Transmedics Group Inc (TMDX) 2025 Q3 法說會逐字稿

Good afternoon, and welcome to the TransMedics third-quarter 2025 earnings conference call. (Operator Instructions) As a reminder, this call is being recorded for replay purposes. (Operator Instructions)

下午好，歡迎參加 TransMedics 2025 年第三季財報電話會議。（操作員指示）提醒您，本次通話將會被錄音，以便回放。（操作說明）

I would now like to turn the call over to Ms. Laine Morgan from Gilmartin Group for a few introductory remarks. Thank you.

現在我謹將電話交給吉爾馬丁集團的萊恩摩根女士，請她作幾句介紹性發言。謝謝。

Thank you. Earlier today, TransMedics released financial results for the quarter ended September 30, 2025. A copy of the press release is available on the company's website. Before we begin, I would like to remind you that management will make statements during this call, including during the question-and-answer portion of the call, that include forward-looking statements within the meaning of federal securities laws. Any statements contained in this call that relate to expectations or predictions of future events, results or performance are forward-looking statements.

謝謝。今天早些時候，TransMedics 發布了截至 2025 年 9 月 30 日的季度財務表現。新聞稿副本可在公司網站上查閱。在會議開始之前，我想提醒各位，管理層將在本次電話會議期間，包括在問答環節中，發表一些符合聯邦證券法定義的前瞻性聲明。本次電話會議中任何與預期或預測未來事件、結果或績效有關的陳述均為前瞻性陳述。

These forward-looking statements address various matters, including, among other things, future events, results and performance, financial guidance and projected expectations, potential market and business conditions, our examination of operating trends, the potential commercial opportunity for our products and services, the potential timing, outcome and impact of new clinical programs, and our potential initiatives, opportunities and plans in the US and globally, including timing and expectations. These statements involve risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by the forward-looking statements. Accordingly, you should not place undue reliance on these statements.

這些前瞻性聲明涉及各種事項，其中包括但不限於未來事件、結果和業績、財務指導和預期、潛在的市場和商業狀況、我們對營運趨勢的考察、我們產品和服務的潛在商業機會、新臨床項目的潛在時間、結果和影響，以及我們在美國和全球的潛在舉措、機會和計劃，包括時間安排和預期。這些聲明涉及風險和不確定性，可能導致實際結果或事件與前瞻性聲明中預期或暗示的結果或事件有重大差異。因此，您不應過度依賴這些說法。

Additional information regarding these risks and uncertainties appears under the heading Risk Factors of our Form 10-Q filed with the Securities and Exchange Commission on July 30, 2025 and our subsequent SEC filings, which are available at www.sec.gov and on our website at www.transmedics.com.

有關這些風險和不確定性的更多信息，請參閱我們於 2025 年 7 月 30 日向美國證券交易委員會提交的 10-Q 表格中的“風險因素”標題以及我們隨後向美國證券交易委員會提交的文件，這些文件可在 www.sec.gov 和我們的網站 www.transmedics.com 上查閱。

You can also find the company's slide presentation with information on third quarter 2025 results on the Investor Relations section of the TransMedics website. TransMedics disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, October 29, 2025.

您還可以在 TransMedics 網站的投資者關係部分找到該公司的幻燈片演示文稿，其中包含有關 2025 年第三季業績的資訊。TransMedics 聲明，除法律要求外，不承擔任何更新或修改任何財務預測或前瞻性聲明的意圖或義務。本次電話會議包含有時效性的信息，僅截至 2025 年 10 月 29 日直播當日的信息準確無誤。

And with that, I will now turn the call over to Waleed Hassanein, President and Chief Executive Officer.

接下來，我將把電話交給總裁兼執行長瓦利德·哈桑內因。

Thank you so much, Laine. Good afternoon, everyone, and welcome to TransMedics' third quarter 2025 earnings call. Joining me today is Gerardo Hernandez, our Chief Financial Officer.

非常感謝你，萊恩。各位下午好，歡迎參加 TransMedics 2025 年第三季財報電話會議。今天和我一起出席的是我們的財務長傑拉爾多·埃爾南德斯。

Organ transplantation remains a key area of focus for policymakers in both the US and around the world. In the US, the ongoing national modernization initiative is focused on growing transplant volumes, while streamlining organ donation, coordination and oversight processes.

器官移植仍然是美國乃至全世界政策制定者關注的重點領域。在美國，正在進行的國家現代化計劃的重點是增加器官移植數量，同時簡化器官捐贈、協調和監督流程。

Internationally, efforts are similarly focused on maximizing utilization of donor organs for transplants, while also finding more efficient ways to manage organ procurements and improving post-transplant clinical outcomes. Globally, TransMedics is uniquely positioned as the ideal solution to address these initiatives through our differentiated OCS technology, NOP clinical and logistical services and our proprietary transplant digital ecosystem.

在國際上，各方的努力也同樣著重於最大限度地利用捐贈器官進行移植，同時尋找更有效的器官獲取管理方法，並改善移植後的臨床結果。在全球範圍內，TransMedics憑藉其差異化的OCS技術、NOP臨床和物流服務以及我們專有的移植數位生態系統，成為應對這些措施的理想解決方案，具有獨特的優勢。

As we will outline today, we are seeing strong signals supporting this conviction. We are now laser-focused on capitalizing on our momentum worldwide to provide our unique solutions to promote organ transplantation and save more lives.

正如我們今天將要闡述的，我們看到了強有力的訊號支持這一觀點。我們現在正全力以赴，利用我們在全球範圍內的發展勢頭，提供我們獨特的解決方案，以促進器官移植並拯救更多生命。

We are extremely proud of our strong results achieved in Q3 despite the anticipated and typical transient seasonal slowdown seen in the US national transplant volumes as reported by UNOS OPTN data in Q3. Specifically, we're very encouraged by the year-over-year growth trend, which we strongly believe is a more relevant and meaningful performance metric, especially in a seasonal quarter like Q3. Let me share the summary of our results for 3Q 2025.

儘管根據 UNOS OPTN 第三季的數據，美國國家移植量出現了預期的、典型的短暫季節性放緩，但我們對第三季的強勁成績感到非常自豪。具體來說，我們對同比成長趨勢感到非常鼓舞，我們堅信這是一個更相關、更有意義的業績指標，尤其是在像第三季度這樣的季節性季度。讓我來分享一下我們2025年第三季的業績總結。

Total revenue for 3Q 2025 was approximately $144 million, or exactly $143.8 million, representing approximately 32.2% growth year-over-year. We experienced year-over-year growth across all three organ segments, driven by higher overall utilization and center penetration of OCS NOP in the US. Specifically, we saw year-over-year growth of nearly 41% in liver, approximately 14% in heart and approximately 5% in lung revenues in Q3.

2025 年第三季總營收約 1.44 億美元，或準確來說是 1.438 億美元，較去年同期成長約 32.2%。在所有三個器官領域，我們都實現了同比增長，這主要得益於美國 OCS NOP 的總體利用率和中心滲透率的提高。具體來說，第三季肝臟收入年增近 41%，心臟收入年增約 14%，肺部收入年增約 5%。

Our overall gross margins for 3Q was approximately 59%, representing 2.9% growth year-over-year. We delivered operating profit of approximately $23.3 million in 3Q, representing more than 16% total revenue -- of total revenue, up from $3.9 million or approximately 4% of total revenue in 3Q 2024.

第三季整體毛利率約 59%，較去年同期成長 2.9%。第三季度，我們的營業利潤約為 2,330 萬美元，佔總收入的 16% 以上，高於 2024 年第三季的 390 萬美元，約佔總收入的 4%。

And finally, we have driven strong cash generation. We have significantly improved our billing processes and have maintained a healthy AR collections, which resulted in the addition of approximately $65.6 million of cash to our balance sheet as we ended 3Q with over $466.2 million in cash.

最後，我們實現了強勁的現金流。我們大幅改善了帳單流程，並保持了健康的應收帳款回收，這使得我們的資產負債表增加了約 6,560 萬美元的現金，截至第三季末，我們的現金總額超過 4.662 億美元。

Shifting now to TransMedics' transplant logistics infrastructure and performance. Transplant logistics service revenue for 3Q was $27.2 million, representing approximately 35% year-over-year growth. Throughout 3Q, we owned and operated 21 aircraft before adding our 22nd aircraft in October, which we were targeting to end 2025 with 22 owned aircraft. In 3Q, we maintained coverage of approximately 78% of our NOP missions requiring air transport compared to approximately 61% in Q3 of 2024.

接下來我們將探討TransMedics的移植物流基礎設施與績效。第三季移植物流服務收入為 2,720 萬美元，較去年同期成長約 35%。在第三季度，我們擁有並營運了 21 架飛機，然後在 10 月增加了第 22 架飛機，我們的目標是到 2025 年底擁有 22 架自有飛機。第三季度，我們維持了約 78% 的 NOP 任務空運覆蓋率，而 2024 年第三季則約為 61%。

Meanwhile, we have continued to add to our pilot crew, enabling us to experiment with double shifting a portion of our fleet by year-end. We are pleased by our strong operational 3Q performance achieved despite the expected transient seasonality. We are confident that this seasonal impact is behind us as we have seen volume rebound in September and into early Q4.

同時，我們不斷擴充飛行員隊伍，使我們能夠在年底前嘗試對部分機隊實行雙班制。儘管存在預期的暫時性季節性因素，但我們對第三季強勁的營運業績感到滿意。我們相信這種季節性影響已經過去，因為我們看到9月份和第四季初的銷售已經反彈。

Moving now to update on our Next-Gen OCS ENHANCE Heart and DENOVO Lung clinical programs. We are thrilled to report that several US heart and lung transplant centers are approaching the initiation of patient enrollment for the ENHANCE Heart and DENOVO Lung trials. We remain confident that the enrollment will start in Q4 2025. Meanwhile, our team is actively working to complete our responses to the remaining FDA questions and expect that all IDE conditions for both trials will be satisfied by early next year.

接下來，我們將介紹我們的下一代 OCS ENHANCE 心臟和 DENOVO 肺部臨床計畫的最新進展。我們很高興地宣布，美國多家心臟和肺移植中心即將開始招募患者參與 ENHANCE 心臟和 DENOVO 肺移植試驗。我們仍有信心，招生工作將於 2025 年第四季開始。同時，我們的團隊正在積極努力完成對 FDA 剩餘問題的答复，並預計到明年初，兩項試驗的所有 IDE 條件都將得到滿足。

We're very excited about initiating these two programs to demonstrate the potential positive clinical impact of our Gen 2 modification on heart and lung transplantation in the US. Importantly, we hope that these programs will catalyze significant OCS Heart and OCS Lung adoption in the US in 2026 and beyond.

我們非常高興能夠啟動這兩個項目，以展示我們的第二代改良技術對美國心臟和肺移植的潛在積極臨床影響。重要的是，我們希望這些項目能夠促進 OCS 心臟和 OCS 肺在 2026 年及以後在美國廣泛應用。

Now, please allow me to discuss our effort to expand our TransMedics NOP model outside of the US, which represents a key midterm growth driver for TransMedics. As I stated before, TransMedics' US NOP success has been highly visible across the global transplant markets.

現在，請容許我談談我們為將 TransMedics NOP 模式擴展到美國以外所做的努力，這代表了 TransMedics 中期成長的關鍵驅動力。正如我之前所說，TransMedics 在美國 NOP 的成功在全球移植市場中已廣為人知。

This resulted in many international geographies engaging with TransMedics to explore the potential for replicating all or a portion of our NOP model and our integrated logistics platform to help them grow their transplant programs. Importantly, through these market engagements, we became very aware of their significant needs for a dedicated transplant logistics support for reasons similar to those we've seen and experienced in the US.

