NASDAQ:CDNA CareDx Q2 2025 Earnings Report $11.84 +0.02 (+0.17%) Closing price 08/15/2025 04:00 PM EasternExtended Trading$11.92 +0.09 (+0.72%) As of 08/15/2025 07:50 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. ProfileEarnings HistoryForecast CareDx EPS ResultsActual EPS-$0.16Consensus EPS $0.12Beat/MissMissed by -$0.28One Year Ago EPS$0.25CareDx Revenue ResultsActual Revenue$90.51 millionExpected Revenue$90.72 millionBeat/MissMissed by -$215.00 thousandYoY Revenue Growth-6.10%CareDx Announcement DetailsQuarterQ2 2025Date8/6/2025TimeAfter Market ClosesConference Call DateWednesday, August 6, 2025Conference Call Time4:30PM ETUpcoming EarningsCareDx's Q3 2025 earnings is scheduled for Monday, November 3, 2025, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by CareDx Q2 2025 Earnings Call TranscriptProvided by QuartrAugust 6, 2025 ShareLink copied to clipboard.Key Takeaways Positive Sentiment: CareDx reported Q2 adjusted revenue of $90.5M, up 14% year-over-year, and delivered $9.1M in adjusted EBITDA versus a loss last year, while reaffirming full-year guidance at a $367M–$373M range. Positive Sentiment: The company achieved its eighth consecutive quarter of sequential volume growth with ~49,500 tests (+13% YoY), driven by expanding kidney surveillance protocols (now >60 nationally) and 20% YoY growth in kidney testing. Positive Sentiment: At the World Transplant Congress, CareDx unveiled AlloSure Plus, an AI-driven diagnostic integrating multiple biomarkers for personalized rejection risk scoring, with Epic integration planned later this year. Negative Sentiment: A draft LCD policy for molecular allograft testing could impose frequency limits or bundled payments, potentially creating a $15M–$30M annual headwind; CareDx is preparing public comments to influence the final rule. Positive Sentiment: Operational excellence efforts, including 100% RCM workflow implementation, have cut claim submission time by 60%, boosted prior-authorization success by 45%, and driven cash collections to 105% of testing services revenue. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallCareDx Q2 202500:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Please 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 the conference over to Caroline Corner, Investor Relations. Caroline CornerInvestor Relations at CareDx00:00:10Thank you, operator. Good afternoon. Thank you for joining us today. Earlier today, CareDx released financial results for the second quarter twenty twenty five ending 06/30/2025. The release is currently available on the company's website at www.caredx.com. Caroline CornerInvestor Relations at CareDx00:00:27Joining me on today's call are John Hanna, President and Chief Executive Officer and Abhishek Jain, Chief Financial Officer. 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 security 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. Caroline CornerInvestor Relations at CareDx00:01:16Accordingly, 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 on this conference call speaks only to the live broadcast today, 08/06/2025. 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. Caroline CornerInvestor Relations at CareDx00:01:52Reconciliations of 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. John HannaDirector, President & CEO at CareDx00:02:00Thank you, Caroline, and welcome to everyone joining today's call. This week concluded the World Transplant Congress or WTC, the largest global transplant event of 2025 held here in San Francisco, California. At the event, we unveiled our evolved brand identity with a fresh new look that embodies the notion that we are together in transplant with the clinicians and patients we serve. At the WTC, there were more than 40 abstracts and 16 oral presentations with scientific data on kidney, heart, lung and liver demonstrating CareDx's advances in AI predictive diagnostics, transplant access and organ specific innovation. These studies reflect the strength of our scientific collaborations and the growing body of evidence supporting CareDx solutions. John HannaDirector, President & CEO at CareDx00:02:53We view this breadth of scientific data as a leading indicator of future peer reviewed publications and clinical adoption. On our WTC micro site at caredx.com/wtc, you can see our new branding, view the full list of CareDx abstracts presented this week and sign up to participate in our post conference webinar highlighting the data presented on CareDx products. Now on to the quarter. Throughout my prepared remarks, I will be referencing our presentation posted on the Investor Relations section of our website. We made good progress against our growth drivers and financial KPIs in the second quarter as outlined on Slides three and four of our presentation. John HannaDirector, President & CEO at CareDx00:03:39Adjusted revenue, which excludes revenue associated with tests performed in prior periods was $90,500,000 up 14% year over year. Excluding the prior period test, adjusted EBITDA was $9,100,000 compared to an adjusted loss of $300,000 last year. With half of the year completed, we are reaffirming the midpoint of our twenty twenty five revenue guidance and narrowing the range to $367,000,000 to $373,000,000 We continue to expect adjusted EBITDA of 29,000,000 to $33,000,000 Abhishek will provide additional detail on our guidance in his prepared remarks. In testing services, adjusted testing services revenue was $66,000,000 for the second quarter, up 14% year over year as shown on Slide five. We delivered approximately 49,500 tests in the second quarter, up 13% from the prior year as shown on Slide six. John HannaDirector, President & CEO at CareDx00:04:41It was our eighth consecutive quarter of sequential testing volume growth with growth across all three organs, heart, kidney and lung. In kidney, we have made significant progress expanding surveillance testing protocols. On the third quarter twenty twenty four call, we said it would take two to three quarters to turn surveillance protocols back on. I'm pleased to share that in the second quarter, we surpassed 60 surveillance protocols nationally and kidney testing volume grew nearly 20% year over year. Our growth strategy is working. John HannaDirector, President & CEO at CareDx00:05:19To further differentiate our solution in kidney transplant monitoring, we launched AlloSure Plus at this week's World Transplant Congress. AlloSure Plus is an AI driven diagnostic that integrates AlloSure results and standard of care measures such as serum creatinine and proteinuria to deliver a personalized risk score of rejection. We plan for AlloSure Plus to be seamlessly reported with every AlloSure result via our Epic integrations as we roll out Epic connectivity in the second half of the year. Multiple abstracts at WTC underscore the clinical utility of AlloSure Plus, including an abstract by Doctor. Romain Brisseau of the Paris Transplant Group who presented data highlighted on Slide six from over 3,000 patients and 4,000 biopsies across 20 global centers validating the performance of AlloSure Plus risk rejection score and demonstrated that it accurately identifies both subclinical and acute rejection supporting earlier and more precise clinical decision making. John HannaDirector, President & CEO at CareDx00:06:29There were over 30 abstracts on AlloSure Kidney at the WTC, including an oral abstract highlighted on slide seven of our presentation with new data from the K OAR study presented by Doctor. David Wojciechowski at the UT Southwestern Medical School that showed early elevations in AlloSure post transplant are prognostic for graft loss at three years, laying the foundation for earlier intervention and immune modulation strategies. This data reinforces the value of