Adaptive Biotechnologies Corporation

Good day and thank you for standing by. Welcome to the Adaptive Biotechnologies first quarter 2025 earnest conference call. At this time, our participants are in list only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you need to press star one one on your telephone. You will then 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 the conference over to your first speaker today, Karina Calcidea, Head of Investor Relations. Please go ahead.

Thank you, Antoine, and good afternoon, everyone. I would like to welcome you to Adaptive Biotechnology 5 Earnings Conference Call. Earlier today, we issued a press release reporting adaptive financial results for the first quarter of 2025. The press release is available at www.adaptivebiotech.com. We are conducting a live webcast of this call and will be referencing to a slide presentation that has been posted to the investor section in our corporate website. During the call, management will make projections and other forward-looking statements within the meaning of federal security laws regarding future events and the future financial performance of the company. These statements reflect management's current perspective of the business as of today. Actual results may differ materially from today's forward-looking statements depending on a number of factors which are set forth in our public filings with the SEC and listed in this presentation. In addition, non-GAAP financial measures will be discussed during the call, and a reconciliation from non-GAAP to GAAP metrics can be found in our earnings release. Joining the call today are Chad Robbins, our COO and co-founder, and Kyle Pisco, our Chief Financial Officer. Additional members from management will be available for Q&A. With that, I'll turn the call over to Chad.

Thanks, Karina. Good afternoon, and thank you for joining us on our first quarter earnings call. As highlighted on slide three, we are off to an excellent start this year, demonstrating strong execution across both top and bottom line results. In MRD, revenue increased 34% from a year ago. Significant growth was observed in clinical volumes, ASP, and pharma sequencing. This quarter, we also received our first Medicare recurrence monitoring coverage in MCL, a key part of our strategy to grow the lifetime value of each ClonoSeq Medicare patient. In immune medicine, we're making progress on our preclinical antibody program in autoimmunity. Dequence in gross margin improved by 17 percentage points year over year to 62%. At the same time, Operating expenses decreased by 9%, underscoring our disciplined cost management while driving strong, sustainable growth. As a result, cash burned for the quarter was $23 million, a 38% improvement compared to the same period last year. Given the strength of our performance and sustained momentum, we are raising our full-year guidance to reflect one, a higher MRD revenue range, two, lower operating expense range, and three, a lower annual cash burn. Kyle will provide more details during his remarks. Of note, our four-year outlook has minimal exposure to tariffs, trading policy updates, and NIH funding pressures. Importantly, I want to highlight our solid cash position of $233 million. We believe our cash on hand provides ample runway to achieve our strategic objectives without the need to raise additional capital in the current market environment. Let's now take a closer look at the MRD business on slide five. Clonacy clinical revenue in the first quarter grew 55% first prior year. Tests delivered reached a new record high of over 23,000 in the quarter, representing a 36% increase versus prior year and a 10% increase sequentially. Growth was once again observed in all reimbursed indications. Multiple myeloma continues to be the largest contributor of U.S. clonacy volume at 42%, followed by ALL at 33%, CLL at 10%, DLBCL at 7%, and MCL at 5%. Looking at other key growth metrics in the quarter, it's encouraging to see the positive trends that align with the successful execution of our strategy. Blood-based testing contributed 44% of MRD tests in the U.S. versus 39% a year ago. This increase was primarily driven by strong growth in DLBCL and MCL. Tests in the community grew 42% versus prior year and 14% sequentially. NHL contribution jumped to 12% from 10% a year ago, driven by continued ramp in MCL and the launch of our enhanced assay and DLBCL. The number of ordering healthcare providers grew 31% from the prior year and is now over 3,400. And our pace of EMR integrations is accelerating. We now have 27 live integrations, including five of our top 10 accounts. We expect to add at least five more accounts in the next month. We are seeing a notable lift in individual account growth rates post-integration, and growth in integrated accounts is outpacing growth in non-integrated accounts. In addition, we're making solid progress on our initiatives to increase Colonial Seek ASP. In Q1, ASP was north of 1220 per test, representing a 14% year-over-year increase. Importantly, we closed and or renegotiated six key agreements with major national payers, including Aetna, Humana, Anthem, Horizon, and two of the Blue Cross Blue Shield programs. Alongside these payer wins, we've expanded our reimbursement operations team and continue to optimize revenue cycle management. Given this progress, we are confident in achieving an average ASP of $1,300 per test for fiscal year 2025, setting us up for continued future ASP growth. Looking at MRD Pharma on slide six, our MRD Pharma business had a strong start to the year with sequencing revenue growth of 11% versus prior year. This quarter, we also recognized 4.5 million in regulatory milestones. We continue to see significant momentum following the ODAC recommendation in multiple myeloma last year. As you can see from the chart, over 60% of our portfolio today is in multiple myeloma. including 22 new studies which closed in the last 12 months. The majority of these studies are using MRD as a primary or secondary endpoint. They tend to be larger phase two and three studies, often with large milestones attached. We're also seeing a halo effect from this decision in other disease states like CLL, where treatment advances are necessitating more sensitive MRD assessment in clinical trials. Additionally, We see growth opportunities for the pharma business and DLBCL as multiple companies are preparing to advance MRD-directed therapy. To wrap up on MRD, we achieved strong results for the quarter in both our clinical and pharma businesses. As shown on slide seven, the stage is set to achieve our full year strategic goals. We are on track to end the year with over 45% of clonacy testing done in blood. We are on track with EMR integrations, including oncoEMR launch with Flatiron in the second half. We are on track to begin phase one testing with Neogenomics in an initial set of accounts in the second half of the year. We're on track to go live with NovaSeqX in the second half of this year. And we continue to have key data readouts spanning multiple indications. Importantly, we are on track to be adjusted EBITDA positive in the second half of this year. Now, let's turn to immune medicine on slide nine. Our immune medicine business focuses on two differentiated immune-based therapeutic strategies. One is in cancer with our partner Genentech. The second is in autoimmunity based on our highly targeted precision immunology approach. Our focus this year is on three main goals. First, it's to generate the size and quality of data to successfully develop a digital TCR antigen prediction model that supports our cancer cell therapy program with Genentech. As we successfully scale our data, we're also making good progress in training and improving the performance of our AI and ML models. We're aiming to replace our TCR discovery cellular assays with a digital model that can rapidly and accurately predict TCR antigen binding. This has the potential to meaningfully reduce both time and cost of selecting the best TCRs to include in a cancer cell therapy. among other future potential high-value therapeutic applications. Our second goal is to build a robust preclinical data package for our lead T-cell depletion program in autoimmunity. We're in the process of testing and characterizing a subset of promising antibody candidates in our lead indication. The third goal, as we execute on these two focused therapeutic strategies, We are managing to a target immune medicine cash burn between $25 and $30 million. We continue to strategically gate our IM R&D investments and grow our farmer business revenue to partially fund this spend. Now I'm going to pass it over to Kyle to walk through the financial results and our updated full year guidance. Kyle? Thanks, Chad.

