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JPMorgan Healthcare Conference

Jan 12, 2023

Allen Gong
Analyst, J.P. Morgan

Okay. Hello, everyone. Welcome to the last session of Wednesday here at the J.P. Morgan Healthcare Conference. My name is Allen Gong. I'm on the Medical Supplies and Devices team here at J.P. Morgan. It's my pleasure to introduce Waleed Hassanein and some of the other management team from TransMedics. We're gonna start with some prepared remarks and then move into Q&A.

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

Thanks, Allen, thanks, J.P. Morgan, for the kind invite, thank you all for being here. I guess the MedTech team left the best for last. I promise to be light and don't spend too much time to delay your your cocktail hour after this. I'm Waleed Hassanein, I'm the Founder, President, and CEO of TransMedics, I have the privilege to be accompanied here today by Stephen Gordon, my CFO, and Dr. Tamer Khayal, our Chief Commercial Officer, who will be happy to address any of your questions after the presentation. Just a standard forward-looking statement cautionary note. Just for a reminder, we never preannounce, we're looking forward to announcing our Q4 results in sometime in February.

Let's just dive right in. Transplant is a very, very important area of medicine that is highly underserved by this big problem called shortage or perceived shortage of donors. In the United States, this is all public figures available on the OPTN website. In 2021, we had nearly 14,000 donors. Despite that, we only utilized 2,500 lungs for transplant, 3,800 hearts, and 8,600 livers. What that means is there is a significant underutilization of the donor pool that exists today. That unutilized donor pool could have doubling or tripling the number of organ transplant in heart and lung, and nearly 50% increase of liver transplantation in the US. What does TransMedics do? TransMedics has developed a very unique and integrated approach to overcoming these limitations through three mechanisms.

One, through our first and best of its kind technology called the Organ Care System, technology platform that covers heart, lung, and liver transplant. We build significant clinical evidence that I will summarize for you in the next few slides. Finally, we developed the largest, widest, and deepest moat to surround everything we're gonna talk about today by developing our integrated logistical infrastructure to maximize utilization in the United States of organ transplants. First, the technology. We have the only FDA multi-organ platform perfusion technology that is portable. No other technology on planet Earth has multi-organ platform, meaning catering lung, heart, and liver transplant. No other technology on planet Earth has the portability aspect that exists in our technology.

No other technology is even FDA approved for more than one organ at a time, and it's only limited to two companies, and we've already displaced them from the United States. That's number one. Two, what is the OCS does? Simply stated, the OCS replicates human physiology outside of the human body. We keep hearts, lungs, and livers in a normal, functioning, living state outside of the human body. The heart is beating, the lung is breathing, the liver is producing bile, the kidney is making urine. Why is that important? Why am I spending a few seconds to articulate that?

That is the main reason why the OCS is unique to be able to increase the utilization of organs that historically have not been used because of limitation of the historical platform of cold storage, because we could not assess organs outside of the human body, because we could not protect organs from damage on ice. The OCS has the complete opposite effect of that. You don't have to believe me, you have to look at the data. We have sponsored, we TransMedics sponsored the largest number and the largest size trials in the history of organ transplant. No other technology or company or entity has that kind of level of evidence. When you look at our level of evidence, we didn't target the routine organ transplant, the 2,500 lungs and 3,800 hearts.

We targeted the entire column, the gray and the red, to show that could we have an impact in increasing utilization of these organs that are currently being wasted on an annual basis. We did this systematically through 3 verticals: lung transplant, heart transplant, and liver transplant. What are the results? What is the impact? We've done all that. We spent all this time, all this money. What is the impact? The impact is very clear. It's very binary. The OCS is associated with the highest rate of organ utilization of solid organ in the history of organ transplant. We moved lung utilization from 23% to nearly 90%. We moved heart utilization from 30%- 80%.

We created an entire de novo new transplant category called heart transplant from DCD donors, meaning heart that stopped beating for 30-35 minutes. We were able to revive them, resuscitate them, and make nine out of every 10 hearts successfully transplanted with excellent post-transplant results. 3 years ago, there was no such thing as DCD heart transplant. Today, DCD heart transplant is the fastest-growing sector of the market in heart transplantation in the U.S. and around the world, and it's only thanks to the OCS and the TransMedics platform. Could we double lung and heart transplant? The answer is absolutely yes, based on these results, not my prediction. How are the outcomes? How are the clinical outcomes of these additional organs that we're adding to the pool? That's what this slide shows.

