Thanks everyone for joining us. I'm Dave Rescott, Senior Medtech Analyst here at Baird. Happy to have Waleed with us from TransMedics, President and CEO of the company. I think he's going to walk through maybe 10 minutes or so of slides, and then we can dive into the Q&A. Great. I'll pass it off to you. Great. Thank you, David, for the opportunity to be here today. Good morning, everyone. This is our forward-looking statement. TransMedics is in the very exciting field of organ transplantation. Organ transplant happens to be the gold standard of treating a very chronic and very expensive disease condition called end-stage organ failure. It's the gold standard of treatment because it provides patients with end-stage organ failure with the best quality of life and the longest life expectancy. It also happens to be the most cost-effective treatment for this very expensive disease condition. What is the problem in organ transplant? It's supply constraint. It's the availability of donors. It's our ability to utilize the available donor organs for transplantation. TransMedics transformed the field over the last several years. We increased the supply of organs by increasing the yield and utilization of donated organ to actual transplant and delivering superior clinical outcomes. Let me walk you through our achievements to date and what excites us about the future and the future growth ahead of us. TransMedics approached this from a very different approach. We started as a medical technology company, but over the last four years, we built a very wide, deep, and large moat around that core business. First, we delivered the best technology for organ preservation by keeping organs in their normal physiologic functioning state outside of the human body, delivering superior clinical outcomes and the highest rate of organ utilization. Next, we built the only national end-to-end service model around the technology, called the National OCS Program, or NOP, that delivers clinical and surgical services for organ transplant cases across the country. Third, we added vertically integrated air and ground logistics network to make sure that every organ can be utilized for transplant can actually reach a potential recipient. And fourth, we added a vertical or a broad digital ecosystem that can run the entire national transplant program indefinitely for the NOP and our network of utilizing centers. Finally, the last piece of the puzzle was adding a new service to truly become sticky with the organ transplant programs across the U.S., which is a donor and recipient screening service. So literally, simply stated, two years from now any transplant program across the United States will wake up in the morning and be connected to the OCS TransMedics digital ecosystem. They could run their entire transplant program through our network. And they could go to bed at night, the last thing they see is a TransMedics digital ecosystem giving them status of their organs that were offered and transplanted throughout the day. We've proven over the last four years that we can not just only be a top-line grower, but a significantly profitable business. We've grown our revenue 86% over the last four years, generating significant operating leverage. We have a very healthy balance sheet, north of $470 million in the bank. And this year we're forecasting, or at least our guidance is contemplating 20%-25% year-over-year growth. This is our technology platform, three technology platforms that are already approved by FDA and one that we're very excited about coming, which is the OCS Kidney, and we'll talk about that shortly. The NOP network, again, is the only national network. We started with three hubs. Today we're operating out of 20 clinical hubs across the United States. That gives us access to the broadest number of donors across the country. We have vertically integrated and own and operate 22 aircraft, 140 pilots, 50 procurement surgeons, 250 clinical specialists and coordinators across the country. This is our digital ecosystem, and as you can see, it's a broad platform that manages not just our NOP network, but also gives full visibility and transparency to the transplant programs across the country, as well as a massive digital command center that runs the entire national operations. Last year alone, we've done more than 35% of the national transplant volume were managed through the digital command center in the bottom left corner of the slide. But this is what we've achieved. As you know, this is a business of what have you done for me lately? So we are very excited about the next gear of growth that, in our opinion, will be fueled by four massive engines of growth that we're very excited about and making some strategic investment in. First is expanding our heart and lung franchise in the U.S. Second, accessing the largest segment of organ transplant in the business, which is the kidney transplant market. Third is doubling the total addressable market by tackling the second-largest market of organ transplant in Europe. And finally, bringing in the next generation of the OCS technology platform that will generate significant leverage. So let's tackle each one of those and why we are making these strategic investment now and not waiting, and why we're excited about these opportunities. So first, expanding our heart and lung franchise. Everybody knows that our liver franchise has grown exponentially, has been a major catalyst and engine and driver of our growth. We have two areas that we're very excited about, the heart and lung market. These are twin engines of our growth for 2027 and beyond. Let me give you a scale of what we're talking about. In heart, there's a segment of the heart market assessed at approximately 2,200 hearts that are DBD donors, less than four hours of preservation. We don't sell in that market today. We don't touch that segment of the market. This is a new clinical indication for us. In the lung, the entire market in the U.S. is about 3,200 lung transplants, and again, this is a very nascent market for us in the U.S. What are we going to do? We're going to tackle these two