Good day, everyone, and welcome to today's CareDx, Inc. First Quarter 2024 Earnings Conference Call. [Operator Instructions] Please note this call is being recorded, and I will be standing by if you should need any assistance. It is now my pleasure to turn today's conference over to Greg Chodaczek. Please go ahead, sir. .

Thanks, Travis, and good afternoon, and thank you for joining us today. Earlier today, CareDx released financial results for the quarter ending March 31, 2024. The release is currently available on the company's website at www.caredx.com.

John Hanna, President and Chief Executive Officer; and Abhishek Jain, 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 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 historical 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. 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 9, 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 be -- 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 filed with the SEC. I will now turn the call over to John. .

Thank you, Greg, and to everyone for joining today's call. I want to start by thanking our CareDx employees and the transplant community for their warm welcome. It is an honor to be a part of this organization and its mission to improve transplant patient outcomes by providing innovative testing and digital and product solutions globally. .

Before I begin with my prepared remarks on our first quarter 2024 performance, I want to acknowledge an exciting new development that emerged yesterday. The Centers for Medicare and Medicaid Services announced a new initiative called the Increasing Organ Transplant Access Model.

The proposed initiative aims to increase access to kidney transplants for all people living with end-stage renal disease. In the program, participating transplant hospitals would be measured by increases in the number of kidney transplants, increased organ acceptance rates and post-transplant outcomes. .

We are pleased to hear about this latest development and the potential it holds for the approximately 90,000 patients on the organ transplant list awaiting a new kidney. The CMS initiative is a proposed 6-year mandatory program for approximately 50% of all kidney transplant hospitals in the U.S. scheduled to begin on January 1, 2025.

For CareDx, we anticipate this initiative to be a tailwind for the adoption of our solutions that improve patient transplant outcomes, a critical component to the program's evaluation. .

Turning to our results. Our first quarter results are better than anticipated, stemming from growth across all businesses and our operational discipline. I will start today's call by sharing highlights from the quarter, including examples of the significant value our solutions create for patients and transplant centers that is driving our growth.

Then I will turn the call over to Abhishek for a detailed look at our financials and outlook for 2024. .

CareDx posted strong growth in the first quarter that builds upon the momentum created in the second half of 2023. For the first quarter, we reported revenue of $72 million, up 10% from the prior quarter.

In the Testing Services business, we delivered approximately 42,000 tests, up 6% from the fourth quarter and representing the third consecutive quarter of growth in Testing Services volumes. Revenue was $53.8 million, up 8% quarter-over-quarter, primarily excluding onetime collections from tests performed in prior quarters. .

Our Testing Services business is propelled by continued innovation that is highlighted in a growing body of clinical evidence supporting the clinical utility of our solutions, HeartCare, AlloSure Kidney and AlloSure Lung.

At the International Society of Heart and Lung Transplantation Annual Meeting in Prague, our products were featured in over 30 oral presentations, posters and 2 symposia.

In an oral presentation of late-breaking clinical study data, the first peer-reviewed findings from our large multicenter Surveillance of HeartCare Outcomes Registry, or SHORE, were presented during an ISHLT scientific session.

The SHORE study is the largest prospective observational study of its kind in heart transplantation with 67 participating centers, over 2,700 patients enrolled, encompassing over 11,000 patient encounters. .

Independent researchers presented results that demonstrated that surveillance testing with HeartCare, the combined use of both AlloSure Heart and AlloMap Heart outperformed testing with donor-derived cell-free DNA alone in characterizing patients' risk for acute rejection.

Notably, dual positive results from HeartCare in the first 6 months also predicted poor outcomes at 2 years compared to patients with donor-derived cell-free DNA positive results alone or dual negative results in the first 6 months. These findings support the prognostic value of HeartCare. These data are highlighted in our earnings presentation. .

We believe the SHORE study findings are significant and have the potential to transform the way providers care for heart transplant patients because of the clinical importance of having both AlloMap gene expression profiling and AlloSure donor-derived cell-free DNA to assess allograft health. .

We believe that HeartCare has the potential to become the new standard of care and surveillance biopsies will be performed more sparingly. We anticipate the first of several publications generated from the rich data set created by the SHORE study to be in print this year. .

