All right. First, I'd like to say, I'd like to welcome everyone to the CareDx 2024 Annual Investor Day. My name is Anna Czene, Vice President of Corporate Communications. With me today, you can see we have members of our executive leadership team here sitting at the front of the room. We've got our Office of the CEO, Michael Goldberg, Alex Johnson, and Abhishek Jain. In addition to that, we have our Chief Scientific Officer, Robert Woodward. We have Marica Grskovic, Chief Operations Officer. We have Kashif Rathore , Chief of Patient and Digital Solutions. GS, unfortunately, could not be here today for personal reasons. We have Stacy Boland, who is our Senior Vice President and Head of Human Resources, and Jeff Novak, our General Counsel.
We have a full agenda today, and you're going to hear from many of our leaders, and we really look forward to providing you with an overview. We have our safe harbor statement. You can find copies of this presentation on our investor relations website, and notably, these slides and the accompanying oral presentation contain forward-looking statements. All right, so without further ado, I'd like to turn it over to Michael Goldberg, who is our Chairman of the Board at CareDx.
Hi, welcome everyone. Many of you, we had a chance to see over the course of the last couple of days in San Francisco. For those of you who we didn't, we look forward to engaging around the exciting vision that CareDx has and will continue to have. Next slide, please. So, we've been operating since November 1 as an Office of the CEO, and it is more of a partnership structure than it is a hierarchical structure. So, Abhishek, Alex and I interact multiple times on a daily basis, seven days a week, and it's actually been inspiring for me to reach in, roll my sleeves up, and be as involved as they have allowed me to be in the business.
The board has tremendous confidence in the senior leadership team, which you have seated here, and in the bench strength that exists below them. In part, that's evidenced by the strong business performance over the last two quarters, which we have every confidence will continue to extend in a sequential nature. I am the chair of a search committee of the board, which consists of three of my colleagues, the chair of the Finance and Audit Committee, the chair of the Human Capital and Compensation Committee, and our former CEO and chair, Peter Maag. Next slide, please. The search is in its early innings. We're using Russell Reynolds as our international consultants on this. They've begun sourcing candidates. We've begun interviewing them.
Let me review with you the ideal candidate profile that we're seeking. First is somebody with deep background in molecular diagnostics so that they understand the innovation and product development cycle, and they understand how to obtain and sustain high-value reimbursement for our products. Second is a valuable operating record, ideally over the growth interval that we would anticipate over the next five years, which would be from $300 million growing toward $1 billion. Third would be experience as a public company CEO, so that they have familiarity with dealing with our most important customers, our investors. Our patients are the mission that animates us, but our shareholders are the people for whom we are responsible to serve as well.
And we want a CEO who understands that and can relate well to you and to your community. Importantly, we're also interested in somebody who has an invaluable track record in M&A and business development to add inorganic growth as a driver to our strong organic growth opportunity.
And finally, with respect to a leadership style, somebody who's patient, mission-focused, because that's the culture of the organization. Someone who is consensual in their decision-making and management style, and somebody who's a true team builder. In terms of expectations, this is likely to take six to nine months to fill the position, so you can expect this team to be delivering our Q4 results and our Q1 results. With that, let me turn it over to my colleague, Alex Johnson, who will speak to our transplant vision.
Thanks, Michael.
Great. Thanks, and good morning. Our vision remains intact. We are looking to be the leading partner in transplant centers, and it's good for patients. It's good business. As part of this, we have a large opportunity. Many here today are very familiar with the large transplant market opportunity. These are some of the highest-need patients, most expensive patients in healthcare in the U.S. today, and they have to be managed for the rest of their lives.
And we're very focused on creating solutions that extend long-term allograft survival. You know, high clinical value solutions. This is a good business. We've been very successful for many years, and it is our focus area. And one of the ways we get there is to go deep. Focus is one of the keys to life, and we continue to focus on transplant, and that really helps us in many ways, some of which we'll go into a little bit more today.
Today, on the stage, you see some of the team members who have been here for a long time. We've built this company over the last decades, and we're going to be the company that continues to bring innovation to the transplant clinic for the next generation. The other, the other part of highlight is that we're taking a very sharp pencil on our business. We're making sure that we allocate capital well and in the businesses that matter and produce good returns. There is a mix.
We have a large, diverse base of businesses, but our testing service business, make no mistake, is a very strong business with very strong gross margins, and our ability to grow remains intact. You've heard about the unmet need, and some of these statistics are probably well known to many of you around this patient population. What has not changed is the fact that these patients need to be managed the rest of their lives, and it's this constant balance, this struggle between immunosuppression and infection, right? Too much immunosuppression, too little, right? And in many cases, these patients lose that battle, and they lose their kidney, they lose their heart, or they lose their lung.
This is a challenge that will continue for many years because simply the population that has this End-Stage Renal Disease and are going on to dialysis and have these morbidities is significant. Right now, you know some of the statistics around CKD, but one highlight I'll mention is that the economics of transplant is very successfully matched against dialysis. So it costs about $45,000 a year for CMS to pay for a patient who has had a kidney transplant. It's almost $100,000 a year to manage that same patient on dialysis. So the economics are very strong in transplant in general, the tailwinds, and we have the ability to create management solutions that can help patients, patient management and really creating these standards for long-term, longitudinal patient management.
We're going to talk a little today about our strategy in terms of our innovation, but also making sure that you know that over the next years, we're going to be the company that continues to bring these innovations. It's a part. It's about going deep, it's about focus, it's about understanding the unmet need, working with clinicians. You can see our acceleration of innovations has been significant over the last five, six years. We have this ability to now understand the market, and when you talk about innovations like Xeno, when you talk, when you talk about multimodality, we're going to be able to continue to bring those solutions, those high-value solutions, to the marketplace. Scale is important.
There's a large patient population, but it is concentrated, and this, and this lets us continue to innovate and really, again, go deep into these transplant centers and with these clinicians to understand where the opportunities are. We looked at the TAM. The billing article has, has obviously changed some dynamics for some, a certain population of our patients in surveillance and kidney, but the TAM remains very large and significant. Part of the opportunity here is that it's growing.