markets using both the OCS technology platform and a new technology that we built for cold, Controlled Hypothermic Organ Preservation System, or CHOPS, to access approximately 5,400 heart and lung a year, which dramatically expand our TAM in the U.S. from heart and lung market. We have four shots at goal with this program alone. Two shots with OCS, one in heart, one in lung, to access this significant opportunity, but also two shots with the second product, which is CHOPS, for any center that wants to segment the market based on a price point. That will be our portion as well. Second is the kidney market. This is one of the most exciting area that we're focusing on in TransMedics. It is the largest transplant segment that's conducted today. Let's talk about some important metrics. People think, "Waleed, why are you excited about kidney? Kidney is a very robust organ. There's no problems. It's very common to do kidney transplant." Well, there are significant problems in kidney transplantation, and we are going to fix that with the OCS and NOP. Let's start from the top. Every year, there's 21,000 deceased donor transplants in the U.S. You need to know that last year, we lost nearly 10,000 kidneys for one reason, and one reason alone, which is long time on ice. That's huge problem. Second, when you transplant a kidney today, you have a chance of 30%-55% that the kidney doesn't function well, adding significant cost. What are the costs we're talking about? CMS being the sole payer of end-stage renal disease in the United States. CMS covers the waiting list alone for more than $10 billion annually. The cost of DGF costs CMS close to $250 million annually. What is the OCS going to do? OCS Kidney will give us direct access to nearly 30,000 kidney transplants in the United States coming from deceased donors, and OCS will deliver the highest rate of utilization and significantly reduce DGF, which means a significant cost efficiency to CMS. We could not be more excited about the kidney program, and we expect that to roll out the second half of 2027. Next is we're investing in replicating the success of the NOP in Europe. Why Europe? People are saying, "Waleed, why are you focusing on Europe?" Well, Europe happens to be the second-largest international transplant market. We have an opportunity to nearly double the total addressable market. If you don't believe me, the numbers in Europe, as you can see here, is nearly equivalent to the United States. In fact, they do more kidney transplant in Europe than in the U.S. So for us, this is a huge opportunity to double our addressable market and do it with a proven technology and a proven service model that we've successfully executed on in the United States. Finally, the OCS 3.0. That is a complete redesign and reimagination of the platform. Why? To scale. To be able to go from 5,000 transplants last year to 10,000 transplants in 2028 to 20,000 transplants in 2030, 30,000 transplants in 2032. What does 3.0 give us? Gives us significant leverage, both on the product and the service, and significant de-risking of the supply chain. We could not be more excited about the significant operating product leverage that we gain with 3.0, and that should be the first leading edge of 3.0 is going to come with the kidney program second half of next year, and then we will go back and transform liver, heart, and lung in 2029 and 2030. To summarize, TransMedics is a very unique opportunity to transform not only organ transplantation, but also do that and deliver significant shareholder value. Why do we believe that? Well, we have the best technology with the best clinical evidence to support this technology. We build a very large, deep, and broad moat that is extremely difficult to replicate and extremely costly to replicate. We have four shots at goal to significantly transform and grow this business at scale, and we have the execution track record that gives us the confidence to be here. The numbers speak for themselves, 86% growth CAGR over the last three years and 6.5x revenue growth. We could not be more excited about what the future holds for TransMedics, and thank you so much for the opportunity to present. Yeah. Thank you. A lot to dive into here, but maybe first to start, I know you appointed a new CFO last week. Maybe just to start, touch on the decision to do that, the background, and why now is the right time for that. Great. That's an excellent question. As you can see, our business is growing rapidly. It's becoming more complex. It's growing internationally, not just locally. We saw an opportunity to add in somebody with Fernando's talent in scaling a large med tech operation, not just in the U.S., but globally. Also, we saw an opportunity to refocus Gerardo, who has tremendous knowledge of the business on a new area, a new geography that he has tremendous experience with, which is the LATAM region. Our team is laser-focused in Europe, yet there are opportunities in LATAM region, and it's coming to us, and we did not want to turn away from it. We saw an opportunity to do two things at the same time, elevate our team ability to execute with the addition of Fernando to help the team execute throughout these challenges of growing the business internationally, and also refocus Gerardo on the new and upcoming LATAM region. We felt it's the best of both worlds. Yeah. You've had these long-term goals to hit, what, 10,000 transplants in the U.S., nearly 30% operating margins, I think by 2028 is the timeframe. Does the new CFO in this place give you the opportunity to rethink some of those at all, o r at this point, would the assumption be that those are still the longer-term goals at this point? I think, David, our goal is our top-line goal, our operating goals are not going to change. These are things that we discussed a lot during the process, bringing in Fernando. If anything, I'm looking forward to Fernando's expertise and help with the team to really buttress these assumptions and add operating firepower to make us achieve these goals with more confidence than less. I don't expect the top-line goals to change, and I'm looking forward