All right, great. I think we'll get started. Thanks for joining us this afternoon. My name's Matt Stanton. I'm on the Life Science Tools and Diagnostics team here at Jefferies. Happy to have CareDx with us back at the conference this year. Joining us from the company, our new CEO, John Hanna, as well as CFO, Abhishek Jain. Gentlemen, thank you for joining us this afternoon here.
Thank you.
I guess maybe first one to, to kick it off, you know, for you, John. You know, now that you've had a bit of time here, over the last few months to kind of immerse yourself in, in CareDx, talk about some of the early learnings. You know, what surprised you? What's maybe stronger than you thought, and, you know, maybe what you didn't fully appreciate from, from the outside?
Yeah, thanks for the question. I'm just thrilled to be a part of the company. CareDx has an incredible history in transplantation, supporting institutions globally in their efforts to improve the outcomes of patients that undergo transplant. And some of the things that, you know, really surprised me early on has been just the quality of the team at CareDx. We have incredible individuals that are passionate about what they do in this market space, the commitment of the KOLs and thought leaders to supporting our work, the extensive publications supporting the clinical utility of the products, and then the patients. The outpour of, you know, appreciation from patients to CareDx for what the employees do every day, and supporting them has just been remarkable, and I think it's a, a really exceptional company in a space of really critical unmet clinical need.
Thanks. And I want to jump to your background in a second, but maybe if we dial it back even more. I think you have, you know, a bit of a unique background. You originally, you know, started, correct me if I'm wrong, on the insurance side.
Yeah.
You know, how does that maybe offer a bit of a different perspective or approach as we think about, you know, payer dynamics and things like that within the CareDx context?
Yeah, insurance, you know, reimbursement is so critical in these companies and, you know, I had the fortune of spending the first 10 years of my career in the insurance market, really understanding how a payer thinks about covering and paying for service and just the mechanics of how a claim gets paid. It's kind of a black box, right? We all experience it personally. Like, we get these EOBs in the mail, and we're like: "What are they doing? What does this mean?" But behind the curtain, right, there's a process, there's a machine. And you really, if you understand the dynamics there and how the work is undergone, you can take advantage of it, quite frankly, right? If you have a strategy that you can execute against to get paid, it can drive up your ASP and reimbursement as a company.
I think the other really critical thing is clinical evidence, right? In my career, in this space, we've always focused on publishing the highest quality clinical evidence possible. CareDx is no exception to that. The company has incredibly high-quality publications. In the past 30 days, we've had two publications come out, one in heart and one in kidney, both with the highest number of patients tested in those indications in the history of the product. So I'm really thrilled to be a part of a company that's so committed to the development of clinical evidence, because that is the key to driving reimbursement in the marketplace.
That's helpful, and maybe kind of sticking with that theme. You know, you spent a decade at Veracyte. You know, were there fairly early when it was a one-product company, saw it scaled up into a successful multi-product company, ran commercial, marketing. You know, just love to learn a bit more about your approach to multi-product portfolios. You know, best practices you think you can leverage at CDNA, which also kind of checks the boxes, right, of a strong multi-product portfolio within the diagnostic space.
Yeah, I think there's two things to a multi-product portfolio. First, you have no leverage as a single-product company. Like, you can't negotiate with an insurance company because you've got just one product, and so it's really difficult to get traction in the market and get into networks. When you start to build out a multi-product portfolio, where you have different mixes of commercial and Medicare insurance, you can come up with strategies around contracting that optimize your total reimbursement based on your mix and do some creative things. And so similar to, you know, where Veracyte was when I departed the company, CareDx has a nice multi-product portfolio today with growing commercial reimbursement that enables us to execute on some strategic contracting to drive up ASP long term in the marketplace.
I think the second thing around multi-product portfolio is really how you get leverage on the business. So one of the things that I was really attracted to about this company is we have this captive market of transplantation, where you have somewhere between 80 and 100 centers in the U.S. market that do the bulk of all procedures and transplants and manage those patients. And as a company focused on transplant exclusively with products in multiple organs, we can have a field force that is pan-organ, that drives volume at a fixed OpEx cost. And so in some of my prior companies, that wasn't something we were able to do because we were targeting different indications and different subspecialties, and so we never got that leverage.
CareDx has the fortune of really focusing in on that market, which gives us a real nice view into long-term profitability of the company.
