Hi, good afternoon, everyone. Thanks for joining us. My name is Matt Sykes. I'm the life science tools and diagnostics analyst at Goldman Sachs, and I have the pleasure of having the senior management team from CareDx joining me today. Reg Seeto, President and CEO, Abhishek Jain, CFO, and Robert Woodward, Senior Vice President, R&D. Reg, Abhishek, and Robert, thank you very much for joining us.
Thank you.
Thank you, Matt. Thanks for the chance to be here.
Great. Maybe, I think it'd be helpful for you, Reg, to kind of set the stage first. Maybe for the benefit of the audience, talk a little bit about where, who CareDx is, market you serve, and then kind of some of the trends that you're seeing in your business and over the course of this year.
Yeah, CareDx is a company that's been around for more than two decades. We're a company that's 100% focused on transplant, which is fairly unusual in the sector itself. We're a company that really has focused on how do we bring innovation and drive a difference in patient outcomes, and it's really been central to our mission over the last, you know, two decades. The one thing that we have evolved as a company is our vision, which is to be the leader in the transplant ecosystem and to be a leading partner. There, what we hope to do is bring along a series of offerings on the pre, peri, and post-transplant patient journey. It's been something that, you know, over the last, you know, two decades, has been our entire focus as a company.
Great. Maybe, you know, obviously, there's been a pretty significant change. We had recently the articles of billing from MolDx in March. Maybe could you help one, kind of summarize the issues that prompted this change, the steps that you're taking to modify your approach and kind of the impact on CareDx in terms of growth and the business moving forward? Just kind of, I think everyone would benefit from sort of an education of the issue, more broadly speaking, and what the impact is to CareDx.
Yeah, no, thanks, Matt. I'll talk a bit about some of the changes, and I'll have Robert, who's been with the company more than two decades and been through every major MolDx approval in our organization, talk a bit about, you know, what that impacts in terms of coverage. I'll have Abhishek talk a bit about the changes to the growth that's taking place as a result of this. Essentially, the billing article came through in March 2nd, and actually, there's been a second billing article that came out on May 7th and on May 4th, sorry. These billing articles were meant to be, you know, clarifications by MolDx. From our viewpoint, we believe these are changes to the coverage.
We believe they're impermissible, they have made a significant difference of how we think of how we run out and operate our business as an organization. We weren't expecting these changes to take place, the last 60 to 90 days have really been a significant change for us as a company as we've dealt with how to operationally implement these changes. The initial expectation was that one would have to contact thousands of healthcare providers, would have to change IT systems at more than 550 sort of transplant centers and practices, one would have to educate all these particular healthcare providers.
To have that done within 30 days, it wasn't something that was reasonable, and it wasn't something that, you know, we expected that we could be achieved during that time. Maybe, Robert, you can cover more of the detail on the changes specifically related to the Billing article.
You know, we've had long-standing coverage from Medicare for AlloMap and heart all the way back to 2006. The donor-derived cell-free DNA, we were the first on the market and had coverage on that for Medicare since 2017. That was in kidney transplant, reaffirmed in heart transplant when they added that in 2020. None of these coverages had limitations that were subsequently introduced by the billing articles, starting with the one that was on March 2nd. These, the billing article, you know, has some impacts where they've made changes to coverage policy, where they have limitations on its use relative to a biopsy.
When these non-invasive tests could be used, and impacts on surveillance use, where they say, if it's gonna be used for surveillance, it must be in where you would otherwise do a biopsy, which wasn't in place before. Lastly, on doing more than one test at a time, whereas the heart, what we call HeartCare, using AlloMap and AlloSure, at the same visit, which has really been enthusiastically adopted by the heart transplant community, was specifically required in previous versions of the Billing article, has since been changed in this version.
All of these are impacts that are to how docs can think about where they and when they can use the test, which is something they've responded quite a bit to, in addition to the requirement that in order to submit claims, we now have to have this knowledge of whether it was used for surveillance or for cause. As Reg mentioned, that we've had to change forms and processes and educate clinicians on how to get us that information.
