Good day, and welcome to the CareDx first quarter 2022 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Ian Cooney, Vice President, Investor Relations. Please go ahead.
Good afternoon and thank you for joining us today. Earlier today, CareDx released financial results for the quarter ended March 31, 2022. The release is currently available on the company's website at www.careDx.com. Reg Seeto, Chief Executive Officer, and Ankur Dhingra, Chief Financial Officer, will host this afternoon's call. Before we get started, I would like to remind everyone that management will be making statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical facts should be deemed to be forward-looking statements.
All forward-looking statements included, without limitation, our examination of historical operating trends, expectations regarding coverage decisions, pricing and enrollment matters, and our future financial expectations and results are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results to differ materially from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and descriptions of the risks and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission. The information provided in this conference call speaks only to the live broadcast today, May 5th, 2022 . CareDx disclaims any intention or obligation, except as required by law, to update or revise any information, financial projections, or other forward-looking statements, whether because of new information, future events, or otherwise.
This call will also include a discussion of certain financial measures that are not calculated in accordance with the generally accepted accounting principles. Reconciliation to the most directly comparable GAAP financial measure may be found in today's earnings release filed with the SEC. I will now turn the call over to Reg.
Thanks, Ian. Good afternoon, everyone, and thank you for joining us for CareDx first quarter 2022 earnings call. The first quarter was a tale of two contrasts, where January was the lowest month in transplant volumes since April 2020, while March was our highest ever month in patient test results in testing services. With that in mind, I'd like to provide the following highlights for the quarter. Number one, delivery of a strong revenue quarter achieved in spite of the slow start to the year for the testing services and the products business line. Number two, accelerating performance in patient and digital solutions driven by our recent acquisitions. Number three, extending our scientific leadership with real-world, multicenter, prospective, and long-term data generation.
Four, helped ensure that the transplant community receives accurate information about our tests after a jury found that Natera’s superiority claims were false and awarded CareDx $44.9 million in damages. Five, leading with innovation in artificial intelligence and xenotransplantation and taking responsibility as a transplant company to increase equity in transplant. Now on to performance. We recorded our highest ever revenue quarter in spite of a slow start. Q1 marked the third consecutive quarter of flat to negative sequential transplant volumes, with January and early February most notably impacted by Omicron, followed by a strong rebound in March. With no sequential transplant volume growth for three straight quarters, we hope transplant volume declines have hit a nadir and the Q2 will reverse this volume trend.
Note, our transplant volume numbers are based on the full month of UNOS data versus weekly data which are directional until the full month of data becomes available. Now for kidney testing services, we continue with our winning formula of adding AlloSure-named protocols, adding new centers, and expanding further into community nephrology. At the end of March, we have more than 80 AlloSure Kidney protocols in commercial use. Offsetting the fewer transplants being done, we had our second-highest quarter with AlloSure volume in community practices. The peak Omicron wave had an acute impact on our kidney testing services, including staff shortages in transplant centers. However, I'm pleased to report that March we set a record for testing services volume. On the pipeline side, we're excited in progressing the next wave of innovation in the kidney space.
For AlloMap Kidney, another recent publication confirmed the clinical validation of AlloMap Kidney using data generated in the Validated CLIA Workflow from samples in the OKRA study. For heart and lung testing services, the HeartCare attachment rate was over 95%, continuing to highlight the value of multimodality to physicians. We're also pleased to run over 900 AlloSure Lung tests in its second quarter since launch. At ISHLT, the largest heart and lung transplant conference in the world, the full force of CareDx was on display with the highest number of industry presentations and with my appointment as the corporate chair for the ISHLT Foundation and with our board member, Dr. Hannah Valantine, being awarded the prestigious Lifetime Achievement Award. On to the second topic.
We accelerated performance in our patient and digital solutions with first quarter revenues of $6.2 million, driven by our recent acquisitions of MedActionPlan and The Transplant Pharmacy. Our AlloCare app now has more than 17,000 users and serves as the foundation for digitally connecting patients across the transplant journey. We have expanded this functionality by incorporating TxAccess into this AlloCare app to now help pre-transplant patients navigate the wait list process as we digitally connect patients across the patient journey. We are thrilled to build this de novo digital business over the last three years and have started to scale with revenues. These revenues are now comparable to our products business line, which achieved $6.8 million in revenue in Q1.
