Good day, and thank you for standing by. Welcome to the Adaptive Biotechnologies Second Quarter 2025 Financial Results Conference Call. 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 Calzadilla, Vice President, Investor Relations and FP&A. Please go ahead.

Thank you, Shannon, and good afternoon, everyone. I would like to welcome you to Adaptive Biotechnologies Second Quarter 2025 Earnings Conference Call. Earlier today, we issued a press release reporting Adaptive financial results for the second quarter of '25. 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 Investors section of our corporate website. During the call today, management will make projections and other forward-looking statements within the meaning of federal securities laws regarding future events and the future financial performance of the company. These statements reflect management's 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 Robins, our CEO and Co-Founder; and Kyle Piskel, our Chief Financial Officer. Additional members from management will be available for Q&A. With that, I'll turn the call over to Chad. Chad?

Thanks, Karina. Good afternoon, and thank you for joining us on our second quarter earnings call. Our second quarter results demonstrate strong execution with outperformance on both the top and bottom line. In addition to delivering ahead of expectations, we're also tracking ahead of schedule on key milestones for the year as shown on Slide 3. Our MRD business achieved profitability this quarter, delivering approximately $2 million in positive adjusted EBITDA, which we anticipate to increase going forward. MRD revenue grew 42% year-over-year, driven by significant increases in clinical volume. We successfully integrated clonoSEQ into Flatiron's OncoEMR, expanding access in the community. We've begun processing clonoSEQ tests on the NovaSeq X, a major step in scaling operations and improving margins. NCCN guidelines for multiple myeloma were updated to strengthen support for ID testing at diagnosis, reducing barriers to MRD testing and helping drive volume. And we launched the first phase of our collaboration with NeoGenomics. Total company sequencing gross margin improved by 14 percentage points year-over-year to 64% and cash burn for the quarter was approximately $11 million, representing a 36% improvement over the same period last year, ending with a solid cash position of $222 million. Given these strong results, we are again raising our full year guidance to reflect a higher MRD revenue range and a lower annual cash burn. Kyle will share more details on this shortly. Let's now dive into the MRD business on Slide 5. clonoSEQ revenue grew 57% year-over-year in the second quarter, driven by strong demand across all reimbursed indications. We delivered over 25,300 tests, up 37% versus prior year and up 10% sequentially, an increase of about 2,200 tests versus Q1. Multiple myeloma remains the largest contributor, accounting for 41% of U.S. clonoSEQ volume, followed by ALL at 33%, CLL at 10%, DLBCL at 8% and MCL at 5%. We continue to see positive momentum across several key growth indicators. Blood-based testing represents 44% of MRD tests, up 40% from a year ago. In multiple myeloma, blood-based contribution rose to 23% compared to 21% last quarter. Community-based testing grew 16% quarter-over-quarter, reflecting our expanding footprint outside of academic centers. NHL volume rose to 14% of total, up from 11% last year, led by continued growth in DLBCL and MCL. Ordering health care providers grew 35% to over 3,700, reflecting strong provider adoption. And over 18,000 unique patients were tested in Q2, up 40% year-over-year and 10% sequentially. On the reimbursement front, ASP for clonoSEQ continued its upward trend, reaching above $1,290 per test, a 17% increase year-over-year. Year-to-date, we've closed or renegotiated 8 key agreements with major national and regional payers, with additional agreements anticipated to close in the back half of this year. We remain confident in achieving an average ASP of $1,300 per test for fiscal year 2025 with a solid growth trajectory well into the future.. Now let's take a look at the progress of EMR integrations on Slide 6. Integrating clonoSEQ into EMR systems across academic and community settings remains a key driver of volume growth. In the academic setting, we began Epic integration about 18 months ago, and we're now live at 40 sites, including 13 added since our last call. Epic accounts that have been live for over a year are growing on average about 2x faster than nonintegrated accounts. Among our top 10 accounts, 4 are now Epic integrated, and we're seeing acceleration in those accounts following integration. In the community setting, this quarter, we achieved a major milestone with the integration of clonoSEQ into Flatiron across 113 community account groups, many of which include multiple practice locations. This marks a significant advancement in our strategy to scale in the community oncology space. It also provides OncoEMR users with a more streamlined