TransMedics Group, Inc.

Good afternoon and welcome to Transmedic's first quarter 2025 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 would now like to turn the call over to Lane Morgan from the Gilmartin Group for a few introductory comments. Please go ahead. Thanks, operator.

Earlier today, Transmedics released financial results for the quarter-ended March 31, 2025. A copy of the press release is available on the company's website. Before we begin, I would like to remind you that management will make statements during this call, including during the question-and-answer portion of the call, 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, future results and events, including financial guidance and projected estimates, our examination of operating trends, the potential commercial opportunity for our products and services, the potential timing, outcome, and value of new clinical programs, the potential impact of tariffs on our business, our expectations for growth and opportunities in our operations, and financial guidance and or expectations, including revenue, gross margins, and operating trends, operating expenses in 2025 and beyond are based upon our current estimates and various assumptions. These statements include 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. Additional information regarding these risks and uncertainties appears under the heading risk factors of a form 10-K filed with the Securities and Exchange Commission on February 27, 2025. Our subsequent SEC filings and the forward-looking statements, including today's earnings press release, which are available at www.sec.gov and on our website at www.transmedics.com. Transmedics claims 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, May 8th, 2025. And with that, I will now turn the call over to Waleed Hassameen, President and Chief Executive Officer.

Thank you so much, Lane. Good afternoon, everyone, and welcome to Transmedic's first quarter 2025 earnings call. Joining me today is Gerardo Hernandez, our Chief Financial Officer. As we discussed previously, We viewed 2025 as an important year for Transmedics, mainly to transition and shift into our second year of growth for Transmedics OCS NOP platform. Despite external distractions in January, we remained laser-focused throughout Q1 on our business fundamentals, operational execution, and our unwavering support for our clinical transplant partners and users. In doing so, we continue to be successful in expanding the utilization of available donor organs for transplantation and increased OCS NLP adoption, all resulting in our core mission of delivering what we believe to be the best possible clinical outcomes and the most cost-efficient therapy for our transplant recipients. The results speak for themselves. Our 1Q performance demonstrates that the strength of our business fundamentals, the effectiveness of our strategy, and the unrivaled value of our business model. Importantly, our ability to execute at a very high level despite unexpected external pressures is a testament to the strong support of the transplant clinical community to Transmedic's mission and the resilience of our incredible team. Now let me proceed to discuss our business performance throughout the first quarter of the year, which was our strongest quarter to date in the history of Transmedics. Here are the key operational highlights for 1Q. Total revenue for 1Q 2025 was $143.5 million, representing approximately 48% growth year over year and approximately 18% sequential growth from 4Q 2024. Growth was driven primarily by higher overall utilization and center penetration of OCS and OP in the US for liver and heart transplants. And that happened across both DBD and DCD organs. This enabled us to achieve a new high watermark for overall case volume in 1Q 2025. Meanwhile, transmedics transplant services revenue for 1Q was approximately $55.3 million, up from $35.5 million in Q1-24 and up from $46.7 million in Q4-24, representing approximately 56% year-over-year and 18.5% sequential growth. Our overall gross margins for 1Q improved to 61.5%, up from 59% in 4Q-24. Finally, we delivered operating profit of $27.4 million in one queue, representing approximately 19% of total revenue and up from 8.6 million or 7% of total revenue in 4Q 2024. Shifting now to transmedics, transplant, logistics, infrastructure, and performance for the quarter. Transplant logistics services revenue for 1Q was 26.1 million, representing approximately 80% year-over-year and 20% sequential growth. Throughout 1Q, our daily average aircraft availability was approximately 15.4, up from 14 in 4Q24. Given that we reached a critical mass of owned aircraft capacity, we will retire the reporting of this metric going forward. Throughout the first quarter, we were able to cover 78% of our NOP missions requiring air transport compared to 75% in Q4 of 2024. As we've discussed previously, we are now focusing