AlloSure Kidney in early risk stratification and long term management. We also had a strong representation in heart transplantation at WTC with nine abstracts highlighting CareDx products, including five from the SURE registry presented by leading institutions such as NYU, University of Washington, Cedars Sinai, University of Chicago, and UCLA. These studies reinforce the clinical value of heart care. John HannaDirector, President & CEO at CareDx00:07:34For example, an analysis of 2,200 patients in the SHORE study presented by Doctor. Jeff Tutteberg of Stanford University on slide eight of our presentation shows that in patients with persistently elevated dual positive heart care were ninety percent more likely to experience adverse outcomes post heart transplant regardless of biopsy results. These findings support the use of heart care to reduce reliance on biopsies through multimodal surveillance combining AlloMap Heart and AlloSure Heart to provide a more comprehensive and predictive view of allograft health. Commercially, reception has been strong for our expanded indication for AlloSure Heart for pediatric patients. There's a movement towards standardized protocol development at a number of pediatric heart transplant centers who recognize the need for noninvasive testing in this population due to the risks and challenges of biopsy under general anesthesia for pediatrics. John HannaDirector, President & CEO at CareDx00:08:42Recently, a youth patient and his mother spoke to our company at a town hall and shared their near death experience with a surveillance biopsy under general anesthesia. It is stories like theirs that embolden us to deliver on our mission to create life changing solutions that enable patients to thrive. Turning to lung, at WTC, Doctor. Sam Waite of the UCLA Lung Transplant Program presented data on slide nine of our presentation showing the power of precision monitoring with AlloSure lung. The study showed that tracking relative changes in AlloSure lung improved detection of subclinical lung allograft injury and infection. John HannaDirector, President & CEO at CareDx00:09:28This approach demonstrated higher sensitivity and specificity, especially in single lung recipients, reinforcing the clinical value of AlloSure lung in guiding earlier interventions. In evidence generation, we made big strides this quarter executing against our market access strategy for publishing evidence, expanding medical policy coverage, and getting into payer networks. Today, we announced a significant milestone. The first manuscript of the K OAR study was published in the American Journal of Transplantation. The study highlighted on slide 10 of our presentation is the largest prospective study of its kind and with 56 participating centers that enrolled over 1,700 kidney transplant patients who received over 18,000 AlloSure tests in the study. John HannaDirector, President & CEO at CareDx00:10:24The study followed the DART protocol, which prescribed seven tests in year one and four annually in years two and three. The manuscript findings confirm that Kidney is a clinically actionable tool that enhances rejection management by showing that AlloSure Kidney levels correlate with rejection severity, higher levels associated with ABMR and mixed rejection, and lower levels linked to borderline or TCMR1a. This stratification capability positions AlloSure Kidney as a critical tool for tailoring immunosuppression and biopsy decisions based on individualized patient risk. In the second quarter, we added 4,200,000 new covered lives for AlloMap Heart and became an in network provider with a large commercial health plan in the Northeast covering 1,200,000 lives. Importantly, our AlloSure CPT code went live in April And in July, at the clinical lab fee schedule meeting, the CLFS advisory panel voted to crosswalk the code to a similar testing code. John HannaDirector, President & CEO at CareDx00:11:37We anticipate the agency will release preliminary pricing recommendations in September and and provide the opportunity for public comment. I would like to spend a few minutes now on the draft LCD policy for molecular testing for solid organ allograft rejection published on July 17. We view the draft policy as a significant step forward. The policy affirms coverage for surveillance testing without a tie to protocol brought biopsy, which has been the primary focus of our advocacy efforts. As a reminder, the draft LCD public comment period lasts for forty five days after publication. John HannaDirector, President & CEO at CareDx00:12:21Medicare rules generally require draft policies to be finalized within one year as outlined on slide 11 of our presentation. We are currently in the public comment period until August 31 and intend to comment on several aspects of the draft LCD, including allowing clinicians to determine the cadence of surveillance testing based upon established practices and the patient's pretest risk of rejection. The extensive evidence supporting AlloMap Heart and HeartCare as a multimodal method that identifies rejection with greater accuracy than cell free DNA or gene expression testing alone and the newly proposed concept of bundled payments for surveillance testing. We plan to publish our letter on our website following the close of the comment period. Today, I would like to provide a framework for how we are thinking about the potential impact of the draft policy. John HannaDirector, President & CEO at CareDx00:13:22I'll describe two separate potential scenarios that we have modeled. In the first scenario, assuming the draft policy is implemented as written with bundled payments for surveillance testing, we estimate the impact of surveillance testing frequency limits to be an approximate 15,000,000 headwind on a full year basis. With commercial focus on driving adherence to testing protocols, we estimate over time the proportion of patients that receive more tests than the frequency limits will exceed the proportion receiving fewer tests. Half of this impact comes from kidney surveillance testing in year one that exceeds the proposed frequency limit and the other half from heart surveillance testing in years two and three that exceed the proposed frequency limit. In the second scenario, if the draft policy were to be finalized without bundled payments for surveillance testing and without frequency limits and the proposed policy to pay for only one molecular test per date of service is maintained such that AlloMap Heart is effectively no longer reimbursed as a part of heart care, we estimate the impact to be an approximate $30,000,000 headwind on a full year basis. John HannaDirector, President & CEO at CareDx00:14:45Importantly, we continue to drive protocol adoption and adherence, which has been demonstrated to improve patient outcomes and have not changed how we engage and support our customers in response to the draft policy. Once the draft is finalized and we have a clear estimate, we will update our long range financial expectations. Moving on to our operational excellence initiatives, we are continuing to improve our enterprise infrastructure and business processes to operate more efficiently such that revenue growth outpaces operating expenses as we scale. We made progress with the launch of our Epic instance, which we believe will be a key differentiator, making it easier for healthcare providers to order AlloSure and AlloMap testing and receive test results. We anticipate going live with three pilot sites through Epic Aura in the third quarter and plan to make a broader push for Epic integration starting in the fourth quarter. John HannaDirector, President & CEO at CareDx00:15:52In the second quarter, we continued to make progress with revenue cycle management driving