Morning, everyone. Suraj Kalia, Senior Medical Device Analyst at Oppenheimer. Really pleased to have Waleed Hassanein and Gerardo Hernandez from TransMedics. Gentlemen, I know the schedule is packed, and I know a lot of people on the call today want to ask a lot of questions. Folks, for those of you on the call, let me just set the stage. You guys know the drill. Either put it in the chat box, or you can email me, or any of my juniors will be more than happy to ask any questions, as long as it's not related to the quarter. I really do not want to go there. Okay. Waleed, good morning. Thank you for taking the time. Let me start out. Give us a high-level snapshot, Waleed, over the last three to four years, right? The overall transplant market, there is so much chatter. Companies are getting acquired, you know, overall transplant volumes, and it's pretty much coincided with you guys' entry, you know, into the market. I'd love for you to set the stage for the audience in terms of, as you look back, what are the lessons learned, right? What were the issues? How are you all adapting as you all move along? Good morning, Suraj. Thank you for the opportunity to be with you here today. You're absolutely right, Suraj. Since TransMedics was approved in late 2021, the transplant market in the U.S. has been living a period we call internally a period of renaissance. The main driver of that renaissance, we're seeing national organ transplant volume grow double digits year over year. We're seeing a significant uplift of DCD utilization across heart and liver. We're seeing significant growth in DCD donors. In our humble view, all this renaissance is driven by one and one reason only: that the OCS has been approved for broader utilization in the United States. Because without the OCS, DCD was never a clinical reality in the United States, specifically for heart and for liver, and for the same extent for lungs. After that, the introduction of the NOP that we pioneered in early 2022. NOP is a very, very important factor driving the catalyst, especially towards growing the national transplant volumes. Because if we had relied on the hospital infrastructure to be able to accommodate that growth in transplant procedure and manage the organs on OCS, I don't think we would have achieved the same results. Yes, we are extremely, extremely proud and humbled by these dynamics that TransMedics and the OCS and NOP played a key role to actually achieve. However, we believe that we're still in the early innings. We believe there's more catalyst in front of us. There's more growth in front of us. We believe, as I stated in December at our Investor and Analyst Day, that we have a huge greenfield opportunity in front of us. I really cannot comment on what other dynamics and acquisitions and the like, you know, that is happening because it's not up, you know, it's not our business. Frankly, we're laser-focused on our business. We know who's driving that growth and who's driving that success. We know who has been growing double and triple digits over the last three years. That's really our top priority at the moment. We are extremely bullish about the future of organ transplant as long as we are continuing to do our job and focus on what's the most important, which is patient outcome: growing transplant volume and improving patient outcomes. That's what's going to carry organ transplantation into the future. Waleed, you mentioned you're laser-focused. You know, obviously, Q3 was a surprise to everyone. And given your track record over three years, and then Q4, you guys bounced right back, right? And our monthly tracker, and I'm not asking you to comment on our monthly tracker so far as indicating, you know, trending towards a healthy Q1. But set the stage, you know, in terms of what was the key course correction that you all decided on after Q3? Suraj, that's an excellent question. As I stated on the Q3 call, we highlighted, first of all, in the Q2 call, we said the second half of the year is going to be choppy. We attributed that to two things. One, we knew that we have a higher rate of scheduled maintenance for our aircraft in the second half of 2024. Plus, we said there could be some impact of seasonality of summer vacations and Christmas holidays. That's exactly what happened to us in Q3. Unfortunately, we got hit by a double whammy. Not only was our plane downtime at an all-time high because not only did we have scheduled maintenance, but also we had a significant number of unscheduled maintenance needs related to weather patterns and the like, and some unanticipated airplane-on-ground incidences. Also, the seasonality of the summer vacation impacted the overall national transplant volume; it was down, you know, 4% or 5%. We were down 4% or 5%. For me, and on the Q3 call, we said, "This is a bump in the road. This should not cause any panic." People did not listen. Unfortunately, or fortunately, our view is the same. It was a bump in the road, and we were able to overcome it in Q4. You know, we are looking forward to a great year ahead of us. That is really it. I would not call there was a course correction because course correction means that we were doing something wrong, and we corrected it. That had nothing to do with us other than the plane. The plane, we were the ones getting the plane down. It was an unlucky situation coupled by the seasonality of the summer vacations. We bounced right back. Again, I'm looking forward to Q1 results and into this year. Waleed, plane maintenance, right? Your comments are well taken, especially given what you had said on the Q2 call. One of the questions that keeps coming up, Waleed, in