On the third topic, we further extended our scientific leadership during Q1 with real-world data generation across kidney with ADMIRAL, heart with SHORE, and lung with our multi-center lung study. In kidney now, the ADMIRAL publication showed AlloSure as the first and only donor-derived cell-free DNA test with demonstrated long-term utility in both surveillance and full course testing. AlloSure also demonstrated a greater than 60% improvement over creatinine in the accuracy of identifying rejection. By contrast, our competitors have not been able to come close to showing this magnitude of improvement over standard care. In heart, SHORE, our multimodal registry with our FDA-cleared AlloMap and our leading donor-derived cell-free DNA test, AlloSure, has shown higher one-year survival compared to UNOS statistics. This is the largest heart transplant data set, which has shown increased clinical utility showcased at this year's ISHLT.
HeartCare helps improve clinical decision-making, and we're excited to hear that the new ISHLT draft guidelines are considering including donor-derived cell-free DNA in addition to AlloMap. As a reminder, we are the only covered multimodal transplant approach covered by Medicare. In lung, our multi-center AlloSure Lung clinical utility study was published in JHLT. This real-world experience in partnership with NIH was conducted during the COVID pandemic. This AlloSure Lung surveillance resulted in an 83% reduction in invasive bronchoscopies compared to a surveillance bronchoscopy program. Importantly, AlloSure identified subclinical graft injury in patients where there was no clinical suspicion. Number four, moving on to false advertising case against Natera. We received a positive jury award in our favor of $44.9 million, including $21.2 million in compensatory damages and $23.7 million in punitive damages.
While post-trial motion practice is ongoing, our counsel believes this to be one of the largest damages awards in a false advertising case in our space. We believe this speaks for itself. While new opportunity entrants focused on short-term path to profits have been aggressive with their approaches in comparison to our tests, we believe it's important to build and maintain trust by investing in science and proper studies. As a leader in the space, it is our obligation to patients to call out companies that intentionally mislead the transplant community. On to the fifth topic. As the transplant field evolves, CareDx remains at the forefront of driving innovation. We believe the future is multimodality and artificial intelligence or AI is a core part of that innovation. In kidney, we invested in algorithms including iBox, with prognostic data published in the leading journal BMJ.
In heart, we just announced last week at ISHLT our partnership with OrganX developing AI algorithms, including in identifying cardiac allograft vasculopathy trajectories, also known as CAV, with prognostic data published in the leading journal Circulation. In the exciting world of xenotransplantation, we were proud to be partners with the University of Maryland School of Medicine on the world's first successful pig to human heart transplant. We're now providing our XenoSure and XenoMap biomarkers in supporting xenotransplantation research and development. In cell therapy and stem cell, we continue to make progress with four presentations of new data at the recent Tandem Meetings of Transplantation and Cellular Therapy Meetings of ASTCT and CIBMTR covering AlloCell, AlloHeme, and AlloSeq. Finally, as a transplant company, we are focused on equity and transplant. We have national efforts with the Minority Organ Tissue Transplant Program, also known as MOTP, and regional initiatives.
The most recent being the Pluralist Initiative, where we partnered with UC Davis Health to improve awareness and education about organ transplant in underserved communities throughout California. I want to summarize that our core focus is testing services. We have a robust base business as we have now faced three consecutive quarters of negative to flat transplant volume growth. We hope we've hit the nadir with transplant volume declines. As transplant volumes improved in February, March, we saw our strongest testing service results for heart and kidney in the month of March. We have a focused strategy and over the last 18 months, we've been pleased with the continued introduction of new catalysts from AlloSure Heart to AlloSure Lung, and our latest focus is AlloMap Kidney, which is in late development. We're also pleased with our expansion to community nephrology and the creation of dedicated abdominal and cardiothoracic teams.
Now, outside testing services, we continue to scale in both the products and digital businesses and see growth built off new launches with the AlloSeq franchise and now executing on the recent acquisitions for the patient digital solutions. Beyond our current commercial business lines, we are building the long-term future by investing in areas of disruptive innovation with the development of offerings in artificial intelligence as part of multimodality, stem cell and cell therapy with AlloHeme and AlloCell, and xenotransplant field with XenoSure and XenoMap. We look forward to building this incredible company focused on the transplant patient and community. With that, I'll turn the call over to Ankur to discuss our first quarter financials.