You know, we think the market's growing mid-single digits. You know, you understand the prevalence, you see the incidents, but what's happening now is that you've got this tailwind of about mid-single digits transplant, and you've got a huge population on top of that, of this 400,000 patients, the majority of which have never, never been managed using molecular tools. So the adoption curve is intact and growing. The upsides is, are interesting. You can talk about recovering living donors.
This is something we've highlighted in the past in terms of during the pandemic. Living donors decreased. In fact, you had quarter-over-quarter decrease in living donation in kidney, and a lot of that was patients didn't want to travel, potential donors didn't want to travel, and you're starting to see that come back. Actually, the last couple of quarters, we've seen an increase now in living donation, and if that continues, rather than be a headwind, that will be a tailwind to kidney donation growth rates. Another interesting part of the long-term value is looking at the growth from utilization, and this is interesting. About 20, about 18 months ago, there were some significant changes around allocation.
What happened was, now it's become much more of a market-driven approach for these transplant centers to take an organ. In the past, they were really linked to the OPO, and they had to have, you know, a decision very quickly, and if that local transplant center didn't want to take the organ, they wouldn't take it. And then sometimes it got picked up by other centers. Today, that radius has now expanded to 250 miles around the OPO, which is the organ procurement organization. So now you've got a bit of market forces in place, and if you're a transplant center and you don't want to take an organ, somebody else will, and they'll take it just about immediately. And so now you have an incentive to either take these organs, which before you might have passed on.
Today, you're taking those organs, so those are a little bit. The organs may be not pristine anymore. They may be higher risk organs, so you're taking more organs, so your utilization goes up. But the other piece is, if you have a higher risk organ, how do you manage that patient? You watch them more closely, you monitor them more closely, and you use innovations and tools like AlloSure and AlloMap to make sure that organ extends and that allograft survives for as long as possible. So there's actually a bit of a double tailwind for the utilization. And then, of course, we have longer-term trends that are really in the background. Perfusion. TransMedics certainly has a tremendously successful story, and when you start to see some of these devices, you know, this is a significant tailwind.
On the business longer term, and then, of course, xeno-engineered organs, when they, when they appear, we're certainly working on them for R&D purposes. We'll be there as well. Our testing service strategy really has four pillars. As we go through the pillars, the partner of choice status is something we think we have today, and we want to continue to have. It not just allows us to have scale, but it allows us to be deep within these transplant centers across multi-offerings.
When transplant centers want to innovate, we're the ones they want to partner with. That lets us have this valuable flywheel, this kind of well head of innovation coming to CareDx that lets us innovate and ensure that next generation of technologies and innovation is our CareDx innovations. Finally, or next, we have our core business of AlloMap and AlloSure. Really, the meat of our business here.
You know, about three-quarters of our business, roughly, is testing services, and we're going to continue to invest and reinvest in our core. This is a very strong business, and we want to increase adoption, both in AlloMap and AlloSure, and we're doing that in kidney. We're expanding HeartCare with extensive data, and now we're moving into lung. So that core business is, is certainly an overindex focus of ours. We want to get paid. We want to get paid for the innovation that we produced, and we want to get paid for the patient results that we've, that we've generated.
Today, Abhishek will talk more about this later this morning, as to how we've really looked at the opportunity and again, overindexing for that part of our strategy to ensure that we have the ability now to collect more for these patient results, that today, many of which are not becoming reimbursed, certainly not being reimbursed on the commercial side.
And we have a large, multifaceted strategy to execute on that, including really generating the clinical data that we've used for adoption in the past to reposition it and reanalyze and position it for commercial payers to ensure that we can get paid. And that's a focus that we've accelerated over the last six months, and Robert will talk a bit more about some of the clinical studies we have coming out that will let us enhance reimbursement. And finally, innovation.
Innovation is our core blood, and we, we will continue to generate the multimodality approach for our portfolio. We think it's, we think it's good science, we think it's good medicine, we think it's good business. Clinicians have clearly responded to multimodality in heart, whereas roughly 90% of our heart patients who are tested receive HeartCare, both multimodality AlloMap and AlloSure. And we think that's, that's the extension of the clinical paradigm that clinicians want to see.
They've told us this, and we're continuing to innovate within that model. And not only clinicians, but Medicare has told us that this model works. So earlier this summer, we had HeartCare, Medicare approved or Medicare reimbursed, and so really have had that multimodality validated, not just clinically and from a business standpoint, but from reimbursement as well. And finally, we have new innovation opportunities like cell therapy.
We're continuing to talk about that, and we're continuing to make sure we take a sharp pencil and make sure these opportunities remain intact while still focusing on the businesses that really generate the outsized returns today. Let me talk a little about the impact of our billing article on our business and where it stands today. So the headline is: we've really set a baseline in Q3. We've told you this, and now we've returned to growth. We grew 4.1% from volume sequentially versus the third quarter of this year. So we're back to a growth trajectory. In the meantime, we've updated most of our systems, centered clinical education, our internal systems, our operating expenses now, primarily in the third quarter, continued into the fourth quarter as well.
We're planning to live within what is now this new billing article reimbursement model. So while there's significant opportunity for the billing article to get overturned, for the LCD to become more expansive for access, that's not, that's not what we're planning for, not in our financial model anyway. We certainly are planning for lots of ways to look at the billing article to be overturned, and you'll hear about that a little later. But today, we are making sure that we are having a cost expense model that makes sense for what we know today. We are continuing to fight for patient access, and this is, this is the exciting part, and a part that now, over the last eight weeks, has taken a new, a new momentum groundswell.
What we've seen over the last six months is that professional societies like ISHLT and ASTS have written letters to congressional leaders, to CMS, saying, "This rollback for patients against surveillance, for kidney patients against multimodality testing is wrong. It needs to be rolled back." And what we've seen now is that patients have now raised their voices as well over the last month, and it's all coming to a large and significant head.
What's happened in December is there was a large Capitol Hill advocacy day. Hundreds of patients were on Capitol Hill talking to congressional leaders and actually having significant dialogue. And one of the interesting parts of this is now this has become an equity issue. Black and Hispanic patients are underrepresented for the number of transplants they get versus their proportion of the population.
