TransMedics Group, Inc. (TMDX) 2026 Q3 法說會逐字稿

Good afternoon, and welcome to TransMedics third quarter 2026 earnings conference call. (Operator Instructions) As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Hannah Jeffrey from The Gilmartin Group for a few introductory comments.

下午好，歡迎參加 TransMedics 2026 年第三季財報電話會議。(接線員指示) 提醒各位，本次通話將錄音以供重播。現在我想把電話交給來自 The Gilmartin Group 的 Hannah Jeffrey，請她先做幾點開場說明。

Thanks, operator. Good afternoon, and welcome to TransMedics' Third Quarter 2026 Earnings Call. I'm joined by our President and CEO, Waleed Hassanein; and our CFO, Fernando Araujo. During this call, we will make forward-looking statements, which are based on how we see things today and are subject to various assumptions. As described in our SEC filings, actual results may differ materially due to risks and uncertainties.

謝謝，接線員。下午好，歡迎參加 TransMedics 2026 年第三季財報電話會議。我與我們的總裁暨執行長 Waleed Hassanein，以及財務長 Fernando Araujo 一同出席。在本次通話中，我們將發表前瞻性陳述，這些陳述係基於我們目前對情勢的看法，並受各項假設所影響。如我們向 SEC 提交的文件所述，實際結果可能因風險與不確定性而出現重大差異。

Our conference call remarks will also include both GAAP and non-GAAP financial results. Reconciliations between GAAP and non-GAAP measures, along with information regarding our use of forward-looking statements can be found in today's press release and in the presentation slides available on our website. With that, I will hand the call over to Waleed.

我們在電話會議中的發言也將包含 GAAP 與非 GAAP 的財務結果。GAAP 與非 GAAP 指標之間的調節表，以及我們使用前瞻性陳述的相關資訊，可在今日新聞稿與我們網站上的簡報投影片中查閱。接下來，我把電話交給 Waleed。

Thank you, Hannah. Good afternoon, everyone, and thank you for joining TransMedics third quarter 2026 earnings call. I'm delighted to be joined today by Fernando Araujo, our new Chief Financial Officer, who will review our third quarter financial results in detail later on, on this call.

謝謝你，Hannah。各位下午好，感謝各位參加 TransMedics 2026 年第三季財報電話會議。我很高興今天與我們的新任財務長 Fernando Araujo 一同出席，他稍後將在本次通話中詳細說明我們第三季的財務結果。

TransMedics has built one-of-a-kind transplant business founded on five fundamental -- five foundational assets that are extremely difficult to replicate. At the core is our transformative OCS technology platform, amplified by our clinical organ procurement and donor screening services and enabled by our vertically integrated logistics network and NOP digital assets.

TransMedics 建立了一個獨一無二的移植事業，奠基於五項根本——五項基礎資產，而這些資產極難被複製。其核心是我們具變革性的 OCS 技術平台，並由我們的臨床器官取得與捐贈者篩檢服務加以放大效益，同時由我們垂直整合的物流網路與 NOP 數位資產提供支撐。

Together, they form a single integrated platform with one purpose to increase the number of organ transplants and improve outcomes for patients worldwide. Our goal is crystal clear, to be the trusted partner to every stakeholder in organ transplantation committed to growing transplant volumes, maximizing efficiency and improving post-transplant clinical outcomes. We are very proud of what we've built, but we are not standing still. We firmly believe our best innings are still ahead, and this conviction is why we continue to invest in innovation-driven growth across technology, services and digital transformation of the transplant ecosystem. I will update you on the progress of these initiatives shortly.

它們共同構成一個單一整合平台，只有一個目的：增加器官移植數量，並改善全球患者的治療結果。我們的目標非常明確：成為器官移植領域每一位利害關係人的可信賴夥伴，致力於提升移植量、最大化效率並改善移植後的臨床結果。我們對已建立的成果深感自豪，但我們不會停下腳步。我們堅信最精彩的階段仍在前方；正因如此，我們持續在技術、服務以及移植生態系的數位轉型上投入，以創新驅動成長。我稍後將向各位更新這些計畫的進展。

Turning to 3Q results. The third quarter of 2026 was the strongest in TransMedics' history for both revenue and case volume. Third quarter highlights include: total revenue of approximately $203 million, up approximately 41% year-over-year; transplant product revenue of $113 million, up approximately 29% year-over-year and transplant service revenue of roughly $79 million, up approximately 44% year-over-year.

接著談第三季（3Q）業績。2026 年第三季是 TransMedics 歷史上營收與案例量（case volume）最強勁的一季。第三季重點包括：總營收約 2.03 億美元，年增約 41%；移植產品營收 1.13 億美元，年增約 29%；移植服務營收約 7,900 萬美元，年增約 44%。

Despite typical third quarter seasonality, OCS Liver and Heart case volume grew both year-over-year and sequentially, modestly surpassing the all-time high levels we set in the second quarter of 2026. As our near and midterm growth initiatives begin contributing to case volumes, we fully expect product revenue growth to accelerate further and converge with our service growth rates.

儘管第三季通常具有季節性因素，OCS 肝臟與心臟的案例量仍在年比與季比皆成長，並小幅超越我們在 2026 年第二季創下的歷史高點。隨著我們近期與中期的成長計畫開始對案例量做出貢獻，我們完全預期產品營收成長將進一步加速，並與服務營收的成長率趨於一致。

TransMedics transplant logistics generated approximately $41 million in revenue, up approximately 50% year-over-year. We supported approximately 86% of NOP missions requiring air transport using our own fleet. This is consistent with our second quarter performance and meeting our steady state goal of managing more than 80% of our NOP missions. We ended the quarter with approximately $493 million in cash and cash equivalents. Looking at our third quarter results, we are especially proud of our record revenue performance, which was driven primarily by market share gains in Liver and Heart and strong clinical service revenue.

TransMedics 的移植物流業務創造約 4,100 萬美元營收，年增約 50%。在需要空運的 NOP 任務中，我們使用自有機隊支援約 86%。這與我們第二季的表現一致，並符合我們穩態目標：管理超過 80% 的 NOP 任務。本季結束時，我們持有約 4.93 億美元的現金及約當現金。回顧第三季成果，我們特別以創紀錄的營收表現為傲；其主要驅動因素為肝臟與心臟市場占有率提升，以及強勁的臨床服務營收。

Again, we delivered this growth despite typical third quarter seasonality and lower overall US disease donor volume that was down 6% in 3Q 2026. Importantly, we achieved these results with no incremental contribution yet from ENHANCE Part B or DENOVO. We also drove product service margin expansion and generated approximately $20 million in cash. Beyond this strong financial performance, we also successfully advanced several of our near and midterm growth initiatives.

再次強調，即便面臨第三季典型季節性因素，以及 2026 年第三季美國整體疾病捐贈者（disease donor）量下滑 6%，我們仍交出成長成績。重要的是，我們在 ENHANCE Part B 或 DENOVO 尚未帶來任何額外貢獻的情況下就達成這些結果。我們也推動產品與服務毛利率擴張，並創造約 2,000 萬美元現金。除了強勁的財務表現之外，我們也成功推進多項近期與中期的成長計畫。

Let me start with the Heart, where we're working to further expand OCS adoption in the existing indication and expand into new indications in the United States. Our ENHANCE Heart Part A program was designed to demonstrate the safety and effectiveness of our OCS Heart 2.0 enhancements and a new proprietary perfusion solution within our current OCS Heart indications, which covers extended criteria DBD and DCD donor hearts.

我先從心臟業務談起。我們正努力在既有適應症中進一步擴大 OCS 的採用，並在美國拓展至新的適應症。我們的 ENHANCE Heart Part A 計畫旨在於目前 OCS Heart 的適應症範圍內，證明 OCS Heart 2.0 的升級與一款新的專有灌流液（perfusion solution）的安全性與有效性；目前適應症涵蓋擴大標準的 DBD 與 DCD 捐贈者心臟。

We completed enrollment of 175 patients in September. And in October, FDA approved a continued access protocol, or CAP, allowing us to enroll an additional 90 patients in the CAP protocol. We expect CAP enrollment to begin in late fourth quarter 2026 or early first quarter 2027.

我們已於 9 月完成 175 名患者的收案。10 月，FDA 核准一項持續使用方案（continued access protocol，CAP），使我們得以在 CAP 方案下再收案 90 名患者。我們預期 CAP 收案將於 2026 年第四季末或 2027 年第一季初開始。

ENHANCE Heart Part B is designed to open an entirely new indication for TransMedics, focusing on DBD donor hearts preserved within roughly 4 hours of preservation. This segment represented approximately 2,200 heart transplanted in 2025. In late October, FDA approved our IDE protocol amendment to include the TransMedics Controlled Hypothermic Organ Preservation System, or CHOPS, as the control arm.

ENHANCE Heart Part B 的設計目標是為 TransMedics 開啟一個全新的適應症，聚焦於在約 4 小時保存時間內完成保存的 DBD 捐贈者心臟。此細分市場在 2025 年約有 2,200 例心臟移植。10 月下旬，FDA 核准我們的 IDE 方案修正案，將 TransMedics 受控低溫器官保存系統（Controlled Hypothermic Organ Preservation System，CHOPS）納入對照組（control arm）。

That gives us two shots on goal in this segment, OCS Heart and the TransMedics CHOPS with the potential to offer the market two distinct options at different price points. Part B is designed to enroll approximately 600 patients, 400 on OCS and 200 on CHOPS.

這讓我們在該細分市場有兩個「進球機會」：OCS Heart 與 TransMedics CHOPS，並有望以不同價位向市場提供兩種截然不同的選擇。Part B 設計收案約 600 名患者，其中 400 名使用 OCS、200 名使用 CHOPS。

Participating centers are now completing their internal IRB processes, and we expect Part B to be a major catalyst for our Heart business beginning in the first quarter of 2027. Next is expanding adoption of OCS in the lung transplant market, which we believe could be a sleeping giant for TransMedics business. Our DENOVO Lung program leverages our Gen 2.0 OCS Lung enhancement, and again, a new proprietary perfusion solution to generate data that we believe will catalyze a large untapped US lung transplant market of approximately 3,500 transplants annually, the vast majority of which use no form of machine perfusion today. In late October, FDA also approved our IDE protocol amendment to include CHOPS as the DENOVO control arm.

