VCYT - NASDAQ

Good day, and thank you for standing by. Welcome to the Veracyte Fourth Quarter 2025 Financial Results Webcast. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Shayla Gorman, Senior Director, Investor Relations. Please go ahead.

Good afternoon, everyone, and thank you for joining us today for a discussion of our fourth quarter and full year 2025 financial results. With me today are Marc Stapley, Veracyte's Chief Executive Officer; and Rebecca Chambers, our Chief Financial Officer. Dr. John Leite, our Chief Commercial Officer; and Dr. Phil Febbo, our Chief Medical and Scientific Officer, will join us for Q&A. Veracyte issued a press release earlier this afternoon detailing our fourth quarter and full year 2025 financial results. This release and a copy of the presentation we will review during the call today are available in the Investors section of our website at veracyte.com. Before we begin, I'd like to remind you that statements we make during this call will include forward-looking statements as defined under applicable securities laws. Forward-looking statements are subject to risks and uncertainties, and the company can give no assurance they will prove to be correct. Additionally, we are not under any obligation to provide further updates on our business trends or our performance during the quarter. To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that Veracyte files with the Securities and Exchange Commission, including the most recent Forms 10-Q and 10-K. In addition, this call will include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures are included in today's earnings release accessible from the Investors section of Veracyte's website. I will now turn the call over to Marc Stapley, Veracyte's CEO.

