(TMDX) 2023 Q1 法說會逐字稿

Good afternoon, and welcome to TransMedics First Quarter 2023 Earnings Conference Call. (Operator Instructions) As a reminder, this call is being recorded for replay purposes.

下午好，歡迎來到 TransMedics 2023 年第一季度收益電話會議。 （操作員說明）作為提醒，正在錄製此通話以供重播。

I would now like to turn the call over to Brian Johnston from the Gilmartin Group for a few introductory comments.

我現在想把電話轉給 Gilmartin Group 的 Brian Johnston，請他發表一些介紹性的評論。

Thank you. Earlier today, TransMedics released financial results for the quarter ended March 31, 2023. A copy of the press release is available on the company's website. Before we begin, I'd like to remind you that management will make statements during this call, including during the question-and-answer portion 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。今天早些時候， TransMedics 發布了截至2023年3月31日的季度財務業績。新聞稿的副本可在公司網站上獲取。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發表聲明，包括在問答部分發表聯邦證券法含義內的前瞻性陳述。本次電話會議中包含的與未來事件、結果或業績的預期或預測相關的任何陳述均為前瞻性陳述。

All forward-looking statements, including, without limitation, are examination of operating trends, the potential commercial opportunity for our products and our future financial expectations, which include expectations for growth in our organization, and guidance and our expectations for revenue, gross margin and operating expenses in 2023 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 place undue reliance to these statements.

所有前瞻性陳述，包括但不限於對經營趨勢、我們產品的潛在商業機會和我們未來財務預期的審查，其中包括對我們組織增長的預期，以及我們對收入、毛利率和2023 年的運營費用是基於當前的估計和各種假設。這些陳述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陳述預期或暗示的結果或事件存在重大差異。因此，您不應過分依賴這些陳述。

Additional information regarding these risks and uncertainties appears under the heading, Risk Factors on our Form 10-K filed with the Securities and Exchange Commission on February 27, 2023, and our subsequent filings with the Securities and Exchange Commission, which are available at www.sec.gov and on our website at www.transmedics.com. TransMedics disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, May 1, 2023.

有關這些風險和不確定性的更多信息，請參見我們於 2023 年 2 月 27 日向美國證券交易委員會提交的 10-K 表格中的風險因素以及我們隨後向美國證券交易委員會提交的文件，這些信息可在 www. sec.gov 和我們的網站 www.transmedics.com。除非法律要求，TransMedics 不承擔更新或修改任何財務預測或前瞻性陳述的任何意圖或義務，無論是因為新信息、未來事件還是其他原因。此電話會議包含時間敏感信息，僅截至 2023 年 5 月 1 日今天的現場直播準確無誤。

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

有了這個，我將把電話轉給總裁兼首席執行官 Waleed Hassanein。

Thank you, Brian. Good afternoon, everyone, and welcome to TransMedics First Quarter 2023 Earnings Call. As always, joining me today is Stephen Gordon, our Chief Financial Officer. Since our last update, we have continued building on our strong 2022 performance, making progress on many of our previously outlined growth goals for 2023. I'm thrilled to report that our first quarter results demonstrated significant commercial momentum and accelerated clinical adoption through the TransMedics NOP. Importantly, in Q1, we also made progress in scaling our supply capacity of our OCS perfusion modules. Here are the top line results.

謝謝你，布萊恩。大家下午好，歡迎來到 TransMedics 2023 年第一季度財報電話會議。與往常一樣，今天加入我的是我們的首席財務官斯蒂芬戈登。自上次更新以來，我們繼續鞏固 2022 年的強勁表現，在實現我們之前概述的 2023 年增長目標的許多方面取得了進展。我很高興地報告，我們第一季度的業績顯示出巨大的商業勢頭，並通過 TransMedics 加速了臨床採用不。重要的是，在第一季度，我們在擴大 OCS 灌注模塊的供應能力方面也取得了進展。這是最重要的結果。

In Q1, we achieved total revenue of $41.6 million, representing 162% year-over-year growth and 32% growth over 4Q 2022. As predicted, NOP continued to be the primary driver for our revenue growth, a trend we expect to continue for the foreseeable future. Importantly, we also demonstrated continued improvement down the P&L as we benefited from increasing operating leverage which Stephen will detail in his section of today's call. Before I move on to discuss the 1Q details, I would like to take a moment to mention that TransMedics has released our first annual ESG report which was published this morning on our website.

第一季度，我們實現了 4160 萬美元的總收入，同比增長 162%，比 2022 年第四季度增長 32%。正如預測的那樣，NOP 仍然是我們收入增長的主要驅動力，我們預計這一趨勢將持續下去可預見的未來。重要的是，我們還證明了損益的持續改善，因為我們受益於經營槓桿的增加，斯蒂芬將在他今天的電話會議中詳細介紹這一點。在我繼續討論第一季度的細節之前，我想花點時間提一下，TransMedics 已經發布了我們的第一份年度 ESG 報告，該報告已於今天上午在我們的網站上發布。

Now let me move on and provide some more granular highlights on 1Q 2023. Overall, 1Q represented another new high watermark for case volume, driven by liver and heart cases, which increased sequentially for the fifth consecutive quarter. Meanwhile, lung volumes continue to lag as we work to help rebuild this very important market. In line with our outlined growth strategy, we also grew the number of liver and heart transplant programs using OCS and NOP. There were 32 liver programs that used OCS and NOP in 1Q, of which 15 were active repeat users.

現在讓我繼續並提供 2023 年第一季度的一些更詳細的亮點。總體而言，第一季度代表了病例數量的另一個新高水位線，受肝臟和心髒病例的推動，連續第五個季度連續增加。與此同時，在我們努力幫助重建這個非常重要的市場時，肺活量繼續滯後。根據我們概述的增長戰略，我們還增加了使用 OCS 和 NOP 的肝臟和心臟移植項目的數量。第一季度使用 OCS 和 NOP 的肝臟項目有 32 個，其中 15 個是活躍的重複用戶。

For heart, there were 40 programs that use OCS and NOP, of which 11 were active and repeat users. There were 9 lung programs that use the OCS and NOP, of which 6 were repeat users. We are not concerned by the lung center trend given the small numbers and our previous guidance that our initiatives will take approximately 12 to 18 months to materially impact lung program growth.

對於心臟，有 40 個程序使用 OCS 和 NOP，其中 11 個是活躍和重複用戶。有 9 個肺項目使用 OCS 和 NOP，其中 6 個是重複用戶。考慮到數量較少和我們之前的指導，我們的舉措將需要大約 12 到 18 個月才能對肺部計劃的增長產生實質性影響，我們並不擔心肺部中心的趨勢。

In terms of the NOP contribution, approximately 91% of our total U.S. case volume came from NOP. On a per organ basis, approximately 96% of liver, 83% of heart and 91% of lung cases were from NOP program. We view these NOP penetration rates are as very encouraging and in line with our goal of having TransMedics NOP managing the lion's share of U.S. transplant volume over the next several years.

就 NOP 貢獻而言，我們美國總案件量的大約 91% 來自 NOP。在每個器官的基礎上，大約 96% 的肝臟、83% 的心臟和 91% 的肺病例來自 NOP 計劃。我們認為這些 NOP 滲透率非常令人鼓舞，並且符合我們的目標，即讓 TransMedics NOP 在未來幾年內管理美國移植量的最大份額。

In 1Q, we also began to increase production and sterilization capacity. The increase was driven primarily by the scaling of our second shift in our operational existing clean room. We expect to see further gradual capacity expansion as we bring our new clean room online and fully operational. Given that we received FDA certification of our new clean room in 1Q, we are confident that the time line for the new clean room to be operational remains on track for late Q2.