We throughout the same studies that I shared with you earlier, we not only looked at the impact of utilization, but we also looked at the impact of post-transplant complications, severe complications that would add cost to the therapy, would add length of stay, et cetera. We've demonstrated that using the OCS, we were able to reduce these complications in range of anywhere between 50%-84% across all three disease categories. For lung, it was 50% reduction, for heart it was 65% reduction, for liver, we reduced short-term complication and long-term complication by 43% and 84%. That... This is huge. Now you say, "Okay, you... We developed the technology.

FDA approved it, we demonstrated significant clinical value, we didn't stop here," and this is very important for us and near and dear to us. We didn't stop here because we recognized very quickly with the commercialization of our first organ, which was the lung, that the system doesn't have enough resources to be able to double the organ transplant market with the current way or the historical way of doing organ transplant. TransMedics jumped in, as we always do, and created a whole new paradigm. Think of what I'm gonna talk about now, which we're calling the NOP or the National OCS Program, simply stated, TransMedics is creating the Amazon Prime model for organ transplant under the NOP. That is what we're doing, we will show you the results. What is the NOP?

Think of the NOP as a combination technology, clinical and surgical services, and logistical coordination of everything that takes place from the minute a donor is identified to procuring that organ, placing it on our technology, managing that organ, organizing logistics, private air and ground transport from donor to recipient, anywhere in the United States to any center, transplant center in the United States. The benefits are three things: maximize transplant volume for that center, enhance their clinical outcome, and reduce the learning curve that happens when you're using a very sophisticated technology, in the hands of, you know, a very busy transplant program. The ultimate outcome is this transplant program sees significant revenue and volume growth without the historical limitations that existed in transplantation: time, distance, infrastructure barriers, resource barriers.

One very unique and very distinguished factor is maximizing work-life balance. We're taking transplant to the 21st century. It's no longer just about the clinical indication. It's the clinical indication and doing it in a humanely hour with a much more scalable business model for the transplant center, so they don't have to do transplants in the middle of the night. We can maximize the efficiency of the human capital of this transplant program. Again, where does TransMedics play a role? Right there. This is the Amazon Prime of organ transplant. TransMedics is working hand-in-hand with major transplant programs across the United States and major organ procurement organizations across the United States. We have a 1-800 number manned twenty-four/seven by a team of dedicated coordinators.

We get a call, we mobilize three things. We mobilize a surgeon, a clinical specialist technology, and organize all logistics, air and ground. We go to Anchorage, Alaska, to procure hearts, lungs, and liver, bring them all the way to Tampa in Tampa General Hospital in Tampa or Massachusetts General Hospital in Massachusetts. We take care of the entire process, soup to nuts. At the end, from a business model perspective, we charge for our technology cost. In addition, we have a premium for the service cost. The logistics cost, air and ground, is a pass-through to the transplant program, as they do today. All the costs associated with the NOP, technology and service, are all reimbursed 100% by both CMS and commercial payers. There are reimbursement mechanisms in place. We don't have to create a new DRG or a new CPT or anything like that.

Organ transplant is very unique because of the huge economical benefit of an organ transplant and all, everything we talked about is fully reimbursed. How do we run the program? How do we cover the entire United States? How do we create the Amazon Prime out of Andover, Massachusetts? We don't run it out of Andover, Massachusetts. We're headquartered in Andover, Massachusetts, we have 16 hubs across the United States, where each one of these hubs have technology, surgeons, clinical specialists who are on call 24/7 to respond to the 800 call that we get from a transplant program. It gives us broad geographical coverage on literally accessing any potential donor, not just across the continental U.S., Puerto Rico, Hawaii, and Alaska.

This is some example of missions, transplant missions that TransMedics fully supported through the NOP up until end of Q2. You can see times and distances here that are can never be achieved with historical ways of doing organ transplant. You know, long distances, long hours, across the United States. We're not keeping that a secret. We have championed the education to all members of the transplant stakeholdership. from government, CMS, HHS, UNOS, but also all commercial payers that are involved in organ transplant, to increase awareness of the NOP, increase awareness of the importance of NOP to increase organ supply. Why is that important? Because these payers, whether CMS or commercial payers, pay hundreds of millions of dollars in annual basis to keep patients alive, waiting for an organ transplant.

