(TMDX) 2024 Q1 法說會逐字稿

Good afternoon and welcome to Transmedics' first-quarter 2024 earnings conference call.

下午好，歡迎參加 Transmedics 2024 年第一季財報電話會議。

At this time, all participants are in a listen-only mode.

此時，所有參與者都處於只聽模式。

We will be facilitating a question-and-answer session towards the end of today's call.

我們將在今天的電話會議結束時安排問答環節。

As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Lynn Morgen from the Gilmartin Group for a few introductory comments.

謹此提醒，本次通話將會被錄音以供重播。我現在想將電話轉給吉爾馬丁集團的林恩摩根 (Lynn Morgen)，請其發表一些介紹意見。

Thank you, operator.

謝謝你，接線生。

Earlier today, TransMedics released financial results for the quarter ended March 31st, 2020.

今天早些時候，TransMedics 發布了截至 2020 年 3 月 31 日的季度財務表現。

For 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.

如需新聞稿副本，請造訪公司網站。在我們開始之前，我想提醒您，管理層將在本次電話會議期間（包括電話會議的問答部分）發表聲明，其中包括聯邦證券法含義內的前瞻性聲明。

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, our 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.

本次電話會議中包含的與對未來事件、結果或業績的預期或預測相關的任何聲明均為前瞻性聲明，所有前瞻性聲明包括但不限於我們對營運趨勢的審查、我們產品的潛在商業機會和時機新的臨床項目和我們未來的財務預期，其中包括對我們組織和指導成長的預期以及我們對收入的預期。

Gross margins and operating expenses in 2024 and beyond are based upon our 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 or Accordingly, you should not place undue reliance on these statements and additional information regarding these risks and uncertainties appear appears under the heading Risk Factors of our Form our 10 K filed with the Securities and Exchange Commission on February 27th, 2020 for our subsequent Form 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 candidate to claim 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.

2024 年及以後的毛利率和營運費用是基於我們目前的估計和各種假設。重大差異，或因此，您應該請勿過度依賴這些聲明，有關這些風險和不確定性的其他資訊出現在我們於2020 年2 月27 日向美國證券交易委員會提交的表格10 K 的風險因素標題下，用於我們的後續表格和後續表格10 Q今天的收益新聞稿中包含的文件和前瞻性聲明，可在www.SEC.gov 和我們的網站www.TransMedics.com 上獲取，候選人聲明任何意圖或義務，除非法律要求更新或修改任何財務預測或前瞻性陳述，無論是由於新資訊、未來事件或其他原因。

This conference call contains time-sensitive information and is accurate only as of the live broadcast today, April 30th, 2024. And with that, I will now turn the call over to Waleed Hassanein, President and Chief Executive Officer.

本次電話會議包含時效性訊息，僅截至今天（2024 年 4 月 30 日）直播時準確。

Thank you, Lane.

謝謝你，萊恩。

Good afternoon, everyone.

大家下午好。

And welcome to TransMedics First Quarter 2024 earnings call.

歡迎參加 TransMedics 2024 年第一季財報電話會議。

As always, joining me today is Stephen Gordon, our Chief Financial Officer.

像往常一樣，今天與我一起出席的是我們的財務長 Stephen Gordon。

For the past two years, TransMedics has delivered exceptional revenue growth while making transformational investments in our business.

過去兩年，TransMedics 在對我們的業務進行轉型投資的同時，實現了卓越的營收成長。

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.

2024 年是另一個關鍵的一年，不僅是為了實現卓越的成長，而且是為了擴大我們的基礎設施和產品線，以推動獲利能力的進一步成長，更重要的是，增加移植量。

Specifically, we are focused on three verticals.

具體來說，我們專注於三個垂直領域。

First, completing the initial build-out phase of our TransMedics aviation fleet and transplant logistics infrastructure.

首先，完成 TransMedics 航空機隊的初始建設階段並移植物流基礎設施。

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.

其次，準備啟動三個主要的新臨床項目，以加速 OCS 肺部和 OCS 心臟的採用，並擴大我們在美國 OCS 心臟的臨床適應症。

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 with 1Q results representing a new high watermark for our business. Let me review the key highlights for first quarter performance.

最後，透過我們獨一無二的 NOP 進一步增加全國移植總量。程式.在各個方面，我們以非常強勁的勢頭開始了新的一年，以實現這些目標，第一季的業績代表了我們業務的新高水位。讓我回顧一下第一季業績的主要亮點。

Total revenue for Q1 grew to $96.9 million, representing 133% growth over Q1 2023 and a 19% sequential growth from Q4 2023.

第一季的總營收成長至 9,690 萬美元，比 2023 年第一季成長 133%，比 2023 年第四季環比成長 19%。

This growth was achieved through increased utilization of both Four-Cs product across lung, heart and liver as well as TransMedics transplant logistics service.

這一增長是透過提高肺部、心臟和肝臟領域 4-C 產品的利用率以及 TransMedics 移植物流服務來實現的。

I want to highlight that the diversified nature of our growth to dispel any potential miss perception that our growth is only driven overwhelmingly by transplant logistics revenue growth.

我想強調的是，我們成長的多元化性質，以消除任何潛在的誤解，即我們的成長主要是由移植物流收入成長所推動的。

Said differently, we fully expect I repeat, we fully expect our future growth to be driven by both increased product and transplant logistics adapt 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.

換句話說，我們完全期望我重複一遍，我們完全期望我們未來的成長將由產品和移植物流的增加推動，適應TransMedics 移植物流服務第一季的營收為1,450 萬美元，高於去年第四季的920萬美元，相當於約58季環比成長率。

We are continuing to demonstrate that our integrated and cost effective efficient, TransMedics MOP and logistics service infrastructures.

我們將繼續展示我們整合且具有成本效益的高效 TransMedics MOP 和物流服務基礎設施。

It's delivering real value to transplant programs across the US.

它為美國各地的移植項目帶來了真正的價值。

We remain focused on expanding our operational capabilities for TransMedics logistics throughout 2024, which will which I will detail further on later in the presentation today.

我們仍然致力於在 2024 年擴大 TransMedics 物流的營運能力，我將在今天的演講中進一步詳細介紹這一點。

Our overall gross margins for Q1 was 62%, up from 59% last quarter.

我們第一季的整體毛利率為 62%，高於上季的 59%。

And in line with our expectations, we are extremely confident that we will be able to further improve the gross gross margin over the next 12 to 18 months as we achieve more leverage of scale in both products and service operations.

與我們的預期一致，我們非常有信心，隨著我們在產品和服務營運方面實現更大的規模槓桿，我們將能夠在未來 12 至 18 個月內進一步提高毛利率。

Strong growth in revenue and gross margins enabled us to deliver GAAP operating profit of $12.4 million, which represents 13% of total revenue.

營收和毛利率的強勁成長使我們能夠實現 GAAP 營業利潤 1,240 萬美元，佔總收入的 13%。

Net income was $12.2 million.

淨利潤為 1220 萬美元。

We are very proud to have achieved these profitability metrics while still investing heavily in future growth.

我們非常自豪能夠實現這些獲利指標，同時仍在大力投資未來的成長。

We remain laser focused, however, on delivering sustainable positive operating cash flow over the next several quarters.

然而，我們仍然專注於在未來幾季提供可持續的正營運現金流。

Before moving on to our momentum beyond our financial performance.