一季度，我們也開始增加生產和殺菌能力。這一增長主要是由於我們在現有運營潔淨室中進行第二班的規模擴大所致。隨著我們將新的潔淨室上線並全面投入運營，我們希望看到進一步逐步擴大產能。鑑於我們在 1 季度獲得了新潔淨室的 FDA 認證，我們相信新潔淨室在第二季度後期投入運營的時間表仍將按計劃進行。

Our 1Q results clearly demonstrated the fast pace of growing clinical demand for our OCS technology and the NOP service model. We remain laser focused on bolstering our supply chain and NOP infrastructure to sustain and further accelerate our growth.

我們第一季度的結果清楚地表明了對我們的 OCS 技術和 NOP 服務模型的臨床需求的快速增長。我們仍然專注於加強我們的供應鍊和 NOP 基礎設施，以維持並進一步加速我們的增長。

Let me outline our key focus areas to keep up with this accelerated demand, specifically on OCS production availability and NOP infrastructure capacity. So first, production -- product availability. As we -- as mentioned, we're continuing to invest in our manufacturing capacity and supply chain to ensure continuous product availability. More specifically, we are enhancing production and sterilization capacity as well as raw material supply chain management. For production and sterilization capacity, as stated, we are on track to bring our new clean room production space online by midyear, but we are not stopping here. We have already secured additional new space in our current facility to support the increased production build as well as raw material and finished goods inventory growth.

讓我概述一下我們的重點關注領域，以跟上這種加速增長的需求，特別是 OCS 生產可用性和 NOP 基礎設施能力。首先，生產——產品可用性。正如我們 - 如前所述，我們將繼續投資於我們的製造能力和供應鏈，以確保持續的產品可用性。更具體地說，我們正在加強生產和滅菌能力以及原材料供應鏈管理。對於生產和滅菌能力，如前所述，我們有望在年中之前將新的無塵室生產空間上線，但我們不會就此止步。我們已經在現有設施中獲得了額外的新空間，以支持增加的生產建設以及原材料和成品庫存的增長。

In addition, we are working with specialized third-party workflow optimization experts to revamp our production process workflow to maximize efficiencies within both clean room spaces. Lastly, we are significantly increasing our sterilization capabilities by qualifying a brand-new major sterilizer while working to expand the capacity and the throughput of our current sterilization partner. This expanded sterilization capacity will be online in H2 2023.

此外，我們正在與專業的第三方工作流程優化專家合作，改進我們的生產流程工作流程，以最大限度地提高兩個潔淨室空間的效率。最後，我們通過鑑定全新的主要滅菌器來顯著提高我們的滅菌能力，同時努力擴大我們當前滅菌合作夥伴的容量和吞吐量。這種擴大的滅菌能力將於 2023 年下半年上線。

For raw material management, historically, we've never had our raw material shortage. However, as we are significantly increasing our production capacity to meet the growing clinical demand for OCS technology, we have established a new dedicated raw material planning and monitoring team within our operations team. This new team's function is to establish a scalable process to closely track our growing demand for raw material and proactively replenish our raw material to meet our near-, mid- and long-term needs.

對於原材料管理，從歷史上看，我們從未出現過原材料短缺的情況。然而，由於我們正在顯著提高我們的生產能力以滿足對 OCS 技術不斷增長的臨床需求，我們在我們的運營團隊中建立了一個新的專門的原材料規劃和監控團隊。這個新團隊的職能是建立一個可擴展的流程，以密切跟踪我們對原材料不斷增長的需求，並主動補充我們的原材料以滿足我們的近期、中期和長期需求。

Second, we continue to expand our NOP infrastructure. Specifically, we will grow our surgical and field clinical staffing throughout the next 12 to 18 months to meet the growing demand for the NOP clinical services across the U.S. We are also planning to opportunistically add 2 to 3 new launch points later this year to expand our coverage and reach larger pools of potential donors faster and more efficiently.

其次，我們繼續擴展我們的 NOP 基礎設施。具體來說，我們將在未來 12 到 18 個月內增加我們的外科和現場臨床人員，以滿足全美對 NOP 臨床服務不斷增長的需求。我們還計劃在今年晚些時候適時增加 2 到 3 個新的啟動點，以擴大我們的業務覆蓋範圍並更快、更有效地接觸到更多的潛在捐助者。

Next, we will revamp and scale the logistical management of the NOP case flow. We have recruited a senior logistics executives from Amazon to lead our initiative to streamline, scale and digitize the entire logistical workflow of our NOP program, literally, starting from the initial transplant centers call to the NOP hotline through the organ arriving at the transplant center. One key feature of this exciting new initiative is creating a digital, central command and control and dispatch center -- I'm sorry, creating a digital, central command, control and dispatch center here in and over to oversee and manage our national NOP workload. We hope to start sharing more granular detail on this exciting initiative towards the end of 2023.

接下來，我們將改進和擴展 NOP 案件流程的後勤管理。我們從亞馬遜招聘了一名高級物流主管來領導我們的計劃，以簡化、擴展和數字化我們 NOP 計劃的整個物流工作流程，從字面上看，從最初的移植中心呼叫 NOP 熱線到到達移植中心的器官。這個激動人心的新計劃的一個關鍵特徵是創建一個數字化的中央指揮控制和調度中心——對不起，在這里和各地創建一個數字化的中央指揮、控制和調度中心來監督和管理我們的國家 NOP 工作量.我們希望在 2023 年底開始分享有關這一令人興奮的計劃的更多詳細信息。

Additionally, we announced at ISHLT in April that we are planning for the launch of our customer-facing portion of the TransMedics OCS connect application. This is a secure and HIPAA-compliant app that will provide surgeons and clinicians with real-time updates on the overall status of the organ on OCS as well as logistics and travel time information. It will also enable secure real-time communication of case information between our team, managing the organ and the transplant program clinical staff. We are very excited about this new function of our OCS connect and we hope it will provide more transparency and confidence to our users about the status of their organs and route to their transplant center.

此外，我們在 4 月份的 ISHLT 上宣布，我們計劃推出 TransMedics OCS 連接應用程序的面向客戶的部分。這是一個安全且符合 HIPAA 標準的應用程序，它將為外科醫生和臨床醫生提供器官在 OCS 上的整體狀態以及物流和旅行時間信息的實時更新。它還將使我們的團隊、管理器官和移植計劃臨床人員之間能夠安全地實時交流病例信息。我們對 OCS 連接的這一新功能感到非常興奮，我們希望它能為我們的用戶提供更多的透明度和信心，讓他們了解自己的器官狀態和前往移植中心的路線。

Finally, and as we have stated several times, we fully intend to eventually control the entire air and ground transport function for the NOP transplant cases. This will help remove a critical bottleneck for our growth. We are seeing our NOP volumes are starting to outpace the capacity, the availability and flight radius of the fragmented transplant air charter model that we and the transplant programs are using today. We also announced that ISHLT that we expect to launch this important TransMedics aviation initiative sometime in H2 2023. We are actively engaged on several fronts to establish a national dedicated NOP transplant charter flight network to cover our existing and potential new hubs. I'm looking forward to discussing this exciting initiative further in the latter half of this year. In the meantime, please allow me to take this opportunity to discuss in detail and clarify the current way of air transportation for organ transplants in the United States.