Starting on slide 10 with results for the first quarter. Total revenue was $52.4 million, representing 25% growth from the same period last year. 83% of revenue came from MRD and 17% from the immune medicine. MRD revenue grew 34% versus prior year to $43.7 million, with clinical and pharma contributions of 65% and 35%, respectively. Clonacy test volume, including international, increased 36 percent to 23,117 tests delivered versus last year, and ASP in the U.S. grew approximately 14 percent. MRD pharma revenue grew 7 percent versus prior year to 15.2 million, inclusive of 4.5 million in milestones. Immune medicine revenue was 8.7 million. down 6% from a year ago, driven by an anticipated 23% decrease in Genentech amortization, partially offset by a 12% increase in IM, pharma, and academic services. Moving down the P&L, sequencing gross margin, which excludes milestones and Genentech amortization, was 62% for the quarter. This represents a significant improvement of 17 percentage points versus prior year, as we leverage lower overhead costs and stable direct labor supporting increased volumes while improving pricing across both our clinical and pharma revenues. Total operating spend for the quarter, inclusive of cost of revenue, was $82 million, representing a 9% decrease from last year. This decrease was mainly driven by lower R&D spend from both MRD and immune medicine businesses. As you can see from the segment reporting table at the bottom of the slide, MRD adjusted EBITDA is now at a loss of $4.1 million versus a loss of $17.3 million a year ago. This improvement of 76% is driven by both higher revenue and lower operating spend. Amine Medicine adjusted EBITDA loss was also improved 21% versus Q1 of last year due to reductions in operating spend. Total company adjusted EBITDA was a loss of $12.7 million in the first quarter compared to $28.2 million in the prior year. Interest expense from our royalty financing agreement with OrbitMed was 2.9 million, which was slightly higher than interest income. Net loss for the quarter was 29.8 million. Now, let's turn to our full year 2025 updated guidance on slide 11. We are raising our full year MRD revenue guidance to a range of 180 to 190 million, up from our previous range of 175 to 185 million. This increase is driven by stronger than expected clinical volume performance in the first quarter and higher MRD milestone payments anticipated for the year. Given the strong ClonoSeq test volumes in the quarter and the momentum we are seeing, we now expect approximately 30% growth in 2025 volumes versus 2024. And we anticipate sequential growth in the remainder of the quarters. We also expect revenue from MRD milestones to be between 8 and 9 million, up from our previous guidance of 6 to 7 million. With respect to revenue trends throughout the year, we now expect MRD revenue to be approximately 45-55 weighted between the first and second half, respectively. We are also lowering our full-year total company operating spend guidance, including cost of revenue to a range of 335 million to 345 million. down from the previous range of $340 million to $350 million. We continue to expect approximately 69% of this spend to be driven by the MRD business and 23% by the immune medicine business, with the remainder attributed to unallocated corporate costs. Lastly, we are also lowering our full-year total company cash burn guidance to a range of $50 million to $60 million, down from the prior range of $60 million to $70 million. This improvement is primarily driven by higher than expected MRD revenue and reduced unallocated corporate burn. We now expect approximately 24% of this year's cash burn to come from the MRD business. Still anticipate burn from the immune medicine business to be between 25 and 30 million, with the remainder attributed to unallocated corporate costs. We remain focused on disciplined execution to drive sustainable growth while managing our resources responsibly. and I look forward to providing you with further financial updates throughout the year. With that, I'll hand it back over to Chad.