to his contribution to help us achieve these goals. In the press release, you reiterated the 2026 guide, called out the potential to, or called out that you could revisit that on the Q3 results. I know a lot of people track the transplant volumes and the flight data. I am curious to hear what your interpretation of some of the trends in Q3 have been relative to what they historically are, and then, I guess, relative to what you had contemplated in the commentary for the guide. Sure. Issuing a press release in the middle of the quarter, we needed to give the street our strong confidence in the stated guidance, and that this management change is not causing any change in our confidence level on the previously stated guidance. That being said, we are still in the middle of the quarter. As you said, the data is public. The tracking, the flight information, we had a banner July. Then August hit. We said you always have to expect seasonality in August, and it did. Now we are in September, so we needed to give ourself an opportunity to finish the quarter, and then we will revisit the guidance based on the quarter results. From everything we are seeing, plus integrating the revenue coming out of the new entity, PAD Aviation, in Europe. We felt that it is perfect to just reiterate the guidance and leave the team the opportunity to address any updates and tweaks to the guidance based on the performance, not as a guess in the middle of the quarter. Yeah. I think, typically, I guess the past two years, sequentially, the revenue in the U.S. is down mid to high single. I think consensus sits at high single. Banner July, weaker August. We are in the early weeks of September. Any thought on either what the second half of September has to do or relative to what the commentary has been so far at all, or? Yeah. David, that is an excellent question. We do not comment on the performance mid-quarter. We got to let September roll, and we will let the data speak for itself. Yeah. Q2 results, you have the Product revenue right in the U.S., you have the Service revenue in the U.S. I want to say Product revenue was up 15% year-over-year. Service revenue was up 30%, and so the bigger driver of growth, total growth was that Service revenue line. Can you walk through what specifically drove that, how you would expect that to trend as you go forward? Yeah. And whether or not at some point we should expect more normalization of those two line items. Sure. We expect product and Service revenue to be very close to each other. Obviously, the Product revenue is the one that drives the Service revenue. In Q2, there was a slight dislocation where a major transplant program that already uses the OCS from a product perspective nearly in every transplant they do, we gained market share for their logistics operation as well. That was what caused that dislocation or increased Service revenue growth in Q2 over the Product revenue. We expect this to normalize. Growth needs to come from product and service at nearly equal rate. However, that might be up and down based on gaining market share, and that's what we expect to see. If we see that again, it means that we're gaining more market share on the logistics from existing product customer. Ideally, at scale, they should be very close to each other. Is this something where you see the benefit in Q2 and that's it, or is that new service contract coming online in Q2 likely to carry into Q3 and Q4? No. Our contracts are annualized, and with auto-renewal, unless the center wants to change. So we expect that to carry forward as a part of our service offering. Okay. From an opportunity perspective, is there still accounts out there that could be as big or as meaningful as the one that you captured? Yes. We have several in the hopper to make that transition. Again, we've clearly stated that the reason why we wanted to vertically integrate logistics is we saw an opportunity for us to deliver a lot of cost efficiencies to the transplant program. That example that I just gave you proves that we are still delivering a very cost-effective way of transporting organs, taking over one of the largest transplant programs in the country. Logistics needs like that proves that. We're excited about it, and we expect to see more market share gain in logistics from different transplant programs. On the product side, and not to knock it, but I think the 15%, 16% product growth in Q2 is one of the slower growth levels that you've put up in the past couple of years. Normally I would think that mid-teens maybe is the right way to think about growth in the Product segment versus the 22%- 25% guide that you have for the year. Is there any reason to think that that should not be the case, meaning that is the total product or underlying transplant market that you're capturing sharing something better than the 15%, and there was a one-time anomaly in Q2? How would you think about that product component? Again, we stated in the beginning of the year that 2026 is going to be a choppy year because of all the dynamic between OPOs and decertification and CMS modernization initiatives that may impact our performance throughout the year. I think Q1 and Q2 performance nationally, not just OCS, but TransMedics performance proved that to be true. Certainly, we expect the Product revenue to grow at the scale that matches our expectation for the year. Remember, there's very little, if any, contribution of two major program, de novo and ENHANCE Part B in the guidance. These are catalysts for the future. Q2, we believe is an anomaly. We should expect Product revenue to grow at a healthy clip going forward to match the guidance for the year. Now, when you think about the levels of penetration you're at in heart and liver DCD, DBD in the U.S., relative to that, we'll just say mid-teens growth number you put up on the product side, is that a fair way to think about what the trajectory of the business over the next 18- 24 months looks like, and then you've got these clinical trials and additional pieces coming on top of that, or would you expect based on where penetration is today that maybe off of that