Guardant Health - Q4 2025

Transcript

Moderator (participant)

Good afternoon. Thank you for attending the Guardant Health Q4 2025 earnings call. My name is Cameron, and I'll be your moderator for today. All lines will be muted during the presentation portion of the call, with an opportunity for questions and answers at the end. If you would like to ask a question, please press star one on your telephone keypad. I would now like to pass the conference over to your host, Eric Hershey, VP of Investor Relations. You may proceed.

Eric Hershey (VP of Investor Relations)

Thank you. Earlier today, Guardant Health released financial results for the quarter and year ended December 31st, 2025. Joining me today from Guardant are Helmy Eltoukhy, Co-CEO, AmirAli Talasaz, Co-CEO, and Mike Bell, Chief Financial Officer. Before we begin, I'd like to remind you that during this call, management will make forward-looking statements within the meaning of federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. This call will also include a discussion of non-GAAP financial measures, which are adjusted to exclude certain specified items. Additional information regarding material risks and uncertainties, as well as the non-GAAP financial reconciliation to most directly comparable GAAP financial measures, are available in the press release Guardant issued today, as well as in our 10-K and other filings with the SEC.

Guardant disclaims any intention or obligation to update or revise financial projections and forward-looking statements, whether because of new information, future events, or otherwise, except as required by law. The information in this conference call is accurate only as of the live broadcast. With that, I would like to turn the call over to Helmy.

Helmy Eltoukhy (Co-CEO)

Thanks, Eric. Good afternoon, and thank you for joining our Q4 and full year 2025 earnings call. Starting on slide three. 2025 was a breakout year for Guardant, where years of investment continues to fuel breakthrough innovation and best-in-class execution across our portfolio. In oncology, we introduced groundbreaking applications for Guardant360 Liquid, upgraded Guardant360 Tissue onto our Smart platform, and expanded Reveal to support therapy monitoring. In screening, we expanded Shield to include a multi-cancer detection result report. At the same time, we made significant progress driving adoption across the portfolio. We have seen exceptional growth in our oncology business, primarily due to the new capabilities and insights enabled by our Smart apps that are increasing both the breadth and depth of ordering of Guardant360 more than a decade after its launch.

In MRD, we received Medicare coverage for CRC surveillance in early 2025, and growing clinical data generation for Reveal positions us well for additional reimbursement coverage this year. 2025 represents the first full year for Shield IVD, where very meaningful volume and revenue generation exceeds our expectations. We have significantly expanded the commercial team and established impactful strategic partnerships to meet the growing demand for a high-performing, blood-based screening option. These advancements reflect our growing execution at scale as we deliver actionable insights to physicians and patients across the care continuum. Importantly, this execution has directly driven strong financial performance, both accelerating our top-line growth and strengthening our path to profitability. Now, I'd like to share a story that illustrates the real-world impact of our tests.

A 60-year-old man had gone his entire life without being screened for colorectal cancer, despite repeated recommendations from his physician each year to undergo a colonoscopy. Although he agreed to stool-based testing on several occasions, the kits were never completed once they arrived at his home. During a routine office visit, the patient was offered a Shield blood test, which he agreed to, and the test was completed that same day in the office. The Shield result was positive, which motivated the patient to undergo his very first colonoscopy, following his physician's recommendation. The colonoscopy identified stage 1 colon cancer, and the patient was quickly scheduled for surgery. Because the cancer was caught early, he has been informed that his treatment is likely curative.

The patient expressed deep gratitude for the accessibility and ease of use of the Shield blood-based test, which removed a long-standing barrier to screening and ultimately delivered a life-changing result. Turning to top-line performance on slide four, we delivered $281 million of revenue in the Q4, representing 39% year-over-year growth, and $982 million of revenue or 33% year-over-year growth for the full year. This exceptional performance reflects continued broad-based growth across our oncology screening and biopharma and data businesses. Taking a closer look at our oncology business in slide five, oncology revenue increased 30% to $190 million, and oncology volumes grew 38% to approximately 79,000 tests in the Q4. Turning to slide six, our Smart platform is driving a clear step change in oncology volumes.

Guardant360 continues to benefit from a consistent rollout of new Smart Platform applications, which drive deeper clinical adoption. Guardant360 Tissue gained traction following the major product upgrade released in the Q2 of 2025, and Reveal volumes have benefited from Medicare reimbursement for CRC surveillance in the Q1 of 2025. Together, these drivers will continue to catalyze very strong growth in our oncology business. Moving on to slide seven. With each patient tested, our data repository continues to deepen and diversify, bringing together rapidly growing Smart epigenetic profiles, multimodal longitudinal data sets, and an expanding set of earlier stage and asymptomatic patient data through Reveal and Shield. This growing data asset is becoming a durable moat. Each additional test compounds the breadth, quality, and uniqueness of our data set, which in turn strengthens the insights we can deliver.

By applying our Infinity AI learning engine to this expanding data treasury, we can accelerate therapeutic discovery and biomarker development to our biopharma partners while uncovering new biological insights that reinforce our clinical franchise. The result is a compounding flywheel that steadily increases the clinical utility of our portfolio and expands the impact of what we can deliver to physicians and their patients. We have already applied Infinity AI to develop 15 smart applications on Guardant360 Liquid, and we believe these applications meaningfully expand the clinical utility of Guardant360 Liquid, while further extending our leadership in the liquid CGP market. Looking more closely at some of the recent highlights within our oncology business in slide eight, all of our oncology products contributed meaningfully to our Q4, 38% year-over-year growth in volumes, with Guardant360 delivering remarkable volume growth of nearly 30% year-over-year.

