CareDx Q4 2023 Earnings Call Transcript

Quartr
Provided by Quartr
February 28, 2024

There are 12 speakers on the call.

Operator

Greetings, and welcome to CareDx Inc. 4th Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded.

Operator

It is now my pleasure to introduce your host, Greg Hategcek, Managing Director of Investor Relations. Thank you, sir. You may begin.

Speaker 1

Good afternoon and thank you for joining us today. Earlier today CareDx released financial results for the quarter full year ended December 31, 2020 3. The release is currently available on the company's website at www.caredx.com. Joining the call today is Alex Johnson, President of CareDx's Patient and Testing Services Abhishek Jain, Chief Financial Officer and Robert Woodward, Chief Scientific Officer. Also joining the call today is Michael Goldberg, Chairman of the Board.

Speaker 1

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 the 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, including without limitation, our examination of historic operating trends, expectations regarding coverage decisions, pricing and enrollment matters, and our 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.

Speaker 1

For a listen listen description 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, February 28, 2024. 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 generally accepted accounting principles. Reconciliation to the most directly comparable GAAP financial measure may be found in today's earnings release with the SEC.

Speaker 1

I will now turn the call to Alex.

Speaker 2

Thank you, Greg. Good afternoon, everyone, and welcome to CareDx's 4th quarter and full year 2023 earnings conference call. CareDx ended 2023 in a solid growth and market leadership position after a challenging start to the year. Our team spent the last year addressing the complexities associated with the billing article, reconfiguring the company to adjust to the Medicare changes to coverage and fighting to restore patient access to transplant innovation. Before we move into the details of the quarter and the year, let me step back for a moment and offer a bit of perspective.

Speaker 2

We are still in the early stages of a $6,000,000,000 market opportunity to help care for some of the highest need patients in the U. S. Healthcare system. Transplant patients in the U. S.

Speaker 2

Are experiencing incrementally improved short term outcomes, but are still far away from having their newly transplanted kidney, heart or lung last as long as it should. We continue to believe that effective care means truly understanding transplant patient management. And this requires focus from our entire team working closely with some of the world's best clinicians, researchers and transplant centers. Our ability to successfully lead and execute in this growing market in the face of complexities associated with the billing article revisions is reflected in our results. Last year, we executed deliberately, quickly and with high impact as demonstrated by our performance.

Speaker 2

We reduced our cost structure and stabilized our revenue base. Consistent with our pre announcement, we reported full year revenue of 280,000,000 exceeding the high end of our updated guidance. We have regained our growth footing in our testing services business with patient test volumes up 4% quarter over quarter, an increase for the 2nd sequential quarter in a row. We delivered about 40,000 tests in the 4th quarter and patient testing services volume was approximately 165,000 patient results for the full year. We continue to make progress in driving our innovations into clinical practice.

Speaker 2

This year, we witnessed strong support from leading medical societies and from patients advocating for access to transplant molecular testing, including AlloSure and AlloMap, underscoring the pivotal role our innovations play in improving transplant patient care. In 2023, 2 new Medicare coverage approvals supported the clinical value and market opportunity of our innovation pipeline. AlloSure Lung was the 1st donor derived cell free DNA approved for coverage by Medicare for lung transplant patients. And with the approval of HeartCare in August 2023, our clinical approach of multimodality testing was confirmed by CMS. This approval defines a reimbursement pathway for our differentiated product portfolio, one that can leverage our rich pipeline of innovation to help improve patient outcomes.

Speaker 2

On the commercial payer side, we saw good progress. We ended the year with an additional 15,000,000 covered lives. We expanded existing coverage for 31,500,000 lives in our cardiothoracic business, primarily by adding coverage in the 1st 6 months post transplant for AlloMap Heart. Looking at our other businesses, we are pleased with the double digit growth in both our Patient and Digital Solutions and lab products business lines, representing year over year growth of 29% and 15% respectively. Before moving on to 2024, I will touch on our recent patent litigation news.

Speaker 2

As we mentioned in our statement following a jury verdict in late January, CareDx was assessed damages of approximately $96,000,000 We intend to seek judicial review of the jury decision and monetary damages. We expect there to be active briefing on this matter at least through Q3, 2024 in the District Court. The matter would then be subject to appeal to the Federal Circuit. Precise timing would be speculative, but we would expect any resolution for the patent litigation to be a multi year, multi step process. Looking forward to 2024.

Speaker 2

In our Testing Services business, the focus is on strategic profitable growth, continuing to grow patient testing volumes and market penetration for AlloMap and AlloSure, while expanding reimbursement and coverage. There is a significant opportunity to gain coverage for non reimbursed tests. This year, we will continue to invest in multicenter, purpose driven studies to help secure additional reimbursement coverage. As mentioned last quarter, K OAR, our kidney allograft outcomes registry completed the last patient clinical visits and we are now finalizing our data collection and monitoring. K OAR was designed to demonstrate the clinical utility of AlloSure in a variety of outcomes and we continue to expect a publication this year.

