Earnings Call Transcript
CareDx, Inc. (CDNA)
Earnings Call Transcript - CDNA Q4 2024
Operator, Operator
Good afternoon, everyone. Welcome to the CareDx, Inc. Fourth Quarter and Fiscal Year 2024 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, you will have the opportunity to ask questions during our question-and-answer session. Now at this time, I'll turn things over to Ms. Caroline Corner, Investor Relations. Please go ahead, ma'am.
Caroline Corner, Investor Relations
Thank you, operator. Good afternoon. Thank you for joining us today. Earlier today, CareDx released financial results for the year ending December 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. 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. Reconciliations 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.
John Hanna, CEO
Thank you, Caroline, and welcome to everyone joining today's call. In early January, we preannounced our fourth quarter and fiscal year 2024 financial results, highlighting what was a transformational year for CareDx. I want to start by congratulating the approximately 650 employees globally at CareDx for supporting the care of transplant patients from the early stages of establishing a donor to recipient match all the way through post-transplant monitoring, sometimes for the rest of the patient's life. We impacted the lives of over 50,000 patients in 2024 and in 2025, look forward to continuing to deliver on our mission to create life-changing solutions that enable transplant patients to thrive. In the fourth quarter, we reported quarterly revenue of $86.6 million, up 32% year-over-year. Positioned to build upon that performance, we reiterate our 2025 guidance of $370 million in revenue and our target to exit 2027 with $500 million in revenue and 20% adjusted EBITDA. At CareDx, we continue to drive gains in positive adjusted EBITDA due to revenue growth and disciplined management of our operating expenses and achieved $9.8 million in adjusted EBITDA in the fourth quarter and $27.8 million for the full year. We generated $22 million in cash from operations in the fourth quarter and ended the year with a cash balance of $261 million and no debt. We are committed to long-term profitable growth. And in 2025, we expect an adjusted EBITDA gain of between $29 million and $33 million. I'm going to highlight several accomplishments from the fourth quarter and then turn to the key growth drivers for 2025, which you should anticipate hearing from me providing further commentary on throughout the year. In Testing Services, we delivered approximately 45,500 tests in the fourth quarter, up 14% from the prior year. The fourth quarter was our sixth consecutive quarter of sequential testing services growth. We again experienced testing services volume growth across all organs: heart, kidney and lung. Testing services revenue was $63.8 million for the fourth quarter, up 37% year-over-year. We completed our plan to add 30 sales and marketing team members to promote and sell our transplant solutions. We also completed the addition of 20 team members to our billing organization to drive greater collections and expand our ASP. We will continue to invest in our commercial operations where we see an outsized opportunity to drive growth by further penetrating the market. We continue to make strides in payer coverage. In the fourth quarter, we expanded AlloMap Heart coverage from beginning at month 6 post-transplant to month 2 post-transplant by 21 million commercial lives and added 12.2 million new commercial covered lives for AlloSure. For the full year 2024, we added or expanded coverage for 28 million lives for AlloMap Heart and added 36 million new commercial covered lives for AlloSure. This coverage and disciplined revenue cycle management will continue to drive our ASP in future quarters. Moving on to our patient and digital solutions, which includes our transplant pharmacy, software tools and remote patient monitoring services, we reported revenue of approximately $11.4 million in the fourth quarter, representing 18% year-over-year growth. We continue to see strong synergies between patient and digital solutions and our testing services offerings. When accounts use three or more CareDx patient and digital solutions, they have a 50% greater new patient capture rate for our testing services. In the fourth quarter, our digital solutions team in collaboration with our partner, Leidos, was awarded a contract by the U.S. Department of Health and Human Services that provides us the opportunity to bid on projects associated with the Organ Procurement and Transplant Network, or OPTN, modernization initiative. This multiyear initiative aims to modernize the data collection, reporting, organ allocation and other facets of the organ transplant system to better serve the more than 100,000 individuals on the national organ transplant waitlist. This partnership leverages CareDx's deep expertise in transplant software development, data science, and AI and Leidos' experience in health systems and large-scale health IT programs. We are proud to be a part of this initiative, which