Transmedics Group Inc (TMDX) 2024 Q1 法說會逐字稿

Good afternoon and welcome to Transmedics' first-quarter 2024 earnings conference call. (Operator Instructions) As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Laine Morgan from the Gilmartin Group for a few introductory comments.

下午好，歡迎參加 Transmedics 2024 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。現在，我想將電話轉給 Gilmartin 集團的 Laine Morgan，請她作一些介紹性評論。

Thanks, operator. Earlier today, TransMedics released financial results for the quarter ended March 31, 2024. A copy of the press release is available on the company’s website. Before we begin, I would like to remind you that management will make statements during this call, including during the question-and-answer portion of the call, that include forward-looking statements within the meaning of federal securities laws. Any statements contained in this call that relate to expectations or predictions of future events, results or performance are forward-looking statements.

謝謝，接線生。今天早些時候，TransMedics 發布了截至 2024 年 3 月 31 日的季度財務表現。新聞稿的副本可在該公司的網站上查閱。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。

All forward-looking statements, including without limitation, are an examination of operating trends, the potential commercial opportunity for our products and timing of new clinical programs and our future financial expectations, which include expectations for growth in our organization and guidance and our expectations for revenue, gross margins and operating expenses in 2024 and beyond, are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not undue reliance on these statements.

所有前瞻性陳述（包括但不限於）對營運趨勢、我們產品的潛在商業機會和新臨床項目時機以及我們未來財務預期的審查，其中包括對我們組織和指導增長的預期以及我們對 2024 年及以後的收入、毛利率和運營費用的預期，均基於當前估計和各種假設。這些聲明涉及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。因此，您不應過度依賴這些聲明。

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, 2024, and our subsequent Form 10-Q 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, April 30, 2024. And with that, I will now turn the call over to Waleed Hassanein, President and Chief Executive Officer.

有關這些風險和不確定性的更多信息，請參閱我們於 2024 年 2 月 27 日向美國證券交易委員會提交的 10-K 表格中的“風險因素”標題下的內容，以及我們隨後提交的 10-Q 表格和今天的收益新聞稿中包含的前瞻性聲明，可在 www.sec.gov 和我們的網站 www.transmedics。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（2024 年 4 月 30 日）的現場直播時準確。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, Laine. Good afternoon, everyone, and welcome to TransMedics’ first-quarter 2024 earnings call. As always, joining me today, Stephen Gordon, our Chief Financial Officer. For the past two years, TransMedics has delivered exceptional revenue growth, while making transformational investments in our business. 2024 represents another crucial year, not only for exceptional growth, but also for broadening our infrastructure and product pipeline to drive further growth, profitability, and importantly, increased transplant volumes.

謝謝你，萊恩。大家下午好，歡迎參加 TransMedics 2024 年第一季財報電話會議。像往常一樣，今天與我一起的還有我們的財務長史蒂芬‧戈登 (Stephen Gordon)。在過去的兩年裡，TransMedics 實現了卓越的營收成長，同時對我們的業務進行了轉型投資。 2024 年是另一個關鍵的一年，不僅要實現卓越成長，還要拓寬我們的基礎設施和產品線，以推動進一步成長、獲利能力，更重要的是，增加移植量。

Specifically, we are focused on three verticals: first, completing the initial buildout phase of our TransMedics aviation fleet and transplant logistics infrastructure; second, preparing for the launch of three major new clinical programs to accelerate OCS lung and OCS heart adoption and expand our clinical indications for OCS heart in the US; and finally, growing the overall national transplant volumes even further through our one of a kind NOP program. On every front, we have started the year with very strong momentum towards achieving these goals.

具體來說，我們專注於三個垂直領域：首先，完成 TransMedics 航空機隊和移植物流基礎設施的初始建設階段；第二，準備啟動三個重大新臨床項目，以加速 OCS 肺部和 OCS 心臟的採用，並擴大我們在美國對 OCS 心臟的臨床適應症；最後，透過我們獨一無二的 NOP 計畫進一步增加全國的移植總量。在各個方面，我們都以非常強勁的勢頭開啟了新的一年，朝著實現這些目標的目標邁進。

With 1Q results representing a new high watermark for our business, let me review the key highlights for first quarter performance. Total revenue for Q1 grew to $96.9 million, representing 133% growth over Q1 2023 and a 19% sequential growth from Q4 2023. This growth was achieved through increased utilization of both OCS product across lung, heart and liver, as well as TransMedics transplant logistic service. I want to highlight the diversified nature of our growth to dispel any potential misperception that our growth is only driven overwhelmingly by transplant logistics revenue growth.

第一季的業績代表了我們業務的新高，讓我回顧一下第一季業績的關鍵亮點。第一季總營收成長至 9,690 萬美元，較 2023 年第一季成長 133%，較 2023 年第四季較上季成長 19%。這一增長是透過增加肺部、心臟和肝臟中 OCS 產品的利用率以及 TransMedics 移植物流服務的利用率來實現的。我想強調我們成長的多元化性質，以消除任何潛在的誤解，即我們的成長僅主要受到移植物流收入成長的推動。

Said differently, we fully expect, I repeat, we fully expect our future growth to be driven by both, increased product and transplant logistics adoption. TransMedics' transplant logistics service revenue for Q1 was $14.5 million, up from $9.2 million in Q4 of last year, representing approximately 58% growth quarter-over-quarter. We are continuing to demonstrate that our integrated and cost efficient TransMedics NOP and logistics service infrastructures are delivering real value to transplant programs across the US. We remain focused on expanding our operational capabilities for TransMedics logistics throughout 2024, which I will detail further later in the presentation today.

換句話說，我們完全預期，我再說一遍，我們完全預期我們未來的成長將受到產品增加和移植物流採用的共同推動。TransMedics 第一季的移植物流服務收入為 1,450 萬美元，高於去年第四季的 920 萬美元，季增約 58%。我們將繼續證明，我們綜合且具成本效益的 TransMedics NOP 和物流服務基礎設施正在為美國各地的移植項目帶來真正的價值。我們將繼續專注於在 2024 年擴大 TransMedics 物流的營運能力，我將在今天稍後的演講中詳細介紹。

Our overall gross margins for Q1 was 62%, up from 59% last quarter and in line with our expectations. We are extremely confident that we will be able to further improve the gross margin over the next 12 to 18 months, as we achieve more leverage of scale in both, product and service operations. The strong growth in revenue and gross margins enabled us to deliver GAAP operating profit of $12.4 million, which presents 13% of total revenue; net income was $12.2 million. We are very proud to have achieved these profitability metrics while still investing heavily in future growth.

我們第一季的整體毛利率為 62%，高於上一季的 59%，符合我們的預期。我們非常有信心，隨著我們在產品和服務營運中實現更大的規模效益，我們將能夠在未來 12 到 18 個月內進一步提高毛利率。收入和毛利率的強勁增長使我們實現了 1,240 萬美元的 GAAP 營業利潤，佔總收入的 13%；淨收入為1220萬美元。我們非常自豪能夠在實現這些獲利指標的同時，繼續對未來成長進行大量投資。

We remain laser focused, however, on delivering sustainable positive operating cash flow over the next several quarters. Before moving on to our momentum beyond our financial performance, I'd like to take a moment to recognize the entire TransMedics team, which has worked tirelessly to achieve these results. We are focused on execution to build upon the Q1 result. Now, with that background, let me provide more detail across key operating metrics.

