Transmedics Group Inc (TMDX) 2025 Q2 法說會逐字稿

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

下午好，歡迎參加 TransMedics 2025 年第二季財報電話會議。（操作員指示）提醒一下，此通話將被錄音以供重播。

I would now like to turn the call over to Laine Morgan from The Gilmartin Group for a few introductory comments. Please go ahead.

現在，我想將電話轉給 Gilmartin 集團的 Laine Morgan，請她做幾點介紹性評論。請繼續。

Thank you. Earlier today, TransMedics released financial results for the quarter ended June 30, 2025. A copy of the press release is available on the company's website.

謝謝。今天早些時候，TransMedics 發布了截至 2025 年 6 月 30 日的季度財務表現。新聞稿副本可在該公司網站上查閱。

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 meanings 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.

在我們開始之前，我想提醒您，管理層將在本次電話會議中（包括電話會議的問答部分）發表聲明，其中包括聯邦證券法所定義的前瞻性聲明。本次電話會議中包含的任何與未來事件、結果或表現的預期或預測相關的陳述均為前瞻性陳述。

These include statements about future events, results, or performance, including commentary on potential market and business conditions, our examination of operating trends, the potential commercial opportunity of our products and services, the potential timing, outcome, and value of new clinical programs, the potential impact of tariffs on our business, our expectations for growth and opportunities in our operations, and financial guidance and/or projected expectations, including revenue, growth margins, and operating expenses in 2025 and beyond. 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.

這些包括關於未來事件、結果或表現的陳述，包括對潛在市場和商業狀況的評論、我們對經營趨勢的審查、我們產品和服務的潛在商業機會、新臨床項目的潛在時機、結果和價值、關稅對我們業務的潛在影響、我們對營運成長和機會的預期，以及財務指導和/或預期的期望，包括 2025 年及以後的收入、成長利潤率及營運成本。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預期或暗示的結果或事件有重大差異。

Accordingly, you should not place undue reliance on these statements. 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 May 8, 2025, and our subsequent SEC filings, which are available at www.sec.gov and on our website at www.transmedics.com.

因此，您不應過度依賴這些聲明。有關這些風險和不確定性的更多信息，請參閱我們於 2025 年 5 月 8 日向美國證券交易委員會提交的 10-Q 表的“風險因素”標題下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 find the company's slide presentation with information on second-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.

您可以在 TransMedics 網站的投資者關係部分找到該公司的幻燈片演示，其中包含有關 2025 年第二季業績的資訊。除法律要求外，TransMedics 不承擔更新或修改任何財務預測或前瞻性聲明的意圖或義務。

This conference call contains time-sensitive information and is accurate only as of the live broadcast today, July 30, 2025.

本次電話會議包含時間敏感訊息，僅截至今天（2025 年 7 月 30 日）的現場直播時準確。

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

現在，我將把電話轉給總裁兼執行長 Waleed Hassanein。

Thank you very much, Laine. Good afternoon, everyone, and welcome to the TransMedics second-quarter 2025 earnings call. Joining me today is Gerardo Hernandez, our Chief Financial Officer.

非常感謝，萊恩。大家下午好，歡迎參加 TransMedics 2025 年第二季財報電話會議。今天與我一起出席的是我們的財務長 Gerardo Hernandez。

Organ transplant therapy is experiencing a renaissance globally due to the growing recognition of the life-saving and cost-effective outcomes when treating end-stage organ failure. In the US, federal agencies and Congress are driving a national initiative to modernize the US transplant system to enable greater utilization of donor organs to meet the growing demand for more and better organ transplantation

由於人們越來越認識到治療末期器官衰竭具有挽救生命和成本效益的效果，器官移植治療正在全球復興。在美國，聯邦機構和國會正在推動一項國家倡議，以實現美國移植系統的現代化，從而更有效地利用捐贈器官，滿足日益增長的對更多、更好的器官移植的需求

More recently, this July, the European Society of Organ Transplantation, or ESOT, published a call for action paper in The Lancet, the premier medical journal, highlighting the global importance of organ transplantation. Specifically, the paper reinforced the urgent need for healthcare systems to prioritize investments in organ transplantation as a critical healthcare strategy, given the significant impact on health and cost efficiency of organ transplants.

今年 7 月，歐洲器官移植協會 (ESOT) 在頂級醫學雜誌《柳葉刀》上發表了一份行動呼籲文件，強調器官移植的全球重要性。具體而言，鑑於器官移植對健康和成本效益的重大影響，該論文強調醫療保健系統迫切需要優先投資器官移植作為關鍵的醫療保健策略。

Against this backdrop, we at TransMedics have been relentless in driving significant positive transformation of the transplant therapy globally through our OCS technology, our unique NOP program in the US. This is what drives our mission-oriented TransMedics team and has enabled us to consistently execute and deliver on our plans.

在此背景下，TransMedics 一直堅持不懈地透過我們的 OCS 技術（我們在美國獨特的 NOP 計劃）推動全球移植治療的重大積極轉變。這正是我們以使命為導向的 TransMedics 團隊的動力，並使我們能夠始終如一地執行和實現我們的計劃。

On today's call, as we look into the future beyond our exceptional 2Q performance, I will be sharing our near and long-term vision of key strategic initiatives designed to grow our OCS NOP volumes beyond the 10,000 planned for 2028. Importantly, I will also provide our perspectives in response to some recent market confusion and noise following comments made by a certain player in the organ preservation ecosystem.

在今天的電話會議上，當我們展望第二季度卓越業績之後的未來時，我將分享我們近期和長期的關鍵戰略舉措願景，這些舉措旨在將我們的 OCS NOP 數量擴大到計劃於 2028 年達到的 10,000 個以上。重要的是，我還將針對器官保存生態系統中某位參與者的評論所引起的近期市場混亂和噪音提供我們的觀點。

But first, let me highlight our 2Q performance, which represents a new high watermark for both clinical cases and revenue. Our performance has also demonstrated a significant operating leverage potential of the TransMedics business, even as we continue to invest across several growth initiatives. We strongly believe that this quarter represents just one key milestone of many to come as we work towards achieving our strategic vision to drive TransMedics to become the global standard of care for organ transplantation.

但首先，讓我重點介紹一下我們的第二季業績，這代表著臨床病例和收入都達到了新的高水準。即使我們繼續在多個成長計劃上進行投資，我們的業績也證明了 TransMedics 業務的巨大經營槓桿潛力。我們堅信，本季只是未來眾多里程碑中的關鍵里程碑，我們正努力實現我們的策略願景，推動 TransMedics 成為器官移植護理的全球標準。

We are not stopping here. We are already ramping up our investments to drive the next several waves of growth that will deliver substantially more top and bottom-line growth for TransMedics. Our success has been and will remain fueled by the unique TransMedics trident -- that is to say -- our disruptive and technically unparalleled OCS technology platform, our revolutionary NOP service model, and our unique dedicated transplant logistics network.

我們不會就此止步。我們已經加強投資力度，以推動接下來的幾波成長，從而為 TransMedics 帶來更大的營收和利潤成長。我們的成功一直並將繼續受到獨特的 TransMedics 三叉戟的推動——也就是說——我們顛覆性的、技術上無與倫比的 OCS 技術平台、我們革命性的 NOP 服務模式以及我們獨特的專用移植物流網絡。

Now, let me turn to a more detailed outline of our 2Q performance. The results speak for themselves. Total revenue for 2Q 2025 was $157.4 million, representing approximately 38% growth year over year and approximately 10% sequential growth from 1Q 2025. We experienced sequential growth across all three organ segments, driven by higher overall utilization and center penetration of OCS NOP in the US.

現在，讓我更詳細地概述一下我們第二季的業績。結果不言而喻。2025 年第二季總營收為 1.574 億美元，較去年同期成長約 38%，較上季 2025 年第一季成長約 10%。受美國 OCS NOP 總體利用率和中心滲透率提高的推動，我們的三個器官部門均實現了連續成長。

As I mentioned, this enabled us to achieve a new high watermark for overall case volume. In fact, to dispel any confusion about some of the outside commentary on lung transplantation in the US, OCS Lung experienced approximately 14% sequential growth in 2Q. Our overall gross margin for 2Q was steady at 61.4%, similar to Q1. Meanwhile, we delivered operating profit of approximately $36.6 million in 2Q, representing more than 23% of total revenue and up from $27.4 million or 19% of total revenue in 1Q 2025.

正如我所提到的，這使我們能夠在整體案件數量上創下新高。事實上，為了消除外界對美國肺移植的一些評論的困惑，OCS Lung 在第二季度經歷了約 14% 的連續成長。我們第二季的整體毛利率穩定在 61.4%，與第一季相似。同時，我們在第二季度實現了約 3,660 萬美元的營業利潤，佔總收入的 23% 以上，高於 2025 年第一季的 2,740 萬美元或總收入的 19%。

Finally, we have driven strong cash generation. We have significantly improved our billing cycle and maintained healthy AR collections, which collectively resulted in the addition of approximately $90 million to our balance sheet as we ended 2Q with over $400 million in cash. We hope these results cement our commitment to profitable growth and cash generation.

最後，我們實現了強勁的現金創造。我們顯著改善了結算週期，並保持了健康的應收帳款收款，這共同導致我們的資產負債表增加了約 9000 萬美元，第二季末我們擁有超過 4 億美元的現金。我們希望這些結果能夠鞏固我們對獲利成長和現金創造的承諾。

We are humbled by these results, but we have our sights laser-focused on achieving and surpassing the target of 10,000 transplants -- US NOP transplants in 2028. Importantly, we're planning to go well above that target in subsequent years. In fact, our pipeline strategy of adding the OCS Kidney platform is designed to position us to achieve at least over 20,000 annual US NOP transplant, as we will outline later in this call.

我們對這些結果感到謙卑，但我們的目標是實現並超越 10,000 例移植手術的目標——即 2028 年美國 NOP 移植手術。重要的是，我們計劃在接下來的幾年裡遠遠超越這個目標。事實上，我們添加 OCS 腎臟平台的管道策略旨在讓我們實現每年至少超過 20,000 例美國 NOP 移植，正如我們將在本次電話會議稍後概述的那樣。

We are also actively exploring options of expanding our NOP model internationally. This will enable TransMedics to potentially nearly double our total addressable market, as Europe represents 45% of the global transplant numbers. Stay tuned. We still have significant growth ahead of TransMedics, and we won't rest until we deliver it.