our effort in 2025 on efficiently operating our fleet by double shifting a portion of our planes to the extent possible before investing in additional aircraft to the fleet. We will be opportunistic, however, in adding one or more aircrafts in 2025 to reach our stated goal of 22 owned aircraft before year end. Overall, we are very pleased with our strong performance in 1Q. We are focused on maintaining this momentum throughout 2025. In addition, we are planning to launch two new heart and lung clinical programs later in the year to further catalyze our growth in 26 and beyond. Our 1Q performance underscores the unique attributes of Transmedics business. Transmedics is not only a top line grower, but also an increasingly profitable business capable of generating significant bottom line leverage. We remain confident that this is just the beginning and we believe we are well positioned to deliver sustainable long-term financial results as we gain more efficiency of scale and continue to drive leverage throughout the operation. Moving now to provide a quick status update on our next-gen OCS heart and OCS lung clinical programs. We filed both OCS lung and heart IDEs and are actively discussing the final details with FDA. Based on our interactions, we feel we are on track to initiate both programs in H2 2025 as we communicated earlier in the year. However, the precise launch time of the NextGen lung and heart clinical programs is still fluid and depends on the exact timing of the FDA approval, followed by the center's IRB processes. As we highlighted at our ISHLT symposium in April of this year and previously at our investor day in December of 24, we are planning to run a relatively large-sized trial aimed at building the next generation of level one clinical evidence that is unrivaled in our industry. As stated above, we see these new clinical programs as potential major growth catalysts for Transmedics 26 and beyond. and we are not counting on these two clinical programs to contribute materially to our financial results in 2025. Now, I'd like to address the potential impact of geopolitical, macroeconomic, and tariff policies on transmedics business in 2025. Let me start with the impact of tariffs that may have negatively impacted many device companies. I want to remind all of you that Transmedics is and will continue to be a proud US manufacturer of the OCS technology platform. Importantly, we also are focused on vertically integrating most of the critical technology blocks to minimize supply chain risks on our business. Based on what we know today, we believe that the currently proposed tariffs will have a minimal impact on our business. That said, This is a fluid environment and may change should policies change. Additionally, we are leaning forward and have announced publicly our strategic plan to open a disposable design center of excellence and a new manufacturing facility in the premier biomedical device district of Mirandola, Italy. This district is renowned for its deep expertise in polycarbonate injection molding and disposable perfusion technologies. We expect this plan to give Transmedic several key strategic advantages. First, it enables us to leverage their unique talent to rapidly integrate many of the key disposable critical components for OCS perfusion circuits. Second, provide an alternate disposable manufacturing source to ensure business continuity to our Andover facility. And finally, to provide us maximum flexibility in supplying OCS product OUS. while reducing the potential impact of tariffs on our international business. Now, let me share our perspective on the impact of potential economic downturn on organ transplantation in general and our business in specific. Our experience over the past two decades reinforces our belief that organ transplantation is a lifesaving procedure that is largely insulated from economic cycles. This is due to two important facts. One, the best clinical outcomes associated with the transplant procedure and the highly cost-effective and the highly cost effectiveness of the therapy for payers managing very expensive chronic disease conditions that lead to organ failure. Let me now conclude my remarks by discussing our expectation for the remainder of 2025. As seen in our 1Q results, we began the year with a very strong performance. We are confident that we can maintain this momentum for the overall 2025 annual performance. However, we may experience some level of variability or quarterly seasonality that could impact performance quarter to quarter as we've experienced last year. As a result of our strong 1Q performance and the full year considerations I just outlined, we are raising our full year 2025 revenue guidance to between 565 and 585 million, representing approximately 28 to 32% growth over full year 2024. With that, let me turn the call to Gerardo to cover the detailed financial results for the quarter. Gerardo?

