Good afternoon, and welcome to TransMedics Second Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. We will 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'd now like to turn the call over to Brian Johnston from the Gilmartin Group for a few introductory comments.

Thank you. Earlier today TransMedics released financial results for the quarter-ended June 30, 2023. A copy of the press release is available on the company's website. Before we begin, I would like to remind you that management will make statements during this call, including during the question-and-answer section that include forward-looking statements within the meaning of Federal Securities laws. Any statements contained in this call that relate to expectations or predictions of future events, results or performance are forward-looking statements. All forward-looking statements including without limitation, are examination of operating trends, the potential commercial opportunity for our products and our future financial expectations, which include expectations for growth in our organization and guidance and/or expectations for revenue, gross margins and operating expenses in 2023 are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results over events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. Additional information regarding these risks and uncertainties appears under the heading Risk Factors on our Form 10-K filed with the Securities and Exchange Commission on February 27, 2023, and our subsequent filings with the Securities and Exchange Commission, which are available at www.sec.gov. and on our website at www.transmedics.com. TransMedics disclaims any intention or obligation, except as required by law to update or revise any financial projections or forward-looking statements whether because of new information, future events or otherwise. This conference call contains time sensitive information and is accurate only as of the live broadcast today August 3, 2023. 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 second quarter 2023 earnings call. As always, joining me today is Stephen Gordon, our Chief Financial Officer. The first half of 2023 was an important period for TransMedics as we successfully executed on several operational and strategic growth initiatives. Our efforts have culminated in 2Q being our highest revenue quarter-to-date. We also buttressed our balance sheet with a successful convertible debt offering, and earlier this week we entered into agreements for two acquisitions that will propel us further on our growth trajectory both short and long-term. In 2Q, we demonstrated significant commercial momentum and accelerated clinical adoption through NOP across all three organs. Operationally, we opened our new clean room on schedule and secured a second large sterilization partnership further enhancing our production and throughput capacity. This will better position us to meet the high and growing demand for OCS. Now let me cover the specifics of our 2Q performance. In the second quarter, we achieved total revenue of $52.5 million, representing 156% year-over-year growth and 26% growth over 1Q '23. U.S. sales represented $49 million in revenue, growing 170% year-over-year with OUS sales up 48% to $3.5 million. We also demonstrated continued improvement down the P&L as we benefit from increasing operating leverage. Stephen will cover the detail in his section of today's call. Importantly, we buttressed our balance sheet by issuing convertible debt at highly favorable terms, which provided a net of approximately $393 million to enable us to invest in standing up the TransMedics aviation and logistics network. 2Q also represented another new high watermark for case volume driven by growth across all three organs for the first quarter in many quarters. We saw growth in liver, heart and lungs. Liver and heart increased sequentially for the…

Thank you, Waleed. I will now provide some additional details on the second quarter results and other financial information for the quarter. For the second quarter of 2023, our total revenue was $52.5 million. This is an increase of 156% from the second quarter of 2022 and a 26% sequential increase from last quarter. In U.S., revenue was $49 million, an increase of 170% from Q2 2022 and 31% sequentially from last quarter. The organ breakdown on U.S. revenue is the following. $32.7 million of OCS liver, $13.5 million of OCS heart and $2.8 million of OCS lung. Let me repeat that, $32.7 million liver, $13.5 million heart and $2.8 million lung. Ex-U.S. revenue was $3.5 million, 48% increase from the second quarter of 2022 and the breakdown of that was $3.1 million of heart and $0.4 million of lung. Now regarding the breakout of product and service revenue for the quarter. As a reminder, the service revenue is the added amounts we charge for the surgical procurement and organ management as part of the NOP. In Q2, product revenue was $42.5 million and service revenue was $10 million, so service revenue was 19% of the total. The gross margin for the second quarter of 2023 was 70%. This is flat from a year ago Q2 2022 and up from 69% in the first quarter of 2023. The margin on product revenue was 80% in Q2 2023, that's up from 77% in Q2 of 2022 and it's up from 79% in the first quarter of '23. The margin on service was 28% in Q2 2023, that's up from 20% in Q2 2022 and up from 27% last quarter. The modest sequential improvement in margin is a result of the high revenue in the quarter. Total operating expenses for the quarter…

Thank you, Stephen. We are motivated and humbled by our commercial traction and execution throughout the first half of '23. That said, and as I said before, we strongly believe that we are in the early innings of a long runway of sustained growth for TransMedics. We must now allow for the time needed to scale our NOP infrastructure, integrate our new national logistic network that will enable us to fully capitalize on our unique NOP market opportunity. Our TransMedics NOP and the broader TransMedics team are working diligently and tirelessly to deliver the best clinical support and technology for our clinical transplant programs globally. I want to take this moment to recognize their efforts and contribution. Importantly, I want to take this moment to welcome the Summit team, the entire Summit team, operations, pilots and leadership to the TransMedics family. We are looking forward to their contribution to transforming the field of organ transplant logistics under the TransMedics Aviation umbrella. From where I stand, I see a very bright future for TransMedics. We just need the time to continue to execute so we can reach our TransMedics goal and summit of revenue growth. With that, I will now turn the call to the operator for Q&A. Operator?