Reveal continues to be our fastest-growing product, reflecting growing demand for tissue-free MRD. We are particularly encouraged by the early uptake of Reveal for late-stage therapeutic response monitoring, launched in the Q4, which is broadening its clinical use. We are advancing the clinical evidence supporting Reveal and recently submitted our chemo monitoring data package to MolDX for Medicare reimbursement and data from our CDK4/6 monitoring study for publication. We continued expanding global access in Q4 with the launch of a Guardant360 CDx technology with Policlinico Gemelli, a leading oncology center in Rome, Italy. With approximately 400,000 new malignant tumor cases diagnosed annually across Italy, we are excited to empower oncologists to make more informed treatment decisions for patients with solid tumor cancers. Turning to slide 9 to take a closer look at our Reveal data pipeline.

We continue to make strong progress in generating and publishing compelling data across multiple cancer types. Based on the Medicare coverage we gained for CRC surveillance, we have now submitted additional data packages to support coverage in breast cancer surveillance, immuno-oncology monitoring, and chemo monitoring. As I just mentioned, we also plan to submit the package for CDK4/6 inhibitor monitoring following the publication. We were encouraged to see data from the largest study of MRD in Stage III colon cancer published in the Journal of Clinical Oncology, which shows that detecting ctDNA with Reveal better predicts recurrence and overall survival than standard imaging. Looking ahead, we have ongoing studies across more than five additional tumor types in both the adjuvant and surveillance settings. Together, the growing body of evidence will continue to strengthen the clinical utility of Reveal and support broader adoption in MRD. Moving on to slide 10.

Building on our leadership in tissue-free MRD, we launched Guardant Reveal for therapy monitoring in the Q4, expanding the franchise into a significant new opportunity in late-stage cancer. Physicians can now use a simple blood test to gain a real-time molecular view of treatment response and detect disease progression earlier. While still early in the launch, we have been very encouraged by the initial traction we are seeing. We believe we are building a meaningful competitive moat in our oncology business through the combined strength of Guardant360 and Reveal. Guardant is uniquely positioned with scaled offerings spanning both treatment selection and monitoring, enabling a more comprehensive view of the patient journey. This differentiation is driving deeper clinical adoption, supporting more integrated ordering patterns, and creating a natural synergistic dynamic across the oncology franchise.

When used together, Guardant360 and Reveal enable a seamless approach to therapy selection, monitoring, and retreatment across the continuum of care. We are also excited about the potential for therapy monitoring with Guardant360, highlighted by the results from the AstraZeneca-sponsored SERENA-6 trial. This study demonstrated a progression-free survival benefit when late-stage breast cancer patients were switched to camizestrant following the detection of ESR1 mutations in blood. Upon companion diagnostic approval of Guardant360, we believe this practice-changing protocol could represent a meaningful driver of test volume. Together, these advances reflect the growing role of blood-based monitoring in cancer care. Shifting gears to our biopharma and data business in slide 11, we delivered another year of strong performance, with revenue growing 18% year-over-year to $210 million in 2025.

We are a leader in companion diagnostics, with 25 approvals to date across the U.S., Japan, and Europe, and a robust pipeline of ongoing CDx programs. In the last six months alone, we have announced five new CDx approvals for Guardant360, including the U.S. approval last month for the encorafenib combination therapy in patients with BRAF V600E mutant metastatic colorectal cancer, representing the first FDA approval for Guardant360 in CRC. Our biopharma partner base now includes more than 200 companies, and in January, we announced a multi-year agreement with Merck to develop companion diagnostics and commercialize novel therapies. This partnership reflects the growing role of our Smart platform across both liquid and tissue and drug development and the strategic value of our platform to biopharma customers. We also made significant progress expanding both the scale and utility of our data set through a series of high-impact partnerships.

These collaborations integrate comprehensive EMR records with genomic and epigenomic tumor profiling to accelerate cancer therapy, research, and development, advanced drug response prediction and biomarker insights using multimodal AI, and enable biopharma partners to access EHR and clinical genomic data to support more efficient clinical development of new cancer therapies. With that, I will now turn the call over to Amir Ali for an update on screening.

AmirAli Talasaz (Co-CEO)

Thanks, Helmy. Moving on to slide 12. Shield has delivered extraordinary growth since launch. We delivered $35 million of Shield testing revenue in Q4, driven by approximately 38,000 tests, which was a meaningful step-up compared to 24,000 tests in Q3. Revenue growth has closely tracked volume growth, reflecting ADLT pricing, favorable collections, and a disciplined focus on reimbursable lives. Based on performance to date, we believe Shield is the most successful diagnostic launch in history outside of COVID testing, and it's positioned to be a significant multi-year growth driver for Guardant. Now, turning to slide 13 to take a closer look at screening highlights for the Q4 of 2025. Shield had strong sequential growth in Q4, driven by growing demand from both patients and physicians. Adherence rates remained high, reinforcing the accessibility and convenience of blood-based screening.

To support the growing demand, we continued to scale our commercial organization throughout 2025, exiting the year with approximately 300 sales reps. Last month, we received coverage from TRICARE for active duty service members and their families with no copay. TRICARE will cover Shield for all eligible average-risk individuals aged 45 and older. In Q4, we launched a dedicated health system team, and we are excited to report that we have successfully deployed our first enterprise-scale integrations with large health systems in West Virginia and Georgia. We are excited by the early progress demonstrating the market demand and our ability to operationalize Shield within complex health systems, including full EMR integration and workflow deployment. Beyond CRC, we are excited to expand Shield to include multi-cancer detection results reported in October.

Although it's still early days, we are encouraged with physicians' enthusiasm to get access to MCD findings and strong interest by patients to be part of the MCD data collection initiative. Turning to slide 14. We are very encouraged by Shield's real-world adherence, which reached 93% across the first 100,000 Shield tests ordered. In other words, when physicians order Shield for CRC screening, 93% of patients completed the test. This represents a meaningful improvement compared to other screening modalities, where adherence typically ranges from 25%-71%. As we illustrated in the patient story earlier, the ability to complete the Shield test during an office visit removes key barriers and enables far more patients to complete their CRC screening. Taking a closer look at our recent strategic collaborations to scale our commercial infrastructure on slide 15.

