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spk07: Greetings and welcome to the CARE DX, Inc. fourth quarter 2020 earnings conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Greg Hadachek, Managing Director.
spk01: Good afternoon and thank you for joining us today. Earlier today, CareDx released financial results for the quarter and year ended December 31st, 2020. The release is currently available on the company's website at www.caredx.com. Reg Cito, Chief Executive Officer, and Marcel Conrad, 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 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, February 24, 2021. CARE-DX 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.
spk04: 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 wanted 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 our 100% focus for more than 20 years, and we're expressly proud that 2020 was a year we continued to serve TransLand patients and the TransLand 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 healthcare solutions to TransLand patients and caregivers. Our four-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. 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 and 8 million, respectively. Digging deeper into our testing services for the fourth quarter, CareDx provided over 25,000 AlloShore and Allomat results to the transplant patients in this quarter, growing approximately 78% from Q4 2019. Approximately 40% of our testing volume originated from mobile subotomy. As of the end of December, over 55 transplant centers in the United States have adopted an 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 self-regenerating AlloSeq TX17 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 transformational 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 RemoTrack, our solution enabling remote home-based monitoring of transplant patients. This offering was in response to a need from transplant centers and patients, and we're very proud to be able to put this together within a week. By early April, we established a nationwide network of more than 10,000 mobile phlebotomists, 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 RemoTrack offering. Today, more than 150 centers use RemoTrack. Secondly, in April, we introduced AlloCell, our surveillance solution for patients who received engineered cell transplants for 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, four abstracts were presented showcasing our cellular transplant therapy portfolio, including with our partner Atara Biotherapeutics. This is just the beginning of our also 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 Alloshore lung was published in Transplantation Direct. The LIGO study demonstrated that Alloshore lung could identify patients with acute cellular rejection. A critical need for lung transplant patients whose only option to detect rejection is an invasive bronchoscopy. With lung transplant patients having one of the lowest survival rates for solid organ transplants, We believe Allishaw Lung is a powerful, non-invasive tool in monitoring the health of the transplanted organ. As a reminder, Allishaw for Lung Transplant Patients has been available under compassionate use since February 2019, and in June 2020, we submitted our Allishaw Lung dossier to Palmetto Moldex for Medicare reimbursement. And finally, in November, we received final reimbursement pricing from Palmetto Moldex for Allishaw Heart. As we look to 2021 and beyond, we remain very excited about our prospects. Our Allashore testing volumes continue to impress. Our decision to focus first on the transplant centers with our direct-to-center strategy has allowed Allashore to be used in greater than 70% of transplant centers, and more than 55 transplant centers have adopted an Allashore 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 tumor 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, an app designed by transplant patients 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. LMAP heart testing experienced strong double-digit growth. We were thrilled with the approval of AlloShore Heart when used in combination with LMAP, known as HeartCare. As I previously mentioned, we received Medicare reimbursement for AlloShore Heart at the end of last year. While our growth in heart this past quarter stemmed from an increase in LMAP testing, in December, we began submitting our sure-hard tests for reimbursement for our Medicare patients. Regarding reimbursement for our non-Medicare patients, we are working with healthcare providers to procure commercial reimbursement. Regarding our digital offerings, we recently announced the acquisition of TransChart, a provider of electronic health records 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 Zincopi transplant quality management solutions. With this acquisition, our EMR coverage now extends to over 90 centers in total. As part of the transplant acquisition, we also acquired TxConnect, a leading provider of human biologics donation and transplantation software. TxConnect allows us now to move upstream in the patient journey and connect the centers with the dialysis centers. Last, but certainly not least, our Allocel offering is beginning to bear fruit. Earlier this month, along with our partner, Atara Biotherapeutics, we announced we were presenting data on Allocel 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 Allocel for standardized pharmacokinetic assessment in clinical trials, and highlighted data on AllerHeim and LCKCT for chimerism and recurrent surveillance of stem cell transplant patients. We're very excited about the potential of AllerCell, though we're in very early stages of this significant greenfield opportunity. 2020 was an exceptional year for KDX as we continued to build out our product offerings while driving robust growth in our market of products. That being said, we believe we're 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 wedding formula by adding allocial kidney and heart care protocols and continue EMR integration, build our direct-to-patient strategy with Rheumatrack, Allocare, as well as through our patient care managers, start the direct-to-community strategy with community virology field team, which was hired at the end of last year, and 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, TxConnect, this really provides an opportunity for us now to build a connection with the dialysis centers. This is something that is truly exciting as we continue along that patient journey continuum. In Q2, we'll provide the KL1000 readout at ATC, the largest transplant conference held annually. In Q3, we expect to share Alishaw Lung Medicare reimbursement update, as we hear back from Moldex. And in Q4, We expect to continue the exciting multi-modality work first shown in heart care, but now starting with kidney care as we get clear validation of Alimap kidney. With that, I'm going to turn the call over to Marcel to discuss our financials and 2021 guidance.
