Good afternoon, and welcome to TransMedics' Third Quarter 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] As a reminder, this call is being recorded for replay purposes.

I'd now like to turn the call over to Brian Johnston from the Gilmartin Group..

Thanks, operator. Earlier today, TransMedics released financial results for the quarter ended September 30, 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 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 2021 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. 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 August 6, 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, November 9, 2021.

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

Thank you, Brian. Good afternoon, everyone, and welcome to TransMedics' third quarter 2021 earnings call. Joining me today is Stephen Gordon, our Chief Financial Officer. The third quarter of 2021 was transformative for TransMedics. Our positive momentum throughout the year culminated in the achievement of four strategic catalysts.

Namely, two FDA PMA approval, one FDA 510(k) clearance, as well as the release of positive top line results from our OCS DCD heart trial. In September, we secured FDA premarket approval for OCS Heart and OCS Liver System, both with broad labeling language.

The OCS Liver System was indicated for use with both DBD and DCD organs, while the OCS Heart System was indicated for use with DBD organ. We look forward to expanding our OCS Heart indication to include DCD once the PMA supplement, that has been filed is approved by FDA. Now, let me discuss the financial results for Q3.

Net revenue for the third quarter was $5.4 million, a decline of $1.7 million from Q3 2020. As we expected and have spoken about it previously, Q3 revenue results were adversely impacted by the lack of trial revenues from both liver and heart CAP trials that were not renewed in anticipation for the PMA approvals.

We also saw the resurgence of the Delta variant negatively impacting key lung transplant centers in Q3. Overall, September year-to-date revenue was $20.6 million, which represents 14% growth over 2020. I'm looking forward to leveraging all three OCS products to grow our revenue, starting in Q4 of this year into 2022 and beyond.

Now, let me provide more detail on our progress across our key initiatives. For the DBD Heart FDA approval, contrary to some pre-approval speculations, the OCS DBD heart label has very broad indications. We are thrilled by our competitive position with the approved label.

This label gives us access to the large unutilized DBD heart donor pool, as well as the approximately 25% of the current heart transplant market that has a cross-clamp time of four hours or more. Following FDA approval, post-market commercial activities for OCS Heart were launched in late September.

This is a true validation that the new process that we negotiated with FDA enabled us to quickly transition to post-market commercial activities. As I've stated before, we have a three-pronged go-to-market strategy. We are prioritizing the OCS heart centers that were involved in the recent CAP clinical activities.

Then we will expand into pipeline centers that have expressed interest in the OCS Heart product and finally, we're expanding our National OCS program to include OCS Heart technology in 2022. We're expecting to see early commercial traction starting in Q4 of this year, which should lead to tangible growth in 2022.

The expected DCD heart PMA approval in the second half of 2022 will be an additional catalyst for our OCS Heart growth next year. Now let me turn into the DBD and DCD Liver FDA approval.

We are also extremely pleased with our FDA-approved label for the OCS Liver System, which gives us access to the entire liver transplant market from both DBD and DCD donors. The go-to-market strategy for liver is identical to our heart strategy.

We are also prioritizing our OCS liver centers, expanding into a pipeline of new centers and we are expanding our National OCS program to add OCS Liver technology in early 2022.

Like OCS Heart, we are experiencing early positive commercial momentum with OCS Liver and expecting to see early traction starting in Q4 2021, which should lead to tangible growth into 2022. On the National OCS program, we have expanded our regional presence into nine OPO regions, adding Northern California and San Diego's OPOs in Q3.

We are on track to meet the target goal of 10 regions before year-end. Importantly, now that we have all three organs approved by FDA, we're expanding the National OCS program to include OCS Heart and Liver in early 2022.

Meanwhile, we're continuing to build the necessary infrastructure and resources to ensure the long-term success of this important program. We expect this to continue throughout 2022. The next FDA initiative is OCS Heart DCD indication. As we announced last week, we are thrilled by the top line results from our U.S. randomized Heart DCD trial.