Thanks, Kyle. Our strong first quarter results underscore the focus, agility, and execution of our team. We're operating from a position of strength and have high confidence in our ability to deliver on our raised full-year guidance. As we look ahead, we remain committed to delivering on our promises and creating lasting value for both patients and our shareholders. I'd like now to turn the call back over to the operator and then open it up for questions.

Thank you. At this time, we'll conduct a question and answer session. As a reminder, to ask a question, you will need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while I compile the Q&A roster. Our first question comes from Meg Sykes from Goldman Sachs. Please go ahead.

Hey, thanks for taking our questions. You got Will on for Matt here. Congrats on the quarter and appreciate the color on the 30% volume growth with sequential improvement over the course of the year. Just want to dig a little deeper there. Are there any specific indications you're seeing growth in and how are you seeing contribution from each of the indications trending over the course of this year?

Yeah, thanks, Waylon. I'm going to hand that over to Susan.

Thanks for the question, Will. Yeah, we're seeing sequential growth across all indications. We had a particularly strong quarter for our lymphoma indications, DLBCL and mantle cell lymphoma. You'll recall that we've launched the mantle cell indication just in Q4, so we're seeing a nice conversion of the promotional effort over the last two quarters. And then in DLBCL, we launched an enhanced version of our assay and also saw the availability of our assay in New York State under CLEP approval become live in Q1. So a number of factors that contributed there. In terms of contribution across the indications, over the last, let's say, year, quarter by quarter, the contribution has remained relatively stable where we're seeing the uptick in DLBCL and MCL, which now contribute a total of 12%, as Chad noted, versus 10% a year ago, mostly taking from other indications. And we've made, as you know, a concerted effort to move our business further toward our Medicare-covered indications. So that's actually a great shift that we've been able to see.

That's super helpful. And then just as a follow-up, You touched on the EMR integration on the call. I know last quarter we talked about like 30% plus improvements in the smaller customers and waiting for updates on some of the larger ones. Are we ready to give updates on the larger ones or quantify the uptick you're seeing there?