參與中心目前正完成其內部 IRB 流程；我們預期 Part B 將自 2027 年第一季起成為推動我們心臟業務的重要催化劑。下一項是擴大 OCS 在肺臟移植市場的採用；我們認為這可能是 TransMedics 業務的「沉睡巨人」。我們的 DENOVO Lung 計畫運用第二代（Gen 2.0）OCS Lung 的升級，以及同樣一款新的專有灌流液，以產出我們相信將能催化美國尚未充分開發的肺臟移植市場的數據；該市場每年約 3,500 例移植，而其中絕大多數目前未使用任何形式的機器灌流（machine perfusion）。10 月下旬，FDA 亦核准我們的 IDE 方案修正案，將 CHOPS 納入 DENOVO 的對照組。

Together, OCS Lung and TransMedics CHOPS represent a significant opportunity to transform this market. DENOVO is designed to enroll approximately 450 patients, 300 in OCS and 150 on CHOPS. As with ENHANCE, centers are completing their IRB processes, and we expect DENOVO to be a major catalyst for our Lung business beginning in the first quarter of 2027. Taken together, ENHANCE Heart and DENOVO Lung give us access to conservatively estimated 2,000 to 5,000 incremental US heart and lung cases annually, materially expanding our US addressable market.

綜合而言，OCS Lung 與 TransMedics CHOPS 代表一個可望改造此市場的重大機會。DENOVO 設計收案約 450 名患者，其中 300 名使用 OCS、150 名使用 CHOPS。與 ENHANCE 相同，各中心正完成其 IRB 流程；我們預期 DENOVO 將自 2027 年第一季起成為推動我們肺臟業務的重要催化劑。綜合來看，ENHANCE Heart 與 DENOVO Lung 讓我們得以觸及保守估計每年新增 2,000 至 5,000 例美國心臟與肺臟案例，從而實質擴大我們在美國的可服務市場（addressable market）。

In addition, data from these programs will also help catalyze heart and lung transplant adoption internationally. Beyond our clinical programs, we continue to make progress expanding OCS NOP and transplant logistics in Europe. Tamer and our European commercial team have made significant strides and are preparing to launch OCS NOP in Italy, Netherlands, Belgium -- and Belgium in H1 2027. We are also in active discussion with several additional European countries about expansion beyond these initial markets.

此外，這些計畫的數據也將有助於在國際間催化心臟與肺臟移植的採用。除我們的臨床計畫之外，我們也持續在歐洲擴展 OCS NOP 與移植物流方面取得進展。Tamer 與我們的歐洲商業團隊已取得重大進展，並正準備在義大利、荷蘭、比利時推出 OCS NOP——以及比利時於 2027 年上半年推出。我們也正與數個其他歐洲國家就超出這些初始市場的擴張進行積極討論。

This groundwork supported strong European performance in the third quarter of 2026. Importantly, I'm delighted to report that in October, our PAD Aviation business won TransMedics' first European transplant logistics tender in Italy's Emilia-Romagna region. This is a strategic first step towards our vision of a dedicated pan-European transplant logistics network modeled on what we have built in the United States.

這些前期工作支撐了 2026 年第三季歐洲市場的強勁表現。重要的是，我很高興報告，10 月我們的 PAD Aviation 業務在義大利艾米利亞-羅馬涅（Emilia-Romagna）地區贏得了 TransMedics 在歐洲的首個移植物流標案。這是朝向我們願景邁出的策略性第一步：建立一個專屬的泛歐移植物流網路，其模式以我們在美國所建構的網路為藍本。

With significant need and established budgets for transplant logistics across Europe, we see logistics as a powerful entry point for OCS NOP in the many countries where we are actively engaged. We expect OCS NOP and European transplant logistics together to become another growth catalyst for TransMedics in 2027.

鑑於歐洲各地對移植物流的重大需求與既有預算，我們將物流視為在我們積極投入的眾多國家中，導入 OCS NOP 的強力切入點。我們預期 OCS NOP 與歐洲移植物流的結合，將在 2027 年成為 TransMedics 的另一項成長催化劑。

Meanwhile, we remain laser-focused on OCS Kidney, our entry into the largest transplant market segment with what we believe will be the first portable normothermic oxygenated kidney perfusion system. In the US, approximately 21,000 diseased donor kidneys are transplanted each year and approximately 9,000 more go unused, in part due to prolonged ischemic time. This is the single largest addressable transplant segment available to us in the US and globally. We are building OCS Kidney on our NextGen 3.0 platform, which is designed to add meaningful scale and operating leverage across our business.

同時，我們仍高度聚焦於 OCS Kidney，這是我們進入最大移植市場區隔的產品；我們相信它將是首個可攜式常溫含氧腎臟灌流系統。在美國，每年約有 21,000 顆病逝捐贈者腎臟被移植，另約有 9,000 顆未被使用，部分原因在於缺血時間過長。這是我們在美國及全球可觸及的最大單一移植市場區隔。我們正以 NextGen 3.0 平台打造 OCS Kidney；該平台旨在為我們的業務帶來有意義的規模化與營運槓桿。

OCS Kidney development is progressing well, and we remain on track for the first in-man clinical experience in the second half of 2027. From there, we expect OCS Kidney to become another major growth catalyst for TransMedics beginning in late 2027 and into 2028. And finally, turning to the US transplant and OPO modernization initiatives led by HHS and CMS. On October 30, CMS released its final rule on OPO certification.

OCS Kidney 的研發進展順利，我們仍按計畫於 2027 年下半年進行首次人體臨床體驗。自那之後，我們預期 OCS Kidney 將自 2027 年末起並延續至 2028 年，成為 TransMedics 的另一項主要成長催化劑。最後，轉向由 HHS 與 CMS 主導的美國移植與 OPO 現代化倡議。10 月 30 日，CMS 發布了其關於 OPO 認證的最終規則。

The key highlights were: CMS affirmed the outcome-based 3-tier performance framework and that it will be applied on a DSA-by-DSA basis. CMS allowed for OPOs for the first time to hold multiple DSAs with CMS formalizing when a DSA opens for competition and how successor OPOs are selected. In addition, CMS removed the historical requirements that an organization must have operated as an OPO between 2002 and 2005 to qualify to become an OPO. This opens the door for new entities to become OPOs. However, CMS deferred finalization of a pathway for new OPOs to further rule-making process.

主要重點包括：CMS 確認以結果為導向的三層級績效架構，且將以 DSA 為單位逐一適用。CMS 首次允許 OPO 持有多個 DSA，並由 CMS 正式規範何時 DSA 開放競爭以及如何選定接任 OPO。此外，CMS 移除了歷史性要求：組織必須在 2002 至 2005 年間以 OPO 身分運作，才有資格成為 OPO。這為新實體成為 OPO 打開大門。然而，CMS 延後將新 OPO 的申請途徑定案，留待後續規則制定程序處理。

CMS also stipulated that designation period may be shortened or extended and CMS may directly assign a DSA when time doesn't allow for a full competitive process. Bottom line is, based on our review, we see nothing in the final rule that would prevent TransMedics business from progressing as planned as we do it every day. Meanwhile, we are actively collaborating with approximately 20 OPOs across the United States to help them improve donor organ utilization and meet CMS performance tier metrics. We remain committed to supporting every OPO in meeting or exceeding these metrics because doing so ultimately means saving more American lives. Turning to guidance.

CMS 亦規定，指定期間可能縮短或延長，且當時間不允許完整競爭程序時，CMS 可直接指派 DSA。總結而言，根據我們的審閱，我們在最終規則中未看到任何會阻礙 TransMedics 業務按計畫推進的內容，因為我們每天都在執行。同時，我們正與全美約 20 家 OPO 積極合作，協助其提升捐贈器官使用率並達成 CMS 的績效分層指標。我們仍致力於支持每一家 OPO 達到或超越這些指標，因為這最終意味著能拯救更多美國人的生命。接著談指引。

Given our strong year-to-date performance and balance against the timing of our new program contributing to early 2027 rather than the fourth quarter, we are raising our full year 2026 revenue guidance to a range of $764 million to $774 million, inclusive of approximately $14 million from PAD Aviation, representing growth of approximately 26% to 28% over 2025. Importantly, this range assumes no meaningful incremental revenue from ENHANCE Part B or DENOVO in the fourth quarter.

鑑於我們年初至今的強勁表現，並考量新計畫的貢獻時點將落在 2027 年初而非第四季，我們將 2026 全年營收指引上調至 7.64 億至 7.74 億美元區間，其中包含約 1,400 萬美元來自 PAD Aviation，代表相較 2025 年約 26% 至 28% 的成長。重要的是，該區間假設第四季不會有來自 ENHANCE Part B 或 DENOVO 的任何具實質意義的增量營收。

Fernando will detail the guidance update in his section of today's call. In summary, over the past four years, TransMedics has consistently turned strategic investments into both rapid top line growth and strong bottom line performance. We are a growth company at our core, leading bold, far-reaching innovations across our OCS technology platform, our clinical and logistics services and the digital transformation of the entire transplant ecosystem.

Fernando 將在今天電話會議的他的部分詳細說明指引更新。總結而言，在過去四年中，TransMedics 一直能將策略性投資轉化為快速的營收成長與強勁的獲利表現。我們本質上是一家成長型公司，透過我們的 OCS 技術平台、臨床與物流服務，以及整個移植生態系的數位轉型，推動大膽且深遠的創新。

The progress we made on our growth initiatives in 2026 gives us the confidence that our best years are still ahead. TransMedics is once again well positioned to lead the next wave of innovation in organ transplant worldwide in 2027 and beyond. With that, I will turn the call over to Fernando to review our third quarter financial results in detail. Fernando?