This is a big deal, and about two weeks ago, the Congressional Black Caucus wrote a letter to HHS and CMS demanding that the billing article be rescinded and that no more changes be made until congressional leaders are consulted. There's actually, for those in person today, there's a copy of the letter, back on our back table, and certainly, it's available publicly as well on websites and such. So it's a very impactful letter, and I encourage you to all read it.
For more updates, the Honor the Gift is really the patient advocacy organization that is consolidating a lot of its activities. There's a website, and there's a link actually, we put on the slide. If you want real-time updates on what's going on with these advocacy efforts, I encourage you to go to their media page, and you can sign up for updates. So with that, let me give a small, snippet of actually some of the activities that we saw earlier in December that are advocating for patient care. So we've got a short video for you right now.
[Video Narrator]
It was really inspirational to be there as part of that event with all of those patients, as a guest of the Honor the Gift Coalition. As Alex mentioned, hundreds of patients visiting with their congressional leaders, which has had the, you know, the impact of these letters from Congress to CMS. I do recommend, as he suggested, go to the Honor the Gift website for real-time updates. So I'm now going to go through a little bit of an overview of where we are on some of our clinical studies and pipeline.
Just as a reminder, Alex put the timeline in the beginning of this presentation about our 20 years of development that has led to the tests we have. But it's not just development of tests, it's also generating the evidence. Ongoing multicenter study data is what's necessary, not just to build a good quality test, but also to add data to the armamentarium of what clinicians see as understanding the value of the tests and how the different ways that they can use the tests.
It has led to there being society guidelines that recommend the use of AlloMap and AlloSure. And these are the types of studies, these multicenter, large-scale studies, that can bring data forth that will lead to payer coverage. And this has been something that we have started focusing on the analysis of these for payer coverage for the private payers and potentially Medicare as well. And then I'll also talk a little bit about where we are on some of our future launches from the pipeline.
Over on the right side of this slide, you know, you'll recognize some of our multicenter studies, KOAR, OKRA, et cetera. There are also, in addition to those single center publications, there's national registries. All of this is a good source of data that we can use for additional surveillance evidence and expanded for-cause uses in kidney, things that we discuss with our clinicians, things that we work with them on publications, but ways that we work with them to understand the value that they have defined in using these in their patients over the past several years. And that is not only in kidney, but also in heart. In heart, especially with multimodality, where they've been using HeartCare, and as Alex mentioned, you know, 90% of the time it's HeartCare.
That has generated a lot of data, and this is where we've seen single center publications that have really moved the needle for our payer coverage. Lung is earlier in its adoption cycle, but of course, that leads to what we see early on, which is initial publications that are independent of CareDx, that repeat the clinical utility, that demonstrate what they're seeing. And I think in the lung community, we'll also see a lot about, you know, surveillance value when they have repeated testing and watching the tests over time. These same studies, and we've repeated the chart here that shows the size of these studies and the number of centers, are important for the evidence for payer coverage.
The studies and the data from those, as well as the clinical guidelines, are key things that private payers look at, and they're looking for outcomes, both short-term outcomes and long-term outcomes. Can we demonstrate that there's an improvement in patient outcomes when managed with AlloSure, HeartCare, et cetera? You know, we could also gain from these studies, you know, what are the benefits of looking earlier, looking later, and expand that coverage. For instance, this year, with the ISHLT guidelines, going from starting at 6 months to starting at 2 months, we've seen private payers that have expanded their coverage down from 6 months to starting at two months, capturing all of those early tests in the first year.
Ultimately, this is, you know, leading to precision care that is driven by the decisions from these tests, and those are key things that we capture in these studies. Moving on to the pipeline. I've divided that into two slides. One is the complementary tests that you've heard about probably before, the first UroMap, which differentiates in that it's a urine test. It is something that can maybe, based on the data, provide an earlier look. It allows differentiation of T-cell mediated rejection from from BK viral nephropathy, and has the potential to help differentiate among types of rejection.
AlloMap Kidney, the blood gene expression profiling, also does the same, in that it has that same multimodality that we see in heart, where it adds a mechanism where we're looking at quiescence of the immune system, or lack thereof, if it becomes activated. And that paired with the use of AlloSure to identify injury, provides a powerful way to look noninvasively at what's going on in the kidney. And of course, HistoMap, gene expression in the tissue. It's not one of our noninvasive solutions, but provides a quantifiable view of rejection and our evaluation of rejection that has shown in our studies and those of others, to actually correlate much better even though they were both trained on pathology. The noninvasive tests and the HistoMap are much more highly correlated.
All of these, you know, I have here in the 2024 outlook column, are in various stages of working with CMS on coverage, as well as additional publications that are underway from either individual centers or from our studies. Then finally, you know, the added value to our existing products of having the digital solutions. We've talked about iBox in the past, which is a prognostic algorithm. More recently, AlloView, a predictive algorithm that in combination with AlloSure and other multiple inputs that are critical to kidney decision-making, further can educate and inform on the risk of rejection. Then in heart, the AI-CAV solution, diagnosis for cardiac allograft vasculopathy, using, again, several factors, but into an AI-derived algorithm that adds value for understanding the risk of CAV.
Again, these during 2024 are going to be in various stages of implementation as well as publication. You know, key in the middle, I think, under AlloView, you know, that will transition to wide availability upon a key publication that we expect to see this year. So I will turn it over to Kashif, who will go through a large part of the digital part of our organization, and maybe finish off a little bit on the implementation of these tools. Thanks.
Thank you, Robert. AI is a great segue into our software and digital patient products in that business line. As we've continued to evolve the AI components, coordinated with our testing services, especially for AlloSure in that area, for kidney patient and heart patients, we're going to continue to focus on those in 2024 as well. Let me share some digital and patient business updates with you. We have significant interest from clinicians in our digital portfolio, primarily because the data-driven solutions and the AI-based technologies are really useful in their clinical day-to-day decisions in how they take care of the patients.
As we made investments in the last few years into this digital and software component, we continue to see a great growth, about 29% year-over-year from last year, and primarily due to our SaaS type of software solutions, that's mostly driven by that. Our thought processes really have a connected, integrated portfolio of products that includes our testing services, as well as some of the software products that the doctors, the patients, and the care coordinators can actually collaborate and navigate through the same sort of ecosystem.
