Thanks for joining us at the Stephens Conference. I'm Mason Carrico. I'm the diagnostics and medtech analyst here at Stephens. It's my pleasure to be hosting CareDx this morning. Joining us from the company is John Hanna, CEO, and Abhishek Jain, CFO. Great to have you guys here. Thank you for coming.
Thanks so much for having us, Mason.
Yeah, maybe just to start here, for those who aren't familiar, can you give us a brief overview of CareDx and the reimbursement saga that's played out over the last year and a half, two years, and kind of where we stand today?
Absolutely. So CareDx is a diagnostics solutions company focused in on the organ transplant market. Transplant is a $50 billion market from organ procurement to the surgical procedure of implanting an organ through the follow-up care, including diagnostics, therapeutics, and physician management of patients. CareDx offers solutions across that care continuum in diagnostics, including matching organs to recipients, providing software services to hospitals to allow them to operate their transplant centers more efficiently and with higher quality care. Then on the back end of that procedure, we offer monitoring assays to detect rejection of the organ by the body so that the patient can have a longer graft survival.
In the first quarter of 2023, we had a little bit of a hiccup in our Medicare coverage where the Medicare contractor changed some of the language related to our policy, which resulted in a drop in the utilization of the service of about 10,000 tests quarter over quarter. We have since been successful, I think, in putting to bed that issue, and the draft policy that was introducing more restrictive language around the utilization of the testing has since been withdrawn, and we're seeing quarter over quarter incremental growth. Since Q2 of 2023, we've had five consecutive quarters of testing services volume growth and revenue growth, and we're looking forward to that continuing into the future.
Thanks for that. So on the Q3 call, you guys talked about a two to three quarter timeline for surveillance volumes to really ramp, but 10 transplant centers or so already have protocols in place. So first, could you just talk about what is the process of getting a new protocol in place, and how does that translate to that two to three quarter timeline?
Absolutely. Like many areas of medicine in transplantation, clinicians like to operate based on protocol management of patients so that there's standardization and they can track how changes in care impact the quality of patient outcomes. And in transplant, they'll put in place a protocol on how they manage the patient's post-transplantation, which may include a mix of doing biopsy procedures to look at the tissue to assess for rejection of the organ, as well as blood-based testing, including donor-specific antibody and donor-derived cell-free DNA and gene expression testing that we offer at CareDx. And so we work with these centers to understand how they want to manage their patients and review the clinical literature of the studies that have been published in the use of our tests, and then they will put in place a protocol that's a consensus-based process in the department.
It could be a thoracic department doing hearts and lungs or an abdominal department doing kidneys, and when the clinicians in that department, including the surgeon, the cardiologist, or pulmonologist, or nephrologist managing those patients post-transplantation, all align and agree, they draft a written protocol. It's saved as a part of the EMR. We work with them to implement the workflow to ensure that the patients that fit into that protocol have their blood drawn, get the testing, and that the testing results are acted upon effectively, and so in August of this year, the restrictive language was withdrawn, and we went back to working with centers to implement protocols for surveillance testing, in particular for kidney transplantation, where fewer biopsies are performed because it's a smaller organ. You don't want to stick it with a needle as many times as they do in hearts and lungs.
And in that patient population, we're working through the centers that we have relationships with to re-implement protocols for surveillance testing, which we anticipate will take two to three quarters to get consensus, implement the workflow. And then typically in these centers, when you do implement a protocol, you find that new patient starts are put on the protocol. They're not going to go back and test prevalent patients that were transplanted a year or two prior. And so we have given the expectation that this will be a nice even kind of ramp-up in volume as those protocols are implemented throughout 2025 and 2026.
Just given that you've seen some centers move already, is it fair to say that some centers could move more quickly than that two- to three-quarter assumption? And do you anticipate that some centers and doctors will start running surveillance tests prior to a protocol being in place?