mid-teens number, that there's a step down or a step up at all? David, I want to be crystal clear. We think for heart and lung, certainly for lung, we could not be any lower. There is significant upside in de novo for lung. There is significant upside in ENHANCE for the heart. We are seeing ENHANCE trial Part A completing enrollment in September, which is a signal that when a trial completes enrollment of 175 patients in six months or less than six months, that is a good sign. So we expect 2027 to be a significant acceleration year for heart and lung, and I am specifically referring to acceleration in OCS, acceleration using CHOPS. As I said, the two shots a goal for each organ is very important for us. So we expect these penetration rates that we are currently, you are referring to as mid-teens. In my humble view, these are the bottom of what my expectation is given the focus on de novo and ENHANCE Part B. So stay tuned for next year. Hopefully, that vision will be validated based on the print and based on the trial accrual for ENHANCE Part B and de novo. I think consensus for next year is at a high teens growth for the total business. You talked about acceleration in heart and in lung. Obviously, liver is the other side of that. So would you think that the contribution of acceleration in heart and liver are enough to get the total business to accelerate, or is it you get to the law of large numbers in liver, a deceleration, plus that of the clinical trials in heart and lung acceleration, that gets you up toward the upper teens from a revenue growth perspective? I am not going to comment on guidance for 2027. But listen, we see significant growth opportunities in 2027, leading into the next really big year of growth for TransMedics in 2028, 2030, and beyond. So we are not shy to be expecting that. Again, we will issue the guidance for 2027 when we are ready to do so, but we see 2027 as a huge year for TransMedics to really put that vision in context and hopefully deliver on our promises. That has been delayed somewhat due to the shift in strategy, the addition of CHOPS, allowing the FDA the time to approve CHOPS for the trial. So we understand why that is an issue for 2026, but definitely we are very bullish on 2027 contribution of heart and lung, and liver, and ultimately hopefully end the year with the kidney program coming on top in the U.S. On the margin side, you talked about a couple of pieces to that and the four pillars for growth. Big investment year in 2026. You pulled down some of that operating margin expansion, I guess, in 2026. I guess, when you think about the investments you're making this year, the investments that maybe you still have to make in 2027, how are you thinking about that relative level of expansion on the operating margin side? Is 2027 another big investment year, 2028 is the inflection period, or would you expect to see some more margin fall through? Listen, I want to give Fernando the opportunity to really get his arms around the model. Let him take his time, so I don't want to state anything publicly here other than, listen, we have a publicly stated goal of being in the mid-20s, approaching 30s at scale, somewhere in the 2028, 2029 year. So we expect to be showing tangible progress towards that goal in 2027 to prepare for 2028. 2027 is going to be another investment year, but hopefully the top-line growth will help kind of moderate the impact on the operating lever compared to 2026. But we're still making investments in these four initiatives throughout 2027 and maybe even early 2028. But we expect the top-line growth to kind of moderate the impact on the operating margin. All right. I guess on the competitive perfusion front, there's been some clearances this year differing ways in which you perfuse an organ, the hypothermic versus normothermic. You're vertically integrated, right? You've got your own NOP. So I guess, how do you feel about the competitive moat in the business relative to newer entrants? I don't know if you've seen anything so far that strengthens that view at all, but just curious on competition, how you're thinking about that. Listen, we need to learn and be comfortable. We are comfortable operating in a very busy market. It validates our excitement about transplantation. When we started, nobody knew anything about organ transplant. Now every Tom, Dick, and Harry claims that they could do what TransMedics is doing. Again, we let our execution speaks for itself. So I'll leave it at that. But we need to be comfortable, confident in our technology, in our large five-step deep moat that we created for the business, and our team needs to operate in that crowded market. Again, we let our execution speak for itself. Okay, last two with a minute left. Kidney, I think you said enrollment's going to be beginning in the second half of 2027. Any idea on the size of that trial or the timelines there? Not yet. We don't want to discuss that publicly yet. We want to make sure we align with FDA and all the requirements first before we announce that. We could not be more excited about the Kidney program, and we can't wait for it to get started late next year. Then last on Europe, right? You've got PAD Aviation, you got the planes, right? In the U.S., you've got the planes, clinical support, the surgeons, the logistics center, all of those other pieces behind U.S. NOP. Beyond PAD Aviation, what else do you have to put into play to expand into Europe? From a timeline perspective, is 2028 the time from which we start to model? PAD Aviation is a critical addition to the business to allow us to start bidding on the national and regional logistics contract in Europe. We could not be more excited about that. Other than that, just needing to put the few hubs with few clinical staffers to support these cases. We're going to start slow in Europe, and as the momentum builds, we'll make the necessary adjustments, investments in Europe. We expect it to be modest, and we expect it to be moderated based on demand. Okay, great. We're out of time. Thanks for joining us. Thank you, all.
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