[Operator Instructions] And today's first question comes from Bill Plovanic with Canaccord.

Hi. Great, thanks. Good evening, and thanks for taking my questions. I'm going to skip over guidance here and go right to, one, just looking at the U.S. heart number you are up $13 million to $13.5 million, so the sequential increase was maybe a little less than what investors were looking for. And I'm sure there's some guidance translation, but I was wondering if you could help us understand kind of what are the challenges you're facing in terms of the scale which you referenced in your prepared comments and NOP? And then also have we worked through the manufacturing supply challenges kind of where you are unable to meet demand and if you missed any cases in the quarter because of -- you didn't have supply? Thanks.

Thank you, Bill. Let me start with the second part of the question. We missed cases in the quarter mainly lung, not because of supply chain issues, but because of logistical issues. We could not find planes to get us to where we need to be to achieve our missions. We've done the same -- we lost few missions as well for heart and liver as well in Q3 because of lack of logistical support and capacity in the system. So as far as the other capacity constrain, it's really, we are not satisfied by the growth we are achieving now. We see even bigger growth ahead of us, Bill. And with the NOP cases now are transitioning from your traditional 8 to 12-hour case to 20 to 30-hour case given that many of the transplant programs across the U.S. are now more comfortable allowing the organ to be managed overnight and doing the transplant procedure in the morning to have better quality and better support that we need to beef up our team to be able to withstand that demand and that growth. And we need to beef up our surgical capacity, but most importantly, we need to get the TransMedics Aviation and TransMedics logistics, the broad logistics network up and running to be able to not to lose any case going forward. As far as specifics to the heart, I don't see this as a -- I see this as a little bit of a blip. We're not concerned about it one bit. It's part of the normal ebbs and flows that happens in transplant. But we're not concerned about it and we're obviously tracking all that and we hope to see this recover in Q3 and Q4.

Okay. And if I could circle back to guidance, the revenue guidance contemplates $86 million to $96 million in the back half of the year and you've already done $94 million. So you're essentially saying the business is going down. Can you help us understand kind of what's driving that down in the back half of the year or just any more granularity on the thought process behind guidance? Thanks for taking my questions.

Sure. Thank you, Bill. Three things. One, second half of the year have summer vacations, some holidays at the end of the year that always we are concerned about and what their potential impact on the overall transplant volumes. Two, we need time to integrate and stand up the logistical network in the second half of the year. That's going to add acquire attention and we may have additional cases in the second half of the year that goes uncovered because we don't have access to third-party aircrafts until we have our own network up and operational. And three, just conservatism. We need to be conservative given the huge growth that we're experiencing that we're already on the path to doubling our revenue from last year. I don't think investors should be concerned about where we are, we have a bigger growth wave ahead of us. And right now, it is prudent for our TransMedics team to focus on what's coming in 2024 and beyond given what we've done already and 2023. So I don't want this to be misinterpreted in any way other than we are growing with a neck breaking speed and we need to take that time to acclimatize and integrate on our way to the top of the summit, and we're not anywhere close yet.

Great. Thanks for taking my questions and see you at our conference next week.

We're looking forward to it. Thank you.

Thank you. And the next question comes from Allen Gong with JPMorgan.

Thank you and congrats on a really good quarter. I just had one question on lung. It was kind of encouraging to see that influx upwards a little bit given the challenges you've seen. I'm also curious around the acquisition that you announced with EVOSS. How should we think about what that platform can kind of bring to OCS and what features from that you're planning to maybe incorporate into OCS to help revitalize that market?

Thank you, Allen. We are excited as well about the lung performance this quarter, by no means we are declaring victory. We are continuing to monitor the situation and continue to invest mindshare in reviving that and there are other initiatives we'll be announcing in the second half of this year to help the lung, specifically around the EVOSS and OCS and being fully transparent. We believe the current OCS design is far superior than EVOSS on many fronts. However, EVOSS brings two unique attributes that we think might be of a clinical importance. We need to do the studies to prove it. One is the negative pressure ventilation, and two just a better smaller footprint. Again, we need to lead the first two the results of a clinical program. But we did not want to lose an opportunity to integrate that into the OCS and have the clinicians have access to both positive and negative pressure ventilation. So that's what we see as unique there and we believe it might add some significant clinical benefit. We need to do the trials to prove it.

