Welcome, everyone. My name is Matt Sykes, a life science tools and diagnostics analyst at Goldman Sachs, and I have the pleasure of being joined with John Hanna, President and CEO, and Abhishek Jain, CFO of CareDx. John, Abhishek, thank you very much for joining me today.
Thanks for having us here. We appreciate it.
No problem. Maybe if we could just kind of start out with a quick recap of Q1 results. You got off to a very solid start this year, continued volume growth across the portfolio. What were the highlights in your mind?
Yeah, absolutely. Q1 was our seventh consecutive Quarter of testing services volume growth, and that growth was broad-based across all three indications that we operate in: heart, kidney, and lung transplantation. We had a very, very strong Quarter. We also started out the call talking about the ISHLT conference, the International Society of Heart and Lung Transplantation, where we had 60 abstracts from over 90 transplant centers presenting data on the use of CareDx products. That was greater than 50% of all the centers that do heart and lung transplantation presenting data on CareDx products at the conference. It was a really fantastic event for us, a broad-based set of data talking about the utilization of our services and how we're improving the care for transplant patients.
Got it. Maybe if we start on testing volumes, you talked about signs that transplant centers are reactivating surveillance protocols. Is it a gradual tailwind to growth, the right way to think about it, or should we start to see that maybe in Q2 with even greater impact in the back half? Just help us think about that cadence of that return to surveillance.
Yeah, surveillance is a growing base of business for us. In the Q3 call back in November, I talked about how 10 centers between August 15th and November 1st had implemented new kidney surveillance testing protocols to put patients on what is the 7-4-4 protocol, so seven tests in the first year and then quarterly thereafter to monitor for organ transplant rejection. That continued through the fourth quarter and into the first as more centers readopted protocols for kidney surveillance testing. We've also seen expansion of heart protocols. As more data has been published from the SURE study and presented at ISHLT, we see centers removing biopsies from their protocol and replacing them with HeartCare testing. In the first quarter, we completed enrollment of our Alamo trial in lung transplant, which was 11 centers and enrolled 500 patients nationwide.
Now we're going to follow those patients for three years. Importantly, the majority of those centers implemented commercial protocols to monitor for lung transplant rejection in their center after the experience they had in the trial.
Got it. You recently kicked off an Epic integration process. How are you thinking about sort of the pace and scale of that rollout? Can we start to see material impact by the end of 2025, or is this more of a 2026 and beyond driver?
Yeah, I think Epic is really a 2026 and beyond driver. The pacing of that is we'll complete our Epic integration of our instance of Epic by mid-year, and then we'll begin integrating with our customers. We are trying to have a really tight schedule where every quarter we integrate a handful or more customers such that we have that bilateral integration. We have seen in the marketplace other diagnostic labs and companies that do med tech talk about a volume boost ultimately of 10% or greater as a result of that Epic implementation. We really think this is an important initiative for the company to ensure that we have that continued 15% CAGR through our LRP.
Got it. You launched AlloSure into a few more specialized populations in Q1, and you outlined the penetration there could be relatively high. How has initial uptake been in those new indications?
Yeah, uptake was really strong in those new indications initially. We had a really positive reception from the marketplace on the use of AlloSure, both in pediatrics patients and in simultaneous pancreas kidney transplant patients. I think while the overall size of those markets is not huge, it's nonetheless important to demonstrate that as a company, we're going to address the total potential TAM of these markets and validate our products to ensure that all patients that could potentially get access to our testing have access to a clinically validated test.
How should we think about sort of indication expansion roadmap as you kind of look at the business over time?
Yeah, absolutely. In our LRP, we did not assign a lot of that revenue growth to new products. But from a pipeline perspective, we're very focused on the cell therapy market. There are roughly 10,000 patients annually that get allogeneic stem cell transplants. And those procedures happen in the same roughly 200 health centers in the U.S. that also do solid organ transplants. So it's the same channel for us. Our product for that market that we call AlloHeme, we read out the first year of a two-year trial at the Tandem Cell Therapy and Stem Cell Transplant Conference in February and put out data on that in our Q4 call. So we're making a lot of progress in that space, and we see that as our growth driver beyond the three-year LRP.
