All right. Afternoon, everybody. Thanks so much for joining us. My name is Matt O'Brien. I cover medical technology here at Piper Sandler, and hopefully I don't fall off the stage here. Really excited to have the TransMedics team here with us. From the company, we have Waleed, who's the CEO. Gerardo, who is the incoming CFO. And then Stephen, who's the outgoing CFO. Gents, thanks so much for coming down. Appreciate it.
Thank you, both. Thanks.
So, lots of information yesterday to process. Let's just go ahead and start there. On the CFO transition, it was, you know, a little surprising. So just maybe talk about the timing of the CFO transition and, you know, why now and what's kinda next for that role.
Sure. Matt, thank you for the invitation. There's never a good timing for these types of transitions. Why now? We found ourselves in a situation where we have sort of finished the first wave of growth for TransMedics, and we're preparing for the next wave of growth, which I personally believe could be potentially bigger than the first wave. And we wanted to take this opportunity to bring in a fresh set of eyes to build on what Stephen has developed and prepare TransMedics for the next wave of growth, focusing on not just growing the top line but also maximizing efficiency and profitability of the business and putting the infrastructure to help us manage that next wave of growth, even in a more efficient way, going forward. That's where Gerardo is gonna be tasked to do.
Also, our business today is significantly more complex than where we started this. Gerardo brings in expertise and financial leadership experience from very complex businesses that we're growing rapidly and fast. So, we're looking forward to his contribution. Stephen, his depth of knowledge of TransMedics business and his ability to articulate the value of TransMedics and NOP and the OCS is critical. We are going to work together on our strategic initiatives of educating the national stakeholders in organ transplant in Washington, DC, and we need that. I need that bandwidth, and there's only three members of our team that could do that. It's myself, Stephen, and Tamer. So we want Tamer to focus on the growth, and Stephen and I will focus on national stakeholder outreach for 2025 and beyond. Long transition period.
You know, I'm fortunate to have two consummate professionals. Stephen will be with the company till the end of March to make sure the Q4 filed, the year-end close, is done. After that, he's gonna transition into strategic consultant, working with me on national initiatives, and Gerardo will be leading the finance organization going forward. So that's really the plan as we outlined it yesterday.
Got it. The national initiative, what, what exactly is that? What kinda focus areas? 'Cause I know a lot of the regulatory bodies want to see more and more transplantation. Is that the real focus there is to, to really drive through on the, the regulatory side?
Yes, absolutely. It's educating CMS, HRSA, the bipartisan congressional leadership focusing on increasing utilization of transplants in the United States on all the great work that TransMedics has been doing, the NOP, the impact on double-digit growth for heart and liver last year. They've been at this for four years trying to make an impact. We've been a year and a half, we're able to grow heart and liver transplant double-digit numbers. They need to be educated about this. We need to make sure TransMedics now that we build the network, that we started to experience the full leverage of the network, that we are educating the national stakeholders in organ transplant in the U.S. about what TransMedics is capable of doing and potentially capitalize on opportunities that may exist in the new structure of running organ transplant on a national basis.
You know, we've demonstrated it based on results. We have the infrastructure now on a national basis that nobody else has. We have demonstrated the ability of OCS and NOP to grow overall national volume double digits. Yes, we hit an air pocket in Q3. That is not gonna stop us. We are gonna talk a lot about major growth initiatives coming up second half of 2025, next week.
Got it. Okay. I mean, to that point, the Q4 guide down, you know, it's only about $5 million. You know, stock reacted pretty negatively today, but if you the guide down actually implies a slight deceleration in terms of revenue in Q4 versus Q3 at the midpoint. I think I don't remember. My model's wrong.
Yeah. It's not deceleration. It's more like.
It's more flat, right?
Flat. Yeah.
You know, and typically.
Flat or slight increase.
Right. So the thing I can't figure out, and I know you guys get mad at me for doing this, but I'm gonna keep doing it. The flight data is so good in October and November that I was thinking, okay, things are really trending well there. The organ volume numbers are pretty good so far in Q4. What am I missing to where things would be more flat versus up nicely in Q4?
Listen, flight information could tell you so much. I mean, we did cases in Q3, not on our plane, and you know.
Yeah.
It really. We wanted to. There's only four weeks left in the quarter. We wanted to make sure we don't leave $20 million swing out there. We should have dealt with this with this guidance back in Q3. So we just to clean it up before this event and next week's event. We didn't wanna be talking about Q4. We let the Q4 results speak for themselves.
Got it. So you're just being more conservative than anything else.