我們也在積極探索將我們的 NOP 模式擴展到國際上的選擇。由於歐洲佔全球移植數量的 45%，這將使 TransMedics 的總目標市場有可能翻倍。敬請關注。在 TransMedics 的發展道路上，我們仍具有顯著的成長潛力，我們絕不放棄，直至實現這一目標。

Shifting now to TransMedics transplant logistics infrastructure and performance. Transplant logistics service revenue for 2Q was $29.8 million, representing 56% year-over-year and 14% sequential growth. Throughout 2Q, we owned and operated 21 aircraft. In Q2, we covered 79% of our NOP mission requiring air transport, compared to 78% in Q1. So we're nearly at our target of covering 80% to 85% of our NOP missions requiring air transport. Meanwhile, we're continuing to add to our pilot crew to enable us to experiment with double shifting a portion of our fleet to run even a much more efficient operation by year-end.

現在轉向 TransMedics 移植物流基礎設施和效能。第二季移植物流服務收入為 2,980 萬美元，年增 56%，季增 14%。在整個第二季度，我們擁有並營運 21 架飛機。在第二季度，我們完成了 79% 的需要空運的 NOP 任務，而第一季這一比例為 78%。因此，我們幾乎已經達到了覆蓋 80% 至 85% 需要空運的 NOP 任務的目標。同時，我們正在繼續擴充我們的飛行員隊伍，使我們能夠嘗試對部分機隊進行雙班輪換，以便在年底前實現更有效率的運作。

Moving now to update you on our Next-Gen OCS Heart and Lung clinical programs and the status of the FDA IDEs. We are pleased to report that we have received FDA conditional approval for the OCS Lung IDE in July. We're continuing to collaboratively engage with FDA's leadership to address their final questions and are planning to begin the trial initiation activities after the summer vacation season.

現在向您介紹我們的下一代 OCS 心臟和肺臨床計劃以及 FDA IDE 的狀態。我們很高興地報告，我們已於 7 月獲得 FDA 對 OCS Lung IDE 的有條件批准。我們將繼續與 FDA 領導層合作解決他們的最後問題，並計劃在暑假後開始試驗啟動活動。

On the OCS Heart IDE, we feel we are very close to reaching similar agreement with the FDA leadership to enable the near-term launch of our clinical program. Based on the progress achieved with FDA, we feel we remain on track to launch both programs before year-end. As discussed at our last call, we see these clinical programs as potential major growth catalysts for 2026, but we are not counting on them contributing to our financial results in 2025.

在 OCS Heart IDE 方面，我們感覺我們非常接近與 FDA 領導層達成類似的協議，以便近期啟動我們的臨床計劃。根據與 FDA 取得的進展，我們認為我們仍有望在年底前啟動這兩個計畫。正如我們上次電話會議所討論的那樣，我們認為這些臨床項目是 2026 年潛在的主要成長催化劑，但我們並不指望它們會為我們 2025 年的財務表現做出貢獻。

Now, please allow me to directly and hopefully comprehensively address several misunderstood competitive commentary and the potential impact of US National Transplant Modernization Initiative that has become an unwarranted source of confusion and concerns recently. While we hold all companies operating in the field of organ preservation in very high regards, I want to be crystal clear that our expectation is that, as TransMedics continue to execute and gain more market share, the results of our peers with smaller footprints in the market could be negatively impacted. This should not come as a surprise or be misunderstood as a negative indicator of TransMedics' current or future performance.

現在，請允許我直接並全面地解決一些被誤解的競爭評論以及美國國家移植現代化計劃的潛在影響，這些影響最近已成為不必要的混亂和擔憂的根源。雖然我們非常尊重所有在器官保存領域運營的公司，但我想明確表示，我們的預期是，隨著 TransMedics 繼續執行並獲得更多的市場份額，我們在市場上佔有較小份額的同行的業績可能會受到負面影響。這不應該讓人感到意外，也不應該被誤解為對 TransMedics 當前或未來表現的負面指標。

Please allow me to repeat this sentence again. As TransMedics continue to execute and grow our market share in a certain market, our peers with smaller footprints result could be negatively impacted. This negative impact of our peers should not come as a surprise to the Street or be misunderstood as a negative indicator of TransMedics' current or future performance. TransMedics can only be judged based on our own performance, based on our own technology in our own market.

請容許我再重複一次這句話。隨著 TransMedics 繼續執行並擴大我們在特定市場的市場份額，我們的足跡較小的同行的業績可能會受到負面影響。同行的這種負面影響不應讓華爾街感到意外，也不應被誤解為 TransMedics 當前或未來表現的負面指標。評判 TransMedics 的標準只能是依據我們自身的表現，依據我們在自身市場所採用的技術。

Also, specific to the lung market, we have been very transparent in our view that the poor and equivocal clinical results associated with the non-portable and non-blood-based perfusion technologies have contributed heavily to the current apathy for lung perfusion in the US. Therefore, we see the recent competitive commentary on US trends in lung transplant as a validation of our thesis.

此外，具體到肺部市場，我們非常透明地認為，與非便攜式和非血液灌注技術相關的不良和模棱兩可的臨床結果嚴重導致了美國目前對肺灌注的冷漠。因此，我們認為最近有關美國肺移植趨勢的競爭性評論驗證了我們的論點。

In fact, it is because of the above dynamic that we designed the Next-Gen OCS Lung program to comprehensively overcome these old preconceived negative sentiments existing within the US lung perfusion market. Specifically, we have designed the largest prospective randomized controlled trial in the history of lung preservation for transplant. Please remember that our INSPIRE trial was the largest at approximately 350, but the Next-Gen OCS trial will be even bigger than the INSPIRE trial. We're aiming at a total sample size that will exceed 450 DBD and DCD donor lungs that will be randomized between our Next-Gen OCS Lung platform versus cold-controlled static storage that is currently the standard of care.

事實上，正是由於上述動態，我們設計了下一代 OCS Lung 計劃，以全面克服美國肺灌注市場中存在的這些舊的先入為主的負面情緒。具體來說，我們設計了肺移植保存史上最大規模的前瞻性隨機對照試驗。請記住，我們的 INSPIRE 試驗規模最大，約 350 人，但下一代 OCS 試驗的規模將比 INSPIRE 試驗更大。我們的目標是總樣本量超過 450 個 DBD 和 DCD 供體肺，這些肺將隨機分配到我們的下一代 OCS 肺平台和目前作為護理標準的冷控靜態儲存中。

We are confident that, if the clinical trial achieves the same level of success that we've seen in our preclinical testing, that we will deliver far superior clinical outcomes without the limitations of time and distance. This will be supported by Level 1 clinical evidence compared to the cold storage method that lacks any prospective clinical evidence. If successful, we fully expect that this will further establish the OCS Lung as the next standard of care in lung preservation.

我們相信，如果臨床試驗取得與臨床前測試相同的成功水平，我們將不受時間和距離的限制，提供更優異的臨床結果。與缺乏任何預期臨床證據的冷藏方法相比，這將得到 1 級臨床證據的支持。如果成功，我們完全相信這將進一步確立 OCS 肺部作為肺部保存護理的下一個標準。

With that, I will turn to our views on the long-standing and ongoing HRSA, CMS, US House, and Congressional initiatives to modernize the US transplant system. First, let me start by stating my personal belief that the US transplant system is one of, if not the best, in the world. However, there's always room to improve and modernize to expand organ utilization while optimizing the care of transplant patients and donors.

接下來，我將談談我們對 HRSA、CMS、美國眾議院和國會長期以來為美國移植系統現代化所採取的舉措的看法。首先，我要表明我的個人觀點：美國的器官移植系統是世界上最好的系統之一，甚至可以說是最好的。然而，在優化移植患者和捐贈者的照護的同時，總是有改進和現代化的空間，以擴大器官利用率。

To be clear, TransMedics has been engaged publicly and privately with stakeholders on this topic, providing our views on how industry players like TransMedics can play a crucial role to support all stakeholders, including OPOs, and advance the transplant donation ecosystem in the United States. For context on our views on this topic, I would refer you all to our two public statements from 2022 in response to the RFIs by both HRSA and CMS, and these statements are written statements published on both HRSA and CMS webpage.

需要明確的是，TransMedics 一直在公開和私下與利益相關者就此話題進行交流，提供我們的觀點，即像 TransMedics 這樣的行業參與者如何發揮關鍵作用來支持包括 OPO 在內的所有利益相關者，並推進美國的移植捐贈生態系統。為了了解我們對這個主題的看法，我想請大家參考我們 2022 年針對 HRSA 和 CMS 的 RFI 所做的兩份公開聲明，這些聲明都是在 HRSA 和 CMS 網頁上發布的書面聲明。

Importantly, the success of US NOP in facilitating the growth of overall national heart and liver transplant volume has not gone unnoticed, and we are working with every stakeholder of the US transplant ecosystem to ensure that they understand the following critical facts. First, TransMedics' NOP is a win-win-win to every stakeholder in the US transplant system with an interest in saving more lives in the US. This includes OPOs, HRSA, CMS, commercial payers, and most importantly, patients and their families.

重要的是，美國 NOP 在促進全國心臟和肝臟移植總量增長方面的成功並沒有被忽視，我們正在與美國移植生態系統的每個利益相關者合作，以確保他們了解以下關鍵事實。首先，TransMedics 的 NOP 對美國移植系統的每個利害關係人來說都是三贏的局面，有利於拯救美國更多的生命。其中包括 OPO、HRSA、CMS、商業付款人，最重要的是患者及其家人。

Second, TransMedics' clinical value is supported and an impact on overall transplant volume is supported by hard data and facts that have been collected over the last three years through our NOP infrastructure. And finally, TransMedics is here to stay and ready to serve as a critical and trusted partner in the efforts to modernize the US transplant system to maximize donor organ utilization and save more American lives.

其次，TransMedics 的臨床價值得到了支持，並且對整體移植量的影響也得到了過去三年透過我們的 NOP 基礎設施收集的硬數據和事實的支持。最後，TransMedics 將繼續留在這裡，並準備好成為美國移植系統現代化努力中的重要且值得信賴的合作夥伴，以最大限度地提高捐贈器官的利用率並挽救更多美國人的生命。

As a show of our commitment to this goal, we have taken several actions. For example, we made significant investments to scale our digital NOP ecosystem to give maximum transparency to all US NOP transplant stakeholders. We are expanding our leadership team with dedicated strategic and public affairs experts to ensure that TransMedics is well represented and our data is front and center to any discussions with the stakeholders.

為了表明我們對這一目標的承諾，我們採取了多項行動。例如，我們投入大量資金來擴展我們的數位 NOP 生態系統，以便為所有美國 NOP 移植利害關係人提供最大的透明度。我們正在擴大我們的領導團隊，聘請專門的策略和公共事務專家，以確保 TransMedics 得到良好的代表，並且我們的數據在與利益相關者的任何討論中都處於中心位置。

And finally, we are actively engaged with all stakeholders involved to make our positions clear and to avoid any misunderstandings or confusion. As you can imagine, emotions are running high for some and we need to stay balanced and lead only with facts and data. Finally, we have several strategic initiatives underway to support this work above. We expect to provide more details as they unfold over the next several quarters.