在繼續我們的財務表現之外的動力之前。

I'd like to take a moment to recognize the entire TransMedics team, which had which has worked tirelessly to achieve these results.

我想花點時間向整個 TransMedics 團隊表示認可，他們為取得這些成果而不懈努力。

We are full.

我們已經滿了。

We are focused on execution to build upon Q1 results. Now with that background, let me provide more detail across key operating metrics.

我們專注於以第一季業績為基礎的執行力。現在，有了這樣的背景，讓我提供有關關鍵營運指標的更多詳細資訊。

As I stated above, we set a new high watermark for case volume across all three, Oregon markets in Q1.

正如我上面所說，我們在第一季為俄勒岡州所有三個市場的案件量設定了新的高水位。

Overall, NOP contribution remains at 98 plus percent of our case volume, a trend which we expect will continue throughout the foreseeable future.

總體而言，NOP 貢獻仍占我們案件量的 98% 以上，我們預計這一趨勢將在可預見的未來持續下去。

Turning now to the key TransMedics transplant logistics metrics.

現在轉向關鍵的 TransMedics 移植物流指標。

Through Q1, we continued to expand our fleet of owned aircraft, reaching 14 owned aircraft by end of the quarter.

第一季度，我們繼續擴大自有飛機機隊，到本季末達到 14 架自有飛機。

Meanwhile, the daily average number of active mix.

同時，日均活躍組合數量。

Aviation planes were nine planes in Q1 compared to seven in Q4 of 2023.

航空飛機在第一季為 9 架，而 2023 年第四季為 7 架。

We expect this number will continue to increase throughout the year as we strive to reach 15 to 20 operational aircraft.

我們預計這一數字將在全年繼續增加，我們力爭達到 15 至 20 架營運飛機。

By year end, our owned aircraft covered approximately 49% of our NOP. flight missions in Q1 compared to 35% in Q4 of 23.

到年底，我們自有飛機覆蓋了約 49% 的 NOP。第一季的飛行任務數為 23 次，而第四季為 35%。

This further underscores the potential long runway to drive additional growth and maximizing efficiency across our transplant logistics operations.

這進一步凸顯了推動我們的移植物流業務進一步成長並最大限度提高效率的潛在漫長道路。

As we stated before, at scale, we fully expect to cover 80 plus percent of debt total NOP emissions using our TransMedics logistics services for both air and ground transport.

正如我們之前所說，從規模上看，我們完全希望使用我們的 TransMedics 空中和地面運輸物流服務來覆蓋 80% 以上的 NOP 債務排放總量。

We will continue to use carefully selected highly reliable and safe operators for supplemental lifts to support our additional missions.

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機，以支援我們的額外任務。

From a customer footprint perspective, we have also continued to grow the number of programs that are using our transplant logistics services in Q1, approximately 105 U.S. transplant programs use TransMedics logistics compared to approximately 97 in Q4 of 2023, as we have rapidly achieved this critical mass of users.

從客戶足跡的角度來看，我們在第一季也持續增加使用我們的移植物流服務的專案數量，大約105 個美國移植專案使用TransMedics 物流，而2023 年第四季約為97 個，因為我們迅速實現了這項關鍵目標海量用戶。

We are now focusing on going deeper within these programs and meeting more of their transplant logistics needs going forward.

我們現在專注於深入這些項目並滿足他們未來更多的移植後勤需求。

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.

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，TransMedics 物流的移植計劃具有顯著的成本效率和可靠性。

We look forward to expanding further throughout the year and into 2025 as we scale our air fleet and ground operations.

隨著我們擴大機隊和地面營運規模，我們期待在全年和 2025 年進一步擴大規模。

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.

我們也對來自現實世界結果的臨床證據基礎不斷增加以及臨床移植使用者對我們的產品日益興奮感到鼓舞。

We saw this excitement firsthand in April of this year as we attended the International Society of Heart Lung Transplant conference in Prague at the meeting.

今年四月，當我們參加在布拉格舉行的國際心肺移植協會會議時，我們親眼目睹了這種興奮。

Several scientific presentations by transplant academic experts demonstrating the value of OCS Heart and OCS Lung were presented.

移植學術專家發表了幾場科學演講，展示了 OCS 心臟和 OCS 肺的價值。

Here are the key highlights.

以下是主要亮點。

Dr. Jacobs charter from Duke presented the OCS Heart perfusion or OHP. registry experience with DCD heart transplants in the U.S., the data demonstrated that OCS Heart was used in approximately three quarters of all DCD Heart transplanted at OHP. registry centers.

杜克大學的 Jacobs 博士介紹了 OCS 心臟灌注或 OHP。根據美國 DCD 心臟移植的註冊經驗，數據顯示 OCS 心臟在 OHP 的所有 DCD 心臟移植中大約四分之三使用了 OCS 心臟。登記中心。

The data also demonstrated that OCS DCD heart transplants had superior patient survival outcomes compared to NRPDCD. transplants in high-risk recipients.

數據還表明，與 NRPDCD 相比，OCS DCD 心臟移植具有更好的患者存活結果。高危險群受者的移植。

This provides evidence this provided evidence that OCS Heart affords better protection of the DCD donor hearts as compared to NRP during his presentation, Dr. Schroeder commented that the overall OCSNOP. cost is more favorable to NRP costs when factoring in the cost of dry runs that clinical support, overhead, Anda and hardware costs.

Schroeder 博士在演講中評論說，這提供了證據表明 OCS Heart 與 NRP 相比，OCS Heart 可以更好地保護 DCD 捐贈者心臟。當考慮到臨床支援、管理費用、Anda 和硬體成本的試運行成本時，成本對 NRP 成本更有利。

Importantly, Dr. Shore, I highlighted that the OCSNOP. enhances the ability of for any heart transplant program in the U.S. 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 that TransMedics NOP staff.

肖爾博士，重要的是，我強調了 OCSNOP。增強了美國任何心臟移植計畫向患者提供 DCD 心臟移植臨床服務的能力，而無需承擔管理費用和臨床學習曲線的負擔，並由 TransMedics NOP 提供標準或統一的捐贈者心臟採購和管理職員。

Next, Dr. Danny diminishment from money diminishment from Emory University Medical Center presented the outcomes of OCSDCD. compared to standard of care DBD hearts in the US.

接下來，來自埃默里大學醫學中心的 Danny 博士介紹了 OCSDCD 的結果。與美國 DBD 心臟護理標準相比。

The data showed that OCSDCD. hearts were transported nearly doubled the distance from donor to recipients and had doubled across prime time.

數據顯示，OCSDCD。心臟從捐贈者到接受者的距離幾乎增加了一倍，並且在黃金時段也增加了一倍。

This signifies the broader access to DCD donors afforded by OCSNOP.

這意味著 OCSNOP 可以更廣泛地接觸 DCD 捐助者。

The data also showed that despite higher risk donor factors, OCS clinical outcomes were similar to standard criteria, DBD outcomes in the US.

數據也顯示，儘管捐贈者風險較高，OCS 臨床結果與美國的標準 DBD 結局相似。

This further validates the safety profile of the OCS Heart.

這進一步驗證了 OCS Heart 的安全性。

Simply stated, the OCS enabled a DCD heart transplant to have similar survival outcomes to the U.S. national DBD heart transplant outcomes, which are the best in the world.