has the potential to expand access to organ transplants. Moving on to lab products, which include PCR kits for rapid disease donor HLA typing and 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., we reported revenue of $11.4 million, representing 23% year-over-year growth. Sales of our industry-leading AlloSeq Tx NGS-based HLA typing kits for organ recipients primarily drove this growth. In December, the results of a multicenter prospective study of our AlloSeq cell-free DNA IVD kit, which included 580 transplant patients from three referral centers in Europe were published in the Journal Transplant International. The study demonstrated that AlloSeq cell-free DNA detects allograft rejection consistent with our AlloSure donor-derived cell-free DNA lab-developed test in the U.S. Today, approximately 5% of CareDx revenue comes from outside the U.S. However, there are over 18,000 kidney, 2,000 heart, and 2,000 lung transplants performed annually across the European Union alone. We look forward to these data expanding adoption of AlloSeq cell-free DNA for detecting allograft rejection in the same labs that use our industry-leading AlloSeq Tx 17 NGS HLA typing assay. The transition to NGS in HLA labs globally for HLA typing and the detection of allograft rejection will continue to drive growth in our lab products business. 2024 was a truly transformational year at CareDx, and we believe we are well positioned for continued profitable growth in 2025. I now want to highlight what we view to be our key drivers of growth in 2025 that enable us to achieve our 3-year long-range plan. Number one is our go-to-market strategy to provide solutions to transplant centers across the care continuum to drive testing services volume growth. Our pharmacy, digital and lab products are synergistic to growing our testing services adoption. Number two, evidence generation to expand payer coverage. We continue to demonstrate the testing services we provide improve patient health outcomes and provide significant value to the health care system. Evidence generation, coverage and coding allow us to achieve in-network status and improve payment and ASP. And number three, operational excellence to scale our business profitably, including business process optimization, which allows us to have revenue growth outpace operating expense growth and generate cash. Throughout 2025, we anticipate achieving significant milestones in each of these areas. First, in go-to-market strategy, through our synergistic offering of our patient and digital solutions, we anticipate continued adoption in surveillance testing with AlloSure Kidney, namely the IOTA program, which we anticipate will be implemented by CMS in July of 2025. This program provides both upside and downside risk payments for transplant centers. The two program metrics of importance are growing kidney transplant volumes and the organ acceptance rate at each center. Both of these metrics may drive centers to perform more complex transplant cases, which may increase the risk of rejection. These patients may require more regular monitoring, which we believe AlloSure Kidney is well positioned to support. Each performance year of the IOTA program is assessed independently, so it is crucial that a transplant center understand their IOTA score in real time. CareDx's upcoming release of our quality reporting software, XynQAPI, is designed to specifically allow transplant centers to monitor their IOTA performance score in real time with no manual data entry required. This digital tool is an example of how our synergistic solutions are enabling sales engagements around expanding the use of our AlloSure surveillance testing services and is anticipated to be released prior to the July 2025 start of the IOTA program. Another example of our patient and digital solutions that are driving engagement in kidney surveillance testing is the anticipated launch of our medication therapy management program through our CareDx transplant pharmacy. A key reason why transplant patients undergo organ rejection is the lack of adherence to their immunosuppression medications, which are often the result of symptoms of drug-to-drug interactions. The CareDx transplant pharmacy is launching a medication therapy management program in the first half of 2025 to support those patients in particular, individuals with a less than ideal allograft match that are on a higher dose of immunosuppression medication with greater side effects. In addition, we intend to launch several new products this year, including in testing services: AlloSure Heart for pediatric patients under the age of 15, AlloSure Kidney for simultaneous pancreas and kidney transplant patients, which is primarily performed for patients with insulin-dependent diabetes and renal failure, and our HistoMap Kidney assay, a gene expression profiling test for determining molecular subtype of organ rejection such as antibody-mediated rejection. In our patient and digital solutions, we intend to expand the launch of AlloView, an AI risk prediction model for kidney allograft rejection. And in lab