Thank you, Walid. Good afternoon, everybody. I'm pleased to be here to work with Transmedic's strong first quarter results. As Walid mentioned, Q1 2025 was a strong start to the year, reflecting our discipline execution, continued commercial momentum, and the positive impact of our strategic investments. We saw solid performance across both product and service lines, and positive sequential margin expansion and profitability gains. U.S. transplant revenue, was $139 million, up 51% year-over-year and 19% sequentially. By organ, liver contributed with $109 million, heart with $26 million, and lung with $4 million. OUS revenue was $4 million, down 1% from Q1 of 2024 and up 4% sequentially. OUS revenue by organ was $3.5 million in heart, $0.4 million in lung, and $0.1 million in liver. Product revenue for the first quarter reached $88 million of 44% year-over-year growth and 18% sequentially. Growth was driven by increased organ utilization in liver and continued OCS adoption across both liver and heart. Service revenue came in at $55 million, reflecting 56% year-over-year growth and 18% sequential increase. The primary driver was logistics. which grew 80% year over year and 20% sequentially, fueled by the continued expansion and utilization of our aviation fleet. Total gross margin for the quarter was approximately 61%, representing a decrease of 45 basis points when compared to Q1 of 2024 and a sequential improvement of 226 basis points. The 45 basis points decline was driven by a higher proportion of service revenue, which carries a lower margin profile. partly offset by improvement in product gross margin. The sequential 226 basis point improvement was primarily driven by a recovering product margin, which increased 359 basis points driven by the absence of Q4 related charges for inventory related charges and better cost absorption. Compared to Q1 of 2024, product gross margin improved 448 basis points, driven by cost efficiencies and the absence of not recurring inventory charges. Service gross margin declined 632 basis points versus Q1 of 2024, primarily driven by the higher proportion of aviation business. However, sequentially, service gross margin remains stable and we continue opportunities for margin expansion through operational efficiencies. Total operating expenses for the first quarter of 2025 were approximately $61 million, up 28% year-over-year. The growth was primarily driven by a 51% increase in R&D as we continue to invest in our innovation pipeline. and a 21% increase in SG&A, reflecting investment to strengthen our NOP and command center, along with non-recurring legal and consulting expenses tied to internal processes reviews conducted in Q1 of 2025. Sequentially, total operating expenses declined 4%, lastly due to lower SG&A following one-time expenses recorded in Q4 of 2024 and timing of spend. partially offset by the non-recurring legal and consulting expenses I mentioned before. R&D grew 4% sequentially, consistent with our ongoing investment plan. Operating income for the quarter was $27.4 million, up 121% year-over-year and more than tripling sequentially. Operating margin expanded to 19.1% compared to 12.8% in prior year. Net income for the quarter was $25.7 million, representing a 111 year-on-year increase and 275% sequentially. This result demonstrates that our business model can scale efficiently, drive meaningful financial improvement, and positions the company for sustained momentum in 2025 and beyond. We ended the quarter with $310 million in cash, down $26.5 million from December 31st of 2024. During Q1, we invested approximately $24 million in the purchase of two additional aircraft, and we remain on track to purchase one more this year to reach our target of 22 owned jets by the end of 2025. Earnings per share were $0.76, and diluted earnings per share were $0.70 for the first quarter of 2025. In summary, we are off to a strong start. we feel confident in our momentum and remain focused on execution to continue to grow the number of transplants, advance key projects and programs, and deliver strong results through the rest of the year. Looking ahead, based on the strength of the business, as Walid mentioned before, we are raising our full year revenue guidance to a range of $565 million to $585 million, up from our prior range of $530 million to $552 million. This reflects approximately 30% growth over 2024 at the midpoint of the guidance. Growth is expected to continue to be fueled by the expansion of total transplant volumes, the increased OCS adoption, and continued momentum across our service platform. We continue to expect some quarterly variability in terms of transplant volume growth. However, we are confident in our updated full year guidance. In terms of gross margin, we continue to expect expansion across both product and service gross margin, driven by benefits of scale and operational efficiencies. However, the increasing proportion of service revenue, which operates at a lower margin, will moderate the overall gross margin expansion in 2025. In aviation, we are expecting scheduled maintenance activity to increase in the second half of the year, ramping in Q3 and more significantly in Q4. While this may introduce some quarterly noise, it does not change our expectation for modest gross margin expansion. In terms of capital allocation, we will remain focused on R&D and targeted investment that advance our pipeline, strengthen product development, and enhance logistics efficiency and process simplification. We are balancing strategic growth with financial discipline to drive sustainable long-term profitability. Finally, With stronger expected top-line performance, continued efficiency gains, and spend discipline, we now expect to deliver at least 400 basis points of improvement in operating margin in 2025 versus 2024. While quarterly variability is expected, we are confident in the full-year step-up driven largely by gaining leverage across operating expense base. I'm encouraged by a strong start to the year and the discipline execution across the organization. While there is more work to do, the momentum we are seeing across the business, combined with clear growth drivers, give us conviction in our ability to deliver sustainable growth and continued margin expansion. And with that, I'll turn the call over to Walid for closing remarks.