Many in the transplant clinical community have already taken note of HeartCare's impact on outcomes. Stanford University has led the way as one of the earliest adopters of HeartCare in their journey to discover cases of subclinical rejection non-invasively.

Stanford implemented a HeartCare protocol, which allowed the center to shift further away from using surveillance biopsies to routinely incorporating noninvasive HeartCare testing. They have eliminated greater than 90% of biopsies in patients with dual positive results. And importantly, outcomes have remained excellent.

Improving the outcomes of transplant patients at centers like Stanford is driving the adoption of our testing solutions. .

Building upon the clinical evidence emerging for HeartCare, AlloSure Kidney and AlloSure Lung, we successfully expanded medical policy coverage with Blue Cross Blue Shield plans and other private commercial payers for 14 million lives in the quarter. Payers are acknowledging the utility of our testing solutions in improving patient outcomes.

We anticipate that coverage, coupled with our focused efforts in revenue cycle management, should continue to contribute to margin growth in future quarters. .

Lastly, on our Medicare coverage efforts, there continues to be significant pressure from transplant patient advocacy groups, clinicians and CareDx to restore the long-standing coverage, which has primarily affected kidney transplant patients. We will be unwavering in our efforts to address this policy issue. .

Moving on to our Patient and Digital Solutions business, where we had a good quarter with $9.6 million in revenue, a year-over-year growth of 12%. Currently, over 70% of transplant centers in the U.S. use at least one of our patient and digital solutions.

After acquiring one of our solutions, such as our quality reporting software, and experiencing positive outcomes, we frequently see an uptake of additional value-added solutions such as administrative staff augmentation or patient medication adherence services. .

For example, Tampa General has become a significant user of our patient and digital health solutions. They have adopted 4 products over the last 18 months, addressing their needs, including patient care coordination, quality improvement, HLA lab operations management and logistics support.

We are integrated with their EMR system, enabling them to provide digitally enhanced patient care. As a result, they have improved their quality measurement scores, operational efficiencies and resource utilization across all stages of their transplant patient workflow.

They recently sought our assistance in refining their waitlisting process to increase the throughput of transplantation at their center. Our work with Tampa General demonstrates how CareDx's Patient and Digital Solutions establish us as a trusted and essential partner to the success of their transplant program. .

Finally, in our Products business, we achieved $8.6 million in revenue in the quarter, a 25% year-over-year growth, primarily driven by the continued adoption of our industry-leading AlloSeq Tx NGS-based HLA typing kits.

AlloSeq Tx delivers comprehensive results to HLA laboratories to help identify the best genetic match for organ transplant recipients.

LifeLink Foundation's HLA laboratory recently converted from legacy HLA typing solutions using real-time PCR methods to NGS-based AlloSeq Tx because it eliminates the need for reflux testing to resolve ambiguous results and increases operational efficiencies. .

In summary, we had a strong first quarter. We have reset the business and returned to growth. Testing Services is gaining momentum as our ever-growing data set of evidence continues to demonstrate the clinical utility and need for our novel noninvasive testing.

Traction in our Patient and Digital Solutions is growing, and our Products business continues to gain market share. We are effectively managing our bottom line and driving profitable growth by improving efficiencies throughout the organization, enabling us to sustain a healthy cash balance. .

Given our performance in the first quarter, CareDx is raising its revenue guidance for 2024 to $274 million to $282 million as noted in our press release. Abhishek will provide more detail in his remarks. .

In conclusion, I want to thank the entire CareDx team for their focus and execution. We have an incredibly talented and inspired organization and we look forward to a strong 2024. With that, I will ask Abhishek to share more details on our first quarter results.

Abhishek?.

Thank you, John. In my remarks today, I will discuss our first quarter results before turning to our revised 2024 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 and recent SEC filings for further information. .

Let me start with the key financial highlights. Total revenue for the first quarter was $72 million, up 10% as compared to the fourth quarter of 2023. Testing Services revenue was $53.8 million, up 15% quarter-over-quarter.