products, we plan to provide commentary on the ongoing launch of our Assign 2.0 software that pairs with our AlloSeq Tx 17 NGS assay for HLA typing, and later in the year, the launch of Score 7, our next-generation software for rapid PCR HLA testing. Moving to evidence generation. I will start with kidney. In the fourth quarter, study investigators submitted the first of several anticipated manuscripts from the KOAR registry, a long-term follow-up study of nearly 4,000 patients who underwent kidney transplantation. We anticipate those data will be published in the second half of 2025, and the second KOAR manuscript is expected to be submitted in the second quarter of 2025. The major conference in kidney transplantation and additional abstract data that will lay the groundwork for future publications occurs in August of this year, the World Transplant Congress in San Francisco. In heart, we anticipate the second manuscript from the SHORE registry to be submitted in the first half of 2025 and to be published in the second half of 2025. And in lung, we expect the manuscript to be submitted for publication in the second half of 2025. The International Society for Heart and Lung Transplantation, or ISHLT meeting is taking place in April 2025, where we expect data presented in abstract form to drive future publications in heart and lung. These data in kidney, heart, and lung will be the catalyst for additional commercial payer coverage for AlloSure as we continue to build the evidentiary library that demonstrates AlloSure testing changes clinician behaviors and improves patient health outcomes in each indication. Switching to our pipeline and CareDx's AlloHeme assay for hematologic malignancies. An interim 1-year readout of the 2-year AlloHeme ACROBAT trial to monitor for minimal residual disease recurrence for patients with hematologic malignancies that have undergone an allogeneic stem cell transplant was presented at the Tandem cell transplant and cell therapy meetings last month. These interim data demonstrate AlloHeme detects relapse, a clinically meaningful time ahead of standard of care approaches. We anticipate further interim readouts of this trial throughout 2025 at scientific conferences. These data supporting AlloHeme will build the foundation for our future Medicare coverage submission following the completion of the ACROBAT trial in 2026. In operational excellence, we are improving our enterprise infrastructure and business processes to operate more efficiently such that revenue growth outpaces operational expense as we scale. We have rebuilt our revenue cycle management team and look forward to seeing the impact that may have on ASPs in future quarters. And a key initiative in our supply chain operations is to increase the gross margins of our lab products business. If you recall, as a first phase, we transitioned AlloSeq Tx 17 manufacturing from Fremantle Australia to contract manufacturers in the U.S. and EU to reduce COGS, and we now are taking additional steps in supply chain and manufacturing processes to improve our gross margin profile by the end of 2025. And with that, I will now turn the call over to Abhishek to share more details on the fourth quarter and full year financial results and 2025 guidance.
Abhishek Jain, CFO
Thank you, John. In my remarks today, I will discuss our fourth quarter and full year 2024 financial results before turning to 2025 guidance. Unless otherwise noted, my remarks 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. Let me start with the key financial highlights. We reported full year 2024 revenue of $334 million, up 19% year-over-year, exceeding the high end of our updated guidance. We delivered approximately 176,000 test results in 2024, up 6% year-over-year. Test volumes grew 14% year-over-year in the fourth quarter to approximately 45,500 tests, representing the sixth consecutive quarter of sequential testing services volume growth. Testing Services revenue was $249.4 million, up 19% year-over-year. Patient and Digital Solutions revenue was $43.6 million, up 18% year-over-year and products revenue was $40.8 million, up 22% year-over-year. We reported an adjusted EBITDA gain of $27.8 million in 2024 compared to an adjusted EBITDA loss of $38 million in 2023. Finally, we generated cash of $38 million in 2024 from operations, ending the year with $261 million in cash, cash equivalents, and marketable securities and no debt. Moving to the details, starting with gross margin. Our non-GAAP gross margin for the full year was 69.4%, up 280 basis points as compared to non-GAAP gross margin of 66.6% in 2023. The gross margin expansion was primarily driven by testing services. Our non-GAAP testing services gross margin was 78.9% in 2024 compared to 74% in 2023. The improvement in testing services gross margin was driven by volume growth, ASP expansion as well as continued efficiencies in managing our lab operations. Our Patient and Digital Solutions non-GAAP gross margin for '24 was 35% as compared to 36% in 2023. Excluding our transplant pharmacy, which has a lower gross margin profile, our Patient and