CareDx, Inc. (CDNA) Earnings Call Transcript & Summary
June 8, 2021
Earnings Call Speaker Segments
Matthew Sykes
analystWelcome everybody. It's Matt Sykes, life sciences tools and diagnostics analyst at Goldman Sachs and I have the pleasure of welcoming CareDx today. We have Reg Seeto, the Chief Executive Officer; and Ankur Dhingra, the Chief Financial Officer. Reg, Ankur, thanks for being here. Appreciate it.
Ankur Dhingra
executivePleasure to be here, Matt.
Reginald Seeto
executiveThank you very much.
Matthew Sykes
analystNo problem. Maybe we could just start out and I'll kind of let you guys set the stage a little bit. You've had a couple of announcements in the last couple of days, some pretty exciting stuff. So maybe talk a little bit about that, the recent quarter and just kind of some of the key drivers that investors should be looking for over the course of the year and just sort of start out for us. That would be great.
Reginald Seeto
executiveYes. Thanks, Matt. I mean, it's been an incredible start to what we call ATCR Conference, actually, where we've had more than 40 different abstracts being presented about CareDx offerings. And so it's a real showcase for us. It's actually a great coincidental week to be at the Goldman Sachs conference as well. And as we look at that, it really just establishes what we've been doing over the last 20 years as a company, 100% focused on transplant, 100% focus on the patient and how we deal with unmet needs and bring really meaningful offerings and how we continue to drive innovation, which is the hallmark of what we've done as a company, and then setting standards, which is also what we've done as a company, and then continue to go deep in this patient journey is something that's absolutely critical to us. So really an incredible opportunity for us to do things for patients. Now in terms of the recent quarter, we had a really, really strong revenue growth, and we've seen that continuation in Q1 from the prior 2 quarters. So if we look at Q3 last year versus prior year, we had a 58% growth. If you look at Q4, we had a 64% growth versus prior year quarter. And we look at our most recent Q1 results of 76% revenue growth versus prior year quarter. And so really strong revenue growth, which has been driven by our testing services. If we think of the second half year and what to expect, we expect to be continued strong revenue growth. We've built a really strong winning formula, how we focus on our direct to center strategy and how we continue to add protocols and how we build on this community nephrology strategy, which has been unleashed during the first quarter of this year. And the other thing that you should expect in the second half year is how we continue to build the company and the portfolio for the future. So this is where we have multiple sort of different areas that you'll see during the course of the year, how we build upon the recent KOAR-1000 data, the first and only long-term donor-derived cell-free DNA data, which actually showed some really pivotal information, including the reduction in biopsies and increase in overall survival for these patients. The second is how do we prepare for the potential AlloSure Lung launch as well as we go through the final stages and processes. How do we accelerate multi modality, now having validated heart care with the opportunity now with kidney care? And then again, how do we continue the thematic of 2021 to accelerate this direct-to-patient strategy. So really excited by the journey that lies ahead.
Matthew Sykes
analystGreat. Well, that's a great start. I appreciate that, Reg. And maybe if I'll just kind of start a little bit on the big picture question, just about the transplant market in general. When you look at the transplant market, when you guys got involved, you could say that the perceived TAM was not maybe necessarily that large and -- but as the market grew, you grew along with it and started to really have a leadership position there. And if you look at where the -- your TAM potentially is, including cell therapy, you can get over $10 billion or so. When you -- just talk a little bit about the evolution of cardiacs and your thought process, kind of as the market grew, how you kind of extended along the patient journey and how you look to kind of really take the leadership position within the transplant market?