我們在 2026 年成長計畫上取得的進展，使我們有信心最好的年份仍在前方。TransMedics 再次處於有利位置，將在 2027 年及其後引領全球器官移植領域的下一波創新。接下來，我將把電話會議交給 Fernando，請他詳細回顧我們第三季的財務結果。Fernando？

Thank you, Waleed. Good afternoon, everybody. As this is my first call with the company, I want to reiterate my excitement at joining TransMedics at such an important stage in the company's growth. What drew me here is our differentiated technology, strong market position and multiple growth catalysts, a combination that provides us with a significant opportunity to scale the business, expand operating leverage and drive long-term shareholder value. My focus will be on partnering with the team to execute these growth opportunities with financial discipline while advancing our mission to transform transplant care.

謝謝你，Waleed。各位下午好。由於這是我加入公司後的第一次電話會議，我想再次表達我很興奮能在公司成長如此關鍵的階段加入 TransMedics。吸引我來到這裡的是我們具差異化的技術、強勁的市場地位以及多項成長催化劑；這樣的組合為我們帶來顯著機會，可擴大業務規模、提升營運槓桿並推動長期股東價值。我的重點將是與團隊合作，以財務紀律執行這些成長機會，同時推進我們改變移植照護的使命。

Now turning to TransMedics' third quarter performance. The third quarter delivered strong revenue growth and stable gross margin, reflecting the underlying strength of the business alongside planned strategic investments in R&D and infrastructure to support our next phase of growth. Total revenue was $203 million, up 41% year-over-year, including organic revenue of $194 million, up 35% year-over-year, making this the highest quarterly revenue in our history. US transplant revenue was approximately $186 million, up 34% year-over-year and 1% sequentially.

現在轉向 TransMedics 第三季的表現。第三季實現強勁的營收成長與穩定的毛利率，反映出業務的基本面強勁，同時也包含為支持下一階段成長而在研發與基礎設施上的既定策略性投資。總營收為 2.03 億美元，年增 41%，其中有機營收為 1.94 億美元，年增 35%，創下公司史上最高單季營收。美國移植營收約為 1.86 億美元，年增 34%，季增 1%。

By organ, liver contributed with approximately $150 million, heart approximately $33 million and lung approximately $2 million. International revenue was approximately $6.6 million, up 82% year-over-year, reflecting continued progress as we expand our presence in Europe. Product revenue was $113 million, up 29% year-over-year and 2% sequentially, led by liver and heart. Despite typical third quarter transplant seasonality, liver and heart case volumes grew modestly both year-over-year and sequentially, building on the all-time high we set in the second quarter. We expect product revenue growth to accelerate as our near and midterm growth initiatives begin contributing to case volumes.

按器官別，肝臟貢獻約 1.50 億美元，心臟約 3,300 萬美元，肺臟約 200 萬美元。國際營收約為 660 萬美元，年增 82%，反映我們在擴展歐洲布局方面持續取得進展。產品營收為 1.13 億美元，年增 29%，季增 2%，主要由肝臟與心臟帶動。儘管第三季通常存在移植季節性因素，肝臟與心臟的案例量仍在年比與季比均小幅成長，並延續我們在第二季創下的歷史新高。我們預期，隨著近期與中期成長計畫開始帶動案例量，產品營收成長將加速。

Service revenue was $90 million, up 60% year-over-year and 14% sequentially. Service revenue included $9.4 million of revenue generated from PAD Aviation charter services. Excluding PAD, service revenue was up approximately 43% year-over-year. The growth in service was driven by higher NOP adoption, primarily around liver and heart and continued improvements in logistics, market share gains and pricing adjustments to offset higher fuel costs. The gross margin was 58.5%, down approximately 40 basis points year-over-year.

服務營收為9,000萬美元，年增60%，季增14%。服務營收包含PAD Aviation包機服務所產生的940萬美元營收。若排除PAD，服務營收約年增43%。服務成長主要由更高的NOP採用率所帶動，主要集中在肝臟與心臟領域，並受惠於物流持續改善、市占率提升，以及為抵銷燃油成本上升而進行的價格調整。毛利率為58.5%，較去年同期下降約40個基點。

It's important to note that the gross margin decrease reflects a channel mix shift in the quarter. Service revenue, which carries a lower margin than product revenue, rose to 44% of the total revenue and PAD Aviation diluted gross margin by 260 basis points. Excluding PAD, gross margin was 61.1%, up approximately 230 basis points year-over-year. As PAD is integrated into our business, we expect to see improved margins moving forward. Looking at the margin drivers of our respective channels, product gross margin was 79.2%, up 50 basis points year-over-year.

需要特別指出的是，本季毛利率下降反映了通路組合的變化。服務營收（其毛利率低於產品營收）上升至總營收的44%，且PAD Aviation使毛利率稀釋260個基點。若排除PAD，毛利率為61.1%，較去年同期上升約230個基點。隨著PAD整合進入我們的業務，我們預期未來毛利率將有所改善。從各通路的毛利率驅動因素來看，產品毛利率為79.2%，較去年同期上升50個基點。

This improvement was driven by process improvements related to reduced scrap and cycle count. Service margins improved 440 basis points to 32.2%, driven by logistics efficiencies resulting from pricing improvements across both service and logistics operations, productivity gains from reduced supplemental lift utilization, lower ground transportation cost per mission and improved leverage of fixed operating costs as volume increased. It is worth noting that we do expect some normalization in service margin in the fourth quarter while remaining above historical levels. We plan to keep working these same levers as part of our operational strategy, improving efficiency across NOP and in manufacturing, while next-generation OCS and OCS Kidney are designed to cost less to build and run. Adjusted operating expenses were $89.8 million, up 47% year-over-year and 3% sequentially.

此改善主要來自流程改善，包括降低報廢與改善盤點循環（cycle count）。服務毛利率提升440個基點至32.2%，主要由物流效率提升所帶動，來源包括服務與物流營運的全面定價改善、因降低補充運力（supplemental lift）使用而帶來的生產力提升、每次任務的地面運輸成本下降，以及隨著量增而提高固定營運成本的攤提效益。值得注意的是，我們確實預期第四季服務毛利率會出現一定程度的正常化，但仍將高於歷史水準。我們計畫持續運用相同的槓桿作為營運策略的一部分，提升NOP及製造端的效率；同時，下一代OCS與OCS Kidney在設計上可降低建置與運行成本。調整後營業費用為8,980萬美元，年增47%，季增3%。

The year-over-year increase was driven by planned investments in OCS Kidney, next-generation OCS and our ENHANCE and DENOVO clinical programs, as well as increased headcount to support our development activities, ongoing expansion plan and infrastructure investments, including our US headquarters and the addition of PAD Aviation. The sequential increase was primarily related to the addition of PAD. Excluding these investments, operating expenses declined sequentially, demonstrating continued discipline across our cost base. Adjusted R&D was $29.2 million, up 91% year-over-year, primarily reflecting investment in the strategic growth programs.

年增主要由對OCS Kidney、下一代OCS，以及ENHANCE與DENOVO臨床計畫的規劃性投資所帶動，並包括為支持研發活動、持續擴張計畫與基礎設施投資而增加的人力配置，其中包含我們的美國總部以及新增PAD Aviation。季增主要與新增PAD有關。若排除這些投資，營業費用季比下降，顯示我們在成本基礎上持續維持紀律。調整後研發費用為2,920萬美元，年增91%，主要反映對策略性成長計畫的投資。

Adjusted SG&A was $50.6 million, up 32% year-over-year and 9% sequentially. The year-over-year increase reflects planned investments in the NOP network, IT infrastructure, international expansion and in our Somerville headquarters. Adjusted income from operations was $28.9 million, representing an adjusted operating margin of 14.2%, highlighting our strong top line results and our planned increase in strategic investments. Adjusted net income was $18.9 million and adjusted diluted earnings per share was $0.51. Now for modeling purposes, interest expense was $7.3 million in the quarter, including approximately $3.9 million related to the finance lease for our new Somerville headquarters.

調整後銷售、一般及行政費用（SG&A）為5,060萬美元，年增32%，季增9%。年增反映對NOP網路、IT基礎設施、國際擴張，以及我們位於Somerville總部的規劃性投資。調整後營業利益為2,890萬美元，調整後營業利益率為14.2%，凸顯我們強勁的營收表現以及策略性投資的規劃性增加。調整後淨利為1,890萬美元，調整後稀釋每股盈餘為0.51美元。就模型假設而言，本季利息費用為730萬美元，其中約390萬美元與我們新的Somerville總部之融資租賃（finance lease）相關。

For the full year, we expect total interest expense of approximately $29 million, including approximately $15.4 million related to our new headquarters, partially offset by approximately $11 million of interest income. Our adjusted effective tax rate was 23.8% in the quarter, and we expect it to end at this level for the full year. Our diluted weighted average shares were approximately 40.8 million in third quarter, and we expect the share count to remain at the similar levels for the full year. We ended the quarter with $493 million in cash and cash equivalents, an increase of $20 million sequentially. Approximately $18 million in restricted cash, primarily related to our headquarters lease is reported separately.

就全年而言，我們預期利息費用合計約2,900萬美元，其中約1,540萬美元與新總部相關，並將由約1,100萬美元的利息收入部分抵銷。本季調整後有效稅率為23.8%，我們預期全年將維持在此水準。第三季稀釋加權平均股數約為4,080萬股，我們預期全年股數將維持在相近水準。本季末我們持有現金及約當現金4.93億美元，較前一季增加2,000萬美元。約1,800萬美元的受限制現金（restricted cash）主要與總部租賃相關，並另行列示。

Now turning to our 2026 outlook. As Waleed noted, we're raising our full year 2026 revenue guidance from a range of $737 million to $757 million to a new range of $764 million to $774 million, representing growth of 26% to 28% compared to 2025. This revenue guidance is inclusive of approximately $14 million for the full year from PAD Aviation. Excluding the contributions from PAD Aviation, our updated revenue expectations of between $750 million to $760 million represents growth of 24% to 26% year-over-year. In terms of operating margin, we remain confident in the previously communicated full year adjusted operating margin range of 12.5% to 14%.

