Caris Life Sciences Q1 2026 Earnings Call Transcript

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Provided by Quartr
May 7, 2026

Key Takeaways

  • Positive Sentiment: Strong quarter and balance sheet: Total revenue rose 79% to $216M (Molecular Profiling +85%), GAAP gross margin improved to 65%, adjusted EBITDA was $26M and free cash flow $22.5M, and cash exceeded $825M while a new $400M credit facility cuts interest and extends maturity to 2031.
  • Positive Sentiment: Commercial momentum after sales realignment: Field territories expanded from 82 to 146, activations improved ~20% in Feb–Mar, completed cases were 52.8k in Q1 (up 15% YoY) with an exit run-rate ~56k and management expects >58k cases in Q2.
  • Positive Sentiment: New product launches and MCED readout: Caris launched ChromoSeq (heme whole-genome) and MI Clarity (breast recurrence prognostic), and ACHIEVE-1 for Caris Detect showed 60.3% stage 1–2 sensitivity with 99.2% asymptomatic specificity in a 3,014 high-risk cohort, with a beta/partner commercial launch planned with Everlywell.
  • Positive Sentiment: Reimbursement and ASP tailwinds: Clinical ASP rose 61% (tissue ASP +70% to >$4,300; blood ASP +14%), collections have exceeded prior accruals, the company submitted its 2026 PAMA data on May 1 and expects price stability, supporting the 1,800+ bps YoY margin improvement.
  • Neutral Sentiment: Pipeline priorities and guidance stance: Management reaffirmed full-year guidance and will reassess after Q2 as new launches scale; MRD (tumor-naive and tumor-informed) and commercial rollouts remain priorities but timing and commercial contribution are still being defined.
AI Generated. May Contain Errors.
Earnings Conference Call
Caris Life Sciences Q1 2026
00:00 / 00:00

There are 16 speakers on the call.

Speaker 9

Good afternoon, everyone. Welcome to the Caris Life Sciences Q1 2026 earnings call. My name is Steven. I will be your coordinator today. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand it over to Russ Denton at Caris. Please go ahead.

Speaker 10

Thank you. Earlier today, Caris Life Sciences released financial results for the quarter ended March 31, 2026. Joining from Caris today are David Dean Halbert, our founder, chairman, and CEO, David Spetzler, our president, Brian Brilly, our vice chairman and EVP, Bobby Hill, our chief commercial officer, 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 annual report on Form 10-K 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.

Speaker 10

The information discussed in this conference call is accurate only as of the live broadcast. This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items. A 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 Brian.

Speaker 3

Thanks, Russ, and thank you all for joining our 1st quarter of 2026 earnings call. This is a strong start to the year, and we're pleased to report continued growth, profitability, and cash generation, which will continue to support our investment strategy focused on MCED launch, the broader product pipeline, and commercial platform expansion. As illustrated on slide 3, our platform continues to expand across technology, scale, and commercial breadth. We're now supporting more than 6,100 ordering oncologists with approximately 70% of orders coming through our EHR and portal channels. In the 1st quarter, we completed 52,800 cases, up 15% year-over-year. We're very excited about the initiatives that our CCO, Bobby Hill, is driving, and we began to see the benefits of these in February and March.

Speaker 3

With this clinical activity, our dataset has surpassed 1.07 million profiled cases, including more than 677,000 whole exomes, 728,000 whole transcriptomes, and roughly 790,000 matched profiles. We also reached another important milestone with the recent addition of the 100th Precision Oncology Alliance member, UC San Francisco. We've launched two exciting products, Caris ChromoSeq and Caris MI Clarity. ChromoSeq is a therapy selection assay for hematological cancers, which expands the breadth of our offerings and features a cutting-edge whole genome technology. ChromoSeq was launched on April 1st. In addition, we launched Caris MI Clarity, an exciting prognostic test designed to deliver insight into both early and late distant recurrence risk for breast cancer via digital pathology.

Speaker 3

Finally, and importantly, we're making progress with Caris Detect multi-cancer early detection, and we're getting ready for commercial launch with Everlywell, with plans to add additional channel partners. Our philosophy is a long-term strategic orientation to develop the best offerings on the market and to pursue this innovation while generating profitable growth and maintaining financial strength. We had a strong first quarter with total revenues increasing 79% year-over-year to $216 million. As demonstrated on slide 4, this result was driven primarily by strong performance from clinical profiling. Molecular Profiling Services revenues increased to $211 million in the first quarter, representing an increase of 85% year-over-year. In summary, across the board, we had a very productive first quarter, illustrated by the quarter highlights on slide 5.

