Transmedics Group Inc (TMDX) 2025 Q1 法說會逐字稿

Good afternoon, and welcome to TransMedics' first-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 年第一季財報電話會議。（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 and a few -- for a few introductory comments. Please go ahead.

現在，我想將電話轉給 Gilmartin Group 的 Laine Morgan 和其他一些人，請他們發表一些介紹性評論。請繼續。

Thanks, operator. Earlier today, TransMedics released financial results for the quarter ended March 31, 2025. A copy of the press release is available on the company's website.

謝謝，接線生。今天早些時候，TransMedics 發布了截至 2025 年 3 月 31 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 meaning of federal securities laws. Any statements contained in this call that relate to expectations or predictions of future events, results or performance are forward-looking statements. All forward-looking statements, including, without limitation, future results and events, including financial guidance and projected estimates, our examination of operating trends, the potential commercial opportunity for 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 expectations, including revenue, gross margins and operating trends, operating expenses in 2025 and beyond are based upon our current estimates and various assumptions. These statements include material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements.

在我們開始之前，我想提醒您，管理階層將在本次電話會議中發表聲明，包括在電話會議的問答部分，其中包括聯邦證券法所定義的前瞻性陳述。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有關的陳述均為前瞻性陳述。所有前瞻性陳述，包括但不限於未來結果和事件，包括財務指導和預計估計、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、我們對經營增長和機遇的預期以及財務指導和/或預期，包括 2025 年及以後的收入、毛利率估計和我們當前的經營費用。這些聲明包括重大風險和不確定性，可能導致實際結果或事件與這些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-K filed with the Securities and Exchange Commission on February 27, 2025. Our subsequent SEC filings and the forward-looking statements included in today's earnings press release, which are available at www.sec.gov and on our website at www.transmedics.com. TransMedics disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 8, 2025.

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 2 月 27 日向美國證券交易委員會提交的 10-K 表格“風險因素”標題下。我們隨後向美國證券交易委員會 (SEC) 提交的文件和前瞻性聲明均包含在今天的收益新聞稿中，可在 www.sec.gov 和我們的網站 www.transmedics.com 上查閱。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任何意圖或義務，無論是由於新資訊、未來事件或其他原因。本次電話會議包含時間敏感訊息，僅截至今天（2025 年 5 月 8 日）的現場直播時準確。

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

現在，我將把電話轉給總裁兼執行長瓦利德·哈桑尼 (Waleed Hassanein)。

Thank you so much, Laine. Good afternoon, everyone, and welcome to TransMedics' first-quarter 2025 earnings call. Joining me today is Gerardo Hernandez, our Chief Financial Officer. As we discussed previously, we view 2025 as an important year for TransMedics, mainly to transition and shift into our second year of growth for TransMedics OCS NOP platform. Despite external distractions in January, we remain laser-focused throughout Q1 on our business fundamentals, operational execution, and our unwavering support for our clinical transplant partners and users.

非常感謝，萊恩。大家下午好，歡迎參加 TransMedics 2025 年第一季財報電話會議。今天與我一起出席的是我們的財務長 Gerardo Hernandez。正如我們之前所討論的，我們認為 2025 年對 TransMedics 來說是重要的一年，主要是過渡並進入 TransMedics OCS NOP 平台成長的第二年。儘管一月份受到外界幹擾，但在整個第一季度，我們仍然專注於業務基礎、營運執行以及對臨床移植合作夥伴和用戶的堅定支持。

In doing so, we continue to be successful in expanding the utilization of available donor organs for transplantation and increased OCS NOP adoption, all resulting in our core mission of delivering what we believe to be the best possible clinical outcomes and the most cost-efficient therapy for our transplant recipients. The results speak for themselves. Our 1Q performance demonstrates that the strength of our business fundamentals, the effectiveness of our strategy, and the unrivaled value of our business model. Importantly, our ability to execute at a very high level despite unexpected external pressures is a testament to the strong support of the transplant clinical community to TransMedics' mission and the resilience of our incredible team. Now let me proceed to discuss our business performance through the first quarter of the year, which was our strongest quarter to date in the history of TransMedics.

在此過程中，我們繼續成功地擴大了可用捐贈器官的移植利用率並增加了 OCS NOP 的採用，所有這些都使我們的核心使命成為可能，即為我們的移植接受者提供我們認為最好的臨床結果和最具成本效益的治療。結果不言而喻。我們第一季的業績證明了我們業務基本面的強勁、我們策略的有效性以及我們商業模式的無與倫比的價值。重要的是，儘管面臨意想不到的外部壓力，我們仍然能夠以非常高的水平執行，這證明了移植臨床界對 TransMedics 使命的大力支持以及我們優秀團隊的韌性。現在，讓我繼續討論我們今年第一季的業務表現，這是 TransMedics 歷史上迄今為止表現最強勁的季度。

Here are the key operational highlights for 1Q. Total revenue for 1Q 2025 was $143.5 million, representing approximately 48% growth year-over-year and approximately 18% sequential growth from 4Q 2024. Growth was driven primarily by higher overall utilization and center penetration of OCS NOP in the US for liver and heart transplants, and that happened across both DBD and DCD organs. This enabled us to achieve a new high watermark for overall case volume in 1Q 2025.

以下是第一季的主要營運亮點。2025 年第一季總營收為 1.435 億美元，較去年同期成長約 48%，較上季 2024 年第四季成長約 18%。成長的主要原因是美國 OCS NOP 在肝臟和心臟移植方面的總體利用率和中心滲透率的提高，而這種情況在 DBD 和 DCD 器官中均有發生。這使得我們在 2025 年第一季實現了整體案件數量的新高。

Meanwhile, TransMedics transplant services revenue for 1Q was approximately $55.3 million, up from $35.5 million in Q1 '24 and up from $46.7 million in Q4 '24, representing approximately 56% year-over-year and 18.5% sequential growth. Our overall gross margins for 1Q improved to 61.5%, up from 59% in 4Q '24. Finally, we delivered operating profit of $27.4 million in 1Q, representing approximately 18% -- I'm sorry, 19% of total revenue and up from $8.6 million or 7% of total revenue in 4Q 2024. Shifting now to TransMedics transplant logistics infrastructure and performance for the quarter. Transplant logistics services revenue for 1Q was $26.1 million, representing approximately 80% year-over-year and 20% sequential growth.

同時，TransMedics 第一季移植服務收入約為 5,530 萬美元，高於 24 年第一季的 3,550 萬美元，高於 24 年第四季的 4,670 萬美元，年成長約 56%，季增 18.5%。我們第一季的整體毛利率從 2024 年第四季的 59% 上升至 61.5%。最後，我們在第一季實現了 2,740 萬美元的營業利潤，約佔總收入的 18%——抱歉，是 19%，高於 2024 年第四季的 860 萬美元或總收入的 7%。現在轉向 TransMedics 移植物流基礎設施和本季的績效。第一季移植物流服務收入為 2,610 萬美元，年增約 80%，季增 20%。

Throughout 1Q, our daily average aircraft availability was approximately 15.4, up from 14 in 4Q '24. Given that we reached a critical mass of owned aircraft capacity, we will retire the reporting of this metric going forward. Throughout the first quarter, we were able to cover 78% of our NOP missions requiring air transport, compared to 75% in Q4 of 2024. As we've discussed previously, we are now focusing our effort in 2025 on efficiently operating our fleet by double shifting a portion of our planes to the extent possible before investing in additional aircraft to the fleet. We will be opportunistic, however, in adding one or more aircraft in 2025 to reach our stated goal of 22 owned aircraft before year-end.

整個第一季度，我們的日均飛機可用量約為 15.4 架，高於 2024 年第四季的 14 架。鑑於我們已達到自有飛機運力的臨界規模，我們將不再報告此指標。在整個第一季度，我們能夠涵蓋 78% 需要空運的 NOP 任務，而 2024 年第四季這一比例為 75%。正如我們之前所討論的，2025 年我們的重點是高效運作我們的機隊，在投資增加機隊飛機之前，盡可能地將部分飛機輪換。然而，我們將抓住機會，在 2025 年增加一架或多架飛機，以在年底前實現擁有 22 架飛機的既定目標。

Overall, we are very pleased with our strong performance in 1Q. We are focused on maintaining this momentum throughout 2025. In addition, we are planning to launch two new heart and lung clinical programs later in the year to further catalyze our growth in '26 and beyond. Our 1Q performance underscores the unique attributes of TransMedics business. TransMedics is not only a topline grower, but also an increasingly profitable business capable of generating significant bottom line leverage.