Thank you, Reg. Hello, everyone. We are pleased to deliver another strong business and financial performance despite the backdrop of continued difficult market conditions during the first half of Q1 2022. Let me provide you the details. We recorded total revenues of $79.4 million, up 18% compared to $67.4 million in the first quarter of 2021. Testing services revenue increased 12% year- over- year to $66.4 million. Testing volumes grew by 29% to approximately 42,600 tests, including approximately 900 lung tests. We saw sequential declines in testing volumes in January and early parts of February before strongly rebounding in March, where March was our highest month ever for testing volumes for heart and kidney.
We continue to see strong adoption of our newly launched tests, AlloSure Lung and AlloSure Heart, with HeartCare at greater than 95% attachment rate and AlloSure Lung approaching use in one in two transplant centers in less than six months of launch. Our testing services volume growth has and will continue to exceed our revenue growth as we're in the process of new launches with AlloSure Heart and AlloSure Lung. We are in the process of increasing the coverage to levels we have achieved in AlloMap and AlloSure Kidney. This provides a significant opportunity for future revenue upside as we build out our commercial coverage in these new launches. Today, AlloSure Lung is only at less than 5% coverage and AlloSure Heart at approximately 25% coverage.
Although we look at ASP by test offering, we understand some investors may look at revenues divided by total tests. This aggregate average price declined by about 4.9% versus last quarter of 2021. This decline came from three factors. Higher growth in patients with commercial insurance across all organs where we have lower coverage today, changing volume mix between organs with strong success of AlloSure Heart and AlloSure Lung, where we have lower coverage today. Continued increase in Medicare Advantage patients in our kidney services. Specific now to kidney, although the majority of patients are under Medicare, we have seen an increase in number of patients outside Medicare, which is specifically impacting AlloSure Kidney realized prices. This mix shift has come from two areas.
First, execution of our strategic plan to focus on community nephrology over the last 12 months, which has increased the number of patients on commercial coverage. This is expected to continue as a core part of the growth strategy. The second has been industry shift from Medicare to Medicare Advantage Plans driven by the 21st Century Cures Act. As a reminder, it takes longer to collect from Medicare Advantage Plans and requires additional administrative steps, including prior authorizations. All these represent upside opportunities for us. Overall, our go forward plan is, first, increasing payer coverage in current offerings, including the new launches to positively impact our revenues. Notably for AlloSure Heart, cell-free DNA is under consideration for inclusion in ISHLT guidelines. We are excited by this potential inclusion in guidelines reflecting the excellent data the team has generated.
We're also excited about our upcoming OKRA data readout at ATC next month. Second, investing in infrastructure and capabilities to improve collections, especially from Medicare Advantage plans. Moving on to products. Our first quarter product revenue increased 17% year-over-year to $6.8 million, driven by continued strength of our NGS portfolio that was partially offset by headwinds from Omicron in the earlier part of the quarter. Our digital and patient solutions revenue was $6.2 million, up 164% year-over-year. Saw very strong performance from our newly acquired medication adherence businesses of MedActionPlan and The Transplant Pharmacy. We're excited about this early success as we scale our digital business through organic and M&A investments.
The non-GAAP gross margins for the quarter were 67.9% compared to 70.2% in the first quarter of last year. Non-GAAP gross margins declined primarily in our patient and digital solutions business with the addition of newly acquired businesses. The transplant pharmacy business has a different business model with lower gross margins, but has positive EBITDA, hence accretive to both top line and bottom line. Non-GAAP operating expenses for the first quarter were $60.5 million, up approximately $4 million sequentially from Q4 of 2021. This increase in expenses was driven by investments in R&D and commercial, where we added resources in our clinical and research teams, as well as commercial resources with dedicated cardiothoracic and abdominal teams.
Our legal expenses increased, tied to the false advertising trial where we received a positive jury award in our favor of over $44 million. As mentioned in our last earnings call, we expect legal expenses to remain elevated this year. For the first quarter of 2022, we recorded negative adjusted EBITDA of $5.6 billion compared to adjusted EBITDA of $7.6 million in the first quarter of 2021. Adjusted for the elevated legal expenses I mentioned, our business generates near breakeven to positive EBITDA. Turning to cash flows. Our net cash outflows for the quarter were $29 million, ending the quarter with cash equivalents and marketable securities of $319 million. In Q1, we typically pay out our annual cash bonus to employees, which results in net operating cash outflows.
