Transmedics Group Inc (TMDX) 2022 Q4 法說會逐字稿

Good afternoon and welcome to the TransMedics Fourth Quarter and Full-Year 2022 Earnings Conference Call. (Operator Instructions) Please note, this event is being recorded.

下午好，歡迎參加 TransMedics 2022 年第四季和全年財報電話會議。 （操作員說明）請注意，正在記錄此事件。

I would now like to turn the conference over to Brian Johnston from the Gilmartin Group. Please go ahead.

我現在想將會議轉交給吉爾馬丁集團的布萊恩約翰斯頓。請繼續。

Thank you. Earlier today, TransMedics released financial results for the quarter and full-year ended December 31st, 2022. 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, 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 2022 年 12 月 31 日的季度和全年財務業績。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。本次電話會議中包含的任何與對未來事件、結果或績效的預期或預測相關的陳述均為前瞻性陳述。

All forward-looking statements, including without limitation are 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 margins and operating expenses in 2023 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.

所有前瞻性陳述，包括但不限於對營運趨勢、我們產品的潛在商業機會和我們未來財務預期的審查，其中包括對我們組織和指導成長的預期以及我們對收入、毛利率和營運費用的預期2023年是基於我們目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有重大差異。

Accordingly, you should not place undue reliance on these statements. Additional information regarding these risks and uncertainties appear under the heading, Risk and Risk Factors on our Form 10-Q filed with the Securities and Exchange Commission on November 4, 2022 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 February 22nd, 2023.

因此，您不應過度依賴這些陳述。有關這些風險和不確定性的更多信息，請參見我們於2022 年11 月4 日向美國證券交易委員會提交的10-Q 表格以及我們隨後向美國證券交易委員會提交的文件中的“風險和風險因素」標題，這些資訊可在www. .sec.gov 和我們的網站 www.transmedics.com。 TransMedics 不承擔任何意圖或義務，除非法律要求更新或修改任何財務預測或前瞻性陳述，無論是因為新資訊、未來事件或其他原因。本次電話會議包含時間敏感訊息，僅截至 2023 年 2 月 22 日今天直播時準確。

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

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

Thank you, Brian. Good afternoon, everyone and welcome to TransMedics fourth quarter and full-year 2022 earnings call. As always joining me today is Stephen Gordon, our Chief Financial Officer. Our fourth quarter performance demonstrated continued commercial momentum and accelerated clinical adoption through the NOP. Despite constrained supply of our OCS perfusion module, as we are working to increase finished goods assembly capacity. This marks another quarter of significant sales growth for the business.

謝謝你，布萊恩。大家下午好，歡迎參加 TransMedics 2022 年第四季和全年財報電話會議。一如既往，今天和我一起的是我們的財務長史蒂芬戈登。我們第四季度的業績證明了持續的商業勢頭，並透過 NOP 加速了臨床採用。儘管我們的 OCS 灌注模組供應有限，但我們正在努力提高成品組裝能力。這標誌著該業務又一個季度的銷售大幅成長。

Here are the summary results. 4Q total revenue was $31.4 million, representing 225% year-over-year growth and approximately 22% growth over the third quarter of 2022. As expected, NOP continue to be the primary driver for the revenue growth, a trend we expect to continue for the foreseeable future. Total revenue for the full-year 2022 was $93.5 million, including new product and service revenue of 92.1 and $1.4 million favorable counter revenue adjustment in 3Q. These results represent 209% and 204% year-over-year growth respectively.

以下是總結結果。第四季總營收為 3,140 萬美元，年成長 225%，較 2022 年第三季成長約 22%。未來。 2022年全年總收入為9,350萬美元，其中新產品和服務收入為92.1%，第三季櫃檯收入調整為140萬美元。這些結果分別代表年增 209% 和 204%。

We effectively tripled our revenue in '22 over '21. Stephen will cover the financial details and organ split in his section of this call. Now let me provide some more granular highlights from the quarter and the full-year. Overall, 4Q represented a high watermark for case volume for OCS and NOP, as heart and liver cases increased sequentially for the fourth consecutive quarter. We were also pleased to see modest but encouraging growth of lung activities in Q4, a trend which we hope to maintain in '23.

與 21 年相比，22 年我們的收入實際上增加了兩倍。史蒂芬將在本次電話會議的他的部分中介紹財務細節和器官分割。現在讓我提供本季和全年的一些更具體的亮點。總體而言，第四季度 OCS 和 NOP 病例數量達到了高位，心臟和肝臟病例連續第四個季度連續增加。我們也很高興看到第四季肺部活動適度但令人鼓舞的成長，我們希望在 23 年保持這一趨勢。

Approximately 89% of our total US case volume came from NOP. On a per organ basis, approximately 97% of the liver, approximately 79% of the heart and approximately 85% of the lung cases were from NOP. 2022 has demonstrated to us that NOP is here to stay and is uniquely differentiating TransMedics in the marketplace. Our goal is to drive NOP to be the new standard-of-care for solid organ transplant in the US over the next several years.

我們美國總病例數的大約 89% 來自 NOP。以每個器官為基礎，大約 97% 的肝臟、大約 79% 的心臟和大約 85% 的肺部病例來自 NOP。 2022 年向我們證明，NOP 將繼續存在，並讓 TransMedics 在市場上脫穎而出。我們的目標是在未來幾年內推動 NOP 成為美國實體器官移植的新照護標準。

As we predicted and despite being in the first year of commercial launch of OCS liver and heart in the US, the overall transplant markets saw modest overall transplant volume growth year-over-year. Liver transplant grew by approximately 3%, heart transplant grew by approximately 9% and even lung were up approximately 7% in '22 over '21. We believe this is an encouraging early sign that the use of OCS and NOP are enabling growth in the overall transplant volumes in the US through the use of DCD, the extended criteria and distant donor in the US.