最後，正如我們多次聲明的那樣，我們完全打算最終控制 NOP 移植病例的整個空中和地面運輸功能。這將有助於消除我們增長的關鍵瓶頸。我們看到我們的 NOP 數量開始超過我們和移植計劃今天使用的碎片化移植包機模型的容量、可用性和飛行半徑。我們還向 ISHLT 宣布，我們希望在 2023 年下半年的某個時候啟動這項重要的 TransMedics 航空計劃。我們在多個方面積極參與，以建立一個全國專用的 NOP 移植包機網絡，以覆蓋我們現有和潛在的新樞紐。我期待著在今年下半年進一步討論這一激動人心的倡議。同時，請允許我藉此機會詳細討論和澄清目前美國器官移植的空運方式。

To start, it is important to recognize that all, I repeat, all air transport for heart, lung and liver transplant in the United States are transported via chartered flights. These flights costs are part of the organ acquisition cost center and are an allowed charge for the CMS cost support, all commercial transplant payers and CMS routinely reimburse these costs. Historically, when organ transport was limited to a short distance within the donor service area or DSA, of the involved Organ Procurement Organization or OPO, the OPOs were the main flight coordinators for the transplant programs. Consequentially, a few OPOs purchased their own short-range aircraft to manage local travel. Back then, more than 90% of donor organ allocation came from the transplant programs local OPO DSA, literally less than 250 miles. And only less than 10% came from outside of their local DSA. Today, the reality is the complete opposite. Let me explain why and how.

首先，重要的是要認識到，我重複一遍，在美國所有用於心臟、肺和肝臟移植的空運都是通過包機運輸的。這些航班費用是器官獲取成本中心的一部分，並且是 CMS 成本支持的允許費用，所有商業移植付款人和 CMS 都會定期報銷這些費用。從歷史上看，當器官運輸僅限於相關器官採購組織或 OPO 的供體服務區或 DSA 內的短距離時，OPO 是移植計劃的主要飛行協調員。因此，一些 OPO 購買了自己的短程飛機來管理本地旅行。當時，超過 90% 的供體器官分配來自本地 OPO DSA 的移植計劃，實際上不到 250 英里。只有不到 10% 來自當地 DSA 之外。今天，現實是完全相反的。讓我解釋一下為什麼以及如何。

Approximately 5 or 6 years ago, organ allocation for lungs, hearts and liver transplants shifted from regional to national allocation in the United States. This effectively means that a donor in San Francisco can and should be allocated to the matched recipient in Boston or New York, or Raleigh-Durham, North Carolina. With that change, the rate of organ acceptance by nearly all the leading transplant centers flipped overnight to more than 90% national or distant allocation and only less than 10% local allocation. This led to many OPOs selling their jets and shifting most of the responsibility, if not all the responsibility of air transport coordination back to the transplant programs.

大約 5 或 6 年前，美國肺、心臟和肝臟移植的器官分配從區域分配轉變為國家分配。這實際上意味著舊金山的捐贈者可以而且應該被分配給波士頓或紐約或北卡羅來納州羅利-達勒姆的匹配接受者。隨著這一變化，幾乎所有主要移植中心的器官接受率在一夜之間躍升至超過 90% 的國家或遠程分配，而本地分配僅不到 10%。這導致許多 OPO 出售他們的噴氣式飛機並將大部分責任（如果不是全部）航空運輸協調責任轉移回移植計劃。

To make this more interesting, between 2020 and 2022, the OCS technology became FDA approved in the United States, and the NOP was established. This shift led to a very important shift in the United States organ placements because the OCS enables safe, longer distance procurement across the entire country and from outside the Continental U.S. like Hawaii, Alaska, Puerto Rico and Canada.

更有趣的是，在2020年到2022年間，OCS技術在美國獲得了FDA的批准，並成立了NOP。這種轉變導致了美國器官安置的一個非常重要的轉變，因為 OCS 可以在整個國家以及從美國大陸以外的地區（如夏威夷、阿拉斯加、波多黎各和加拿大）進行安全、更遠距離的採購。

So how do transplant programs coordinate their organ transport charter flights today? They rely exclusively on a few regional charter flight brokers who owns no jets or even have the license to operate a charter flight. They rely -- those charter flight brokers rely exclusively on the third-party owners and operators of charter flights. This is a very cost and operationally inefficient way of running organ transplant -- transportation and will become a major bottleneck for NOP growth going forward. This antiquated, fragmented approach is not geared to the distances that we are now covering, the volume of donor organ missions that we do on a daily basis using NOP or the volume expected in the near and long-term future. Importantly, many of the jets used today are older vintage with very limited flight range and lacks Wi-Fi communication capabilities.

那麼移植計劃如何協調他們今天的器官運輸包機呢？他們完全依賴少數不擁有噴氣式飛機甚至沒有經營包機執照的區域包機經紀人。他們依賴——那些包機經紀人完全依賴包機的第三方所有者和運營商。這是運行器官移植的一種非常昂貴且操作效率低下的方式——運輸，並將成為未來 NOP 增長的主要瓶頸。這種過時的、分散的方法不適合我們現在覆蓋的距離、我們每天使用 NOP 進行的捐贈器官任務的數量或近期和長期的預期數量。重要的是，今天使用的許多噴氣式飛機都是老式飛機，飛行距離非常有限，並且缺乏 Wi-Fi 通信功能。

We saw firsthand in 2022, the massive cost inefficiencies that exist in the current model, and we believe TransMedics managing our own logistical network will create value for our clinical users, their patients and other critical stakeholders in organ transplantation in the United States. We believe strongly that securing this dedicated national network of charter flights under TransMedics aviation, would act as an additional significant catalyst for the growth of NOP and TransMedics business in the United States.

我們在 2022 年親眼目睹了當前模式中存在的巨大成本效率低下，我們相信 TransMedics 管理我們自己的物流網絡將為我們的臨床用戶、他們的患者和美國器官移植的其他關鍵利益相關者創造價值。我們堅信，在 TransMedics 航空下確保這個專用的國家包機網絡的安全，將成為美國 NOP 和 TransMedics 業務增長的另一個重要催化劑。

Again, I hope to share more details as we get this initiative operational later this year. There's no doubt our OCS technology and NOP service model are driving a transformative shift in organ transplantation in the United States as demonstrated by our first quarter performance and strong growth trajectory thus far.

同樣，我希望在我們今年晚些時候實施該計劃時分享更多細節。毫無疑問，我們的 OCS 技術和 NOP 服務模式正在推動美國器官移植的變革，正如我們第一季度的業績和迄今為止強勁的增長軌跡所證明的那樣。

It is important to note that we strongly believe that this is only the beginning. We are not stopping or slowing down. We have bigger goals in mind, and we fully intend to execute on our strategy to achieve sustained long-term growth for our business. We remain laser-focused on execution and navigating the steep growth curve to drive continued success.

值得注意的是，我們堅信這僅僅是個開始。我們不會停止或放慢腳步。我們心中有更大的目標，我們完全打算執行我們的戰略，以實現我們業務的持續長期增長。我們仍然專注於執行和駕馭陡峭的增長曲線以推動持續成功。

As I've done in the past, I would like to share with you all what we see as a potential challenges that could temporarily impact our growth trajectory for the remainder of 2023. First, constraints on our supply chain and production capacity. As stated earlier, we need to be cognizant of our demand for raw materials as we increase production capacity, though we do not currently foresee any issues we could face some delays regarding some parts availability or obsolescence issues that could temporarily hamper our immediate-term growth.

正如我過去所做的那樣，我想與大家分享我們認為可能暫時影響我們 2023 年剩餘時間增長軌蹟的所有潛在挑戰。首先，我們的供應鍊和生產能力受到限制。如前所述，我們需要認識到我們在增加產能時對原材料的需求，儘管我們目前沒有預見到任何問題，我們可能會在某些零件可用性或過時問題方面面臨一些延遲，這些問題可能會暫時阻礙我們的近期增長.