簡而言之，OCS 使 DCD 心臟移植的生存結果與美國國家 DBD 心臟移植的結果相似，這是世界上最好的。

Dr. management also highlighted that the increase of the increased use of OCSNOP. has led to significant reduction in moderate and severe primary graft dysfunction or PGD. after OCS DCD heart transplant.

管理階層博士也強調，OCSNOP 使用量的增加。導致中度和重度原發性移植物功能障礙或 PGD 顯著減少。 OCS DCD 心臟移植後。

Severe PGD. is the most severe early post heart transplant clinical complication and historically has been associated with worse short and long-term patient survival.

嚴重PGD。是心臟移植後最嚴重的早期臨床併發症，歷史上與患者短期和長期存活率較差有關。

Next, Dr. Maurer HU. village sends you from Mayo Clinic presented the OCS Heart DBD experience from the OHB. registry data showed that OCSNOP. resulted in excellent post-transplant clinical outcomes from DBD donors compared to standard criteria.

接下來是 Maurer HU 博士。梅奧診所 (Mayo Clinic) 向您介紹了 OHB 的 OCS Heart DBD 經驗。註冊表資料顯示 OCSNOP。與標準標準相比，DBD 捐贈者獲得了優異的移植後臨床結果。

Donors preserved with static cold storage despite having three times longer distance travel and doubled across time time in the OCS. and OPR.

儘管捐贈者在 OCS 中的旅行距離增加了三倍，時間也增加了一倍，但仍使用靜態冷藏保存。和OPR。

Again, this data validates the broader access to distant donors and potential for improved workflow afforded by the OCSNOP.

這些數據再次驗證了 OCSNOP 可以更廣泛地接觸遠端捐助者以及改善工作流程的潛力。

Dr. de Boer from Baylor St. Luke's presented the OCS Lung EXPAND trial five year clinical results.

貝勒聖路加醫院的 de Boer 博士介紹了 OCS Lung EXPAND 試驗的五年臨床結果。

The data showed that the OCS Lung expand once from extended criteria.

數據顯示 OCS 肺部根據擴展標準擴張一次。

DBD. and DCD. donors had similar survival and freedom from chronic rejection at five years post transplant compared to routine standard criteria.

DBD。和DCD。與常規標準相比，捐贈者在移植後五年的存活率和免於慢性排斥的情況相似。

Ebitda long transplanted at the same program over the same time period.

稅息折舊及攤銷前利潤 (Ebitda) 長期移植到同一計劃、同一時段。

These results support the huge clinical potential of increasing donor lung utilization for transplants using extended criteria, DBD. and DCD. donors in the US.

這些結果支持使用擴展標準 DBD 提高移植供體肺部利用率的巨大臨床潛力。和DCD。美國的捐助者。

Finally, Dr. Steve Hudson from University of Minnesota shared the latest data from the thoracic OCS perfusion registry or the top registry.

最後，來自明尼蘇達大學的Steve Hudson博士分享了胸腔OCS灌注登記處或頂級登記處的最新數據。

The data showed that the OCS Lung enabled the use of extended criteria, donor lungs from DVD and DCD donors and resulted in post-transplant survival outcomes that are similar to standard criteria lung transplant, despite nearly having double 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.

數據顯示，OCS 肺能夠使用擴展標準，即來自 DVD 和 DCD 供體的供體肺，並產生與標準肺移植相似的移植後生存結果，儘管交叉鉗夾時間幾乎增加了一倍，再次進一步驗證了對擴大供體庫和美國肺移植量的潛在增長的巨大臨床影響。

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.

總的來說，這些演講再次強調了我們不斷增長的積極臨床證據以及 OCS 和 NOP 帶來的卓越臨床結果。

Now let me shift gears and talk about our plans to further grow OCS adoption and the overall national U.S. transplant volumes even further. Specifically, I want to 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 part of the clinical indications in the U.S. pending FDA approval, we expect that all three programs will initiate enrollment within the next year.

現在讓我換個話題，談談我們進一步提高 OCS 採用率和美國全國移植總量的計畫。具體來說，我想討論三個新的主要臨床項目，旨在提高我們的OCS、肺和OCS 心臟的採用率，並擴大我們的OCS 部分臨床適應症在美國的臨床適應症，等待FDA 批准，我們預計這三個項目項目將於明年開始招生。

Let me start with detailing the OCS lung program.

讓我先詳細介紹 OCS 肺部計劃。

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.

正如我們多次指出的，我們認為美國肺移植市場的臨床利益相關者需要重新認識 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 enhance workflow remain under appreciated.

更具體地說，我們認為 OCS、肺部和 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然受到重視。

Our goal is to replicate the successful outcomes achieved with OCS.

我們的目標是複製 OCS 的成功成果。

Liver were 62% of transplant volumes at OCS. and OP. programs are now done in the morning working hours compared to middle of the night and replicating that with OCS Lung or said differently, we want to have lung transplant programs and clinical and surgeons' experience firsthand the value of OCSNOP. to enable morning transplants while growing their overall transplant volumes and improving their post-transplant clinical outcomes.

OCS 中肝臟佔移植體積的 62%。和OP。與半夜相比，現在的計畫是在早上工作時間完成的，並透過OCS Lung 複製這一點，或者換句話說，我們希望透過肺移植計畫以及臨床和外科醫生的第一手經驗來了解OCSNOP 的價值。實現早晨移植，同時增加整體移植量並改善移植後臨床結果。

To do this, we're planning to launch a new clinical program to achieve the following.

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 a transplantable donor lungs and Optimiz work hours for transplant program staff.

首先，我們的目標是使用 NOP 進行至少 12 至 24 小時以上的 OCS 肺灌注。模型以增加獲得可移植供體肺的機會並優化移植計劃工作人員的工作時間。

Importantly, we aim to prospectively randomized between OCSNOP. versus controlled cold static storage to assess the clinical value.

重要的是，我們的目標是在 OCSNOP 之間進行前瞻性隨機化。與受控冷靜態儲存來評估臨床價值。

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 long perfusion times on lung function.

我們還計劃使用新開發的接近生理的OCS灌注溶液與血液相結合，以盡量減少較長灌注時間對肺水腫的影響，並有可能消除長時間灌注時間對肺功能的任何臨床擔憂。

We will also use next gen perfusion circuitry and ventilation modalities to maximize that protection for the donor lungs during prolonged OCS perfusion and ex vivo installation, we expect the entire clinical program to be managed via NOP to increase the rate of enrollment and adoption during the trial phase.

我們還將使用下一代灌注電路和通氣方式，在長時間的OCS 灌注和離體安裝過程中最大限度地保護供體肺部，我們預計整個臨床計劃將透過NOP 進行管理，以提高試驗期間的入組率和採用率階段。

From a timing perspective, we are targeting initiation of this program sometime around the end of 2024.

從時間角度來看，我們的目標是在 2024 年底左右啟動該計劃。

Now let me move on to our planned OCS heart programs.

現在讓我繼續討論我們計劃的 OCS 心臟計劃。

We are also actively working on two distinct large OCS heart programs in the U.S. that will be also managed exclusively via the OCSNOP. model.

我們也在美國積極進行兩個不同的大型 OCS 心臟項目，這些項目也將透過 OCSNOP 獨家管理。模型。

The first is OCS Heart therapeutic warm perfusion for DBD heart.