Speaker 3

This strong revenue performance, combined with the operating leverage inherent in our business model, has produced continued positive financial results while we ramp up investments, including revenue growth of 79%, which was driven by volume growth of 15% and a 61% increase in clinical ASP. This revenue growth has led to improved gross margins of 65% on a GAAP basis, up from 47% in the first quarter of last year. We've invested significantly this quarter while maintaining financial discipline. This approach has produced positive adjusted EBITDA of $26 million, as well as positive free cash flow of $22 and a half million.

Speaker 3

This is our 4th straight quarter of positive adjusted EBITDA and positive free cash flow and provides us with valuable strategic flexibility for ongoing investment in our tech platform for new products, as well as the ability to develop new channels, such as MCED. In addition, our balance sheet continues to strengthen, with cash on hand growing to slightly above $825 million, an increase of $23.4 million in the quarter. Finally, as a result of this profitability profile, we were able to attractively refinance our credit facility. The new $400 million debt facility led by Blue Owl and Blackstone offers many advantages.

Speaker 3

Lower costs, saving approximately $6 million in annual interest. An extension of the maturity date three years from January 2028 to April 2031 and a committed delayed draw term loan of $300 million on the same terms for any potential strategic acquisition. We believe that our financial performance gives us unique strategic flexibility, which supported our investment program in the first quarter. We're continuing to invest in our product pipeline, importantly in our MSAT business, which Dr. Spetzler will describe in detail, as well as the expansion plan for our sales organization. We believe that our commercial channel is highly differentiated and has many strategic edges. Bobby Hill is bringing enhanced discipline and alignment to the overall platform. We're committing new resources to expand the commercial footprint with important hires across the platform, expanding the number of territories covered, and building product-focused sales teams.

Speaker 3

As stated previously, our strategy is to maintain financial discipline through a strong balance sheet and profitability. These financial pillars of strength will allow us to realize our mission of making precision medicine a reality to benefit patients and support physicians. I'll now turn the presentation over to Bobby to provide an update on our commercial business and related strategic initiatives. Bobby?

Speaker 2

Thanks, Brian. I will provide a brief update on our molecular profiling business, along with our progress on the initiatives for the commercial teams in 2026. On slide 6, this shows our strong molecular profiling revenues performances for this quarter, with revenues increasing 85% to $211 million. This revenue growth was driven by a 15% year-over-year growth in clinical case volumes to approximately 52,800 profiles and a 61% increase in ASP for our comprehensive profiling tests, reflecting our market access and billing team's continued excellent execution. We continue to see the benefits of ASP driven by our successful launch of MI Cancer Seek last year, and these benefits are reflected on the slide.

Speaker 2

Our tissue ASP increased by 70% to over $4,300, and our blood ASP increased by 14% to just under $2,500, driven by billing our PLA code and improved payment for Caris Assure. Luke will discuss the breakdown of this further during the financial update. Moving on to slide 7. I'll spend a minute on the commercial changes we made at the beginning of the quarter and why we feel good about the trajectory coming out of the quarter. We completed the realignment of the sales teams in January 2026. That included expanding our territory structure from 82 to 146 territories and continuing to build out the field organization.

Speaker 2

We made those changes deliberately to improve coverage, sharpen accountability, and create a stronger footprint for execution across both MI Cancer Seek and Caris Assure, along with setting us up well for product launches. January was a transition month, as expected, given the scale of the realignment and expansion. Following the realignment, activations in February and March grew approximately 20% year-over-year compared with the same 2 months period last year. Full quarter activations increased 17% year-over-year. That reinforces our confidence in the underlying demand trajectory and based on the completion cadence in February and March, supports a quarterly exit run rate of roughly 56,000 completed cases.

Speaker 2

For Q1 overall, we completed approximately 52,800 therapy selection cases, up 15% year-over-year, including approximately 43,600 tissue cases and approximately 9,200 Caris Assure cases. The key point is that demand accelerated as the quarter progressed due to the great work of the sales team, while completed case recognition reflected normal timing between activation and completion. Beyond overall volume, the broader commercial engine continued to perform well. Caris Assure volume grew 58% year-over-year. More than 70% of orders were submitted electronically. Over 3,000 physicians are using EMR integrations. We ended the quarter with more than 270 commercial team members as we continue building toward our approximately 300 person goal. Overall, we feel very good about how the team has performed with the initiatives.