client conversations is like, "Hey, I get it. Planes, you know, there might be some downtime and all that, right? But TransMedics has X planes. And if Y goes down for maintenance, X minus Y should be able—there should be redundancy in the system. What gives?" Help us understand that. Yeah, yeah. That's an excellent question, Suraj. That is absolutely true. That is true when you have a fully operating fleet. We were building the fleet in Q2 and Q3 and into Q4. We just reached 21 planes in Q1 of this year. We still have one more to go. Yes, this is one of the reasons why we want to stop at 22 is to give us a critical mass, and then we can leverage the rest of the year using those 22 planes and see how much efficiency we can derive from those 22 planes that would guide our decision about how many aircraft do we acquire going forward. Also, remember, in Q2 was the first time we have experience building our own service infrastructure, aircraft service infrastructure. That's something that we're committed to going forward, and we're going to expand that to minimize the impact of planes going down. I want to caution the listeners that there's two types of plane maintenance. There's scheduled maintenance, and that is the one that we're in full control over. Our team is a world-class team that can handle that as good as the best out there. The ones that we all are worried about are unplanned maintenance. A tornado hits Cleveland Airport with two airplanes waiting for active missions get hit with a tornado that knocked down the windshield of both aircraft, you know, a blown-up tire on the runway. These are the things that you never anticipate. We learned from—we've learned from these events in Q3, and that's now we're watching and we're growing. We moved fast to bring in more aircraft to make sure that we have this critical mass of planes to help us kind of smoothen these unanticipated circumstances. Moving forward, Waleed, is it fair to say that the pie chart should be more scheduled maintenance, or you would say it's? I think there will be always some unscheduled maintenance, but we hope that that will be more controlled, and the impact will not be as big as what we've experienced in Q3. We have upgraded some of our airplane operations to ensure that while we're waiting, we shouldn't wait on tarmac. For example, if we can get a hangar space, that's where we put our plane to protect our plane from any weather, inclement weather. We have now a much more active weather tracking system that we can bypass the planes around any active weather patterns in the United States. That will continue to improve. You're right. The scheduled maintenance, we can control a lot more than unscheduled maintenance. Waleed, a question came in, and it was similar to a question that I had on the docket. It was for NRP. It's been the talk, you know, for all of last year, as you well know. Waleed, today, as we stand—actually, let me take a step back. Please correct me. One of the things that we have picked up in the field is more and more NRP organs are being transported by OCS. Correct me if our field checks are wrong. If I could push you on that, let's say early 2024, 5% of organs were being transported after NRP were being transported on OCS, right? DCD. Exiting 2024, is it 5% plus delta X? How should we think about—just qualify and quantify where NRP and OCS stack up? Sure. I know this is an important topic, and especially you, Suraj, have taken a lot of effort to get to the bottom of this. From our perspective, you know, as I've stated previously, NRP is not a preservation technology. NRP is nothing but a surgical procedure that has significant limitations, and it's been implemented by the Organ Procurement Organization. Transplant programs, they never asked for NRP. It was a tool that OPOs started using in late 2023, early 2024, to try to maximize, in their view, to maximize organ utilization from DCDs. I think the numbers speak for themselves. The results speak for themselves. We don't believe that that resulted in that significant number of increased utilization of DCDs. That's number one. Number two, even when the NRP is successful, you need to preserve that liver, especially if it's transported across country. You're doing an NRP case that is very, very complicated. The utilization rate of that complicated case is much lower than the OCS. If you take a liver directly from a DCD donor and put it in OCS, we have a utilization rate of nearly 98%. With the NRP, it's much lower. It's between 50%-60%. Why waste these precious organs? What rationale do you have to justify that? Again, this is not my view. The data is clear on the OPTN Explorer, on their OPTN webpage. The average number of donors procured from a DCD is actually below what we procure from a DBD organ. That's number three. Number four, we use OCS after abdominal NRP quite frequently and quite routinely. That number, you know, has been pretty much steady throughout 2024. As I stated earlier, NRP is not a preservation technology that we're concerned about or that is eating in our market share. It isn't. It's a surgical procedure, and organs will be transplanted nationally. These livers need to be preserved. NRP for cardiothoracic organ is a completely different story. We're the lion's share of DCD in the United States at close to 70% last year. That's the number, with 67% to be exact, 66%-67% to be exact. That will continue to grow because we see some significant limitations to thoracic NRP. There are ethical limitations. There are legal limitations. We do not take organs after thoracic NRP because the outcomes are different. That's our view on NRP. Again, NRP