Thank you, Gerardo. As I said before, we're very pleased by our strong start of the year and performance in Q1 that we expect to carry this forward for the remainder of the year. As we stated before, our 1Q results demonstrate the unique and unrivaled attributes of Transmedic's business. We remain confident that this is only the beginning and we are well positioned to continue to drive profitable growth while generating leverage to drive strong, sustainable financial results. In conclusion, We are humbled and proud of the strong clinical user support for transmedics and the resilience of our wonderful team. We remain committed to delivering the highest quality OCS NOP products and services to expand access to our lifesaving transplant technology. With that, I will now turn the call to the operator for Q&A. Operator?

We will now begin the question and answer session. To ask a question, you may press star then 1 on your touch-tone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. The first question comes from Alan Gong from JP Morgan. Please go ahead.

Hi, team. Thanks for the question. Congrats on, you know, just what's really a really strong quarter. You know, I guess starting with where I think it looks like a lot of the upside came from in liver, you know, It's kind of funny, you know, one of your main competitors in that space actually had some news announced today as well. But how should we think about, you know, the main drivers of your growth in liver? We know that you're seeing, you know, more morning adoption, continued growth in DCD. But if you could just break down the drivers of that outperformance in liver and what you're seeing so far in April as well.

Thank you, Alan, for the question. I cannot comment on the news that came out today from the other technology out there. I can only comment on our dynamic as you'd expect me to do. We're extremely confident in our liver platform. We're seeing growth across the verticals, DBD, DCD, we're seeing more utilization of deceased donors across both DBD and DCD. We're gaining share, we're gaining momentum. Again, it's early in the year, but we are bullish about our ability to continue to execute and continue to deliver the results we're delivering because we are convinced that we have the best, I repeat again, the best platform for liver preservation. all the pseudo competitors out there cannot deliver the value that the OCS can deliver in liver transplantation. And the upcoming publications will prove it unequivocally based on data and evidence, not just based on opinions.

Got it. And then just a quick follow-up, just curious what you're seeing so far in April. You know, you raised the guide by more than the beat, but still, you know, given the outperformance in the quarter, it looks like there could be some room for upside if you carry some of that momentum forward. So just curious about what you're seeing so far in April. Thank you very much.

Thanks, Alan. I think you and others know that we take guidance very seriously. Q1 results speak for themselves. It's still early in the year, and we wanted to make sure that we also are putting guidance that can that can be achieved and factor in some potential headwinds coming up in Q2 or Q3 or Q4. So we feel very strongly that the momentum we experienced in Q1 will continue for the full year results, but we expect some variability between quarters, potential seasonality as we've seen last year. That's why the guidance accommodated for all of that. You know, based on April results, we feel confident in the guidance range we put out in front of the community. Gerardo, would you care to comment on that?

No, I feel we have plenty of tailwinds, not only in product sales, but also in service revenue. We have our adoption has increased consistently. We saw adoption increasing in Q4. We saw adoption increase in Q1, as Walid mentioned. It's not only the adoption, but it's organ utilization. It's penetration of organs in different centers. It's power adoption, so plenty of tailwinds.

The next question comes from Matthew O'Brien from Piper Sandler. Please go ahead.

Hi, this is Sam on for Matt. Thank you for taking our question. I guess first I want to touch on, you know, your next or your two next-gen products for the Heart and Lung. We know that you can generate product revenue when these trials are ongoing, but can you talk a little bit about the service revenues and how you anticipate product and service margins could be impacted during these trials?

Thank you for the question. I'd like to comment only on the product revenue at the moment until we have all the trial design completed and approved by FDA. We know we have a high degree of confidence that we will be incurring product revenue. We expect to incur service revenue, certainly on the OCS arm. But we have to stay silent on what should we expect on service revenue on the control arm. That remains to be an area of discussion, so I do not like to comment on it just yet. But we certainly feel very confident that we will be incurring product revenue throughout the heart and lung clinical programs.

Okay, perfect. Thank you. And then we just want to touch on liver again. Obviously, it continues to do really well in the U.S. There are a couple of competitors anticipated to enter the market later this year. So just what kind of gives you that confidence and your guidance and any impact, if any, that you anticipate in the second half of this year?