confidence in future testing ASP growth. As illustrated on slide 12 of our presentation, we have now implemented 100% of RCM workflows and are performing 100% of patient insurance eligibility verifications. As a result of these and other changes to our processes, we have driven improvements across various RCM KPIs, including a 60% reduction in claim submission time, a 45% increase in prior authorization success rate, an 800 basis point reduction in claims rejection rate, and a 160 improvement in total appeals volume since last December. These behind the scenes wins are key leading indicators for longer term ASP growth and are beginning to be reflected financially. Cash collections in the second quarter accelerated to 105% of adjusted testing services revenue and payment per test is increasing across all tests and all payer classes. John HannaDirector, President & CEO at CareDx00:17:11I'll now turn to patient and digital solutions, which includes our transplant pharmacy, software tools, and remote patient monitoring services. In the second quarter, we reported revenue of approximately $12,800,000 representing 19% growth compared to last year as highlighted on Slide 13 of our presentation. Our go to market strategy of solution selling is working and we continue to see our patient and digital solutions helping to unlock growth opportunities for testing services. In the quarter, we released an update to our quality reporting software, ZinQuapi, that now includes an IOTA program performance composite score calculation that accounts for growth in transplant volume, organ utilization rates, and patient outcomes. We have received very positive feedback on the tool with more than 70 transplant programs participating in our educational webinar. John HannaDirector, President & CEO at CareDx00:18:13And although a center's year one performance will not be calculated until July 2026, our quality reporting tool enables them to monitor performance in real time throughout the year. Turning now to lab products, which includes PCR kits for rapid deceased donor HLA typing, NGS kits for transplant recipient HLA typing globally, and IVD monitoring assays for solid organ and stem cell transplant recipients outside of The U. S, revenue of $11,800,000 was up 12% year over year driven by sales of our AlloSeq Tx, our next generation sequencing HLA typing kits for organ recipients. In summary, we had a strong second quarter executing across all of our key drivers including our go to market strategy, evidence generation and operational excellence. Now, I'll turn the call over to Abhishek to share more details on our second quarter financial results. Abhishek JainCFO at CareDx00:19:16Thank you, John, and good afternoon, everyone. In my remarks today, I will discuss our second quarter financial results and revised 2025 guidance. Unless otherwise noted, my comments will focus on non GAAP results. For further information, please refer to GAAP to non GAAP reconciliations in our press release, earnings presentation, and recent SEC filings. We reported revenue of 86,700,000.0 which included a $3,800,000 write off associated with tests performed in prior periods, down 6% year over year. Abhishek JainCFO at CareDx00:19:54Excluding that adjustment, adjusted revenue of 90,500,000.0 grew 14% year over year on a comparable basis. Testing services revenue as reported was $62,000,000 down 13% year over year. In the quarter, as we took a write off of 3,800,000.0 associated with prior period claims for which we do not expect to collect additional payments. With the improvements John outlined in our RCM processes, we do not expect this to recur in future periods. As a reminder, we recognized $13,200,000 in revenue for the test performed in prior periods in the 2024. Abhishek JainCFO at CareDx00:20:39Adjusted to exclude impacts associated with test performed in prior period, testing services revenue was $65,900,000 up 14%. We delivered approximately 49,500 test results in the second quarter, up 13% year over year. This marks our eighth consecutive quarter of sequential testing services volume growth. Patient and Distance Solutions revenue was $12,800,000 up 19% year over year. Product revenue was $11,800,000 up 12% year over year. Abhishek JainCFO at CareDx00:21:14Adjusted to exclude the impact of tests performed in prior periods, our non GAAP gross margin improved three forty basis points to 70.4%. Our adjusted testing services non GAAP gross margin was 77.6% in the second quarter, compared to 76.4% in the second quarter of last year. The 120 basis point improvement was primarily driven by strong volume growth and continued efficiencies in our lab operations. Patient and Distal Solutions non GAAP gross margin for the quarter was 39.5% compared to 36.7% last year. Both our core digital solutions and pharmacy contributed to gross margin expansion with improved pricing and operational efficiencies. Abhishek JainCFO at CareDx00:22:06Excluding our transplant pharmacy, our patient and digital solutions non GAAP gross margin reached 70%. Lab products gross margin was 63.9%, up 17 points compared to 47.1% last year. The improvement was primarily driven by annual price increases, successful negotiations with our suppliers to reduce cost of goods sold, and an intentional shift in sales mix within our NGS portfolio towards 96 plex kits, which have better margins. Moving down the P and L, non GAAP operating expenses were $56,700,000 compared to 55,200,000.0 in the same period last year. The increase was primarily driven by investments in sales and marketing to advance our commercial go to market strategy and accelerating growth. Abhishek JainCFO at CareDx00:22:59We continue to manage our operating expenses well. Year over year operating expenses growth of 3% was well below adjusted revenue growth of 14%. Excluding the impact of tests performed in prior periods, adjusted EBITDA was $9,100,000 in the second quarter, compared to an adjusted EBITDA loss of $300,000 in the 2024. The improvement was driven by revenue growth and operational leverage, which contributed to better gross margins and improved non GAAP operating expenses as a percent of revenue. Turning to cash, we generated $10,000,000 in cash from operating activities in second quarter. Abhishek JainCFO at CareDx00:23:42We ended the quarter with $186,000,000 in cash and cash equivalents with no debt, following a $50,000,000 repurchase of approximately 5% of our outstanding shares. I'll turn next to updated guidance. With half of the year completed, we are narrowing full year 2025 revenue guidance to three sixty seven million to $373,000,000 compared to $365,000,000 to $375,000,000 previously. The midpoint of guidance remains the same. Turning to the underlying drivers of revenue guidance, we anticipate our test volumes to grow mid teens year over year. Abhishek JainCFO at CareDx00:24:22On testing volumes, sequential growth by quarter, we continue to expect 2% to 3% growth in the third quarter and 5% to 6% growth in the 2025. We expect full year ASP of approximately $13.60 dollars per test, adjusted for revenue associated with tests performed in prior periods. This does not assume any changes to Medicare coverage. We expect our patient and digital solutions to grow in the low 20s and lab products revenue to grow in the mid teens for the full year. We expect our full year non GAAP gross margin to be approximately 70% and operating expenses to be approximately $235,000,000 And we expect adjusted EBITDA to be between $29,000,000 and $33,000,000 With that, I'll now turn the call back over to John. John HannaDirector, President & CEO at CareDx00:25:16Thank you, Abhishek. Before closing our prepared remarks, I would like to announce today that Abhishek Jain is retiring from his