CareDx, Inc. (CDNA) Earnings Call Transcript & Summary

June 13, 2023

NASDAQ US Health Care Biotechnology conference_presentation 36 min

Earnings Call Speaker Segments

Matthew Sykes

analyst
#1

Hi. Good afternoon, everyone. Thanks for joining us. My name is Matt Sykes. I'm the Life Science Tools & 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.

Reginald Seeto

executive
#2

Thank you, Matt. Thanks for [indiscernible]

Matthew Sykes

analyst
#3

Great. Maybe I think it would 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, markets you serve and then kind of some of the trends that you're seeing in your business and over the course of this year.

Reginald Seeto

executive
#4

Yes. CareDx is a company that's been around for more than 2 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 2 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. And there, what we'd hope to do is bring along a series of offerings on the pre-, peri- and post-transplant patient journey. But it's been something that over the last 2 decades has been our entire focus as a company.

Matthew Sykes

analyst
#5

Great. And maybe, obviously, there's been a pretty significant change we had recently, the articles of Billing from MolDX in March. Maybe could you help once to 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 in the business moving forward? And just kind of -- I think everyone would benefit from sort of education of the issue with more broadly speaking and what the impact is to CareDx?

Reginald Seeto

executive
#6

Yes. 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 2 decades and been through every major MolDX approved in our organization, talk a bit about what that impacts in terms of coverage. And I'll have Abhishek talk a bit about the changes to the growth that's taking place as a result of this. But essential to Billing Article came through in March 2, and actually, there's been a second Billing Article that came out on May 7 and -- on May 4, sorry. And these Billing Articles were meant to be clarifications by MolDX. From our viewpoint, we believe these are changes to the coverage. We believe they're impermissible, and they have made a significant difference of how we think of -- how we run on and operate our business as an organization. We weren't expecting these changes to take place. And the last 60 to 90 days has 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 be have to contact thousands of health care providers, would have to change IT systems at more than 550 sort of transplant centers and practices, and one would have to educate all these particular health care providers and to have that done within 30 days. It wasn't saying those were reasonable, and it wasn't saying that we expected that we could be -- it could achieved during that time. So maybe, Robert, you can cover more of the detail on the changes specifically related to the Billing Article.

Robert Woodward

executive
#7

So we've had long-standing coverage for Medicare, for AlloMap and Heart all the way back to 2006. And the donor-derived cell-free DNA, we were the first on the market and had coverage in that for Medicare since 2017. That was in kidney transplant, [ reformed ] in heart transplant when they added that in 2020. None of these coverages had limitations that were subsequently introduced in -- by the Billing Articles, starting the one that was on March 2. And so the Billing Article has some impacts where they've made changes to coverage policy where they have limitations on its use relative to a biopsy. So when these non-invasive tests could be used and impacts on surveillance use where they say, well, if it's going to be used for surveillance, it must be in -- where you would otherwise do a biopsy, which wasn't in place before. And lastly, on doing more than one test at a time, whereas the -- 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. And so all of the -- these are impacts that are to how docs can think about where and when they can use the test, which is something they've responded quite a bit, too. 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.

Reginald Seeto

executive
#8

Yes. As a reminder, there's been long established recoveries 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 something to have happened, and the expectation is very short time period has led to a lot of disruption in the marketplace, confusion. As well 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 in the article. But maybe you can talk a bit about the impact as well, Abhishek?