Yeah, as a reminder, there's been long-established, you know, coverage from AlloMap in 2006 through the LCD process, and then moving on to 2017 through AlloSure Kidney, moving on to 2020 through AlloSure Heart, and then the umbrella LCD in 2021. This has been very well-established coverage, so for something to have happened and the expectation, this very short time period, has led to a lot of, you know, disruption in the marketplace, confusion as well. You know, as a company, we've taken responsibility. How do we lead that education and obviously lead all those different types of changes which have been required and asked for? Maybe you can talk a bit about the impact as well, Abhishek.
Sure. No, thanks, Reg, thanks, Matt, for the question. The impact on the growth will come from, I would say, the three pieces, Matt. The first one is that, as I basically stated in the Q1 earnings call, we are seeing the impact on the volumes.
Based on the new base volumes now, excluding that impact, then of the new base volume, the first piece is that, okay, what is it which is coming on the new TRFs? Because in the Q2 , what we basically are saying that unless we receive the test for the AlloSure Kidney on the new TRFs, we will not straightaway bill and revenue recognize. That's where the adoption date comes in play, and we basically shared that 50%, in the month of April, and that number became 60% in the month of May. Basically, of the newer base test volume, the new TRF % of the adoption, that basically is your one set of revenues, which is pretty solid, I would say.
The other piece where we are still receiving the test in the old TRFs from the older systems, that piece now we will have to go back to the transplant centers, and we will have to get the information so that we are in compliance with the new billing article requirements. In my mind, that would still be a lag because we will basically go back and it will take time to get that information, and then we will be able to bill and revenue recognize according to the ASC 606 rules. There will be that impact from the revenue standpoint.
The last piece, I would say, from the growth impact standpoint or the revenue impact standpoint, what Robert was saying on the multimodality, especially on the HeartCare, though Noridian has not adopted the article, we need to basically make sure, okay, what happens once and if they were to adopt on the, on the multimodality side.
Got it. Maybe it would help to kind of differentiate the content of the two billing articles, the March second and the May fourth, and what kind of the difference is between them and what is sort of like, you know, was May fourth an update, and that's what you're following, and sort of how you're defining each of those?
Yeah, the May fourth supplants or replaces the March second billing article. You know, the May fourth was an improvement, but still, that's not enough for where we came from in terms of the established umbrella coverage that we had previously. Some of the major changes was that, as Robert mentioned, there had been this requirement for, you know, surveillance testing being done in lieu of a biopsy, but only if the center had an established protocol. What's opened up there now is that it can be a physician-based protocol, and so in that individual ability of physicians now to make those decisions are being brought back. One of the second changes was this requirement of having seven days.
You cannot do a test if a biopsy was being done in a certain window period of seven days, and so that 7-day period has been taken away, and so that timing element has been removed. The third area that came through is there was gonna be a medical appeal if you gave two tests together, for example, HeartCare. That medical review has gone away and allows us now to go directly to appeals as part of that. Some of the other areas, which I think on the pre-testing side, was helpful, as well as opening up the ability to say if you had the risk of rejection versus saying you had to have rejection as part of that pretest criteria.
While there's been some improvements from March second to May fourth, it's something that we continue to have discussions with the relevant, you know, parties to see if we can, you know, change those as well.
Abhishek, I think you might have mentioned something, but is there any clarity on the timeline for Noridian potentially adopting and issuing the new billing articles from MolDx?
Yeah, I can take the question.
maybe for Robert, yeah.
Robert made the comments. At least I don't know what timelines they have or what they're thinking as of this time.
Certainly, it hasn't happened as of today.
Got it.
Okay.
All right. Yeah. Maybe for you, Robert, do you see commercial payers changing how they reimburse as a result of these changes? I know this is Medicare-focused, but any kind of reaction from commercial payers?
We haven't seen that there's a response of commercial payers to, you know, anything specific about the billing article. They tend to have their own, separate, you know, evaluation when they make decisions about coverage.