That's correct.
Okay. That's good to hear. To that point, you know, being what we see here in Q3, Q4 roughly, and then, you know, second half, I think you're saying is the bigger bump in growth next year. How do we think about the growth trajectory of the business? I know you've talked about getting to these 10,000 organs. That's almost 30%. That's 30%+ growth. You know, it's not gonna be linear. How do we think about just kinda the growth trajectory of the business, over the next couple of years? I mean, is it gonna be more fits and starts as you unlock things clinically? How do we think about it?
Yep. I think, Matt, that's an excellent question. Early on, it's gonna be these step-up function as we unlock things clinically, but then our stated public goal of reaching 10,000 transplants in 2028, that's not changing, but that's not where we're stopping. Next week, we're gonna talk about how we're gonna take 10,000 and make it 20,000, so we are expecting long path of growth. The near term is, yeah, as we stated, the first half of next year. We're gonna see the major step-up in growth mainly the second half of next year, and then that will take us sort of the accelerated way back again, accelerated growth for a period of time. T hen we unlock the third wave of growth, which is, you know, going beyond 10,000 transplants, adding kidney and talking about international markets and even taking more care on the DBD front.
Got it.
All that will be discussed at our investor analyst day next week.
Got it. So these are really unlocks. So, so the clinical studies are gonna unlock DBD liver, things on the heart side, things on the lung side.
The clinical programs next year are mainly focused on heart and lung. It's to unlock lung transplants, which have been really dormant for us for the last few years, and really eliminate this distinction between four-hour heart, more than four hours, less than four hours, DBD, DCD. We are shifting the entire lexicon in heart and lung transplant to, do you wanna do morning heart and lung transplant, you need to use OCS. Do you wanna improve the cardiac function, outside of the body, not preserve it, you need to use OCS. That's the kind of impact of these clinical programs. Again, next week, we'll be sharing some of the pre-clinical data that gives us the confidence and excitement about what these clinical programs will unlock for us from a growth perspective.
Got it. What should we expect on the liver side? Because you're pretty penetrated on the DCD side of liver.
No, we're only penetrated around 55%. So we still have, you know, a good portion of the market, but we're not stopping there. Meaning, we're penetrated 55% of the existing DCD pool, but we're seeing significant uptake of DCD liver transplant, this year over last year. So we expect that to continue. There's a significant dataset that is in publication review as we speak that will even catalyze the liver even further. The other is catalyzing DBD liver transplant. We have not really flexed that yet. That's coming.
How do you do that on the DBD side in the liver?
It's showing outcomes, showing the impacts on outcomes, showing the impact on short and long-term outcomes, and all that is coming in the form of publications that will be hopefully in the public domain in the first half of next year.
Got it. Where do you think that, that penetration rate on the DBD? I know it's pretty lightly penetrating.
It's in the, you know, 20%-30%, or 20%, low 20% range. We expect to penetrate DBD in all organs, not just liver, you know, high 60s%, low 70s%, or even higher. I mean, as we sit here, we're seeing the top utilizers in liver fully penetrated at 85%-95%, and their volume is growing. So we expect to reach somewhere in the 70s% across all organs, across all types of donors.
Got it. Okay. What about on the heart side? I could not figure out the heart market in Q3. What was I missing there? 'Cause I know you're, you know, pretty big market share there. Wh-what am I missing as far as the growth rate on the heart side?
Nothing. We, the Q3 in general, not just for heart but for all organs, but maybe heart was disproportionately impacted. Just we got impacted with the seasonality of summer vacations and, you know, we did not see any other dynamic that could have resulted into this picture. There's no competitive, you know, development or market share loss for another technology. It's just ebbs and flows of organ transplant.
Okay.
And we're just becoming a critical mass in the U.S. and, you know, that we expect this to be a blip going forward. And again, once we get these clinical programs launched, we are going to take the heart and lung market by storm. I really stand by that commitment.
Okay. And I know it's a near-term thing and probably not that big a deal. It was nothing with the ex vivo study finishing up. I don't know if they were really trying to finish the study in Q3, and that's.
I don't believe so. The ex vivo study has been out there since last fall, you know. It's 140 patients, you know. I don't believe it's had an impact, to be honest with you.
Got it. Okay.
I really don't.
All right. Got it. So let's maybe talk a little bit about what we should expect next week. It's really gonna be on the clinical side, really focused on the clinical programs for next year. How impactful can some of those clinical programs be in just the second half of next year?