正如我們預測的那樣，儘管處於 OCS 肝臟和心臟在美國商業推出的第一年，但整體移植市場的整體移植量比去年同期略有增長。與 21 年相比，22 年肝臟移植增加了約 3%，心臟移植增加了約 9%，甚至肺移植也增加了約 7%。我們相信這是一個令人鼓舞的早期跡象，表明透過使用 DCD、擴展標準和美國的遠距離捐贈者，OCS 和 NOP 的使用正在使美國的整體移植量增長。

Simply stated, the OCS and NOP are fundamentally growing the transplant market. We will continue to track this annual trend and we expect to see these growth rates to increase over-time with NOP growth in all the organs. We ended at 4Q '22 with critical mass of transplant program using OCS and NOP. There were 22 liver programs that used OCS and NOP in Q4, of which, there were 12 active users. For heart, there were 29 programs that used OCS and NOP, of which 12 were active users. In lung, there were 13 programs that used OCS and NOP, of which five were repeat users.

簡而言之，OCS 和 NOP 從根本上擴大了移植市場。我們將繼續追蹤這一年度趨勢，我們預計隨著所有器官中 NOP 的增長，這些成長率將隨著時間的推移而增加。我們在 22 年第 4 季結束了使用 OCS 和 NOP 的移植計畫的臨界量。第四季有 22 個肝臟項目使用 OCS 和 NOP，其中活躍用戶 12 個。對於心臟來說，有 29 個程式使用了 OCS 和 NOP，其中 12 個是活躍使用者。在肺部，有 13 個項目使用了 OCS 和 NOP，其中 5 個是重複使用者。

It is important to note, we have achieved the above results, despite being in a supply constraint situation for several weeks during 4Q, as we continue to build-up our production capacity to meet the growing demand for OCS. We were able to navigate this difficult situation, grow our case volume and grow our revenue by leveraging the NOP hub network to supply OCS modules to any location across the US to meet the demand using chartered flight. This early inefficiency in the supply-chain distribution was the primary driver of the 4Q service margin erosion, since TransMedics had to absorb these costs to meet the demand.

值得注意的是，儘管在第四季度連續幾週處於供應緊張的情況下，我們還是取得了上述成果，因為我們繼續建立產能以滿足對 OCS 不斷增長的需求。透過利用 NOP 樞紐網路向美國各地提供 OCS 模組，透過包機滿足需求，我們能夠應對這一困難局面，增加我們的案件數量並增加我們的收入。供應鏈分銷的早期效率低下是第四季度服務利潤下降的主要原因，因為 TransMedics 必須吸收這些成本來滿足需求。

We expect this to be a transient phenomenon and that this will revert once we scale our production capacity and develop more leverage on the logistical process. Let me use this opportunity to update you on several actions that we've taken to enable us to overcome the production capacity constraints over the coming several months.

我們預計這只是一個暫時現象，一旦我們擴大生產能力並在物流過程中發揮更多作用，這種情況就會恢復。讓我藉此機會向您介紹我們為克服未來幾個月的產能限製而採取的幾項行動的最新情況。

We've already expanded our clean room space. The documentation for FDA certification is under review by FDA and we are expecting the certification or FDA decision over the coming months. We are expanding our existing sterilization capacity and are in the final stages of qualifying a larger sterilization partner to expand total capacity and further derisk our supply chain.

我們已經擴大了無塵室空間。 FDA 認證的文件正在接受 FDA 審查，我們預計在未來幾個月內獲得認證或 FDA 做出決定。我們正在擴大現有的滅菌能力，並處於資格更大滅菌合作夥伴的最後階段，以擴大總能力並進一步降低我們的供應鏈風險。

We have staffed a second assembly shift that is now fully operational. Importantly, we've brought on Nick Corcoran who have served in multiple roles of increasing responsibility at Stryker Corporation as our Senior Vice-President of Supply Chain and Operations to lead these initiatives as we continue to scale.

我們已經配備了第二個組裝班次的人員，現已全面投入使用。重要的是，我們聘請了 Nick Corcoran，他曾在 Stryker Corporation 擔任過多個職務，職責不斷增加，擔任我們的供應鏈和營運高級副總裁，隨著我們不斷擴大規模，領導這些舉措。

In summary, we expect to resolve production capacity constraints by the second half of 2023. There's no doubt in our mind that '22 was a transformative year for TransMedics business, as we demonstrated the significant value proposition and growth potential for OCS and NOP in the United States. We strongly believe however, that this is just the beginning of a long runway of sustained significant growth for TransMedics business.

總之，我們預計在 2023 年下半年解決產能限制。然而，我們堅信，這只是 TransMedics 業務長期持續顯著成長的開始。

Let me articulate our strategies to achieve our growth potential. First, starting in 2023 and as soon as we adequately enhance production capacity, we will focus in four areas to grow our US transplant franchise further. Specifically, we will continue to add new transplant program for the NOP initiative in the US for liver, heart and lung.

讓我闡明我們實現成長潛力的策略。首先，從2023年開始，一旦我們充分提高產能，我們將重點放在四個領域進一步擴大我們的美國移植業務。具體來說，我們將繼續為美國的 NOP 計畫增加新的肝臟、心臟和肺移植計畫。

We will drive deeper penetration within existing and new transplant program based on the demonstrated efficiency and clinical outcomes of OCS cases at these programs. Focus on growing the overall transplant volumes at these programs from DCD, extended criteria and distance standard donors using the NOP infrastructure.

我們將根據現有和新的移植項目中已證實的 OCS 病例的效率和臨床結果，推動這些項目的更深入滲透。重點關注使用 NOP 基礎設施增加這些項目的 DCD、擴展標準和距離標準捐贈者的整體移植量。

Finally, reinvigorating the OCS Lung program through the NOP in the US to contribute additional growth. Second, we will continue to expand our NOP infrastructure. Specifically, we are expanding our surgical capabilities and clinical support staff across-the-board and maybe opening new launch points as needed to expand our geographical reach in the US. Third, we are developing -- we are developing a best-in-class dedicated air and ground logistics network for organ transplantation in the United States.