The use of the OCS Heart to resuscitate, preserve and assess DCD donor hearts resulted in a fairly high utilization rate of 89% and clinical outcomes or post-transplant clinical outcomes that met or exceeded at the very high bar of comparing it to U.S. standard criteria DBD Heart transplant outcomes.

The latter is considered to be the best in the world. We have already filed the PMA supplement last week and expect PMA approval of our DCD Heart indication in 2022. Now, let me finish with a summary of our expectation and thoughts for the remainder of this year 2021 and into next year 2022.

The OCS technology is now the only FDA-approved extracorporeal perfusion system for lung, heart and liver transplant across broad clinical indications. We fully plan to leverage this unique position to reach a tremendous inflection point on our growth trajectory starting in 2022.

The early commercial signs from heart and liver are highly encouraging, and we are looking forward to delivering tangible results, to dispel any lingering doubts about our ability to execute our commercial plan for the OCS in the United States.

We are extremely confident in our ability to drive significant growth for TransMedics' business, leveraging all three FDA-approved OCS technologies and transplant indications. COVID and any new variants will always disproportionately negatively impact lung transplantation compared to heart and liver.

Today, our business is more resilient, given that we are now commercial with both heart and liver technologies and not only relying on the lung indication for commercial growth.

Finally, we expect Q4 revenue to be in the range of $7 million to $8 million, as we refocus the organization on our commercial efforts and begin to see initial contribution from OCS Heart and Liver commercial revenues. We intend to be in a position to provide full-year 2022 revenue guidance during our next earnings call.

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

Thank you, Waleed. I will now provide some additional detail on the third quarter results and other financial information for the quarter and the year. First of all, now that we have received approval of all three of our OCS products, clinical trial revenue will no longer be a part of our sales.

So, I will no longer be reporting on both gross and net revenue as they are the same. So for the third quarter of 2021, net revenue was $5.4 million. This declined by $1.7 million from $7.1 million in Q3 of 2020. In U.S., net revenue was $3.1 million, which declined by $2.8 million from $5.9 million in Q3 of 2020.

There were two drivers of lower revenue performance in the quarter. First, we no longer had any clinical trial revenue for either OCS Heart or OCS Liver. Both of the trials and related Continued Access Protocol programs and commercial [technical difficulty] 2020, a quarter that was highly impacted by the COVID-19 pandemic. The ex- U.S.

revenue was $2.1 million for OCS Heart and $1.2 million for OCS Lung. Our gross margin for the third quarter of 2021 was 70% compared to 71% for Q3 of 2020, and our total operating expenses for the quarter were $15.5 million. This is up 61% from Q3 of 2020, which was unusually low due to COVID-19 and it's flat from last quarter at $15.5 million.

The main drivers of our expense growth from Q3 of 2020 were increased resources and expenses related to preparing for the commercial sales of our full product line, as well as the expansion of our National OCS Program.

Secondarily, we have continued to invest in our overall resources and infrastructure to support the expected growth in the business as a result of the recent FDA approvals.

Our operating loss was $11.7 million in the third quarter of 2021 compared to $4.6 million in the third quarter of 2020 and our net loss for the third quarter of 2021 was $13 million compared to $5.1 million in the third quarter of 2020.

Finally, cash, cash equivalents and marketable securities were $102.9 million as of September 30, 2021, which equates to a reduction of $9.3 million from the balance at the end of Q2 2021. And weighted average common shares outstanding for the quarter were 27.7 million.

As we look ahead and as Waleed mentioned, we expect to generate between $7 million and $8 million in revenue in the fourth quarter of '21. This translates to expected net revenue of between $27.6 million and $28.6 million for the full-year 2021, representing 8% to 12% growth over the full-year 2020.

Now, I would like to turn the call back to Waleed for closing comments. Yes, I've been asked to reread the revenue section as maybe it was not quite clear. So, I will just reread that part. In the U.S., OCS Lung net revenue was $2.3 million and OCS Heart net revenue was $0.8 million. And all sales in the U.S. are now commercial sales.