role as CFO at CareDx. On behalf of the Board, all of our employees and the clinicians and patients we serve, I want to thank Abhishek for his outstanding leadership over the past four years. Abhishek maintained disciplined financial management through a turbulent time and is the steward that returned us to growth and profitability. The company is stronger today than when he took the helm, and I want to thank him and wish him all the best. John HannaDirector, President & CEO at CareDx00:25:52Abhishek will continue to support the company on a consulting capacity to ensure a smooth transition. We are also announcing today the appointment of Nathan Smith as CFO. Nathan is a veteran of the molecular diagnostics industry. He was with Myriad Genetics for fourteen years in leadership roles, including Senior Vice President of IR, Finance and Treasury, SVP of FP and A and Corporate Controller. Most recently, Nathan served as CFO for several private equity backed companies. John HannaDirector, President & CEO at CareDx00:26:24Nathan will begin with CareDx tomorrow, August 7, and I look forward to introducing him to you all. And now, I would like to ask the operator to open the line for questions. Operator00:26:57And we will take our first question from Tycho Peterson with Jefferies. Please go ahead. Analyst00:27:04Hi, team. Thanks so much. This is Lauren on for Tycho. One from me around the LCD. You really nicely laid out kind of some of the scenarios that you expect to happen and potential headwinds kind of that's going to come with them. Analyst00:27:18What is the scenario or kind of what is the topics of discussion that you kind of want to bring forward into the public kind of forum where you would see a scenario in terms of kind of baseline margin or kind of improvement? Maybe talk a little bit about that. John HannaDirector, President & CEO at CareDx00:27:36Yeah, thanks for the question, Lauren. I think as we said in our prepared remarks, there are three topics that we'll focus our comments on, including the frequency testing and allowing providers to determine the appropriate frequency for a patient. The evidence supporting heart care as a product that improves the care of heart transplant patients and the need for multimodality testing. And then the third is the newly introduced concept of bundled payments. And we intend to publish our comment letter on our website when the comment period ends. Analyst00:28:16Great. Thank you. I'll hop back in the queue. Operator00:28:21Thank you. And our next question comes from Brandon Couillard with Wells Fargo. Please go ahead. Brandon CouillardManaging Director at Wells Fargo00:28:28Hey, thanks. Good afternoon, guys. Appreciate the color on the kidney test volume growth in the quarter. Any data you can share with us on heart and lung? And with respect to the Epic launch, I think last quarter you talked about having that mostly rolled out by 2Q, now it seems to be more of a second half event. Brandon CouillardManaging Director at Wells Fargo00:28:45Can you just kind of talk through the complexities that might be involved in that and maybe what you're trying to derisk? Thanks. John HannaDirector, President & CEO at CareDx00:28:52Yes. Thanks, Brandon. Appreciate the questions. With heart and lung both grew well on the quarter. Lung obviously is a smaller proportion of our overall volume, but we saw nice steady movement in heart in the second quarter. John HannaDirector, President & CEO at CareDx00:29:08We also have the big ISHLT, the International Society of Heart and Lung Transplant in the second quarter. So people end up being out of the clinic for a week to do that. So we still see continued growth and transplant volumes picked up in the second quarter and that's been a positive for us. I'll let Keith talk a little bit about the Epic implementation and what the timeline looks like there. Keith KennedyCOO at CareDx00:29:34Great. Thanks, John. Yes, we're online we're about two months ahead of anybody who's ever implemented Epic. We took over our instance in June. We initiated our pilot program shortly thereafter, which will be four centers that should go live in the third quarter. Keith KennedyCOO at CareDx00:29:51By the end of the year, we expect to have 10% of our volume. And then we're building out a pipeline and a plan to roll out to try to get to 50% adherence through Epicor as a connector by the end of next year. Does that help, Brandon, to answer your question? Brandon CouillardManaging Director at Wells Fargo00:30:14Yes. Thank you. Operator00:30:17Thank And we will take our next question from Mark Massaro with BTIG. Please go ahead. Analyst00:30:32Is Vivienne on for Mark. Thanks for taking the questions. I just wanted to start off and see if there was any change to the LRP that you established last year as a result of the draft LCD? John HannaDirector, President & CEO at CareDx00:30:47Hi Divya, thanks for the question. We're not providing an update to the LRP until we get greater clarity on the final LCD. Analyst00:30:58Okay. Yes, that's understandable. And then just curious about the $30,000,000 headwind that you cited in the second scenario that you laid out. It was my understanding that a good chunk of AlloMap Heart was run as standalone. And so it was not associated with heart care at all. Analyst00:31:18So I'm just curious what your assumptions were in informing that $30,000,000 headwind? Thanks. John HannaDirector, President & CEO at CareDx00:31:25Thanks for the question. I think we've said consistently that the attachment rate of heart care is upwards of ninety percent. And so that would indicate that if that second scenario were to come to fruition, then AlloMap Heart revenue potentially would go away. That's how we calculated that $30,000,000 headwind. Analyst00:31:58Okay, perfect. That's helpful color. If I could just squeeze in one last one. You talked about great. You talked about the progress in kidney. Just how should we be thinking about maybe an updated split on roughly what percentage are surveillance versus for cause? Just asking because it would be helpful to get some metrics around how that's trending. John HannaDirector, President & CEO at CareDx00:32:27Yes, we haven't split that out, but it is shifting since the August retraction of the draft policy that attempted to limit surveillance testing only in scenarios where you're doing a protocol biopsy and that clarity effectively drove behavior change in the market, which has allowed us to implement those surveillance protocols and drive up kidney testing overall by the twenty percent nearly twenty percent year over year. So we're not breaking that out, but it certainly is a dynamic where we see significant movement toward surveillance over for cause testing as a function of all those protocols being implemented. Analyst00:33:23Okay, perfect. Thanks so much for taking the questions. John HannaDirector, President & CEO at CareDx00:33:27Thank you. Thank you. Operator00:33:30And there are no further questions at this time. This does conclude today's presentation. Thank you for your participation. You may disconnect at any time.Read moreParticipantsExecutivesCaroline CornerInvestor RelationsJohn HannaDirector, President & CEOAbhishek JainCFOKeith KennedyCOOAnalystsAnalystBrandon CouillardManaging Director at Wells FargoPowered by Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) CareDx Earnings HeadlinesCareDx's (NASDAQ:CDNA) Earnings Aren't As Good As They AppearAugust 14 at 11:29 AM | finance.yahoo.comCareDx price target lowered to $22 from $26 at BTIGAugust 13 at 1:20 PM | msn.comIs Elon's empire crumbling?The Tesla Shock Nobody Sees Coming While headlines scream "Tesla is doomed"... Jeff Brown has uncovered a revolutionary AI breakthrough buried inside Tesla's