In addition, we're nearing completion of expansion of our CLIA lab in Brisbane, which provides additional capacity for current tests as well as those in the pipeline like AlloMap Kidney. Regarding the information request from the government, we do not have any material updates to report. We are cooperating and moving expeditiously in responding to the requests. Turning to guidance. We are reiterating our full year guidance of $330 million-$350 million of revenue. As you recall, the lower end of the guidance reflects continued disruptions in transplant volumes as we saw in early part of this quarter. This low end also reflects potential increase in the pace of shift of patients to Medicare Advantage plans.
The high end reflects continued market penetration model built on increased adoption and protocols and a strong rebound in transplant procedure volumes after three quarters of sequential declines. Overall, I'm pleased by our performance despite the COVID-induced weaknesses in the early part of the quarter and consecutive quarters of declines in transplant volumes. Our tests are on a strong adoption curve. In addition, we have a very strong business model, margin profile and balance sheet position. Excluding elevated legal spend, the business generates positive EBITDA. We also have a large opportunity for commercial coverage and are excited about discussions related to inclusion of cfDNA in guidelines, and our new acquisitions are making strong contributions. Very excited about our future. With that, I will open the call for questions.
We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question comes from Brandon Couillard with Jefferies. Please go ahead.
Hey, guys, this is Matt on for Brandon. Thanks for taking the question. I guess first want to appreciate the comments and the prepared remarks, but it's been a little over a month since you won the false advertising lawsuit against one of your key competitors. I'm curious if you could just expand a little bit on any shift in dialogue since then. You know, what's kind of been the response there in the market and if you're seeing any shifts from a commercial perspective? Thanks.
Yeah, I think for us, you know, we've built an excellent reputation with the transplant community of, you know, over the last two decades, which is built on, you know, really excellent scientific data and how we work with different centers. I think when this jury verdict came out, I think it was really a reaffirmation of, you know, what we represent as an organization to the transplant community. I think, you know, the damages themselves speak to, I think the implications. I think it was pretty clear-cut from that perspective.
Great. You commented on the March trends being the highest for both heart and kidney. Any comments you can give as we move through April here? I guess, you know, what kind of gets transplant volumes back to normal after three straight quarters here of, you know, flat to down growth now that hopefully the COVID waves are behind us.
You know, I think it has been a tough three sequential quarters. I think it was good to see some improvements, and we hope it's the nadir of what we've seen in the transplant space. I think for the first four weeks is still relatively early. I think clearly, given how low January was, if you compare it to January, it's much better than January if you look at the month of April. You know, we continue to monitor this trend, but what we can say is that March certainly was our strongest month on record for both heart and kidney.
Great. Last one. I know it's a smaller piece of the business, but the digital solutions, $6 million or so in here in 1Q. If I kind of annualize that, I get to $25 million. What's the right number we should be penciling in for that business for 2022 with some of the newer acquisitions being layered in? Thank you.
Yeah, we're excited that over the last three years we've built a de novo business pretty much from scratch, and it's been one where it's been very strategically thought out. You know, we've seen, you know, progressive traction. I think, you know, we've had some good numbers this quarter by the patient digital solutions. I think we'll continue to see how that progresses during the course of the year. I don't know if there's any comments that you want to make, answer at all.
Yeah, we were super pleased about the performance here, and we just want to see it sustain over a period of time before we can give you color on what to guide.
All right. Appreciate that. Thank you.
The next question comes from Alex Nowak with Craig-Hallum Capital. Please go ahead.
All right, great. Good afternoon, everyone. It was another big deterioration in price this quarter. We knew there was still gonna be some Medicare Advantage changes that had a flow through, but I would say there's a pretty big change quarter-over-quarter. What particularly new happened in Q1 to reduce the approvals for tests? And I guess when do we reach a point where the ASP declines are gonna stabilize and we can start to see them reverse?