Thank you, Shayla, and thank you all for joining us today. Q4 capped off another outstanding year of strong execution for Veracyte with performance across our core businesses that reinforces both the durability of our growth model and the opportunities ahead. I'll review our fourth quarter results, reflect briefly on 2025 and then focus on the growth drivers that give us confidence as we move into 2026. Fourth quarter total revenue was $141 million, representing 19% growth year-over-year. This performance was driven by continued strength in our core testing business, which grew 21% on strong volume and ASP. Decipher volume grew 21% and Afirma grew 12%, together contributing to 16% total testing volume growth. For the full year, we delivered total revenue of $517 million at the high end of our preliminary range and representing 16% growth. During the year, we provided clinically actionable information to nearly 170,000 patients with over 800,000 patients served to date. We remain on track to testing our 1 millionth patient later this year, an important milestone for the company and our team that reflects both the scale and impact of our platform. In addition to our strong revenue and volume growth, we executed against all of the key milestones we set for 2025. We drove continued penetration and share gains, launched Decipher for metastatic patients, expanding our presence in advanced disease and generated meaningful new clinical evidence across endocrinology and neurology. We advanced our pipeline with positive Prosigna outcomes data from the OPTIMA PRELIM study, submitted the technical assessment for TrueMRD and completed enrollment for our NIGHTINGALE lung cancer study. Together, these accomplishments position us well for multiple product launches beginning in 2026. Importantly, we achieved this while delivering industry-leading profitability and cash generation. Adjusted EBITDA margin exceeded 27% in 2025, not only reaching but surpassing our 25% target more than a year ahead of plan. We also completed key operational priorities, including the restructuring of Veracyte SAS and the full transition of all Afirma volume to the more scalable, lower-cost v2 transcriptome platform, improving our operational efficiency in launching new transcriptome-based tests. These actions support the sustainability of our financial profile as we continue to invest in growth. I'm extremely proud of our team's focus on execution and innovation, which enabled us to deliver an outstanding year and reach more patients than ever before. The foundation we've built through the Veracyte Diagnostics platform supports a clear phased expansion strategy anchored by a focused set of drivers contributing to near, mid- and long-term growth. First is the ongoing durable expansion in our core business, Decipher and Afirma, which we believe will support double-digit revenue growth for the foreseeable future. The second phase is our 2026 product expansions with two product launches planned by this summer. We are preparing to launch our inaugural TrueMRD test for patients recovering from muscle invasive bladder cancer, followed by the U.S. launch of Prosigna as an LDT to address early-stage breast cancer patients. The third phase represents our longer-term commitments, including geographic expansion through our IVD strategy and addressing new cancer challenges across the care continuum. Today, I will focus on the first two phases, our core business momentum and the opportunities ahead with our 2026 launches. Starting with Afirma. We delivered approximately 18,250 tests in the fourth quarter, representing 12% volume growth. Throughout the year, we saw a steady pipeline of new account wins and increased utilization per account with the fourth quarter continuing this trend. As of year-end, we believe we have grown Afirma to approximately 38% market share with continued opportunity for further penetration. Importantly, as previously mentioned, we completed the full transition to our v2 transcriptome in the lab during the fourth quarter. Besides being more scalable and cost effective, this new platform enables us to deliver results in challenging cases where we were previously unable due to low RNA. In the fourth quarter, our [ no ] result rate was 2% lower than in the prior quarter, directly contributing to more patients and physicians receiving actionable results to support clinical decision-making. We also saw a steady drumbeat of new publications leveraging data generated from our research [indiscernible] Afirma GRID, which further builds on our extensive body of clinical evidence. The majority of Afirma-related abstracts and publications in 2025 were GRID-related, reinforcing Afirma's position as not only the standard of care in clinical testing, but also what we believe is becoming the primary research platform advancing understanding of thyroid nodules and cancer. This year, we plan to build on this momentum with an updated version of GRID that includes additional signatures designed to support ongoing thyroid nodule research. Given our recent progress, we're confident in Afirma's ability to sustain healthy growth in 2026 and beyond. Turning to Decipher. We delivered approximately 27,200 tests in Q4, marking our 15th consecutive quarter of more than 20% year-over-year volume growth. We reached another record for both the number of quarterly ordering providers and orders per physician. In fact, the number of ordering physicians increased 18% year-over-year in Q4, reflecting Decipher's expanding adoption and its role in supporting treatment decision-making. This momentum has been building throughout the year. Of the more than 300,000 prostate cancer patients tested with Decipher since launch, more than 100,000 were tested in 2025 alone. Decipher is recognized as the only gene expression test with high-quality evidence in NCCN guidelines, which we believe has been an important contributor to this impressive growth. Looking ahead, with the market now penetrated by Decipher at approximately 33%, we remain extremely confident in its ability to sustain strong double-digit growth in 2026 and beyond. This growth outlook is supported by several key drivers. As GRID-enabled research establishes clinical utility for new prostate signatures, we plan to expand our clinical reporting to incorporate these insights. Our first examples are three new predictive signatures, PORTOS, PTEN and PAM 50 that are now widely recognized by key opinion leaders as having utility based on recently published studies. Patients with higher PORTOS scores have been shown to benefit from higher doses of radiation in both post-biopsy and post-RP salvage settings. PTEN used alongside the Decipher score showed promise in the STAMPEDE study for identifying which metastatic patients would benefit from adding chemotherapy. And the BALANCE trial, whose results were presented at ASTRO last fall, found that the PAM 50 molecular signature confidently predicts which patients with recurrent prostate cancer may benefit from hormone therapy with apalutamide in addition to salvage radiation therapy. We are working to add these molecular features to the Decipher report as optional insights, providing additional information for men with high-risk biopsy and RP disease, including those with biochemical recurrence. As a reminder, this patient population has been underserved to date, a trend that we have been focused on improving with augmented clinical evidence supporting Decipher in advanced disease, where its predictive power has been shown to improve patient outcomes. This focus paired with the launch of Decipher metastatic has led to another quarter of more than 30% growth in the combined high-risk RP and metastatic categories, and we believe there remains significant opportunity to expand Decipher's use in advanced disease. Additionally, we view digital pathology and AI-powered analysis as complementary to molecular analysis with the potential for additional data points to provide a more comprehensive assessment of tumor histology. To support further research, we made our digital pathology services and associated AI models available to collaborators last year and have implemented slide scanning as a standard production workflow. We have now scanned over 210,000 slides from over 150,000 patients with outcomes data, representing the majority of our historical data set on Decipher. We plan to leverage this extensive database in combination with whole transcriptomes in an expanding number of collaborations with top academic centers to understand the complementary nature of these two data types in order to continue to evolve our clinical offerings. Generating clinical evidence is a core pillar of our Veracyte Diagnostics platform, and we continue to fuel this flywheel. Decipher Prostate now has more than 100 publications demonstrating its clinical utility and validity across the prostate cancer risk spectrum, plus an additional 100 publications leveraging our research use-only GRID platform. At ASCO GU, data to be presented, including more than 15 abstracts across prostate and bladder cancer, highlight how our platform is contributing to advances in urologic oncology. Multiple abstracts will showcase the power of Decipher GRID to enable novel research, including studies demonstrating how signatures derived from GRID predict adverse outcomes in men on active surveillance. Additionally, several abstracts will be presented, leveraging real-world data on the usage of the Decipher Prostate score in our patient population, including those with metastatic prostate cancer. Moving to bladder cancer. Our Decipher Bladder classifier and associated research use-only GRID data is increasingly being integrated into studies that aim to help researchers identify critical signatures to guide the future of bladder cancer treatment. We're seeing strong momentum generating new clinical evidence for this indication with five abstracts highlighting Decipher Bladder at ASCO GU. We're particularly excited about the findings from the SURE-02 trial, which underscore the importance of molecular subtyping in muscle invasive bladder cancer or MIBC, and support integrating genomic classifiers like Decipher Bladder into clinical trial design and treatment planning. As the field transitions towards more biologically informed evaluation of novel treatment strategies in bladder cancer, we plan to continue investing in this indication to drive future growth. Collectively, these studies highlight how our Decipher tests are increasingly helping guide clinical decision-making, advance biological understanding and accelerate innovation in urologic cancer care. This momentum in bladder cancer extends to our TrueMRD platform, our whole genome sequencing approach to MRD. We remain on track to launch our first indication for MIBC in the first half of this year after completing our technology assessment with MolDX to receive reimbursement, which is in progress. We intend to leverage our strong Decipher brand and channel to serve patients that are treated in the urology and radiation oncology setting, which we believe reaches approximately 70% of MIBC cases. Our initial focus will be on recurrence monitoring in those patients who have completed their initial therapy for MIBC and are not undergoing adjuvant chemotherapy, which we believe is the majority of MIBC patients treated in this setting. We're building a strong and growing body of clinical evidence around our MRD platform. At ASCO GU, TrueMRD will be featured in an oral presentation on a Phase II trial evaluating pembro combined with serial ctDNA monitoring in patients with MIBC that did not undergo radical cystectomy. In this trial, TrueMRD's whole genome sequencing was used during neoadjuvant therapy at restaging and during surveillance to monitor for residual disease, providing more confidence that the cancer was responding to therapy. The results demonstrate that many patients with MIBC may be successfully treated without bladder removal and maintain very low risk of metastatic recurrence. These findings highlight how molecular monitoring may support bladder-sparing treatment strategies while maintaining confidence in managing disease. This therapeutic strategy is being prospectively evaluated in the actively accruing NEO-BLAST study conducted at the University of British Columbia. In addition, there are several other studies that have already been completed across bladder, colorectal and lung cancer as well as other indications. We have a deep pipeline of additional studies underway with 10 in testing or analysis, 13 in contracting and 17 in active planning, spanning MIBC as well as non-muscle invasive bladder cancer, breast, lung, colorectal and immunotherapy treatment response. TrueMRD is a platform that is extensible into other cancer types, and we plan to launch additional indications each year going forward. Our MIBC launch addresses a clinically important market and will serve, we believe, as a foundational proof point that Veracyte is a credible player in this large and expanding space. With strong engagement from leading institutions and encouraging early results, we believe TrueMRD's differentiated approach positions us well to capture meaningful share in the MRD market. Turning now to Prosigna, our second major product launch planned for 2026. Prosigna is based on the well-established and scientifically validated PAM 50 signature, which provides physicians and patients with deeper insights into the biological classification of their cancer and the risk of recurrence to help inform treatment decisions. The opportunity in the U.S. breast cancer market is significant with over 300,000 patients diagnosed each year. Approximately 75% of these patients have early-stage hormone receptor positive disease and would be eligible for Prosigna testing. Clinical data will be an important driver of adoption, and we look forward to the full OPTIMA trial readout, which we expect to be presented at ASCO in June. We believe this data will further strengthen the clinical evidence supporting Prosigna, differentiating it as the next standard in breast cancer prognosis and that numerous ongoing studies will further demonstrate the differentiation of Prosigna in this setting, building on the OPTIMA results. We believe this body of evidence supports the opportunity for Prosigna to capture meaningful share in this market over the next 5 years. We remain on track to launch our LDT for Prosigna over the summer on our new transcriptome lab workflow, the same analytical platform we have built and fully launched for Afirma. To prepare for this, we've begun building out our commercial team, starting with appointing a strong leader for the sales force while also growing our medical science liaison team and engaging KOLs. Meanwhile, our talented marketing team is busy working on all of our prelaunch activities, while our fantastic market access team is working on the Medicare and commercial reimbursement coverage. I couldn't be more excited about our two major product launches this year. The foundation we have built over the last 5 years, including our track record of meeting or exceeding our expectations while expanding our leadership across the cancer care continuum, reinforces the durability of our growth outlook. Our execution across Decipher and Afirma, combined with our ability to navigate through evolving market dynamics reflects the strength and resilience of our operating model. We are entering 2026 with a clear path to sustained double-digit growth, served by a portfolio of tests in prostate, thyroid, bladder and breast. This momentum positions us to deliver lasting value for the patients we serve, the employees who power our mission and our shareholders. With that, I will now turn the call over to Rebecca to review our financial results for the fourth quarter and full year as well as our outlook for 2026.