I think they could be pretty impactful. Next week is gonna be not just about clinical programs. Clinical programs is just one piece of the growth catalyst that we're planning to map out in detail to the investment community. We are going to share our vision and our plans to go from where we are today to 10,000 transplants in the U.S. to beyond 10,000 transplants in the U.S.. What is the international market growth opportunities? Where do we expect to be when we are at 10,000+ in the U.S.? Where's the international growth expectation should be? How are we gonna get there and then end with detailing the near-term growth catalyst next year, and you know, we'll share some of the pre-clinical data that gives us the confidence with the community.
Also, we're gonna. Tamer is gonna talk about how we're gonna translate those all these clinical programs to adoption and how are they gonna drive adoption on DBD, on DCD, heart, lung, liver. Just to give you, to answer the second part of the question, historically, for the last two years, we've never done more than 100-120 lung transplants in NOP in the U.S.. Our lung program alone is 450 lung transplants. If we are unlucky and we only did 50% of that, that's double the lung volume that we've been doing so far. So it could have a meaningful impact. Certainly, we're very excited to get started. If we can do it sooner, we'll do it sooner, but we really need to be patient. There's a lot going on and, you know, some internal, some with FDA. We're very, very excited about what 25, 2025 will bring for TransMedics and beyond.
Got it. Okay. In those clinical studies historically, I think pricing has been a little bit of a discount versus the traditional OCS. Is that right? Is that what we should expect again?
No, first of all, all of our clinical programs would be run through NOP. So we expect pricing to be the same. We expect transportation or logistics to be covered. You know, the things that we might play with is the service fee, especially if we're doing a competitor arm, cold or something, that we will waive to encourage transplant programs to be a part of these clinical programs.
Okay. Got it. I just wanna make sure we cover this, at some point, but the congressional letter that came out that you guys received, have you guys done anything internally in response to that letter, or is it still just your compliance programs are what they are? There's been no real change?
There has been, our compliance program is very high. We responded to that letter, as you know, Matt, publicly. And, you know, it's just the price of success. And, you know, we've been growing market share since that letter, in the aviation business.
The pushback, Waleed, I always get is that at some point, you know, the people are gonna look and say, "Why are you spending so much on these organ transplants?" How do you respond to that kind of concern that's out there among? How, yeah. I mean, somebody will be like, "Oh, why is it $100,000 for this liver all-in cost?"
Because you're saving the insurance company $300,000 worth of biliary complication and $1 million of retransplant liver that occurs at 35% before OCS, and with OCS, it's less than 2%.
Yeah.
Simple as that. That's why Optum Health is covering OCS for all their programs that demand it because Optum Health was exposed to 30%-35% liver retransplantation within the first year, costing them $1 million extra on top of the $1 million that they spend on the initial transplant. That's why you need to use the OCS.
Got it. And the other thing that always comes up is competition. You know, there's only one company that's out there that has warm perfusion. Do you see the cold perfusion companies out there? And then, you know, do you run into the new warm perfusion provider, that might?
No. No.
Okay.
You know, the warm perfusion company has an interesting approach, working directly with OPOs. We respect that, but we don't see that as major impact on our business. We don't see cold perfusion really having any impact. Our goal is to make the cold perfusion results obsolete before they even get published. So that's with our clinical programs for next year.
Got it. Okay. What about the partnership that Warm Perfusion competitor just announced on the medical flight side of things? I mean, is that, can that be?
I highly encourage the community to read the FDA approval letter for that warm perfusion technology. They are not approved for transportation. They don't have battery power that could make it transportable. They do not fit in light-wind light, light jets. The size and weight of that technology cannot be put in an airplane. That's why they did not do well in the U.S.. Many of the institutions that worked with them had to buy a special van to transport these organs. So I, I have no idea why is that partnership even of significance other than the, you know, TransMedics success is creating a lot of this dynamic of people wanna say, "I have a relationship with a-an airplane." That technology is not portable. At the heart of it, it's not portable. That's why they developed a limitation called back to base, where they have to bring the liver on ice through the transplant program because that device is not portable, or it doesn't have the capabilities that the OCS has. So, we don't see that as a major hurdle for us.
Okay. So speaking of aviation, you know, you're now about 61% of your planes are being serviced on the NOP or being used for the NOP. Do you have capacity to go to 100% with those 18 planes now?
No. We have capacity to do minimum of around 80%.
Okay.
We don't wanna do 100% yet. We'll get there, over time. Our focus right now is to do minimum of 80% of our NOP volume that requires air charter to be done on our own jet.
Got it.