Second, clinical NOP staffing. Delays could limit our ability to cover new regions, hubs temporarily until we resolve it. Finally, delays in securing our logistical network and air transport could temporarily slow down -- slow us down later this year and into 2024. That said, given our strong 1Q '23 results, an increased confidence in the trajectory of our finished goods supply balanced with potential scalability challenges above, we are increasing our annual revenue guidance for the full year 2023 to be between $160 million to $170 million, up from our previously communicated guidance of $138 million to $145 million. This new guidance represents 71% to 82% growth over full year 2022 total revenue.

第二，臨床NOP人員配置。在我們解決問題之前，延遲可能會限制我們暫時覆蓋新地區和樞紐的能力。最後，確保我們的物流網絡和航空運輸安全的延遲可能會暫時放慢速度——在今年晚些時候和 2024 年放慢我們的速度。也就是說，鑑於我們 23 年第一季度的強勁業績，我們對成品供應平衡軌蹟的信心增強了鑑於上述潛在的可擴展性挑戰，我們將 2023 年全年的年度收入指導增加到 1.6 億美元至 1.7 億美元，高於我們之前傳達的 1.38 億美元至 1.45 億美元的指導。這一新指引表示 2022 年全年總收入增長了 71% 至 82%。

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

有了這個，讓我把電話轉給斯蒂芬來報導本季度的詳細財務結果。斯蒂芬？

Thank you, Waleed. I will now provide some additional details on the Q1 results and other financial information for the quarter. For the first quarter of 2023, our total revenue was $41.6 million, this is an increase of 162% from the first quarter of 2022 and a 32% sequential increase from last quarter. In the U.S., revenue was $37.5 million, an increase of 177% from Q1 2022 and 29% sequentially from last quarter. The organ breakdown on U.S. revenue was $23.1 million of OCS Liver, $13 million of OCS Heart and $1.4 million of lung. Ex-U.S. revenue was $4.1 million, a 75% increase from Q1 of 2022 and the ex-U.S. revenue was made of $3.8 million of heart and $0.2 million of lung.

謝謝你，瓦利德。我現在將提供有關本季度第一季度業績和其他財務信息的更多詳細信息。 2023 年第一季度，我們的總收入為 4160 萬美元，比 2022 年第一季度增長 162%，比上一季度增長 32%。在美國，收入為 3750 萬美元，比 2022 年第一季度增長 177%，比上一季度增長 29%。美國收入的器官細分為 OCS 肝臟 2310 萬美元、OCS 心臟 1300 萬美元和肺 140 萬美元。美國前收入為 410 萬美元，比 2022 年第一季度和美國以外地區增長 75%。收入來自 380 萬美元的心臟和 20 萬美元的肺。

Regarding the breakout of product and service revenue this quarter, as a reminder, the service revenue includes the added amounts we charge for the surgical procurement and organ management as part of the NOP. In Q1, product revenue was $34 million and service revenue was $7.6 million. So service revenue was 18% of the total in Q1.

關於本季度產品和服務收入的突破，提醒一下，服務收入包括我們作為 NOP 的一部分對手術採購和器官管理收取的額外費用。第一季度，產品收入為 3400 萬美元，服務收入為 760 萬美元。因此，第一季度服務收入佔總收入的 18%。

Gross margin for the first quarter of 2023 was 69%. While this is down from 76% in the first quarter of 2022, it is a sequential increase from the 66% reported in Q4 of 2022. The margin on product revenue was 79% in Q1 and the margin on service revenue was 27% in Q1 2023. The sequential improvement in service margin reflected some of the improvements in production capacity and drove the overall -- the higher overall sequential gross margin. Total operating expenses for the quarter were $30.9 million, 44% above Q1 2022 operating expense, driven primarily by our continued investment in scaling both the NOP as well as the overall company operations.

2023 年第一季度的毛利率為 69%。雖然這低於 2022 年第一季度的 76%，但與 2022 年第四季度報告的 66% 相比是連續增長。第一季度產品收入利潤率為 79%，第一季度服務收入利潤率為 27% 2023.服務利潤率的連續改善反映了產能的一些改善並推動了整體 - 更高的整體連續毛利率。本季度的總運營費用為 3090 萬美元，比 2022 年第一季度的運營費用高出 44%，這主要是由於我們繼續投資擴大 NOP 以及公司整體運營。

Operating loss was $2.1 million in the first quarter of 2023, compared to $9.4 million in the first quarter of 2022, demonstrating the strong leverage in the business as we grow our revenue. Our net loss for the first quarter of 2023 was $2.6 million compared to $10.6 million in the first quarter of 2022. And our total cash was $195.4 million as of March 31, 2023, which equates to a reduction of $5.8 million from the balance at the end of Q4 2022. Our weighted average common shares outstanding for the quarter were $32.3 million.

2023 年第一季度的營業虧損為 210 萬美元，而 2022 年第一季度為 940 萬美元，這表明隨著我們收入的增長，業務的強大槓桿作用。我們 2023 年第一季度的淨虧損為 260 萬美元，而 2022 年第一季度為 1060 萬美元。截至 2023 年 3 月 31 日，我們的現金總額為 1.954 億美元，相當於從 2023 年第一季度的餘額減少 580 萬美元2022 年第四季度末。本季度我們的加權平均已發行普通股為 3230 萬美元。

Overall, our financial results in Q1 2023 reflect our continued execution of the OCS and NOP growth plan. We have been able to unlock additional production capacity as planned, which was reflected in both our top and bottom line results. And just to repeat our guidance update, we are increasing annual revenue guidance to the range of $160 million to $170 million, which represents 71% to 82% growth.

總體而言，我們 2023 年第一季度的財務業績反映了我們繼續執行 OCS 和 NOP 增長計劃。我們已經能夠按計劃釋放額外的生產能力，這反映在我們的頂線和底線結果中。只是為了重複我們的指導更新，我們將年收入指導增加到 1.6 億美元至 1.7 億美元，這代表了 71% 至 82% 的增長。

Now I would like to turn the call back to Waleed for closing comments.

現在我想把電話轉回給 Waleed 以徵求結束意見。

Thank you so much, Stephen. We are thrilled by our 1Q results and continued growth of clinical demand for our OCS technology and the NOP clinical services. That said, as I said before, we strongly believe we are still in the early stage of the long-term sustained growth trajectory we envision for TransMedics. We are not basking in our success. We understand that this steep growth curve could pose potential challenges. We remain focused -- laser-focused on driving our operational, commercial and clinical initiatives while navigating any potential challenges to meet our near- and long-term growth potential. We look forward to continuing to make strides on our strategic initiatives throughout 2023.

非常感謝你，斯蒂芬。我們對第一季度的業績以及對我們的 OCS 技術和 NOP 臨床服務的臨床需求持續增長感到興奮。也就是說，正如我之前所說，我們堅信我們仍處於我們為 TransMedics 設想的長期持續增長軌蹟的早期階段。我們並沒有沉浸在成功中。我們知道，這種陡峭的增長曲線可能會帶來潛在的挑戰。我們仍然專注——專注於推動我們的運營、商業和臨床計劃，同時應對任何潛在挑戰，以滿足我們近期和長期的增長潛力。我們期待在整個 2023 年繼續推進我們的戰略舉措。

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

有了這個，我現在將把電話轉給接線員進行問答。操作員？

(Operator Instructions) Our first question is from Bill Plovanic with Canaccord.

