Caris Life Sciences, Inc. Q3 FY2025 Earnings Call

Good afternoon, everyone, and welcome to the Caris Life Sciences Third Quarter 2025 Earnings Call. My name is Shannon, and I will be your coordinator today. Please be advised that today's conference is being recorded. I would now like to hand the conference over to Russ Denton at Caris. Please go ahead.

Thank you. Earlier today, Caris Life Sciences released financial results for the quarter ended September 30, 2025. Joining from Caris today, David Dean Halbert, our Founder, Chairman and CEO; David Spetzler, our President; Brian Brille, our Vice Chairman and EVP; and Luke Power, our CFO. Before we begin, I'd like to remind you that during this call, management will make forward-looking statements within the meaning of federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. These risks are discussed in our SEC filings, including our prospectus filed with the SEC in connection with our IPO and our quarterly report on Form 10-Q to be filed with the SEC. Except as required by law, Caris disclaims any intention or obligation to update or revise financial projections and forward-looking statements, whether because of new information, future events or otherwise. The information in this conference call is accurate only as of the live broadcast. This call also includes a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items. The reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measures are available in the press release Caris issued today. A copy of today's presentation materials can be found on our Investor Relations website. I will now turn the call over to David Dean Halbert.

Thanks, Russ. Good afternoon, everyone. Before the team walks through our exceptional financial results for the third quarter, I want to take a moment to speak about something even more important. The foundation that makes these results possible and the vision that continues to drive Caris forward. When I founded Caris, my goal was simple: to make precision medicine a reality. Our only purpose is to help patients live longer and have a better quality of life by applying personalized medicine to disease. In 2018, I made the decision to move Caris to Whole Exome and Whole Transcriptome sequencing. It was a bold move at the time, but I believed it was the only path forward. That decision put us at the forefront of precision medicine, where we've remained ever since. 17 years in, I can say with confidence that the mission has only grown stronger. The power of our Whole Exome and Whole Transcriptome platforms across both tissue and blood has exceeded my expectations. The data that we have generated from these platforms, utilizing the cloud and AI, lays the groundwork for what comes next. The next step is what excites me most. I believe that in the not-so-distant future, the work we're doing today will move medicine beyond diagnostics and treatment into true prediction and prevention. We'll be entering a world where we can anticipate disease before it begins and intervene before it ever has a chance to form. I've referred to this concept as cleanse or personalized disease prevention, where we can one day identify and eliminate pathogenic mutations before they ever become disease. In pursuit of this vision and to expand our current platform, I made the decision to incorporate whole genome sequencing into our early detection test. It's another step forward as you consider Whole Exome to be the highlight reel, and whole genome as the full movie. And now as we stand at the intersection of biology and technology, the possibilities are accelerating faster than I imagined. The rapid advancements in artificial intelligence, the explosion of data and sequencing, and the evolution of how data is analyzed and consumed are transforming what's possible. What began as a vision to make precision medicine a reality is happening, including a platform that we believe will redefine how we understand, predict, and ultimately prevent disease. This is the future we've built toward from the very beginning, and I'm excited to continue on this incredible mission.