customer experience, enabling simplified ID/MRD ordering and the option for serial testing directly through the EMR. Looking ahead, we plan to continue expanding EMR integrations over the coming years, further accelerating adoption, simplifying workflows, reducing order discrepancy and strengthening our competitive moats. Looking at MRD pharma on Slide 7. Our MRD Pharma business had another strong quarter with revenue up 20% year-over-year with steady growth in sequencing revenue and $5.5 million in milestones. We ended the quarter with approximately 175 active global clinical trials and a $218 million backlog, up 21% from the prior year. This backlog is a strong leading indicator of future revenue. clonoSEQ is being used as a primary or secondary endpoint in 90 of these studies, many of which may trigger milestone payments upon regulatory approval. On the regulatory front, momentum continues. Recently, the European Medicines Agency, CHMP, issued a positive opinion supporting the use of MRD testing as an early endpoint for conditional approval in multiple myeloma. This decision aligns with the ODAC recommendation and further cements the already strong case for pharma companies to make MRD a central element of their myeloma drug development strategy. As we continue to monitor developments at the FDA, we're optimistic about the growing global support for MRD to accelerate new treatments, not just in multiple myeloma but across all lymphoid malignancies. Turning to Slide 8. I'd like to take a moment to highlight some clonoSEQ MRD data presented this quarter at various conferences. Starting with the MIDAS study in multiple myeloma. This 791-patient study is the first prospective randomized MRD-directed Phase III trial to assess the ability of clonoSEQ to guide myeloma transplant decisions. The study evaluated the use of consolidation therapy versus without transplants in patients who achieved MRD negativity by clonoSEQ at the end of induction. Data shows that patients achieve similar MRD outcomes regardless of whether they received a transplant, supporting the idea that transplant may not be needed for MRD-negative patients. In CLL, promising interim data from Veneto-STOP, an ongoing Phase II study, demonstrated the potential to reduce duration of venetoclax-based therapy in patients who achieve an MRD-negative response. And in DLBCL, several studies presented at the ICML Conference in Lugano showed how clonoSEQ and ctDNA can effectively assess response and complement imaging across different lines and classes of therapy. Q2 also marked an important milestone for the enhanced version of our clonoSEQ ctDNA assay in DLBCL as the FDA granted 2 investigational device exemptions for use in investigator-sponsored trials to assess escalation of therapy for patients who remain MRD positive at the end of frontline treatment. It's exciting to see the expansion of data and studies supporting the interventional use of clonoSEQ MRD in lymphoid malignancies to inform clinical decision-making, and we look forward to more key data readouts at the ASH Conference later this year. In summary, our MRD business is firing on all cylinders. As shown on Slide 9, we're only halfway through the year, and most of our key full year strategic goals have been achieved, including reaching MRD profitability this quarter, ahead of our second half target. Now let's turn to Immune Medicine on Slide 11. Our Immune Medicine business is on track to meet 3 main goals. The first goal is to develop a digital TCR-antigen prediction model. As we scale the size and quality of our data generation, we aim to replace our validated TCR discovery cellular assays with this digital TCR antigen prediction model, which will significantly reduce both cost and time. We're starting to digitally model the ability to accurately select the best TCRs in our cell therapy application with Genentech. We're also making good progress in applying our large training datasets. This includes improving the accuracy of our TCR-antigen binding predictions and deploying our AI/machine-learning models to enable additional partnering opportunities with attractive future monetization potential. The second goal is to build a robust preclinical data package for our lead T cell depletion program in autoimmunity. We are conducting functional and biophysical characterization of our top antibody candidates in our lead clinical indication. We also solidified our patient selection strategy in this indication. This will allow us to select only those patients who we confirm have the specific disease-causing autoreactive T cell receptors and who are at a higher likelihood to respond to our T cell depletion therapy. As we continue to execute on these 2 focused therapeutic strategies, our third goal is to achieve our 2025 cash burn target of $25 million to $30 million by scaling revenue generation from pharma partnering and continuing to thoughtfully gate R&D investments through year-end. Now I'm going to pass it over to Kyle to walk through our financial results and our updated full year guidance.