Yeah, I think the one thing is actually, since the Billing and Coding article's come out, we've actually added some regional plans, both on the heart and kidney side. As you know, doing, you know, commercial coverage doesn't necessarily directly link back to CMS or slash MolDx coverage. Some of the requirements there are different in terms of data, in terms of what you present, in terms of guidelines, in terms of what you present, in terms of different publications, health, economic outcomes, et cetera. That's why on the heart side, we've established a very broad commercial coverage, in that setting as a result of the great, you know, efforts we've put towards market access in building that sort of, that infrastructure area that we really stand out to on the heart side.
Got it. Maybe could you talk about the backlog of AlloSure Kidney Test claim for submission, claim submissions, where you stand today, and, you know, what that backlog could look like in the future quarters?
Sure. I'll take that one. I had basically shared in Q1's call that we had not billed approximately 3,200 tests for the AlloSure Kidney, Medicaid only, and we were planning to submit in Q2. I'm glad to let you know, and we have actually updated our presentation also on our website, that we have now submitted those March tests. The 3,200 tests for AlloSure Kidney have been now submitted. As far as the backlog going forward is concerned, there wouldn't be a backlog of this kind of a particular test, given the fact that we are going to be billing based on what the billing requirement says.
For example, if there's a new TRF that comes in a test with, then, of course, you can straightaway go ahead and bill that, and there won't be any backlog for that. If something is coming in the old TRF, Matt, in that scenario, you will need to go back. You, the way you should see it, 1- the adoption rate, that is the test that you need to supplement, and that test will be the only backlog. I just want to underline the fact that we should also think that this is purely for the AlloSure Kidney and the AlloSure Heart, Medicaid-only test. When we are doing the modeling.
Yeah, just to dimensionalize that, I mean, I think we've shared in our earnings that, you know, 50% in April of tests had migrated over to the new forms, and that was due to the great work and effort of our teams, you know, educating physicians and getting these forms updated. Then, by May, at least the first week of May, we reported that was around 60%. We're on target towards this 80%-85% in Q4. I just want to give a real, you know, shout-out to our team because, you know, basically, you had one billing article, then you had another billing article, and during that period, you had to educate so many, you know, physicians.
Yeah
Healthcare providers with multiple interactions. Some of these institutions, you know, have, like, 20 different healthcare providers. You just don't go there once. You have to go there multiple times. One of the biggest bottlenecks has been the operational limitation of IT systems. You know, as we, as we roll this, you know, process out of getting these TRA forms done.
Okay.
The IT hurdles, are still there for some centers where you can't automatically expect the emails to be updated.
Got it. Abhishek, you talked about sort of the impact of test volumes in April.
Mm-hmm.
It fell in sort of the mid-teens. Has this trend continued, and how should we think about test volume growth for the balance of the year?
Yeah, I would say that the number that I provided, it's been, what, like, three or four weeks ago, right?
Mm-hmm.
It's been pretty recent, and that was the early lead indicator, but, we were basically, we had another billing article, in the beginning of May. I would say that the volumes have been shifting around, so I will let the dust settle a little bit, and then we will provide further update in our next earnings announcement.
Got it. One key area of the debate, you know, has been the frequency of tests. How do you see frequency being, on the kidney side, being impacted longer term? What do you think is the correct kind of cadence of annual tests, assuming we don't go all the way to for cause?
Yeah, I mean, I think one thing to remember, being a physician myself, is that there's a huge unmet need in the transplant patients. You know, one in, you know, five kidney transplant patients will fail within five years. one in three heart transplant patients will fail within five years. One in two lung transplant patients will fail in that 5-year period. One thing is for sure, is that you can't really tell when that organ is going to fail. If you did, it'd be much easier, everyone wouldn't have organs failing, right? It tells us that, you know, there has to be this, you know, this monitoring assessment of patients on a regular basis. Now, most centers, there's only 200 centers in the United States.