Thanks, David, and thank you all for joining our third quarter 2025 earnings call. This is our second call as a public company following our June IPO. As David mentioned, we're pleased to report another record-breaking quarter, one that marks a significant milestone in Caris' history in terms of continued growth and underlying profitability. We've had an outstanding third quarter with total revenues increasing 113% year-over-year to $216.8 million. As shown on Slide 3, this result was driven primarily by strong performance from clinical profile. Molecular profiling services revenues increased to $207.6 million, representing an increase of over 121% year-over-year. And pharma R&D services revenues increased to $9.2 million, an increase of 18.3% year-over-year. On Slide 4, with respect to molecular profiling revenue, you can see the remarkable increase of 121% which was driven by consistent growth in clinical case volumes as well as very strong growth in clinical ASP. Clinical case volumes were slightly less than 51,000 individual profiles representing growth of 18.2% year-over-year, in line with our expectations. Caris Assure for therapy selection continues to gain market share and produced 66% year-over-year case volume growth in the third quarter, which is an increase from the 56% year-over-year growth in the second quarter of this year. In addition, ASP increased to $4,089 per profile for growth of 87% year-over-year. This represents important sequential improvement from the $3,256 per profile in the second quarter. As you may recall, this is primarily due to the new CMS rate of $8,455, which took effect retroactively through November 5 last year, the date of MI Cancer Seeks FDA approval. This mix shift to MI Cancer Seek has driven the increase, and we've also made further progress with private payers. It also includes some overcollections and true-ups relating to prior period cases, which Luke will discuss in more detail later. In summary, across the board, we've had a very productive third quarter, illustrated by the highlights on Slide 5. The strong revenue performance, combined with the operating leverage inherent in our business model, has produced significant margin improvement. And specifically, gross margins improved significantly to 68%, up from 43.7% in the third quarter of last year. It also represents a significant sequential move up from the 62.7% in the second quarter. This was driven by several factors, including strong overall revenue growth as well as lab and other operational efficiencies. In fact, with this gross margin improvement, we have successfully achieved another major milestone in our path to profitability. And this quarter, we generated positive adjusted EBITDA of $51.2 million and net income of $24.3 million as well as positive free cash flow of $55.3 million. Together, the strong profitability profile provides valuable flexibility for ongoing investment in our technology platform for new products as well as the ability to develop new channels such as Multi-Cancer Early Detection. Luke will expand further on these important developments and our philosophy for strategic investment. In addition, our balance sheet continues to strengthen, and due to our cash flow performance, our cash on hand grew to a little under $760 million, an increase of 4.7% sequentially. This continues to provide us with important strategic flexibility for ongoing investment to develop Caris' extraordinary opportunities in MRD, monitoring, early detection, and other markets as well. Slide 6 illustrates the consistent and systematic growth that our team has generated in clinical profile over many years. We've grown clinical case volumes at a CAGR of 28% over the past 5 years, and this growth rate has continued in the first 9 months of 2025 at 23.4% growth year after year. The sustained case volume growth reflects several factors. First, the unparalleled breadth and depth of our Whole Exome, Whole Transcriptome assay technology, 23,000 genes DNA and RNA continues to resonate with oncologists, KOLs, and cancer center leadership. In addition, our differentiated coverage strategy, as well as research orientation and the Caris Precision Oncology Alliance provides us a competitive edge in the market. Finally, we believe that the therapy selection TAM continues to expand with new indications as well as ASP growth. And most importantly, we believe that the penetration rate for comprehensive genomic profiling remains relatively low at about 30%, providing us with growth opportunities to serve more physicians and patients with superior technology over many years. We also benefit from strong operating leverage associated with our established distribution channel, seasoned sales force, and strategic relationships at both the institutional and the individual oncologist level. We are now consistently reaching approximately 6,000 oncologists across the country. In addition, there are other technological efficiencies such as EHR integration, which will further enhance the pipeline connectivity with our clinical client base and have facilitated case volumes. For instance, we are now EHR-integrated with approximately 2,800 clinical sites, and over 65% of our orders come in electronically. As you can see on Slide 7, the Caris data set has continued to grow with our clinical profiling activity and now exceeds 959,000 genomic profiles and 660,000 matched profiles. Since every profile has been generated with our Whole Exome, Whole Transcriptome technology for many years, our data set features 577,000 exomes and 628,000 transcriptomes. This gives our data set tremendous power for our own internal product development and continues to enhance our attractiveness as a preferred research partner for academic medical centers as well as biopharma. We continue to work with potential new partners for the Precision Oncology Alliance. And given the size and breadth that we currently cover, we're being very strategic about adding additional sites. We have important opportunities across the existing 97 sites for deepening relationship penetration and adding new modalities across the continuum of care. As communicated previously, the POA members benefit from access to our CODEai genomic data set as well as the opportunity to publish with us, and the POA collaboration has produced a cumulative total of over 1,150 peer-reviewed publications reflected on Slide 8. In conclusion, we are very pleased with this latest quarter's performance and the demonstration of sustainable growth, profitable business model, and a very exciting future. I'll now turn the presentation over to Dr. Spetzler to discuss our progress on our product pipeline. Spetz?