They're highly motivated to do more transplants. CMS issued that guidance early 2022, asking to double it, number of organ transplants in the United States. Again, we like to point to our track record. The NOP has been the major catalyst for our growth in 2022. These are the public numbers for the sequential growth. You know, in February, we'll reveal the number for Q4 and the total year. You can see significant growth year-over-year. Our cash position has been buttressed with a raise we did in August, so we feel in very good shape. Our gross margins, at least as the final reported in Q3, were in the low 70s. We expect the fully operating, you know, growth.

Mature gross margins will be in the mid-70s. You know, you see the growth. You say, "Okay, TransMedics, we, you know, is this it? Did you reach the pinnacle?" We think absolutely not. We're just getting started. You know, this performance that I just shared with you represent less than 5% penetration of the existing market, and we have a long runway to even double that market. To give you an example, the current market is about 15,000 transplants between lung, heart, and liver. We're gonna probably end 2022 with an 1,000 or 1,100 transplant. That gives you the magnitude. We have a long runway of growth. How are we gonna capitalize on that near term and long term? Near term, there are three major laser-focused initiatives.

1, expanding the capabilities of the NOP, both manpower, clinical power, and logistics. 2, expanding the number of centers that are using NOP. 3, expanding adoption or increasing the utilization of within the existing centers and growing the overall number of transplant within these centers. Long term, we're gonna add additional clinical indication, for example, kidney transplant. We are in the process of securing European individual geography reimbursement coverage. We're developing our next-gen platform that will take the OCS into another decade worth of growth and pioneering that important area of medicine. You know, I'm sure many of you who follow TransMedics also have seen some of the potential competitors out there.

We're here to share with you our view is there are no competitors to TransMedics when you apply the big, large, deep mode called NOP. No other platform that exists today or even in development is portable enough to be able to compete with us in the NOP. More importantly, any company that has the dream to compete with us in technological basis, they better have the resources to do NOP. It's not easy. It's highly cash intense, and it's built on relationships. It's built on trust. It's built on quality of care. We've delivered all that, evidenced by our growth in 2022, and I'm hoping to replicate that in 2023 and 2024. Finally, the message I wanna leave with all of you is TransMedics is a significant growth opportunity.

We're extremely humbled and excited by our growth in 22, but we don't think this is the be all end all. We think this is just the first step in the right direction. Why do we believe that? We believe we're well underway to transform the standard of care based on a disruptive technology. It's first and best of its kind. Unique integrated NOP solution that nobody can replicate easily. We have established U.S. reimbursement. We have a robust FDA of PMA-approved indication and a pipeline of new clinical indication. The NOP doesn't move TransMedics from a supplier of technology to a more integral, integrated partner to the transplant program as a part of the workflow, all fueled with a multibillion-dollar market opportunity that is, that is in the niche of organ transplant.

TransMedics have created that by creating this class of technology and class of service called the NOP. We're very humbled by the growth, but we think this, you know, this is just the beginning of a multiyear, long runway of growth for TransMedics and for the transplant community in the U.S. Thank you for your time and, you know, look forward to taking your questions.

Allen Gong
Analyst, J.P. Morgan

Thank you for that, Waleed. You know, I know you made it very clear that you weren't pre-announcing. It was very clear that there was no number on that graph. If we could just talk qualitatively, right, about the quarter, about what you're seeing heading into January. You know, you clearly had quite a good amount of momentum heading into the third quarter, but you also highlighted that you wanted to be a little bit cautious around the state of your capacity to actually supply all the demand you were seeing. You know, on a qualitative basis, relative to, you know, some of the concerns that you had relative to the momentum that you had, how did your performance progress into fourth quarter, and what are you seeing, you know, in the first week of January?

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

Again, without Allen is a, you know. You know, without revealing anything, we're very confident in our ability to execute. I would leave it at that. You know, the other cautionary statement I would put out there, I know some of our coverage analysts publish monthly transplant numbers. Don't get distracted by the monthly transplant numbers. They mean nothing. Organ transplant monthly numbers they'll do like this. Look at the quarter-to-quarter numbers. That's number one. Number two, I highly recommend to look at the OPTN and UNOS webpage and see that the heart and liver transplant overall national numbers have grown this year over this year being 2022 over 2021. We played a key role in that through the OCS, DCD, and the NOP.

