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Edited Transcript of CDNA.OQ earnings conference call or presentation 24-Feb-21 9:30pm GMT

·34 min read

Q4 2020 CareDx Inc Earnings Call Brisbane Mar 4, 2021 (Thomson StreetEvents) -- Edited Transcript of CareDx Inc earnings conference call or presentation Wednesday, February 24, 2021 at 9:30:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Marcel Konrad CareDx, Inc - Interim CFO * Reginald Seeto CareDx, Inc - President, CEO & Director * Sham Dholakia CareDx, Inc - SVP of Medical Affairs & Clinical Operations ================================================================================ Conference Call Participants ================================================================================ * Alexander David Nowak Craig-Hallum Capital Group LLC, Research Division - Senior Research Analyst * Andrew Harris Cooper Raymond James & Associates, Inc., Research Division - Senior Research Associate * Boobalan Pachaiyappan H.C. Wainwright & Co, LLC, Research Division - Equity Research Associate * Rachel Marie Vatnsdal Piper Sandler & Co., Research Division - Research Analyst * Sung Ji Nam BTIG, LLC, Research Division - Director and Life Science & Diagnostic Tools Analyst * Gregory Peter Chodaczek Gilmartin Group LLC - MD ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Greetings and welcome to the CareDx Inc.'s Fourth Quarter 2020 Earnings Conference Call. (Operator Instructions) As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Greg Chodaczek, Managing Director. -------------------------------------------------------------------------------- Gregory Peter Chodaczek, Gilmartin Group LLC - MD [2] -------------------------------------------------------------------------------- Good afternoon, and thank you for joining us today. Earlier today, CareDx released financial results for the quarter and year ended December 31, 2020. The release is currently available on the company's website at www.caredx.com. Reg Seeto, Chief Executive Officer; and Marcel Konrad, 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, are 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 of 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, February 24, 2021. 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 can be found in today's earnings release filed with the SEC. I will now turn the call over to Reg. -------------------------------------------------------------------------------- Reginald Seeto, CareDx, Inc - President, CEO & Director [3] -------------------------------------------------------------------------------- Thanks, Greg. Good afternoon, everyone, and thank you for joining us. Welcome to CareDx's Fourth Quarter and Full Year 2020 Earnings Conference Call. Before getting into our results, I want to thank all of our CareDx employees and partners. Despite the many challenges of 2020 with COVID-19, all of us at CareDx rallied together and worked tirelessly to develop and deliver new and unique solutions to improve transplant patient lives. Transplant has been a 100% focus to more than 20 years, and we're expressly proud that 2020 was a year we continue to serve transplant patients and the transplant community. Now turning to results. 2020 was an exceptional year for CareDx as demand continued unabated for our innovative first-in-class suite of high-value health care solutions for transplant patients and caregivers. Our full year revenue was $192.2 million, representing over a 51% growth over the prior year. For the fourth quarter of 2020, total revenue was $58.6 million, increasing 64% compared to the year ago quarter. The majority of the growth in the quarter was driven by our testing services revenue, which increased 73%. Product revenue for the quarter was $5.9 million, and digital and the other revenue was $2.4 million to the top line. GAAP net loss for the fourth quarter and full year was $3.5 million and $18.7 million, respectively. Adjusted EBITDA for the fourth quarter and full year 2020 was $4.9 million and $8 million, respectively. Digging deeper into our testing services for the fourth quarter. CareDx provided over 25,000 AlloSure and AlloMap results to the transplant patients in this quarter, growing approximately 78% from Q4 2019. Approximately 40% of our testing volumes originated from mobile phlebotomy. As of the end of December, over 55 transplant centers in the United States have adopted AlloSure testing protocol in their standard of care. In the fourth quarter, product revenue increased 17% compared to the year ago quarter. While our AlloSeq Cell-free DNA and AlloSeq Tx 17, did generate revenue in 2020, we expect both products will begin to produce stronger growth as more COVID-19 vaccines are rolled out in 2021. Revenue from our digital solutions was $2.4 million for the fourth quarter. In 2021, we expect our software solutions will continue our direct-to-center strategy to improve the order workflow as we expand our digital offerings and more U.S.