然而，我們仍然專注於在未來幾季實現可持續的正經營現金流。在談論我們財務表現以外的發展動力之前，我想花點時間感謝整個 TransMedics 團隊，他們為實現這些成果不懈努力。我們專注於執行，以鞏固第一季的業績。現在，有了這些背景知識，讓我提供有關關鍵營運指標的更多細節。

As I stated above, we set a new high watermark for case volume across all three organ markets in Q1. Overall, NOP contribution remains at 98%-plus of our case volume, a trend which we expect will continue throughout the foreseeable future. Turning now to the key TransMedics transplant logistics metrics, through Q1 we continue to expand our fleet of owned aircrafts reaching 14 on aircrafts by end of the quarter. Meanwhile, the daily average number of active TransMedics aviation planes were nine planes in Q1 compared to seven in Q4 of 2023.

正如我上面所述，我們在第一季為三個器官市場的病例數創下了新高。總體而言，NOP 貢獻仍占我們案件數量的 98％ 以上，我們預計這一趨勢將在可預見的未來持續下去。現在談談 TransMedics 移植物流的關鍵指標，透過第一季度，我們繼續擴大自有飛機隊，到本季末將達到 14 架飛機。同時，2023 年第一季 TransMedics 航空活躍飛機的日均數量為 9 架，而第四季為 7 架。

We expect this number will continue to increase throughout the year, as we strive to reach 15 to 20 operational aircrafts by year-end. Our owned aircrafts covered approximately 49% of our NOP flight missions in Q1 compared to 35% in Q4 of 2023. This further underscores the potential long runway to drive additional growth and maximizing efficiency across our transplant logistics operations. As we stated before, at scale, we fully expect to cover 80%-plus of the total NOP missions using our TransMedics logistics services for both air and ground transport.

我們預計這一數字將在全年繼續增加，我們力爭在年底前達到 15 至 20 架投入營運的飛機。我們自有的飛機在第一季涵蓋了約 49% 的 NOP 飛行任務，而 2023 年第四季這一比例為 35%。這進一步強調了推動我們的移植物流業務進一步成長和最大限度提高效率的潛在長期發展空間。正如我們之前所說，從規模上看，我們希望使用我們的 TransMedics 物流服務進行空中和地面運輸，覆蓋 NOP 總任務的 80% 以上。

We will continue to use carefully selected highly reliable and safe operators for supplemental lifts to support our additional missions. From a customer footprint perspective, we have also continued to grow the number of programs that are using our transplant logistic services. In Q1, approximately 105 US transplant programs used TransMedics logistics compared to approximately 97 in Q4 of 2023. As we have rapidly achieved this critical mass of users, we are now focusing on going deeper within these programs and meeting more of their transplant logistics needs going forward.

我們將繼續使用精心挑選的高度可靠和安全的操作員進行補充升降，以支援我們的額外任務。從客戶足跡的角度來看，我們也持續增加使用我們的移植物流服務的項目數量。在第一季度，約有 105 個美國移植計畫使用了 TransMedics 物流，而 2023 年第四季約為 97 個。由於我們已快速獲得了大量用戶，現在我們正致力於深入這些計劃並滿足更多用戶的移植物流需求。

Overall, we're very pleased with the early success of our transplant logistics services and are confident that transplant programs are seeing the significant cost efficiency and reliability of TransMedics logistics compared to historical model. We look forward to expanding further throughout the year and into 2025, as we scale our air fleet and ground operations. We are also encouraged by our growing base of clinical evidence from real world outcomes and the growing excitement around our offering across clinical transplant users. We saw this excitement firsthand in April of this year as we attended the International Society of Heart and Lung Transplant Conference in Prague.

總體而言，我們對移植物流服務的早期成功感到非常高興，並相信與歷史模式相比，移植專案將看到 TransMedics 物流顯著的成本效益和可靠性。隨著我們擴大機隊和地面營運規模，我們期待全年乃至 2025 年進一步擴張。我們也受到來自現實世界結果的臨床證據基礎不斷增長以及臨床移植用戶對我們的產品的日益增長的興趣的鼓舞。今年四月，當我們參加布拉格國際心肺移植協會會議時，我們親眼目睹了這種興奮。

At the meeting, several scientific presentations by transplant academic experts demonstrating the value of OCS heart and OCS lung were presented. Here are the key highlights: Dr. Jacob Schroder from Duke presented the OCS Heart Perfusion or OHP registry experience with DCD heart transplants in the US. The data demonstrated that OCS heart was used in approximately three quarters of all DCD heart transplanted at OHP registry centers. The data also demonstrated that OCS DCD heart transplants had superior patient survival outcomes compared to NRP DCD transplants in high-risk recipients.

會上，移植學術專家作了幾場科學報告，展示了 OCS 心臟和 OCS 肺的價值。以下是主要亮點：杜克大學的 Jacob Schroder 博士介紹了美國 OCS 心臟灌注或 OHP 註冊與 DCD 心臟移植的經驗。數據表明，在 OHP 登記中心移植的所有 DCD 心臟中，約四分之三使用的是 OCS 心臟。數據還表明，對於高風險接受者來說，OCS DCD 心臟移植比 NRP DCD 移植具有更好的患者存活結果。

This provided evidence that OCS heart affords better protection of the DCD donor hearts, as compared to NRP. During his presentation, Dr. Schroder commented that the overall OCS NOP cost is more favorable to NRP costs when factoring in the cost of dry runs, the clinical support overhead, and the hardware costs. Importantly, Dr. Schroder highlighted that the OCS NOP enhances the ability for any heart transplant program in the US to offer the clinical service of DCD heart transplantation to their patients without the burden of overhead costs and clinical learning curves, giving the standard or unified procurement and management of donor hearts by the TransMedics NOP staff. Next, Dr. Mani Daneshmand from Emory University Medical Center presented the outcomes of OCS BCD compared to standard-of-care DBD hearts in the US.

這證明與 NRP 相比，OCS 心臟可以更好地保護 DCD 捐贈者心臟。在演講中，施羅德博士評論說，如果考慮到試運行成本、臨床支援開銷和硬體成本，那麼整體 OCS NOP 成本比 NRP 成本更優惠。重要的是，施羅德博士強調，OCS NOP 增強了美國任何心臟移植計畫的能力，使其能夠為患者提供 DCD 心臟移植的臨床服務，而無需承擔間接費用和臨床學習曲線的負擔，從而由 TransMedics NOP 工作人員對捐贈心臟進行標準或統一的採購和管理。接下來，埃默里大學醫學中心的 Mani Daneshmand 博士介紹了 OCS BCD 與美國標準 DBD 心臟治療的結果比較。

The data showed that OCS DCD hearts were transported nearly double the distance from donor to recipients and had doubled the cross-clamp time. This signifies the broader access to DCD donors afforded by OCS NOP. The data also showed that despite higher risk donor factors, OCS clinical outcomes were similar to standard criteria DBD outcomes in the US. This further validates the safety profile of the OCS Heart.

數據顯示，OCS DCD 心臟從捐贈者到接受者的運輸距離幾乎增加了一倍，阻斷時間也增加了一倍。這意味著 OCS NOP 可以為 DCD 捐贈者提供更廣泛的服務。數據還顯示，儘管捐贈者的風險因素較高，但 OCS 臨床結果與美國標準 DBD 結果相似。這進一步驗證了 OCS Heart 的安全性。

Simply stated that, the OCS-enabled a DCD heart transplant to have similar survival outcomes to the US National DBD heart transplant outcomes, which are the best in the world. Dr. Daneshmand also highlighted that the increased use of OCS NOP has led to significant reduction in moderate and severe primary graft dysfunction or PGD, after OCS DCD heart transplants. If your PGD is the most severe early post-heart transplant clinical complication and historically has been associated with worse, short and long-term patients survive. Next, Dr. Mauricio Villavicencio from Mayo Clinic presented the OCS Heart DBD experience from the OHP registry.