Abhishek Jain

executive
#9

Sure. No, thanks, Reg, and thanks, Matt, for the question. The impact on the growth will come from, I would say, the 3 pieces, Matt. The first one is that as I basically stated in the Q1 earnings call, we are seeing the impact on the volumes. So based on that 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 TRF? Because in the second quarter, what we basically are saying that unless we receive the test for the AlloSure Kidney on the new TRF, we will not straight away bill and revenue recognized. And that's where the adoption rate comes in play. And we basically shared that 50% in the month of April, and that number became 60% in the month of May. So basically, of the newer base test volume, the new TRF percent of the adoption, that basically is your 1/3 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 requirement. So in my mind, that would still be a lag because we will basically go back and it will take time for getting that information, and then we will be able to bill and revenue recognized according to the [ ASC 606 ] rules. So there will be that impact from the revenue standpoint. And the last piece, I would say from the growth impact standpoint or the revenue impact standpoint, what Robert was saying on the multi-modality, especially on the HeartCare, though Noridian has not adopted the article, but we need to basically make sure, okay, what happens once and if they were to adopt on the multi-modality side.

Matthew Sykes

analyst
#10

Got it. And maybe it would help to kind of differentiate the content of the 2 billing articles, the March 2 and the May 4 and what kind of the differences between them? And what is, sort of like, was May 4th an update and that's what you're following and sort of how you're defining each of those?

Reginald Seeto

executive
#11

Yes. The May 4th, the plan replaces the March 2 billing article. And the May 4 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 have been this requirement for surveillance test being done in lieu of a biopsy, but only if the center had an established protocol. So what's opened up there now is there can be a physician-based protocol. And so that individual ability of physicians now to make those decisions are being brought back. One of the second changes was this requirement of having 7 days, you cannot do a test if a biopsy was being done in a certain window period of 7 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 going to be a medical appeal if you gave 2 tests together, for example, HeartCare. So 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 pre-test criteria. So again, while there's been some improvements from March 2 to May 4, it's something that we continue to have discussions with the relevant parties to see if we can change those as well.

Matthew Sykes

analyst
#12

And Abhishek, I think you might have mentioned something about -- is there any clarity on the timeline for Noridian potentially adopting and issuing the new Billing Articles from MolDX?

Abhishek Jain

executive
#13

Yes. I can take the question and then let Robert maybe comment. At least, I don't know what timelines they have or what they're thinking as of this time.

Robert Woodward

executive
#14

Certainly, it hasn't happened as of today.

Matthew Sykes

analyst
#15

Got it. Okay. All right. Yes. And maybe for you, Robert, do you see commercial payers changing how they reimburse as a result of these changes? I know this is Medicare focus, but any kind of reaction from commercial payers?

Robert Woodward

executive
#16

We haven't seen that there's a response of commercial payers to anything specific about the Billing Article. They tend to have their own separate evaluation when they make decisions about coverage.

Reginald Seeto

executive
#17

Yes, I think the one thing is, actually, since the Billing Articles come out, we've actually added some regional plans, both on the Heart and Kidney side. As you know, doing commercial coverage doesn't necessarily directly link back to CMS/MolDX coverage. And so 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. So that's why on the Heart side, we've established a very broad commercial coverage in that setting as a result of the great efforts we've put towards market access in building that sort of that infrastructure and area that we really stand out to come our side.

Matthew Sykes

analyst
#18

Got it. And maybe could you talk about the backlog of AlloSure. Can you touch on claim submissions, where you stand today and what that backlog could look like in the future quarters?

Abhishek Jain

executive
#19

Sure. So I'll take that one. So I had basically shared in Q1 earnings call that we had not billed approximately 3,200 tests for the AlloSure Kidney Medicare-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. Now 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 phase, for example, if there's a new TRF that comes in or test with, then of course, you can say we go ahead and bill that and there won't be any backlog for that. But if something is coming in the old TRF, Matt, in that scenario, you will need to go back. So that particular -- so the way you should see it, one minus the adoption rate. That is a test that you need to supplement and that test will be the only backlog. And I just want to underline the fact that we should also think that this is purely for the AlloSure Kidney and the AlloSure Heart Medicare-only test, so when we're doing the modeling.