-based transplant centers adopt our solutions. Again, 2020 was a transitional year for CareDx, and I would like to highlight several significant product and service offerings we announced last year. Firstly, in March, as COVID-19 infections began to accelerate, we announced the launch of RemoTraC, our solution-enabling remote home-based monitoring of transplant patients. This offering was in response to needs from transplant centers and patients, and we were very proud to be able to put this together within a week. By early April, we established nationwide network of more than 10,000 mobile phlebotomies and, by the end of April, close to 50% of all our daily testing volume originated from mobile phlebotomy. As of the end of December, approximately 6,000 kidney, heart and lung transplant patients have enrolled in our RemoTraC offerings. Today, more than 150 centers use RemoTraC. Secondly, in April, we introduced AlloCell, our surveillance solution for patients, who received engineered cell transplants or allogeneic cell therapy. With allogeneic cell therapy being a rapidly growing clinical development area in oncology, cardiovascular, neurological, autoimmune infectious diseases, we believe our surveillance solution is a perfect partner for companies developing allogeneic cellular therapies. Early this month at the Annual Transplantation and Cellular Therapy Meeting, 4 abstracts were presented, showcasing our cellular transplant therapy portfolio, including with our partner Atara Biotherapeutics. This is just the beginning of our AlloCell offerings as we will continue to develop our products and partner with other companies developing transformative cell therapies. Thirdly, in October, data from our pivotal clinical study for AlloSure Lung was published in Transplantation Direct. The LARGO study demonstrate that AlloSure Lung could identify patients with acute cellular rejection, a critical need for lung transplant patients whose only option to rejection is an invasive bronchoscopy. With lung transplant patients having one of the lowest survival rates for solid organ transplants, we believe AlloSure Lung is a powerful, noninvasive tool in monitoring the health of the transplanted organ. As a reminder, AlloSure for lung transplant patients has been available under compassionate use since February 2019 and, in June 2020, we submitted our AlloSure Lung dossier to Palmetto MolDx for Medicare reimbursement. And finally, in November, we received final reimbursement pricing from Palmetto MolDx for AlloSure Heart. As we look to 2021 and beyond, we remain very excited about our prospects. Our AlloSure testing volumes continue to impress. Our decision to focus first on the transplant centers with our direct-to-center strategy has allowed AlloSure to be used in greater than 70% of transplant centers and more than 55 transplant centers have adopted an AlloSure name protocol as of the end of December. As we continue to add more transplant centers and protocols, we can now start our direct-to-community strategy. Our community nephrology team was hired at the end of last year, and we're very encouraged about the job our team is doing. Combined with our direct-to-patient strategy, we have now started that last mile with the patient. We recently launched AlloCare and that's designed by transplantations and physicians. This app was designed to make managing patients day-to-day health easier by allowing them to easily track progress and health activities, manage medications and set reminders and communicate with our patient care managers for scheduling labs. Moving to the heart franchise. AlloMap Heart testing experienced strong double-digit growth. We were thrilled with the approval of AlloSure Heart when used in combination with AlloMap, known as HeartCare. As I previously mentioned, we received Medicare reimbursement for AlloSure Heart at the end of last year. While our growth in heart this past quarter stemmed from an increase in AlloMap testing. In December, we began submitting AlloSure Heart test for reimbursement for our Medicare patients. Regarding reimbursement for our non-Medicare patients, we are working with health care providers to procure commercial reimbursement. Regarding our digital offerings, we recently announced the acquisition of TransChart, a provider of electronic health record software, supporting the needs of U.S. transplant centers. The TransChart acquisition is another COG in our digital offerings, including auto transplant electronic medical record software and XynQAPI transplant quality management solutions. With this acquisition, our EMR coverage now extends to over 90 centers in total. As part of the TransChart acquisition, we also acquired TX Connect, a leading provider of human biologics donation in transplantation software. TX Connect allows us to help move upstream in a patient journey and connect the centers with the dialysis centers. Last, but certainly not least, our AlloCell offering is beginning to bear fruit. Earlier this month, along with our partner, Atara Biotherapeutics, we announced we were presenting data on AlloCell in a poster titled, A Sensitive and Precise Universal Surveillance Solution for Pharmacokinetic Monitoring of Off-the-Shelf Cell Therapies. This was presented at the transplantation and cell therapy meeting and described the potential use of AlloCell for standardized pharmacokinetic assessment in clinical trials and highlighted data on AlloHeme and AlloSeq HCT for chimerism and recurrence surveillance of stem cell transplant patients. We're very excited about the potential of AlloCell, though we're in very early stages of this significant greenfield opportunity. 