Thanks, Marc. Q4 was another exceptional quarter with $140.6 million in revenue, an increase of 19% over the prior year period. We grew total volume to approximately 48,000 tests, a 16% increase over the same period in 2024 and generated $52.6 million of cash from operations to end the quarter with $412.9 million of cash and cash equivalents on hand. Testing revenue during the quarter was $135.8 million, an increase of 21% year-over-year, driven by Decipher and Afirma revenue growth of 27% and 16%, respectively. Total testing volume was approximately 45,500 tests, an increase of 16% over the prior year period. Testing ASP was approximately $2,984, an increase of 4% compared to the prior year, driven primarily by the impact of higher prior period collections or PPCs. Normalized ASP was also higher at $2,875, a 1% increase compared to the prior year period after adjusting for the approximate impact of $5 million of PPCs in the quarter. Moving to gross margin and operating expenses. I will discuss our non-GAAP results. Non-GAAP gross margin was 75.1%, up 580 basis points compared to the prior year period. Testing gross margin increased 380 basis points compared to the prior year to 76.1%, driven by operational efficiencies from our v2 transcriptome and higher PPCs. Non-GAAP operating expenses were up 12% year-over-year to $65.1 million. Compared to the prior year, research and development expenses increased by $1.6 million to $19 million, driven primarily by clinical investments. Sales and marketing expenses increased slightly to $23.9 million, given higher travel expense. G&A expenses were up $4.7 million to $22.3 million, primarily due to hiring and expenses in our customer service function to support revenue growth and software teams to support new product development. Moving to profitability. We recorded quarterly GAAP net income of $41.1 million and $66.4 million for the full year 2025. Adjusted EBITDA for the quarter was $42.3 million or 30.1% of revenue, well above our expectations given the benefit of prior period collections. For the full year 2025, our adjusted EBITDA margin was 27.6%, ahead of our target of 25%, which was achieved more than a year ahead of our projections. We increased our cash balance by more than $120 million over the course of the year. These results give us the flexibility to invest in our growth drivers and are a testament to our differentiated financial profile. Turning now to our 2026 outlook. We are reiterating our 2026 total revenue guidance of $570 million to $582 million or 10% to 13% year-over-year growth. This reflects testing revenue growth of 14% to 16% for the year with Afirma growth expected to be in the mid- to high single digits and Decipher growth to be approximately 20%. As always, we have not included PPCs in our guidance, but do have a headwind of approximately $10 million of PPCs we recognized in 2025. We expect adjusted EBITDA margin to be approximately 25% in 2026 and in future years, barring any bespoke investments we decide to make, which, of course, we would communicate as appropriate. We expect Q1 adjusted EBITDA margin to be lower given typical seasonality of expenses, including increased compensation, benefits and payroll tax. As always, we plan our expenses on an annual rather than quarterly basis. In closing, I am thrilled with our progress over the course of 2025. As Marc shared, we delivered on or exceeded all of our 2025 goals, including the Decipher metastatic launch and the transition of Afirma to the v2 transcriptome. With a number of exciting catalysts on the horizon for 2026 and beyond, paired with our differentiated financial position, I am more confident than ever in Veracyte's future and proud to be serving more patients at pivotal points in their cancer journey. We'll now go into the Q&A portion of the call. Operator, please open the lines.

[Operator Instructions] Our first question comes from the line of Subbu Nambi of Guggenheim.

I have two topics. Starting with the guidance question. As we sit here 8 weeks into the year, has your conviction in the guidance evolved in any way? What are the assumptions that drive the high end or low end of the range? And maybe some details on the quarterly cadence?

