Thank you all for coming to the TransMedics presentation. For those of you whom I've not yet met, my name is Ryan Daniels. I'm the Group Head of the Healthcare Equity Research Team, very happy to welcome you all to today's presentation in the Growth Stock Conference. A couple of quick housekeeping items before my intro. Number one, we will be up in Adler for the Q&A session immediately following this. I'm also required to let everyone know that our disclosures are available at our website at williamblair.com. With that out of the way, very happy to have TransMedics here for the second year in a row. A great organization. For those of you who were in the audience last year, you may remember I have a bit of a personal story behind this, as my dad had liver cancer. Started doing research and found TransMedics and quickly realized that that would be the only Organ Care System that I would let his organ be put on if he were going to go through a transplantation. Started to dig deeper into the model and really came to appreciate the competitive advantages, the network effects, and the strength of the management team, and so we're really excited to have them here today. Waleed Hassanein, who is the founder of the company and President and CEO, is going to present, and then the rest of the team will be there for the breakout. It's also a very catalyst-rich year for the organization, so really good timing to be here to get an update on the story. They're working on next-gen systems. They're working on the first-ever kidney OCS System. They're moving internationally. They're doing clinical trials. Really an amazing growth story and a lot of key catalysts on the horizon here to continue to drive that growth and propel them towards their organ targets, which I'm sure Dr. Hassanein will talk about in a little more detail. With that, Waleed, I'll ask you to come up and go through the presentation. Again, then we'll go to Adler for the Q&A session. Thanks. Thanks, Ryan. Thank you. Appreciate it. Let me make sure I can see my slide. Good afternoon, everyone. Thank you so much for being here with us today. Ryan, we're grateful for the opportunity to be here in Chicago, the beautiful city of Chicago. This is our disclosure slide. To remind you, TransMedics is in this very unique, very exciting, very inspiring field of organ transplantation. It's a niche market, and we have been privileged to be the one created the area of that market for organ preservation. Very important background on organ transplant. Organ transplant is the gold standard of treating a very expensive and very chronic end-of-life condition called end-stage organ failure. It's the gold standard because it does two very important things. One, it is life-saving for the patient. It has the longest life expectancy, the best quality of life, and it's the most cost-effective treatment for payers, specifically CMS and commercial payers, to treat these very expensive end-stage organ failure conditions. What are the problems in organ transplant that TransMedics has overcome? The fundamental problem in organ transplantation has always been the ability of the market to do more transplants and utilize more donors. When we looked into this area, we found that for 45 years, for organ transplant preservation, it was limited to cold static storage, what we call cold ischemic storage. "Ischemia" means damage that occurs to the organ. What are the problems with cold static storage in organ transplantation, and how TransMedics revolutionize that entire field? First, when you take an organ out from a body and put it on a cold environment and not being oxygenated and not being perfused, you subject the organ to a decay curve called "ischemic injury." The longer the organ stays on ice, the higher the probability of this organ never functioning again, or the higher the probability of complications after organ transplant. That immediately puts a time and distance limitation of how far you can go to salvage organs from donors across the U.S. Number two, when you stop an organ from functioning, you stop the heart from beating, you stop the lungs from breathing, the liver from making bile, and the kidneys from making urine. You have no way of assessing organ viability while you are trying to transplant these organs and make somebody else's life dependent on these organs. You immediately go into this very narrow utilization window where, if you are a clinician in an organ transplant center and you have any doubt about the organ, knowing that the organ is going to be injured when you put it in cold storage and you have no way of evaluating its functionality, you would immediately say no. Even if the organ could be good, just because you know these two hits, you immediately turn down this organ for transplantation, further complicating the utilization rate in organ transplants. Finally, because you have no way of improving or enhancing the organ viability outside of the human body, you end up with a very, very ugly picture in utilization. Before we get to the utilization, this is a very important slide. You hear a lot about all these competitors that are trying to compete with TransMedics in the space of organ preservation. If any of them is cold static or perfusion but ischemic, this is a very relevant graph to tell you that they add zero value to organ transplant. This is a graph that is well-known to anybody in the field of organ transplantation. The longer the organ spends on cold static ischemic storage, the higher the probability that the recipient could actually end up dying. It also adds significant complications that could add significant dollars post-transplant, called