因此，許多國際地區與 TransMedics 接洽，探討複製我們 NOP 模式和整合物流平台的全部或部分內容的可能性，以幫助他們發展移植項目。重要的是，透過這些市場互動，我們非常清楚地意識到，由於與我們在美國看到和經歷的情況類似的原因，他們對專門的移植物流支援有著重大的需求。

To that end, in September, we were excited to announce our plans to launch our first OUS NOP program in Italy. We are now actively establishing up to four hubs to serve as launch points for that program, strategically covering both Northern and Southern Italy. We are also actively staffing up our Italian clinical support teams.

為此，我們在 9 月興奮地宣布了我們在義大利啟動第一個 OUS NOP 計畫的計畫。我們目前正在積極建立多達四個中心作為該計劃的啟動點，以策略性地覆蓋義大利北部和南部。我們也積極擴充義大利臨床支援團隊的人員配置。

Now, it is important to note that we are planning to start building an EU air and ground transplant logistics network similar to the one we have established in the US, however, appropriately sized to meet the European needs. Given our current knowledge of the Italian and European transplant logistics need, we see a significant opportunity for TransMedics to capitalize on by replicating our transplant logistics service in Europe. Please allow me to repeat, we -- given our current knowledge, we see a significant business opportunity and revenue-generating opportunity by replicating our transplant logistics service in Europe to meet the growing needs for a dedicated transplant network -- logistics network in European countries.

現在需要指出的是，我們計劃開始建立一個類似於我們在美國建立的歐盟空運和陸運移植物流網絡，但規模要適當，以滿足歐洲的需求。鑑於我們目前對義大利和歐洲移植物流需求的了解，我們認為 TransMedics 可以透過在歐洲複製我們的移植物流服務來抓住這一重大機會。請容許我再說一遍，根據我們目前的知識，我們看到，透過在歐洲複製我們的移植物流服務，以滿足歐洲各國對專用移植網路（物流網路）日益增長的需求，存在著巨大的商機和創收機會。

We expect the Italian NOP program to launch in the first half of 2026. We're also currently engaged with several other European countries and also engage with regions outside of Europe to expand our program beyond Italy in the coming years. Stay tuned. This initiative will serve as an additional growth catalyst beginning as early as late 2026 and more meaningfully in '27 and beyond.

我們預計義大利 NOP 計畫將於 2026 年上半年啟動。我們目前也與其他幾個歐洲國家合作，並與其他歐洲以外的地區合作，以期在未來幾年將我們的計畫擴展到義大利以外的地區。敬請關注。這項措施將從 2026 年底開始，成為額外的成長催化劑，並在 2027 年及以後發揮更重要的作用。

With that, let me turn to the here and now. We are laser-focused on finishing out 2025 strong to round out another great year for our business and potentially grow the US national transplant volumes for the third consecutive year in a row. We are continuing to drive adoption of our OCS NOP across all organs. We are expanding our OPO partnership to increase organ utilization for transplantation around the United States.

那麼，接下來讓我們來談談當下。我們全力以赴，力爭在 2025 年取得佳績，為我們的業務再添輝煌一年，並有可能連續第三年實現美國全國移植量的增長。我們正在持續推動 OCS NOP 在所有器官中的應用。我們正在擴大與器官獲取組織 (OPO) 的合作關係，以提高全美各地器官移植的使用率。

Next week, we are hosting our annual transplant leadership forums in Boston with approximately 200 transplant leaders from all transplant market segments expected to participate.

下週，我們將在波士頓舉辦年度移植領導論壇，預計將有來自所有移植市場領域的約 200 位移植領導者。

We are continuing to strengthen our clinical support staffing to meet the growing demand. And finally, we remain on track to begin double shifting a portion of our aircraft fleet by year-end to enhance operational efficiency. We are confident that all these activities will position us well to end the year strong and be in a good position for the expected ramp in adoption in 2026.

我們正在不斷加強臨床支援人員配備，以滿足日益增長的需求。最後，我們仍按計畫在年底前開始對部分機隊實行雙班制，以提高營運效率。我們相信，所有這些活動將使我們能夠以強勁的勢頭結束今年，並為 2026 年預期的採用率上升做好準備。

Before I conclude, please allow me to provide a status update on our long-term growth initiatives and our planned new global headquarters and manufacturing facility. First, we are very pleased with the preclinical and product development progress of our OCS Kidney program, which is underway and was announced publicly at the World Transplant Congress Scientific Conference in August.

在結束演講之前，請允許我向大家報告我們的長期成長計劃以及我們計劃建造的新全球總部和製造工廠的最新進展。首先，我們對正在進行的 OCS 腎臟計畫的臨床前和產品開發進展感到非常滿意，該計畫已於 8 月在世界移植大會科學會議上公開宣布。

We expect to reveal the design of our OCS Kidney device in early 2026 at the American Society of Transplant Surgeons Winter Symposium. Second, the development of our Gen 3 OCS platform is well underway with significant progress already made on many of the advanced technology platforms that will be encompassed in that next Gen 3 OCS platform. We expect to share more detail on Gen 3 OCS platform in the second half of 2026.

我們預計將於 2026 年初在美國移植外科醫師協會冬季研討會上公佈我們的 OCS 腎臟裝置的設計。其次，我們的第三代 OCS 平台的開發工作進展順利，許多先進技術平台已經取得了顯著進展，這些平台將包含在下一代第三代 OCS 平台中。我們預計將於 2026 年下半年分享有關第三代 OCS 平台的更多細節。

Third, as Gerardo will outline later, we are actively investing in critical business infrastructure systems to better position TransMedics to scale and grow with strong controls and efficiencies. Finally, we have narrowed down our selection for the new global headquarters of TransMedics to the city of Somerville, a northern suburb of Boston. We are in the final stages of lease negotiations for a state-of-the-art new building to combine all of our functions in one campus, and we expect to announce the location in early January 2026.

第三，正如 Gerardo 稍後將概述的那樣，我們正在積極投資關鍵業務基礎設施系統，以便更好地使 TransMedics 能夠透過強大的控制和效率來擴大規模和發展。最後，我們將 TransMedics 新全球總部的選址範圍縮小到波士頓北部郊區薩默維爾市。我們正在就租賃一座最先進的新大樓進行最後的談判，該大樓將把我們所有的功能集中在一個園區內，我們預計將於 2026 年 1 月初宣布該大樓的選址。

As you can see, we are not slowing down, and we are growing our technology platform and geographical outreach. As I have stated before, our near-term capital allocation strategy is a growth-oriented strategy. That said, while we expect operating margins to fluctuate somewhat as we deploy capital across these initiatives, we have a high degree of confidence in our long-term ability to deliver substantial top and bottom line growth.

如您所見，我們並未放慢腳步，而是不斷發展壯大我們的技術平台和地理覆蓋範圍。正如我之前所說，我們近期的資本配置策略是成長導向策略。儘管如此，我們預計隨著我們在這些舉措中投入資金，營業利潤率會有一些波動，但我們對長期實現營收和利潤大幅增長的能力充滿信心。

Now, let me conclude my remarks by commenting on our expectations for the remainder of 2025, which Gerardo will detail further. Based on our performance to date and our expectation to end the year strong, we are narrowing the range to raise the midpoint of our full year 2025 revenue guidance. We are now guiding to a range between $595 million to $605 million for full year 2025 revenue. This represents approximately 36% growth over the full year 2024 at the midpoint.

現在，讓我以對 2025 年剩餘時間的預期來結束我的發言，Gerardo 將對此進行更詳細的闡述。根據我們迄今為止的業績以及我們對今年年底強勁收官的預期，我們將縮小範圍，提高 2025 年全年收入預期中位數。我們現在預計 2025 年全年營收將在 5.95 億至 6.05 億美元之間。這相當於到 2024 年全年中期成長約 36%。

With that, let me turn the call to Gerardo to cover the detailed financial results for the quarter.

接下來，我將把電話交給傑拉爾多，讓他詳細介紹本季的財務表現。

Thank you, Waleed. Good afternoon, everybody. I am pleased to be here to discuss TransMedics' third quarter results. Please note that a supplemental slide presentation with additional details on our third quarter 2025 results is available in the Investors section of our website.

謝謝你，瓦利德。大家下午好。我很高興來到這裡與大家討論TransMedics第三季的業績。請注意，我們網站的「投資者」部分提供了包含 2025 年第三季業績更多詳細資訊的補充幻燈片簡報。

As Waleed highlighted, we sustained momentum through the third quarter with disciplined execution across the entire TransMedics team. Despite the typical seasonal slowdown in the US transplant activity, where Q2 tends to be one of the strongest periods followed by some moderation, our performance remained strong.

正如 Waleed 所強調的那樣，TransMedics 團隊在整個第三季度保持了良好的發展勢頭，這要歸功於團隊的嚴謹執行。儘管美國器官移植活動通常會經歷季節性放緩（第二季度往往是活動最活躍的時期之一，之後會有所放緩），但我們的業績仍然強勁。

Continued benefits from our ongoing strategic investments drove solid performance across both product and service lines, along with continued margin expansion and improved profitability versus Q3 of 2024. It's worth noting that in our earlier years, our rapid growth trajectory offset the natural seasonality in the US transplant activity.

持續的策略投資帶來的持續效益推動了產品和服務線的穩健表現，同時利潤率持續擴大，獲利能力較 2024 年第三季有所提高。值得注意的是，在早期，我們的快速成長軌跡抵消了美國移植活動的自然季節性波動。

As we've reached greater scale, our results have started to follow those underlying market dynamics more closely, even as the business continues to expand at a healthy pace. Total revenue for the third quarter was approximately $144 million.

隨著公司規模的擴大，即使業務繼續以健康的速度擴張，我們的業績也開始與潛在的市場動態更加緊密地聯繫在一起。第三季總營收約 1.44 億美元。

US transplant revenue was approximately $139 million, up 32% year-over-year and down 9% sequentially. By organ, liver contributed $108 million, heart with $27 million and lungs with $4 million. OUS revenue was $3.6 million, up 41% year-over-year and down 13% sequentially. OUS revenue by organ was $3.2 million in heart, $0.3 million in lungs and $0.1 million in liver.

我們移植收入約 1.39 億美元，年增 32%，季減 9%。按器官劃分，肝臟貢獻了 1.08 億美元，心臟貢獻了 2700 萬美元，肺部貢獻了 400 萬美元。OUS 營收為 360 萬美元，年增 41%，季減 13%。依器官劃分，OUS收入分別為：心臟320萬美元，肺30萬美元，肝臟10萬美元。

Product revenue for the third quarter was $88 million, up 33% year-over-year and down 9% sequentially, reflecting continued momentum across both liver and heart programs and solid underlying activity levels compared to 2024. The sequential decline was in line with the typical seasonality moderation in transplant activity during the third quarter.

第三季產品營收為 8,800 萬美元，年成長 33%，季減 9%，反映出肝臟和心臟計畫持續成長勢頭，以及與 2024 年相比穩健的潛在業務活動水準。這一連續下降與第三季移植活動的典型季節性緩和相符。

Service revenue for the third quarter was $56 million, up 31% year-over-year and down 8% sequentially. The primary driver of growth was logistics revenue, which increased 35% year-over-year, reflecting continued expansion and strong utilization of our aviation fleet compared to 2024. Sequentially, logistics revenue declined 9%, consistent with the expected seasonal slowdown in transplant volumes during the third quarter.