If you do that overlap of Venn diagram, you know, majority of those, 200+ are on the kidney side, about 150+ on the heart side, about 60, 70+ on the lung side. If you look at that Venn diagram, most of them have what they call existing protocols, and those protocols go through what should be monitored, whether it's biopsies or whether it's looking at different blood tests or whether it's looking at different, you know, other forms of commonly established, clinical testing they'll do as part of that process. I think, you know, the goal of what we've brought to the armamentarium and physicians is really that ability to fix and incorporate as part of that process. That process is center by center.
Many people think that if you're seeing, you know, a transplant center and you can relate that to many others, it hasn't been the case. What we've tried to do is help with the standardization across those, you know, 200 + centers and bringing, you know, what we think would, you know, be something that can be added to the armamentarium as well. What we've seen during this process of Billing and Coding article is each center is going through their own process. It's very much a center-by-center approach. First, with the education, then the operational implementation, and then they're saying, "Let us revisit how we now incorporate this as part of our, you know, protocol within that system and institution." It's something that, you know, we're seeing good progress.
What reassured me during ATC, which is the world's, you know, largest conference on transplant, was the fact that, you know, physicians just coming out and saying: Look, we really need this test, really believe in this test. We think it's critical in the way that, you know, we assess our, you know, and monitor our patients and how we continue to do the right thing by patients. It was really, you know, to me, I spoke with over 100 physicians at the meeting, and really hearing that was really, you know, really meaningful to me as the CEO of the company.
Got it. You talked about in March that you're, you know, you were gonna update the HeartCare submission to MolDx. Any update on where we stand there or?
There's several publications that speak to the clinical validity and clinical utility of using HeartCare, the AlloMap, and AlloSure tests together to significantly reduce the use of invasive biopsies relative to either test alone. We've prepared those in the standard technical assessment format for MolDx, and they're under consideration.
Any timeline on what we should expect?
Well, it's very hard to put a timeline with those guys.
Okay.
I would just add one thing. I mean, at ATC, once again, which is, you know, the world's largest transplant conference, there was discussion on all the different types of approaches in how you look after, you know, transplant patients. In one particular symposia, one of the leading institutions in the United States talked about how they used HeartCare to reduce their biopsy load by more than 85%. It truly was an impressive number, if you think of how biopsies were very much the standard in the past in this field on heart transplant, and how this leading institution actually had an 85% reduction. It's a good reminder of how technology can be used to evolve standards.
Got it. Abhishek, just on the restructuring that you announced in Q1, reducing headcount by 12%, $40 million-$50 million annual cost savings, are you still expecting it to phase in at sort of the 25% in Q3, another 25% in Q4? Do you see the need for contemplating further cost savings initiatives beyond this?
I think, taking a step back here, I think from the philosophy of the company's standpoint, that we would want to be a positive adjusted EBITDA company, and, therefore, we basically started to take the actions as early, as soon as we basically started to see the impact of the Billing article, and we announced that we are taking steps to reduce the expenses by $40 million-$50 million. For example, on the headcount side, the 12% reduction that I spoke about, we have already taken the actions, and most of that restructuring will be complete in Q2 itself. That impact will start to show up in Q3, and similarly, some of the other actions around the discretionary spend and all will start to see the impact in Q3.
From that standpoint, I think we are on track to be able to start to see most of the $40 million-$50 million annualized savings that will start to show up in Q3 and some in Q4. We stay on track to achieve those cost-saving goals.
Got it. Do you expect these cost savings initiatives to impact either R&D or sales and marketing spend, and how are you managing that?
The cost savings are going to be basically across every single line in the P&L, the COGS line as well, because there's a volume reduction impact. Then, of course, we are also taking other actions to take care of some of the fixed component of the COGS. Also, we are looking into the R&D, S&M, and the G&A, pretty much every nook and corner there. My sense from the R&D and SM standpoint, that R&D is where we are trying to prioritize the important projects that will help us drive the revenues or get the coverage. That's how we are looking at the R&D spend.