接著談我們對2026年的展望。如Waleed所提，我們將2026全年營收指引由7.37億至7.57億美元上調至7.64億至7.74億美元，較2025年成長26%至28%。此營收指引包含PAD Aviation全年約1,400萬美元的貢獻。若排除PAD Aviation的貢獻，我們更新後的營收預期為7.50億至7.60億美元，年增24%至26%。就營業利益率而言，我們仍對先前溝通的全年調整後營業利益率區間12.5%至14%保持信心。

As a reminder, this range primarily reflects the accelerated investments in our OCS Kidney program, which is critical strategic growth driver for the business. Looking ahead, we expect gross margin to remain around current levels in the near to midterm as we continue to invest in R&D and in the international expansion. At the same time, the operational improvements we are driving in manufacturing and across the NOP, along with disciplined management of our broader cost base give us the capacity to keep investing in R&D and new technology without losing sight of profitability. Over the long-term, we expect those investments to pay off. Greater scale and utilization across our international platform, together with the efficiencies designed into OCS Kidney and next-generation OCS should support a higher sustainable gross margin profile with potential to further improvement.

提醒一下，該區間主要反映我們對OCS Kidney計畫加速投資，而該計畫是公司關鍵的策略性成長驅動因素。展望未來，隨著我們持續投入研發與國際擴張，我們預期毛利率在短期至中期將大致維持在目前水準。同時，我們在製造端與整個NOP推動的營運改善，以及對更廣泛成本基礎的紀律管理，使我們有能力在持續投入研發與新技術的同時，不忽視獲利能力。長期而言，我們預期這些投資將帶來回報。國際平台更大的規模與使用率提升，加上OCS Kidney與下一代OCS在設計上導入的效率，應可支撐更高且可持續的毛利率結構，並具備進一步改善的潛力。

To close, on our capital allocation, priorities remain focused on long-term value creation, supporting innovation across our technology and clinical pipeline, strengthening our NOP and international platform and building the systems and infrastructure required to support scale. With that, I'll turn the call over to Waleed for his closing remarks.

最後，就資本配置而言，我們的優先事項仍聚焦於創造長期價值：支持我們技術與臨床產品線的創新、強化NOP與國際平台，以及建置支援規模化所需的系統與基礎設施。接下來我把電話交回給Waleed，請他做結語。

Thank you, Fernando. In summary, the third quarter was the strongest in TransMedics' history, recorded revenue of approximately $203 million, up 41% year-over-year, recorded case volume -- record case volume and margin expansion in both of our product and service businesses, and we delivered all of this before any incremental contribution yet from ENHANCE Heart Part B and DENOVO Lung.

謝謝你，Fernando。總結來說，第三季是TransMedics史上最強的一季，營收約2.03億美元，年增41%；病例量—創下紀錄的病例量；且我們的產品與服務業務兩者皆實現毛利率擴張；而且在ENHANCE Heart Part B與DENOVO Lung尚未帶來任何額外貢獻之前，我們就已達成上述成果。

We enter 2027 with strong momentum and a robust set of growth catalysts. ENHANCE Heart Part B and DENOVO Lung target large, untapped heart and lung segments with two shots on goal in each through OCS and CHOPS. In Europe, we plan to launch OCS NOP in Italy, the Netherlands and Belgium, building on our first European transplant logistics win achieved in October of this year.

我們以強勁動能與一系列有力的成長催化劑邁入2027年。ENHANCE Heart Part B與DENOVO Lung鎖定規模龐大、尚未被開發的心臟與肺臟市場區隔，並透過OCS與CHOPS在各自領域提供兩次達標機會（two shots on goal）。在歐洲，我們計畫在義大利、荷蘭與比利時推出OCS NOP，延續我們於今年10月取得的首個歐洲移植物流案的勝利。

And OCS Kidney remains on track for first-in-human clinical experience in the second half of 2027, our path into the largest transplant market. Again, our strategy is crystal clear. Our execution is proven. Our conviction has never been stronger. We are building the global platform to transform organ transplantation, and we strongly believe our best years are still ahead.

而OCS Kidney仍按計畫在2027年下半年展開首次人體（first-in-human）臨床經驗，這將是我們進入最大移植市場的路徑。再次強調，我們的策略非常清晰。我們的執行力已被證明。我們的信念從未如此堅定。我們正在打造改變器官移植的全球平台，並堅信我們最好的年份仍在前方。

With that, I will turn the call over to the operator for questions. Operator?

那麼，我將把電話交給接線員進行提問。接線員？

(Operator Instructions) Bill Plovanic, Canaccord.

(接線員指示) Bill Plovanic，Canaccord。

It's Zachary on for Bill. Congrats on the quarter. I want to start with expanding into Europe. Obviously, American investors might not have a lot of visibility into what those operations look like. Can you take a second and talk about the cadence of tenders you might get with the markets that you're going into moving forward? And just what maybe reimbursement and operations might look like, how NOP is different over there versus in the US?

我是代替 Bill 的 Zachary。恭喜本季表現。我想先從拓展歐洲談起。顯然，美國投資人可能不太清楚那邊的營運樣貌。你能否花點時間談談，未來你們進入的市場中，可能會收到標案（tender）的節奏/頻率會是如何？以及報銷（reimbursement）與營運可能會是什麼樣子、NOP 在那邊相較於美國有何不同？

Zach, that's a very important question, but it's a very complex and will require a significant amount of time to address it in detail. However, to highlight, all the geographies that we are actively engaged with had some level of reimbursement for the product and the service and definitely for the logistics. So reimbursement comes first before we engage in any of these geographies.

Zach，這是個非常重要的問題，但也非常複雜，需要相當多時間才能詳細說明。不過先強調一點：我們目前積極投入的所有地理區域，對產品與服務、以及物流（logistics）都已有某種程度的報銷機制。因此，在我們進入任何這些地區之前，報銷一定是第一優先。

We believe that the -- from a clinical demand, Europe, as we always said, is a mirror image of the US, which effectively nearly double our total addressable market, and it's a critical market for organ transplantation. What's unique about Europe is transplant logistics is well established, budgets has been well established and the access to PAD Aviation enables us to compete and as we've proven successfully in these tenders.

我們相信——從臨床需求來看，歐洲如同我們一直所說，是美國的鏡像市場，基本上可使我們的整體可服務市場（TAM）幾乎倍增，而且它是器官移植的關鍵市場。歐洲的獨特之處在於：移植物流體系已相當成熟、相關預算也早已建立；再加上我們能取得 PAD Aviation 的資源，使我們得以競爭，且我們已在這些標案中成功證明了這一點。

I'll leave it here. We are confident in the strategy. We see transplant logistics as a unique attributes of the European market entry strategy given the pre-existing budgets for logistics. But at the end of the day, it has to also be supported with revenue growth from OCS and NOP. And in all the geographies, we're actively engaged with OCS and NOP-type services are reimbursed.

我先說到這裡。我們對這項策略很有信心。鑑於歐洲市場原本就有既定的物流預算，我們將移植物流視為歐洲市場進入策略中的獨特優勢。但歸根結底，也必須有來自 OCS 與 NOP 的營收成長作為支撐。而在我們積極投入的所有地區，OCS 與 NOP 類型的服務都有獲得報銷。

Ryan Daniels, William Blair.

Ryan Daniels，William Blair。

This is Matthew Mardula on for Ryan. Congrats on a really strong quarter. So regarding the strong organic revenue growth seen in the third quarter, why do you think TransMedics wasn't as impacted by the traditional seasonality seen this quarter? I know you discussed how industry volume was down and how you took market share. But just given the really strong organic revenue growth, what caused those market share gains, especially this quarter?

我是代替 Ryan 的 Matthew Mardula。恭喜本季表現非常強勁。關於第三季強勁的有機營收成長，你認為為什麼 TransMedics 在本季沒有像以往那樣受到傳統季節性因素的影響？我知道你們提到產業量能下滑以及你們取得市占。但就這麼強的有機營收成長而言，這些市占提升的原因是什麼，尤其是在本季？

And then lastly, kind of given that Q3 performance, should we still think of seasonality in Q3 the same as before? Or do you have more of that ability to offset it now?

最後，基於第三季的表現，我們是否仍應像以前一樣看待第三季的季節性？還是你們現在更有能力去抵消這種影響？

Thank you for the question. I think what blunted the seasonality impact in this quarter is the healthy adoption and market share gains that we've gained in all market segments for heart and liver, both DBD and DCD. This is really a result of the experience, both experiencing the benefits of NOP, but also, in the case of the heart, the contribution of the ENHANCE Part A catalyzed that adoption. Also, the participation of the OPO program that we're supporting many OPOs in the country to help them salvage more organs and transplant more organs. So that's why we weathered the storm this quarter.

謝謝你的提問。我認為本季季節性影響之所以被削弱，是因為我們在心臟與肝臟的所有市場區隔（包含 DBD 與 DCD）都出現健康的採用率提升與市占成長。這主要來自於使用者的經驗——一方面親身體驗到 NOP 的效益；另一方面，就心臟而言，ENHANCE Part A 的貢獻也催化了採用。此外，我們也參與並支持 OPO 計畫，協助全國許多 OPO 搶救更多器官並完成更多移植。因此我們才能在本季挺過這波逆風。

As far as going forward, I think with the success of Part B, ENHANCE Part B and DENOVO, we might be able to blunt the seasonality. The reality is, there was seasonality in Q3 in August this year. But the success of our team, NOP team and taking market share, both in DBD and DCD for heart and liver helped us blunt that. So I don't want to guess. I think the success of Part B, ENHANCE and DENOVO could help us blunt that going forward. But Q3, there is always seasonality during the summertime.

至於未來，我認為隨著 ENHANCE Part B 與 DENOVO 的成功，我們或許能進一步削弱季節性影響。現實是，今年第三季的 8 月確實存在季節性。但我們團隊的成功、NOP 團隊的表現，以及在心臟與肝臟的 DBD 與 DCD 兩類別中取得市占，幫助我們降低了影響。所以我不想妄下定論。我認為 Part B、ENHANCE 與 DENOVO 的成功，未來可能有助於我們削弱季節性。但第三季在夏季期間一向都會有季節性。

Great. And I know you talked about the OPO final rule, and I might have missed this, but do you plan to apply to become an OPO? And if you do plan to apply, how does that kind of non-for-profit requirement for OPOs determine the ultimate structure? And then if you're not planning to apply kind of what's the reasoning behind that?