As I stated earlier, the community needs to step back and understand why is the liver doing so well for us. There is a good reason for that. The good reason is Transmedics and OCS liver platform is delivering the best results in the history of liver transplantation. And we're doing that while providing the most convenient, the most cost-efficient way of delivering the liver transplantation at the transplant institute. This is why the market is adopting our platform. Anybody could claim that they have a potential competing technology. They need to prove it. We stand by our product. We stand by our data. And as I said, this is all going to be coming out to light very soon in major publication in peer review journal that highlights all the value that I just outlined. That's why the liver program is doing well, and that's why we expect the liver program to continue to do well. And I'm going to go on a limb and say Transmedics is not just stopping at where we are. Transmedics is working very hard to ensure that the OCS liver platform is the next standard of care in DBD and DCD liver transplantation in the United States and around the world. Anybody could claim anything. We have the evidence to support us, and we are not stopping. We are continuing to push innovation, clinical programs, data to ensure that this leadership position of our liver platform will continue to lead from the front.

Great. Thank you. The next question comes from Bill Plovanic from Canaccord. Please go ahead.

Great. Thanks. Good evening. Thanks for taking my question. So as we look at the quarter, I mean, liver was fantastic, and we've talked about that already. You know, we did see receivables go up pretty significantly from the fourth quarter. Just any commentary there? And then on the guidance, you know, Gerardo, you know, basically it assumes flatline the rest of the year. You did make some commentary about the trials. Do you still think that the clinical trials will add 2% to 5% to the numbers this year, or have you pulled that out and are basically saying it's next year?

Let me start with the last part, Bill. We've always stated that the clinical trials for this year will be a very, very small contributor. We estimated it to be between 2% and 5%. We think it's still within that range, maybe towards the lower end of that range. But really, what we have always stated that these clinical programs are the catalyst for 26 and beyond. And I'll let Gerardo specifically address the AR question.

Yes, the increasing receivables basically is really related to the timing of billing. We had a couple of elements that affected Q1, and the billing that we had to do through the quarter actually was done later in the quarter. So we delayed that process, and what I can tell you is that now we're in, let's say, recovering the receivables, and we're in good position to go back. uh to our original plan we are expecting to end the year more or less in somewhere around our 45 to 60 a day pso uh and we should see recovery already in q2 and i would like bill if you allow me to just uh add uh one additional commentary to her other points um

As we've stated before, we are transitioning our entire NOP platform to be managed completely through our new NOP digital ecosystem. Part of that transition is a full automated billing mechanism that will significantly reduce that time between the completion of the case and the bill being generated. And that's coming the second half of the year. That will help achieve the goal stated by Gerardo.

Okay. And I just want to, just to go back to the first question on the guidance, Willie, you know, you did that 143 and change in the first quarter. It's basically flatlined for the year. Is that how we should think of the second quarter to be very similar to the first quarter? Or is it like last year where it kind of went up a little and then kind of, you know, the back half of the year slowed down a lot? I mean, how should we just think about the second quarter here?

I really think, Bill, we can't comment in the second quarter, given that we're already close to the middle of the second quarter. But from a high-level expectation, we always expect to do better. That's not a secret. But we also expect some seasonality. Maybe it will hit in Q2, maybe it will hit in Q3. That's why the guidance is structured the way it's structured. But we're trying to reflect in the guidance the way we see how the business is operating. But based on the early signals in Q2, we expect to see a little bit of modest improvement over Q1. But we still have some weeks to go.

Thanks for taking my questions.

The next question comes from Justin Wang from Morgan Stanley. Please go ahead.

Hey, thanks for taking our questions. I'm stepping in for Patrick here. I was wondering if you could talk a little bit more on the durability of OCS and NOP pricing. I understand that it adds solid value to transplant centers and payers, but do you think that competitive entries and a more cost-sensitive CMS could pressure your pricing here? Thank you so much.