Thanks, Brian. I will begin by giving a quick update on our MRD CRC solution on Slide 9. We are working to obtain reimbursement on Caris Assure MRD Colorectal. The data we submitted includes over 100 patient samples evaluated on the Whole Exome and Whole Transcriptome Caris Assure platform, incorporating our PTEN gene expression in AI-based signature. As part of our submission, we also compared our performance to that of a commonly used third-party MRD assay in colorectal cancer. Samples tested within 60 days of one another. Among these cases, we demonstrated 96.3% positive percent agreement and 100% negative percent agreement. The disease-free survival curve on the right shows that patients identified as likely to recur experienced shorter disease-free survival, while those predicted as no event remained disease-free for extended periods. The separation between these groups with a p-value less than 0.005, supports the test's ability to accurately distinguish recurrence risk. Using the ABCDai scores, we demonstrated consistent signal detection and strong correlation with known molecular and clinical features. This data supports our belief that MRD detection grounded in Whole Exome and Transcriptome data can capture a broader molecular landscape and offer deeper insights into tumor biology. In addition to our MRD Colorectal, we continue to make progress on other solutions in our pipeline and expect to finalize these additional solutions for submission shortly. These are reflected on Slide 10. The first is Caris ChromoSeq which is our therapy selection offering within the hematological malignancies cancer space, including AML, MDS, and MPN as well as suspected myeloid malignancies where other causes have been ruled out. As communicated previously, this approach utilizes both whole genome and whole transcriptome sequencing, and the solution provides more than 200x depth of coverage of the genome and approximately 1.6 billion reads per patient, enabling detection of mutations, fusion, copy number changes, expression, and ploidy across the genome. The second submission expected is for MI Clarity, which focuses on patients with breast cancer who are ER positive and HER2 negative, typically lymph node-negative or with limited nodal involvement primarily in Stage I or Stage II disease. MI Clarity combines our tissue platform and digital AI analytics to produce both early and late return recurrence scores designed to inform individualized treatment and monitoring strategies, and we believe this will offer superior performance to existing third-party offerings. MI Clarity was developed and validated on samples from 2 large randomized controlled trials, and results will be shared at a large upcoming international conference. We are very excited for these solutions and believe that they can continue to expand our unique approach to building out our suite of solutions in an efficient manner. Like our MRD Colorectal submission and as stated on previous calls, we will hold off on providing potential launch dates until we have made it through the expected rounds of feedback. And then finally, I will give a brief update on our current studies progress. As reflected on Slide 11 on the early detection slide, our ACHIEVE-1 study is complete with enrollment of 3,000 subjects. ACHIEVE-2, which is targeting 25,000 subjects, is well underway with over 15,600 patients already enrolled. That brings our combined total to more than 18,600 subjects across more than 40 different cancer types and normal controls. The ACHIEVE program remains the cornerstone of our early detection platform with particularly strong representation across normal and premalignant populations, over 14,000 normal subjects and more than 2,500 with advanced adenomas. This gives us a powerful data set to refine our assay performance and validate early signals across multiple tumor types. David already touched on this, but we are incorporating whole genome into early detection, and we will be utilizing the data set to provide the readouts and ACHIEVE-1 in the first half of 2026, utilizing the whole genome. On the right side of the slide, you can see our MRD and monitoring portfolio, which now includes more than 3,300 subjects across a range of indications, which are currently undergoing contracting and enrollment. Enrollment is balanced across key solid tumors with the largest cohorts in non-small cell lung cancer, rectal and esophageal gastric cancers. The data generated from these efforts will feed directly into our development pipeline and commercial readiness planning. As Brian mentioned earlier, we continue to believe that we are in the early innings of the potential for precision medicine and remain very excited for the impact that this will have not just on patients of today, but also those in the future. I will stop there, and now pass it over to Luke for the financial updates. Luke?