2020 was an exceptional year for CareDx as we continue to build out our product offerings, while driving robust growth in our market of products. That being said, we believe we are just getting started. Everything we do at CareDx has one focus, and that is to be the leading partner for transplant patients and the transplant ecosystem. This focus and commitment to the transplant community are the driving forces behind our growth. And I expect 2021 to be another exciting year for CareDx. In summary, for 2021, the key growth drivers and milestones are to: accelerate our direct-to-center strategy; continue our winning form of adding AlloSure Kidney and HeartCare protocols and continue EMR integrations; build our direct-to-patient strategy with RemoTraC, AlloCare as well as through our patient care managers; start the direct-to-community strategy with community nephrology field team, which was hired at the end of last year; and to create the new businesses in cell therapy and stem cell transplant. A few key milestones to highlight over the coming quarters, include, in Q1, the launch of our new digital offering, TX Connect. This really provides an opportunity for us to now build a connection with the dialysis centers. This is one that is truly exciting as we continue along that patient journey continuum. In Q2, we'll provide the K-OAR 1,000 readout at ATC, the largest transplant conference, held annually. In Q3, we expect to show AlloSure Lung Medicare reimbursement update as we hear back from MolDx. And in Q4, we expect to continue the exciting multimodality work first shown in HeartCare, but now starting with KidneyCare as we get clear validation of AlloMap Kidney. With that, I'm going to turn the call over to Marcel to discuss our financials and 2021 guidance. -------------------------------------------------------------------------------- Marcel Konrad, CareDx, Inc - Interim CFO [4] -------------------------------------------------------------------------------- Thank you, Reg. Turning first to the income statement. Our fourth quarter of 2020 testing services revenue increased 73% year-over-year to $50.3 million. The growth in the fourth quarter testing services revenue was driven by AlloSure Kidney and AlloMap Heart patient results. Our fourth quarter product revenue increased 17% year-over-year to $5.9 million, and our digital and other revenue was $2.4 million. Our gross margins continue to improve year-over-year. For the fourth quarter of 2020, the GAAP gross margin was 68% compared to a gross margin of 65% in the same period of 2019. The non-GAAP gross margin for the quarter was 70% compared to 68% in the prior year quarter. For the fourth quarter of 2020, net loss was $3.5 million compared to a net loss of $4.8 million in the same quarter of 2019. Our net loss per share was $0.07 for the quarter compared to a net loss per share of $0.11 in the fourth quarter of 2019. For the fourth quarter of 2020, our non-GAAP net income was $4.3 million compared to a non-GAAP net income of $1.6 million in the same period of 2019. We are making good progress with our earnings per share. Our basic and diluted non-GAAP net income per share in the fourth quarter of 2019 was $0.09 and $0.08, respectively, compared to a basic and diluted non-GAAP net income of $0.04 in the same period of 2019. As a reminder, we define adjusted EBITDA as a non-GAAP net income before interest, income tax, depreciation, amortization and other expense. For the fourth quarter of 2020, we recorded positive adjusted EBITDA of $4.9 million compared to an adjusted EBITDA gain of $1.5 million in the fourth quarter of 2019. Cash, cash equivalents and marketable securities at December 31, 2020, was $224.7 million. We continue to strengthen our balance sheet, in particular, our cash position. Earlier this month, we successfully completed a public offering of approximately 2.2 million shares of common stock, raising roughly $189 million after deducting underwriting discounts and commissions and estimated offering expenses. In January, we also repaid the CMS advance payment of approximately $20.5 million to CMS in full. On an operating basis, in the fourth quarter, we generated record cash from operating activities of $7.2 million. Now turning to guidance. We are providing our initial 2021 revenue expectations to reflect the continued growth of AlloSure as well as the other growth drivers outlined by Reg. And as such, anticipate $255 million to $265 million revenue for the year. Our guidance balances the continued uncertainties around COVID pandemic, but emphasizes further market penetration. We feel 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. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) Our first question is from Brandon Couillard with Jefferies. -------------------------------------------------------------------------------- Unidentified Analyst, [2] -------------------------------------------------------------------------------- This is [Matt] on for Brandon this afternoon. To start off with guidance, 2020 revs came in well ahead of your initial guidance, pretty impressive feat given the backdrop last year. Part of it tied to your quick turnaround with RemoTraC, but a number of other positive growth developments as well. So as we look out to 2021, Reg, can you perhaps talk about some of the key growth drivers for this year? And where you see the greatest potential for upside as well? -------------------------------------------------------------------------------- Reginald Seeto, CareDx, Inc - President, CEO & Director [3] -------------------------------------------------------------------------------- Yes. Thanks, Matt. So we actually got a really nice engine of growth. And I think testing serves as the area that we have focused on. We have a really great winning formula, and we'll continue to win protocols within centers and add new centers. So that's sort of the winning formula we established. I think secondly, what's really exciting is we built out the community nephrology team at the end of last year is they're building out to expand in the community, and this will be an area of incremental opportunity and growth for us as an organization. The third is when we look at AlloSure Heart with the recent approval of reimbursement with multimodality, this will be another area of incremental growth and reimbursement for us as well. So certainly