We are excited to announce collaborations with Quest Diagnostics and PathGroup, which will broaden our national reach in 2026. Our collaboration with Quest enables access to their national sales organization and allows providers to order Shield and receive results directly through the Quest Connectivity System, which was used by approximately 650,000 clinicians and hospital accounts last year. We remain on track to launch this collaboration later this quarter. The PathGroup cooperation went live in the Q4 and expands Shield's reach to more than 250 health systems across 25 states. We look forward to seeing the positive impact of our growing commercial infrastructure in 2026 and years to come. Moving on to slide 16. Our goal has always been to detect many cancer types early when they are most treatable.

With that in mind, we developed Shield as a multi-cancer detection platform. Turning to slide 17. In Q4, we expanded Shield to include a multi-cancer results report, which includes findings for nine of the most common cancers in addition to CRC. With each positive MCD finding, the report includes a cancer site of origin or CSO caller, which provides tumor-specific information, giving more clear guidance to physicians for subsequent diagnostic workup. The Shield MCD report is available to Shield CRC patients who opt in and authorize the release of their medical data to Guardant. As a result of this initiative, we expect our Shield data repository to grow exponentially, and we look forward to leveraging this high-quality data to support reimbursement and regulatory approvals, drive a deeper understanding of clinical utility, and support future technology improvements.

We are encouraged to see the recent passage of legislation establishing a Medicare coverage pathway for multi-cancer detection tests. While this is not expected to be a meaningful driver of our business in the near term, we view this as a positive step forward for the field. Turning to slide 18. Our outstanding commercial performance in 2025, reflected in rapidly growing revenue, was driven by several factors. We achieved ADLT status for Shield, securing a $1,495 reimbursement rate that supports healthy ASP and gross profit, enabling us to reinvest in commercial expansion. We also benefited from meaningful first-mover advantage and clear product market fit, which drove broad provider adoption. Our best-in-class commercial execution, continued progress with EMR integration, inclusion in NCCN guidelines, were additional key contributors to our growth trajectory in 2025.

We believe these foundational achievements position Shield for continued strong growth ahead. Looking more closely at our 2026 setup, the ADLT rate of $1,495 has now been incorporated into the clinical lab fee schedule and is secured through December 2027. We also expect to see benefits from our collaboration with PathGroup, alongside the continued expansion of our field force throughout the year. Additional growth drivers include ACS guideline inclusion, targeted direct-to-consumer campaign launches, and the expansion of self-pay Shield into select market outside the U.S. Turning to slide 19. We continue to invest aggressively in R&D to improve our product performance. As part of that process, we have rigorously evaluated dozens of external technologies over the years.

We recently completed the acquisition of MetaSyte Diagnostics, which brings a new technology in-house that is complementary to the Smart Platform and also brings on an impressive team, further strengthening our world-class R&D organization. We are excited for the technology's potential to enhance our CRC screening, multi-cancer detection, and ultimately, the entirety of our oncology product portfolio. It also has the potential to accelerate our multi-disease detection pipeline. With that, I will now turn the call over to Mike for more detail on our financials.

Mike Bell (CFO)

Thanks, AmirAli. Turning to slide 20, I'll review select financial highlights for the quarter and full year ending December 31, 2025. Unless otherwise noted, all growth rates are year-over-year. Total revenue in the Q4 increased 39% to $281.3 million, reflecting strong execution across oncology, biopharma and data, and screening. Oncology revenue increased 30% to $189.9 million, driven by continued strong volume growth. We reported approximately 79,000 oncology tests in Q4, up 38%, demonstrating sustained momentum across the portfolio. Guardant360 Liquid volumes increased nearly 30%, supported by expanding clinical utility from Smart apps launched over the past year, and Guardant360 Tissue remains strong following a major upgrade introduced in Q2.

Reveal continued to be our fastest-growing oncology product, benefiting from CRC surveillance reimbursement and ongoing strength in breast and lung cancer. We were also encouraged by the early uptake of Reveal for late-stage therapy response monitoring launched in Q4. Average selling prices were stable sequentially, with Guardant360 Liquid in the range of $3,000-$3,100, Guardant360 Tissue approximately $2,000, and Reveal between $600-$700. As a reminder, we've submitted data packages to MolDX for Medicare reimbursement, covering breast MRD and both immunotherapy and chemotherapy response monitoring. Successful outcomes will provide upside to Reveal ASP. Biopharma and data revenue was $54.0 million, up 9%, which was in line with our expectations. Screening revenue totaled $35.1 million from approximately 38,000 Shield tests.

Shield ASP was approximately $850, consistent with expectations and reflecting our focus on Medicare-covered patients. Out-of-period revenue totaled approximately $18 million for the Q4 of 2025, including approximately $3 million related to screening. This was in line with prior periods, compared to approximately $17 million in both the Q3 of 2025 and the Q4 of 2024. For the full year, total revenue grew 33% to $982.0 million. Oncology revenue increased 26% to $683.6 million. We reported approximately 276,000 oncology tests, representing 34% growth. Guardant360 volume growth accelerated to 25% for the year, driven by continued Smart app adoption.

Guardant360 Tissue volumes strengthened in the H2 following the Smart Platform upgrade, and Reveal remained our fastest-growing oncology product throughout the year. Biopharma and data revenue grew 18% to $210.1 million. Finally, screening revenue totaled $79.7 million in our first full calendar year since launch, generated from approximately 87,000 Shield tests. Turning to Slide 21. Non-GAAP gross margin improved to 66% in Q4, compared to 63% in the prior year. For the full year, non-GAAP gross margin increased to 66%, up from 62% in 2024. This improvement was primarily driven by a significant reduction in Reveal cost per test, which improved from over $1,000 in Q3 2024 to under $500 throughout 2025. We also made meaningful progress improving Shield gross margins.

