Transmedics Group Inc (TMDX) 2021 Q4 法說會逐字稿

Good afternoon, and welcome to TransMedics Fourth Quarter and Full Year 2021 Earnings Conference Call. (Operator Instructions) As a reminder, this call is being recorded for replay process.

下午好，歡迎參加 TransMedics 2021 年第四季和全年財報電話會議。 （操作員說明）謹此提醒，此通話正在錄音以供重播。

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

我想將電話轉接給 Gilmartin Group 的 Brian Johnston，請其發表一些介紹意見。

Thanks, operator. Earlier today, TransMedics released financial results for the quarter ended December 31st, 2021. A copy of the press release is available on the company's website.

謝謝，接線生。今天早些時候，TransMedics 發布了截至 2021 年 12 月 31 日的季度財務業績。新聞稿的副本可在該公司網站上取得。

Before we begin, I would like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the Safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. All forward-looking statements, including, without limitation, 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, regulatory approvals and reimbursement, and guidance and/or expectations for revenue, gross margins, and operating expenses in 2022 are based upon our current estimates and various assumptions.

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，其中包括聯邦證券法含義內的前瞻性聲明，這些聲明是根據1995 年《私人證券訴訟改革法案》的安全港條款制定的. 本次電話會議中包含的任何與對未來事件、結果或業績的預期或預測相關的陳述均為前瞻性陳述。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成長的預期、監管批准和報銷以及指導和/或期望2022 年的收入、毛利率和營運費用是基於我們目前的估計和各種假設。

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 on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our quarterly report on Form 10-Q filed with the Securities and Exchange Commission on November 9th, 2021. 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 that is accurate only as of the live broadcast today, February 23rd, 2022.

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。因此，您不應過度依賴這些陳述。有關與我們業務相關的風險和不確定性的清單和描述，請參閱我們於 2021 年 11 月 9 日向美國證券交易委員會提交的 10-Q 表格季度報告的風險因素部分。TransMedics 不承擔任何意圖或義務除非法律要求，否則更新或修改任何財務預測或前瞻性陳述，無論是由於新資訊、未來事件或其他原因。本次電話會議包含時效性訊息，僅截至今天（2022 年 2 月 23 日）直播時準確。

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

接下來，我會將電話轉給總裁兼執行長 Waleed Hassanein。

Thank you, Brian. Good afternoon, everyone, and welcome to TransMedics fourth quarter and full year 2021 earnings call. Joining me today is Stephen Gordon, our Chief Financial Officer.

謝謝你，布萊恩。大家下午好，歡迎參加 TransMedics 2021 年第四季和全年財報電話會議。今天加入我的是我們的財務長史蒂芬戈登。

2021 was a milestone year for TransMedics as we achieved every one of our strategic goals, catalyzing our potential commercial growth for 2022 and beyond. We secured 2 FDA PMA approvals and successfully launched the OCS Heart and Liver Systems commercially in the U.S., thus achieving our goal to end the year with access to 3 critical transplant markets. We also filed our PMA supplement for DCD heart indication for our OCS technology, while launching and expanding our National OCS Program, which now covers 11 major U.S. regions.

2021 年對 TransMedics 來說是里程碑式的一年，我們實現了每項策略目標，促進了 2022 年及以後的潛在商業成長。我們獲得了兩項 FDA PMA 批准，並成功在美國推出了 OCS 心臟和肝臟系統商業化，實現了我們在年底進入 3 個關鍵移植市場的目標。我們還為 OCS 技術的 DCD 心臟指示提交了 PMA 補充，同時啟動和擴展了我們的國家 OCS 計劃，該計劃現已覆蓋美國 11 個主要地區。

Q4 2021 marked our first fully commercial quarter in which all 3 OCS products contributed to our commercial revenue, and the results speak for themselves. Net revenue for the fourth quarter was $9.7 million, representing 27% growth from Q4 2020 and 80% growth from Q3 2021. Net revenue for the full year 2021 was $30.3 million, representing an 18% growth over the prior year. We believe these results represent a strong first step towards achieving our commercial growth goals.

2021 年第四季是我們第一個完全商業化的季度，所有 3 個 OCS 產品都為我們的商業收入做出了貢獻，結果不言而喻。第四季淨收入為 970 萬美元，較 2020 年第四季成長 27%，較 2021 年第三季成長 80%。2021 年全年淨收入為 3,030 萬美元，較上年增長 18%。我們相信這些結果是實現我們商業成長目標的堅實的第一步。

As we move forward, we expect to benefit from several key catalysts through 2022. The first catalyst would be several OCS-related clinical data readouts and strategic presentations that will be presented at the upcoming 2022 Annual Meeting of the International Society for Heart and Lung Transplantation or ISHLT. This meeting will be held in Boston from April 27th to 30th. These presentations will feature the OCS DCD Heart Trial full results and 1-year outcomes, the OCS EXPAND Heart trial 2-year follow-up outcome data, benchmarked against standard criteria hearts in the U.S., EXPAND Lung Trial 5-year follow-up data, an overview of the OCS Heart Perfusion Registry structure in the U.S., the first-ever presentation highlighting the TransMedics National OCS Heart and Lung Program at a major scientific society meeting, and finally, TransMedics will be hosting a symposium to share our strategic vision for how we plan to leverage the OCS technology, the clinical indications approved, and the National OCS Program to potentially increase heart and lung transplant volumes in the U.S.