Thanks, Chad. Starting on Slide 12 with results for the second quarter. Total revenue was $58.9 million, representing 36% growth from the same period last year. 85% of the revenue came from the MRD business and 15% from Immune Medicine. MRD revenue grew 42% versus prior year to $49.9 million, with clinical and pharma contributions of 65% and 35%, respectively. ClonoSEQ test volumes, including international, increased 37% to 25,321 tests delivered versus last year. ASP in the U.S. grew about 17% to $1,290. The continued improvement in ASP is mainly driven by our contracting initiatives, improving our pricing and revenue cycle management activities, including aged collections. MRD Pharma revenue grew 20% versus prior year, inclusive of $5.5 million in milestones. Immune Medicine revenue was $8.9 million, up 13% from a year ago. Moving down the P&L. Sequencing gross margin, which excludes milestones and Genentech amortization, was 64% for the quarter. This represents an improvement of 14 percentage points versus prior year as we continue to leverage lower labor and overhead costs with increasing volumes and higher pricing across both our clinical and pharma revenues. Total operating expenses for the quarter, inclusive of cost of revenue was $83.9 million, representing a 1% increase from last year, excluding the Q2 2024 asset impairment cost. This increase was mainly driven by higher sales and marketing spend attributed to EMR efforts and higher people costs, partially offset by lower cost of revenue and R&D spend. As you can see from the segment reporting table at the bottom of the slide, the MRD business achieved positive adjusted EBITDA of $1.9 million, a massive improvement versus a deficit of $11.3 million a year ago. This is a significant milestone for the business, and we continue to expect positive MRD adjusted EBITDA going forward. Immune Medicine adjusted EBITDA loss also improved 14% versus Q2 of last year. Total company adjusted EBITDA was a loss of $7.2 million in the second quarter compared to a $21.4 million loss in the prior year. Interest expense from a royalty financing agreement with OrbiMed was $2.9 million, which was slightly higher than interest income. Net loss for the quarter was $25.6 million. Now let's turn to our full year 2025 updated guidance on Slide 13. We are again raising our full year MRD revenue guidance to a range of $190 million to $200 million, up from our previous range of $180 million to $190 million. This increase is driven by stronger-than-expected clinical volume performance in the second quarter and higher MRD milestone revenue anticipated for the year. Given the strong clonoSEQ test volumes in the quarter and the momentum we are seeing, we now expect approximately 35% growth in fiscal year 2025 volumes versus 2024, and we anticipate sequential growth in both the third and fourth quarters. We also expect revenue from MRD milestones to be between $14 million and $15 million, up from our previous guidance of $8 million to $9 million. This updated MRD revenue guide represents significant growth of 31% to 37% versus fiscal year 2024 and 32% to 39% for the MRD base business, which excludes MRD milestones at the midpoint. We are reiterating our full year total company operating expense guidance, including cost of revenue to be between $335 million and $345 million. We continue to expect approximately 69% of this to be driven by the MRD business and 23% from Immune Medicine, with the remainder attributed to unallocated corporate costs. Lastly, we are lowering our full year total company cash burn guidance to a range of $45 million to $55 million, down from the prior range of $50 million to $60 million. This improvement is primarily driven by the higher-than-expected MRD revenue. We now expect approximately 18% of this year's cash burn to come from the MRD business and still anticipate burn from Immune Medicine to be between $25 million and $30 million, with the remainder attributed to unallocated corporate costs. The strong financial performance of the first half of the year has set up the MRD business to achieve recurring adjusted EBITDA profitability and a clear pathway to cash breakeven in the near term. Across the business, we will remain focused on this disciplined execution to drive continued sustainable growth while managing our investments appropriately. With that, I'll hand it back over to Chad.

Thanks, Kyle. Our second quarter results are a clear testament to our disciplined execution and strategic focus across every part of the business. Achieving positive adjusted EBITDA in our MRD business marks a major milestone, one that reflects the strength of our model and the commitment of our team. We're confident in delivering on our raised full year guidance and remain focused on execution with the discipline, urgency and precision needed to deliver on our goals and create long-term value for our patients, our partners and our shareholders. With that, I'd like to now turn the call back over to the operator and open it up for questions.

Our first question comes from Dan Brennan from TD Securities.

Nice quarter, obviously. Maybe the first one, just on the volume side, really strong volume. Chad, you called out a lot of the vignettes about the success and the impact of Epic. I just wonder if you could speak a little bit on Flatiron. Obviously, you just did the rollout now. It's pretty massive. Are there any early things to note on what you're seeing so far? And can you just remind us how you're thinking about the volume growth guide that you've given for the back half of the year and how we might think about the benefits of the new accounts on Flatiron and how those might flow through in terms of volume shrink?