第一個是針對 DBD 心臟的 OCS Heart 治療性溫灌注。

This program is aimed at increasing utilization of DBD heart from both standard and extended criteria donors to increase the overall heart transplant volumes in the US, we intend to target 12 hours 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.

該計劃旨在提高標準和擴展標準捐贈者對 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，以增加捐贈者心臟的獲取和優化我們移植專案人員的工作時間。

We will also aim to prospectively randomized or OCSNOP. versus controlled cold static storage to assess the clinical value.

我們也將致力於前瞻性隨機或 OCSNOP。與受控冷靜態儲存來評估臨床價值。

We're planning not only to use our newly developed near physiologic OCS perfusion solution combined with blood.

我們計劃不僅使用我們新開發的近生理 OCS 灌注溶液與血液結合。

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 targeting initiation some of this program sometimes around the end of 2024.

但在這個特定項目中，我們添加了一種新的專有代謝增強治療劑，以最大限度地保護捐贈者心臟並改善其移植後臨床表現。從時間角度來看，我們的目標是在 2024 年底左右啟動該計劃的部分內容。

And finally, our second heart program is a new program that will require a new technology from the ground up.

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。

It's aiming at OCS Heart called oxygenated perfusion for DBD hearts that are preserved for less than six hours.

它的目標是 OCS Heart，稱為氧合灌注 DBD 心臟，保存時間不超過 6 小時。

This program is designed to support a new FDA clinical indication for OCS Heart in the U.S. that will allow us to profuse and preserve standard criteria DBD heart for less than six hours, which is not our current clinical indications in the US.

該計劃旨在支持美國 OCS 心臟的新 FDA 臨床適應症，這將使我們能夠在不到六個小時的時間內豐富和保存標準 DBD 心臟，這不是我們目前在美國的臨床適應症。

To do this, we are planning to offer a new lower-cost product that utilizes called oxygenated blood based perfusion technology.

為此，我們計劃提供一種新的低成本產品，該產品利用基於含氧血液的灌注技術。

More specifically, we're developing our new pulsatile, fully portable cold perfusion technology and cold profusion circuitry to achieve easy to use system for use within our existing NOP. model.

更具體地說，我們正在開發新的脈衝式、完全便攜式冷灌注技術和冷灌注電路，以實現在我們現有的 NOP 中使用的易於使用的系統。模型。

Again, we'll aim to prospectively randomized to hold controlled a controlled cold static storage to assess the clinical value, and we are targeting early 2025 to initiate this important clinical program.

同樣，我們的目標是前瞻性隨機化以控制受控冷靜態儲存來評估臨床價值，我們的目標是在 2025 年初啟動這項重要的臨床計畫。

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 are not stopping here.

正如您所看到的，我們正在推動一系列非常強大的臨床計劃，旨在推動美國 OCS 病例數量和全國心胸移植總量的顯著增長，但是，我們並沒有就此止步。

We are also continuing to invest heavily in our next-gen OCS technology platform for all four for all three organs that will be highly automated optimized for NLP. 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.

我們也將繼續大力投資下一代 OCS 技術平台，用於所有四個器官的所有三個器官，該平台將針對 NLP 進行高度自動化最佳化。工作流程，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。

We plan to share more details and details on this initiative later this year. To summarize, we are highly encouraged by our Q1 performance and our focus on several initiatives designed to further propel growth for TransMedics products and services.

我們計劃在今年稍後分享有關此舉措的更多細節和細節。總而言之，我們對第一季的業績以及我們對旨在進一步推動 TransMedics 產品和服務成長的多項舉措的關注感到非常鼓舞。

Given our strong performance in Q1, we are increasing our annual revenue guidance to 390 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.

鑑於我們第一季的強勁表現，我們將年度營收指引提高至 390 至 4 億美元，這比 2023 年全年營收成長 61% 至 66%。接下來，讓我致電史蒂芬，介紹本季的詳細財務表現。

Thank you, Waleed.

謝謝你，瓦利德。

I will now provide some additional detail on the Q1 results and other financial information for the quarter.

我現在將提供有關第一季業績和本季度其他財務資訊的一些額外詳細資訊。

Starting with revenue.

從收入開始。

For the first quarter of 2024, our total revenue was $96.9 million.

2024 年第一季度，我們的總收入為 9,690 萬美元。

This is an increase of 133% from the first quarter of 2023 and a 19% sequential increase from last quarter.

這比 2023 年第一季成長了 133%，比上季環比成長了 19%。

The $96.9 million included $0.9 million related to our flight school.

9,690 萬美元包括與我們的飛行學校相關的 90 萬美元。

We have now exited all of the somewhat Legacy Charter business.

我們現在已經退出了所有有點遺留的包機業務。

So other than this 900 K from the flight school, all revenue is transplant related in the U.S. transplant revenue was $91.9 million.

因此，除了來自飛行學校的這 90 萬美元之外，所有收入都與移植相關，在美國，移植收入為 9,190 萬美元。

U.s. revenue increased 145% from the first quarter of 2023 and 22% sequentially from last quarter.

我們。營收較 2023 年第一季成長 145%，季增 22%。

And as Wally said, Q1 2024 revenue included $14.5 million of logistics revenue.

正如沃利所說，2024 年第一季的收入包括 1,450 萬美元的物流收入。

The organ breakdown on U.S. revenue was $67 million of liver $1.2 million of heart and $4.7 million of loan.

美國收入中的器官細分為 6,700 萬美元的肝臟、120 萬美元的心臟和 470 萬美元的貸款。

All organs growing substantially over Q1 2023 and sequentially from Q4 2023, ex U.S. revenue was $4.1 million, a 1% increase from Q1 of 2023 and a 16% sequential increase from last quarter.

所有器官在 2023 年第一季以及從 2023 年第四季開始連續成長，美國除外的收入為 410 萬美元，比 2023 年第一季增長 1%，比上季度連續增長 16%。

The ex U.S. breakdown was $3.1 million of heart and $1 million of luck.

美國前的損失是 310 萬美元的愛心和 100 萬美元的運氣。

Next on the product and service revenue.

接下來是產品和服務收入。

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.

請注意，我們的服務收入包括我們對 NOP 收取的附加費用。手術採購和器官管理的臨床服務還包括後勤收入。

The flight school is also included in service revenue.

飛行學校也計入服務收入。

In Q1, product revenue was $61.3 million and service revenue was $35.5 million for the service portion was 36.7% of the total gross margin for the first quarter of 2024 was 62%.

第一季度，產品收入為 6,130 萬美元，服務收入為 3,550 萬美元，服務部分佔總毛利率的 36.7%，2024 年第一季為 62%。

This is down from 69% in the first quarter of 2023 and up from 59% last quarter.

這比 2023 年第一季的 69% 有所下降，但比上季的 59% 有所上升。

In comparison to Q1 last year.

與去年第一季相比。

This reflects the higher service component of our business, which did not include logistics in the first quarter last year.

這反映出我們業務的服務部分較高，去年第一季不包括物流。

Product margin was 77% in Q1 recovering as expected to more normalized product margins from the 73% we saw in Q4, which included a one-time unfavorable IT service margin was 36%, improved from 35% last quarter as we continue to gain efficiency in our service offering.

第一季的產品利潤率為77%，如預期從第四季的73% 恢復到更正常化的產品利潤率，其中包括一度不利的IT 服務利潤率為36%，隨著我們繼續提高效率，該利潤率從上季度的35% 有所改善在我們的服務中。

And as a reminder, all costs related to aviation, including fuel pilots, maintenance and depreciation are included on our service costs.