第三季服務收入為 5,600 萬美元，年增 31%，季減 8%。成長的主要驅動力是物流收入，年成長 35%，反映出與 2024 年相比，我們的航空機隊持續擴張和強勁利用率。與上一季相比，物流收入下降了 9%，這與第三季移植數量預期出現的季節性放緩相符。

Total gross margin for the quarter was approximately 59%, up nearly 290 basis points year-over-year and down roughly 260 basis points sequentially. The year-over-year improvement was driven by higher fleet utilization, cost efficiencies in logistics and limited unplanned aircraft downtime.

本季總毛利率約 59%，較去年同期成長近 290 個基點，較上季下降約 260 個基點。與上年相比，業績的提升主要得益於機隊利用率的提高、物流成本效益的提高以及計劃外飛機停機時間的減少。

We are also starting to see early benefits from spreading the scheduled maintenance more evenly throughout the year. Sequentially, the decline mainly reflects lower activity levels in the quarter and the impact of investments we are making in infrastructure to drive future efficiencies and support our anticipated growth in 2026.

我們也開始看到，將計畫維護工作更均勻地分散到全年，已經帶來了一些初步的好處。從環比來看，下降主要反映了本季活動水準的降低，以及我們為提高未來效率和支持我們2026年預期成長而對基礎設施進行的投資的影響。

Total operating expenses for the third quarter of 2025 were $61 million, up 8% year-over-year, and the increase was primarily driven by a 7% increase in R&D expenses, reflecting continued investment in our innovation pipeline and the ramp-up of our product development capabilities.

2025 年第三季總營運支出為 6,100 萬美元，年成長 8%，成長主要由研發支出成長 7% 推動，這反映了我們對創新管道的持續投資以及產品開發能力的提升。

SG&A expenses grew 8% year-over-year, reflecting ongoing expansion of our IT infrastructure and investments in strategic growth initiatives. Sequentially, total operating expenses were up 2%, primarily driven by an increase in SG&A in support of our ongoing expansion activities.

銷售、一般及行政費用年增 8%，反映了我們 IT 基礎設施的持續擴張以及對策略性成長計畫的投資。與上一季相比，總營運費用增加了 2%，主要原因是為支持我們持續的擴張活動，銷售、一般及行政費用增加。

Operating income for the quarter was $23 million, up 494% year-over-year and down 36% sequentially. Operating margin expanded to 16% compared to 4% in the prior year. Net income for the third quarter was $24 million, representing a 477% year-over-year increase and a 30% sequential decrease. Earnings per share were $0.71 and diluted earnings per share were $0.66 for the third quarter of 2025.

本季營業收入為 2,300 萬美元，年增 494%，季減 36%。營業利益率從上年的 4% 成長至 16%。第三季淨收入為 2,400 萬美元，年增 477%，季減 30%。2025 年第三季每股收益為 0.71 美元，稀釋後每股收益為 0.66 美元。

We ended the quarter with $466 million in cash, up $66 million from June 30, 2025. This increase was driven by strong operating cash generation, supported by continued improvement in our billing processes and healthy collections, reflecting our focus on efficiency and disciplined working capital management.

本季末，我們持有現金 4.66 億美元，比 2025 年 6 月 30 日增加了 6,600 萬美元。這一成長得益於強勁的經營現金流，以及帳單流程的持續改善和良好的收款情況，這反映了我們對效率和嚴格營運資金管理的重視。

Overall, our third quarter performance reflects the same disciplined execution, efficiency gains and progress across our clinical and innovation programs that we've demonstrated throughout the year. Together with the scalability of our model, these results continue to validate our ability to deliver strong financial performance and sustained momentum through the rest of 2025 and beyond.

總體而言，我們第三季的業績反映了我們全年所展現的嚴謹執行、效率提升以及在臨床和創新項目方面取得的進展。結合我們模型的可擴展性，這些結果繼續驗證了我們有能力在 2025 年剩餘時間及以後實現強勁的財務業績和持續的成長勢頭。

Looking ahead, as Waleed mentioned before, we are narrowing our full year revenue guidance to a range of $595 million to $605 million. With only one quarter left in the year, this reflects our increased visibility and continued confidence in the strength of the business. At the midpoint, this represents roughly 36% growth over 2024, driven by expanding transplant volumes and sustained momentum across our service platform.

展望未來，如同瓦利德先前所提到的，我們將全年營收預期範圍縮小至 5.95 億美元至 6.05 億美元。今年只剩下最後一個季度了，這反映出我們提高了業務的可見度，並對我們業務的實力持續充滿信心。中期來看，這代表到 2024 年將成長約 36%，這主要得益於移植數量的增加以及我們服務平台持續成長的勢頭。

In terms of gross margin, as mentioned in previous calls, we expect overall margins to remain around 60% over the coming years. This outlook reflects the various factors influencing both product and service margins beyond just mix. As we expand internationally and continue investing ahead of growth, we may experience some near-term pressure on margins. However, we expect those impacts to normalize and margins to recover as volumes scale across markets.

就毛利率而言，正如先前電話會議中提到的，我們預計未來幾年整體毛利率將保持在 60% 左右。這種觀點反映了除了產品組合之外，影響產品和服務利潤率的各種因素。隨著我們向國際市場擴張，並繼續在成長之前進行投資，我們可能會在短期內面臨利潤率的一些壓力。然而，我們預期隨著各市場銷售量的擴大，這些影響將逐漸恢復正常，利潤率也將隨之回升。

In terms of capital allocation, our focus is on driving long-term value. We are concentrating our investments in three key areas: first, fueling growth through continued R&D investments and targeted expansion into selected international markets; second, building a stronger foundation by implementing systems that simplify and optimize processes across the business, improving efficiency and scalability as we grow; and third, enhancing our infrastructure to support long-term scalability, including our planned move to a new global headquarters to accommodate growth, ongoing upgrades to expand our manufacturing and product development capabilities, and our continued evaluation of strategic opportunities that could further strengthen our platform for the future.

在資本配置方面，我們的重點是創造長期價值。我們將投資集中在三個關鍵領域：第一，透過持續的研發投入和有針對性地拓展特定國際市場來推動成長；第二，透過實施簡化和優化業務流程的系統來建立更強大的基礎，隨著業務的增長提高效率和可擴展性；第三，加強我們的基礎設施以支持長期可擴展性，包括我們計劃搬遷到新的全球

Collectively, these initiatives play an important role in preparing TransMedics for its next stage of expansion as we move towards the 10,000 transplant milestone and beyond and reinforce our global leadership in transplantation.

這些舉措共同為 TransMedics 的下一階段擴張做出了重要貢獻，我們將朝著 10,000 例移植手術的里程碑邁進，並鞏固我們在移植領域的全球領導地位。

Aligned with our focus on efficiency, we have also made progress on our double shifting pilot program to improve fleet utilization. Pilot hiring and training are advancing well, and we continue to expect early results in the first half of 2026. This insight will help us determine the appropriate fleet size and utilization model to maximize efficiency and capital returns.

為了提高效率，我們在雙班制試點計畫方面也取得了進展，以提高車隊利用率。飛行員招募和訓練進展順利，我們仍然預計在 2026 年上半年就能取得初步成果。這項洞察將有助於我們確定合適的車隊規模和利用模式，從而最大限度地提高效率和資本回報。

Recently, in October, we achieved our goals of owning 22 jets by the end of 2025. Looking ahead, we remain open to acquiring additional jets when the right conditions are in place, whether to enhance US capacity or to support our international expansion efforts.

最近，在 10 月份，我們實現了 2025 年底擁有 22 架噴射機的目標。展望未來，我們仍會在適當的條件下購買更多飛機，無論是為了增強美國的運力還是為了支持我們的國際擴張努力。

Finally, with stronger top line performance, continued efficiency gains and disciplined spending, we expect to deliver at least 750 basis points of operating margin expansion for the full year of 2025 compared to 2024. While there could be additional upside, that will depend on our final sales performance and the timing of our investment plan for Q4 of 2025. We continue to expect operating margins to reach or approach 30% by 2028.

最後，憑藉更強勁的營收表現、持續的效率提升和嚴格的支出控制，我們預計 2025 年全年營業利潤率將比 2024 年提高至少 750 個基點。雖然可能還有進一步上漲的空間，但這取決於我們最終的銷售業績以及我們 2025 年第四季的投資計畫的時間表。我們仍預計到 2028 年，營業利潤率將達到或接近 30%。

While we may see some fluctuations as we expand internationally and invest ahead of growth, we remain confident in the long-term direction and scalability of our model. Our OCS technology, together with NOP platform and integrated logistics network, give us a clear advantage in expanding access to transplantation worldwide. With the scalability of our model and strong execution across the organization, TransMedics is well positioned to sustain growth, expand margins and deliver long-term value, while giving more patients a second chance at life.

雖然隨著我們在國際市場擴張和成長前進行投資，可能會出現一些波動，但我們對我們模式的長期方向和可擴展性仍然充滿信心。我們的 OCS 技術，加上 NOP 平台和一體化物流網絡，使我們在擴大全球移植機會方面擁有明顯的優勢。憑藉我們模式的可擴展性和整個組織的強大執行力，TransMedics 已做好充分準備，能夠維持成長、擴大利潤率並創造長期價值，同時為更多患者提供第二次生命的機會。

And with that, I'll turn the call over to Waleed for closing remarks.

接下來，我將把電話交給瓦利德，請他作總結發言。

Thank you so much, Gerardo. Overall, we're very pleased with our third quarter performance and the significant progress our team continues to make across multiple growth initiatives. Importantly, we are now laser-focused, as I stated earlier, on ending 2025 on a strong note and better position TransMedics for another strong growth year in 2026.

非常感謝你，傑拉爾多。總體而言，我們對第三季的業績以及團隊在多個成長計畫中持續取得的顯著進展感到非常滿意。重要的是，正如我之前所說，我們現在正全力以赴，力爭在 2025 年取得佳績，並為 TransMedics 在 2026 年的又一個強勁增長年做好準備。

It's becoming increasingly clear that TransMedics is uniquely positioned with unparalleled attributes that include OCS technology, NOP clinical services, the transplant logistics network and our proprietary NOP Connect digital platform. All of these collectively enable us to deliver unrivaled life-saving solutions to global transplant markets.

越來越明顯的是，TransMedics 擁有獨特的優勢，包括 OCS 技術、NOP 臨床服務、移植物流網絡以及我們專有的 NOP Connect 數位平台，這些優勢使其處於獨特的地位。所有這些因素共同使我們能夠為全球移植市場提供無與倫比的救生解決方案。

Of course, none of this would have happened without our dedicated world-class TransMedics team that are working around the clock to make organ transplantation more accessible to patients who are waiting for a new lease on life in the form of a new organ. We are inspired and committed to continue our drive to expand the access to organ transplantation and improve post-transplant clinical outcomes of organ transplant therapy around the world.

當然，這一切都離不開我們敬業的世界一流 TransMedics 團隊，他們日以繼夜地工作，使器官移植更容易惠及那些等待新器官以重獲新生的患者。我們深受鼓舞，並致力於繼續努力，擴大器官移植的機會，並改善世界各地器官移植治療的術後臨床結果。

With that, I will now turn the call to the operator for Q&A. Operator?

接下來，我將把電話轉交給接線生進行問答環節。操作員？

(Operator Instructions)

（操作說明）

Allen Gong, JPMorgan.