spk03: Thank you, Reg. Turning first to the income statement. Our fourth quarter of 2020 testing service revenue increased 73% year-over-year to $50.3 million. The growth in the fourth quarter testing services revenue was driven by AlloShore Kidney and Allomab 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 percent compared to a gross margin of 65 percent in the same period of 2019. The non-GAAP gross margin for the quarter was 70 percent compared to 68 percent 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 7 cents for a quarter compared to a net loss per share of 11 cents 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 9 cents, and $0.08 respectively, compared to a basic and diluted non-government income of $0.04 in the same period of 2019. As a reminder, we define adjusted EBITDA as a non-government 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 31st, 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 Alloshore, 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.
spk07: At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Our first question is from Brandon Couillard with Jefferies. Please proceed with your question.
spk05: Hey guys, this is Matt on for Brandon this afternoon. Thanks for taking the questions to start off with guidance. You know 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 remote track, 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? Thanks.
spk04: Yeah, thanks, Matt. So, you know, we've actually got a really nice engine of growth. And I think, you know, testing serves as the area that we've, We have a really great winning formula, and we'll continue to win protocols within centres and add new centres. That's sort of the winning formula we've established. I think, secondly, what's really exciting is we've built out the community nephrology team at the end of last year. There's the ability now to expand in the community, and this will be an area of incremental opportunity and growth for us as an organisation. The third is when we look at Alice Shaw-Harton with the recent approval for 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.
spk05: Thanks. And then on Alice, 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, you know, if at all conversations have evolved here, clearly being out there with a known, you know, cell therapy entity that has multiple programs in its pipeline is pretty impressive validation for you guys. So, you know, just curious how conversations with other partners are progressing from here. Thanks.
spk04: You know, Alacil is really an exciting opportunity since part of the, you know, the future long-term growth as we see it replicating what we did with Alacil with AlloSure by creating a new market with universal surveillance to allogeneic cell therapies. With the TARA, 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, who we're working with, and I think with the relationship we built there, they felt comfortable about 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 because more of these get approved in the future. As a reminder, there isn't you know, any allogeneic cell therapy approved today, but we believe that is the way of the future.
spk05: Thanks. And then just one last quick one on remote track. 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, you know, any tweaks or improvements you've made to the program as you get more data and feedback as we approach the one-year launch coming up next month? Thanks, guys.
spk04: Yeah, no, I think with Rheumatrack, this is something that, you know, was probably the highlight of, you know, of last year, what we did as an organization as we rallied around, you know, supporting patients and transplant centers with 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, you know, centers are using it. In terms of just thinking in terms of margin, we have, you know, 40% were used in Q2. And then in Q3, that went to about 30%. And then in Q4, we went back up to the higher end of the 40%. And so we expect to have remote track as a core part of our business. It's really something which, you know, patients want with 9 out of 10 patients, you know, highly satisfied. And it's something that Transplant Center is now that they've had the service, want us to keep as well. So it'll be a core part of our business moving forward. I think in terms of the additional support you know, 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 in 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 have planned during the course of this year. Super. Thank you. Thank you again.
spk07: Our next question is with Rachel Vettensahl with Piper Sandler. Please proceed with your question.
spk08: Hey, everyone. This is Rachel. I'm for Steve. Thanks for taking the questions, and congrats on a really nice year. So first off, you've had some really nice success with hard care since the launch in mid-November. Can you tell us about the attachment rate for heart care, so the number of allomap heart tests that you're seeing currently run alongside of those AlloSure hearts? And where do you think that attachment rate could go over the next one to two years?
spk04: Yeah, heart care 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. So the innovation we continue to bring. The second thing is, you know, before the, you know, approval, the attachment rate was around the 60 to 7% mark. And it's only in the end of last year that we actually were able to start talking about hard care directly. The attachment rate has increased around the 70 to 80% mark. So We see this as something where you bring additional clinical utility, there'll be increased usage from clinicians and also centers. The one thing to note is that, you know, we expect to continue to see this attachment rate, you know, progress during the course of this year now that we've started the ability to talk about it actively.