some really strong potential growth drivers as we move into 2021, and we look really forward to continuing what we do for patients every day. -------------------------------------------------------------------------------- Unidentified Analyst, [4] -------------------------------------------------------------------------------- And then on AlloCell, as you mentioned in your prepared remarks, you presented some pretty interesting data with your partner, Atara, at the transplantation and cell therapy meeting earlier this month. The opportunity is clearly still in the pretty early innings, but curious if you could elaborate on how, if at all, conversations have evolved here. Clearly, being out there with a known cell therapy entity that has multiple programs in its pipeline is pretty impressive validation for you guys. So just curious how conversations with other partners are progressing from here. -------------------------------------------------------------------------------- Reginald Seeto, CareDx, Inc - President, CEO & Director [5] -------------------------------------------------------------------------------- Yes. AlloCell is really an exciting opportunity since part of the future longer-term growth as we see it, replicating what we did with AlloSure by trading in new market with universal surveillance to allogeneic cell therapies. With Atara, we're really proud to be able to share that partnership because the way our agreements are written is that we actually can't disclose what we're working on and who we're working with. And I think with the relationship we built there, they felt comfortable with us sharing information of what we were doing. In terms of all the partners that we've spoken to, particularly those in the clinic, there's a lot of excitement about working with a new standard, one which we're helping to create. I think the importance for us is it's not about driving meaningful revenue, it's about building partnerships with as many of these allogeneic cell therapy companies as we continue to build out this space together. This is a wonderful opportunity (inaudible) as more of these get approved in the future. As a reminder, there isn't any allogeneic cell therapy approved today, but we believe that is the way of the future. -------------------------------------------------------------------------------- Unidentified Analyst, [6] -------------------------------------------------------------------------------- And then just one last quick one on RemoTraC. I think you said it was 40% of volumes here in the fourth quarter. Any thoughts on how you're thinking about that in the first quarter here or full year '21? And then any tweaks or improvements you've made to the program as you get more data and feedback as we approach the 1-year launch coming up next month? -------------------------------------------------------------------------------- Reginald Seeto, CareDx, Inc - President, CEO & Director [7] -------------------------------------------------------------------------------- Yes. No, with, I think, with RemoTraC, this is something that was probably the highlight of last year what we did as an organization as we rallied around supporting patients and transplant centers. It's such an unmet need, and we were able to put it together so quickly and had such a fantastic response that now more than 150 centers are using it. In terms of -- just thinking in terms of margin, we have -- 40% were used in Q2, and then in Q3 that went to about 30%, and then Q4, we went back up to the higher end of the 40%. And so we expect to have RemoTraC as the core part of our business. It's really something which patients want, with 9 out of 10 patients highly satisfied and it's (inaudible) that transplant centers now that they've had the service want us to keep as well. So it will be a core part of our business moving forward. I think in terms of the additional learnings, it really is this ability to directly connect with the patient, which was extremely valuable. Having that direct consent with these 6,000-plus patients has been extremely valuable, as now we can interact with many time points. The other thing is it's really helped with our introduction of AlloCare. Because now as an example, we can start bringing additional offerings to these patients, AlloCare is one and others that we had planned during the course of this year. -------------------------------------------------------------------------------- Operator [8] -------------------------------------------------------------------------------- Our next question is with Rachel Vatnsdal with Piper Sandler. -------------------------------------------------------------------------------- Rachel Marie Vatnsdal, Piper Sandler & Co., Research Division - Research Analyst [9] -------------------------------------------------------------------------------- This is Rachel on for Steve. Congrats on a really nice year. So first off, you've had some really nice success with HeartCare since the launch in mid-November. Can you tell us about the attachment rate for HeartCare? So the number of AlloMap Heart tests that you're seeing currently run alongside of those AlloSure Heart. And where do you think that attachment rate could go over the next 1 to 2 years? -------------------------------------------------------------------------------- Reginald Seeto, CareDx, Inc - President, CEO & Director [10] -------------------------------------------------------------------------------- Yes. HeartCare was truly something, which was exceptional because we validated multi-modality, which had never been done before. And so having this combination diagnostic was something that's adding clinical