Good morning, everyone. Suraj Kalia, Senior Medical Devices Analyst at Oppenheimer. I know a lot of you are very anxious for this fireside chat. We're pleased to have today CEO Waleed Hassanein and CFO Gerardo Hernandez-Omana from TransMedics with us this morning. Gentlemen, always a pleasure to discuss with you about the space. Thank you so much for taking the time this morning.
Thank you so much, Suraj, for the opportunity. We're excited to be here.
Waleed, let me start out first with a comment, and then we'll jump into questions. Despite the noise, I do want to congratulate you and the team. Been following you for what? 5, 6 years now, and you guys have delivered on what you all have set out originally, and you all have consistently hit your target. I do want to congratulate you guys on the impact you all have had on the organ transplantation space. Kudos to you guys. Waleed, let's start out with the topic du jour, right? One of the things that you had said on the Q4 call was TransMedics is exploring to become, you know, more of an integrated contributor to the national transplant ecosystem.
If you could dissect it a little bit more, there is a lot of chatter about CMS meetings. Any additional color that you can fill in the blanks for us?
Sure. Suraj, first of all, thank you for your kind comment. This is a reflection of a team effort by the TransMedics team. We are excited about where we are, but we think that these are just the early innings, and there's a lot more that's coming from TransMedics to help grow organ transplantation and tackle bigger and higher peaks in organ transplant. One of which is that topic that you are asking me about. We started as a medical device company. We did the largest number of trials and the largest size trials in the history of organ transplant. We got five FDA indications for three organ transplant market segments.
We came out from FDA approval process, and we decided that the device alone is not enough, and we need to reinvent ourselves. We built the first of its kind national organ procurement infrastructure and created the NOP. That really delivered significant success for organ transplantation patients in the U.S. as well as TransMedics. 18 months into it, we identified another opportunity to further expand our NOP reach into vertically integrating transplant logistics and creating the first 100% dedicated air and ground transplant logistics in the nation and frankly, around the world. That generated significant momentum for TransMedics and significant momentum for organ transplantation. Two years into it became very obvious to us that we need to invest even further and build a very sophisticated digital ecosystem.
We call it the NOP Connect and NOP Access, and that generated significant success and momentum. Now we're sitting here with the first and only fully operational national network for organ procurement that includes 50+ world-class transplant surgeons, 240+ clinical specialists, operating out of 18 hubs across the nation, surrounded with a very sophisticated digital ecosystem to manage organ transplantation for approximately nearly 30% of the nation's volume. All that gave us the confidence and the interest to do more. For us to do more, we have to be an integral part of the national federal transplant ecosystem as a member of OPTN.
That's what we are trying to pursue today to do more for organ transplant, generate more organ transplants to save more American lives and deliver it in the most cost-effective fashion, as we have proven throughout the NOP system over the last several years. That's really where it's coming from, Suraj. We are building off of the foundation that we built and the infrastructure that we built and the success that we built. We believe this is gonna be, if given the opportunity by the regulators, this could be a huge win-win-win-win to everybody involved. It's gonna be a win for the patients, win for transplantation, win for the U.S. transplant system, and win for other OPOs, and win for TransMedics.
We're very excited about this potential opportunity when we hope we're fortunate enough to be successful in this endeavor.
Waleed, if I could and feel free, I respect, you know, some of the confidentialities surrounding discussions, so I don't want to breach any of those. Logic tells you that such an endeavor as a CMO would not be part of TransMedics, right? It's probably gonna be set as a nonprofit arm's length entity. I presume that's potentially on the one of the paths that any additional color you could provide on how if the regulators give you all approval, the mechanics of something like this, or you would say for competitive reasons, or you don't want to get the spike the ball just yet, you don't want to go there.
Yeah, yeah. I'm not sure I follow, Suraj. What do you mean by CMO?
Like a contract organization, right? For organs. Would the nonprofit be set up?
Oh, you mean OPOs.
For OPOs.