Yeah, I'll make some comments, Alex, and I'll pass it to Ankur. I mean, I think as we look at this shift in payer mix, I mean, there are a couple of areas that, you know, we see. First is, you know, the highest increasing number now of commercial patients across all organs has been a change for us. The second is obviously the new launches, particularly now with, you know, lung coming on board as well. And the third, we've talked a bit about the MA shift, which Ankur will go a bit more in details, but these have been the three primary drivers with the change. I'll hand over to Ankur.
Yeah. Reg summarized the three main drivers there, right? As we've seen in the latter part of last year, and also in this part now. The thinking in general, Alex, there is, as we had said during our previous earnings call at the end of the year, is that we're anticipating this decline to continue through this year, specifically more acute in the first half, as more and more patients continue to shift. There are secular changes happening both in the market, as well as our business, where more and more patients are shifting towards either commercial or MA plans. In terms of our go forward plan, there are two tangents to it, right?
One is continue to work with the private payers on commercial coverage. Very pleased with some of the upcoming discussions here, potential with ISHLT. And then we continue to build infrastructure of improving the collection rates with the Medicare Advantage plans. Our thinking is what will take us this year to work through this in infrastructure, and we'll see some results until the latter part of the year, specifically for the Medicare Advantage plans. You may have also noticed the more recent public news around the Medicare Advantage plans and the challenges that the industry is facing. We're working through that and putting our piece of the infrastructure there.
Just wanna make it clear, when you are getting paid, you are still getting paid a similar rate as you would have last year or the year before on the volume. I guess, would the company ever provide a volume number of tests that are currently being paid just so we can have a more apples-to-apples comparison?
Yeah. When we sign our contracts, we do sign those contracts and receive payments for at or above what our agreements are. Just to the spirit of the question, we don't discount our pricing. We always sign contracts at or above the Medicare rates. In terms of second part of your question, yeah, we've considered, there's some information we had shared during our Investor Day, and we'll give more color around the mix of how our commercial volume has been increasing over the last few years. We'll give you more color on that.
Okay. No, that's helpful. The company's always had a, I would say, a very strong earnings leverage potential.
Mm-hmm.
Given the focus on the 250 transplant centers or so, and then plus the community piece. We haven't necessarily seen it turn to a profit. We've been close, but never quite got there. I'm curious, when do we get to that point where we turn the switch and start to let some of the volume turn into profit? Why, I guess, why won't the legal spend actually roll down now that the jury trial has finished?
I might just make a quick comment on the profitability piece. I think, you know, as we've, if we stay just with AlloSure Kidney or with AlloMap, I think, you know, we have really strong, you know, margins greater than 75%. We have operating margins in the 20% high range there as well as we'd previously talked about when we're at scale. I think the difference here is now we've moved into other organs where we have lower coverages and also, you know, that's a part of, you know, investing and growing. I mean, I think we are not just focused on one area.
We need to be a company that expands and has, you know, future scale moving into lung, moving into liver, and then also as we think of the future pipeline, particularly, you know, areas of disruptive innovation such as Xeno or looking into, you know, cell therapy. I will move over to Ankur to answer the rest of that question.
Yeah. I think that's from a business model perspective, that's the main thing that the tests that have scaled, that business model is nicely profitable. We continue to build on our strong market position to keep expanding into the other organs. You see that in our increased R&D spend. You increased that in continued investment in the commercial side. Certainly commercial coverage will drive a very strong operating leverage, and we'll certainly have that. In terms of second part of your question around the legal spend, we still do have several matters. Even though the trial has completed, there's still several matters of various kind that will continue to remain open for the year.
At least for the current year, and we don't guide for future years yet. For 2022, I'm anticipating that this will remain at elevated level.
Okay. Just lastly, what was the acquisition benefit for revenue in the quarter?
As we mentioned, if you look at our digital business, which was up 164%, a big part of that contribution came from the acquisitions.
Okay. Thanks for the update. Appreciate it.
The next question comes from Andrew Cooper with Raymond James. Please go ahead.
Sorry, I left myself on mute there for a second. Appreciate the questions. Maybe first just one on the P&L. You know, we talk about the pricing dynamics. We talk about not necessarily having scale in some of these organs yet. When we look at the testing services gross margin, it actually ticked up about 100 basis points sequentially. Just maybe give me a sense for what you're doing there to help offset some of these things, especially in a market where it feels like everybody else is talking about labor headwinds and cost of goods headwinds. What's working for you on the gross margin front?