Shield's non-GAAP gross margin improved from negative levels at launch to 52% in Q4 2025. This reflects strong ASPs under the Medicare ADLT rate, disciplined focus on reimbursable testing, and continued volume-driven cost reduction. Shield cost per test declined sequentially and exited the year at approximately $450, in line with our operational plan. Non-GAAP operating expenses were $260.0 million in Q4, up 21%, and $903.7 million for the full year, up 19%. Full-year operating expense was modestly above guidance due to two Q4 items. First, an increase in accrual for the 2025 company bonus plan, which reflects the strong performance in the year across financial, regulatory, and commercial milestones. Second, the continued reinvestment of incremental screening gross profit into sales and marketing to accelerate our commercial build-out.

Adjusted EBITDA loss improved to $64.9 million in Q4, compared to $78.4 million in the prior year quarter. For the full year, adjusted EBITDA loss improved to $220.9 million versus $257.5 million in 2024. Turning to slide 22. We continue to improve cash performance in 2025. Free cash flow burn was $233 million for the year, an improvement of $42 million and in line with our guidance. Importantly, excluding screening, the core business generated positive free cash flow in both Q3 and Q4. We expect the core business to be free cash flow positive for the full year 2026, and remain committed to achieving company-wide cash flow breakeven by the end of 2027.

As Amir already mentioned, in December, we acquired MetaSyte for $59 million in upfront cash, plus up to $90 million in contingent consideration tied to future commercial and regulatory milestones. We believe this technology enhances our existing product portfolio and accelerates our multi-disease detection pipeline. Following the MetaSyte acquisition and our November equity and convertible debt financing, we ended the year with approximately $1.3 billion in cash, providing sufficient runway to fund our growth initiatives and reach company-wide cash flow breakeven. Turning to slide 23. We enter 2026 with solid momentum across the business and increasing visibility into our growth drivers. For full year 2026, we expect revenue to be in the range of $1.25 billion-$1.28 billion, representing growth of 27%-30%.

This outlook reflects the same strength in oncology and accelerating expansion in screening, firmly positioning us to achieve our 2028 long-range revenue target of $2.2 billion. We expect oncology revenue growth of 25%-27% in 2026, supported by volume growth of approximately 30%. We believe demand fundamentals remain strong across the portfolio. Guardant360 Liquid should continue to benefit from adoption of Smart Apps, and Guardant360 Tissue growth should continue to build on the Smart Platform upgrade and continued strong commercial execution. Reveal is expected to remain our fastest-growing oncology product, driven by MRD and therapy monitoring. Note that our oncology guidance does not include potential upsides during the year from SERENA-6 ESR1 monitoring, FDA approval of Guardant360 Liquid CDx, and the launch of Reveal Ultra.

For biopharma and data, we're encouraged by recent strategic partnerships and the strength of our CDx pipeline. For 2026, we're forecasting low double-digit revenue growth, supported by both ongoing collaborations and new program starts. We expect screening revenue to be in the range of $162 million-$174 million, driven by 210,000-225,000 tests, a meaningful growth from approximately $80 million revenue and 87,000 tests in 2025. As in 2025, we expect sequential increase in Shield volumes every quarter, with the increases expected to be greater toward the back half of the year. This reflects early year seasonality at PCP offices, the ramping productivity of our growing number of sales reps, and the expansion of EMR capability through our Quest and PathGroup collaborations.

Note that our screening guidance does not include potential upside from Quest co-promotion activities as well as ACS guideline inclusion, which we continue to expect in the near future. We continue to make steady progress improving gross margins across our products through ASP optimization, workflow efficiencies, transition to NovaSeq X, and disciplined cost management. For 2026, we expect non-GAAP gross margins to be in the range of 64%-65%, reflecting ongoing operational improvements, volume growth, and expected product mix. We expect non-GAAP operating expenses of $1.03 billion-$1.05 billion, representing 14%-16% growth year over year. We anticipate continued operating leverage as revenue growth outpaces expense growth. R&D and G&A are expected again to remain relatively stable, with incremental investment primarily directed towards screening, sales, and marketing. Finally, we remain focused on reducing cash burn each year.

For 2026, we expect free cash flow burn of $185 million-$195 million, an improvement from 2025. Excluding screening, we expect the remainder of the business to be free cash flow positive for the full year. Finally, turning to slide 24. Looking ahead, we have a rich set of catalysts across our business that will drive continued growth. In oncology, we expect to launch several new products, including Guardant360 Liquid CDx for lung FDA approval, our ESR1 monitoring test, and Reveal Ultra. In addition, we expect to release additional apps driven by our Smart Platform and advance reimbursement across multiple indications for Reveal.

In biopharma and data, we expect new CDx approvals as well as additional strategic biopharma and Infinity AI data partnerships. In screening, we look forward to inclusion in ACS guidelines in the near future, driving commercial expansion with Quest and expanding self-pay Shield outside the U.S.. With that, we'll now open the call for questions.

Moderator (participant)

Thank you. We will now begin the Q&A session. If you would like to ask a question, please press star followed by one on your telephone keypad. If you'd like to remove your question, press star followed by two. Again, to ask a question, press star one, and as a reminder, if you are using a speakerphone, please remember to pick up your handset before asking a question, and we will pause here briefly as questions are registered. The first question comes from the line of Dan Leonard with UBS. You may proceed.

Dan Leonard (Managing Director and Senior Equity Research Analyst of Life Science Tools & Diagnostics and Healthcare Services)

Thank you very much. I'd like to talk a little bit about Reveal therapeutic monitoring. Helmy, both you and Mike commented on that in your prepared remarks. Could you elaborate further on how you're framing that opportunity, both for Reveal volumes as well as for Guardant360 volumes as well? Thank you.