On the S&M side, we are looking to see as to, okay, how do we take care of the channel strategy, and what are the ways to kind of, be more efficient and effective. We will definitely see impact in both R&D and the S&M line.
Okay. Just focusing a little bit more on the market, how do you see your penetration in the market and competitive advantages potentially changing as a result of some of these changes that have happened, and/or your restructuring efforts, you know, given that it's impacting each line? What do you see, sort of like, your presence in the market and how that could change or get augmented?
Yeah, it's actually really interesting. I mean, I think during a time of change, typically, we've seen the Billing article, you know, leaders take the chance to lead and to step up. One of the comments that came to me, from, you know, one of our top centers, which actually uses us plus, another competitor, actually said: "You know, I haven't heard from the other company, and it's been months. I've reached out to them, and the one thing that impresses me about your company, Reg, is that as soon as this happened, you reached out to us directly. Within two days, you had not only your CMO, but, you know, your MSL team out there to help educate us about these changes, and that really meant the world to me.
I've reached out to others, but I haven't heard back necessarily." So for him, he actually said, "I am moving, you know, everything to CareDx just because of the fact that you've taken this initiative and you've led from upfront." I do think, you know, time to change, this provides an opportunity. Although Abhishek described this change in volume that we're seeing, I think others have described this high teens, and we'll see how that sort of, you know, smooths out over time. Importantly here is we have a chance to lead, and I think that's really important for me in a space where there isn't a lot of players in the space. We've seen some players actually automatically reduce their efforts across the space. For us, I think this provides an opportunity.
Any time that something like this happens, you convert it into an opportunity. I think if anything, it provides us now a chance to go into and reaffirm our position as a market leader across the 200+ transplant centers in the space.
I'm also curious about some of the conversations you're having with the transplant centers, because the changes seemed to take everyone by surprise, and it didn't seem to be, you know, sort of roundly agreed upon by the transplant centers this is, you know, necessary, or a change that needed to happen. As you've kind of engaged with those clients, clearly, there's some stories about the one that you just told about sort of reinforcing your relationship or strengthening your relationship. Could you maybe talk about how their view of these changes, you know, what has surprised you about that, if anything, but also, can they have any kind of, like, impact on sort of the direction and changes in your business, independent of some of these changes that have been made?
Yeah, what struck me is the level of support, across the board, you know, really saying that how valuable these tests are to their clinical practice, and actually saying, you know, "We don't blame you. We don't see this as, you know, your fault. We see something has changed in with this Billing article." They've actually been very supportive during this time of change. I think one of the hurdles and challenges, though, is there's only a finite amount of time that, you know, physicians and healthcare providers have to be educated. There's only a finite number of time they have to reach out to their IT systems and programs and say: We need you to change and update the system.
There's only a finite number of times that they can, you know, deal with, you know, these changes, particularly when a second Billing and Coding article came out. I think it has been very, you know, chaotic out there with, you know, two changes within 60 days of a, of what we call a Billing and Coding article, expecting that to be implemented in a very short period. I think, you know, again, what we've seen is this strong support, but also, a little bit of frustration as well that, you know, all these changes have to come through and, you know, we were initially given, you know, 30 days to have this all done, then another Billing and Coding article, you know, comes out. I think if anything, it's taught us that the transplant is a small field in some ways.
It's one where, you know, people have long memories, and it's one where they have really appreciated us being committed to the space. They've said, you know, the association support, I mean, physicians, multiple physicians have reached out directly to MolDX, and they've shared that with us. You know, the association support was incredible. You know, ASTS, AST, ISHLT, the level of, you know, patient support that we've had from the patient associations, TRIO, et cetera, was truly, you know, just you don't see that necessarily in every therapeutic area, but the velocity and the strength of that support was just incredible.