Beyond, okay. Yeah, because I mean, the cell transplant has been something that's been talked about for a while at the company, but it's always seemed like it's far off. Now you're saying you're actually doing clinical studies.
We are very focused on this. I talked in the call about how I added a new Chief Product Officer to the company in the first quarter. That was really to have an executive-level focus on the pipeline development of the stem cell therapy products and other products that we're looking at longer term. To have that executive-level engagement in the pipeline and have an individual on my staff that's accountable to ensuring that we meet the timelines and get that product on market.
Okay. Now, shifting over to the impact that you're expecting as the IOTA program begins in July, both in terms of procedure volumes as well as demand for your software that helps transplant centers monitor their scores, what is your expectation for that?
Yeah, I'm very excited about the IOTA program. As you are aware, there are roughly 6,000 kidneys a year that are harvested in the US and available for transplant that are not utilized for one reason or another. The IOTA program incentivizes transplant centers to utilize a higher proportion of the kidneys that are available to them, which should be a tailwind to volume growth of transplantation in the marketplace. We think that in the second half of this year, we'll see a re-acceleration of kidney transplant volume into 2026. We recently talked about how we have modified our quality reporting and dashboarding software to incorporate all of the IOTA metrics that centers are going to be analyzed against so that they can see in real time how they're performing against those scores.
The interesting thing about the IOTA program is that the quality outcome measure is not just a single point-in-time measure. It's going to be a cumulative measure over the six years of that program. You could imagine now growing the volume of kidney transplantation, really with a focus on using, I would say, more compromised organs or poor matched organs. Those patients are going to be needed; those patients will need to be monitored into the future for organ rejection because they're going to be scored and valued on how the cumulative outcome of those patients will be, not just the one-year outcome.
Got it. I think there's a really good example, just to segue into sort of the portfolio offering, meaning I think people see CareDx initially as a testing company, but you're not. You have a lot of digital solutions and other kinds of offerings. You actually put yourself sort of along the line of the patient journey the whole way. Taking this example of sort of the synergies between your digital and testing services, are you kind of continuing to see the benefits of the full portfolio approach? Kind of are you sort of falling into a cohort of using more than three of your services, like you talked about the investor day?
Yeah, that's a great question. I would say one of the things that made me really excited about joining CareDx as a company, in addition to its legacy relationship or legacy reputation of really being a phenomenal company from an evidence generation perspective, was this view that it did have an end-to-end portfolio of solutions to help the transplant center function more efficiently and drive their volume of transplantation and quality of outcomes. In diagnostics, as you've seen over the years, there have been a number of companies who make a beachhead in an indication and then expand their diagnostic offerings across the care continuum. At CareDx, we have that beachhead, but our offering expansion is not just diagnostic tests, but software solutions, staff augmentation, IVD kits. We have a transplant pharmacy to support patients post-transplantation with all their therapeutic needs. We really have a unique equation as to how we address the needs of a customer and how we support them in the management of their patients.
Got it. Abhishek, maybe shifting more towards RCM, which is something that you've been very focused on for the last couple of years. You guys described a unique approach to RCM last quarter. We kind of noted that it could take six to eight quarters to see the full impact. Kind of looking towards the longer term, how significant could denial reductions and ASP uplift be from that process as you kind of look out show what that could accomplish?
Yeah, the good news is that since Keith joined about eight months ago, he has taken over the RCM team, and he has made some really strategic, important decisions in that function. Previously, I think we were more focused on driving a very specific set of tests so that we can continue to do the cash collections. Keith is focused on improving the end-to-end workflows. He's trying to make sure that, okay, it's not only that we do the automation of the workflows, but also from the eligibility standpoint, from the pre-authorization standpoint, from collection of medical records, submission of the claims, and then the appeals. All of those processes are kind of working like a smooth and well-oiled machine to be able to drive the cash collections higher.