Outside the U.S., net revenue was $2.3 million. $2.1 million of that was OCS Heart and $0.2 million was OCS Lung. I hope that's clear..

Thank you, Stephen. Overall, despite COVID obstacles and the expected bumpiness in sales, 2021 has proven to be a truly transformative year for TransMedics. We have every expectation that 2022 will be as well. Earlier in the year, we outlined an ambitious timeline for key major catalysts to be achieved.

Here we are in November, and I'm thrilled to say that we have delivered on every promise we made earlier in the year. We have executed on target throughout 2021. We plan to leverage our unique market position to laser focus on commercial growth in 2020, as we embark on even higher growth trajectory for TransMedics.

With unrivaled OCS technology, three FDA-approved products with broad transplant labeling indications, solid operational footing and our National OCS program, we are better positioned than ever to deliver on our growth goals and transform organ transplantation.

In conclusion, our OCS technology and clinical programs have helped to expand the possibilities for so many patients and families desperate for organ transplants across the United States.

And as we take the next steps on our path, we remain extremely grateful for all the donor families, our patients, trial investigators and their teams who have gotten us to this point. With that, I will now turn the call to the operator for questions and answers.

Operator?.

[Operator Instructions] Your first question comes from the line of Bill Plovanic from Canaccord. Your line is open..

Just a couple of questions first, just as you start commercialization and we get the metrics, I'm just trying to understand, you're going after the CAP study sites first for both heart and liver.

Wondering if we could get some color on kind of where you stood at the end of Q3? Kind of where you expect to be at the end of Q4 and you're rolling into the additional sites and then the National OCS program. And then my second question is for the National OCS program.

At what number of kind of OPOs signed up, do you have full national coverage? Thanks..

Thank you, Bill. On the first question, our go-to-market strategy had these three well-defined components of targeting the initial transplant programs, followed by pipeline centers, followed by the national program.

As we've been in commercial world now for - with heart and liver for the last several weeks, we're seeing the demand, kind of, is pulling us from two to one and three to two. So to be clear, we plan to prioritize the clinical centers that have access to OCS and have training in OCS.

However, we expect that in Q4, there may be pipeline programs initiated given their - the pull dynamic that we're seeing post-FDA approval. The same thing applies to the national program. We are seeing national program being pulled potentially even earlier than 2022. However, we're trying to kind of prioritize the other two.

From a granular perspective, I suspect that we will be active - fully commercially active in Q4, I would say somewhere between 30%, to 50% of the trial centers so that, puts us in anywhere between seven to 10 heart centers and similar to - in the liver program.

We are not going to have the full 25 heart centers and the full 20 liver centers active in Q4. We expect that to happen in early 2022. So that's answering the first question. The second question, hopefully, I don't want to talk about it on this call.

But hopefully, next call, we are going to highlight some of the momentum that is - have been injected into the national program through our commercial team's strategy to expand the national program to not just rely on OPOs to be able to allocate organs, but also involve the transplant program.

Net-net, we have teams that are covering the nine active regions that we are obligated to today for heart and lungs. We are building our infrastructure on livers very rapidly here. And we are hoping that by Q1 or early Q2, 2022, we'll be able to have a full breadth of the national program across the three organs.

Does that answer your question, Bill?.

It does, thank you very much. And then if I could follow up with just – yes you have the data out there, the FDA approvals out there now for heart and liver.

I was wondering if this is having an impact on the international business or just how we should think about that and thanks for taking my questions?.

Thank you, Bill. I think, absolutely, but we're not going to see that tangible impact from international business anytime in 2021. Just - they move slower and reimbursement remains a big hurdle. I can assure you that having all three organs approved by FDA is going to help some of our formalized reimbursement discussions with major markets in Europe.

When do we see tangible proof of that, probably second half of 2022. I don't suspect it will have an earlier impact than that..

Great..

Just because the nature of that how things - how long things take in Europe..

Your next question comes from the line of Allen Gong from JPMorgan. Your line is open..