Absolutely. There are always exceptions to the rule. And we did see here, as of the start of September, I think we shared on the call, the Q3 call, that 10 centers had already implemented surveillance testing protocols in kidney between September 1st and the date of our call in early November. And those are early adopters. As you know, in this medical field, we have an adoption curve for technology that tends to be quite long. And we had a number of clinicians that were chomping at the bit to get going again because they've seen in their practices the impact of not using the testing on patient outcomes. And they were ready to get started again as soon as that restrictive language was removed, and we shared with them that we were ready to begin accepting those samples.
Got it. And maybe to a level set here, could you just remind us how many kidney centers there are in the U.S.? And then when you think about whether it's the proportion that ultimately put a protocol in place or looking 12 months out, how many will have a protocol in place? Could you just give us some color on that?
Yeah, that's a great question, so there are approximately 250 transplant programs across the United States in about 180 health systems. A program could be a thoracic program, hearts and lungs, or abdominal, kidney, pancreas, liver, and so they overlap. You're going to have two programs within the same center. I don't think I could estimate how many will implement a protocol, only to say that we believe that the evidence supporting surveillance testing is very strong. There are multiple peer-reviewed independent publications showing that donor-derived cell-free DNA testing picks up organ damage well in advance of biopsy, and so if you're able to detect that damage ahead of seeing it on the tissue and effectively treat those patients with increased immune suppression dosage, you can improve patient outcomes longer term and increase graft survival.
And that's the data that has emerged over the past 12 months or so and that I anticipate will continue to be published on because there is a strong, I think, belief among the clinical community that this is the right paradigm for managing these patients.
Looking back prior to the, well, I guess billing article change initially, I think you guys had 100 AlloSure Kidney protocols. I think most of those were in the centers. I think some were in the community setting. But do you think that those centers that previously had a protocol could move more quickly? The 10 centers that you've signed up, had they had a protocol in place in the past?
Certainly, like I said, there are early adopters, and you would hope that centers that previously had a protocol could re-implement it. I think an important context here is that this change in the billing article was a year and a half ago, so there's been substantial time that's passed where behaviors have changed inside of the transplant center on how they're managing those patients, and so changing behavior in a clinical setting is one of the hardest things to do and what we all focus on in this industry around physician behavior change for better patient outcomes, and so in addition to just adopting the protocol, which is typically a Word document, no more than a sheet of paper, we've got to change the behavior of the team inside of the transplant center in how they're managing these patients.
That's really the hurdle that we have to overcome in order to drive that utilization of surveillance testing in the market.
Okay. You showed a slide at your Analyst Day that outlined frequency of testing, where that currently stands compared to essentially the AlloSure Kidney protocol. For the centers that have put out protocols, could you just give us some color, if you have it, on what that frequency of testing looks like, how it compares?
Yeah. So the 10 centers that I referenced in the Q3 call all are following the ARTS protocol by and large. And that was the reason behind calling out the 10 because we've always referred to the ARTS protocol as the standard of care, which is seven tests in the first year, four in the second, and four in the third. And so we anticipate that those centers will follow that protocol and do, on average, seven tests in the first year. On average, across our business, historically, we did see that number be a little bit lower. And particularly in years two and three, it trails off. And I think this is where, as we think about the policy and what we've heard from our Medicare contractors and other KOLs, is utilizing the testing is always based upon a physician pre-test risk assessment.
If the patient is two years out from transplantation, they're doing very well, and they don't feel there's a need for testing. They may not do four tests in that third year. They may trail off the utilization of the testing, which is medically appropriate.
Okay. You talked about how you've seen some surveillance start to ramp up. Is most of that coming from the protocol centers, and I don't know your visibility into it, but how quickly did you see that change once it was implemented?
Yeah, it has predominantly come from the centers that have implemented those protocols. We saw the change pretty quickly after the start of September when those protocols were initiated in those early adopter centers, and then that trend continued through the month of October.