That is the reason he's spending most of his time in building the RCM team and what he has already done in terms of changing the entire leadership team there in the beginning of the year. We have brought a very experienced team, starting from the Vice President for this function, as well as the people who are reporting into this VP to be able to kind of look into this from what good looks like and how do we drive the ASPs, not only from the incremental growth standpoint, but actually how do we kind of be very strategic and from their experience take the ASP to close to $2,000 or beyond. That is where the mindset is so that we actually make some fundamental changes to this whole approach.
Got it. Just focusing a little bit more on the commercial spend, it looks like you've been making some investment into the commercial team. Kind of what areas are you deploying these new reps in? Should we still be thinking about sort of six months for them to fully ramp up? How do you think about productivity per rep, and how do you enhance that?
Yeah, we grew the field force by about 50% in the fourth quarter. In total, we added 30 individuals in sales and marketing. The investments that we've made in commercial have been that twofold. One is to have greater density of field force individuals so they call on fewer accounts. As you know, the story in our business is we get about 50% adherence to the protocols that are in place, either 7-4-4 in kidney or 11-4-4 in heart. Ensuring that the clinicians are using the product consistent with the protocol and/or the patients are getting the blood drawn is really important. The only way to do that is to have greater focus on a fewer number of accounts per individual.
On the marketing side, I've always found in my career that having a really strong marketing organization is what makes your sales function operate more efficiently, whether it's the messaging, the collateral, the strategy, et cetera. Marketing is kind of the brains behind a sales organization and driving it forward, and then upstream marketing around the product development aspect. We put a lot of resources into marketing where there weren't very many previously, and then grew that field force density to ensure that we had the right level of coverage and customer support for our transplant customers.
Okay. Getting a little more specific, just a question I have is just the new CPT code. How is that helping with contracting efforts? Should it have a noticeable impact on ASPs this year, or should we be thinking further in the future?
I think the CPT code is important because it enables us to get into contract with a payer. Many payers don't like to contract for miscellaneous codes because they pay for a lot of stuff using miscellaneous codes, and they don't want to set a price for it when someone could bill a service that's $30 or $3,000 all using the same code. Getting the CPT code for AlloSure was really important for us for our long-term strategy. That's done. We had some success in the first quarter. I called out that a large Blue Cross plan in the Southeast, in particular, had brought us in-network that had previously covered AlloSure, but wouldn't give us the contract because we didn't have the code.
Now that we got the code, we're in-network, and we're able to go talk to doctors and say, "AlloSure is now an in-network service for all your kidney transplant patients." They're going to have likely a very low copay, if any at all, depending on their benefits. It's just like any other service, like when they go see their primary care provider or when they see their nephrologist, they pay the copay, and it's pretty seamless. That's a really positive thing, I think, to volume in those markets. On the ASP side, we guided a blended ASP of $1,360 for the year.
I don't think that the CPT code is going to impact that ASP rate in this calendar year, but as we work through the year to try to get as many contracts as we can, we could see some tailwind in 2026 from the code.
Okay. Got it. Abhishek, you already have pretty impressive gross margins for the industry. How much room is left to expand as you improve ASPs and work on cost per test and also kind of work to improve the margins in some of your smaller businesses? Which of those are the biggest lever?
Yeah. No, I think there's still a lot of room to grow our gross margins, Matt. Starting with the testing services, our gross margins are already in the high 70s there, close to 80%. That's given the fact that we are still getting paid on 50% of our tests. As we kind of grow our ASPs, hopefully that is going to help us expand our gross margin further on the testing services side. When I talk about the other two businesses, the opportunity there is even more. For example, the products business, the current margins are in the mid-50%. There's a lot of work that the team is doing to actually grow the gross margins there upwards of 70%. That may take a couple of years to get there.
For example, we have some contractual agreements that basically bind us into some kind of a raw material cost, which is more fixed. We are working on renegotiating those contracts to be able to bring the gross margins higher for the products business. Now, going to the digital and the transplant pharmacy, transplant pharmacy is generally a low-gross margin business because this is a pass-through. Still, there is more opportunity there. I would definitely say that on the digital services side, because we are selling these softwares and the margins are like mid-60%, you can definitely expand the margins on the digital side also. All in all, definitely margin expansion opportunities lie across our portfolio, and we are basically working on pieces of those.