（操作員說明）我們的第一個問題來自 Canaccord 的 Bill Plovanic。

I'm going to start out with -- and congratulations on the quarter. Just curious, how did capacity issues impact new account adoption? Like are you constraining your sales folks from bringing on new accounts and over this past quarter and then what does the new clean room add in terms of net capacity? And how does that come online over the next few quarters? And then how does that impact gross margin?

我要開始 - 並祝賀本季度。只是好奇，容量問題如何影響新帳戶的採用？比如你是否限制你的銷售人員在過去的這個季度引入新客戶，那麼新的無塵室在淨容量方面增加了什麼？在接下來的幾個季度中，它是如何上線的？那麼這對毛利率有何影響？

So Bill, thank you for the question. I'll address the first two parts of the question, and then I'll let Stephen address the impact on gross margin. So the ramping up of the capacity limited to a lesser extent in Q1 compared to Q3 and Q4 of last year, our ability to go deeper in some of the accounts. We tried not to limit new accounts addition in Q1. That's why you see the growth in the new accounts for heart and liver, but you noticed that the repeat and active users remain slightly up or remain flat. It's because we wanted to get new accounts in, yet we wanted to supply our traditional users with the added capacity. That started in the beginning of Q1. At the end of Q1, this constraint pretty much dissolved based on the increased capacity.

比爾，謝謝你提出這個問題。我將解決問題的前兩部分，然後讓斯蒂芬解決對毛利率的影響。因此，與去年第三季度和第四季度相比，第一季度產能的增加受到了較小程度的限制，我們有能力更深入地研究一些客戶。我們試圖在第一季度不限制新帳戶的添加。這就是為什麼您看到 heart 和 liver 的新帳戶有所增長，但您注意到重複用戶和活躍用戶保持小幅上升或持平。這是因為我們想獲得新帳戶，但我們想為我們的傳統用戶提供額外的容量。這始於第一季度初。在第一季度末，由於產能增加，這一限制幾乎消失了。

As far as the new clean room capacity, we expect at least, and this is a guesstimate at this point because I believe the additional workflow optimization and efficiencies would even increase that substantially. I -- we guesstimate approximately 4 times the capacity I would say, over the next 18 to 24 months because when we open that new clean room, it's not going to be fully staffed. It's not going to be double shift it will take time. But it will add additional capacity gradually. That's why I said gradually. But definitely, over the next 18 to 24 months, we expect a significant capacity increase. The key point to the audience or the people listening is we're not just stopping at the current -- we are constantly looking at capacity. We're constantly -- we do not want to get back to a situation where we were at in Q2, Q3 and Q4 of last year. So Nick and the team are constantly monitoring that, and we are going to be aggressive on making sure that we avoid a significant back-order situation from happening to us again.

就新的無塵室容量而言，我們至少有預期，這是目前的猜測，因為我相信額外的工作流程優化和效率甚至會大幅增加。我 - 我們估計在接下來的 18 到 24 個月內，容量大約是我所說的 4 倍，因為當我們打開那個新的無塵室時，它不會配備滿員。這不會是雙班制，這需要時間。但它將逐漸增加額外的容量。這就是為什麼我說逐漸。但可以肯定的是，在接下來的 18 到 24 個月內，我們預計產能會顯著增加。對聽眾或聽眾來說，關鍵是我們不只是停留在當前——我們一直在關注容量。我們一直 - 我們不想回到去年第二季度、第三季度和第四季度的情況。因此，Nick 和團隊一直在監控這一點，我們將積極確保避免再次發生嚴重的延期交貨情況。

With that, I'll turn it on to Stephen to discuss the gross margin.

有了這個，我會把它交給斯蒂芬討論毛利率。

Bill, this is Stephen. So regarding gross margin, we did -- we were able to see a sequential increase. Primarily, that was around the service margin this quarter because we didn't have as much logistical costs of moving disposables quickly around the country to meet NOP needs. So we're able to kind of reduce that some. At the same time, we do have additional costs from the new clean room that's already kind of baked into our margin. So as I've said in the past, I expect moderate increase in margin as our revenue grows and sequentially, and I still feel like that's the right answer.

比爾，這是斯蒂芬。因此，關於毛利率，我們做到了——我們能夠看到連續增長。這主要是本季度的服務利潤率，因為我們沒有那麼多的物流成本在全國范圍內快速移動一次性用品以滿足 NOP 需求。所以我們能夠減少一些。與此同時，我們確實有來自新潔淨室的額外成本，這些成本已經計入我們的利潤。因此，正如我過去所說的那樣，我預計隨著我們收入的增長和連續增長，利潤率會適度增長，我仍然覺得這是正確的答案。

Great. And for my second question, just on the aviation. You talked about the potential expansion and thanks for going through that in detail. A, what's the most likely pathway to business and the cost to do so to get into? Is this an acquisition or is this building it kind of plane by plane. And then b, do you think you'll need to raise capital or equity or debt or some form to do what you're looking to do. And then c, how does this impact the revenue gross -- the P&L revenue gross margin operating.

偉大的。關於我的第二個問題，關於航空。您談到了潛在的擴展，並感謝您詳細介紹了這一點。 A，最有可能的商業途徑是什麼？這樣做的成本是什麼？這是一次收購還是這個建築是逐個飛機建造的。然後 b，你認為你需要籌集資金、股權、債務或某種形式來做你想做的事嗎？然後 c，這如何影響收入總額——損益收入毛利率運營。

Thank you, Bill. Again, I'll address the first two parts of your question, and I'll let Stephen address the impact on the P&L. We evaluated all different options of how to build the TransMedics aviation business in TransMedics. We have completely eliminated the organic option of adding one plane at a time because it will take significantly long time for TransMedics to secure a Part 135 charter operating license is going to take at least 12 to 18 months. So our two most efficient paths are either acquiring a Part 135 operator that had significant assets of jets that we can leverage quickly or creating a joint venture with one operator that had, again, a license and a significant number of assets. These are the two options that we are actively pursuing across the United States.

謝謝你，比爾。同樣，我將解決您問題的前兩部分，我將讓斯蒂芬解決對損益表的影響。我們評估瞭如何在 TransMedics 中建立 TransMedics 航空業務的所有不同選擇。我們已經完全取消了一次添加一架飛機的有機選擇，因為 TransMedics 需要很長時間才能獲得第 135 部分的包機運營許可證，至少需要 12 到 18 個月。因此，我們最有效的兩條途徑是收購擁有大量噴氣式飛機資產的 Part 135 運營商，我們可以快速利用這些資產，或者與一家再次擁有許可證和大量資產的運營商建立合資企業。這是我們在美國積極尋求的兩種選擇。

As far as the ability to finance this, we've always stated publicly that we do not expect to tap into our current balance sheet to finance anything related to the aviation business. So we're exploring different modalities of financing that is non-dilutive or less dilutive forms of financing options in front of us. And we're working with our advisers on the different options.

至於為此提供資金的能力，我們一直公開表示，我們不希望利用我們目前的資產負債表來為與航空業務相關的任何事情提供資金。因此，我們正在探索擺在我們面前的非稀釋性或稀釋性較低的融資選擇的不同融資方式。我們正在與我們的顧問就不同的選擇進行合作。

I'll turn it on Stephen.

我會在斯蒂芬身上打開它。

Yes, Bill, from a P&L perspective, so today, the revenue for flights is not in our P&L. So we would think of that as an adder from a revenue perspective for each transplant, whether it's $20,000 or $30,000 depends on the length of the flight. So that will be one change. So more of our revenue would be in the service bucket, although we think the service revenue, the service margin will be improved. The overall company gross margin percent may come down a bit. But from a dollar perspective, it should be an accretive to our income. And once we're in positive EPS, it would be favorable to EPS.