utility space. So that's one thing I want to give a shout out to the innovation we continue to bring. The second thing is before the approval, the attachment rate was around the 60% to 70% mark. And it's only in the end of last year that we actually were able to start talking about HeartCare directly. The attachment rate has increased around the 70% to 80% mark. So we see this is something where you bring additional clinic utility. There'll be increased usage from clinicians and also centers. The one thing to note is that we expect to continue to see this attachment rate progress during the course of this year now that we've started the ability to talk about it actively. -------------------------------------------------------------------------------- Rachel Marie Vatnsdal, Piper Sandler & Co., Research Division - Research Analyst [11] -------------------------------------------------------------------------------- Great. And going off to that clinical utility, especially given the uptick that you've seen in such a short term with the launch, can you give us some more color on your conversations that you're having with commercial payers about reimbursement? Obviously, you guys have a really high reimbursement rate on AlloSure Heart, which is great. So tell us about some of those conversations you're having? Do you think you'll hit that high number with them as well? And what's the feedback been so far? -------------------------------------------------------------------------------- Reginald Seeto, CareDx, Inc - President, CEO & Director [12] -------------------------------------------------------------------------------- Well, with AlloMap, firstly, we have 80% commercial coverage, all the major payers. And I think with the addition of AlloSure Heart, we anticipated building out the team for this, which we've specifically done. I think we've had some initial wins, which has probably happened just because of our preparation. As you look at it both Kaiser and Geisinger, the 2 of the accounts that started looking at AlloSure Heart, for example, in commercial pay. So this is an area that we continue to work on, but we've built a lot of experience. We've built out a new team as we look at how we drive this commercial pay adoption. -------------------------------------------------------------------------------- Rachel Marie Vatnsdal, Piper Sandler & Co., Research Division - Research Analyst [13] -------------------------------------------------------------------------------- Great. So the last question for me. So lately, you've talked a lot about getting closer to the patient and how that's driving further adoption. So can you talk about the success you've had from hiring patient care managers, deploying tools like RemoTraC and AlloCare? And really how much that has driven that additional adoption? And then how much room do you have to grow via tools like that? -------------------------------------------------------------------------------- Reginald Seeto, CareDx, Inc - President, CEO & Director [14] -------------------------------------------------------------------------------- Patient care managers is something that we've invested heavily in because we believe it's the way of the future. We believe it's also -- as we manage the patient from pretransplant, peritransplant, post-transplant, our patient care managers play a critical role, and we've already started that process. We have patient care managers who look after the patient pretransplant already. And some of these patient communities actually follow the patients into the post-transplant space as well. So that continuum is firstly really important. What I would share is with the advent of these PCMs is they've had a significant impact on the business and the way that we operate. So for example, when we have the ability to call patients at a transplant center, the adherence rate achieved by our patient care managers is double of that than when a center, for example, calls up the patients to schedule. So we know by offering this white glove premium service, the patient care managers had a lot of success in driving and maintaining adherence. But I would also say that if you look at add-on opportunities, I think we saw that with AlloCare. That was something that was introduced and added to patients that we had this interaction with, and that was obviously (inaudible) that administered throughout -- also through our patient care managers. So we really see this as a strategic asset. And the goal is to get that last smile to the patient, and that's really what we're able to do at the start of last year. And again, I would remind you that as we look at, for example, getting early in pretransplant, we talk about our TX Connect offering. This is something that we see as also an opportunity to start earlier in terms of the patient journey. So our commitment is to the patient, along all stages of that transplant journey. -------------------------------------------------------------------------------- Operator [15] -------------------------------------------------------------------------------- Our next question is with Alex Nowak with Craig-Hallum Capital Group. -------------------------------------------------------------------------------- Alexander David Nowak, Craig-Hallum Capital Group LLC, Research Division - Senior Research Analyst [16] -------------------------------------------------------------------------------- Just curious what the latest AlloSure penetration numbers are, just given all the new data that you're seeing. And then in the 55 centers where you do have AlloSure and protocol, does that mean you're mostly fully penetrated within those accounts? Or are