了解。我知道你提到 OPO 最終規則（final rule），我可能漏聽了：你們是否計畫申請成為 OPO？如果你們計畫申請，OPO 的非營利（non-for-profit）要求會如何影響最終的組織架構？如果你們不打算申請，背後的原因是什麼？

This is all speculation. We can't apply to something when we don't know what the rules are. And CMS has not announced the rules yet, has not -- all they said -- all they stated is they will -- any new entity wishing to become an OPO will have to wait for a new rule-making process. We will have to wait for that rule-making statement, and we'll see what the conditions are before we decide whether or not it makes sense for us to apply or not.

這些都還只是推測。在規則尚未明確之前，我們無法申請任何東西。而 CMS 也尚未公布規則——他們唯一說的是：任何希望成為 OPO 的新實體，都必須等待新的規則制定（rule-making）流程。我們必須等到該規則制定聲明出來，看看條件是什麼，再決定我們是否要申請、以及申請是否合理。

Young Li, Jefferies.

Young Li，Jefferies。

I wanted to follow up on the trials and CHOPS economics. Can you maybe just talk a little bit more about if you're charging for using CHOPS with the trials, the level that you might charge and how much of a premium it would be priced versus other code systems?

我想追問試驗（trials）以及 CHOPS 的經濟性。你能否多談一點：在試驗中使用 CHOPS 你們是否會收費、可能的收費水準，以及相較於其他編碼系統（code systems）會有多大的溢價？

Young, thank you for the question. We are focusing on the clinical impacts of these programs. We are not focusing on the commercial impact of these programs yet. Our top priority right now is to initiate these programs because of the significant potential value that the patients would experience using these programs. The bottom line is, we are not going to discuss any of the pricing or any of that.

Young，謝謝你的提問。我們目前聚焦在這些計畫的臨床影響。我們還沒有把重點放在這些計畫的商業影響上。我們當下的首要任務是啟動這些計畫，因為病患使用這些計畫可能獲得的價值非常可觀。總之，我們不會討論任何定價或相關內容。

It's way too premature. We need to get the program started. We need to get the data flowing. And when CHOPS is 510(k) in the US, we can talk in detail about the commercial rollout of CHOPS. But until then, the priority is getting the clinical programs initiated, getting the clinical value to the transplant patient, utilizing more organs and gaining the confidence in the two options that are available for heart and lung transplants.

現在談這些還太早。我們需要先把計畫啟動。我們需要讓數據開始產出。等到 CHOPS 在美國取得 510(k) 後，我們就能詳細討論 CHOPS 的商業化推廣。但在那之前，優先事項是啟動臨床計畫、把臨床價值帶給移植病患、使用更多器官，並建立對心臟與肺臟移植兩種可用方案的信心。

Great. And I guess to follow up on the EU question. Are you able to size the tender that you won in Italy? How big could that be for you? Is it like a multiyear tender or just 1 year?

很好。我想追問歐盟的問題：你們能否估算在義大利贏得的那個標案規模？對你們而言可能有多大？這是多年期標案還是只有 1 年？

It's a multiyear tender. Again, we are going through the process right now of finalizing that. Again, everything we are going to be involved with in Europe going forward is going to be a multiyear tendering process, especially in Italy, it's going to be region by region. The goal is the aggregate of these different regions will be several millions, if not tens of millions of dollars annually, but we just won the first, hopefully, out of many. So we're excited about this important first step.

這是多年期標案。同樣地，我們目前正在走流程以完成最終定案。同樣地，未來我們在歐洲參與的所有事項都會是多年期的招標流程；尤其在義大利，會以各區域（region）逐一推進。目標是把這些不同區域加總起來，每年將達到數百萬美元，甚至可能是數千萬美元的規模，但我們剛贏得第一個——希望只是眾多中的第一個。因此我們對這個重要的第一步感到非常振奮。

And the reason why we engaged is, it has the significant potential of growing our revenue in Italy. So we're excited about that. And hopefully, we will win additional tenders. There are several tenders coming up late in the fall and early in the winter.

而我們之所以參與，是因為這在義大利具有顯著的潛力可帶動我們的營收成長。所以我們對此感到振奮。也希望我們能贏得更多標案。秋末與初冬將有數個標案即將推出。

Allen Gong, JPMorgan.

Allen Gong，摩根大通。

This is Henry on for Allen. There are a couple of questions from us, and I'll ask them both upfront. So, obviously, a strong quarter, a good strong beat. But when we look at the guidance, it was raised a bit lower. Can you talk about any conservatism or just the philosophy behind the guide?

我是代替 Allen 的 Henry。我們這邊有幾個問題，我會先一次把兩個都問完。很明顯，本季表現強勁，且大幅優於預期。但當我們看指引時，雖然有上調，但幅度偏小。你能談談是否有任何保守考量，或是你們給指引背後的理念嗎？

And then second question, we've seen a little bit of softness maybe in the fourth quarter October flight trends. Can you just talk about what you're seeing and any trends there from your side?

第二個問題，我們看到第四季 10 月的航班趨勢似乎有些疲軟。你能談談你們這邊看到的情況，以及相關趨勢嗎？

On the first part of the question, our philosophy on guidance has always been to be conservative. Q4, obviously, we have the holiday season coming up, and we don't know what, if any, seasonality might happen. We're also being conservative and not factoring in any meaningful contribution from ENHANCE Part B or DENOVO. That's why our guidance is what it is. On the second part -- on the second question, listen, again, as I've stated many times, the flight trend is an indicator.

關於第一個問題，我們對指引的理念一向是保守。第四季很明顯有假期旺季即將到來，而我們不知道季節性會如何發生（如果有的話）。我們也採取保守作法，沒有把 ENHANCE Part B 或 DENOVO 的任何實質貢獻納入考量。這就是我們指引如此設定的原因。至於第二部分——第二個問題，聽著，如同我多次提到的，航班趨勢是一個指標。

It's not the be-all, end-all. But yes, I mean, the flights are down in October. It's a fact, but we still have November and December, and we've seen similar trends in Q3. So it's difficult for me to predict the full quarter based on a couple of weeks' worth of softness in flights. Also, as you can see in Q3 results, we had more car transports in Q3 than aviation.

它不是唯一、也不是決定一切的因素。但沒錯，我的意思是，10 月航班確實下滑。這是事實，但我們還有 11 月和 12 月，而且我們在第三季也看過類似趨勢。所以僅憑航班在幾週內出現的些許疲軟，就要我預測整個季度，對我來說很困難。另外，如你在第三季結果中所見，我們第三季的汽車運輸量多於航空運輸。

So, again, we need to weigh all that into our guidance and not just read the tea leaves based on a couple of weeks of soft flights and conclude what the quarter would look like. And we believe we achieved that level -- that balance of conservatism in the guidance we stated.

所以，再次強調，我們需要把所有這些因素納入指引的權衡，而不是只根據幾週航班疲軟就「看茶葉渣」下結論，認定這一季會長什麼樣子。我們相信，我們在所提出的指引中達到了那個水準——也就是保守性之間的平衡。

Chris Pasquale, Barclays.

Chris Pasquale，巴克萊。

Waleed, I want to make sure that we understand how ENHANCE Part A impacted your results. 175-patient study, how much of that activity took place in the third quarter, and what percentage of those cases do you think are really incremental to the business versus procedures that TransMedics likely would have been involved in anyway?

Waleed，我想確認我們理解 ENHANCE Part A 對你們結果的影響方式。175 位病人的研究，其中有多少活動發生在第三季？你認為這些案例中，有多少比例是真正為業務帶來增量，而不是 TransMedics 原本就很可能會參與的手術？

Chris, thank you for the question. We've always stated that ENHANCE Part A we don't consider as incremental because these are the indications we have. However, the excitement about the outcomes that were seen by the transplanting surgeons certainly helped increase our adoption in Q3. There's no equivocality about it. Many of the transplant programs are commenting anecdotally about how these hearts are coming out of the device looking better, recovering quicker, less edema, all the potential benefits that we had hoped that we would replicate in the clinic from what we've seen in the preclinical phase.

Chris，謝謝你的問題。我們一直都說，ENHANCE Part A 我們不視為增量，因為這些是我們既有的適應症。不過，移植外科醫師看到的結果所帶來的興奮感，確實有助於我們在第三季提高採用率。這點毫無疑問。許多移植中心在軼事層面評論，這些心臟從裝置取出時看起來更好、恢復更快、水腫更少，以及我們希望能把前臨床階段所見複製到臨床上的所有潛在效益。

So we have a high degree of confidence that, that Part A, albeit the same indication, helped drive deeper adoption in this indication because transplant programs were excited to see the enhancements in Part A.

因此我們非常有信心，Part A 雖然仍是相同適應症，但確實因為移植中心對 Part A 的增強效果感到振奮，而推動了在此適應症上的更深度採用。

And then maybe one for Fernando. Congratulations on the new role. I would love any directional commentary you can provide at this time on R&D spending and how that's going to trend as we get into '27. It stepped up a lot this year, and that's before Part B gets going. It's before DENOVO, before Kidney moves into first-in-human testing.

接著可能有一題給 Fernando。恭喜你擔任新職務。我想聽聽你目前能提供的任何方向性評論，關於研發支出以及進入 2027 年後的趨勢。今年研發支出大幅上升，而那還是在 Part B 尚未啟動之前。也在 DENOVO 之前、在腎臟進入首次人體試驗之前。

And so, as we think about just sort of what the budget looks like for all the programs you guys have going on next year, does that need to move meaningfully higher? Or have you front-loaded some of that expense here this year?

所以，當我們思考你們明年所有進行中的專案預算大概會是什麼樣子時，研發支出是否需要顯著再往上？還是你們已經在今年把部分費用前置投入了？

Yes. No, thank you for the question. And like I said in the prepared remarks, we expect the R&D to be fairly stable at this level for the foreseeable future here, like meaning for the next few quarters. That said, we are in the middle of our budget process. And obviously, we're going to be able to refine the overview and provide better detail as we get through the fourth quarter earnings and provide full year guidance for 2027.