In our patient and digital services, the inception for that business line was really to provide a moat and keep a strong presence in the testing in the transplant centers, so where we become sort of one company, one stop shop for these transplant centers to have kind of one partner that they collaborate with. And then, of course, in 2024, we're going to continue to grow the focus on strengthening that moat, continue to service our patients with the post-transplant and pre-transplant patient care that we provide, as well as with the digital portfolio. Look, the growth component, and we have a great pathway to that, that we've penetrated about in 70% of the transplant centers that are solid organ transplant centers. In.
That's about 175 or so, our number, out of the 250 centers in the country with our testing services and digital products. So that leaves us with a great opportunity to actually accelerate business by cross-selling into that 70% of the centers, but also not to ignore that 30% of the remainder centers where we could find penetration. So gives us a great wide space and great opportunity to continue to actually reinforce some of our products and bring those customers into the CareDx fold. The product portfolio, as we went through for the last couple of years, we've acquired multiple businesses in different digital products.
The idea always has been all along to actually create a patient journey across the transplant, you know, kind of patient ecosystem, and connect that patient journey for more data-driven, insightful, sort of decision-making for these clinicians. Our integrated care solutions from one company going to put that back into the, into the mix that we wanna be one transplant partner for you centers. It provides portfolios integrated as logistical support, the patient management aspects, the quality improvement aspects, operational support, and laboratory management. So if you look at the intention, it's really to create and provide an integrated product portfolio that.
Transplant centers can interact with in the digital, paired with the testing services, tests that we provide, there's huge amount of data that we could utilize with Roberts Group and the innovations to create the next set of products and solutions. Of course, when you buy different software products, there's the disconnectedness in, you know, different workflows that the patients and the providers have to interact. And if I can give you a little bit of sense of what we've been working on, this is an introduction to a new platform or a new sort of idea that our transplant centers will have access to, which is called CareDx Pro. And I have another slide where I can share some visual with you after this.
But if you look at the ecosystem, if we're providing different solutions to our transplant centers, it's a very disconnected, sort of disparate effort that we have to go one product at a time and implement one product, sort of in a two months, three months so timeframe, takes a long time. What we have done is actually created this one single unique interface to have a connected ecosystem called CareDx Pro. Kind of like Microsoft Pro. I don't know if there's Microsoft or Apple fans there, but the idea is that with one portfolio, one screen, you'll be able to interact with different offerings that CareDx provides. So you're not looking at disparate implementations and spending the time and effort in, you know, for these centers.
Single framework, plug and play, and unified experience. The way it looks in the re-- in the fold in. So imagine this is the screen where it is, Epic or Cerner or any other major EHR. What we have done is actually incubated all the products into that one single experience, where a user can click on that, one button within their EHR and get into the CareDx play, the product environment. In here, I would like to actually call out in some of the more strengthening efforts with this, application, which is probably small for you to visualize, but, box around it is called Care Portal.
It is our own developed utility that we launched last year, and happy to report all customers have been transitioned to that. This is how we're able to respond to the evolution and market changes and needs around those tests, and where providers can go and place an AlloSure AlloMap test from that workflow, and then receive the results from right there into their workflow. Which makes us kind of live into that Epic and Cerner ecosystem going forward in a very seamless, collaborative, connected way. Wanted to share these updates with you. Now I'll pass the microphone to Abhishek, who will provide us the financial and as well as operational updates.
Thank you, Kashif, and thank you everyone for being with us today. Let me start with our preliminary Q4 and FY 2023 financial highlights. Again, very pleased with the results, because our revenue came in at above the guidance that we provided last quarter, which was $274 million to 278 million, and we're expecting our FY 2023 revenue to be between $279 million and $280 million, approximately. This beat to the guidance has been driven by the patient test results that we saw in Q4. As Alex pointed out, that we are very pleased to see that we have now set the baseline on the revenues, and we are seeing our volume growth for the second consecutive quarter there.
Thirdly, our testing services revenue came in slightly higher as compared to what we were expecting, given the fact that in Q3, our revenues were slightly higher because of the one-time events. But equally, happy to see that our non-testing services businesses, both patient and digital solutions and products, growing nicely to be able to mitigate some of the impact of the billing article on our testing services revenue. Last but not the least, we continue to maintain a very strong balance sheet, and we have a cash position of $235 million at the end of last year, and this is despite the fact that we used $26 million in cash to buy back 2.8 million shares under our share buyback program.
So with that, let me start to provide a little bit more color on some of these areas. Starting with the revenues, keeping it pretty high level, that, as I said, revenues are going to be $279 million to 280 million approximately. And we continue to see that our products business and the patient and digital solutions that grew year-over-year pretty nicely, and that basically helped us kind of reduce the impact of the billing article on our testing services revenues. The volume story, I think the takeaway here on this particular slide, is that we were impacted significantly with the introduction of the billing article in the second quarter. As I called out previously, our second quarter volumes dropped by almost, like, $25 million, and majority of that came from the kidney testing services.
But the good news is that, we have now set the base here, and we are back to growth. To be honest, I cannot be more proud of the company, how we responded during this time, especially Q2 and Q3, as we kind of, educated the transplant centers, and we went about the operational implementation of the billing article. Good to see that now the baseline has been set, and we are back, into the growth territory. This has been one of the newer slides that we're presenting this time. The billing article has impacted the product mix. If you have a look at our cardiothoracic, which includes lung, it is - from the volume standpoint, it's closer to 60% now.
Prior to billing article, the volumes were primarily from the kidney services, which was above 50%. So there has been a shift from the volume standpoint in our product mix. When we also look at our revenues, you will start to see that revenue is also shifting, where our cardiothoracic franchise is making more than 50% of our revenues, pretty much in line with the volume mix that we see for this particular mix. And this is another slide around the payer mix between the Medicare and the commercial. What I would want to highlight here is that Medicare makes up about 30% of our volume in the post-billing article scenario and makes up about 50% of our revenues.
Now, this includes some of the coverage restrictions that we have seen post the billing article that we did not have in the past. I think the second takeaway on this particular slide is the opportunity that Alex discussed previously and how Robert was articulating on how do we get the payer coverage. Now, on the commercial side of the house, the 70% of the volume makes up only 50% of our revenues, which basically is we can do the extrapolation, and we can find how big that opportunity is, but fairly large.