總體而言，我們對第一季的強勁表現感到非常滿意。我們致力於在 2025 年全年保持這一勢頭。此外，我們計劃在今年稍後啟動兩個新的心臟和肺臨床項目，以進一步促進我們在 26 年及以後的成長。我們第一季的業績凸顯了 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。

We remain confident that this is just the beginning, and we believe we are well positioned to deliver sustainable long-term financial results as we gain more efficiency of scale and continue to drive leverage throughout the operation. Moving now to provide a quick status update on our next-gen OCS Heart and OCS Lung clinical programs. We filed both OCS Lung and Heart IDEs and are actively discussing the final details with FDA. Based on our interactions, we feel we are on track to initiate both programs in H2 2025, as we communicated earlier in the year. However, the precise launch time of the next-gen lung and heart clinical programs is still fluid and depends on the exact timing of the FDA approval followed by the center's IRB processes.

我們仍然相信這只是一個開始，我們相信，隨著我們獲得更高的規模效率並在整個營運過程中繼續提高槓桿率，我們有能力實現可持續的長期財務表現。現在就提供有關我們的下一代 OCS 心臟和 OCS 肺臨床計劃的快速狀態更新。我們已提交 OCS 肺部和心臟 IDE，並正在積極與 FDA 討論最終細節。根據我們的互動，我們認為我們預計在 2025 年下半年啟動這兩個項目，正如我們今年早些時候溝通的那樣。然而，下一代肺和心臟臨床計畫的特定啟動時間仍不確定，取決於 FDA 批准的特定時間以及中心的 IRB 流程。

As we highlighted at our ISHLT Symposium in April this year and previously at our Investor Day in December of '24, we are planning to run a relatively large-sized trials aimed at building the next generation of Level 1 clinical evidence that is unrivaled in our industry. As stated above, we see these new clinical programs as potential major growth catalysts for TransMedics '26 and beyond, and we are not counting on these 2 clinical programs to contribute materially to our financial results in 2025. Now I'd like to address the potential impact of geopolitical, macroeconomic, and tariff policies on TransMedics' business in 2025. Let me start with the impact of tariffs that may have negatively impacted many device companies. I want to remind all of you that TransMedics is and will continue to be a proud US manufacturer of the OCS technology platform.

正如我們在今年 4 月的 ISHLT 研討會上以及先前在 2024 年 12 月的投資者日上所強調的那樣，我們計劃進行相對大規模的試驗，旨在建立我們行業中無與倫比的下一代 1 級臨床證據。如上所述，我們認為這些新的臨床項目是 TransMedics 26 年及以後的潛在主要成長催化劑，我們並不指望這兩個臨床計畫會對我們 2025 年的財務表現做出重大貢獻。現在我想談談地緣政治、宏觀經濟和關稅政策對 TransMedics 2025 年業務的潛在影響。首先我要說一下關稅的影響，它可能對許多設備公司產生了負面影響。我想提醒大家，TransMedics 現在是並將繼續成為 OCS 技術平台的美國驕傲製造商。

Importantly, we also are focused on vertically integrating most of the critical technology blocks to minimize supply chain risks on our business. Based on what we know today, we believe that the currently proposed tariffs will have a minimal impact on our business. That said, this is a fluid environment and may change should policies change. Additionally, we are leaning forward and have announced publicly our strategic plan to open a disposable design center of excellence and a new manufacturing facility in the premier biomedical device district of Mirandola, Italy.

重要的是，我們還專注於垂直整合大多數關鍵技術模組，以最大限度地降低我們業務的供應鏈風險。根據我們目前掌握的情況，我們認為目前提出的關稅對我們的業務影響微乎其微。話雖如此，這是一個流動的環境，可能會隨著政策的變化而改變。此外，我們正在向前邁進，並已公開宣布我們的戰略計劃，在義大利米蘭多拉首屈一指的生物醫學設備區開設一次性設計卓越中心和一個新的製造工廠。

This district is renowned for its deep expertise in polycarbonate injection molding and disposable perfusion technologies. We expect this plan to give TransMedics several key strategic advantages: first, it enables us to leverage the unique talent to rapidly integrate many of the key disposable critical components for OCS perfusion circuit; second, provide an alternate disposable manufacturing source to ensure business continuity to our Andover facility; and finally, to provide us maximum flexibility in supplying OCS product OUS, while reducing the potential impact of tariffs on our international business. Now, let me share our perspective on the impact of potential economic downturn on organ transplantation in general and our business in specific. Our experience over the past two decades reinforces our belief that organ transplantation is a life-saving procedure that is largely insulated from economic cycles. This is due to two important facts: one, the best clinical outcomes associated with the transplant procedure and the highly cost effectiveness of the therapy for payers managing very expensive chronic disease conditions that lead to organ failure.

該區因其在聚碳酸酯注塑和一次性灌注技術方面的深厚專業知識而聞名。我們預計該計劃將為 TransMedics 帶來幾項關鍵的戰略優勢：首先，它使我們能夠利用獨特的人才快速整合 OCS 灌注迴路的許多關鍵一次性部件；第二，提供替代的一次性製造源，以確保我們安多弗工廠的業務連續性；最後，為我們提供最大的 OCS 產品 OUS 供應潛在關稅，同時減少對我們國際靈活性的影響。現在，讓我分享一下我們對潛在經濟衰退對器官移植總體以及我們業務具體影響的看法。過去二十年的經驗讓我們更加堅信，器官移植是一種拯救生命的手術，並且在很大程度上不受經濟週期的影響。這是由於兩個重要事實：第一，移植手術具有最佳的臨床效果，並且對於治療導致器官衰竭的昂貴慢性疾病的付款人來說，這種療法具有很高的成本效益。

Let me now conclude my remarks by discussing our expectation for the remainder of 2025. As seen in our 1Q results, we began the year with a very strong performance. We are confident that we can maintain this momentum for the overall 2025 annual performance. However, we may experience some level of variability or quarterly seasonality that could impact performance quarter to quarter as we've experienced last year. As a result of our strong 1Q performance and the full year considerations I just outlined, we are raising our full-year 2025 revenue guidance to between $565 million and $585 million, representing approximately 28% to 32% growth over full-year 2024.

現在，讓我以討論我們對 2025 年剩餘時間的期望來結束我的演講。從我們第一季的業績可以看出，我們今年的業績開局非常強勁。我們有信心在2025年全年業績中保持這一勢頭。然而，我們可能會經歷一定程度的變化或季度季節性，這可能會影響季度業績，就像我們去年經歷的那樣。由於我們第一季的強勁表現以及我剛才概述的全年考慮，我們將 2025 年全年收入預期上調至 5.65 億美元至 5.85 億美元之間，比 2024 年全年增長約 28% 至 32%。

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

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。杰拉爾多？

Thank you, Waleed. Good afternoon, everybody. I'm pleased to be here to walk through TransMedics' strong first quarter results. As Waleed mentioned, Q1 2025 was a strong start to the year, reflecting our disciplined execution, continued commercial momentum, and the positive impact of our strategic investments. We saw solid performance across both product and service lines, and positive sequential margin expansion and profitability gains.

謝謝你，瓦利德。大家下午好。我很高興來到這裡介紹 TransMedics 強勁的第一季業績。正如 Waleed 所提到的，2025 年第一季是一個強勁的開端，反映了我們嚴謹的執行力、持續的商業動能以及策略投資的正面影響。我們看到產品和服務線均表現穩健，利潤率和獲利能力均連續擴大。

US transplant revenue was $139 million, up 51% year-over-year and 19% sequentially. By organ, liver contributed with $109 million, heart with $26 million, and lung with $4 million. OUS revenue was $4 million, down 1% from Q1 of 2024 and up 4% sequentially. OUS revenue by organ was $3.5 million in heart, $0.4 million in lung, and $0.1 million in liver.

