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Edited Transcript of CDNA earnings conference call or presentation 27-Feb-20 9:30pm GMT

Q4 2019 CareDx Inc Earnings Call

Brisbane Mar 25, 2020 (Thomson StreetEvents) -- Edited Transcript of CareDx Inc earnings conference call or presentation Thursday, February 27, 2020 at 9:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Michael Bell

CareDx, Inc - CFO

* Peter Maag

CareDx, Inc - Chairman & CEO

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Conference Call Participants

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* Alexander David Nowak

Craig-Hallum Capital Group LLC, Research Division - Senior Research Analyst

* Brandon Couillard

Jefferies LLC, Research Division - Equity Analyst

* William Robert Quirk

Piper Sandler & Co., Research Division - Former MD and Senior Research Analyst

* Yi Chen

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

* Gregory Peter Chodaczek

Gilmartin Group LLC - MD

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Presentation

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Operator [1]

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Greetings, and welcome to CareDx, Inc. fourth quarter financial results conference call. (Operator Instructions) Please note, this conference call is being recorded.

I would now like to turn the conference over to your host, Greg Chodaczek, Managing Director. Thank you. You may begin.

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Gregory Peter Chodaczek, Gilmartin Group LLC - MD [2]

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Good afternoon, and thank you for joining us today. Earlier today, CareDx released financial results for the quarter and year ended December 31, 2019. The release is currently available on the company's website at www.caredx.com. Peter Maag, Chief Executive Officer; and Michael Bell, 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 the 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 future financial expectations and results are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results to differ materially from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements.

For a list and descriptions of these -- of the risks and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission. The information provided in this conference call speaks only to the live broadcast today, February 27, 2020. CareDx disclaims any intention or obligation, except as required by law, to update or revise any information, financial projections or other forward-looking statements, whether because of new information, future events or otherwise.

This call will also include a discussion of certain financial measures that are not calculated in accordance with generally accepted accounting principles. Reconciliation to the most directly comparable GAAP financial measure may be found in today's earnings release filed with the SEC.

I will now turn the call over to Peter.

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Peter Maag, CareDx, Inc - Chairman & CEO [3]

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Thanks, Greg, and good afternoon, everyone. I am pleased to welcome you to the CareDx call reviewing our results for the fourth quarter and full year 2019. Before we dive into the results, I wanted to highlight Robert Montgomery. Many of you may have seen the news flow on Rob, a kidney transplant surgeon, who recently received a heart transplant himself. Rob is not only using AlloMap and AlloSure for his heart transplant surveillance, but he will also be speaking at the upcoming CEoT conference and introduce our immune optimization study called KIRA. It is for patients and clinicians like Rob that we at CareDx are coming to work every day. Together with the transplant community, we have built a tremendous platform in transplantation over the last 20 years.

Now turning to results. 2019 was a very exciting year for CareDx as continued momentum for our high-value health care solution for transplant patients and caregivers drove robust revenue growth. Our full year revenue was $127.1 million, representing 66% growth over the prior year and clearly exceeded our most recent guidance range of $124 million to $125 million.

For the fourth quarter of 2019, total revenue was $35.8 million, increasing 52% compared to the year ago quarter. The majority of the growth in the quarter came from our testing services revenue, which increased 55%. Product revenue for the quarter was $5.1 million, and digital revenue added $1.6 million to the top line.

With us again posting positive adjusted EBITDA in the fourth quarter, we feel very comfortable about the execution of our plan to build a powerful platform in transplantation. CareDx has never been stronger.

Digging deeper into our testing services for the fourth quarter, CareDx provided 14,055 AlloSure Kidney and AlloMap Heart results to transplant patients in the quarter, growing 63% from the 8,632 results in Q4 2018. Since launch in October 2018, over 150 centers have provided AlloSure results to their kidney transplant patients. By end of 2019, over 30 transplant centers in the United States had adopted an Allosure testing protocol into their standard of care.