works only when the organ is around the corner, you know, very short-distance transport. Again, it's a national organ allocation scheme that we're running in the United States. We don't see that as a big issue for us. We coexist with NRP for livers. We do liver NRP all the time on OCS because we are the ones that are maintaining that liver overnight. NRP can maintain livers overnight on ice. Waleed, reading a question verbatim from a client, can you ask about what drives continued share gains growth in 2025, given that they are already in most of the major accounts? There's got to be same-store growths, right? That's an excellent question. There's absolutely nothing wrong with the same-store growth in transplant. That's not 100% accurate across all three organs. For example, lung, we only have four or five stores out of 40. We have huge room to grow new stores in lung. In heart and liver, yes, we're in 75 stores each. In liver, we still have 15-20 new stores to penetrate. That aside, let me tell you where the huge growth opportunities in front of TransMedics are. It's not about opening up new accounts. We're at 17% or 18% DBD penetration in liver. We need to grow that. We're at 53% DCD penetration in liver. We need to grow that. We are only at 8% DBD penetration in heart. We need to grow that because people need to remember 70% of unutilized donor hearts are DBD donors. We still have huge room for improvement, not just to penetrate the DBD market, but to grow the overall heart market. We're at 66% or 67% of the DCD in the United States exiting last year. We still have room to grow, and DCD donation is growing. Lung is a dormant market. DBD and DCD is a huge opportunity for us. We look at the new clinical programs for heart and lung as a significant catalyst for growth, not just for 2025. In fact, 2025 is all organic growth. It's really 2026 and beyond. For us, we still have long room to go to grow the business. We haven't even talked about kidney yet. You know, our number of 10,000 transplants by 2028 does not include kidneys. Kidney alone would add 25,000 procedures to our TAM in the United States annually. There is a long way to go on our growth opportunity. Very few technologies out there can state that because it is just they cannot address the limitations that we can overcome with the OCS and NOP. It's interesting, Waleed. XVIVO also confirmed the same numbers that you guys have been talking about for overall. Waleed, reading another client question verbatim. Assumption for 2020 to 2025 calendar 2025 growth increase OCS adoption and service revenue. Expect some level of quarter-to-quarter variability, but tends to normalize in following quarters. The expectation is when one or two quarters are flat or down than normal. Do you think the street has gotten the message on this? What do you think normalization means? I think what Gerardo meant to say is that after Q3, we have Q4. Specifically on the results of Q3, where everybody panicked, and we said there's no need to panic, and people panicked, and we normalized in Q4. That's exactly what he was talking about. He never mentioned we expect two quarters of variability. He never mentioned which quarter. He is here. He can address it himself. I know, absolutely. I think in the past, the variability has been there always, Suraj. With the extreme growth, I would say that the company has delivered in the past years, the company was able to go through those variabilities. Now we are at scale. Now it's harder to go or to just go through that variability. That's exactly the message that we want to pass on. Just don't panic. If there is variability in one quarter, either up or down, it will tend to normalize. It will tend to normalize. That's our expectation. The key number is our full-year guidance. I think, yeah, I want to underscore what Gerardo ended with. We stand by our full-year guidance. We never issue the quarter-to-quarter guidance or anything like that. That's the most important message. Waleed, one of your competitors, OrganOx, has come up regularly in client discussions, and surely you'll have seen the capital raise recently. There are both sides of the coin, right, in terms of how, you know, the Metra device, you know, in liver for normothermic and whatnot. Help us understand how you all see it, how TransMedics sees competition, you know, in the current state of affairs, the portability or lack thereof, you know, clinical trials. Help us understand, especially as it relates to OrganOx, because that seems to dominate client conversations recently. Sure. Again, guys, I'm the CEO of TransMedics. I can only talk about TransMedics. You guys spend a lot of time asking me questions about competition. My job is to focus on growing TransMedics business. We are very thrilled that OrganOx were finally able to raise some capital. We know that half of their raise was a secondary offering, so we wish them all the best. It's important to have competitors in the marketplace because that validates the market, number one. Number two, it keeps us honest. Number three, it gives different options to the transplant community. We believe that the OCS have unique capabilities that positions us far above any other player in the field. NOP, on top of that, even distances us even further from just being another preservation technology. Integrating the network effect of logistics gives us another layer of opportunities to distance ourselves from anybody else in the field. Obviously, this is a very important area in medicine, transplantation, and we love to have other participants and players in the field. Our results and our data and our presence and our