Speaker 2

We also have other unique opportunities to publish evidence that can influence payer coverage policies by working with leading researchers who have had extensive experience with AlloSure Kidney. In heart, we anticipate an interim readout for our ongoing surveillance heart care outcomes registry or SHORE. The data from patient encounters in the early years of SHORE have been collected and monitored. We are now working towards publication of interim readout with the twin goals of supporting the utility of multimodality testing and heart care coverage beyond year 1. We expect publication in 2024.

Speaker 2

These studies are expected to generate the evidence that along with the build out of our revenue cycle management infrastructure such as commercial payer coverage and billing appeals process will support an improved rate of reimbursement. In our Patient and Digital Solutions business, we aim to further increase the adoption of our portfolio offerings in 2024. Over 70% of transplant centers in the U. S. Use 1 or more of our digital solutions.

Speaker 2

As we first shared last month, we have now started to roll out a new platform, which enables greater uptake of CareDx services. The platform called CareDx Pro is embedded within a transplant center's electronic medical record workflow. This allows clinicians and administrators to have a single interface to access our digital health and SaaS solutions, as well as for clinicians to seamlessly order and view test results for AlloSure, AlloMap and HeartCare. Our growing lab products business is global. We have a strong portfolio and we'll continue to expand the business to new transplant laboratories worldwide with best in class kitted products using NGS and qPCR technologies.

Speaker 2

Our market leadership for NGS HLA typing through our AlloSeq TX line and broad geographical footprint allows us to benefit from scale leverage as our products business grows further. From an operational perspective, we'll remain focused on thoughtfully managing our cost structure and investments. You heard this during our annual Investor Day last month and it is worth repeating. This commitment underscores the dedication of our leadership team to driving growth and value for investors. We have taken multiple actions to reduce costs, including a recent Q4 action to streamline even further.

Speaker 2

You'll see us continue to take steps to manage our near term costs and COGS as we drive towards profitability. AirDx is taking a disciplined approach to investments that support our clinicians, patients and employees and deliver shareholder value. Finally, I would like to touch on our advocacy efforts on behalf of transplant patients. We and our coalition partners continue to be actively engaged in discussions with HHS and CMS, while we support patient advocacy efforts to restore full access for Medicare beneficiaries. The transplant community has made substantial progress.

Speaker 2

Some of you may have seen the Honor the Gift efforts in Washington DC in early December, where hundreds of transplant patients, physicians and advocates made a public plea on Capitol Hill to stop the recent rollback in Medicare coverage. Notable speakers at the press conference included Senator Dillenbrandt, former Speaker of the House Newt Gingrich and Reverend Al Sharpton, which shows the wide ranging bipartisan nature of the concerns here. We and the broad transplant community will continue to fight for access to transplant innovation in 2024 and beyond. In fact, as recently last Friday, The Wall Street Journal published their 4th powerful editorial since September, highlighting the patient access issue for transplant tests and the coverage disparities for Medicare patients. We are encouraged by our momentum as we enter 2024.

Speaker 2

Our team is laser focused on executing our plan. We are building on the testing services revenue baseline set in the second half of twenty twenty three, expanding patient access to our innovative portfolio across all three businesses and expediting our journey back to profitability. With that, I will ask Abhishek to share more details on our results for 2023 and our outlook for 2024. From there, we will go to Michael Goldberg, our Board Chair for an update on our CEO search before moving into the Q and A. Abhishek?

Speaker 3

Thank you, Alex. In my remarks today, I will focus on our Q4 and full year 'twenty three results before turning to 'twenty four guidance. Unless otherwise noted, my remarks will focus on non GAAP results. Please refer to GAAP to non GAAP reconciliations in our press release today for further information. I'll start with the financial highlights.

Speaker 3

Number 1, reported full year 2020 revenue of $280,300,000 exceeding the high end of our updated guidance. Number 2, delivered over 165,000 patient test results in 2023. Patient test volumes grew 4% in the 4th quarter to approximately 39,900 tests as compared to the 3rd quarter, a 2nd consecutive quarter of sequential growth. Number 3, reported full year 2020 3 testing services revenue of 209,700,000 dollars 4th quarter testing services revenue of $46,700,000 came in better than expected, primarily driven by volume growth. Number 4, reported patient and digital solutions revenue of $37,100,000 in 2023, up 29% year over year.

Speaker 3

And product revenue of $33,500,000 up 15% year over year. Number 5, maintained a strong cash position of $235,400,000 at the end of December and no debt. And we bought 2,900,000 shares for approximately $27,500,000 in cash in 2023. Moving to the details, starting with testing services. Testing services revenue for the Q4 was $46,700,000 down 2% as compared to the Q3 of 2023.