I'll leave it at that.

Allen Gong
Analyst, J.P. Morgan

I guess... Sorry, gonna poke at it a little bit more.

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

Sure. Sure.

Allen Gong
Analyst, J.P. Morgan

When it comes specifically to, I guess, the supply and capacity, right? You were making efforts to really enhance your manufacturing to see that you could, you know, really generate the amount of product to meet demand. How have those efforts gone?

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

We started these efforts, as you know, Allen Gong, in Q3. We continue to put a full court press. This is obviously one of the biggest area that the entire team has been focusing on for the last two quarters, and we'll be focusing on it for another two quarters. I segment it into three areas. One, we added three times the production floor capacity that we originally had. Two, we've more than doubled our assembly staff. Our issue is not about raw material or access to semiconductors. Our problem is the demand in the field far outstripped our ability to have finished goods inventory in the shelf. We need to produce more of the disposable that generates the revenue per transplant. We've quadrupled our entire footprint for production.

We've doubled our manufacturing staff, kept them onto two shifts because we're still not leveraging the new clean room yet. It's going through the FDA qualification process now. Hopefully by end of Q1, beginning of Q2, we'll have that qualification process behind us, and Q2 will be staffing that new space from the second shift that we've been implementing in Q3 and Q4. That second shift really is the secret of why we suffered from back order situation, but we continued to perform, we continued to support our centers in Q3 and Q4 because of that second shift. If we hadn't moved quickly to build that second shift, probably our performance would have been impacted, but we were on top of it.

Our goal is by summertime 2023, this supply constraint is gonna be thing of the past, and then we'll be looking at the, at the next frontier of building additional manufacturing capacity, fixing the logistical problems of air and ground transport, which again, we're focusing on the next wave of growth, how are we gonna mitigate against that risk. The last vertical that we've been doing is we've added leadership, new leadership, new middle management to the operations team at TransMedics to focus on scalability, adding new automated processes, forecasting to make sure that we are never surprised by increased demand in the future.

Question in the audience?

Speaker 5

Yeah, sure.

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

Sorry. Microphone, yeah.

Speaker 5

Thanks. On NOP, could you help us understand the marginal economics? A couple of things there. How do you charge for that, and what does it cost you? If you think about your NOP capacity, like how many organs could you potentially procure per quarter? How do you quantify that?

Stephen Gordon
CFO, TransMedics Group

Yeah. It's a lot of detail. I mean, certainly the service component of our NOP has a lower margin than the device. Really, we've installed this NOP as a method to increase the sale of our devices. You know, as Waleed showed, our blended margin is 72%. The product margin is quite a bit higher than that. The service margin is lower than that. There's still reasonable margin on the NOP. As far as the capacity, also, you know, those 15 hubs are outfitted with a cardiothoracic surgeon and abdominal surgeon. We have about 13 cardiothoracic surgeons on staff. We have about seven abdominal surgeons. We supplement that with about 20 to 30 contracted surgeons.

We still have quite a lot of capacity in those surgical resources and clinical resources, but we're not stopping where we are. We're gonna continue to grow those throughout 2023. We probably need at least 20 cardiothoracic and 20 abdominal surgeons.

Speaker 5

Is the attachment rate of your NOP programs to your existing customers, what is that? If we think about just the incremental growth you're seeing quarter-over-quarter, is most of this coming because you have NOP or once you implant that NOP, I think the hospitals take-

Stephen Gordon
CFO, TransMedics Group

Yeah, I would say pretty much today, NOP is the business model. It's really approaching 90% across each organ. You know, some of them ramped a little faster, but at this point, this is the business model going forward.

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

Tamer, can you comment on the stickiness of the NOP customers?

Tamer Khayal
CCO, TransMedics Group

Yeah, most of the customers that use NOP are repeat customers. That's why the NOP grow. That's why our business grow. We believe, and we've shown data that without it, we would have been stagnant, like the clinical trial rates. Commercially speaking, now everybody using our product through NOP is continuing to use it. We've never had a customer that.