隨著我們的前進，我們預計到2022 年將受益於幾個關鍵催化劑。第一個催化劑將是一些與OCS 相關的臨床數據讀數和策略演示，這些數據將在即將舉行的國際心肺移植學會2022 年年會上進行展示或 ISHLT。本次會議將於4月27日至30日在波士頓舉行。這些演示將介紹 OCS DCD 心臟試驗的完整結果和 1 年結果、OCS EXPAND 心臟試驗 2 年隨訪結果數據（以美國標準標準心臟為基準）、EXPAND 肺試驗 5 年隨訪數據，美國OCS 心臟灌注登記結構的概述，在一次重要的科學協會會議上首次強調TransMedics 國家OCS 心肺計劃的演講，最後，TransMedics 將舉辦一次研討會，分享我們的戰略願景我們計劃如何利用OCS 技術、已批准的臨床適應症以及國家OCS計劃來潛在增加美國的心臟和肺移植量

Our second expected 2022 catalyst will be the FDA approval of the OCS DCD Heart indication. We submitted our PMA supplement for the DCD indication in November 2021, and we continue to expect approval by midyear. This indication will position the OCS as the only FDA-approved technology for both DBD and DCD heart transplantation. It's important to note that DCD donors are rapidly growing in the U.S. They represented 30% of the overall donor pool in the United States in 2021 according to the national transplant database. As a reminder, we announced very strong top line results from our OCS DCD Heart trial in Q4. And as mentioned above, we will unveil the full dataset at the upcoming ISHLT meeting.

我們預計 2022 年的第二個催化劑將是 FDA 批准 OCS DCD 心臟適應症。我們於 2021 年 11 月提交了針對 DCD 適應症的 PMA 補充資料，我們繼續預計在年中獲得批准。這一適應症將使 OCS 成為 FDA 批准的唯一用於 DBD 和 DCD 心臟移植的技術。值得注意的是，DCD 捐贈者在美國正在迅速成長。根據國家移植資料庫，到 2021 年，DCD 捐贈者占美國捐贈者總數的 30%。謹此提醒，我們宣布了第四季度 OCS DCD Heart 試驗的非常強勁的營收結果。如上所述，我們將在即將舉行的 ISHLT 會議上公佈完整的數據集。

Our third catalyst will be the further expansion of our National OCS Program or NOP. Given that this represents a major catalyst for our business, allow me to spend few minutes to remind you of the vision of the NOP and its potential transformative value to transplant programs in the U.S. From a high level, the NOP is allowing TransMedics to become a critical partner to major transplant programs in the U.S. by providing an end-to-end technology and clinical service solution for donor organ procurements. The value proposition of the NOP to transplant programs are clear and powerful. The national program enabled transplant centers to grow their transplant volumes by eliminating historical barriers such as ischemic time, distance, and resource constraints.

我們的第三個催化劑將是國家 OCS 計劃（NOP）的進一步擴展。鑑於這是我們業務的主要催化劑，請允許我花幾分鐘時間提醒您 NOP 的願景及其對美國移植項目的潛在變革價值。從較高的層面來看，NOP 正在讓 TransMedics 成為一個通過為捐贈器官採購提供端到端技術和臨床服務解決方案，成為美國主要移植計畫的重要合作夥伴。 NOP 移植計劃的價值主張清晰而有力。該國家計劃透過消除缺血時間、距離和資源限制等歷史障礙，使移植中心能夠增加移植量。

The NOP also enabled transplant programs to better manage their transplant schedules by allowing transplant procedures to be performed in the morning rather than as an emergent procedure in the middle of the night, thus removing significant logistical frictions within the program. Finally, the NOP maximizes work-life balance for the clinical and surgical staff at these institutions, which has the potential to help alleviate some of the staffing concerns and facilitate talent attraction and retention at these transplant programs that utilizes NOP. In totality, we believe these unparalleled value drivers will help reduce central resource constraints and learning curves, thereby facilitating rapid clinical adoption of the OCS technology.

NOP 還允許移植手術在早上進行，而不是在半夜進行緊急手術，使移植計劃能夠更好地管理其移植計劃，從而消除了計劃內的重大後勤摩擦。最後，NOP 最大限度地實現了這些機構臨床和外科工作人員的工作與生活平衡，這有可能有助於緩解一些人員配置問題，並促進這些利用 NOP 的移植計畫吸引和留住人才。總的來說，我們相信這些無與倫比的價值驅動因素將有助於減少中央資源限制和學習曲線，從而促進 OCS 技術的快速臨床採用。

In terms of our progress to date, throughout 2021, we established 11 NOP regions across the United States with the expectation to expand to approximately 15 regions by end of 2022. This will provide broad coverage to potentially procure organs from donors to recipients almost anywhere in the United States. It is important to note that each one of these NOP regions represents a launching point for OCS technology and clinical staff to perform donor procurement using OCS technology, either within the region or outside of the region.