Digital Solutions non-GAAP gross margin for '24 was 59%. Our products non-GAAP gross margin for '24 was 49% as compared to 54% in 2023. Moving down the P&L. Non-GAAP operating expenses for the year were $212 million, down approximately $21 million from 2023, demonstrating the continued discipline in managing our operating expenses. The reductions in our operating expenses were driven principally by a reduction in legal spend. Earlier this week, the District Court reversed the jury decision in the patent litigation case brought by our competitor, overturning the prior $96 million verdict. In our year-end 2024 GAAP financial statements, we reversed the $96 million accrued liability recorded in 2023, resulting in a positive GAAP net income of approximately $52.5 million for 2024. Our adjusted EBITDA gain for the full year was $28 million as compared to adjusted EBITDA loss of $38 million in 2023. Adjusted EBITDA margin improved from a loss of 14% in 2023 to a gain of 8% in 2024. The improvement in adjusted EBITDA was driven by revenue growth and operational leverage, which contributed to better gross margins and non-GAAP operating expenses as a percent of revenue. Turning to our cash balance, we ended the year in a strong position with cash, cash equivalents, and marketable securities of $261 million and no debt, an increase of approximately $26 million year-over-year. The increase in our cash balance was driven by strong cash flow from operating activities. Given the strong cash position and our confidence in the business, our Board authorized another share buyback program in February 2025 of up to $50 million over 2 years. As a reminder, we repurchased approximately $29 million worth of shares in a previously approved share buyback program that expired in December 2024 at an average price of $19.4 over a 2-year period. Turning to guidance, we expect our revenue to be in the range of $365 million to $375 million in 2025. The midpoint of our '25 guidance assumes approximately 17% growth from our adjusted '24 revenue of $316 million. Our adjusted 2024 revenue excludes the $17 million in revenue associated with tests performed in prior periods. Let me now provide more details on our '25 guidance. For testing services, we anticipate our test volumes to grow mid-teens year-over-year. We estimate our ASP to be approximately $1,360 a test on a blended basis for the full year. We do expect to see some seasonality in our testing volumes. Additionally, in the first quarter so far, we have seen impacts from weather events. We expect modest growth of 2% to 3% in the first quarter, 5% to 6% in the second quarter, 2% to 3% in the third quarter, and 5% to 6% growth in the fourth quarter of 2025. On ASP, we expect $1,335 per test for Q1 '25 growing proportionately throughout the year. Also, this does not assume any changes to Medicare coverage. Our Patient and Digital solutions and lab products revenue is expected to grow in the mid-teens year-over-year, approaching approximately $100 million in total. We expect our non-GAAP gross margin to be approximately 70% for the full year 2025. We're expecting our operating expenses to be approximately $235 million, an increase of approximately 11% year-over-year. We expect our adjusted EBITDA gain for the full year 2025 to be between $29 million and $33 million. Q1 is generally our soft quarter due to the reset of employee benefits, such as 401(k) matching, payroll taxes, etc. Q1 of '25 will also have a full quarter impact of recent hires. We expect low single-digit adjusted EBITDA in Q1, mid-single digit in Q2, high single digit in Q3 and remaining in Q4 of 2025. With that, I will now turn the call over to John to deliver closing remarks.
John Hanna, CEO
Thank you, Abhishek. At CareDx, we are deeply proud of the work we do to support the care of patients on their journey to a curative transplant. Earlier this month, we were honored to have Meryl Zul, one of our first AlloMap heart transplant patients, join us to celebrate the 18th year of the gift given to him, a newly transplanted heart. Meryl is a father, grandfather, nurse, and respected patient advocate for donors and recipients of life. He loves creating music and art, which he shared with our team. For the past 18 years, he has dedicated himself to living a rich and meaningful life profoundly impacting the transplant community through his selfless volunteer efforts. It is the stories like Meryl that inspire our employees every day to continue their important mission to create life-changing solutions that enable transplant patients to thrive. I would now like to ask the operator to open the line for questions.
Operator, Operator
Thank you, Mr. Hanna. We go first this afternoon to Matt Sykes of Goldman Sachs.
Unidentified Analyst, Analyst
Hey guys, congrats on the quarter. This is Prashant on for Matt. So you previously talked about multi-solution customer accounts generating more testing services revenue. Can you talk about your efforts in converting your existing accounts with less than three solutions to three or more solutions versus acquiring new customer accounts?