Helmy Eltoukhy (Co-CEO)

Yeah, we're very excited about Reveal for therapy monitoring. We think it's a important opportunity to really solidify and work synergistically with Guardant360. If you think about it, you know, all the volume we have with, you know, 360, patients are being tested in terms of therapy selection. And then, you know, this idea of coupling that with Reveal for essentially monitoring how those patients are doing on therapies is really exciting. And then the nice thing about that is, you know, unfortunately, as some of those patients progress, they're gonna need a new therapeutic decision in terms of, you know, hopefully a next generation drug or a next line therapy that can be applied to them.

And so Reveal for therapy monitoring really bridges to that next Guardant360 test, and we have a very unique platform and portfolio that allows these tests to work together. And so I would say that when we get some of the reimbursement wins for IO monitoring and chemo monitoring, this could be a very important driver for growth over the next few years for the oncology business.

Dan Leonard (Managing Director and Senior Equity Research Analyst of Life Science Tools & Diagnostics and Healthcare Services)

Thank you very much.

Moderator (participant)

The next question comes from the line of Puneet Souda with Leerink Partners. You may proceed.

Puneet Souda (Senior Managing Director and Equity Research Analyst of Life Science Tools & Diagnostics)

Yeah. Hi, guys. Thanks for taking my questions. So first one, Helmy, for you, when you look at the strong growth that you've seen in oncology, maybe could you elaborate, you know, how should we think about that throughout the year and both in G360 versus Reveal? How should we think about the growth of those products? Because, you know, important drivers like the camizestrant launch and other things that you've mentioned are actually still not in the guide. So just trying to think about, you know, sort of how should we think about both of these products, you know, volume growth throughout the year.

Helmy Eltoukhy (Co-CEO)

Yeah, maybe I'll start, and I'll have Mike sort of jump in. We're very bullish about 2026 in terms of the progress we've made in 2025 and what we're seeing at the beginning of the year here. So, you know, I would say that we think it's gonna be another strong year for Guardant360, you know, something around, you know, at least 20% growth in terms of volumes. And then obviously, another very strong year for Reveal. It'll continue to be our fastest-growing product. We think we'll see some acceleration, obviously, with Reveal for therapy monitoring as well and on top of that. So, you know, I think we're well underway for our sort of LRP Investor Day projections in 2028.

Mike Bell (CFO)

Yeah, well, maybe just to add, because we didn't talk about tissue. I think, you know, in the back half of 25, we saw a nice acceleration with Guardant360 Tissue following the Smart upgrades that we did back in May of last year. And so I think that also as we look forward in 2026, we continue to expect tissue to accelerate. We think this getting the FDA approval for Guardant360 during the year, you know, also could potentially have a pull-through impact on Guardant360 Tissue as well. So, yeah, we're feeling bullish about all of the, all of the products across oncology.

Moderator (participant)

The next question comes from the line of Doug Schenkel with Wolfe Research. You may proceed.

Doug Schenkel (Managing Director and Senior Equity Research Analyst of Life Science Tools & Diagnostic)

Hi, good afternoon, and thank you for taking my questions. Both on Shield, and they're related. It's really great to hear that you are expecting to be free cash flow positive in 2026, excluding Shield. I'm curious, what you're thinking in terms of Shield's specific burn. I think you've provided color on that in the past and I guess kind of building off of that, I believe you exited 2025 with approximately 300 Shield-focused reps. How should we be thinking about the pacing of rep hiring throughout 2026, and, you know, where do you think the sales force should be at year-end? Thank you very much.

Helmy Eltoukhy (Co-CEO)

Mike, do you want to start with the—

Mike Bell (CFO)

Yeah. Yeah, I start on the question on screening burn, Doug. Yeah. No, for 2025, you know, again, our overall burn for the company was $233 million. Of that, roughly around $220 million was screening. You know, we sort of set a target of $200 million. Actually, we pushed quite hard on that, particularly towards the end of the year. We're really wanting to take advantage of our first mover position. And, you know, we mentioned again on the call that excluding screening, the rest of the business was actually cash flow free cash flow positive for Q3 and Q4. For 2026, we think a similar level of burn on screening as 2025, so around that sort of $220 million mark.

Again, you know, we're gonna be making heavy investments on the commercial side, really building out that infrastructure. And we still, we still expect 2026 to be a year of investment for screening and then 2027 to be a year of inflection, where we start to get a lot of operating leverage on that commercial infrastructure that we've built. And maybe just that, you know, point out one other, one other thing, you know, we again, we set our whole company free cash flow guidance $185 million-$195 million burn. So that's implying that the rest of the business now is, is, strongly cash flow positive in 2026, you know, at the sort of midpoint of that guidance around $30 million positive cash flow. So, yeah, we're feeling really good about how we're sort of managing the burn.

AmirAli Talasaz (Co-CEO)

In terms of commercial infrastructure and field force, we are very excited with a very powerful commercial platform that we built in 2025, and we are gonna continue to build out that commercial organization in 2026. I'm not gonna get into the specifics of maybe exact headcount of the field force, but maybe just to give you some direction and color, the way that you can think about it, we will continue to invest our incremental gross profit that we are gonna generate this year into further build out of our commercial infrastructure on both sales and marketing, and majority would go still in building, sales force and hiring more, people.

Doug Schenkel (Managing Director and Senior Equity Research Analyst of Life Science Tools & Diagnostic)

Great. Thank you very much.

Moderator (participant)

The next question comes from the line of Tycho Peterson with Jefferies. You may proceed.

Tycho Peterson (Managing Director and Senior Equity Research Analyst of Global Equity Research)

Hey, thanks. Want to start off on, you know, one of the bigger topics on ADLT pricing. You know, what, what is your latest thinking, and what have you baked into the guide, if anything, for, for Guardant360? And then, you know, overall, you are guiding for a decel in volumes and, and on, and revenue in oncology. Presumably some conservatism there. There's a lot you didn't bake in, but where do you think kind of the most conservatism is in, in the outlook on oncology?