there still opportunities for growth in those centers? And then just where do the remaining 200 transplant centers sit in the pipeline for protocol? -------------------------------------------------------------------------------- Reginald Seeto, CareDx, Inc - President, CEO & Director [17] -------------------------------------------------------------------------------- Yes. Thanks, Alex. I mean I think our focus is our direct-to-center strategy. So you're right. Of the 200-plus centers in the U.S. that has been where we built our moat around focusing on, not just having account managers and clinical staff, but also how do we improve that operational workflows, that's really important for us. So we have 70% of the centers that we've mentioned in the release that we cover. In terms of the protocols, the good thing about the protocols is that some are higher than the ARTS schedule. Some are at the ARTS schedule and some are below the ARTS schedule. But -- so there's continued opportunity as with the protocols. More importantly, we are now based on 2019 -- 2020 data, sorry, is 1 in 3 patients started on AlloSure. So we see there's continued opportunity to even grow at a much faster rate than what we've done with AlloMap, which is after 15 years, 1 in 2 patients. And so we continue to focus on that point of initiation. That's really important for us to do that. Maybe one thing just to highlight is not only do we have this penetration of the -- within the 70% centers in AlloSure, but we also have more than 90 centers now, more than 90 centers that have this EMR interface. And so as you think of what we're doing, Alex, and developing this competitive mode is, how do we get deeper and deeper within these centers as well, and that's also why we did the recent TransChart acquisition. -------------------------------------------------------------------------------- Alexander David Nowak, Craig-Hallum Capital Group LLC, Research Division - Senior Research Analyst [18] -------------------------------------------------------------------------------- Okay. Very helpful. And then maybe could you just preview the KOAR data that you do have coming out the middle of this year? Just how should we be gauging or looking for success comparing AlloSure to creatinine? And then remind us, what sort of data do you need to show to Medicare with regards to the original coverage with evidence development? -------------------------------------------------------------------------------- Reginald Seeto, CareDx, Inc - President, CEO & Director [19] -------------------------------------------------------------------------------- We're really excited by KOAR. I mean it's such a large data set built across more than 50 centers and over 1,000 patients. And so KOAR 1,000 with the time of 1 year follow up, we can share some really large data sets, which I think is important for the community. I think KOAR was an observational study based off looking at correlation with EGFR and also looking at how it did with some of the biopsy cohorts. So we'll be sharing information that at ATC, but we're excited by this data set. It will also be noted that at (inaudible) there's going to be also the ADMIRAL data set, which is commercial experience of patients, also another large data set with AlloSure. So I think the key thing is, by the time we get to the middle of the year, there'll be a large set of data showing the experience with AlloSure and how we continue to bring insights and innovation into this space. So I look forward to those coming forward. In terms of your question of the study, originally, this was part of the CDD when we had this -- the KOAR study set up. And that's something that we've met the commitment with as part of the study design and also with the follow up. So that was something that was originally part of the MolDx approval. -------------------------------------------------------------------------------- Alexander David Nowak, Craig-Hallum Capital Group LLC, Research Division - Senior Research Analyst [20] -------------------------------------------------------------------------------- Okay. Got it. And then you mentioned at the end of your prepared remarks regarding AlloMap Kidney, and I think I missed it. Was that Q4 milestone when you expect to submit for reimbursement or (inaudible) MolDx? Or what was that milestone? -------------------------------------------------------------------------------- Reginald Seeto, CareDx, Inc - President, CEO & Director [21] -------------------------------------------------------------------------------- Yes. The milestone was just to share when we got [CLIA] validation. CLIA is one of the gating steps for commercial application and also for approval. And so it was really just to share a key milestone for us because it means that it's now being validated in CLIA lab. -------------------------------------------------------------------------------- Operator [22] -------------------------------------------------------------------------------- Our next question is with Andrew Cooper from Raymond James. -------------------------------------------------------------------------------- Andrew Harris Cooper, Raymond James & Associates, Inc., Research Division - Senior Research Associate [23] -------------------------------------------------------------------------------- I guess maybe first, thinking about sort of the community nephrology opportunity. I know we've talked about it a little bit before. But as you get deeper there, clearly, there's a lot more surviving patients than there are patients moving through a transplant center in any given year, which you've got a lot more nephrologists as well. I mean what