Allen Gong，摩根大通。

Hi team, thanks for the question. I guess, my first is just on the trajectory into 4Q and then after that into 2026. So based on your guide, you're expecting to get to roughly just under 30% in fourth quarter, around [$155 million-plus] sales. So how should we think about that as a run rate looking forward into 2026? And should we think about 2025 as being an appropriate year when it comes to seasonality, given we've seen you kind of normalizing more towards market growth as you've grown larger?

大家好，感謝你們的提問。我猜，我的第一個目標應該會在第四季實現，然後持續到 2026 年。根據你的指導，預計第四季銷售額將略低於 30%，約為 1.55 億美元以上。那麼，我們該如何看待2026年的運行率呢？考慮到隨著貴公司規模的擴大，市場成長逐漸趨於正常化，我們是否應該將 2025 年視為季節性因素的合適年份？

Thank you, Allen. Let me start with the second part of the question first, if you allow me. As I've stated publicly before, I think seasonality in organ transplant is something that we all have to be comfortable with and anticipate year after year, especially as we continue to grow and be a dominant player in the US transplant market. As Gerardo mentioned, we see this seasonality every year, and we saw the seasonality every year nearly for the past almost a decade. And so, we should expect that going forward.

謝謝你，艾倫。如果可以的話，我想先回答問題的第二部分。正如我之前公開表示的那樣，我認為器官移植的季節性是我們所有人都必須適應並年復一年地預料到的事情，尤其是在我們不斷發展壯大並成為美國移植市場的主導者的情況下。正如 Gerardo 所提到的，我們每年都會看到這種季節性現象，而且在過去近十年裡，我們幾乎每年都會看到這種季節性現象。因此，我們應該預料到這種情況會持續下去。

Now, let me turn to the first part of your question. We plan to issue our guidance for 2026 at our next earnings call. I think 2025, our focus right now is to end 2025 strong and achieve our stated guidance. And then, that gives us time to evaluate our initiatives, the clinical programs that are underway, then we will issue guidance for 2026, which we fully expect to be a growth year for TransMedics over 2025, but allow us the time to state our 2026 expectations with the benefit of finishing the year and adding these data points that will be crucial to providing guidance for the full year 2026.

現在，讓我來回答你問題的第一部分。我們計劃在下次財報電話會議上發布2026年業績指引。我認為，2025 年，我們目前的重點是取得強勁的收官成績，並實現我們既定的目標。這樣，我們就有時間評估我們的各項措施和正在進行的臨床項目，然後我們將發布 2026 年的指導意見。我們完全預期 2026 年對於 TransMedics 而言將是比 2025 年增長的一年，但請允許我們利用完成這一年並添加這些數據點的優勢，來闡述我們對 2026 年的預期，這些數據點對於提供 2026 年全年的指導意見至關重要。

Thanks, And then, a quick follow-up just on international. I know the Italy announcement was definitely a pleasant surprise. And I guess, when we think about your efforts to expand beyond that to cover the breadth of Europe, I imagine it won't be quite as straightforward as you can call it that as your efforts in the US.

謝謝。接下來，我想快速問國際方面的問題。我知道義大利的公告絕對是一個令人驚訝的消息。我想，當我們想到您試圖將業務擴展到整個歐洲時，我想這不會像您在美國所做的那樣簡單直接。

But what kind of challenges do you anticipate ahead of you for that? And how long do you think it will take before you can get your NOP and your logistics services in Europe to the same level as they are in the US Thank you.

但你預計未來會面臨哪些挑戰？您認為需要多久才能使您在歐洲的NOP和物流服務達到與美國相同的水平？謝謝。

Thanks, Allen. Again, Europe is not a homogeneous geography. We have to be respectful and design our NOP to be tailored to each country's specific clinical and regulatory requirements. Italy is going to be a very important first step. We're very encouraged by where we are in Italy right now, and we hope to be able to deliver Italy early -- or in the first half of 2026.

謝謝你，艾倫。再次強調，歐洲的地理環境並非同質的。我們必須尊重各國的具體臨床和監管要求，並據此設計我們的國家職業治療方案。義大利將會是非常重要的第一步。我們目前在義大利的進展令我們倍感鼓舞，我們希望能夠儘早——或者在 2026 年上半年——完成義大利專案的交付。

We're heavily engaged with other geographies in Europe. And as I said, every geography has its own specific requirements. However, the -- what's universal in Europe is the need for a dedicated transplant logistics network. It's not going to be at the scale of the US for sure.

我們與歐洲其他地區的業務聯繫非常緊密。正如我所說，每種地理環境都有其自身特定的要求。然而，歐洲普遍存在的問題是需要一個專門的器官移植物流網絡。肯定不會達到美國的規模。

It's going to be smaller. But that has a huge opportunity to even facilitate clinical adoption for the OCS in many of the European geographies that we're engaged with, as well as other regions outside of Europe. So we need to focus on our first kind of beachhead in Italy, deliver on our promises and deliver world-class service, achieve success there. And we believe wholeheartedly, especially in Europe, success delivers success. And if it works in Italy and it works well, this is going to propagate across Europe.

它會更小一些。但這為在我們參與的許多歐洲地區以及歐洲以外的其他地區推廣 OCS 的臨床應用提供了巨大的機會。因此，我們需要專注於我們在義大利的第一個灘頭陣地，兌現我們的承諾，提供世界一流的服務，在那裡取得成功。我們堅信，尤其是在歐洲，成功會帶來更大的成功。如果這種模式在義大利行之有效，並且效果顯著，那麼它將在整個歐洲推廣開來。

And if it works in Italy, it will work anywhere in Europe, just given how the Italian environment is very complicated and very -- has a lot of needs.

如果它能在義大利奏效，那麼它在歐洲任何地方都會奏效，因為義大利的環境非常複雜，而且有很多需求。

Bill Plovanic, Canaccord.

Bill Plovanic，Canaccord。

Yeah, great, thanks for taking my question. I'm going to just start off -- first, I just wanted to get clarity. So you believe that you'll have the final IDE sign-off from FDA on the ENHANCE and DENOVO and enroll -- when you say enroll, treat the first patients or book the first revenue in the first half of '26, is that what you're saying at this point?

好的，謝謝您回答我的問題。我先從頭說起——首先，我只是想弄清楚情況。所以您認為您將獲得 FDA 對 ENHANCE 和 DENOVO 的最終 IDE 批准，並開始招募患者——您說的招募、治療第一批患者或在 2026 年上半年獲得第一筆收入，是您目前的意思嗎？

No. Bill, thank you for the question. We are going to enroll the first patients and probably first handful of patients and book the revenue in Q4 of 2025. What we are saying is we have conditional approval for a fairly sizable initiation of the trial, so especially for the heart. So we can -- that's going to happen in Q4.

不。比爾，謝謝你的提問。我們將招募第一批患者，可能只有少數幾名患者，並在 2025 年第四季確認收入。我們想說的是，我們已經獲得了有條件批准，可以啟動相當大規模的試驗，特別是針對心臟的試驗。所以我們可以——這將在第四季度發生。

What I'm saying is that limitation or cap is going to be removed or these conditions will be removed once we address all the remaining questions for FDA, and that will come in Q1 of 2026 or early 2026. And then -- and now, the trial will be uncapped and unconditional. It's going to be open. But we're going to enroll and book our first revenue in Q4.

我的意思是，一旦我們解決了FDA剩餘的所有問題，這些限製或上限將被取消，或者這些條件將被取消，這將在2026年第一季或2026年初實現。然後——現在，審判將不再設上限，也不再附加任何條件。它將開放。但我們計劃在第四季度開始招生並實現第一筆收入。

Okay. Perfect. And then, just trying to understand, on the operating margin guide, you're saying 750 bps, which is 16% for the year, which is $96 million, which -- that's like $10 million on the midpoint of the fourth quarter is only 6.5%. So I'm just trying to understand, as you talk about the build-out of Europe logistics, like can you put a dollar amount on this for us? Is this $10 million, $100 million?

好的。完美的。然後，我只是想了解一下，關於營業利潤率指引，您說全年為 750 個基點，即 16%，也就是 9600 萬美元，這相當於第四季度中點的 1000 萬美元，只有 6.5%。所以，我只是想了解一下，當您談到歐洲物流建設時，您能否給我們估算一下這需要多少美元？是1000萬美元，還是1億美元？

Like how should we think about the CapEx required and the timing of those investments?

我們應該如何考慮所需的資本支出以及這些投資的時機？

Bill, this is Gerardo. In terms of CapEx and investment for the European NOP, we will be providing a little bit more color next year in our next call. However, for my anticipated forecast on operating margin in 2025, it assumes that it has certainly space to improve upside. It assumes that we land in the low end of our guidance range and that we actually deliver on our investment plan in the US in Q4.

比爾，這位是傑拉爾多。關於歐洲 NOP 的資本支出和投資，我們將在明年的下一次電話會議上提供更多細節。然而，對於我預期的 2025 年營業利潤率，我認為它肯定還有提升的空間。它假設我們的業績達到預期範圍的下限，並且我們實際上在第四季度實現了在美國的投資計劃。

So I believe we have space to surpass what I shared, but we'll see where we land.

所以我相信我們還有超越我所分享的成果的空間，但最終結果如何，我們拭目以待。

Ryan Daniels, William Blair.

瑞安·丹尼爾斯，威廉·布萊爾。

This is Matthew Mardula on for Ryan Daniels. So I want to touch up with HHS decertifying an OPO in the middle of the year. Have you seen any disruptions from the OPO decertification? And I understand that HHS wants to increase the number of transplants and not have organs go to waste. But could the continued decertification of OPOs impact the number of organ transplants? Or do you just view this as a kind of small minimal risk?

這裡是馬修馬杜拉，替瑞安丹尼爾斯為您報道。所以我想補充一下美國衛生與公眾服務部 (HHS) 在年中取消 OPO 認證的情況。OPO取消認證是否造成了任何干擾？我理解美國衛生與公共服務部希望增加器官移植數量，避免器官浪費。但是，器官獲取組織（OPO）持續被取消認證會不會影響器官移植的數量？還是你認為這只是一種很小的風險？

Thank you for the question. At the first part of the question, we do not see any disruption to organ transplantation in the US based on the actions taken by HHS. That's number one. Number two, we believe wholeheartedly that if the stated goals and vision of HHS and HRSA and CMS to be achieved, actually, we believe it actually could provide a tailwind to organ transplant efficiency in the United States by having more performance metrics that everybody could get behind and be held accountable to.

謝謝你的提問。對於問題的第一部分，根據美國衛生與公眾服務部採取的行動，我們沒有看到對美國器官移植造成任何干擾。這是第一點。第二，我們完全相信，如果 HHS、HRSA 和 CMS 所提出的目標和願景能夠實現，我們相信，透過制定更多人人都能支持並對其負責的績效指標，實際上可以為美國的器官移植效率帶來助力。

So we have to wait and see, and we have to allow the time for these initiatives to materialize, but we are confident in our ability to operate in the current OPO model or any other modernization model that will come -- that may come out from this initiative. And frankly, we see this as a potential opportunity, not a potential risk, but we have to wait and see.

所以我們必須拭目以待，也必須給這些舉措一些時間來落實，但我們有信心在當前的 OPO 模式下運營，或者在未來的任何其他現代化模式下運營——這些模式可能會從這項舉措中產生。坦白說，我們認為這是一個潛在的機會，而不是潛在的風險，但我們必須拭目以待。

So much for those insights.

以上就是我所了解的全部內容。

Thank you.

謝謝。

Chris Pasquale, Nephron Research.