We are pleased to announce that enrollment in our kidney allograft outcome's AlloSure Registry or K-OAR study is nearly completed. We have a total of 55 centers in the study. The study called for 1,500 patients to be monitored using our AlloSure protocol of 15 tests over 3 years. So for the next 3 years, the study centers will continue to observe transplant patients for kidney allograft issues, and patient data will continue to be mined for vital insights driving the field over.

Just recently, we announced that the American Journal of Transplantation accepted for publication a paper titled, "High Levels of Donor-derived Cell-free DNA Identifies Patients with T cell-mediated Rejection 1A and Borderline Allograft Rejection at Elevated Risk of Graft Injury." Based on the data presented in this paper, which shows AlloSure's ability to discriminate the clinical relevance of T cell-mediated rejection or borderline biopsies, we believe AlloSure will ultimately change how clinicians care for transplant patients who have ambiguous rejection based on biopsy read. This study may help define the term "liquid biopsy" for transplant medicine.

Turning to our OKRA study. OKRA stands for Outcomes of Kidney Care in Renal Allograft. We began enrolling patients in September 2019 and enrollment continues to ramp nicely. As a reminder, this multicenter, prospective, observational clinical trial is designed to measure outcomes of kidney transplant recipients managed with KidneyCare, the combination of donor-derived cell-free DNA using AlloSure, gene expression profiling using AlloMap and prognostic graft assessment using iBox. The OKRA study is designed to ultimately include 4,000 patients, adding in our previous multicenter prospective study. This gives us an extensive and in-depth set of patient outcome.

Over the next 5 years, we expect significant data and findings from K-OAR and OKRA. These findings will not only be published in peer-reviewed journals but will ultimately lead to changes in the way patients are medically cared for after transplantation. For example, based on the analysis and data of the first 7,000 K-OAR samples and the recently published TCMR data, we were able to identify clinical relevance of AlloSure between the 0.2% and 1% level, which is very exciting since these new insights can directly impact clinical decision making.

Now shifting to heart. AlloMap testing volume grew solidly in the fourth quarter. HeartCare, the combination of AlloMap and AlloSure Heart, gained great traction in the cardiac transplant community. This traction might be driven by our ongoing Surveillance HeartCare Outcomes Registry or SHORE. As of December 31, 2019, we had recruited 39 centers into the SHORE study.

In the fourth quarter, product revenue increased 10% compared to the year ago quarter. We expect our 2 recently launched product, AlloSeq Cell-free DNA and AlloSeq Tx, which created a lot of enthusiasm at our global beta sites to start to generate revenue in 2020 and to help drive growth and global expansion this year and beyond.

Revenue from our digital solutions was $1.6 million for the quarter. This revenue was generated from our software solutions, which are used in 84 transplant centers in the U.S., many of which have also adopted AlloSure, AlloMap or both. Over the next year, we will continue to expand our digital offerings, including further embedding our AlloSure protocol into transplant center EMR platform.

I want to take a few minutes to briefly summarize 2019 and offer some thoughts about 2020 and beyond. I'm very proud of the numerous successes our team has had over the past 12 months as we continue to advance CareDx as a true transplant company and as an essential partner to transplant patients and caregivers.

In 2019, our clinical and marketing teams were very busy attending and presenting data at 8 industry conferences. At the American Transplant Congress in June, we showcased 12 abstracts and hosted an incredibly well-attended Lunch Symposium, which included presentations from 7 prominent leaders in transplantation.

During the Lunch Symposium, we formally announced KidneyCare, the combination of our clinically validated AlloSure testing with AlloMap Kidney and iBox, which will deliver personalized and prognostic solutions for transplant patients. According to many of the clinicians that attended our symposium, they not only see value in identifying when there might be an issue with a transplant patient, but also the possibility of optimizing immune suppression in a subset of patients.

As many of you know, the side effect of immunosuppressants are not trivial. For example, they carry the severe risk of infection. We strongly believe that the ability to personalize the approach to immunosuppressants will lead to better outcomes and quality of life for transplantation. With this approach, CareDx promises to bring precision medicine to the transplant clinic.

This past November, we had a significant presence at the American Society of Nephrology Kidney Week, where 3 abstracts were presented on the utility of AlloSure as a surveillance tool and as a marker of allograft injury. As with all of the conferences we attended, participant turnout at our booth, podium presentations and symposium was exceptional.