提醒一下，所有與航空相關的成本，包括燃油飛行員、維修和折舊都包含在我們的服務成本中。

Total operating expenses for the quarter were $47.5 million, 54% above Q1 2023 OpEx.

該季度的總營運支出為 4,750 萬美元，比 2023 年第一季的營運支出高出 54%。

This expense growth was driven by 94% growth in R&D related to investments in new product development and OP tools and products, quality and regulatory resources.

這項費用成長是由與新產品開發、OP 工具和產品、品質和監管資源投資相關的研發成長 94% 所推動的。

Sg&a grew 45%, primarily related to higher personnel costs and overall corporate infrastructure.

SG&A 成長了 45%，主要與人員成本和整體公司基礎設施的增加有關。

I want to point out that our operating expenses grew significantly throughout the year last year.

我想指出的是，去年我們的營運費用全年大幅成長。

So the year-on-year growth comparison next quarter, it should not be as pronounced as it was this quarter.

所以下個季度的年成長對比，應該不會像本季那麼明顯。

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 compared with an operating loss of $2.6 million and also a net loss of $2.6 million in Q1 of 2023 and basic earnings per share in the quarter was $0.37 and diluted earnings per share in the quarter was $0.35.

鑑於強勁的營收和利潤率表現，我們能夠實現1240 萬美元的GAAP 營業利潤，即收入淨利潤1220 萬美元的13%，而2023 年第一季的營業虧損為260 萬美元，淨虧損為260 萬美元，本季基本每股收益為 0.37 美元，稀釋每股收益為 0.35 美元。

Total cash at the end of the quarter was $350.2 million as of March 31st, 2024.

截至 2024 年 3 月 31 日，本季末現金總額為 3.502 億美元。

This is down $44.6 million from December 31st, 2023, $39 million of cash was used to purchase three additional jets in Q1, bringing our total number of owned jets to 14 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.

這比2023 年12 月31 日減少了4,460 萬美元，第一季使用了3,900 萬美元現金購買了另外三架飛機，使我們擁有的飛機總數達到14 股，本季已發行基本加權平均普通股為3,280 萬美元，稀釋加權平均該季已發行普通股為 3,470 萬美元。總之，第一季對於 TransMedics 來說是一個非常成功的季度，我們的收入逐年增長，環比增長，毛利率提高，盈利能力下降良好。

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 U.S.

所有這些都繼續驗證我們的策略，即利用我們的 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, while these 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 will turn the call back to our lead for closing comments.

最後，重申一下，在發表上述評論的同時，我們正在將年度收入指引更新為 3.9 億至 4 億美元，這意味著 2023 年全年增長 61% 至 66%。的結束評論。

Thank you, Stephen.

謝謝你，史蒂芬。

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.

總體而言，我們對第一季的業績感到謙卑和自豪，因為我們同時推動了收入的持續成長，擴大了基礎設施並實現了盈利，同時推進了我們的臨床和研發管道。

We're looking forward to continuing to execute on all the major initiatives throughout 2024 to drive broader adoption of OCSNOP. 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.

我們期待在 2024 年繼續執行所有主要舉措，以推動 OCSNOP 的更廣泛採用。整體移植量的成長以幫助需要器官移植的患者。現在，我將把電話轉給接線員進行問答。

Operator?

操作員？

(Operator Instructions) Allen Gong, JPMorgan.

（操作員指令）Allen Kong，摩根大通。

Thanks for the question and congratulations on a really strong quarter out of the gate.

感謝您的提問，並祝賀本季的表現非常強勁。

You know, I understand that no aviation likely help support, you know the beat in the services, but I think it was the beat in disposables that might be a little bit more surprising, given the fact that that kind of thing on a dollar basis relative to my forecast drove more of the upside.

你知道，我知道沒有航空業可能會提供幫助，你知道服務的節拍，但我認為一次性用品的節拍可能更令人驚訝，因為這種事情以美元為基礎相對於我的預測，上漲幅度更大。

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?

所以我想除了完成一些 NOP 之外。您之前可能因外部物流的限製而損失的案例，本季還有哪些正確的做法可以讓您推動這些額外的銷售？

Thank you, Allen, for the question on a lot of things.

謝謝艾倫提出很多問題。

When I went right in the first quarter and we hope to continue to execute in the same tone going forward, the most important thing is on the outcomes, the outcomes that are being achieved across the board.

當我在第一季採取正確的行動時，我們希望繼續以同樣的基調繼續執行，最重要的是結果，全面實現的結果。

I'm now more transparent to the clinical users.

我現在對臨床用戶更加透明。

Specifically, the liver continues to grow.

具體來說，肝臟繼續生長。

They know but specifically for Heart and Lung, you know the the there was the Lund outcomes are getting better.

他們知道，但特別是對於心肺來說，你知道隆德的結果正在變得更好。

Our team has been working very hard at them and educating the market demonstrating the better outcomes and achieved with our newer use model and it resonated in the quarter.

我們的團隊一直在努力工作，並教育市場，展示了我們新的使用模式所取得的更好成果，並在本季度引起了共鳴。

Also, we're seeing the outcomes in heart is really helping growing the heart market and certainly the discouraging results.

此外，我們看到心臟的結果確實有助於心臟市場的發展，當然也看到了令人沮喪的結果。

We heard at the ISHLT from the cold for Fusion.

我們在 ISHLT 上聽說 Fusion 受到了冷落。

A study I may have may have fueled that, but it's really the outcomes that is driving our growth and we plan to continue to lean on outcomes.

我可能進行的一項研究可能推動了這一點，但真正推動我們成長的是結果，我們計劃繼續依靠結果。

And that's why we are investing in these three major cardiothoracic programs deliver delivers is already there and continues to grow, and we will continue to add centers and go deeper within existing centers.

這就是為什麼我們投資這三個主要的心胸外科項目，交付已經存在並繼續成長，我們將繼續增加中心並在現有中心內進行更深入的研究。

So everything went right.

所以一切都很順利。

Also the growth in the IT and the logistics business was important to help us get access to the cases that we couldn't get access to.

此外，IT 和物流業務的成長對於幫助我們接觸到我們無法接觸到的案例也很重要。

That's also helped.

這也有幫助。

But the fundamental growth from product is based basically in clinic based on clinical outcomes.

但產品的根本成長基本上是基於臨床結果的臨床。

Got it.

知道了。

And then a follow-up just kind of on seasonality and how we should think about that strength carrying forward? You know, if we kind of take the quarter, you just put up back it out of your updated guide really looks like you're setting your what should hopefully be a very achievable bar for the balance of the year, especially as you are now, you're adding more planes, you're going to be starting the quarter with more planes than used you had on average in first quarter.

然後是關於季節性的後續行動，以及我們應該如何考慮這種優勢的延續？你知道，如果我們採取這個季度的方式，你只需將其從更新的指南中恢復出來，看起來你確實正在設定今年剩餘時間內非常可實現的目標，尤其是現在，如果您要添加更多飛機，本季度開始時您將使用比第一季平均使用的飛機更多的飛機。

So why is this kind of a right target to go with and how should we think about the seasonal cadence implied by that guidance should be relatively flat?

那麼，為什麼這種目標是正確的呢？

I guess why would that be the case? I should yield the growth sequentially.