克里斯·帕斯誇萊，腎臟單位研究。

Waleed, logistics penetration has been in the high-70s for three straight quarters now. Curious how you think about where that goes over time. Is 80% a bit of a ceiling because the other 20% are drivable? Or do you think that, that number could still go higher as you guys continue to roll out the service?

Waleed，物流滲透率已經連續三個季度維持在 70% 以上了。很好奇你覺得隨著時間的推移，它會如何發展。80%是不是有點限制了，因為剩下的20%也可以開？或者您認為，隨著你們繼續推廣這項服務，這個數字還有可能繼續上升？

Thank you, Chris. I want to clarify, Chris, that 79% -- or yes, 78% or 79% or 80%, it's our planes for only the mission requiring air transport. So we expect that number to go up definitely in the low-to-mid 80s. I think in 2025, we see a ceiling in the low-80s or 80%, roughly speaking, just because of some of the existing contracts that are supporting other logistics providers in the United States. The other element to that is the long-distance transport.

謝謝你，克里斯。克里斯，我想澄清一下，79%——或者說，78%、79%或80%——指的是我們用來執行需要空中運輸任務的飛機。因此我們預計這個數字肯定會上升到 80 多歲。我認為到 2025 年，我們會看到成長率達到 80% 左右的上限，粗略地說，這主要是因為一些現有的合約正在支持美國的其他物流供應商。另一個因素是長途運輸。

Remember, our planes are short distance or relatively speaking, they're light jets. So any Alaska or Puerto Rico or -- I'm sorry, any Hawaii missions, we have to do it on third-party aircraft because that's a longer jet. But Alaska and Puerto Rico, we can do on our jet.

請記住，我們的飛機是短程飛機，或者相對而言，它們是輕型噴射機。所以任何前往阿拉斯加、波多黎各或——抱歉，任何前往夏威夷的任務，我們都必須使用第三方飛機，因為那是一架更長的噴射機。但是去阿拉斯加和波多黎各，我們可以坐私人飛機去。

So to summarize, we expect that number to go up in the mid-80s at least in the foreseeable future as we continue to gain market share and we continue to prove to the community that TransMedics logistics is providing not just the safest, the most efficient, but also cost-effective logistics partnership in organ transplant.

總而言之，我們預計在可預見的未來，隨著我們不斷擴大市場份額，並且不斷向業界證明 TransMedics 物流不僅提供了最安全、最高效的器官移植物流合作夥伴關係，而且還提供了最具成本效益的物流合作夥伴關係，這個數字至少會上升到 80 多例。

And then, sort of related to that, you guys rolled out the new NOP Connect kind of digital ecosystem earlier this year. I'm curious whether we have enough experience with that now to see what impact that's having, either on your collection or sort of cash conversion cycle being simplified or on adoption of the broader services that you put into place?

然後，與此相關的是，你們今年稍早推出了新的 NOP Connect 數位生態系統。我很好奇我們現在是否有足夠的經驗來觀察它對收款或現金轉換週期簡化，或對推廣您實施的更廣泛服務的影響？

Chris, that's an excellent question. We are -- not only we feel very excited about the rollout of this new ecosystem, we are already taking some very good feedback from the community, and we are rolling our 2.0 or 0.2 version of it in Q4. We are seeing some great efficiencies. I wouldn't go as far as saying we're seeing the full efficiency or the full impact yet. We expect that to come throughout 2026.

克里斯，這是一個很好的問題。我們不僅對這個新生態系統的推出感到非常興奮，而且已經從社區獲得了一些非常好的反饋，我們將在第四季度推出 2.0 或 0.2 版本。我們看到效率顯著提高。我不會斷言我們已經看到了全部的效率或全部的影響。我們預計這種情況將在 2026 年全年發生。

Josh Jennings, TD Cowen.

喬什·詹寧斯，TD Cowen。

Hi, good afternoon. Thanks for taking the questions. I wanted to circle back just on the 2025 guidance, revenue guidance update and just the increase of $5 million at the midpoint. Waleed, maybe help us think through, and Gerardo, some of the assumptions baked in there. I mean, was 3Q results better than TransMedics' internal expectations with stronger start than expected? In October, you have another plane. But maybe just help us think through what's driving the guidance increase, a little bit more detail.

您好，下午好。謝謝您回答問題。我想再談談 2025 年的業績指引、收入指引更新以及中期增加 500 萬美元的情況。Waleed，或許可以幫我們跟 Gerardo 一起思考一下，這裡麵包含的一些假設。我的意思是，TransMedics第三季的業績是否優於公司內部預期，且開局比預期更強？十月你還有一趟航班。但或許您可以幫我們更詳細地分析一下是什麼因素導致了業績指引的上調。

Thank you, Josh. As you know, we don't give that much detail. All I can say is, we are confident. One, we are pleased by the results of Q3. Two, we are confident in the trends we saw at the end of Q3, into early Q4.

謝謝你，喬許。如你所知，我們不會透露那麼多細節。我只能說，我們充滿信心。第一，我們對第三季的業績感到滿意。第二，我們對第三季末到第四季初所看到的趨勢充滿信心。

But we have to be prudent. We're still early in Q4. We still have two more months to go, and we have to be respectful of that. Gerardo, do you want to add anything else?

但我們必須謹慎行事。現在還處於第四季初期。還有兩個月的時間，我們必須尊重這一點。傑拉爾多，你還有什麼要補充的嗎？

Well, no, I think we have a number of tailwinds, as Waleed was mentioning, [Chris]. What we're seeing in terms of OCS adoption, organ utilization, it's really fueling the momentum of the OCS. So we're confident to get to the number. Of course, as you know, our philosophy has been to not only achieve, but as much as we can, go above and beyond. But we're confident with where we are right now.

不，我認為我們有很多有利因素，正如瓦利德所提到的。[克里斯]從器官移植的普及和器官利用率來看，器官移植確實推動了器官移植的發展動能。所以我們有信心達到這個數字。當然，如您所知，我們的理念不僅是取得成就，而且盡可能做到超越預期。但我們對目前的狀況充滿信心。

Great. And just a follow-up. I think it's clear that there really hasn't been an overhang in terms of some of the headlines that came out on DCD donors and some of the New York Times expose, but wanted to just confirm that. Any impact to donor registrations that you're seeing? And then, maybe give us the status of the wait list for liver, heart and lung transplants.

偉大的。還有一個後續問題。我認為很明顯，關於 DCD 捐贈者的一些新聞標題和《紐約時報》的一些曝光並沒有造成太大的影響，但我只是想確認一下。您觀察到捐贈者登記數量受到任何影響嗎？然後，或許可以告訴我們肝臟、心臟和肺移植的等待名單的最新情況。

We just anecdotally talked to -- some heavy OCS users have talked about their waitlist going down because volumes have increased dramatically, but I think those have refilled, but maybe help us on those two topics.

我們只是和一些 OCS 重度用戶進行了非正式的交談——他們談到他們的候補名單減少了，因為訂單量大幅增加，但我認為這些候補名單已經重新滿了，但也許可以幫助我們解決這兩個問題。

Thanks, Josh. Let me address the second piece first. We can't comment really on the waitlist because the waitlist is a very dynamic situation, as you know, Josh, and all that data is published. The facts are, for the last three years when we were operating NOP, many centers wiped down the waitlist and rebuilt it half a dozen to a dozen times. The growth in the national transplant volume speaks for itself.

謝謝你，喬希。讓我先回答第二個問題。我們不能對候補名單發表任何評論，因為候補名單的情況非常複雜，如你所知，喬希，而且所有相關數據都會公佈。事實是，在我們營運 NOP 的過去三年裡，許多中心都清空了候補名單，然後又重建了六到十二次。全國器官移植數量的增長本身就說明了一切。

So the fact that centers are wiping down the waitlist, yes, that's a transient effect. It takes a quarter, maybe sometimes in very -- in large or midsized centers that are efficient with their outreach, they could rebuild it within a quarter, and some centers take a quarter to rebuild.

所以，各中心清除候補名單這一事實，是的，這只是暫時的。重建可能需要一個季度，有時在規模很大或中等的、外展效率很高的中心，他們可以在一個季度內重建，而有些中心則需要一個季度才能重建。

So for that, we don't -- we are actually -- we're focusing on one thing. We're focusing on opening up the supply of available suitable organs for transplants, and we -- and the centers are responsible of rebuilding their waitlist because these are life-saving transplant procedures, as you know. So that's our answer to the second half.

所以，為此，我們並沒有——實際上——我們只專注於一件事。我們正致力於增加可用於移植的合適器官的供應，我們和各中心有責任重建他們的等待名單，因為正如你們所知，這些都是可以挽救生命的移植手術。這就是我們對第二部分的回答。

For first half, listen, it's a very unfortunate expose that came out. But as we've stated numerous times, we cannot allow either intentional or unintentional bad behavior from certain players in the transplant community to be taken out of context and negatively impact the national transplant volume, which is helping a lot of patients who are waiting anxiously on the waiting list for an organ transplant.

前半部分，聽著，這是一起非常不幸的曝光事件。但正如我們多次聲明的那樣，我們不能允許移植界某些人的故意或無意的不良行為被斷章取義，從而對全國移植數量產生負面影響，而全國移植數量正在幫助許多在器官移植等待名單上焦急等待的患者。

So -- and I hope that some of these investigative reporters understand that, that, yes, it's important to highlight some bad acts, but we have to remember that these are very, very few, very, very limited. And ultimately, the number 1 focus for us and anybody else who is involved in organ transplantation is to focus on the patients. And it is not in the best interest of the patients to portray transplantation as the Wild Wild West because it isn't.

所以——我希望一些調查記者能夠理解，是的，揭露一些不良行為很重要，但我們必須記住，這些行為非常非常少，非常非常有限。歸根結底，對於我們以及所有參與器官移植的人來說，首要關注點是病人。將器官移植描繪成蠻荒之地並不符合病患的最佳利益，因為事實並非如此。

The US organ transplant system remains to be, in my humble opinion, one of the best, if not the best, transplant system on planet Earth. So we have to be cognizant of that.

依我拙見，美國的器官移植系統仍然是地球上最好的移植系統之一，甚至可以說是最好的。所以我們必須意識到這一點。

Understood. Thank you.

明白了。謝謝。

Suraj Kalia, Oppenheimer & Co.

蘇拉吉·卡利亞，奧本海默公司

Waleed, can you hear me all right?

瓦利德，你聽得清楚我說話嗎？

I can Hi.

嗨。

So Waleed, one for you and one for Gerardo. So Waleed, I'll start out with you. Look, short-term gyrations aside, you guys have delivered on your numbers. Waleed, there is this pervasive belief that incremental liver share gains are -- will be difficult to come by. Can you argue the reverse is true for FY26?

瓦利德，一杯給你，一杯給傑拉爾多。瓦利德，那我就先從你開始吧。拋開短期波動不談，你們的績效指標已經達標了。瓦利德，人們普遍認為，肝臟市場份額的逐步增長是——將會是——難以實現的。你能論證2026財年的情況正好相反嗎？

Or your confidence for FY26 is you would characterize that it's predicated on heart and lung contribution through the trials, the OUS endeavor that you talked about? Just set the stage for us as how you guys are thinking as you shift gears in FY26?

或者，您對 2026 財政年度的信心是基於您提到的 OUS 專案以及試驗中心臟和肺部的貢獻？請您為我們介紹一下，在2026財年轉型之際，你們的想法是什麼？

Suraj, thank you so much for the thoughtful question. Let me dissect that important question into different pieces. First, it is, in my view, a false assumption propagated by some of the bear thesis out there that the penetration in liver will be difficult to come by. We see it completely different. We think we are early in our liver penetration, and we have a long greenfield opportunity in liver transplant to grow our adoption rate over the next several years, not just 2026.