spk08: Great. And going off of that clinical utility, especially given the uptake that you've seen, such as for terminal launch, Can you give us some more color on your conversations that you're having with commercial payers about reimbursement? Obviously, you guys got a really high reimbursement rate on Alistair Hart, 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?
spk04: Well, with Alimap, firstly, we have 80% commercial coverage, all the major companies. And I think with the addition of Allishaw Hart, we anticipated building out a 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 we look at it. And both Kaiser and Geisinger are two of the accounts that started looking at Allishaw Hart, for example, and commercial pay. 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.
spk08: 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 RemoTrack 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?
spk04: 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, you know, as we manage the patient from pre-transplant, peri-transplant, post-transplant, our patient care managers play a critical role. And we've already started that process. We have... you know, patient care managers who look after the patient pre-transplant already. And some of these patient care managers actually follow the patients into the post-transplant space as well. So that continuum is firstly really important. What I would share is, you know, with the advent of these PCMs, 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. And 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 have had a lot of success in driving and maintaining adherence. What I would also say is that if you look at add-on opportunities, I think we saw that with Allocare. That was something that was introduced and added to you know, patients that we had this interaction with, and that was obviously something that was administered also through our patient care managers. So we really see this as a strategic asset, and the goal is to, you know, get that last mile 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, you know, as we look at, for example, getting early and pre-transplant, we talk about our TX Connect offering. This is something that, you know, we see as also an opportunity to start earlier in terms of that patient journey. So our commitment is to the patient along all stages of that transplant journey.
spk08: Great. Congrats again on the year. Thanks.
spk04: Thank you.
spk07: Our next question is with Alex Nowak with Craig Hallam Capital Group. Please proceed with your question.
spk10: Great. Good afternoon, everyone. Just curious what the latest Allisher penetration numbers are, just given all the new data that you're seeing. And then in the 55 centers where you do have Allisher 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?
spk04: Yeah, thanks, Alex. I mean, I think, you know, our focus is our direct-to-center strategy. So you're right, of the, you know, the 200-plus centers in the U.S., that has been where we've built our moat around focusing on, you know, not just having account managers and clinical staff, but also how do we improve that operational workflow. So that's really important for us. So we have, you know, 70% of the centers that we've mentioned in the release that we we cover. In terms of the protocols, the good thing about the protocols is that, you know, some are higher than the ARDS schedule, some are at the ARDS schedule, and some are below the ARDS schedule, but so there's continued opportunity as with the protocols. More importantly, we are now based on 2019, 2020 data, sorry, is one in three patients started on started on Allishore. So we see there's continued opportunity to even grow at a much faster rate than what we've done with Alimap, which is after 15 years, one in two 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 of Allishore, 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, in developing this competitive mode, it's how do we get deeper and deeper within these centers as well. And that's also why we did the recent trans chart acquisition.
spk10: Okay, very helpful. And then maybe could you just preview the keyword data that you do have coming out the middle of this year, just How should we be gauging or looking for success comparing Alisher 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?
spk04: We're really excited by CAEL. I mean, it's such a large data set built across, you know, more than, you know, 50 centers and, you know, over 1,000 patients. And so KOR1,000 will be the time of one-year follow-up where we can share some really, you know, large data sets, which I think is important for the community. I think, you know, KOR 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, you know, we'll be sharing information of that at ATC, but we're excited by this data set. It'll also be noted that at fiat there's going to be um also the admiral data set which is commercial um you know experience of patients also another large data set with it with alishaw so i think the key thing is you know by the time we get to the middle of the year there'll be a large sets of data showing the experience with alishaw and how we continue to bring insights and innovation into the space i look forward to those coming forward in terms of your question of um The study originally, this was part of the CDD when we had this, the CAEL study set up, and that's something that, you know, 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 Moldex approval.
spk10: Okay, got it. And then you mentioned at the end your prepared remarks regarding LMF kidney, and I think I missed it. Was that Q4 milestone when you expect to submit for reimbursement or small decks or what was that milestone?
spk04: Yeah, the milestone was just to share when we got clear validation. Clear is one of the gating steps for, you know, commercial application and also for approval. And so it was really just to, you know, share information. you know, a key milestone for us because it means that it's now being validated in ClearLab.
spk10: I see. Got it. And then, you know, probably in 2022. Okay. Understood. Thank you. Thanks, Alex.
spk07: Our next question is with Andrew Cooper from Raymond James. Please proceed with your question.
spk11: Hey. Thanks for the question. 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. What sort of tools can you add and continue to sort of bring to bear there to really attack, you know, I think what is a much larger sort of space to go after as opposed to, you know, a couple hundred transplant centers? Just how should we think about kind of strategically the way you're going after that?