最後，我們積極與所有相關利益者接觸，明確我們的立場，避免任何誤解或混淆。你可以想像，有些人的情緒非常激動，我們需要保持平衡，只用事實和數據來引導。最後，我們正在實施幾項策略性措施來支持上述工作。我們預計將在接下來的幾個季度內提供更多細節。

With that, I also want to take a moment to address a point of confusion following the review of few unfortunate DCD cases in a recent New York Times article. Please let there be no uncertainty. The declaration of death for any DCD or DBD donation case in the United States is entirely independent of the organ procurement surgeons, whether it's TransMedics' NOP surgeon or any other procurement entity.

除此之外，我還想花點時間解決最近《紐約時報》的一篇文章中對幾個不幸的 DCD 案例進行回顧後產生的一個困惑點。請不要有任何不確定性。在美國，任何 DCD 或 DBD 捐贈案例的死亡宣告完全獨立於器官採購外科醫生，無論是 TransMedics 的 NOP 外科醫生還是任何其他採購實體。

This is purely and solely with the responsibility of the independent declaring physician working for the donor hospital and contracted by the local OPO. There is a crystal clear line of demarcation of this particular clinical responsibility. Please remember that while this is a complex market dynamic, there are clear and established protocols in place and that TransMedics' NOP surgical procurement team strictly adheres to these established protocols.

這完全由在捐贈醫院工作並與當地 OPO 簽約的獨立申報醫生負責。這種特殊的臨床責任有著非常明確的界線。請記住，雖然這是一個複雜的市場動態，但有明確且既定的協議，並且 TransMedics 的 NOP 外科採購團隊嚴格遵守這些既定協議。

With that, let me return to the fundamentals of our business. Our TransMedics OCS platform, the OCS NOP clinical support model and the dedicated transplant logistics network, and more recently, the entire NOP digital ecosystem were all prospectively designed to give TransMedics a significant unique position that could operate freely in both the current transplant system as well as any potential system of the future.

說到這裡，讓我回到我們業務的基本面。我們的 TransMedics OCS 平台、OCS NOP 臨床支援模型和專用移植物流網絡以及最近的整個 NOP 數位生態系統均經過前瞻性設計，旨在讓 TransMedics 佔據重要的獨特地位，可以在現有移植系統以及未來的任何潛在系統中自由運行。

We are not sitting still. We are working with all stakeholders to ensure that the success of our model in saving more American lives is well recognized and that we will continue to deliver cost-efficient transplant services that meet the highest clinical standard for our users, partners, and most importantly, patients in need. I want to repeat again. TransMedics is here to play a critical role and it's here to stay, whether in the current system or any system of the future.

我們並沒有坐以待斃。我們正在與所有利益相關者合作，以確保我們的模式在拯救更多美國人生命方面的成功得到廣泛認可，並且我們將繼續為我們的用戶、合作夥伴以及最重要的有需要的患者提供符合最高臨床標準的具有成本效益的移植服務。我想再重複一遍。TransMedics 在這裡發揮關鍵作用，並且它將繼續存在，無論是在當前系統還是未來的任何系統中。

Before I conclude, please allow me to now summarize, at a high level, ongoing and planned investment initiatives designed to catalyze growth over the next several years. More specifically, we intend to: one, expand our infrastructure footprint to best position us to scale well beyond 10,000 transplants and attract and retain top-tier talent capable of supporting our Gen 3 technology requirements. Specifically, we are now fully engaged in identifying the best location to be our new long-term global headquarters for TransMedics.

在結束之前，請允許我從高層次總結一下旨在促進未來幾年成長的正在進行的和計劃中的投資舉措。更具體地說，我們打算：一、擴大我們的基礎設施覆蓋範圍，使我們能夠擴展到超過 10,000 個移植手術，並吸引和留住能夠支持我們的 Gen 3 技術要求的頂級人才。具體來說，我們現在正全力尋找作為 TransMedics 新的長期全球總部的最佳地點。

Two, deliver on our OCS platform pipeline of OCS Kidney followed by Gen 3 OCS platform for Heart, Lung, and Liver. Three, expand our entire US OCS NOP clinical and logistics team to meet the growing demand and minimize bottlenecks. Four, position ourselves to capitalize on any opportunities stemming from the national modernization initiatives.

二、在我們的 OCS 平台管道上交付 OCS 腎臟，隨後是針對心臟、肺和肝臟的 Gen 3 OCS 平台。三、擴大我們整個美國 OCS NOP 臨床和物流團隊，以滿足不斷增長的需求並最大限度地減少瓶頸。四是積極掌握國家現代化建設機會。

And finally, we are strategically exploring select geographical expansion opportunities. This entails evaluating the potential for replicating the successful OCS NOP across several European countries. It has become increasingly clear that there is a significant interest for TransMedics to replicate our US success outside of the US, including the dedicated transplant logistics network in European countries. We are thrilled by this potential, and as we always say internally, if TransMedics doesn't do it, who would?

最後，我們正在策略性地探索選擇性地理擴張機會。這需要評估在幾個歐洲國家複製成功的 OCS NOP 的可能性。越來越明顯的是，TransMedics 有濃厚的興趣在美國以外複製我們在美國的成功，包括在歐洲國家建立專門的移植物流網絡。我們對這種潛力感到非常興奮，正如我們經常在內部說的那樣，如果 TransMedics 不做，誰會做呢？

Based on the above, you can see that we are not slowing down. To be clear, given the breadth and magnitude of opportunities ahead, combined with our demonstrated ability to generate operating leverage and free cash flow, our near-term capital allocation strategy is growth-oriented. Again, our near-term capital allocation strategy is focused on growth. While our operating margin will 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 while aiming at consistently maintaining positive cash generation.

從以上情況可以看出，我們並沒有放慢腳步。需要明確的是，鑑於未來機會的廣度和規模，再加上我們已證明的產生經營槓桿和自由現金流的能力，我們的近期資本配置策略是以成長為導向的。再次強調，我們的近期資本配置策略著重於成長。雖然我們的營業利潤率會隨著我們在這些計劃中部署資本而有所波動，但我們對自己長期實現大幅營收和利潤增長，同時持續保持正現金流的能力充滿信心。

Now, let me conclude my remarks by commenting on our expectation for the remainder of 2025. First, I'll remind you all that we are in Q3, which includes summer vacation season for our users in the US and outside of the US. We fully expect to see some minor and transient seasonality in our 3Q performance, similar to what we saw last year. To be clear, we expect this seasonality to be transient and minor in nature.

現在，讓我以對 2025 年剩餘時間的期望來結束我的演講。首先，我要提醒大家，我們正處於第三季度，這包括美國和美國以外用戶的暑假。我們完全預期第三季的業績會出現一些輕微且短暫的季節性變化，與去年的情況類似。需要明確的是，我們預期這種季節性變化將是短暫的、輕微的。

Importantly, we fully expect to end the year strong as we did last year. That being said, our exceptional first-half performance and strong overall trajectory gives us the confidence to raise our full-year 2025 revenue guidance to between $585 million and $605 million, representing approximately 35% growth over full year 2024 at the midpoint.

重要的是，我們完全期望今年能夠像去年一樣強勁結束。話雖如此，我們上半年的出色表現和強勁的整體發展軌跡使我們有信心將 2025 年全年收入預期提高到 5.85 億美元至 6.05 億美元之間，相當於比 2024 年全年中期增長約 35%。

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

說完這些，讓我把電話轉給傑拉爾多，讓他介紹本季的詳細財務結果。

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

謝謝你，瓦利德。大家下午好。我很高興在這裡討論 TransMedics 強勁的第二季業績。請注意，我們網站的「投資者」部分提供了詳細介紹我們 2025 年第二季業績的補充幻燈片演示。

As Waleed highlighted, we sustained momentum through Q2 with discipline execution across the entire TransMedics team. Strong transplant volume growth, combined with the positive impact of our ongoing strategic investments, drove solid performance across both product and service lines, along with continuing margin expansion and improved profitability.

正如 Waleed 所強調的，我們透過整個 TransMedics 團隊的紀律執行，在第二季度保持了良好的發展勢頭。移植量的強勁成長，加上我們持續的策略投資的正面影響，推動了產品和服務線的穩健表現，同時利潤率持續擴大，獲利能力不斷提高。

US transplant revenue was approximately $152 million, up 40% year over year and 10% sequentially. By organ, liver contributed with $116 million, heart, $32 million, and lung, $4 million. OUS revenue was $4 million, down 12% from Q2 of 2024 and up 2% sequentially. OUS revenue by organ was $3.5 million in heart, $0.4 million in lung, and $0.2 million in liver.

美國移植收入約 1.52 億美元，年增 40%，季增 10%。按器官劃分，肝臟貢獻了 1.16 億美元，心臟貢獻了 3,200 萬美元，肺部貢獻了 400 萬美元。OUS 營收為 400 萬美元，較 2024 年第二季下降 12%，季增 2%。按器官劃分的 OUS 收入為心臟 350 萬美元、肺 40 萬美元、肝臟 20 萬美元。

Product revenue for the second quarter reached $96 million, up 34% year over year and 9% sequentially. Growth was driven by increasing organ utilization in liver and OCS adoption across both liver and heart. Service revenue for the second quarter reached $61 million, up 44% increase year over year and 11% sequentially. The primary driver was logistics revenue, which grew 56% year over year and 14% sequentially, fueled by the continued expansion and utilization of our aviation fleet.

第二季產品營收達到 9,600 萬美元，年增 34%，季增 9%。成長的動力來自於肝臟器官利用率的提高以及肝臟和心臟中 OCS 的採用。第二季服務收入達到 6,100 萬美元，年增 44%，季增 11%。主要驅動力是物流收入，得益於我們航空機隊的持續擴張和利用，物流收入年增 56%，季增 14%。

Total gross margin for the quarter was approximately 61%, representing an increase of 78 basis points compared to Q2 of 2024 and broadly aligned to Q1 of 2025. The year-over-year increase was primarily driven by 431-basis-point improvement in service margin, reflecting higher TransMedics fleet utilization and cost efficiencies in logistics operations.

本季總毛利率約為 61%，與 2024 年第二季相比增加了 78 個基點，與 2025 年第一季大致持平。年比成長主要得益於服務利潤率提高 431 個基點，反映出 TransMedics 車隊利用率提高以及物流營運成本效率提高。

Product margin was flat compared to Q2 of 2024 and declined 172 basis points sequentially, largely due to higher freight expenses. The increase in freight was a deliberate action to accelerate inventory replenishment to our hubs. Overall, we are seeing the expected progress in gross margin improvement, driven by operational efficiencies and the benefit of scale. That said, we expect this improvement to moderate in the second half of the year as scheduled aviation fleet maintenance ramps up in Q3 and becomes more pronounced in Q4, as previously discussed in our Q1 call.