Speaker 3

As discussed in our Q3 earnings call, 4th quarter revenue was expected to be lower due to the 4th quarter impact of heart care tests that were outside of the new coverage criteria from MolDX as well as the exclusion of one time settlement to the large Medicare Advantage payer. As mentioned earlier, testing services volume increased by 4% sequentially and we are pleased to see both kidney and heart franchisee grow for the 2nd consecutive quarter. As Alex alluded earlier, we stay focused on executing our testing services strategy to increase market penetration and drive volume growth. Our non GAAP testing services gross margin was 72% in the 4th quarter as compared to 74% a quarter ago. We are pleased with the efforts of our lab operations team in keeping the gross margin above 70% despite a significant top line impact from billing article revisions.

Speaker 3

Our operations team continues to execute on reducing the shipping and specimen processing costs, improvements in inventory management and scrap reduction and optimization of collection kits usage. Moving to our Digital and Patient Solutions and Lab Products businesses. Our Patient and Digital Solutions business recorded revenue of $9,600,000 in the 4th quarter, up 14% year over year and $37,100,000 for the full year 2023, up 29% as compared to 20 22. Strong top line results were driven by both organic growth and our acquisitions of HLA Data Systems and MediGo. Our Patient and Distress Solutions business non GAAP gross margin for the Q4 was 42% as compared to 34% a year before.

Speaker 3

For the full year 2023, non GAAP gross margin improved by 600 basis points to 37% as compared to 31% in 2022. The gross margin expansion was driven by the top line growth, cost saving initiatives, our transition to a recurring SaaS based model and the higher gross margin profile of our newer acquisitions. Our products business recorded revenue of $9,200,000 in the 4th quarter, up 8% year over year and $33,500,000 for the full year 2023, up a solid 15% year over year. Growth in the Products business was driven by our higher margin NGS offering. Products business non GAAP gross margin for the 4th quarter was 46% as compared to 54% a year ago, primarily due to a one time inventory charge associated with end of life for one of our products in this business.

Speaker 3

Products business non GAAP gross margin for the full year 2023 grew an impressive 500 basis points to 54% as compared to 49% in 2022. And it was driven by organic growth, cost efficiencies from supply chain optimization with ongoing manufacturing site consolidation and a continued shift to ingest offerings in our revenue mix. Our team is focused on improving gross margins further as they drive for efficiencies and complete the planned site consolidation in 2024. Moving down the P and L. Non GAAP operating expenses for the Q4 were $54,200,000 down approximately $3,500,000 sequentially from Q3.

Speaker 3

So the sales and marketing spend increased $1,600,000 primarily related to our targeted policy efforts to restore Medicare coverage, G and A expenses came down $4,400,000 as a result of our focus on reducing legal expenses. Our adjusted EBITDA losses is in Q4 were $10,300,000 as compared to $10,900,000 in Q3. We have also accrued 90 $6,300,000 for damages awarded by a jury in the IP litigation case in the Q4 of 2023. As Alex mentioned earlier, we intend to seek judicial review of the verdict and believe that we have good and substantial defenses against the claim unless in the suit and we will vigorously defend ourselves. For further disclosures on this matter, please refer to our recently filed 10 ks.

Speaker 3

Turning to cash. We continue to maintain a strong balance sheet with $235,000,000 in cash, cash equivalents and marketable securities with no debt. Cash used in operations for the full year 2023 was $18,400,000 down 27% as compared to 25,200,000 dollars in 2022. Despite the operational and financial challenges introduced by the billing article revisions, the improvement in cash used in operations in 2023 is a testament to the outstanding efforts of the entire KDX team. The cash used in operations was positively impacted by our RCM initiatives that delivered a 5th consecutive quarter of collections over testing services revenue and added $17,000,000 to cash in 2023.

Speaker 3

Finally, I would also to note that we earned $3,200,000 in interest income in the 4th quarter and $11,900,000 in 2023. Based on our current cash position and anticipated cash usage in operations, we continue to believe that we do not need to raise cash in the foreseeable future. Finally, turning to guidance. We expect full year 2024 revenue to be in the range of $260,000,000 to $274,000,000 The midpoint of our 2024 guidance assumes number 1, low to mid single digit testing services revenue growth based on annualized actual testing services revenue for the Q4 of 2023. Number 2, Medicare reimbursement remains as currently implemented.

Speaker 3

No incremental revenue assumed from new coverage decisions from either Medicare or large commercial payers. Number 3, mid single digit growth for both products and patient and digital solution businesses year over year. We are expecting our gross margin to be approximately 63% to 65% with Testing Services gross margin slightly above 70%, products business gross margin in the mid-50s and digital and patient solutions gross margin in the high-30s. We expect our non GAAP operating expenses to be between $207,000,000 to $215,000,000 down from an annualized 4th quarter run rate basis, while absorbing for merit increases, benefits reset and inflation. We expect adjusted EBITDA to be between $20,000,000 to $30,000,000 in 2024 with quarterly improvements in adjusted EBITDA losses throughout the year.