When you think about sort of ideal gross margin structure, but also at the same time, you want to capture the entire patient journey, it's going to put you in businesses like the transplant pharmacy that are lower margin, but presumably very necessary and an important part of your offering. I guess, John, when you and Abhishek as well, when you look at the company from a portfolio basis, how do you balance that? Be like, "Look, we want to have these gross margins, but the transplant pharmacies are a really important business for us." There's probably only so much you can do to improve it. How do you think about it from a strategy point of view?
Yeah, I think this is a question that I got very frequently when I first joined the company, which was, "Why should I care that you have this software portfolio? Why should I care that you have this pharmacy business?" I was asked that by many investors. That is a great question. Let me go look at this and get back to you, because I'm brand new, two weeks in. I don't have an answer for you yet. As I spent the first 100 days of my tenure with the company looking at these issues, what I came to realize was these are incredibly strategic assets to the company because of the service that we provide to the transplant centers.
In our annual, or not annual, in our investor day in October of last year, we shared that in centers that use three or more of our digital and patient solutions, which is our software and pharmacy services, we capture 50% more of the patients that they transplant on our testing protocols. Those centers generate two times the revenue for CareDx than centers that use less than three of our digital and patient solutions. It is really a proxy for how well integrated and deeply we have sold into that transplant center, into that account. I think that those services are incredibly strategic to the future of our testing services business.
They may drag on gross margins somewhat, but as Abhishek described, after I realized, "Oh, these are incredibly strategic," the next thing I said was, "Okay, Abhishek, how do we drive up gross margins on these businesses?" Because I want both. Of course, I'm going to be greedy about that. I think there's a path there. As Abhishek described, there's a clear path on the lab products business. As you know, when you look at IVD kit manufacturers, you tend to see 70-80% gross margins on those businesses. I think there's a path for us to get there. On the digital side, what I found was a significant amount of the drag on the gross margin on the digital was the professional services that we were providing.
If a center bought one of our products, we went through an implementation cycle that we were charging below cost to do that implementation to get the business. We have made some adjustments to some of those pricing structures. We have also had the benefit of migrating most of those solutions to date from on-prem to SaaS, which makes the deployment cost near zero. We still provide some staff augmentation services that are not as great gross margin as the software, but we have a path there on the software as well, and we are going to get there. The pharmacy is always going to be a pass-through in a low-gross margin business. I will tell you, the customers that I speak with across the country that utilize our pharmacy service are incredibly passionate about it.
The value of having a transplant-trained pharmacist talking with a transplant patient over the phone about their drug-to-drug interactions and adherence rate to the therapeutics and the consequences of non-adherence is invaluable relative to what you see just a general pharmacist do at a Walgreens or wherever else they could get their prescriptions. Our customers really value that service. We continue to staff it with transplant-trained pharmacists to support those patients because we know it's meaningful to the customer.
Got it. Abhishek, just kind of sticking to margins more on the operating side, but just in regards to operating expenses, R&D, kind of where do you see the most room for leverage over time as you strive towards that 20% adjusted EBITDA margin target? What areas do you see as needing further investment?
Yeah. No, I think that's a great question. As I think we have stated, Matt, there's a lot of leverage in our business. We kind of operate in this unique market where we are dealing with a limited number of transplant centers and limited programs. Once we build our sales and marketing organization, we will be able to drive a lot of leverage from there. The operating expenses for R&D is, again, this is basically the innovation part as to how you continue to drive the pipeline to be able to drive the growth. Because at the end of the day, we would want to drive the leverage by growing our top line. That's the most important part. Because if you solve for that, everything else becomes easy to achieve.