產品利潤率與 2024 年第二季相比持平，季減 172 個基點，主要原因是運費增加。增加貨運量是為了加速我們樞紐的庫存補充而採取的行動。總體而言，我們看到毛利率在預期的改善中取得進展，這得益於營運效率和規模效益的推動。儘管如此，我們預計這種改善將在下半年放緩，因為定期航空機隊維護將在第三季度增加，並在第四季度變得更加明顯，正如我們在第一季電話會議上所討論的那樣。

Total operating expenses for the second quarter of 2025 were $60 million, up 6% year over year, and the increase was primarily driven by a 50% increase in R&D expenses, reflecting continued investment in our innovation pipeline and a ramping support for product development capabilities. SG&A expenses grew 3% year over year, driven by ongoing expansion of our IT infrastructure, investment in strategic growth initiatives, and the impact of inflation. Sequentially, total operating expenses were broadly in line, as a modest increase was mostly offset by the absence of non-recurring legal expenses in Q1 of 2025.

2025 年第二季的總營運費用為 6,000 萬美元，年成長 6%，成長主要由於研發費用成長 50%，這反映了我們對創新管道的持續投資以及對產品開發能力的持續支持。銷售、一般及行政費用年增 3%，這主要得益於我們 IT 基礎設施的持續擴張、對策略性成長計畫的投資以及通貨膨脹的影響。連續而言，總營運費用基本上保持一致，因為適度的成長大部分被 2025 年第一季非經常性法律費用的消失所抵消。

Operating income for the quarter was $37 million, up 192% year over year and 33% sequentially. Operating margin expanded to 23%, compared to 11% in the prior year and 19% in Q1 of 2025. Net income for the second quarter was $35 million, representing a 186% year-over-year increase and 36% sequentially.

本季營業收入為 3,700 萬美元，年增 192%，季增 33%。營業利潤率擴大至 23%，而去年同期為 11%，2025 年第一季為 19%。第二季淨收入為 3,500 萬美元，年增 186%，季增 36%。

Earnings per share were $1.03, and diluted earnings per share were $0.92 for the second quarter of 2025.

2025 年第二季每股收益為 1.03 美元，每股攤薄收益為 0.92 美元。

We ended the quarter with $401 million in cash, up $90 million from March 31, 2025. This increase was driven by strong operating cash generation, supported by meaningful improvement in our billing cycle, which, together with the continued healthy collections, reduced our accounts receivable balance, underscoring or commitment to process efficiency and our focus on efficient working capital management.

本季末，我們的現金為 4.01 億美元，比 2025 年 3 月 31 日增加了 9,000 萬美元。這一成長是由強勁的營運現金產生推動的，這得益於我們結算週期的顯著改善，再加上持續健康的收款，減少了我們的應收帳款餘額，強調了對流程效率的承諾以及我們對高效營運資金管理的關注。

Our first-half results reflect disciplined execution, continued gains in operating efficiency, and meaningful progress in our clinical and innovation programs. Together with the scalability of our business model, these results continue to validate our ability to drive meaningful financial improvement and position the company for sustained momentum through the rest of 2025 and beyond.

我們的上半年業績反映了嚴格的執行、營運效率的持續提高以及臨床和創新項目的重大進展。結合我們業務模式的可擴展性，這些結果繼續證明了我們推動有意義的財務改善的能力，並使公司在 2025 年剩餘時間及以後保持持續發展勢頭。

Looking ahead, given the strength of the business, as Waleed mentioned before, we are raising our full-year revenue guidance to a range of $585 million to $605 million, up from our prior range of $565 million to $585 million. This reflects approximately 35% growth over 2024 at the midpoint. Growth is expected to continue to be fueled by the expansion of total transplant volumes, increased OCS adoption, and the continued momentum across our service platform. Our updated guidance reflects the strength of our first-half results and sets a proven baseline for the second half with clear room for upside as momentum continues.

展望未來，鑑於業務實力，正如 Waleed 先前提到的，我們將全年收入預期從先前的 5.65 億美元至 5.85 億美元上調至 5.85 億美元至 6.05 億美元。這反映了 2024 年中期約 35% 的成長。預計總移植量的擴大、OCS 採用率的提高以及我們服務平台的持續發展勢頭將繼續推動成長。我們更新後的指引反映了我們上半年業績的強勁表現，並為下半年設定了可靠的基準，隨著勢頭的持續，下半年還有明顯的上漲空間。

In terms of gross margin, we continue to expect overall gross margin to remain approximately at 60% over the coming years. This accounts for the various factors influencing both product and service margins beyond just mix. In terms of capital allocation, we are focused on initiatives that drive long-term value, balancing strategic growth with financial discipline to deliver sustainable, profitable growth. Our investments will continue to prioritize R&D to advance our pipeline, implement systems that simplify and automate core processes, and improve efficiency across our logistics operations.

就毛利率而言，我們預計未來幾年整體毛利率將維持在60%左右。這解釋了影響產品和服務利潤率的各種因素，而不僅僅是組合。在資本配置方面，我們專注於推動長期價值的舉措，平衡策略成長與財務紀律，實現可持續的獲利成長。我們的投資將繼續優先考慮研發，以推進我們的產品線，實施簡化和自動化核心流程的系統，並提高我們整個物流營運的效率。

One example of this approach is our double-shifting pilot program designed to optimize fleet utilization. We know additional jets will be needed to support continuing growth, and this program will help determine the right fleet size to drive operational efficiency and maximize the return of our capital investments. We expect to see early outcomes of the program in the first half of 2026. While our target remains to own 22 jets by the end of 2025, we will continue to be opportunistic, moving forward only when the right conditions are in place. That may mean holding off on additional purchases this year or accelerating acquisitions if favorable opportunities arise.

這種方法的一個例子是我們旨在優化車隊利用率的雙班試點計劃。我們知道需要更多的飛機來支持持續成長，而該計劃將有助於確定合適的機隊規模，以提高營運效率並最大限度地提高我們的資本投資回報。我們預計將在 2026 年上半年看到該計劃的早期成果。雖然我們的目標仍然是到 2025 年底擁有 22 架噴射機，但我們將繼續抓住機會，只有在適當的條件下才會向前邁進。這可能意味著今年暫緩額外收購，或在出現有利機會時加速收購。

At the same time, we will make targeted investments to support growth well beyond 2028, including the development of our NOP network in selected international geographies. Our plan moves to a new global headquarters to accommodate the growing scale and complexity of our business and continue with ongoing enhancement for manufacturing and product development infrastructure. These initiatives are at different stages of implementation and will be rolled out over time. Together, they represent critical steps to position TransMedics for its next phase of growth as we work to surpass 10,000 transplant milestones and expand our global leadership in organ transplantation.

同時，我們將進行有針對性的投資，以支持 2028 年以後的成長，包括在選定的國際地區開發我們的 NOP 網路。我們的計劃是遷至新的全球總部，以適應日益增長的業務規模和複雜性，並繼續不斷增強製造和產品開發基礎設施。這些措施目前處於不同的實施階段，並將逐步推出。在我們努力突破 10,000 例移植里程碑並擴大我們在器官移植領域的全球領導地位的過程中，它們共同代表了 TransMedics 進入下一階段成長的關鍵步驟。

Finally, with stronger top-line performance, continued efficiency gains, and spend discipline, we expect to deliver at least 650 basis points of operating margin expansion for the full year of 2025 compared to 2024. While quarterly variability is expected, as Waleed highlighted, we are confident in the full-year step-up driven largely by greater leverage across our operating expense base. Over the long term, we are targeting an operating margin at or approaching 30% by 2028. The path may not be linear year over year as we continue investing in the capabilities and infrastructure outlined earlier.

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紀律，我們預計 2025 年全年營業利潤率將比 2024 年增長至少 650 個基點。正如 Waleed 所強調的，雖然預計季度業績會出現波動，但我們對全年業績的成長充滿信心，這主要得益於我們營運費用基礎槓桿率的提高。從長遠來看，我們的目標是到 2028 年實現營業利潤率達到或接近 30%。由於我們繼續投資於前面概述的能力和基礎設施，因此路徑可能不會逐年線性發展。

Our differentiated OCS technology, combined with our NOP and vertically integrated logistic capabilities, give us a unique advantage to broaden access globally. Built on these strengths and addressing the significant unmet need in organ transplantation, we believe TransMedics is well positioned to deliver sustainable growth, expand margins, and create substantial long-term shareholder value.

我們差異化的 OCS 技術，結合我們的 NOP 和垂直整合的物流能力，為我們提供了在全球擴展通路的獨特優勢。基於這些優勢並解決器官移植領域尚未滿足的重大需求，我們相信 TransMedics 完全有能力實現永續成長、擴大利潤率並創造可觀的長期股東價值。

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

最後，我將把電話交給瓦利德，請他做最後發言。

Thank you so much, Gerardo.

非常感謝，傑拉爾多。

Overall, we're very pleased with our 2Q performance which, once again, underscored the unique attributes of TransMedics business. TransMedics is not only a top-line grower, but also an increasingly profitable business capable of generating significant bottom-line leverage. We remain confident that this is just the beginning, and we believe we are well positioned to deliver sustainable long-term financial results while also investing significantly in our business as we gain more efficiency of scale and continue to deliver leverage throughout the operation.

總體而言，我們對第二季的業績非常滿意，這再次凸顯了 TransMedics 業務的獨特屬性。TransMedics 不僅是一家營收不斷成長的公司，也是一家獲利能力不斷增強、能夠產生顯著獲利槓桿的公司。我們仍然相信這只是一個開始，我們相信我們有能力實現可持續的長期財務業績，同時隨著我們獲得更高的規模效率並在整個營運過程中繼續發揮槓桿作用，我們也將對我們的業務進行大量投資。

TransMedics is a very unique business, providing unparalleled life-saving solutions in a huge untapped market. We look forward to continuing our upward trajectory while saving more lives and delivering significant value to every transplant stakeholders, not just in the US, but globally.

TransMedics 是一家非常獨特的企業，在巨大的未開發市場中提供無與倫比的救生解決方案。我們期待繼續保持上升勢頭，同時拯救更多生命，並為每個移植利益相關者（不僅在美國，而且在全球範圍內）提供重大價值。

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

說完這些，我現在將電話轉給接線生進行問答。操作員？

(Operator Instructions) Allen Gong, JPMorgan.

（操作員指示） 摩根大通的 Allen Gong。

Thanks, team. So my first question is kind of going to be on the seasonality. And I think you've done a really good job of preparing us for seeing that kind of summer disruption from dock locations, from aviation maintenance. So I'm just curious about what you're seeing so far in July because we have access to the very high-level data showing kind of the summer dip as expected. But just curious to hear what you're seeing relative to expectations.