Reginald Seeto
executiveIt's actually -- the last 20 years, there's a lot of learnings in how we've evolved as a company. And I think that you're seeing this real acceleration of CareDx in the last 3 years, but it was built off some very similar foundations, which is, first, start with the unmet need. There continues to be an incredible opportunity to help out patients and graft survival. So the example I'd give is 1 in 5 kidney patients today will still have their organ fail within 5 years. 1 in 3 livers will fall within 5 years. And unfortunately, for lung patients, it's 1 in 2. So at the end of the day, there's still an unmet need. And I think if you look at -- when we first developed gene expression profiling with AlloMap, how do we help improve that journey? And so that was the genesis of the company's first commercial offering, we're looking at immuno acquiescence. And then if we went along then to the kidney space, while AlloSure was launched at the end of 2017, it was how do we look at injury and then how does that -- be interpreted if it's a formal rejection. And so with these new technologies we brought to market, we were able to create a TAM at that time, which we called it a $2 billion TAM, and it was based on incidence prevalence, obviously, price. And at that stage, when we presented even 3 years ago, I think people were fairly skeptical. If you look at fast forward in 2019, I think everyone in 2019 was talking about at least a $2 billion TAM, right. So it's an interesting evolution of how this market sort of was created initially by CareDx. What we found, though, is their learnings, Matt. So what we learned from the AlloMap launch is that there was importance to have surveillance. And so what we saw with AlloSure Kidney is we launched with a surveillance protocol. And so you've seen the expansion of that TAM. And further from that, we've also seen the benefit of doing multimodality. So recently, at the end of last year, we had the first and only approval by MolDx for a multimodal technology with both AlloMap and AlloSure Heart being combined. And so with that, we've actually expanded the TAM. And so you start off with the $2 billion, and now we have a TAM today, which is at $4 billion conservatively. And so as you think of this continued journey, we believe that you can add other things, not just multimodality, but go beyond that and continuing increasing this TAM opportunity. We're really good at expanding the TAM. And I think if we've shown anything through history, we've had this incredible ability to generate really meaningful clinical utility data to demonstrate that. I think as we also think of this TAM and how we penetrate it is one of the key things that we've been really good with driving adoption is improving the workflow. And I think it's not just thinking of technologies to create a marketplace that is unmet need. It's not just about expanding the TAM by understanding how do you address things such as surveillance and then multimodality. It's also making sure that we can actually capture that TAM, which is one of the most critical points, right? And I think having that 20-year history in addressing things as operational workflow, which are important to Sanis has really helped us over on this space. So it's been a fantastic journey and one that we think will continue to expand and grow the TAM.
Matthew Sykes
analystGot it. And yes, and I think one thing that I've been particularly impressed with CareDx is just how you've done such a great job of following the patient on the care journey and kind of developing value-added service that really help you connect directly to the patient. Could you just talk about how that connectivity evolved and how your close connection with the patient kind of helps the overall experience and then, ultimately, your relationship with the transplant centers and the entire value chain?
Reginald Seeto
executiveI've been at a lot of companies that talked about patient first, patient centricity. And what I can say is CareDx actually lives and believes it. And it's just incredible. Every single town hall, we have these monthly starts off with the patient. As we look at every single one of our presentations, it starts off with the patient. If we think of who we hire, everyone has a connection to the patient. Our Head of Sales, his daughter is a heart transplant recipient. Our Head of Clinical Ops is a kidney pancreas patient. One of our Florida reps, her daughter is a kidney transplant recipient. My aunt is on her third kidney wait. So it's important to build a culture around patient centricity. So it all starts from the inside in view, and I think that's made us very powerful as a company and organization. What we're seeing from there is it's allowed us to make decisions, which put patients first. And so what we've developed as a bit of a culture is how do we help the patient. And one of the examples in the field, for example, is -- when I started is we developed this whole concept of patient care managers. So that was the first offering, how do we not just do advocacy work, but how do we improve support for the patients. We had patient care managers who would directly interact with patients on protocols, for example, and work with them directly to help with scheduling and other additional hurdles they may have been going through. And the result of that, what we've seen, for example, by addressing the unmet need is an adherence rate that's twice that what a center cause that particular patient. What we've been able to do since then, though, is add additional offerings for patients. So how do we make their lives easier, and RemoTraC is one such example where we brought an offering -- a mobile offering during the middle -- onset of COVID, which really was a patient-driven need. And from there, it's actually now brought us more than 7,000 patients who are directly consented, and 9 of these 10 patients say, "We want RemoTraC to continue," for example, right? So it all -- it's all based around patient culture, bringing meaningful offerings and then continuing to interact with that patient. It's so critical for us. And we have actually some recent acquisitions like TX Connect, connecting the referral patients from the dialysis center to the transplant center. We actively manage 7,000 patients on the waitlist of that 100,000. We manage 1 in 3 patients that are on the active transplant for kidneys, and then we manage patients who are post-transplant. So that patient journey is absolutely critical for us, and we'll continue to bring meaningful offerings, but it's a culture-driven approach that we have.