2019 was also a productive year for our regulatory and reimbursement team as we received regulatory approvals and reimbursement wins for both AlloSure and AlloMap. In February 2019, AlloSure became available under a compassionate use program for lung transplant patients.

In May, Anthem Blue Cross of California and 10 of its affiliated health plans designated AlloMap Heart as a contracted service. With this change, approximately 80% of all insured lives in the U.S. are now covered for AlloMap.

In August, AlloSure received a positive draft local coverage determination for Medicare coverage in heart transplantation, demonstrating the value AlloSure can bring to transplant patient care. We expect MolDx will make a final coverage decision about AlloSure-Heart in the second quarter, followed by pricing in the second half of 2020.

In October 2019, BlueCross BlueShield South Carolina became the first private payer to issue a positive coverage decision on AlloSure Kidney, and we will continue to work hard to expand coverage to even more patients in 2020.

Finally, in November, we further advanced transplant patient care with the launch of AlloSure 3.0, our next iteration in continued transplant patient-focused improvement. This latest version of AlloSure provides better care with only 1 tube of blood required, better science with the lowest limit of detection now at 0.12% and better insights by stratifying patients with T cell-mediated rejection.

On the business development front, we furthered our commitment to the transplant community by acquiring OTTR, a leading provider of organ transplant patient tracking software; and XynManagement, a supplier of solutions to simplify transplant quality tracking and waitlist management. We also entered into a partnership with Cibiltech for its iBox technology, a data analysis tool that provides an early prediction of an individual risk of allograft rejection and transplant loss.

We believe these transactions will not only expand our direct patient reach, but they will also deliver vital analytics to those providing care to transplant patients. Last, but certainly not least, in September, our commercial team launched AlloSeq Cell-free DNA, our kit-based, donor-derived cell-free DNA surveillance test; and AlloSeq Tx, the first-of-its-kind next-generation sequencing HLA typing solutions utilizing hybrid capture technology.

Now looking ahead, 2020 should be even more exciting as our pipeline is full, our clinical studies are enrolling quickly and providing robust data, and we continue to enhance our digital offering. In 2020, we have several opportunities to continue our rapid growth. First and foremost is the continued adoption of AlloSure Kidney. With only 4% penetration of this very large and growing market, we are still at the early stages of adoption. With Heart, we anticipate seeing continued adoption of surveillance protocols for HeartCare and expect Medicare coverage of AlloSure Heart later in the year.

With our products business, we are excited about our newly launched AlloSeq Tx and AlloSeq Cell-free DNA product and our ability to accelerate our business overseas. 2020 will also see CareDx expand into stem cell and cellular therapies with our [AlloHeim] and AlloSeq HCT offering.

Finally, we plan to expand our digital offerings by launching [AlloCare], our tool for kidney transplant patients, which will be aimed at improving and enhancing patient engagement.

Everything we do at CareDx has one focus and that is to be the leading partner for transplant patients and the transplant ecosystem, with leading the Honor the Gift campaign, CareDx is supporting the community in extending Medicare coverage for immunosuppressive medication. Overall, we continue to receive positive news from HHS and the kidney health initiative.

It is great to see transplantation being the news and even being singled out in the residential addresses and maybe, more importantly, health care budget. Community nephrologists, large dialysis providers and the transplant community are coming together to increase the number of kidney transplants. It has never been a better time for CareDx to be a transplant-focused company.

With that, I will turn the call over to Mike to discuss our financials and 2020 guidance.

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Michael Bell, CareDx, Inc - CFO [4]

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Thank you, Peter. Turning first to the income statement. Our fourth quarter of 2019 testing services revenue increased 55% year-over-year to $29.1 million. The growth in the fourth quarter testing services revenue was primarily driven by AlloSure Kidney patient results. Although we did experience a lift in AlloMap Heart testing, partly due to transplant centers' excitement over HeartCare and the use of surveillance protocols.