Reginald Seeto

executive
#20

Yes, just to dimensionalize that, I mean, I think we've shared in our earnings that 50% in April of tests had migrated over to the new forms, and that was due to the great work and efforts of our teams, educating physicians and getting these forms updated. And then by May, at least the first week of May, reported that was around 60%. We're on target towards this 80%, 85% in Q4. I just want to give a real shout out to our team because basically, you had one Billing Article, then you had another Billing Article. And during that period, you had to educate so many physicians and health care providers with multiple interactions. And some of these institutions have like 20 different health care providers. So you just don't go there once, you have to go to them multiple times. And one of the biggest bottlenecks has been the operational addition of IT systems. So as we roll this, process out of this, getting these TRF forms done, the IT hurdles are still there for some centers where you can't automatically expect the e-mails to be updated.

Matthew Sykes

analyst
#21

Got it. And Abhishek, you talked about sort of the impact of test volumes in April, sort of in the -- 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?

Abhishek Jain

executive
#22

Yes. I would say that the number that I provided has been what, like 3 or 4 weeks ago, right? 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. So 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.

Matthew Sykes

analyst
#23

Got it. One key area of debate has been the frequency of tests. And 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 test assuming we don't go all the way to forecast?

Reginald Seeto

executive
#24

Yes. I mean I think one thing to remember, being a physician myself, is that there's a huge unmet need in the transplant patients. One in 5 kidney transplant patients will fail within 5 years, 1 in 3 heart transplant patients will fail in 5 years, and 1 in 2 lung transplant patients will fail in that 5-year period. And 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 and everyone wouldn't have organs failing, right? And so it tells us that there has to be 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, majority of those, 200 plus on the Kidney side, about 150 plus on the Heart side, about 60, 70 plus on the Lung side. But 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 other forms of commonly established clinical testing, they'll do as part of that process. So I think the goal of what we have brought to the armamentarium and physicians, is really that ability to fix it and incorporate as part of that process. So -- and their process is center by center. Many people think that if you're seeing a transplant center and you can relate that to many others, it hasn't been the case. So what we've tried to do is help with the standardization across those 200-plus centers and bringing what we think would be saying that can be added to armamentarium as well. What we've seen during this process of Billing Article is each centers going through their own process. So it's very much a center-by-center approach versus the education, then the operational implementation and then they're saying, let us revisit how we now incorporate this as part of our protocol within that system and institution. So it's something that we're seeing good progress. What reassured me during ATC, which is the world's largest conference on transplant was the fact that 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 we assess our -- and monitor our patients and how we continue to do the right thing by patients. So it's really, to me, I spoke with over 100 physicians at the meeting and really hearing that was really meaningful to me as a CEO of the company.

Matthew Sykes

analyst
#25

Got it. And you talked about in March that you were going to update the HeartCare submission of MolDX. Any update from where we stand there?

Robert Woodward

executive
#26

So there's several publications that speak to the clinical [ ability ] 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. And so we've prepared those in the standard technical assessment format for MolDX and they're under consideration.

Matthew Sykes

analyst
#27

Any timeline on when we should expect that to come?

Robert Woodward

executive
#28

Well, it's very hard to put a timeline with those guys.

Reginald Seeto

executive
#29

I would just add one thing. I mean, at ATC, once again, which is the world's largest transplant conference, there was discussion on all the different types of approaches in how you look after 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 [ bleeding ] institution actually had an 85% reduction. So it's a good reminder of how technology we use to evolve standards.

Matthew Sykes

analyst
#30

Got it. Abhishek, just on the restructuring that you announced in Q1, reducing head count by 12%, $40 million to $50 million annual cost savings. Are you still expecting it to phase in at sort of the 25% in Q3 another 25% in Q4? And do you see the need for contemplating further cost savings initiatives beyond that?

Abhishek Jain

executive
#31

Yes. So I think taking a step back here, I think from the philosophy of the company 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 to $50 million. So for example, on the head count side, the 12% reduction that I spoke about, we have already taken the actions and most of that restructuring will be completed in Q2 itself. So that impact will start to show up in Q3. And similarly, some of the other actions around the discretionary spend and all, we'll start to see the impact in Q3. So from that standpoint, I think we are on track to be able to start to see most of the $40 million to $50 million annualized savings that will start to show up in Q3 and some in Q4. So we stay on track to achieve those cost-saving goals.