AmirAli Talasaz (Co-CEO)

Yeah, in terms of ADLT, you know, I think we're still on track in terms of FDA submission, making very good progress there. We think that hopefully gets through the finish line in the H2 of this year and then, you know, potentially sets up second sort of next ADLT pricing rate for Guardant360 at the beginning of 2027. So nothing is baked in, in terms of ADLT pricing for Guardant360, for 2026. In terms of the second part of your question, I look-

Mike Bell (CFO)

Yeah, yeah. I mean, maybe on the volumes, you know, 2025 was an incredibly, incredibly strong year, particularly with, with Guardant360 and, you know, just the, with the smart apps driving the volume, volume. But, you know, I think we look at, we look at twenty twenty-six as just, just continuing that, that trend. You know, our guide is, you know, 30%, oncology volume growth. And so, you know, we think, that's incredibly strong. And again, you know, that's coming across all of the portfolio. Helmy mentioned it earlier, but, you know, we still expect, strong traction with, with Guardant360 Reveal being the, the fastest-growing product and, you know, tissue continuing to accelerate.

So yeah, I think we're feeling really positive about the guide that we put out for oncology growth next year or this year, I should have said.

Tycho Peterson (Managing Director and Senior Equity Research Analyst of Global Equity Research)

Okay, Mike, and then just to follow up, you know, on speaking of conservatism, you're also guiding for Shield ASPs to be, you know, down relative to where you exited 2025. You know, what's the thought process there? And also, what are you baking in for international? I know you flagged that as incremental.

Mike Bell (CFO)

Yeah, on Shield ASP, you know, we've seen this trend over the past few quarters. We've really focused on the Medicare population and reimbursable tests, and I think, you know, we've done a really great job there. But there is, we are seeing a lot of demand for it from the under 65s. And so I think, you know, our assumption going into 2026 is that demand will continue to grow, and that sort of mix of commercial versus Medicare is just going to increase. So, that's really what, you know, the fundamentals of how we see the ASP moving. We still, you know, we'll maintain the ADLT rate at $1,495. You know, that's now gonna be in place for 2026 and 2027.

We're seeing great reimbursement from Medicare Advantage payers, and that's been leading to some out-of-period truths as well. Our ASP for Medicare Advantage is getting stronger and stronger. But yeah, it's just really gonna be... It's a mixed impact between Medicare and non-Medicare. On the international side, if the question was focused on Shield, you know, we've seen small contribution from Abu Dhabi in 2025. I think, you know, we expect, again, the international contribution to be relatively small in 2026, and really the driver of the vast majority of the volume and the volume growth is gonna come from the U.S. in 2026.

Tycho Peterson (Managing Director and Senior Equity Research Analyst of Global Equity Research)

Thank you.

Moderator (participant)

The next question comes from the line of Daniel Markowitz with Evercore ISI. You may proceed.

Daniel Markowitz (VP)

Hey, thanks for taking my question. I wanted to ask on Reveal Ultra. It sounds like that's an area where there's a lot of excitement internally. Can you talk a bit about what will be differentiated about the offering, how you see the tumor-informed competitive landscape evolving, and when we can expect to see some data or a more substantial update on that asset? Thanks.

Helmy Eltoukhy (Co-CEO)

Yeah, we're excited about Reveal Ultra, you know, making good progress there. We're on track for launching it this year, and, it's something where we believe that, the true clinical sensitivity of that test will be best in class. I think there's a lot of, I would say, contrived messaging in this space in terms of, different bars that people are using. But we believe that this will, I think, redefine sensitivity in the tumor-informed space. There are other features of the test. It's gonna do more than I think other tumor-informed, offerings. We always have a special sauce at Guardant with all our tests in terms of when we launch them, and so I think I would just say stay tuned, as we, share more details later this year about that test.

Daniel Markowitz (VP)

Got it. Thank you.

Moderator (participant)

The next question comes from the line of Andrew Brackman with William Blair. You may proceed.

Andrew Brackmann (Research Analyst)

Hey, guys. Good afternoon. Thanks for taking the questions. AmirAli, you, you sort of talked about the recent MCED legislation and sort of the longer-term impact there. Can you maybe just sort of broaden out that commentary, talk to us sort of about the importance there for Shield in particular? And as you sort of think about the necessary steps for Guardant to sort of take advantage of that, can you just remind us on sort of the data generation and sort of path to FDA approval here? Thanks.

AmirAli Talasaz (Co-CEO)

Yeah. So, as soon as I came about this MCED bill that just passed. So, we are, as I mentioned in the prepared remarks, encouraged to see the passage of the legislation. It's moving the whole field forward, but it's not gonna be a meaningful driver of our business based on the business plan that we have in near term. But again, it's good for the field. You know, maybe as we go through midterm and talking about more than triannual testing with Shield, maybe there would be opportunities enabled with this MCED deal for us. But again, in near term, we don't look at it as a meaningful driver of our business.

Moderator (participant)

The next question comes from the line of Subbu Nambi with Guggenheim. You may proceed.

Subbu Nambi (Managing Director and Equity Research Analyst)

Hey, guys. Thank you. Hey, guys. Thank you for taking my question. A follow-up to Andrew's question, AmirAli, what has the opt-in rate for MCED Shield been so far? And if you were to accumulate significant data by year-end, would you be able to submit something to the FDA for MCED approval? I know it doesn't matter to the core story, but just trying to figure out if, as we think about upside.

AmirAli Talasaz (Co-CEO)

Yeah, thanks for this important question. You know, when we are thinking about the data that now we are generating with this MCD offering for Shield, when the physician patients are opting in, on one side, we are really encouraged by the enthusiasm that we are seeing on the provider side, and participation by patients to opt in to release their medical record to us. On the other side, on the data side, I think, hopefully in near future, we would be the company that has access to the widest, broadest clinical data in terms of clinical utility of MCD testing in U.S. patient population. So we are seeing good adoption rate. I don't want to get to the, you know, the exact number of it. It's trending up, but so far so good.

So far so good, and we are very excited with it.