Our fourth quarter product revenue increased 10% year-over-year to $5.1 million, and our digital revenue was $1.6 million. Our gross margins continue to improve year-over-year. For the fourth quarter of 2019, the gross margin was 65% compared to a gross margin of 55% in the same period of 2018. On a sequential basis, the gross margin was down slightly from the third quarter due to fluctuations in our estimated reimbursement rates by AlloSure and AlloMap, which moved slightly up or down each quarter.

The non-GAAP gross margin for the quarter was 68% compared to 59% in the prior year quarter. It's worth highlighting that the non-GAAP gross margin for the testing services business, for the 3 months ended December 31, 2019, has improved to 76% compared to 66% in the same period of 2018.

For the fourth quarter of 2019, net loss was $4.8 million compared to a net loss of $3.8 million in the same period of 2018. Our net loss per share was $0.11 for the quarter compared to a net loss per share of $0.09 in the fourth quarter of 2018. For the fourth quarter of 2019, our non-GAAP net income was $1.6 million compared to a non-GAAP net income of $0.3 million in the same period of 2018. Our non-GAAP net income per share in the fourth quarter of 2019 was $0.04 compared to a non-GAAP net income of $0.01 in the same period of 2018.

As a reminder, we define adjusted EBITDA as non-GAAP net income before interest, income tax, depreciation, amortization and other expense. For the fourth quarter of 2019, we recorded our sixth consecutive quarter of positive adjusted EBITDA, with a gain of $1.5 million compared to an adjusted EBITDA gain of $0.8 million in the fourth quarter of 2018.

Cash and cash equivalents at December 31, 2019 was $38.2 million. We continue to hover around the breakeven mark for net cash used in operating activities using only $1.1 million of operating cash in the fourth quarter.

Turning to guidance. We are providing our initial 2020 revenue expectations to reflect the continued growth of AlloSure as well as the other growth drivers outlined by Peter. And as such, anticipate $165 million to $168 million revenue for the year. Our guidance does anticipate increased competition on Allosure, but balances that with the expectation that additional market entrants will accelerate overall patient penetration.

We feel very well positioned to continue to lead the field in bringing novel solutions to the transplant clinic.

With that, I will open the call for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question comes from Bill Quirk with Piper Sandler.

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William Robert Quirk, Piper Sandler & Co., Research Division - Former MD and Senior Research Analyst [2]

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Great. First question from me. I guess with respect to the 30 transplant centers who have incorporated AlloSure Kidney into protocol, can you give us a rough estimate in terms of what they represent with respect to the total market?

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Michael Bell, CareDx, Inc - CFO [3]

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Bill. Yes, it's Mike here. I mean, roughly, we focused our targets on those centers in top 100 performing centers. I'd say that, that 30, it's representing about 20% of the total.

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William Robert Quirk, Piper Sandler & Co., Research Division - Former MD and Senior Research Analyst [4]

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All right. Perfect. And then a couple of additional questions here. Mike, I guess, first I'll say thank you. And that is, philosophically, thank you for the revenue guidance, but help us think a little bit about some of the puts and takes with respect to operating expenses? Should we expect this to be another big ramp-up here given the clinical trials and obviously, the entrants of competition? Just help us better understand how to think about the pacing over the course of the year.

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Michael Bell, CareDx, Inc - CFO [5]

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Yes. Bill, I'd say, last year, we had a big ramp-up in sales and marketing expense, particularly in the first half of last year. And we feel -- on the sales and marketing side now, we're pretty much fully fleshed out with the sales force. We'll continue to add to that, but we won't see the huge growth in sales and marketing expense in 2020. So maybe that's increasing, something like a million dollars a quarter. You're right, on the research and development side, that's probably the area of most investment for us in 2020. And we should see that research and development expense continue to grow throughout the year, similar to how it grew in the last 2 quarters of 2019.

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William Robert Quirk, Piper Sandler & Co., Research Division - Former MD and Senior Research Analyst [6]

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Okay. Got it. And then last one from me, and I'll let somebody else jump on. Can you talk a little -- maybe can you expand on your comments with respect to private payers? We certainly caught BlueCross BlueShield of South Carolina decision. How active are you talking to other private payers? And then also, does the guidance or model assume any expansion of coverage?