primary graft dysfunction, primary nonfunction, or delayed graft function. All of which are directly related to the time the organ spends in this very unnatural, non-physiologic condition of cold storage. More importantly, this is the ugly picture that we lived with in the U.S. for the last 45 years. We're only utilizing a fraction of the available precious donor pool for us on an annualized basis. We're utilizing 20% of the lung, 27% of the heart, and 60% of the kidney and liver, leaving the vast majority of the donor pool in the U.S. completely untapped. TransMedics changed all this. How did we change it? First, we focused on eliminating or minimizing ischemia during preservation. For us to be able to do that, we had to develop from scratch a system that mimics human physiology in a medical technology in a device environment. It had to be portable because we wanted the organ to be protected in this physiologic environment, in our system, from the minute it's removed from the donor body until it is transplanted. Two, we allowed the organ to remain active. The heart is beating, the lungs are breathing, the liver is producing bile, and the kidney is making urine. We did this not just to evaluate the function but also to give us the opportunity to enhance and improve organ viability and give it medication, antibiotics, and pharmacological functional metabolic enhancers. Not only preserve but also improve organ viability and chances for the organ to be viable for transplant. In addition, we provide online diagnostics and hemodynamic monitoring of the organ. We eliminate this guessing game that used to go on with cold storage, with cold static storage, where the surgeons and physicians are no longer guessing whether this is an organ that should be transplanted or not. They could evaluate it up to the minute the organ is ready to be transplanted. This is our platform. The three organs on the right side of the screen are the lung, heart, and liver. These are fully FDA approved, and they were commercial across the U.S. and Europe. Our new kid in the block is the kidney system, which we're extremely excited about. It represents the cutting edge of our Gen 3 technology, which we'll discuss later. I can't underscore how excited we are about the upcoming kidney platform, which will give us significant access to the largest portion of the transplant market in the U.S. and around the world. It's not FDA approved yet. It's actually our next -generation technology that we're launching into the clinic early next year. We didn't stop here. We didn't just develop the first physiologic portable platform for organ transplantation. We took it a step further. We developed the first of its kind national -based service organization dedicated 24/7 to procurement, management, and transportation of organs in the U.S. We did this because we could see a significant impact on improving the utilization rate and increasing the supply of organs, which we had to invest in to create that national network, not only to create a bigger, deeper, wider moat around technology as a business but also to increase the overall transplant market. I remember when we were going public in 2019, the biggest questions we used to get were, "Waleed, is TransMedics cannibalizing the current market, or do you truly have an impact on growing the market? We've proven that we can do the latter, and this is one of the key unique attributes that enabled us to do that at a fast double-digit number. Today, we operate out of 19 hubs across the U.S., strategically located to allow us to be at the donor hospital, procuring an organ using our surgeons, with our clinical staff, with our technology within two hours from notification. That gives us maximum flexibility. We didn't stop here. We added a vertical integration of our logistics network. When I stated this in early 2023, I said we have to be involved in logistics. People didn't understand how important this is. Today, 82% of our NOP volume is done on our own fleet. We run one of the most efficient aircrafts on the planet, the Phenom 300E, 110% dedicated to organ transplant missions. There's no high -net-worth individual flying in our jets. It's 100% dedicated to transplant. We did this because in 2023, we were losing 25%-30% of our potential volume of cases that are coming to our NOP hotline because we could not find a third-party aircraft to transport these organs. More importantly, we saw a national problem that CMS and HRSA have been focusing on, which is fair and equitable access across the U.S. for patients in the South and for patients in the Midwest, where they're not getting transplanted at the same rate as if you were on the East Coast or the Northeast or the West Coast of the U.S. With TransMedics' transplant logistics network, we're able to guarantee that every organ in our care will reach to the target recipient no matter where that recipient is across the U.S.. Today, we operate 22 dedicated aircraft and 140 pilots, as I said, covering 82%-83% of the national volume of NOP volume in our service. To make all that work in unison, we had to develop a proprietary digital ecosystem that gives maximum transparency and control and allows us to scale. When we started the NOP, the first year of NOP, we did 900 transplants. Last year, we did nearly 30% of the U.S.'s total transplant volume for heart, lung, and liver. We're talking about nearly 9,000 missions last year. For that to happen, to be able to scale, we had to create a digital ecosystem that, one, gives us the ability to scale, but more importantly, transparency to the clinical stakeholders, transplant programs, coordinators, and