Okay. And we've been hitting on AlloSure Kidney a lot, but maybe just to touch on AlloSure Heart. There's been a lot of changes, obviously, over the past year, year and a half, especially around HeartCare, winning back coverage there. What is the, I guess, maybe the best way to frame it is prior to this LCD being withdrawn, what was the reimbursement dynamic with HeartCare and when you were paid on AlloSure? What does the LCD, now that it's been withdrawn, change?
Yeah, the withdrawal of the draft policy did not really impact HeartCare, which is the combined use of AlloMap Heart, our gene expression test that's been on the market now for over 20 years and is a standard of care in detecting immune activity in patients that have undergone a heart transplant that have stable heart ejection fraction, and then AlloSure Heart, which detects organ damage through donor-derived cell-free DNA. The combination of those two products, when both are elevated or positive, we find that the yield of rejection on biopsy is significantly higher than when either product alone is positive or when you have a dual negative result.
The emergence of that literature in multiple publications, including most recently in the two-year interim readout of our SHORE study, gave confidence to the Medicare contractor to cover HeartCare, the combined utilization of both tests in patients with stable heart function. We continue to be reimbursed for that. I think we're going to see here in the coming years more and more evidence suggesting that not only does it increase the yield of rejection on biopsy, the results of that testing is driving clinician behavior as to whether or not they perform biopsy, and the dual result is prognostic of longer-term outcomes of those patients.
Correct me if I'm wrong here, but I think at some point, AlloSure, under the HeartCare coverage that you guys won, was not reimbursed after a certain time period. Does this LCD or does the withdrawal of the draft change that at all?
Yeah, I think that that issue that was brought up over a year ago was a bit ambiguous. And there's always gray areas in reimbursement. I don't think there's anything in the policy explicitly stating that it's not covered beyond one year, but it is billed slightly different. And what we have experienced most recently is that that testing is being reimbursed by the contractor. And in the off chance that a claim has been denied, we've appealed that claim for medical necessity, and through the appeals process, we've been reimbursed. So we feel good about the coverage status of HeartCare for patients on an ongoing basis. Given the high acuity of this condition, remember, as a society, we're paying upwards of $1.25 million for every heart transplant that occurs.
The utilization of this testing to ensure a good prognosis of graft survival and the appropriate management of those patients is a significant value add to the health system.
On CMS's statement about the MACs potentially issuing LCDs sometime in the future, what are your expectations around the timing of that? And do you have any visibility into it? Are you talking with the contractors about what this could look like?
Absolutely. We talk with our contractor and with the agency frequently. And that's just a prudent kind of housekeeping activity. And we, of course, have other products that they opine upon that we're engaged in discussions with them about. I think first and foremost, the LCD that is active right now is dated 2021. These LCDs, as you know, take 18 months to get written and then finalized through draft and comment. And so really, the literature behind that LCD is upwards of five years old at this point.
So what I anticipate is that if and when a new LCD would be issued on solid organ graft rejection monitoring assays, that it would include an update to the literature, which includes the substantial amount of evidence that's been published to date demonstrating that these tests can detect subclinical rejection of the graft before biopsy and really make the case for surveillance testing to extend graft survival. And so that's what I anticipate. I think we have, by and large, made a strong argument that there should be coverage for surveillance testing in this space, given all of that evidence and the impact that the administrative change to the billing article had on patient management, which I think was really, quite frankly, likely an unintended consequence.
Right. Right. Maybe on clinical evidence, you guys have published some pretty significant studies over the past 12 months. You've touched on those. Looking out over the next 12 or so months, what data milestones or publications should we be paying attention to? And is there anything specifically that those enable, whether it's just more doctor confidence in the tests, indication expansions, anything like that?
Absolutely. I think we've been really pleased with the evidence that has come out over the past 12 months supporting the products. In particular, we began a series of studies upwards of four to five years ago that are large multi-center prospective studies in heart, kidney, and lung. You saw earlier this year the first interim readout of the SHORE publication, which includes nearly 3,000 patients prospectively enrolled and managed using the combination of AlloSure Heart and AlloMap Heart or HeartCare. We anticipate future publications coming out of that data set. So when we do these large multi-year, multi-center studies, we anticipate that the PIs, the lead investigators from the academic institutions, will publish five, six papers out of this data set, really showing the management of these patients in totality and then subsegmented populations and how they're managed going forward.