Subbu Nambi (Managing Director and Equity Research Analyst)

Thank you so much.

Moderator (participant)

The next question comes from the line of Michael Ryskin with Bank of America. You may proceed.

Speaker 18

Hey, guys. Thank you for taking the question. This is Aaron on from Mike. Can you talk a little bit more about the puts and takes of the Shield guide? Obviously, Q4 saw the 14,000 in sequential volume growth, but, you know, should we think about, think about that as more of an anomaly and just kind of thinking about how much conservatism is embedded within the guide? And I guess the second part of that is, you know, thinking about Quest and Path, PathGroup, those look like upsides to the guidance, and so, how should we be thinking about the timing of those impacts or those tailwinds as we head through the year? Thank you.

AmirAli Talasaz (Co-CEO)

Yeah, sure. Like, obviously, we are very excited with this guide of, like, 87,000 volume going to midpoint of 217,000 and a very huge revenue growth and contribution. You know, on the other side, when we are thinking about the guide, you know, we are again, just in the still very early inning of this launch. This is just the second year of launch, and we want to be thoughtful with our guidance. You know, we typically don't want to get too excited and get ahead of our skis just based on one quarter performance, but the trends are very positive. We are, again, very excited of how 2026 is gonna shape out for us. In the prepared remarks, we talked about, you know, some of the 1Q seasonality in PCP offices. It's kind of normal for us.

But again, in terms of year-over-year growth for us, I think we are very excited with the guide that we put out there, and there are some upsides. We'll see, like, you know, we are very optimistic about the ACS guideline, and we believe it should be in near here. It's not part of our guide right now till they update their guideline. Quest, PathGroup, very minor contribution. We are counting on some benefit of the EMR connectivity enabled through this Quest and PathGroup integration, but we are not counting any kind of contribution in terms of the volume contribution of the core promotion and volume that comes from Quest salespeople. We are gonna monitor it.

It should be positive, but since we don't know exactly how positive it would be, we wanna monitor for the first few months of the launch and see how it goes, and then if appropriate, we would adjust our guidance accordingly. But we just want to be thoughtful about that matter as well.

Moderator (participant)

The next question comes from the line of Mark Massaro with BTIG. You may proceed.

Mark Massaro (Managing Director and BTIG Life Science and Diagnostic Tools Analyst)

Hey, guys. Thank you for the questions. I wanted to also ask about Shield. So primarily, you know, one of the success stories of one of the drivers of the success of Cologuard was their direct-to-consumer TV launch. How are you thinking about spending in 2026? Is it more select digital, or do you anticipate some spend on TV? And then I also wanted to ask about Quest. There is access for the, I believe, the Quest salespeople to promote Shield. I just want to double-check that these reps are incentivized, and then can you just maybe give us a sense for where the Shield test might sit in their bag relative to the other products they're selling?

AmirAli Talasaz (Co-CEO)

Yes. So some DTC pilot has actually happened for us in 2025 in select markets, and in 2026, we are excited that hopefully, consumers and even physicians would see even more of that. So we have some active campaigns that they are about to get finalized, and we are excited to put it out there and see what the impact would be. So we are very excited about it. The rest, stay tuned after we launch it in very near future. In terms of Quest, yeah, actually, the salespeople are incentivized. It's part of their commission plan.

And what we do know is actually, it was very important and interesting for the Quest management team to get access to Shield as a very differentiated brand that gives them opportunity to talk about something new and something exciting, exciting with the accounts. So again, we are gonna monitor how the launch goes with Quest in terms of co-promotion part of it. It should be, again, positive, but we'll see how positive it would be.

Moderator (participant)

The next question comes from the line of Kyle Mikson with Canaccord. You may proceed.

Kyle Mikson (Director and Senior Equity Research Analyst)

Hey, guys. Thanks for the questions. On the MetaCyte acquisition, interesting to see that. Most of the consideration is tied to future pre-commercial performance and the regulatory approval, too, of the technology. So, first one, wondering what the path is to non-cancer launches, and then second, it seems like they use mass spec. How does that factor into your NGS-heavy platform? Thanks.

AmirAli Talasaz (Co-CEO)

Yeah. So we are very, actually excited about this acquisition, to bring a, you know, very high quality world expert on some specific complementary technologies to our Smart platform. So we are very excited to go to work and see what we can do. It's a small tech tuck-in again, so let us make more progress, and we will talk about it at the right time.

Moderator (participant)

The next question comes from the line of Casey Woodring with JPMorgan. You may proceed.

Casey Woodring (VP of Equity Research)

Great. Thank you for taking my questions. Just a couple more on Shield, maybe. So you mentioned that the guide is back-half weighted. What does that guide imply for Shield in 1Q? You know, I think that that comment would imply a sizable step down, sequentially. And then, you know, I guess on the ACS commentary you made, if that hits in the H1 of 2026, can you help us think about the upside to volumes in the back half of the year and what that could look like? Thank you.

AmirAli Talasaz (Co-CEO)

Yeah. Maybe I start with the ACS part. You know, let us actually see when it would happen. It should be in near future, but, you know, I think when you think about a dozen states that they have state-level mandates that even younger patient populations should get access to the test. And the whole screening market is maybe about 40%, you know, this, you know, 65 years and above, and more are, in fact, on the younger patient side. That could be an interesting upside and growth driver for us once we start really going much deeper on the commercial testing within those states. But let's first see actually when they update their guideline, and we go from there.

In terms of Q1, you know, yeah, that's true that, you know, there's some Q1 seasonality in PCP offices, which, you know, in terms of screening and so forth. But our team has done a very good job, you know, to reschedule appointments that have been kind of impacted or the events that have been impacted. And we are on track to screen more patients in Q1 than in any other previous quarters post-launch. So let's see how the rest of the quarter goes, but, and we will talk about it in our next earning call.

Moderator (participant)

The next question comes from the line of Dan Arias with Stifel. You may proceed.