We delivered over 42,000 patient test results, up 6% sequentially, representing the third consecutive quarter of Testing Services volume growth. .

Reported Patient and Digital Solutions revenue of $9.6 million, up 12% year-over-year, and Products revenue of $8.6 million, up 25% year-over-year. Improved adjusted EBITDA losses to $1.9 million as compared to $10.3 million loss in Q4 of '23. Finally, we maintained a strong cash position of $216 million at the end of March 2024 and no debt. .

Due to the strong overall performance in the first quarter, we are raising our full year 2024 revenue guidance to $274 million to $282 million from our prior guidance of $260 million to $274 million. .

Moving to the details, starting with the Testing Services. Testing Services revenue for the first quarter was $53.8 million, up 15% sequentially. Strong Testing Services revenue for Q1 was driven by the third consecutive quarter of growth in Testing Services volumes.

Testing Services patient results grew to over 42,000 tests, up 6% sequentially, across both abdominal and cardiothoracic testing services. This growth is attributed to our continued success in reestablishing use of AlloSure Kidney and strong performance in heart testing services. .

In addition, Testing Services revenue benefited from continued revenue cycle management initiatives, including pursuing unpaid claims from tests delivered in the prior quarters. These efforts added approximately $3.7 million in revenue in the first quarter. We'll continue to aggressively pursue unpaid historical claims. .

Our non-GAAP Testing Services adjusted gross margin was 76% in the first quarter compared to 72% in the fourth quarter of 2023. Adjusted for the $3.7 million revenue, as discussed earlier, Testing Services gross margin stayed healthy at 74%.

Our lab operations team continues to drive efficiencies and manage expenses well with initiative focus on improving logistics and sample processing costs. .

Now turning to the other businesses. Our Patient and Digital Solutions business reported revenue of $9.6 million in the first quarter, up 12% year-over-year. Strong top line results were driven by core digital offerings.

Our Patient and Digital Solutions business non-GAAP gross margin for the first quarter was 34% compared to 31% in the first quarter of 2023. .

Our Products business recorded revenue of $8.6 million in the first quarter, up 25% year-over-year. Growth in the Products business was once again driven by NGS-based [ digital ] solutions for HLA labs. Our non-GAAP gross margin for our Products business was 46% in the first quarter, down from 52% from the first quarter of 2023.

We have completed the end-of-life build for one of our products and ramped up manufacturing capabilities with our contract manufacturers in the U.S. and Europe. We are on track to substantially close our manufacturing operations in Fremantle, Australia as part of our site consolidation initiative.

We expect these initiatives will help us improve the gross margin of this business to the mid-50s on a sustainable basis. .

Moving down the P&L. Non-GAAP operating expenses for the first quarter were $52.3 million, down approximately $1.9 million as compared to the last quarter and down over $9 million as compared to the first quarter of 2023.

We have made substantial progress in managing our expenses while ensuring that we continue to invest in areas that will help drive growth. .

Adjusted EBITDA for the first quarter of 2024 was a loss of $1.9 million compared to an adjusted EBITDA loss of $10.3 million in the fourth quarter of 2023 and a loss of $6.4 million in the first quarter of '23. The first quarter was positively impacted by $3.7 million in revenue as discussed earlier.

We are pleased with the progress that we're making on driving profitable growth. .

Turning to cash. We maintained a strong balance sheet of $216 million in cash, cash equivalents and marketable securities, with no debt. Cash used in operations for the first quarter was $15.3 million as compared to $8.4 million last quarter and a positive cash from operations of $0.7 million a year ago.

Cash usage in the first quarter is seasonally higher due to annual bonus payouts. 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. .

Turning to guidance. Based on the healthy performance across all businesses in the first quarter of 2024, we are now raising the full year revenue guidance to $274 million to $282 million.

The midpoint of our 2024 guidance assumes low double-digit Testing Services revenue growth based on annualized actual Testing Services revenue for the fourth quarter of '23.

No change in medical coverage, no incremental revenue assumed from new private payer coverage decisions or onetime benefits associated with collections, and high single-digit growth year-over-year for our Products business and mid-single-digit growth year-over-year for our Patient and Digital Solutions businesses.