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

It's, yeah, it's 100%, basically.

Speaker 7

What % of your OCS customers have NOP today?

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

Ninety.

Tamer Khayal
CCO, TransMedics Group

90%.

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

90%. All new customers are NOP. We no longer offer direct acquisition. Direct acquisition is limited to literally, less than a handful of historical centers, small volume centers in the Midwest that have been a part of our trial and had acquired the technology as a part of the trial, and they're just still at that model. All new centers are NOP 100%. We don't allow direct acquisition model anymore.

Speaker 5

Okay.

It's 100% of your revenue now, I guess, or close to that is NOP.

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

About 95%. Yeah.

Speaker 5

Can you talk about, I guess, the recurring part of that revenue stream, if any?

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

Yeah.

Speaker 5

I'm assuming there's some recurring revenue in current.

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

Of course.

Speaker 5

What % of that revenue is recurring?

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

Hundred percent. Hundred percent. Whatever we make in Q3, you know, we need to generate more transplant to make that and grow it to grow that revenue. All of our revenue is procedure-based revenue. We charge $70,000-$80,000 per transplant. Whatever you see, Jim, is all, you know, recurrent, you know, revenue coming from this, either new centers or existing centers doing more transplant, either within the existing volume or growing the overall volume. The vintage of that account dictates if they're growing their overall volume. Centers that adopted NOP earlier in the year, they're finishing 2022 with higher volume than last year. Centers that adopted, say, in Q3, You can see an incremental, but, you know, it's really within their existing volume still.

just, it's only a matter of time. We just started this a year ago, so we expect to see that same aggregation happening in 2023 and 2024.

Speaker 5

I guess maybe, if I can ask it a bit differently.

It's a service, it's a service model, and so is there a service component to it? I mean, I'm just trying to understand how you charge-.

Stephen Gordon
CFO, TransMedics Group

Yeah. We think about.

Speaker 5

-your customers, and then is it like not-

Stephen Gordon
CFO, TransMedics Group

You think about.

Speaker 5

We're talking about kinda Amazon Prime. Well, you know, we all pay $120 a year. That's obviously recurring.

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

Yeah, yeah.

Stephen Gordon
CFO, TransMedics Group

That's not how our model works.

Speaker 5

Okay.

Stephen Gordon
CFO, TransMedics Group

Our model is per transplant. For every transplant, we're selling the device and we're selling a service increase on top of that per transplant. The nice thing about it is every sale we make is also a live save, and every sale we make is a device and it's a service component.

Allen Gong
Analyst, J.P. Morgan

You know, I think for us, right? The idea of the NOP kind of feels a little bit like a no-brainer, right? You're taking the burden of really procuring and transporting organs away from the transplanting center. You know, unfortunately, you're not at 100% penetration yet. To us, it really feels like it could be something that every center should find valuable. You know, if there's any pushback, if any, when you're going to new centers, you clearly aren't at 100% yet. What is the concerns? What are the concerns, I guess, that you're trying to address before you can really expand into new accounts and new centers?

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

Sure. I'll start, and Tamer, please weigh in. I think we need to take a step back and recognize that we're only three quarters into this. We're confident that all major transplant program will convert to NOP over the next year or two. That's not a question. That's only a matter of time. There is our biggest commercial effort, in addition to staffing the NOP and doing the cases day in and day out, is really education. Education mainly to transplant programs that have not heard about NOP, to transplant administrators that their surgeons heard about NOP, used NOP, but they're trying to understand what is this $20,000 extra NOP charge, the service component, in addition to the OCS cost. That's what Tamer's team is great at.

One last educational piece, and it's very straightforward, is really educating the transplant administrator of how to bill through the existing reimbursement mechanisms to recoup their money and even make profit.

Speaker 6

Tamer, you wanna comment?

Tamer Khayal
CCO, TransMedics Group

Yeah. We're disrupting a field that's been stagnant for 40 years. To do this at three quarters is not the end of the world, it's just the beginning. As Waleed said, education is key, clinical education and reimbursement and administrative education, because to transform the field, you need to show them the way, and that's what we continue to do. It's taking some time, but at the end of the day, as you said, Allen, and as we've been saying, there's no way a center can increase their volume, maintain their quality of outcome, and meet the metrics that they're under to continue to be a center of excellence for transplant without using NOP and OCS. There's just no way out there.