就我們迄今為止的進展而言，整個2021 年，我們在美國各地建立了11 個NOP 區域，預計到2022 年底擴大到約15 個區域。這將為美國幾乎任何地方的潛在捐贈者和接受者獲取器官提供廣泛的覆蓋範圍。美國。值得注意的是，這些 NOP 區域中的每一個區域都是 OCS 技術和臨床工作人員使用 OCS 技術在區域內或區域外進行捐贈者採購的啟動點。

In addition, starting in early 2022, NOP or the national program will expand to enable NOP cases that can be initiated directly by the transplant program requesting that TransMedics procure and deliver organs to their program. This should maximize efficiency and adoption of the NOP. As we look ahead, our goal in 2022 is to expand the National OCS Program to include heart and liver procurements to drive OCS adoption across the 3 platforms. To facilitate our expansion, TransMedics has launched a broad awareness campaign of the National OCS Program across major transplant programs, CMS, and commercial transplant players in the U.S. To that end, we're planning to expand this awareness campaign by making key presentations at several major transplant conferences to further educate the broader transplant community about the National OCS Program.

此外，從 2022 年初開始，NOP 或國家計畫將擴大到允許移植計畫直接啟動 NOP 病例，要求 TransMedics 為其計畫採購和交付器官。這應該可以最大限度地提高 NOP 的效率和採用率。展望未來，我們 2022 年的目標是擴大國家 OCS 計劃，將心臟和肝臟採購納入其中，以推動 OCS 在 3 個平台上的採用。為了促進我們的擴張，TransMedics 在美國的主要移植項目、CMS 和商業移植參與者中發起了一項廣泛的國家OCS 計劃宣傳活動。為此，我們計劃透過在多個移植項目上進行重要演講來擴大這項宣傳活動。大型移植會議，以進一步教育更廣泛的移植界有關國家 OCS 計劃的資訊。

As I've stated before, we are confident that the National OCS Program will be a major driver for OCS commercial growth and overall transplant growth in the United States. Following the FDA approval of the OCS DCD indication -- the OCS DCD Heart indication, we see the NOP as the most significant catalyst for our commercial growth in 2022. We're looking forward to monitoring this impact of the NOP on OCS adoption throughout 2022 and beyond.

正如我之前所說，我們相信國家 OCS 計劃將成為美國 OCS 商業成長和整體移植成長的主要推動力。繼 FDA 批准 OCS DCD 適應症（OCS DCD 心臟適應症）後，我們將 NOP 視為我們 2022 年商業成長的最重要催化劑。我們期待在 2022 年監測 NOP 對 OCS 採用的影響超越。

Shifting now to key commercial infrastructure initiatives and provide some background on potential new metrics that we may use to track our commercial success moving forward. On the infrastructure -- the commercial infrastructure, through 2022, we will be focused on the following 4 key initiatives as demand for OCS technology increases. First, increasing the internal surgical expertise for the NOP. We have already established a world-class team of cardiothoracic surgical expertise composed of 8 full-time surgeons supported by 6 contract surgical consultants which are strategically distributed across the United States. We expect to continue to grow our cardiothoracic team to meet the demand.

現在轉向關鍵的商業基礎設施計劃，並提供一些有關潛在新指標的背景知識，我們可以使用這些指標來追蹤我們未來的商業成功。在基礎設施方面－商業基礎設施，到2022年，隨著OCS技術需求的增加，我們將重點放在以下4個關鍵措施。首先，提高 NOP 的內外科專業知識。我們已經建立了一支世界一流的心胸外科專業團隊，由 8 名全職外科醫生和 6 名合約外科顧問組成，這些顧問策略性地分佈在美國各地。我們希望繼續擴大我們的心胸團隊以滿足需求。

On the Liver side, we've started the build out of the surgical capabilities to match our cardiothoracic group. Second, expanding our clinical OCS perfusion regional support for NOP; we ended 2021 with 36 OCS perfusion specialists covering the 11 active regions discussed above. We expect to expand this team further through 2022 as we add Liver and Heart to the NOP program and open up new regions. Manufacturing infrastructure; we're actively working to expand our cleanroom production capacity to meet the anticipated mid- and long-term demand for our product. Finally, long-term technology upgrade; in 2021, we initiated the first phase of our next-generation OCS development program which will continue through 2022 with an emphasis on improving our OCS technology, electronics, supply chain.

在肝臟方面，我們已經開始建立與我們的心胸外科團隊相匹配的外科能力。其次，擴大我們對 NOP 的臨床 OCS 灌注區域支持；截至 2021 年，我們擁有 36 名 OCS 灌注專家，涵蓋上述 11 個活躍區域。隨著我們將肝臟和心臟添加到 NOP 計劃並開闢新區域，我們預計到 2022 年將進一步擴大團隊。製造基礎設施；我們正積極努力擴大無塵室產能，以滿足對我們產品的預期中長期需求。最後，長期的技術升級； 2021 年，我們啟動了下一代 OCS 開發計畫的第一階段，該計畫將持續到 2022 年，重點是改進我們的 OCS 技術、電子產品和供應鏈。

Let's move now to the potential new reporting metrics to track commercial execution going forward. To better measure the impact of the NOP program on OCS cases in the U.S. and our commercial traction generally, we intend to provide additional information starting on the Q1 2022 earnings call. Let me provide some background. As the utilization of the NOP expands further in the U.S. through 2022 and beyond, the historical way of tracking OCS centers may become less relevant given the potential flexibility afforded by the NOP to allow any transplant program in the U.S. to use OCS without the traditional initiation process and timeline. We're planning to report the NOP contribution to the total revenue per organ, per quarter. We hope that this additional detail will provide further clarity on our business progress towards maturing our commercial program.