Sure, Dan. Thanks for the question. I'm going to have Susan jump in with some details on Flatiron.

Sure. Dan, so as you know, we went live nationally with OncoEMR on July 1. So we are in very early days of the integration. And remember that many of the OncoEMR accounts are accounts where we have little or no existing business. So this integration does represent a significant opportunity to expand in the community. Prior to the integration, these accounts made up about 6% of our total volume, about 20% of our community volume. We're very pleased with the initial results we are seeing, albeit it is very early, both in terms of the volume and the workflow, and we're receiving resoundingly positive feedback from our customers. We are also observing that a majority of the ordering HCPs at these accounts are opting to use the serial monitoring feature that Chad alluded to in his earlier remarks. And that's a new feature of our ordering process that's currently unique to OncoEMR. And we do expect that it will support more consistent ordering at clinically appropriate time points in the community. Now we did build the Flatiron launch into our guide as a growth driver, both for Q3 and Q4. But I do think there's potential for upside. We'll continue to gain insight into exactly what the pace and degree of acceleration that we can expect from this is as we gain a little bit more experience.

Terrific. Yes, there'd be a lot to unpack on that, which we can do later. Maybe just on the pricing side, just a second follow-up there in terms of pricing came in, nice success there. I know you mentioned, I guess, contracting and things. Could you unpack a little bit about what you saw on clonoSEQ pricing? I know you reiterated the full year guide. It seems like you have a lot of momentum there. I'm just wondering across different payer types, where are you seeing the biggest traction? And what do you assume for the back half of the year, which arguably could be conservative?

Yes. Thanks for the question, Dan. This is Kyle. On the pricing improvement, I think we're gaining the growth from the contracting efforts we implemented in the back half of last year, and we're starting to see that pull through across a number of the Blue Cross payers. Medicare, just a percentage of mix is mixing to the newer price point. And so we're seeing those effects. But as we look forward to the second half of the year, a number of our larger contracting implementations with the larger national payers come into play. So I think we're well set up into the second half of the year to continue to see some improvement. We did have some initial wins. It's a little early to say if it's going to continue at this rate with California and Medicaid as well in the second quarter. So that's giving us some momentum heading into the back half of the year.

If I can just sneak one more in. Just on the EBITDA side, really nice traction in the quarter. How do we think about as we look ahead and you're balancing investments in the business versus really seeing some of this EBITDA margin potential flow through. How might we think about where you can end the year and what that means as we look ahead to '26 on the MRD side?

Kyle, you start just in terms of numbers, and then I'll provide some further commentary.

Yes. A great milestone for the business to achieve positive adjusted EBITDA. I think in terms of back half of the year, we are set up with the right trajectory to continue to repeat adjusted EBITDA profitability. In terms of the magnitude of that, some of that will vary depending on the timing of milestones, et cetera. But we're thinking about this as the business is set up to continuously produce positive adjusted EBITDA, and we're seeing that for the longer term here.

Yes, Dan. For the MRD business, we are experiencing a strong acceleration, as shown by the last few quarters. However, we are still in the early stages and have significant growth potential ahead in blood-based testing within the community setting and generating additional data. We will keep investing in the MRD business. In the medium term, we also have international markets to explore, and we may allocate additional capital towards new tests and blood-based measures to support the MRD business. Looking ahead, we will balance our capital allocation and investments to align with our growth trajectory.

Our next question comes from Andrew Brackmann from William Blair.

Chad, maybe around your commentary around expanding the footprint into the community channel. Flatiron is obviously a major lever there. But can you maybe just talk about some of the other drivers there, which should help you drive growth here, not just in the second half, but even longer term, be that indications or blood sample type.

Yes. One of the things that we highlighted in our prepared remarks was the NeoGenomics collaboration. And we're excited about that because 60% of the accounts that they're in, we're not in at all yet. So that's a really nice opportunity for us to increase our penetration. And Susan, do you want to come in on some other efforts that we're doing in the community in terms of putting together pathways, et cetera?