美國移植收入為 1.39 億美元，年增 51%，季增 19%。按器官劃分，肝臟貢獻了 1.09 億美元，心臟貢獻了 2600 萬美元，肺部貢獻了 400 萬美元。OUS 營收為 400 萬美元，較 2024 年第一季下降 1%，季增 4%。按器官劃分的 OUS 收入為心臟 350 萬美元、肺 40 萬美元和肝臟 10 萬美元。

Product revenue for the first quarter reached $88 million, up 44% year-over-year growth and 18% sequentially. Growth was driven by increased organ utilization in liver and continued OCS adoption across both liver and heart. Service revenue came in at $55 million, reflecting 56% year-over-year growth and 18% sequential increase. The primary driver was logistics, which grew 80% year-over-year and 20% sequentially, fueled by the continued expansion and utilization of our aviation fleet. Total gross margin for the quarter was approximately 61%, representing a decrease of 45 basis points when compared to Q1 of 2024 and a sequential improvement of 226 basis points.

第一季產品營收達到 8,800 萬美元，年增 44%，季增 18%。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持續採用 OCS。服務收入達到 5,500 萬美元，年增 56%，季增 18%。主要驅動力是物流，得益於我們航空機隊的持續擴張和利用，物流年增 80%，季增 20%。本季總毛利率約為 61%，與 2024 年第一季相比下降了 45 個基點，與上一季相比提高了 226 個基點。

The 45 basis points decline was driven by a higher proportion of service revenue, which carries a lower margin profile, partly offset by improvement in product gross margin. The sequential 226 basis point improvement was primarily driven by a recovery in product margin, which increased 359 basis points, driven by the absence of Q4 related charges -- Q4 inventory-related charges and better cost absorption. Compared to Q1 of 2024, product gross margin improved 448 basis points, driven by cost efficiencies and the absence of nonrecurring inventory charges. Service gross margin declined 632 basis points versus Q1 of 2024, primarily driven by the higher proportion of aviation business. However, sequentially, service gross margin remained stable and we continued opportunities for margin expansion through operational efficiencies.

45 個基點的下降是由於服務收入佔比增加，導致利潤率較低，但產品毛利率的提高部分抵消了這一影響。連續 226 個基點的改善主要得益於產品利潤率的回升，產品利潤率增加了 359 個基點，這得益於第四季度相關費用的消除——第四季度庫存相關費用以及更好的成本吸收。與 2024 年第一季相比，產品毛利率提高了 448 個基點，這得益於成本效率的提高和沒有非經常性庫存費用。服務毛利率較 2024 年第一季下降 632 個基點，主要原因是航空業務佔比較高。然而，服務毛利率連續保持穩定，並且我們繼續透過提高營運效率來擴大利潤率。

Total operating expenses for the first quarter of 2025 were approximately $61 million, up 28% year-over-year. The growth was primarily driven by a 51% increase in R&D as we continue to invest in our innovation pipeline, and a 21% increase in SG&A, reflecting investments to strengthen our NOP and command center, along with nonrecurring legal and consulting expenses tied to internal processes reviews conducted in Q1 of 2025. Sequentially, total operating expenses declined 4%, largely due to lower SG&A following onetime expenses recorded in Q4 2024 and timing of spend, partially offset by the nonrecurring legal and consulting expenses I mentioned before. R&D grew 4% sequentially, consistent with our ongoing investment plan. Operating income for the quarter was $27.4 million, up 121% year-over-year and more than (inaudible) sequentially.

2025 年第一季總營運費用約 6,100 萬美元，年增 28%。這一成長主要得益於我們繼續投資於創新管道，研發費用增加了 51%，銷售、一般及行政費用增加了 21%，這反映了加強 NOP 和指揮中心的投資，以及與 2025 年第一季進行的內部流程審查相關的非經常性法律和諮詢費用。總營運費用較上季下降 4%，主要是由於 2024 年第四季記錄的一次性費用和支出時間導致銷售、一般及行政費用降低，但被我之前提到的非經常性法律和諮詢費用部分抵銷。研發費用較上季成長 4%，與我們正在進行的投資計畫一致。本季營業收入為 2,740 萬美元，比去年同期成長 121%，比上一季成長更多（聽不清楚）。

Operating margin expanded to 19.1% compared to 12.8% in prior year. Net income for the quarter was $25.7 million, representing a 111% year-on-year increase and 275% sequentially. This result demonstrates that our business model can scale efficiently, drive meaningful financial improvement, and positions the company for sustained momentum in 2025 and beyond. We ended the quarter with $310 million in cash, down $26.5 million from December 31, 2024. During Q1, we invested approximately $24 million in the purchase of two additional aircraft, and we remain on track to purchase 1 more this year to reach our target of 22 owned jets by the end of 2025.

營業利益率從上年的 12.8% 擴大至 19.1%。本季淨收入為 2,570 萬美元，年增 111%，季增 275%。這一結果表明，我們的商業模式可以有效擴展，推動有意義的財務改善，並為公司在 2025 年及以後的持續發展勢頭做好準備。本季末，我們的現金為 3.1 億美元，較 2024 年 12 月 31 日減少 2,650 萬美元。在第一季度，我們投資了約 2,400 萬美元購買了另外兩架飛機，我們仍計劃在今年再購買一架飛機，以實現到 2025 年底擁有 22 架飛機的目標。

Earnings per share were $0.76 and diluted earnings per share were $0.70 for the first quarter of 2025. In summary, we are off to a strong start. We feel confident in our momentum and remain focused on execution to continue to grow the number of transplant, advance key projects and programs, and deliver strong results through the rest of the year. Looking ahead, based on the strength of the business, as Waleed mentioned before, we are raising our full year revenue guidance to a range of $565 million to $585 million, up from our prior range of $530 million to $552 million. This reflects approximately 30% growth over 2024 at the midpoint of the guidance.

2025 年第一季每股收益為 0.76 美元，每股攤薄收益為 0.70 美元。總而言之，我們有一個好的開始。我們對我們的發展勢頭充滿信心，並將繼續專注於執行，繼續增加移植數量，推進重點項目和計劃，並在今年剩餘時間內取得強勁成果。展望未來，正如 Waleed 先前提到的，基於業務實力，我們將全年收入預期從先前的 5.3 億美元至 5.52 億美元上調至 5.65 億美元至 5.85 億美元。這反映了指導中期 2024 年約 30% 的成長。

Growth is expected to continue to be fueled by the expansion of total transplant volumes, the increased OCS adoption, and continued momentum across our service platform. We continue to expect some quarterly variability in terms of transplant volume growth. However, we are confident in our updated full year guidance. In terms of gross margin, we continue to expect expansion across both product and service gross margin, driven by benefits of scale and operational efficiencies. However, the increasing proportion of service revenue, which operates at a lower margin will moderate the overall gross margin expansion in 2025.

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。我們仍然預期移植量成長方面會存在一些季度變化。不過，我們對更新後的全年指引充滿信心。在毛利率方面，我們預計受規模效益和營運效率的推動，產品和服務毛利率將繼續擴大。然而，利潤率較低的服務收入佔比的增加將減緩2025年整體毛利率的成長。

In aviation, we are expecting scheduled maintenance activity to increase in the second half of the year, ramping in Q3 and more significantly in Q4. While this may introduce some quarterly noise, it does not change our expectation for modest gross margin expansion. In terms of capital allocation, we will remain focused on R&D and targeted investments that advance our pipeline, strengthen product development, and enhance logistics efficiency and process simplification. We are balancing strategic growth with financial discipline to drive sustainable long-term profitability. Finally, with stronger expected top line performance, continued efficiency gains, and spend discipline, we now expect to deliver at least 400 basis points of improvement in operating margin in 2025 versus 2024.

在航空領域，我們預計下半年定期維護活動將會增加，第三季將大幅增加，第四季將更加顯著。雖然這可能會帶來一些季度噪音，但不會改變我們對溫和毛利率擴張的預期。在資本配置方面，我們將繼續專注於研發和有針對性的投資，以推進我們的產品線，加強產品開發，並提高物流效率和流程簡化。我們正在平衡策略成長與財務紀律，以實現可持續的長期獲利能力。最後，憑藉更強勁的預期營收表現、持續的效率提升以及嚴格的支出管控，我們預計 2025 年的營業利潤率將比 2024 年提高至少 400 個基點。

While quarterly variability is expected, we are confident in the full year step-up, driven largely by gaining leverage across our operating expense base. I'm encouraged by our strong start to the year and the disciplined execution across the organization. While there is more work to do, the momentum we are seeing across the business, combined with clear growth drivers, give us conviction in our ability to deliver sustainable growth and continued margin expansion.