現在讓我們討論潛在的新報告指標，以追蹤未來的商業執行情況。為了更好地衡量 NOP 計劃對美國 OCS 案件的影響以及我們的整體商業吸引力，我們打算從 2022 年第一季的財報電話會議開始提供更多資訊。讓我提供一些背景知識。隨著NOP 在美國的使用在2022 年及以後進一步擴大，鑑於NOP 提供的潛在靈活性允許美國的任何移植計劃在沒有傳統啟動的情況下使用OCS，追踪OCS 中心的歷史方式可能會變得不那麼重要。流程和時間表。我們計劃報告每季 NOP 對每個器官總收入的貢獻。我們希望這些額外的細節能進一步明確我們在成熟商業計劃方面的業務進展。

Now let me briefly discuss our views on potential headwinds and uncertainties that may negatively impact us in 2022. The most obvious is the COVID pandemic. Based on our performance in Q3 and so far in Q1, we see minimal impact of COVID Omicron on heart and liver transplant trends. However, as we stated before, lung will always be disproportionately impacted by any new COVID waves or variants. Finally, the global supply chain issues. So far, our team has done a good job managing our supply chain network, particularly in mitigating impacts from the shortage of semiconductors. However, this is an area that we cannot always control and may negatively impact us throughout 2022.

現在讓我簡要討論一下我們對 2022 年可能對我們產生負面影響的潛在不利因素和不確定性的看法。最明顯的是新冠疫情。根據我們第三季和第一季迄今的表現，我們認為新冠肺炎 Omicron 對心臟和肝臟移植趨勢的影響微乎其微。然而，正如我們之前所說，任何新的新冠病毒浪潮或變種都會對肺部造成不成比例的影響。最後是全球供應鏈問題。到目前為止，我們的團隊在管理供應鏈網路方面做得很好，特別是在減輕半導體短缺的影響方面。然而，這是一個我們無法始終控制的領域，並且可能在 2022 年對我們產生負面影響。

Now let me finish with a summary of our expectations and thoughts for 2022. We believe our first fully commercial quarter in Q4 '21 results represent a very encouraging start. We look forward to building on this momentum through 2022 and deliver sequential quarter-to-quarter growth. We are extremely confident in our ability to drive significant growth leveraging all 3 FDA-approved OCS technologies, the broad transplant indications approved, and the National OCS Program. COVID and any new variants will always disproportionately negatively impact lung transplantation compared to heart and liver. As we stated before, our business today is more resilient after the commercial launch of the OCS Heart and Liver technologies.

現在，讓我總結一下我們對 2022 年的期望和想法。我們相信，我們在 21 年第 4 季的第一個完全商業化的季度業績代表了一個非常令人鼓舞的開始。我們期待在 2022 年之前繼續保持這一勢頭，並實現季度環比增長。我們對利用 FDA 批准的全部 3 項 OCS 技術、批准的廣泛移植適應症以及國家 OCS 計劃推動顯著增長的能力充滿信心。與心臟和肝臟相比，新冠病毒和任何新的變種總是會對肺移植產生不成比例的負面影響。正如我們之前所說，在 OCS 心臟和肝臟技術商業推出後，我們今天的業務更具彈性。

As much as we're excited about 2021 results, we are laser-focused on making 2022 even bigger success and truly transformative commercial year for the business. Based on above opportunities and potential headwinds and given that we are still in the early phases of full commercialization activities, we are providing an annual revenue guidance of a range between $49 million to $55 million for the full year 2022. This range represents a solid 62% to 82% growth over 2021.

儘管我們對 2021 年的業績感到興奮，但我們仍專注於在 2022 年取得更大的成功，並成為該業務真正變革的商業年。基於上述機會和潛在的不利因素，並考慮到我們仍處於全面商業化活動的早期階段，我們為 2022 年全年提供 4900 萬至 5500 萬美元的年收入指導。這個範圍代表了 62 2021 年增長%至82%。

With that I will turn the call to our Chief Financial Officer, Stephen Gordon, to review our detailed financial results for the quarter and the full year.

接下來，我將致電我們的財務長史蒂芬戈登，以審查我們本季和全年的詳細財務業績。

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 2021, our net revenue was $9.7 million. This is an increase of 27% in the fourth quarter of 2020 and an 80% sequential increase from the last quarter. In the U.S., net revenue was $7.2 million. U.S. net revenue also increased 27% from the fourth quarter of 2020 and the sequential growth was 132% from last quarter. The organ breakdown on U.S. revenue was $1.8 million of OCS Lung, $4 million of OCS Heart, and $1.5 million of OCS Liver. And ex-U.S. revenue was $2.5 million, up 25% from Q4 of 2020 and included $0.4 million of OCS Lung and $2.1 million of OCS Heart.