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

We have tangible examples of that, guys. This is not a hypothesis. I mean, to give you one example, the largest experienced center of using OCS in the heart vertical is Duke. So Duke in April, in the middle of the International Society of Heart Lung Transplant meeting, they said, "We, yeah, we love the OCS. We are. It's a big portion of our transplant volume. It's more than 75% of our volume. We are the world expert in using OCS. We will never use the NOP." Guess what? Duke is 100% NOP, heart, lung, and liver. It's a no-brainer. It just takes the time. They tried it once, twice, 3 times.

All of a sudden, now their administrator is insisting that they have to use NOP because they're no longer having these huge workforce problems with perfusionist refusing to work in the middle of the night to manage organs, and it could be delivered to them, at, you know, whichever time they need to do the surgery. Their liver transplant program took off, and now they're 100% NOP. It's only a matter of time.

Tamer's team is doing a great job in keeping the awareness and education going. You know, we're dealing with this temporary, supply problem right now, so we're kinda focusing on servicing our existing account. Once we are we put that supply thing behind us, you know, as I said, one of the major vertical for growth in 2023 will be adding new centers and going deeper in existing center and growing the overall volume for all centers that are using NOP.

Allen Gong
Analyst, J.P. Morgan

Got it. I think, you know, one question that, you know, I still have, and as I think at least some investors still have as well, is sort of the mix of organs that people are really using the OCS for, right? Because I think one of the really clear value propositions is the fact that you can, you know, transport organs further and really start attacking expanded criteria.

Especially for organs like heart, where this traditionally just wasn't possible.

When we think about adoption-

You know, you haven't provided this in the past, but how should we think about the mix of usage of OCS between standard criteria and expanded criteria? Is it more on the expanded side, and then you gradually kind of increase usage in standard criteria? What does the adoption curve look like at a new center?

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

That's an excellent question, Allen. For us, we like to see a healthy mix of both, because the only way we can grow the number of transplants is we need to see some of that red part of the bar chart being used. We're seeing that, and we're monitoring that on daily basis. We have an OCS Connect app. We're looking at every organ that is being done in the NOP. Is it the DCD? Is it the DBD? Where is it? Where is the donor? Where is the recipient? That gives us quickly an understanding of the distance between the donor and recipient. What NOP created is a new indication that we hope to see, but we saw it a lot faster than what we anticipated. The new indication is they're no longer just looking at the clinical indication.

They're... Sometimes it's even secondary. What I'm referring to is the logistics and work-life balance aspect of the NOP. We're seeing major transplant institutions saying, "We're not gonna say no to any organ. Send the NOP team to get us the organ. Bring 1, 2, 3, 4... sometimes four organs a night. Stagger them overnight. We'll do the transplant procedure starting at 6:00 A.M. instead of 1:00 A.M. or 2:00 A.M. in the morning, as historically been. We're not gonna turn down a single organ because our OR is busy. TransMedics have the staff. They're gonna stay with the organ, and when we're free, we'll do the transplant." That's what we're seeing centers that are really adopted deep in the 50 to 60, 65% penetration grow their transplant volume by 30%, 40%, 50% in 2022.

It's only a matter of time when other centers get to that. To answer Allen's question, it's a healthy mix. I would say it's 50/50. We like to see that. Two, there's a new indication, which is logistics, work-life balance, management of OR resources at these major transplant institutions that now, you know, in the post-COVID era, they're trying to kinda balance between scheduled procedures and transplant emergent procedure, and the NOP give them that flexibility to do that.

Tamer Khayal
CCO, TransMedics Group

I'd like to add, that NOP, as Waleed said, is not just proving simplicity of logistics, but that kind of discrimination of indications that used to happen before the use of NOP and OCS is out of the door because now OCS is rendering every organ non-extended. That term extended is on its way to the wayside. It's gonna fade out. Plus, NOP now is giving the latitude to every transplant center to go after any organ. That terminology is really out of the practice. They go after any organ. As Waleed said, it's a very healthy mix that we're seeing, nearly 50-50 split between what used to be called routine organs and extended criteria organs.