最後，透過美國 NOP 重振 OCS 肺部項目，以促進進一步成長。其次，我們將繼續擴大 NOP 基礎設施。具體來說，我們正在全面擴大我們的手術能力和臨床支援人員，並可能根據需要開設新的啟動點，以擴大我們在美國的地理覆蓋範圍。第三，我們正在開發——我們正在為美國器官移植開發一流的專用空中和地面物流網絡。

This is critical, let me repeat, this is critical to managing our growth potential and controlling our transportation costs and improving our service margins. Importantly, we strongly believe that this initiative would create a significant catalyst for further growing the NOP franchise in the US. Importantly, it will create a larger, deeper and wider moat around our NOP offering, while uniquely positioning us to more fully -- to more fully transform the standard-of-care in the United States. Finally, by continuing to invest in our next-gen OCS and next Organ programs, this is critical to our long-term growth, importantly, to further distance our self from any potential competitors on the horizon.

讓我再說一遍，這對於管理我們的成長潛力、控制我們的運輸成本和提高我們的服務利潤至關重要。重要的是，我們堅信這項措施將為進一步發展 NOP 在美國的特許經營權創造重要的催化劑。重要的是，它將圍繞我們的 NOP 產品創造一條更大、更深、更寬的護城河，同時使我們能夠更全面地、更全面地改變美國的護理標準。最後，透過繼續投資我們的下一代 OCS 和下一個 Organ 項目，這對我們的長期成長至關重要，重要的是，可以進一步拉開我們與潛在競爭對手的距離。

Let me conclude this section by sharing some important facts to help quantify the magnitude of growth in front of TransMedics that we are planning to fully capitalize on. In '22, we transplanted approximately 1,000 cases on OCS. This represents only 7% of the existing total US liver, heart and lung transplants in 2022. We strongly believe that we have the potential and are creating the NOP infrastructure to be able to perform the lion's share of the existing US transplant volumes for liver, heart and lung transplants.

讓我透過分享一些重要事實來結束本節，以幫助量化我們計劃充分利用的 TransMedics 的成長幅度。 22 年，我們在 OCS 上移植了大約 1,000 例。這僅佔 2022 年美國現有肝臟、心臟和肺移植總量的 7%。心臟和肺移植。

In addition, we also expect to benefit from our ability to grow the overall transplant volumes as we have demonstrated early on in '22 by enabling the use of organs from DCD, extended criteria and distant standard criteria donors, that were seldomly utilized for transplantation in the US due to the limitations of historical procurement and preservation methods. This effectively will grow our total addressable market opportunity for TransMedics and organ transplantation.

此外，我們還期望受益於我們增加整體移植量的能力，正如我們在 22 年初所展示的那樣，透過使用來自 DCD、擴展標準和遠距離標準標準供體的器官，這些器官很少用於移植美國由於歷史採購和保存方式的限制。這將有效地增加我們在 TransMedics 和器官移植領域的整體潛在市場機會。

In all, we are humbled and thrilled by our successes in '22 and we're looking-forward to continuing to build on this solid foundation to catapult TransMedics to new heights in '23 and beyond. We are confident in our strategy and we are laser-focused on execution of our plans to drive the next gear of growth for TransMedics and NOP.

總而言之，我們對 22 年的成功感到謙卑和興奮，我們期待著繼續在這個堅實的基礎上發展，在 23 年及以後將 TransMedics 推向新的高度。我們對我們的策略充滿信心，我們專注於執行我們的計劃，以推動 TransMedics 和 NOP 的下一個成長階段。

As mentioned, 4Q results continue to outpace our forecasted demand plan and challenge our finished goods production capacity. As we stand today, we foresee this issue continuing with us until probably the end of Q2, which may be -- which may be impacted by temporary shortage of supply of finished OCS products in the immediate term. During this ramp-up process, we may find ourselves in another back order situation in Q1 or Q2 2023.

如前所述，第四季度的業績繼續超過我們預測的需求計劃，並對我們的成品產能提出挑戰。就我們今天的情況而言，我們預計這個問題可能會持續到第二季​​末，這可能會受到短期內 OCS 成品供應暫時短缺的影響。在這個加速過程中，我們可能會發現自己在 2023 年第一季或第二季陷入另一個延期交貨的情況。

That said, based on our 4Q and full-year results and balancing these results with expected finished goods pressures in H1 2023, we are setting our annual revenue guidance for full-year '23 to be between USD138 million and USD145 million in revenue, representing a strong 50% to 57% growth over '22 total revenue excluding contra-revenue reversal.

也就是說，根據我們的第四季和全年業績，並平衡這些結果與2023 年上半年的預期製成品壓力，我們將23 年全年營收指引設定在1.38 億美元至1.45 億美元之間，相當於較 22 年總收入（不包括收入逆轉）強勁增長 50% 至 57%。

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

接下來，讓我給史蒂芬打電話，介紹本季的詳細財務表現。

Thank you, Waleed. I will now provide some additional detail on the Q4 results and other financial information for the quarter and the year. For the fourth quarter of 2022, our total revenue was $31.4 million. This is an increase of 225% from the fourth quarter of 2021 and a 22% sequential increase from last quarter. In the US, revenue was $29.1 million. US revenue increased over 300% from the fourth quarter of 2021 and 25% sequentially from last quarter.

謝謝你，瓦利德。我現在將提供有關第四季度業績以及該季度和年度其他財務資訊的一些額外詳細資訊。 2022 年第四季度，我們的總收入為 3,140 萬美元。這比 2021 年第四季成長了 225%，比上季環比成長了 22%。在美國，收入為 2910 萬美元。美國營收較 2021 年第四季成長超過 300%，較上季較上季成長 25%。

The organ breakdown on US revenue was $16.1 million of liver, $11 million of heart and $1.9 million of lung. Ex-US revenue was $2.3 million, a 5% decline from Q4 of 2021 in US dollars, but in constant currency, non-US revenue grew 7%. And the ex-U.S. revenue was $2.1 million of heart, $0.2 million of lung and $0.1 million of liver.

美國收入中的器官細分為肝臟 1,610 萬美元、心臟 1,100 萬美元和肺 190 萬美元。美國以外的營收為 230 萬美元，以美元計算較 2021 年第四季下降 5%，但以固定匯率計算，非美國營收成長了 7%。還有前美國心臟收入為 210 萬美元，肺部收入為 20 萬美元，肝臟收入為 10 萬美元。

We also are reporting the breakout of product and service revenue this quarter. The service revenue includes the added amounts we charge for the surgical procurement in organ management as part of the NOP. In Q4, product revenue was $25.1 million and service revenue was $6.3 million, so the service portion was about 20% of the total in Q4.