John Hanna, CEO
Yeah. Thanks for the question, Prashant. And yes, absolutely. In our Patient and Digital solutions, we're really focused on our XynQAPI product for quality reporting and dashboarding that enables, in particular, kidney transplant centers to monitor their performance leading into the IOTA program where they now have the new metrics to assess. We shared how we're working on launching a medication therapy management program, which is geared toward assisting patients having drug-to-drug interactions that cause them to skip taking immune suppression, which can lead to rejection. These types of patient and digital solutions, as they become more adopted at transplant centers across the country, we believe they're synergistic and will drive the use of AlloSure, whether in kidney, heart, or lung.
Unidentified Analyst, Analyst
Got it. That's helpful. And then my follow-up is, can you talk about the impact on ASPs that launching these tests like AlloSure Heart Pediatric and AlloSure Kidney for simultaneous kidney and pancreas transplantation will have? I imagine you may initially have to provide some tests without reimbursement. So how large of a dilutive impact, if at all, will this have on gross margins in 2025?
John Hanna, CEO
Yeah. Thanks for the question, Prashant. I think those two indications, in particular, AlloSure Heart Pediatric and AlloSure Kidney for simultaneous pancreas and kidney are relatively smaller indications but very important and high acuity conditions. We anticipate that we will be paid on those claims consistent with how we're paid on other commercial claims for AlloSure Heart and for AlloSure Kidney when a patient undergoes a simultaneous pancreas and kidney transplant. So we're not providing any guidance that indicates that would negatively or positively impact gross margins for '25.
Unidentified Analyst, Analyst
Thank you.
Operator, Operator
Thank you. We go next now to Tycho Peterson at Jefferies.
Unidentified Analyst, Analyst
Hey. This is Noah on for Tycho. Congrats on the quarter. I wanted to ask about litigation, particularly with the reversal, what is the path forward from here? If you're no longer on the hook for the $96 million and you have $200 million in cash, how are you kind of thinking about capital allocation from there? I know you have the buyback authorization, but also what kind of options are there in organic and also M&A. Thanks.
John Hanna, CEO
Yeah. Thanks, Noah, for the question. The path forward with any IP litigation, we anticipate that it will likely be appealed. However, our assessment is that having those patents invalidated is significant such that we reverse that accrual and believe along with our audit partners that it was the appropriate thing to do at this time. In terms of the share buyback and capital allocation, first and foremost, we're going to continue to reinvest in the business where we see opportunities for continued growth. Second, we'll look for strategic opportunities in the marketplace adjacent to transplant and in that transplant plus field. And then third, if we don't see any opportunities, we'll go to share buybacks and buy back shares as appropriate.
Unidentified Analyst, Analyst
Great. That's helpful. And then for my follow-up here, if I could just ask on new hires. I think you noted that you completed that in 4Q. And so I'm wondering about the ramp to see impact from new hires, particularly how that will play out first half versus second half in 2025.
John Hanna, CEO
Absolutely. We typically see the new hire ramp in this space to be roughly 6 months to get them fully ramped up and effective in the field. As Abhishek commented in our prepared remarks, we've seen a little bit of disruption here in Q1 from weather and fires. But that also has given us time to focus on training, call planning, field strategy, and we expect to have a stronger quarter in Q2.
Operator, Operator
Thank you. We'll go next now to Mark Massaro at BTIG.
Mark Massaro, Analyst
Hey, guys. Thank you for taking the questions. Congrats on a good quarter. I wanted to hit the topic of prior period collections. Maybe Abhishek, can you clarify how much might have hit in Q4? And then I think I heard you say the number for full year '24, but can you just repeat that? And then as we think about 2025, is there any contribution for prior period collections in the guidance?
Abhishek Jain, CFO
Thanks for the question, Mark. So on your first question, the Q4 revenue includes about $2.2 million in revenue, which is associated with the tests that were outside of Q4. What I've also called out is that throughout 2024, we recognized about $17 million in revenue that were tests performed in prior periods. In the 2025 guidance, we are not baking in contributions from these one-time tests, which remains an upside.
Mark Massaro, Analyst
Okay. That's very helpful. And then I think I heard you guys talk about mid-teens volume for 2025 and ASPs of 1360. I'd be curious to try to understand how much of that mid-teens volume is baking in increased surveillance testing? And then maybe more broadly, what are you seeing now that we're into the month of February? What are you seeing in the marketplace for surveillance testing here in Q1?