謝謝，團隊。所以我的第一個問題是關於季節性的。我認為你們已經為我們做好了充分的準備，讓我們能夠應對夏季碼頭和航空維修中出現的此類混亂情況。所以我只是好奇你在七月到目前為止看到了什麼，因為我們可以獲得非常高級的數據，顯示出預期的夏季下降。但我只是好奇地想聽聽您相對於預期看到了什麼。

Allen, thank you for the question. We're seeing some signs of seasonality, maybe not as pronounced as last year, but still, we're still early. August is about to start, so it's still early. So we assume some seasonality in Q3, given all the factors we described. And yeah, we're starting to see it in July. But again, what we've seen so far is, I would call it, slightly less impact than last year. But again, it's too early to really make that a trend.

艾倫，謝謝你的提問。我們看到了一些季節性的跡象，可能不像去年那麼明顯，但我們還為時過早。八月就要開始了，所以時間還早。因此，考慮到我們所描述的所有因素，我們假設第三季會出現一些季節性。是的，我們將在七月開始看到它。但我認為，到目前為止我們看到的影響比去年略小。但現在要真正使其成為一種趨勢還為時過早。

Got it. And then kind of moving higher level to some of the news that's been coming out recently, the New York Times podcast that came out today, kind of talking about how there's a lot of pressure to grow organ volumes. You're kind of corroborating what you're saying. You're a really important partner with that.

知道了。然後從更高層次來看最近出現的一些新聞，今天播出的《紐約時報》播客，談到了增加器官數量的巨大壓力。你正在確認你所說的話。在這方面，您是一位非常重要的合作夥伴。

And while you made it very clear that your side of the business is very separate from the side of the business that actually makes the termination of DCD, are you concerned at all that greater oversight over OPOs over DCD usage could lead to unfortunately an impact on you just because there are fewer of those procedures happening, centers are being a bit more cautious, what have you?

雖然您明確表示，您的業務與實際終止 DCD 的業務是截然不同的，但您是否擔心，對 OPO 和 DCD 使用情況的更嚴格監督可能會對您造成不幸的影響，因為這些程序越來越少，中心也越來越謹慎，您有什麼看法？

Allen, that's a very important question. I think I actually -- I see it as the opposite. I think some level of organization and organizational structure and oversight will actually benefit the transplant market, especially in DCD. We all have been debating and discussing for the last two years this notion of NRP.

艾倫，這是一個非常重要的問題。我認為我實際上——我認為事實恰恰相反。我認為某種程度的組織、組織結構和監督實際上將有利於移植市場，尤其是在 DCD 領域。過去兩年來，我們一直在辯論和討論 NRP 這個概念。

That was haphazardly implemented. It cost the system significant amount of dollars. It lost many organs unnecessarily. These organs could have been put in OCS, protected right away, saved these organs, and did it with a much more cost-efficient way. And unfortunately, it was haphazardly implemented in the system because of the lack of oversight.

這是隨意實施的。這使得系統花費了大量的金錢。它無謂地失去了許多器官。這些器官本可以放入 OCS，立即受到保護，保存這些器官，並以更具成本效益的方式完成。不幸的是，由於缺乏監督，該系統被隨意實施。

So we see this as just one example that some level of oversight is actually -- could potentially be beneficial, not detrimental. But we have to wait and see. As I tried to highlight in my script, we feel confident that the unique attributes of our business allows us to operate in the current system or any system in the future. And we stand by that statement.

因此，我們認為這只是一個例子，表明某種程度的監督實際上可能是有益的，而不是有害的。但我們還需拭目以待。正如我在腳本中試圖強調的那樣，我們相信，我們業務的獨特屬性使我們能夠在當前系統或未來的任何系統中運作。我們堅持這說法。

Chris Pasquale, Nephron Research.

克里斯‧帕斯誇萊 (Chris Pasquale)，腎元研究機構。

Thanks, and congrats on the quarter. Waleed, to start with, congratulations on getting the IDE approved for the lung trial. Just curious whether you can share if there were any substantive changes in the design of that trial with what you agreed to finally with the FDA relative to what you laid out in the proposal at ISHLT.

謝謝，恭喜本季取得佳績。瓦利德，首先，恭喜 IDE 批准您的肺部試驗。我只是好奇您是否可以分享一下，與您在 ISHLT 提案中列出的內容相比，該試驗的設計與您最終與 FDA 達成的協議相比是否有任何實質性變化。

Chris, thank you for the question. The clinical trial design, as we know it, is not touched. Most of the remaining questions are actually focused on preclinical testing, working with the preclinical testing reviewer. So I'm not aware of any changes to the clinical trial design as we outlined in ISHLT. And we're looking forward to wrapping this part up and publishing the full design of the clinical program on clinicaltrial.gov sometime in late August, early September, as we approach the IRBs and the trial would be in the formal kind of initiation process.

克里斯，謝謝你的提問。我們所知的臨床試驗設計並未受到影響。剩餘的大部分問題實際上都集中在臨床前測試上，與臨床前測試審查員合作。因此，我不知道我們在 ISHLT 中概述的臨床試驗設計有任何變化。我們期待完成這部分工作，並在 8 月底或 9 月初在 clinicaltrial.gov 上發布完整的臨床計劃設計，屆時我們將與 IRB 接洽，試驗將進入正式的啟動程序。

Great. Thank you. And then, curious your thoughts on the US heart market. Your own business there continues to grow really nicely. Your penetration continues to tick up. But if we look at the last six to eight quarters now, the market itself has been relatively flat. We saw some growth in 1Q that kind of reversed this quarter, and so we're still on that flattish trend.

偉大的。謝謝。然後，好奇您對美國心臟市場的看法。你們在那裡的業務繼續順利發展。您的滲透力持續上升。但如果我們回顧過去六到八個季度，市場本身相對穩定。我們在第一季看到了一些成長，但本季卻出現了逆轉，因此我們仍然處於平穩趨勢。

What do you think is holding back volumes in that segment and maybe contrast that with the continued strong growth we're seeing in liver? And what can you do to get it growing again?

您認為是什麼阻礙了該領域的銷量，並將其與我們在肝臟領域看到的持續強勁增長進行對比？那麼你可以做些什麼來讓它再次成長呢？

Chris, I think as we stated before, heart getting double-digit growth last year or the year before have -- last year and the year before, overall heart market grew. So this is just the ebbs and flows of organ transplant, the waiting lists -- as waiting lists are being replenished. So that's kind of the noise level -- the detailed noise level that happens quarter to quarter.

克里斯，我認為正如我們之前所說，去年或前年心臟市場實現了兩位數的成長——去年和前年，整個心臟市場都在成長。所以這只是器官移植的起伏，等待名單正在補充。這就是噪音水平——每個季度發生的詳細噪音水平。

However, the way we are going to approach this and hopefully normalize this going forward is going to be through our clinical program. This is why we were really are thrilled or anxious to get the heart clinical program approved like the lung and getting that rolled out, because that you will see a lot of dynamic change once we introduce that next-gen heart technology.

然而，我們將透過臨床計劃來解決這個問題並希望使其在未來正常化。這就是為什麼我們真的很高興或急切地希望心臟臨床計畫能夠像肺部一樣獲得批准並推廣，因為一旦我們引入下一代心臟技術，你就會看到很多動態變化。

But we expect the market to rebound, and this happens every now and then and it's probably multifactorial. But again, Q3 has this noise level of seasonality, but I suspect the heart market will normalize by Q4. And hopefully, into '26 with both the heart and lung next-gen activities underway, we're going to see significantly different dynamic in 2026. That's one -- that's the majority of the reason.

但我們預期市場將會反彈，這種情況時有發生，而且可能是由多種因素造成的。但是，第三季再次受到季節性噪音的影響，但我懷疑心臟市場將在第四季恢復正常。希望隨著 2026 年心臟和肺部下一代活動的開展，我們將在 2026 年看到顯著不同的動態。這是其中之一——這是主要原因。

But also, we discussed this before, Chris, that the growth of DCD -- with DCD, there's a higher rate of lack of progression, which ultimately impacts the heart the most. So that could be a factor for it, but that will also normalize as more oversight comes on board with DCD. So it will -- this is -- we look at this as a transient phenomena.

但是，克里斯，我們之前也討論過這個問題，DCD 的生長——對於 DCD，缺乏進展的幾率更高，這最終對心臟的影響最大。所以這可能是一個因素，但隨著 DCD 受到更多監督，這種情況也會變得正常化。所以它將 — — 這是 — — 我們將其視為一種短暫現象。

The rate of heart failure is not going down. The rate of waiting list expansion is not going down. We are playing a key role of opening up the supply of organs, so there is absolutely no reason why to believe that this transient phenomena of slowing down is going to be something that will stay with us for the long term.

心臟衰竭的發生率並未下降。等候名單的擴大速度並沒有下降。我們在開放器官供應方面發揮關鍵作用，因此完全沒有理由相信這種暫時的減緩現象會長期伴隨我們。

Great. Thank you, Waleed.

偉大的。謝謝你，瓦利德。

Josh Jennings, Cowen.

喬許‧詹寧斯，考恩。

Thanks. Good afternoon, Waleed. Congratulations on another strong quarter. Was hoping -- I think you laid it out clearly that TransMedics is well positioned to thrive throughout this modernization of the US transplant network. I know your team and Stephen Gordon is down in Washington, seeing you relayed that you've been meeting with the committees and interacting with committees and Congresspeople throughout this year.

謝謝。下午好，瓦利德。恭喜您又一個季度取得強勁業績。希望如此——我認為您已經明確指出，TransMedics 已做好準備，在美國移植網路的現代化過程中蓬勃發展。我知道您的團隊和史蒂芬戈登都在華盛頓，看到您轉達的消息是，您今年一直在與委員會會面，並與委員會和國會議員互動。

But do you see any headwinds for TransMedics as this US transplant network evolves? Or is it simply, as you stated, the technology, the NOP, the logistics are all driving transplant volume growth and that is the goal of this modernization of the transplant network?

但是，隨著美國移植網路的發展，您是否認為 TransMedics 會面臨任何阻力？或者正如您所說的那樣，技術、NOP、物流都在推動移植數量的成長，而這正是移植網路現代化的目標？

Thank you for the question, Josh. I think I want to be very balanced in what I say to answer this question. I think the results of the NOP are black and white and they are not going unnoticed by all the stakeholders. The major impetus for this transformation is what -- is growing the national transplant volume.

謝謝你的提問，喬希。我想我會非常平衡地回答這個問題。我認為 NOP 的結果非常明確，所有利害關係人都會注意到。這種轉變的主要動力是全國移植數量的成長。

The system has been at this for a good portion of the last five years. Guess who has been growing the national transplant volume in the US? None of these initiatives, yet. It has been the NOP and OCS and vertical integration of logistics. That's not going unnoticed by the stakeholders.