是的，比爾，從損益的角度來看，所以今天，航班收入不在我們的損益中。因此，從收入的角度來看，我們認為這是每次移植的加法器，是 20,000 美元還是 30,000 美元取決於飛行的時間長短。所以這將是一個變化。所以我們更多的收入將在服務領域，儘管我們認為服務收入，服務利潤率將會提高。公司整體毛利率可能會有所下降。但從美元的角度來看，它應該會增加我們的收入。一旦我們的每股收益為正，這將有利於每股收益。

The next question is from Allen Gong with JPMorgan.

下一個問題來自摩根大通的Allen Gong。

Congratulations on the really strong quarter. We -- there's obviously a lot of really exciting things to talk about when it comes to heart and liver, but I do want to like kind of touch on lung a little bit. It's clearly continuing to face pretty significant challenges even as the rest of your portfolio is taking off. I understand that lung really was impacted quite a bit by COVID and has not really come back necessarily in the same way for you even as transplants have recovered. So what kind of details can you provide on your strategy to really get that market back up and running for OCS?

祝賀這個非常強勁的季度。我們——當談到心臟和肝臟時，顯然有很多非常令人興奮的事情要談，但我確實想稍微談談肺部。即使您的其他投資組合正在起飛，它顯然仍將繼續面臨相當大的挑戰。我知道肺確實受到了 COVID 的相當大的影響，並且即使移植已經恢復，也不一定會以同樣的方式恢復。那麼，您可以提供哪些關於您的戰略的詳細信息，以真正讓該市場為 OCS 恢復和運行？

Thank you, Allen, for the question. I think as -- I'll focus on what I stated publicly before. And hopefully, as the year progresses, we will be able to reveal some of more granular detail about our initiatives. So basically, what we're doing is literally we are trying to leverage three things. We're trying to leverage the NOP and the success of the NOP in liver and heart to rev up the lung market. So that's one angle and we discussed that in detail at the ISHLT.

艾倫，謝謝你提出這個問題。我認為——我將專注於我之前公開發表的內容。希望隨著時間的推移，我們將能夠揭示有關我們計劃的一些更詳細的細節。所以基本上，我們正在做的實際上是我們試圖利用三件事。我們正試圖利用 NOP 和 NOP 在肝臟和心臟方面的成功來加速肺部市場。這是一個角度，我們在 ISHLT 上對此進行了詳細討論。

The second angle is we're trying to reeducate the market, market in general, including patients group, about the importance of OCS Lung and what does it mean to a patient on the waiting list waiting for a lung transplant. And also the market in the form of the pulmonologists and the transplant surgeons. Because I believe the last 3 years of -- I mean, the 3 years with COVID, people just kind of lost focus on even understanding what the importance of machine perfusion for lung would be. So that's another area.

第二個角度是我們正在努力重新教育市場，包括患者群體在內的整個市場，了解 OCS Lung 的重要性以及它對等待肺移植的等候名單上的患者意味著什麼。還有肺科醫生和移植外科醫生形式的市場。因為我相信過去 3 年——我的意思是，與 COVID 相關的 3 年，人們只是有點失去了注意力，甚至不了解機器灌注對肺的重要性。那是另一個領域。

The third area is we're -- and this is the area that I'm going to be as vague as I can. And hopefully, as the year progresses, we will provide more granularity around it. We're trying to find the right mix of a catalyst to kind of quickly galvanize a major clinical focus on machine perfusion for lung using our platform, our NOP. I'll leave it at that, Allen, but I promise you that hopefully within the next quarter or 2, we will discuss in detail.

第三個領域是我們——這是我將盡可能模糊的領域。希望隨著時間的推移，我們將圍繞它提供更多的粒度。我們正試圖找到合適的催化劑組合，以使用我們的平台 NOP 快速激發對肺部機器灌注的主要臨床關注。艾倫，我就此打住，但我向你保證，希望在下一個或第二個季度內，我們將進行詳細討論。

Again, I am not concerned about the trend we saw in Q1. We're watching what's happening in Q2, and we feel that the early initiatives are starting to bear fruit. But we're not stopping here. We're going to continue to push forward with all 3 prongs as we move forward. And we will explore other modalities as well. So this is an important market for us, and we're not going to give it up that easy.

同樣，我不關心我們在第一季度看到的趨勢。我們正在關注第二季度發生的事情，我們認為早期的舉措開始見效。但我們不止於此。在我們前進的過程中，我們將繼續推進所有 3 個方面。我們還將探索其他方式。所以這對我們來說是一個重要的市場，我們不會輕易放棄。

And then another question with a bit of a more positive slant. When I look at your updated guidance, it looks like a really impressive be in raised quarter. But when I look at what you've kind of left for yourself, 2Q, 3Q, 4Q, you're basically implying flat revenues, right? On a quarterly basis. Now I'm not saying the cadence will exactly be like that. But what's really holding you back from meaningfully outperforming that once you have capacity up and running at the end of 2Q. Like why shouldn't you be able to really outperform this bar you set for yourself?

然後是另一個更積極的問題。當我查看您更新的指南時，它看起來確實令人印象深刻。但是當我看看你為自己留下的東西時，第二季度、第三季度、第四季度，你基本上意味著收入持平，對吧？每季度一次。現在我並不是說節奏會完全像那樣。但是，一旦你在第二季度末有能力啟動並運行，真正阻礙你顯著超越的原因是什麼。比如為什麼你不能真正超越你為自己設定的標準？

Thank you, Allen. Excellent question. So Allen, we were trying in the script, we're trying to identify a nuance that is taking place as we ramp up production capacity, which has been our achilles heel for the last 3 quarters. Now we're straining our ability to secure raw material at the same pace or at the same volume as we historically have kept in inventory. So we have to be conservative and prudent to make sure that we allow Nick and the team to have enough buffer of raw material. They don't know what's coming around the corner. We are ramping up our purchasing of every raw material we use for the build of all of our product solutions. So we had to leave some room to allow for some surprises to take place.

謝謝你，艾倫。很好的問題。所以艾倫，我們在劇本中嘗試，我們試圖確定在我們提高產能時發生的細微差別，這在過去 3 個季度一直是我們的致命弱點。現在，我們正在竭盡全力以與我們歷史上保持庫存的速度或數量相同的速度或數量獲得原材料。所以我們必須保守和謹慎，以確保我們讓尼克和團隊有足夠的原材料緩衝。他們不知道拐角處會發生什麼。我們正在加大對用於構建我們所有產品解決方案的每種原材料的採購。所以我們不得不留出一些空間來讓一些驚喜發生。

And also, as you know, we are conservative by nature, and we like to be realistic. We know what the I think in med tech, having 70% to 80% growth is not an easy thing to do. And we think this is very realistic and we hope to do better. But right now, I cannot -- we have to be prudent that the team is working very hard to make sure that we don't run out of raw material.

而且，如您所知，我們天生保守，我們喜歡現實。我們知道我對醫療技術的看法，實現 70% 到 80% 的增長並非易事。我們認為這是非常現實的，我們希望做得更好。但現在，我不能——我們必須謹慎，團隊正在非常努力地工作，以確保我們不會用完原材料。

The other area, as I stated on the call, the other area is making sure that we're ramping up our staffing and also ramping up our control of our logistical network, specifically aviation. If we get all these 3 done, Allen, this is really when I feel confident that going forward and our long-term growth trajectory. But this is a year that we're still building. We're still building our supply infrastructure, our NOP infrastructure, we're upgrading and scaling our logistics. We're adding a whole new business units in TransMedics called TransMedics aviation. So we have to be prudent. We have to be realistic, and we feel pretty strongly and pretty excited about the opportunity here and the potential in front of us. And we feel that the guidance we outlined reflect reality from where we see it.