Matthew Sykes

analyst
#32

Got it. And do you expect these cost savings initiatives to impact either R&D or sales and marketing spend? And how are you managing that?

Abhishek Jain

executive
#33

Yes. So 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. And then, of course, we are also taking other actions to take care of some of the fixed component of the COGS. And also, if we're 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. So that's how we are looking at the R&D spend. Whereas 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. So we will definitely see impact in both R&D and the S&M line.

Matthew Sykes

analyst
#34

Okay. And then 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, 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?

Reginald Seeto

executive
#35

Yes. It's actually really interesting. I mean, I think during a time of change, particularly we've seen the Billing Article, the leaders take the chance to lead and to step up. And one of the comments that came to me from one of our top centers which actually uses us plus some -- another competitor actually said, 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 2 days, you had not only CMO, but 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. And so for him, he actually said, I am moving everything to CareDx just because of the fact that you've taken this initiative and you've led from upfront. I do think times of change, this provides an opportunity now, 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 smooths out over time. But 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're seeing some players actually automatically reduce their efforts across the space. But 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-plus transplant centers in the space.

Matthew Sykes

analyst
#36

I'm also curious about some of the conversations you're having with the transplant centers. Because the changes seem to take everyone by surprise. And it didn't seem to be sort of roundly agreed upon by the transplant centers, this is necessary or a change that needed to happen. But 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, 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 have been made?

Reginald Seeto

executive
#37

Yes. What struck me is the level of support across the board and really saying that how valuable these tests are to their clinical practice. And actually saying we don't blame you. We don't see this is your fault. We see something has changed in -- with this billing article, and 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 physicians and health care 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 deal with these changes, because then a second Billing Article came out. So I think it has been very chaotic out there with 2 changes within 60 days of what we call a Billing Article, expecting that to be implemented in a very short period. So I think again, what we've seen is the strong support, but also a little bit of frustration as well that all these changes have to come through. And we were initially given 30 days to have this all done and another Billing Article comes out. And I think if anything, it has taught us that the transplant is a small field in some ways. It's one where people have long memories and it's one where they have really appreciated us being committed to the space, and they've said, the association support. I mean physicians -- multiple physicians have reached out directly to MolDX and they've shared that with us. And the association support was incredible. ASTS, AST, ISHLT, the level of patient support that we've had from the patient associations, TRIO, et cetera, was truly just -- you don't see that necessarily in every therapeutic area, but the velocity and the strength of that support was just incredible.

Robert Woodward

executive
#38

And that 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. And their letters are -- to MolDX are all posted on their websites and instructed to read them and see that their frustration around the process of how this came about, but also they were all very upset with the level at which this was Medicare taking decision away from physicians about when they could use COVID tests and having this very narrow specification of use that they had all expressed in their letters. And their concern about patient impact and equity and transplantation, expressing that the government has been moving towards having, at least in kidney transplant, they care, move 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. So 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 and really expands the concern.

Matthew Sykes

analyst
#39

Got it. Maybe shifting focus a little bit and just talking about the overall transplant market growth. You kind of detailed a lot of sort of the impact on staffing and other things that have impacted. Where are we now in terms of transplant procedure growth? And what is your view in terms of how that's trending?

Reginald Seeto

executive
#40

I mean, long term, we believe that transplant volumes have potentially doubled in the 5- to 10-year period. And that's something that we see there are multiple different areas that are driving that. I mean, for example, we have, on the Heart side, different perfusion, transportation companies work in that space, which will be applicable to other organs. We see the future of potential xenotransplant, which is very exciting. We've seen government initiatives come into play to try to get more efficiencies across the system, whether it's with OPOs or with nephrologists, many of these patients on the pre-transplant side with LDLs. So 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 2 years, that is the impact of COVID. COVID has certainly disrupted that projection, particularly on the Kidney side, where 1/3 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 level. So I do think the longer-term opportunities there, I think they've seen some impacts. And certainly, last quarter, we saw there was a minus 3% quarter-to-quarter growth. But what we're seeing this quarter is an improvement in that trend, the high single digits on a quarter-to-quarter improvement. So we do think this trend will hopefully continue. I do think 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.