我想為什麼會這樣呢？我應該按順序產生增長。

Thank you. Thanks, Alan.

謝謝。謝謝，艾倫。

And I think they know there's there's many layers to answering that question, Allan and Stephen, please comment as well from your perspective, I think we as we always are cognizant of what potential operational challenges in front of us.

我認為他們知道回答這個問題有很多層面，艾倫和史蒂芬，也請從你的角度發表評論，我認為我們一如既往地認識到我們面前的潛在營運挑戰。

For example, we are very proud to have up operating 14 planes, hopefully in Q2, but we know that in the second half of the year.

例如，我們非常自豪能夠營運 14 架飛機，希望在第二季度實現，但我們知道要到下半年才能實現。

We have some of these planes are due for some annual service, so they're not going to be accessible to us.

我們有一些飛機將進行年度維修，因此我們將無法使用它們。

And so we factor that into the guidance.

因此，我們將這一點納入指南中。

We also factor in some of the, you know, any potential seasonality from summer vacations coming up or the holidays.

我們也考慮了即將到來的暑假或假期的一些潛在季節性因素。

So we always are prudent when it comes to guidance we want we want to when we issue guidance, we we take it very seriously.

因此，當涉及到我們想要的指導時，我們始終保持謹慎，當我們發布指導時，我們會非常認真地對待它。

So that's layered into our expectations here even for now, I would just say, look, we don't expect a down quarter sequentially.

因此，即使是現在，這也已經融入了我們的預期，我只想說，看，我們預計季度不會出現連續下滑。

We expect modest growth quarter over quarter, and that's the way we've modeled it.

我們預計季度環比將出現溫和成長，這就是我們的建模方式。

And I would expect that's what will come. And also and finally, and to put a bracket around that.

我希望這就是將會發生的事情。最後，還要加上括號。

We're operating from a much bigger starting point now.

我們現在正從一個更大的起點開始運作。

So we have we have to be cognizant of that.

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，TD·考恩。

Hi, good evening.

嗨，晚上好。

It's great to see such an impressive start to the year.

很高興看到今年有如此令人印象深刻的開局。

I was hoping that will lead to just circle back on the discussion we had earlier in the quarter, just about you have you have a lot of you have seen a lot of pipeline initiatives initiatives both on the technology front and on the clinical development front.

我希望這會導致我們回顧一下我們在本季度早些時候進行的討論，你們中的許多人都看到了技術方面和臨床開發方面的許多管道計劃舉措。

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?

但我們應該如何看待 OCS 系統可能會降低 DCO 捐贈者、DCD 捐贈者在心臟、肝臟和肺部沒有進展的比例，這是否會在未來 12 至 24 個月內發生？

And Josh, that's exactly our goal.

喬什，這正是我們的目標。

As we discussed this is the only system that we're aware of that exist out there that could help that picture.

正如我們所討論的，這是我們所知道的唯一可以幫助實現這一目標的系統。

Are those?

是那些嗎？

Yes. So with that's something we're planning to leverage over the next 12 to 24 months for sure.

是的。因此，我們計劃在未來 12 到 24 個月內充分利用這一點。

And we're hoping that once we launch these clinical programs, that becomes an opening on to the next program being focused on specifically growing the DCD. utilization.

我們希望一旦啟動這些臨床項目，就能為下一個專門培養 DCD 的計畫開啟機會。利用率。

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

出色的。然後是 ILTS 中的另一個主題。從本週開始，我想問如何更好地了解使用 OCS 的好處以及是否有優勢。北美對於融合和脂肪肝的熱情，以及患有脂肪肝的捐贈者的百分比，以及 OCS 保存方面的巨大差異。與冷藏甚至冷紙充氧灌注相比。

Thanks for taking the questions.

感謝您提出問題。

Thank you. bThank you, Josh, and thank you for asking the question.

謝謝。 b謝謝你，喬什，也謝謝你提出這個問題。

It's a very important question.

這是一個非常重要的問題。

Without running the risk of burning some of the key planning session presentations at the upcoming Altius and the community should be expecting that we will reveal data that shows our clinical superiority of fatty livers using one profusion compared to any other modality.

在不冒即將舉行的Altius 會議上的一些關鍵規劃會議演示文稿的風險的情況下，社區應該期待我們將披露數據，顯示我們使用一種豐富的脂肪肝治療方法相對於任何其他方式的臨床優越性。

And I'll leave it at that.

我就這樣吧。

It doesn't make sense to put fatty livers on ice, whether through perfusion or controlled or non-controlled static cold storage, it just doesn't make any sense because fat cells with cold storage or any cold and a form of preservation can deals and then the liver becomes more of a foreign object and a physiologic body.

將脂肪肝放在冰上是沒有意義的，無論是通過灌注還是受控或非受控的靜態冷藏，它只是沒有任何意義，因為冷藏或任何冷藏和某種形式的保存都可以處理脂肪細胞然後肝臟就變得更像是異物和一個生理體。

So we're looking forward to the to our investigators and lead users to present presenting this data at the plenary session on Saturday.

因此，我們期待我們的調查人員和主要用戶在周六的全體會議上展示這些數據。

And sorry to sneak a follow up.

抱歉偷偷跟進。

And but just any help just thinking about the percentage of donor livers that are fatty imagine it's a sizable chunk of the donor pool.

但只要想想脂肪供體肝臟的百分比，想像一下它在供體庫中佔很大一部分，就會有任何幫助。

Thanks a lot.

多謝。

It's very it's very it's a very sizable chunk.

這是非常非常非常大的一塊。

And again, the definition of fatty, it's varied some people consider fatty liver, anything greater than 15% will be presenting data on fatty liver greater than 25% or 30% even.

再說一次，脂肪的定義不同，有些人認為脂肪肝是不同的，任何大於 15% 的脂肪肝數據都會大於 25% 或 30%。

So we experienced the full gamut and again, there is a tremendous evidence supporting warm perfusion on OCS platform are having superior outcomes to any other modality for preservation of fatty livers.

因此，我們體驗了全方位，並且再次有大量證據支持 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結果。

And I'll leave it at that, Josh, thanks much.

我就這樣吧，喬什，非常感謝。

William Plovanic, Canaccord.

威廉‧普洛瓦尼克，《Canaccord》。

John on for Will tonight.

今晚約翰替威爾上場。

Thanks for taking our questions.

感謝您回答我們的問題。

I just wanted to first touch on the aviation know you said 80% with probably the term rate of direct cases that can be supported by you and what services and what level of jets are needed to reach the 80%?

我只是想先談談航空業，您說的 80% 可能是您可以支援的直接案例的期限率，以及需要哪些服務和什麼級別的飛機才能達到 80%？

And when could we see that?

我們什麼時候才能看到這一點？

And thank you. Thank you, John.

謝謝你。謝謝你，約翰。

And 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 on so far.

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，但我們完全期望到目前為止將這些估計增加到 10,000 架以上。

That's that's our expectation.

這就是我們的期望。

And the key for us is to build enough in this Phase two to continue to demonstrate the growth.

對我們來說，關鍵是在第二階段建立足夠的力量來繼續展示成長。

And as we need more, we will we will have more planes on.

當我們需要更多時，我們將擁有更多的飛機。

But right now we're hoping to end this year around 20 between 15 and 20 planes and hopefully by end of next year to be between 25 and 30.