organ procurement organizations; that goes all the way from establishing a command center that runs all of our NOP logistics and NOP dispatch but also communication with the transplant program. We're very excited about this, and it's one of our unique attributes that gives the users full control and full visibility to what we're doing. Let me talk to you about what all that means and what the future looks like for TransMedics. This is to show you TransMedics and NOP were responsible for 26% of the U.S. transplant volume last year. For that to happen, we did about 30% of the mission for the entire country running through our network. We're not stopping here. This amounted to about 5,200 transplants, roughly speaking. We publicly stated that our goal is to do 10,000 U.S. transplants by 2028, and we are standing by that goal. We also upped that, and we said by 2030, we envision doing 20,000 U.S. transplants on the NOP network when we add the kidney to that. By 2032, we're committing to approximately 30,000 global transplants to be done on our NOP network. Let me show you another impact. Remember that question that I told you we used to be asked during the IPO timeframe? Can TransMedics really impact the national volume, or is it nothing but cannibalizing the existing market? Here's the data to prove to you that TransMedics not only can, but TransMedics was solely responsible for growing the national transplant volume in the U.S. This is the national transplant volume with OCS, NOP volume, reaching 25% growth over the last three years. The same national transplant volume without the OCS, NOP cases would have declined by nearly 1%. That's proof of what the impact of the network of NOP and OCS and TransMedics is doing on the national transplant volume. This is why we are actively engaged with HRSA, with CMS, with major organ procurement organizations around the country, and with major transplant institutions around the country to talk about what's next, what's coming, and how TransMedics can do more to expand the utilization of donor organs across the U.S. When we talk about utilization, you cannot ignore this slide. The OCS, our technology, and the NOP have the highest reported utilization rate of donated organs on planet Earth. Period. Full stop. No other technology, service, or combination thereof comes even close to that. The highest we've heard from some of the competing platforms out there is 50%-55%. There's a significant advantage to utilizing more organs. There's a significant advantage to saving more lives and saving healthcare dollars in the U.S. and around the globe. That's the magnitude of what TransMedics can do. We're not stopping here. This is our growth strategy over the next three years. The next 2026 and 2027 are investment-heavy years to really tee up the growth for this business as we see it. 2026 and early 2027, it's all about our Gen 2 technology for heart and lung to generate more adoption in heart transplants in the U.S., moving away from just preservation into enhancing cardiac function outside of the human body, moving into daytime scheduled heart and lung procedures, and revving up the lung market that has been a sleeping giant for us. In 2027, we introduced the kidney platform. As I stated, the kidney platform is one of the most exciting new product introductions TransMedics has ever been involved with. It gives us overnight access to nearly 25,000 deceased kidney transplants in the U.S. and another 25,000 to 30,000 deceased kidney transplants in Europe. More importantly, in the U.S. last year alone, 9,000 kidneys were wasted because of ischemic time. We can change all that. This is why CMS has been extremely supportive of TransMedics' mission and supportive of our technology. We are going to get the next Gen heart and lungs approved sometime in 2027. We're expanding internationally. We're expanding internationally because the global transplant market is 55% U.S., 40% Europe, and 15% the rest of the world. Europe is a very important long-term growth opportunity for TransMedics. As we sit here, the success of U.S. NOP is generating significant momentum in Europe to a point that they're coming to us, asking us to replicate the NOP models in Europe, and we believe that this is a very important long-term growth strategy. Let me leave you with one of the most exciting things that we're working on, that we're investing heavily in. Today, for the NOP to work, we have to have technology; we have to have surgeons; we have to have clinical specialists, especially the army of highly dedicated, world-class clinical specialists we have in TransMedics. They live, and they babysit every organ from the minute the organ leaves the human body until it arrives to the recipient, and they could even stay with the organ overnight until the surgeon is ready to transplant that organ. This is a highly appreciated mission and commitment by our team, and we couldn't stand here without the commitment of our team. We need to think efficiently of how to scale that, to go to 10,000 - 20,000 - 30,000 transplants from 5,200 transplants. I cannot hire enough and train enough human beings to take care of these organs. What are we doing about it? We are building the first Class III FDA life-sustaining medical technology that is remotely monitored and controlled using cloud-based computing, run from a command center at our headquarters in Boston, Massachusetts. OCS Gen 3 is not only going to give us significant operating scalability leverage, but it's also designed from the ground up to give us significant operating leverage by lower part count, automated assembly, and lower BOM. I can't tell you