Thanks, David. Brian mentioned some of these already within the highlights. And as you can see within our earnings release, we'll continue to provide a summary metric table. So I'll go through the next few slides relatively quickly. Turning to Slide 12. You can see we delivered another outstanding quarter with total revenue increasing 113% year-over-year, reflecting exceptional organic performance across the business. The main driver, as expected, was our molecular profiling business, which grew 121% compared to Q3 of last year. Our molecular profiling business continues to perform at a high level, and therapy selection volumes were up 18% for the quarter and 23% year-to-date, right in line with our expectations for mid- to high teens growth in the second half of the year. And this is separate from any potential new solutions that David mentioned earlier around MRD, Caris ChromoSeq, MI Clarity, and early detection. More importantly, this growth is showing up in the bottom line. We are seeing continued improved commercial reimbursement following our FDA approval for tissue and stronger-than-expected contracting for blood. These tailwinds drove gains in cash flow and adjusted EBITDA and have also delivered better-than-expected ASP across both tissue and blood solutions. As Brian mentioned earlier, we also saw stronger-than-expected collections both on current and prior cases, and this resulted in a $37.9 million revenue true-up for the quarter. That true-up reflects increased payment activity from commercial payers and highlights the continued positive trend we have seen in reimbursement. And as we said before, as payer history continues to build, we expect these true-ups to become smaller over time, particularly post 9 to 12 months of launch. So even excluding that benefit, our underlying base ASP improved ahead of our expectations. For tissue, we're now 10 months into launch of our FDA-approved solution and are beginning to see steady predictable patterns, and this is reflected in the $3,500 base ASP for the third quarter and a little under $4,300 with the true-ups. We also still expect Q4 base ASP for tissue to be around $3,600, and with the third quarter performance, including the true-up, expected full year tissue ASP to be trending slightly above $3,400 for the year. Within tissue, MI Cancer Seek continues to remain 78% of the total tissue volume. And we surpassed a major milestone of 200 million covered lives for MI Cancer Seek, which includes governmental and commercial payers, and that's a direct result of the excellent execution by our market access team. Switching to blood. Blood space ASP reached $2,377 per case, and with true-ups that exceeded $3,000 per day. Improved tissue contracting continues to have a positive impact on our blood ASP, so we're raising Q4 guidance to be in the $2,300 to $2,400 per case range, which, along with the Q3 performance, will put us close to $2,500 per blood ASP for the full year. Within blood, another great market trend continues to play out. And we saw that for Q3, where 40% of our blood cases also had a tissue case performed, which was up from the mid-30% range last quarter. Turning briefly to pharma revenue. As expected, revenue declined sequentially this quarter, several projects and associated customer spend shifted into Q4, which is a similar pattern we experienced last year. That said, pharma revenue was still up 18% year-over-year, reaching $9.2 million. Pharma continues to remain a smaller part of our overall mix, but it's strategically important, and our focus remains on building longer-term partnerships on multiyear agreements rather than one-off projects. Similar to prior year, we do expect sequential improvement as we move into the fourth quarter versus Q3 performance. These revenue numbers obviously had a very positive impact on our gross margin for the quarter, which was 68% and up from the 43.7% in the third quarter of 2024. And was the result of the continued excellent work by our labs teams in maintaining operating efficiencies with the increased volume, along with that ASP improvement. In fact, one of the key milestones we achieved in Q3 was being able to get our turnaround time for tissue down to 8 days and blood at 7 days. Considering the sequencing requirements for our Whole Exome, Whole Transcriptome solutions, this demonstrates the significant progress we are making on lab efficiencies and the excellent work by our teams. We will also see these great trends on Slide 14, and we believe with the continued improvement in ASP and our updated revenue guidance, which I'll discuss in a little bit, that we should be getting to a 62% gross margin for the full year 2025, which would be an increase from the 43.4% that we had in 2024. Moving down from an operating expense standpoint, we continue to demonstrate excellent operating leverage, and the 9% ramp year-over-year was primarily driven by an increase in stock-based compensation. We continue to look for efficiencies not just with the emergence of AI and the potential impact that has on business processes. But also on our R&D efforts in which our efficiency efforts are supported by having one platform across the care continuum. In fact, due to the improved performance, we actually hit the milestone of not just having positive adjusted EBITDA but also net income, which is our first in our 17-year history. The last item I will comment on from this slide before jumping to the guidance slide is free cash flow. Q3 was obviously great in this regard as we achieved positive free cash flow for the quarter in the amount of $55.3 million. This performance continues to strengthen our balance sheet and allows us to build up some dry powder ahead of the new solutions David discussed earlier. With regards to our investment approach, and as I've stated before, this continues to be opportunistic, and we're currently assessing opportunities for expansion in marketing and sales, along with assessing any external opportunities that may arise. The main goal for us financially continues to be not to hoard profits but to focus on our mission, as David Halbert discussed at the start of the call. And finally, jumping to Slide 15, I'll give a brief update on guidance. As previously communicated, we'll continue to provide guidance on the total revenue and expected clinical therapy selection volume basis. And with regards to these, given the excellent performance of Q3, we're upping our total revenue to be within the range of $720 million to $730 million for FY '25, which would be a 75% to 77% increase over 2024 and increasing our expectations for clinical therapy selection volume to be even a 21% to 22% for the year. I will wrap up there. I will now turn it back over to the operator.

Our first question comes from Vijay Kumar with Evercore ISI.

Congrats on a nice quarter! Maybe my first question on the performance here in the quarter. ASPs clearly came in strong. What is your implied Q4 guidance? Assuming, Luke, I think revenues are down sequentially. So does it include any true-ups? And what was underlying gross margins in Q3, excluding the true-ups?

Yes, Vijay. So yes, as I stated in Q2, we'll never forecast any potential true-ups because, again, we don't know those until the end of each quarter. So it's not assuming anything there. So for total revenue for Q4, our assumption in the guidance we put out is in the $200 million to $210 million range for total revenue. So to answer your other question then, what was our underlying gross margin without the true-ups in Q3, that was about 61%, excluding that true-up that we had in Q3.

Understood. And then maybe one on the clinical side here, this colorectal MRD data that you're showing. Is this enough for you guys to submit to CMS or what kind of data is needed if there's any additional data that's required, could you update us on when we could expect the data?