Speaker 3

Before we open the line for questions, I would like to turn the call over to Michael to discuss the ongoing CEO search. Michael?

Speaker 4

Thank you, Abhishek. We would like to briefly touch on the CEO search well underway. The Board is leading an exhaustive search process aided by the search firm of Russell Rentals. As communicated previously, we remain on track to announce a new CEO within the originally projected 6 to 9 month timeframe from the initiation of the search in November. The office of the CEO, comprising of Alex, Avishak and myself, continues to successfully drive the business forward.

Speaker 4

For over 2 decades, CareDx has been dedicated to improving transplant patient outcomes and extending long term allograft survival. And we look forward to a strong 2024. With that, I'll hand it over to the moderator to open the line for questions.

Operator

Thank you. We will now be conducting a question and answer session. Our first question comes from Andrew Cooper with Raymond James. Please proceed with your question.

Speaker 5

Hey, everybody. Thanks for the questions. Maybe just to start, super high level, obviously, a lot of noise, a lot that's happened through the course of 2023. It feels like this 4Q result really kind of getting back to stability and the base to grow from. But did anything stand out when you think about sort of ordering patterns, the cohorts of patients that you're seeing those orders for or anything like that, I guess, across both kidney and heart in the Q4?

Speaker 5

Just any surprises, any changes, any commentary there on sort of what you're really seeing in the end market would be great.

Speaker 2

Thanks for those nice comments. And I think it is back to stability. It's back to growth. And I think we're excited to continue to serve more patients. And I think Q4 was a terrific baseline to grow on.

Speaker 2

And before that, we grew on Q3. And so I'll add I'll ask Abhishek to add some commentary. But I think the headline here is that we feel very good about consistent patterns that we've seen going forward for patient mix.

Speaker 3

Thank you, Alex. I think you have covered it pretty well that we are very happy to see the 2nd consecutive quarter of our testing services volume growth And that gives us a lot more confidence as how the business is progressing as well as the growth is coming from both of our heart and the kidney franchises. So that gives us all the more comfort that we are basically kind of growing in the areas where we need to. The good news is that we are seeing the market growth in the heart side, the transplant volume growth to be in the double digit last year. So definitely a lot more promise there as we enter into 2024.

Speaker 5

Okay, Helpful. And then maybe just sticking to testing services, the gross margin side of things, like I said, obviously, some lumpiness through the course of 'twenty three, but I think you said low 70s or slightly above 70 for the year. Just any puts and takes there? And then as it pertains to the ongoing sort of legal dispute, maybe talk about your ability to, if you had to digest some form of royalty, how you would think about that in terms of 70 plus percent margins with, frankly not a very large proportion of your tests actually being paid for at all in the first place?

Speaker 3

Yes. So I think on the testing services gross margin having like above 70%, that in itself is like very, very healthy. We usually have been in the low 70s, mid-70s kind of a gross margin range. And with the billing article revisions, if I were to take the noise out, we basically kind of dropped to mid-60s, high-60s kind of a gross margin range. And that's the reason I was happy to see that we came in slightly above 70% because I remember calling out that testing services gross margin without that noise is close to 68% to 70% in our previous calls.

Speaker 3

So from that standpoint, we have started to definitely see the improvement there, and we'll continue to work through as to how do we drop most of our revenue incrementals to the gross margin because we are not going to be increasing our spend other than the variable cost that we need to spend on the tests that we need to run. So that's the first part. And the second piece, I think, to your question that a lot of our tests are not being paid. You're absolutely right. And I did kind of articulate that that's a significant opportunity that we have in front of ourselves.

Speaker 3

I took the example of Q4, 40,000 tests, maybe you should be booking $100,000,000 revenue, but we booked 47. So there's a large opportunity, and that's the piece that we continue to work on through, like spending a lot of time and effort in generating the data that we need to and then going after the coverage. And finally, through our RCM initiative, getting that full coverage that we've gained coming through the collections to our revenue in the P and L. So it's an overall process. So I still feel that continue to do that test and having that ability to gain that the opportunity that basically is the right thing to do as compared to worrying too much about the tests that are not paid today because we will get there.

Speaker 5

Okay, helpful. And then maybe just one last one, if I can sneak it in. Just you've pulled a lot of cost out of the system. It's been impressive from that perspective. As we think about the commentary on not needing to tax raise, how do you think about the path to breakeven as you sit today?