Happy to. Yes, Andrew, a couple of other things that are consistent in our strategy, one is a continued focus on the large national strategic accounts, these oncology practice networks that control a large proportion of the cancer patients in the community settings. So those, we have a separate sales team that focuses specifically on top-down strategy, engaging with the C-suite, et cetera, to ensure that we have a unified direction from their leadership and policies that we can advance that can be consistent across the entire network. The other key thing is engaging academic thought leaders to help us drive community adoption. They have the credibility with those providers. They have the referral networks that they can use to leverage their influence. And therefore, we've increasingly and particularly in light of the recent NCCN guideline update with multiple myeloma, we've been leveraging our thought leaders and partnering with them to deliver education to the community on things like why it's important to perform an ID test at the time of diagnosis. So in combination with our EMR strategy and our collaboration with Neo, those are some of the key things that are consistent in our community strategy. And you mentioned blood, that will always be a part of the conversation and a key adoption driver for community clinics.

And then as a follow-up here, Chad, just want to follow up to some of the comments you made to Dan's last question around additional investments here. clonoSEQ clearly has a long growth way ahead of it. But as you think about adding menu here, some other labs are trying to become more of a one-stop shop, what are some of the key sort of characteristics that you might consider as you're thinking about bringing on additional tests?

I look at it in two ways: one is brand and the other is channel. First, I consider how to leverage our brand in MRD. The second aspect is how to utilize the superior channel we've developed in the hem/onc space. These are the broad considerations from an MRD perspective. Additionally, I evaluate the infrastructure we have established to validate and support diagnostics more widely. For instance, we are developing a TCR-antigen prediction model, which could potentially have applications in diagnostic channels. Though we are in the early stages, these are areas we continue to explore.

Our next question comes from David Westenberg from Piper Sandler.

I actually wanted to tack on for Dan's question on profitability. And again, congrats on the profitability in the MRD business. But you also implied cash flow positive on a go-forward basis. Given the factors in terms of fluctuations in milestone payments and whatnot, do you have visibility on what the milestone payments look like maybe this quarter and next? And if you don't get any in the next couple of quarters, is there a chance for you to go below? And essentially, what I'm laying out with this question is the ability for you to not be held to a certain number if there is indeed milestones or not milestones.

Yes. Thanks, David. This is Kyle. As it relates to the back half of the year, we implied in our guide that there's about $4 million to $5 million to go in the back half of the year as we have $10 million altogether. So again, yes, could those be lumpy on a quarter-by-quarter basis? Certainly. I think as I think about cash flow positivity and where the business trajectory is headed, I'm trying to think about that on an annualized basis, just given quarter-to-quarter we can have variability in spend, investment, et cetera. But I think what we're set up to do is to continue to deliver that with the trajectory of the clinical business and the volume growth we're seeing there, strong performance in the pharma business as well. So I think we're not exactly there yet, but with the NovaSeq coming online, the trajectory of the business is set up to deliver that in the near term.

Thank you. I want to discuss the clonoSEQ volumes, which are experiencing strong acceleration with a 37% year-over-year growth. You've started at a higher base and achieved a 10% sequential growth, indicating that things are progressing well. Can you rank the key factors driving these volume increases? I suspect that much of this is due to integrations, but are there any other factors we might be overlooking, such as new indications like DLBCL? Additionally, can you provide insights into how these integrations are progressing and what you anticipate for volume growth in the upcoming quarters? I believe you mentioned seeing double the volume growth in Epic integrated compared to non-Epic integrated, or possibly it was Flatiron. Do you expect that trend to continue for several years? I apologize for the lengthy question, but could you clarify the integration process when managing multiple orders with specific timing? Have you ever received more than four tests ordered at once? I hope that makes sense. Thank you.

Yes, let me address those questions one by one. Regarding volume growth, we anticipated some upside, and we saw that materialize in the second quarter. We plan to leverage EMR integrations continually. Notably in Q2, we experienced strong growth in mantle cell lymphoma, which we recently launched, and in diffuse large B cell lymphoma, a newer indication with data that continues to support its clinical use. The recent NCCN guidelines update has also provided a boost. We are witnessing robust global support for MRD pharma, which has positive effects in clinical settings. Our blood testing, especially in multiple myeloma, has increased. All of our efforts are contributing to growth, not just one factor, and this trend will persist. In terms of integrations, we significantly increased our pace of integrations through Epic in Q2, completing 13, the highest number so far, and we have doubled our total from 20 to 40 in the last six months. While there are many dependencies on our accounts that can affect future integration speeds, we are confident in our goal to have about 50% of our volume integrated by the end of the year. Eventually, the pace of integrations may slow down, but we are still ahead of our initial efforts and have much opportunity to enhance existing integrations, allowing us to better differentiate growth in integrated versus non-integrated accounts. Lastly, regarding the episode, Kyle, would you like to address that, or should I?