Yes. I'll take that one. It is enough data for us to submit. We don't know how they'll necessarily respond and what additional data that they will want. But we do have additional data ready, and some of the studies that we listed will be reported out soon.

And sorry, when you say this is enough to submit, have you submitted or are you planning to submit to the CMS?

We'd like to only talk about that after it's been approved because the process is complex and long.

Our next question comes from the line of Dan Brennan with TD Cowen.

Congrats on the quarter. Maybe just one more on price. If you don't mind. Just could you walk through a little bit of kind of the success on the underlying pricing ex the true-ups, how you saw the progression in terms of payment rates against the $8,455 rate for the tissue side? Like how are you doing versus expectation? Maybe just give a little color on the commercial success there in Q3 versus Q2 and same thing on Medicare. And then kind of how are you thinking about, I think you said kind of price in that same ZIP code, the underlying price for 4Q. So just kind of what's assumed in 4Q as we think about the underlying price across Medicare and commercial?

Yes, Dan. So effectively, what we're assuming for our base, and is what I said in the presentation, is about a base for tissue of 3,600 for Q4. Now we obviously think there's a possibility it might come in a little bit higher than that, but I'm being cautious in the guidance I'm putting out there until I get a little bit more history on the payments. By the time we get to the end of the year, we'll have about 9 months of payment histories from payers. And based on our historical experience, you're probably in that 9 to 12 months where you have like a very established trend. So what we saw in Q3 happened, and what we've seen throughout the year is actually the response we're seeing from commercial payers has been very, very, very good. So that's what's kind of driving it. And when we discussed I think it was in Q2 as well, like we have an underlying goal for ourselves, too, that we should be getting to an overall percentage of what the Medicare rate is for our overall ASP. And I think we're probably about a quarter ahead of where we thought we were going to be at the start of the year. And again, that's due to the great work of the market access team and the billing team. So I think what we'll see going forward is trying to get above my next goal for the company and the next goal for, obviously, the market access team in the first half of next year is to try and get above a $4,000 ASP for tissue, and I think we can deliver on that.

Great. And then maybe just on the pipeline, just on early detection, you gave a lot of cover, David in terms of the ACHIEVE study. There's a lot of excitement in that space right now. Can you just kind of walk us through a little bit more of timelines? I think you said, what, ACHIEVE-2 16,000 enrolled, ACHIEVE-1 like just kind of walk us through kind of how we think about the cadence of publications go to market? Like would you guys consider launching an LDT? Just how does that work and kind of the spending associated with that?

Yes. We'll read out ACHIEVE-1 in the first half of next year. The accrual rate on ACHIEVE-2 is pretty strong. So it's probably late next year or early in '27 when we'll read that one out. And we would consider an LDT launch for sure.

And that would be after ACHIEVE-2, you consider the LDT launch?

No. Before, I think ACHIEVE-1 gets us where we need to be on that.

Our next question comes from the line of Michael Ryskin with Bank of America.

I want to dig into your volume guidance for the year. You bumped that up a little bit. You're looking at, I think, 21% to 22% for the year, a pretty good cadence start of the year. It is a little bit of a conservative assumption for 4Q. But if I just look at the total volumes on a patient basis, you're kind of trending in that 50,000 to 51,000, 2Q, 3Q, 4Q. So as we think forward to next year and just sort of beyond, what gives you confidence you can kind of reaccelerate that and take a step function? Maybe just talk about the sequential versus the year-over-year growth? And how do we think about volumes progressing beyond the next couple of quarters? And I got a follow-up.

Yes. Thanks, Mike. So yes, for Q3, obviously, the 18% came in kind of in line with what we were expecting. And kind of the reason for that guide and kind of the actual results, we were actually pretty cognizant about this coming into the year is that Q3 last year was actually probably one of our highest quarters at 35%. So it was a very tough comp coming into the year, and we wanted to be careful setting expectations against that. Now as you mentioned, what we did with the updated guidance is we're increasing the higher range on that volume based on what we've seen play out later in the quarter. So we feel very good about being in that total 197,500 cases to 198,500 cases for the year as we sit here today. So then that would obviously get you in that kind of 22%. Now you asked about what we think for next year, we're not going to release the guide right now because of what Brian mentioned on the call, and I'll leave Brian jump in, in a minute about the commercial pipe. We've seen kind of an uptick after the summer months, especially among ordering physicians and obviously, especially with our blood volume. So one of the key things that we're working towards now for blood for Q4 is we got the 7,500 cases, probably a quarter than we were anticipating earlier. So our expectation now is, okay, can we get above 8,000 cases for the quarter in Q4. And then once we have that, one of the other key catalysts for blood that we've obviously mentioned on the previous call, too, is getting the New York State approval since we're not selling in New York right now. And I think that will obviously give another additional kick to the volume from blood. So I think what we'll do at the end of the year, especially when we report that preliminary numbers and probably for JPMorgan, we'll put out a guide around what we expect our therapy selection volume to be.