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升。我們今年的強勁開局和整個組織的嚴格執行令我感到鼓舞。雖然還有很多工作要做，但我們在整個業務中看到的勢頭，加上明確的成長動力，讓我們相信我們有能力實現可持續成長和持續的利潤率擴大。

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, Gerardo. As I said before, we're very pleased by our strong start of the year and performance in Q1, that we expect to carry this forward for the remainder of the year. As we stated before, our 1Q results demonstrate the unique and unrivaled attributes of TransMedics business. We remain confident that this is only the beginning, and we are well positioned to continue to drive profitable growth while generating leverage to drive strong, sustainable financial results. In conclusion, we are humbled and proud of the strong clinical user support for TransMedics and the resilience of our wonderful team. We remain committed to delivering the highest quality OCS NOP products and services to expand access to our life-saving transplant technology.

謝謝你，傑拉爾多。正如我之前所說，我們對今年的強勁開局和第一季的表現感到非常滿意，我們希望在今年剩餘時間內繼續保持這種勢頭。正如我們之前所說，我們的第一季業績證明了 TransMedics 業務的獨特和無與倫比的屬性。我們仍然相信這只是一個開始，我們已準備好繼續推動獲利成長，同時發揮槓桿作用，實現強勁、可持續的財務表現。總之，我們對 TransMedics 強大的臨床用戶支援以及我們優秀團隊的韌性感到謙卑和自豪。我們始終致力於提供最高品質的 OCS NOP 產品和服務，以擴大我們拯救生命的移植技術的使用範圍。

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。

Congrats on just what's really, really strong quarter. I guess, starting with where I think it looks like a lot of the upside came from, in liver. It's kind of funny. One of your main competitors in that space actually had some news announced today as well. But how should we think about the main drivers of your growth in liver?

恭喜您本季取得如此出色的成績。我想，首先我認為很多好處都來自於肝臟。這有點搞笑。您在該領域的主要競爭對手之一今天實際上也發布了一些新聞。但是，我們該如何看待肝臟生長的主要驅動力呢？

We know that you're seeing more morning adoption, continued growth in DCD. But if you could just break down the drivers of that outperformance in liver, and what you're seeing so far in April as well?

我們知道，您會看到早晨採用率的提高以及 DCD 的持續成長。但是，如果您可以分析肝臟表現優異的驅動因素，以及您在四月迄今為止看到的情況呢？

Thank you, Allen, for the question. I cannot comment on the news that came out today from the other technology out there. I can only comment on our dynamic as you'd expect me to do. We're extremely confident in our liver platform. We're seeing growth across the verticals, DBD, DCD.

謝謝艾倫提出的問題。我無法對今天其他技術發布的新聞發表評論。我只能按照您所期望的方式對我們的動態進行評論。我們對我們的肝臟平台非常有信心。我們看到了垂直產業、DBD、DCD 的成長。

We're seeing more utilization of disease donors across both DBD and DCD. We're gaining share. We're gaining momentum. Again, it's early in the year, but we are bullish about our ability to continue to execute and continue to deliver the results we're delivering because we are convinced that we have the best, I repeat again, the best platform for liver preservation. All the pseudo-competitors out there cannot deliver the value that the OCS can deliver in liver transplantation.

我們看到 DBD 和 DCD 中疾病捐贈者的利用率都在增加。我們的份額正在增加。我們正在獲得動力。再說一次，現在才年初，但我們對繼續執行和繼續實現我們所交付成果的能力充滿信心，因為我們確信我們擁有最好的，我再說一遍，最好的肝臟保存平台。所有偽競爭對手都無法提供 OCS 在肝臟移植方面所能提供的價值。

And the upcoming publications will prove it unequivocally based on data and evidence, not just based on opinions.

即將出版的出版物將根據數據和證據而不是僅基於觀點明確地證明這一點。

Got it. And then just a quick follow-up. Just curious what you're seeing so far in April. You raised the guide by more than the beat, but still, given the outperformance in the quarter, looks like there could be some room for upside if you carry some of that momentum forward. So just curious about what you're seeing so far in April.

知道了。然後只是快速的跟進。我只是好奇四月份到目前為止你看到了什麼。您將指導價提高到了超出預期的水平，但考慮到本季度的優異表現，如果您保持這種勢頭，似乎還有一定的上漲空間。我只是好奇你在四月到目前為止看到了什麼。

Thanks, Allen. I think you and others know that we are -- we take guidance very seriously. Q1 results speak for themselves. It's still early in the year. And we wanted to make sure that we also are putting guidance that can be achieved and factor in some potential headwinds coming up in Q2 or Q3 or Q4.

謝謝，艾倫。我想您和其他人都知道我們—我們非常重視指導。Q1 的結果不言而喻。現在還只是年初。我們希望確保我們制定的指導是可以實現的，並考慮到第二季、第三季或第四季可能出現的一些不利因素。

So we feel very strongly that the momentum we experienced in Q1 will continue for the full year results, but we expect some variability between quarters, potential seasonality as we've seen last year. That's why the guidance accommodated for all of that. Based on April results, we feel confident in the guidance range we put out in front of the community.

因此，我們強烈感覺到，我們在第一季經歷的勢頭將持續到全年業績，但我們預計季度之間會存在一些差異，並可能受到去年看到的季節性影響。這就是為什麼指導意見要適應所有這些情況。根據四月份的結果，我們對向社區發布的指導範圍充滿信心。

Gerardo, would you care to comment on that?

杰拉爾多，您願意對此發表評論嗎？

No, I feel we have plenty of tailwinds, not only in product sales, but also in service revenue. We have -- our adoption has increased consistently. We saw adoption increase in Q4. We saw adoption increase in Q1. As Waleed mentioned, it's not only the adoption, but it's organ utilization.

不，我覺得我們有很多順風，不僅在產品銷售方面，而且在服務收入方面。我們的採用率一直持續增加。我們看到第四季採用率有所增加。我們看到第一季的採用率增加。正如瓦利德所說，這不僅涉及收養，還涉及器官利用。

It's penetration of organs in different centers. It's our adoption. So plenty of tailwinds.

它滲透到不同中心的器官。這是我們的收養。因此有很多順風。

Matthew O'Brien, Piper Sandler.

馬修·奧布萊恩、派珀·桑德勒。

This is Sam, on for Matt. I guess, first, I want to touch on your next -- your two next-gen products for the heart and lung. We know that you can generate products revenue when these trials are ongoing, but can you talk a little bit about the service revenues and how you anticipate products and service margins could be impacted during these trials?

我是 Sam，代替 Matt。我想先談談你們的下一款​​產品——兩款針對心臟和肺部的下一代產品。我們知道，在進行這些試驗時，您可以產生產品收入，但您能否談談服務收入以及您預計這些試驗期間產品和服務利潤率會受到怎樣的影響？

Thank you for the questions. I'd like to comment only on the product revenue at the moment until we have all the trial design completed and approved by FDA. We know we have high degree of confidence that we will be incurring product revenue. We expect to incur service revenue certainly on the OCS arm, but we have to stay silent on what should we expect on service revenue on the control arm. That remains to be an area of discussion, so I do not like to comment on it just yet.

謝謝您的提問。在我們完成所有試驗設計並獲得 FDA 批准之前，我目前只想對產品收入發表評論。我們知道，我們非常有信心將獲得產品收入。我們預期 OCS 部門肯定會產生服務收入，但對於控制部門的服務收入預期，我們必須保持沉默。這仍是一個有待討論的領域，所以我現在還不想對此發表評論。

But we certainly feel very confident that we will be incurring product revenue throughout the heart and lung clinical programs.

但我們確實非常有信心，我們將透過心臟和肺部臨床計畫獲得產品收入。

And then I just want to touch on liver again. Obviously, it continues to do really well in the US. There are a couple of competitors anticipated to enter the market later this year. So just what kind of gives you that confidence in your guidance and any impact, if any, that you anticipate in the second half of this year?