Of course, this stays one of our focus areas as we look into investing into the right studies, to be able to get the right additional evidence, to be able to get payer coverage, as well as investing in the health economic studies to be able to drive the commercial payers in terms of helping us get the coverage in this area. Building onto the same theme, since the payer coverage stays one of the important areas for us, I would want to highlight some of the coverage successes that we have seen in last year. Particularly when we look at the expansion of our coverage in the heart franchise, where, as Robert mentioned, that after the ISHLT guidelines, we are now covered post 2 months instead of the post 6 months.
So there is an earlier use in the guidelines, and we have been working extensively in that particular area to be able to expand our coverage, and there have been quite a few successes in the last one year. Cash collections continues to stay strong, and I know that this is one area where we focused last year pretty heavily. We built the scale towards the end of 2022, and we started to see the results, and this is the fifth consecutive quarter where we are now seeing that our revenues, our collections are higher than the revenues. We have added approximately, like, $17 million more in our cash, and it definitely has been one key source to reduce our cash burn, and we are really pleased with this outcome here.
We continue to keep this as one of our focus areas as we move into the FY 2024. Turning over to the billing article impact and the mitigating actions. Starting with the billing article, so of course, the billing article impact on our bottom line has been close to $100 million at a very high level, right? The company basically took swift action in Q2 and Q3, and we have made significant progress in the last two quarters. We have made up, like, more than 50% of the impact that was there, that has been there due to the billing article.
Now, there's more ground that we need to cover as a company, and, I will be providing more information in the Q4 earnings call as to how we plan to bridge that gap. But what I can offer to you right now, that in Q4, as we started to see the results on our volumes and everything else, we've started to take further, actions, and we, went through another workforce reduction in Q4, and we are also focusing on some of the other areas that we feel are the rightful areas. And probably the second takeaway here is that we have been very thoughtful as to how we would want to basically cover this gap.
Instead of going too fast and making the mistakes and putting our long-term growth at stake, we have been thoughtful as to how we basically take a phased approach and cover this particular ground and make sure that our long-term growth is not impacted. In summary, I would say that KDX has a very differentiated financial phenotype. We have a large market, which is growing. Our volumes are now stable, and they have started to grow. And of course, if I start to go down on the P&L, when we start to look at the growth margins, testing services still produces strong growth margins of 68%-70%, roughly. And we have, of course, our goal set to continue to improve the growth margins in that area.
When I start to look at the growth margins for the products business and the digital and the solutions business, as I've discussed in the past in my earnings calls, is that we have seen a fairly sizable expansion of the growth margins in both of our business lines, and we're not done there as yet, and this stays one of the focus areas as we move in 2024. Cash position, I think I've already spoken about the cash position, that this continues to stay one of the very differentiated factor for CareDx because we do not anticipate raising cash. We do not have any debt, and this stays a core area. The share buyback of $26 million is probably another example how confident we feel about our position in this particular area.
Last but not the least, we have a path to return to profitability and the positive operating cash flow, and we'll be providing more color on the same in our Q4 earnings call. With that, let me ask, Jeff, who is our General Counsel, to provide a quick update on the legal and the regulatory framework.
Thanks, Abhishek. I'm just going to provide a brief update on our legal and regulatory landscape, and for further information, you can refer to our filings. On SEC and DOJ, we were pleased that the SEC issued a declination letter in September, and we continue to cooperate with the DOJ. With respect to TPE, we have had success on a number of TPE claims on the appeals process, and that appeals process is ongoing.
On Natera's patent infringement suit against CareDx, trial is scheduled for later this month, and we were pleased to report that the judge invalidated one of the three patents asserted against CareDx. We are appealing the court's decision in the false advertising matter with Natera, in which the court threw out a jury's verdict of $44.9 million. That process is ongoing. Last, we have moved for dismissal of the securities class action filing against CareDx, and we're awaiting a decision from the court there. Thank you.
Thank you very much, Jeff. And before I turn it over to Anna for the Q&A, I'll summarize by saying that we are the transplant company. We are the ones who are driving the innovation in this space. The market. We are, we are serving a large TAM, and the market is growing. We have the right financial phenotype, and the right gunpowder to be able to continue to push the growth and make the investments in the rightful areas. And with that, let me have Anna facilitate the Q&A. Thank you.
All right. Thank you, Abhishek. And why don't we start with the first question, from one of our virtual attendees? So we have a question from Alex Nowak, from Craig-Hallum. The first question begins with: "Good afternoon. Q4 volume was strong, yet ASPs did decline versus Q3. Can the team expand on the ASP dynamics seen this quarter, and when ASP's testing services revenue volume stabilizes?" Abhishek, would you like to take that question?
Yeah, absolutely. Can you hear me okay? All right. Hey, Alex, good to have a question from you. Missed the opportunity to talk one-on-one with you. But on the ASP side, when we look at the Q3 ASP, I did call out in the earnings call a couple of one-time factors there, and I called out those one-time factors were approximately $4 million or so. So if you were to take out those couple of factors in Q3, and then if you were to kind of compare the ASPs between Q3 and Q4, you will not see that decline.
I would also add that there have been a lot of disturbance in this particular space, given the billing article starting with Q1, where we did not recognize the $8.9 million, and then in Q2, some of that revenue was recognized. But then in Q2, there were, like, all of these tests that we had to supplement, and then in Q3, there were more factors on the Medicare coverage. My sense is that Q4 is a much cleaner quarter to be able to set our basis on the ASPs. Back to you, Anna.
All right. Thank you, Abhishek. The next question comes again from Alex Nowak. It was mentioned the board is looking for a CEO with M&A experience. What sort of M&A makes sense here? Additional tests, more in the digital product area of transplant, ex vivo perfusion, transplant logistics? So, I will turn that question over to Michael Goldberg.
Yeah, thanks, Alex. I think we have not made a determination. We'll be having a strategy review in the spring, which is our normal cycle for the board, to make kind of scoring assessments and prioritization of various acquisition targets. I think we'll also wait till we have a new CEO in, and deliver a few more quarters of organic growth with the existing operating model, before you'll see anything kind of transformative.
