All right, welcome everyone. My name's Matt Stanton. I'm on the Life Science Tools and Diagnostics Team here at Jefferies. Happy to have the team from CareDx back with us at the conference here this year in London. We'll have John open up with some opening remarks, and then we'll jump into some Q&A. Guys, thanks for being here today. I appreciate it.
Great. Thank you very much. I'm John Hanna, President and Chief Executive Officer at CareDx. I'm joined by Abhishek Jain, our Chief Financial Officer. I want to thank Matt and the entire team at Jefferies for inviting us to speak this week at the conference. We'll be making forward-looking statements during the presentation today. This is our Safe Harbor statement. Please refer to the Investor Relations page of our website to download this presentation and any other financial materials. So at CareDx, we've put in place an experienced leadership team to drive profitable growth, including leaders from across the diagnostics, life science tools, and biopharma industry. We have over 650 employees globally, including 180 in our commercial organization driving growth worldwide in the transplant market.
We have 110 individuals in our R&D organization building the next generation of products that'll drive growth in the marketplace, and roughly 80 software engineers supporting both our lab testing, lab products, and digital solutions. CareDx addresses a large market. The transplant market is a $50 billion market in the U.S. alone, from organ procurement to the transplant procedure through to follow-up care for patients, including pharmaceuticals, diagnostics, and utilization at the hospital and clinic level. There are roughly 46,000 transplants performed in the U.S. alone, which means we're spending over $1 million per transplant in the United States. Make no doubt this is a high acuity and costly condition. Transplant is a profitable service line within a health system, and health systems are willing to pay for additional services that allow them to increase the volume of procedures they perform and the quality of care for patients post-transplantation.
At CareDx, we have performed approximately 1 million monitoring assays post-transplantation to detect rejection. 70% of the centers in the United States use one or more of our software products to optimally manage their program and their patients. We sell roughly 200,000 HLA typing kits annually to match organs to recipients, and we fill about 150,000 prescriptions annually out of our transplant pharmacy for patients that are taking immunosuppression and other medications in order to manage their organ health. Briefly on our Q3 financial highlights: we generated $82.9 million in revenue in the quarter, an increase of 23% year- over- year. We performed approximately 44,500 monitoring assays, which was a 16% growth year- over- year. Our gross margins on a non-GAAP basis across the entire business were 69%.
We had a positive adjusted EBITDA on the quarter of $6.9 million, an improvement of almost $18 million year- over- year, and we closed the quarter with a cash balance of $241 million. Q3 was our fifth consecutive quarter of testing services volume growth since the second quarter of 2023 across all organs, and we revised our guidance for the full year 2024 to be $327 million-$331 million, with a 69% gross margin and a positive EBITDA of $18-$22 million on the fiscal year. At CareDx, we're focused on four building blocks for growth of the company, the first being the transplant volume itself, second being customer adoption of our products, third is patient adherence to the testing regimen, and then fourth is our pipeline of new products that we're introducing into the market.
On the first transplant volume, we have a number of tailwinds that are driving this market, including government intervention to drive more transplantation. There's approximately $40 billion spent in the U.S. on dialysis. The government is instituting programs, including the program called IOTA, to drive more kidney transplantation and get patients off of dialysis to this curative treatment. The second are technological advances in the marketplace, including organ perfusion and regeneration, as well as biopharmaceuticals to treat conditions such as antibody-mediated rejection to sustain organ health post-transplantation. In aggregate, we see this market growing organically by roughly mid-single digits. On the heart and lung side, it grows at low double digits, and in the kidney market, we're growing at high single digits from 2022- 2023.
At CareDx, we offer a synergistic portfolio of solutions to transplant centers that helps us drive our testing services volume growth, and this customer adoption of the entire portfolio is critical. It starts on the left-hand side with us offering solutions to HLA labs, including lab information management software, HLA lab testing kits to match organs to donors, both rapid testing PCR-based kits as well as NGS high-resolution kits, and then waitlist management software to rapidly type and match organs to patients and get them into the surgical procedure. In the transplant center itself, we offer a number of programs to help care quality and system efficiency, including a transplant EMR. We have quality reporting software that ingests EMR data and creates dashboards and reports that allows the transplant center to report their care quality outcomes to regulatory agencies, including the Centers for Medicare and Medicaid Services.