sort of tools can you add and continue to sort of bring to bear there to really attack, I think, what is a much larger sort of space to go after as opposed to a couple of hundred transplant centers? Just how should we think about kind of strategically the way you're going after that? -------------------------------------------------------------------------------- Reginald Seeto, CareDx, Inc - President, CEO & Director [24] -------------------------------------------------------------------------------- Yes. Thanks, Andrew. I mean we have a pretty efficient process and it's threefold. The first is we have patients that transition from the center to the community. So we have a process that's in place there. I think that's maintained and managed by our patient care managers. So there's this continuum of scheduling and continuum of communication. That's the first thing. The second thing is, at the end of last year, we built out our community nephrology team, and they're managing the 1,000 community nephrologists who actively are involved with transplant patients in the community. And so there's a subset that have been identified that take more of an active role in the setting. And then there's another 8,000-plus community nephrologists who don't play so much of an active role in transplant that may have an interest, particularly some of the changes in the executive order. And so we also have an indirect field approach and reaching out to this group through an inside sales team. So we had the reach that's necessary, and it's fairly efficient. And we've been experiencing some really good not only insights but success in that space. -------------------------------------------------------------------------------- Andrew Harris Cooper, Raymond James & Associates, Inc., Research Division - Senior Research Associate [25] -------------------------------------------------------------------------------- Okay. That's helpful. And then maybe one more just on AlloCell, but obviously, you're early on, like you said, in building sort of the market in general. But when you think about this, is it reasonable to expect that over kind of a couple of years, this could become one of the de facto sort of has to have components of a clinical trial if you're a pharma company? And sort of from that perspective, when they're looking at assessing their trial, what else is out there that competes with what AlloCell is trying to do from that perspective? -------------------------------------------------------------------------------- Reginald Seeto, CareDx, Inc - President, CEO & Director [26] -------------------------------------------------------------------------------- Well, that's why we're so excited by AlloCell. There is no standard out there. And so there are -- some companies are trying their own internal homebrews in terms of how they can do these -- do the monitoring. But really, what you're seeing, what we're doing is a universal standard that can be applied to any therapeutic that comes on as we measure that therapeutic cell concentration. And I think that's why it's really, really exciting. As we firstly use clinical studies and correlate to outcomes, this is [link] that sort of opens that initial discussion. And I think as the future, as these companies start learning with us and doing it together, then there's the opportunity to say, how do you use us more proactively either in decision-making as part of their process. But what I would say, so far, is that it's been very positive given that recreating the space. And this is (inaudible) that again is dependent on allogeneic cell therapies make it to market, but by partnering so early with all these clinical and some even preclinical companies allows us that opportunity to create the standard. -------------------------------------------------------------------------------- Operator [27] -------------------------------------------------------------------------------- Our next question is with Sung Ji Nam with BTIG. -------------------------------------------------------------------------------- Sung Ji Nam, BTIG, LLC, Research Division - Director and Life Science & Diagnostic Tools Analyst [28] -------------------------------------------------------------------------------- I just have a couple of quick ones. The ADMIRAL study that you guys are presenting at the cutting-edge of transplantation meeting in a couple -- in a few days. Just kind of curious, is this the first lung study where you'll be showing long-term outcomes data? Obviously, you have a KOAR coming up in the second quarter. -------------------------------------------------------------------------------- Reginald Seeto, CareDx, Inc - President, CEO & Director [29] -------------------------------------------------------------------------------- Yes. This is really exciting because it's a large -- again, a large data set, multicenter collected set of data, which is representing commercial -- real commercial experience. They're not under a study setting. And we're looking at 1,000 patients over a multiyear period. So I think it's exciting to have that and also timing it with what will come with KOAR as part of that as well. I might also just -- we actually have Sham on, our Head of Medical -- Sham, do you want to make any comments as well? -------------------------------------------------------------------------------- Sham Dholakia, CareDx, Inc - SVP of Medical Affairs & Clinical Operations [30] -------------------------------------------------------------------------------- Yes. So we're excited very much about ADMIRAL because it really sort of sets the scene for what KOAR potentially is going to show us where, not only are