簡單來說，OCS讓DCD心臟移植的存活率與美國國家DBD心臟移植的存活率相近，是全世界最好的。Daneshmand 博士也強調，OCS NOP 的使用增加已導致 OCS DCD 心臟移植後中度和重度原發性移植物功能障礙或 PGD 顯著減少。如果您的 PGD 是心臟移植後早期最嚴重的臨床併發症，並且從歷史上看與更糟糕的情況有關，那麼短期和長期患者都會存活下來。接下來，梅奧診所的 Mauricio Villavicencio 博士介紹了從 OHP 註冊中心獲得的 OCS 心臟 DBD 經驗。

The data showed that OCS NOP resulted in excellent post-transplant clinical outcomes from DBD donors, compared to standard criteria donors preserved with static cold storage, despite having three times longer distance travel and doubled cross-clamp time in the OCS NOP arm. Again, this data validates the broader access to distant donors and potential for improved workflow afforded by the OCS NOP. Next, Dr. Gabe Blore from Baylor St. Luke's presented the OCS lung expand trial five-year clinical results. The data showed that the OCS lung expand lungs from extended criteria DBD and DCD donors had similar survival and freedom from chronic rejection at five-years post-transplant compared to routine standard criteria DBD lung transplanted at the same program over the same time period.

數據顯示，與使用靜態冷藏保存的標準供體相比，OCS NOP 組的 DBD 供體移植後臨床結果非常出色，儘管 OCS NOP 組的運輸距離是 DBD 供體的三倍，交叉箝制時間是 DBD 供體的兩倍。再次，這些數據驗證了 OCS NOP 能夠更廣泛地接觸遠距離捐贈者，並且具有改善工作流程的潛力。接下來，貝勒聖路加醫院的Gabe Blore博士介紹了OCS肺部擴張試驗五年臨床結果。數據顯示，與同一項目在同一時間段內移植的常規標準 DBD 肺相比，來自擴展標準 DBD 和 DCD 供體的 OCS 肺擴張肺在移植後五年具有相似的存活率和無慢性排斥反應。

These results support the huge clinical potential of increasing donor lung utilization for transplants using extended criteria DBD and DCD donors in the US. Finally, Dr. Steve Huddleston, from the University of Minnesota shared the latest data from the thoracic OCS perfusion registry or the TOP registry. The data showed that the OCS lung enabled the use of extended criteria donor lungs for DBD and DCD donors and resulted in post-transplant survival outcomes that are similar to standard criteria lung transplant, despite nearly having doubled the cross-clamp time, again, further validating the huge clinical impact on expanding the donor pool and the potential growth of lung transplant volumes in the US. Collectively, these presentations once again highlighted our ever-growing body of positive clinical evidence, as well as the exceptional clinical outcomes enabled by OCS and NOP.

這些結果支持了在美國使用擴展標準 DBD 和 DCD 捐贈者增加移植供肺利用率的巨大臨床潛力。最後，明尼蘇達大學的 Steve Huddleston 博士分享了胸腔 OCS 灌注登記處或 TOP 登記處的最新數據。數據顯示，OCS 肺使得 DBD 和 DCD 供體能夠使用擴展標準供體肺，並且儘管阻斷時間幾乎增加了一倍，但移植後的存活結果與標準標準肺移植相似，這再次驗證了 OCS 肺對擴大供體庫和美國肺移植量潛在增長的巨大臨床影響。總的來說，這些報告再次強調了我們不斷增長的積極臨床證據，以及 OCS 和 NOP 所帶來的卓越臨床成果。

Now, let me shift gears and talk about our plans to further grow OCS adoption and the overall national US transplant volumes even further. Specifically, I want to discuss three new major clinical programs designed to grow adoption of our OCS lung and OCS heart, as well as expand our OCS heart FDA clinical indications in the US. Pending FDA approval, we expect that all three programs will initiate enrollment within the next year. Let me start with detailing the OCS lung program. As we stated many times, we believe that the clinical stakeholders across the United States lung transplant market need to be reintroduced to the potential positive clinical value of the OCS lung perfusion and assessment.

現在，讓我換個話題，談談我們進一步擴大 OCS 採用率和美國全國整體移植量的計畫。具體來說，我想討論三個新的主要臨床項目，旨在增加我們 OCS 肺部和 OCS 心臟的採用，以及擴大我們在美國 OCS 心臟 FDA 臨床適應症。等待 FDA 批准後，我們預計所有三個項目將在明年開始招募。讓我先詳細介紹一下 OCS 肺部計劃。正如我們多次指出的那樣，我們認為需要重新向美國肺移植市場的臨床利益相關者介紹 OCS 肺灌注和評估的潛在積極臨床價值。

More specifically, we believe the ability of the OCS lung and NOP to increase their transplant volumes, improve their post-transplant clinical outcomes and enhanced workflow remain underappreciated. Our goal is to replicate the successful outcomes achieved with OCS liver where 62% of transplant volumes at OCS NOP programs are now done in the morning working hours compared to middle of the night and replicating that with the OCS lung. Said differently, we want to have lung transplant programs and clinical and surgeons experience firsthand the value of OCS NOP to enable morning transplants while growing their overall transplant volumes and improving their post-transplant clinical outcomes. To do this, we're planning to launch a new clinical program to achieve the following.

更具體地說，我們認為 OCS 肺和 NOP 增加移植量、改善移植後臨床結果和增強工作流程的能力仍未被充分重視。我們的目標是複製 OCS 肝臟移植的成功成果，其中 OCS NOP 計畫中 62% 的移植工作都是在早上工作時間完成，而非半夜， OCS 肺移植也將實現相同的效果。換句話說，我們希望肺移植計畫、臨床和外科醫生能夠親身體驗 OCS NOP 的價值，以實現早晨移植，同時增加他們的整體移植量並改善他們的移植後臨床結果。為此，我們計劃啟動一項新的臨床計劃，以實現以下目標。

First, we will target a minimum of 12 to 24-hour plus of OCS lung perfusion using the NOP model to increase access to transplantable donor lungs and optimize work hours for transplant program staff. Importantly, we aim to prospectively randomize between OCS NOP versus controlled cold static storage to assess a clinical value. We also plan to use newly developed near physiologic OCS perfusion solution combined with blood to minimize the impact of longer perfusion on lung edema and potentially eliminate any clinical concerns of lung perfusion times on lung function. We will also use next-gen perfusion circuitry and ventilation modality to maximize the protection for the donor lungs during prolonged OCS perfusion and ex-vivo ventilation.

首先，我們將使用 NOP 模型實現至少 12 至 24 小時以上的 OCS 肺灌注，以增加可移植供體肺的機會並優化移植計畫工作人員的工作時間。重要的是，我們的目的是前瞻性地隨機選擇 OCS NOP 與受控冷靜態儲存來評估臨床價值。我們還計劃使用新開發的近生理 OCS 灌注溶液與血液結合，以盡量減少較長時間灌注對肺水腫的影響，並可能消除肺灌注時間對肺功能的任何臨床擔憂。我們還將使用下一代灌注迴路和通氣方式，在長時間 OCS 灌注和離體通氣期間最大限度地保護供體肺。

We expect the entire clinical program to be managed by NOP to increase the rate of enrollment and adoption during the trial phase. From a timing perspective, we are targeting initiation of this program sometimes around the end of 2024. Now, let me move on to our planned OCS heart programs. We are also actively working on two distinct large OCS heart programs in the US that will be also managed exclusively via the OCS NOP model.

我們預期整個臨床項目由 NOP 管理，以提高試驗階段的入組率和採用率。從時間角度來看，我們的目標是在 2024 年底左右啟動該計劃。現在，讓我來談談我們計劃的 OCS 心臟計劃。我們也積極進行美國兩個不同的大型 OCS 心臟項目，這兩個項目也將透過 OCS NOP 模型進行專門管理。

The first is OCS heart therapeutic warm perfusion for DBD hearts. This program is aimed at increasing utilization of DBD hearts from both, standard and extended criteria donors to increase the overall heart transplant volumes in the US. We intend to target 12-hour plus of OCS heart perfusion using the NOP model to increase access to donor hearts and optimize the work working hours for our transplant program staff. We will also aim to prospectively randomized OCS NOP versus controlled called cold static storage to assess the clinical value.