spk04: Yeah, 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 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 immunologists who don't play so much of an active role in transplant but may have an interest, particularly some of the changes in the executive order. And so we also have an indirect field approach in reaching out to this group through an in-sales sales team. So we have 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.
spk11: Okay, that's helpful. And then maybe one more just on Alice L. But, you know, obviously, you're early on, like you said, in building sort of the you know, the market in general. But when you think about this, you know, is it reasonable to expect that over kind of, you know, a couple years this could become, you know, one of the de facto sort of have to have components of a clinical trial if you're a pharma company? And sort of from that perspective, when they're looking at, you know, assessing their trial, what else is out there that competes with what Allocell is trying to do from that perspective?
spk04: Well, that's why we're so excited by LSOB. There is no standard out there. And so, you know, some companies are trying their own internal homebrews in terms of how they can do the monitoring. But, you know, really what you're seeing, what we're doing is a universal standard that can be applied to any, you know, therapeutic that comes on as we measure homebrews that therapeutic cell concentration. And I think that's why, you know, it's really, really exciting. You know, as we firstly use clinical studies and correlate the outcomes, this is something that sort of, you know, 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, you know, decision-making as part of that process. But what I would say so far is that it's been very positive given that, you know, we're creating the space. And this is something that, again, is dependent on allergenic cell therapies made to market. But by partnering so early with all these, you know, clinical and some even preclinical stage companies allows us that opportunity to create the standard.
spk11: Great. I'll stop there. Appreciate the time.
spk04: Thanks again.
spk07: Our next question is with Sunji Nam with BTIG. Please proceed with your question.
spk09: Hi, thanks for taking the questions. 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 few days, I'm just kind of curious, is this the first long-term study where you'll be showing long-term outcomes data? Obviously you have a KOR coming up in the second quarter.
spk04: Yeah, this is really exciting because it's a large, again, a large data set, multi-center collected, you know, set of data, which is, you know, representing commercial, real commercial experience, so not under a study setting. And, you know, we're looking at, you know, 1,000 patients over, you know, a multi-year period. So I think it's exciting to have that and also timing it with what will come with K.O.L., as part of that as well. I might also just, we actually have Sham on, ahead of medical. Sham, do you want to make any comments as well?
spk02: Yes, so we're excited very much about ADMOR because it really sort of sets the theme for what Kay or Patanshi is going to show us, where not only are we talking about the validation of the performance of AlloShore in allograft projection, both clinically indicated and subclinical, but also the other sequelae of disease that we see in transplant patients. So, the ability to see and predict de novo DSA, and really model EGFR decline, which is the standard for outcome. And so, Admiral really sets the theme saying monitoring patients with the Allosteroids surveillance tool really now can abrogate 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 Kira is sort of that first step towards that journey.
spk09: Gotcha. 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 measure cellular kinetics, I believe. Is this also a multimodality testing solution? I think you talked about AlloTeam and AlloSpeak being performed as well. So I'm just trying to get a better sense of the composition of this platform, AlloCell platform.
spk04: Yeah, so LSL is specifically for allogeneic cell therapy therapeutics. So there we're looking at, you're right, the pharmacokinetics, which includes what you described. As we look at, you know, different, you know, CMAX, we look at the persistence. And so it's not part of multimodality. So it's not something which we've been doing, for example, with – kidney care, heart care, and lung care, for example. So they're in solid organ where we have multimodality, and this is in allogeneic cell therapy where 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.
spk09: Gotcha. That makes sense. Thank you so much.
spk04: Thank you.
spk07: Our next question is with Yi Chen with HC Wainwright. Please proceed with your question.
spk06: Hi, this is Bubalan 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?
spk04: Yes, hi, this is Marcel.
spk03: Yes, hi, 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.
spk06: All right, that's helpful. Is the 2021 revenue guidance leaning towards the conservative side. Thanks so much.
spk04: Yeah. Hi, it's Reggie. I mean, I think we, um, you know, we, we think it's a, it's a really, you know, the best number we have at this time point. Um, and, uh, you know, we, we do have a history of, of, uh, of meat and beat, but I, I do think, you know, it's, it's early with a lot of the, you know, different, um, opportunities like community astrology we mentioned. So I think we'll have more insight as the year progresses. But, you know, 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, you know, we feel good about the numbers and we look forward to continued growth.
spk06: That's it from me. Thank you.
spk04: Thank you.
spk07: 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 Cito for closing remarks.
spk04: Well, thank you again. And, you know, for all those listening in, you know, 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. 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.
spk07: This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.
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