In the near term, I do anticipate that in kidney, we will see a readout of our KOAR publication, which looks at decision-making and the identification of subclinical rejection with three-year follow-up on about 3,600 patients enrolled from 56 centers across the country using the ARTS protocol. So that study is in analysis. As I understand, the PIs are drafting manuscripts, and I'm looking forward to hopefully first half of 2025, seeing a publication come out on that. We also have what we call the OKRA study, which is similar patient population to KOAR, but a subset where we're also using AlloMap Kidney to manage those patients. So this is a new product that looks at immune activity in kidney, similar to our AlloMap Heart, looking at immune activity in heart. And if the combination of those two has an added impact on decision-making in the management of patients.
And then the third is our ALAMO study, which is a 500-patient study with five years of follow-up in lung. And I don't anticipate that we'll see a manuscript on that in 2025, but we'll really look to 2026 for something to come out in the lung space.
Okay. You guys have won some regional payers over the past 12 months, maybe a bit longer than that, but as you look out over the next few years, what do you think it takes to get national payers on board?
Yeah. And so that question, coupled with your prior, the impact of these publications is twofold. First, the building of evidence around how it impacts the management of patients or outcomes of patients drives adoption in the marketplace. So specifically, as we saw the AlloSure data read out in abstract form at ISHLT in 2023, and then later in the year, in late 2023 and early 2024, we've seen a shift in utilization of HeartCare and increased utilization of HeartCare. And that's really driving the heart volume growth in the market because clinicians have realized that the combination of the two is prognostic of outcome. And thus, having those answers is critical to how they manage these heart transplant patients. The second is in driving payer reimbursement and coverage for the products.
So year to date, we have obtained 31 million additional covered lives across all of our products in the U.S. And as we obtain covered lives, it enables us to get paid and reimbursed for the test in a commercial payer setting and negotiate network contracts so that we can get first-pass payment on those claims. And so that's what we're very focused on going into 2025, is increasing the penetration of our network contracting so that we can pull through that coverage that is the benefit of all the investment we've made in the clinical studies over the past five years.
Got it. And on those $31 million covered lives, getting contracts in place, is it fair to say you haven't seen much benefit from these at this point? How do you think about that starting to flow through in 2025? Is it baked into your long-term targets?
Yeah, absolutely. So in our long-term plan, we guided a low single-digit contribution of ASP because it's very hard to predict ASP growth and coverage and how we pull through the cash collection. However, we did also add 20 individuals to our billing organization to try to collect more cash and get those ASPs up. So we see that as a potential upside to the plan that we laid out in October. We have not really substantially benefited from those 31 million covered lives in the current year. I think we have seen an uptick in ASPs because we've done a better job of collections on the existing coverage that we have in the commercial marketplace with the team we have in place.
I'm looking forward to these 20 individuals ramping up here over the next several months and trying to really push in 2025 to drive collection and ASP growth.
Got it. And just on cash collections, how long is that runway? You guys have obviously collected a lot over the past 12 months. Do you still see a lot of room to improve there?
I think so, Mason. There is still definitely room to continue to actually improve the cash collection, specifically when we talk about the Medicare Advantage payers. The higher number that we've collected in the past four to six quarters have been primarily due to that, okay, we saw the shift from Medicare to Medicare Advantage from 2021 to 2022. We were not getting paid. And then you start to go after these payers, and you basically started to collect a lot of money from those payers. But still, there is potential opportunity out there because we are not getting fully reimbursed at the rate of the Medicare with these Medicare Advantage payers. So my sense is that there's still definitely an opportunity to not only collect for the payers that have gone past by, but also continue to improve the ASPs on those payers on a regular and consistent basis.