第一個是針對DBD心臟的OCS心臟治療溫灌注。該計劃旨在提高標準和擴展標準捐贈者的 DBD 心臟的利用率，以增加美國的整體心臟移植量。我們打算使用 NOP 模型實現 12 小時以上的 OCS 心臟灌注，以增加獲得捐贈心臟的機會並優化我們的移植計畫工作人員的工作時間。我們也將前瞻性地隨機分析 OCS NOP 與受控的冷靜態儲存，以評估臨床價值。

We're planning not only to use our newly developed near physiologic OCS perfusion solution combined with blood but in this particular program we're adding a new proprietary metabolic enhancing therapeutic agents to maximize protection of the donor heart and improve its post-transplant clinical performance. From a timing perspective, we are talking are getting initiation some of this program sometimes around the end of 2024. Finally, our second heart program is a new program that will require a new technology from the ground-up. It's aiming at OCS heart cold oxygenated perfusion for DBD hearts that are preserved for less than six hours.

我們不僅計劃使用我們新開發的近生理 OCS 灌注溶液與血液結合，而且在這個特定的項目中，我們還將添加一種新的專有代謝增強治療劑，以最大限度地保護捐贈的心臟並改善其移植後的臨床表現。從時間角度來看，我們正在討論在 2024 年底左右啟動該計劃的一些部分。最後，我們的第二個心臟計劃是一個新計劃，需要從頭開始採用新技術。其旨在對保存時間少於六小時的DBD心臟進行OCS心臟冷氧灌注。

This program is designed to support a new FDA clinical indication for OCS heart in the US that will allow us to perfuse and preserve standard criteria DBD hearts for less than six hours which is not our current clinical indications in the US. To do this, we're planning to offer a new lower cost product that utilizes cold oxygenated blood-based perfusion technology. More specifically, we're developing our new pulsatile fully portable cold perfusion technology and cold perfusion circuitry to achieve easy-to-use system for use within our existing NOP model. Again, we'll aim to prospectively randomized to hold controlled cold static storage to assess the clinical value.

該計劃旨在支持美國 FDA 對 OCS 心臟的新臨床適應症，這將使我們能夠對標準 DBD 心臟進行灌注和保存少於六小時的時間，這不是我們目前在美國的臨床適應症。為此，我們計劃推出一種採用冷氧血灌注技術的新型低成本產品。更具體地說，我們正在開發新的脈動式全便攜式冷灌注技術和冷灌注電路，以實現易於使用的系統，可在我們現有的 NOP 模型中使用。再次，我們將前瞻性地隨機抽樣進行受控冷靜態保存以評估臨床價值。

And we are targeting early 2025 to initiate this important clinical program. As you can see, we are advancing a very strong pipeline of clinical programs designed to drive significant growth in OCS case volume and the overall national cardiothoracic transplant volume in the US, however, we're not stopping here. We're also continuing to invest heavily in our next-gen OCS technology platform for all three organs that will be highly automated, optimized for NOP workflow and designed to streamline the clinical support workload to allow us to continue to deliver the highest clinical quality of care and achieve better product leverage. We plan to share more details in this initiatives later this year.

我們的目標是在 2025 年初啟動這項重要的臨床計畫。正如您所看到的，我們正在推進一系列非常強大的臨床項目，旨在推動 OCS 病例數量和美國全國心胸外科移植總量的大幅增長，然而，我們並不會止步於此。我們也將繼續大力投資於適用於這三個器官的下一代 OCS 技術平台，該平台將高度自動化，針對 NOP 工作流程進行最佳化，並旨在簡化臨床支援工作量，使我們能夠繼續提供最高的臨床護理品質並實現更好的產品槓桿。我們計劃在今年稍後分享有關該計劃的更多細節。

To summarize, we are highly encouraged by our Q1 performance and are focused on several initiatives designed to further propel growth for TransMedics products and services. Given our strong performance in Q1, we are increasing our annual revenue guidance to $390 million to $400 million which represents 61% to 66% growth over full year 2023 revenue. With that, let me turn the call to Stephen to cover the detailed financial results for the quarter.

總而言之，我們對第一季的業績感到非常鼓舞，並專注於旨在進一步推動 TransMedics 產品和服務成長的多項措施。鑑於我們第一季的強勁表現，我們將年度營收預期上調至 3.9 億美元至 4 億美元，這比 2023 年全年營收成長 61% 至 66%。說完這些，請容許我把電話轉給史蒂芬，來介紹一下本季的詳細財務結果。

Thank you, Waleed. I will now provide some additional detail on the Q1 results and other financial information for the quarter. So starting with revenue, for the first quarter of 2024, our total revenue was $96.9 million. This is an increase of 133% from the first quarter of 2023 and a 19% sequential increase from last quarter. The $96.9 million included $0.9 million related to our flight school.

謝謝你，瓦利德。我現在將提供有關第一季業績和其他財務資訊的更多詳細資訊。因此從營收開始，2024 年第一季度，我們的總收入為 9,690 萬美元。這比 2023 年第一季成長了 133%，比上一季成長了 19%。這 9,690 萬美元中包括與我們的飛行學校相關的 90 萬美元。

We have now exited all of the Summit Legacy Charter business, so other than this $900,000 from the flight school, all revenue is transplant-related. In the US, transplant revenue was $91.9 million. US revenue increased 145% from the first quarter of 2023 and 22% sequentially from last quarter. And as Waleed said, Q1 2024 revenue included $14.5 million of logistics revenue.

我們現在已經退出了所有的 Summit Legacy Charter 業務，因此除了來自飛行學校的這 90 萬美元之外，所有收入都與移植有關。在美國，移植收入為 9,190 萬美元。我們營收較 2023 年第一季成長 145%，較上一季成長 22%。正如瓦利德所說，2024 年第一季的收入包括 1,450 萬美元的物流收入。

The organ breakdown on US revenue was $67 million of liver, $20.2 million of heart and $4.7 million of loan, all organs growing substantially over Q1 2023 and sequentially from Q4 2023. Ex US revenue was $4.1 million, a 1% increase from Q1 of 2023 and a 16% sequential increase from last quarter. The ex US breakdown was $3.1 million of heart and $1 million of lung. Next, on the product and service revenue.

美國收入中的器官細分為肝臟 6,700 萬美元、心臟 2,020 萬美元和貸款 470 萬美元，所有器官在 2023 年第一季和 2023 年第四季均大幅增加。美國以外的營收為 410 萬美元，較 2023 年第一季成長 1%，較上一季成長 16%。美國方面的分項數字為心臟手術 310 萬美元、肺手術 100 萬美元。接下來是關於產品和服務收入。

As a reminder, our service revenue includes the added amounts we charge for the NOP clinical service of surgical procurement and organ management and also includes the logistics revenue. The flight school is also included in service rep. In Q1, product revenue was $61.3 million and service revenue was $35.5 million. So the service portion was 36.7% of the total.

提醒一下，我們的服務收入包括我們為NOP臨床服務（手術採購和器官管理）收取的附加費用，還包括物流收入。飛行學校也包括在服務代表範圍內。第一季度，產品收入為6,130萬美元，服務收入為3,550萬美元。因此服務部分佔總量的36.7％。

Gross margin for the first quarter of 2024 was 62%. This is down from 69% in the first quarter of 2023 and up from 59% last quarter. In comparison to Q1 last year, this reflects the higher service component of our business which did not include logistics in the first quarter last year. Product margin was 77% in Q1, recovering as expected to more normalized product margins from the 73% we saw in Q4 which included a onetime unfavorable item.