how important that platform is for our long-term aspiration. By 2029, we'll have the kidney approved in the U.S., and then that's going to be a huge catalyst for our growth, both in the U.S. and internationally. We have a robust growth runway in front of us. We already generated profitability last year. As we sit here today, our focus is on capitalizing on these growth initiatives, investing heavily in getting to these major catalysts to our growth. People may think that we've arrived and we're now focusing on just EPS. EPS, we'll focus on when it's the appropriate time. Our top focus is generating the growth to get from $605 million - $2.5 - $3 billion top line over the next four - five years. That's our focus, doing that with efficiency and operating leverage discipline. To that point, let me just share with you how excited we are about the near-term catalyst, which is ongoing today, increasing our adoption in heart and lung transplants through ENHANCE Heart and DENOVO Lung. What is the vision for these two programs? The vision for these two programs is to increase our footprint in cardiothoracic transplantation and replicate the success that we have in liver by shifting the narrative from preservation into enhancement, by shifting an emergent procedure that has to happen in the middle of the night that costs the system a significant amount of dollars into a more scheduled or semi-scheduled procedure, and by demonstrating superiority over any ischemic preservation method, whether cold perfusion or cold storage. That's the vision of these two programs. To that end, some of the competition panicked when we launched ENHANCE Heart and DENOVO Lung, and they said, There's no way you can compare our cold static device to TransMedics. We don't feel comfortable comparing ourselves to them. We said, No problem. We developed the CHOPS, the Controlled Hypothermic Organ Preservation System. What does the CHOPS do? The CHOPS provide a well-controlled temperature for cold ischemic storage. You said, Waleed, you just talked to us about this not being good for the organ I agree. It is not good for the organ. There is a segment of the market right here in blue that TransMedics doesn't have indication for today. Any heart transplant coming from a DBD donor that's preserved less than four hours, we are not operating in that market segment. We're operating in the DCD market segment and the DBD greater than four hours. Why leave that portion of the pie completely untackled? Especially when we give them a chance to compare, if they're really believing in it, compare themselves to OCS. This is why CHOPS was developed. It gives us two shots a goal to tackle that new market segment that, as of 2025, we had zero revenue coming from. Some people said, Waleed, you're cannibalizing your existing market.. The complete opposite is true. I am adding a new market segment in heart transplant that I have not been able to tackle for the last three years, intentionally, meaning we staged this. We're very excited about what's coming on CHOPS. Again, I say all this standing on our track record. This is our financial performance, both from a top-line revenue growth over the last three or four years and profitability and operating margin and operational margin trends. We're standing here with a stated guidance of another 20%-25% growth expectation for 2026. You say, Waleed, if you're that confident, why the heck is your stock in the 60s? I tell you, it's a buying opportunity. I bought $3 million worth of our stock last year. I wish I could do more. The bottom line is here, guys; we're not letting the stock being in the mid-60s distract us. We know that if we execute on that growth strategy, the stock will take care of itself. Our focus is to continue to deliver, to continue to execute, and to continue to put points on the board while being financially disciplined. We need to do a better job articulating why it is important for us to continue to invest in the business because we're not done yet. The growth is still ahead of us. To go from $605 million - $2.5 billion-$3 billion, that's a real opportunity, and we are not going to let it slip through our fingers. To summarize, we believe TransMedics is a one-of-a-kind growth opportunity. It built on fundamentally game-changing technology surrounded by a state-of-the-art creative service platform called the NOP, the vertical integration of logistics. Very robust pipeline of innovations that could scale this opportunity in a very cost-effective way. The clinical outcomes are the best in the industry. We set the bar by others that should be measured with. We are committed to continuing to set the bar based on level 1 evidence. We're not the ones who are getting 510(k) approval without clinical. We're the ones who are doing the largest -size, largest volume clinical trial for a reason. It's not like we like to interact with FDA. We love the FDA, we work with them very closely, but it's about building a higher level of evidence to give us the maximum runway in that market space that we created from whole cloth. Every member of our team is focused on one thing and one thing only, what's best for the transplant patient. I keep reminding our team, if we keep the patient dead center on our screen, we'll never make a bad decision operationally. We let our track record speak for itself. Again, I'm grateful for the opportunity to be here, Ryan, and I appreciate you all taking the time to be here today. Thank you. We'll go ahead and go to Adler up on the second -floor balcony. Please join me in thanking the team from TransMedics. Thank you.
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