另一個領域，正如我在電話會議上所說，另一個領域是確保我們正在增加人員配置，並加強我們對後勤網絡的控制，特別是航空。如果我們完成所有這 3 項，艾倫，這真的是我對前進和我們的長期增長軌跡充滿信心的時候。但這是我們仍在建設的一年。我們仍在建設我們的供應基礎設施，我們的 NOP 基礎設施，我們正在升級和擴展我們的物流。我們在 TransMedics 中增加了一個全新的業務部門，稱為 TransMedics 航空。所以我們必須謹慎。我們必須現實一點，我們對這裡的機會和我們面前的潛力感到非常強烈和興奮。我們認為我們概述的指南反映了我們所看到的現實。

The next question is from Cecilia Furlong with Morgan Stanley.

下一個問題來自摩根士丹利的 Cecilia Furlong。

Great. Congrats on another strong quarter. I wanted to start, Waleed, some of your comments in the Q&A, just about the center targeting balance that you talked about in 1Q as you work through some of the supply. And as you think going forward, just as capacity increases, can you talk about how you're thinking about the focus on bringing on new or the earlier stage NOP users versus really recircling on and driving deeper utilization across your current repeat users. And then also, as we think about [23 2], what are you contemplating the balance from a commercial standpoint on trying to reinvigorate lung versus driving those heart as well as liver sites going forward?

偉大的。祝賀又一個強勁的季度。我想開始，瓦利德，你在問答中的一些評論，關於你在第一季度討論的一些供應時談到的中心目標平衡。當你思考未來時，就像容量增加一樣，你能談談你是如何考慮專注於吸引新的或早期階段的 NOP 用戶，而不是真正地重新循環並推動當前重複用戶的更深入利用。然後，正如我們考慮的那樣 [23 2]，從商業角度來看，您如何考慮嘗試重振肺與推動心臟和肝臟部位向前發展之間的平衡？

Thank you, Cecilia, for the question. I think my answer for both questions will be the same, Cecilia. We've always said from the day we went public, we've said TransMedics is not a single organ company. We're not a single-trick pony. TransMedics full potential happens when we have all three organs firing in all cylinders. Also, as we gained FDA approval of heart and liver, we also stated publicly that, that kind of makes the business more resilient to any headwinds in one organ, i.e., the [lung] delays. So from our perspective, we are going to continue to push on all three fronts to achieve our overall growth for the business, regardless where it's coming from. So that's number one or the second half of your question.

塞西莉亞，謝謝你提出這個問題。 Cecilia，我想我對這兩個問題的回答都是一樣的。從上市那天起，我們就一直說，TransMedics 不是一家單一的器官公司。我們不是只會耍花招的小馬。當我們讓所有三個器官都在所有氣缸中燃燒時，TransMedics 的全部潛力就會發揮出來。此外，當我們獲得 FDA 對心臟和肝臟的批准時，我們還公開表示，這使得企業對一個器官的任何逆風更有彈性，即 [肺] 延遲。因此，從我們的角度來看，我們將繼續推動所有三個方面，以實現我們業務的整體增長，無論它來自哪裡。所以這是你問題的第一或第二部分。

The first half of your question, again, we stated this last quarter that our growth strategy is not a single focus point. We're focusing on going deeper in our existing accounts or existing centers, but also growing the number of users in the United States. And that's something we're going to continue to pursue. That's why at some point, hopefully in the future, at some point, the number of centers is really going to be [new] to us. It's really as long as we're demonstrating growth -- and the third element to the strategy is growing the overall U.S. transplant volume. So one can argue, if we just stay with one core group of centers, and we were able to penetrate their existing volume deeper and grow their overall volume by 30% or 40%, that could achieve significant success growth-wise for TransMedics, but that's not what we're doing. We're doing all of above.

你問題的前半部分，我們在上個季度再次聲明，我們的增長戰略不是一個單一的焦點。我們正專注於深入我們現有的賬戶或現有的中心，同時也在增加美國的用戶數量。這是我們將繼續追求的目標。這就是為什麼在某個時候，希望在未來的某個時候，中心的數量對我們來說真的是[新的]。只要我們展示了增長，它就真的存在——該戰略的第三個要素是增加美國的整體移植量。所以有人可以爭辯說，如果我們只停留在一組核心中心，並且我們能夠更深入地滲透他們現有的數量並將他們的總數量增加 30% 或 40%，那麼 TransMedics 就可以在增長方面取得顯著的成功，但是那不是我們正在做的。我們正在做以上所有事情。

We're targeting existing centers to grow their penetration and overall volume. We're targeting new centers to hook them up on NOP and its benefits for them and for their patients and for their staff and going deeper and growing their overall volume. So that's what we'll be doing over the next few years. And that we believe that if we achieve that coherent strategy, that is the recipe for a huge growth and successful TransMedics. And in our humble view makes TransMedics more resilient to any of these headwinds that we could experience throughout this growth potential.

我們以現有中心為目標，以增加它們的滲透率和整體數量。我們的目標是新的中心，讓他們了解 NOP 及其對他們、他們的病人和他們的員工的好處，並深入和增加他們的整體數量。這就是我們未來幾年要做的事情。我們相信，如果我們實現這一一致的戰略，這就是 TransMedics 實現巨大增長和成功的秘訣。以我們的拙見，TransMedics 對我們在整個增長潛力中可能遇到的任何不利因素更具彈性。

Great. Super helpful. And if I could follow up as well. Just on margins, and specifically, the service margin component of gross margin that we saw pick up. Stephen, if you could talk through how we should think about just that component of gross margin through the balance of the year? And then secondly, on OpEx as well as we think specifically SG&A some of the initiatives you talked about in terms of building out, adding incremental components to NOP. Just how we should think about the balance of this year from an OpEx and SG&A standpoint.

偉大的。超級有幫助。如果我也可以跟進。就利潤率而言，特別是我們看到的毛利率中的服務利潤率部分。斯蒂芬，你能否談談我們應該如何在今年餘下的時間裡只考慮毛利率的那一部分？其次，在 OpEx 以及我們特別考慮的 SG&A 方面，您談到了一些在構建、向 NOP 中添加增量組件方面的舉措。我們應該如何從 OpEx 和 SG&A 的角度考慮今年的平衡。

Thanks, Cecilia. So first, on the service margin, we were able to see, as I mentioned, an increase in Q1 from this kind of challenging situation we're in Q4, so I think we should see that stay. So we should be kind of at that level. I don't expect a big increase in that level that we were in Q1, but we should remain there as long as we don't fall into another device or disposable shortage situation. So that will help as our revenue grows and help our overall margin for the company. As far as OpEx, I mean, we grew OpEx about 44%. I think I mentioned in the last call, kind of growth overall annually in the 30%, 35% range. That includes a lot of these initiatives. So I think that gives a sense of how we're investing.