Matthew Sykes
analystGot it. I mean you mentioned that RemoTraC, and I wanted to get to that. I've always been impressed by the pivot you guys made last year. It was very impressive. And you're obviously -- patient feedback says that you should really -- that's a valuable service. How are you thinking about the investment in the cost side of RemoTraC going forward and the impact it might have on margins relative to the benefit that it's giving you in terms of connectivity of the patient and an eventual -- translate into eventual revenue, additional revenue?
Reginald Seeto
executiveI'll make with comments, then I'll hand over to Ankur. I mean it's so easy to forget about during the peak of COVID, during mid-March and what was around that time point. But we put together an offering within 4 days, which is now used by more than 150 centers of the 200-plus centers in the United States. And for us, putting the patient first, we actually had a group that -- of about 40 people that we put together and said, what can we do for our patients? And we had this strategy session. We went through every single idea. We did -- and there was 1 thing that stood out at the end of the day. It was the safety of the patient, how do they get access to necessary tests, including, obviously, the test that we're providing to ensure that the monitoring of the organs could still take place. And that was the genesis of how RemoTraC was developed. It was a patient first approach and one where we all sat together and said, what can we do for the patient? In parallel, we actually had multiple centers actually reach out to us, including also patients in saying, "CareDx, we needed your help." So this sort of approach from brainstorming this approach from actually having outreach from customers taught us something very valuable that we could play a central role in this whole COVID process. And we were just so grateful that we'll provide that opportunity to deliver this offering. I'll now hand it over to Ankur to talk about some of the margin questions as well.
Ankur Dhingra
executiveYes. I think the way we think about it, Matt, this is -- the RemoTraC is part of our structure, right? It enables certain aspects of our growth, both in the near term in terms of driving adoption with our patients, but also in terms of becoming a foundation for our direct-to-patient strategy as well. So what was developed as part of a response to the pandemic eventually drove significant higher penetration for our tests, has become a solid strategic foundation. And we think that it is enabling us to do things that we didn't think we would be able to do even 6 quarters ago. So we see it as a strategic investment that is here to stay.
Matthew Sykes
analystGot it. Maybe just focusing -- moving on to the testing solutions segment. Just looking to get a sort of update on the product segment. You mentioned on the lung later this year, but also AlloSure Heart, which has had a strong start to the quarter. The division grew sort of above 50% and seems to be gaining momentum. So what are some of the key drivers for that segment in 2021? And any kind of update on the uptake in AlloSure Heart?