是的。不，謝謝你的問題。如同我在事先準備的發言中提到的，我們預期在可預見的未來，研發支出會大致維持在目前這個水準，也就是接下來幾個季度。話雖如此，我們正處於預算編列流程中。而且很明顯，隨著我們走完第四季，我們將能更精準地完善整體概覽，並在第四季財報與提供 2027 全年指引時給出更好的細節。

But we expect that we are stable at this level that we are, at least for the next few quarters. And then we will see what is up next in terms of new technology that the team really wants to pursue. And we'll make sure that we have the financial capability to really support that while maintaining, which is very important, the profitability at the levels that we anticipate here.

但我們預期至少在接下來幾個季度，會穩定維持在目前這個水準。之後我們會再看團隊接下來真正想追求的新技術是什麼。我們也會確保具備財務能力來充分支持，同時維持——這點非常重要——我們預期的獲利水準。

Josh Jennings, TD Cowen.

Josh Jennings，TD Cowen。

Waleed, hoping to just circle back on ENHANCE Part A and just wanted to get an update on just timing of filing and potential approval for the NextGen OCS Heart System for the current indication. And then you gave some positive feedback in your answer to Chris around heart transplant surgeons' feedback. I would love to hear your team's kind of response to that feedback and your optimism that this next-generation OCS Heart can enable day-only heart transplant surgeries.

Waleed，我想回到 ENHANCE Part A，想請你更新一下：針對目前適應症，NextGen OCS Heart System 的申報時程以及可能獲批的時間點。另外，你在回覆 Chris 時提到一些心臟移植外科醫師的正面回饋。我也很想聽聽你們團隊對這些回饋的反應，以及你們對於這一代 OCS Heart 是否能促成「僅白天」心臟移植手術的樂觀程度。

Thank you, Josh, for the question. I think, as always, it's a very loaded question, Josh. I want to be cautious. Until the final results of the trial are read out, everything I stated is anecdotes. I was trying to address Chris's question what -- how confident are we that the contribution of heart market share gain was from ENHANCE Part A, and that was what I was trying to address.

謝謝你，Josh，這個問題。我想一如既往，這是一個資訊量很大的問題，Josh。我想保持謹慎。在試驗最終結果公布之前，我所說的一切都只是軼事。我是在回應 Chris 的問題——我們對於心臟市場份額提升的貢獻有多少來自 ENHANCE Part A，有多大信心——我試著回答的是這個。

However, I've always stated when a trial enrolls ahead of schedule, that gives us good signals. And this trial enrolled even faster. This portion of the trial enrolled even faster than the DCD heart enrolled with a much higher number of patients. So we are cautiously optimistic.

不過，我一直都說，當一項試驗的收案進度超前，會給我們很好的訊號。而這項試驗收案更快。這一部分的收案速度甚至比 DCD 心臟那項更快，而且病人數更多。所以我們抱持審慎樂觀。

We need to wait for the follow-up period to be concluded, and the plan is to be filing the PMA amendment for the existing indication based on Part A sometime in '27. And obviously, it will be up to the FDA to review the material and issue their opinion on the matter. But we are cautiously optimistic, Josh, and we hope to be able to submit for a PMA indication in 2027.

我們需要等待追蹤期結束；計畫是在 2027 年某個時間，基於 Part A 就既有適應症提交 PMA 修正案。當然，最終仍取決於 FDA 審查資料並就此事提出其意見。但我們抱持審慎樂觀，Josh，也希望能在 2027 年提交 PMA 適應症申請。

Maybe one follow-up just on CHOPS and any update on the 510(k) filing and clearance time line, and just remind us how you could launch CHOPS outside of ENHANCE Part B and DENOVO?

想再追問一下 CHOPS：510(k) 申報進度與核准時程是否有更新？另外也請提醒我們，您如何能在 ENHANCE Part B 與 DENOVO 之外推出 CHOPS？

Thank you, Josh. As we've always stated, our commitment to FDA was to ensure that CHOPS is 510(k) cleared independently of the trial. And we are going to deliver on that commitment to FDA. Right now, we believe the second half of '27 is the target time line where we may receive that 510(k) decision, given that we are prioritizing H1 to getting the device ready for the regulatory 510(k) review process. And we still are holding ourselves to that time line.

謝謝你，Josh。如同我們一直以來所說，我們對 FDA 的承諾是確保 CHOPS 能夠獨立於試驗之外取得 510(k) 核准（cleared）。而我們也會履行對 FDA 的這項承諾。目前我們認為 2027 年下半年是可能收到該 510(k) 決定的目標時程，因為我們正優先在上半年（H1）把裝置準備好，以進入法規 510(k) 審查流程。我們仍然以該時程作為自我要求。

So yes, the answer is yes. There's a possibility that we will have CHOPS 510(k) approved in 2027 before ENHANCE Part B is completed. In fact, that's what FDA would love to see us deliver on. And depending on timing of filing the ENHANCE Part A PMA amendment or PMA supplement, we might have that as well before year-end of 2027. But we have to wait and see.

所以是的，答案是肯定的。確實有可能我們會在 2027 年、在 ENHANCE Part B 完成之前，就讓 CHOPS 取得 510(k) 核准。事實上，這正是 FDA 希望我們能交付的成果。而且視 ENHANCE Part A 的 PMA 修正案或 PMA 補充案的送件時點而定，我們也可能在 2027 年底之前取得該項進展。但我們還得再觀察。

Samantha Munoz, Piper Sandler.

Samantha Munoz，Piper Sandler。

Congrats on a great quarter. I guess, first, could you talk about what you're seeing competitively in the market? It looks like you gained a good amount of share in liver and heart this quarter. And then maybe could you just provide more color in terms of whether you're going deeper into accounts or is this gaining new accounts?

恭喜本季表現非常出色。我想先請教，您在市場上看到的競爭態勢如何？看起來你們本季在肝臟與心臟領域拿下了相當多的市占。另外能否再多補充一些細節：這是你們在既有客戶中滲透更深，還是新增了更多新客戶？

Thank you, Sam, for the question. As I stated before, it's really difficult for me to comment on competition. I think that question should be saved for the competition. My focus is to make sure that every quarter our team is making progress, taking market share, and growing our top line. And I think Q3 met that expectation.

謝謝你，Sam，謝謝你的問題。如我先前所說，我很難去評論競爭對手。我認為這個問題應該留給競爭對手來回答。我的重點是確保每一季我們的團隊都在前進、拿下市占並推動營收成長。我認為第三季達到了這個期待。

And we're working hard on Q4 and into 2027. We need to -- as I stated before, we need to be extremely confident and comfortable to operate in a very, very crowded market today. And that's why we lead with innovation. And we're constantly challenging the status quo and any potential competitor based on innovation. And we were willing to put our innovation, our technology, and our services against anybody to continue to be in that leadership position.

我們也正努力衝刺第四季並一路延伸到 2027 年。如我先前所說，我們必須在今天這個非常、非常擁擠的市場中，具備高度信心並能夠自在運作。這也是為什麼我們以創新作為領先策略。我們持續挑戰現狀，並以創新來面對任何潛在競爭者。我們願意拿我們的創新、技術與服務去和任何人比較，以持續維持領導地位。

So, I guess, that's the answer on the status of the competition.

所以，我想這就是我對競爭態勢的回答。

And then just one more on CMS's recent final rule. It looks like they're placing greater scrutiny on transport-related adverse events. Could you talk kind of like what you see for those in the market and whether there's an opportunity for TransMedics to differentiate itself based on the reliability of its NOP network?

另外再問一題，關於 CMS 最近的最終規則。看起來他們對運輸相關的不良事件採取更嚴格的審視。你能談談你在市場上看到這類事件的情況，以及 TransMedics 是否有機會基於其 NOP 網路的可靠性來凸顯差異化嗎？

Thank you, Sam. I think the examples that CMS are focusing on are the traditional examples that we've seen for many, many years. Some kidneys that are shipped on commercial flights, they might not make it on time or they might end up in the wrong aircraft, that kind of stuff.

謝謝你，Sam。我認為 CMS 所聚焦的例子，是我們多年來一直看到的傳統案例。例如有些腎臟是透過商業航班運送，可能無法準時抵達，或是被放上錯的航班之類的情況。

So for us, it is crystal clear, and CMS knows it and everybody in the field of organ transplant knows it, that having the vertical integration of transplant logistics gives us the highest degree of reliability that we can give back to the transplant community, whether it's an OPO or a transplant center, because we can track the organ from the minute it leaves the donor body until it arrives to the recipient. Not us tracking it, but also we developed the digital ecosystem to enable that full transplant tracking of the organ by the accepting transplant program and the OPO staff that were involved in that particular organ.

因此對我們而言非常清楚；CMS 也知道，器官移植領域的所有人也都知道：移植物流的垂直整合，能讓我們為移植社群提供最高程度的可靠性——不論是 OPO 或移植中心——因為我們可以從器官離開捐贈者身體的那一刻起，一路追蹤到送達受贈者為止。不只是我們在追蹤；我們也建立了數位生態系，讓接受器官的移植計畫以及參與該器官流程的 OPO 人員，都能進行完整的移植追蹤。

So there's no doubt in my mind that we deliver the best logistic -- transplant logistics service on planet Earth. The key for us is to continue to innovate, continue to drive more market share, and hopefully help many of the OPOs to deliver more organs and utilize more organs for transplantation.

所以我毫不懷疑，我們提供的是地球上最好的移植物流服務。我們的關鍵是持續創新、持續推動更高市占，並希望協助更多 OPO 交付更多器官、讓更多器官能被用於移植。

Suraj Kalia, Oppenheimer.

Suraj Kalia，Oppenheimer。

Waleed, can you hear me all right?

Waleed，你聽得到我嗎？

I can hear you just fine, Suraj.

