Alright, good morning. My name is Bill Plovanic. I'm a Senior Analyst here with Canaccord. Welcome to the Canaccord Growth Conference. I think their 45th annual. With us up next, we have the CFO of TransMedics, Gerardo Hernandez, and the Chief of Cardiothoracic Program, Farhan Zafar. With that, I'll hand it over to Gerardo.
Thank you. Thank you, Bill, and thank you, everybody, for being with us this morning still. Before we start, this is the note regarding the forward-looking statement. Now we can move into our vision. I would like to start with that slide. TransMedics' vision is to increase the number of organ transplants and improve the post-transplant outcomes. This is our guiding principle. This is what we keep in mind every day in every action or decision that we take. Now, how is that vision translating into the everyday? If we take a look at the U.S. national adult transplants for the combined number of heart, lung, and livers from 2022 to the latest, I think, from 2022 to 2024, we can see that the total number of transplants grew by 20%. However, when we remove TransMedics from this equation, the total number of transplants grew only 2%.
That is a clear testament, a clear evidence that TransMedics is positively impacting thousands of lives of patients every year and really increasing the number of transplants, not just gaining market share, but also increasing the number of transplants. Now, it's not only about numbers. It's also about outcomes. There are a number of papers out there where we have clinically proven that the OCS technology delivers outstanding outcomes. I'm not going to go through all of those, but I just want to call one of them. For instance, the ischemic biliary complications in the case of the liver. For the OCS, the ischemic biliary complication, that is a marker for morbidity, for complications post-transplant, and even death, has a 2.1%. Just last week at the WTC, one center actually shared the same number of the same KPI for one of our competitors, for the competitor. That number was 11%.
That is 5x worse in terms of more frequent complications after the transplant. That is another evidence on how TransMedics is delivering on its mission and providing better outcomes. How are we doing it? The key way of doing it is what we call the TransMedics Trident, and it's composed of three different columns. The first one, and the most important one, is our OCS multi-organ platform, which allows us to keep organs functioning outside of the human body. It also minimizes organ damage and increases utilization. That's the first one. The second one is our NOP, our National OCS Program, where we have 17 hubs located across the U.S. with procurement, with team of procurement, clinical specialists that are always ready to go for the next mission.
Importantly, we just launched our NOP Connect Digital Systems, where now everyone involved in a specific transplant, in a specific mission, can see real-time where the organ is and what is the status of the organ from donor to recipient, as well as all of the administrative documents that need to be there, like the approved quotes or the invoice, etc. We have all of that evidence located in one single place at the power of one finger, as you use your mobile, if you use your mobile. We also have our vertically integrated logistics network, where coordinated from our command center in Andover, Massachusetts, it works 24/7, 365. From there, we coordinate our aviation fleet, 21 jets so far. We have more than 100 pilots, our maintenance hub, and a network of ground transportation that allows us to transport the organs in a safely, fast, and efficient way.
I want to highlight the efficient way because that network effect is what allows us to actually pass those efficiencies back to the transplant centers that partner with us, right? More specifically, when we have dry runs. When you have the dry runs, we are able to pass on to the centers 50% of discount on the transportation cost, which no other company can do that. We are able to do that just because we are integrated. All of that, we're really making the impossible possible. Sorry, these are maybe some sensitive videos for some, but I believe it's important to show how our devices, our OCS technology, is actually keeping organs alive. You can see the lungs breathing, the heart beating, the liver producing bile, and the kidney producing urine. That's the difference that we're making.
That's how we're able to increase the number of transplants and have better outcomes because this is the closest to physiology that you can get today. I hope you enjoy these videos. I love these videos. It's really... Yes. All right. I often get the question about how much can we grow? To me, this slide really helps us to visualize how much TransMedics can grow. By the way, this is just U.S., all right? This is just U.S. and the organs where we currently participate. Last year, according to the OPTN data in the U.S., we had approximately 17,000 donors. That means that we had 17,000 lungs, 17,000 hearts, and 70,000 livers potentially available for transplantation. In the case of lungs, only 20% of those 17,000 lungs were actually transplanted. 80% were wasted. In the case of heart, 75% was wasted. In the case of liver, 40% was wasted.