Reginald Seeto
executiveYes. AlloSure Heart was all about bringing clinical utility. As a physician myself, you use tools or tests if they bring things meaningful. And the fact that today, we have 80%, 85% attachment rate tells me and tells you that there's something clinically meaningful and relevant with AlloSure Heart or through HeartCare. And that was just so important for us. I mean, again, it's really important for us to generate multicenter prospective studies and to generate real clinical insights so that it can influence that clinical decision-making. And so what we saw with AlloSure Heart was sort of twofold through heart care, was this clinical utility, which is front and foremost, as they looked at how they were thinking of treating the patients. And the second area is that, historically, there's never been a surveillance protocol for AlloMap, and I think what we're able to do here is also bring in this heart protocol, which is [ 11 4 4 ] protocol. So I think the utility of that is linked. That's also helped contribute to the overall growth profile of AlloSure Heart/HeartCare. The one thing I would add is during COVID, and again, not to talk too much about COVID, but not only did it change the way we interact with patients and not only did it lead to the way that we could leverage and lean on the ecosystem, what we learned was behavior has changed. And so traditionally, biopsies were done routinely on heart patients post transplant. But what was clear is both in heart and also lung where these were core elective procedures, invasive procedures couldn't be done during the peak of COVID. And so it provided the opportunity for many centers then to move on to HeartCare, either with the patient use or through studies they initiated. And at the same time, on the lung side, we were asked to create the reference there because there's no sort of replacement or alternative for an invasive bronchoscopy. So we were really proud during that time to be able to be pulled in as part of the ecosystem and help create some of these innovative reference standards based upon our technologies. But I do think, again, it's all about clinical unmet need, bringing something that's a value to the physician and focusing on the patients first, and that's really helped us.
Matthew Sykes
analystGreat. And maybe could you talk about lung and just perhaps the rollout of other solid organs over time just given the universal LCD? And how should we think about the cadence of new tests over time as we think about you rolling into additional solid organs?
Reginald Seeto
executiveYes. We -- I mean, we were thrilled with the universal LCD. Not only did it provide a pathway for other solid organs, but it also showed that there was a pathway for multimodality. We firmly and truly believe multimodality is the way the future. And when we had HeartCare approved at the end of last year, and we're the only company to have done so, it really -- we weren't too sure if it would be slight -- that would just be a single approval, whether it would be something that would translate into other approvals. And I think the pathway in criteria being set, as long as you can add clinical utility and clinical benefit. So that's a really important point to note, which is great, because as we look at what we've done in KidneyCare, as we look at what we've done with LiverCare, which we just announced patients being enrolled earlier this week and also what we've done in LungCare, that's the basis of how we're driving future innovation. It's this multi-value approach. Now back to your question about the other solid organs and thinking about the cadence. It's a real opportunity for us now to leverage all the technologies and learnings we've had because we were the first to bring donor-derived cell-free DNA. We're the first to bring gene expression profile and the first to bring multimodality. So what we have here now is the opportunity to work within these 200-plus centers where there's an entire concentric circle or Venn diagram where all the different organs are covered. If you think of the cadence, we have -- in the first half of the year, we've talked about LiverCare. And so that means that now that process has started. If we think about the second half of the year, we're already starting preparing for lung launch. And I think, obviously, Ankur will comment a bit on the process that we're going through MolDx, but that's something that is now faster and accelerated from where we were before the universal LCD. So that's why it provides a much faster market approval for us. And then if you think of the cadence as you think into 2022, in that 12 months, is how do we accelerate, obviously, KidneyCare or AlloMap Kidney as a component of that. So there is a nice cadence of expansion to other solid organs. There's a nice cadence of how you think about multimodality, we truly think is the way the future. And I think beyond multimodality, we already have new potential ways exploring that, which we'll share at another time point. But Ankur, anything to comment on the time line as well?
Ankur Dhingra
executiveYes, I can. We can say on lung, with the new universal LCD just going live this week, our technical assessment on lung that we filed a while ago will now undergo under this new -- will undergo assessment under this new LCD. So our expectation is to get to a path here in the back half of this year from a technical assessment perspective. And then one of the good things, as Reg was mentioning under the new LCD, is that we don't have to then take another step to determine coverage for this organ. Once the technical assessment is complete, we straightaway go to the price determination and billing articles, et cetera. So coming up here.