OPOs. Yeah, yeah.
right?
Yeah.
Would it be set up as a nonprofit arm? Just any additional color.
Sure. I really cannot comment on that. These are very sensitive topics. It's in the hands of the regulators, but they're, you know. Becoming an OPO is just one mechanism of being a part of the OPTN system. There's other opportunities. I'll leave it at that, but it's really in the hands of the regulators, and we wanna work very closely with the regulators and make sure that we do the right thing. We'll have to wait and see.
Fair enough. I won't press you on that. Waleed, at the best you can guess today, whatever decision happens, would this be a 2026 event, or do you think it could be later in 2027, just given the idiosyncrasies of regulatory approvals and whatnot?
I think, again, it's up to the regulators, but the public statements made by CMS and HRSA that they indicated that they will be in a position to make decisions on this topic by end of 2026. For me, it's more of a 2027 event if TransMedics would even be in the mix here. It will be a 2027 event.
Fair enough. Okay. Let's switch gears. Waleed, one of the things, again, from the Q4 call that generated a lot of questions from clients was about the competitive dynamics for the control arm of Part B in ENHANCE. You know, how should we think about from that time to now what has happened? You know, how are you navigating any additional color you all can present us?
Sure. Suraj, that competitive dynamic that I referred to in the last earnings call, we actually are very excited about that, because it sent to me personally a clear signal that competition is shaking in their boots to compare their results to TransMedics or to OCS. For me, we are just focusing on doing the highest level evidence, collecting the highest level clinical evidence that is much needed in the field. That competitor does not have a single prospective randomized clinical trial. All their data is retrospective. The community are criticizing them for being cherry-picked. The control arm was handpicked by whoever was analyzing at the time using data from the COVID era.
It's really noisy at best. When they created this tempest in a teacup for us, again, that's a question that should be for them. TransMedics will never shy away from competing fairly. TransMedics will never shy away from building level one evidence. That's our calling card. That's our game plan from day one, and we are going to take full control of our study, including a control arm that is FDA, is gonna be FDA under FDA oversight and will generate the level one evidence that we're hoping to deliver from this trial. We hope the results will speak for themselves and validate our excitement about the value of OCS and standard criteria DBD hearts for transplantation.
Waleed, one of the questions that came up through many clients post Q4 was: How can the competitors throw a wrench? How can they slow down the process? You know, part of my explanation, and I won't go into that, is just in terms of the software and, you know, the IRBs, what they sign up for. Maybe in your own words, you could articulate if somebody could slow things down, how they would, and what are the mechanisms to counter that, intrinsic or extrinsic mechanisms.
Sure. I'll tell you what actually happened, rather than me kinda philosophizing about what the mechanisms. They basically raised serious concern for their technology to be compared to OCS. They shared that with the centers, and they created, again, a tempest and around it unnecessarily. Not too dissimilar from the behavior of other companies when Abiomed was being compared to the intra-aortic balloon pump, and the intra-aortic balloon pump manufacturer at the time raised the same issue. The difference is, you know, the decision lies within the transplant center. The decision lies with the transplant surgeon. We did not wanna put them in an awkward place.
Obviously, we respect our relationship with them, and we said, "Listen, if this is gonna create a friction between the center and that competitor, we don't want to put ourselves or that transplant program in these tough situations." We had a creative way of solving the problem and generating the evidence that we need to generate, and that's what we're pursuing. That's how it really simply happened. There's nothing more complicated than this.
Are there any spillover effects for Part A?
Not that we are aware of. Part A is on track. Again, you know, I would say, you know, the spillover is just this cloud over ENHANCE. In our solution to this that we're gonna announce and discuss at the ISHLT, we are going to rev up the protocol and potentially, you know, clear up this confusion altogether once and for all, not just for Part B, but for Part A as well.
Got it. Waleed-
Suraj, you, we have to wait till the ISHLT because I wanna make sure that I'm not sharing anything while we're.
Yeah
In active dialogue with FDA. Please, I have to respect that.