I do have a few more updates that I can share. So we've started to analyze the data across both accounts that have been live for at least one year And then also now have five of our top 10 largest accounts integrated, several of which just went live in Q1, but I can share some data. So first let's start with accounts that have been live for at least a year. These are generally smaller accounts, but there are a couple of larger ones in there as well. Six of those seven accounts exceeded 75% year-over-year growth over the past year since going live. And in total, the volume in that group of accounts more than doubled over the past year. Among the newer sites that went live, let's say went live in the past quarter, which included three of our largest accounts, we saw an average quarter-over-quarter growth of 27%, and that exceeded the 18% we saw in those same sites a quarter immediately preceding integration. So we are continuing to see an acceleration, and I think particularly in those large accounts, those growth rates are quite, I'm quite pleased with them.

Really impressive results there. Thank you for the color. You bet.

Thank you. Our next question comes from Mark Massaro from BTIG. Please go ahead.

Hey, guys, thank you for taking the questions. I wanted to start with the strong performance on the core Clonaseq volume number. It looks like it was up, I think, 2,000 tests sequentially. Other labs in the space have talked about weather. I think we're seeing impacts of roughly 100 to 150 bps across other reference labs. So I'm just curious, how did you drive the growth? Where did it come from? I know you talked about a larger contribution from Klonosig blood, and maybe could you spell out if you had a weather impact in Q1?

Sure, I can take that. Thanks, Mark. We did not see any notable weather impacts this particular quarter. The big growth drivers, one that I noted was non-Hodgkin's lymphoma indications with DLBCL and MCL. We did see an increase in the total contribution of blood, but a lot of that was driven by DLBCL and MCL, which are both entirely blood-based indications. Additionally, the acceleration of our EMR integrations, you know, we added seven accounts since the end of last year, and several of those, three of those were among our top 10. So the acceleration we're seeing in utilization of those accounts certainly contributed, and I am optimistic that as we continue to increase the pace of EMR integrations, we'll continue to see good contribution from those sites.

Yeah, and I'll just kind of add to that, Mark, and as we talked about, it's not any one thing. It's a combination of these strategic factors that I kind of checked off through my prepared remarks. It's, you know, all those things that Susan mentioned that together are coming together and kind of we're executing on the strategy of blood-based testing, increasing community accounts, EMR integrations, et cetera. And obviously with the launch of the new indications on top of that, you know, they're starting to be a really nice uptake from the clinical community.

Sounds good. So you, yeah, yeah, that makes perfect sense. Oh, sorry, Chad.

No, I'm just saying, you know, we had started off and said we'd 25% plus growth with the emphasis on the plus and now I think we're quite confident in our 30% growth kind of modified range.

Okay, yep, perfect. I wanted to ask about the $4.5 million milestone payment in Q1. You are now a little over halfway towards your revised goal. So I'm just curious, is there any change to the funnel? My impression is that maybe the funnel is growing following the big catalyst you had last year with the ODAC. I just wanted to get a sense for how you think about the timing of recognizing these throughout the year.

Thanks, Mark. This is Kyle. As it relates to the funnel, I think what's happening is more and more milestones are becoming available to us. Certainly, we're adding more and realizing more from an offsetting factor, but we are having more come earlier. And the realization we experienced in Q1 with a couple milestones coming through I think just provide this more clarity and confidence in our 2025 outlook and what, you know, potential room for upside even further from that. But, you know, we want to kind of be prudent with all the stuff that's going on with the FDA and just, you know, hold the guide a little cautious from that perspective. But all that being said, you know, I think we're seeing more and more trials read out and all these things are a positive for our business.

Okay, great. And last one for me. Chad, you rattled off a number of large health plans, so it's nice to see that positive momentum building there. Can you give us a sense for, you know, to what extent are you contracting or being disciplined with the higher Medicare rate that you have perhaps as a baseline? I'm just curious how that pricing and contracting discussions are going as it relates to pricing.

Yeah, no, it's a great question, Mark. We inject a significant amount of discipline in our pricing, meaning we will not accept a contracted rate unless it's at or, you know, very close to the Medicare rate. You know, we have to keep our ASPs up.

Okay, great. Thanks, guys. You bet.

Thank you. Our next question comes from David Westenberg from Piper Center. Please go ahead.