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。 2021 年第四季度，我們的淨收入為 970 萬美元。 2020 年第四季成長 27%，季增 80%。在美國，淨收入為 720 萬美元。美國淨收入也較 2020 年第四季成長 27%，較上季較上季成長 132%。美國收入中的器官細分為 OCS 肺 180 萬美元、OCS 心臟 400 萬美元、OCS 肝臟 150 萬美元。還有美國以外的地方營收為 250 萬美元，比 2020 年第四季成長 25%，其中包括 40 萬美元的 OCS Lung 營收和 210 萬美元的 OCS Heart 營收。

Q4 revenue performance was driven predominantly by the FDA PMA approvals of both our OCS Heart and OCS Liver Systems in late Q3 of 2021, making Q4 our first full commercial quarter in which we had all 3 OCS products approved in the U.S. Early traction with OCS Heart and OCS Liver was partially offset by the impact of the recent COVID Omicron surge on lung transplant volume in Q4. Gross margin for the fourth quarter of 2021 was 72%. That's up from 63% in the fourth quarter of 2020, primarily reflecting our transition from clinical trial revenue to commercial revenue. The total operating expenses for the quarter was $18.3 million. This is 71% above Q4 of 2020 operating expenses driven by our investment in our commercialization, including the National OCS Program, as well as R&D spending on our next-generation technology and infrastructure and scale up throughout the company. And as a reminder, Q4 2020 was a very low spending quarter due to the COVID situation at that time.

第四季的營收表現主要是由2021 年第三季末FDA PMA 批准我們的OCS 心臟和OCS 肝臟系統推動的，這使得第四季度成為我們第一個完整的商業季度，我們的所有3 個OCS產品都在美國獲得批准。OCS Heart 的早期吸引力OCS 肝臟被近期新冠肺炎 Omicron 激增對第四季度肺移植量的影響部分抵消。 2021年第四季毛利率為72%。這比 2020 年第四季的 63% 有所上升，主要反映了我們從臨床試驗收入轉向商業收入的轉變。該季度的總營運費用為 1830 萬美元。這比2020 年第四季的營運支出高出71%，這是由於我們對商業化的投資（包括國家OCS 計畫）以及對下一代技術和基礎設施的研發支出以及在整個公司範圍內的擴展而推動的。提醒一下，由於當時的新冠疫情情勢，2020 年第四季的支出非常低。

Our operating loss was $11.3 million in the fourth quarter of 2021 compared to $5.9 million in the fourth quarter of 2020. And our net loss for the fourth quarter of 2021 was $12.7 million compared to $6.3 million in the fourth quarter of 2020. And finally, cash, cash equivalents, and marketable securities were $92.5 million at the end of December -- as of December 31st, 2021, which equates to a reduction of $10.4 million from the balance at the end of Q3 2021. Weighted average common shares outstanding for the quarter were 27.8 million.

2021 年第四季我們的營運虧損為1,130 萬美元，而2020 年第四季為590 萬美元。2021 年第四季的淨虧損為1,270 萬美元，而2020 年第四季為630 萬美元。最後，截至 2021 年 12 月 31 日，截至 12 月底，現金、現金等價物及有價證券為 9,250 萬美元，相當於 2021 年第三季末的餘額減少 1,040 萬美元。季為 2,780 萬。

Now let me share some detail on the full fiscal year 2021 results. For the full year, net revenue was $30.3 million, an 18% increase over the prior year, and the organ breakdown for the full year was: $9.9 million in U.S. Lung, $10.1 million in U.S. Heart, and $1.9 million in U.S. Liver, and outside the U.S. was $0.8 million of Lung and $7.6 million of Heart. Gross margin for the full year 2021 was 70% compared to 65% in 2020. And total operating expenses were $60.6 million for the full year 2021, up 41% from $43 million in 2020. Operating loss was $39.4 million for the full year 2021 compared to $26.4 million in 2020, and net loss was $44.2 million in 2021 compared to $28.7 million in 2020.

現在讓我分享 2021 財年全年業績的一些細節。全年淨收入為 3,030 萬美元，較上年增加 18%，全年器官細分為：美國肺臟 990 萬美元，美國心臟 1,010 萬美元，美國肝臟 190 萬美元，美國以外地區的肺臟費用為80 萬美元，心臟費用為760 萬美元。 2021 年全年的毛利率為70%，而2020 年為65%。2021 年全年的總營運費用為6,060 萬美元，比2020 年的4,300 萬美元增長41%。2021 年全年的營運虧損為3,940 萬美元，2021 年全年的營運虧損為3,940 萬美元。2020 年淨虧損為 2,640 萬美元，2021 年淨虧損為 4,420 萬美元，而 2020 年淨虧損為 2,870 萬美元。

Overall, 2021 was an extremely important year for TransMedics in which we transitioned our business from one focused on clinical trials and our regulatory pathway to a fully commercial multi-organ business. As Waleed discussed, we are looking forward to further realizing our commercial business in 2022 and are providing annual revenue guidance of $49 million to $55 million for the fiscal year 2022, and this represents 62% to 82% growth over 2021. And also, for modeling purposes, we expect gross margin to continue to grow, and we would expect to exit 2022 in the mid-70% range, and we expect expenses to grow in 2022 likely in the 25% to 30% range or around 1/3 of the rate of revenue.