Got it. And then just a quick follow-up on profitability. I think it was definitely encouraging to see gross margins for both the product and service piece of your business improve as well as pretty good expense control on the operating side. When we think about the further investments, you might need to make on building out TransMedics air freight piece of the business, how should we think about that for the back half of the year, what's the Summit Aviation initiatives as well as in 2024? Thank you.

Yeah, hi, Allen. This is Stephen. Yeah, definitely, we are seeing some kind of modest improvement in margin with volume growth, but we're going to continue to invest by incorporating Summit. Summit, I think is a modest increase in the overall spend rate, but we're going to bolster that with aircraft that we intend to purchase, and so we will see depreciation come onto our books for aircraft over the second half of the year.

Next question, operator.

Yes. The next question comes from Suraj Kalia with Oppenheimer.

Hi, Waleed, Stephen, can you hear me all right?

We can hear you just fine.

Perfect. Congrats on a nice quarter. So Waleed, a bunch of questions I'll just throw them your way and hop back in queue. So Waleed, I missed your, forgive me many calls going on. I missed your comments about heart, it was sequentially flat if there are any mitigating factors you could walk us through? That would be question number one. In terms of Bridge to Life integration with the next-gen form-factor Waleed, can you give us a little more specifics in terms of how you're thinking about it, the timing of this acquisition of assets and the incremental clinical improvements that you're thinking about that necessitated this asset acquisition? And finally, Stephen for you in terms of Summit Aviation, is this the end of the road or should we start thinking 12, 18, 24 months down the line we would need to buy more planes to complement this fleet? Gentlemen, thank you for taking my questions.

Thank you, Suraj. Suraj, the heart was up in Q2 over Q1, maybe not at the same pace that it was in Q1 over Q4. But it's up, it's not down and it's not flat. Factors to that, again, we're not concerned about it one bit. This is the ebbs and flows of organ transplantation. There were a few cases that we lost because we couldn't find planes to meet the mission, but it's not the only reason. It's just the ebbs and flows of organ transplant. Coming out of the ISHLT, there may have been some confusion, confusing remarks made at ISHLT, we took care of that and we feel very strongly that the heart will rebound in the second half of the year and going forward, and we're monitoring this very closely. Net-net, we are not concerned about that dynamic one bit. The heart is growing, and we are tracking it and we hope to report better that this issue is not existence in Q3. Remind me again, what's the second half of the -- the second part before we go to the aviation? There was a second part.

Yes. Waleed, I was curious about.

The EVOSS. Yes. So Suraj, as you know the next-gen program for TransMedics has already started. It's been ongoing for the last year. So, the reason for the timing for the EVOSS acquisition is three things. We think that negative pressure ventilation might add a clinical benefit to combine it with our positive pressure ventilation. We are not going to release a product that has OCS name on it that has one ventilation mode, it will have both ventilation mode. To the form factor, the bottom line is we need to make sure that the final form factor would be the right form factor for the OCS to lung system that be lighter, smaller than the existing OCS platform. So, that's all we can comment on it at the moment. Now let me turn it on to Stephen to address the specific question about Summit.

Yes, the answer Suraj about Summit is, this is not the end all, Summit is a relatively smaller operator, and we need to buttress the fleet by investing in additional planes. We've already started that process which we bought two earlier in Q3 and we're going to continue to buy more as we go through the next 12 months. So, it's definitely not the -- it's the beginning, it's simply not the end.

Thank you.

Thank you, Suraj.

Thank you. And our next question comes from Ryan Daniels with William Blair.

Yes, thanks for taking the questions. Congrats on the strong performance. Waleed, one for you, I think you mentioned eight aviation hubs, and I'm curious how that will correlate to the current NOP hub infrastructure, meaning will you consolidate that a bit and change it now that you actually own the assets and could be a little more flexible there given your internal ownership?

Ryan, it's good to have you on our call. Thank you for the question. We are exploring all of above at the moment, Ryan. I hate to give an answer that might send people to think that there's a definitive direction. The definitive direction is we did the math, we based on data and historical performance and national heat map of donors, and we believe that if we put air assets at 8 out of our 15 hubs across the United States will result in nearly 100% coverage of the Continental U.S. For us that's huge. The workflow part is still underway, workflow optimization. We might actually open new hubs. Let us do the work, I hate to front run this, I want the team at TransMedics to take the time to do it right, and definitely once we have it, we will be sharing it on our upcoming calls.

Okay.