Hi. Thanks for taking my question. So I wanted to ask, on your so many different multiple myeloma trials, I'm guessing that a lot of times with drugs, you might be seeing tighter testing intervals. Is there kind of a way to show better outcomes through tighter testing intervals? And I'm just like maybe thinking about that as multiple myeloma and all the clinical trials you're in. But, you know, maybe some of the other indications as well could benefit from titer intervals.

Yeah, it's an interesting question, David. I mean, I think what you mean by titer, of course, is more frequent testing, if I'm correct. Yes. And so, you know, there's clearly a balance here. But in general, because, of course, it increases the cost of the study, but in general, we are seeing a greater interest in increased frequency of testing. In some indications in particular, the kinetics of disease can be indicative of, you know, of the patient's performance over time. And so, additionally, because the FDA has myeloma, they've specified a certain range within which a primary endpoint can be defined. It's generally sort of within the 9 to 15 months of the start of therapy. And so in those studies, we do see people utilizing multiple time points to be able to give themselves some optionality. And additionally, I think over time, we'll see that in the leukemias, in DLBCL, which are increasingly blood-based indications. The frequency of testing is certainly a conversation topic in many of these trial designs.

Got it. No, very helpful. And then I just wanted to ask about um, technology or, or, um, addressing market adjacencies. Don't get me wrong. I mean, you just recently got into DBO, DLBCL and, and that's a very large market. So you definitely have a large market as itself, but is there any, any technology or, um, any kind of ways to address other maybe, uh, blood malignancies, um, and then, um, or, you know, maybe even improvements in terms of the technology in terms of getting to, um, greater sensitivity. I mean, I think 10 to the minus eight is probably really difficult to do, but maybe you get, you improve, can improve like the confidence interval or the, or the, the, the, yeah.

Yeah, I mean, I think the way I can answer that is to say that we're absolutely at all times looking at ways that we can continue to enhance our technology, you know, improving the sensitivity. To some extent, the sensitivity of the assay is simply limited by the amount of input material, right? We're also balancing that with what's practical in the clinic or practical for a clinical trial. And so we are actively looking at a number of strategies that could allow us to continue to extend the sensitivity in the assay. in practical settings, as well as ways that we might enhance the technology or even new technological approaches we could bring to solve some of the problems that continue to exist in the space. For example, the very strong desire in the clinic for an entirely blood-based approach to MRD monitoring in multiple myeloma, which is something we can support, but that there may still be ways to improve upon.

Got it. Thank you very much for taking the questions and congrats on the quarter.

Thank you.

Thanks, David.

Thank you. Our next question comes from Tejas Savant from Morgan Stanley. Please go ahead.

Hello, this is Yuko on the call for Tejas. Thank you for taking my questions. Just regarding the Epic integration, in addition to the volume list from the EMR integrated accounts, are you also realizing associated cost savings productivity gains as a result? If so, what could it mean in the context of your goal to have 50% of your ordering volume coming from EMR integrations by year end? And is that factored into your updated OpEx guide as well?

Yeah, thanks for the question, Nicole. So it's an interesting one because, of course, most of the volume that we have going through integration has really only been going through integration for the past one to two quarters at most. But I think that where you're headed is fair. The idea that there are potentially operational efficiencies to be gained in the medium to long term as more and more of our volume goes through these integrations. I can tell you, just as an anecdote, that the largest account, our number one largest account, integrated in October. And they have told us that under their measurement, they have achieved a 90% decrease in callbacks from our staff to address order discrepancies since integration. So you can imagine that's also not just saving them time, which is fantastic, also saving us time on that particular account. If we can achieve even half that improvement in callbacks at other accounts over at a scale, you can imagine that can help us either redirect our staff time or save staff time entirely. But I don't, we have not incorporated any operational savings into our guide in 2025. at this time, and we'll be continuing to monitor that. There are a number of ways, by the way, beyond just reducing callbacks on orders that we can leverage EMR to reduce total operational time, but those gains will be probably achieved over the next couple of years.

And one other area of potential upside is looking at revenue cycle management and being able to leverage our EMR integrations to kind of reduce time to cash.