Yeah, thanks for noticing that, Andrew. Even though the headline gross margin number went the other way, the testing services improved because we have two things that are going on there. On one side, we're adding into capacity where a new facility will go live potentially here in Q2. We have strong operating effectiveness programs in place for our laboratory, where we've been working on automating our laboratory production and movement of our test services, which has been driving very good operating leverage within the lab. Both in terms of our current volumes and also in preparation for the newer tests like lung as well as potentially AlloMap Kidney. We've been investing in some of the automation procedures there.
That has helped us at least counter some of the inflationary pressures and be able to retain the healthy margin profile of that business.
Okay, great. Just on the current business, can you give a sense for, you know, when we think about Omicron, what the impacts were obviously to the transplant volumes, we can see that, but also to kind of more recent transplant recipients coming in versus maybe folks who were further removed from their transplant. Was there any discrepancies you could see on kind of who was showing up to clinics and how we think about that recovery, hopefully as overall volumes of transplants are coming back as well?
Yeah, probably, I think in three areas. I mean, first between the Omicron impact, the first is on the transplant volumes, and that I think has been quite evidenced with the lowest in January since the start of COVID at that peak. The second is actually the labor shortage across centers actually has almost to a T. We've spoken to, you know, the centers in the United States, and they all had sort of issues with, you know, staffing, which sort of impacted some of the areas where they could support us as well. In terms of patient access, we've always been around this reach of steady state, about 40% for the mobile phlebotomy. I think we've had good access there as well for, you know, during this time of Omicron and its peak.
I think, you know, as we see this recovery, probably the biggest disproportionate piece will be living donors on the kidney side. As you know, 25%-30% of the kidney volume is living donors. I think during the peak and, you know, when we've had sort of these ebbs and flows, that's the group that gets impacted the most, particularly with them having to do, you know, donor chains, et cetera, and being deemed more of an elective procedure. There, I think you can see more of an uptick. As staff, I think we mentioned previously, as staff come back, then there'll be a replica of what was done in the past, where people may work on the weekends to do some of these procedures.
Currently, that hasn't been the case because they'll still make up for the staffing shortages which have existed.
Great. Okay, helpful. Then maybe just to sneak one last one in, even though it's not exactly a small question, but just what's the latest? You know, we saw the validation data you announced earlier this morning. So what's the latest timeline you can give us for AlloMap Kidney potentially getting to MolDX and for consideration for coverage?
Yeah, I'll make some comments and I'll see if Ankur wants to say as well. I mean, we're really thrilled with AlloMap Kidney. As you know, we've established this multimodal approach, firstly with heart and with the only company with multimodal approval, and that's through demonstrating increased clinical utility. I think that we certainly have done on the heart side. As we look at kidney, it's been not just adding AlloMap Kidney, but also looking at iBox, what we call this combination multimodality, which is something we're excited about. With AlloMap Kidney, I think it's been generating the, what we call these clinical validation papers have been important part of that process. I think we're making good headway to late development.
I don't know if Ankur wants to weigh in anything additional.
No, that's a good color, so well covered there, right.
Great. I'll stop there. Thanks again.
The next question comes from Matt Sykes of Goldman Sachs. Please go ahead.
Hi, this is Nick on from Matt. Maybe just kind of a follow-up to the last question. You know, any commentary on payer feedback or receptivity to some of the recent data, some of the OKRA data sets that you guys have published?
Yeah, I think that when you're talking about the recent data, I don't think we've the OKRA data. That'll come at ATC. We've published on the kidney side, the ADMIRAL data and we've talked about the KOAR data, which is our long-term data on the kidney side. On SHORE, what we just recently talked about was the long-term data for SHORE. Both these long-term studies showed the increased outcome of survival versus those using you know statistics. That I think you're referring to those two sets of data, right? Versus OKRA.
Yes. Yes. Thank you.
Yeah. Okay. I just want to confirm. Yeah. I think for us, I think particularly if we take firstly the heart side, what we've seen is, you know, I think Ankur may have alluded to it and also myself is, you know, we have AlloMap on the international guidelines and, you know, we were just ISHLT last week. I think with the data we're generating and producing and working with obviously extensive centers and KOLs there's consideration now for AlloSure, for example, or dd-cfDNA if we need to be incorporated into the guidelines. This is for consideration. For us, it could be another important milestone as we look at, you know, payer coverage in this space. Certainly the team has made progress.