Matthew Sykes

analyst
#41

Do you think there will be a change in -- and you said there's not many players in this space, but any change in the competitive landscape or the composition of folks that are in this market as with all 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. So do you see the competitive landscape or at least the composition of competitors changing over the next year or two years?

Reginald Seeto

executive
#42

Yes. I do think there'll be a change in dynamics. I mean I think we often take a view which companies will be in 3 years' time and we do think there will be a definitive change in that landscape. We've already seen it in the current change of the Billing Article where I think one organization is taking out their [indiscernible] kept their medical field force, for example. So we do see these changes taking place real time. And 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. And for us, the good thing is we've made it known publicly into all the transplant community. We've been around for 2 decades, similar to what Robert's been around with the company and we plan to be around the next 2 decades, although hopefully, Robert, you'll be nice and well tied by them. But the point is they appreciate their commitment. And I do think the challenge for others is that if you're not a 100% focused in transplant, it's very hard to stay in this space because what we've done is we've made so many different investments on this -- in this transplant space, whether it's pre-connecting the transplant centers to data centers, transplant centers, whether it's on the quality systems where we now have 1 in 4 centers with our quality systems, whether that's being the #2 and #3 EMR systems in transplant, whether it's saying we want to invest in the product type business, whether it's looking at the #1 medication discharge form company that we acquired. So I do think it requires investment focus and I don't think all companies have their patients if they're not all in on transplant.

Matthew Sykes

analyst
#43

Got it. And 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.

Abhishek Jain

executive
#44

Yes. No, absolutely, Matt. And this is one area that we had focused for a while now. And then we start to see the results starting Q4 and Q1 where we actually collected 110% cash off the testing services or revenues. And 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. And we had shared information on some of the Medicare Advantage payers where we had some of the parts 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 out. So 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.

Reginald Seeto

executive
#45

I don't -- I think, Abhishek, you can take a bit more credit here. I mean, I think we, over the last 3 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. And collections has gone outstandingly well. This 110% of collections or cash above our testing service revenues, and we expect that to continue. And I think it's really a great analogy what -- if you go over the Billing Article, it's a good analogy that if we have to supplement tests like that are on the new forms, it's something that we're going to also bring in, 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 Q1, absent some of that Billing Article, where if you factored in some of those tests, we will hit our goal, this adjusted EBITDA profitability. We would have had our highest testing service revenues. We would have had, in conjunction with the highest testing services, volume that we achieved during this time. So 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.

Matthew Sykes

analyst
#46

Maybe on the catalyst side, maybe talk a little bit about what we should be thinking about.

Reginald Seeto

executive
#47

Yes, I'll make some comments. 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 we have -- they 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. Sultan ], 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 we have -- this has the impact to make a difference on value-based care and so 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. But I'll let Robert -- Robert leads all these amazing initiatives.

Robert Woodward

executive
#48

Since you ended up on AI, I'll speak to that first. That's where our years of experience is really going to help us because as everybody is aware, when you want to train and develop an AI algorithm, validated, you need a lot of data. And so 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. So as we come out with AI CAV and Heart and AI Kidney, which will include ALLOVIEW and iBox, all of these products are dependent on these data sets and on our ability to deliver them as a validated tool that the clinicians trust. 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. And so that's the view that we want to 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. And so then 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.

Matthew Sykes

analyst
#49

Perfect. With that, we're out of time, but thank you very much. I appreciate you guys for joining.

Unknown Executive

executive
#50

Yes. Thank you.

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