蘇拉傑，非常感謝你提出的這個深思熟慮的問題。讓我把這個重要的問題拆解成幾個部分來分析。首先，在我看來，一些看空者所散佈的「肝臟滲透會很困難」的假設是錯誤的。我們的看法完全不同。我們認為，我們目前在肝臟移植領域的滲透還處於早期階段，未來幾年（不僅僅是 2026 年）肝臟移植領域還有很長的綠地發展空間，可以提高我們的採用率。

Where is it coming from? It's going to be coming from DBD penetration. It's going to be coming from more DCD penetration. It's going to be coming from more challenging -- from expansion potentially of the DCD wait period. So we are very, very much believers that -- the notion that growth in liver is going to be difficult to come by, we believe that's a false assumption, propagated by the wrong narrative. So that's number one.

它來自哪裡？它將來自DBD滲透。這將源自於DCD技術的更廣泛應用。它將來自更具挑戰性的地方——可能是 DCD 等待期的延長。所以我們非常非常相信──認為肝臟生長會很困難的觀點，我們認為這是一個錯誤的假設，是由錯誤的敘述傳播開來的。這是第一點。

Number two, we fully believe and expect that the next-gen heart and lung clinical programs will generate significant momentum in the adoption of both DBD and DCD heart and lung. And listen, we are all going to experience that as it materializes throughout 2026. But that is our expectations going into '26. And that's where we stand from a US perspective.

第二，我們完全相信並期望下一代心臟和肺臨床計畫將極大地推動 DBD 和 DCD 心臟和肺的採用。聽著，隨著它在 2026 年逐步顯現，我們都將親身經歷這一切。但這就是我們對2026年的預期。這就是我們從美國角度所處的立場。

Again, the initiation of NOP OUS will be a potential catalyst, albeit in the second half of 2026, but it is going to become a catalyst for us in next year. A lot of publications are in the launching pad or in review that will generate that evidence that will be required or will facilitate the adoption picture that I just described, Suraj. I hope I addressed your question.

再次強調，NOP OUS 的啟動將是一個潛在的催化劑，儘管要到 2026 年下半年才會啟動，但它將在明年成為我們的催化劑。蘇拉傑，許多出版物正處於籌備或審查階段，它們將產生所需的證據，或有助於實現我剛才描述的這種收養局面。希望我的回答能幫助你。

Fair enough. And Gerardo, if I could, look, our math is your liver shares, you gained by almost 100 bps in the quarter, but your service revenues were obviously down, right? And one of the things that you and Waleed have been telegraphing for some time now is third-party ground transport and third-party flights picked up in the quarter. Gerardo, what -- how should we think about -- is this a blip of the screen? Is this something structural as we look forward? Just help us understand both qualitatively and quantitatively. It would be great.

很公平。Gerardo，如果可以的話，我想說，根據我們的計算，你的肝臟業務份額在本季度增長了近 100 個基點，但你的服務收入顯然下降了，對吧？你和瓦利德已經暗示了一段時間，該地區將引入第三方地面交通和第三方航班。Gerardo，我們該怎麼看待這件事？這只是螢幕上的一個瞬間嗎？這是我們未來發展中需要考慮的結構性問題嗎？請您從定性和定量兩個方面幫助我們理解。那太好了。

Suraj, if you allow me, I'll address one point, and then I'll turn it on to Gerardo to address the rest of it. We never telegraphed or articulated or suggested that third-party service or transportation is growing in Q3. That was a misunderstanding, or it is a misunderstanding if somebody thinks that way.

蘇拉傑，如果你允許的話，我先說明一點，然後剩下的部分就交給傑拉爾多來說明。我們從未暗示、闡明或表明第三方服務或運輸在第三季度會成長。那是一種誤會，或者說，如果有人那樣想的話，那就是一種誤會。

All what we wanted to clarify is two important points, and I'll repeat them again if you allow me. One, tracking tail numbers alone is not 100% reflective of our revenue within the quarter for a variety of different reasons.

我們想要澄清的只有兩點，如果允許的話，我再重複一次。第一，由於各種不同的原因，僅追蹤尾部數字並不能 100% 反映我們當季的收入。

Two, there is -- a good portion of our clinical missions are done using car transport alone. This was the only two simple facts that we wanted to highlight to the community who are just laser-focused on tracking tail numbers. And so, that's just a clarification. Gerardo, can you please address the rest?

第二，我們的臨床任務大多是僅靠汽車運輸完成的。我們只想向那些只專注於追蹤尾號的社群強調這兩個簡單的事實。所以，這只是一個澄清說明。Gerardo，剩下的問題可以回答一下嗎？

Yeah. Well, in reality, there is not much to add, Waleed, more. Suraj, we didn't see any, I would say, significant change in the, let's say, split between ground and air transportation through the quarter compared to what we've seen earlier in the year. And we are assuming more or less the same thing for Q4. I think that's what I would say, not much more to add.

是的。其實，瓦利德，也沒什麼好補充的了。Suraj，與今年稍早的情況相比，我們並沒有看到本季地面運輸和航空運輸之間的比例發生任何顯著變化。我們預計第四季的情況也大致相同。我想這就是我想說的了，沒什麼要補充的了。

Thank you.

謝謝。

Patrick Wood, Morgan Stanley.

派崔克‧伍德，摩根士丹利。

Amazing. I'll keep it to one, just given the time. Waleed, you mentioned double shifting twice at the start in the comments. And just curious how you're seeing that as an opportunity, what that means both financially for you guys, but then also for your customers and the ability to potentially service them faster? Is that a valid thought process? Just how do you see that affecting the business overall?

驚人的。鑑於時間允許，我就只訂一個吧。瓦利德，你在評論中兩次提到一開始要上雙班。我很好奇你們是如何看待這個機會的，這對你們的財務狀況意味著什麼，對你們的客戶意味著什麼，以及你們能否更快地為他們提供服務？這種思路合理嗎？您認為這會對公司整體業務產生怎樣的影響？

Thank you, Patrick. Double shifting, Patrick, will give us at least -- in '25, we're just experimenting or piloting this program. The concept is to maximize the efficiency of our existing fleet and truly sweat the assets that we have before we think of adding any additional investment in our fleet.

謝謝你，派崔克。派崔克，雙班制至少能帶給我們──在 2025 年，我們只是在試驗或試行這個計畫。我們的理念是，在考慮對車隊進行任何額外投資之前，盡可能提高現有車隊的效率，並真正充分利用我們擁有的資產。

So from an impact standpoint, and this is just my perspective, and Gerardo, please correct me if I'm wrong, the idea is, at scale -- at a certain scale, we will start seeing efficiencies in the bottom line and the margin contribution of the service with that model. But Gerardo, please correct me if I'm wrong.

所以從影響的角度來看，這只是我個人的看法，Gerardo，如果我錯了請糾正我，我的想法是，規模化之後——達到一定規模後，我們將開始看到這種模式下服務的利潤率和利潤貢獻有所提高。但是傑拉爾多，如果我說錯了，請糾正我。

No, that's right. And basically, what will be happening, Patrick, there is that the same number of planes will fly higher number of missions, maximizing the return on capital. That's basically the concept.

沒錯。派崔克，基本上，接下來會發生的情況是，同樣數量的飛機將執行更多的任務，從而最大限度地提高資本回報率。這就是基本概念。

Taking as much. Thanks guys.

盡可能多拿走。謝謝各位。

Matthew O'Brien, Piper Sandler.

馬修·奧布萊恩，派珀·桑德勒。

This is Samantha on for Matt. I guess, first, I know the 10,000 transplant target has been out there for a while, but we're now seeing you start to communicate potentially even surpassing that target. I guess, what gives you the confidence that you can get there? And then, how much of that is dependent upon these next-gen heart and lung programs?

這裡是薩曼莎替馬特報道。我想，首先，我知道10,000例移植手術的目標已經提出一段時間了，但我們現在看到你們開始溝通，有可能甚至超過這個目標。我想，是什麼讓你有信心實現目標呢？那麼，其中有多少取決於這些新一代的心肺治療計畫呢？

Thank you for the question. We have a very high degree of confidence that we will get there. And we -- when we set that target, we set that target without the expectation of acceleration of heart and lung. So our hope is to get to 10,000 transplants even without the contribution of the next-gen heart and lung programs. The contribution of heart and lung transplant, the new programs, will be to accelerate the path or increase the contribution of the heart and lung in the mix.

謝謝你的提問。我們非常有信心能夠實現目標。我們－當我們設定這個目標時，我們設定這個目標時並沒有期望心臟和肺部加速運轉。因此，即使沒有下一代心臟和肺移植計畫的貢獻，我們也希望能夠實現 10,000 例移植手術的目標。心臟和肺移植等新項目的貢獻在於加速心臟和肺在整體治療中的應用或提高其在整體治療中的貢獻。

So that's -- we have a very high degree of confidence. And please, I want to reiterate what I've stated before. If we continue on the current trajectory of growth without any catalyzation of growth in US transplant volumes, in 2028, 10,000 transplants will represent approximately 50% to 55% of the national heart, lung and liver volumes, which means we have not saturated the market. The opposite is true. We have another probably approximately half of the market to continue to grow heart, lung and liver through.

所以——我們對此非常有信心。還有一點，我想重申我之前說過的話。如果我們繼續保持目前的成長軌跡，而美國器官移植量又沒有成長的催化劑，那麼到 2028 年，10,000 例移植手術將約佔全國心臟、肺和肝臟移植總量的 50% 至 55%，這意味著我們還沒有飽和市場。事實恰恰相反。我們還有大約一半的市場空間可以繼續拓展心臟、肺和肝臟方面的業務。

On top of that, what we said is, the kidney program being introduced in 2027 will give us an access to an additional 23,000 to 25,000 procedures in 2027 and beyond, and that could even catalyze our growth beyond the 10,000 target into 20,000 by 2030. So that's what we stated. So we have a very high degree of confidence reaching the 10,000 transplants. Our results are pointing in that direction. Our growth rates are pointing in that direction.

此外，我們說過，2027 年推出的腎臟計畫將使我們在 2027 年及以後能夠進行額外的 23,000 至 25,000 例手術，這甚至可能促使我們的增長超過 10,000 例的目標，到 2030 年達到 20,000 例。這就是我們所說的。因此，我們非常有信心達到1萬例移植手術的目標。我們的研究結果也指向這個方向。我們的成長率正朝著這個方向發展。

And we are hoping that the next-gen heart and lung clinical programs will accelerate the path to getting there. And again, we remain convinced that 2028, at 10,000 transplant with the current market growth, we would be at approximately half of the US heart and lung and liver transplant market, leaving room for growth even beyond that.

我們希望下一代心臟和肺部臨床計畫能夠加快實現這一目標的進程。我們仍然堅信，按照目前的市場成長速度，到 2028 年，移植手術數量達到 10,000 例時，我們將佔據美國心臟、肺和肝臟移植市場約一半的份額，並且還有很大的成長空間。

That's perfect. If I could sneak in one more also on the next-gen heart and lung programs. It's great to hear that those are going to start enrolling this quarter. How are you thinking about the duration of these trials and how long they're going to take to enroll?