我聽得很清楚，Suraj。

Gentlemen, congrats on a great quarter. Waleed, a couple of quick questions, there are like a gazillion calls going on at the same time. As part of the IDE approval for ENHANCE B, were any protocol amendments mandated? That's part A. And part B of my question, Waleed, I would love to get your comments on the RE-UP procedure.

各位先生，恭喜本季表現很棒。Waleed，我有幾個快問快答，因為同時間有非常多場電話會議在進行。就 ENHANCE B 的 IDE 核准而言，是否有任何被要求的試驗方案修訂（protocol amendments）？這是第一部分。第二部分，Waleed，我很想聽聽你對 RE-UP 程序的看法。

There's always something new that people keep bringing up. Any of your comments and thoughts on RE-UP versus NRP and how we should think about it moving forward would be greatly appreciated. Gentlemen, congrats again.

大家一直提出一些新的東西。你對 RE-UP 相較於 NRP 的任何評論與想法，以及我們未來應如何看待它，都將非常有幫助。再次恭喜各位。

Thank you, Suraj. We appreciate it. On the first part of the question, mandated protocol amendments by FDA? The answer is no. We made proposals to the protocol, the FDA reviewed it, and they allowed it.

謝謝你，Suraj。我們很感謝。關於第一部分：FDA 是否要求強制性的試驗方案修訂？答案是否定的。我們對方案提出了建議，FDA 審查後予以同意。

So there's no FDA-mandated protocol changes. Related to RE-UP, I think our position on RE-UP, like many others, and I think Farhan gave a very data-driven presentation that actually raised a lot of questions about the validity of the RE-UP procedure. He did that in our symposium at the ISHLT. I'll leave it at that. And again, I point to our great results in Q3, where we took market share both in DBD and DCD heart.

所以沒有 FDA 強制要求的方案變更。至於 RE-UP，我認為我們對 RE-UP 的立場和許多人一樣；而且我想 Farhan 做了一場非常以數據為基礎的簡報，實際上也對 RE-UP 程序的有效性提出了許多疑問。他是在 ISHLT 我們的研討會上做的。我就先說到這裡。另外我也提醒各位，我們在第三季的表現非常好，無論在 DBD 或 DCD 心臟方面都拿下了市占。

And I also remind the audience that RE-UP is only used in 1 center in the United States. But our position on RE-UP is well stated in a public presentation that was data-driven from Farhan, our Head of the Cardiothoracic team, at the ISHLT.

我也提醒大家，RE-UP 在美國只在 1 家中心使用。但我們對 RE-UP 的立場，已在 ISHLT 上由我們心胸外科團隊負責人 Farhan 以數據為基礎的公開簡報中清楚闡述。

David Rescott, Baird.

David Rescott，Baird。

Congrats on the results here. Just one from us. I guess it's a two-parter, so maybe you can count it as two. I think you commented on this US TMA, OPO modernization after -- that's going on.

恭喜這次的成果。我們這邊只有一題。我想這其實是兩個部分，所以你也許可以把它算作兩題。我記得你提到過美國的 TMA、以及正在進行的 OPO 現代化——在那之後的進展。

And we've seen some other things, I think, recently there's this new DCD rule I think that's coming into effect in November, and then on the kidney side, you had the National Care -- the Kidney Care National Plan that came out a couple of weeks ago. So curious as to what your thoughts are if at all on both of those.

而且我們也看到一些其他動向，我想最近有一項新的 DCD 規則將在 11 月生效；另外在腎臟方面，幾週前也發布了 National Care——也就是 Kidney Care National Plan（全國腎臟照護計畫）。所以想請教你對這兩件事是否有任何看法。

And then more of a high-level question on this topic, more related to how you see kind of the political landscape or just this broader policy environment playing out today versus what it kind of looked like a couple years ago, and where you foresee that going over the next couple of years, of course, as you continue to expand and drive data and adoption of the technology?

接著就這個主題再問一個更高層次的問題，更多是關於你如何看待當前的政治版圖，或更廣泛的政策環境，相較於幾年前大概是什麼樣子；以及你預期未來幾年會如何發展——當然，前提是你們持續擴張並推動數據與技術採用。

Thank you, David. That's a very complex set of comments/questions. Let me start by the biggest and most impactful one, which is the HHS Kidney Care National Plan that was issued in October 2026.

謝謝你，David。這是一組非常複雜的評論／問題。我先從影響最大、最關鍵的一項開始，也就是 2026 年 10 月發布的 HHS《腎臟照護國家計畫》。

In that plan, HHS clearly stated that their goal is to increase kidney transplantation by approximately 2,000 kidneys per year, which they estimate in that report that we have an economic benefit per transplant of approximately $4.7 million per transplant. You multiply 2,000 kidneys by $4.7 million, you end up with $9.4 billion implied value for each year added to the transplant patient, or kidney added -- or 2,000 kidneys added for the transplant population, which amounts to $200 billion of projected economic benefits through 2040.

在該計畫中，HHS 明確表示其目標是每年將腎臟移植數量提高約 2,000 顆；他們在報告中估算，每增加一例移植的經濟效益約為每例 470 萬美元。你把 2,000 顆腎乘以 470 萬美元，就得到每年為移植病患新增的隱含價值 94 億美元——也就是為移植族群新增 2,000 顆腎所帶來的價值——累計到 2040 年，推估經濟效益約 2,000 億美元。

That's based off of 2,000 kidneys added. As I highlighted, and the data is crystal clear on it, last year there were about 9,000 kidneys discarded only for ischemic time. There's only 1 device that we're aware of that could reduce ischemic time and frankly eliminate ischemia during preservation, and making more kidneys available for transplant, which is the OCS Kidney when it becomes available. So we see these initiatives as highly complementary, highly focused on what OCS, and NOP, and TransMedics do well, which is maximize donor organ utilization for transplant, increase efficiency, and improve post-transplant clinical outcomes. We do all of the above.

這是以新增 2,000 顆腎為基礎。如我先前強調的，而且數據非常清楚，去年僅因缺血時間（ischemic time）就有大約 9,000 顆腎被丟棄。據我們所知，只有一種裝置能夠縮短缺血時間，坦白說是在保存期間消除缺血，並讓更多腎臟可用於移植——那就是 OCS Kidney（當它可用時）。因此，我們認為這些倡議與 OCS、NOP 以及 TransMedics 的強項高度互補、且高度聚焦：最大化捐贈器官用於移植的利用率、提升效率，並改善移植後的臨床結果。上述我們全都在做。

The same thing applies for the DCD ruling. The DCD ruling pretty much we saw some cowboyish behavior that came into the system. What HRSA and CMS are trying to do is put protocols in place to maximize patient safety and maximize utilization of organs. Again, we stand by the utilization rate of OCS in the DCD and DBD population to be the highest ever recorded in the history of organ transplant, north of 94% or 95%. So we are not afraid of these initiatives.

同樣的道理也適用於 DCD 裁定。在 DCD 裁定方面，我們確實看到一些帶點「牛仔式」的行為進入了體系。HRSA 與 CMS 正在做的是建立相關流程規範，以最大化病人安全並最大化器官利用。同樣地，我們以 OCS 在 DCD 與 DBD 族群中的利用率為傲，這是器官移植史上所記錄到的最高水準，超過 94% 或 95%。所以我們不害怕這些倡議。

We're not afraid of the initiatives of even CMS final rule. We do not see any of these things as negative or detrimental. We see it all as complementary, and we see TransMedics' role is to be supportive to all stakeholders in the field, OPOs, transplant centers, and regulators, to ensure that we are delivering the best organ transplant care to American patients in the US. So we are inspired by what's going on. I'm not going to comment on the political environment.

我們也不害怕甚至是 CMS 最終規則的相關倡議。我們不認為這些事情有任何負面或不利影響。我們認為這一切都是互補的；而我們也認為 TransMedics 的角色，是支持領域內所有利害關係人——OPO、移植中心與監管機構——以確保我們為美國境內的病患提供最佳的器官移植照護。因此，我們對正在發生的事情感到振奮。我不會評論政治環境。

The issue around organ transplantation has always been bipartisan from day 1. Both administrations, both types of political views, have supported organ transplantation. So we'll leave it at that.

器官移植議題從第一天起一直都是跨黨派的。不論哪一屆政府、不論哪種政治觀點，都支持器官移植。所以我們就說到這裡。

Tom Stephan, Stifel.

Tom Stephan，Stifel。

Apologies if this has been asked, just jumping between calls. But I wanted to ask a bit on trends and the base business guidance. If I look at October flights and then maybe take the typical November and December declines in the US transplant market relative to October? You're getting to OCS vols maybe down sequentially in the fourth quarter versus the third quarter.

如果這題已經有人問過先致歉，我只是一直在不同電話會議間切換。但我想問一下趨勢以及基礎業務指引。如果我看 10 月的航班數據，然後再套用美國移植市場相對於 10 月在 11 月與 12 月通常會下滑的情況？那你們第四季的 OCS 量可能會較第三季呈現季減。

Yet based on the core business guide for revenues and your service revenue commentary, it sounds like you do expect product revenue to be up sequentially in 4Q, correct me if I'm wrong there. So for that, I think it's roughly a $198 million midpoint guide for -- implied for 4Q on total revs in the base biz. I guess, Waleed, what gives you the confidence in hitting that number when it seems like trends in 4Q maybe are tracking down sequentially and not up?

但依照你們核心業務的營收指引以及你們對服務營收的評論，聽起來你們預期第四季產品營收會較前一季成長；如果我理解有誤請糾正。因此，我想以基礎業務來看，第四季總營收指引中位數大約是 1.98 億美元——也就是隱含的第四季總營收。我想問，Waleed，當看起來第四季趨勢可能是季減而不是季增時，你們憑什麼有信心達到這個數字？

Tom, thank you for the question. I think your characterization that Q4 -- second half of Q4 usually goes down is -- I don't think it's accurate. I think the opposite is true. We see a significant up-ramp in the second half of Q4 for a variety of different reasons. So we expect to see the same here.