Got it. And on that point, I think a couple of years ago, when surveillance volumes were really ramping, that's when that shift was occurring right off the bat. And it kind of muddied the waters with surveillance ASPs for AlloSure Kidney. As we look at surveillance volumes ramping from here, just because of the work that you've done, are surveillance volumes accretive to ASP from here?
The surveillance volume for Medicare, they are being reimbursed at the same rate, right? So basically, we haven't had a situation where we were getting these tests for surveillance, and we were not getting paid. We are just not billing those if they were not according to the policy.
Right. Prior to all this, though, back in 2020, 2019?
In 2020 and 2019, since we were not even having that kind of a division, whether the test is coming for surveillance or whether this is coming for cause, right? You basically had all those tests come in, and then if they were as per the protocol and as per the policy, they were being billed, and Medicare would reimburse 100% of those tests, right, so you basically had the full Medicare rate of $2,840 that we were getting reimbursed on prior to, I would say, the Q1 of 2023. There wasn't any difference in the ASP for surveillance or for cause because you were getting paid everything.
In more specific, were you getting denials from Medicare Advantage?
Yes, of course. That's the challenge, right? So Medicare Advantage was denying the claims and non-paying. And as Abhishek articulated, we've done a great job, I think, of going back and telling those payers, "Hey, you're obligated to pay for this. This is a Medicare benefit for these patients." We've been able to negotiate one-time payments that we've been able to flow through to the bottom line. And then on a go-forward basis, post that negotiation, we find that they do pay for the testing. And that has enabled us to increase our ASP up to the $1,300-ish rate that we've experienced in 2024.
I think to your question, yes, as kidney volumes increase, that could be another tailwind to ASPs in 2025, given that the bulk of those claims are Medicare patients, assuming we can collect the Medicare Advantage money, right, which continues to be a question mark and we continue to push on. But as Abhishek said, that's kind of baked into the current ASP rate right now, right? Because that is a mix of Medicare and Medicare Advantage. So we're at the $1,335. We can continue to push them. Then you could see some appreciation there. But again, we guided low single digit because it's unpredictable.
Got it. Okay. So operationally, you guys have made a lot of improvements over the past 12 months. The reimbursement backdrop, I would say, is much more favorable now. But if we kind of think about market drivers, the IOTA program, could you talk about that a little bit? One, maybe just for those who aren't familiar, what is it? What's the goal of it? What is it trying to obtain going forward? And maybe how does that benefit you guys?
Yeah, that's a great question. And I'll add that as a company, I've been with the organization a little over six months now. We did make some substantial changes to our management team and reorganize the business to grow profitably into the future. And we're still on that journey, right? So that's something we'll continue to provide updates on in future quarters and how our progress is building as we really try to put in place, I think, the systems and processes to allow the business to scale efficiently. On the IOTA program and the secular market growth, we have a lot of belief that there are a number of factors driving the transplant market. First and foremost is government intervention, I would say, or motivation to really move, especially in the kidney market, the $40 billion in dialysis spend toward effective curative treatment of transplantation, right?
We have all of these patients, roughly 100,000 on the waitlist currently to get an organ that don't have access to one. The vast majority of those are kidney transplants, about 90,000 of the 100,000 waitlist is kidney. The IOTA program was intended to drive higher volume of kidney transplantation while also maintaining quality. In the marketplace, transplant centers, there are, as I said, only about 250 programs because each needs to be accredited and report their outcome data to the agency and to local healthcare regulatory authorities. As you ramp up your program, you want to ensure that you have high-quality outcomes on the back end.
We think as a company, we're uniquely positioned to support those programs by offering solutions, as I described, across the patient journey, including one of our products that's very popular in the market that enables the transplant center to do that quality reporting and dashboarding. It's a software product that effectively ingests the EMR system data, builds dashboards and quality reports so that the center has visibility into how they're doing from a care quality perspective and have really a finger on the pulse of that. And then we can provide them guidance on how to improve the quality and outcomes of their transplant patients. We do that through our testing. We have medication adherence programs.