Got it. That's super helpful. And then a second unrelated question. With a number of headlines around cost-cutting at pharma, is it possible to see more back-end loaded or milestone-based agreements with pharma versus pay-as-you-go type of contracts? Have you seen any shifts in types of MRD agreements with pharma over the last six months or so?

Actually, I've mentioned this at a couple of investor conferences. We're actually trying to, over time... when contracts come up for renewal, do the opposite of that, which is to move more to a recurring revenue model business to kind of front load the fee-for-service or sequencing component of that and move away from some of the kind of lumpier, hard-to-predict from a time perspective kind of milestones. So, you know, it really depends, you know, on the focus of, pharma companies and the indications that they're doing. But no, we have not seen that and don't anticipate being impacted by it.

Got it. Thank you so much.

You bet.

Thank you. Our next question comes from Rachel Vinsdahl from PJ Morgan. Please go ahead.

Hey, this is Sebastian Sandler on for Rachel. Thanks for taking the question. I'd like to turn back to the strong sequential growth in clonacy volume seen. I think it was one of the best step-ups in terms of absolute tests since 4Q23, looking at the slides, around 2000. So just looking ahead to the rest of the year, I'm wondering if this around 2000 test step-up is appropriate. And then I'm curious if there's any further upside to the acceleration based on the number of drivers you laid out in the call.

Sure. Thanks for the question, Sebastian. I mean, I am very pleased to see the volume growth in Q1. The step-up only strengthens my confidence in our potential for the remainder of the year. As you know, when we started the year, we talked about there being an upside, and I think some of that materialized in Q1. And with this updated guidance, we still see room for upside, and we do still anticipate sequential growth quarter over quarter, although I won't speculate on whether that the magnitude of the step up will look the same every single quarter. I think the reason for us being prudent on that is simply that we have a number of strategic initiatives that we are pursuing this year and that will go live in the second half. And these are just things that we haven't done before. So we're kind of erring on the side of under promise and over deliver right now versus speculating too much about how much upside, how fast that upside can be realized. EMR is a big driver particularly in the second half, but we have to see how the Flatiron launch goes. Those are in accounts that are new or emerging for us, so we're going to wait and see how quickly we can leverage that to help us with adoption of those community accounts. The Epic integrations, we have a long slate of those plans, but it's not fully in our control when they get done since we need to rely on account side IT resources. So we'll be eager to provide further updates, and we feel very confident. We don't see any material headwinds at this point, but it's still early in the year.

Understood. Thank you for the color. And then turning to the community setting, you called out, I think, 40% plus growth there. So I'm curious if this was driven mostly by adding new accounts or deeper penetration into existing accounts, and then just curious on the outlook in the community setting for the rest of the year. Thank you.

Yeah, you know, both. We still, we have a number of community accounts where we now have some significant volume. We have now an account in our top 10 that is a community account, which, by the way, was one of the ones that just went live recently with an integration. In fact, our first ever non-EPIC point-to-point integration. Although that hasn't had time to drive volume yet, it just happened in April. You know, I am bullish about the opportunity there. And so we do have accounts where we have significant penetration and where it's really about continuing to drive that depth. We also have accounts that have not ordered or are just getting started. And so both contributed in Q1 to the continued growth. I'm really pleased with the work that our community-focused field team is doing. And I'm excited about the potential of not only our Flatiron integration to help us lift the community business in the later part of the year, but also the work we're doing with Neogenomics, which, albeit we will only launch in a selected group of Phase 1 accounts in the second half of this year, but in 2026 and beyond, that'll be an important driver for our community footprint and our community growth pace.

Great. Thank you so much.

Thank you. Our next question comes from Tom Stevens from TD Cowan. Please go ahead.

Hey, guys. Thanks for taking my question, and congratulations on a really strong operating quarter. My first one is just on the contribution of kind of mantle cell into this year and also more broadly just the level of new patient ads, that is the number of new chrono-seq IDs in this quarter versus 4Q. I was hoping you could comment on, A, the number of MCLs you expect in guidance this year, And B, the number of new patient ads, as it were.