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

One simple example, we mentioned this earlier in our meetings, in one-on-one meetings. Anchorage, Alaska donors historically and Honolulu, Hawaii donors historically have not been utilized for transplant in the West Coast of the United States. If they are, they are utilized once or twice a year. Today with NOP, it's routinely our team is flying to Anchorage, Alaska for hearts, lungs, and livers through the NOP. Routinely, we're flying to Puerto Rico. Routinely, we're flying to Hawaii. I'm using these very long examples because historically these were organs that transplant programs would call them extended criteria because of distance. They're no longer calling them that because they know the NOP team is gonna get it for them. That's what Tamer's talking about.

That transition, we're excited to see it happen that rapidly, but we really think this is just the beginning. We're going to see that grow even more in 2023 and 2024 and beyond. That's what excites us about the future and the growth potential here for this business and the NOP as a catalyst to that.

Allen Gong
Analyst, J.P. Morgan

Does anyone have any questions? We have a few minutes left.

Speaker 6

How much of the capacity constraint is finding the medical professionals that you need? You said before about the NOP has the staff.

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

Right. Right now, we have good capacity. We're not satisfied, because where we wanna go is, you know, as I stated, if we end at 2022 with 1,000 or 1,100 transplant, we wanna in 4 or 5 years from now to be doing 7,000-10,000 transplants. We gonna ramp up to that. It's not a constraint today, but it was a constraint early on where we only had 1 launch point with 1 or 2 surgeons, and we were getting calls from all over. It's becoming less and less, but we're continuing to invest in that team. For example, we grew our clinical specialist group from 20 people to nearly 85 people. For us, that represents the sales team.

We don't have a sales team. We don't have a traditional sales team, but we have an 85 person strong clinical team that is well-honed to use to operate the NOP across the country. That's what's driving our revenue.

Speaker 6

Can you just talk about reimbursement? Maybe just as a follow on, just in terms of, I guess, distances in NOP, maybe talk a little bit about the opportunity outside the U.S. and what are some of the challenges there in terms of opening up NOPs, in different countries?

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

Sure. Reimbursement in the U.S. is pretty straightforward, Jim. In the U.S., because of the huge health economic benefit of an organ transplant compared to medical therapy or mechanical circulatory support, CMS and commercial payers pay for organ transplant in the same way. They pay for a procedural cost. It's DRG for CMS or a case rate for commercial payers. For heart, lung or liver, it's approximately $800,000 all in reimbursement. In addition, there is a separate budget called Organ Acquisition Cost Center, only dedicated to organ procurement, preservation, and testing on the donor. They separated these two budgets because they wanna promote more organ transplant. They wanna incentivize the centers to be more aggressive and go out on more organs, because for them, that's a cost-saving procedure. They separated these two.

All the costs that we talked about, technology cost, transportation cost, and NOP cost, comes from the Organ Acquisition Cost Center. That's why we're focused our effort, laser-focused our effort in the U.S. because reimbursement exists. We are gonna turn this business cash flow positive in the U.S. alone. Internationally, the challenge is reimbursement because you need to fight the reimbursement battle per geography, and sometime countries like Italy or Spain, you need to do the reimbursement battle within the region. We've been at it for several years, and we expect to see that as a catalyzing growth mid or, and long term. We're in Europe, we're in the Middle East, we're in Israel, we're in Australia, we're in Hong Kong and Taiwan.

We have presence OUS, our overall revenue, approximately 15%, 20% of our revenue. 15%?

Speaker 6

Yeah. It's getting lower.

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

It's getting lower with our OCS growth. Is international. The ability to replicate NOP outside of the U.S., we will never be able to replicate it exactly like the U.S. outside the U.S., but we have successful examples in the Netherlands where we... the government financed the entire program. We train their team, we give them the workflow, and they've grown their heart transplant volume by 40% last year. Now we're being approached by other geographies like the U.K., Germany, to try to do something, what we call internally NOP Light, something lighter than the full bore model that we have in the U.S., just because of the reimbursement issues and the, and the legislative issues within these geographies, having third-party managing organ procurement.

Speaker 6

Unfortunately, as much as I would like to keep asking questions, we are out of time. Thank you all for coming today.

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

Thank you.

Speaker 6

Thank you to the management team for

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

Thank you.

Speaker 6

being here.

Waleed Hassanein
Founder, President, and CEO, TransMedics Group

Thanks.

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