在過去五年的大部分時間裡，該系統一直處於這種狀態。猜猜是誰增加了美國的全國移植量？目前這些措施均尚未實施。它已經將NOP和OCS以及物流垂直整合。利害關係人不會忽視這一點。

So headwinds, we're seeing none, but as you can imagine, the emotions on the other side of the equation could be running high, and there may be some fictitious fear that OPOs are worried that some of them will be decommissioned and that TransMedics may want to take over. That's not our goal at all. We work with OPOs very collaboratively, in fact, because our goals are aligned. So that's why I want it to be balanced.

因此，我們沒有看到任何不利因素，但正如你可以想像的那樣，等式另一邊的情緒可能會高漲，並且可能存在一些虛構的恐懼，即 OPO 擔心其中一些將被解散，而 TransMedics 可能想要接管。這根本不是我們的目標。事實上，我們與 OPO 的合作非常緊密，因為我們的目標是一致的。所以這就是我希望它保持平衡的原因。

Do we see headwinds from the stakeholders? No, because the data is clear. Our goals are aligned. It's a win-win for everybody. But because this is an emotional topic and sensitive topic to some of the major stakeholders that have been in a virtual kind of unipole for the last 40-plus years, we should expect some misunderstanding, and that's why we're over-communicating and over-engaged and always highlighting this is not to replace anybody. This is to work collaboratively with the existing system and any potential new modification to the system in the future.

我們是否看到來自利害關係人的阻力？不會，因為數據很清楚。我們的目標是一致的。這對每個人來說都是雙贏的。但由於這是一個情緒化且敏感的話題，對於過去 40 多年來一直處於虛擬單極狀態的一些主要利益相關者來說，我們應該預料到會產生一些誤解，這就是為什麼我們過度溝通、過度參與，並始終強調這並不是為了取代任何人。這是為了與現有系統以及未來系統的任何潛在新修改協同工作。

I hope I'm addressing your question, Josh.

我希望我能回答你的問題，喬希。

Yes. Thank you very much. And then just a follow-up on the clinical trials. So I think you've made nice progress with the FDA and expecting to start both trials before the year-end. Was wondering if you could share any progress with CMS just in terms of reimbursement for the trials, particularly in the study groups for heart and lung clinical development. Thanks again.

是的。非常感謝。然後只是對臨床試驗的後續。所以我認為您與 FDA 的合作取得了良好的進展，並有望在年底前開始這兩項試驗。想知道您是否可以與 CMS 分享在試驗報銷方面的任何進展，特別是在心臟和肺臨床開發研究小組方面。再次感謝。

Yeah. We're not engaged with CMS, Josh, because we already approved with the technology. The modifications we're having, we don't see this as requiring any CMS engagement at the moment.

是的。喬希，我們沒有與 CMS 合作，因為我們已經批准了這項技術。我們正在進行的修改目前並不認為需要任何 CMS 參與。

Understood. Okay. Thank you very much.

明白了。好的。非常感謝。

Ryan Daniels, William Blair.

瑞安丹尼爾斯、威廉布萊爾。

Hey. This is Matthew Mardula on for Ryan Daniels. Thank you for taking our question. And I want to talk about the lung transplants. And I know lung transplants are a small percentage of your revenue right now, but how do you see the Next-Gen OCS helping penetrate into the lung transplants? And I know you've mentioned before that the Next-Gen OCS will account for a small amount of revenue this year, but any insight into the growth of the next year or long term would be great to hear about.

嘿。這是 Ryan Daniels 的 Matthew Mardula。感謝您回答我們的問題。我想談談肺移植。我知道肺移植目前只佔您收入的一小部分，但您認為下一代 OCS 將如何幫助滲透到肺部移植領域？我知道您之前提到過，下一代 OCS 今年的收入將佔一小部分，但如果您對明年或長期的成長有任何見解，那將非常有幫助。

Thank you for the question, Matt. I think I'll keep this high level. I think the lung trial or the Next-Gen OCS platform is designed to address the two or three major historical concerns that have plagued the US lung perfusion market based on the suboptimal outcomes seen at the early ex-vivo perfusion study.

謝謝你的提問，馬特。我想我會保持這種高水準。我認為肺部試驗或下一代 OCS 平台旨在解決困擾美國肺灌注市場的兩三個主要歷史問題，這些問題是基於早期體外灌注研究中看到的不理想結果。

So what are these perceptions? The perceptions are that the longer the lung are perfused, the higher the probability of the lung getting edematous. The longer the lung is perfused, it may not work after transplant, that sometimes the system is not protective of the lung and there's a hesitation of taking a lung for proper evaluation on machine perfusion.

那麼這些看法是什麼呢？人們的看法是，肺灌注的時間越長，肺水腫的可能性就越高。肺灌注的時間越長，移植後可能無法正常運作，有時系統無法保護肺，人們會猶豫是否要取肺進行機器灌注的適當評估。

There's the perception that putting the lung on ice overnight is safe. Why? Because there is no data to prove or disprove any of these subjective individual perceptions. First, the OCS Next-Gen technology for lungs is designed to overcome all the limitations of the historical perfusion technologies that were in the market in the US. We reduce edema significantly. We maintain lungs for extensive period of times of exceeding 24 hours.

人們認為將肺放在冰上過夜是安全的。為什麼？因為沒有數據可以證明或反駁任何這些主觀的個人看法。首先，OCS Next-Gen 肺部技術旨在克服美國市場上歷史灌注技術的所有限制。我們顯著減少了水腫。我們長時間維持肺部狀態，時間超過 24 小時。

Now, we're conducting the trial comparing ourselves to cold storage and we're allowing the comparison for any types of lungs, DBD or DCD. So we will prove with Level 1 evidence that the OCS will have potentially superior outcome to cold storage. So we will kill two birds with one stone: one, overcoming the historical limitation of non-portable acellular perfusion; and we will hopefully unequivocally deliver Level 1 evidence proving the superiority of the OCS platform over cold storage.

現在，我們正在進行與冷藏進行比較的試驗，並且允許對任何類型的肺部（DBD 或 DCD）進行比較。因此，我們將以 1 級證據證明 OCS 的效果可能優於冷藏。因此，我們將一舉兩得：一是克服非便攜式無細胞灌注的歷史限制；二是我們希望明確提供一級證據，證明 OCS 平台優於冷藏。

That's what gives us the excitement about the potential future of our lung next-gen platform to give us access, and not just access, to become the next standard of care in that market. That's why we're investing and putting our dollar and our investment where our mouth is to prove that we are superior on both fronts. That's what gives us the confidence and excitement, and we just can't wait to go execute this trial and actually deliver the Level 1 evidence to prove it.

這就是讓我們對肺部下一代平台的潛在未來感到興奮的原因，它讓我們能夠訪問，而不僅僅是訪問，成為該市場的下一個護理標準。這就是為什麼我們要投資，把我們的資金和投資付諸實踐，以證明我們在這兩方面都更勝一籌。這給了我們信心和興奮，我們迫不及待地想要執行這次試驗，並真正提供一級證據來證明這一點。

Great. Thank you so much.

偉大的。太感謝了。

Matt O'Brien, Piper Sandler.

馬特奧布萊恩、派珀桑德勒。

Hi. This is Samantha on for Matt. Thanks so much for taking our question, and congrats on a good quarter. I guess I want to talk first about what you're hearing in the field about DCD donations. Are there any increasing concerns in the operating room following the New York Times article? And then also, I guess, bigger picture, where do we stand in terms of utilization of DCD organs? And how much more room is there to grow in that category?

你好。我是 Samantha，代替 Matt 發言。非常感謝您回答我們的問題，並祝賀您本季取得了良好的業績。我想先談談您在現場聽到的有關 DCD 捐贈的情況。《紐約時報》報道之後，手術室裡的擔憂是否加劇了？然後我想，從更大的角度來看，我們在 DCD 器官的利用方面處於什麼位置？這一類別還有多少成長空間？

Samantha, thank you for the question. We're not seeing any hesitation or concern or pullback on DCD donation. DCD donation is here to stay. It's a life-saving donation. It's really part of the renaissance that is happening in organ transplantation.

莎曼珊，謝謝你的提問。我們沒有看到對 DCD 捐贈有任何猶豫、擔憂或減少。DCD 捐贈將繼續存在。這是一次拯救生命的捐贈。這確實是器官移植領域復興的一部分。

The New York Times article incidences have been known in the field for a good portion of the last two years. This is not news, guys. Unfortunately, it was publicized as sensational news, but it's not news in the people in the community. We have heard about these cases for the last two years. So that's not news, and we're not seeing any pullback or concerns or anything like that. So that's number one.

過去兩年中，《紐約時報》文章事件已為業內人士所熟知。夥計們，這不是什麼新聞。不幸的是，這件事被宣傳為聳人聽聞的新聞，但對社區民眾來說卻不是什麼新聞。過去兩年來我們一直聽說這些案件。所以這不是新聞，我們也沒有看到任何回調或擔憂或類似的事情。這是第一點。

I'm sorry, can you repeat the second part of the question one more time?

抱歉，您能再重複問題的第二部分嗎？

Sure, just about utilization of DCD organs and -- yeah, go ahead.

當然，只是關於 DCD 器官的利用——是的，繼續吧。

Yeah. Utilization of DCD remains unchanged between 50% and 55% that actually materialized to become a DCD donor. There's between 45% to 50% that does not progress to become a DCD. That number has not changed materially, at least across all three organs.

是的。DCD的利用率維持在50%~55%之間，實際成為DCD捐贈者。有 45% 到 50% 的患者不會發展成 DCD。至少對所有三個機構來說，這個數字並沒有實質的改變。

Great. Thank you. If I can sneak in one more about the next-gen clinical program. I know you said previously that both arms of the trial will use the NOP service. How will that work, specifically in the cold storage arm? Will that still generate revenue for you?

偉大的。謝謝。如果我可以再偷偷地透露一點有關下一代臨床計劃的資訊。我知道您之前說過，試驗的兩個部分都將使用 NOP 服務。這將如何運作，特別是在冷藏部門？這還能為您帶來收入嗎？

Yes, the plan is both arms will go through NOP to maintain the blinding of the accepting surgeon. I will reserve the commentary on the revenue generation until we get the trial started, just to make sure that we need to wait and see how the rollout will be.

是的，計劃是兩組都將透過 NOP 來維持接受手術的外科醫生的盲法。我將保留對收入產生的評論，直到我們開始試驗，只是為了確保我們需要等待並觀察推出的情況。

But the expectation is there will be some revenue generated, at least from logistics, on the control arm. We're waiving the service fee for our surgeons and our team to procure these organs at a sign of good faith to make sure that we're not making any money on technologies that are not ours.

但預計控制部門至少會從物流產生一些收入。我們免除了我們的外科醫生和團隊獲取這些器官的服務費，以表示誠意，確保我們不會利用不屬於我們的技術來賺錢。

Okay. Got it. Thank you so much.

