TransMedics Group, Inc.

Good afternoon and welcome to Transmatic's fourth quarter and full year 2021 earnings conference call. At this time, all participants are in listen-only mode. We'll be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would like to turn to go over to Brian Jensen from Gilmartin Group for a few introductory comments.

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. 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 State of 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. material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these four legal 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 and is accurate only as of the live broadcast today, February 23, 2022. And with that, I'll turn the call over to Waleed Hassaneen, President and Chief Executive Officer.

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. 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 two FDA PME 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 three critical transport 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. Q4 2021 marked our first fully commercial quarter in which all three OCS products contributed to our commercial revenues. and the results speak for themselves. Net revenue for 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. As we move forward, we expect to benefit from several key catalysts through 2022. First, 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 IASHLT. This meeting will be held in Boston from April 27th to 30th. These presentations will feature the OCS DCD heart trial full results and one-year outcomes, the OCS expand heart trial two-year follow-up outcome data benchmarked against standard criteria hearts in the U.S., expand lung trial five-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. 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 mid-year. 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 data set at the upcoming ISHLT meeting. 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 a 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. 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 center resource constraints and learning curves, thereby facilitating rapid clinical adoption of the OCS technology. In terms of our progress today, 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. 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 three 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 payers 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. As I 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 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. 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 four 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 eight full-time surgeons supported by six contract surgical consultants. which are strategically distributed across the United States. We expect to continue to grow our cardiothoracic team to meet the demand. 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 NLP. 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 NLP program and open up new regions. Manufacturing infrastructure. We're actively working to expand our clean room production capacity to meet the anticipated mid- and long-term demand for our product. Finally, long-term technology upgrades. 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. 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 US 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 US 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. 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. Now let me finish with a summary of our expectations and thoughts for 2022. We believe our first fully commercial quarter in Q421 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 three 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. 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 the 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. 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.

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 Oregon 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 XUS 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. Q4 revenue performance was driven predominantly by the FDA PMA approvals of both of our OCS heart and OCS liver systems in late Q3 of 2021, making Q4 our first full commercial quarter in which we had all three OCS products approved in the U.S. Early traction with the 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. 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 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. 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 Oregon breakdown for the full year was $9.9 million in U.S. lung, $10.1 million of U.S. heart, and $1.9 million of 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 in 2020. 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 improve modestly through 2022, 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, around a third of the rate of revenue. Now, I would like to turn the call back to Ali for closing comments.

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 and these catalysts to drive significant growth across all three transplant markets. With that, I will now turn the call to the operator for Q&A. Operator?

Thank you, sir. As a reminder, to ask the question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Again, if you would like to ask the question, press star the number 1 on your telephone keypad. Please sign by while we compile the Q&A roster. Your first question comes from the line of Bill from Canaccord. Your line is open.

Great, thanks. Good evening. 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. I just want to be clear that, you know, expect Q1 to be above Q4, even taking into account that long will be negatively impacted both in the U.S. and internationally. Yes. Okay. Second question, just that the U.S. heart number was much stronger than we expected. It seems like you're getting traction. I just wonder if you could provide us some clarity. I know you mentioned that the metrics will change to the NLP on per quarter, but I was just curious, you went out initially, and I don't think the NLP 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 NLP for heart and liver? Thanks.

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 that's why we said we're going to start looking at these metrics starting in Q1, where we believe that it would be broader sample size, larger sample size, that can give us some meaningful trends that we can look at going forward. So to answer the first part of the question, you know, it concentrated a number of centers, you know, 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 roll heart and liver international program? We're already doing that in Q1 of 2022, and we will continue to do that throughout the year.

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

Thanks for taking my questions. Thank you, Bill. It's a mix. The national program facilitates some, and some have gone through the direct acquisition process. um so that's that i think that's the answer to the question it's still a mix um and uh the national program facilitates uh the initiation a lot more quicker than going through the internal center processes that include some you know supply chain you know hospital supply agreements and all that wonderful stuff but we in q4 it was a mix between the two processes and uh you know It helped in the results, but we expect that to kind of streamline throughout 2022. And, you know, 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. Thank you.

Again, if you would like to ask the question, press star then the number one on your telephone keypad. Your next question comes from the line of Mike Ott from Oppenheimer. Your line is open.

Good afternoon and congrats on a nice first quarter with all three indications. Waleed, today I believe you reiterated your expectation for FDA approval in mid-22 of the PMA supplement for DCD heart. And I was wondering, could you just confirm that that's regardless of whether or not there's a panel? That is correct, Mike. Okay. And then how has the FDA dialogue been so far around DCD heart? Couldn't have been any better. That's great. And then understanding that, you know, lung tends to be the most impacted by COVID. How would you characterize, you know, both Omicron and staffing is impacting your current first quarter? Obviously, you know, in an answer to a prior question, you mentioned you still expect sequential growth over 4 to 21. But how is the, you know, the scene on the ground today, I guess?

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

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

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. That's great to hear. Thanks for everything, Wally. Appreciate it. Thank you, Mike.

Your next question comes from the line of Josh Jennings with Golan. Your line is open.

Hi, this is Brian here for Josh. Thank you for taking my questions. 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?

Thank you, Brian. We are hoping 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, many of the liver cases are being procured by different teams, not necessarily by the same program's 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 projects. into these separate markets that, you know, 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, you know, and, you know, if, you know, if, 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.

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 ahead of that, can you share how you're tracking relative to your internal expectations with generating physician awareness of liver and heart, your data there, and just where do you expect to be after these upcoming data readouts?

So, Brian, 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 the ISHLT. We'll talk about those at our next call. But right now, I suspect 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 deposition, and that will continue throughout 2022 on many, many fronts. And again, hopefully at the IASHLT, a lot of these initiatives will be announced, and also we can discuss them at the next call.

Terrific. Thank you.

If there are no further questions at this time, I would like to turn the conference back to Waleed Hassani for further comments.

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.

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