I think what I can say, Tom, is that in Q1, we were very pleased with the growth. We saw 28% quarter-over-quarter growth, and the contribution of MCL was 5%, which is up from about 3.5% a year ago. That indication, as you know, is a smaller indication, but I think one with a significant unmet need that is well-suited to the value proposition of ClonoSeq. And certainly, we're encouraged by the recurrence monitoring coverage that we achieved earlier in Q1, which, while it won't change our promotional strategy, we've been promoting the importance of serial monitoring of patients off therapy since launch. It certainly strengthens our resolve to make sure we drive testing in that space because we can now get paid for a larger number of these tests, which I think are clinically very, very valuable to patients. You know, in terms of MCL growth over time, We haven't commented specifically on the contribution of any one indication, but I do think that it's possible to have, you know, a higher single-digit contribution over the course of the next year or so. That is an indication, again, that we believe we can penetrate quickly because of the treatment paradigm there being so conducive to the use of MRD.

And just on clonotric ID, I'm not sure I got that in your response.

Right. Sorry. So more generally, the contribution of Clonaseq ID. I mean, we are starting to see an increased contribution of repeat patients. This is beyond MCL. Of course, I'm talking about the business overall. At this point, I think about a third, maybe a little less, 30 percent of our tests are ID tests. And then another 20 percent are first MRDs and about half of the tests are repeat MRDs. That's kind of how the business breaks out right now.

Cool. And then just one more follow-up on just kind of how you're thinking about gross margins for the year. 62% sequencing is obviously very impressive. You know, I know you have lots of spinning plates with EMR initiatives into the back half, but just wondering what the kind of fee-per-service contribution to ASPs were in the quarter, and just to make sure that the Novosig X transition is still on track for Q3, and maybe why not raise the cash burn, or excuse me, reduce the cash burn guidance more than the B in Q1.

Yeah, thanks for the question, Tom. As it relates to, you know, progress on gross margin, first quarter was great. We're seeing, you know, improving our cost structures, improving the lab, and the volume is certainly helping that. You know, NovaSeq is still on track for the second half of the year, and, you know, we would reiterate the five to eight percentage point improvement from that in the first 12 months post-launch. So everything's kind of coming along with gross margins, so I don't have any concerns there and expect to see it continue to grow, especially as we get more and more pricing favorability from both our clinical and pharma businesses.

Yeah, and if you recall, Tom, we talked about 70% plus gross margins at scale, and we're a little bit ahead of the pace based on a really strong quarter.

Oh, and on your question about cash burn, you know, I think, yes, opportunity there to beat the number we put in our guide. But, you know, again, we're just, it's early, you know, the exact timing of NovaSeq launch, you know, all those types of things. But certainly an opportunity for some additional upside and reducing our burn further, given the strong performance that you want.

Right. So no, just like, is there like incremental reinvestment in the sales force or anything like that we should be aware of?

Nothing currently planned. We did make some investments in our revenue cycle management, our reimbursement operations team, and we believe those are paying off accretively. But, you know, no major expansions from there.

Awesome. Thank you, guys. Great stuff.

Thank you. Our next question comes from Songji Nam from Scotiabank. Please go ahead.

Hey, this is Corey Rosenbaum. I'm for Songji. Thanks for taking my questions, and congrats on the quarter. So, first, on DLBCL, do you expect the upgraded assay with the seven-fold increase in sensitivity to meaningfully change the trajectory of adoption in the indication? And could you talk about the potential use case expansions with the significant improvement in sensitivity?

Sure. Thanks for the question, Corey. So, first off, I think that, you know, the primary opportunity to leverage the enhanced assay to drive adoption I think is in the pharma setting where as you know, we've faced somewhat increased competition in recent years and I think there is a strong desire to have a very sensitive assay, particularly in the frontline end of therapy setting where a number of companies are going after study designs in which patients essentially receive additional treatment of varying classes based on the fact that they are MRD positive, even though they've achieved conventional complete response by PET-CT. So that detecting that disease at those levels where imaging isn't revealing anything there requires that particular degree of sensitivity compared to other use cases. And so in the pharma setting, that's where the enhanced assay has really been on an important part of our messaging and our data generation. You know, of course, in the clinic, this is important broadly as well. And we are increasing our focus on that endotherapy use case as a, frankly, a synergy with what's going on in clinical trials. We anticipate that over time, these clinical trials will read out, they'll be successful, there'll be opportunities. for patients to be treated with additional therapy when they don't achieve MRD negativity by the end of a standard round of, let's say, RCHOP. And even now, there are opportunities for patients to enroll in clinical trials. And so it's to patients' benefit for us to be able to provide the most sensitive assay possible in the clinical setting as well.