Speaker 2

I'll now turn it over to Dr. Spetzler to continue our progress on our product pipeline, in particular around Caris Detect. Spetz.

Speaker 4

Thanks, Bobby. I wanted to start with an important milestone for the quarter for Caris, which is the final readout for ACHIEVE-1 for Caris Detect described on slide 8. At the high level, these data points serve as our clear validation, clinical accuracy study, and reinforce our conviction that our whole genome solution, whole genome sequencing approach to early detection is fundamentally differentiated. In the ACHIEVE-1 data, Caris Detect delivered a 60.3% stage 1 and stage 2 sensitivity with a 99.2% asymptomatic specificity across a 3,014 subject high-risk cohort. This is a meaningful result in early detection, particularly when you consider both the size of the evaluable cohorts and the complexity of the underlying biology we are trying to detect. What gives us confidence in these results is not just the top-line numbers, but the platform underneath them.

Speaker 4

Caris Detect is built on the foundation of Caris molecular profiling data, which now includes more than 1 million processed cases and over 50 billion molecular markers. That breadth and depth of data matters. It is what allows our AI models to identify difficult-to-detect biological signals associated with early-stage cancer with a level of resolution that we believe is differentiated in the field. When you look at performance by stage, the pattern is exactly what you would see in a high-performing assay. Sensitivity increases consistently with stage: 56.8% in stage 1, 67.7% in stage 2, 79% in stage 3, and 98.6% in stage 4. We also reported 96% benign tumor and high-risk patient specificity alongside the 99.2% asymptomatic specificity results.

Speaker 4

We split the population of patients without cancer into two different groups because a false positive in a patient with a benign tumor or precancerous lesion should have a very different implication than a false positive in a healthy person. Taken together, those data show a strong balance between sensitivity and specificity across clinically relevant populations. The cancer type readouts were also encouraging. In the total stage 1 and 2 data sets, we saw sensitivity of 53.7% in breast, 74.1% in prostate, 73.4% in lungs, 60.6% in uterus, 61.8% in bowel, 81.3% in head and neck, 70% in pancreatic cancer. Maybe the most important strategic point on this slide is that these results were generated using only 1 of 9 potential pillars.

Speaker 4

In other words, we believe there is still room to improve from here, as additional pillars may further strengthen overall performance over time. When we look at ACHIEVE-1, we do not just see a successful data readout, we see proof that the biological foundation is working and a platform that still has meaningful upside ahead of it. We have been doing a beta launch the last few weeks and still anticipate commercial launch later in Q1 with Everlywell. Moving to slide 9, this also reflects the status of our robust pipeline, and I'll touch on these before letting Luke wrap up with the financials. First, as Brian mentioned, Caris ChromoSeq is now launched with MolDX coverage. This is a whole genome heme therapy selection solution designed for AML, MDS, MPN, and suspected myeloid malignancies.

Speaker 4

The assay is differentiated by greater than 200X steps of coverage across the whole genome. The ability to detect the full range of clinically relevant genomic alterations at approximately 1.6 billion reads per patient. Second, we have also launched the digital AI-only version of Caris MI Clarity. Caris MI Clarity is designed for post-menopausal patients with HR-positive, HER2 negative, node-negative early-stage breast cancer at the time of diagnosis. We see this as an important extension of our platform into recurrence risk assessment designed to support better decision-making and reduce unnecessary therapy. Third, in MRD Tumor-Naive, we continue to focus on colorectal cancer. This solution uses the Caris Assure platform, is tumor-naive biased design, and is intended to support minimal residual disease detection from a whole blood sample. We are currently compiling additional data for the MolDX technical assessment.

Speaker 4

Fourth, in MRD Tumor-Informed, development and launch planning have made progress. This is a pan-tumor opportunity intended for stage 1, 2, and 3 disease. It uses tumor-normal whole genome sequencing to identify trackers with a proprietary approach designed to minimize false negatives and maximize tracker count to achieve ultra-low sensitivity. Finally, before wrapping up, I also want to provide an update on Caris Assure. We recently completed our submission to New York State, and we will provide an update to everyone once we hear back on that submission. We had a very productive few months so far in 2026 with the newly launched solutions and are continuing to generate additional data and multiple avenues to extend the same molecular and AI foundation across therapy selection, risk recurrence, early detection, and MRD. With that, I will turn it over to Luke for the financial update.