So just diving into the guidance for a second. I know this is the first time you're providing a full year target. But just looking at where street expectations were for the full year, it looks like you're coming in modestly below, especially given that this will kind of be your first quarter with both heart and liver added on to the portfolio.

So if I think about it, it looks like you're only up a bit sequentially. So, I wonder if you could provide just a little bit of guidance on how we should be thinking about the sequential growth in your three platforms, right. It looks like lung, despite Delta, held in pretty well.

So going into fourth quarter, should we expect lung to improve or stay modestly flat? And then between heart and liver, what is the breakdown in growth that you expect?.

Hi, Allen, this is Stephen. I can answer that question. So, I think because of what we're seeing in the Delta variant, we tend to have been conservative on lung. So, I don't expect much growth in lung sequentially from Q3 to Q4. And it's really - there's some unknown still out there with COVID.

We have some good weeks with lung transplants, but then we'll have some really bad weeks. I think - most of the momentum will be on heart because we have a bit of a head start as we - that was approved early in September. So, I think most of the momentum will be there. And then liver, we're really just at the early stages of commercializing.

So that will be trailing behind. So it can kind of give you a sense, I would expect, heart to lead, lung to be about the same and then liver kind of behind that, if that makes sense..

But Allen, to build on what Stephen just said, looking at it sort of on an annualized basis yes, the liver might be a little bit lagging behind the heart. But overall, Q4, we expect to see some significant liver revenue compared to Q3 and Q2, where it was nearly zero or at zero.

So, I think Stephen is just giving the sort of the pace, but we expect to see three organs contributing to the revenue line with the cadence that Stephen described..

And then just a quick follow-up I know the dynamics are going to be a little bit different between trial to commercial. But when we look at historically, you were obviously able to generate really strong volumes from heart and liver while they were undergoing their clinical trials.

So when we think about where you can get to in the back half of 2022, once you kind of move past that ramp-up period in centers that you highlighted for the first half of the year? Is there any reason why we shouldn't expect you to be able to kind of get back up to those, same unit per center levels? Or do you think it's prudent to stay a bit more conservative and expect a more gradual ramp-up as they kind of work around when to use the cases commercially? Thanks a lot, guys..

Thank you, Allen. I think - Allen I think we - our expectation is to be at least at the same level, if not above. And we see the national program contributing a lot in second half of next year to make that expectation of above, hopefully, reality. So that's where we stand right now. We're - as we see that the demand building up here at the end of 2021.

With just awareness of the national program in the early innings here, we are forecasting that, that program could potentially be a major driver for even growth beyond what we've seen before - what we've ever seen before..

Your next question comes from the line of Cecilia Furlong from Morgan Stanley. Your line is open..

Thanks for taking the questions. This is Calvin on for Cecilia. Just two questions from me. You announced some pretty positive DCD top line results last week.

So six-month data looked pretty strong versus, I think, EXPAND - I think EXPAND plus CAP pooled analysis was showing six-month survival of, I think, 92% versus the 95% here in the DCD arm? So could you just talk a little bit about what's next from here now with the PMA supplement submission behind you? What does the path to approval and commercialization look like from here? And more importantly, how would the DCD label change the rate of OCS heart adoption acceleration in '22?.

Yes. Thank you, Calvin. Yes. So the DCD results were really very, very strong, as we've stated before. We see the PMA being approved in 2022. We see the DCD label expansion, providing an additional catalyst once that happened. But our goal here is to continue to drive adoption within the DBD, the large DBD portion of the heart transplant domain.

And definitely, we plan significant exposure to detailed data and potentially even publications by the time ISHLT Meeting is here held in Boston in end of April 2022. All of that will maximize awareness, maximize visibility to the data. And I think we look at both DBD and DCD as a sort of that one, two punch to grow our heart footprint into 2022.

Taking a step back and from a timeline perspective, we see from now until the DCD approval, the carrier of our growth will be the DBD indication. And, hopefully, the expansion of the label with the DCD approval will be a second sort of a catalyzing effect later in the year once that happens..