Yes. Thanks, Subbu. I'll start. I mean, obviously, we're 8 weeks into the quarter, but only 8 weeks into the year. We've reiterated our guidance, and so you can -- that we gave earlier in the year. So you can see from that, our conviction in our guidance continued to be strong. I'll ask Rebecca to talk a little bit about the seasonality and the potential drivers of the high and low end range.

Yes, happy to do so. Thanks, Marc, and thanks, Subbu. Great to hear your voice. So I think the first thing to be aware of is for the first quarter, sequentially, this is a quarter where we do see seasonal trends. We had obviously an incredibly large prior period collection quarter in the fourth quarter. And historically, if using last year as a proxy, that does not typically tend to repeat in the first quarter. That's typically -- last year, it was around $500,000. So that is one thing to be aware of from a sequential trend perspective. From a volume perspective, Afirma is typically the lowest in the first quarter and followed by the third quarter with the second and fourth quarter being stronger. And with Decipher, it's highly dependent in the first quarter on weather. If you use last year as a proxy, we had -- maybe we were up maybe 100 samples or so sequentially and had a pretty big weather impact in the first quarter of last year. This year, tracking to date is around the same from a weather impact. And so obviously, we'll catch that up throughout the course of the year, but that is something to be aware of on a go-forward basis. What would get us to the high end of the range would be a couple of different things. The first, we do have a no result rate assumption for Afirma in guidance. At the low end, we would assume little to no benefit from the no result rate. At the high end, we would assume about the same level we saw in the fourth quarter. So that would be one thing to take into account. If we do get prior period collections, that's not baked in. That could bias us to the high end. And then obviously, volume outperformance. Specifically, I think Decipher has more -- the error bars are wider on Decipher than Afirma, given the nature of the kind of portion of the adoption curve of where we are at. And so from Decipher perspective, if we were to see more penetration or more share gains, that would obviously lend itself to the high end of the guide as well. Hopefully, that helps. Anything else to add, Marc?

No, just a reminder that we're not -- in our guide for revenue, we're not guiding for the new product launches for a very simple reason that we expect those to be more of a revenue driver in 2027, but those, of course, aren't included in the guidance either.

Super helpful. One of the goals of the OPTIMA study is to expand the intended use population. What readout is required for this to occur? And if successful, how big would this market be?

Yes. So I'll start and then I'll hand over to John to talk about the market opportunity here. But the way we describe this is there's the patients, 300,000 patients a year with breast cancer. There's about 75% of them or 225,000 of them that are addressed by what we believe will be the Prosigna indication there. Our first and foremost goal is to penetrate that market as it currently stands and then obviously expand from there. And so you can expand into, for example, premenopausal, you can expand into all the different risk categories within that 225,000. But John, maybe you can just give a little bit more commentary on how OPTIMA is going to address this.

Yes. So thanks, Subbu. OPTIMA has included in their enrollment criteria up to nine nodes. Currently, Oncotype is approved up to three. We'll have to see what the performance of the test ultimately will be with the OPTIMA trial results before we can provide very directed commentary on how we expect to leverage that data.

And remember, OPTIMA is expected to read out. We hope at ASCO. Of course, we're hoping that the -- and expecting that the results are positive and that it reads out when we're looking for it to, and we're ready to launch when that happens. Thanks for that question, Subbu.

Our next question comes from the line of Puneet Souda of Leerink Partners.

This is Carlos on for Puneet. I've got two questions. So the first one is you had a really healthy beat of your 25% margin target. You were at, I think, 27.6% for the year, but you're guiding to go back down to a long-term target of 25% in 2026. If you could just walk through some of the push and pulls there. Is that just conservatism? Is it true-ups? Is there an increase in OpEx that we should be looking out for? Anything there would be helpful.

Yes. Thanks for the question. At a high level, we've got two product launches coming this year. And the way I think about it is as we launch those products, if we see an opportunity to invest faster to go faster, we will absolutely want to be able to take that. And so that's one. Obviously, building clinical evidence and clinical studies and so on in -- especially in MRD as we expand into more indications is important. So it's -- I think for us, it's really important to have the flexibility to be able to do that while remaining extremely profitable relative to the industry. And I'm proud of the fact that we got there about a year earlier than we anticipated. I always said a well-run business in this diagnostics industry should be able to get to 25% and sustainably remain there. Rebecca, do you want to add?

Yes. I would just say specifically to the 25% guide versus the 27.6% over the course of 25 Recall, we did have $10 million of prior period collections over the course of 2025. And given we don't imply that in the guide, we wouldn't include that in our OpEx guide either. But we do have significant investments per Marc's point, that all have an incredibly high ROI associated with them. And given we are -- our goal here is to serve as many cancer patients as we can with high-value quality products, we're going to invest in those things. And while they're not necessarily going to be impactful and are included in our guide in 2026, they're absolutely critical for the long-term performance of this organization, and we feel very positively about the benefit they will have both to all of our stakeholders, including patients. And so when it comes down to it, that's what we're focused on, driving revenue growth, driving patient adoption and really serving as many folks as we can. And everything we're investing in here is very high ROI. So that's what I would add. I would just say what we are investing in specifically are those new product introductions, the software and bioinformatics resources required, the commercial resources required, the revenue growth support through our customer service, billing and lab operations team. And again, remember, last year, we did invest in the back half more so than the first half. And so obviously, you have the full year annualization of that impact as well. So I think you can see kind of the opportunity breadth of what we have in front of us is so high. It would almost be foolish not to do our best to invest these dollars. And in things like further Decipher penetration, bolstering Afirma for the long-term [ the ] MRD platform as well as Prosigna and then obviously, the long-term growth drivers, which are a much smaller percentage of the pie vis-a-vis IVD nasal swab at this point in time.