Yes, David, and Susan, feel free to chime in. From an ordering perspective, the clinicians are still ordering test by test effectively. They can, in certain integrations, place reminders for future orders. But really, we're just paid a bundle for Medicare, and that's specific to the Medicare coverage and Medicare line of business. So if we get an eligible test for Medicare, that is paid once for the effective 4 tests.

David, I believe you were specifically inquiring about serial testing and how it relates to the logistics of our integrations. One of the distinctive features we've introduced in the Flatiron OncoEMR system is the ability to order multiple tests by default. This can be set for 3, 6, 9 tests on a recurring basis—whether that’s every 3 months, 6 months, 9 months, annually, or each time a patient visits. Alternatively, orders can be placed one test at a time. I won’t share specific statistics, but it's still early, and we've observed a promising increase in clinicians choosing to order on a regular schedule of 3, 6, 9, or 12 months. This reflects the enthusiasm surrounding repeat ordering and the capabilities we are implementing in these EMR systems.

Our next question comes from Mark Massaro from BTIG.

Congratulations on a strong quarter. I have a few questions about the EMR integrations. It seems that everything is progressing well. You have 40 integrations on Epic, with 13 occurring in the second quarter. This suggests that you began the second quarter with 27. Would you consider those 27 established sites as mature integrated locations? The reason I ask is that I'm trying to understand how long it typically takes to reach a level of maturity where you see growth at twice the rate within mature Epic integrations. Additionally, I wanted to inquire about Flatiron. I recognize that this involved a large number of sites, over 100, so was it simply a matter of implementing it overnight? Also, do you have enough data to determine if Flatiron could achieve similar success as the mature Epic sites?

I think I can take those questions, Mark. So first on Epic. So we're defining mature sites as those that have been live for at least a year. So not all of those 27. In fact, it's more like 6 at this point. And we are looking at those specifically because we wanted to understand if the early impact that we're seeing immediately post integration, which is generally pretty significant, can be sustained. So in fact, if I were to talk about the impact in the 3 months post integration, there's usually a larger impact. But over time, we wanted to see what that looked like, and we do see a consistent pace of increased growth. But it's still, because we've been doing this for about 18 months, and we have a smaller group that we started with, that has been live for at least a year, including a number of smaller accounts. Frankly, they're mostly smaller accounts in that initial group. We'll have to continue to learn more as we gain more data. But 6 months from now, we'll have a much larger group. We'll have about 20 that have been live for a year.

Okay. That's really helpful. So my second question is on the next topic.

Oh, I'm sorry. Did you want me to go ahead on the Flatiron one? Sorry, I didn't....

Of course, keep going.

Thanks. Sorry. You're correct that Flatiron was essentially pushing a button. On July 1, all of those 113 account groups went live. We actually did a small pilot with 4 of them prior, but all of the rest went live on July 1. And it's, I think, too early to say whether we can anticipate similar patterns, but I will point back to what Chad was talking about, the serial testing option, which is easier to use in Flatiron's OncoEMR than it is to use a similar feature like standing orders in Epic. At least it's easier for us to have visibility into it and it's easier to schedule the patient. And so we do anticipate that we'll have a better ability to follow through on serial orders and help support clinicians in delivering appropriate testing frequency with Flatiron. So I do see some upside there, but it's very early to speculate beyond that.

Okay. For my last question, I want to gain a clearer understanding of the Neo collaboration. It seems you have launched Phase I. Could Chad or someone else from the team elaborate on what Phase I includes and what Phase II will entail? I understand this is a commercial partnership, so my assumption is that Neo representatives will be promoting clonoSEQ to many of their clients. Can you provide some insight into the potential lift we might expect? I assume this will have more of an impact in 2026, but should we anticipate any effects in the latter half of 2025?

Sure. So Phase I is our pilot effort with a very small handful of small accounts, again, with the intent of ensuring that we've worked through all the operational processes, the collaboration and handoffs between the 2 companies with accounts that are willing to do the process in a fairly manual manner. So it's really intended for us to learn and gather insights both from the customer and from our own processes as opposed to generate any material impact on volumes. And I would extend that expectation through the remainder of 2025. We do have the plan to bring on additional accounts during the course of the second half of this year, but I don't anticipate material impacts to our volumes beyond what we've already guided. 2026 and 2027 is where we will see that material lift when we launch nationally in the early part of next year.