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Peter Maag, CareDx, Inc - Chairman & CEO [7]

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Well, thank you very much, Bill, for the question. I think the team is focused on engaging property payers. Just as a reminder, 70% to 80% of our patient population are Medicare patients, and so private payers are really outside. No, we don't see any -- we don't have modeled into our guidance any significant upside in this year.

But the team is continuously working on that and are doing a great job. And we have established relationships with AlloMap, our heart transplant solution. So there should be some level of uplift on the AlloSure side this year. But we're still thinking that this is very early in the process. With about only 5% penetration, we have ample ways to go. And the only -- a few centers we have now critical mass to engage with private payers to make sure that they're also covering kidney transplant patients for their surveillance. So our current guidance is not including maybe a little bit of an upside through to private payers in both.

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Operator [8]

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Our next question comes from Brandon Couillard with Jefferies.

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Brandon Couillard, Jefferies LLC, Research Division - Equity Analyst [9]

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Peter, Mike, maybe a bit of a follow-up on Bill's question there. Just talk to us about philosophically how you approached setting guidance for the year in the context of competition, the degree to which the guide kind of handicaps for that dynamic? And any numbers you can help us with to sort of understand the approach?

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Peter Maag, CareDx, Inc - Chairman & CEO [10]

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Well, Brandon, thank you very much. I think our guidance continues to be following our AlloSure adoption, that's our key lead for growth in the company. And here we have seen some linear growth adoption in transplantation, which we see also, if you benchmark us to specialty pharma or other transplantation products that there is linear adoption that the solutions are adopted in various transplant centers. We have started extremely strong into 2020, and we will be updating guidance as we report on the first quarter, again.

So as we're thinking into 2020, yes, we have the uncertainty around competition entering the field. But we just only recently learned that probably their commercial launches are delayed to our previous expectations, which is not reflected in our guidance this year. Again, so no, there is a balance of competition coming, but also maybe competition expanding our market and increasing the opportunity for accelerated growth in patient adoption of surveillance tools for cell-free DNA and especially AlloSure.

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Brandon Couillard, Jefferies LLC, Research Division - Equity Analyst [11]

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Okay. And I understand that you're kind of consolidating AlloMap and AlloSure volumes as far as you report now, but just sort of think about the heart business in 2020. Would you expect AlloMap to kind of return to that more normalized to mid-single-digit type growth level? Or do you think the AlloMap Heart -- and excuse me, AlloSure Heart and some of the surveillance efforts you're making can maybe push that up a little bit of the year?

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Peter Maag, CareDx, Inc - Chairman & CEO [12]

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I'll let Mike speak to it, but our heart franchise is working extremely well based on the great combination of AlloMap, our gene expression profiling tool together with our cell-free DNA testing AlloSure. The short trial is really adopting extremely rapidly. There are so many centers in the U.S. excited about joining the call. So the heart franchise has been a bit of a surprise in 2019, and we are starting 2020 with great momentum. Mike, did you want to make a comment?

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Michael Bell, CareDx, Inc - CFO [13]

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Yes. Thanks, Peter. Yes, Brandon, I'd say more specifically, we still expect the uptake of the surveillance protocols on AlloMap, that's been driven by HeartCare. So probably, our guidance is expecting low double-digit growth for AlloMap, so higher than the past were for this low single digit. So yes, low double-digit growth.

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Brandon Couillard, Jefferies LLC, Research Division - Equity Analyst [14]

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Perfect. Good. And then last for me. Do you expect any major data readouts for the K-OAR study this year, perhaps at ATC? And any impact on -- as far as volumes that might be contemplated from that?

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Peter Maag, CareDx, Inc - Chairman & CEO [15]

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Brandon, that gives me just to put in a blanket for the American Journal of Transplantation publication on ambiguous rejection, which is really carrying the existing K-OAR initial data set of more than 7,000 samples received on K-OAR together with our insight that AlloSure is helpful in the stratification of a big use rejection, which is incredibly exciting for us because it helps us to not only data-mine K-OAR patients but also put it into context of what we learned on the TCMR, the low-grade rejection.