Okay. That's really helpful. And then just as one other question. So when we're looking at the Decipher market, you had really great momentum, 27% growth in the fourth quarter, still plenty of penetration to go with the market only 40% penetrated, but the penetration is growing quickly, and we're seeing competitors investing a lot more into their competing assays. One of them that had struggled a bit managed to return to double-digit volume growth that they announced earlier this week, for example. If you could just give a little update on the competitive space that Decipher operates in, what you're seeing, that would be very helpful. I appreciate it.

Yes, happy to. A couple of kind of macro level things. I mean the way we see the market growing is at about -- from an incidence standpoint, was about 6%. Decipher represents based on our math now coming out of the year of 2025, about 33% market penetration. So as you can see, 1/3 of patients are getting Decipher, more importantly, 2/3 are not. We haven't seen any change in the competitive dynamics or competitive environment at all. In fact, if you look at the way Decipher grew in 2025 and our guide going forward, it's continuing to represent very strong growth. And that's driven by the masses of evidence that we talk about regularly, the NCCN guidelines that we have and where Decipher sits in that. And so we remain extremely confident in Decipher's ongoing growth trajectory, and we're very encouraged when we see how that's -- even coming into this quarter, how that's progressing in the marketplace.

And just one thing to add. I mean, we grew 22,000 tests in 2025 versus 2024. If you look at the other players in the market and do an extrapolation of what you think their total year volumes were, they aren't that far off of what our peer growth was. And so that's just an explanation point to Marc's point that we really are not seeing a difference in competitive dynamics. And recall, there are three players in this market and at least vis-a-vis the preannouncement, I do believe we're seeing kind of maybe share move from one to the other in any given quarter. But again, our competitive dynamics are such that -- are so strong that we don't necessarily even see that noise.

And maybe just -- Rebecca, remind me, just punctuate one other point. As you look across the NCCN risk spectrum, Decipher is doing and always has done extremely well in the intermediate and low. Low has been, I would say, our second highest and high has probably been the lowest. And I think we've mentioned a few times over the last couple of quarters, how we're seeing since the launch of Decipher metastatic, a nice increase in growth in the high risk. And of course, you've got the RP in the metastatic population there as well. And so with that growing in like the 30% range, it's actually really exciting to see further penetration across the care continuum, which has always been our strategy with all of our tests and particularly with the type of evidence that we generate.

Our next question comes from the line of Bill Bonello of Craig-Hallum Capital Group.

Yes. Two things. So to start with, I might come also at the margin question, but probably from the opposite point of view. I mean, just sort of back of the envelope math, it looks like you're giving yourself $10 million to $15 million of incremental investment to launch two products and at some point, you have to put together an entirely new sales force, I would imagine, for breast cancer. So help us understand why that's enough spend to allow you to be competitive with those two products.

I love your question, Bill. Marc is going to answer it, but.

I mean -- and if anything, I would say, when you talk about the room, that might be room for us to add incremental spend if we need it. Remember what I said, if we want to -- we see an opportunity to go faster, we have the room to go faster. the baseline assumption might even be a little bit less than that. And the reason for that is as we launch these new products, if you think about how 2026 shapes out, we need to add maybe a dozen sales reps at the beginning for the Prosigna side. And then, of course, MRD plays into our existing channel in neurology, where the majority of patients are served in that setting. And so there's not a significant amount of incremental investment there. So beyond the sales team and the market development activities, the bulk of actually launching a new product is in clinical evidence development, and that's been ongoing and is already in the run rate for us and has been for years. And again, it's playing the similar formula to Decipher. Many of the studies that are actually going to drive these products are studies that others will do over time. So I'd say, Bill, the answer to the question is we're confident we can do it with that. And if we need to spend more, we will spend more, and we will go faster.

Yes, I absolutely agreed with Marc. And Bill, you had let's take the math offline because the amount we will be spending year-over-year versus 2025 is significantly higher than the $10 million you cited. So Marc is absolutely right on the drivers of that investment. But yes, the investment, given the gross margin expansion that we expect from the [ UA ] Transcriptome transition allows the math to be much -- to be decently higher than that $10 million cited.

Excellent. I've never been good at math. Then the follow-up, which is sort of cheating because it's really a different question. But can you just talk about how you're thinking about capital allocation? I mean you're sitting with a lot of cash and generating really strong cash flow, and it looks like you will continue to do that.

Yes. Happy to do that. No change in our philosophy around capital allocation. We've been generating cash for a while now. We've had a strong balance sheet. We've made some important decisions, including acquiring C2i in order to drive our MRD platform. And we're continuing to look at opportunities in the marketplace, but our philosophy and our bar hasn't changed one bit. Other than that, as you can see, and we just talked about, there's investment in our ongoing business. We're obviously spending money, as you would expect us to, on organic discovery type of activities and building infrastructure, things like software development and so on. And those are kind of the main ways we think about allocating capital. And so we'll continue to be very deliberate about that.

Our next question comes from the line of Doug Schenkel of Wolfe Research.

The first topic I wanted to dig in on is gross margin, which stepped up by about 200 basis points in the fourth quarter. How much of that can be directly attributed to the v2 transcriptome? And then just one clarification also on gross margin. Rebecca, in your prepared remarks on Q1 adjusted EBITDA margin being lower. Is that an expectation of being lower than the target guidance number for the year or down sequentially from Q4?

Yes. Let me take the back part of that first. So yes, it would be -- we would expect Q1 to be below the guide for the year and definitely lower sequentially, right? You have to remove the PPCs and then obviously, the start of the year costs, whether it's benefits, comp, taxes, health care, et cetera, will impact that. So -- and then obviously, PPC. So yes, absolutely, Q1 should be down sequentially for sure. Vis-a-vis your question on gross margin in Q4, that really is the two things that -- the thing you cited and the thing I cited. So together, we have the perfect answer, Doug. No result rate benefit and the cost benefit from the UA transcriptome as well as the PPCs. And those are -- the PPCs is the larger impact of -- no result rate is the larger impact of the two.