我們也報告了本季產品和服務收入的突破。服務收入包括我們對器官管理中的手術採購收取的額外費用，作為 NOP 的一部分。第四季度，產品收入為2,510萬美元，服務收入為630萬美元，因此服務部分約佔第四季總收入的20%。

Gross margin for the fourth quarter of 2022 was 66%. This is down from 72% in the fourth quarter of '21 and reflects the higher NOP service component and the early inefficiency that Waleed mentioned in his remarks. The margin on product revenue was 79% in Q4 2022 and the margin on service was 14% in Q4 '22.

2022年第四季毛利率為66%。這比 21 年第四季的 72% 有所下降，反映出較高的 NOP 服務成分以及瓦利德在演講中提到的早期效率低下。 2022 年第四季的產品收入利潤率為 79%，2022 年第四季的服務利潤率為 14%。

Total operating expenses for the quarter were $27.5 million, that's 50% above Q4 of '21, driven primarily by our continued investment in scaling our NOP infrastructure and resources to be able to meet growth in NOP demand. Our operating loss was $6.8 million in the fourth quarter of '22 compared to $11.3 million in the fourth quarter of '21, primarily result of the growing revenues in the business. And our net loss for the fourth quarter of 2022 was $6.7 million, compared to $12.7 million in the fourth quarter of 2021.

本季的總營運支出為 2,750 萬美元，比 21 年第四季成長 50%，這主要是由於我們持續投資擴大 NOP 基礎設施和資源以滿足 NOP 需求的成長。 22 年第四季我們的營運虧損為 680 萬美元，而 21 年第四季營運虧損為 1,130 萬美元，這主要是由於業務收入不斷增長。我們 2022 年第四季的淨虧損為 670 萬美元，而 2021 年第四季的淨虧損為 1,270 萬美元。

Total cash was $201.2 million as of December 31st, 2022, which equates to a reduction of $3.3 million from the balance at the end of Q3 of 2022. And weighted-average common shares outstanding for the quarter were 32 million. From a cash perspective, TransMedics remains in a very strong position to continue to execute our strategy and increase OCS and NOP utilization throughout the organ transplant field.

截至 2022 年 12 月 31 日，現金總額為 2.012 億美元，相當於 2022 年第三季末的餘額減少 330 萬美元。從現金角度來看，TransMedics 仍然處於非常有利的地位，可以繼續執行我們的策略並提高整個器官移植領域的 OCS 和 NOP 利用率。

Now let me share some detail on the full-fiscal year 2022 results. For the full-year, total revenue was $93.5 million, a 209% increase over the prior year and included the $1.4 million favorable reversal of contra revenue in Q3. US organ breakdown for the full-year was $46.1 million of liver, $29.9 million of heart and $8 million of lung. And OUS was $8.5 million of heart, $0.9 million of lung and $0.1 million of liver.

現在讓我分享 2022 年全年業績的一些細節。全年總收入為 9,350 萬美元，比上年增長 209%，其中包括第三季 140 萬美元的對銷收入有利逆轉。美國全年器官支出為肝臟 4,610 萬美元、心臟 2,990 萬美元和肺 800 萬美元。 OUS 包括 850 萬美元的心臟、90 萬美元的肺臟和 10 萬美元的肝臟。

Product revenue for the year was $79.2 million and service revenue was $14.2 million. Gross margin for the full-year was 70%, the same as in 2021 and product margin was 79% and service margin was 21% for the full-year of 2023. And total operating expenses were $96.7 million for the full-year 2022, that's up 60% from $60.6 million in 2021. Operating loss was $31 million -- $31.4 million for the full-year 2022 compared to $39.4 million in '21 and net loss was $36.2 million in '22 compared to $44.2 million in '21. Overall, 2022 was a significant year for TransMedics, as we demonstrated the commercial strength of the OCS, the NOP and TransMedics in general.

該年度產品收入為 7,920 萬美元，服務收入為 1,420 萬美元。 2023年全年毛利率為70%，與2021年相同，產品利潤率為79%，服務利潤率為21%。 60%。總體而言，2022 年對 TransMedics 來說是重要的一年，因為我們總體上展現了 OCS、NOP 和 TransMedics 的商業實力。

As Waleed discussed, we are very enthusiastic about our opportunities to grow OCS and NOP adoption in 2023 and over the next several years. To repeat what Waleed earlier comment, we're providing annual revenue guidance in the range of $138 million to $145 million, which represents 48% to 55% or 50% to 57% excluding the favorable contra reversal '22.

正如 Waleed 所討論的，我們對 2023 年及未來幾年增加 OCS 和 NOP 採用的機會非常熱衷。重複瓦利德先前的評論，我們提供的年收入指導範圍為 1.38 億美元至 1.45 億美元，這相當於 48% 至 55% 或 50% 至 57%，不包括有利的相反逆轉 '22。

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

現在，我想將電話轉回瓦利德以徵求結束意見。

Thank you, Stephen. To summarize, '22 was a transformative year for TransMedics, delivering exceptional 209% revenue growth. We strongly believe however that we are in the early-stage of a long sustained growth period for our business and organ transplantation in general in the US. We are now laser-focused on scaling our production capacity and NOP clinical and logistics infrastructure to achieve our goals. With OCS and NOP, TransMedics is uniquely positioned to lead the global transplant space into the future. We look forward to furthering our impact in 2023.

謝謝你，史蒂芬。總而言之，22 年對 TransMedics 來說是變革性的一年，營收成長了 209%。然而，我們堅信，我們的業務和器官移植在美國總體上處於長期持續成長的早期階段。我們現在專注於擴大我們的生產能力以及 NOP 臨床和物流基礎設施，以實現我們的目標。憑藉 OCS 和 NOP，TransMedics 處於獨特的地位，能夠引領全球移植領域的未來。我們期待在 2023 年進一步擴大我們的影響力。

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

現在，我將把電話轉給接線員進行問答。操作員？

(Operator Instructions) Our first question is from Allen Gong with J.P. Morgan.