2024年第一季的毛利率為62%。這一比例低於 2023 年第一季的 69%，但高於上一季的 59%。與去年第一季相比，這反映了我們業務中服務成分的增加，而去年第一季則不包括物流。第一季的產品利潤率為 77%，與第四季度（包括一次性不利項目）的 73% 相比，恢復到了預期的更正常的產品利潤率。

Service margin was 36%, improved from 35% last quarter as we continue to gain efficiency in our service offering. And as a reminder, all costs related to aviation, including fuel, pilots, maintenance and depreciation, are included on our service COGS. Total operating expenses for the quarter were $47.5 million, 54% above Q1 2023 OpEx. This expense growth was driven by 94% growth in R&D related to investments in new product development, NOP tools and product quality and regulatory resources.

服務利潤率為 36%，高於上一季的 35%，因為我們不斷提高服務效率。提醒一下，與航空相關的所有成本，包括燃料、飛行員、維修和折舊，都包含在我們的服務成本中。本季總營運費用為 4,750 萬美元，比 2023 年第一季營運支出高出 54%。這筆費用的成長主要是由於對新產品開發、NOP 工具以及產品品質和監管資源的投資相關的研發費用增加了 94%。

SG&A grew 45%, primarily related to higher personnel costs and overall corporate infrastructure. I want to point out that our operating expenses grew significantly throughout the year last year, so the year-on-year growth comparison next quarter should not be as pronounced as it was this quarter. Given the strong revenue and margin performance, we were able to deliver GAAP operating profit of $12.4 million or 13% of revenue; net income was $12.2 million. These compared with an operating loss of $2.6 million and also a net loss of $2.6 million in Q1 of 2023.

銷售、一般及行政開支增長了 45%，主要由於人員成本增加和公司整體基礎設施建設增加。我想指出的是，去年全年我們的營業費用都有很大的成長，所以下個季度的年成長應該不會像本季那麼明顯。鑑於強勁的營收和利潤率表現，我們能夠實現 1,240 萬美元或 13% 的收入的 GAAP 營業利潤；淨收入為1220萬美元。相較之下，2023 年第一季的營業虧損為 260 萬美元，淨虧損為 260 萬美元。

And basic earnings per share in the quarter was $0.37 and diluted earnings per share in the quarter was $0.35. Total cash at the end of the quarter was $350.2 million as of March 31, 2024. This is down $44.6 million from December 31, 2023. $39 million of cash was used to purchase 3 additional jets in Q1, bringing our total number of owned jets to 14.

本季每股基本收益為 0.37 美元，每股攤薄收益為 0.35 美元。截至 2024 年 3 月 31 日，本季末的總現金為 3.502 億美元。這比 2023 年 12 月 31 日下降了 4,460 萬美元。

Basic weighted average common shares outstanding for the quarter were 32.8 million and diluted weighted average common shares outstanding for the quarter were 34.7 million. In summary, Q1 was a very successful quarter financially for TransMedics. We grew our revenue both annually and sequentially, improved our gross margin and showed good drop-down to profitability. All of this continues to validate our strategy of leveraging our NOP clinical service and logistics service to increase utilization of the Organ Care System and to increase the number of transplants in the US.

本季基本加權平均流通普通股為 3,280 萬股，稀釋加權平均流通普通股為 3,470 萬股。總而言之，第一季對於 TransMedics 來說是財務上非常成功的一個季度。我們的收入逐年和逐季都有所成長，毛利率也有所提高，獲利能力也呈現良好的下降趨勢。所有這些繼續驗證了我們的策略，即利用 NOP 臨床服務和物流服務來提高器官護理系統的利用率並增加美國的移植數量。

Finally, just to repeat Waleed's earlier comment, we are updating our annual revenue guidance to be in the range of $390 million to $400 million which represents 61% to 66% growth over the full year 2023. Now, I'll turn the call back to Waleed for closing comments.

最後，重複 Waleed 先前的評論，我們將更新我們的年度收入預期，將其調整為 3.9 億美元至 4 億美元之間，這意味著 2023 年全年的成長率為 61% 至 66%。現在，我將電話轉回給瓦利德，請他作最後評論。

Thank you, Stephen. Overall, we are humbled and proud of our Q1 results as we simultaneously drove continued revenue growth, expanded our infrastructure and achieve profitability while advancing our clinical and R&D pipelines. We're looking forward to continuing to execute on all the major initiatives throughout 2024 to drive broader adoption of OCS NOP and growth of the overall transplant volumes to help patients in need of an organ transplant. With that, I will now turn the call to the operator for Q&A. Operator?

謝謝你，史蒂芬。總體而言，我們對第一季的業績感到謙卑和自豪，因為我們在推進臨床和研發管道的同時，推動了營收的持續成長、擴大了基礎設施並實現了盈利。我們期待在 2024 年繼續執行所有重大舉措，以推動 OCS NOP 的更廣泛採用和整體移植數量的增長，以幫助需要器官移植的患者。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 for the question and congratulations on a really strong quarter out of the gate. I understand that aviation likely helps support the beat in the services but I think it was the beat in disposables that might be a little bit more surprising. It would impact that kind of on a dollar basis, at least relative to my forecast growth more of the upside. So, I guess other than pull through of some of the NOP cases that you were maybe previously losing due to the limitations of outside logistics, what else kind of went right in the quarter for you to drive these additional volumes?

感謝您的提問，並祝賀您本季取得了非常強勁的成績。我理解航空業可能有助於支持服務業的節拍，但我認為一次性用品的節拍可能會更令人驚訝。這會對美元產生一定影響，至少相對於我預測的成長而言，這會產生更大的上行影響。那麼，我想除了處理一些您之前可能由於外部物流的限製而失敗的 NOP 案件之外，本季度您還做了哪些順利的事情來推動這些額外的業務量？

Thank you, Allenn, for the question. A lot of things went right in the first quarter and we hope to continue to execute in the same tone going forward. The most important thing is the outcomes. The outcomes that are being achieved across the board are now more transparent to the clinical users.

謝謝艾倫提出這個問題。第一季很多事情進展順利，我們希望在未來繼續以同樣的基調執行。最重要的是結果。現在，全面取得的成果對於臨床使用者來說更加透明。

Specifically, the liver continues to grow. But specifically for heart and lungs, the lung outcomes are getting better. Our team has been working very hard at educating the market, demonstrating the better outcomes achieved with our newer use model and it's resonated in the quarter. Also, we're seeing the outcomes in heart is really helping growing the heart market.

具體來說，肝臟會不斷生長。但具體到心臟和肺部，肺部的結果正在越來越好。我們的團隊一直在努力教育市場，展示我們新的使用模式所取得的更好成果，並在本季產生了共鳴。此外，我們看到的成果確實有助於心臟市場的成長。

And certainly, the discouraging results we heard at the from the cold perfusion study may have fueled that. But it's really the outcomes that is driving our growth and we plan to continue to lean on outcomes and that's why we are investing in these three major cardiothoracic programs. Deliveries is already there and continues to grow and we will continue to add centers and go deeper with an existing center, so everything went right. Also, the growth in the logistics business was important to help us get access to the cases that we couldn't get access to that also helped, but the fundamental growth from product is basically based on clinical outcome.