We expect our gross margin to be at the high end of our previously reported range of approximately 63% to 65%, driven by the improved Testing Services gross margin. .

Due to improved revenue expectation and gross margin, we expect our adjusted EBITDA losses for the full year '24 to be between $14 million to $24 million as compared to the previously guided $20 million to $30 million. .

I would like to thank the entire CareDx team for their focus and delivery in executing against our plan for 2024. Before we open the line for questions, I would like to turn the call over to John to deliver closing remarks. .

Thank you, Abhishek. As we conclude our prepared remarks, I want to again express how proud I am to be a member of the CareDx team. Our strong results this quarter underscore the value of our solutions and our commitment to serving patients. And now I would like to ask the operator to open the line for any questions. .

[Operator Instructions] Our first question comes from Bill Bonello with Craig-Hallum Capital Group. .

Nice quarter. So just first, just a housekeeping item. It's interesting that you called out the prior period collections.

Just thinking about this, as you work on revenue capture, won't prior period revenue become kind of a normal thing for a while? Or is this just a lot bigger than what you might expect in a typical quarter?.

Thanks, Bill. Appreciate the question. I'm going to ask Abhishek to take this one. .

Yes. Thanks for the question, Bill. And you're right that we continue to pursue some of those unpaid claims from the prior period tests, Bill. And we would want to provide enough color so that we can model these appropriately.

But going back to your question, once we have had the success in negotiating these with these payers, it definitely becomes a tailwind as we kind of look at this from the go-forward basis. .

Okay. And then just the second thing is just the -- what -- go ahead. .

Yes. Bill, I was just going to add. I think in Q4, we also had onetime prior period collections, and we see this amount of prior period potential revenue declining over time as we negotiate through these onetime events. So we call it out here because we don't anticipate it to continue to be a substantial sum into perpetuity.

We do think this balance will draw down, so we will continue to call that out when it occurs. But we're not providing those onetime events as a part of our go-forward guidance. .

Okay. That makes sense. But when I think about it -- sorry to just beat this one. But when I think about it, so it is a prior period, I get it. It's something you weren't paid.

But does it also speak a little bit to run rate? In other words, that's $3.5 million that you never were getting paid in the past that presumably looking forward, you will be getting paid? Or should we not think about it like that?.

That's what we're hoping to occur, Bill. And so we would anticipate that on a go-forward basis, we'd see improvement in ASPs as a result of working through these processes with individual payers. .

Okay. Thank you.

And then the other thing was just can you talk about what you're seeing in terms of physician behavior on the kidney surveillance testing side? Has it ticked back up since CMS put out that letter at the end of February? Or what's kind of the situation there?.

Yes, that's a great question. Thanks, Bill. And as we stated in our prepared remarks, our volumes grew across all 3 segments of the business, heart, kidney and lung. We have implemented the requirements that CMS has put in place or that the MACs have put in place for payment of testing, and we continue to see our volumes grow as a result of that.

We don't think that is going to change substantially going forward other than to acknowledge that the agency has stated that they intend to continue to provide access to monitoring assays for transplant rejection, and we'll continue to support that and communicate it in the field with clinicians as they adopt these products going forward. .

Our next question comes from Matt Sykes with Goldman Sachs. .

Congrats on the quarter. This is Prashant Kota on for Matt.

So with the billing article revisions last year having impacted your product mix from being majority kidney to majority heart and lung for both volumes and revenues, do you anticipate that trend continuing in the near term? And how will that impact ASPs?.

Thanks for the question. I'm going to ask Abhishek to take this one. .

Prashant, yes, we have called out in our Investor Day meeting that cardiothoracic is now about 60% of our volume. And given the fact that we are seeing that the heart franchise is kind of growing pretty -- at a pretty decent pace, we believe that this trend will continue.

Now one quarter will not provide us if there is a permanent shift further from here, but I would expect this to continue. .

Got it.

And then can you speak to any synergies that may exist upstream of organ transplant surveillance? For example, within the organ transplant delivery network involving companies such as TransMedics?.

Yes. Thanks. I'm going to ask Alex Johnson, our President of Testing Services, to take this question. .