Okay. All right, the next question, we'll take a couple of additional remote inquiries, and then I'll turn it over to the group here. From Yi Chen: Thank you for the update. Of the testing strategies you have noted, where do you see the current bottlenecks, and how are you specifically looking to overcome that? Alex Johnson, would you like to take that question?
Sure. So the fog of the billing article is generally behind us, but certainly not for all centers. Even if centers now can operationally order AlloMap or AlloSure HeartCare, there's still an understanding of what are the boundaries and the guardrails around Medicare reimbursement, what's the right protocol for the center, how do clinicians want to manage their patients within those protocols? Sometimes it's discretion. And so that education process does continue, and it's not just a CareDx effort, it's at these hospitals as well. You know, when you hear the word bottleneck, right, I think it also implies that there's a withholding of care. And I think partially the biggest withholding of care, of course, in the last nine months, has been this Medicare billing article that has really restricted access.
The biggest area of change, of course, would be to pull back that billing article or have the LCD pushed in a way and put out in a way, in a permanent methodology that would increase patient access for those surveillance patients. So both of those are focus areas of ours. And finally, you know, there's this natural adoption curve that we are helping to engender with better data at the centers to understand how these patients can be managed using our molecular testing tools between the guardrails of this billing article, specifically around special populations, high-risk populations, right?
Some patients that were actually for cause, right, may actually still be for cause, but some patients who were actually monitored as surveillance may actually have had some clinical underlying reasons why they were surveilled and monitored longitudinally. So a bit of definitional understanding, and clinicians are getting much more comfortable now with understanding how they can manage patients. And so you're seeing center by center, those start to come back, and we're starting to see those definitive metrics, and we track those very closely at the center and the clinician level.
Thank you, Alex. Next question comes from Andrew Cooper, from Raymond James. Can you give a better sense for the source of additional cost-saving initiatives executed in Q4? After multiple rounds of cuts already, should we assume the remainder needed to offset the billing article impact needs to come from revenue growth as opposed to cost savings, or is there potentially more room on the cost side? Abhishek?
Yeah, sure, Andrew. So, in the fourth quarter, the actions that we took, they basically were around, number one, the workforce reduction. We took another look at our headcount, and we made some choices there. The second piece was around the whole clinical trials, and we have decided to prioritize certain studies that we feel are most important for us, as a company to be delivering, to get the payer coverage, so on and so forth. Then the third piece is that we are continuously looking at our legal spend as to what needs to get done there. But there are things that we are doing as a company. Again, we need to be able to make sure that we are able to kind of cover the gap which has been created by the billing article.
As I said, that we have to be thoughtful as to how much of that gap can be covered through our organic growth, which basically we are definitely kind of contemplating in our discussions and in our models, but also continuously seeing at our cost savings as to how much more gap that we need to cover through the cost savings. So this is a question of more like prioritization on some of our cost actions based on how we are kind of seeing the numbers panning out, and we'll continue to kind of make sure that we are able to make those choices going forward to be able to return to profitability.
All right. Thank you, Abhishek. Thank you, our virtual attendees, for submitting your questions. Now we'll take some questions from the audience. So the first person, if you'd like to raise your hand, if you could please state your name and affiliation. We'll start there, there, and there, and Maxi has the microphone.
Thanks, guys. This is Mason with Stephens, Mason Carrico with Stephens. So could you give us some color around the timelines or your expectations for coverage for AlloMap Kidney as well as UroMap? I think you guys had said these submissions were for the standalone tests, I believe, and then multimodal data would come after.
Yeah. So, it's hard to give timelines as we, you know, we have the back and forth with CMS on Medicare coverage for those, but they continue to be in process, and we don't see any major impediments. It's just that we need to work through the details.
Got it. Then one last one here. Any incremental detail you can give us around your thoughts on burn as we progress into 2024?
Yeah. So, let me provide you a very high level calculation here, right? I'm not providing the 2024 guide as of right now. That will, of course, come with the Q4 earnings call. But if, for example, we were to look at the Q3 cash, which was $268 million, and it ended the current quarter at about $235 million, that's where we used about $33 million in cash. And of the $33 million, of course, we used $26 million for the share buyback. Now we used $7 million. There are puts and takes through the working capital. Some of the stuff that you will basically have in the CapEx.
We'll provide all of those details, but that's the cash that we used in the current quarter, and that probably we can start to kind of hypothesize and extrapolate as to what that range in Q4 is going to be based on the fact that there is going to be organic growth, number one, and number two, we are not planning to increase our expenses, right? So you will basically use the range of the cash burn and start to say that if there's a profitable growth, organic growth, then where that cash burn is going to land. And that will basically also provide you the information that why we feel very comfortable with the $235 million that we have in the bank.
Got it. Thank you.
Okay, the next question here. We'll have two questions here and then one over here, okay? There are two questions there, but let's finish this up, and then we'll move over here.
Okay. Mark Massaro, BTIG, thanks for putting on this presentation today. My question is around heart care, because I believe, if I have this correct, that the utilization is limited to year one of testing. So can you talk about the demand for testing beyond year 1 and the opportunity? I guess, what are we waiting on? I think there's a data. Is it a particular study that will read out? Can you talk about the timing of that and your expectations around expanding that to years beyond 12 months?
I can talk about the study first and then pass it over to Alex. Certainly, we are analyzing data from SHORE that we anticipate should cover additional years beyond year one. And so we anticipate that publication this year for sure, that would inform on that.
Then just an update on KidneyCare. Where are we on multimodality beyond heart?
Well, so KidneyCare obviously was being studied in OKRA, not was, is being studied in OKRA. So the first step, as was already, you know, suggested, is that coverage for AlloMap Kidney, and then as we move beyond that, analyzing the data from the OKRA study and determining whether that's, you know, going to suffice as intended, now that we have the model set with HeartCare is what's necessary.
Timing-wise on OKRA readout , are you hoping later this year?
Probably not that soon.
Okay. One last question for me. Palmetto MolDX held an open meeting, I think, was it August.
Yes.
or September? Can you just clarify if they have a year to issue the final, and just what some of your expectations might be, you know, as we think about any potential changes to the billing article that we saw last March?