Okay. Second topic is Decipher bladder. Data coming out of ASCO GU looks pretty impressive. Our understanding is most of your Decipher volume is still in prostate today. Can you comment on roughly what percentage of Decipher is bladder and then how you expect that to trend over time? And I guess a big reason, it's probably obvious, but a big reason I'm asking this is on the bladder sparing data being presented at ASCO GU, it does seem like that could support increased use of Decipher into earlier stage or potentially neoadjuvant chemo decision-making workflows. And that could actually support multiple Decipher informed decision points across the bladder care continuum over time. So if that's the case, I could see where this could turn into a much bigger growth driver over time. if I'm thinking about this the right way. So any help there would be appreciated.

Yes, Doug, I think your question is spot on. And so the way to think about the bladder in the numbers today, it's a very small portion of the total Decipher number that we talk about. And I think we've been relatively consistent in describing how we think about the bladder classifier. We need more evidence, exactly the type of evidence that's coming out at ASCO GU in order to drive the clinical utility of that test in, for example, the neoadjuvant setting that you just described, and then what I really love about it is then you've got this Decipher classifier that can be used at that very early stage. And I've always said, as you move the patient through the care continuum, you have patients who need MRD as well. We have the Decipher -- we will have the TrueMRD tests as well for those patients. So I love that we're filling out that care continuum. And I think it's kind of important to have these be part of the diagnostic and prognostic and predictive workflow as well. Phil, do you want to talk a little bit about some of the interesting things that we're going to see at ASCO GU?

Yes. And thanks for the question. So I would say the GU ASCO abstracts in aggregate really demonstrate how understanding the different subtypes of earlier-stage bladder cancer is increasingly becoming part of care because bladder cancer is in this transition where we're really looking at how to maximize response to neoadjuvant therapy to move patients to a bladder-sparing approach. And the studies we'll be presenting kind of shows how our Decipher bladder can inform those decisions and where we see higher proportion of responses in kind of -- in luminal versus nonluminal subtypes. And so not only managing that. Additionally, we see -- you're seeing how we're -- with Decipher Bladder also pairs nicely with the follow-on with our muscle invasive bladder cancer MRD, again, trying to identifying how patients are doing when patients are working towards a bladder sparing approach. So the bottom line is our portfolio of studies showing that understanding the subtypes of bladder cancer help inform that neoadjuvant therapy just increases the interest, and we're getting a lot of interest on that bladder test.

Our next question comes from the line of Kyle Mikson of Canaccord Genuity.

Congrats on a strong year. I wanted to start on the '26 guidance. I think Rebecca, in response to Subbu's question, you parsed out Afirma and Decipher expectations for the year with respect to revenue. I think you said mid-single digit to high single digit for Afirma and then Decipher 20% growth you kind of left. So could you just talk about the volume expectations for both of those products for '26? And then any puts and takes for each of those like for Afirma, maybe some volume shifts because of the v2 or Decipher, you have a lot of digital pathology stuff going on. So we would love to hear that.

Yes. Happy to do so, Kyle. Thanks for the question. Effectively, given the prior period -- you can effectively assume that the volume growth number embedded in the guide is higher than the revenue growth guide because of the $10 million of prior period collection impact. So that's the easiest way to think about it. And remind me what the second part of your question was, sorry?

I mean it was just kind of like puts and takes for volume growth for the year. There's a lot of kind of exciting stuff on tailwind especially.

Yes. So on the new transcriptome at the low end of the Afirma guide, we would assume no benefit. At the high end, we'd assume kind of what we saw in the fourth quarter. And then on Decipher, there's a lot of different things that we're working on. Obviously, the continuous drumbeat of publications and podium presentations. Obviously, the ASCO GU showing was incredibly strong. We would expect just that flywheel to continue throughout the year. The other thing on the Decipher front is we are working on our new signatures that Marc cited in his prepared remarks. Those may not be necessarily additive to 2026, but will be important as we think about looking to '27 and beyond and continued competitive differentiation. And then the last one I would cite is really kind of on the high-risk biochemical recurrence metastatic side. We've seen a lot of traction there since the ASTRO presentation back in Q3. And I would suspect that, that trend continues, if not, even becomes even stronger as we go throughout the course of 2026 and beyond.

Perfect. I had a follow-up on MRD. I was curious what you're doing now to seed the market for the launch for MRD and MIBC in the first half of the year, there's a lot going on in bladder cancer, whether it's on the therapeutic approval side or clinical trial side in MRD. So how are you going to make sure that your voice is heard other than these data and things like that in presentations?

Yes, I think that's a great question. There are a couple of layers to it. I mean, first and foremost, as you know, our initial test in TrueMRD, which is a platform, is going to be in muscle invasive bladder cancer. And for that, we really already have a lot of voice of the customer and that we are visiting those customers because of Decipher. And so at the appropriate time, and remember, we don't want to obviously distract from our very well-run Decipher business on the prostate side, at the appropriate time and the appropriate accounts, we will be spending time with those customers. We will be describing the clinical studies that have already been done in that setting, and we'll be helping those customers to understand what our TrueMRD offering is and how they're able to use it. John, do you want to add anything with respect to that?

No, I think you answered it well. I mean the only thing that I would add is we have a standing policy that we would only pursue tests commercially once they're reimbursed. I think what you're hearing here is prudence, not conservatism. We are confident in the performance of the test as we've seen, as we've published. It addresses a meaningful clinical question that physicians are asking, which is how many patients are going to recur post surgery that after neoadjuvant treatment after surgery are intended to be curative. Beyond that, we have lots of studies in the hopper that we continue to pull the Decipher play on, which is to continue to expand clinical utility through evidence.