And just my second question is just on - can you talk a little bit about what the latest is on kidney? Very much understanding, it's not a 2021 event, but just curious, any progress worth noting there.

As you start increasing your focus on that platform going forward, how do you sort of plan to balance commencing your clinical work on kidney with launching heart and liver in the U.S. and driving those service model forward? Thanks so much, guys..

Thank you, Calvin. Great question, Calvin. I'm only going to partially address that question, and I plan to fully address it in our next call. But our top priority and laser focus is in commercial growth from our approved three indications. That being said, kidney is an important part of our long-term growth potential.

To address the concern about distraction, we are pursuing a strategy that will have a dedicated kidney sort of team within the organization that's not heavily involved in that or not involved at all in our commercial programs to avoid any distraction. So, I will stop here.

And we plan to map out the strategy in our first call of next year to - as we see kidney as a potential end of 2022, kind of, start to that kidney program. That should give us enough 12 months head start on getting heart, liver and lung solidified in the commercial setting in the United States..

Your next question comes from the line of Josh Jennings from Cowen and Co. Your line is open..

This is Brian here for Josh. Thank you for taking my questions. To start, can I ask about the timing assumptions behind the expected DCD heart approval? I believe you referenced an approval in the second half of 2022 in your prepared remarks.

So does this generally assume a filing by year-end and a review of six months or so? And are you factoring in the possibility of a panel in your timing assumption? And I have a follow-up, if I can..

Thanks, Brian. Yes, the PMA supplement has already been filed. So, we're not assuming filing. It's already been filed. But we have to give the review team ample time to give us sort of concrete feedback whether or not we're going to a panel. And if we do, we have to assume 12-months horizon.

So, we have baked all that into our prepared comments to ensure that we're giving FDA full flexibility, and we never predict timelines when PMAs are under review. But we feel very confident about the data. If the indication has to go through another panel, we feel very confident in our ability to secure a positive panel for that indication.

But we don't know if that's going to be the case. But from a timeline perspective, Brian, we have to assume that, that is a possibility and we have to buffer for that. So that's what the comments are intended to achieve..

And on DBD Heart, you referenced some confusion about the broadness of the U.S. label. I believe this was a reference specifically to confusion among investors.

But can you comment on whether there was also noise in the field about the label as well? And just - I think I was experiencing some technical difficulties when you gave this, but I think you referenced $800,000 in sales for DBD Heart in the third quarter, which would be in less than a month.

Can you just comment on how this tracked relative to your expectations?.

Sure, thank you Brian. So, the specific comments we made about pre-approval sort of speculation was really from some of our discussions with investors and the Street noise that came after the panel meeting. We did not experience any issues with the actual heart transplant community.

The bottom line is we - the indication speaks for themselves and they're very broad. And as I outlined in the prepared remarks that it gives us access to the large, huge pool of unutilized DBD donor pool - the donor heart pool.

In addition, it gives us access right away to approximately 25% of the existing heart transplant cases that are of four hours or more of cross-transplant. So, that is very important. So the remarks were specifically on investors and the Street kind of concerns that came out after the panel meeting.

Regarding the revenue of $800,000 in two weeks or two and half weeks, listen we always stated that we spend a lot of time working with FDA on mapping out a whole new path.

For post-market conversion to commercial revenue from trials that did not look anywhere close to the - what we've had to do for the lung to accelerate adoption and accelerate the conversion pace from pre-commercial to commercial. And I think the $800,000 is a solid validation that this process is actually working.

And so, we were hoping to achieve that, and we achieved it. So for us, it wasn't a surprise. It was always the hope to be able to achieve that with the process we negotiated with FDA. So, we're looking forward to continuing monitoring that pace in Q4 and into 2022. I hope that addresses your question, Brian..

[Operator Instructions] Your next question comes from the line of Suraj Kalia from Oppenheimer. Your line is open..

So Waleed, as you look to Q4 and beyond, now the DCD Heart data looked really good.