Matthew Sykes
analystGot it. Just stepping back for 1 second. One thing that we talked about when we recently initiated on the sector and CareDx was sort of the growing appreciation for the value of the platform or the infrastructure that certain companies have developed. And I think you're a great example of that in terms of the infrastructure, the knowledge, the sales and marketing expertise, reimbursement experience, et cetera, the ability to kind of drop new tests and technologies, most of which you do organically, kind of into that infrastructure gives you a competitive advantage. How do you feel about kind of the infrastructure that CareDx has, the platform that you provide? And what kind of competitive advantage do you think that gives you and will continue to give you within the transplant market?
Reginald Seeto
executiveYes. I think one of the defining features of CareDx is really the fact we've been in transplant for more than 20 years, but we're 100% focused on transplant. And what that has allowed us to do is have this single focus of how do we continue to do the right things by patients, but how do we become the leading partner within the transplant ecosystem. So with that sort of mindset and approach, we have built an incredible infrastructure, which we continue to add on quarter-on-quarter. And the focus of that, I would say, is the transplant center. So if you think of the pretransplant, peritransplant, post-transplant into the community reentry sort of pathways, we play a step at every single step for that patient journey in one form or the other, and we continue to add upon those. And so if you think of the pretransplant space, for example, we talked about TX Connect. So we have the ability now to connect those 350,000 plus dialysis patients to the transplant center. We talked about the waitlist management, which we actively manage the 7,000 patients there. We talk about working with administrators with more than 35 centers on the Zen quality tools. And then we talked about the -- we have 80% coverage of all the HLA labs, which we have the latest technology through AlloSeq Tx17, and we have the rapid typing of HLA through QTYPE. So all these offerings are just on the pretransplant side alone, which we barely talk about. If you look at the post-transplant side, clearly, we have a series of different technologies, which exist in -- commercialize in heart and in kidney. And then we have the opportunity now to expand those within liver, lung and other solid organs. And also we have an active role that we play also in the stem cell center. So if you think of this entire ecosystem, there are only 200-plus centers in the United States, and we have a coverage of all these. We have the largest field force that exists in the United States at 100% transplant focus. It's unique in terms of its mix from account managers, account specialists to field lab service reps to patient care managers into clinical -- medical clinical science liaisons. So it's such an incredible infrastructure that it's really hard for others to come into the space, and that's because we're so dedicated and we're so focused. And we want to be a partner for the ecosystem. That's the mindset we have. So I think it's a bit of surprise and shock, for others that come in the space and say, "Well, we have to either focus on other areas, but how do we then come in the space where a lot of the options are taken away?" So one example is 2019, we had this thematic of direct to center through EMR. And so we deliberately and actively then went to bring in the other EMR tool and then recently started the issue we've got in the TransChart EMR tool. So we have more than 90 centers in the solid organ space, which have a direct transplant EMR connection. So again, really focusing on the center and this whole operational workflow is something that we shouldn't be taking for granted, but it's a wonderful infrastructure that's being built.
Matthew Sykes
analystGreat. And I think what's key to that infrastructure is not a huge revenue contributor today, but just the digital segment. You talked a couple -- about a couple of the initiatives you have on the pretransplant side. But how do you see some of these digital initiatives adding value to the overall CareDx platform? And do you think they could contribute in terms of revenue over the long term? And then just you made an announcement this morning of a small transaction, Transplant Hero, maybe how that fits in to the overall digital strategy?
Reginald Seeto
executiveYes. Absolutely. I mean I think for us, we believe connecting the patient, not only through offerings, but also through data capture and collection and through digital offerings is really important. At this stage, it's not meant to be the driver of revenue. So when we acquired Atara and we acquired TransChart, they were to further the operational improvements and to get deep in the moat versus saying, how do we drive top line revenues in this space. Now certainly, that's happening, but it wasn't a driver of strategic decision. And along with these acquisitions came some really, really smart people and created an acceleration or step acceleration in what we want to do in the digital space. So it allowed us to build things such as AlloCare, which was a transplant-specific patient app, looking at patients on AlloSure and how do they continue in a way that's fairly seamless by driving adherence and also increasing connectivity. And what you see is with Transplant Hero, which we announced earlier on this morning, is the ability to add additional patients, which go across different organs and which also actually a more socially -- social media focused as a driver of patient acquisition, but also they're well-known through their patient medication. So we have the ability to have an additional forum, additional approach with Transplant Hero. But clearly, both platforms will have the best of both in terms of the functionality. But again, it's part of a very deliberate strategy as we now look at direct to patient. And again, it's -- we feel like there are so many opportunities to connect the patient, and this is just another example of how we do that.