We also offer staff augmentation services to these centers in the event they need support collecting, aggregating data, and reporting this data to regulatory agencies, and then post-transplantation in the graft health space, we offer remote patient monitoring services, both for medication adherence and in higher acuity conditions such as lung transplantation, where the patients actually have wearables, and we monitor them 24/7 for potential infection as well as rejection of the organ. We provide monitoring assays for graft health through our blood-based donor-derived cell-free DNA testing as well as our AlloMap RNA expression gene expression testing, and then we're introducing new products in tissue diagnosis to look at subcategorization of rejection and enable more effective treatment, particularly in the area of antibody-mediated rejection, where we see an increasing investment in new therapeutics to sustain graft health.
We know that selling this portfolio across all of our solutions is critical because in institutions where we sell three or more of our solutions beyond just our testing services, we have a 50% higher capture rate of patients that get on our monitoring assays, and those centers generate two times the amount of revenue than centers that use less than three of our solutions in the center, and so we are very focused as an organization on solution selling across our entire portfolio into every transplant center. On patient adherence, as we work with transplant centers across the country, they typically implement a protocol for the utilization of our testing services.
The typical protocol following our ARTS and HARTS publication, which looks at both kidney, heart, and lung transplantation, in kidney is to use seven tests in the first year, four in the second, and four in the third for monitoring for rejection, and in heart and lung, it's 11 tests in the first year, four in the second, and four in the third for monitoring for rejection. But as you can see by this chart, relative to the recommended number of tests to receive in the first year, we only see patients follow through with about 50% adherence to those protocols. So there's significant opportunity for the company to grow its testing volume in the accounts where we already have business by driving both clinician and patient adherence to the testing regimen, and fourth is our product pipeline.
In 2025, we'll be launching two product extensions, including AlloSure for simultaneous pancreas and kidney transplantation and AlloSure Heart for pediatric patients under the age of 18, and then we have three new diagnostic products that we are looking to launch in the 2025- 2026 horizon, including AlloMap Kidney, which is a gene expression assay to look at immune activity that complements AlloSure Kidney, which assesses organ damage through donor-derived cell-free DNA, HistoMap Kidney, which is a tissue-based assay to subsegment the type of rejection between antibody-mediated rejection, cellular rejection, mixed rejection on a tissue biopsy after an elevated AlloSure result, and then the third product is UroMap, which is a product that uses a urine-based sample for patients that are suspected of having BKV nephropathy, which is a viral infection of the kidney.
And in these patients, typically when you have rejection, you increase the dosage of immunosuppression to reduce organ rejection. However, if the patient has a viral infection and I increase immune suppression, they're going to die from the viral infection. And so I want to dial down the immunosuppression to allow the immune system to fight the virus. So this is a critical decision point in a patient that has an elevated AlloSure result that needs further analysis and treatment. As we think about growth, another area of growth for us that we've seen significant success in in 2023 is growth in our average sales price of our products and the amount of cash we collect. Those collections are driven by an evidence strategy to drive coverage and reimbursement for our products.
In the top left, starting with our heart products, AlloMap Heart, which has been on the market for nearly 20 years now, is well established and covered by all payers in the United States with approximately 90% coverage. AlloSure Heart, earlier in that journey, has about 40% of all claims we submit covered by payers in the United States. An example here is the Blue Cross and Blue Shield Federal Employee Program. This year, recently decided to cover AlloSure Heart in addition to AlloMap for their patients as a result of the SURE publication, which was a multi-year study, a readout of a two-year interim analysis using both AlloMap and AlloSure for patients who are monitored for heart rejection. And then on the bottom, our AlloSure Kidney product is covered for roughly 60% of the claims we submit.
This is because patients that have kidney transplantation are typically under Medicare coverage, so a higher proportion of those claims are paid by Medicare, and then 30% of our AlloSure Lung claims are covered by payers nationally in the United States, where a smaller proportion are Medicare patients, and that product is the earliest in its journey around evidence coverage. An example here in the bottom right, Highmark Blue Cross Blue Shield recently, based on the AlloSure Kidney publication in Nature and Medicine, decided to cover AlloSure Kidney for all of their 2.5-ish million patients in the Pittsburgh and Pennsylvania area, and so we have a number of publications driving this coverage and reimbursement strategy. In heart, in particular, the SURE study enrolled nearly 3,000 patients with five years of follow-up across 67 sites in the U.S.