Speaker 6

Thanks, David. Turning to slide 10, we delivered another strong quarter financially with total revenue of $216 million, up 79% year-over-year. The main driver remained Molecular Profiling, which grew 85% versus Q1 of last year, and that was on continued ASP improvement and volume growth. Therapy selection completed volume was up 15% in the quarter. As Bobby discussed, we were very pleased with how we exited the quarter. While completed cases came in modestly below our initial expectations due to timing, as discussed, activations improved sequentially for the quarter for both tissue and blood following the January realignment. That stronger case intake we saw exiting the quarter gives us great confidence in the Q2 and the balance of the year.

Speaker 6

Turning to pharma and research revenue, this was $5.4 million versus Q1 2025 revenue of $6.8 million and was due to the deliverable movement of our discovery and data businesses under contract, which will flow through over the balance of the year and is supported by improved contract activity. Overall, our revenue continue to translate into a strong bottom line with positive adjusted EBITDA and positive free cash flow for the fourth consecutive quarter, reflecting the disciplined approach we continue to take as we invest in the business. As I stated on the last earnings call, we intend to utilize this financial strength to fund the pipeline and commercial investments throughout 2026. You can start to see that in the numbers.

Speaker 6

Operating expenses were $136 million in Q1, up from $132 million in Q4, and purchases of property and equipment were just over $10 million, up from $5.1 million in Q4. That is as we continue to prepare for pipeline launches, including early detection, while still delivering positive adjusted EBITDA of $26 million in the quarter and a positive free cash flow of $23 million in the quarter, which also include our annual bonus payments of $30.5 million. Turning to slide 11, Q1 continued to validate the strength of our molecular profiling business, with molecular profiling revenue being $211 million in the quarter, up 85% versus Q1 of last year.

Speaker 6

Reported revenue and ASP continued to benefit from favorable collections across both MI Profile and Caris Assure. As this chart on the right shows, we have seen a meaningful buildup in the underlying revenue base over the last seven quarters, with additional upside where collections have exceeded prior accrual assumptions as we continue to have collection success from the excellent work by our billing and market access teams. At the assay level, MI Profile base ASP was $4,091 in Q1, and Caris Assure base ASP was $4,421, showing the benefit from payer contract in progress and stronger collection experience. With regards to our ASP, I also want to spend a minute on reimbursement framework because there has been a little confusion on this point recently. For us, both assays are CDLTs and not ADLTs.

Speaker 6

That means these are reported under PAMA. The 2026 PAMA reporting window runs from May 1 through July 31 based on data from January 1 through June 30 of 2025, with any related fee schedule update becoming effective January 1 of 2027. As an update, we submitted our PAMA data on May 1 and do not expect any downward adjustments from that. We also continue to support the broader CRUSH efforts and do not view that as changing our underlying reimbursement position. Turning to slide 12, this highlights the key commercial and reimbursement tailwind supporting the business in Q1. That is demonstrated by our approach of always focusing on the technology first. Starting with MI Profile, we continue to benefit from MI Cancer Seek and the steady improvement we have seen through 2025 into Q1 of 2026.

Speaker 6

That progress has been supported by our contracting and payer collection experience, as demonstrated on the previous slide. At this point, we're above 225 million covered lives for MI Cancer Seek, which we expect to continue to increase throughout the course of this year. The assay represented more than 75% of our tissue volume in Q1. As touched on before, we also delivered about 9% completed volume growth in MI Profile in the quarter compared to Q1 of 2025, including a record February and March period following the sales realignment that also drove stronger sequential activations versus Q4 and is due to the great work done by our sales team following the realignment. That momentum will flow into Q2.

Speaker 6

On the Caris Assure side, this came in line with our expectations with Assure's volume growing 58% year-over-year, importantly, volume also increased 7% sequentially. We continue to see traction in blood as we grow our penetration there with a differentiated solution. This continued leverage resulted in Molecular Profiling Services gross margin being 65% in Q1 compared with 47% in Q1 of last year, which is an improvement of over 1,800 basis points year-over-year. Finally, moving to guidance on slide 13. You can see we're reaffirming our guide from February, I'll address two key components on this prior to opening up the call to questions. Starting with volume, based on the February and March trends, we remain confident of the full year volume framework.