Speaker 5

Is there more cost you can pull out? Is it more a function of, hey, we've got to get the top line higher than where we are today? Just how do we think about that trajectory to get to EBITDA and cash flow breakeven longer term?

Speaker 3

No, that's a great question, Andrew. And the way I kind of see about the adjusted EBITDA losses, if you look at the guide, we are guiding about $20,000,000 to $30,000,000 of adjusted EBITDA losses for the next year. Now in my mind, we will have basically the first half to be more front loaded with our losses. And you can kind of model it based on a low double digit adjusted EBITDA losses as we begin the 2024 and hopefully get to a low single digit kind of adjusted EBITDA losses by the time we get to the 2024 end. That will basically set us up pretty solid to get back to adjusted EBITDA profitability and generating cash flow from operations in 2025.

Speaker 3

I'm not guiding for the 2025, but that's at least my thinking is that we are looking for improving the adjusted EBITDA losses throughout the year. Great.

Speaker 2

I'll stop

Speaker 3

there. And maybe one more time. Yes. Go ahead. I can quickly take the second part of your question on the cash flow and that also the reason that we have $235,000,000 in cash.

Speaker 3

I can draw a quick parallel to our cash usage in operations in 2023, which I called out at about $18,000,000 So looking at the adjusted EBITDA losses in 20 4%, my sense is that the cash usage in operations would be very similar to those adjusted EBITDA losses without kind of thinking about any over collections or the improvement through the RC initiative. So that standpoint, if you're talking about a $25,000,000 at the midpoint cash to usage with $235,000,000 in cash and basically having a foundation by the end of 2024 to get back to adjusted EBITDA profitability in the next year, then you probably don't need to raise cash. So that's how we are kind of thinking from the management standpoint.

Speaker 2

Great.

Operator

Our next question comes from Matt Sykes with Goldman Sachs. Please proceed with your question.

Speaker 6

Hey, guys. Congrats on the quarter. This is Prashant on for Matt. Can you hear me?

Speaker 3

Yes, Prashant. We can hear you very well.

Speaker 6

Okay, great. So are you first off, are you still seeing any lingering impacts of the billing article across your business segments?

Speaker 2

Sure. Certainly, we are. I mean, our revenue and volumes in testing services are still significantly below what they were when the billing article was introduced in March. So we're still I mean that is just a numerical fact of our performance. What we are seeing though is certainly clinicians and centers getting much more comfortable with the billing article rules and coverage and for all their patients.

Speaker 2

And so what we're really seeing now is new protocols being put in place at these centers, and we're seeing that we saw that in Q4 in kidney, multiple centers putting in protocols that now allow them to manage patients in kidney with AlloSure in a way that's consistent with the Medicare billing article.

Speaker 6

Got it. And then could you just elaborate on the path to launching a multi modality product and obtaining reimbursement? How long does that typically take? And specifically for kidney, are you required to obtain Medicare coverage and then private payer coverage for AlloMap kidney before proceeding with kidney care?

Speaker 2

Sure. So there's a couple of things to unpack there and I think the pathway to multimodality reimbursement is a multi step conversation and we can certainly give you some highlights of that. I think the headline is that we've done this now with heart care. It was a multiyear process. We were able to produce the evidence and data for Medicare to do that.

Speaker 2

And that's not a trivial exercise. And as we go into kidney, it's we know the playbook. We know where the minefields are, so to speak, in data analysis. It was a challenging effort, one that was ultimately extremely successful with Medicare. And now as we've talked about, our heart care still consistently has an attach rate of well over 90% for AlloSure and AlloMap being used together for patients.

Speaker 2

For a little more context, I'll turn it to Robert to add some more on the process itself, which is I think part of your question as well. Persan?

Speaker 7

I think one thing you asked was the coverage for both tests before multi modality. That's not necessarily a requirement, but it's certainly something that we'll look at when we're looking at the data from our OCRA study, where we used both AlloSure and AlloMap kidney and where we see that going next. I think you asked how long or what time. I think it's more about the data than the time. And so as we assess that and look towards the future, we'll start to put together that plan.

Speaker 6

Got it. Thank you. That's really helpful. And then my last question is, do you see Euromap cannibalizing AlloMap Kidneys eventual sales at all? And how do these two tests complement each other in the kidney transplant space?

Speaker 7

They're really they come from different directions in the AlloMap kidney, the mechanism of looking at immune status and whether there's activation of the immune system or whether it's quiescent. And in urine, the Euromap has a very different approach of being everything there can be about evaluating cellular mediated rejection and especially the whether or not there's an influence of BK virus. And so as we're bringing these 2 and defining their paths and where they'll be used in the market, and we work with clinicians, there's really unique opportunities for each of them. So I think we'll see them in parallel and not in each other's way.

Speaker 2

Thank

Operator

you. Our next question comes from Brandon Couillard with Jefferies. Please proceed with your question.