Yes. Thanks. We acquired a company called MediGO a couple of quarters ago. And there's a lot of work going on to increase the utilization and consequently, organ supply upstream. And I think that's where we're going with this. And there's quite a bit of excitement around this space.

And I think we've certainly seen this in the increase in heart transplant. Certainly, that's a growth area that is outpacing other areas of the market for transplant. And I think these areas are places that we can continue to play in. And we have digital tools as well as products. Our product business primarily is pre-transplant. .

And so we're able to think about ways to incorporate our tools upstream as well, and that utilization increase as well as better outcomes really completes the whole ecosystem for our patients and the clinicians. So it's a great question. We're very well positioned to play there as well as in the entire transplant journey. .

Got it. And then just lastly, I would love to get your sense high level of key takeaways from that proposed IOTA Model from CMS. I haven't actually read through the document fully, but would love to get details behind the incentive plan that it mentions and its impact on you. .

Yes, this is Alex again. I can take this. I did read all 300 or so pages or at least tried to get through it last night. We're still going through it. I think the headline here is that there's a clear need to continue to increase the organ supply and increasing utilization and reducing discards and improving outcomes.

I mean these are all things that are going to help patients. .

And so when you look at it, you've already got a nice upswing on -- just from a market perspective, kidney transplants have been growing nicely. I think they grew year-over-year in Q1 about 6%. Heart has continued to grow, actually seemingly above that. Last year, I think heart was 11% from an annualized growth basis.

And so you've got some significant upsides here. We'll see where this goes. This is proposed. And we're certainly monitoring and we'll read closely, and we'll see how these value-based care initiatives continue to drive the market forward. .

And we are extremely, I think, well positioned to play there because that's exactly where our products can best be positioned, right? It's not just more transplant. It's higher-risk organs, it's better utilization of these organs. And what do you need when you have higher-risk organs? You need to watch them more carefully.

You need to use digital tools. You need to use products like AlloSure to help monitor these patients. And so this is something where we're extremely well positioned, and we're really looking forward to seeing where this goes. .

Our next question comes from Mason Carrico with Stephens. .

In terms of the guidance increase for Testing Services, so $4 million or so, $3 million to $4 million or whatever the cash collections were, this quarter is benefiting there.

But if you could, could you walk back through what the assumptions were in the Testing Services guide? Really, what I'm looking for here is this, are you incorporating now a higher growth rate in volumes? Are you seeing anything that has maybe accelerated adoption trends above your initial assumptions? So just any color in that makeup again. .

Yes. Thanks, Mason. I'm going to ask Abhishek to walk through those assumptions for you. .

Yes. So Mason, yes, based on the volume growth that we saw in the Q1, we have now raised the full year Testing Services volume growth expectation to high single-digit as compared to the mid single-digit that we were assuming previously. So that's the first change at the midpoint of our guide..

And the second piece is the Products business that we were assuming to be growing at a high single-digit -- that we were assuming to be growing at a mid single-digit, we are now assuming that business is going to grow in a high single-digit. So we're making a couple of changes based on the results that we have seen in the first quarter.

And now at the midpoint of our new guide on a adjusted '23 revenue basis, Mason, we have increased the overall revenue growth from a 4% year-over-year to 8% year-over-year. So almost doubling the growth rate there. .

Got it. The part I missed, the volume growth, is what you're guiding. You've got it. That makes sense. And appreciate the detailed color on HeartCare. Given the opportunity and potential for that offering, could you just give us a sense where utilization of HeartCare stands today? What portion -- and I know you may not want to get too specific here.

But as we kind of look at your heart volumes, how much is coming from HeartCare today versus AlloMap or AlloSure Heart stand-alone?.

Yes, Mason. So again, I think that's like the next level of details. We generally do not provide the volumes at the organ level. But having said that, in the HeartCare, there's no change from the commercial payer standpoint, as you know. And on the HeartCare also from the Medicare, now we have the coverage for the first year.

And the second year is the piece that we are working towards, seeing as to how do we get that coverage back. .

There are no further questions in the queue at this time. This does conclude today's program. Thank you for your participation. You may disconnect at any time..