Speaker 6

We continue to expect tissue growth in the low teens and blood growth in the high 50s to low 60s. The stronger activation trend exiting Q1 supports our guide view. That timing gap between activations and completed cases should normalize as we move into Q2 and throughout the year with the realignment completed. With respect to the pipeline, we have launched Caris ChromoSeq, which was approved by MolDX and priced at $3,228, and also MI Clarity. After Q2, we will evaluate and incorporate the contribution from those launches along with any incremental impact from our continued sales strategies and commercial expansions.

Speaker 6

On revenue, while Q1 performance points us towards the higher end of the range with a beat on our expectations for the quarter, we are reconfirming guidance today and will evaluate after Q2 with the additional history of the new launches and the continued execution. I will stop there and turn it back over to the operator for questions. Operator?

Speaker 9

Thank you. Our first question comes from the line of Michael Ryskin of Bank of America. Your line is now open.

Speaker 1

Hi, this is Alexa Chen on for Mike. Thank you so much for taking our questions. I just have a couple ones here. Maybe to start, can you talk about the impact that the sales realignment might have had on tissue volumes this quarter? As a follow-up, can you discuss your confidence in achieving the 20% volume growth target for the year, given the softer start? We appreciate that the sales force is realigned and that trends improved in February and March, but it still appears to require a significant ramp from here. Thank you.

Speaker 6

Yeah, as any time when you realign a sales organization and put them into new territories, we saw a little bit, you know, slower start to the very beginning of the year. Beginning of the year sometimes is slower, that's why we chose to do it then. What we saw with tissue volume each month after that and what we're trending at, we feel confident that we're going to achieve 20% year-over-year by the end of Q4. Yes. One of the reasons why we also disclosed kind of the exit rate on the completions for February and March is what also gives us confidence.

Speaker 6

You can see based on those numbers, we've improved dramatically on the tissue front from where we were running on a monthly rate last year, with over 15,500 on average from February and March. We believe that continued trend is going to benefit us as we go into Q2. We feel good about the low teens guidance.

Speaker 1

Great. Thank you so much.

Speaker 9

Thank you. Our next question comes from the line of William Ruby of TD Cowen. Your line is now open.

Speaker 12

Hi. Thank you. First question is just on the clinical volumes in the first quarter. Did weather hold back the clinical volumes at all? If so, by how much?

Speaker 6

No. It's like the reason why we pointed out we've gotten the cases in the door. What we expect to happen and the reason why we're reaffirming that guide from a volume standpoint is what you'll see now is an improvement in the sequential growth from Q1 to Q2 that we were initially expecting kind of a 7% growth and sequentially from Q1 to Q2. Now that's gonna be 10%. Those cases will flow through in the second quarter and it'll be caught up by the end of the second quarter as we progress into the second half of the year.

Speaker 12

Got it. If you could just discuss the traction in blood testing. What's been the strategy impact and where are you having the most type of success and types of accounts and just on that please.

Speaker 6

Yes. We've expanded before Q1 our liquid product specialist team, a bunch of individuals that are highly skilled at, you know, helping the appropriate patients get blood testing. We saw 135% growth on their targets quarter-over-quarter. Because of that quarter-over-quarter growth, we've also said that we're gonna double the size of that team again in Q2, to, you know, tissue profiling was our base business and now we're getting good at selling blood profiling and so, for the right patients and we'll continue to do that, take those learnings to the rest of the sales force.

Speaker 6

Probably also worth saying version of Assure that we submitted to New York State significantly increases the amount of RNA profiling that we're doing, going up to about 600 million reads from 5 million reads.

Speaker 12

Thank you. Appreciate it.

Speaker 9

Thank you. Our next question comes from the line of Vijay Kumar of Evercore. Your line is now open.

Speaker 11

Hi guys. Thank you for taking my question. Maybe first one on a big picture question if you will. Luke, you brought up the CRUSH initiative. You know, space has been under pressure. You know, investors are nervous about reimbursement in the space. Just talk us high level, is there a rest of the space on the reimbursement front? If so, how is Caris differentiated from others peers in the space when it comes to reimbursement?

Speaker 6

It's the reason why we wanted to call it out in our script is there's been some confusion. What we've managed to do is it's a little unique in that we managed to go through and we went through the CDLT process. Our codes are like CDLT, not ADLT. We actually feel very good and we actually submitted our PAMA submission last week, based on the time, timeframe. Vijay, we feel good about it. Don't feel like there's already mechanisms in place outside of CRUSH for pricing review and PAMA is obviously the key one for us. Based on our submission we feel really good about our pricing. As I said, we don't expect any downward adjustments from that. We feel good about the initiatives. We're supportive of CRUSH obviously.