When we look into how much can we grow, can we continue to grow just by increasing organ utilization, it provides a huge runway to continue to expand our business. Utilization is key. I don't know why the presentation is moving there. Utilization is key. However, we also can win on the OCS adoption or market share, where in lung, we have 4%, in heart, 19%, and in liver, 27% at the end of 2024. Those are numbers that we share in our Q4 earnings release. The runway to continue to grow in the U.S. in our current market, in our current organs, is huge. By the way, the clinical programs that we are about to start are exactly tackling the kind of heart. In the case of heart, this DBD section that we currently don't have an indication for.
That's going to be a huge lever to accelerate growth, as well as in the case, whoops, as in the case of lung. Next comes kidney. Kidney, according to OPTN data, in 2024, we have more than 20,000 transplants, and that represents approximately 60% organ utilization. A lot of organs, a lot of kidneys are being wasted. Based on our preclinical data, we are extremely excited with the outcomes that we are seeing. I believe that the model, the proposal, the proposition that we're going to have in the kidney model is going to be extremely compelling for many players in the field. That's a huge opportunity that is coming. We expect to start the trial late 2026 or early 2027.
We are transforming all that growth that is coming, but the best of that, as a CFO, is that we're actually able to convert all that growth into a P&L that increasingly gets stronger as we grow. As you could see in our last two quarters of results, our model, our operating model, has proven to scale efficiently while expanding our margins. That's something that is incredible for our business model. We can continue to expand margins as we bring growth to the business and generate significant cash flow. We are expecting that by 2028, we should be, once we get to the 10,000 transplants, we should be north of the $1 billion in revenue, and we should be at or approaching 30% of operating margin. That's our current view. TransMedics is really uniquely positioned to continue to drive sustainable, profitable growth.
I would like to call out just two elements. Sorry, four elements. The first one is our TransMedics Trident, which I already covered, our OCS, the National OCS Program, and our vertically integrated logistics. We have significant growth potential, not only on the organs that we currently participate, but also in U.S. kidney and international. The international market also represents a very important growth opportunity that we are really looking forward to unlocking in the short term. We have also expanding margins as we grow. This is that equation of growing and then expanding margins as you grow, which is a very powerful equation. We are confident that we can continue to do so, as we have proven already in results.
Last but not least, we have a wealth of knowledge, a group of leadership, in general, Team TransMedics that is committed to integrity, transparency, quality, and increase the number of transplants as well as the outcomes post-transplant. With that, I promised that I was going to finish soon. All right, you see?
We can drive 12 minutes left. Great. We'll move on to the fireside chat portion of that. You want me to take that? Thanks, Gerardo, and Dr. Zafar. I'll start out with, you know, we'll start out with numbers first. We've got a packed room here. You gave guidance to 35% of revenue at the midpoint. We got 650 bps of operating margin expansion. What are you assuming in terms of second-half growth, given that you expect seasonality in Q3? I think we just put out a note late last night about looking at the UNOS database and tail number, tracking number. It looks like, you know, we saw a modest high single-digit decline in July versus June. Just how should we think about that, and especially as it relates to kind of guidance and expectations?
Yeah, we feel very confident with our guidance. We know that Q3 has seasonality. By the way, looking into the last three years, from 2022, 2023, 2024, all of the years, you can actually see the decline in Q3. At the same time, you can see that Q2 is a strong quarter in all of those years. We have a strong quarter in Q2, followed by lighter quarters in Q3, and then a recovery in Q4. We are extremely confident with our guidance, Bill. We believe that we should at least do the same as we did in the first half. That's how we get to approximately $600 million. We know that there is plenty of opportunity to grow. That's why we decided to take a prudent approach in the guidance, however, leaving space for an upside.
As we think about the heart and lung trials that you're getting ready to kick off, you're working through the FDA with final IDE, because my understanding was conditional IDE. When do you expect enrollment? What type of contribution will that make? To set the level playing field here, just so people understand, in those trials, do you book revenue? What do you book? How does that all work?