總體而言，2021 年對 TransMedics 來說是極其重要的一年，我們將業務從專注於臨床試驗和監管途徑轉變為完全商業化的多器官業務。正如 Waleed 所討論的，我們期待在 2022 年進一步實現我們的商業業務，並為 2022 財年提供 4900 萬至 5500 萬美元的年收入指導，這意味著比 2021 年增長 62% 至 82%。出於建模目的，我們預計毛利率將繼續增長，預計2022 年毛利率將在70% 左右，我們預計2022 年費用增長可能在25% 至30% 範圍內，即1/3 左右。收入率。

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. In summary, we're pleased with our Q4 and 2021 performance, and we remain confident in our ability to build on this commercial success throughout 2022, particularly given our expectations to achieve several key regulatory and clinical catalysts in the near term. We look forward to leveraging our momentum in these catalysts to drive significant growth across all 3 transplant markets.

謝謝你，史蒂芬。總而言之，我們對第四季度和2021 年的業績感到滿意，我們對在2022 年全年取得商業成功的能力仍然充滿信心，特別是考慮到我們期望在短期內實現幾個關鍵的監管和臨床催化劑。我們期待利用這些催化劑的動力來推動所有 3 個移植市場的顯著成長。

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) Your first question comes from the line of Bill Plovanic from Canaccord.

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

First question is just a guidance question. I think, Waleed, you said we should expect sequential -- even with the impact of COVID in the first quarter. Just back to Q1 to be above Q4 even taking into account that lung will be negatively impacted both in the U.S. and internationally?

第一個問題只是一個指導性問題。我想，瓦利德，你說過我們應該期待連續的結果——即使第一季受到了新冠疫情的影響。即使考慮到肺部在美國和國際上都會受到負面影響，還是回到第一季高於第四季？

Yes.

是的。

Okay. Second question, the U.S. heart number was much stronger than we expected. It seems like you're getting traction. Just wondering if you could provide us some clarity. I know you mentioned that the metrics will change to the NOP and organ per quarter. But I was just curious as you went out initially, and I don't think the NOP program is on Heart or Lung yet. Just kind of how many centers -- how broad is the initial commercialization? Or is this concentrated? How should we think about that for both Heart and Liver starting out, and then kind of rolling on that same question was just when do you expect to fully roll out NOP for Heart and Liver?

好的。第二個問題，美國的心臟數據比我們預期的強得多。看來你正在獲得牽引力。只是想知道您是否能為我們提供一些說明。我知道您提到指標將更改為每季的 NOP 和器官。但當你最初出去時我只是好奇，我認為 NOP 計劃還沒有針對心臟或肺部。只是有多少個中心──初始商業化的範圍有多大？或者說這是集中的？對於心臟和肝臟來說，我們應該如何考慮這一點，然後就同樣的問題進行思考，您預計什麼時候會全面推出針對心臟和肝臟的 NOP？

Thank you, Bill. Very important question. We -- as I stated in my previous call or last quarter's call that we expected to roll out Heart in Q4 in the NOP, but it's obviously early days, and we expected liver to roll in, in early 2022. In 2021, in Q4, there was, in fact, small contribution in both Heart and Liver from the NOP in Q4. It's still early. So we're going to start looking at these metrics starting in Q1 where we believe that there will be broader sample size, larger sample size that can give us some meaningful trends that we can look at going forward.

謝謝你，比爾。非常重要的問題。正如我在之前的電話會議或上個季度的電話會議中所說，我們預計將在NOP 第四季度推出心臟產品，但這顯然還為時過早，我們預計肝臟產品將在2022 年初推出。2021年第四季事實上，第四季 NOP 對心臟和肝臟的貢獻很小。現在還早。因此，我們將從第一季開始研究這些指標，我們相信會有更廣泛的樣本量，更大的樣本量可以為我們提供一些有意義的趨勢，我們可以在未來關注這些趨勢。

So to answer the first part of the question, it concentrated number of centers in Q4 for both Heart and Liver, but we expected that. That was the first quarter that we had commercial activities on both fronts. When do we expect to Heart and Liver international program. We're already doing that in Q1 of 2022. And we will continue to do that throughout the year.

因此，為了回答問題的第一部分，它集中了第四季度心臟和肝臟中心的數量，但我們預計會如此。這是我們在這兩個方面都開展商業活動的第一季。我們預計什麼時候進行心臟和肝臟國際計劃。我們已經在 2022 年第一季這樣做了。我們將在全年繼續這樣做。

And then just if I could, how long -- a lot of these centers have experience, but how long does it take for you to go back to and get them scaled up again? And I understand this national program may circumvent some of that. But I'm just curious, as you get back out there, you mentioned all these people were raising their hand prior to the approval and just what's your experience since then.