The third piece is the GNA, and that's where you would want to stay more strict, I would say, that you don't want to be having your GNA to be kind of even growing at the pace where some of the other expenses in the OpEx lines are growing. You would want to actually control them all the more closely. All in all, I would say that from the leverage standpoint, one is the mix of each of the lines as to how they would be growing, but in combination, how do you grow these three lines at a much lower rate as compared to your revenue growth to be able to kind of drive the EBITDA margin expansion? That's how our philosophy is. Starting from the top line growth, sales and marketing, we will continue to invest till the time we basically see that, okay, we continue to achieve the top line growth, we will invest in that. Similarly, we need to have the right products that will help us achieve, continue to add more to our top line growth.
Yeah. And just drilling down on that for one second, just because when the billing article came out and all the issues that you dealt with, you actually had to significantly cut some costs. I think a large portion of that was GNA. It did not seem like you were adding it back as volumes were returning. Is your comment about GNA more about, "Let's just keep this as stable as we can, even as we grow revenues," versus, "We actually have areas to cut"?
There's a reason why the G&A came down. G&A came down because of the legal spend. We have basically tightened up that particular thing. As you would have seen in most of our updates, how we are kind of cleaning up that whole legal environment for the company, starting from the DOJ and the SECs and the IP litigation, the securities class action, the employment matters, we are removing pretty much every single overhang in the last, I would say, four to six quarters. The pace has even increased since John joined in terms of reducing the legal spend and closing out these matters as much as possible. That has been the reason. We did cut some of the sales and marketing, and that's the reason we are now building the sales and marketing team too. We are making those investments that we had to basically cut down at that time.
Got it. I do want to ask about the adoption of AlloSeq cf DNA product outside of the U.S. and more broadly, kind of how are you thinking about ex-U.S. expansion? Could that growth require further resource allocation to your European operations at any point? I mean, it's kind of like I always think about the U.S. diagnostics industry as very U.S.-focused. There's like Japan is usually the first one. Europe is kind of like a little bit of a different market. How are you thinking broadly about ex-U.S. and then specifically maybe cite the AlloSeq cf DNA?
Yeah. The European market for transplant in aggregate is nearly as large as the United States. There is a lot of transplant that occurs in Europe specifically. Our international headquarter is in Stockholm, where we do our manufacturing for our IVD kits that are registered through IVDR in Europe. We do have a commitment to that market. It is a significant market for us in our current portfolio of IVD products, which includes PCR testing for deceased donor HLA, NGS testing for recipient in HLA, and then the AlloSeq cf DNA for monitoring post-transplantation. We think that could be a sizable market for us. We are not intending to ramp up spend substantially there because the bulk of our sales is through distributors in these markets. We do not do direct sales in Europe.
That's intentional because we don't have the breadth of product portfolio to really walk in the lab and sell across the laboratory. You do need strategic people there, mainly in the medical function, to help drive local studies, generate evidence, and that then leads to ultimate coverage and reimbursement of the tests in those local markets. That's where the bulk of our spend in non-manufacturing and COGS goes to. We've actually made a lot of headway in the evidence generation for AlloSeq cf DNA in Europe. There was a multi-country, multi-site trial published earlier this year showing the performance of AlloSeq cf DNA and the ability to detect rejection ahead of biopsy, and those results were concordant to U.S.-based AlloSure performance.
The belief around the value of the product is growing substantially in Europe through conferences, word of mouth, talking with KOLs, doing medical-to-medical kind of interaction, peer-to-peer interactions. That is how we intend to drive that market. We are not going to roll out some big field force in Europe to sell it.
Okay. Got it. At your investor day this year, you talked about expanding into opportunities in pretransplant and post-transplant space. What are the nearest opportunities, nearest term opportunities there, and how are you progressing towards this portfolio expansion?
Yeah, that's a great question. This was part of the impetus for us to hire this Chief Product Officer to come in and really focus on the pipeline. Our most near-term pipeline products are in the cell therapy space. We haven't planted a flag in the pretransplant indications or post-transplant indications yet. It is something that we have a lot of interest in because if you've got the channel there, you're talking with clinicians, why not? This is something that we're evaluating actively.
Which begs the question, even though you do prioritize organic investment, will this require or will this lead to more inorganic investment on your part?