labs. One that is helping AI escape from our computer screens and manifest itself here in the real world all while creating a 25,000% growth market explosion starting as early as October 23rd. | Brownstone Research (Ad)Wells Fargo & Company Lowers CareDx (NASDAQ:CDNA) Price Target to $14.00August 10, 2025 | americanbankingnews.comCareDx (NASDAQ:CDNA) Shares Gap Down Following Weak EarningsAugust 9, 2025 | americanbankingnews.comCareDx, Inc (NASDAQ:CDNA) Q2 2025 Earnings Call TranscriptAugust 8, 2025 | msn.comSee More CareDx Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like CareDx? Sign up for Earnings360's daily newsletter to receive timely earnings updates on CareDx and other key companies, straight to your email. Email Address About CareDxCareDx (NASDAQ:CDNA) engages in the discovery, development, and commercialization of diagnostic solutions for transplant patients and caregivers in the United States and internationally. It also provides AlloSure Kidney, a donor-derived cell-free DNA (dd-cfDNA) solution for kidney transplant patients; AlloMap Heart, a gene expression solution for heart transplant patients; AlloSure Heart, a dd-cfDNA solution for heart transplant patients; and AlloSure Lung, a dd-cfDNA solution for lung transplant patients. The company offers Olerup SSP, which is used to type human leukocyte antigen (HLA) alleles based on sequence specific primer technology; QTYPE that enables precision in HLA typing; and Ottr, a transplant patient management software. In addition, it provides AlloSeq Tx, a high-resolution HLA typing solution; AlloSeq cfDNA, a surveillance solution to measure dd-cfDNA in blood; AlloSeq HCT, a solution for chimerism testing for stem cell transplant recipients; Allocell, a surveillance solution that monitors the level of engraftment and persistence of allogeneic cells for patients who have received cell therapy transplants; and XynQAPI cloud-based transplant quality management software, as well as AlloCare, a mobile app that offers a patient-centric resource for transplant recipients. The company offers its products directly to customers, as well as through third-party distributors and sub-distributors. It has a license agreement with Illumina, Inc. for the distribution, development, and commercialization of NGS products and technologies; and Cibiltech SAS to commercialize iBox, a software for the predictive analysis of post-transplantation kidney allograft loss. The company was formerly known as XDx, Inc. and changed its name to CareDx, Inc. in March 2014. 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PresentationSkip to Participants Operator00:00:00Please 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 the conference over to Caroline Corner, Investor Relations. Caroline CornerInvestor Relations at CareDx00:00:10Thank you, operator. Good afternoon. Thank you for joining us today. Earlier today, CareDx released financial results for the second quarter twenty twenty five ending 06/30/2025. The release is currently available on the company's website at www.caredx.com. Caroline CornerInvestor Relations at CareDx00:00:27Joining me on today's call are John Hanna, President and Chief Executive Officer and Abhishek Jain, Chief Financial Officer. 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 security 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. Caroline CornerInvestor Relations at CareDx00:01:16Accordingly, 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 on this conference call speaks only to the live broadcast today, 08/06/2025. 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. Caroline CornerInvestor Relations at CareDx00:01:52Reconciliations of 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. John HannaDirector, President & CEO at CareDx00:02:00Thank you, Caroline, and welcome to everyone joining today's call. This week concluded the World Transplant Congress or WTC, the largest global transplant event of 2025 held here in San Francisco, California. At the event, we unveiled our evolved brand identity with a fresh new look that embodies the notion that we are together in transplant with the clinicians and patients we serve. At the WTC, there were more than 40 abstracts and 16 oral presentations with scientific data on kidney, heart, lung and liver demonstrating CareDx's advances in AI predictive diagnostics, transplant access and organ specific innovation. These studies reflect the strength of our scientific collaborations and the growing body of evidence supporting CareDx solutions. John HannaDirector, President & CEO at CareDx00:02:53We view this breadth of scientific data as a leading indicator of future peer reviewed publications and clinical adoption. On our WTC micro site at caredx.com/wtc, you can see our new branding, view the full list of CareDx abstracts presented this week and sign up to participate in our post conference webinar highlighting the data presented on CareDx products. Now on to the quarter. Throughout my prepared remarks, I will be referencing our presentation posted on the Investor Relations section of our website. We made good progress against our growth drivers and financial KPIs in the second quarter as outlined on Slides three and four of our presentation. John HannaDirector, President & CEO at CareDx00:03:39Adjusted revenue, which excludes revenue associated with tests performed in prior periods was $90,500,000 up 14% year over year. Excluding the prior period test, adjusted EBITDA was $9,100,000 compared to an adjusted loss of $300,000 last year. With half of the year completed, we are reaffirming the midpoint of our twenty twenty five revenue guidance and narrowing the range to $367,000,000 to $373,000,000 We continue to expect adjusted EBITDA of 29,000,000 to $33,000,000 Abhishek will provide additional detail on our guidance in his prepared remarks. In testing services, adjusted testing services revenue was $66,000,000 for the second quarter, up 14% year over year as shown on Slide five. We delivered approximately 49,500 tests in the second quarter, up 13% from the prior year as shown on Slide six. John HannaDirector, President & CEO at CareDx00:04:41It was our eighth consecutive quarter of sequential testing volume growth with growth across all three organs, heart, kidney and lung. In kidney, we have made significant progress expanding surveillance testing protocols. On the third quarter twenty twenty four call, we said it would take two to three quarters to turn surveillance protocols back on. I'm pleased to share that in the second quarter, we surpassed 60 surveillance protocols nationally and kidney testing volume grew nearly 20% year over year. Our growth strategy is working. John HannaDirector, President & CEO at CareDx00:05:19To further differentiate our solution in kidney transplant monitoring, we launched AlloSure Plus at this week's World Transplant Congress. AlloSure Plus is an AI driven diagnostic that integrates AlloSure results and standard of care measures such as serum creatinine and proteinuria to deliver a personalized risk score of rejection. We plan for AlloSure Plus to be seamlessly reported with every AlloSure result via our Epic integrations as we roll out Epic connectivity in the second half of the year. Multiple abstracts at WTC underscore the clinical utility of AlloSure Plus, including an abstract by Doctor. Romain Brisseau of the Paris Transplant Group who presented data highlighted on Slide six from over 3,000 patients and 4,000 biopsies across 20 global centers validating the performance of AlloSure Plus risk rejection score and demonstrated that it accurately identifies both subclinical and acute rejection supporting earlier and more precise clinical decision making. John HannaDirector, President & CEO at CareDx00:06:29There were