Matthew Sykes
analystGreat. And maybe we can just discuss cell therapy in potentially very large market. It's still pretty early. But maybe could you talk about your investment in progress within cell therapy and how big of an opportunity is this for you? And maybe any potential for more partnerships like the one you have with Atara?
Reginald Seeto
executiveYes. I think the opportunity we've described in bigger than the $5 billion TAM is something that we believe in -- we don't control that destiny in the sense that it's dependent on other allogeneic cell therapy companies making it to market through an FDA approval. So today, there are autologous cell therapy approvals, but they are not allogeneic cell therapies, which is why we think in the 5- to 10-year horizon, there could be a meaningful contribution because we do believe allogeneic cell therapies will be the way of the future in terms of -- based on the complete responses and the profile of treatment that we saw in cell therapy from an autologous perspective. The clear thing from manufacturers and biotech and large pharma is that they are moving to off-the-shelf platforms. And so for us, again, it's about the unmet need. There is definitely an unmet need in oncology. But more importantly, we believe that we can now create another universal standard with AlloCell, and that creates an opportunity for us to do so at the beginning. And it allows our strategy to focus on building these meaningful partnerships. Atara was the first one we're allowed to disclose. Just for transparency, none of our agreements allow us to disclose if we're working with a partner. So we actually had to go to Atara several times and seek their permission actually to share the fact that we're in partnership. And I think we have others that haven't sort of allowed us to share that. But all I can say is that where we've presented data, where we've shared the vision of what we can do with AlloCell, there has been singular interest in saying this is an incredible opportunity for us to think of how we could partner and how we could look at monitoring the patient who receives cell therapy, and then eventually, how does that lead to clinical intervention, right? The similar approach as we talk about AlloSure, how does it leads to clinical utility as part of that. So the grafting kinetics and looking at persistence, for example, what are the right ranges? And then ultimately, what do you do in terms of a clinical decision to do reinfusion if it's suboptimal, et cetera. So this is an incredible opportunity. It's one where we're dependent on others. The way we're approaching it is a bit of a stealth mode. We have a dedicated team of about 20 people who are working on this exclusively. One of the challenges you're facing when you have a business that's grown so quickly and that is barely penetrated by TAM like the solid organ opportunity is that you don't want other opportunities lost. So a very deliberate approach by us is to foster that entrepreneurial development of AlloCell and the continued laser-like focus for them because we depend on them building that 5 to 10 window picture for the future as well.
Matthew Sykes
analystGot it. One area that we haven't talked about is kidney. And can you just talk about the progress that you made there and the potential for KidneyCare eventually and some of the trends you're seeing in AlloSure Kidney?
Reginald Seeto
executiveYes. KidneyCare, again, we think that's the way of the future. And in terms of -- we had that as part of the OKRA study. And OKRA has -- will be finished enrollment by the end of the year. We also signaled that the AlloMap Kidney validation, clear lab validation will be completed also by the end of the year. And so what we're seeing with the universal LCD now is the ability to accelerate what we think would be required to eventually bring this to market. But what's clear is we started this enrollment of OKRA, there's 50-plus centers later than other studies that were being done by others, and we've had a really rapid enrollment because of the interest in innovation. We'll be finished before the end of the year. So not only do we have more centers than other concurrent registries that are taking place by others -- and we started later, but we will finish sooner. And that's because at the end of the day, people want innovation. And so AlloMap Kidney, along with iBox as part of KidneyCare, which is part of the OKRA study, is what's underpinning that sort of excitement. And so yes, so really excited by that. By the end of the year, I'm sure we've got to share more progress, but the 2 things we've shared publicly is the clear lab will be ready in terms of AlloMap Kidney, and secondly is that OKRA will finish enrollment by the end of the year. And certainly, with the recent guidelines, we know the approach that we'll take already for that.