（操作員說明）我們的第一個問題來自摩根大通的 Allen Kong。

This is actually Rohan on for Allen. I just wanted to start off with 2023 guidance and specifically I was hoping you could talk more about what this range assumes by organ in addition to new center adds and penetration rates?

這實際上是羅漢為艾倫辯護的。我只想從 2023 年的指導開始，特別是我希望您能更多地討論一下除了新的中心增加和滲透率之外，器官所假設的範圍是什麼？

You mean 2023 guidance?

你是說2023年指導嗎？

Yes.

是的。

Yeah, we never provide guidance on center or organ, we provide total revenue guidance for the year and we're not planning to change that anytime soon.

是的，我們從不提供有關中心或器官的指導，我們提供當年的總收入指導，並且我們不打算很快改變這一點。

And then I guess shifting over to the next question, would you be able to comment more on the durability of demand that drove outperformance during fourth quarter? And also just if you could give additional color on the supply situation as it stands today and specifically, I guess, your ability to meet demand in '23, given that we're kind of most of the way through the first quarter already?

然後我想轉向下一個問題，您能否對推動第四季度表現優異的需求持久性進行更多評論？另外，您是否可以對目前的供應狀況提供更多信息，特別是，我想，鑑於我們已經完成第一季度的大部分時間，您在 23 年滿足需求的能力？

On the demand, we believe that the demand was really in the early innings in '22, even in Q4 we expect that demand to continue to grow throughout '23 and beyond. And this is why we're focusing on scaling our supply capacity. This is why we are adding new leadership, expanding footprint of our production space, adding second shift because we need to create that infrastructure to allow us to continue to be ready to meet that growing demand. We do not expect this demand to be a one-and-done thing, we expect this to continue to grow. And until we're out of the supply capacity, we have to be prudent and we have to be conservative in our guidance and our estimation because we know that what back order situation could create. So I hope I addressed your question?

關於需求，我們認為需求確實出現在 22 年的早期階段，即使在第四季度，我們也預期需求將在 23 年及以後持續成長。這就是我們專注於擴大供應能力的原因。這就是為什麼我們要增加新的領導層，擴大我們的生產空間，增加第二班，因為我們需要創建基礎設施，使我們能夠繼續做好滿足不斷增長的需求的準備。我們預計這種需求不會是一勞永逸的事情，我們預期這種需求會持續成長。在我們超出供應能力之前，我們必須保持謹慎，我們的指導和估計必須保守，因為我們知道延期交貨的情況可能會造成什麼。所以我希望我回答了你的問題？

Yeah, that was helpful. And I guess just to clarify something, I believe you mentioned that you hope to resolve production capacity by the second half of this year, if I'm not mistaken, just wanted to -- okay, great. Thank you.

是的，這很有幫助。我想只是為了澄清一些事情，我相信你提到你希望在今年下半年解決產能問題，如果我沒記錯的話，只是想 - 好吧，太好了。謝謝。

That's correct.

這是正確的。

That's correct.

這是正確的。

The next question is from Cecilia Furlong with Morgan Stanley.

下一個問題來自摩根士丹利的塞西莉亞·弗隆。

Waleed, I wanted to follow-up a bit on the supply dynamics and you talked about a bit of pressure in 4Q. I don't know if there's a way to quantify the impact from a top line standpoint. But as we think about the first few quarters of '23 ahead of scaling supply, how should we think about upside relative to the 4Q run rate?

Waleed，我想跟進一下供應動態，您談到了第四季度的一些壓力。我不知道是否有辦法從頂線的角度來量化影響。但當我們在擴大供應之前考慮 23 年前幾個季度時，我們應該如何考慮相對於第四季度運行率的上行空間？

Cecilia, because we expect the demand to continue to grow and we expect the demand to continue to outstrip our ability to meet it. I would be -- from our perspective, we would highly advise to plan Q1 and Q2 either flat or modest growth because we expect to find ourselves again outstripping our increased capacity that we are experiencing with the second shift. This is why we're taking this methodical and conservative approach to our guidance.

Cecilia，因為我們預期需求將持續成長，我們預期需求將持續超越我們的滿足能力。從我們的角度來看，我們強烈建議第一季和第二季計劃持平或適度成長，因為我們預計會再次超過我們在第二次轉變中所經歷的產能成長。這就是為什麼我們在指導中採用這種有條理且保守的方法。

And if I could follow-up, Stephen, on gross margin, as you think about just your initiatives in '23 to ramp the logistics side. How should we think about the margin expansion story? I know you've talked about the 75 or mid-70s at scale. How should we think about the progression in '23? And coupled with that too, just from an OpEx standpoint, from an SG&A side, as you think about continuing to build out the NOP model, can you talk through how you're thinking about just the ramp on a relative basis in '23?

史蒂芬，如果我可以跟進毛利率，就像你在 23 年為提升物流所採取的舉措一樣。我們該如何看待利潤擴張的故事？我知道您曾大規模談論過 75 年代或 70 年代中期。我們該如何看待 23 年的進展？除此之外，僅從 OpEx 的角度來看，從 SG&A 方面來看，當您考慮繼續建立 NOP 模型時，您能否談談您如何考慮 23 年相對基礎上的成長？

And it's good question about margin. So margin was challenged in Q4 because of the limited supply and we had to do -- provide other costs that allowed us to be able to grow the revenue. That's going to continue in 2023. I would expect similar margins overall, maybe slight sequential improvement throughout the year. The goal, the mature goal in the mid-70s, I don't see that in '23 until we're completely out of supply constraints and with more revenue on the top line. As far as spending, we do expect to grow spending in '23. I would model just for modeling purposes, I would think of a range of about 25% to 30% overall OpEx, single digit on R&D and the rest in SG&A.

這是關於保證金的好問題。因此，由於供應有限，第四季度的利潤率受到挑戰，我們必須提供其他成本，使我們能夠增加收入。這種情況將在 2023 年持續下去。這個目標是 70 年代中期的成熟目標，我認為在 23 世紀我們不會完全擺脫供應限制並且收入增加。就支出而言，我們確實預期 23 年支出將會成長。我只是出於建模目的而進行建模，我會考慮整體營運支出的 25% 到 30% 左右，其中個位數用於研發，其餘用於 SG&A。

The next question is from Joshua Jennings with Cowen.