當然，我們在冷灌注研究中聽到的令人沮喪的結果可能加劇了這種情況。但真正推動我們成長的是成果，我們計劃繼續依靠成果，這就是我們投資這三個主要心胸外科計畫的原因。交付已經存在並繼續增長，我們將繼續增加中心並深入現有中心，所以一切都進展順利。此外，物流業務的成長對於幫助我們獲得無法獲得的案例也起到了很大的作用，但產品的根本成長基本上是基於臨床結果。

Got it. And then a follow up just kind of on seasonality and how should we think about that strength carrying forward. So if we kind of take the quarter you just put up, back it out of your updated guide, it really looks like you're setting what should hopefully be a very achievable bar for the balance of the year, especially as you're adding more planes, you're going to be starting the quarter with more planes than you had on average in first quarter, so why is this kind of a big target to go with? And how should we think about the seasonal cadence implied by that guidance? Should it be relatively flat? I guess, why would that be the case? I shouldn't view the growth sequentially?

知道了。然後是關於季節性的後續問題，以及我們應該如何看待這種優勢的延續。因此，如果我們以您剛剛提出的季度數據為基礎，將其從更新後的指南中撤出，看起來您確實為今年的平衡設定了一個非常可實現的標準，特別是當您增加更多飛機時，您將在本季度開始時擁有比第一季平均更多的飛機，那麼為什麼要設定這麼大的目標呢？我們應該如何看待該指導暗示的季節性節奏？它應該相對平坦嗎？我想，為什麼會這樣呢？我不應該按順序查看增長情況嗎？

Thanks, Allen. I think there's many layers to answering that question, Allan and Stephen, please comment as well from your perspective. I think we always are cognizant of what potential operational challenges in front of us. For example, we are very proud to have operating 14 planes hopefully in Q2. But we know that in the second half of the year, we have some of these planes are due for some annual service.

謝謝，艾倫。我認為回答這個問題有很多層次，Allan 和 Stephen，請從你們的角度發表評論。我認為我們始終清楚我們面前潛在的營運挑戰。例如，我們非常自豪能夠在第二季度運作 14 架飛機。但我們知道，今年下半年，我們的一些飛機將進行年度維護。

So they're not going to be accessible to us. So we factored that into the guidance. We also factored in some of the potential seasonality from summer vacations coming up for the holidays. So we always are prudent. When it comes to guidance, we want to -- when we issue guidance, we take it very seriously. So that's layered into our expectations here. Stephen?

因此我們無法訪問它們。因此我們將其納入了指導範圍。我們也考慮了即將到來的暑假的一些潛在季節性因素。因此我們始終保持謹慎。當談到指導時，我們希望——當我們發布指導時，我們會非常認真地對待它。這與我們的期望相符。史蒂芬？

And Allen, I would just say, look, we don't expect a down quarter sequentially. We expect modest growth quarter-over-quarter and that's the way we've modeled it and I would expect that's what will come in.

艾倫，我只想說，你看，我們預計本季的業績不會連續下滑。我們預期季度環比將出現溫和成長，這就是我們的模型，我預計也會出現這樣的結果。

Yeah. Also, finally, Allan, to put a bracket around that, we're operating from a much bigger starting point now. So we have to be cognizant of that.

是的。最後，艾倫，總之，我們現在是從一個更大的起點來開展工作的。所以我們必須認識到這一點。

Thank you.

謝謝。

Josh Jennings, TD Cowen.

喬許詹寧斯（Josh Jennings），TD Cowen。

I was hoping that will lead to -- to circle back on the discussion we had earlier in the quarter, just about you have a lot of -- you announced a lot of pipeline initiatives both on the technology front and on the clinical development front. But just how should we be thinking about the OCS system potentially reducing the percentage of DCO donors -- DCD donors that do not progress in heart, liver and lung? And is that something that could happen in the next 12 to 24 months?

我希望這能夠引出我們在本季早些時候進行的討論，你們宣布了很多在技術方面和臨床開發方面的計劃。但是，我們究竟該如何看待 OCS 系統可能降低 DCO 捐贈者（即心臟、肝臟和肺臟無法進展的 DCD 捐贈者）的比例呢？這會在未來 12 到 24 個月內發生嗎？

Josh, that's exactly our goal. As we discussed, this is the only system that we're aware of that exists out there that could help that picture is the OCS. So that's something we're planning to leverage over the next 12 to 24 months for sure. And we're hoping that once we launch these clinical programs, that becomes an opening to the next program being focused on specifically growing the DCD utilization.

喬希，這正是我們的目標。正如我們所討論的，據我們所知，目前唯一能夠幫助解決這個問題的系統就是 OCS。所以，我們肯定計劃在未來 12 到 24 個月內充分利用這一點。我們希望，一旦我們啟動這些臨床項目，這將為下一個專注於提高 DCD 利用率的項目打開大門。

Excellent. And another topic, just with ILTS kicking off this week. I wanted to just ask about just get a better understanding on the benefits and advantages of using OCS for normal thermic perfusion in fatty livers and just the percentage of donors that have fatty livers and how dramatic a difference there is in preservation for OCS versus cold storage or even cold hyper oxygenated perfusion.

出色的。另一個話題，本週 ILTS 就此拉開序幕。我只是想問一下，以便更好地了解使用 OCS 對脂肪肝進行正常熱灌注的好處和優勢，以及患有脂肪肝的捐贈者的百分比，以及 OCS 的保存與冷藏甚至冷高氧灌注的保存有何顯著差異。

Thank you. Thank you, Josh. Thank you for asking the question. It's a very important question. Without running the risk of burning some of the key planning session presentations at the upcoming ILTS, the community should be expecting that we will reveal data that shows clinical superiority of fatty livers using warm perfusion compared to any other modality. And I'll leave it at that. It doesn't make sense to put fatty livers on ice, whether for perfusion or controlled or noncontrolled static cold storage. It just doesn't make any sense because fat cells with cold storage or any cold form of preservation congeals and then the liver becomes more of a foreign object than a physiologic body. So we're looking forward to our investigators and lead users to be presenting this data at the Plan A session on Saturday.

謝謝。謝謝你，喬希。感謝您提問。這是一個非常重要的問題。在不冒著在即將召開的 ILTS 上錯過一些關鍵規劃會議演講的風險的情況下，社區應該期待我們公佈數據，證明使用溫灌注治療脂肪肝相對於任何其他治療方式都具有臨床優勢。我就講到這裡。將脂肪肝放在冰上是沒有意義的，無論是灌注或受控或不受控制的靜態冷藏。這根本說不通，因為冷藏或任何冷保存形式的脂肪細胞都會凝結，然後肝臟就會變成外來物而不是生理體。因此，我們期待我們的研究人員和主要用戶能夠在周六的 A 計劃會議上展示這些數據。

And sorry to seek a follow-up on but just any help just thinking about the percentage of donor livers that are fatty. I imagine it's a sizable chunk of the donor pool.

很抱歉尋求後續幫助，但只是想了解捐贈肝臟中脂肪的比例。我想這佔了捐贈者總數的很大一部分。

It's a very sizable chunk. And again, the definition of fatty, it's varied. Some people consider fatty liver anything greater than 15%. We'll be presenting data on fatty liver greater than 25% or 30% even. So we experienced the full gamut. And again, there's a tremendous evidence supporting warm perfusion on the OCS platform having superior outcomes to any other modality for preservation of fatty livers. And I'll leave it at that, Josh.

這是一個相當大的塊。再次強調，脂肪的定義是多種多樣的。有些人認為脂肪超過15%就是肝。我們將展示脂肪肝超過25％甚至30％的數據。所以我們體驗了全部的內容。再次強調，有大量證據支持 OCS 平台上的溫灌注比任何其他脂肪肝保存方式具有更好的效果。我就講到這裡，喬希。

William Plovanic, Canaccord.

威廉‧普洛瓦尼克 (William Plovanic)，Canaccord。

It's John on for will tonight. Thanks for taking the question I just wanted to first touch on aviation. You said 80% is probably the term rate of US cases that to be supported by you. What services and what level of jets are needed to reach that 80%? And when could we see that?