And so yes, there will continue to be a readout. There's a tremendous wealth of abstracts that will be presented at the American Transplant Congress. I think cell-free DNA and especially AlloSure has been at the fulcrum of innovation in kidney transplantation and CareDx being the leader, you'll see a lot of outflow of great clinical data, not coming -- not only out of care, but also out of all the other clinical studies that we currently have ongoing. So a very exciting year for us on K-OAR.

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Operator [16]

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Our next question comes from Alex Nowak with Craig-Hallum.

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Alexander David Nowak, Craig-Hallum Capital Group LLC, Research Division - Senior Research Analyst [17]

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Peter, you highlighted a number of studies under consideration at the Analyst Day in January. I'm just curious, have you finalized any of these? Which ones in particular should we be watching? And what is incorporated in the guide for new clinical studies?

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Peter Maag, CareDx, Inc - Chairman & CEO [18]

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Yes. Thank you very much. I think the 2 studies to watch and see us execute against this year are really OKRA, which is the combination of AlloMap and AlloSure, together with the iBox solution, which we call KidneyCare. And this is a similar effort undergoing combining the K-OAR study now with the OKRA study, where we will have 4,000 patients. We call it the ultimate kidney transplant registry, recruiting in more than 50 centers in the United States. We are well advancing on the recruitment on OKRA, and we'll be updating on OKRA in the first quarter call because this is really, for us, a pivotal clinical trial in the KidneyCare combination.

The second one is KIRA. I had started the call today highlighting our effort in immunosuppressive optimization with kidney transplantation. This is a trial, which is very exciting. If you think about it, AlloSure is very, very well-established already as a rejection monitoring tool. But maybe KIRA is pushing us towards immune optimization of kidney transplant patients. And demonstrating this in a large-scale study with multicenter engagement will be extremely exciting for the field and demonstrate security access, cutting edge and pushing the envelope because this is the Holy Grail in kidney transplantation and clearly access at the fulcrum.

So to just summarize, OKRA and KIRA will be at the center. But then you would see SHORE as our heart transplant clinical trials and then [ROAR], which is our international trial for cell-free DNA adoption as tertiary important. Now I will also put in that we are doing clinical studies on cellular therapies or stem cells. Our [AlloHeim] product is extremely promising, and we're very excited about the best pipeline product type of product. And that will be detailed clinical trials and stuff.

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Alexander David Nowak, Craig-Hallum Capital Group LLC, Research Division - Senior Research Analyst [19]

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Okay. Great. Understood. And just want to come back on competition and just follow-up on Brandon's question. Are you hearing anything from the physicians you work with, specifically around either switching or wanting to join your competitors' registry trial? Just anything that you're hearing that made you want to include competition into the guide at this point. Is there any way to quantify what you're assuming from competition, too?

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Peter Maag, CareDx, Inc - Chairman & CEO [20]

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Like I said, I think, actually, competition has increased the awareness of novel biomarkers in the field of kidney transplantation. So in a way, this is -- CareDx has been trailblazing the field. And now there are other entrants. So I think this is creating awareness, and I actually think that this will be leading to a much bigger market adoption going forward.

In terms of very specific comments in individual tenders, yes, we hear other competitors placing their registries. But we haven't seen any substantial clinical adoption of seeing real patients without being provided in a clinical setting. So I would say that there is maybe noise out there, but it's incredibly difficult to quantify at this stage. But we feel extremely well positioned with our service offering on our SHORE and actually being a complete service provider for these transplant center. So we feel very well for this.

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Alexander David Nowak, Craig-Hallum Capital Group LLC, Research Division - Senior Research Analyst [21]

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No. Understood. And actually, just a follow-up on that last piece there. You did ramp up the patient management team over the past 12 months. I'm just curious, are you seeing any change in patient compliance? And how is this benefiting AlloSure -- people staying on the AlloSure protocol?