Yes. And it's a good time to remind everybody why our test is differentiated. Our TrueMRD test is a whole genome-based approach. And so to John's point, the whole genome data that we're going to generate for every single patient of every single incidence of care during their treatment journey and the recovery journey, more importantly, is going to be valuable data and valuable information that will drive future clinical studies. So over time, you see the Decipher playbook play out over and over again in MRD as well as it does in our whole transcriptome business.

Our next question comes from the line of Andrew Brackmann of William Blair.

Maybe we could actually just pick up where you left off there, Marc, and sort of using the Decipher playbook for TrueMRD as well. I think in the past, you talked about sort of driving some collaborations through GRID on TrueMRD. Can you just remind us sort of how you can sort of replicate some of the learnings on using that GRID platform from other tests like Decipher into TrueMRD? And any similarities or differences as you move from Decipher to TrueMRD?

Yes. I mean it's a great question. I don't think there's a ton of lessons learned other than the high-level one that making that grid information available is certainly driving and has driven over the years a lot of research. That research is on the existing tests, but also importantly, as you heard when we talked about PORTOS, PTEN and PAM 50 it actually drives research around other biomarkers as well, and we can expand those by adding them to the report, the clinical report over time. So you've got this great workflow of research finds the most interesting outcomes and clinical factors or clinical information that can be deployed as a test, and then it's very simple for us to just add that without even changing the nature of our test at all. And that's why we have this kind of uniform platform that we use across all of our tests. Do you want to add something?

Yes. So with respect to specifically our MRD, as Marc mentioned, it's whole genome on the tumor, it's also a whole genome on the germline whole genome on the cell-free DNA. That whole genome across -- lets us really track the tumor. So we use the whole genome to provide a clinically validated MRD test that says tumor detected, not detected. If it's detected, it gives a tumor fraction. Because we're doing whole genome, the GRID approach is that we will leverage that additional data through collaborations, through research to look at things like tumor heterogeneity, clonal evolution, the emergence of genome-wide signatures associated with resistance to platinum or other therapies used. That's how our MRD really aligns well with what we've done with Decipher and what we're doing with Afirma, where we do -- we get paid for a transcription signature, but we use the whole transcriptome through research to look at the biology and develop new biomarkers.

And what I love about this Andrew, is you start in one indication or one risk category and then you expand from there. You start in prognostic and you expand into predictive and so on. And so you fill out the care continuum and you fill out the clinical uses of the test across that care continuum. And I don't see it being any different in MRD than we've demonstrated already in transcriptome.

Okay. All of that's great color here. I'll stick on TrueMRD. This is more sort of housekeeping. Can you just sort of remind us on the reimbursement strategy here? I think you're going after two codes versus sort of the bundle. So can you just level set us on expectations there? And as you sort of think about dollar amounts, I don't know if you're willing to share sort of what defines success for you there. But anything qualitatively you can share with respect to sort of where your mind is at on sort of levels of reimbursement there?

Yes. Too early on the dollars, but I'll ask John to talk a little bit about the process we're going through.

Yes. On the reimbursement side, Andrew, as I mentioned, we're looking to pursue recurrence detection post patients who have been treated either with or without neoadjuvant therapy and have undergone a radical cystectomy. Those are management decisions that are made with curative intent. And so as such, it is presumed that the patient is cancer-free. And as such, it does not conform to the NC 90.2 limitation of having to bundle testing for MRD. And so those will be coded and billed individually. So we'll have two main codes. One is the initial landmark setting test that determines the MRD signature, as Phil described earlier as well as then each sequential plasma test is also billed independently. As it relates to pricing, that's something that we're still negotiating through the MolDX process.

And then Andrew, the population that John laid out based on our own research, we believe it's about 70% of the patients that are seen in our channel.

Our next question comes from the line of Lu Li of UBS.

First one on the new product revenue contribution. I understand that it's not included in the guide. I wonder whether you guys have like kind of an internal target that you wanted to hit? And then secondly, on the MRD new indication, you have CRC and lung on the slide. I wonder, is it fair to assume that those will be the next indications?

Let me start with the second one and then Rebecca, you can go with the first one. But the -- I wouldn't assume no. What I don't want to do yet because it's so dependent on a couple of things, including cohorts is put out a road map for exactly what's coming when. And that's why we've been saying the way we have a new indication every year. We will want to flex and adjust that and have agility to be able to do so on an ongoing basis based on the channel, the clinical evidence, the cohorts, the publications of that evidence, the reimbursement and so on. So we're not going to be more specific about the indications at this point. We have said you should expect us to focus, first and foremost, on indications where we have some channel reach or we're building channel, and that will certainly be a factor over time.

Yes. And on your new product introductions, of course, we have our internal goals. I would highlight them on the MRD front as being more around the customer experience and less around the revenue contribution over the course of 2026. That will obviously become more of a factor in '27 and beyond. But this year, we're really working on ensuring a great customer experience for MRD and various other critical deliverables that we're citing internally. On Prosigna, that is expected to be launched here over the summer and the benefit of that and the expectations for that are going to be highly tied to the OPTIMA readout and the timing of the OPTIMA readout and how that all goes. We have a range of outcomes internally. But again, we're seeding the market, and we aren't going for volume from the get-go. What we're really focused on is KOL engagement and spreading the word and really kind of taking the approach of a top-down KOL engagement and ensuring that, that is where we're really focusing on volume growth from the get-go. Over a 5-year time frame, we do believe this will translate into strong share across the entirety of that market. But again, in 2026, we're looking to build the foundation more so than really AMP revenue from Prosigna and MRD.