How do you all think in terms of increasing utilization per center overall and on an organ basis, if I were to map out a pie chart with the National OCS program versus more feet on the ground versus just publications you mentioned, what do you think would be necessary to increase utilization as you all think over the next four quarters to eight quarters?.

Thank you, Suraj. That's a very important question. Suraj, we see three key important - three important key factors here to drive deeper utilization and adoption. One is awareness of the results. It is critical.

Right now, for the last several weeks, the entire leadership of the commercial team has been heavily engaged in multiple one-on-one and national webinars focusing on reminding the heart community and the liver community of our trial results.

So that is the near-term number one goal to engage with the community and reacquaint them with the results and the aggregated results of EXPAND and what it means, highlight the DCD results, but not highlight it too much, so we don't confuse the market.

And then you execute - the next prong is to get them engaged and starting using the technology in DBD Hearts, which they haven't used in a long time. So getting that engaged and replicating these results in their own hands is worth its weight in gold.

That's what generates the momentum and now the data that they saw theoretically now translated into data from their own hands and then that starts the ball - the ball rolling. And then the third element is the national program.

I think the national program, once it is initiated for hearts and livers it's going to be a huge catalyst or a driver for further adoption. Because now that we've lived through them hopefully, the brunt of COVID, mindsets are changing.

And nobody really - the majority of the transplant community we're dealing with, they really do not want to go out and procure these organs in the middle of the nights any longer. And what they're doing right now, Suraj, is they are looking at us, evaluating us, partnering with us to see if we can truly deliver on that turnkey solution.

They're engaging with the lung colleagues and hearing positive feedback on - in the early cases in the lung. So, we see that as continued growth throughout the year. The last element is to get all this data published and we are targeting.

We're putting an onus to ourselves that we are going to meet that one of the last catalysts for 2021, deliver data to be published in a high-impact journal before year-end. And we're on track to do that.

But two heart papers, one for the full EXPAND data for a two-year outcome as well as the DCD trial case results will all be published, hopefully, by the ISHLT. That is the target that we are targeting.

And on top of that, fulsome program planned for the ISHLT Meeting here in Boston for going deeper into the data, highlighting the national program on a more open forums to make sure everything we've been talking about for the last six months or nine months is fully dispersed throughout the community in a scientific form like the ISHLT Meeting.

I hope that addresses your question, Suraj..

And Waleed, if I could, for the - for my second question, and I'll hop back in queue. It's a sub-part question. So Waleed, we have seen the data, right? And the data in pockets is exceptionally good.

What is the single most pushback you're getting in the field for OCS for any indication? And also, do you feel there is a need for harmonizing protocols more specifically related to heart worldwide? Thank you for taking my questions..

Thank you, Suraj. Very important questions as always. The first one, the only pushback we get today for liver and heart is new programs wanting to make sure they understand the money flow. And the commercial reimbursement, really not reimbursement, but how to optimize the reimbursement dollars.

And we have buttressed our team with a Black Belt heart failure reimbursement expert that just joined us in late October, early November from ex-Thoratec, Abbott leader. And she is well known to the field and that is helping tremendously address these early kind of jitters and concerns about optimizing reimbursement dollars.

That is the biggest hurdle we're seeing today, just lack of understanding of how to optimize the reimbursement structure to accommodate the OCS and potentially even the national program service cost. On the second part of the question, the harmonization, thank you for bringing this up.

We are going to start that path of leading discussions at academic societies and scientific society starting in the ISHLT in April, expanding it at the ACT Meeting in June because now we have the FDA approval, we have the national program. We're actively engaged with CMS. Now, we're reengaging, now that we have all approvals in hand.

So, we are going to see a lot of activities and initiatives in 2022 towards that goal of harmonization and really redefining the protocols for the next standard of care, which will have OCS heavily involved and we will be a key catalyst and driver for these changes..

I don't see any question at this time. I will turn it over back to Waleed for any closing remarks..

Thank you, operator. We thank you all very much for taking the time to join us tonight. We are looking forward to our next call. And have a great end of the year and we'll speak soon. Thank you very much..

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