penetration rates and market share speaks for itself. I'll leave it at that. Again, OrganOx was in the U.S. when we were doing our clinical trial. OrganOx was in the U.S. when we were approved. OrganOx was in the U.S. when we launched NOP. OrganOx, God willing, will continue to exist. You know, we're in a completely different league, so we wish them all the best. Waleed, switching gears, clinical trials and the next-generation products and indications is something that also dominates client conversations. First, I know in your past commentary, you've said you all would unveil the trial design at ISHLT. That's correct. Question number one, is that still on track? Question number two is, Waleed, superiority for trial design, you and I know it is not easy to show superiority, right? Absolutely. That's why we did it. People put in composite endpoints and this and that. Can you shed some color? What gives you the confidence? You're smiling. What gives you the confidence for superiority? Because it's an important thing, right? Suraj, again, I very much enjoy our conversation because you ask some very, very intelligent questions. Suraj, we stand by our commitment to do two things. One, we will reveal the detailed preclinical results at ISHLT at our Monday luncheon symposium at the ISHLT here in Boston. Also, we will end that luncheon symposium with me giving a detailed overview of the actual trial design. Hopefully, by that time, one or maybe both trials will be approved by FDA so we can speak about it freely. That is number one. That is not going to change. That is our commitment to the community. On the other aspect of the question, again, I reiterate TransMedics' commitment to leading with evidence. We believe wholeheartedly that the next-gen OCS technologies that we are launching into the second half of this year will give TransMedics further leverage to be able to demonstrate superiority of transplant outcomes in both heart and lungs. That is why we are leading with that evidence. Yes, it is not going to be a small trial. We know that. We are the company that sponsored the largest number and the largest size clinical trials in the history of organ transplant. We stand by that commitment. Why did we do it? We did it because this addresses all the noise about how about this technology, how about this approach, how about this or that. Demonstrating superiority is a class by itself. We think the OCS next-gen capabilities will enable us to achieve that. Again, our confidence is coming from the results we've seen in the preclinical phase, which always in our history, in our track record, we've done seven pivotal trials with the US and two European, always tracked well. We are very, very encouraged and bullish about getting these clinical programs started so we can actually validate that excitement. Waleed, a question has come in, and it is a slight twist on my question. What I was going to ask is, you know, there's a lot of drama in Washington, DC nowadays, right? Rightly or wrongly. I guess where I was going is, how do you all see any macro-level dislocations? How are you all buffering for that? The question that has come in is, could that impact any of the clinical trials, you know, timing, any other regulatory approval, so on and so forth? That's an excellent question. Of course. Of course it could. As we sit here, we're not aware of it, but we all know that tomorrow could bring in a different reality. We have been keeping an open line of communications with the FDA. Our review team are still employed, but we could find out tomorrow that they're not or something else is happening. That's why, again, we've been very cautious about what we discuss until we actually get these trials approved. Yes, you know, the environment is rapidly moving. Also, another thing we're doing is we are trying to engage, not just be an innocent bystander, but to engage, to try to at least be closer, you know, to be able to provide some perspective and try to influence the decision not to derail the progress. Got it. Gentlemen, we are up on time. Let me see any more questions. One more, but it's about xenografts, and I'm going to skip that for now, Waleed. Gerardo, one for you is 25-30 planes exiting calendar. Twenty-five still the right number to think about it, or has your thought process changed on what is the optimal number? Right now, we are planning to close the year with 22, Suraj, 22 planes that we expect that will give us somewhere between 18-20 operational planes in average every month. That is almost 70% more than the average that we have in 2024. That should give us significant operational leverage and efficiencies throughout the year. This is a key year in which we really want to see the impact of that asset utilization on our margins. From there, we have a better visibility on how many more if we need additional more. Basically, you'll have looked at scheduled, unscheduled maintenance, and then kind of reverse engineered the 22 is the right number for exiting 2025. That's the way to think about it. At this point in time, it's 22. That's the number that we discussed. I think to get to the 10,000 transplants, we will need to get more planes. Suraj, the question is how many and when. Really, the results of this year will help us to have better visibility on those answers. Correct. Gentlemen, folks, we are up on time. Waleed, Gerardo, thank you so much for taking the time this morning answering our questions and client questions. I know you guys have a full day. Congrats on all the progress, and hopefully, we get through the storm once again. Do appreciate your help. Thank you. Thank you, Suraj. Take care.