Speaker 19

Good afternoon. This is Paul on for Dan. Thanks for the question. I guess I just want to follow up on Subu's question about kind of regulatory strategy for multi-cancer shield. One of your competitors had some data out this afternoon with, you know, not meeting a primary endpoint with a very, very large MCED trial in terms of looking for stage shift. And then, you know, one other piece was this week in the New England Journal, there was some FDA willingness to, you know, be a little more flexible on what evidence generation might look like. I'm just wondering if, you know, any of these developments kind of influence what you would look to do for your evidence generation strategy and for your regulatory strategy with Shield MCD?

AmirAli Talasaz (Co-CEO)

Actually, this news just came out, so I don't know all the details of it, you know, beyond this call with you guys. But I think, when I think about it, really, what is important in the field of multi-cancer detection is the performance of detecting early stages. And we believe with the technology that we have for Shield, the performance of early stage detection, you know, as it's shown in CRC, could be very interesting, and that could have a meaningful impact. On the other side, I think it really highlights what we are doing to capture all the clinical evidence, medical record of the patients who are going through MCD testing in U.S., and really establish the utility of this MCD testing at very large scale.

We are going to benefit from this commercial scale of Shield, and we can put that, you know, evidence together in a very, you know, OpEx friendly and in a very, quick way. So I think it's kind of, we are getting more bullish with the pathway that we went after screening business and what we are doing with our MCED offering.

Moderator (participant)

The next question comes from the line of Luke Sergott with Barclays. You may proceed.

Luke Sergott (Director of Healthcare Equity Research)

Great. Thanks for the question, squeezing me in. So on the Shield demand and, and after you guys have had this, you know, for a year and a half now, but this is like the first full year launch, been great. You're going to trend even further for next year. Can you kind of give us a sense of where the demand is coming from? Like, how much of this is from the care gap closure versus winning share from colonoscopy or FIT or Cologuard or any of the other tests?

AmirAli Talasaz (Co-CEO)

Yes, so the demand is coming from PCP physician in terms of patient type. Still, we are really focused on unscreened patient population. I think some of the latest data that I've seen about still 90% of the patients who are getting screened by Shield have not been screened before, at least during the last five years, when we got access to their medical record and claims. So, really, our messaging is working, and we are increasing the rate of, overall screening. Care gap and, you know, those kind of opportunities still is ahead of us. We need to get, you know, into, we need to qualify for quality scores, and Shield still is not. Once we get to the HEDIS, that would be a huge additional growth driver for us.

So care gap program is not part of our growth right now.

Moderator (participant)

The next question comes from the line of Jack Meehan with Nephron Research. You may proceed.

Jack Meehan (Partner- Life Science Tools & Diagnostics)

Thanks. Good afternoon. Appreciate all the color on the screening investments you're making. Was wondering if you could share color on the oncology side, specifically just to mark to market, how large the sales force is there now and planned investments. And then second, you've talked about the NovaSeq X transition. When in the years is that taking place, and any way you can quantify level of savings you expect? Thank you.

AmirAli Talasaz (Co-CEO)

Yes, I think the obvious is, Mike said we reached cash flow positivity on the oncology side of last year, and we obviously will be generating cash this year. We're in a really good spot in terms of where we are with oncology. We've been essentially reinvesting in the business as a matter of course, as we see opportunities for growth on the sales side, as we see the revenue per rep sort of grow. We saw two around a healthy number in terms of as a matter of course expansion of the team. So we're in a healthy spot, and we'll continue to sort of invest where we see return on investment in terms of potential volume growth. In terms of the NovaSeq transition, maybe I'll let Mike take that one.

Mike Bell (CFO)

Yeah. You know, I mean, first of all, we successfully transitioned the Reveal, obviously, NovaSeq X, just over a year ago. As well as workflow efficiencies, you know, we saw a nice reduction in the cost per test of Reveal. And with Guardant360, we started that transition. It'll take time to fully be implemented. Probably around about the middle of the year, I would expect all the Guardant360 liquid tests to be on NovaSeq X. And yeah, we, you know, we expect to see a nice improvement in our cost per test. I think, you know, just putting to quantify it a little bit, you know, our gross margin currently for Guardant360 is in the high sixties.

And probably what, you know, once we've gone through the full move to NovaSeq X, and things are working properly, you know, they expect to see, you know, maybe 200 basis point improvement and sort of pushing that Guardant360 gross margins into the low 70% level. So, yeah, no, we're feeling very positive about the switch, and it's gonna have a nice impact on our P&L.

Eric Hershey (VP of Investor Relations)

Operator, one more question, please. Thank you.

Moderator (participant)

Perfect. Our last question comes from the line of Bill Bonello with Craig-Hallum. You may proceed.

Bill Bonello (Senior Research Analyst)

Hey, guys. Thanks a lot for hanging on and taking another question. So, this one, I guess, is probably for Helmy. I think the... If I understand it right, that the, you know, FDA approval would open the door to physicians being able to order both tissue and blood from Guardant concurrently. I'm just curious, you know, what your sense of is for the appetite for using both tests up front, and then also touch on maybe any reimbursement challenges that you might anticipate if that it becomes more common.

Mike Bell (CFO)

Yeah. As you know, guidelines, I think, are increasingly recommending that, for patients up front, especially in lung cancer and breast cancer, which are some of our two largest indications for 360. And, yeah, one of the challenges is, you know, the way that LDT is reimbursed, you know, it really is, it's not possible to order them concurrently. So that's obviously been a little bit of a headwind that sort of will become a tailwind once we get FDA approval for Guardant360. So we do see that as a potential driver. Obviously, you know, we wanna make sure it's done in the cases where it's, you know, there's clinical utility for the patients and value for treatment selection.

We're very confident that, I think, will be a, I think, important catalyst for our tissue business going forward.

Moderator (participant)

Due to the interest of time, that was our last question. That will conclude today's call. Thank you for your participation, and enjoy the rest of your day.