Speaker 6

We've been at this a very long time and we kind of firmly believe that we're pretty set from a pricing standpoint.

Speaker 11

Just to be clear, Luke, on that point, are you trying to make a distinction between CDLT and ADLT and maybe CDLT is having more visibility on the pricing element if there's any rest of the space?

Speaker 3

I think how we priced both MI Cancer Seek's PLA code and Caris Assure's PLA code did not go through the ADLT pathway. Those were priced MI Cancer Seek through crosswalk and Caris Assure through gap fill. We are subject because we did not do ADLT to the 3-year PAMA cycle that's going through. As Luke said, we put our PAMA data into PAMA on May 1st and then feel very good about price stability.

Speaker 11

That's helpful. Maybe Luke, one on the guidance comment you made here on the Q on Q 10%. Was it a volume comment or a revenue comment? If you could just clarify what was true ups in that Q1? What was underlying gross margins, extra ups, and how should we think about gross margin progression?

Speaker 6

Gross margin came in exactly in line with what our expectations was in the kind of mid-60s. Our focus right now this year is more on the investment side. I think as we progress into later on this year and into next year, we'll start focusing more on improving the margin standpoint. Generally it came right in line what our expectations were from the gross margin standpoint. From a true up standpoint, that was very minimal compared to what we've seen last year. We continued to execute and continued to appeal on the reimbursement front and continued to have success. It was a very small percentage compared to what you saw in Q4.

Speaker 6

As we progress throughout 2026, as I stated previously, those will start getting smaller and smaller as we continue to have the uptick in the overlying ASP.

Speaker 11

Understood. Sorry, and the 10%, was it volume or revenues?

Speaker 6

That's from a volume standpoint. The way we were thinking about it is that 2.5% that will flow from Q1 will flow into Q2 from a completed standpoint. The cases came in the door in Q1, but it will be completed in Q2. What our expectation is now for Q2 is over 58,000 cases which would be a 10% sequential growth from Q1.

Operator

Thank you.

Speaker 9

Thank you. Our next question comes from the line of Subbu Nambi of Guggenheim. Your line is now open.

Speaker 14

Hi, this is Ricky on for Subbu. Thank you for taking our question. Maybe one for Bobby. You ended the quarter with, I think you said, over 270 sales reps, and earlier in the year you said you would increase head count by 20%-25%. It sounds like you still have more reps left to hire. Could you give us some color on how that hiring is progressing and also on how the 20 or so new reps that you've brought on year to date have been ramping up? Thank you.

Speaker 2

Yes, we're progressing right on track of where we want to be. We changed territory size or territories and made them smaller. We went from 82 to 146 territories. We'll continue to grow that amount. We have the first wave hired. We're sending them through training. They're already out making calls. We've significantly revamped our training program. It's, we're excited with that development. Yes, we're on track to hit that 300 number and hire them all in Q2. Approximately 300 number, and we feel very good about the ramp-up and what we've changed.

Speaker 9

Thank you. Our next question comes from the line of Casey Woodring of JP Morgan. Your line is now open.

Speaker 8

Hello, this is Martha Runbat on for Casey. Thank you for taking my question. Apologies if I missed this, but how should we think about 2Q volumes for tissue and blood, any color you can share there? Also on the pharma R&D revenues. Another one would be on the initial insight test uptake. Are you assuming any contribution this year? Thank you.

Speaker 6

I can definitely take that. As we just stated, our expectation is for a 10% sequential improvement from Q1 to Q2 in volume. That would get you above 58,000 cases, which again we feel very good about based on what we saw exiting the quarter. From a blood and tissue standpoint, you will see those tissue cases flow into Q2. We would expect to be in the 47.5 thousand cases for tissue and then approaching over the 10 feel very confident about those for Q2. From a revenue standpoint for Q2, our expectations right now based on the initial guide that we put out in February was for that kind of 32% growth in overall total revenue. The last question, the contribution from Caris Detect.

Speaker 6

Again, we'll assess that. Our plan is to still launch that in Q2, that we're progressing along very nicely. I'll assess that as we get into the Q2 earnings on what the contribution is going to be for the second half of the year.

Speaker 8

Thank you.

Speaker 9

Thank you. Our next question comes from the line of Patrick Donnelly of Citi. Your line is now open.