今晚由約翰代替威爾上場。感謝您提出這個問題，我只是想先談談航空問題。你說的80%可能是你支持的美國案件的期限率。要達到那 80% 需要什麼服務和什麼等級的噴射機？我們什麼時候可以看到它？

Thank you. Thank you, John. We think that -- at the current estimates, we think somewhere between 25 and 30 planes will get us there. But we fully expect to increase those estimates beyond 10,000. So that's our expectation. And the key for us is to build enough in this phase to continue to demonstrate the growth. And as we need more, we will have more planes. But right now, we're hoping to end this year around 20, between 15 and 20 planes and hopefully, by end of next year, it could be between 25 and 30. And then we'll assess from there.

謝謝。謝謝你，約翰。我們認為——按照目前的估計，大約需要 25 到 30 架飛機才能到達那裡。但我們完全預期這些估計數字將超過 10,000。這就是我們的期望。對我們來說，關鍵是在此階段建立足夠的資源以持續成長。當我們需要更多飛機時，我們就會擁有更多飛機。但目前，我們希望今年年底飛機數量能達到 20 架、15 至 20 架之間，並希望在明年年底達到 25 至 30 架之間。然後我們將從那裡進行評估。

Great., thanks. Maybe more for Stephen but any operating profit, cadence or guidance for the remainder of this year?

太好了，謝謝。對史蒂芬來說可能更多，但今年剩餘時間的營業利潤、節奏或指導是什麼？

John , this is Stephen. I'm not prepared to give any guidance other than we're pleased with where we came out in Q1. And we hope we're on path to having sustainable profit going forward because we're a little bit ahead of where we thought we'd be, but that's about all I can say at this point.

約翰，這是史蒂芬。除了我們對第一季的業績感到滿意之外，我不准備給出任何指導。我們希望未來能夠走上可持續獲利的道路，因為我們比我們想像的要領先一點，但這就是我目前能說的全部。

Great. And maybe just squeeze one more in here. But while we missed the cold option perfusion for heart for only six hours, especially with the competitor cases that are notably going much longer than that.

偉大的。也許可以再擠一個在這裡。但是，雖然我們只錯過了六個小時的心臟冷灌注選項，但競爭對手的灌注時間顯然要長得多。

Thank you, John. John, you heard the outcomes with me. They failed a trial in Europe. So why would I subject us to bad outcomes? And we are more sensible where we want to protect the outcome for the patient. And we're providing this as a lower-cost solution for this small segment of the market that is below 6 hours.

謝謝你，約翰。約翰，你和我一起聽到了結果。他們在歐洲的審判中失敗了。那我為什麼要讓我們承受這種不好的結果呢？當我們想要保護患者的治療結果時，我們會變得更明智。我們為這個少於 6 小時的小部分市場提供這項低成本解決方案。

For longer hours, we hope to prove it based on the new heart program that warm perfusion is a better solution than cold perfusion. That's the rationale for why we're limiting it, at least based on an indication standpoint. And remember, all of the data that we heard at the ISHLT is not an FDA-level data. They're all few centers, a handful of cases, except for the European multicenter trial that failed the primary effectiveness end point.

對於更長的時間，我們希望基於新的心臟程序來證明溫灌注比冷灌注是更好的解決方案。這就是我們限制它的理由，至少從指示的角度來看是這樣。請記住，我們在 ISHLT 上聽到的所有數據都不是 FDA 級別的數據。除了未能達到主要有效性終點的歐洲多中心試驗外，其他都是少數中心、少數案例。

Got it. Thank you again.

知道了。再次感謝您。

Suraj Kalia, Oppenheimer.

蘇拉傑‧卡利亞 (Suraj Kalia)、奧本海默 (Oppenheimer)。

Waleed, can you hear me all right?

瓦利德，你聽得到我說話嗎？

Yeah.

是的。

Gentlemen, congrats again on a blockbuster quarter. So Waleed, I just want to go back on one of the points that you made at our conference a month or so ago. And even on this call, you were talking about the next generation of trial. So Waleed, stratify for us the standard criteria DBD hearts that are technically off-label for you all today, just so that people can compare and contrast as to what the denominator should be in terms of market penetration.

先生們，再次恭喜您本季取得了巨大的成功。所以瓦利德，我只想回顧一下你在一個月前我們的會議上提出的一個觀點。甚至在這次電話會議中，您還在談論下一代試驗。因此，Waleed，請您今天為大家對技術上屬於標外用途的 DBD 心臟進行分層，以便人們可以比較和對比市場滲透率方面的分母應該是什麼。

Also, Waleed, the trial that you mentioned, that would be beginning, I believe, you said early next year, that is cold perfusion but would it also have physiologic beats?

另外，瓦利德，您提到的試驗將在明年年初開始，那是冷灌注，但它也會有生理節拍嗎？

Thank you, Suraj, for the question. So let me address this in multiple points. First, right now, our FDA-approved indication does not cover standard criteria DBD hearts. Our plan is to have a new indication to cover that. Is it 4 hours? Is it 6 hours? The market segment of between -- the less than 4 hours is about 900. If you go down to -- up to 6 hours, about maybe 1,200 transplants, plus or minus, at least that's based on last year's number. The reality is we want to access this segment of the market, no matter how big or how small it is, we want to be, 2 years from now, every heart transplanted in this country should be preserved on a TransMedics technology. Whether cold perfusion or warm perfusion, it will be a TransMedics technology. And we want to have the full gamut of FDA indications like we have it for lung and we have it for liver. So that's number one.

謝謝蘇拉吉提出的問題。因此，讓我從多個角度來討論這個問題。首先，目前，我們獲得 FDA 批准的適應症並不涵蓋標準 DBD 心臟。我們的計劃是推出新的適應症來解決這個問題。是4小時嗎？是6小時嗎？少於 4 小時的市場部分約為 900 個。如果將時間縮短到 6 小時，大概會有 1,200 例移植手術，或多或少，至少這是基於去年的數字。現實情況是，我們希望進入這個細分市場，無論它有多大或多小，我們都希望兩年後，這個國家每一顆移植的心臟都應採用 TransMedics 技術保存。無論是冷灌注還是熱灌注，它都是一種TransMedics技術。我們希望獲得 FDA 的全部適應症，就像我們對肺癌和肝臟的適應症一樣。這是第一點。

Number two, we have 2 heart programs, 1 warm focusing on therapeutic and optimization modalities for DBD donors; and 1 cold. The warm we expect to start before year-end this year. The cold, because it requires a full-blown new system and full new circuitry, will start in the first half or beginning of 2025. And that is the one that is focused on the new FDA clinical indication. I hope I addressed the question.

第二，我們有 2 個心臟項目，1 個重點關注 DBD 捐贈者的治療和優化模式；和 1 例感冒。我們預計今年底前將開始回升。由於寒冷需要全面的新系統和全新的電路，因此寒冷將於 2025 年上半年或年初開始。這就是專注於新的 FDA 臨床指徵的方法。我希望我解答了這個問題。

Yes, fair enough.

是的，相當公平。

And there was one segment, I apologize, Suraj. Yes, it will be pulsatile. The cold perfusion will be pulsatile which is a distinguishing factor that we have that nobody else has.

有一個片段，我很抱歉，蘇拉吉。是的，它會搏動。冷灌注將是脈動的，這是我們獨有而其他人所沒有的顯著特徵。

Fair point. Okay. Stephen, one question for you and I'll hop back in queue. One of the questions that frequently comes up in investor discussions is and maybe you can quantify this a little better for everyone's consumption. And the question that comes up is, hey, how does TransMedics depreciate its planes? What are its all-in cost per hour for aviation?