I believe their policy is that they have to finish their LCD, any changes, and come out with a final by the date of when they released the draft, which was early August sometime. So that's, I think, the only thing that sets a timeline. I'd say it's really hard to predict what they're going to do. We've done what we can to provide them opportunities to find ways to provide patient access on their side.
Hi, Matt Sykes from Goldman Sachs. Thanks for taking the time to host us today. I guess just a long-term question on sort of the financial algorithm. You guys have done a good job of reestablishing a base level of revenue. But when I think about sort of growth and gross margins, pretty comfortable with the gross margin.
But in terms of growth, how should we be thinking about the different pieces of growth? I mean, you've got pretty good penetration already in a lot of the transplant centers. You've done a lot of work on cash collections. So should we be thinking about this as sort of rising ASPs, talk about testing services, as being one of the main drivers of growth, in addition to digital, which will start contributing more and more as that becomes a bigger contributor?
Can this get you back to that sort of double-digit growth, that you had previously? And is it really the ASPs that we should be focusing on for this long-term growth, or are there other factors that I'm not including?
Yeah, I think there's, I think you're layering on these different growth buckets, right? So you've got this organic growth, and then you've got this market penetration. And I think as this is an interesting model, as the population of patients who have been tested with AlloSure or AlloMap, and they've been on some of these protocols, age, there's a higher chance they're going to continue on, right? Whereas if you started in year eight, you probably are not going to start.
And so here you've got this aging of the population who are transplant patients who have been using these monitoring tools. And so you have this adoption curve that not only continues for new patients to be increased, but these older patients who have been this prevalent population to continue. So I think you're getting this growth lever separate from just the underlying transplant market growth. So there's this adoption increase, and our data and additional population studies will continue to help grow that market.
I think on the top of this, the third is what you're talking about, which is getting paid in a, in a more efficient way. And, you know, that's a, that's a double whammy in a way, in a good way, right? Because you're suddenly, not only are you growing, but you're getting paid for a higher percentage of tests. So I think when you layer on those, there's a really, a very strong growth narrative that continues for quite a long time.
These, these tests, you know, are primarily, and certainly in kidney, very under-reimbursed for private payers. And so there's a lot of room. And as, as Abhishek talked about, and our entire team is actually focusing on, how do we actually increase that? You'll see that in some of the ASPs. So when you look at the top-line revenue growth, really these accretive pieces do create a very long-term, nice growth narrative.
Okay, let's, let's take a question over here.
Thanks. Brian Gagnon, Gagnon Securities. Abhishek, if you didn't have the legal spend, would you be close to break even right now?
I would still say that there will be some more ground to cover. If when you say no legal spend, like, thinking about zero, right?
Well, not them, but.
Yeah. So there will always be some kind of a legal spend, in my mind, the baseline. And yes, there has been some elevated legal spend because of some of the things that we have been dealing with, that kind of, Jeff kind of spoke about. Yes, if you are able to kind of clean up that, that landscape, then, of course, you will have much more smaller ground to cover. It will substantially reduce the ground that we need to cover to come back to profitability.
Do we think that throughout 2024, that the legal spend will continue to decrease?
I'll say that we will continuously work towards reducing the legal spend, but how we solve for some of these things that we are into litigation, now, that is not sometimes in our hands and sometimes you have to go through the appeals process and everything. But as a company, we are definitely committed to making sure that we are not investing, and I'll underscore the fact, we do not want to invest in the legal spend, but we also do not want to kind of put anything from the shareholder value standpoint in jeopardy either, because we are not fighting some of the things that we should be fighting for.
Understood. Alex, it's been about nine months since the first billing article hit. I know it would be anecdotal, but have you begun to hear of any patients who would have been caught, if they had been using surveillance testing that now have rejection?
Yeah, we have. Yeah, we have. And actually, we hear anecdotal from the field and clinicians talking and saying there are patients, and we've got a couple centers on the East Coast, kind of mid-Atlantic area, that have talked to us about patients they're seeing now with rejections they would never have expected to see, and these were patients who were on surveillance. And so the, you know, the very sad part about this, you know, patient access issue is that, you know, many of these patients, if they didn't have rejection or injury detected earlier, it's going to be detected sometime, and it's going to be later. And so typically, it's later stage, it's harder to treat. You've already had organ function decline.
And so there's a, you know, it, it's a very negative cycle here, where these patients now have these comorbidities because, because the graft function is just significantly decreased. And so you're starting to see this anecdotal, and I think, you know, you wouldn't expect to see this in your- in month one right after the billing article stopped. So, you know, nine months, we're starting to see some of these cases come out, and you'll see more and more as these detection of rejections and injury is picked up later and later and later. So, unfortunately, yeah, we're hearing these more and more, and, and it's, it's unfortunately, probably going to continue until access is restored.
Thank you.
Okay, a question just came in from a virtual attendee, so why don't we take that, and then I'll take more questions from the room. We have Brett Dark from Bellevue, and the question is: In a scenario where CMS, HHS respond-- rescinds the billing article and reimbursement coverage returns to where it was, this would catapult profitability. Given the company has laid out plans today around profitable growth with the billing article in place, can we assume this enhanced profitability would lead to shareholder-friendly measures, i.e., more buybacks, dividends. I'm sorry, the question's cut off a little bit. If you could scoot it up, please. Reinvested unnecessarily in the business. Okay, let me just read the last sentence again because I got cut off there.
Given the company has laid out plans today around profitable growth with the billing article in place, can we assume this enhanced profitability would lead to shareholder-friendly measures, i.e., more buybacks, dividends, versus being reinvested unnecessarily in the business?
I'll take that one. Thanks, Brett, and thanks for staying up late for this. I think I would accept your premise with one caveat, and that is, yes, it would catapult profitability. That's not the caveat. The caveat is that you can assume the board will consider a series of shareholder-friendly measures that you know balance all the considerations that we need to balance. I wouldn't presume that any short-term windfall from change in the reimbursement landscape at CMS would lead to an immediate share buyback. Certainly, probably not dividends, until such time as we're really confident with the operating models' robustness, which we're very close to declaring now.
You know, as you have known from being a shareholder with us, we pride ourselves on listening to our shareholders, and we certainly have been responsive to share buybacks in the past and remain open to them in the future.