Operator

Hey, this is Albert Hu on for Patrick here. Thanks for the two Q color. Just curious on the profitability side for both two Q and for the year. I think you previously had noted, a certain range, a certain cap for the EBITDA profitability, and it's been since updated to positive. Just curious what you can share with us on both the EBITDA assumption for two Q and then for the full year. I know you have some investments in there and maybe perhaps share with us what those are as well. Thank you.

Speaker 6

From a EBITDA standpoint and from a free cash flow standpoint, I'll repeat what I kinda stated on the last earnings call. We're gonna utilize the kinda financial profile we have. We're gonna get that pretty close to neutral from a free cash flow standpoint in Q2. One of the key things that we're gonna push on is with the early detection launch, there's gonna be an increase in Q2 from a CapEx standpoint. We're expecting about $30 million of CapEx of property and equipment purchases. Again, that includes the NovaSeq Xes that we're ramping up. We've also started to ramp up from an inventory purchase standpoint ahead of the detection launch. You're gonna have additional spend from that standpoint.

Speaker 6

Our goal going into Q2 is to utilize obviously the free cash flow that we're generating to fund the preparation for the Detect launch, along with pushing obviously MI Clarity and Caris ChromoSeq as well. From an EBITDA standpoint, we're not guiding to that metric because again, the key focus for us is pushing the pipeline through, pushing through the commercial activities that Bobby is putting in place and along with getting the Detect product launch. From an estimate standpoint for Q2, we have the 32% growth for revenue and expect a mid gross margin of 60%-65% is where we expect gross margin. We'll also ramp up our OpEx as well from where we were at $136 million to over $140 million.

Speaker 6

Again, that will get you a small EBITDA, but it's not our primary focus for Q2.

Operator

Got it. That's super helpful. Well, first, congrats on the pipeline coming out here. It's great to see launches and reimbursement coming through. Just curious on the MRD front. I think you mentioned on the update on the prepared remarks that it's still in prepared for being launched. I'm just curious what that priority is, MRD exactly. What is that priority in the pipeline for you guys? Is that something that, you know, you guys are putting emphasis on and aiming to launch perhaps late this year or sometime next year? What can you share with us on the MRD and timeline front, please? Thank you.

Speaker 4

Now that we have these other product launches done and behind us, MRD is the next priority. We'll be focusing on that quite heavily.

Operator

Okay, perfect. Thanks so much. I'll hop back in with you.

Speaker 9

Thank you. Our next question comes from the line of Mark Massaro of BTIG. Your line is now open.

Speaker 7

Hey, guys. Thank you for taking the questions. I wanted to start on a pipeline question. Now that you have MolDX approval for ChromoSeq and it's launched, can you speak to the unmet need? I think oftentimes there's a whole lot of conversation about solid tumor profiling, but can you just sort of speak to the unmet need in myeloid?

Speaker 4

Sure. What happens today is that those patients get a whole lot of small panel tests, a combination of different technologies, it's not comprehensive, and they often miss things. Those tests are also not designed to pick up resistance components. With our approach, we're able to, in one fell swoop, not only identify all of the components that allow optimal therapy selection, but also identify when that therapy is no longer effective. It's a truly comprehensive approach to hematological malignancies and not the hotspot that is being done today. With the turnaround time that the team was able to achieve and what we're seeing from the launch, that gets patients a complete answer faster than that they would get with testing with multiple different tests trying to chase down a diagnosis.

Speaker 7

Okay. That's helpful. I know that breast cancer is one of the important indications in your early detection initiatives. Can you just speak to that disease state relative to others? How should we think about the landscape progressing over time as you guys think about screening for various cancer types?

Speaker 4

Yeah. I mean, breast cancer is one of the more common types of cancer. It's already highly screened for, mammography has its limitations. It's important to us to make sure that we're servicing that patient population really, really well. The performance that we have shown in ACHIEVE-1 is already superior to mammography. You know, it's inevitable that older technologies are gonna be replaced by future superior technologies, and that's what's happening right now.

Speaker 7

Understood. Thanks so much.

Speaker 9

Thank you. Our next question comes from the line of EV Kozelowski of Goldman Sachs.

Speaker 5

Hi, thanks for taking my questions. wanted to ask on the quarterly run rate you gave for February and March of 56,000 tests relative to the 52.8 you reported for the quarter. I think you said that was up 20% year-over-year relative to February and March last year. I guess, could you talk through the split between tissue and blood, and then how durable you think the acceleration in volumes is post the sales force realignment? Was there a level of pent-up demand in the latter half of the quarter?