好的。知道了。太感謝了。

Bill Plovanic, Canaccord Genuity.

Canaccord Genuity 的 Bill Plovanic。

Hi. It's Zachary on for Bill. Thank you for taking my question, and congrats on the quarter. So you called out that it was heart and liver that drove the quarter. Just taking a step back, are there any share trends you wanted to call out in Q2, whether it's on the organ specifically or DBD and DCD broadly? Thank you.

你好。札卡里 (Zachary) 代替比爾 (Bill)。感謝您回答我的問題，並祝賀本季取得佳績。所以您說是心臟和肝臟推動了本季的發展。退一步來說，您想在第二季度指出哪些份額趨勢，無論是具體針對器官還是廣泛針對 DBD 和 DCD？謝謝。

Zach, thank you for the question. As you know, we don't comment on the share inter-year. We talk about our share at year-end because of the different variabilities between quarters. But we continue to take market share, both DBD and DCD, in heart and lung and liver. I'm sorry, heart and liver and, to a lesser extent, lung, just because the numbers are small.

札克，​​謝謝你的提問。如您所知，我們不對跨年度股票發表評論。由於各季度之間存在不同的差異，因此我們將在年底討論我們的份額。但我們繼續在心臟、肺臟和肝臟領域佔據 DBD 和 DCD 的市場份額。對不起，是心臟和肝臟，以及程度較輕的肺，只是因為數量較少。

Got it. Thank you. And do you have thoughts on any new competition coming into the liver market later this year?

知道了。謝謝。您對今年稍後進入肝臟市場的新競爭對手有何看法？

Not that I'm aware of. Are you aware of any?

據我所知沒有。您知道嗎？

Yeah. I mean, we've heard that there's private companies coming in, or at least one to be named, I guess, but I won't name them on your public call. But thank you for taking my question.

是的。我的意思是，我們聽說有私人公司加入，或至少有一家公司的名字，但我不會在你的公開電話會議上透露他們的名字。但感謝您回答我的問題。

Thank you. We always welcome competition. It keeps us honest. And as long as we're all aiming to save lives, that's a great thing for organ transplant.

謝謝。我們始終歡迎競爭。它讓我們保持誠實。只要我們都致力於拯救生命，這對器官移植來說就是一件好事。

Justin Wang, Morgan Stanley.

摩根士丹利的賈斯汀王（Justin Wang）。

Hey, everyone. I'm just filling in for Patrick. Thanks for the questions. I was wondering if you can spend a few minutes to talk more about NOP Access. What has early surgeon and center feedback been like? And how do you see this affecting the overall NOP ecosystem longer term? Separately, can you talk about how Access will work with OCS Connect? Thank you.

嘿，大家好。我只是替帕特里克代班而已。感謝您的提問。我想知道您是否可以花幾分鐘時間進一步討論 NOP Access。早期外科醫生和中心的回饋如何？您認為這將對整個 NOP 生態系統產生怎樣的長期影響？另外，您能談談 Access 如何與 OCS Connect 協同工作嗎？謝謝。

Thank you for the question. The early feedback with the first, I would say, a couple of dozens or three dozen users has been, off the chart, exceeding our expectation. Again, it's still early, but we're pleased and humbled by that success.

謝謝你的提問。我想說，第一批幾十到三十個用戶的早期回饋已經超出了我們的預期。再次強調，現在還為時過早，但我們對這項成功感到高興和榮幸。

NOP Access is an expanded version of NOP Connect, so it's not two different platforms. The customer-facing part of the ecosystem is the Access. The back-end facing part of the ecosystem is NOP Connect. So it's one of the same. Again, it's a part of the ecosystem. So they work simultaneously and homogeneously and seamlessly together.

NOP Access 是 NOP Connect 的擴充版本，因此它們不是兩個不同的平台。生態系統面向客戶的部分是 Access。生態系的後端部分是 NOP Connect。所以它是其中之一。再說一次，它是生態系統的一部分。因此它們可以同時、均勻、無縫地協同工作。

Thank you.

謝謝。

And there's a third side to this, which is the logistics and route mapping portion of that, so all of which work seamlessly together.

還有第三個方面，即物流和路線規劃部分，因此所有這些都可以無縫協作。

Thanks.

謝謝。

Suraj Kalia, Oppenheimer.

蘇拉傑·卡利亞（Suraj Kalia），奧本海默。

Hi, Waleed and team. Congrats on a great quarter. Hey, Waleed, and forgive me if I screwed this up, I believe in the last quarter, you had said 2% to 5% of FY growth would come from the clinical trials. But I thought in your commentary, I heard you are not expecting any growth or any contributions from the clinical trials, but yet you are raising guidance. Did I get all of that right, or did I misunderstand something there?

嗨，Waleed 和他的團隊。恭喜本季取得優異成績。嘿，瓦利德，如果我搞砸了，請原諒我，我相信在上個季度，你說過 2% 到 5% 的財年增長將來自臨床試驗。但我認為，在您的評論中，我聽說您並不期望臨床試驗帶來任何成長或貢獻，但您卻提高了指導。我理解的是否全部正確，或者我是否誤解了某些內容？

Thank you, Suraj. Let me clarify the first comment. The 2% to 5%, I believe, came during our Investor Day. So that's in December. Last call, end of year, we said we do not expect any substantial contribution. This quarter, we're saying we have enough organic growth that we are not even counting on any growth from the clinical trial in '25.

謝謝你，蘇拉傑。讓我澄清一下第一則評論。我相信，2% 到 5% 的成長是在我們的投資者日期間實現的。那是在十二月。最後一次，也就是年底的時候，我們說過我們不期望任何實質的貢獻。本季度，我們認為我們已經有了足夠的有機成長，我們甚至不指望 25 年臨床試驗帶來的任何成長。

As Gerardo said in his commentary, there is some potential upside. But just given the timing of initiation of these trials, I did not want the community to factor in any substantial growth or any growth for that matter in '25. There is enough organic growth in our business that we will meet the guidance as outlined.

正如傑拉爾多在評論中所說，這還存在一些潛在的好處。但考慮到這些試驗的啟動時間，我不希望社區考慮任何實質的增長或 25 年的任何增長。我們的業務有足夠的有機成長，我們將達到所概述的指導目標。

Got it. And Waleed, for my follow-up question, for the Next-Gen OCS, the lung trial is obviously a superiority trial. And you mentioned a lot of factors contributing to poor lung uptake, reducing edema, graft failure, so on and so forth.

知道了。瓦利德，對於我的後續問題，對於下一代 OCS，肺部試驗顯然是一項優效性試驗。您提到了許多導致肺部吸收不良、水腫減少、移植失敗等的因素。

Waleed, what parameters in the Next-Gen OCS specifically give you confidence in generating superiority? Is there a difference in perfusion parameters, event rate assumptions in the null hypothesis? Any additional color at this stage that you can give us to help gauge the confidence in generating superiority? Gentlemen, congrats again, and thanks for taking my questions.

瓦利德，下一代 OCS 中的哪些參數具體讓您有信心創造優勢？零假設中的灌注參數、事件率假設是否有差異？在此階段，您能為我們提供任何額外的資訊來幫助衡量創造優勢的信心嗎？先生們，再次恭喜你們，感謝你們回答我的問題。

Thank you very much for the questions, Suraj. So the detail and all the statistics and assumptions will be outlined in the clinicaltrials.gov posting for the trial. But at a high level, what gives us the confidence is what is the most frequent and most damning short-term complication after lung transplant is primary graft dysfunction, grade 3. What is primary graft dysfunction grade 3? It is lung edema that compromised lung oxygenation capacity. What gives us the confidence is we reduced lung edema in our preclinical testing significantly compared to every control subject that we compared ourselves to.

非常感謝您提出的問題，蘇拉傑。因此，試驗的詳細資訊以及所有統計數據和假設都將在 clinicaltrials.gov 的試驗公告中概述。但從高層次來看，讓我們有信心的是肺移植後最常見、最嚴重的短期併發症是原發性移植物功能障礙，即第 3 級。什麼是原發性移植物功能障礙 3 級？肺水腫損害了肺的氧合能力。讓我們充滿信心的是，與我們對比的每個對照對象相比，我們在臨床前測試中顯著減少了肺水腫。

So in addition, we have revamped the ventilation system, we've revamped the perfusion flow to minimize hemolysis, all of which gives us better physiologic control over the lung perfusion and ventilation than we've ever had before. But again, until we replicate this in a clinical program, it's our thesis and hypothesis. But we're excited that our preclinical results were that strong. So stay tuned.

因此，此外，我們還改進了通風系統，改進了灌注流量以盡量減少溶血，所有這些都使我們能夠比以前更好地對肺灌注和通風進行生理控制。但是，在我們將其複製到臨床項目之前，這只是我們的論點和假設。但我們很高興我們的臨床前結果如此強勁。敬請關注。

Thank you.

謝謝。

David Rescott, Baird.

大衛雷斯科特，貝爾德。

Great. Thanks for taking the questions. Congrats on the really strong order here. Appreciate the comments on seasonality -- typical Q3 seasonality that you've seen. There's been some focus on the third-party flight data just around the volumes of the trends in July. And I wanted to confirm at least it looks like from our perspective that pretty much the trends that you're seeing in July so far, quarter over quarter, are pretty much exactly what you saw last year in the month of July.

偉大的。感謝您回答這些問題。恭喜您在這裡獲得如此強勁的訂單。感謝您對季節性的評論——您所看到的典型的第三季季節性。人們開始關注第三方航班數據中七月航班量的趨勢。我想確認的是，至少從我們的角度來看，到目前為止，7 月的趨勢與上一季相比，與去年 7 月的趨勢基本上相同。

So I wanted to clarify that at least nothing in July so far is different from the typical seasonality that you've seen. And when I think about the comments that you made already on it, when you look at what you saw last year on a quarter-over-quarter basis, kind of pulled down the US revenue, down I think 3% to 5% or so on a quarter-over-quarter basis. So when you think about the way Q3 is shaking up, is there anything in your mind that leads you to believe that the seasonality you saw last year is not the right kind of guidepost for where seasonality can be shaken up this year?

因此我想澄清的是，至少到目前為止，七月的情況與您所看到的典型季節性沒有什麼不同。當我想到您已經對此發表的評論時，當您查看去年季度環比情況時，美國收入有所下降，我認為環比下降了 3% 到 5% 左右。因此，當您思考第三季的動盪方式時，您是否認為去年看到的季節性並不是今年季節性動盪的正確路標？

Thank you, Dave, for the question. So let me address the first part.

謝謝戴夫提出的問題。那麼讓我來談談第一部分。

I'm only commenting on what we've seen in July. The flight tracker, we've always said it's not 100% accurate, and I'll leave it at that. You also have to remember that with our vertical integration of logistics, as well as the more physiologic protection of OCS, we're doing more ground transportation than flight sometimes. So again, third-party flight tracker, I know people are very proud of it, but it's not 100% reflection of our business. So that's number one.