Thanks. Maybe one for you, Abhishek, as it relates to guidance and visibility. You know, obviously, last year was a tumultuous year. You had the guidance out there, you pulled it, post the billing article, reestablished guidance at a lower level, factoring that in. You know, fast-forward to this year, you come out with the 2024 guide, you're able to bump it, you know, after the first quarter. I guess just kind of higher level, talk about, you know, improvements around visibility, where we sit, you know, today versus even six or nine months ago. And then are there any kind of areas you'd still like to see a little bit, you know, visibility as we think about that kind of return to normal, you know, pre-billing type, you know, visibility you had?
... Sure. In my mind, the short answer is visibility has improved, like, dramatically as compared to where we have been about nine months ago and where we are today. When there were some coverage and the documentation-related changes introduced last year, we have been trying to figure out, okay, how do we implement some of those changes? How do we educate? And then we had very little visibility on how much successful are we going to be, and how long will it take to actually make the changes with all of the transplant centers? And that's the reason we basically gave ourselves a couple of quarters to get that visibility, and we reset the base of the company in Q4 of last year. We said that, "Okay, now we have enough, that our volumes are stable.
We are growing for the last couple of quarters, and this is how we are going to be reestablishing the guidance." When we started to think about the guidance of 2024, the whole idea was to continue to build on that baseline and stay, in my mind, a little bit more conservative as we provided the guide for 2024, which we basically upped when we announced the results in Q1. Long story short, a lot better visibility as compared to where we have been. Where we would want to be more clearer, I would say there's only one piece, and that is the LCD, the draft LCD. Now we know that the billing articles have now been rescinded. They have been taken back.
Those were introduced, like, last year, but there's still the draft LCD, which is out there, and the outer timeline for that to finalize is August. So by then, we will probably have enough visibility in the future. John, anything else that you might want to add?
No.
Is it fair to say in terms, if you think about the kind of the LCD outcomes, you've still kind of baked in when you reset that guidance, kind of like status quo, so that any, you know, any, I guess, positive or more concrete details would, you know, that's already kind of reflected in the guide in terms of downside and kind of what we saw last year. Is that fair to say?
Absolutely.
Okay.
So the current draft LCD, what it contains is already baked into the guidance, and, if there's an upside, if there's something else were to happen, yeah, that will be an upside.
Okay. All right. I want to shift over to something that, you know, I think either came out on the day or right before you guys reported the first quarter earnings. You know, not a lot of time to digest, but, you know, late April, CMS issued a proposal for increasing organ transplant access, the IOTA model. It looks to kind of increase transplants, like a six-year program, 50% of the kidney hospitals in the U.S. have involved in that, and it'll start early 2025. So I guess now that we've had some time to kind of digest it, I'm sure you've, you know, talked both internally and to folks in the field. You know, how should we think about the opportunity there for CareDx and that program as CMS rolls it out?
Yeah, we're really pleased to see CMS take this action and support, you know, the 90,000+ patients on the transplantation wait list nationally. The IOTA model really incentivizes centers to increase the volume of transplantation that occurs at the center while maintaining quality of care outcomes. We think we're uniquely positioned to support centers in this for a couple of reasons. One, in order to increase the volume, they're gonna be using likely organs that weren't being used previously, slightly more compromised organs. In order to do that, you need to monitor the patients more closely with testing, like donor-derived cell-free DNA, for their immune suppression levels, for rejection, to ensure the health of that organ. To drive those higher volumes, you also need to do faster matching from your wait list.
One of the key kind of components of CareDx's portfolio of products is a software suite of products that supports wait list management, transplantation, EMR system, patient medication adherence, post-discharge. And then we have a quality software that ingests all of the EMR data at the center and does quality reporting that's required back to the agency to maintain their credentials and the IOTA reporting system. So they're gonna be giving a score to each center based on a scoring system of the increase in volume, the utilization of available organs, and then quality outcomes. And there are significant dollars on the line in the sums of hundreds of thousands for those centers that score very high in the model, and then significantly less for those that score low in the model. And so we have centers already that are approaching us, asking for help.
We need to get prepared for this. We have six months before the program starts. We wanna make sure we have the full software suite in place, as well as our testing protocols ready, so that we can be optimal as we go into 2025 and start this program.
Yeah, that, that's really helpful. I was gonna ask, you know, which areas of the portfolio it touched. You kinda got to the next question, but, you know, kinda sticking with that theme, you know, I hear 90,000 patients on the, on the wait list, you know, potential higher volumes, more organs coming in. I guess, you know, any way to kind of start to dimensionalize just how meaningful that could potentially be in, in 2025? And, you know, you talked about kind of this six-month runway here. You know, is there any OpEx or spend that needs to come in today so that you're ready to, you know, take advantage of that, in early 2025?