謝謝，塞西莉亞。因此，首先，在服務利潤率方面，正如我所提到的，我們能夠看到我們在第四季度的這種具有挑戰性的情況下第一季度有所增加，所以我認為我們應該看到這一點。所以我們應該處於那種水平。我預計我們在第一季度的水平不會有很大的提高，但只要我們不陷入另一種設備或一次性短缺的情況，我們就應該保持這種水平。因此，這將有助於我們的收入增長，並有助於我們公司的整體利潤率。就運營支出而言，我的意思是，我們的運營支出增長了約 44%。我想我在上次電話會議中提到過，每年總體增長率在 30%、35% 之間。這包括很多這樣的舉措。所以我認為這讓我們了解了我們的投資方式。

Next question is from Suraj Kalia with Oppenheimer.

下一個問題來自 Suraj Kalia 和 Oppenheimer。

Waleed, Stephen, Tamer. Can you hear me all right?

瓦利德、斯蒂芬、塔默。你能聽到我說話嗎？

Yes. Prefect Suraj.

是的。蘇拉傑省長。

Perfect. Gentlemen, congrats on another nice quarter. So Waleed, I was asked a question by a client then suffice it to say, through me for loop. Maybe you can help clarify. So the question was should TransMedics have waited to get into the logistics, i.e., TransMedics aviation till a critical mass of organs are under their belt. I believe you gave a number of 535 done till sometime in April. Would it have made more sense to reach 1,000, 2,000? Any additional color there would be great.

完美的。先生們，恭喜你又迎來了一個不錯的季度。所以瓦利德，我被客戶問了一個問題，然後通過我的 for 循環就足夠了。也許你可以幫助澄清。所以問題是 TransMedics 是否應該等待進入後勤，即 TransMedics 航空，直到達到臨界質量的器官。我相信你給出了 535 的數字，直到 4 月的某個時候才完成。達到 1,000、2,000 會更有意義嗎？任何額外的顏色都會很棒。

Sure. Suraj, thank you for the question. We -- of course, we would have never entertained this thought if we do not believe that not only we've achieved a critical mass that what we see coming will literally -- could literally put the entire logistics into a screeching halt. So we feel very confident that we are on the -- we have enough critical mass today. But more importantly, we are very concerned that our volume by year-end is going to literally be at a much higher scale that could actually start becoming a bottleneck finding airplanes. We're having problems finding airplanes for our missions today. Not at the end of the year, and we know our volume is going to be significantly higher by year-end and definitely into 2024. So it makes perfect sense. The question makes sense, and this -- we want to reiterate that we believe we are -- we have reached a critical mass today and what we see coming would even behoove us to act quickly and decisively before it becomes another area that we are talking about on these calls.

當然。蘇拉傑，謝謝你的提問。我們——當然，如果我們不相信不僅我們已經達到了臨界質量，而且我們所看到的即將發生的事情——真的可以讓整個後勤工作戛然而止，我們就永遠不會考慮這個想法。因此，我們非常有信心，我們今天擁有足夠的臨界質量。但更重要的是，我們非常擔心到年底我們的數量將真正達到更高的規模，這實際上可能開始成為尋找飛機的瓶頸。我們今天在為我們的任務尋找飛機時遇到了問題。不會在今年年底，我們知道我們的銷量到年底會顯著增加，而且肯定會持續到 2024 年。所以這是完全有道理的。這個問題是有道理的，而且——我們想重申，我們相信我們是——我們今天已經達到了臨界質量，我們看到即將發生的事情甚至需要我們在它成為我們正在談論的另一個領域之前迅速而果斷地採取行動關於這些電話。

Fair enough. Waleed, one for you or one for Stephen, and I'll hop back in queue. So Waleed, it's been a little over a year with the heart approvals. Whether it's heart, whether it's livers, how should we think about the pie? Are you all taking away share from cold storage? Or do you think the overall pie is increasing? Waleed, that's for you?

很公平。 Waleed，一個給你，一個給 Stephen，我會跳回隊列。所以瓦利德，已經一年多了，得到了內心的認可。不管是心，還是肝，我們應該怎麼看待餡餅？冷庫的份額你們都拿走了嗎？還是你認為整體大餅在增加？瓦利德，這是給你的嗎？

And Stephen, for you, if I may, so when TransMedics aviation, we look at it, would it be a separate "subsidiary", so the P&L would be different? Or would everything be under the TransMedics umbrella traditional reporting, so to speak, in OpEx and so on and so forth. And Stephen, would I be too far off in saying all said and done in 2 years, including 25 surgeons per organ, let's say, 16 planes lease -- obviously, the form but -- we are talking about an incremental expense somewhere $50 million, $70 million per year.

斯蒂芬，對你來說，如果可以的話，那麼當 TransMedics 航空時，我們會考慮它，它會是一個單獨的“子公司”，所以損益表會有所不同嗎？或者一切都在 TransMedics 傳統報告的保護傘下，可以這麼說，在 OpEx 等等。斯蒂芬，我說兩年內說的和做的一切是否太過分了，包括每個器官 25 名外科醫生，比方說，16 架飛機租賃——顯然，形式但是——我們正在談論大約 5000 萬美元的增量費用，每年 7000 萬美元。

Thank you, Suraj. So let me address the first question. The answer is both. We're taking a significant portion of the existing market, and we're growing the overall market. And again, the numbers speak for themselves. We've seen heart grew by 9% last year, lung grew by 7%, liver grew by 3%. We expect the overall growth of these organs to be higher in 2022 -- I'm sorry, 2023. And we're taking a meaningful percentage of their current volume. Why? Because we're streamlining the process through the NOP. And this is what I said earlier to Cecilia's question. Our strategy is not just to cannibalize the existing market. Our strategy is to do that plus grow the overall market. And I think our -- I believe that our results speak for themselves. We have demonstrated our ability to do both in our 2022 results, and we are continuing to see that trajectory in '23, and we expect that to continue going forward.

謝謝你，蘇拉吉。那麼讓我來解決第一個問題。答案是兩者兼而有之。我們正在佔據現有市場的很大一部分，並且正在發展整個市場。再一次，數字不言自明。去年我們看到心臟增長了 9%，肺增長了 7%，肝臟增長了 3%。我們預計這些器官的總體增長將在 2022 年更高——對不起，2023 年。我們正在佔他們目前數量的很大一部分。為什麼？因為我們正在通過 NOP 簡化流程。這就是我之前對 Cecilia 的問題所說的話。我們的戰略不僅僅是蠶食現有市場。我們的戰略是做到這一點加上發展整個市場。我認為我們的——我相信我們的結果不言自明。我們已經在 2022 年的結果中證明了我們有能力做到這兩點，並且我們將在 23 年繼續看到這種軌跡，我們希望這種情況會繼續向前發展。

And Suraj, let me address the question on the subsidiary. I don't expect it to be a separate subsidiary reporting separately. I expect it to be part of our overall P&L. And when it comes to -- well, I can't really talk about the investment at this moment, what I can say is, it will include a revenue component added revenue as well as cost. So it's not going to be a breakeven. It will be added bottom line to TransMedics as well. I hope that makes sense.

Suraj，讓我來談談關於子公司的問題。我不希望它成為單獨的子公司單獨報告。我希望它成為我們整體損益表的一部分。說到——好吧，我現在不能真正談論投資，我能說的是，它將包括增加收入和成本的收入部分。所以這不會是收支平衡。它也將被添加到 TransMedics 中。我希望這是有道理的。

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

我們的問答環節到此結束。我想將會議轉回給 Waleed Hassanein 作閉幕詞。

Thank you. We thank you all for your time this evening, and we look forward to having our next call for our Q2 results. Have a wonderful evening.

謝謝。感謝大家今晚抽出時間，我們期待著下次電話會議，了解我們的第二季度業績。祝你度過一個美好的夜晚。

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

會議現已結束。感謝您參加今天的演講。您現在可以斷開連接。