You mentioned the patient, I mean, the physician support. As we educated them on what was going on, they reached out and got their own copies of this billing article and made their decision that they needed to write in as well. You know, their letters are all, to MolDX are all posted on their websites, and it's instructive to read them and see that their frustration around the process of how this came about, but also they were all very, you know, upset with the level at which this was Medicare taking decision away from physicians about when they could use covered tests, and having this very narrow specification of use that they had all expressed in their letters.
That their, you know, concern about patient impact and equity in transplantation, you know, expressing that, you know, the government's been moving towards having, at least in kidney transplant, the care moved more towards local community nephrologists rather than tertiary care centers to reduce costs, and this pushes back in the other direction because these non-invasive tests would be less available to the community nephrologists, and patients would end up spending more time in tertiary care centers. It was interesting, the breadth of things that the physicians came up with, that they were worried about that hadn't really occurred to us. It really expands the concern.
Got it. Maybe shifting focus a little bit and just talking about the overall transplant market growth. You've kind of detailed a lot of the sort of the impact on staffing and other things you've impacted. Where are we now in terms of transplant procedure growth, and what is your view in terms of how that's trending?
I mean, long term, we believe that, you know, transplant volumes have the potential to double in the 5 year-10 year period. That's something that, you know, we see there are multiple different, you know, areas that are driving that. I mean, for example, we have on the hard side, different, you know, perfusion, transportation companies working in that space, which will be applicable to other organs. We see the future of potential xenotransplant, which is very exciting. We're seeing government initiatives come into play to try to get more efficiencies across the system, whether it's with OPOs or with nephrologists, managing these patients on the pre-transplant side with LDO. I think there's a series of multiple levers that I think will lead to that. I think what we've seen over the last two years, though, is the impact of COVID.
COVID has certainly disrupted that projection, particularly on the kidney side, where a third of the patients are living donors. That has traditionally been the source of organs, and that hasn't recovered since COVID and remains below pre-COVID levels. I do think the longer-term opportunity is there. I think they've seen some impacts. Certainly last quarter, we saw there was, you know, -3% quarter-over-quarter growth. What we're seeing this quarter is an improvement in that trend, you know, the high single digits on the quarter-over-quarter improvement. We do think, you know, this trend will hopefully continue.
I do think, you know, with all the innovation, including ours in this space and with such critical patients, which have this huge unmet need, that we'll start seeing this improvement and this growth again in the transplant volumes.
Do you think there'll be a change in you said there's not many players in this space, any change in the competitive landscape or the composition of folks that are in this market as a result of these changes? Maybe people find it just too challenging and not worth it to initially participate. You've obviously spent a long, long time in this market, and it's what you do. Do you see the competitive landscape or at least the composition of competitors changing over the next year or two?
I do think there'll be a change in dynamics. I mean, I think we often take the view, you know, which companies will be in three years' time, and do you think there'll be a definitive change in that landscape? You know, we've already seen it in the current, you know, change to the Billing and Coding article, where I think one organization's taken out their sales field force, but kept their medical field force, for example. We do see these changes, you know, taking place real-time, and, you know, there are some companies that I think are taking a second look where they want to be in transplant. Again, it creates an opportunity for us. I mean, there are a finite number of transplant centers and practices that we believe that we can sort of interact with.
We're a highly efficient sort of field organization, you know, for us, the good thing is we've made it known, you know, publicly and to all the transplant community, we've been around for two decades, similar to what Robert's been around with the company, and we plan to be around the next two decades. Hopefully, Robert, you'll be nice and well retired by then. You know, but the point is, they appreciate their commitment, and I do think the challenge for others is that if you're not 100% focused on transplant, it's very hard to stay in this space because what we've done is, you know, we've made so many different investments on this in this transplant space, whether it's pre-track, connecting the transplant centers to dialysis centers to transplant centers, whether it's on the.
you know, quality systems, where we now have one in four centers with our quality systems, whether it's buying the number two and number three EMR systems in transplant, whether it's saying, you know, we wanna invest in the products type business, whether it's looking at, you know, the number one medication discharge form company that we acquired. I do think, you know, it requires investment focus, and I don't think all companies have that patience if they're not all in on transplant.