Speaker 8

Hey, thanks. This is Matt on for Brandon. Maybe going back to the guide, can you help us a bit more in terms of the cadence as we move through 'twenty four? I think historically you'd seen a bit of a step up in 1Q. Do you expect that this year?

Speaker 8

And then is it kind of $66,000,000 $67,000,000 a quarter evenly spread out? Or are there maybe some initiatives or other items that kick in, in the back half that would make that a bit more weighted for the year? Any color there would be appreciated.

Speaker 3

Sure, Matt. And let me break this down by the business because of the billing article revisions last year. Things have been ups and downs, up and down throughout the year. So starting with the testing services business, what I would suggest, start with the Q4 actual revenue baseline there. And then based on the overall yearly guidance, I would basically suggest that you should bake in a sequential growth quarter over quarter for that particular business.

Speaker 3

And for the other two businesses, since they are a little bit more, I would say seasonal, specifically our products business, you should be looking at the year over year growth starting in Q1, 2024 and you should basically model for the non testing services business slightly differently. And that will basically give you the cadence as to how the quarterly revenue number should look like.

Speaker 8

Okay, that's helpful. And then going back to capital allocation, no debt, dollars 235,000,000 of cash exit in the year. There's the potential litigation payout, which is sizable, but as you talked about in the prepared remarks, could be a multi year process. You repurchased about $25,000,000 of shares here in 2023. How should we think about your capital allocation plans going forward?

Speaker 8

Is more of the buyback on the table? Just how you're thinking about cash usage here in 'twenty four and beyond? Thanks.

Speaker 3

No, absolutely. And from the context standpoint, you picked it up pretty well that we bought actually 2,900,000 shares for like $27,000,000 in 2023 and most of those purchases were actually in the 4th quarter. So we were like pretty confident with the $235,000,000 in cash. And based on the fact that we have taken a lot of cost out of our system and based on the needs that we were projecting for cash, we feel very comfortable in actually pursuing the share buyback program. But with this IP litigation, jury award, even if there are like multiple steps that we have to go through starting with the district court and then possible appeals, multi step, multi year process, We are taking a stance here to pause the share buyback program for now and we will assess as to how some of these other pieces will play out.

Speaker 3

And at that time, we will bring the discussion or the decision on the share buyback program back onto the table.

Speaker 7

Okay. Thank you.

Operator

Our next question comes from Alex Nowak with Craig Hallum. Please proceed with your question.

Speaker 9

Okay, Greg. Good afternoon, everyone. If you look at the normal revenue for 2023, I'm basically taking what you did in Q4 here and annualizing it. The guide for 2024 comes in at basically about 4% growth, give or take a little bit. I guess the question is what level of growth can the company ultimately achieve in 2025, 2026, pick a time point in the future without necessarily more reimbursement?

Speaker 3

So I would basically say that there are multiple parts for the testing services to grow. And of course, there's a secular market growth where we are seeing a good momentum in our transplant volumes. Specifically, if you look at the heart side, they have been growing on a low double digit basis in the last year. And also kidney kind of growing at a high single digit. My sense is that if we continue to see that kind of a growth pattern, the secular organic growth, that's basically the first piece.

Speaker 3

And then we heard from some of our same space company like TransMedics, all the things that they are doing in this particular space to be able to kind of grow the usage of the organ, so and so forth. So we feel very good that this particular space can actually grow in high single digit to a low double digit kind of scenario. But absolutely, let me have Alex kind of add further. But my sense is that there's a lot of opportunity in this space to grow at a much more higher rate.

Speaker 2

Yes, Alex. And you mentioned without reimbursement. And obviously, that's a nice tailwind for us as well because that will apply to broad swaths of our business as different commercial payers come on. And certainly there's upside with the Medicare as well. I think Abhishek covered it well.

Speaker 2

One of the interesting data points is that when you look at heart and kidney, which is really the bulwark of our transplant testing services volume, right? Back in 2020, you're 25,000 combined transplanted organs between heart and kidney. Last year, it was 30,000, right? So you're getting this really significant growth even during the pandemic, even when living donor volumes had basically flat lined for quite a while. And they're coming back.

Speaker 2

And I think you saw that last year. And when you look at utilization and other tailwinds here, you really start to see a model where when you have 8% transplant volume just overall market growth in 2023, I think that's not long to think how long can that last for. And when you look at all the different avenues, whether it's not just better utilization, but also the opportunity for living donation to increase, you really see that tailwind on our business. So thanks for leaving out the reimbursement piece, because I think it does let us take apart the story piece by piece because there are significant areas where our revenue can increase in the long and middle term areas.