然後我只想再談一次肝臟。顯然，它在美國繼續表現良好。預計今年稍後將有幾家競爭對手進入市場。那麼，是什麼讓您對自己的指導如此有信心，並且您預計今年下半年會產生什麼影響？

As I stated earlier, the community needs to step back and understand why is the liver doing so well for us. There is a good reason for that. The good reason is TransMedics and OCS Liver platform is delivering the best results in the history of liver transplantation. And we're doing that while providing the most convenient, the most cost-efficient way of delivering the liver transplantation at the transplant institute. This is why the market is adopting our platform.

正如我之前所說，社會需要退一步思考，了解為什麼肝臟對我們如此有益。這是有充分理由的。理由是 TransMedics 和 OCS Liver 平台在肝臟移植史上取得了最佳成果。我們在這樣做的同時，也為移植機構提供了最方便、最具成本效益的肝臟移植方式。這就是市場採用我們的平台的原因。

Anybody could claim that they have a potential competing technology. They need to prove it. We stand by our product. We stand by our data. And as I said, this is all going to be coming out to light very soon in major publication in peer-reviewed journal that highlights all the value that I just outlined.

任何人都可以聲稱他們擁有潛在的競爭技術。他們需要證明這一點。我們對我們的產品負責。我們堅持我們的數據。正如我所說的，這一切很快就會在同行評審期刊的主要出版物中曝光，突出我剛才概述的所有價值。

That's why the liver program is doing well, and that's why we expect the liver program to continue to do well. And I'm going to go on a limb and I say TransMedics is not just stopping at where we are. TransMedics is working very hard to ensure that the OCS Liver platform is the next standard of care in DBD and DCD liver transplantation in the United States and around the world. Anybody could claim anything, we have the evidence to support us, and we are not stopping. We are continuing to push innovation, clinical programs, data, to ensure that this leadership position of our liver platform will continue to lead from the front.

這就是肝臟計畫進展順利的原因，也是我們期望肝臟計畫繼續進展順利的原因。我要冒險說一下，TransMedics 不會止步於現狀。TransMedics 正在努力確保 OCS Liver 平台成為美國乃至全球 DBD 和 DCD 肝臟移植的下一個護理標準。任何人都可以聲稱任何事情，我們有證據支持我們，我們不會停止。我們將繼續推動創新、臨床項目和數據，以確保我們的肝臟平台的領導地位繼續保持領先地位。

Bill Plovanic, Canaccord.

比爾·普洛瓦尼克（Bill Plovanic），Canaccord。

So as we look at the quarter, I mean, liver was fantastic, and we've talked about that already. We did see receivables go up pretty significantly from the fourth quarter. Just any commentary there? And then on the guidance, Gerardo, basically, it assumes flat line the rest of the year. You did make some commentary about the trials.

因此，當我們回顧本季時，我的意思是，肝臟非常棒，我們已經討論過這一點了。我們確實看到應收帳款從第四季開始大幅增加。那裡有什麼評論嗎？然後，根據指導，Gerardo，基本上假設今年剩餘時間將持平。您確實對審判發表了一些評論。

Do you still think that the clinical trials will add 2% to 5% to the numbers this year? Or have you pulled that out and are basically saying it's next year?

您是否仍認為臨床試驗會使今年的數字增加 2% 到 5%？或者你已經把它拿出來並且基本上說是明年？

Let me start with the last part, Bill. We've always stated that the clinical trials for this year will be a very, very small contributor. We estimated it to be between 2% and 5%. We think it's still within that range, maybe towards the lower end of that range, but really, we have always stated that these clinical programs are the catalyst for '26 and beyond.

比爾，讓我從最後一部分開始。我們一直表示，今年的臨床試驗只會起到非常小的貢獻。我們估計這個比例在2%到5%之間。我們認為它仍然在這個範圍內，可能接近這個範圍的低端，但實際上，我們一直表示，這些臨床項目是 26 年及以後的催化劑。

And I'll let Gerardo specifically address the AR question.

我會讓 Gerardo 具體解答 AR 問題。

Hi, Bill. Yes, the increase in receivables basically is really related to the timing of billing. We had a couple of elements that affected Q1 and the billing that we had to do through the quarter actually was done later in the quarter. So we delayed that process. And what I can tell you is that, now, we're in -- let's say, recovering the receivables, and we're in a good position to go back to our original plan.

你好，比爾。是的，應收帳款的增加基本上與結算時間有關。有幾個因素影響了第一季度，我們必須在本季度完成的計費實際上是在本季後期完成的。所以我們推遲了這個過程。我可以告訴你們的是，現在，我們——比如說，正在收回應收帳款，而且我們有能力回到我們最初的計劃。

We are expecting to end the year, more or less, somewhere around our 45 to 60 days DSO, and we should see recovery already in Q2.

我們預計今年年底的 DSO 大約在 45 至 60 天左右，我們應該在第二季度看到復甦。

And I would like -- Bill, if you allow me to just add one additional commentary to Gerardo's point. As we've stated before, we are transitioning our entire NOP platform to be managed completely through our new NOP digital ecosystem. Part of that transition is a full automated billing mechanism that will significantly reduce that time between the completion of the case and the bill being generated. And that's coming in the second half of the year. That will help achieve the goal as stated by Gerardo.

我想——比爾，如果你允許我對傑拉爾多的觀點補充一點評論。正如我們之前所說，我們正在將整個 NOP 平台轉變為透過我們的新 NOP 數位生態系統進行完全管理。這種轉變的一部分是全自動計費機制，這將大大縮短案件完成和帳單產生之間的時間。這將在今年下半年實現。這將有助於實現 Gerardo 所說的目標。

Okay. And I just want to -- just to go back to the first question on the guidance, Waleed. You did that $143 million and change in the first quarter. It's basically flat for the year. Is that how we should think of the second quarter to be very similar to the first quarter?

好的。我只是想——回到關於指導的第一個問題，瓦利德。您在第一季就實現了 1.43 億美元的收入和變化。今年基本持平。我們是否應該認為第二季與第一季非常相似？

Or is it like last year where it kind of went up a little and then kind of the back half of the year slowed down a lot? I mean, how should we just think about the second quarter here?

或者像去年一樣，先是略有上漲，然後在下半年大幅放緩？我的意思是，我們該如何看待第二季？

I really think, Bill, we can't comment in the second quarter given that we're already close to the mid of second quarter. But from a high-level expectation, we expect -- we always expect to do better. That's not a secret. But we also expect some seasonality. Maybe it will hit in Q2, maybe it will hit in Q3.

比爾，我真的認為，我們無法在第二季發表評論，因為我們已經接近第二季中期了。但從高層次的期望來看，我們期望——我們總是期望做得更好。這不是什麼秘密。但我們也預期會有一些季節性。也許它會在第二季度出現，也許它會在第三季度出現。

So that's why the guidance is structured the way it's structured. But we're trying to reflect in the guidance the way we see how the business is operating. But based on early signals in Q2, we expect to see a little bit modest improvement over Q1, but we still have some weeks to go.

這就是指南採用這種結構的原因。但我們正試圖在指導中反映我們對業務運營的看法。但根據第二季的早期訊號，我們預計情況會比第一季略有改善，但仍需要幾週的時間。

Justin Wang, Morgan Stanley.

摩根士丹利的賈斯汀王（Justin Wang）。

I'm stepping in for Patrick here. I was wondering if you can talk a little bit more on the durability of OCS and NOP pricing. I understand that it adds solid value to transplant centers and payers. But do you think that competitive entries in a more cost-sensitive CMS could pressure your pricing here?

我在這裡代替帕特里克。我想知道您是否可以再多談談 OCS 和 NOP 定價的持久性。我知道它為移植中心和付款人增加了實質的價值。但您是否認為，在成本較為敏感的 CMS 中，競爭產品可能會對您的定價造成壓力？

Justin, thank you for the question. I think as I've stated before, the question is not about pricing. The question should be about value. We priced our technology based on the significant value that the OCS delivers to the transplant center, to the payer, and to the patient. In fact, we believe that we're leaving some value on the table because it's always been our culture not to gouge the market.

賈斯汀，謝謝你的提問。我認為正如我之前所說，問題不在於定價。問題應該是關於價值的。我們根據 OCS 為移植中心、付款人和患者帶來的巨大價值來為我們的技術定價。事實上，我們相信我們留下了一些價值，因為我們的文化一直是不欺騙市場。

We're there to be their long-term partner. We're there to be the next standard of care for organ transplant in the long-term. Unfortunately, because of our value, any -- how do I state this? Any potential competitor is just taking a 20% discount from our price and saying, I'm cheaper than TransMedics. People need to step back and say, what is your value?