Great. Thank you for that insight. And I appreciate the pharma commentary throughout the call. But can you discuss the current split between later stage clinical trials versus earlier stage trials for the active trials underway with the MRD pharma partners?

Yeah.

I'm sorry. The majority of our studies are in later stage trials for multiple myeloma, which is, as you know, sort of 60 plus percent of our business and the most well-developed indication. In some of our earlier stage indications, for example, in lymphomas, where we have a smaller portion of our business, the mix tends more towards earlier phase studies. But in general, the use of MRD is really evolving toward registrational uses, whether primary endpoint or secondary endpoint status, and increasingly toward the utilization of MRD as a means to direct therapy, stratify patients, and so that by nature is helping the business evolve toward a later phase, you know, more heavily weighted mix.

Appreciate it. Thank you.

Thank you. As a reminder, to ask a question, you would need to press star 11 on your telephone and wait for your name to be announced. Our next question comes from Andrew Brackman from William Blair. Please go ahead.

Hey, everyone. This is Maggie Bowie on for Andrew. Thanks for taking our questions. Maybe just to start, it's nice to see the reduction in the OpEx guide for the full year. On the MRD side, can you talk about any areas in particular you're seeing leverage from? And then just what other areas do you think that you could see leverage from building out from here? And then just looking further out over the next few years, where do you plan to prioritize your investment spend? Thank you.

Yeah, thanks for the question. As it relates to leverage, I think we're seeing a ton of leverage across the business, first and foremost in the labs. You know, again, increasing volume, some of the assay consolidation initiatives we put in place in last year and we're seeing the fruits of that labor pay off. Secondarily, you know, we're seeing a ton of leverage through our volumes increasing in our field force as well. So that's, you know, all of those things are driving improvement. And while we're making investments in our reimbursement operations, you know, at least early days from those investments seem to be paying off and gaining leverage, but we'll continue to kind of monitor that. So I think all those things, you know, are pointing to, you know, a healthy profile for this business longer term. In terms of prioritizing our investments, you know, I think some of this has been discussed previously in terms of what we do with our assay going forward. But, you know, we'll provide more color into that, you know, as things progress.

Great. Oh, sure. I can just add perhaps that, you know, a couple of things that we've talked about throughout this call will potentially be areas where we'll be able to or want to continue to invest and may ramp up investment over time. Revenue cycle management is the one that Kyle alluded to. EMR integration and related sort of technology investments that can help us increase the stickiness of our business, increase our access to data that will support our ability to operate effectively. There are some potential investments we're evaluating there. Data generation will remain a priority for the foreseeable future in addition to some earlier stage R&D investments that we're assessing. And then lastly, you might wonder, I didn't mention commercial field force. We don't have any near-term plans. We looked at the investment we've made and I think we're very comfortable with covering 90% of the relevant patient population. We have reasonably sized balanced territories and reasonable numbers of HCP and account targets per rep. So we're pretty happy there, but we will evaluate whether there are additional or new deployment strategies that we might want to implement over time in response to the evolution of the market dynamics.

Got it. Thank you. That was super helpful. And then maybe just one on the Neogenomics Partnership. Can you just update us on the progress you're making there and talk about what work is being done to ensure readiness for the early pilot launch in the second half of this year? and then just how you're thinking about how that will inform your full launch down the line. Thank you.

Sure. I'm really pleased with how that partnership has been progressing and very grateful to be working with great partners on the NEO side. The work we've been doing up till this point was to select the phase one accounts that we wanted to target based on a variety of criteria that will allow us to gain insight to ensure that we optimize the broader national launch at the beginning of next year. We've been finalizing the TRS design, test requisition form design. We've been designing or creating the field direction and designing accompanying training. We've been determining how samples will actually flow between the companies, how orders and reimbursement data will flow between the companies. And we've been firming up how we will manage handoffs between various members of our cross-functional teams that face our customers. So all that work will inform the second half phase one launch and will directly benefit the longer term national launch.

Great. Thanks so much.

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