那很完美。如果我能再補充一點關於下一代心臟和肺部計畫的相關資訊就更好了。很高興聽到他們這季就要開始招生了。您認為這些試驗的持續時間以及招募受試者需要多長時間？

The duration of these trials, for us, it really -- it doesn't really matter what the duration is. We expect it to be somewhere between 12 to 18 months. But what is important for us is to see the trajectory or the impact -- to see the impact of these trials in the form of trajectory of penetration of heart and lung volumes every quarter. Given that these are -- these trials are revenue generating, the numbers will count in our quarterly report. That is what we are excited to see because we will know the impact even before the trial is completed.

對我們來說，這些試驗的持續時間其實並不重要。我們預計需要 12 到 18 個月。但對我們來說，重要的是要看到軌跡或影響——以每季心肺容量滲透軌跡的形式來觀察這些試驗的影響。鑑於這些試驗能夠帶來收入，這些數字將計入我們的季度報告。我們很期待看到這一點，因為在試驗完成之前我們就能知道其影響。

David Rescott, Baird.

David Rescott，貝爾德。

Oh great, thanks for taking the questions. Lili, I wanted to follow up on some of your comments around the timing of the trial. I'm just looking for maybe some more color on what the -- the difference between starting enrolling the trial in Q4 and having these full conditional limitations, I don't know if limitations, but the full conditions on the trial that gets the IDE fully cleared in Q1.

太好了，謝謝你回答這些問題。莉莉，我想就你之前關於審判時間安排的一些評論做個後續說明。我只是想了解一下——在第四季度開始招募試驗參與者和在第一季完全獲得 IDE 批准之間有哪些區別，我不知道這是否是限制，但試驗的全部條件是什麼。

Is it something similar for both heart and lung? Would it be fair to assume maybe the Part A of the heart trial is good to go and start enrolling in Q4 and maybe it's Part B that comes in, in 2026? Just trying to understand what's going on there and maybe whether or not there is any change in the contribution you have baked in from clinical trials in Q4.

心臟和肺的情況類似嗎？是否可以合理假設心臟試驗的 A 部分已經準備就緒，將於第四季度開始招募受試者，而 B 部分可能要到 2026 年才會啟動？我只是想了解那裡發生了什麼，以及您在第四季度從臨床試驗中獲得的收益是否有所變化。

David, thank you for the question. I just want to remind you that we really didn't account for much contribution in Q4 from the trial, pretty much 0 contribution for the trial. We're actually -- we appear to be ahead of schedule. So let me clarify, however, the difference between the two trials as we know them today. The heart conditional approval is for both Part A and Part B.

大衛，謝謝你的提問。我只是想提醒您，我們在第四季度並沒有從試驗中獲得多少收益，試驗的收益幾乎為零。實際上，我們似乎已經提前完成了計劃。那麼，讓我來澄清一下我們今天所知的這兩個審判之間的差異。心臟手術的有條件批准適用於A部分和B部分。

We have a sizable conditional approval, so we can start enrolling in both Part A and Part B in Q4. The lung is slightly different. It's more a limited -- the lung is one part, so it's not two parts. And it's a fairly limited condition for approval because the questions that are asked for the lung is pretty straightforward, and we think we will overcome it fairly quickly. And the FDA conditions were limiting, given that the questions are fairly straightforward.

我們已獲得相當可觀的有條件批准，因此我們可以在第四季度開始招收 A 部分和 B 部分參保人員。肺部略有不同。更確切地說，肺部是一個整體，而不是兩個部分。而且，這個批准條件相當有限，因為對肺部提出的問題相當直接，我們認為我們很快就能克服它。鑑於這些問題相當簡單明了，FDA 的條件卻很嚴苛。

So what I'm saying on this call is, we should -- we are expecting to enroll our first patients or cohort of patients in heart and lung in Q4 and hoping that by early Q1, we will remove all conditions from both IDEs and now will be -- the trials will be wide open across all indications, across the two parts for heart and the one part for lung. And then, we will not be capped. That's really the message I was telegraphing in the prepared remarks.

所以，我在這次電話會議上要說的是，我們預計將在第四季度招募第一批心臟和肺部疾病患者或患者群體，並希望到第一季度初，我們將從兩項 IDE 中移除所有適應症，屆時，試驗將全面開放，涵蓋所有適應症，包括心臟疾病的兩個部分和肺部疾病的一個部分。這樣一來，我們就不會受到限制了。這正是我在準備好的演講稿中想要傳達的訊息。

Okay. That's very helpful. And maybe on Europe, a two-part question. I know you provided some comments on it already. But I know the market in Europe is pretty fragmented and there's different agencies, maybe we'll say, that control organ donation and allocation across different end markets, so I guess -- or different countries.

好的。那很有幫助。關於歐洲，或許可以提出一個包含兩個部分的問題。我知道您已經就此發表了一些評論。但我知道歐洲的器官捐贈和分配市場相當分散，不同的機構（或許我們可以這麼說）控制著不同終端市場（或不同國家）的器官捐贈和分配。

I guess, the first part, for Italy, is the assumption that organs that are transplanted through the new service in Italy will likely stay in Italy? Or is it possible that those are going to get moved around transplants in Europe? And then, as it relates to the margin comments there, I know you called out gross margins staying in this 60% range in general, but maybe some near-term headwinds as you expand in Europe.

我想，對義大利來說，第一部分假設是透過義大利新服務進行移植的器官很可能會留在義大利？或者這些器官有可能在歐洲各地進行移植手術嗎？至於利潤率方面，我知道您提到毛利率總體上會保持在 60% 左右，但隨著您在歐洲擴張，可能會面臨一些短期不利因素。

I'm just trying to get a context for the timing of this maybe step-down in margins and step back up in margins and still staying consistent in the 60% range. Maybe there's a difference between gross and operating, but any clarity there would be helpful. Thank you.

我只是想了解利潤率可能會下降，然後又上升，但仍然保持在 60% 左右的時間點的背景。毛利和營業利潤之間或許存在差異，但如果能對此進行澄清，將會很有幫助。謝謝。

Sure. Thanks, David. So I'll address the first part, and Gerardo will address the part around the margins. So we are not planning, at least early on, to impact the movement of organs at all within each geography in Europe that we will be operating on. Everybody needs to be aware that -- and let me be very specific about Italy.

當然。謝謝你，大衛。所以我會先講第一部分，剩下的部分由 Gerardo 來講。因此，至少在初期，我們並不打算對我們在歐洲進行手術的每個地區內的器官運輸產生任何影響。每個人都需要意識到這一點——讓我特別強調一下義大利的情況。

Italy today, there is movement of organs across Italy. There's movement of organs from Switzerland to Italy. There's movement of organs from Italy to Switzerland. The same for some select other European countries. Our role is not to change any of the current dynamics that are routinely happening today.

如今，義大利各地都在進行器官移植。瑞士的管風琴正運往義大利。義大利的管風琴正在運往瑞士。其他一些歐洲國家也存在同樣的情況。我們的職責不是改變當今正在發生的任何常規動態。

Our role is to facilitate the utilization of these organs to actual transplant successfully. Our role, even if it's a local transplant within Italy, based on our knowledge today, David, that they are having significant challenges of even securing logistics to move organs even within Italy. So for us, that's a huge opportunity and a huge business opportunity to solve that problem as we've solved it here in the US at a much bigger geographical scale.

我們的職責是促進這些器官的利用，並最終成功用於移植手術。大衛，即使是在義大利境內進行器官移植，根據我們目前掌握的信息，他們甚至在確保義大利境內器官運輸的物流方面都面臨著巨大的挑戰。所以對我們來說，這是一個巨大的機遇，也是一個巨大的商機，我們可以像在美國一樣，在更大的地域範圍內解決這個問題。

And now, I'll turn it to Gerardo to address the margin question.

現在，我將把問題交給傑拉爾多，讓他來回答利潤率問題。

David, in our Q4 call, we're going to be providing a little bit more details on what to expect in the margin. But what I can confirm to you is, I remain confident that our long-term margin is around 60%. I believe that, that's the level that we're going to be seeing as volumes scale across in the US already, but mostly outside of the US. But more importantly, we are laser-focused on the operating margin.

大衛，在我們的第四季財報電話會議上，我們將提供更多關於利潤率預期方面的細節。但我可以向你確認的是，我仍然相信我們的長期利潤率在 60% 左右。我認為，隨著美國乃至美國以外地區銷售的不斷增長，我們將會看到這樣的水平。但更重要的是，我們高度關注的是營業利益率。

That is -- because of the way we operate, operating margin is more relevant than the gross margin. Yes, so Q4 is when we're going to provide a little bit more details.

也就是說——由於我們的營運方式，營業利潤率比毛利率更重要。是的，我們將在第四季度提供更多細節。

Okay.

好的。

Mike Matson, Needham & Company.

Mike Matson，Needham & Company。

Yeah, thanks.

嗯，謝謝。

So I had a question on the heart trial design, and this may apply to lung, too, but I wasn't able to find lung in the clinicaltrials.gov yet. But the endpoint is patient and graft survival at 30 days. And so, my understanding is that that's typically, even without using TransMedics in the -- well into the 90s.

我有一個關於心臟試驗設計的問題，這可能也適用於肺部，但我還沒有在 clinicaltrials.gov 上找到肺部試驗的資訊。但最終目標是患者和移植器官在 30 天時的存活率。因此，我的理解是，即使在 90 年代沒有使用 TransMedics，這種情況通常也是如此。

So -- and I think you're running this study with the intention of showing superiority. So are you going to have -- I mean, is this trial powered enough to actually show superiority from a high-90s number or mid-90s number versus what you're actually going to get with your -- using OCS for those organs?

所以——而且我認為你們進行這項研究的目的是為了證明自己的優越性。所以，你們打算──我的意思是，這項試驗的效力是否足以證明，90%以上的數字或90%中段的數字比使用OCS治療這些器官實際能達到的數字更優越？

Thank you, Mike, for the question. I want to clarify one important point. The primary effectiveness endpoint is not actually patient and graft survival at 30 days alone. It's patient and graft survival at 30 days with freedom of primary graft dysfunction within the first 72 hours after heart transplant. When you combine these two, you end up not in the high-90s as just a patient survival, but probably in the low-to-mid 80s.

謝謝你的提問，麥克。我想澄清一個重要的觀點。主要療效終點其實並非僅僅是患者和移植器官在 30 天時的存活率。指心臟移植術後 30 天患者和移植器官的存活率，以及術後 72 小時內未發生原發性移植器官功能障礙。將這兩者結合起來，最終的患者存活率不會達到 90% 以上，而可能只有 80% 左右。

And that gives us the signal, the wider signal to enable us to power the study appropriately to aim for superiority. So a great point you raised, however. I think the clarification is that we are not -- that primary endpoint is not just patient and graft survival. It's patient and graft survival with freedom of primary graft dysfunction. That -- these two combination is what makes this powered enough for -- to hopefully demonstrate superiority.

這為我們提供了訊號，更廣泛的訊號，使我們能夠適當地進行研究，以期取得優異結果。所以，你提出的觀點非常好。我認為需要澄清的是，我們並非——主要終點不僅僅是患者和移植器官的存活率。它能確保患者和移植器官的存活，並避免原發性移植器官功能障礙。正是這兩者的結合，才使得它擁有足夠的動力，有望展現優越性。

So we're very excited getting the trial launched. And both lung and heart are of the same design or the same selection of primary effectiveness endpoint to exactly achieve the goal and avoid the statistical anomaly of the very high patient survival numbers in the United States.

所以我們對啟動這項試驗感到非常興奮。肺部和心臟都採用了相同的設計或相同的主要療效終點選擇，以精確實現目標，避免美國患者生存率過高這一統計異常現象。

Okay. That makes a lot of sense. And then just for kidney, I think you said you're going to unveil the design in early '26. But I imagine you're going to have to run a trial there as well, so -- before you can get it approved. So just can you talk about the timing of that?