Speaker 2

Yes. The split follows our normal split growth when we went from January into February and March. We saw ramp-ups in both products, and we're excited about what that was able to do and you know, the quickness of that turnaround. As we look at that volume, as Luke had discussed, going into Q2, we still feel very confident that we'll be able to achieve the numbers that we've set forth for guidance, and we expect both products to continue their growth.

Speaker 5

Great. Then any update on the M&A and kind of capital allocation strategy? I mean, I know there's a focus kind of to reinvest more organically, but any specific areas or gaps in your portfolio that you would look to fill inorganically?

Speaker 3

EV, hey, it's Brian. There's no gaps, and, you know, we've been a pioneer through organic growth and building our technology platform. There's nothing in particular that we think we need. On the other hand, you know, we're very strong with respect to our financial profile. Our new debt facility gives us additional flexibility. We're definitely in a position of being flexible and tactical if we see the need.

Speaker 5

Great. Thank you.

Speaker 9

Thank you. Our next question comes from the line of Tycho Peterson of Jefferies. Your line is now open.

Speaker 15

Hey, team, this is Noah on for Tycho. Thanks for taking our questions. Wanted to start by asking about the pharma R&D business. I think it came in a few million dollars light of consensus expectations on revenue. How are you thinking about the commercial investment in that business? Can you speak to, you know, orders or backlog performance that, you know, justifies maintaining the guide here?

Speaker 6

Yeah. As we kind of stated on the last earnings call, you always have Q1 and Q3 are always kind of the lower quarters from a pharma standpoint. It's just a natural cadence that we progress through throughout the year. The revenue, the reason why we're maintaining the guidance is that revenue delta from the Q1 expectation, it's based on contracts we already have under contract. The Genentech deal that we publicly disclosed, there was revenue dollars that moved from Q1 that will flow into Q2.

Speaker 6

The same with some of our data partners that we have under contract that will deliver that data in the next quarter or two. We feel good about that, and we do expect from a Q2 standpoint to obviously see that increase that we've seen over the last couple of years, where Q1 is always lower and Q2 ramps up, Q3 comes down, and Q4 ramps up. We feel confident right now based on that existing guidance playing out.

Speaker 15

Okay, thanks. That's helpful. I wanted to ask one more. You know, I know a competitor had, you know, a recent study that went to ODAC for, you know, liquid biopsy-informed drug trial that ODAC voted against. How are you thinking about implications for serialized liquid biopsy testing, and, you know, do you have any embedded assumptions for, you know, liquid testing tests per patient expanding in the long run? Thanks.

Speaker 4

I mean, that was really more about one specific mutation, not liquid in general. There's still incredible clinical utility of liquid profiling. You know, the fact that the ESR1 targeted agent wasn't approved doesn't really impact the broader utility of profiling.

Speaker 15

Thanks.

Speaker 9

Thank you. Our final question comes from the line of Kyle Mikson of Canaccord Genuity. Your line is now open.

Speaker 13

Hi, this is Dr.

Speaker 9

Kaufman for Kyle Mikson. Thank you for taking our questions. Congratulations again on the ChromoSeq approval and launch. Just to kind of tap into that again, what is the rate that you got for this test? From, like, a dollars and cents perspective, what is the addressable market we're looking at? Thanks.

Speaker 4

Yeah. The rate is $3,228 is what we got from MolDX.

Speaker 2

Yeah, from a market standpoint, there are about 50,000 patients that meet the 3 indications that are set forth in the MolDX indications for the 3 different ones. There are existing medical policies for commercial commercial lines of business that we believe that when we submit to payers, that we will gain coverage on because of the depth and performance of our assay. We're already deploying the team to go talk to a lot of the payers and add where we are already contracted with MI Cancer Seek. It would give us the opportunity to add the coverage there as well.

Speaker 13

Got it. Thank you. Just one more for me. You spoke to the expansion of your Precision Oncology Alliance on this call for which you plan to host your summit on the eve of the ASCO conference. On ASCO, can you elaborate what types of data you'll be presenting for pipeline and recently launched products, including MCED and MRD, among others? Thanks.

Speaker 4

I mean, we have a lot of data that we'll be presenting. It's embargoed until the conference, we can't really talk about it now. There's gonna be a lot of it.

Speaker 13

Got it. Thank you.

Speaker 9

Thank you. This does conclude the Q&A session and the program. I'd like to thank you for your participation. You may now disconnect.

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