Okay. All right. And then if I can get a follow-up on the strong EBITDA number in the quarter, the free cash flow, I mean, even if a good chunk of this was attributed to the true-up, clearly, you're moving to profitability and cash flow positive earlier than you expected. Can you talk about incremental spend priorities? And just, again, how do you balance the profitability versus the opportunity to reinvest back in the business? Just want to get a sense of if things come through again on the top end, on the higher end, where that extra money will go.

Yes. Yes. And it's a great question because obviously, we're in a fantastic position financially right now. And obviously, that's why David Halbert said what he said at the start of the call, like we're going on to our next phase. And one of those phases is obviously doing whole genome for early detection. So there is going to be an increase in spend there. Now for Q3, we did have kind of on the lower end of the previous range I put out for OpEx. It was like $114 million. Now I do expect for Q4 based on obviously starting the ACHIEVE-1 study and running whole genome for that to be kind of in the higher $120 million for OpEx for Q4. So that's going to be some of the investment, too, of those kind of additional free cash flow that we have for Q3. Then the other thing that I mentioned on the call, we're also assessing opportunities for the sales and marketing teams with additional spend there. We spend kind of a lot of time in Q3 just thinking about, okay, how do we want to be structured as we go forward with the new solutions that we have in our pipeline, along with our therapy selection. So there's going to be an increase in spend there as well. And then there's also external opportunities that we'll continue to assess.

Mike, it's Brian. The business model that we've built over a number of years, though gives us a tremendous amount of flexibility. So the numbers have kind of definitely come into their own with respect to profitability. And that's being driven by growth overall, but also by the operating leverage inherent in our business in both the tech platform, which is set up in sort of this one assay format that's very, very powerful as well as the channel that we've built over many years. So as you've mentioned before, our growth has sort of doubled over the past few years, while headcount has been basically flat in the channel. So we benefit from very strong relationships, senior relationships at the top of the house with respect to cancer center leadership as well as individual physicians. We're up to 6,000 or so now ordering physicians. So it's a very efficient business model that we think is well-suited for ongoing profitable growth. So I think it gives us David Halbert directly us well as Luke from a financial perspective to invest in the business, whether it's tweaking the sales force, as Luke was talking about, but also really leaning into what we think is a tremendous opportunity in early detection. So it's not like we're going to have to make really tough decisions either way. I think this business model is going to support our strategic moves against what is, we think, just historic market opportunities across the whole molecular information landscape.

Our next question comes from Doug Schenkel with Wolfe Research.

Starting on MRD. Once you have MolDX coverage, what is the commercialization strategy to scale that business? And specifically, what I'm getting at is, can you go after it, get it with your existing oncology sales force without material headcount expansion? And then relatedly, how should we think about initial pricing? Will that align with currently reimbursed tumor-naive levels? Or do you think MolDX will actually allow for premium pricing, given the breadth and depth of your assay?

I'll take the first part, which is straightforward. Our relationships with physicians and cancer centers appreciate our technology and are looking for more modalities from us. MRD and monitoring fit perfectly into that. There’s clearly a demand in the marketplace for a complete solution from us. We won't need additional headcount; the same sales force and MSLs will continue working with the physicians. Our existing channel will support these same physicians and institutions. This makes for an efficient and natural launch from our perspective. Spetz, do you want to address the pricing, or Luke, would you like to take that?

Yes, I can take that. Yes. So Doug, so obviously, we're going to be talking with MolDX, so we don't know. Obviously, we think there should be a premium to it based on what we're doing because it's obviously the exact same assay that we got covered for therapy selection. But obviously, it's a different indication now for MRD. We'll have those discussions. But given the position we're in, we're obviously not price sensitive. I think once we actually get to the stage of getting that approval, we'll be ready to launch it even if it's not at like a very high price, even if it's that something similar today.

Okay. Super helpful. And Luke, I think it's another one for you, but just on a different topic. You got to really robust 68% gross margin, and I think it was 24% adjusted EBITDA margin this quarter. As we think about new products and the mix shift towards liquid biopsy over time, I'm not sure it's going to be a straight line, but I can easily see an excel how the gross margins move into the low 70s. The EBITDA margin gets into the high 20s, anything you think we should be thinking about as we're updating our models for the next couple of years, given an excel, it looks like things can move up pretty quickly, but there are definitely a lot of opportunities for you to invest in pipeline products.