The KOR and OKRA studies in kidney enrolled 25, I'm sorry, 3,600 patients with three-year follow-up across 56 sites, and then the ALAMO study in lung has enrolled 500 patients with five years of follow-up across 19 sites. And each of these studies is designed to retire questions around coverage and evidence supporting the clinical utility of these products so that we can get paid by Medicare and commercial payers going forward. And so with this strategy focused on four areas of growth and our evidence generation, we've provided a long-term guide toward profitable growth and capital allocation that includes exiting 2027 with $500 million in revenue, a 15% CAGR over that three-year period, and greater than 70% gross margins for our business. We anticipate that in 2027, we will have a 20% adjusted positive EBITDA, which means that we will generate about $100 million in profit in that year.
And then over the three-year period, we anticipate adding about $100 million in cash to our balance sheet. From a capital allocation perspective, we're focused first and foremost on looking at M&A to expand our product offering to the transplant center community to better service that community, investing in our core business where we see outsized returns and profitable growth, and then lastly would be share buybacks where we don't see any other area to invest the cash. I want to touch on briefly the future growth of the company beyond the inline products. So beyond the three-year guide horizon that we've given, we're focused on moving beyond solid organ transplantation into stem cell transplantation and CAR T therapies. Today, there are approximately 5,600 registered clinical trials globally in stem cell transplantation and CAR T.
There are 220 institutions that are accredited to do bone marrow transplantation and about 148 that are accredited to do cell therapy in the United States. These institutions are a subset of the existing transplant centers that we call on today. And so we're building a set of products to leverage our existing channel in solid organ transplant into bone marrow transplant and stem cell transplantation. We have two products addressing this market. The first is a product called AlloCell, which looks at the pharmacokinetics of a stem cell transplantation and what we call the peak and trough. So when you inject a patient with a new graft, a new stem cell graft, there is a sudden expansion of that graft, and then it comes back to a trough and levels out.
The monitoring of the pharmacokinetics of that new immune system in the patient is critical because this is a high acuity condition that they could potentially die from, number one. Then number two, the average cost of implementing this new immune system is north of $1 million per patient. So monitoring for the initial peak and trough of this new immune system is a critical condition. Then beyond that, we have an assay called AlloHeme, which monitors for cancer relapse in these patients that have had a stem cell transplantation. This is typically in patients that have leukemia and lymphoma that have failed on systemic chemotherapy. They then get a stem cell transplantation. We initially monitor it with AlloCell, and then on an ongoing basis, we monitor with AlloHeme for regression and recurrence of that cancer.
And so these are the future products that we're looking to launch that'll be beyond the three-year growth horizon that we've provided. And so in closing, we've put the right team in place here at CareDx to drive profitable growth. We're addressing the right markets, and we have the right products to address unmet medical needs in the transplant marketplace. And so I'll end there. And again, thanks to the Jefferies team for having us to present today.
Super. Appreciate the presentation there, John. Maybe just quick on into some Q&A, Abhishek, one around kind of guidance and visibility. I think it's pretty clear that the visibility started to come back into the model this year. As we look at kind of the next few years, you guys pointed to the 15% CAGR on the recent earnings call. You kind of talked about, I think, low teens growth in 2025 accelerating to high teens in 2026 and 2027. Can you just kind of talk about high-level the growth assumptions around that, whether it's in the testing service or the other products business, and kind of what I think there's a bit of a headwind debating, but what gets you from the low teens kind of the high teens in the out years to get to that mid-teens overall?
Sure. So I'll take this question, Matt. And the way we are thinking about the 2025- 2027 ramp-up or the acceleration in our growth is basically as we start to build our commercial organization where we are kind of investing and we are hiring people. And as we start to kind of try and get back the surveillance testing, what we are anticipating is that the growth will accelerate in the outer years. In 2025, when we have guided the low teens, actually, if you exclude the one-time revenue that we have received for the test done in the prior periods, we are talking about 17% growth in 2025. And then we go from the 2025- 2026 at the mid-teens and 2027 will be the high teens.