We've seen that, you know, out of the gates, there are a couple of key accounts that sign up on the heart side, like Geisinger, et cetera. I think with the potential guidelines for AlloSure is really exciting. On the kidney side, you know, our team has been built out under Ankur, and I think what we've seen here is, you know, the utility of the ADMIRAL data is being well-received, and also CARE, which is long-term data. These are the types of data which I think the payers request, which is long-term utility, and also how it influences clinical decision-making.
We're excited by the data that's been generated, and I think, you know, the team are really pleased to be the only company that has this sort of data to go out towards payers as well, particularly the long-term piece.
Got it. Thank you. You know, you guys have talked about some of the investments you're making, whether it's, you know, in AI or some other related fields. Could you just maybe comment a little bit more on, you know, the SG&A ramp that we're seeing? You know, what are the impacts that you guys are having from that investment?
Yeah. I might make some comments, and I'll hand over to Ankur as well. I mean, I think as we scale and build as an organization, you need to have an innovation hub, which is the R&D piece. As you look at the commercial execution, there's the SG&A piece. Investment is a core part of what we need to do as an organization. We could always decide not to do it, but I think it'd be remiss in this type of environment not to continue to grow as a company dedicated in transplant. In terms of the SG&A side, what we've been doing, particularly commercial side is we've actually split out our field team to be in a dedicated above the diaphragm, below the diaphragm, so cardiothoracic and abdominal teams.
On the R&D side, we've continued to invest in developing this pipeline in some of the areas you mentioned, such as in AI, that is critical. These are being licensed in, but there are other areas such as AlloMap Kidney, other organs such as, you know, AlloSure Lung, and UroMap on kidney. We have a pretty extensive pipeline. This is really building for the future. I think it's easy to just focus on, you know, one successful offering, two successful offerings, three successful offerings. In terms of, you know, if you look at AlloSure, AlloMap and HeartCare. For us as a company, it's really important to sustain ourselves by continuing to drive a pipeline, one that's built on innovation. AI will form a core part of that.
I know you called it out specifically, but have Ankur just comment on the specifics in terms of changes to spend that you might be able to share.
Oh, that's yeah, that's very well covered. Now, in terms of G&A, that's meaning between SG&A, I think the sales side, Reg has covered well. On the G&A side, the two components, one, of course, is very large increase in the legal spend that we've talked about and remains elevated. The second part is we are scaling the core infrastructure of the company, in making sure we have the right systems and the procedures, that are well suited for a company, both for our size and where we could be over the next two, three years or so.
Got it. Appreciate it. Thank you.
The next question comes from Yi Chen with H.C. Wainwright. Please go ahead.
Hey, congratulations. This is Chase on behalf of Yi Chen. You guys have answered all of our questions. Maybe I was wondering if you could summarize all the upcoming catalysts for this year and any specific events that we should keep an eye out for. The second question is on AlloCell and AlloHeme, any specific plans for this year, along with your digital solutions offerings. Thank you.
Yeah. Got you. I think if I understood, I think you said any upcoming catalyst. I didn't catch the full second question.
Digital.
Specifically on AlloCell and AlloHeme, as well as your digital solutions. Any short-term, long-term plans that we should keep an eye out for?
Got you. All right. Yeah. I mean, I'll take the latter first. I mean, certainly with, you know, building disruptive innovation, whether it's, you know, looking at AlloCell or AlloHeme, I'd encourage you to look at the full presentation we just delivered at the tandem meetings representing ASTCT and CIBMTR. There we had both analytical validation to AlloCell as well as for AlloHeme. These are areas which, you know, we're investing for the future. I think we've also actively been enrolling in a study which is also shared at that presentation, called the ACROBAT study, and that's for AlloHeme.