We have a specialty pharmacy where our pharmacists will work directly with their patients to ensure they maintain adherence to their immune suppression medications, which is the number one reason why a graft would fail, is not taking the meds. And then we have staff augmentation services. So if that center is struggling to meet its quality scores and it needs help doing that data analysis and managing their program, we will deploy people into the center, similar to the way you think about a large software enterprise software company, supporting that organization to manage their transplant program. And all of that is really, in my mind, geared toward driving more utilization of our testing services on the back end, which improves outcomes of patients, as is evidenced by our literature.
Got it. And maybe to even simplify beyond that, the IOTA program, there's more to it than this, obviously, but increasing the number of kidney transplants per year, which I would assume that means utilizing more at-risk organs. So the benefit to you guys is potentially twofold or more, right? More kidney transplants and then potentially more utilization of your tests because they do improve outcomes in monitoring.
Absolutely. Absolutely. So we, in our long-range plan, guided mid-single-digit secular growth of the market. What we've seen in 2023 was low double-digit in heart and lung and high single-digit in kidney. And so the implementation of a program like IOTA, which we're supportive of and have provided our commentary to the agency on, really is a tailwind to that growth. So you could see that growth higher than the mid-single digit that we put in our plan. I think you're absolutely right. It's all about using what are often referred to as compromised or marginal organs. In the United States, roughly 25% of the kidneys that are harvested are not transplanted, right?
They go unused and they're discarded because either there isn't a perfect match in the HLA typing or there's some problem with the organ that's observed post-harvesting the organ, and the center does not want to take the risk on transplanting that organ and having a poor outcome, and so IOTA is intended to incentivize increasing that volume of transplantation, hopefully while maintaining the high-quality outcome, and we think we have the programs and solutions in place to help those centers maintain those outcomes longer term.
Has that program spurred conversations with transplant centers in terms of what they can utilize, the solutions that you guys offer and kind of jump-started those?
Absolutely. And unfortunately, the program was delayed by the agency. So we don't anticipate it to start in January 2025. We think perhaps January 2026 it'll start. But the main commentary from the transplant centers to the agency was, "We're not ready to do this yet. We need to get ourselves organized around this new objective that you've put in place. We've always had the quality objective in mind. Now, increasing volume year over year is a new objective, and we need to put in place the right programs to enable that." And like I said, our solutions, including we have a software system that allows waitlist management. We have a software system for HLA Lab Information System management, which allows them to do the virtual matching of a donor organ to a patient.
And then the quality improvement software and medication adherence on the back end are all intended to provide this solution set to the center to allow them to achieve their objectives. Transplantation is a profitable service line within a hospital system. We think that there is willingness to pay for solutions like this. And as the volumes grow in the marketplace, we'll benefit on the back end by increasing testing services volumes.
Yeah, maybe that's a good transition here. At your investor day, you showed a slide how utilization, three or more, I think, of your patient and digital solutions products, on average, those centers had higher testing. Maybe for those who missed it or are unfamiliar with kind of that statistic, you could hit on that and how exactly it does translate into more testing volume.
Yeah, and I think this is a great example, quantification of how we're executing the strategy at CareDx of being a solutions provider, a diagnostic solutions provider to the transplant centers. When we have three or more of our patient and digital solutions utilized at a transplant center, which could be our quality reporting software, our waitlist management software, our medication adherence programs, remote patient monitoring, we find that the capture rate or the proportion of patients that get transplanted, that get on our testing is 50% higher, and then those centers generate two times the revenue for CareDx than centers that use fewer than three of our software solutions and patient solutions, and I think that's just a testament to the visibility that they have into the improvement in outcomes that are delivered by utilizing our services.
That's why we have the higher capture rate, higher adherence, and higher revenue coming out of those centers.
Is there one specific offering that tends to have the most material impact in driving incremental testing, or is it too difficult to see that in isolation?