我只是對我們七月所看到的情況進行評論。我們一直說航班追蹤器不是 100% 準確的，我就不多說了。您還必須記住，透過我們對物流的垂直整合以及 OCS 的更多生理保護，有時我們的地面運輸比飛行運輸更多。再次強調，我知道人們對於第三方航班追蹤器感到非常自豪，但它並不能 100% 反映我們的業務。這是第一點。

Number two, what we're seeing in July doesn't give us any concerns or more concerns than what we have seen before as the typical seasonality that we've been seeing for the last two or three years during the summertime. So we're not pushing panic buttons. None of that. It's pretty much par for the course. If anything, as I commented, I believe, to Allen's question, it's slightly less impacted than last year. But again, it's early in the quarter. It could shake up to be like last year. It's still early in the quarter, and obviously, we can't predict.

第二，七月出現的情況並沒有給我們帶來任何擔憂，也沒有給我們帶來比過去兩三年夏季常見的典型季節性特徵更嚴重的擔憂。所以我們不會驚慌失措。這些都不是。這幾乎是意料之中的事。如果有的話，正如我對艾倫的問題所評論的那樣，我相信，它受到的影響比去年要小一些。但話說回來，現在還處於本季初期。它可能會像去年一樣震動。現在仍處於本季初期，顯然我們無法預測。

As far as last year versus this year overall, I don't think I have enough data points to say that last year is not the norm or is the norm. It's just last year is what was visible and resulted, as you said, exactly 3% to 5% down quarter over quarter. But we came back and recovered in Q4. And if you look at our H2, we grew 9% last year. I think these are, relatively speaking, good numbers to model going forward for this year.

就去年與今年的整體情況而言，我認為我沒有足夠的數據點來判斷去年不是常態或是常態。這只是去年的情況，正如您所說，季度環比下降了 3% 到 5%。但我們在第四季恢復了元氣。如果你看一下我們的下半年，你會發現我們去年成長了 9%。我認為，相對而言，這些數字可以為今年的發展提供良好的參考。

But I also would like Gerardo to comment from his perspective.

但我也希望傑拉爾多從他的角度發表評論。

Hi, David. I think a couple of days ago, there was an article where one of our covering analysts actually went back and reviewed the transplant volume seasonality between Q3 and Q4. I think it's since 2022, '23, and '24. The result of the analysis basically says that there is no -- that there is seasonality, but the magnitude of the seasonality changes -- has been changing year over year.

你好，大衛。我記得幾天前有一篇文章，其中我們的一位分析師實際上回顧了第三季和第四季之間的移植量季節性。我認為是從 2022 年、2023 年和 2024 年開始的。分析結果基本上表明，不存在季節性，但季節性變化的幅度逐年變化。

So there is no one specific, let's say, line or assumption that we could take for this year. Where we are -- I mean, we're confident in the full year. We know that there is going to be a deceleration in Q3, but we're going to get back and get within our guidance. And as I said, I think our guidance sets up a prudent baseline and with the potential upside to surpass.

因此，對於今年我們無法採取任何具體的路線或假設。我們目前的情況——我的意思是，我們對全年充滿信心。我們知道第三季將會減速，但我們將回到我們的預期範圍內。正如我所說，我認為我們的指導設立了一個審慎的基準，並且具有超越的潛在上升空間。

Okay, perfect. And then on the operating margin guide that you have for the full year, you raised it versus the last quarter, obviously raised it versus where you entered the year, implying kind of a step down in the expansion that you saw in the first half of the year.

好的，完美。然後，就全年營業利潤率指南而言，您將其與上一季相比有所提高，顯然與年初相比有所提高，這意味著您在上半年看到的擴張有所放緩。

And so my question is more toward, if at all, or I guess what, and then if at all, is there any contribution contemplated in there from the clinical trials that are expected to be up and running by the back half of the year? And then when we think about the incremental dollar amount per case in the clinical trial into '26, and we start to model that in the model, how should we be thinking about how clinical trials are going to flow through the P&L, specifically kind of on the R&D and OpEx gross margin side? Thank you.

所以我的問題更多的是，如果有的話，或者我猜是什麼，那麼，是否有任何預期在下半年啟動和運行的臨床試驗的貢獻？然後，當我們考慮 26 年臨床試驗中每個病例的增量美元金額時，我們開始在模型中對其進行建模，我們應該如何考慮臨床試驗將如何流經損益表，特別是在研發和營運支出毛利率方面？謝謝。

Right. So for this year first, the vast majority for increasing operating margin is gaining operating leverage at operating expenses. That's where we're going to gain, as you may recall, I said, at least 650-basis-point increase. What is really driving the number is the amount of investment that we're expecting to have over the second half of the year.

正確的。因此，首先就今年而言，提高營業利潤率的絕大部分是透過增加營業費用來獲得營業槓桿。這就是我們要獲得的收益，你可能還記得，我說過，至少增加 650 個基點。真正推動這一數字的是我們預計今年下半年的投資額。

Now, some of those investments are in different stages. So depending on how they actually materialize, they could maybe slip into next year or not. So that's why we're taking a -- I'm taking a conservative approach to say at least 650. There could be room for upside if we, for instance, get higher in our guidance range or we decide to move one of the projects, et cetera, to next year. So there is room, but it is not the contribution of the clinical program that is driving that improvement. It's actually our operating expenses and our planned investments in the second half of the year.

目前，其中一些投資正處於不同的階段。因此，根據它們的實際實現情況，它們可能會延續到明年，也可能不會。所以這就是為什麼我們要採取——我採取保守的方法，至少要達到 650。例如，如果我們提高指導範圍，或決定將其中一個項目等移至明年，那麼就可能存在上漲空間。因此，還有空間，但推動這種改善的並不是臨床計畫的貢獻。這實際上是我們下半年的營運費用和計劃投資。

I think for 2026, what I would like to say today is just reiterate what I said during the call. We are expecting to be at -- reaching or at 30%, which will be at or approaching 30% operating margin in 2028. The path is -- it may not be linear, but we're confident on that one. So I wouldn't want to talk about next year's yields yet. I think when we come to provide a little bit more guidance of 2026, that's when I'll be sharing more thoughts.

我認為對於 2026 年來說，我今天想說的只是重申我在電話會議中所說的話。我們預計到 2028 年營業利潤率將達到或接近 30%。這條路徑可能不是直線的，但我們對此充滿信心。所以我現在還不想談明年的收益。我想，當我們為 2026 年提供更多指導時，我會分享更多想法。

Thank you. Congrats again.

謝謝。再次恭喜。

Mike Matson, Needham & Company.

麥克‧馬森 (Mike Matson)，Needham & Company。

Yeah, thanks. Thanks for fitting me in here. I guess just want to ask one on the heart and lung clinical program. So I understand that's not going to have much of an impact this year, but looking at next year, how many of those patients that get enrolled in the trial do you think would kind of otherwise have been captured by TransMedics as transplants and you would have gotten OCS revenue from? In other words, is it going to be cannibalizing some of the existing business you otherwise would have had? Or is it going to 100% be additive to your volumes?

是的，謝謝。謝謝你讓我來這裡。我想只是想問一個有關心肺臨床項目的問題。所以我知道這不會對今年產生太大影響，但展望明年，您認為參加試驗的患者中有多少人會被 TransMedics 捕獲作為移植，並且您會從中獲得 OCS 收入？換句話說，它是否會蠶食你原本擁有的一些現有業務？或者它會 100% 增加你的銷量嗎？

Thank you for the question. I think, as we said before, it will be hundreds of patients that we actually don't have access to today. Out of the 450 lungs, we expect 300 patients that we don't have access to today. Out of another similar number for heart, we -- about 300 or 350 of those are DBD hearts that we don't even have the indication for today. So we discussed this before. This is not to cannibalize our existing volume. This is to add and to increase our indication.

謝謝你的提問。我認為，正如我們之前所說，今天我們實際上無法接觸到數百名患者。在 450 個肺部中，我們預計有 300 個患者目前無法取得。在另一個類似的心臟病例中，我們 - 其中約有 300 或 350 例是 DBD 心臟，我們今天甚至還沒有發現相關跡象。我們之前討論過這個問題。這並不是要蠶食我們現有的產量。這是為了補充和增加我們的指示。

Yeah. No, I know long term it would increase. I was just wondering if some of the patients that may have been --

是的。不，我知道從長遠來看它會增加。我只是想知道，有些可能已經--

No, I'm talking about even at the short term.

不，我指的是短期內的情況。

Okay. All right. And then, you commented on a lot of the headlines in the quarter, but there's one thing I didn't really hear anything on and I just thought I would ask about it. So one of your competitors, OrganOx, got approved for use of their device during flight. I know they don't have the logistics capabilities, at least as of now, or planes or anything like that, but do you think that that changes the competitive dynamics at all or makes them any more competitive in liver than they already have been?

好的。好的。然後，您對本季度的許多頭條新聞發表了評論，但有一件事我並沒有真正聽到任何消息，我只是想問一下。因此，您的競爭對手之一 OrganOx 已獲准在飛行期間使用其設備。我知道他們沒有物流能力，至少目前沒有，或飛機或類似的東西，但你認為這會改變競爭態勢或使他們在肝臟方面比現在更有競爭力嗎？

Mike, I've stated before, and thank you for the question, the OrganOx device invented the back-to-base model for a reason. The device cannot fly. You have to add wings to the device to be able to fly this device. This device is so large and so wide and so tall.

麥克，我之前說過，謝謝你的提問，OrganOx 設備發明了回基模型是有原因的。該設備無法飛行。您必須為該設備添加機翼才能使該設備飛行。這個裝置又大又寬又高。

Based on our knowledge of the configuration of aircrafts in the United States or charter flight, they would require a large jet to be able to -- and not any large jet to have that configuration. It's going to be too expensive to fly, and ultimately, the device doesn't have the battery capability. I think this is another unwarranted noise in the system that we don't see it at all. This device is designed to be back-to-base model. Period. All stops.

根據我們對美國飛機或包機配置的了解，他們需要一架大型噴射機才能實現這種配置——而不是任何大型噴射機都能實現這種配置。飛行成本太高，而且該設備最終不具備電池容量。我認為這是系統中另一個我們根本看不到的不必要的噪音。該設備設計為返回基地模型。時期。全部停止。

Understood. Thank you.

明白了。謝謝。

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

謝謝。我們的問答環節到此結束。我想將會議交還給 Waleed Hassanein 並請他作最後發言。

Thank you all very much. Have a wonderful evening, and we look forward to continuing the dialogue. Bye.

非常感謝大家。祝您有個美好的夜晚，我們期待繼續對話。再見。

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

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。