Yes, there is a lot to discuss. We have talked as a company about our strategy not to target an extremely high positive EBITDA margin. Our goal is to reinvest in the business. Brian mentioned the importance of early detection, which aligns with David's vision and will be a key focus for us next year, alongside MRD. Given our position, maintaining a 68% gross margin, even without true-ups, is favorable for us. We are achieving a neutral EBITDA and positive adjusted EBITDA without the true-ups, demonstrating our efficiency. Looking to the future, MRD has potential, especially as Medicare reimbursement and commercial adoption are beginning to increase. However, it may take time before MRD becomes a high gross margin product; we'll need to refine it as we have with therapy selection over the years. This could compress margins initially. On the other hand, we plan to launch data self-pay for early detection, which should contribute positively to gross margins. Overall, we will be in a strong position with our growing pipeline. Still, I want to emphasize that we aim to keep adjusted EBITDA numbers below 30%, as our priority is reinvestment and future growth.

Our next question comes from the line of Casey Woodring with JPMorgan.

Congrats on the quarter. So you guys called out strong Caris Assure volumes this quarter. Another liquid biopsy competitor also called out an acceleration in blood-based therapy selection volumes. Just kind of curious how you guys are seeing the market movement towards blood? And has it accelerated in the past few quarters and expectations for that in the future year?

Do you want me to take that Brian? Or do you want to take that?

Yes, I can address that.

Yes, Casey, so like it was great for Q3, obviously, seeing that acceleration in the growth rate from Q2, especially knowing that we've only probably been like a little over a year since we launched Caris Assure now. I think what we're seeing in the market and kind of what I called out in the presentation, what we're seeing is more concurrent testing, which is definitely benefiting us. So last quarter, like about 35% of our blood cases also had a tissue case performed, and that went up to 40% for Q3. So I think that's playing out. I think there's more indications. And I think physicians are obviously getting more and more comfortable with what we're offering with the Whole Exome, Whole Transcriptome along with our tissue and seeing kind of the benefits of that. And obviously, the chips of traction, which is unique to us in the sequencing that we do on that. I think they're starting to see that play out a little bit more.

Got it. That's helpful. And then maybe just a quick follow-up. By our estimation, it looks like the guide implies a pretty sizable sequential step-up in pharma R&D services in 4Q. Can you just provide any color on visibility into that, how you're thinking about the 4Q ramp in pharma R&D? And then what percentage of that growth is going to be driven by the data licensing piece?

Yes. So for Q4, effectively, like the $200 million to $210 million of total revenue, that's in the guide. Effectively, our molecular profiling, the guide is showing $180 million and then we're showing $20 million to $30 million in pharma because you asked the question how much is known. We have a lot of contracts working through the pipeline right now. And similar to what we saw in Q4 of last year, where we did have a pretty big step-up. We do think there's going to be a step-up from Q3. But again, what we would put in the guide for pharma for Q4 would be that $20 million to $30 million range because, again, it's going to depend on timing. And obviously, what we're trying to do as a company is not do a one-time deal and get into longer-term partnerships. Now you asked about the data component there will be an element of that, but we're not going to start breaking out kind of the three pillars in pharma until we actually start getting kind of that pharma revenue greater than 10%, 20% of our mix. We've always been clinically focused. We're always going to be clinically focused, but we do think there's strategic importance within pharma. And we will build it up. But for now, for Q4, it's in that $20 million to $30 million for pharma range.

Our next question comes from the line of Patrick Donnelly with Citi.

This is Alberto on for Patrick here. So going off Doug's earlier question, obviously, the EBITDA this quarter was very impressive. And you also mentioned that the cap is around 30%. So just making sure our expectations are in line here. Would you say that Q4 is going to see around similar EBITDA margins as this quarter? And then perhaps into the next couple of quarters, it ramps up a bit before getting capped at around slightly below 30%. Is that the right way to think about it? Or would you say...

Yes. I would actually think of what we're putting in the guide because again, we're not assuming any true-ups. We had the kind of true-ups reflected for Q3. So that $200 million to $210 million. And obviously, with the 60 kind of mid-60s gross margin and then your OpEx in the $120 million, you kind of get into that kind of somewhat similar to Q3, a little less than Q3, though, is what I would guide to.

Perfect. And then as a follow-up, on another similar question earlier, on early detection, what would you guys say is your consideration for pricing strategy there? Obviously, there are only a couple of tests in the market today. But curious what you guys are thinking in terms of where to go in terms of pricing strategy and what factors are in the considerations for early detection mix?

Yes, I don't think we should continue, go ahead, Luke.