Okay, before all this started, you guys were making really impressive progress on cash collections. Maybe talk a little bit about kind of where you are today and what, if any, does this have an impact on that? You obviously got a lot of other things that you're doing today, but that was a really good kind of fundamental part of the story that was improving.
Yeah, no, absolutely, Matt. This is, this is one area that we had focused for a while now, then we start to see the results starting Q4 and Q1, where we actually collected 110% cash off the testing services revenues. The way I'm thinking that we will continue to make good progress on our cash collection in the next few quarters to come still, because when I look at the commercial payers, there's still definitely room to basically go back and try to collect more money. We had shared information on some of the Medicare Advantage payers, where we had some of the past outstandings that we have been trying to go back and do more efforts there, so on and so forth.
Of course, on the Medicare side, the collections will be more dependent on how the revenues shape up. My sense is that collections overall would still stay pretty. I would say it will still stay the way it has been in the last couple of quarters and definitely should stay strong.
I think, Abhishek, you take a bit more credit here. I mean, I think we over the last, you know, three quarters, the last 12 months, we had a very specific plan to deliver on for Q1 of 2023, and that involved the 3 Cs, collections, coverage, and catalysts. Collections has gone outstandingly well. This 110%, you know, of collections or cash above our testing services revenues, and we expect that to continue. I think it's really a great analogy, if you go with a billing article, it's a good analogy that if we have to supplement tests like that aren't on the new forms, it's something that we're gonna also bring in, you know, in the future and have those submitted as part of that process. We're really good at operational execution.
I think we would have had an amazing, you know, Q1, absent some of that billing article, where if you factored in some of those tests, we would hit our goal of this adjusted EBITDA profitability. We would have had our highest testing service revenues. We would have had, you know, in conjunction with the highest testing services volume that we achieved during this time. I do think on the collection side, it really is a strong performance that you and your team have done, particularly with that infrastructure, identifying laser focus, how do we build and execute on that.
Perfect. Maybe on the catalyst side, maybe talk a little bit about what we should be thinking about?
Yeah, I'll make some comments and I'll let Robert add as well. I mean, on the catalyst side, we have one of the richest pipelines on transplant, and the great thing is, you know, we have, these submitted through AlloSure Lung, AlloMap Kidney, through that process. We're also really excited by UroMap, which is, a urine-based, test, working with the world leader in this space, Dr. Stan Jordan. An area that at ATC, which really stood out, which is what's hot and what's new, is the field of AI.
The future for us is overlaying so many different areas in the field of AI. We think this has the impact to make a difference on value-based care. We're bringing out more on the AI side in terms of that pipeline, which I think can make a real big difference in this space. I'll let Robert. Robert leads all these amazing initiatives.
Since you ended up on AI, I'll speak to that first. That's where our years of experience is really gonna help us, because as everybody's aware, when you wanna train and develop an AI algorithm, validate it, you need a lot of data. The registry studies, the large trials that we've done over the years have really served us well in creating data sets that enable us to lead on the AI front. As we come out with AiCAV in heart and AI kidney, which will include iBox, AlloView and iBox, all of these products are dependent on these data sets and on our, on our ability to deliver them as a validated tool that the clinicians trust.
You know, one of our collaborators always ends his talks, or at least he used to, with a statement that: AI will not replace nephrologists, but nephrologists who use AI will replace those who don't. You know, that's the view that we wanna bring to clinicians, is that having these tools, and there's enough data now with AlloSure, that that's included in some of them, as a much better marker to be even included in the AIs, really will make a difference. We'll just continue that, right? As we introduce our urine-based tests, AlloMap, not just in heart, but also in kidney, HistoMap for evaluating the true molecular causes of rejection in the kidney tissue. All of these will work together through the AI offerings.
Perfect. With that, we're out of time, but thank you very much. Appreciate you guys for joining.
Yeah, thank you. [crosstalk]