Fair enough. Please forgive me if my questions seem to
No, no. That's perfect.
De Novo , Waleed, any latest and greatest on De Novo and, you know, with kickoff, and how should we think about the lung trials from your past commentary on the phone?
Yeah. Well, thank you for asking, Suraj. De Novo falls in the same category as Part B of ENHANCE because guess what? That competitor also sells a Styrofoam box for lungs. We are gonna take control of that as well. So far, the De Novo hasn't. They are still in the IRB processes because remember, De Novo was approved earlier in sort of the late January timeframe. We are expecting the same dynamic. We are talking to FDA about both trials, not just ENHANCE.
Got it. Waleed, a couple of questions that come up more recently with clients, including this morning, we're in Europe. You know, there is this particular consideration of geopolitics, right? You have been very clear about Europe, you know, remapping what has been done in the U.S. in Europe, given the opportunity there.
Mm-hmm.
Understand that loud and clear. For Europe, is the geopolitics part of the equation? For U.S., obviously, there is this oil and, you know, fuel prices and whatnot. How do you see the stress levels in these two buckets? Are you all reconsidering, given geopolitics, your Europe expansion plans? If you could kindly comment also on domestically, what's going on with fuel and if we should. You know, what's the stress point there?
Sure. I think in Europe, we were born in Europe, so we don't see the geopolitical dynamic really playing a big role. We are investing in Europe. We have European entities. Again, we at least based where I sit, I'm not feeling that geopolitical dynamic playing an active role. Again, we are investing heavily in our European initiative, and the community and the government see that. For example, I am heading to Italy in April to stand next to the Minister of Economy and Finance and Minister of Health and Governor of Lombardia, the President of Lombardia, to announce the OCS budget approval to cover OCS cases across Italy. We are investing in building a European dedicated air and ground transportation network.
We're partnering with European entities on our relationship with Mercedes-Benz. For me, we've always acted as an international company. We've always acted, you know, respecting the local laws and the local culture. That's been our DNA because we were born in Europe, if you remember, Suraj. That's number one. Number two, you know, we're not stopping in Europe. We have initiatives across the GCC region. That's impacted by what's going on geopolitically for sure. It was never a near-term event like the European initiative we're actively engaged with. Now to answer the second part of your question about the fuel in transplantation. We have always dealt with the fuel issue. It's a transparent issue.
It's something that the system and everybody that operates in organ transplantation is very familiar with. It's called a fuel surcharge. The difference is TransMedics is gonna be very careful in how to manage that because we want to always deliver be a partner to the transplant program, do not gouge the system based on fuel prices, and we will always be delivering a cost-effective mechanism to this. Fuel prices going up and down, it's something that transplantation have dealt with for decades. This is not any different.
There are no quote-unquote mechanisms or buffers inbuilt.
There is.
Okay.
Yeah, there is. Again, I don't wanna talk about it.
Okay.
Payers know it.
Fair enough.
Centers know it, because again, we are gonna do it differently than the transportation and logistics contractors. We're gonna be more cost-efficient in our approach than anybody else because we own the fleet, and we operate the fleet, and we are a transplant entity. We're not a logistics entity. We wanna be always reminding the community that that's who we are, that's our DNA. We are gonna do everything in our power to recoup some of that any changes in fuel prices, but in a more respectful and cost-efficient way on the transplant program.
Fair enough. Waleed, going back to the clinical trials, you know, obviously kidney is one that you've been very excited in recent presentations, you know, in terms of urine production and, you know, obviously the volume for kidney transplants is huge. Eclipses what we have at heart, lung, and liver. Maybe, how should we think about the kidney trial? Is it early 2027 start? When could we get our arms around trial design, how y'all are thinking about next steps more concretely?