好的。這很有道理。至於腎臟手術，我想你說過你會在 2026 年初公佈設計方案。但我認為你也需要在那裡進行試驗，這樣才能獲得批准。那麼，您能談談這件事發生的時間嗎？

And then, is that also a trial where you would -- when you started, you would actually get paid for those organs as well, like we are with the heart and lung trials?

那麼，這也是一項試驗嗎？當你開始進行這項試驗時，你實際上也會像我們進行心臟和肺部試驗那樣，因捐贈這些器官而獲得報酬？

Yes. Mike, excellent question. Yes, we are unveiling the design of the technology and the product. There will be a significant trial in the United States and maybe even international trial. But this is all going to be revenue-generating trial.

是的。麥克，問得好。是的，我們將揭曉這項技術和產品的設計。美國將進行一場重要的審判，甚至可能進行國際審判。但這都將是一場以營利為目的的試驗。

And we're excited about that trial because this trial is also going to be powered for superiority, and it will have a huge ramification not only on the clinical outcome for patients, but also financial ramification, given that CMS is the sole payer for end-stage renal failure expenses in the United States.

我們對這項試驗感到興奮，因為這項試驗也將以證明其優越性為目標，而且它不僅會對患者的臨床結果產生巨大影響，還會產生巨大的經濟影響，因為 CMS 是美國終末期腎衰竭費用的唯一支付方。

So this is a trial that I hope and I believe CMS will be watching very keenly, and they will support it because it will have huge cost efficiencies, given the increased -- improved outcomes and higher utilization of kidneys that should be afforded by this.

所以，我希望並且相信美國醫療保險和醫療補助服務中心（CMS）會非常密切地關注這項試驗，並且會支持它，因為它將帶來巨大的成本效益，包括提高治療效果和增加腎臟利用率。

Daniel Markowitz, Evercore.

Daniel Markowitz，Evercore。

Hey guys, thank you for taking my questions. The first one, you mentioned that the prior guide wasn't assuming anything for 4Q from next-gen heart and lung trials. It's nice to hear that's running a bit ahead of schedule. Just confirming, does the new guide assume some contribution since that's running ahead of schedule now that you're closer and have visibility to it?

大家好，感謝你們回答我的問題。第一點，您提到先前的指南沒有對第四季度下一代心臟和肺部試驗做出任何假設。很高興聽到這個專案進展比預期提前了一些。我確認一下，既然你們現在離目標更近，也更了解情況了，那麼新指南是否需要你們做出一些貢獻呢？

That's an excellent question. Yes and no. The answer is, from a contribution, no. Yes, we're ahead of schedule. But realistically speaking, if we start enrolling in November, the impact is going to be miniscule.

這是一個很好的問題。是，也不是。從貢獻者的角度來看，答案是否定的。是的，我們進度超前了。但實際上，如果我們從 11 月開始招生，影響將微乎其微。

That's why we always guided without any meaningful contribution. All what we want to achieve is having the first handful of patients enrolled gives us an early signal of how the trial is rolling out and really teeing up to early 2026.

這就是為什麼我們總是袖手旁觀，卻沒有任何實質貢獻的原因。我們希望透過招募首批患者，儘早了解試驗的進展情況，並為 2026 年初的試驗做好充分準備。

Got it. Okay. And then, the second one, I wanted to ask on recent industry news. We had OrganOx takeout announcement. I just wanted to give you an opportunity to kind of react to this announcement.

知道了。好的。其次，我想問最近的產業新聞。我們發布了 OrganOx 收購公告。我只是想給你們一個機會，讓你們對這個消息做出反應。

What do you think this means for the market and more specifically for TransMedics over the coming years?

您認為這對市場，尤其是對TransMedics公司未來幾年的發展意味著什麼？

Thank you, Daniel. This is an excellent question. As I stated publicly before on my call with investors, we're very, very pleased, and congratulations to OrganOx and the OrganOx team about this acquisition. We're very pleased because it shows three things. One, it shows that TransMedics have created a multibillion-dollar industry in organ transplantation that didn't exist before.

謝謝你，丹尼爾。這是一個很好的問題。正如我之前在與投資者的電話會議上公開表示的那樣，我們對此非常非常高興，並祝賀 OrganOx 和 OrganOx 團隊完成此次收購。我們非常高興，因為它說明了三件事。第一，這顯示 TransMedics 創造了一個價值數十億美元的器官移植產業，而此前這個產業並不存在。

We're very pleased because it shows how undervalued TransMedics stock is, given the huge difference and improvement in OCS Liver and market share that OCS Liver have over any other platform in the market in the US. And number three, it validates that this is an area of the market that is now becoming an exciting opportunity for med tech industry.

我們非常高興，因為這表明 TransMedics 的股票被嚴重低估了，考慮到 OCS Liver 的巨大差異和改進，以及 OCS Liver 在美國市場上相對於任何其他平台所擁有的市場份額。第三，它證實了這個市場領域現在正成為醫療科技產業令人興奮的機會。

So again, congratulations to OrganOx, but we feel very confident in our position. We feel very confident that we are way undervalued, given our leadership position, given our outcomes, given our numbers, given our market share, and we are determined to go and continue to execute and grow our market share in liver, heart, lung and soon kidney.

再次恭喜 OrganOx，但我們對自己的處境非常有信心。鑑於我們的領導地位、業績、數據和市場份額，我們非常有信心我們被嚴重低估了，我們決心繼續前進，並在肝臟、心臟、肺臟以及即將到來的腎臟領域擴大我們的市場份額。

Great, thanks for taking my questions.

太好了，謝謝你回答我的問題。

Tom Stephan, Stifel.

湯姆·史蒂芬，斯蒂費爾。

Apologies if any of this has been asked; jumping between calls. But maybe just one for me. Waleed, market slowed in the third quarter for the second straight year, and we saw somewhat of an accompanying deceleration in OCS. So maybe can you talk about why OCS seemingly faces, I'd just say, a bit of incremental pressure during times when the US transplant market seems to slow down?

如果這些問題之前已經問過，請見諒；我一直在接電話。但也許我只需要一份。Waleed，市場在第三季連續第二年放緩，我們看到OCS也出現了一定程度的相應放緩。那麼，您能否談談為什麼在美國器官移植市場似乎放緩之際，OCS 似乎面臨一些漸進的壓力？

And then, how should we be thinking about that dynamic maybe if market softness persists?

那麼，如果市場疲軟的局面持續下去，我們該如何看待這種動態呢？

I'm sorry, I missed the second part of the question.

抱歉，我漏看了問題的第二部分。

Yeah. I was just wondering how we should think about that dynamic, I guess, if market softness persists.

是的。我只是在想，如果市場疲軟的局面持續下去，我們該如何看待這種動態。

That's an interesting question. So we believe that the market softness and the seasonality, as I stated before, this is something that is endemic in organ transplants, and we've seen this for several years. I think what's changing is, TransMedics is taking a bigger market share in the market.

這是一個有趣的問題。因此，我們認為市場疲軟和季節性因素，正如我之前所說，是器官移植領域普遍存在的現象，我們已經看到這種情況好幾年了。我認為正在改變的是，TransMedics 在市場上的佔比越來越大。

And that market share is not -- is spread between top users and the current users, and we're expanding organically to newer centers. And when we look at Q3 this year, what we saw is our market share within our repeat users and top 20 accounts and consistent users was maintained, was well maintained within the institution.

而且，市場佔有率並非分散在頂級用戶和現有用戶之間，我們正在逐步擴展到新的中心。當我們回顧今年第三季時，我們發現，我們在回頭客、前 20 名帳戶和穩定用戶中的市場份額得到了保持，並且在機構內部得到了很好的保持。

Any variability happens with the centers that are still coming new to the NOP or not constant users in NOP, we're tracking that dynamic. And again, we are not too concerned about it because we are maintaining our growth year-over-year. That's why I said it's much more relevant for us to look at our growth year-over-year. It's very relevant to us to track our penetration within DBD and DCD. And all of these metrics are pointing in the right direction.

任何變化都發生在那些剛加入 NOP 或 NOP 不是固定用戶的中心，我們正在追蹤這種動態。而且，我們並不太擔心，因為我們保持了逐年成長。所以我說，對我們來說，關注年度成長情況更為重要。追蹤我們在DBD和DCD領域的滲透率對我們來說非常重要。所有這些指標都指向正確的方向。

It's just we're becoming a bigger player in the market, and that's why it impacts us on the Q-to-Q variability. That's all I can comment on at this point. And again, we should expect this variability every year and especially in Q3, especially if we see a significant uptick in Q2. Usually, this variability happened after a very strong Q2.

只是因為我們在市場上的市佔率越來越大，所以才會對我們的季度間波動產生影響。目前我只能就此發表一些評論。再次強調，我們應該預料到每年都會出現這種波動，尤其是在第三季度，特別是如果我們在第二季度看到顯著增長的話。通常情況下，這種波動發生在第二季度非常強勁之後。

It's really helpful. Thanks Wali.

這真的很有幫助。謝謝瓦利。

Thank you.

謝謝。

Young Li, Jefferies.

楊李，傑富瑞。

Alright, great, thanks for squeezing me in here. I'll just keep it to one. So I appreciate all the clarifications and color on the trial enrollment. I guess, I'm kind of curious what factors allow you to enroll these trials faster than the prior trials that you have run?

好的，太好了，謝謝你們擠出時間。我就只訂一個吧。因此，我非常感謝您對試驗招募的所有解釋和說明。我很好奇，是什麼因素讓你們能夠比以往的試驗更快招募到受試者？

I think we're not saying it's going to enroll faster. I think our fastest enrolling trial was the DCD Heart trial when we enrolled 90 patients in nien months. We're not saying it's going to be faster. And all what we're saying is, given the impact, given the anticipated impact, given the momentum we're seeing in centers, how rapidly they're going through the initiation process, demonstrating their excitement about these trials that usually -- that excitement, that momentum is usually coupled with rapid enrollment. That's all what we're saying.

我認為我們並不是說它的招生速度會更快。我認為我們招募速度最快的試驗是 DCD 心臟試驗，我們在九個月內招募了 90 名患者。我們並不是說它會更快。我們想說的是，考慮到試驗的影響、預期的影響以及我們在各個中心看到的勢頭，以及他們啟動試驗的速度之快，都表明了他們對這些試驗的熱情，而這種熱情和勢頭通常都伴隨著快速的招募。這就是我們想說的全部。

We need to go and execute it. We need to go and deliver on that. That's all what we're saying. It's all a reflection of how successful the program is. And we're looking forward to launching this program.

我們需要去執行它。我們需要去完成這項任務。這就是我們想說的全部。這一切都反映了該專案的成功程度。我們期待著啟動這個項目。

And again, we'll be looking at the execution as it happens.

我們也會繼續關注執行過程。

Any follow-up question, Young Li?

李同學，還有其他問題嗎？

I'm okay.

我沒事。

This concludes our question-and-answer session. I would like to turn the conference back over to Waleed Hassanein for closing remarks.

我們的問答環節到此結束。我謹將會議交還給瓦利德·哈桑內因先生，請他作閉幕致詞。

Thank you all very much, and look forward to chat again early next year. Thank you very much. Have a great evening.

非常感謝大家，期待明年年初再次與大家交流。非常感謝。祝你有個美好的夜晚。

Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

謝謝。會議已經結束。感謝各位參加今天的報告會。您現在可以斷開連線了。