們的首要目標是確保在我們公司工作的每個人都擁有他們夢想中的絕對最佳的職業發展經歷。

And so long as that is happening, then all of our goals pretty much happen automatically.

只要這種情況發生，那麼我們所有的目標幾乎都會自動實現。

And I think a great -- another metric I can share with you that I got from our HR department is our percentage of employees who voluntarily terminate, we call voluntary termination rate is about 5%.

我認為我可以與大家分享的另一個指標是我從人力資源部門獲得的一個很好的指標，那就是我們自願終止合約的員工比例，我們稱之為自願終止率約為 5%。

That is far lower than I think any of our peers, but certainly far lower than the averages in the biotech sector and definitely outside biotech.

這遠低於我認為的任何同行，但肯定遠低於生物技術領域的平均水平，而且絕對低於生物技術領域的平均水平。

So the numbers say we're doing things right, the people say we're doing things right.

因此，數字顯示我們正在做正確的事情，人們也說我們正在做正確的事情。

And I hope all of you agree that we're doing the things you want to see us do.

我希望你們所有人都同意我們正在做你們希望我們做的事情。

Have a great day.

祝你有美好的一天。

Operator, you can close the call.

接線員，您可以結束通話了。

Thank you for participating in today's United Therapeutics Corporation Earnings Webcast.

感謝您參加今天的聯合治療公司收益網絡廣播。

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. Thank you again for your participation.

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。再次感謝您的參與。

You may now disconnect.

您現在可以斷開連線。