我們是他們的長期合作夥伴。從長遠來看，我們將成為器官移植護理的下一個標準。不幸的是，由於我們的價值，任何——我該怎麼說呢？任何潛在的競爭對手都會在我們的價格上打 20% 的折扣，然後說，我比 TransMedics 便宜。人們需要退一步思考，你的價值是什麼？

Most of these competitors, specifically in the liver, we should ask what is your value? What are you delivering? You should be at 0 or near 0 from a price standpoint because you're not delivering much value. What is the value of a machine perfusion that the liver has to be preserved on ice for six or eight hours before you perfuse it? So where is the value of machine perfusion?

大部分這些競爭對手，具體到肝臟，我們要問你的價值是什麼？你要送什麼？從價格角度來看，您應該為 0 或接近 0，因為您沒有提供太多價值。機器灌注有什麼價值，在灌注前必須將肝臟在冰上保存六到八個小時？那麼機器灌注的價值到底在哪裡呢？

You've just killed the value of machine perfusion. And why do you do that? Because the technology is not capable of being portable. Even if it is -- has wings to it, it's not delivering the physiologic perfusion and value of preservation and assessment that the OCS is delivering. So based on these facts and based on the significant economical efficiency that is gained throughout the paradigm of organ transplantation from reducing the waitlist time to improving the post-transplant complication rate, to increasing the survivability of the recipient with the originally transplanted organ and significantly reducing the re-transplant rate, we are delivering significant cost efficiency to payers, to transplant programs and certainly the best quality of life and best life expectancy for the patient.

你剛剛扼殺了機器灌注的價值。為什麼這麼做？因為該技術不具備便攜性。即使它有翅膀，它也無法提供 OCS 所提供的生理灌注和保存和評估的價值。因此，基於這些事實以及在整個器官移植過程中獲得的顯著經濟效益，從減少候診時間到改善移植後併發症發生率，再到提高接受者使用原移植器官的存活率以及顯著降低再移植率，我們為付款人和移植項目提供了顯著的成本效益，當然也為患者提供了最佳的生活品質和最佳的預期壽命。

Based on that, we think CMS will continue to reimburse for OCS, and commercial payers, not just CMS, because we're delivering significant economic value to these payers. And again, the data speaks for itself.

基於此，我們認為 CMS 將繼續向 OCS 和商業付款人（而不僅僅是 CMS）報銷，因為我們為這些付款人提供了巨大的經濟價值。再說一遍，數據說明了一切。

Chris Pasquale, Nephron Research.

克里斯‧帕斯誇萊 (Chris Pasquale)，腎元研究機構。

I wanted to ask a couple of questions about margins. The updated guidance for 4 points of full year operating margin expansion represents great progress, but you actually delivered more than 7 points here in 1Q. So was there any spending that got pushed out of 1Q and is going to come later in the year to drive that dynamic? Or are there other margin headwinds that you're contemplating with that outlook?

我想問幾個有關利潤的問題。更新後的全年營業利潤率成長 4 個百分點的指引代表著巨大的進步，但實際上你們在第一季就實現了超過 7 個百分點的成長。那麼，是否有任何支出被推遲到第一季度，並將在今年晚些時候到來以推動這種動態？或者您正在考慮這種前景中的其他利潤阻力？

Hi, Chris. No, the majority, as I mentioned, the vast majority of the operating margin increase is going to be driven by gains in operating leverage in operating expenses. So basically, what is happening? Most of the -- or a large part of our investment is planned for later in the year. And that's what basically is going to balance out.

你好，克里斯。不，正如我所提到的，營業利潤率的成長絕大部分將由營業費用中的營業槓桿的成長所推動。那麼基本上，發生了什麼事？我們的大部分投資都計劃在今年稍後進行。這基本上就是要達到平衡。

So that's why we're comfortable on the full year 400 basis points, at least. That's what I mentioned, at least.

這就是為什麼我們對全年至少 400 個基點感到滿意。至少這就是我所提到的。

Okay. That's helpful. And then on gross margin, nice result this quarter on the product side of the business. The service gross margin was similar to what we saw in 4Q, even though service revenue improved sequentially. What's the real gating item to get that service gross margin higher?

好的。這很有幫助。就毛利率而言，本季產品業務取得了不錯的成績。儘管服務收入環比有所提高，但服務毛利率與第四季度相似。提高服務毛利率的真正關鍵因素是什麼？

You've got basically the fleet of planes that you would like to have. Is it just a matter of really increasing the utilization of those assets? Or is there something else that sort of triggers a change in the profitability of that piece of the business?

您基本上已經擁有了您想要的飛機隊。這真的只是提高這些資產的利用率的問題嗎？或是否有其他因素導致該業務獲利能力改變？

No, that's exactly what you mentioned, it's doing the utilization of the assets. Let me give you a couple of examples. In Q1 last year, I mean, just to share, in Q1 last year, we owned 14 planes. The average operating aircraft per day was 9. And we were servicing only 49% of our NOP missions.

不，這就是你提到的，就是對資產的利用。讓我給你舉幾個例子。我的意思是，去年第一季度，我們擁有 14 架飛機。平均每天運營飛機9架。我們僅完成了 49% 的 NOP 任務。

Today, we own 21 planes. We have around 16 average operational aircraft in Q1, and we are 78%. So what I'm trying to say here is, there is plenty of room to continue to utilize our fixed assets. And as long as we -- as much as we continue to do so, we will be able to expand the margins. That's why we are exploring the double shifting project.

如今，我們擁有 21 架飛機。我們第一季平均營運飛機約 16 架，佔 78%。所以我在這裡想說的是，我們還有足夠的空間來繼續利用我們的固定資產。只要我們繼續這樣做，我們就能夠擴大利潤率。這就是我們探索雙班倒項目的原因。

That's why we are exploring other elements within the logistics team to improve the efficiency of the fleet. But it's basically volume. It's basically volume, Chris.

這就是為什麼我們正在探索物流團隊中的其他元素來提高車隊的效率。但它基本上是體積。基本上就是音量問題，克里斯。

Suraj Kalia, Oppenheimer.

蘇拉傑·卡利亞（Suraj Kalia），奧本海默。

Waleed, Gerardo, congrats on a fantastic quarter. So Waleed, thank you for giving all the details. On the external disturbance you referenced in your remarks, Waleed, there was probably not one surgeon or hospital administrator who had not heard of the allegations, and there was fear this could lead to softness, yet the math implies you guys actually picked up share. So maybe if you can help us understand how new store, same-store sales shaped up in the quarter? Did you see pockets of softness?

瓦利德、傑拉爾多，祝賀你們取得了出色的季度業績。所以 Waleed，謝謝你提供所有細節。關於您在評論中提到的外部幹擾，瓦利德，可能沒有一位外科醫生或醫院管理人員沒有聽說過這些指控，而且人們擔心這可能會導致軟弱，但數學計算表明您實際上獲得了份額。那麼，您能否幫助我們了解本季新店和同店銷售額的情況？你看到柔軟的地方了嗎？

How you'll overcame, if any, disturbance, as you mentioned, external disturbance that you mentioned?

如果有的話，您將如何克服您所提到的外部幹擾？

Thank you, Suraj. If you allow me to correct you, I didn't say disturbance, I said distraction. And frankly, it's a nuisance distraction. I think the results speak very loudly that the clinical transplant community have voted with their action, not with their word. We reached out to every user of the OCS platform and non-user in the United States, across all three platforms when this garbage came out in January.

謝謝你，蘇拉傑。如果你允許我糾正你的話，我沒有說“幹擾”，而是說“分心”。坦白說，這是一種令人厭煩的干擾。我認為結果清楚地表明，臨床移植界是用行動而不是言語來投票的。當一月份這個垃圾訊息出現時，我們聯繫了美國所有三個平台上的每位 OCS 平台使用者和非使用者。

And we've made our points clear, and the results show their position. So we look at these results with a high degree of pride and humility. And we are continuing to laser focus on our users, servicing our users' need, and making sure that we're there for them as they have been there for us throughout Q1. And again, we're doing this because we're delivering significant value to the transplant community across all three platforms. And we're looking forward to the next phase this year -- later this year when we get the heart and lung programs kicking to start getting momentum in the cardiothoracic aspect of this.