Yeah, I don't, I don't see us making any significant OpEx spends to prepare for that. This is already part of our product suite. I think that the program is incredibly meaningful. Oftentimes, the agency will create programs like this as a prelude to a new reimbursement model that they ultimately will implement, right? They'll do a pilot study, and then they'll implement the program... here, they're gonna run the pilot with half of the centers, look at the outcome, and then likely implement something. If you anticipate there are 30,000-ish, you know, transplants today, and they want a 50% increase in kidneys, specifically in half of the centers, then you could assume that over the 5-year period, you're gonna increase that by 10,000 transplants. And so today, the market is growing high single digits just in transplant volume.
This could kick it up into the low teens over that period, and that increase in transplantation is a tailwind for us as we further penetrate the market and there's more patients available.
Yeah, that, that's really helpful. And maybe shifting gears over to, to ASPs, there were some headwinds, you know, in the back half of 2023. Maybe, Abhishek, just kind of remind us what you're penciling in, for ASPs in, in 2024. I think the guidance bump was more tied to volume than pricing. Correct me if I'm wrong there. But just how you're thinking about, pricing as we move through the rest of, of 2024 here.
Yeah, sure. On the ASP, this has been one of the questions that we would receive in the last couple of years. Last year was a little bit more challenging on the ASP with some of the changes on the coverage and how we have been kind of going about this one. What I called out that Q4 of last year is our base for the ASP numbers. From the guidance standpoint on the ASP, what we are saying now is that the ASP deterioration is behind us, what we have seen in the year 2022, 2023. Now we are looking to improve the ASP. The current guide of 2024 actually assumes a low single-digit improvement in the ASP.
So that's how I would say that, okay, based on the ASP that we have taken Q4 of last year, no deterioration. Actually, there is going to be a increase in the ASP for the full year 2024. And of course, with John, with all of his background that he kind of elaborated on, on the insurance and everything, this stays one of his priorities, I'm sure, to as to how do we kind of continue to increase the ASPs and continue to gain the opportunity that we have between the current ASP of roughly $1,200 to the Medicare rate. So there's a whole lot of ground that we need to cover.
Okay. On the competitive front, you know, on one hand, post-billing article, you could argue maybe there was reason for others to pull back. You also just laid out a scenario under IOTA that drives, you know, market volume higher over the next few years. So I guess, you know, how do we think about the competitive, you know, dynamic today? Has it changed much? Have you seen people pull back? Are you seeing people invest more? You know, what... How has the competitive landscape changed over the last, you know, six to twelve months, if it has at all?
Yeah, I think the competitive landscape remains pretty consistent to where it was in 2022. You know, everyone pulled back a little bit, and that really was a function of the administrative requirements around submitting claims to get paid. You know, I'll just reiterate, all our, our test is covered by Medicare. All the claims that we submit do get paid. It's really a function of: do you have the documentation required to receive the payment? And so we had to do the work in the field to collect that documentation, just like others did, and that little blip in the business resulted in people just pulling back a bit from the market. We haven't seen any changes in the dynamics. We haven't lost any accounts, right?
It's really around, in the kidney space, specifically, reduction in volume within existing accounts, but they still are accounts, right? And so as we work through with those accounts, the scenarios in which they can order the tests, where we can get paid from Medicare, and the documentation required to do that, and their willingness to collect that information and send it to us along with the sample, we see volumes going up. And that's why we've had three consecutive quarters of sequential volume growth in that market, since Q2 of 2023.
Okay, that's helpful. We talked about revenue before, but also, you know, you bumped the adjusted EBITDA guidance on 1Q as well, a bit higher. Maybe talk a bit about, you know, what's kind of underpinning that improved outlook for 2024, and then, you know, obviously, not guiding for 2025, but as we think about 2025 and a return to kind of positive adjusted EBITDA, you know, maybe not for the full year, but is there a pathway to return to positive adjusted EBITDA at, you know, sometime in 2025? Is that something you feel comfortable with?
Yeah, absolutely, Matt. So, we upped the guidance on the midpoint of revenue by $11 million. So we were at $267 million for FY 2024, and then we increased the midpoint to $278 million. And it goes back to what John was saying around the operating leverage that we have in this company, where the most of the revenue, we are able to kind of drop it to the bottom line. And that's how we basically build the guidance, where that increase in the midpoint of the revenue, that's what I dropped it to the OpEx and to improve the adjusted EBITDA guide. So that's basically is the link. And if you see the adjusted EBITDA, that whole improvement is driven by the revenue increase while trying to keep the operating expenses more or less flattish.