I think I repeat what I said before, Suraj. We're not just excited about the kidney program. We think the kidney program is going to be the largest program that TransMedics have sponsored to date. Given the significant demand and interest in our kidney device, we're actually actively investigating the potential of releasing the product, the kidney product both in the U.S. and Europe for clinical trials at the same time, rather than prioritizing the U.S., just because the demand and the excitement. As far as the detailed clinical protocol, again, this is gonna be a very complex trial because kidney transplantation in the U.S. is an OPO kinda controlled therapy.
We need to work with the OPOs pretty closely. In Europe, it might be different. Stay tuned. We think we are gonna be in a position to talk about the clinical protocol in more fulsome way by the Q3 call or later in the year before the holidays for sure.
Yeah. Got it. Fair enough. Gerardo, if I could pose you a question. You know, where are we on the double shifting? Anything you can tell us, you know, about that expansion of this program and you know, what are the next milestones or key points we should look at moving forward?
Yes, that's a great question, Suraj. You know, as we shared before, we'll have better view on the outcome of the program by the end of Q2, early Q3. However, we currently have around 20%-30% of our fleet. It's like four to six planes, depending on the time, that are already double shifting. I've seen already initial numbers that actually suggest increasing productivity, which is exactly what we want to achieve, but it's just early stage. We really need to wait and see a little bit more flights, really, more flights to understand what's the real impact before we can act upon that information.
Fair enough. The Somerville facility, Gerardo, where are we on that? Are you all still gonna be using Andover? How should we think about as you'll enter 2027? Is it basically just gonna be Somerville, is it, Andover is in the past? Also the implications for, you know, any financial implications thereof.
Yes. That's a great question. I think the next couple of years will be transition years, Suraj, because we're building, right? The building is really on core and shell. So we need to build. We need to prepare everything so that we can move in. Realistically speaking, we probably will be moving part of the organization at the end of this year, and then through 2027, maybe early 2028, the rest of the organization. That's the way we're seeing it. Because of the lease accounting and how that works, we will likely have already some impact on the P&L or charges in the Q1 P&L because of that. So that's something that will come, and I'll explain that as we go in Q1 earnings call.
Fair enough. Gentlemen, one last question, and maybe, Waleed, I'll come back to you. I know this might be a little way, but I'll still ask.
Mm-hmm.
Waleed, all the noise set aside, what is the key thing you think the street is still missing about TransMedics? Your outcomes we know. You guys have done what you all set out to do. There is noise, I get it. From a story perspective, what is the thing that you are at liberty to highlight that we are potentially missing in the big picture?
Where should I start, Suraj? The list is too long.
The one that is most important, let's just-
No, I think seriously speaking now, I'm not sure if the street is missing it as much as the street loves the noise and loves to kinda latch into anything that moves. Listen, TransMedics have been printing quarter-over-quarter for the last, I mean, I stopped counting, you know, great results. People think we're peaked. We are still in early to mid-innings. We still have room to grow. ENHANCE and De Novo are critical for us. Liver will continue to grow. We haven't even scratched the surface on kidney. Kidney is gonna be a game changer for TransMedics. Yeah, Europe and international is gonna be a game changer for TransMedics.
I wouldn't have allowed Tamer to leave his seat and focus on Europe if I don't believe that. You know, there's a lot in front of us. The initiative about being more integrated into the OPTN in the U.S. will be a huge game changer for, not just for TransMedics, it's gonna be a game changer if the regulators allow us to partner. This will be a game changer for patients, for the U.S. transplant system, and for organ donation in general. You know, we're very excited about where we are. We're very bullish about the future of TransMedics. The noise, there will always be noise. We can't be distracted by the noise. We're laser-focused on execution. You know, we know how to execute.
We have a lot of irons in the fire, and we have a very strong pipeline. We haven't even talked about Gen III technology yet. It's very exciting where we are. You know, we're looking forward to continue to deliver. Hopefully with execution, the noise will quiet down.
Gentlemen, once again, thank you so much for taking the time. Always a pleasure and, you know, congrats on all the progress. Look forward on the Q1 call. Thank you so much.
Thank you. Thank you so much, Suraj, for the opportunity.
Take care.