但目前我們希望今年年底能擁有約 20 架（15 至 20 架）飛機，並希望在明年年底達到 25 至 30 架。

And then we'll we'll assess from there.

然後我們將從那裡進行評估。

Great. Thanks.

偉大的。謝謝。

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

也許對史蒂芬來說更多，但今年剩餘時間有任何營業利潤節奏或指導嗎？

So hey, John, this is Steven.

嘿，約翰，這是史蒂文。

On the hub 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 the hubbing sustainable profit going forward because we're a little bit of ahead of where we thought we'd be.

關於樞紐，除了我們對第一季的表現感到滿意之外，我不准備提供任何指導，我們希望我們能夠走上未來樞紐可持續利潤的道路，因為我們有點領先我們以為我們會在哪裡。

So but that's about all I can say at this point.

但這就是我現在能說的全部。

Great. Thanks, Neena.

偉大的。謝謝，妮娜。

Going to squeeze one more in here.

還要再擠一個進去。

But while we might limit the cold chain for fusions and for hard for us to only six hours, especially with the competitor cases, there are notably going much longer than that thinking I'm taking your questions.

但是，雖然我們可能會將聚變冷鍊和硬質冷鏈限制在六個小時內，特別是對於競爭對手的情況，但顯然，我認為我正在回答您的問題的時間要長得多。

Thank you, John and John, you heard you heard the outcomes with me and they failed that trial in Europe.

謝謝你們，約翰和約翰，你們和我一起聽到了結果，但他們在歐洲的試驗失敗了。

So why would I subject and us too to bad outcomes.

那為什麼我和我們也會遭受不好的結果呢？

And we are more sensible where we want to protect the outcome for the patient.

當我們想要保護患者的治療結果時，我們會更明智。

So and we're providing this as a lower-cost solution for this small segment of the market that is below six hours and for longer hours, we hope to prove it based on the new heart program that warm perfusion is a better solution than core perfusion.

因此，我們將其作為針對六小時以下和更長的一小部分市場的低成本解決方案，我們希望根據新的心臟計劃證明熱灌注是比核心更好的解決方案灌注。

And that's the rationale for why we're limiting it, at least based on an indication standpoint.

這就是我們限制它的理由，至少從指示的角度來看。

And remember, all of the data that we heard that ICOP is not an FDA level data for all fewer few centers, handful of cases up except for the European multicenter trial that failed the primary effectiveness endpoint.

請記住，我們聽到的 ICOP 的所有數據都不是 FDA 級別的數據，僅針對少數幾個中心、少數病例，除了未能達到主要有效性終點的歐洲多中心試驗之外。

Got it. Thank you again.

知道了。再次感謝你。

Suraj Kalia, Oppenheimer.

蘇拉吉·卡利亞，奧本海默。

While these Can you hear me. All right. Yes, gentlemen, congrats again on a blockbuster quarter.

雖然這些你聽得到我說話嗎？好的。是的，先生們，再次恭喜這個季度的轟動。

So really just want to go back on one of the points that you made at our conference a month or so ago.

所以我真的只想回顧一下您大約一個月前在我們的會議上提出的觀點之一。

And even on this call you you were talking about them generation trial So will you stratify for us the standard criteria, DBD heart that are technically off label for you all today?

即使在這次電話會議上，您也在談論它們的一代試驗，那麼您願意為我們分層標準標準嗎？

Just so that people can compare and contrast as to what the denominator should be in terms of market penetration also will the trial that you mentioned that would be beginning, I believe you said next year, early next year that is called profusion But would it also have is the logic behind?

只是為了讓人們可以比較和對比市場滲透率的分母應該是什麼，你提到的即將開始的試驗也會，我相信你說明年，明年初，這就是所謂的豐富，但這也會嗎？有什麼邏輯嗎？

And thank you, Suraj, for the questions.

謝謝蘇拉吉提出的問題。

So let me address I'll address this in multiple multiple points.

因此，讓我來解決這個問題，我將在多個方面解決這個問題。

First, right now, our FDA approved indication does not cover standard criteria.

首先，目前我們 FDA 核准的適應症不涵蓋標準標準。

Dbd hearts.

Dbd 心。

Our plan is to have an new indication to cover that. And is it four hours is six hours.

我們的計劃是有一個新的適應症來涵蓋這一點。四小時還是六小時。

The market segment of between less than four hours is about 900.

4小時以內的細分市場約有900家。

If you go down to up to six hours, about maybe 1,200 transplants plus or minus some at least that's based on last year's number.

如果縮短到 6 小時，大約可能會進行 1,200 例移植手術，加上或減去一些，至少這是基於去年的數字。

The reality is we want to access this segment of the market, no matter how big or how small it is.

現實情況是，我們希望進入這一部分市場，無論它有多大或多小。

We want to be two years from now every heart transplanted in this country should be preserved on a TransMedics technology, whether cold perfusion for warm perfusion.

我們希望兩年後在這個國家移植的每顆心臟都應該採用 TransMedics 技術保存，無論是冷灌注還是熱灌注。

It will be at 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.

它將採用 TransMedics 技術，我們希望擁有 FDA 的全部適應症，例如我們有針對肺部的適應症和針對肝臟的適應症。

So that's number one.

所以這是第一。

Number two, we have two heart programs, one one, focusing on therapeutic and optimization modalities for DBD donors and one called the warm we expect to start before year end this year, the coal because it requires a full-blown new system and full new circuitry will start in the first half or beginning of 2025.

第二，我們有兩個心臟項目，一個專注於DBD 捐贈者的治療和優化方式，另一個是我們預計在今年年底前啟動的溫暖項目，即煤炭項目，因為它需要一個成熟的新系統和全新的系統。

And that is the one that is focused in the new FDA clinical indication.

這就是 FDA 新臨床適應症的重點。

I hope I addressed the question.

我希望我回答了這個問題。

Fair enough. And so and there is one segment I apologize, Suraj. Yes, it will be pulsatile and the cold perfusion will be positive, which is a distinguishing factor that we have that nobody else has FairPoint. Okay, Steve, and one question for you and I'll hop back in queue.

很公平。所以，有一個片段我要道歉，Suraj。是的，它將是脈動的，並且冷灌注將是積極的，這是我們擁有的區別因素，而其他人沒有 FairPoint。好的，史蒂夫，問你一個問題，我會重新排隊。

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.

投資者討論中經常出現的問題之一是，也許你可以更好地量化這一點，以適應每個人的消費。

And the question that comes up is, hey, how does TransMedics depreciate its planes?

出現的問題是，嘿，TransMedics 如何對其飛機進行折舊？

What are it's all in as per our for aviation, how are the margins where they are would love for you to take all of these and wrap it up into some numerics and there are numbers that people can slice and dice because Gentlemen, congrats again.

根據我們的航空業，這一切是什麼，他們希望您將所有這些內容包裝成一些數字，並且人們可以對這些數字進行切片和切塊，因為先生們，再次恭喜您，利潤率是多少。

Thank you for taking my questions.

感謝您回答我的問題。

Thanks, Suraj.

謝謝，蘇拉吉。

Was a question I can answer.

這是一個我可以回答的問題。

It is how we depreciate.

這就是我們貶值的方式。

So we depreciate the planes over 10 years with a 50% of our residual value.

因此，我們對飛機進行 10 年折舊，折舊率為殘值的 50%。

So that has been we've been clear from day one that's in our Q's and K's.