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Peter Maag, CareDx, Inc - Chairman & CEO [22]

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Very good question. No, there are some centers where we have 99% compliance rate, 98% compliance rate. I think this is a center, which is absolutely leading. And then we see some compliance rates with 55%, which is a huge opportunity if we're combining that with our patient care management tool. Now overlaying this with maybe our software tool, but with our auto offering, where it's very convenient to engage patients into a longitudinal clinical trial. I think that would be -- that's very beneficial to CareDx and a huge growth opportunity going forward. So the patient care managers, where we have direct interactions that have, by and large, experience in managing transplantations over a long period of time are going to be pivotal tool of increasing compliance and adherence, not only to the AlloSure regimen and protocol that maybe even for supporting a longitudinal patient management for transplantations going forward.

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Alexander David Nowak, Craig-Hallum Capital Group LLC, Research Division - Senior Research Analyst [23]

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Okay. Got it. And just last quick question for me. We saw a lung study get published on clinicaltrials.gov. Just where are you at from developing an AlloSure lung testing going through the reimbursement process?

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Peter Maag, CareDx, Inc - Chairman & CEO [24]

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No. Thank you very much. We'll see submission of lung data this year into the MolDx program. I think we've not been setting time lines in terms of when lung will be reimbursed. It is somewhat a guarded opportunity. But lung -- AlloSure is available today on a compassionate use program. And as these clinical trials readout, we'll be submitting to MolDx. This is probably more, in terms of a reimbursement, a 2021 discussion and relevant for revenues in 2020.

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Operator [25]

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

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Yi Chen, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [26]

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Just to clarify, the most recent publication, AlloSure's ability to differentiate rejection is based on the original AlloSure but not Allosure 3.0. Is that correct?

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Peter Maag, CareDx, Inc - Chairman & CEO [27]

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It is based on AlloSure available at that stage. So it is combined AlloSure and AlloSure 3.0 depending on which patient was recruited at what stage. I don't think that AlloSure 1.0, 2.0, 3.0 would have any substantial impact on the level of measurement on donor-derived cell-free DNA.

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Yi Chen, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [28]

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Okay. So we can assume that the new patients enrolled in the OKRA study will have the AlloSure 3.0 because it's available now?

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Peter Maag, CareDx, Inc - Chairman & CEO [29]

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Yes. No, I think, going forward, any patient that's currently tested on AlloSure would receive the updated AlloSure 3.0.

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Yi Chen, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [30]

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Okay. So we shouldn't expect any significant differences in terms of further improvement of the result by using AlloSure 3.0, right?

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Peter Maag, CareDx, Inc - Chairman & CEO [31]

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Well, the clinical results on the level of donor-derived cell-free DNA level will probably not change. No, I think we are talking here about marginal improvement, but more importantly, actually, improvements in terms of how we service patients and the patient experience and the center experience with the lowest level of detection and the ability to differentiate TCMR 1A based on the data that we have.

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Yi Chen, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [32]

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Got it. Regarding AlloSeq cfDNA kit that's sold outside the U.S., does that revenue get recorded on the testing line or the product revenue line?

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Michael Bell, CareDx, Inc - CFO [33]

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It's Mike. Yes, that's a kit, and it will be outside the U.S. And so yes, when we have revenue for that, we'll start including that in our product line. So the product line will be both pre and post transplant, and it will be for the kit business, not the U.S. testing service business.

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Yi Chen, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [34]

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Got it. Do you expect any significant growth for sales outside the unit -- outside of U.S.?

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Michael Bell, CareDx, Inc - CFO [35]

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Well, a lot of our strategy on the product side and the launch of these products is to enable us to expand outside the U.S. I think when we look at our product business last year or in 2019, the growth was overall 10%. And in our guidance, we're looking at the growth now for the product business of around 20%. So that's coming from the new product launches. And again, most of -- the AlloSeq Cell-free DNA is outside the U.S., so some of that growth's coming from out of the U.S.

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Operator [36]

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We have reached the end of the question-and-answer session. At this time, I'd like to turn the call back over to Peter Maag for closing comments.

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Peter Maag, CareDx, Inc - Chairman & CEO [37]

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Well, I'll keep this short. Thank you very much for joining this call, and I'm looking very much forward to soon update you about our first quarter results. So thank you very much. Talk to you soon.

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Operator [38]

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This concludes today's conference. You may disconnect your lines at this time. And we thank you for your participation.