over 30 abstracts on AlloSure Kidney at the WTC, including an oral abstract highlighted on slide seven of our presentation with new data from the K OAR study presented by Doctor. David Wojciechowski at the UT Southwestern Medical School that showed early elevations in AlloSure post transplant are prognostic for graft loss at three years, laying the foundation for earlier intervention and immune modulation strategies. This data reinforces the value of AlloSure Kidney in early risk stratification and long term management. We also had a strong representation in heart transplantation at WTC with nine abstracts highlighting CareDx products, including five from the SURE registry presented by leading institutions such as NYU, University of Washington, Cedars Sinai, University of Chicago, and UCLA. These studies reinforce the clinical value of heart care. John HannaDirector, President & CEO at CareDx00:07:34For example, an analysis of 2,200 patients in the SHORE study presented by Doctor. Jeff Tutteberg of Stanford University on slide eight of our presentation shows that in patients with persistently elevated dual positive heart care were ninety percent more likely to experience adverse outcomes post heart transplant regardless of biopsy results. These findings support the use of heart care to reduce reliance on biopsies through multimodal surveillance combining AlloMap Heart and AlloSure Heart to provide a more comprehensive and predictive view of allograft health. Commercially, reception has been strong for our expanded indication for AlloSure Heart for pediatric patients. There's a movement towards standardized protocol development at a number of pediatric heart transplant centers who recognize the need for noninvasive testing in this population due to the risks and challenges of biopsy under general anesthesia for pediatrics. John HannaDirector, President & CEO at CareDx00:08:42Recently, a youth patient and his mother spoke to our company at a town hall and shared their near death experience with a surveillance biopsy under general anesthesia. It is stories like theirs that embolden us to deliver on our mission to create life changing solutions that enable patients to thrive. Turning to lung, at WTC, Doctor. Sam Waite of the UCLA Lung Transplant Program presented data on slide nine of our presentation showing the power of precision monitoring with AlloSure lung. The study showed that tracking relative changes in AlloSure lung improved detection of subclinical lung allograft injury and infection. John HannaDirector, President & CEO at CareDx00:09:28This approach demonstrated higher sensitivity and specificity, especially in single lung recipients, reinforcing the clinical value of AlloSure lung in guiding earlier interventions. In evidence generation, we made big strides this quarter executing against our market access strategy for publishing evidence, expanding medical policy coverage, and getting into payer networks. Today, we announced a significant milestone. The first manuscript of the K OAR study was published in the American Journal of Transplantation. The study highlighted on slide 10 of our presentation is the largest prospective study of its kind and with 56 participating centers that enrolled over 1,700 kidney transplant patients who received over 18,000 AlloSure tests in the study. John HannaDirector, President & CEO at CareDx00:10:24The study followed the DART protocol, which prescribed seven tests in year one and four annually in years two and three. The manuscript findings confirm that Kidney is a clinically actionable tool that enhances rejection management by showing that AlloSure Kidney levels correlate with rejection severity, higher levels associated with ABMR and mixed rejection, and lower levels linked to borderline or TCMR1a. This stratification capability positions AlloSure Kidney as a critical tool for tailoring immunosuppression and biopsy decisions based on individualized patient risk. In the second quarter, we added 4,200,000 new covered lives for AlloMap Heart and became an in network provider with a large commercial health plan in the Northeast covering 1,200,000 lives. Importantly, our AlloSure CPT code went live in April And in July, at the clinical lab fee schedule meeting, the CLFS advisory panel voted to crosswalk the code to a similar testing code. John HannaDirector, President & CEO at CareDx00:11:37We anticipate the agency will release preliminary pricing recommendations in September and and provide the opportunity for public comment. I would like to spend a few minutes now on the draft LCD policy for molecular testing for solid organ allograft rejection published on July 17. We view the draft policy as a significant step forward. The policy affirms coverage for surveillance testing without a tie to protocol brought biopsy, which has been the primary focus of our advocacy efforts. As a reminder, the draft LCD public comment period lasts for forty five days after publication. John HannaDirector, President & CEO at CareDx00:12:21Medicare rules generally require draft policies to be finalized within one year as outlined on slide 11 of our presentation. We are currently in the public comment period until August 31 and intend to comment on several aspects of the draft LCD, including allowing clinicians to determine the cadence of surveillance testing based upon established practices and the patient's pretest risk of rejection. The extensive evidence supporting AlloMap Heart and HeartCare as a multimodal method that identifies rejection with greater accuracy than cell free DNA or gene expression testing alone and the newly proposed concept of bundled payments for surveillance testing. We plan to publish our letter on our website following the close of the comment period. Today, I would like to provide a framework for how we are thinking about the potential impact of the draft policy. John HannaDirector, President & CEO at CareDx00:13:22I'll describe two separate potential scenarios that we have modeled. In the first scenario, assuming the draft policy is implemented as written with bundled payments for surveillance testing, we estimate the impact of surveillance testing frequency limits to be an approximate 15,000,000 headwind on a full year basis. With commercial focus on driving adherence to testing protocols, we estimate over time the proportion of patients that receive more tests than the frequency limits will exceed the proportion receiving fewer tests. Half of this impact comes from kidney surveillance testing in year one that exceeds the proposed frequency limit and the other half from heart surveillance testing in years two and three that exceed the proposed frequency limit. In the second scenario, if the draft policy were to be finalized without bundled payments for surveillance testing and without frequency limits and the proposed policy to pay for only one molecular test per date of service is maintained such that AlloMap Heart is effectively no longer reimbursed as a part of heart care, we estimate the impact to be an approximate $30,000,000 headwind on a full year basis. John HannaDirector, President & CEO at CareDx00:14:45Importantly, we continue to drive protocol adoption and adherence, which has been demonstrated to improve patient outcomes and have not changed how we engage and support our customers in response to the draft policy. Once the draft is finalized and we have a clear estimate, we will update our long range financial expectations. Moving on to our operational excellence initiatives, we are continuing to improve our enterprise infrastructure and business processes to operate more efficiently such that revenue growth outpaces operating expenses as we scale. We made progress with the launch of our Epic instance, which we believe