The two programs that we see as being the most correlated to that result are the quality reporting software and the medication adherence program. Medication adherence is so critical in this space, and it really is a proxy for outcome. But without the quality reporting, you can't see it, right? So as we work with centers, they implement quality reporting. They say, "Wow, we need medication adherence. We implement that. Wow, we need to do more testing to make sure we're detecting this earlier." And so those two have been super critical. But again, the efficiency of using all of these services, and I think back in maybe the Q2 call or Q1 call, I talked about an example center being Tampa General, where they use five of our solutions across the patient journey and all of our testing services in every organ line.
That is an example of what excellence looks like for us. The outcomes and quality of care there is really phenomenal. That's one of the top transplant centers in the country by both volume and outcomes.
Got it. I'll ask two more here, and then I'll open it up. It seems like this has been a focus of M&A and kind of given the synergistic benefit of this to your testing business. Is this probably going to continue to be an area where you think about layering on new solutions through M&A?
Yeah. We feel like we have a pretty comprehensive solution set for transplant centers today. In our long-range plan, we've said that we're going to exit 2027 at $500 million in revenue and 20% adjusted EBITDA and add another $100 million in cash to the balance sheet, which is a very healthy business in this market and we think gives us flexibility to do M&A where we think it's strategically aligned with our business and with our long-term strategy. Beyond the three-year horizon, we've talked about stem cell transplantation monitoring assays as being the next driver of growth for the company, in particular our AlloSure and AlloHeme products that are starting to emerge as we see this market of autologous and allogeneic stem cell transplantation start to take hold in hematology oncology and then hopefully in the future in autoimmune disorders. So we see a potential growth opportunity there.
In addition, we're going to look at inorganic opportunities that are aligned with addressing the needs of transplant centers, both those that are doing solid organ transplantation and stem cell transplantation, which are overlapping, by the way. So stem cell transplantation and HemOnc is done at roughly 200 centers that are also the same 200 that do solid organ transplant. So we're not extending into new markets. This is the same market, same customer that we're going to be selling these products to. And so the more that we can sell to that same customer and gain leverage on our channel, we think it allows us to grow profitably into the future, even beyond that three-year horizon. And so that's how we're thinking about inorganic opportunities and really, I would say, opportunities that are more transformational versus tuck-in as we've done in the past.
Then the investments you called out on the Q3 call to the billing team, the commercial team, do you feel like you have the scale that you need now? How should we think about incremental investments?
Yeah, we believe that these investments are going to give us the scale to deliver on our 2025 objectives. And we may make future incremental investments if we see that the return would be significant enough to go ahead and add there. So adding 30 commercial individuals, we think, is going to have a strong impact on the year and allow us to capture that opportunity for surveillance testing in kidney that exists. And then on the billing side, we think adding the 20 billing individuals is going to really enable us to collect more cash and deliver on our ASP targets throughout the year. So that's the scope of what we're thinking about today. I think the one additional investment that we've called out is in data science and artificial intelligence.
We hired a chief data and AI officer, and she's beginning to build out her team because we think there's a lot of opportunity to, first and foremost, improve our assays that are reliant upon data science and algorithms as the core performance of criteria of the assay. Number two, to mine the rich data that we have from transplant centers that we work with all over the country because of the SaaS-based software solutions we have deployed in these centers. We have this moat of data or this lake of data on utilization, drug utilization, genomics, etc., that we should be able to build decision support tools off of to help the transplant centers better manage their patients.
And then the third area, we see this growing push from an investment perspective in biopharma in treatment of antibody-mediated rejection or cellular rejection in the transplant space, and helping them do synthetic trial analysis and development throughout the life cycle of a development of a therapeutic, we think, is something that we have the unique capability to do with our data assets.
Got it. That all makes sense. Any questions from the audience before we wrap up here? All right. Thank you, guys.
Thank you, Mason. We appreciate your time.
Thank you, Mason.