我們已經明確表達了我們的觀點，結果也顯示了他們的立場。因此，我們非常自豪和謙卑地看待這些結果。我們將繼續關注我們的用戶，滿足用戶的需求，並確保我們為他們提供服務，就像他們在整個第一季為我們提供服務一樣。我們這樣做是因為我們透過這三個平台為移植界帶來了巨大的價值。我們期待今年的下一階段——今年晚些時候，我們將啟動心臟和肺部項目，開始在心胸外科方面取得進展。

We did not see any softness. The opposite is true. And again, now, the focus of our entire team is to making sure that we are here and have the capacity to meet the demand. The demand is continuing to grow day-over-day, week-over-week, month-over-month.

我們沒有看到任何柔軟。事實恰恰相反。現在，我們整個團隊的重點是確保我們在這裡並且有能力滿足需求。需求日復一日、週復一周、月復一月地持續成長。

Fair enough. And Waleed, one of the other things obviously is OCS economics, almost every discussion this comes up, right? And in one of our recent events, some of the physicians said, hey, it would really help hospitals because they are not billing properly, and the point was raised, it would really help if TransMedics develops a reimbursement team that can help us understand reimbursement and guide us through the process, because where you all have stepped in, it seems like it's helped the site. So walk us through if that is on the docket in terms of just helping transplant sites walk through the reimbursement steps. Gentlemen, congrats again.

很公平。瓦利德，顯然，另一件事就是 OCS 經濟學，幾乎每次討論都會談到這個，對嗎？在我們最近的一次活動中，一些醫生說，嘿，這真的會對醫院有幫助，因為他們沒有正確計費，並且有人提出，如果 TransMedics 建立一個報銷團隊，可以幫助我們了解報銷並指導我們完成整個流程，那將非常有幫助，因為你們所有人的介入似乎對該網站有所幫助。因此，如果這只是幫助移植網站完成報銷步驟的議程，請向我們介紹一下。先生們，再次祝賀。

Suraj, unfortunately, that tells me that, that particular view comes from a new user or a new partner to TransMedics OCS. TransMedics has always had reimbursement experts, both full-time internal and external, that work and help all transplant programs in the United States and in Europe, do the market access and billing work. In fact, we are the only entity, only technology that formed the National Transplant Administration Working Group assembled from leading transplant programs that are highly utilizing OCS with -- and have secured additional reimbursement from commercial payers to help other transplant programs in the US achieve the same results, completely unpaid, completely independent of TransMedics.

不幸的是，蘇拉傑告訴我，這種特定觀點來自 TransMedics OCS 的新用戶或新合作夥伴。TransMedics 一直擁有全職內部和外部報銷專家，他們致力於幫助美國和歐洲的所有移植項目進行市場准入和計費工作。事實上，我們是唯一一個實體，也是唯一一個技術，組成了國家移植管理工作小組，該工作組由高度利用 OCS 的領先移植項目組成——並且已從商業付款人那裡獲得額外報銷，以幫助美國其他移植項目實現同樣的結果，完全免費，完全獨立於 TransMedics。

So it's a great idea. We agree with that view for sure, and we have been implementing that. And again, our results and our growth could not be achieved -- could not have been achieved without making headway on the proper billing, as you outlined.

所以這是一個好主意。我們當然同意這個觀點，我們也一直在實踐這個觀點。再說一次，正如您所概述的，如果沒有在正確的計費方面取得進展，我們的成果和成長就不可能實現。

Next question, operator?

接線員，下一個問題是什麼？

David Rescott, Baird.

大衛雷斯科特，貝爾德。

Congrats on the really strong quarter here. Waleed, I wanted to follow up on some of your comments already on just the way you're thinking about the rest of the year and the guide. I know historically you've called out just the unknowns around whether or not Q2 or Q3 sees more seasonality. And I think if you looked at the past two years, Q2 was a seasonally stronger quarter, Q3 was a seasonally weaker quarter. And so if we were to pretty much take that mid-single-digit market growth that's played out in liver and heart the past two years, it puts you around $150 million or so in Q2.

恭喜本季業績表現強勁。瓦利德，我想跟進一下你的一些評論，了解你對今年剩餘時間和指南的看法。我知道，從歷史上看，您只是指出了第二季或第三季是否會出現更多季節性變化的未知數。我認為，如果回顧過去兩年，第二季度是季節性較強的季度，而第三季度是季節性較弱的季度。因此，如果我們按照過去兩年肝臟和心臟領域出現的中等個位數市場成長來計算，那麼第二季的市場規模將達到 1.5 億美元左右。

So I guess my question is, at this point is there anything in your mind that leads you to believe that what we've seen in the past two years, meaning stronger Q2, kind of weaker Q3 on a seasonality basis, would not play out again this year?

所以我想我的問題是，現在您是否認為過去兩年所見的情況（從季節性來看，第二季度表現強勁，第三季表現較弱）今年不會再次出現？

At this point -- David, thank you for the question. At this point, you perfectly outlined. It's either Q2 or Q3. And yes, the odds are looking at Q3 just because of the summer vacations. But we are also living in very volatile times.

此時——大衛，謝謝你的提問。至此，您已經完美地勾勒出了輪廓。要嘛是 Q2，要嘛是 Q3。是的，由於暑假的原因，第三季的賠率很高。但我們也生活在非常動盪的時代。

So one has to be prudent and -- but if nothing -- if we're just looking at the past two years, I agree with you. The Q2 should be an uptick from Q1, and Q3 is probably the higher probability where we see a little bit of slowdown because of the summer vacation impact and summer vacation on the overall transplant volume. But we don't see any more tangible evidence that points us in one direction over the other at this point.

因此，我們必須謹慎——但如果沒有——如果我們只看過去兩年，我同意你的看法。第二季應該會比第一季上升，而第三季略有放緩的可能性更大，因為暑假的影響以及暑假對整體移植量的影響。但目前我們還沒有看到任何更確鑿的證據來表明這一方向是正確的。

Okay, great. And then on the two clinical trials, liver -- sorry, lung and heart, I understand the value to hospitals or physicians in participating in that trial. When you think about the potential for, on the heart side, accounts to be interested in doing a heart transplant as a part of this trial versus doing a heart transplant, not a part of the trial, how do you think about the potential for the revenue coming in for heart patients to be incremental or something on top of the growth that you already would have as opposed to maybe cannibalizing some of the underlying heart transplants that you likely were going to capture in the future at some point as well?

好的，太好了。然後關於兩項臨床試驗，肝臟——對不起，是肺和心臟，我了解醫院或醫生參與試驗的價值。當您考慮心臟方面的潛在風險時，帳戶可能會對作為試驗一部分的心臟移植感興趣，而不是進行不屬於試驗的心臟移植，您如何看待心臟病患者的收入潛力是增量的還是在已有的增長之上的，而不是可能蠶食一些您可能在未來某個時候也會獲得的潛在心臟移植？

Excellent question, David. I think we need to point out that we have two segments of the heart trial, one that is focusing on our current indication and one much larger that is focused on a brand-new indication that we currently don't have. And that is -- that cannot be cannibalized since we don't have that indication in the US anyway. And that's the indication that happens to be a 750-patient trial versus the current indication segment of the trial is only 200.

非常好的問題，大衛。我認為我們需要指出的是，我們的心臟試驗有兩個部分，一個部分專注於我們目前的適應症，另一個部分更大，專注於我們目前沒有的全新適應症。那是——這是無法被蠶食的，因為無論如何我們在美國都沒有這種跡象。這項試驗恰好涉及 750 名患者，而目前的試驗適應症部分只有 200 名患者。

So we do not see this as cannibalization. We see this as an advancement on both trials. But I just wanted to be giving you the black and white answer is, there's a 750-patient trial that is an indication we currently do not have in the US. So we're looking forward to the start of these trials. And hopefully, the results will validate our view that this is not going to be cannibalizing.