Okay. Thank you, Michael. We still have a little bit of time to take questions from the group in attendance. Next question from anyone in the group? Okay, we have another question here.
Thanks. Matt Sykes from Goldman again. Could you just characterize your relationship with MolDX at this point? Just given all the issues that happened, some of the perception would be there was a communication issue to begin with. Could you talk about some of the steps that you've taken to improve that relationship to make things maybe a little more seamless in the future?
I think that, you know, it can be said that we still have, you know, open lines of communication. We don't think that it's had any impact on any pending submissions. They're, in that respect, you know, a very professionally run organization that, you know, can do one thing in one way and worry about other things in a different way. And, you know, I wouldn't have any hesitation, you know, if I need to and have a specific issue, about calling up Gabe and saying, "Hey, what's going on? We need to talk about this.
Thank you.
Okay, thank you. Do we have another? We have, I think Ross raised his hand just a tad faster, so we'll start there and then move here.
Okay. Mark Massaro, BTIG again. I guess this is for Abhishek. So, it has to do with, you know, that nice return to stabilization that you called out, I believe, in Q3. Q4, you had a nice, I think, 4% increase volume-wise. I'm just trying to think if there's anything that poses a threat to, ongoing sequential volume growth from here.
Because it would seem that as transplant centers get more acclimated with the changes to the billing articles, that you would suspect that utilization will likely kind of, sort of, you know, tick back up. So I'm just wondering if there's anything in Q1 we should be thinking about. I know elsewhere in diagnostics, we think about the health plan and deductibles resetting and such. So anyway, would love to see if you're feeling good about sequential volume growth from here?
No, sure. Mark, to be honest, I have the benefit of having Alex here, who, who is a lot more closer to the testing services volume. So why don't you take this question, Alex, and then I will basically add further as needed.
Yeah, I think, you know, the significant challenges and headwinds are generally behind us for, you know, idiosyncratic events. I think right now, centers are getting used to these new testing protocols and guardrails around coverage, and so, for us, it's growth going forward.
Then, sorry, last one. I think you indicated that you'll provide more comments in your Q4 call, as I'm sure you will. But do you think at that time, as you're building confidence in the business, getting back to sequential growth, do you think you'll have enough visibility to provide commentary about timing of adjusted EBITDA positivity on the Q4 call?
Oh, that is definitely my goal, Mark, 100%, that there is still more time that I will be able to now figure out in the next six weeks as to what that timeline looks like, and that, to be honest, my goal is to provide more color at that time on the timing. Otherwise, I'll provide a bit more detail as to when that is expected. Thank you.
Okay, next question over here, and then we'll go back there, but let's come back here.
Okay.
Boy, a lot of questions. Who was it? I'm sorry.
Did you have anything to add to that? Okay. All right, let's start this question.
All right, so billing article rescind would be great, but you still only get paid for about 50% of the tests that you do. Now, it's really nice that you do this for the world and all these patients. So what moves that needle forward? Because that's just all incremental revenue and profitability that today, as a company, you're eating. So how do we move that from 50% to 60% to 70%? And I think you're at about 80% reimbursement for heart care today. So how do you move that forward, and what's the timeline look like? And Robert, do you need more data to provide the commercial insurance companies, or is this just a time process to get this to really move up?
Well, one of the things that we do is work with them to understand what they need, right? And so the focus this year has largely been around heart care because we had, you know, guidelines, and we were able to use those and go in and talk with them. The same time, start to get some discussion on kidney reimbursement. And, you know, that organization works with Alex. I'll let him continue on some of the answer for your question.
Sure. At a very high level, you're absolutely right, Brian. We did 40,000 tests in Q4. If you were to get paid on every test, you're talking about $100 million plus in revenues. You did 46, 47, so you're absolutely right, there's a huge opportunity. Now, how do we get there? That's the reason this stays the most important priority for CareDx. This is a very interesting, I would say, and a very complicated project that we have undertaken under Marica, where we are now looking from the beginning, where for the commercial payers, what are the things that we need to do to drive the coverage, number one. For that, of course, Robert spoke about a lot of things that we have started to do on the studies and generation of that evidence.
The second piece is around getting actually starting some of the health economic studies that we are doing now. Then the third piece there is that how Marica is leading the effort, that once the test is in, if you need to take the prior authorization, if you need to obtain more records, if you were to kind of continue to pursue these appeals multiple times to be able to get paid, though we have built that structure, but continue to hone in on that particular structure to increase that percent, that is a goal.
But it will take time, because I'm seeing that in that chain, if one thing were to get missed out, you will not get paid. And if you're not going to get paid, you will not have the revenues to recognize. Marica, I don't know if you would want to add something further there.
We said we are reengineering our intake process and also our billing processes. There is some room for improvement there as well. So, working with centers, making sure that tests are submitted in a timely fashion with all the orders, all the necessary documentation, and then implementing our changes in the billing processes that will allow us to be way more efficient, will certainly bring another positive effect.
Okay, moving on to the next question here.
Matt, thanks. Hold on. The last one, I promise. You know, prior to the billing article, there was a lot of discussion among investors about the competitive landscape in transplant. Since then, there's been other things that to talk about, but could you maybe revisit the competitive landscape, how you see CareDx fitting into it, and has the changes in the billing article resulted in any level of distraction or market share shifts or anything like that, that you can see? Any kind of commentary on that would be helpful. Thank you.
Sure, no, and thanks for that. I think when you look at the billing article, what's happened over the last nine months is that we have been in the lead to educate and work with these transplant centers to help educate, update their systems. And as we continue to lead with our innovative portfolio, multimodality, which is something we've done for years, I think that lead continues to get extended. And, you know, I can't speak for other companies, and I won't, but I can say that we're very focused on that next layer of innovation and making sure these clinicians and these transplant centers have everything they need to best manage their transplant patients.
I think we're the company, and probably the only company, that is doing that at scale across multiple technologies, multiple platforms, looking at all the organs and then looking at stem cell as well. So I think what you have here is a bit of an extension of the gap here, where our focus now is becoming even more pronounced in the marketplace.
All right. Thank you, Alex. Any final questions for the group? Okay, well, this concludes our 2024 investor meeting, annual investor day meeting. Thank you all for joining us. We very much appreciate your attendance. Thank you.