But for us the priority is to provide 100% coverage -- 100% availability, 100% coverage across the Continental U.S., that is the number one priority for the network to get operational.

Makes sense. And then regarding your comments about clients getting more comfortable with NOP and going to 20 to 30-hour cases kind of improving the work-life balance and outcomes by allowing them to be in the morning versus anytime at night. I'm curious if that's something that's also driving active and repeat users and maybe increasing the overall use of NOP such that there might be cases that before they didn't use it, didn't use OCS, but now just because of that luxury in order to improve the work-life balance they are actually moving more of their cases to the platform?

Ryan, absolutely correct. But it's not just -- it's well beyond work-life balance at the moment. It's safer, it's safer for the patient, it's safer for the staff, it is less cost intense to have your primary transplant staff operate in the morning and actually could enable them to do multiple cases back to back versus paying double time in the middle of the night with the emergency or trauma teams that are on call, and it may or may not be the right talent assembled to do a safe transplant procedure. The other benefit in addition to that is in major academic institution, it provides a better teaching and training opportunity for the fellows that are involved in organ transplantation. So it's well beyond just work-life balance for the clinical staff, it's really -- it's a comprehensive benefit, and as you know, we've always stated that one of the benefits of NOP is to enable that to happen and we're really glad to see this happening and taken off that soon. We expect this to be a late transition. We're seeing this transition happening sooner than what we expected, but we need to make sure that we have staffed up for it and making sure that our team is fresh, safe and ready to cover these cases for as long as they need to.

Perfect. That's very helpful. And then one last one, just in regards to the potential CapEx for planes. I don't know if you mentioned this, but should we be thinking of outright purchases or leases? And then if it's a purchase, is CapEx $10 million to $12 million range that we should be thinking per plane? Thanks.

Yeah. Ryan, I think in the near term it is CapEx, it his purchases and the range is pretty close to what you just described.

And Ryan, just to add to what Stephen said, the reason why we looked at both options. We believe strongly that this is the right initial assumption to have the best cost profile for the operation, leasing and aircraft adds significant margin to the lessor that we want to make that an efficient process, so we can pass some of the cost savings and efficiencies to our transplant users.

Great. Thanks again for taking my questions and congrats on all the strategic momentum.

Thank you.

Thank you, Ryan.

Thank you. And the next question comes from Josh Jennings with TD Cowen.

Hi, thanks for taking my questions. I was hoping Waleed just ask a follow-up on OCS lung franchise and just the lung initiatives that you guys have in place and trying to help double lung transplant volumes in the United States. I know there has been some talk about the technology acquisition, but can you just help us, just remind us of I guess the thrust there both in terms of collaboration with the lung transplant surgeon community and any other societies? And just the cadence of how you see OCS being adopted at a higher clip into 2024 and beyond?

Thank you, Josh. I think, Josh we're in the early stages of these initiatives. I think the second half of this year we will start ramping up. We wanted to wait until we announce the acquisition because we believe this is going to be one of the catalysts that will get people's attention. As you may know in the community, there was a lot of focus on what's coming next and EVOSS had some attention focused on it. We wanted to get that acquisition completed, we'll use that as a potential catalyst. But there are other several catalysts that we're working on with the existing OCS platform. It's going to take some time to get the next-gen lung system integrated with negative pressure ventilation and the new form factor operational, and we will probably use that as a second wave of growth, not the first wave of growth. We have other ideas and concepts to how do we can get the lung growing in '24 maybe the next-gen lung system will be sort of late '24 or early '25 time horizon, but we have others that we are planning to enact and implement in later this year and early next.

Okay. And I apologize if this question was already asked at another earnings calls well, but just in terms of the roadmap to profitability, if you're adding the aviation business, by tucking that in, but any high-level comments and I think we frequently get asked about just the revenue run rate where transplant could hit EBITDA positivity, I don't know if there is any updated thoughts, I know that acquisition isn't closed yet, but anything on roadmap to profitability or just any margin impact from a high level from this Summit Aviation acquisition? Thanks for taking the questions.

Hi, Josh. It's Stephen. Well, first, I would say we were EBITDA positive this quarter. But no, it's a very good question. I would say we're not prepared to say that at this call about where we think it's going to be once we integrate aviation, it's probably going to change. It's going to change so much, some on the investment side, but also, we're going to be adding additional revenue from aviation which we haven't had before. So give us some time to model that through and we'll prepare that for future calls.

Understood. Thanks Stephen.

Thank you. And this concludes the question-and-answer session. I would like to return the call over to Waleed Hassanein for any closing comments.

Thank you. Thank you all for joining us on the Q2 call. We look forward to speaking with you again for Q3. Have a great afternoon, everyone.

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