will be a key differentiator, making it easier for healthcare providers to order AlloSure and AlloMap testing and receive test results. We anticipate going live with three pilot sites through Epic Aura in the third quarter and plan to make a broader push for Epic integration starting in the fourth quarter. John HannaDirector, President & CEO at CareDx00:15:52In the second quarter, we continued to make progress with revenue cycle management driving confidence in future testing ASP growth. As illustrated on slide 12 of our presentation, we have now implemented 100% of RCM workflows and are performing 100% of patient insurance eligibility verifications. As a result of these and other changes to our processes, we have driven improvements across various RCM KPIs, including a 60% reduction in claim submission time, a 45% increase in prior authorization success rate, an 800 basis point reduction in claims rejection rate, and a 160 improvement in total appeals volume since last December. These behind the scenes wins are key leading indicators for longer term ASP growth and are beginning to be reflected financially. Cash collections in the second quarter accelerated to 105% of adjusted testing services revenue and payment per test is increasing across all tests and all payer classes. John HannaDirector, President & CEO at CareDx00:17:11I'll now turn to patient and digital solutions, which includes our transplant pharmacy, software tools, and remote patient monitoring services. In the second quarter, we reported revenue of approximately $12,800,000 representing 19% growth compared to last year as highlighted on Slide 13 of our presentation. Our go to market strategy of solution selling is working and we continue to see our patient and digital solutions helping to unlock growth opportunities for testing services. In the quarter, we released an update to our quality reporting software, ZinQuapi, that now includes an IOTA program performance composite score calculation that accounts for growth in transplant volume, organ utilization rates, and patient outcomes. We have received very positive feedback on the tool with more than 70 transplant programs participating in our educational webinar. John HannaDirector, President & CEO at CareDx00:18:13And although a center's year one performance will not be calculated until July 2026, our quality reporting tool enables them to monitor performance in real time throughout the year. Turning now to lab products, which includes PCR kits for rapid deceased donor HLA typing, NGS kits for transplant recipient HLA typing globally, and IVD monitoring assays for solid organ and stem cell transplant recipients outside of The U. S, revenue of $11,800,000 was up 12% year over year driven by sales of our AlloSeq Tx, our next generation sequencing HLA typing kits for organ recipients. In summary, we had a strong second quarter executing across all of our key drivers including our go to market strategy, evidence generation and operational excellence. Now, I'll turn the call over to Abhishek to share more details on our second quarter financial results. Abhishek JainCFO at CareDx00:19:16Thank you, John, and good afternoon, everyone. In my remarks today, I will discuss our second quarter financial results and revised 2025 guidance. Unless otherwise noted, my comments will focus on non GAAP results. For further information, please refer to GAAP to non GAAP reconciliations in our press release, earnings presentation, and recent SEC filings. We reported revenue of 86,700,000.0 which included a $3,800,000 write off associated with tests performed in prior periods, down 6% year over year. Abhishek JainCFO at CareDx00:19:54Excluding that adjustment, adjusted revenue of 90,500,000.0 grew 14% year over year on a comparable basis. Testing services revenue as reported was $62,000,000 down 13% year over year. In the quarter, as we took a write off of 3,800,000.0 associated with prior period claims for which we do not expect to collect additional payments. With the improvements John outlined in our RCM processes, we do not expect this to recur in future periods. As a reminder, we recognized $13,200,000 in revenue for the test performed in prior periods in the 2024. Abhishek JainCFO at CareDx00:20:39Adjusted to exclude impacts associated with test performed in prior period, testing services revenue was $65,900,000 up 14%. We delivered approximately 49,500 test results in the second quarter, up 13% year over year. This marks our eighth consecutive quarter of sequential testing services volume growth. Patient and Distance Solutions revenue was $12,800,000 up 19% year over year. Product revenue was $11,800,000 up 12% year over year. Abhishek JainCFO at CareDx00:21:14Adjusted to exclude the impact of tests performed in prior periods, our non GAAP gross margin improved three forty basis points to 70.4%. Our adjusted testing services non GAAP gross margin was 77.6% in the second quarter, compared to 76.4% in the second quarter of last year. The 120 basis point improvement was primarily driven by strong volume growth and continued efficiencies in our lab operations. Patient and Distal Solutions non GAAP gross margin for the quarter was 39.5% compared to 36.7% last year. Both our core digital solutions and pharmacy contributed to gross margin expansion with improved pricing and operational efficiencies. Abhishek JainCFO at CareDx00:22:06Excluding our transplant pharmacy, our patient and digital solutions non GAAP gross margin reached 70%. Lab products gross margin was 63.9%, up 17 points compared to 47.1% last year. The improvement was primarily driven by annual price increases, successful negotiations with our suppliers to reduce cost of goods sold, and an intentional shift in sales mix within our NGS portfolio towards 96 plex kits, which have better margins. Moving down the P and L, non GAAP operating expenses were $56,700,000 compared to 55,200,000.0 in the same period last year. The increase was primarily driven by investments in sales and marketing to advance our commercial go to market strategy and accelerating growth. Abhishek JainCFO at CareDx00:22:59We continue to manage our operating expenses well. Year over year operating expenses growth of 3% was well below adjusted revenue growth of 14%. Excluding the impact of tests performed in prior periods, adjusted EBITDA was $9,100,000 in the second quarter, compared to an adjusted EBITDA loss of $300,000 in the 2024. The improvement was driven by revenue growth and operational leverage, which contributed to better gross margins and improved non GAAP operating expenses as a percent of revenue. Turning to cash, we generated $10,000,000 in cash from operating activities in second quarter. Abhishek JainCFO at CareDx00:23:42We ended the quarter with $186,000,000 in cash and cash equivalents with no debt, following a $50,000,000 repurchase of approximately 5% of our outstanding shares. I'll turn next to updated guidance. With half of the year completed, we are narrowing full year 2025 revenue guidance to three sixty seven million to $373,000,000 compared to $365,000,000 to $375,000,000 previously. The midpoint of guidance remains the same. Turning to the underlying drivers of revenue guidance, we anticipate our test volumes to grow mid teens year over year. Abhishek JainCFO at CareDx00:24:22On testing volumes, sequential growth by quarter, we continue to expect 2% to 3% growth in the third quarter and 5% to 6% growth in the 2025. We expect full year ASP of approximately $13.60 dollars per test, adjusted for revenue associated with tests performed in prior periods. This does not assume any changes to Medicare coverage. We expect our patient and digital solutions to grow in the low 20s and lab products revenue to grow in the mid teens for