Justin, thank you for the question. I think as I've stated before, the question is not about pricing. The question should be about value. We priced our technology based on the significant value that the OCS delivers to the transplant center, to the payer, and to the patient. In fact, we believe that we're leaving some value on the table because it's always been our culture not to gouge the market. We're there to be their long-term partner. We're there to be the next standard of care for organ transplant in the long term. Unfortunately, because of our value, any... How do I state this? any potential competitor is just taking a 20% discount from our price and saying I'm cheaper than transmedics. People need to step back and say, what is your value? Most of these competitors, specifically in the liver, we should ask, what is your value? What are you delivering? You should be at zero or near zero from a price standpoint because you're not delivering much value. What is the value of a machine perfusion that deliver has to be preserved on ice for six or eight hours before you perfuse it? So where is the value of machine perfusion? You've just killed the value of machine perfusion. And why do you do that? Because the technology is not capable of being portable. even if it has wings to it, it's not delivering the physiologic profusion and value of preservation and assessment that the OCS is delivering. So based on this, based on these facts, and based on the significant economical efficiency that is gained throughout the paradigm of organ transplantation, from reducing the waitlist time to improving the post-transplant complication rate, to increasing the survivability of the recipient with the originally transplanted organ, and significantly reducing the re-transplant rate, we are delivering significant cost efficiency to payers, to transplant programs, and certainly the best quality of life and the best life expectancy for the patient. Based on that, we think CMS will continue to reimburse for OCS and commercial payers, not just CMS, because we're delivering significant economic value to these payers. And again, the data speaks for itself. Thank you so much.

The next question comes from Chris Pasquale from Nefron Research. Please go ahead.

Thanks. I wanted to ask a couple questions about margins. The updated guidance for four points of full year operating margin expansion represents great progress, which actually delivered more than seven points here in 1Q. So was there any spending that got pushed out of 1Q and is going to come later in the year to drive that dynamic? Or are there other margin headwinds that you're contemplating with that outlook?

Hi, Chris. No, the majority, as I mentioned, the vast majority of the operating margin increase is going to be driven by gaining in operating leverage, in operating expenses. So basically what is happening, most of the, or a large part of our investment is planned for later in the year. And that's what basically is going to balance out. So that's why we're comfortable on the full year 400 basis points, at least. That's what I mentioned, at least.

Okay, that's helpful. And then on gross margin, nice result this quarter on the product side of the business. The service gross margin was similar to what we saw in 4Q, even though service revenue improved sequentially. What's the real gating item to get that service gross margin higher? You've got basically the fleet of claims that you would like to have. Is it just a matter of really increasing the utilization of those assets, or is there something else that sort of triggers a change in the profitability of that piece of the business?

No, that's exactly what you mentioned. It's doing the utilization of the assets. Let me give you a couple of examples. In Q1 last year, I mean, just to share, in Q1 last year, we owned 14 planes. The average operating aircraft per day was nine. And we were servicing only 49% of our NOP missions. Today, we own 21 planes. we have around 16 average operational aircraft in Q1, and we are serving 78%. So what I'm trying to say here is there is plenty of room to continue to utilize or fix assets. And as long as we, as much as we continue to do so, we will be able to expand the margins. That's why we are exploring the double shifting project. That's why we are exploring other elements within the logistics team to improve the efficiency of the fleet. But it's basically volume. It's basically volume, Chris.

Okay, thank you.

The next question comes from Suraj Kalia from Oppenheimer. Please go ahead.

Wally, Gerardo, congrats on a fantastic quarter. So Walid, thank you for giving all the details. On the external disturbance you referenced in your remark, Walid, there was probably not one surgeon or hospital administrator who had not heard of the allegations, and there was fear this could lead to softness. Yet the math implies you guys actually picked up shares. So maybe if you can help us understand how new stores, same stores, sales shaped up in the quarter? Did you see pockets of softness? How you overcame, if any, the disturbance, as you mentioned, external disturbance that you mentioned?

Thank you, Siraj. If you allow me to correct you, I didn't say disturbance. I said distraction. And frankly, it's a nuisance distraction. I think the results speak very loudly that the clinical transplant community voted with their action, not with their word. We reached out to every user of the OCS platform and non-user in the United States across all three platforms when this garbage came out in January. And we've made our points clear and the results shows their position. So we look at these results with a high degree of pride and humility, and we are continuing to laser focus on our users, servicing our users' need, and making sure that We're there for them as they have been there for us throughout Q1. And again, we're doing this because we're delivering significant value to the transplant community across all three platforms. And we're looking forward to the next phase this year, later this year, when we get the heart and lung programs kicking to start getting momentum in the cardiothoracic aspect of this. We did not see any softness. The opposite is true. And again, now the focus of our entire team is to making sure that we are here and have the capacity to meet the demand. The demand is continuing to grow day over day, week over week, month over month.