And just one clarification, Mark. When you mentioned that Neo reps are going out and selling clonoSEQ tests. And I want to just be clear on how that works. They're going out and selling a COMPASS panel that will include as a part of a battery of ID tests done at diagnosis that will include the ID clonoSEQ test as part of the COMPASS workup. And then effectively they're selling the COMPASS workup with MRD baked in as is. And then secondly, as part of their recurrence monitoring or the monitoring across the patient life cycle, they have an offering called CHART, and they'll be selling effectively clonoSEQ embedded into the CHART offering as the clonoSEQ MRD test.

Our next question comes from Rachel Vatnsdal from JPMorgan.

This is Sebastian Sandler on for Rachel. So I wanted to touch on the NCCN update for multiple myeloma, which recommended the baseline clonal ID testing to enable MRD testing later on. You called out the 10% sequential growth in unique patients. And since the update came in late June, I wouldn't think that 10% included any impact from the guideline update. I'm just wondering if you've seen any changes in ordering patterns, especially around that clonal ID testing and how that's been trending since the update. And then just how should we think about these unique IDs translating into MRD testing later on?

Thanks for the question, Sebastian. To begin with, the NCCN guidelines update is certainly beneficial for us and something we are actively utilizing, especially in community settings through both our direct education efforts with healthcare professionals and the knowledge leader-driven education I mentioned earlier. It supports our message about the importance of tracking every patient with multiple myeloma using clonoSEQ. This opportunity is best secured if testing is done at diagnosis or if an appropriate sample is collected for subsequent NGS minimal residual disease testing. While this update supports our goals, we do not expect a specific increase in volumes solely due to this. However, I believe it will enhance our ongoing efforts. I am optimistic that in community settings, it will provide a compelling and credible reason for this testing to take place. Anecdotally, we have numerous examples of accounts that are currently evaluating and seriously considering upfront ID testing protocols in the community, with some already implementing them. However, this does not represent the majority of our ID testing; consistently, around 30% of our test volume has come from IDs over the past few years. I do not expect that to change dramatically, but as we see more support for ID testing in both mature indications like ALL and newer indications, as well as in myeloma, I believe we will continue to see a strong contribution from ID testing over time.

Got it. And then just one on the backlog. Seemed like that's growing nicely, closing at around $218 million after ending 2024 a little over $200 million. It also looks like the primary endpoint stepped up to 17 from 10 ending 4Q last year. So just how should we think about the burn there translating to sequencing revenues? And is there any meaningful difference in the burn rate between these primary versus secondary endpoints? And then lastly, have you seen any recent change in pharma customer behavior in that segment, just given some of the headlines around tariffs and ? And do you anticipate any headwinds there going forward? I think some of your peers have called out a bit of bumpiness there. So just wondering if you're seeing any or building any into the guide.

Sure. Go ahead, Kyle.

As it relates to the backlog, in terms of the burn profile, I think of it as we're continuously replenishing our backlog with new bookings, and that's what's highlighted by the improving backlog relative to exit value of 2024. I think the timeframe of which that backlog converts into revenue is really unchanged. Maybe a little bit of a pull forward. But obviously, with the dynamics at the FDA and our pharma partners' investments, it's still contingent upon when their trials are reading out, how many patients are enrolling, and when we can enable some of that MRD testing. But broadly, don't think the profile has changed dramatically, and we're going to continue to grow bookings, and we're confident in the pipeline we have around the pharma business.

Yes. And as it relates to more general question about our MRD pharma business going forward and impacts of tariffs, NIH and the FDA. First, we'll start with the tariffs and the FDA. There's very little impact as we look through the portfolios. We're really not subject to NIH funding in terms of very little percentage of our business. As it relates to the FDA, I would just start by saying globally that there is really a growing global support for MRD to use as an endpoint for the acceleration of therapy in multiple myeloma. And even more broadly, there's coalitions forming in other indications as well. So we're very positive on the acceleration of MRD therapies based on MRD. So the ODAC recommendation last year, along with the CHMP positive opinion on MRD using MRD as an early endpoint, it's just continued in further validation of MRD as a predictor of response. So overall, we're very bullish on the MRD pharma opportunity.

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