公平地說。好的。史蒂芬，我問你一個問題，然後我就回到隊列。投資者討論中經常出現的一個問題是，也許你可以更好地量化每個人的消費。那麼隨之而來的問題是，TransMedics 如何折舊飛機呢？航空每小時的全部成本是多少？

How are the margins where they are? I would love for you to take all of these and wrap it up into some numeric or numbers that people can slice and dice. Gentleman, congrats again.

他們那裡的利潤怎麼樣？我希望你能把所有這些都整理成一些數字，以便人們可以對其進行分析。先生，再次祝賀。

Thanks, Suraj. Well, the question I can answer is how we depreciate. So we depreciate the planes over 10 years with a 50% residual value. We've been clear from day one. That's in our using case.

謝謝，蘇拉傑。嗯，我可以回答的問題是我們如何折舊。因此，我們對飛機進行10年折舊，殘餘價值為50％。從第一天起我們就很清楚了。這就是我們的使用案例。

We haven't talked about the margin of aviation versus the margin of the service. But all in, we're at that 36% and we expect some improvement. Certainly, I can say the aviation is a bit on the lower side versus the service which is a bit on the higher-than-that side but we haven't talked about anything more details on that, so that's what I can answer to that question.

我們還沒有討論航空利潤與服務利潤的關係。但總體而言，我們已達到 36%，並且我們期待有所改善。當然，我可以說航空業的價格略低，而服務業的價格略高，但我們還沒有談論這方面的更多細節，所以這就是我所能回答的。

[Jack], William Blair.

[傑克]，威廉布萊爾。

Yeah, hi, guys, this is Jack on for Ryan Daniels. Congrats on the strong start to the year. Can you share any general feedback from customers that have used TransMedics aviation? And maybe if or how that feedback has changed since you began integrating the aviation segment?

是的，大家好，我是傑克，代表瑞安丹尼爾斯報道。恭喜您今年取得了良好的開端。您能否分享一下使用過 TransMedics 航空的客戶的一般回饋？自從你們開始整合航空領域以來，這些回饋是否發生了變化或如何改變了？

Thank you for the question. I think the only thing that I can share publicly is I point out to the results. I point out to their rapid pace by which we went from zero to 105 customers using our TransMedics logistical services. And we expect to go deeper within these accounts.

感謝您的提問。我認為我唯一可以公開分享的事情就是指出結果。我想指出的是，我們使用 TransMedics 物流服務的客戶數量從零成長到 105 個，發展速度非常快。我們希望對這些敘述有更深入的了解。

I'll leave it at that. I think centers are beginning or are actually witnessing the better structure, the more efficient cost structure and the availability that is afforded by TransMedics logistics. And again, I point to the results.

我就不說了。我認為中心正在開始或實際上見證更好的結構、更有效率的成本結構和 TransMedics 物流所提供的可用性。我再次指出結果。

Understood, thank you. Can you just provide an update here on what you're seeing in the international markets and kind of what the expectations are there? And just as a quick follow-up then to, are there any like encouraging opportunities following the ISHLT meetings that took place?

明白了，謝謝。您能否就您所看到的國際市場的最新情況以及預期提供一些資訊？那麼，作為一個快速的後續問題，在 ISHLT 會議召開之後，是否還存在任何令人鼓舞的機會？

Excellent question and thank you for asking it. There is a tremendous focus on the success of NOP in the United States that are many major European countries are coming to TransMedics and offering to collaborate on establishing NOPs across Europe. We're seeing similar behavior in the Middle East, specifically in Saudi Arabia. We had several discussions at the ISHLT.

非常好的問題，謝謝您提出這個問題。美國非常關注 NOP 的成功，許多歐洲主要國家也加入 TransMedics 並提出合作在歐洲各地建立 NOP。我們在中東，特別是沙烏地阿拉伯也看到了類似的行為。我們在 ISHLT 進行了幾次討論。

The way I want to characterize it is, absolutely, we're focusing on replicating the success of the NOP because we believe the problem that the NOP solves for in the US is exactly the same problem ex US. However, we want to prioritize securing reimbursement first to make sure that our services will get reimbursed. And one final qualifier, when I talk about NOP ex US, we're talking only on the clinical support service, no logistics and no surgical procurement, just for clarification purposes. So yes, there's a huge momentum around NOP replication OUS and TransMedics fully expects to be ready to implement those once we are confident that our services will be reimbursed.

我想表達的是，我們絕對致力於複製 NOP 的成功，因為我們相信 NOP 在美國解決的問題與美國以外的問題完全相同。然而，我們希望優先確保報銷，以確保我們的服務能夠得到報銷。最後再說明一下，當我談到美國的 NOP 時，我們只談臨床支援服務，不包括物流和手術採購，只是為了澄清一下。所以是的，NOP 複製 OUS 的勢頭十分強勁，一旦我們確信我們的服務能夠得到報銷，TransMedics 就完全有信心準備好實施這些措施。

Perfect. Thanks guys, and congrats again, gentlemen.

完美的。謝謝大家，先生們，再次恭喜你們。

Thank you.

謝謝。

(Operator Instructions) [Samantha], Piper Sandler.

(操作員指示)[薩曼莎]，派珀·桑德勒。

Hi, this is Samantha on for Matt. I guess just to start off, if you could talk a little bit more about your guidance for the rest of the year and what's baked into the low end and the high end of that range.

大家好，我是 Samantha，為 Matt 主持節目。我想首先，您能否再多談一下今年剩餘時間的指導，以及該範圍的低端和高端是什麼。

Samantha, this is Stephen. Yeah, I mean we think there's opportunity to continue to grow sequentially, as I mentioned in an answer to the earlier call. And if we're able to add or go deeper in a few of our centers, we should be able to get to that high end. I mean some of these things will come to fruition. And so the low end is just being a little bit more conservative about the pace of how we do that, so it's a pretty narrow range and we feel confident that we'll be able to meet it.

莎曼珊，這是史蒂芬。是的，我的意思是我們認為有機會繼續連續成長，正如我在之前的電話會議中提到的那樣。如果我們能夠增加或深入我們的一些中心，我們應該能夠達到那個高端。我的意思是其中一些事情將會實現。因此，低端只是對於我們實現這一目標的速度稍微保守一點，所以這是一個相當狹窄的範圍，我們有信心能夠滿足它。

Great. And then just one more from us. I know you've talked a little bit in the past about the expected product service mix. And how can we expect that to change throughout the year particularly -- your costs throughout the year?

偉大的。然後我們再說一個。我知道您過去曾談論過預期的產品服務組合。我們如何預期這項變更會在全年產生影響—特別是您的全年成本？

Yeah, so it's a good question. We've been kind of keeping an eye on the product and service mix. It ended up 36.7% service. I think it's going to get a little bit more than that.

是的，這是個好問題。我們一直在關注產品和服務組合。最終服務率為36.7%。我認為結果還會比這更多。

It might be between, say, between 37% to potentially 39%. I think that's probably the top end. So it's a little higher than I had given a view earlier in the year based on the outcomes we're seeing. But we still think we're going to see overall gross margin continue to improve.

可能在 37% 到 39% 之間。我認為那可能就是最高境界了。因此，根據我們看到的結果，這個數字比我今年早些時候給出的預測要高一些。但我們仍然認為整體毛利率將繼續提高。

Thank you.

謝謝。

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

謝謝。我們的問答環節到此結束。我想將會議交還給瓦利德·哈桑寧 (Waleed Hassanein)，請他作最後發言。

Thank you so much, operator. Thank you so much, everybody, for joining us on this call this evening and we're looking forward to our next call. Have a wonderful evening, everyone.

非常感謝，接線生。非常感謝大家參加今晚的電話會議，我們期待下次電話會議。祝大家有個美好的夜晚。

Thank you. This concludes today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful day.

謝謝。今天的電話會議到此結束。我們感謝大家參加今天的演講。現在您可以斷開連接並享受美好的一天。