John Hanna, CEO
Yeah. Thanks for the question, Mark. Yes, we do believe that surveillance testing is going to contribute substantially to that mid-teens volume growth. In Q4, kidney testing outpaced all other organs, and we continue to have institutions that are turning on surveillance protocols through the quarter. Those institutions move at their own pace, right? So as I've said previously, it will take us probably 2 to 3 quarters to turn those protocols back on. It will take time for new patients to get started on protocol and that volume to build through the course of the 12 months following the initiation of that protocol. So we're on that journey. We feel really good about it. And going forward, that is a primary focus of our team in having those discussions and engagements.
Mark Massaro, Analyst
Okay. Great. And then one last quick one. It looks like you just provided a $5 million buffer on the guidance. I think you preannounced a revenue guide of $370 million, and now it's $365 million to $375 million. Maybe just the rationale for that. Maybe it's due to weather or other variability. But can you also just explain what you think some of the levers are to the upper end and the lower end of the guide?
Abhishek Jain, CFO
Yes. At the midpoint of our guidance, the $370 million assumes the mid-teens, the 17% growth from the adjusted 2024 revenue. To bridge the low end and the high end of the guidance is about a $5 million difference, assuming plus/minus 1% on volume and plus/minus 0.5 percentage point on ASP along with a small portion in non-testing services.
Mark Massaro, Analyst
Alright. Thanks for taking the questions.
John Hanna, CEO
Yeah. No, it's a great question. On the upside, it's really about the speed at which surveillance in kidney comes back on and how effective we are with the new billing organization that we've built with a focus on operational excellence to collect cash. Our reimbursement rate at $1,360 is less than half of our Medicare reimbursement rate. We think there's a lot of opportunity there.
Mark Massaro, Analyst
Great. Thanks, guys.
Operator, Operator
Thank you. We go next now to Bill Bonello at Craig-Hallum.
Bill Bonello, Analyst
Hey, guys. Thanks a lot. A couple of questions. First of all, just following up on the ASP front, that assumes it's pretty flat, which I get makes total sense in terms of a guide. But can you just kind of lay out for us a little bit what some of the opportunities or the most important opportunities you have to improve revenue capture?
John Hanna, CEO
Absolutely. We've brought in a new leader for the billing team to up-level the skill set across the organization. And it's really about understanding what dials and knobs can drive cash collection and billing. We asked about the right appeal letters to overturn claims denials and whether we're appealing them in a timely manner. There's a lot of industrial engineering operations work that needs to go into the billing workflow and processes, and we've revamped ours. We want to collect cash, and I believe we have the leadership team in place to do that.
Bill Bonello, Analyst
That's really helpful. And just as a follow-up on that, from the systems standpoint, I mean, are the systems you have sort of capable of implementing those tools? Or is part of what you're going to be doing sort of upgrading the systems themselves?
John Hanna, CEO
Yeah, the system is capable of it. We upgraded our license and the modules we're using. You can customize workflows in the system. A lot of what we were doing was very basic out of the box previously. We came in and said, let's build the team, let's upgrade the system, and ensure we have the right talent to execute and collect what's left on the table.
Bill Bonello, Analyst
That's really helpful. And then just switching gears. On KOAR, can you remind us of the study objectives and what you're looking for?
John Hanna, CEO
It's an important study because, as you know, Bill, the more evidence you build, the weight of evidence grows. KOAR is a prospective multicenter study of nearly 4,000 patients with a control group evaluating the efficacy of AlloSure Kidney to detect rejection ahead of other standard of care tools like serum creatinine, proteinuria, and ultrasound. This will solidify that the use of the product is the best way to guide physician management.
Bill Bonello, Analyst
That's helpful. Thank you.
Operator, Operator
We'll go next to Andrew Cooper at Raymond James.
Andrew Cooper, Analyst
Hey, everybody. Thanks for the question. Maybe just first starting a little bit on the P&L. Abhishek, I think you called out legal spend down really helping the EBITDA. Even if we adjust for some of the new hires and comp increases at the start of the year, why isn't that the right starting point? Why couldn't we see something higher than that kind of $29-plus million guidance framework that you're laying out right now?