Right. For 2025, we didn't assume any impact at all, any incremental impact from the trials. The numbers that we're going to deliver this year are excluding the trials. If we start booking incremental revenue, that's going to be upside. The way this is going to work is that the OCS part of both trials for heart and lung will be invoiced as usual. We'll have revenue from the technology, we'll have revenue from the service, and we'll have revenue from the logistics part. In the case of the control arm, we're going to have revenue for the logistics. We will waive the cost of our service, and we don't charge for the technology because it's not our technology.
We are very confident and expect to enroll first patient before the end of this year.
In both trials?
In both trials.
Great. I think one of the surprises, we look at the service margin. I get a lot of questions on that. Just how should we think about that? I think longer term, you said maybe 30%, but what are the puts and takes as you scale up that business?
Yeah, there are multiple puts and takes in service margin and in product margin, Bill. To simplify the view of our business, my guidance is to look at TransMedics as a 60% overall gross margin business. In some cases, we'll be ups or we'll be down, but the long term is around the 60%.
Okay. We'll look at Q2. Heart had a great Q2. It was a really nice step up. We saw that same kind of seasonality in the second quarter of 2024, and then we saw it kind of went up a lot, and then it came back down. Is there something different about the step up this year than last year or something going on in the marketplace? How should we think about, and I'm kind of getting at what's the sustainability? It's like you had a nice step up in market share in Q2. We saw it again last year, and then it came down. Anything going different this year versus last?
I think we're seeing a very similar profile to what we saw last year. Nothing really new. Our Trident, the TransMedics Trident, continues to drive OCS adoption. We're very pleased with those results. You see in Q1, Q2 seeing that increase in share. It's positive. We're really positive. Obviously, in Q2, you always have ISHLT. We announced more on the programs, and that generated some excitement. I'm sure some of that is generating energy around the heart side.
Okay. Moving on to market share. You have, I think, by our numbers, you're right around 35% in the liver in the second quarter, mid to high 20s, 26% in the heart, and about 4% in the lung. You talked about 10,000 organs, right? I think it was 2028. What's more important to getting there? Is it gaining market share? Is it growing the market? What's the biggest driver there?
Bill, internally, we are no longer focusing on 10,000. We're focusing on 10,000 and beyond. We believe that we can achieve 20,000- 30,000 transplants in the following, you know, by 2030. That's when we add kidney. Our view is it's already above and beyond the 10,000. To do that, we will need to do both. We need to gain share, but more importantly, as you saw, we need to have less organs wasted. Improve the organ utilization as well.
How important are the heart and lung trials to getting there? I think the way we think about it is, you know, liver's been fantastic, heart's been solid, obviously, lung small penetration, even though it was first product to market. As you think about it, I want to stick on the 10,000. I think we're more near-term focused. How important are heart and liver or heart and lung in getting to that 10,000?
Oh, absolutely key, because for heart, we are getting to a market segment that we don't have indication in currently. DBD hearts that are sub-4 hours or standard hearts, our program is designed to go beyond preservation to enhance function of the organ on OCS. That's where I think there's a lot of upside for us to gain that and have a similar impact as we have on the liver side. Definitely, that's going to be a very short-term impact we will see.
Has it been a label issue where liver is a DBD label, if I understand correctly, where heart's only extended DBD and DCD? Is that for the, how do you, for the physicians, you're right, liver is what, 70%-80% case stacking? How much is heart today and how do you get that perception to get the heart physicians to really adopt that?
I think that that's the point of our clinical program. What we have seen is that even for standard hearts, we have been encouraged by our clinical data that we're able to see improved function in hearts that are even standard hearts preserved for sub-4 hour. If we are able to demonstrate that in the clinical trial setting, we believe that would be a change in their practice, a fundamental change in their practice. Not only that, we're able to demonstrate preserving these hearts for up to 24 hours. Again, that has not been done before. That would allow what you're saying, that now they can have the flexibility to stack these cases and have the same level of experience or benefit that the liver community is facing today.
Is there something different about the heart surgeons versus the liver surgeons, or why the adoption has been what it has in each one of those markets?
Now, being a heart surgeon, I would definitely think there's a difference, but let's put that aside. I think fundamentals are the same. It's to have a better outcome from the graft, long-term survival, decreased morbidity. We believe, and we have demonstrated that in our use to date, we're continuing to improve that. I think that would spread across heart and lung as much as it has in liver.