下一個問題是約書亞·詹寧斯和考恩提出的。

And I'll echo the -- it's good to see strong finish to the year. I was hoping Waleed to just ask about, I guess, the three buckets that you called out on the call, DCD extended criteria, DBD and then distant standard organs, donor organs. And just it seems like -- I think you mentioned earlier in some public commentary just about OCS volumes were kind of spread widely throughout each of those buckets. And maybe if you could just build on comments earlier in the year today and just help us think through because I think some are thinking that OCS opportunity may be limited or heavily weighted towards the [DCB] opportunity, but looking at the National Database, it seems like DCD organs are still very, very early in terms of the step up in '22 versus '21? Sorry, one winded question, but I hope you got the gist of it.

我也同意這一點——很高興看到今年的強勁收官。我希望瓦利德只問一下，我猜，你在電話中提出的三個桶，DCD 擴展標準，DBD，然後是遙遠的標準器官，捐贈器官。看起來 - 我想您之前在一些公開評論中提到 OCS 數量在每個類別中廣泛分佈。也許您可以在今年早些時候的評論的基礎上幫助我們思考，因為我認為有些人認為 OCS 機會可能有限或嚴重偏重於 [DCB] 機會，但看看國家數據庫，它看起來DCD 器官在22 年與21 年的進步方面仍然非常非常早期？抱歉，這是一個囉嗦的問題，但我希望你能明白要點。

This is exactly why we -- I went through the script to highlight that we're growing the overall transplant market, not just by DCD organ. In fact, DCB organ when you look at the blended rate across all three organs was less than 50%. But we're actually seeing DDD organs either distance procurement is leading the way extended criteria, DBD organs. OCS is being used across all transplants, including transplants within the same hospital and using NOP. So this is not intended to segment or limit. I was trying to actually highlight the opposite that the OCS is being used across the gamut of organ transplants.

這正是我們的原因——我仔細閱讀了劇本，強調我們正在發展整個移植市場，而不僅僅是 DCD 器官。事實上，當你觀察所有三個器官的混合率時，DCB 器官低於 50%。但我們實際上看到 DDD 器官或遠端採購正在引領擴展標準，DBD 器官。 OCS 正在用於所有移植，包括同一醫院內的移植和使用 NOP。所以這並不是為了分割或限制。我實際上是想強調相反的情況，即 OCS 正在應用於器官移植的各個領域。

And just two other areas we just heard surgeons talk about recently, one was the rapid recovery approach that you may be or some centers are using particularly OPOs when donors are either becoming more compromised and there's not enough time to match and use serology testing to match the donor with recipients and just explain the organ putting on the OCS system and then running those serology tests and then matching the organ. And then also just the stacking of organ transplant procedures by NOP adopters, would love to hear kind of how early we are in those two approaches that OPOs were using, as well as liver organ transplant centers, a rapid recovery and stacking and where you see those two buckets kind of contributing to growth in '23 and '24?

最近我們剛剛聽到外科醫生談論的另外兩個領域，一個是快速恢復方法，您可能會使用這種方法，或者當捐贈者變得更加脆弱並且沒有足夠的時間來匹配和使用血清學測試來匹配時，您可能會使用OPO。然後，NOP 採用者的器官移植程序的堆疊，很想聽聽我們在 OPO 所使用的這兩種方法中處於多早的階段，以及肝器官移植中心，快速恢復和堆疊以及您在哪裡看到的這兩個面向對23 年和24 年的成長做出了貢獻？

We're very early on both. Stacking is becoming more and more a routine process in the active users and heavy users, the super users of NOP and they're preaching it to their colleagues and other transplant programs. The rapid deployment of NOP to salvage and organ, it's in their way early innings. I think we are just scratching the surface. This is another mechanism of how can we increase the supply of organs from routine standard organs that traditionally would have been lost because there is no OCS or no NOP that would sell these organs. We've done a handful of those procedures throughout '22 and we expect that this is just a beginning. We expect this to grow. We're seeing more OPOs coming to us, not just for that, but coming to us just to encouraging us to creating hubs near major OPOs to help them out, allocate more organs. And again, we're evaluating all this with laser focus on making sure we are progressing and expanding and growing methodically and with maintaining the highest clinical quality of managing these organs and delivering NOP service.

我們在這兩方面都還處於早期階段。對於活躍用戶和重度用戶、NOP 的超級用戶來說，堆疊正變得越來越成為常規過程，他們正在向同事和其他移植程序宣傳這一點。 NOP 迅速部署到搶救和器官上，這在前幾局就阻礙了他們。我認為我們只是觸及了表面。這是我們如何增加常規標準器官供應的另一個機制，傳統上這些器官會因為沒有 OCS 或 NOP 出售這些器官而失去。我們在 22 年期間已經完成了其中一些程序，我們希望這只是一個開始。我們預計這一數字將會成長。我們看到越來越多的 OPO 來到我們這裡，不僅僅是為了這個，而是為了鼓勵我們在主要 OPO 附近建立中心，以幫助他們擺脫困境，並分配更多器官。再次，我們正在評估所有這一切，重點是確保我們有條不紊地進步、擴展和成長，並保持管理這些器官和提供 NOP 服務的最高臨床品質。

The next question is from Bill Plovanic with Canaccord.

下一個問題來自 Canaccord 的 Bill Plovanic。

My first question is just on the impact of supply in the fourth quarter. How much -- how many cases do you think you lost, number one. Number two, as we look at the kind of active users and the accounts you're in, how much impact did this have on new account adoption or your limitation of new account adoption? And then I have some follow-ups on that.

我的第一個問題是關於第四季供應的影響。第一，你認為自己輸掉了多少案件。第二，當我們查看活躍用戶的類型和您所在的帳戶時，這對新帳戶採用或您對新帳戶採用的限制有多大影響？然後我對此有一些後續行動。

I think let me start with the second part of the question. Of course, it impacted initiation of new program. We were highly selective and we -- however, we maintained an open dialogue. We expressed why we couldn't do it sometime, but we could do it. We mobilized heaven and earth to make sure that NOP hubs that have supply would go and get these organs. So of course, it negatively impacted our ability to grow active users in Q4, but we had already forecasted that. And until we're out of this supply constraint, we expect this to continue to happen and our team is getting great at making sure we're managing expectation appropriately and not causing any untoward reaction.