因此，我們從第一天起就在 Q 和 K 中明確這一點。

We haven't talked about the margin of the aviation versus the margin of the service.

我們還沒有討論航空業的利潤率與服務業的利潤率。

But all in, we're at that 36% and we expect some improvement.

但總而言之，我們的比例為 36%，我們預計會有一些改進。

Certainly, I can say the the aviation is a bit on the lower side versus the service, which is a bit on the higher than that side.

當然，我可以說航空業相對於服務業來說有點偏低，而服務業則比這方面稍高。

But we haven't talked about anything more detailed than that.

但我們還沒有討論過比這更詳細的事情。

So that's but So well, I can answer that question.

那麼好吧，我可以回答這個問題。

[Jackson], William Blair.

[傑克森]，威廉布萊爾。

Yes, hey, guys.

是的，嘿，夥計們。

This is Jackson on for Ryan, Daniel, thanks for taking the question and congrats on the strong start to the year.

我是傑克遜，丹尼爾，感謝您提出問題，並祝賀今年的強勁開局。

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?

您能否分享使用過 TransMedics 航空業務的客戶的一般回饋，以及自從您開始整合航空部門以來，這些回饋是否或如何發生了變化？

Thank you for the question on.

謝謝你的提問。

I think the only thing that I can share publicly is just if I point out to the results, I point out to the their rapid pace by which we went from 0 to 105 customers are using our TransMedics logistical services and we expect to go deeper within these accounts.

我認為我唯一可以公開分享的就是我指出結果，我指出我們從 0 到 105 名客戶正在使用我們的 TransMedics 物流服務的快速步伐，我們希望在內部更深入這些帳戶。

And I'll leave it at that.

我就這樣吧。

I think centers are beginning or are actually witnessing the at the better structure.

我認為中心正在開始或實際上正在見證更好的結構。

The more efficient cost structure and availability that is afforded by TransMedics logistics.

TransMedics 物流提供更有效率的成本結構和可用性。

And again, I point to the results.

我再次指出結果。

Understood, thank you.

明白了，謝謝。

Can you just provide an update on what you're seeing in the international markets and kind of what the expectations are there?

您能否介紹一下您在國際市場上看到的最新情況以及對此的期望？

And just as a quick follow-up into, are there any like encouraging opportunities following the ISHLT. meetings that took place.

作為快速跟進，ISHLT 後是否還有類似的令人鼓舞的機會。舉行的會議。

Thanks to excellent question and thank you for asking it.

感謝您提出了很好的問題，也感謝您提出這個問題。

And 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 and OPs across Europe.

人們非常關注 NOP 在美國的成功，許多歐洲主要國家都加入 TransMedics 並提出在歐洲各地建立 OP 方面進行合作。

We're seeing similar behavior in the Middle East, specifically in Saudi Arabia, we had several discussions about essential piece.

我們在中東，特別是在沙烏地阿拉伯看到了類似的行為，我們就重要部分進行了多次討論。

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 ex U.S.

我想描述的方式是，我們絕對專注於複製 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。

However, we want to prioritize securing reimbursement first to make sure that our services will get reimbursed.

然而，我們希望首先優先考慮報銷，以確保我們的服務能夠得到報銷。

And one final qualifier when I talk about NOPXU. S, we're talking only on the clinical support service, not no logistics and no surgical procurement, just for clarification purposes.

當我談論 NOPXU 時，還有最後一場預選賽。 S，我們只談論臨床支援服務，而不是物流和手術採購，只是為了澄清目的。

So yes, there's a huge, huge momentum around NOP replication for US., and we TransMedics fully expect to be ready to implement those once we are confident that our services will be reimbursed.

所以，是的，美國的 NOP 複製有著巨大的勢頭，一旦我們確信我們的服務將得到報銷，我們 TransMedics 完全希望準備好實施這些計劃。

Perfect. Thanks guys, and congrats again, gentlemen.

完美的。謝謝你們，再次恭喜先生們。

Thank you.

謝謝。

(Operator Instructions) [Samantha], Piper Sandler.

（操作員說明）[Samantha]，Piper Sandler。

Hi, this is Samantha on for Matt.

大家好，我是為馬特代言的薩曼莎。

Thank you so much for taking our question.

非常感謝您提出我們的問題。

I guess just to start off, if you could talk a little bit more about guidance.

我想這只是開始，如果你能多談談指導的話。

So guidance for the rest of the year and kind of what's baked into that low end and high end of that range as Samantha?

那麼今年剩餘時間的指導以及薩曼莎在該範圍的低端和高端中融入了什麼？

This is Stephen.

這是史蒂芬.

Yes, I mean we think there's opportunity to continue to kind of grow sequentially, as I mentioned in answer to the earlier call, and if we're able to, you know, add up or go deeper in a few of our centers, we should be able to get to that high end and some of these things that will come to fruition and until the low end is just being a little bit more conservative about the pace of how we do that.

是的，我的意思是，我們認為有機會繼續按順序增長，正如我在回答之前的電話會議時提到的那樣，如果我們能夠，你知道，在我們的一些中心增加或深入，我們應該能夠達到高端，其中一些事情將會實現，直到低端我們對實現這一目標的步伐更加保守。

So it's a pretty narrow range, and we feel confident that we'll be able to meet it.

所以這是一個相當窄的範圍，我們有信心能夠滿足它。

Okay, thank you. And then just one more from us on I know you've talked a little bit in the past about the expected product service mix and totally expect that to change throughout the year, particularly from Yes, but I can do more. Yes, aircraft throughout the year.

好的謝謝。然後是我們的另一則訊息，我知道您過去曾談論過預期的產品服務組合，並完全期望這一點在一年中會發生變化，特別是從「是」開始，但我可以做得更多。是的，全年都有飛機。

Yes. So it's a good question.

是的。所以這是一個好問題。

We've been kind of keeping an eye on the product and service mix.

我們一直在關注產品和服務組合。

It ended up from 36.7% service.

最終服務率為 36.7%。

I think it's going to get a little bit more than that.

我認為它會比這個多一點。

It might be between, say between 37 to potentially 39%.

可能介於 37% 到 39% 之間。

I think that's probably the top end was a little higher than I had given some of you earlier in the year based on the outcomes we're seeing, but we still think we're going to see overall gross margin continued to improve.

我認為，根據我們所看到的結果，這可能比我今年早些時候給你們中的一些人的結果要高一些，但我們仍然認為我們將看到整體毛利率繼續改善。

Thank you.

謝謝。

Thank you.

謝謝。

This concludes our question-and-answer session.

我們的問答環節到此結束。

I'd like to turn the conference back over to Waleed Hassanein for closing remarks.

我想將會議轉回瓦利德·哈薩因 (Waleed Hassanein) 致閉幕詞。

Thank you so much, operator, thank you so much, everybody, for joining us in this call this evening, and we're looking forward to our next call.

非常感謝接線員，非常感謝大家參加今晚的電話會議，我們期待下一次電話會議。

Have a wonderful evening, everyone.

祝大家有個美好的夜晚。

Thank you.

謝謝。

This concludes today's conference call.

今天的電話會議到此結束。

We thank you all for attending today's presentation.

我們感謝大家參加今天的演講。

You may now disconnect your lines and have a wonderful day.

您現在可以斷開線路並度過美好的一天。