Okay. To move on, just go back to logistics. I think one of the things you talked about on the earnings call was this jet maintenance, right? You've got this huge fleet of jets, and we looked at the utilization tail number data, which I know you're shifting a little more to ground. How do we think about that maintenance? You bought newer planes, so they are going to need maintenance and kind of in and out of service. How confident are you that you can predict what that schedule will look like and continue to support your operations?
Oh, we're extremely confident on that, Bill. Our logistics team is doing an amazing job of that. Like hard maintenance, the soft, heavy maintenance to the planes is, let me illustrate this differently. It's like a car. Every certain mile, you need to do some sort of maintenance. Jets are exactly the same, but in terms of miles, it's hours. As we fly more often, then the timing in which we need to run those heavy maintenance shifts changes. Last year, we had a lot of planes' maintenance falling in the second half, in Q3 particularly. Now that they're flying more, actually, that maintenance is starting to be spread a little bit more throughout the year. I believe that as of next year, the maintenance issue, the scheduled maintenance issue will be not an issue anymore.
We wouldn't be calling it like get ready because we're going to have heavier maintenance, not anymore. It'll be much more spread. We're using more of the jets, so the maintenance is happening whenever it needs to happen throughout the year.
Okay. In last time logistics, I think you're 78%, 79% penetrated today. I think in the past, you said 80%. Is there any reason it can't go above 80%? Is there some limitation?
We're aiming, our internal goal is to be somewhere between 80% and 85%. Can it go up? Yes, but there is always, maybe there is a flight that is too long that our planes can do. Those types of things that are above and beyond our control, we wouldn't be able to do so with our fleet. However, we believe that the 80%- 85% is an achievable range. Now, bear in mind that as we continue to grow, that 80 % to 85% is not the same, it's not a static number. It actually increases year- over- year as our transplant volume grows.
As we look at all your organs in transplant, what's the mix between aviation and ground?
We have approximately 30%- 40% of the total mix, it's ground. 30%- 40% ground, and the rest is aviation.
With the looking at the standard DBD organs, do you expect that the ground will go up if you're doing more short haul?
No, if anything, we see those organs on OCS surgeons making the decision to stay longer, have the organs longer so they can plan their ORs. We really feel that even the standard hearts would go on longer preservation. I don't anticipate that to change the ratio of ground versus aviation as much.
All right. I'm going to switch to the clinical trials. You know, we talked a little about the current label on heart and lung and that you're looking to expand those. You announced the ENHANCE for heart on August 4, the conditional approval, you asked de novo for the lung on the second call. When do you expect final, you know, you mentioned first enrollment, but what are you working through with the FDA to get the final sign-off to actually get the trials kicked off? Because once you do that, then it's contracting and kind of patient enrollment and what have you.
We have some questions on the animal studies we did. We're in active conversation with the FDA to resolve those. The conditional approval does not limit us to start the trial now. We're actually interacting with centers at the same time in parallel. We hope to resolve everything that the FDA has questions about within, I would say, six to eight weeks. We are in parallel continuing to interact with centers and get the IRB and contract process going as well.
Okay. Last question. We're out of time, but I'll ask one more because I have the podium. You talked about the kidney opportunity. What's that market like today competitively? My understanding, it's super competitive. It's a lower price. When you came into heart, lung, and liver, those were much different market dynamics. Why do you think you're pretty confident about making an impact in kidney? What are you going to do differently than everybody else?
Kidney is very connected to heart, so I'll take this one. What excites us the most is the biggest impact on outcomes. Today, as Gerardo showed, over 20,000 deceased donor organs are transplanted. Even in those 21,000 or above 20,000 kidney transplants, 30%- 35% of these transplant patients require dialysis post-transplant. That's a huge impact. That's one, number one analysis to improve outcome, preserve these kidneys better. Really, today, most of these kidneys, the majority of these kidneys are either ice or cold perfusion or a mix of those. We do see a potential impact that we, with our physiologically maintained kidney perfusion, can deliver to the community.
Great. Thank you for your time today.
Thank you, Bill.
Thanks.