Fair enough. And Waleed, one of the other things obviously is OCS economics, almost every discussion this comes up, right? And in one of our recent events, you know, some of the physicians said, hey, it would really help hospitals because they are not billing properly. And the point was raised, it would really help if Transmedics develops a reimbursement team that can help us understand reimbursement. you know, and guide us through the process because there you all have stepped and it seems like it's helped the site. So walk us through if that is on the, you know, on the docket in terms of just helping transplant sites walk through, you know, the reimbursement steps. Gentlemen, congrats again and thank you for taking my questions.

Thank you, Suraj. Suraj, unfortunately, That tells me that that particular view comes from a new user or a new partner to Transmedics OCS. Transmedics has always had reimbursement experts, both full-time internal and external, that work and help all transplant programs in the United States and in Europe. do the market access and billing work. In fact, we are the only entity, only technology that formed the National Transplant Administration Working Group, assembled from leading transplant programs that are highly utilizing OCS and have secured additional reimbursement from commercial payers to help other transplant programs in the U.S. achieve the same results, completely unpaid, completely independent of transmedics. So it's a great idea. We agree with that view for sure, and we have been implementing that. And again, our results and our growth could not be achieved, could not have been achieved without making headway on the proper billing, as you outlined. Next question, operator.

The next question comes from David Rescott from Baird. Please go ahead.

Great. Thanks for taking the questions and congrats on the really strong quarter here. Walid, I wanted to follow up on some of your comments already on just the way you're thinking about the rest of the year and the guide. I know, you know, historically, you've called out just the unknowns around whether or not Q2 or Q3 sees more seasonality. I think if you look at the past two years, you know, Q2 was a seasonally stronger quarter, Q3 was a seasonally weaker quarter. And so if we were to pretty much take that, you know, mid single digit market growth that's played out in liver and heart the past two years, it puts you at you know, around 150 million or so in Q2. So I guess my question is, at this point, is there anything in your mind that leads you to believe that what we've seen the past two years, meaning stronger Q2, kind of weaker Q3 on a seasonality basis, would not play out again this year?

At this point, David, thank you for the question. At this point, you perfectly outlined it's either Q2 or Q3. And yes, the odds are looking at Q3 just because of the summer vacations. But we are also living in very volatile times. One has to be prudent, but if nothing, if we're just looking at the past two years, I agree with you. The Q2 should be an uptake from Q1, and Q3 is probably the higher probability where we see a little bit of a slowdown because of the summer vacation impact and summer vacation on the overall transplant volume. But we don't see any more tangible evidence that points us in one direction over the other at this point.

Okay, great. And then, you know, on the two clinical trials, lung and heart, you know, I understand, you know, the value to hospitals or physicians in participating in that trial. You know, when you think about the potential for on the heart side, you know, accounts to be interested in doing a heart transplant as a part of this trial versus doing a heart transplant, not a part of the trial. You know, how do you think about the potential for the, you know, revenue coming in for heart patients to be incremental or something on top of the growth that you already, you know, would have as opposed to it, maybe cannibalizing some of the underlying, heart transplants that you likely were going to capture in the future at some point as well. Thank you.

Excellent question, David. I think we need to, you know, point out that we have two segments of the heart trial, one that is focusing on our current indication and one much larger that is focused on a brand new indication that we currently don't have. And that cannot be cannibalized since we don't have that indication in the U.S. anyway. And that's the indication that happens to be a 750 patient trial versus the current indication segment of the trial is only 200. So we do not see this as cannibalization. We see this as an advancement on both trials. But I just wanted to be giving you the black and white answer is You know, there's a 750-patient trial that is an indication we currently do not have in the U.S. So we're looking forward to the start of these trials, and hopefully the results will validate our view that this is not going to be cannibalizing. This is going to be additive because the significant advancements that users will see with the next-gen technology and solutions that we are deploying as a part of these programs. All right, perfect. Thanks, and congrats again.