Speaker 9

It makes sense if we're transplanting higher risk organs, they just need to be tested. So your answer makes total sense there. I just want to be crystal clear around the moves with reimbursement. Again, so much has transpired over this last year. So as we enter right now, based on everything you're seeing with your conversations with CMS and the like, is it fair to say we're the reimbursement that sits today is pretty much set in stone and the only view that you have is things can only go higher from here.

Speaker 9

Like there's nothing is you're looking at that could say, hey, that could be another shoe to drop.

Speaker 2

I mean, I think set in stone is really probably not the way we would look at it. There's certainly a LCD process that's going on now as well as significant public pressure and outcry to bring back coverage for this, the Medicare patient transplant test. So I think certainly there's an ongoing process that will play out certainly in 2024 that we'll see. We are currently in our base case, we're assuming that nothing does change, which will be very unfortunate for patients, But that's what we'll live with and that's what we'll execute on if things don't change. But I think there is significant processes going on right now that could potentially change.

Speaker 2

And I think as more data comes out, not just in 2024, but in future years around surveillance, for example, for Medicare, which is really the area that was pulled back on for patients, That's something where we have our K OAR study that can help generate data that may in fact be impactful evidence that can help bring back some of the coverage. So I think there's a number of shots on goal here for us to continue on growing it and making sure that coverage model evolves from where it is today. Can you just outline

Speaker 9

the scenarios here with the LCD if it does get finalized as it stands at Medicare? I guess, what could happen?

Speaker 2

Maybe I'll ask you just to clarify. Sure. Maybe I'll ask Robert to answer it. But I think just to clarify your question, meaning what would change with our business if it was solidified today as proposed? What's the maybe if you

Speaker 3

can clarify the question a bit?

Speaker 9

Absolutely. Scenarios on when this LCD does get finalized because again Medicare came out with the draft and ideally I guess legally they have to finalize that within a year if they're going to do so. So when it does get finalized, is that going to change whether it be transplant centers' interpretation of what they can get billed for or what you can get billed for and thus what test they can run? I'm just trying to understand how this changes the scenarios out there.

Speaker 7

This is Robert. So the draft that they came out with very closely parallels and incorporates a lot of the language from the billing articles. And so it really seems to have been their response to a lot of pressure that there wasn't a public process. So they put in place a public process to get to the same place even though they didn't halt what they had already done. So as already been mentioned, our base case for the business is it's going to be this way and as is in the billing article.

Speaker 7

And if finalized in their draft form, if they didn't make any changes or any substantive changes, then it would continue as currently for patients and businesses and providers as far as finding ways to do the testing within the scope of what they're allowing.

Speaker 9

Got it. Makes sense. Lastly, just any status on the DOJ inquiry?

Speaker 3

No, nothing material over there, Alex. We have disclosed in the 10 ks whatever we had to, but on the DOJ side, nothing of substance.

Speaker 9

All right. I appreciate the update. Thank you.

Operator

Our next question comes from Yi Chen with H. C. Wainwright. Please proceed with your question.

Speaker 10

Thank you for taking my questions. Within the next 12 to 18 months, do you expect there could be any potential upside regarding the reimbursement policies?

Speaker 2

Sure. And I think I lost the last piece of your question. You're asking changes to reimbursement and what was the last piece?

Speaker 10

No, that was the question. Basically, your guidance, your 2024 guidance is based on current reimbursement policy, right? So I'm asking if there's any potential improvement on reimbursement policy within the next 12 to 18 months?

Speaker 2

Yes. That's a I think an opportunity for a catalyst with potential this finalization of the LCD that can, as Robert mentioned, can happen before potentially before August. They have until August to finalize. And so what's in there if there is an opportunity to change coverage for these Medicare patients, I think would certainly be very impactful for our business. On top of that, we have additional studies, that we've have in publication, whether it's drafting or analysis K OAR and SHORE that can provide additional data and evidence for payers to continue to add coverage for their patient populations.

Speaker 2

And those will happen as we mentioned, SHORE and K OAR, certainly some publications in the next 12 months.

Speaker 10

Got it. And between different types of transplant, kidney, heart, lung, which type of transplant do you expect to be to provide the largest growth driver for the top line revenue?

Speaker 2

Yes. I think there's a growth right now that is in heart that's significant. And certainly, as the billing article changed our mix a bit, heart will continue to be a good growth driver. However, the ability for kidney to come back with living donors also will continue to push that mix.

Speaker 3

Abhishek, anything else on the mix you want to talk? I think from the opportunity standpoint, the way I see it, there are 2 different pieces. If the billing article coverage were to get changed with some of our data publication or our policy efforts, then of course, there's a sizable opportunity on the kidney side. As well as when I talk about the studies on the KOR, if that data turns out to be in the right manner, then of course, there's a significant opportunity there based on what I have previously called out that we have very limited commercial coverage there. So that can basically drive a fairly sizable upside.