所以我們不認為這是蠶食。我們認為這是兩項試驗的進步。但我只是想給你一個明確的答案：有一項涉及 750 名患者的試驗表明，我們目前在美國還沒有進行過這樣的試驗。因此，我們期待這些試驗的開始。希望結果能夠驗證我們的觀點，即這不會造成損害。

This is going to be additive because the significant advancements that we -- that users will see with the next-gen technology and solutions that we are deploying as a part of these programs.

這將是附加的，因為我們——用戶將看到我們作為這些計劃的一部分部署的下一代技術和解決方案的重大進步。

Mike Matson, Needham & Company.

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

Just curious on the decision to open the facility in Mirandola, Italy. I mean, you don't have a lot of international business, at least right now. I mean, I understand you're growing so fast you probably need to add capacity somewhere, but why there versus somewhere in the US or elsewhere?

我只是好奇在義大利米蘭多拉開設工廠的決定。我的意思是，至少現在，你們沒有很多國際事業。我的意思是，我知道你們發展得如此之快，可能需要在某個地方增加產能，但為什麼是在那裡而不是在美國或其他地方？

Mike, I can't speak more granular other than saying that Mirandola, Italy happens to be the Mecca for cardiopulmonary or perfusion technologies and plastics innovation. Every major perfusion technology company, whether in the dialysis, in the cardiopulmonary bypass, or ECMO company on the planet has a major R&D and manufacturing headquarter in Mirandola, Italy. Guess what? Our main revenue-generating product is a perfusion disposable unit that is made of polycarbonate and polyurethane, and it has the same components that has significant engineering and design and manufacturing talent that exists in Mirandola, Italy. So that's one of the main reasons why and I have to leave it at that.

麥克，我無法說得更詳細，只能說義大利米蘭多拉恰好是心肺或灌注技術和塑膠創新的聖地。世界上每家主要的灌注技術公司，無論是透析公司、心肺旁路公司或 ECMO 公司，都在義大利米蘭多拉設有主要的研發和製造總部。你猜怎麼著？我們的主要創收產品是一種由聚碳酸酯和聚氨酯製成的灌註一次性裝置，它具有相同的組件，並且擁有義大利米蘭多拉的重要工程設計和製造人才。這就是主要原因之一，我必須就此打住。

The second is, we are -- as we grow, and we're growing very rapidly, we need to start thinking about business continuity. And given that we're putting that infrastructure in Mirandola for R&D, it made perfect sense for us to add the manufacturing component to it, given the talent that exists in that region, specifically on the vertically integrating key technology blocks that requires that talent that doesn't exist in the US. And frankly, it doesn't exist in the US as much as it is available in abundance with significant expertise in Mirandola, Italy.

第二，隨著我們的成長，而且我們的成長非常迅速，我們需要開始考慮業務連續性。鑑於我們將基礎設施放在米蘭多拉用於研發，考慮到該地區現有的人才，將製造組件添加到其中是完全合理的，特別是在垂直整合關鍵技術領域，這需要美國不存在的人才。坦白說，美國沒有那麼多這樣的人才，而義大利米蘭多拉卻擁有豐富的專業知識。

Okay. Got it. So it sounds like you're probably bringing something in-house that you were -- having made in that kind of region to begin with and just deciding to kind of do it yourselves now. Is that fair or --

好的。知道了。因此，聽起來你們可能把一些你們在那個地區製作的東西帶回公司內部，現在只是決定自己動手做。這樣公平嗎？--

That's fair.

這很公平。

Okay. All right. And then just one on -- from a policy perspective. I know there's all constant headlines out of D.C., but I know there's some effort underway to kind of revamp the transplant policy at the federal level. So I was just wondering if there were any updates there, if you're hearing anything about the way things could potentially move.

好的。好的。然後從政策角度再談一點。我知道華盛頓的新聞不斷，但我知道聯邦政府正在努力修改器官移植政策。所以我只是想知道那裡是否有任何更新，您是否聽到有關事情可能如何發展的任何消息。

Mike, we're not aware of anything imminent, but we're keeping our eyes and ears wide open, and we are actively engaged with many of the policymakers and the decision-makers that are involved in that particular topic. So I'll leave it at that.

麥克，我們不知道有什麼即將發生的事情，但我們會密切關注，並積極與涉及該特定主題的許多政策制定者和決策者接觸。所以我不再談論這個了。

(Operator Instructions) Josh Jennings, TD Cowen.

（操作員指示）Josh Jennings，TD Cowen。

Strong quarter. I was hoping to talk about -- ask about the clinical trials. Waleed, at ISHLT, you made some -- at the symposium, you obviously presented some high-level details on the lung and heart trials. First on the lung trial, maybe you can just help us report back on the enthusiasm or buzz that was generated within the lung transplant surgeon community and the impetus or desire to get involved in this clinical program.

本季表現強勁。我希望談論——詢問有關臨床試驗的情況。瓦利德，在 ISHLT 研討會上，您顯然介紹了一些有關肺部和心臟試驗的高級細節。首先關於肺部試驗，也許您可以幫助我們報告肺移植外科醫生社區中產生的熱情或嗡嗡聲以及參與該臨床計畫的動力或願望。

Thanks, Josh. I think the buzz was pretty loud, and it's not just in the lung, I think the buzz with the heart was as loud as the lung, if not louder. So we were -- it was unfortunate that we could not declare the two IDEs approved by the time of the ISHLT, but the buzz was loud. And what I tell you, from our perspective, not just in the US, but as you've seen in our symposium, the buzz, even OUS is becoming louder and saying, why we need access to these innovations in Europe and Australia. So our team is working hard since the ISHLT trying to kind of garner harness that momentum.

謝謝，喬希。我認為嗡嗡聲相當響亮，而且不僅僅是在肺部，我認為心臟的嗡嗡聲與肺部一樣響亮，甚至更響亮。所以我們——很遺憾我們無法在 ISHLT 之前宣布這兩個 IDE 獲得批准，但大家的熱情很高。我想告訴你們的是，從我們的角度來看，不僅在美國，而且正如你們在我們的研討會上看到的那樣，這種熱議甚至在美國以外的國家也越來越強烈地要求我們在歐洲和澳大利亞獲得這些創新。因此，自 ISHLT 以來，我們的團隊一直在努力工作，試圖利用這種勢頭。

First things first, we need to get the FDA approval in hand and move forward to executing our plans in the US and definitely, try to capitalize on the momentum and interest generated OUS as well.

首先，我們需要獲得 FDA 的批准，並繼續在美國執行我們的計劃，當然，也要嘗試利用 OUS 產生的勢頭和興趣。

Understood. And maybe on the heart program, there was a question during the symposium from the surgeon just about the risk of designing the trial for superiority in low-risk DBD trial, lower risk, head-to-head against standard of care practice. Maybe you can just talk about your confidence level on OCS delivering superiority over standard of care.

明白了。也許在心臟計畫上，外科醫生在研討會上提出了一個問題，即設計低風險 DBD 試驗的優勢、降低風險、與標準護理實踐進行正面交鋒的試驗風險。也許您可以談談您對 OCS 提供優於標準護理的服務的信心程度。

Josh, I think -- again, we don't want to comment from our perspective. That's why we designed the trial. That's why we are going to generate that first Level 1 evidence head-to-head to standard of care. No other technology in the field, from cold storage to cold perfusion, to cold -- controlled cold storage have done that. We're the only technology that is going to put it -- put that question to the test.

喬希，我認為——再說一次，我們不想從我們的角度發表評論。這就是我們設計該試驗的原因。這就是為什麼我們要產生第一個與護理標準直接對應的 1 級證據。從冷藏到冷灌注，再到冷控冷藏，該領域中沒有任何其他技術可以做到這一點。我們是唯一能夠對此問題進行檢驗的技術。

And it's a very high bar, the test of a Level 1 FDA pivotal PMA trial, and we'll let the data speak for itself.

這是一個非常高的標準，是 FDA 一級關鍵 PMA 試驗的測試，我們將讓數據說明一切。

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

我們的問答環節到此結束。我想將會議交還給瓦利德·哈桑尼恩 (Waleed Hassanein) 並請他致閉幕詞。

Thank you, operator. Thank you all for your time this evening, and we're looking forward to meeting again in a few weeks and months here. Have a wonderful evening, everybody.

謝謝您，接線生。感謝大家今晚抽出時間，我們期待幾週或幾個月後在這裡再次相聚。祝大家有個美好的夜晚。

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。