That's the goal.
Is there a gating factor to get you to that 80%? I don't know if it's pilots or something else like that.
Not at the current levels. Obviously, as the volume grow, we need to expand our investment. But right now, our goal is to stop at acquiring 22 jets, which gives us 22 jets- 23 jets gives us 20 operational at all times, assuming two to three are always in maintenance. And we're staffing for that. And then we'll sweat these assets until there's enough demand that justifies additional plane purchases. You know, we'll have to wait to see that demand materializing before we make that investment.
Got it. Okay. And of all the NOP cases that you do, what % are on planes or any plane versus just ground transportation?
I would say right now, it's 70/30, 70% plane, 30% ground.
Got it. Okay. Another thing that comes up a lot is pricing.
Mm-hmm.
Price discipline, price discipline. Can you guys maintain this level of pricing, and why is that?
We are maintaining it because for many reasons. One, we are delivering significant value compared to anybody in the industry. We think our price actually is fairly priced. We're not gouging the market in any way. We actually think we're leaving some value on the table, but that's fine. We are long-term focused. Number three, we are sharing significant cost savings with the transplant programs, especially with the network effect that we created around NOP and aviation that nobody else in the industry can match. One example, for DCD donors today, any hospital that does not use TransMedics logistics are liable for the entire round-trip cost of a private jet charter flight from their location to the donor and with a 50% risk to come back empty-handed, which the 50% chance that the DCD doesn't progress.
If they use TransMedics Aviation, we protect them 50%, meaning they have a 50% discount if that donor doesn't progress. Nobody in the industry can give that cost savings to the transplant program. That's why we're maintaining our price, and that's why we think that we're providing significant value and sharing cost savings and the value of the network effect that we created in NOP with our transplant program.
Yeah. I've never understood it 'cause LVADs cost $400,000 all in. People live for a year on those. So, you know, with these.
With multiple infections and strokes and hemorrhages and the like.
Got it. Okay. All right. Couple minutes left here. Maybe Stephen, just on the margin side of things, from transient headwinds in Q3, how do you think the service margins are gonna change over the next couple of years as the plane efficiency improves?
Yeah. They're definitely gonna improve, right? So clear, you know, there were things that happened in Q3 that are not gonna repeat. And just by, by definition, you know, the efficiency of the planes and using more of our own planes and less of third-party planes is gonna improve the margin. I'll let, you know, Gerardo get his arms around it and think about the long-term, you know, guidance or, or numbers, what that's gonna be, but it's, it's gonna definitely improve.
Okay. And Gerardo, how do you think about just guiding going forward? I know the streets, I think they're at 27%-28% for next year. I mean, how do you guys think about that figure, margin expansion, and then just general messaging in terms of cadence throughout the course of the year?
It's my second day in the company.
Yeah.
So, what we're gonna be doing in the next week is really get together as a leadership team, see where we are, review our projections, then some guidance that makes sense where we feel comfortable with.
Okay. Okay.
Mm-hmm. Maybe on the 25, maybe on the 20, we don't know yet.
Yeah.
We need to do the math.
I think the philosophy and guidance is not gonna change in TransMedics. We are conservative by nature, you know, and we like to let our results speak for themselves, and performance dictates where we go, so I suspect that will continue, but Gerardo needs to get his arms around the model and.
Okay. Understood. So what about on the margin side of things, especially with all these clinical programs kicking in next year? I mean, should we expect more of a kind of flatlining, pun intended at all, with the EBIT margins of the company for the next, I don't know, year and a half or so?
I don't know. I don't know. Because I think if we are right on our and the momentum and the uptake that these programs will generate, that might take care of it. So but, let us do some more work on that.
Okay. And I don't wanna take away too much of your thunder for next week, but what, you know, how when you guys start coming out with new technologies, it's pretty exciting. So what can you share just even just, anything at all? I don't know what the right word is, but just on the heart programs, the two heart programs, and the lung program. I mean, what is gonna be really compelling about those programs? 'Cause it's not something you guys generally, you know, your clinical programs are pretty rigorous.
We are going to take the heart and lung market by a storm. Anybody who thinks that we are gonna be satisfied leaving the bulk of heart transplant being done in cold is thoroughly mistaken. We are going to change the lexicon in heart and lung transplant next year. That's it. I'm gonna leave it at that.
All right.
We're gonna share the detail next week.
Sounds good. We're excited. All right. We're all out of time, so we'll have to cap it off there. Thanks so much for all the feedback. Appreciate it.
Thanks.
Thank you.