The next question comes from Mike Mattson from Needham and Company. Please go ahead.

Yeah, thanks. Just, you know, curious on the decision to open the facility in Mirandola, Italy. I mean, you don't have a lot of international business, at least right now. I mean, I understand you're growing so fast you probably need to add capacity somewhere, but, you know, why there versus, you know, somewhere in the U.S. or elsewhere?

Mike, I can speak more granular other than saying that Mirandola Italy happens to be the mecca for cardiopulmonary or perfusion technologies and plastics innovation. Every major perfusion technology company, whether in the dialysis, in the cardiopulmonary bypass, or ECMO company on the planet, has a major R&D and manufacturing headquarter in Mirandola, Italy. Guess what? Our main revenue generating product is a perfusion disposable unit that is made of polycarbonate and polyurethane. And it has the same components that has significant engineering and design and manufacturing talent that exists in Mirandola, Italy. So that's one of the main reasons why I have to leave it at that. The second is as we grow and we're growing very rapidly, we need to start thinking about business continuity. And given that we're putting that infrastructure in Mirandola for R&D, it made perfect sense for us to add the manufacturing component to it given the talent that exists in that region. specifically on the vertically integrating key technology blocks that requires that talent that doesn't exist in the U.S. And frankly, it doesn't exist in the U.S. as much as it is available in abundance with significant expertise in Mirandola, Italy.

Okay, got it. So it sounds like you're probably... you know, bringing something in-house that you were, you know, having made in that kind of region to begin with and just deciding to kind of do it yourselves now. Is that fair?

That's fair.

Okay. All right. And then just one on, you know, from a policy perspective, I know there's constant headlines out of D.C., but, you know, I know there's some effort underway to kind of revamp the

transplant policy at the federal level so you know i was just wondering if there were any updates there if you're hearing anything about you know the way things could potentially move thanks um mike we we are um we're not aware of anything imminent um you know um uh but we're keeping our eyes and ears um wide open and and uh uh you know um We are actively engaged with many of the policy makers and the decision makers that are involved in that particular topic. So I'll leave it at that.

Okay, thank you.

As a reminder, if you have a question, please press star one. The next question comes from Josh Jennings from TD Cowan. Please go ahead.

Hi, good afternoon. Strong quarter. I was hoping to talk about, ask about the clinical trials we'll lead at ISHLT. You made some, at the symposium, you obviously presented some high-level details on the lung and heart trials. First on the lung trial, maybe you can just help us or report back on the enthusiasm or buzz that was generated within the lung transplant surgery community and the impetus or desire to get involved in this clinical program.

Thanks, Josh. I think the buzz was pretty loud, and it's not just in the lung. I think the buzz in the heart was as loud as the lung. It's not louder. So we were, you know, it was unfortunate that, you know, that we could not declare the two IDEs approved by the time of the ICHLT, but the buzz was loud. And what I tell you, you know, from our perspective, not just in the US, but as you've seen in our symposium, the buzz, even OUS is becoming louder and saying why we need access to these innovations in Europe and Australia. So our team is working hard since the ICHLP trying to kind of harness that momentum. First, First things first, we need to get FDA approval in hand and move forward to executing our plans in the U.S. and definitely try to capitalize on the momentum and interest generated OUS as well.

Understood. And maybe on the HART program, there was a question from the surgeon just about the risks of designing the trial for superiority in low-risk and low-risk DBD trial, lower risk, you know, head-to-head against standard of care practice. Maybe you can just talk about your confidence level on OCS delivering superiority over standard of care. Thanks a lot.

Josh, I think, you know, again, we don't want to comment, you know, from our perspective. That's why we designed the trial. That's why we are going to generate that first level one evidence head to head to standard of care. No other technology in the field from cold storage to cold perfusion to cold controlled cold storage have done that. We're the only technology that is going to put that question to the test. And it's a very high bar, the test of a level one FDA pivotal PMA trial. And we let the data speak for itself.

I appreciate that and looking forward to tracking along.

Thank you, Josh.

This concludes our question and answer session. I would like to turn the conference back over to Walid Hassanin for closing remarks.

Thank you, operator. Thank you all for your time this evening, and we're looking forward to meeting again in a few weeks and months here. Have a wonderful evening, everybody.

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