Matthew Sykes
analystGot it. Ankur, maybe a couple of things on the financial side. Just looking at margins, you guys have sort of a longer-term goal of 75% gross margins. And you've outlined on one of your slides kind of some of the steps that -- to get you there. How do you feel about that sort of 75% goal? And what are some of the key steps in your mind just to achieve that gross margin goal?
Ankur Dhingra
executiveYes. Sure. Sure. Yes, I feel very good about that 75% target over a period of time. I can tell you as I was joining this company, one of the things that stood out very clearly to me was that the company was already self-funded. They were already generating cash. We're cash flow positive last year and already had significant growth investments already built into the P&L. So that was quite impressive. As I've now spent a little over 2 months into the company and have had a chance to look at the portfolio, I can say that there are parts of the portfolio that have been in the market for a while around the heart side and now several years on the kidney side. And the way that part of the business performs, I have good confidence that we can get to the 75% long-term gross margin. We've identified 4 main areas that we think we can -- which can get us there, right? So volume being one, for sure, as we continue to drive market penetration for products that are already in the market as well as add new tests and organs into our portfolio. That volume will drive quite a bit of leverage. We also think within our manufacturing environment, we have some meaningful opportunities and programs going on to continue to drive efficiency, and just aside to volume, which is driving productivity within our laboratory environment. And then 2 very important ones, one, multimodality. So we saw with HeartCare is that the price per patient takes a meaningful change in a multimodality environment. So as we add that, say, for the -- next up would be kidney, which is a reasonably large franchise, that can have a meaningful impact. And then last but not the least and very important is the commercial coverage. In our P&L today, we still perform a lot of tests, which are out of network. So as we work with our private payers and drive commercial coverage, you saw us publishing good KOAR data yesterday around the clinical utility for kidney. Some of these steps that we continue to take in improving both the clinical utility of the test and kind of give clarity around potential real-world outcomes that these tests can generate will help us keep driving commercial coverage. A lot of that cost is already in my P&L. So to the extent we drive that commercial coverage would be an important factor, too. So we have a good path. The team knows the playbook. We just have to keep driving it. And at the same time, as we launch new organs, that playbook will kind of continue.
Matthew Sykes
analystGot it. You talked a little bit about -- just on the flip side, that's some of the potential cost savings. I know you guys are in kind of growth mode, but you have mentioned in the past things like lab automation, things like that, that could actually help, and you talked about some efficiencies. Maybe just spend a little time on the cost side and where you think you can take some out?
Ankur Dhingra
executiveYes. Sure. So laboratory automation is definitely one area that we are -- that we look at. We actually have active programs that are going in. As we tackle higher volume of activity, we kind of keep looking at that to say, "How can we drive throughput without a commensurate increase in the cost?" So several programs underway in that area. We also think as we look at our OpEx leverage, there is potential leverage in our sales and marketing. We have very strong commercial network, which is well connected into the centers. We are investing on the nephrology side right now. But overall, I think over the next several years, if you take a 2- to 3-year view, I would expect that our sales and marketing growth is likely going to be slower than the pace at which our revenue would grow. We would be able to -- we expect our new organs that we will add into the pipeline over a few years, a lot of that can flow through within -- from our current commercial structure as well. So 2 areas where I see largest efficiency and productivity opportunities.
Matthew Sykes
analystGot it. And then just on capital allocation. You obviously made an announcement this morning, but just in general, how are you thinking about organic versus inorganic investments in the current environment?