the full year. We expect our full year non GAAP gross margin to be approximately 70% and operating expenses to be approximately $235,000,000 And we expect adjusted EBITDA to be between $29,000,000 and $33,000,000 With that, I'll now turn the call back over to John. John HannaDirector, President & CEO at CareDx00:25:16Thank you, Abhishek. Before closing our prepared remarks, I would like to announce today that Abhishek Jain is retiring from his role as CFO at CareDx. On behalf of the Board, all of our employees and the clinicians and patients we serve, I want to thank Abhishek for his outstanding leadership over the past four years. Abhishek maintained disciplined financial management through a turbulent time and is the steward that returned us to growth and profitability. The company is stronger today than when he took the helm, and I want to thank him and wish him all the best. John HannaDirector, President & CEO at CareDx00:25:52Abhishek will continue to support the company on a consulting capacity to ensure a smooth transition. We are also announcing today the appointment of Nathan Smith as CFO. Nathan is a veteran of the molecular diagnostics industry. He was with Myriad Genetics for fourteen years in leadership roles, including Senior Vice President of IR, Finance and Treasury, SVP of FP and A and Corporate Controller. Most recently, Nathan served as CFO for several private equity backed companies. John HannaDirector, President & CEO at CareDx00:26:24Nathan will begin with CareDx tomorrow, August 7, and I look forward to introducing him to you all. And now, I would like to ask the operator to open the line for questions. Operator00:26:57And we will take our first question from Tycho Peterson with Jefferies. Please go ahead. Analyst00:27:04Hi, team. Thanks so much. This is Lauren on for Tycho. One from me around the LCD. You really nicely laid out kind of some of the scenarios that you expect to happen and potential headwinds kind of that's going to come with them. Analyst00:27:18What is the scenario or kind of what is the topics of discussion that you kind of want to bring forward into the public kind of forum where you would see a scenario in terms of kind of baseline margin or kind of improvement? Maybe talk a little bit about that. John HannaDirector, President & CEO at CareDx00:27:36Yeah, thanks for the question, Lauren. I think as we said in our prepared remarks, there are three topics that we'll focus our comments on, including the frequency testing and allowing providers to determine the appropriate frequency for a patient. The evidence supporting heart care as a product that improves the care of heart transplant patients and the need for multimodality testing. And then the third is the newly introduced concept of bundled payments. And we intend to publish our comment letter on our website when the comment period ends. Analyst00:28:16Great. Thank you. I'll hop back in the queue. Operator00:28:21Thank you. And our next question comes from Brandon Couillard with Wells Fargo. Please go ahead. Brandon CouillardManaging Director at Wells Fargo00:28:28Hey, thanks. Good afternoon, guys. Appreciate the color on the kidney test volume growth in the quarter. Any data you can share with us on heart and lung? And with respect to the Epic launch, I think last quarter you talked about having that mostly rolled out by 2Q, now it seems to be more of a second half event. Brandon CouillardManaging Director at Wells Fargo00:28:45Can you just kind of talk through the complexities that might be involved in that and maybe what you're trying to derisk? Thanks. John HannaDirector, President & CEO at CareDx00:28:52Yes. Thanks, Brandon. Appreciate the questions. With heart and lung both grew well on the quarter. Lung obviously is a smaller proportion of our overall volume, but we saw nice steady movement in heart in the second quarter. John HannaDirector, President & CEO at CareDx00:29:08We also have the big ISHLT, the International Society of Heart and Lung Transplant in the second quarter. So people end up being out of the clinic for a week to do that. So we still see continued growth and transplant volumes picked up in the second quarter and that's been a positive for us. I'll let Keith talk a little bit about the Epic implementation and what the timeline looks like there. Keith KennedyCOO at CareDx00:29:34Great. Thanks, John. Yes, we're online we're about two months ahead of anybody who's ever implemented Epic. We took over our instance in June. We initiated our pilot program shortly thereafter, which will be four centers that should go live in the third quarter. Keith KennedyCOO at CareDx00:29:51By the end of the year, we expect to have 10% of our volume. And then we're building out a pipeline and a plan to roll out to try to get to 50% adherence through Epicor as a connector by the end of next year. Does that help, Brandon, to answer your question? Brandon CouillardManaging Director at Wells Fargo00:30:14Yes. Thank you. Operator00:30:17Thank And we will take our next question from Mark Massaro with BTIG. Please go ahead. Analyst00:30:32Is Vivienne on for Mark. Thanks for taking the questions. I just wanted to start off and see if there was any change to the LRP that you established last year as a result of the draft LCD? John HannaDirector, President & CEO at CareDx00:30:47Hi Divya, thanks for the question. We're not providing an update to the LRP until we get greater clarity on the final LCD. Analyst00:30:58Okay. Yes, that's understandable. And then just curious about the $30,000,000 headwind that you cited in the second scenario that you laid out. It was my understanding that a good chunk of AlloMap Heart was run as standalone. And so it was not associated with heart care at all. Analyst00:31:18So I'm just curious what your assumptions were in informing that $30,000,000 headwind? Thanks. John HannaDirector, President & CEO at CareDx00:31:25Thanks for the question. I think we've said consistently that the attachment rate of heart care is upwards of ninety percent. And so that would indicate that if that second scenario were to come to fruition, then AlloMap Heart revenue potentially would go away. That's how we calculated that $30,000,000 headwind. Analyst00:31:58Okay, perfect. That's helpful color. If I could just squeeze in one last one. You talked about great. You talked about the progress in kidney. Just how should we be thinking about maybe an updated split on roughly what percentage are surveillance versus for cause? Just asking because it would be helpful to get some metrics around how that's trending. John HannaDirector, President & CEO at CareDx00:32:27Yes, we haven't split that out, but it is shifting since the August retraction of the draft policy that attempted to limit surveillance testing only in scenarios where you're doing a protocol biopsy and that clarity effectively drove behavior change in the market, which has allowed us to implement those surveillance protocols and drive up kidney testing overall by the twenty percent nearly twenty percent year over year. So we're not breaking that out, but it certainly is a dynamic where we see significant movement toward surveillance over for cause testing as a function of all those protocols being implemented. Analyst00:33:23Okay, perfect. Thanks so much for taking the questions. John HannaDirector, President & CEO at CareDx00:33:27Thank you. Thank you. Operator00:33:30And there are no further questions at this time. This does conclude today's presentation. Thank you for your participation. You may disconnect at any time.Read moreParticipantsExecutivesCaroline CornerInvestor RelationsJohn HannaDirector, President & CEOAbhishek JainCFOKeith KennedyCOOAnalystsAnalystBrandon CouillardManaging Director at Wells FargoPowered by