然後，如果可以的話，需要多長時間——這些中心很多都有經驗，但是你需要多長時間才能回去並再次擴大規模？我知道這個國家計劃可能會規避其中的一些內容。但我只是好奇，當你回到那裡時，你提到所有這些人在批准之前都舉起了手，從那時起你的經歷是什麼。

Thank you, Bill. It's a mix. The national program facilitates some and some have done through their direct acquisition process. So that's -- I think that's the answer to the question. It's still a mix. And the national program facilitates the initiation a lot more quicker than going through the internal center processes that include supply chain, hospital supply agreements and all that wonderful stuff. But we -- in Q4, it was a mix between the 2 processes, and it helped in the results, but we expect that to streamline throughout 2022. And it's too early to kind of forecast which direction it's going to take, but we are bullish in the national program. So we hope to see continued traction on that front.

謝謝你，比爾。這是一個混合。國家計劃促進了一些，有些已經透過直接收購過程完成了。我認為這就是問題的答案。它仍然是一個混合體。國家計劃比透過內部中心流程（包括供應鏈、醫院供應協議和所有這些精彩的東西）更快地促進啟動。但我們 - 在第四季度，這是兩個流程的混合，它對結果有所幫助，但我們預計整個 2022 年都會簡化。現在預測它將採取哪個方向還為時過早，但我們正在看好國家計劃。因此，我們希望看到這方面的持續發展。

(Operator Instructions) Your next question comes from the line of Mike Ott from Oppenheimer.

（操作員說明）您的下一個問題來自奧本海默的邁克·奧特（Mike Ott）。

Congrats on a nice first quarter with all 3 indications. Waleed, today I believe you reiterated your expectation for FDA approval in mid-'22 of the PMA. I was wondering can you just confirm that that's regardless of whether or not there's a panel.

恭喜第一季表現出色，所有 3 項指標均已達成。 Waleed，今天我相信您重申了 FDA 在 22 年中期批准 PMA 的期望。我想知道你能否確認一下，無論是否有面板。

That is correct, Mike.

這是正確的，麥克。

Okay. And then how has the FDA dialog been so far around DCD Heart?

好的。那麼到目前為止 FDA 圍繞 DCD Heart 的對話進展如何？

Couldn't have been any better.

再好不過了。

That's great. And then understanding that Lung tend to be the most impacted by COVID, how would you characterize both Omicron and staffing is impacting your current first quarter? Obviously, in an answer to a prior question, you mentioned you still expect sequential growth over 4Q '21. But how is the scene on the ground today, I guess?

那太棒了。然後，了解肺科往往是受新冠肺炎影響最嚴重的行業，您如何描述 Omicron 和人員配置對您目前第一季的影響？顯然，在回答先前的問題時，您提到您仍然預計 21 年第四季會出現環比成長。但我猜今天現場的情況如何？

Thank you, Michael. That's an important question. As I stated to Bill, we expect sequential growth Q1 over Q4. The driver behind no longer a long-only business. It's a lung business, it's a heart business, it's a liver business. And liver and heart are much less likely to be impacted by Omicron. And we're looking forward to keep driving the commercialization momentum here in Q1. And hopefully, we'll be discussing these results in May. So as we sit here today, Omicron is only impacting 1 out of 3 drivers to our growth, which is the lung, more improved processes within major transplant programs. The NOP is helping alleviate some of the staffing shortage at institutions. But lung will always be disproportionately impacted compared to harder. So we're fortunate to have access to commercial revenue and activities from heart and liver, but the NOP is also helping the lung close that gap a little bit of the impact of Omicron.

謝謝你，麥可。這是一個重要的問題。正如我對比爾所說，我們預計第一季將比第四季實現環比成長。背後的驅動力不再是一個只做多頭的生意。這是肺的生意，這是心臟的生意，這是肝臟的生意。肝臟和心臟受 Omicron 影響的可能性要小得多。我們期待在第一季繼續推動商業化勢頭。希望我們能在五月討論這些結果。因此，當我們今天坐在這裡時，Omicron 只影響了我們生長的三分之一驅動因素，即肺部，以及主要移植項目中更多改進的流程。 NOP 正在幫助緩解一些機構的人員短缺問題。但與更嚴重的疾病相比，肺部總是會受到不成比例的影響。因此，我們很幸運能夠獲得來自心臟和肝臟的商業收入和活動，但 NOP 也透過 Omicron 的影響幫助肺部縮小了這一差距。

That's great to hear. And then finally, more of a big picture question. Is there anything that you're tracking out of Washington related to either OPO oversight or focus on outcomes or anything else that we and investors should be paying attention to?

聽到這個消息我很高興。最後，更多的是一個大局問題。您在華盛頓追蹤到的任何內容是否與 OPO 監督或關注結果或我們和投資者應該關注的其他內容有關？

Thank you, Mike. That's a very important question. There's a lot of Washington-based initiatives that are focused on organ transplantation. That's all I can share right now. There's a lot. The biggest ones are driven by CMS, and it is not necessarily just an OPO oversight. It's really focusing on expanding and increasing the utilization of donor organs for transplant across heart, lung, liver, and kidney. TransMedics is heavily engaged with all the Washington stakeholders in transplantation. And we hope that these initiatives and these engagements or interactions will have some meaningful impact sometime in late 2022 or just continue to educate the key stakeholders on the importance of new technologies into the transplant ecosystem to meet that goal of increasing organ utilization for transplant. So yes, there is a significant focus on organ transplantation in the U.S. in Washington driven by CMS and Congress, and we're heavily engaged in all of the above.