Tom，謝謝你的問題。我認為你把第四季——通常第四季後半段會下滑——這樣的描述，我覺得不太準確。我認為事實正好相反。我們看到第四季後半段會有顯著的加速上升，原因有很多。所以我們預期這次也會一樣。

Yes, October was clearly a soft month, but again, I'm not willing to give up on the quarter just off a couple of weeks of slowness in October. And from our track record, from our history, from our performance, usually the last six to eight weeks -- six to seven weeks in Q4 is usually a significant recovery for a variety of different reasons. So what gives us the confidence is our track record. What gives us the confidence is we're living this day in and day out. And we're not just looking at trends in the rearview mirror, and also all the catalysts that are coming up in front of us in the remainder of Q4 and exiting the year.

是的，10 月顯然是比較疲弱的一個月，但我不願意只因為 10 月幾週的放緩就放棄對整個季度的判斷。從我們的紀錄、歷史與表現來看，第四季最後六到八週——大概六到七週——通常會因為多種原因而出現明顯回升。所以讓我們有信心的是我們的過往紀錄。讓我們有信心的是我們每天都在第一線經歷這些。而且我們不只是用後照鏡看趨勢，也會看第四季剩餘時間以及跨年之際在我們前方即將出現的所有催化因素。

Yes, and Tom, just maybe adding, I think you referenced that you were jumping calls, so you probably didn't hear Waleed answered a similar question before. But what is important to highlight on top of what he already highlighted here is the fact that just taking the flight data might not necessarily be all comprehensive.

是的，Tom，我再補充一下：我想你提到你在不同電話會議間切換，所以你可能沒聽到 Waleed 先前已回答過一個類似的問題。但除了他剛才提到的重點之外，還有一點很重要：單純看航班數據未必能涵蓋全貌。

There is clear evidence that we're making really good progress on other forms of transportation as well, including ground. So just wanted to make sure you have confidence, we have done a pretty good job in making sure that we have confidence in this guidance. And we believe we are guiding to a degree conservatively in the way we're thinking about the sequential progress between third quarter and fourth quarter.

有明確證據顯示，我們在其他運輸方式上也取得了很好的進展，包括地面運輸。所以只是想確保你有信心：我們在確保對這份指引有把握方面做得相當不錯。而且我們相信，在思考第三季到第四季的環比進展時，我們的指引在某種程度上是偏保守的。

I might have to check back on that OPTN data. But all makes sense. And then quick follow-up just on op margins next year in 2027. I think Street ex-PAD has been modeling positive year-over-year op margin expansion next year. So maybe talk about kind of your level of comfort in that with the base business posting operating margin accretion in '27, given all the initiatives that, I think, clearly have some nice momentum.

我可能得回頭再查一下那個 OPTN 數據。不過都說得通。接著快速追問一下 2027 年明年的營業利益率。我認為市場（Street）在排除 PAD 後，模型預估明年營業利益率會年增擴張。所以能否談談，在基礎業務於 2027 年實現營業利益率提升（margin accretion）這件事上，你們的把握程度如何？畢竟我認為所有這些倡議顯然都有不錯的動能。

And then as a tack-on, it'd be great if you can help us with what the PAD impact in '27 from a margin standpoint might look like, how will that business's op margin maybe compares to the base business?

另外再加問一題：如果你們能協助我們理解 2027 年 PAD 對毛利／利潤率的影響大概會是什麼樣子就太好了；從營業利益率角度來看，那項業務的營業利益率可能會如何與基礎業務相比？

Tom, first of all, a few of your questions that truly get into the '27 guidance, which I'm going to defer to our fourth quarter earnings, where I'm going to be able to provide a more detailed understanding of the business. So I'm not going to comment on the PAD performance in 2027. I'm going to wait for when we get to the call in the fourth quarter, like I said. But what I would say to you is, to your question related to the margin, I think it's safe to say, and it was part of my prepared remarks, we feel very strong about the way the progression of the business is going from a gross margin standpoint. And we believe that with the productivity programs that we have in place, both for product and service, we'll be able to hit those numbers and continue to drive continued progress, which is what we're going to keep using for margin leverage as well as continuing to do a fairly good job in making sure that we fund the business on the R&D side of the house.

Tom，首先，你有幾個問題確實深入到「27 年指引」的範疇，這部分我會留待我們第四季財報電話會議再說，屆時我能對業務提供更詳細的說明。因此，我不會評論 2027 年 PAD 的表現。如我所說，我會等到第四季的電話會議再談。但我想回應你關於毛利率的問題：我認為可以很有把握地說，而且這也在我事先準備的發言中提到，我們對業務在毛利率面向的進展趨勢非常有信心。我們相信，憑藉已經到位的生產力提升計畫（涵蓋產品與服務），我們將能達成那些數字並持續推動進一步的進展；這也將是我們用來取得毛利率槓桿的方式，同時也會持續相當妥善地確保我們在研發端為業務提供資金支持。

So hopefully it answers your question for today, and like I said, I'm looking forward to being able to refine the models which we're working through right now as it relates to the budget, and we'll guide at a more detailed level in February.

希望這能回答你今天的問題；如我所說，我也期待能在目前正針對預算推進的過程中，進一步精煉我們的模型，並在二月提供更細緻層級的指引。

Mike Matson, Needham & Company.

Mike Matson，Needham & Company。

Yes. So I just want to ask one on the kidney trial. I don't know if you're able to talk about how you expect to design the trial, but my understanding is the standard of care there's hypothermic perfusion. So is that what you'd likely be using as your control? And then how do you sort of avoid the same issue you had with the heart and lung trials where the competitors didn't want you using their devices for the trial?

是的。我想就腎臟試驗問一個問題。我不確定你是否能談談你們預期會如何設計該試驗，但據我了解，標準治療是低溫灌流。所以你們很可能會把它作為對照組嗎？另外，你們要如何避免在心臟與肺部試驗中遇到的同樣問題——也就是競爭對手不希望你們在試驗中使用他們的設備？

Thanks, Mike. We are at least a year away from discussing the detail on the kidney trial design. So we still have a long way to go. It's way too premature to start talking about the kidney trial design. However, related to the control arm, the control arm is the standard of care, as you said.

謝謝你，Mike。我們至少還要一年才會討論腎臟試驗設計的細節。所以我們還有很長的路要走。現在就開始談腎臟試驗設計還為時過早。不過，關於對照組，如你所說，對照組就是標準治療。

It's cold perfusion. It's been in the market for 25 years. We don't expect the same reaction, given that this technology is not in the hands of the transplant programs. It's in the hands of the organ procurement organizations. They manage it broadly.

也就是冷灌流。這項技術已在市場上存在 25 年。我們不預期會有同樣的反應，因為這項技術並不掌握在移植計畫手中。它掌握在器官採購組織（OPO）手中。他們在更廣泛的層面進行管理。

So we don't expect the same dynamic here as the highly concentrated call points for heart and lung that we've experienced with the controlled hypothermic storage. So -- but we have a long ways to go before we can share the detail of the design of the kidney trial, and obviously, we will do that in the first half of 2027.

因此，我們不預期這裡會出現與我們在受控低溫保存（controlled hypothermic storage）下、心臟與肺部那種高度集中使用點所經歷的相同態勢。不過，在我們能分享腎臟試驗設計細節之前，還有很長一段路要走；而且很明顯地，我們會在 2027 年上半年提供相關資訊。

Daniel Markowitz, Evercore ISI.

Daniel Markowitz，Evercore ISI。

I wanted to know, following the final OPO rule, how are you thinking about timing of potential decertifications and transitions? Could those handovers create further near-term disruption to donor activity before we see the benefits of reform come through? I guess, overall, just wondering how you expect this dynamic to impact the more near-term, call it, 2027, and then in the longer term beyond '27 as well.

我想了解，在 OPO 最終規則發布後，你們如何看待潛在撤銷認證（decertifications）與交接轉換的時間點？這些交接是否可能在我們看到改革效益顯現之前，對捐贈活動在短期內造成進一步干擾？整體而言，我想知道你們預期這種動態會如何影響較近期、也就是所謂 2027 年，以及更長期、超過 27 年之後的情況。

Thank you, Daniel. It's very hard, obviously, nobody knows what the impact is, but from reading the CMS final rule, I think actually CMS is being very thoughtful about this and trying to minimize the disruption. They're extending the runway from a timeline perspective. They're opening the door for many of the OPOs in Tier 2 to merge even before the decertification process takes place. They're giving a lot of runway for Tier 2s.

謝謝你，Daniel。這當然非常難說，沒有人知道實際影響會是什麼；但從我閱讀 CMS 的最終規則來看，我認為 CMS 其實相當審慎周全，並試圖把干擾降到最低。他們在時間表上延長了緩衝期。他們也為許多位於第二級（Tier 2）的 OPO 打開了在撤銷認證程序發生之前就先行合併的大門。他們給了 Tier 2 很多緩衝時間。

So I -- my own perception is, this is going to be a lot more controlled, and we hope that it doesn't show -- it doesn't result in any disruption in the national volume, given that's already done. I mean, the final rule has come out. CMS is not changing their mind. Unless something happens during the challenge process, we don't expect much to change.

所以——我自己的看法是，這將會更受控地進行；我們也希望它不會——不會導致全國總量出現任何干擾，因為那件事已經定案了。我的意思是，最終規則已經發布。CMS 不會改變主意。除非在申訴（challenge）程序期間發生某些事情，否則我們不預期會有太多變化。

That concludes our Q&A session. I will now turn the conference back over to Dr. Waleed Hassanein for any closing remarks.

問答環節到此結束。接下來我將把電話會議交回給 Waleed Hassanein 醫師，請他做結語。

Thank you, operator. We thank you all very much for taking the time to be with us tonight, and we wish you all happy holidays. And we will meet again early next year. Thank you very much. Have a good evening.

謝謝你，接線員。非常感謝各位今晚撥冗與會，也祝各位佳節愉快。我們將在明年年初再度相會。非常感謝。祝各位晚安。

This concludes today's call. Thank you for participating. You may now disconnect and have a wonderful rest of your day.

今天的電話會議到此結束。感謝各位參與。您現在可以掛線，祝您今天剩餘時間愉快。