we talking about the validation of the performance of AlloSure in allograft rejection, but clinically indicated in subclinical, but also the other sequela of disease that we see in transplant patients. So the ability to see and predict de novo DSA, and we need to model EGFR decline, which is the standard for outcome. And so ADMIRAL really sets the theme saying, monitoring patients with AlloSure, the surveillance tool, really now can aggregate the course of their outcome. And now it creates potential, real interventional studies that will really -- you'll see a paradigm shift from us going forward where KOAR is sort of that first step towards that journey. -------------------------------------------------------------------------------- Sung Ji Nam, BTIG, LLC, Research Division - Director and Life Science & Diagnostic Tools Analyst [31] -------------------------------------------------------------------------------- Got you. Fantastic. That's great. And then just on AlloCell, just kind of curious -- I'm not sure if I should know this already, but obviously, it measures cellular kinetics, I believe. Is this also a multimodality testing solution? I think you talked about AlloHeme and AlloSeq being performed as well. So I'm just trying to get a better sense of the composition of this platform, AlloCell platform. -------------------------------------------------------------------------------- Reginald Seeto, CareDx, Inc - President, CEO & Director [32] -------------------------------------------------------------------------------- Yes. So AlloCell is specific to allogeneic cell therapy therapeutic. So there, we're looking at -- you're right, the pharmacokinetics, which includes what you described as we look at different [CMS], we look at the persistence. And so -- it's not part of multimodality. So it's not saying, which we've been doing, for example, with KidneyCare, HeartCare and lung care, for example. So it's a -- it's -- they're in solid organ, where we have the multimodality, and this is in allogeneic cell therapy. We're really just measuring the cell concentrations and then seeing if there's any clinical interventions and decisions that need to be made as we work with the partners on this. -------------------------------------------------------------------------------- Operator [33] -------------------------------------------------------------------------------- Our next question is with Yi Chen with H.C. Wainwright. -------------------------------------------------------------------------------- Boobalan Pachaiyappan, H.C. Wainwright & Co, LLC, Research Division - Equity Research Associate [34] -------------------------------------------------------------------------------- This is Boobalan dialing in for Yi Chen. I have a couple of questions. So the first one, how much more do you think you need to spend on operating expenses to support growth in 2021? -------------------------------------------------------------------------------- Marcel Konrad, CareDx, Inc - Interim CFO [35] -------------------------------------------------------------------------------- This is Marcel. So we came out in Q4 with over $58 million of revenue. We had an 8% EBITDA margin. So we continue to invest in the business. We want to grow a sustainable business. And as we go throughout the year, we'll update on the specific expense line items there. -------------------------------------------------------------------------------- Boobalan Pachaiyappan, H.C. Wainwright & Co, LLC, Research Division - Equity Research Associate [36] -------------------------------------------------------------------------------- All right. That's helpful. And is the 2021 revenue guidance leaning towards the conservative side? -------------------------------------------------------------------------------- Reginald Seeto, CareDx, Inc - President, CEO & Director [37] -------------------------------------------------------------------------------- Yes. It's Reg, here. I mean I think we -- we think it's really the best number we have at this time point. And we do have a history of meet and beat, but I do think it's early with a lot of the different opportunities like community nephrology we mentioned. So I think we'll have more insight as the year progresses, but -- and there's also some of the uncertainties with COVID as we look through the course of this year, which we're seeing as well. But we feel good about the numbers, and we look forward to continued growth. -------------------------------------------------------------------------------- Operator [38] -------------------------------------------------------------------------------- Ladies and gentlemen, we have reached the end of our question-and-answer session, and I would like to turn the call back to Reg Seeto for closing remarks. -------------------------------------------------------------------------------- Reginald Seeto, CareDx, Inc - President, CEO & Director [39] -------------------------------------------------------------------------------- Well, thank you again to all those listening in. It was great to be able to share the great year that CareDx had during 2020. And more importantly, we're really excited about what 2021 will bring. So again, we look forward to many more interactions during the course of the year. But what I would say is stay safe and be well, and we'll continue our mission as a company, which is putting transplant patients first. Thank you again. -------------------------------------------------------------------------------- Operator [40] -------------------------------------------------------------------------------- This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.