我想讓我從問題的第二部分開始。當然，它影響了新計劃的啟動。我們經過嚴格挑選，但我們保持了開放的對話。我們表達了為什麼有時我們做不到，但我們可以做到。我們動員了天地力量，確保有供應的 NOP 中心能夠去取得這些器官。當然，這對我們在第四季度增加活躍用戶的能力產生了負面影響，但我們已經預測到了這一點。在我們擺脫供應限制之前，我們預計這種情況將繼續發生，並且我們的團隊正在努力確保我們適當地管理期望並且不會引起任何不良反應。

The first one, as you know, we never really quantified the magnitude other than the number of weeks and in Q3, we had, I think, 1.5 or two weeks of shortage that we could not perform cases. In Q4, we had approximately two to three weeks of shortage and it impacted both liver and heart. So we're hopefully marching towards a time where this is not -- is no longer an issue.

第一個，如您所知，除了周數之外，我們從未真正量化過其嚴重程度，在第三季度，我認為我們有 1.5 週或兩週的短缺，導致我們無法執行案例。在第四季度，我們經歷了大約兩到三週的短缺，這對肝臟和心臟都有影響。因此，我們希望邁向一個不再是問題的時代。

And then if I could dig into it. So from my understanding from the manufacturing standpoint, there's kind of multiple points. There was one human problem where you didn't have enough people, you added the second shift, kind of what revenue level can you support with the second shift until the incremental capacity comes on board, which I think you said you expect now by the end of the second quarter or end of the first quarter for that incremental capacity?

然後我是否可以深入研究它。因此，從我對製造角度的理解來看，有許多要點。有一個人的問題，你沒有足夠的人，你增加了第二班，在增量產能出現之前，你可以用第二班支持什麼收入水平，我想你說過你現在期望的增量產能是在第二季末還是第一季末？

I said we expect the incremental capacity to start coming online in the second half of the year. I wasn't specific end of the first or end of the second. So that's number one. Number two, right now, we are not providing granular information on the revenue potential because we are just trying to maximize the throughput and manage the existing demand. So I would caution not to share anything at this point because this is all going to change within the next few months here. Once the new clean room comes online, once (inaudible) finish bringing in the additional firepower that needs to run this with a smooth process, once he finish layout and everything else, this could have significant efficiencies to increase the numbers, whatever number we think we have today.

我說我們預計增量產能會在下半年開始上線。我沒有具體說明第一個結尾或第二個結尾。所以這是第一。第二，目前，我們沒有提供有關收入潛力的詳細信息，因為我們只是試圖最大化吞吐量並管理現有需求。因此，我警告現在不要分享任何內容，因為這一切都將在接下來的幾個月內發生變化。一旦新的無塵室上線，一旦（聽不清楚）完成引入需要平穩運行的額外火力，一旦他完成佈局和其他一切，這可能會顯著提高數量，無論我們認為我們今天有多少。

The next question is from Suraj Kalia with Oppenheimer.

下一個問題由蘇拉吉·卡利亞和奧本海默提出。

So first and foremost, exceptional quarter, congrats to you, Stephen, Tamer and the whole team. So Waleed, let me start out on NOP, do you have the flexibility to increase NOP pricing over time? And the second part to that question is, so you mentioned the active sites versus total size for each organ, great. But a number of these sites, as we know, are contracted for transport with some other agency. I'd love to get your perspective of what happens -- how long a process is that to facilitize them to NOP? And then how does the process work there?

首先，也是最重要的，這是一個出色的季度，恭喜你、史蒂芬、塔默和整個團隊。 Waleed，讓我從 NOP 開始，您是否可以靈活地隨著時間的推移提高 NOP 定價？這個問題的第二部分是，你提到了每個器官的活性位點與總大小，很好。但據我們所知，其中許多站點都與其他一些機構簽訂了運輸合約。我很想聽聽您對所發生情況的看法——幫助他們實現 NOP 需要多長時間？那麼這個過程是如何進行的呢？

Suraj, let me address the -- I'm sorry, can you repeat the first part of the question? I got the second part. What was the first part?

Suraj，讓我解決這個問題——對不起，你能重複一下問題的第一部分嗎？我得到了第二部分。第一部分是什麼？

So just the flexibility of NOP pricing, right? We are today what 15,20 grant, why couldn't we increase it to 30, 40, 50 over time because that's what the statistics indicate with the current logistics providers end up charging.

那麼 NOP 定價的彈性，對吧？我們今天的補助金是 15,20，為什麼我們不能隨著時間的推移將其增加到 30、40、50，因為這就是統計數據表明當前物流提供者最終收取的費用。

Right. So Suraj, listen, we are early in the NOP and our strategy has always been that NOP is nothing, but a catalyst to drive growth of the disposable sales and disposable utilization. So we cannot overprice the NOP portion that actually end up having a negative impact, not a positive impact. And when we talk about NOP service charge, this is excluding the any playing charges. This is just personnel on the surgical front, surgical procurement fee and clinical management of the organ. We think we are in good shape. In the future, we reevaluate, but right now I'm not expecting significant changes on the pricing of the NOP service component.

正確的。所以 Suraj，聽著，我們處於 NOP 的早期階段，我們的策略始終是 NOP 沒什麼，而是推動一次性銷售和一次性利用率成長的催化劑。因此，我們不能對 NOP 部分定價過高，因為這實際上最終會產生負面影響，而不是正面影響。當我們談論 NOP 服務費時，這不包括任何播放費用。這只是手術前線的人員、手術採購費用和器官的臨床管理。我們認為我們的狀態很好。未來，我們會重新評估，但目前我預期 NOP 服務組件的定價不會有重大變化。

Related to the transportation, listen, transportation for organ transplant in this country is a broken field. It is not harmonized. It is individualized. Many of those contracts you're referring to are with entities that don't even own a single jet and they're are nothing but brokers in the middle of the night trying to brokers a flight from a high net worth individual or another operator and it is very inefficient from a cost structure standpoint. I am not worried one bit about what existing contract we do, I am more laser focused on establishing our own network and creating the Amazon or FedEx model for organ transplantation for the NOP. I am confident if we do this right and we do it at the scale we want to do it at that the existing contracts will melt and there won't be any issue for us to see transformation of the field in the way we hope to see.