No, you go, Brian.

No, I was just saying that's not something we are ready to disclose right now. We believe our capability is very special, and we will highlight our advantages in both technology and data sensitivity and specificity. Like the rest of our platform, our approach will emphasize premium capability and premium pricing.

Our next question comes from the line of Subbu Nambi with Guggenheim.

You mentioned 43% of your blood test has tissue attached. Do you expect any momentum here in the coming 12 months? And where could this go long term?

Yes, that's a great question. I can't predict the long-term trajectory, but we've seen that percentage increase over the year, which I consider a positive sign. Lung indication is particularly important, especially for blood tests, and it makes up a significant portion of this. As more indications and drug approvals emerge related to this area, we could see changes. For Q4, I currently estimate that it will be around 40% based on what I'm observing, and we do expect a slight increase. However, I’m not in a position to say whether it will reach 50% or 60% over the next year. That remains a possibility, but until we observe how our ordering physicians respond, I prefer not to provide specific guidance.

So we're pretty happy with the current sensitivity of MRD on the exome, transcriptome platform. So I don't know that that's necessary. There are aspects of whole genome that are particularly well suited to early detection that are not necessarily directly translatable to MRD.

Our next question comes from the line of Mark Massaro with BTIG.

Congrats on the strong quarter. So I wanted to ask a question about data and pharma. So other companies have talked about sort of a challenging pharma environment, yet you guys leverage a massive data set with over 950,000 genomic profiles both whole exome, whole transcriptome. I would just be curious if you could give us a sense for the types of conversations you're having with pharma, to what extent is a companion diagnostic pathway part of your strategic road map? And just can you give us a sense for any multimodal model conversations you might be having with some pharma companies.

I believe there is a noticeable change in how data is utilized and in the development of foundational models and AI applications. We are seeing an emerging trend in the integration of both image data and molecular data, which is becoming increasingly important. Ultimately, the objective is to develop companion diagnostic components. The significance of the data lies in its ability to facilitate the introduction of new drugs to the market, and having a companion diagnostic strategy is crucial for that.

Great. And then I'll ask one other. I know you were asked about just what percentage of your tissue test can be accompanied by a blood test already. I wanted to just ask, you're seeing a nice sequential increase in your Caris Assure volume. And I think it's probably too early to ask a question like this, but one of the larger competitors just reported a really huge liquid number in their Q3. I just wanted to get a sense if you're seeing any change in competitive environment? Or do you think it's just too early, and it's just a matter of attaching blood to your tissue?

Mark, it's Brian. I don't think there's been any significant change in the competitive landscape. It's important to remember that this market is still quite underdeveloped, with therapy selection penetration at around 30% to 35%. We have a considerable journey ahead to educate and support physicians, help institutions build and sustain precision oncology programs, and encourage the use of both solid and liquid biopsies. Everyone appears to be capitalizing on a tremendous opportunity, as well as a total addressable market that is continuously growing with new developments in early indications, companion diagnostics, and molecular signatures. If anything, the situation seems positive, as there's increasing utilization and understanding of the underlying technologies. We believe that the unique advantages Caris provides are very favorable for us.

Our next question comes from the line of Jack Meehan with Nephron Research.

I wanted to start by asking about Caris Assure. If I look at the underlying ASP and strip out the true-ups in the quarter, it looks like it stepped up still almost $500 relative to Q2. I was just curious what is pulling that up. You talked about contracting with commercial payers on the tissue side. I'm wondering if that traction might be pulling blood along with it.

Yes, Jack, that's correct. Having FDA approval for the tissue is crucial as we approach payers to include Assure. Another important factor contributing to the increase in ASP for Assure this year is the PLA code we received in Q4 last year. We have been going through gap fill this year, and while the PLA code is on the clinical lab fee schedule, it is not currently priced. We are being priced at the local rate of $3,649, but we know that next year it will be added to the clinical lab fee schedule at that same rate. This is beneficial for us as both of our therapy selection solutions now have individual PLA codes that are effectively priced on the clinical lab fee schedule, which helps since many commercial medical policies reference that fee schedule. Yes. So in many ways, whole genome is a simpler assay than whole exome and whole transcriptome because you don't have hybridization, and you don't have dates. So operationally, there are advantages to whole genome. And then for the first part of the question, aneuploidy changes are one of the first things that happens in cancer. And you can see that early on, especially in precancerous lesions. And whole genome gives us more resolution there.

I don't think so. Listen, we're very happy with this quarter. We're super excited about this marketplace, and I think our prospects are very, very strong. So we look forward to speaking with all of you again soon.

This concludes today's conference. Thank you for your participation. You may now disconnect.