I think as you look at, you know, continued progress here, it's about partnerships where we can publicly disclose them in addition to this continued enrollment on ACROBAT, and we'll provide additional, commentary on that because enrollment's going extremely well. In terms of, looking at, some other catalysts we've talked about, I think ones we've talked about is, you know, having, you know, UroMap and AlloMap Kidney on the kidney side has been, you know, areas to watch during the course of this year as we provide updates. If you think of specific, scientific, you know, milestones, we just completed SHORE, presentation ISHLT. In terms of, ATC, which comes up in June, we'll be talking about the overall readout as well. These, again, the long-term studies looking at multimodality. This really is the way of the future.
I think generating long-term study data, which is from a multi-center prospective data set, is what we do, and that allows us to continue to drive innovation but stay ahead of others because the bar, clinical bar is being raised as well. I think these are a couple of areas that you wanna keep an eye on. We'll also share a bit more on our artificial intelligence. I think this is really, in some ways, the future of what the industry is moving towards. Not necessarily I've seen on the diagnostic side, but certainly as we look at the macro space, right? AI is such a core part of what can make a difference in many different industries and sectors. I think our investment in artificial intelligence is core, and so we'll provide more of an update on that.
We aim actually do a potential innovation day as well as part of that. Typically, we talk about disruptive innovation, such as we did the Xenotransplantation Day, earlier on, this quarter. Maybe more to watch out for on the AI side as well. Exciting future.
Excellent. Thank you so much.
The next question comes from Mason Carrico with Stephens Inc. Please go ahead.
Hey, guys. Maybe just two quick ones for me here. I know AlloMap Kidney is a ways off, but in terms of thinking about the initial attachment rate for that test, what are some key differences that should be taken into account, and for maybe why it would be different than where AlloSure Heart's attachment rate currently sits?
Yeah. I think at the end of the day, it's about clinical utility. I think when you look at attach rates, we believe that as long as you demonstrate clinical utility, then there'll be uptake. I don't think you'll find any other proxy or any other benchmark which has shown what HeartCare has done. You know, given what we saw in HeartCare, what we've done in Kidney Care is actually pretty similar, right? In terms of the technologies, in terms of designs, in terms of trying to understand, you know, what really, you know, matters to the physicians. On top of that, we've also included iBox, which is a prognostic algorithm, as part of that. I think at the end of the day, what's really important, being a physician myself, is demonstrating utility.
If it's not useful, then you really won't get that type of attachment. I think that sort of speaks for itself, and that's why we've moved on to other organs as well and developed LungC are and LiverC are as part of that sort of development process as well. You know, just as one final point, Mason, I mean, we developed this approach without knowing if there would be a reimbursement pathway because we believe at the end of the day, you know, the way you help clinicians is adding clinical utility and helping them in the decision-making.
Got it. Then any updated thoughts on potential commercial payer wins for AlloSure Kidney maybe this year and in 2023? Do you have the studies and evidence that you need to begin pushing on these payers for specifically for AlloSure Kidney?
Yeah. I'll make a comment, then I'll hand over to Ankur as well. I think some of that, one of the questions just came up earlier and, you know, what's the impact of some of these, you know, studies we're doing? I think firstly, long-term studies are important 'cause it goes beyond some of these short-term studies we've done. We're the company that has that long-term data generation, whether on the heart or on the kidney side. I think particularly the ADMIRAL study was really helpful as we look at, you know, demonstration of benefit with both for cause and also for surveillance, as well. If I think of, you know, what we think is critical, you know, generating the right data sets is important.
On the heart side, as we saw, having, for example, guideline changes can also be something that's incrementally beneficial as well. I'll hand over to Ankur to make any additional comments.
Yeah. We've been having very good discussions with a lot of payers around, especially with the ADMIRAL data, which provides the first long-term data on AlloSure Kidney. We have a plan with a large list of payers that we're meeting with for the remainder of the year as well as going into early 2023. Certainly a front and center focus there.
Got it. Thanks, guys.
This concludes our question and answer session. I would like to turn the conference back over to Reg Seeto for any closing remarks.
Yeah. Thanks very much. I mean, at CareDx, we're building a really special company, one that's 100% focused on the transplant patient. We've been doing it for more than two decades. For us, it's really this unique ability to really be front and center in this space, and it's brought us attention not only of the transplant community, but I think in patients and what we do for them day in, day out. Again, for all the investors on the line, thank you for your interest in this space. It really makes a difference to the transplant community knowing that this is an area of focus for them. Thank you, and have a great day.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.