與交通有關，聽著，這個國家器官移植的交通是一個破碎的領域。它不協調。它是個性化的。您提到的許多合約都是與甚至不擁有一架飛機的實體簽訂的，他們只不過是半夜試圖中介高淨值個人或其他運營商的航班的經紀人，從成本結構的角度來看，這是非常低效的。我一點也不擔心我們所做的現有合同，我更專注於建立我們自己的網絡並為 NOP 的器官移植創建亞馬遜或聯邦快遞模型。我相信，如果我們做得正確，並且按照我們想要的規模去做，那麼現有的合約將會消失，我們將不會有任何問題，以我們希望看到的方式看到該領域的轉變。

So for you Waleed, in terms of lungs, love to get your thoughts, obviously, you'll have gone gangbusters on heart and liver, right? Everyone is now focusing their attention on lungs. How soon could this take off? Any additional color there would be great. And Stephen, specifically for you, when we started out FY '22, guidance was approximately $50 million, if memory serves me right? Here we are, we ended the year with almost double because you guys did have couldn't provide product for the last two quarters or some weeks in. So help us understand FY '23 guide, what is the level of conservatism built into these numbers as you'll see the year ahead?

所以對你來說，瓦利德，就肺部而言，喜歡了解你的想法，顯然，你的心臟和肝臟會變得非常強大，對嗎？現在每個人都將注意力集中在肺部。這要多久才能起飛？任何額外的顏色都會很棒。史蒂芬，特別是對你來說，當我們開始 22 財年時，指導金額約為 5000 萬美元，如果我沒記錯的話？在這裡，我們以幾乎翻倍的價格結束了這一年，因為你們在過去兩個季度或幾週內確實無法提供產品。明年你會看到什麼？

Stephen, you want to address the second part first?

史蒂芬，你想先解決第二部分嗎？

Yeah, so the conservatism question first. I don't think I can give specifics around it. The thing I would say to you, though, is last year was really our first year of commercialization. So there was really a lot of unknown in how the market was going to evolve and especially the pace that the market was going to evolve. So now we have a lot more information. We have a lot more history and so we will put that all together with our guidance. So I can't really talk about the level of conservatism, but I can tell you, we just have a lot more information today to predict than we did a year ago.

是的，所以首先是保守主義問題。我認為我無法提供具體細節。不過，我要對你們說的是，去年確實是我們商業化的第一年。因此，市場將如何發展，尤其是市場發展的速度，確實存在許多未知數。所以現在我們有更多的資訊。我們有更多的歷史，因此我們會將它們與我們的指導結合在一起。所以我不能真正談論保守主義的程度，但我可以告訴你，我們今天比一年前有更多的資訊可以預測。

Suraj, I want to also add or build on what Stephen just said. Listen, we know we have lived in two quarters with level of conservatism, I'm sorry, level of back order situation. We know what the impact is on our customers, our NOP franchise and the revenue. We have to be conservative at least in the first half of this year to make until we are out of this supply constraint, we have to be extremely careful, prudent and conservative. But it's not at the same level as Stephen said, last year, we didn't know the ramp curve of NOP and especially on heart. Remember, we started heart at NOP less than 20%. We ended the year at high 70s, low 80s. So we have better visibility now.

蘇拉傑，我還想補充或借鏡史蒂芬剛才所說的內容。聽著，我們知道我們已經經歷了兩個季度的保守主義程度，對不起，缺貨情況。我們知道這對我們的客戶、我們的 NOP 特許經營權和收入有何影響。至少在今年上半年，我們必須保持保守，直到我們擺脫供應限制，我們必須極度謹慎、謹慎和保守。但這並不像史蒂芬說的那樣，去年我們不知道NOP的斜坡曲線，尤其是心臟的斜坡曲線。請記住，我們在 NOP 低於 20% 時開始心跳。我們以 70 年代的最高價、80 年代的最低價結束了這一年。所以我們現在有更好的能見度。

Now let me go back to your first question about the lungs. Listen, given the huge negative impact that lung has been suffering from for the last several years, we have to be cautious. We have to assume that our efforts is going to take the full year or we start seeing some tangible progress or uptake in the lung numbers and the lung activities in the U.S. We are taking this very seriously. We're focused on that and we guide for patients and we guide for looking at the long-term horizon. This is not going to happen overnight.

現在讓我回到你關於肺部的第一個問題。聽著，考慮到過去幾年肺部遭受的巨大負面影響，我們必須保持謹慎。我們必須假設我們的努力將花費一整年的時間，或者我們開始看到美國的肺部數量和肺部活動取得一些切實的進展或吸收。我們專注於這一點，為患者提供指導，並為著眼長遠發展提供指導。這不會在一夜之間發生。

Remember, the ISHLT is not happening until end of April. That is usually a big catalyst for lung and heart activities every year. So we're not going to have that impact until probably Q2. So we need to -- we're guiding for the full year impact not in the Q1 or Q2. So I hope I'm addressing your question and we're looking forward to your visit on Friday.

請記住，ISHLT 要到 4 月底才會發生。這通常是每年肺部和心臟活動的重要催化劑。因此，我們可能要到第二季才會產生這種影響。因此，我們需要——我們指導的是全年影響，而不是第一季或第二季。所以我希望我能回答您的問題，我們期待您週五的來訪。

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

Thank you. We want to thank everybody for joining us on this call and we're looking forward to speaking again on our 1Q '23 call. Thank you. Have a great evening, everyone.

謝謝。我們要感謝大家參加本次電話會議，並期待在 23 年第一季的電話會議上再次發言。謝謝。祝大家有個愉快的夜晚。

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

會議現已結束。感謝您參加今天的演講。您現在可以斷開連線。