Now, when I start to think about our path to return to profitability, we basically had $2 million of adjusted EBITDA losses in the first quarter. In my mind, I have always called out that our goal is to be in low single-digit adjusted EBITDA losses by the end of this year.
Mm-hmm.
Now, that basically sets up very well to return to profitability in 2025. I don't want to, and we don't want to make a commitment for 2025 now, but we probably will be falling short if we do not return to profitability in 2025.
Okay, that's helpful. We touched on this a bit earlier, but just around the LCD and Medicare, you know, coverage efforts, you know, there's been no shortage of efforts being put on Medicare, I think, right? I mean, we've seen even editorials in The Wall Street Journal. So I guess, you know, clearly folks are taking notice. You know, from your guys' view, you know, can you talk about the evolution of these efforts and how you think it might, you know, actually shape the pathway going forward?
Yeah, we, we've seen editorials in the journal, we've seen patient advocacy groups taking action, we've seen physician groups taking action. Obviously, companies like CareDx have taken action on this, and we also have seen the agency move their position pretty substantially. In February, they effectively reversed the changes to the billing article back to the original language and put out a press release stating their intent to continue to pay for monitoring assays for transplant rejection, which was an unprecedented move. You don't see the agency putting out press releases about local coverage policy changes, and especially not about billing articles, right? So I think they heard loud and clear from the community that this was a misstep on the part of the contractor, and they wanted to do right by patients and clinicians that are treating those patients.
We've had many positive discussions with the agency about this. We feel really good about the changes that were made, and we're anticipating the finalization of the draft LCD, that's out there right now, which should happen within two months or so, in the August timeframe.
Okay. And jumping over to the SURE study, we saw some recent, you know, data published there for, you know, HeartCare, you know, the combination of both AlloSure and AlloMap. Can you just walk through maybe, you know, quick, the high-level takeaways from that data and how you, you know, expect the evidence generated there to potentially, you know, drive coverage decisions over time?
Yeah. SURE is a landmark study in this space, and, you know, from a clinical utility perspective, you really want to see a difference in physician behavior in the different results that you see from testing. And in SURE, we saw very clearly a statistically significant difference when you had positive, dual positive HeartCare results, so AlloMap-Heart and AlloSure-Heart, both positive for rejection, the likelihood ratio for a biopsy was significantly higher. Whereas when you had a single, either donor-derived cell-free DNA or AlloMap, a positive result, and when you had dual negative results, the utilization of biopsy was very, very low. And so we see this spread in the treatment regimens based on the test results, and that's really, as a payer, what you want to look for is: Is my test guiding treatment decisions in the patient population?
SURE, this publication that we saw in the Journal of Heart and Lung Transplantation is the first interim readout of that study. It's a five-year follow-up study. This was a two-year intermediate readout of that study. We'll continue to follow those patients all the way until they have five years of follow-up and report on a number of different findings from that research, and we're looking forward to many publications coming out of that data set.
Okay. On capital deployment, you know, you guys have a pretty, pretty strong balance sheet, over $200 million of, of cash. You know, just updated thoughts on how you're thinking about deployment, more broadly, you know, any level of appetite for, for M&A here? Is the focus really on the, the core business and kind of driving that organic growth?
No, absolutely. We feel good about, like, having the cash on our balance sheet and the strong, the strength that we have because of that. $215 million is what we have. There are various ways of using that cash, Matt, and it could be in our share buyback program, or the capital, using the capital in M&A, or doing something else that is more appropriate to create the value for our shareholders, right? So this gives us the optionality, and with John coming in, and as he kind of works through his strategic plan, we'll figure out as to how we would want to drive the company in the next 3-5 years.
That will basically take us to a high growth path, and how do we want to use the capital to support that long-term plan? Based on that, we will start to make the calls there.
Okay, that's helpful. And maybe one quick last one is just, you know, around some of the litigation with Natera. Obviously, the balance sheet helps you kind of weather the storm there. How should we think about kind of the range of outcomes there and, you know, any updates we should be looking for on the horizon here?
Yeah, I think that the updates we're going to be looking for is the court's determination around the validity of the patents that they've asserted against us. So in the jury trial, one patent was invalidated, a second was found to be non-infringed upon, and then the third, the jury found infringement, and they determined a specific royalty and damages to that. We are, you know, appealing that determination with a focus on invalidity of all three patents. We think that the art there is rather weak, and we're going to continue to push on this. So we think the range of outcomes are no worse than what the jury decided-
Yeah
... to a scenario where all three patents get invalidated, and this all goes away.
Okay. And I think with that, we're just about out of time.