Speaker 3

If you were to talk about the heart on the yellow shore heart primarily, I think that's where the shore comes in play. Can we get the coverage for surveillance back for greater than 1 year where we have limited coverage now from Medicare? So that is another piece that will play out from the opportunity standpoint. And last but not the least, some of the health economic studies that we have been working on, how those are going to play out in some of the commercial coverage that we're trying to get on the AlloSure Heart. So I would say, again, there are multiple pieces that are in place.

Speaker 3

And to be honest, in my mind, they both are like equally in play. I called out the revenues are pretty much fifty-fifty between HeartKD and the Heart franchises. So I see the opportunity lie in both the areas.

Speaker 10

Thanks. And lastly, regarding the litigation expenses, is it going to be a recurring item every quarter going forward?

Speaker 3

No, I think glad that you asked this question, Yuchang, because this has been one of our key focus areas and that where we have been trying to limit the legal expenses. Happy to report that if you look at our G and A expenses for the Q4, it has come down by roughly $4,500,000 And I know that the team has been very focused in trying to figure out as to how to bring those expenses down, be it through like being more effective and efficient in some of the cases that we need to do. And to be honest, some of the legal cases that we have been kind of into, they have started to kind of taper off. For example, the SEC investigation has been decided in our favor. On the TBE audit, there have been a lot of claims that have been actually adjudicated in our favor, and now we have a template there that we can use.

Speaker 3

So some of the legal spend is kind of coming down, and we are looking for every single opportunity to be able to reduce them. But looking at the Q4, G and A, dollars 4,500,000 down primarily driven by the legal spend there. So that stays a priority.

Speaker 10

Thank you.

Operator

Our next question comes from Mason Carrico with Stephens. Please proceed with your question.

Speaker 11

Hey, guys. This is Jacob on for Mason. Thanks for taking the questions. So just maybe a cleanup on the guide and apologies if this has been touched on and jumped on a little bit late. But I think you said that your 2024 revenue guidance assumes low to single digit testing service revenue growth.

Speaker 11

Just wondering if maybe you could break that down a little bit further in terms of growth between different organ times, kidney, heart, lung. And are you baking in any ASP increases on there that would be upside due to commercial wins or anything during the year?

Speaker 3

No, sure. So on the testing services side, yes, we are expecting a low to mid single digit revenue growth. And one of the important pieces there is that I'm baking this in on a 4th quarter revenue base for the testing services revenue. So just from the example standpoint, if you were to kind of have a testing service revenue on the Q4 annualized, you will basically get a lower revenue growth for the next year because you're not taking it for the full year. But from the assumption standpoint, what I'm assuming is that testing services volume growth would be very similar to the transplant volume growth that we are seeing, which is mid single digit.

Speaker 3

So that's the first part of the play. And then the second piece on the ASP, I'm kind of expecting about 2% to 4% headwind, and there could be different scenarios on the ASP. But I'm not expecting ASP headwinds to be similar to what we had seen in 2022 based on our experience in the last few quarters and based on all the collection efforts and the RCM efforts where we have been collecting a lot more cash. So limited headwinds for the ASPs, but the transplant volume growth of mid single digit driving the testing services volume growth in mid single digit lowered by ASP headwind a little bit that gives us a low to mid single digit growth for the testing services revenue, if that makes sense.

Speaker 11

Okay, got it. Thank you. That's super helpful. And just maybe one follow-up here on AlloMap Kidney. And again, sorry, if this is already been touched on.

Speaker 11

But just wondering what your expectations are around when you could get a CMS decision on coverage for that test?

Speaker 7

Ongoing process as far as seeking coverage and so we don't have any specific expectation. We work to get it as soon as we can.

Speaker 11

Okay, got it. Thanks guys. Appreciate it.

Operator

We have reached the end of our question and answer session. This concludes today's conference. Thank you for your participation. You may disconnect your lines at this time.

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Key Takeaways

  • CareDx reported full-year 2023 revenue of $280.3 million, surpassing the high end of its guidance, and saw testing services patient volume rise 4% sequentially in Q4 to about 40,000 tests (165,000 tests for the year).
  • Patient & Digital Solutions revenue grew 29% year-over-year and Lab Products grew 15%, with gross margin expansions driven by SaaS transition, organic growth, and supply chain optimizations.
  • In 2023 Medicare granted first coverage for AlloSure Lung and approved HeartCare, establishing a reimbursement pathway for multimodality transplant testing.
  • A jury awarded $96 million in damages in patent litigation, which CareDx intends to appeal, expecting a multi-year judicial process.
  • For 2024, CareDx forecasts revenue of $260 million – $274 million, gross margins of 63%–65%, and adjusted EBITDA losses of $20 million–$30 million, aiming for full operational cash flow breakeven in 2025.
A.I. generated. May contain errors.
Earnings Conference Call
CareDx Q4 2023
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