What we are assuming in this particular growth is that most of this growth is driven by the volume, and volume is driven by, as John basically pointed out, the four building blocks there. So the volume growth, which is a secular market growth, which is the mid-single-digit, and then we look at the customer adoption and the patient adherence as the other high-single-digit, the ASP is baked in at a low-single-digit. So and pipeline has a very small number in our growth numbers for 2027. So that's how we kind of like modeling the revenue growth in the next three years.
Okay. That's helpful. And on some of the growth investments, you're investing both on the sales and marketing and then some new reps, I think, on the billing side as well, both of which are, I think, halfway or so progressed, but should be wrapped here in the near future. How do we think about kind of the ROI and the visibility into the ROI on those hires? And I think for next year, like you talked about kind of low single-digit ASP lift, but if we think about some of the new coverage wins, John outlined and those folks coming on board, I mean, is there opportunity for ASP to kind of move above that low single digit from both the investments as well as the coverage decisions as we look out into next year and beyond?
Yeah, thanks, Matt. I appreciate the question. I think field-facing individuals always have a high ROI, right? We're always going to continue to invest in the growth. And I think as we look at the solution set that we offer, we have a significant opportunity to sell more solutions into transplant centers, which translates into volume growth. And so that's how we've thought about increasing the field-facing team and the density of individuals across the country. On the ASP, ASPs are difficult to predict and appreciation in those ASPs. We've done a nice job of executing on coverage this year with an additional 31 million lives year to date covered across all of our products. And so we're going to try to translate that into network contracts and increase reimbursement.
But given the unpredictability of that, we assigned a low single-digit number to the growth over that three-year period from ASP appreciation. But we certainly have a lot of headroom and opportunity there.
Okay. That's helpful. And on the OpEx leverage side, seeing really nice progress year to date, 3Q was no different. Can you just talk about kind of the levers into that improvement around the OpEx? And I think one of the bigger ones has been kind of an elevated legal spend. I don't know if there's any way to kind of triangulate what that's running at today, what that was in 2023, and then going forward, should we expect kind of a more normalized legal spend within the OpEx line?
Sure. The operational leverage is like one of the critical components as we kind of look for the profitable growth. When we look at the three-year horizon, we are going to be increasing our OpEx at half the rate of the revenue growth. And when we start to look into the G&A, to your point, we have reduced our legal expenses only in the first three quarters of this year by like almost $16 million. So our legal spend has come down pretty dramatically. And the way you would want to think about the operational leverage is that we are not anticipating our G&A spend to go up quite a bit.
It should be a very small increase or pretty much flattish in the next two to three years' time, whereas we will continue to make investments in the S&M and R&D as we continue to build the pipeline as well as we continue to build our commercial organization to kind of tap into all of these revenue growth opportunities.
Okay. And maybe one on capital deployment. I mean, you laid out pretty clear kind of the priorities there. I mean, I think as we think about M&A, maybe just talk about, since you've joined that, John, maybe kind of how the funnel's developed, level of kind of actionable deals as we sit here today. And then is there any kind of parameters you're thinking about around size of deal or kind of valuation metrics as you think about the return? We've seen a lot of kind of dispersion across the space, but maybe private side hasn't really caught up to the public side. So we'd just kind of love to hear about M&A strategy funnel and where that sits today.
Yeah, I think we're early in development of that funnel and criteria, Matt. So I don't have a lot of comments there other than to say that I agree with you around private valuations. And for us, M&A is probably more so oriented toward driving scale of the business versus tuck-in acquisitions like the company has previously done to add smaller capabilities.
Okay. That's helpful. And I guess maybe one quick one is more near-term on the guidance. I think, Abhishek, you guys talked about kind of a 1% headwind tied to hurricane dynamics to start off the quarter. As we've kind of moved along the quarter, sitting here mid-quarter, any kind of update on visibility or ability to recoup that? Is that possible or do we think about that as kind of lost type testing capture?
Yeah, I'll say anything's possible. We believe that it's critical that those patients get their monitoring assay. However, as you saw in our chart when we talked about adherence, that's not always the case. And so we've observed a very interesting behavior where we experienced a blip in volume as a result of the hurricane, and that volume did not come back, and presumably those patients just skipped their testing for that month. But we are diligently following up with them to try to ensure that their graft health is being appropriately monitored and they're appropriately cared for.
Okay. Thanks. I think with that, we're out of time. So, John, I appreciate you joining us today.
Thank you again.
Thank you.