Yeah, potentially. I think what we see right now is there's a lot of opportunity in our current pipeline to sustain our growth rate even beyond our LRP. As you know, we recently initiated our share buyback program because we felt like we've made substantial investments in our commercial infrastructure to capture the market potential that's right there in front of us with our inline products. We've made investment in our innovation portfolio to bring forward our pipeline. The last piece there from a capital allocation perspective was to buy back shares because we felt like we were undervalued and there was opportunity to give value back to shareholders. We went ahead and executed that a couple of weeks ago and then put out the press release last week completing the share buyback. We're certainly open to exploring inorganic opportunities if there's something that fits with our portfolio that makes a lot of sense for the company.
Now, going back to organic for a minute, you've continued to release new evidence supporting your tests and actually seen positive coverage decisions following releases. Are there trials that you're particularly excited about that we should be thinking about in terms of catalysts?
I mean, the main catalysts are the three trials that we've talked about for some time, SURE, KOAR, and then Alamo in heart, kidney, and lung respectively. SURE, we've had one publication come out. The second publication has been submitted. We said we were going to do that in the first half of the year, and we completed that. We are excited about seeing that in print ultimately. That is data that has come from the abstracts that were submitted last year to ISHLT in 2024 that showed that patients that have a dual positive result on HeartCare, so they had a positive AlloMap and a positive AlloSure test result, the Meyer curve of death or graft loss was statistically significantly worse than patients that either had a single positive test or a dual negative.
Showing that spread of prognosis and that the test provides prognostic value in the management of these patients, I think, is incredibly insightful and has led to further adoption of the product and utilization of it on protocol. We are still looking forward to the first KOAR manuscript showing up in print. We did get that manuscript submitted, and we talked about that on the call. I think that is going to be significant for pushing payer coverage. With lung, Alamo just completed enrollment of the final patient, the 500th patient, and then we have three years of follow-up. I anticipate there will be some interim data that is written up and submitted before the end of the year.
Got it. Okay. Looking bigger picture, there's just a few other players trying to gain share in transplant diagnostics. What are you doing to make sure CareDx continues to set the standard, not just with tests like AlloSure, but in sort of how you support transplant centers from end to end? I think as others are going, it's more of like a test-specific strategy. You've kind of taken the entire industry. You're the transplant company.
Yeah, we're the transplant company.
How do you actually make that materially to your benefit? How do you translate that into capturing and keeping market share?
Yeah, brand is extremely valuable in these markets. I think that creating brand value is important. Then how you leverage that, there are a number of tactical ways to execute on it. We certainly have a strong brand in the marketplace. It could be stronger. We're working on that because the company certainly had its ups and downs, and that somewhat harmed the brand. I think with the new management team, our new focus and commitment to patients and clinicians and being the solutions provider to transplant centers is really important. I think when it comes to competition, you can't rely completely on your brand. One of the things that is, I would say, one of the pillars of a brand in a biotech space is the evidence supporting the products.
Continuing to invest in evidence generation is very important to us, and it's important to the clinical community. If we show a level of commitment to them, they're going to continue to show commitment to us and continue to be CareDx customers long term.
My last question, which is kind of a good segue because my personal opinion, the last question is, what do you think is underappreciated by CareDx? I think part of it is you're not seen by investors technically as a transplant company. You're seen as a testing company right now. There are all these other things you do that are actually reaching some level of materiality in terms of revenue contribution. How do you capture that, and what do you think is underappreciated?
Yeah, I think that there's a lot of things that are underappreciated. I think in the macro, our equation to addressing this market is very different than what you see from other LDT labs in the markets that they address. Having the solution set, spanning software, IVD kits, pharmacy, and our core LDT business is unlike any other. I couldn't name another LDT company that has that set of assets under management and that goes to market in the way that we do. I think that is an equation for profitable growth. We will continue to demonstrate that into the future as we execute on our three-year plan.
Great. John, Abhishek, thank you very much.
Thanks so much, Matt. We appreciate you having us here.
Thank you.