Ankur Dhingra
executiveYes. So both organic and inorganic, as you would imagine, are heavily focused on growth, which are either bringing new products to the market or in cases where we believe we need to add newer capabilities. In those cases, we end up taking the inorganic mode as well. The focus of the company is on the transplantation market, right, from the point of where that customer either gets into a waitlist or is considering a transplant where we have now have a TX Connect app to the point where we already have a fairly extensive post-transplant monitoring tool set in connection with the patient. So we have incredible credibility in that space. We have great connections with majority of the players in that entire transplant journey. And we think there are still significant areas, either within the testing services or in the pretransplantation space or the peritransplantation space where CareDx can meaningfully make a positive contribution to some of the assets and businesses. So that's how we look at our capital allocation where our -- in our hands, the assets that can drive either an increase in the available organs during transplantation or the volume of transplantation activity or anything that can help us improve patient outcomes or specific allograft outcomes as well. So that's where our focus remains. You've seen quite a few digital investments that we've made, but our focus overall remains on that entire transplantation journey. Reg, you would like to add anything?
Matthew Sykes
analystYes. Okay. Yes. I think maybe just in closing, one thing I'd like to ask is, what do you think is the most underappreciated aspect of the CareDx story that investors quite -- aren't quite getting out?
Reginald Seeto
executiveI always find an interesting question -- because I think for me that I try to reflect on what I think CareDx represents, and I think we're a leader in transplant. We have this incredible moat, and we drive innovation. But I thought I'd actually -- to understand what's misunderstood, I thought I'd ask a couple of investors today live at the end of each meeting what do they say they understand. And so I'll just read out some of the -- 3 quotes that I got. One of them said, "We have a single focus on transplant. We apply this to other organs like every heart, and it's and open-ended story." So that was verbatim number one. Verbatim number two, "It's an ongoing story, growth rate's incredible and not burning cash." Investor #3 is, "You have an incredible lead over others. You put such a distance. You have a multiyear growth runway, and you just need to drive penetration." So it's interesting to see what -- that was understood. I think for me reflecting back, there probably -- I look at the lens of what's understood and misunderstood through the eyes of investors. I think about -- in this role for the last 7 to 8 months, I, in the first 90 days, spoke to 135 investors and obviously more since then and may repeat. But what was clear is we have a set of historical investors who are still in the stock [Audio Gap] and that there was a market to be created through unmet need. So there was a -- there was this real $2 billion TAM at the time. So we felt it was very powerful. We had the recent investors since Q4 who really have understood the story about it's not just about this $2 billion TAM. There is a $12 billion TAM that you guys are going to capture. You're going to drive multi modality. What you've done with patient management has been incredible. And as you go forward, how do you continue to expand the TAM? So it's this impressiveness, it's just not stopping it, too, but the ability to expand and add to that TAM. So that's more the recent investors from Q4 today. I think as we continue over the last -- this over these last 2 weeks, Ankur and I spoke to another probably 110 investors. And what's clear is there are new investors that really can appreciate this whole future strategy of connecting the patient, and I think there are so many things we can do on this patient journey. And I think that, that's an area where not everyone will be the same level, and they won't understand this whole patient journey, but these are the new investors that are coming in now. And I think it creates multiple opportunities, whether it's a direct to provider strategy, it's a direct to payer strategy. But the point here is that there's an endless number of opportunities as we look at transplant and that patient journey. So again, we feel really excited. We know we have the incredible platform, which you described. And also your vote of confidence with initiation as well, we feel honored to be working and presenting it in the Goldman Sachs conference. Really appreciate the opportunity to do that as well.
Matthew Sykes
analystGreat. Well, I think with that, we're out of time. Well said. Reg, Ankur, thank you so much for joining us. Really appreciate it.
Ankur Dhingra
executiveThank you. I was a pleasure again.
Matthew Sykes
analystTake care.
For developers and AI pipelines
Programmatic access to CareDx, Inc. earnings transcripts and 32,000+ others is available through the
EarningsCalls.dev REST API. Plans from $24.99/month — full transcripts, speaker segments,
full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.