謝謝你，麥克。這是一個非常重要的問題。華盛頓有很多針對器官移植的倡議。這就是我現在能分享的全部。有很多。最大的問題是由 CMS 驅動的，它不一定只是 OPO 的監督。它真正的重點是擴大和提高心臟、肺、肝臟和腎臟移植供體器官的利用率。 TransMedics 與華盛頓移植領域的所有利益相關者密切合作。我們希望這些措施和這些參與或互動能夠在2022 年末的某個時候產生一些有意義的影響，或者只是繼續教育主要利益相關者，讓他們了解新技術在移植生態系統中的重要性，以實現提高移植器官利用率的目標。所以，是的，在 CMS 和國會的推動下，美國華盛頓非常關注器官移植，我們積極參與上述所有活動。

Your next question comes from the line of Josh Jennings with Cowen.

你的下一個問題來自喬許·詹寧斯和考恩的對話。

This is Bryan here for Josh. Maybe to start on the national program. I wanted to ask about the NOP per organ per quarter metric you referenced. Do you have an assumption of the percentage of revenue that will come from NOP utilization in '22? And how much do you expect that to vary by organ?

這是布萊恩為喬希服務的。也許要開始國家計劃。我想詢問您提到的每季每個器官的 NOP 指標。您是否假設 22 年 NOP 利用率將帶來收入百分比？您預計不同器官的差異有多大？

Thank you, Bryan. We are hoping to be -- to end 2022 at approximately 25% to 30% of our revenue per organ coming from NOP, approximate percentage by year-end. Is it going to vary by organ? Initially, probably yes. Some organs are more amenable to the national program than others. For example, liver, historically, there are many of the liver cases are being procured by different teams, not necessarily by the same programs team. Heart is going to be probably the most challenging because that is still a very conservative process. But we expect to, over the year, that we will start seeing momentum and penetration into these separate markets that lung, heart, and liver that we end the year, roughly speaking, between 25% and 30% overall revenue coming from the national program. That's our target for end of 2022. But in the beginning, it's going to be variable. And if we're looking at it, it's probably going to be led by liver and followed by lung and followed by heart in the beginning of the year and then hopefully it will catch up throughout 2022.

謝謝你，布萊恩。我們希望在 2022 年底，我們每個器官的收入中約有 25% 至 30% 來自 NOP（到年底的大致百分比）。會因器官而異嗎？最初，可能是的。有些機構比其他機構更服從國家計畫。例如肝臟，歷史上有很多肝臟病例是由不同團隊採購的，不一定是同一個專案團隊採購的。心臟可能是最具挑戰性的，因為這仍然是一個非常保守的過程。但我們預計，在這一年中，我們將開始看到對肺、心臟和肝臟這些獨立市場的勢頭和滲透，粗略地說，25% 到 30% 的總收入來自國家計劃。這是我們 2022 年底的目標。但在一開始，它會有所改變。如果我們觀察的話，年初可能會以肝臟為主導，其次是肺部，最後是心臟，然後希望能在 2022 年趕上。

Okay, understood. That's helpful. And I wanted to ask about the clinical data. It sounds like you'll have a good amount of data coming out in April. Maybe just (inaudible) generating physician awareness of liver and heart, your data there, and just where do you expect to be after these upcoming data readouts?

好的，明白了。這很有幫助。我想問一下臨床數據。聽起來四月將會有大量數據發布。也許只是（聽不清楚）讓醫生了解肝臟和心臟、您那裡的數據，以及在這些即將到來的數據讀出之後您期望在哪裡？

So, Bryan, we're never satisfied about the awareness. In fact, there are many programs that we're working on to continue to increase awareness. We'll talk about those at ISHLT, we'll talk about those at our next call. But right now, TransMedics will always be engaged in a broad campaign of maximizing awareness of the clinical data, the national program awareness the reimbursement process for the national program and direct position, and that will continue throughout 2022 on many, many fronts. And again, hopefully, at the ISHLT, a lot of these initiatives will be announced and also we can discuss them at the next call.

所以，布萊恩，我們對意識永遠不會滿足。事實上，我們正​​在進行許多計劃來繼續提高人們的認識。我們將在 ISHLT 上討論這些內容，我們將在下次電話會議中討論這些內容。但目前，TransMedics 將始終致力於一場廣泛的活動，以最大限度地提高對臨床數據的認識、國家計劃的認識、國家計劃的報銷流程和直接立場，並將在 2022 年在許多方面持續進行。再次，希望在 ISHLT 上能夠宣布許多此類舉措，我們也可以在下次電話會議上討論。

There are no further questions at this time. I would now like to turn the conference back to Waleed Hassanein for further comments.

目前沒有其他問題。現在我想將會議轉回瓦利德·哈薩因以徵求進一步的意見。

Thank you, operator. I want to thank everybody for joining us on this call this evening. We wish you a pleasant evening, and we're looking forward to speaking again to announce the Q1 results. Have a wonderful evening, everybody. Thank you.

謝謝你，接線生。我要感謝大家今晚加入我們的電話會議。我們祝您度過一個愉快的夜晚，我們期待再次發言以宣布第一季的業績。祝大家有個美好的夜晚。謝謝。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。