Abhishek Jain, CFO
Yeah. That's a great question, Andrew. On the adjusted EBITDA, we did $28 million in adjusted EBITDA in 2024. I backed out the $70 million in revenue that we called out pertaining to the period prior to 2024. You arrive at about $10 million in adjusted EBITDA. Our guidance midpoint of $31 million is a prudent target factoring in operational scaling investments.
Andrew Cooper, Analyst
No, that's helpful. And then, as we think at a higher level about the IOTA program and the updates to organ procurement and utilization, how much of a lift can programs like that drive for AlloSure and/or AlloMap adoption? Why can't that happen a little bit faster?
John Hanna, CEO
We're pushing, Andrew. I don’t disagree. There’s a huge role for our services, particularly in the context of the IOTA program. We've had active conversations with transplant centers about everything from our digital tools to ensure they have the tools needed for managing patient health outcomes.
Andrew Cooper, Analyst
Okay. Helpful. Thank you.
Operator, Operator
We go next now to Mason Carrico at Stephens.
Mason Carrico, Analyst
Hi, guys. Sorry if I missed this, but could you update us on the number of protocols you have in place today? Any wins worth calling out year-to-date?
John Hanna, CEO
We didn’t provide a protocol number, Mason. We've talked about the importance of this being a long-term journey. We are seeing movement consistent with what I've described, where once a center initiates a protocol, they will initiate it in new transplant patients.
Mason Carrico, Analyst
Got it. Thanks, guys.
Operator, Operator
Thank you. We go next now to Eduardo Martinez at H.C. Wainwright.
Eduardo Martinez, Analyst
Good afternoon. This is Eduardo on for Yi Chen. A quick question. I guess you've talked about it already about the pharmacy management for the patients suffering from drug-drug interactions. Do you have any more details about what strategies you're planning on implementing?
John Hanna, CEO
Yeah. Thank you for the question. We have digital tools for text-based medication reminders, and at the point of discharge, the clinician can download an overview of the patient’s medication regimen. This program is designed to help patients navigate their immunosuppression regimen and address drug-to-drug interactions.
Eduardo Martinez, Analyst
Great. That's really helpful. And then pivoting more towards the hematopoietic stem cell transplantation study, I'm curious what the timeline is on that study, and what kind of vision you have for that product?
John Hanna, CEO
It's a 2-year study. In February, we presented a 1-year interim readout at a major conference. We're nearing full enrollment, and we plan to launch the product once we have completed the trial and gathered compelling data for Medicare coverage submission.
Eduardo Martinez, Analyst
Great. Great. And I guess one final curiosity is about your thoughts on xenotransplantation. Do you have any interest in partnerships in that area?
John Hanna, CEO
CareDx has partnerships in xenotransplantation, specifically for monitoring xeno grafts that have been utilized in nearly all of the procedures performed to date. We collaborate with companies developing modified organs and with the transplant centers executing those procedures.
Eduardo Martinez, Analyst
Okay. That's great. Thank you.
John Hanna, CEO
Great. Thank you.
Operator, Operator
We go next now to Thomas DeBourcy at Nephron Research.
Thomas DeBourcy, Analyst
Hi guys. Can you hear me all right?
John Hanna, CEO
We can hear you, Thomas.
Thomas DeBourcy, Analyst
Okay. Great. My question relates to your kidney data for this year in the KOAR study. I was curious about what that incremental data adds to your existing evidence base, and if there's potential to drive greater protocol compliance or additional payer wins.
John Hanna, CEO
Yes, the answer is yes to both. There are many clinicians waiting for more data before adopting these products. Well-designed studies like KOAR are crucial for both clinician adoption and payer coverage. We anticipate the initial KOAR manuscript to be published in the second half of 2025, which will impact payer policies in subsequent years.
Thomas DeBourcy, Analyst
Great. Thank you.
Operator, Operator
Thank you. And gentlemen, it appears we have no further questions at this time. So that will bring us to the conclusion of today's call. Again, we'd like to thank you for joining CareDx's fourth quarter and fiscal year 2024 earnings conference call. Again, thanks so much for joining us. We wish you all a great remainder of your day. Goodbye, everyone.