Yes, that's very helpful. Maybe just a quick question on the Decipher Q4 volume. If you look at it sequential basis, I think that's only up like 500 units. Wondering if there anything to call out or just like why it's like slightly lower than like Q4 '24 number?

Yes, I'm happy to take that one. Effectively, in any given quarter, you can have a day or two of volume that falls on either side of the quarter, right? In Q4 of '24, that was a good guy. In Q4 of '25, it was -- we had a day that didn't get out or day plus actually that didn't get out. So I think that all makes itself up, and that's typical -- that is absolutely typically quarterly impacts and quarterly volatility, and it's not any underlying trend. Over the course of the fourth quarter, we had across every single metric we track just an outstanding quarter. And so I definitely would not -- 500 samples doesn't make me flinch one way or the other, 600, 700, whatever the course may be. But I think that's -- I wouldn't get overly wrapped around that axle. We've had many quarters like this before that fall on one side and folks tend to get a little excited about it. And a quarter or two or three later, it all normalizes. So I wouldn't read into it.

Our next question comes from the line of Tom DeBourcy of Nephron Research.

I actually wanted to ask on, I guess, the testing revenue where I think you're guiding to $10 million to $12 million. And it seems like, I guess, in Q4, you still had biopharma revenue, and I would expect in 2026, while maybe not from the same source, you may also have biopharma revenue, whether it's from MRD or other clinical trials. And so just how to think about product versus biopharma revenue as we -- I guess, there's IVD launches or just, I guess, biopharma onetime revenue?

Yes, happy to answer that, Tom. Implied in the guide is less than $1 million of biopharma revenue, call it, 0 at the low end and 1 at the high end. That's an incredibly specific range. And the reason why it's that specific is because unless something is signed and booked, we don't include it. That's just our philosophy. So obviously, with shutting down the French entity, that was where the vast majority of the biopharma revenue came from. And so we will, obviously, with the Decipher franchise, the MRD franchise, continue to go after biopharma. But this, again, is less about a revenue strategy, and it's much more about evidence strategy, and that's really where we're focused. And so that's not necessarily the driving force. On the product front, we have implied something closer to that around $10 million that you cited. And that is down year-over-year. That's down year-over-year for two reasons. One is we have a new contract manufacturer and obviously, the variable of their ability to produce, we wanted to give ourselves just some wiggle room around. And then the second is we are not selling to U.S. customers ahead of the LDT launch. Let me be very clear. We are not selling the IVD to U.S. customers ahead of the LDT launch. And therefore, that contribution, which was quite small in nature, is not included in the guide.

Our next question comes from the line of Keith Hinton of Freedom Capital Markets.

Just wanted to follow up quickly on Decipher and bladder, just to make sure that I sort of understood the comment. So based on the exciting data at ASCO GU, is investing additional commercial resources there becoming a near-term priority just based on what you've seen? Or do you feel like you need to see more data? And if so, is there more data that you're aware of in the near term? And then if you do decide to invest commercially there, how much synergy is there with the existing Decipher franchise and the MRD franchise as well?

Yes, I can take that one. Thank you for the question. No, the answer is no. The rate-limiting step in the growth of Decipher Bladder is not tied to commercial investments per se. As Marc mentioned earlier, there's a very high degree of overlap between bladder cancer patients who are currently managed by the physicians that we call on for Decipher Prostate. We feel we can manage that and have the bandwidth and capacity to manage that through our current channel and sales personnel in our systems. I think the parts that are rate limiting are all this great evidence that you're seeing at ASCO GU still needs to be completed, still needs to be published. And those are, in general, what allows us then to update our own clinical reports and to essentially leverage that great data to see demand and create more demand.

And then just broadly, our investment in commercial this year will be mostly on the Prosigna LDT U.S. side. And then on MRD to your question, because of the overlap in urology, I think about the MRD investment being in future years as we broaden into other indications.

Our next question comes from the line of Mike Matson of Needham & Company.

I really just have two questions, not to pile on, on the TrueMRD, but I was wondering if you could just tell us the annual number of patients that you think are candidates and then the number of tests per year you would expect to be used on those patients on a given patient? And then the second question is really just on tax rate. So do you expect to start paying taxes in '26? And what would be the appropriate rate to model? So.

I'll take the latter because it's fast and easy. So we always have to pay some state taxes where we've blown through our NOLs, but that's in the run rate. So I wouldn't think too hard about that. But effectively, we are expecting our GAAP and non-GAAP tax rate to be around the mid-single digits this year. So we still have a decent chunk of NOLs to get through. One thing that we'll be talking about over the course of this year as we look at the profitability profile going forward is our valuation allowance, but more to come on that in the back half of the year if we're looking like that might be something that gets released.

Yes. And on the available market, we're estimating just around 20,000 patients for a SAM. You also have to factor that there's going to be some serial repeat testing on a per patient per episode of care basis. The details of that are still under discussion through our tech assessment with...

Our next question comes from the line of Kallum Titchmarsh of Morgan Stanley.

This is Jason on for Kallum. A lot has been asked, so I'll just keep it to one. Maybe on Percepta nasal swab, you recently completed enrollment for the NIGHTINGALE trial. Can you just provide some color on what are the next milestones we should be looking at? Any color you can share on time line for trial completion, data readouts, commercialization and just any milestones we could track?

Yes, that was one of our key accomplishments in 2025 was getting the final patients enrolled through that study. And now it's a question of -- I think a couple of milestones. One is the follow-up. And of course, you got to wait for at least a year, if not 2, for those patients to be followed up to confirm benign. And then it's getting that publication ready, getting it published, which can take time. And then it's a serial conversation then with MolDX and payers in order to get it reimbursed. And so this is why this one is very clearly in our -- it's not in our 5-year -- 3- to 5-year plan, it's more in our 5- to 10-year plan.