Guardant Health, Inc. Q4 FY2025 Earnings Call

Thank you for joining the Guardant Health Q4 2025 Earnings Call. My name is Cameron, and I will be your moderator today. I would now like to hand over the conference to your host, Zarak Khurshid, VP of Investor Relations. Please go ahead.

Thank you. Earlier today, Guardant Health released financial results for the quarter and year ended December 31, 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.

Thanks, Zarak. Good afternoon, and thank you for joining our fourth quarter and full year 2025 earnings call. Starting on Slide 3. 2025 was a breakout year for Guardant, where years of investment continued 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 results 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. And 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 4. We delivered $281 million of revenue in the fourth quarter, 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 on Slide 5. Oncology revenue increased 30% to $190 million and oncology volumes grew 38% to approximately 79,000 tests in the fourth quarter. Turning to Slide 6. 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 release in the second quarter of 2025 and Reveal volumes have benefited from Medicare reimbursement for CRC surveillance in the first quarter of 2025. Together, these drivers will continue to catalyze very strong growth in our oncology business. Moving on to Slide 7. 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 Infinity AI learning engine to this expanding data treasury, we can accelerate therapeutic discovery and biomarker development for 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 on Slide 8. All of our oncology products contributed meaningfully to our fourth quarter 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 therapy response monitoring launched in the fourth quarter, 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 our Guardant360 CDx technology with Policlinico Gamelli, 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 II 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 5 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 fourth quarter, 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 on 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 6 months alone, we have announced 5 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 multiyear 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 for 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 AmirAli for an update on screening.

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 is positioned to be a significant multiyear growth driver for Guardant. Now turning to Slide 13 to take a closer look at screening highlights for the fourth quarter 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 continue 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 co-pay. TRICARE will cover Shield for all eligible average-risk individuals aged 45 and older. In Q4, we launched a dedicated health systems 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 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 test 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% to 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 PA Group, 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 collaboration went live in the fourth quarter 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 the fourth quarter, we expanded Shield to include a multi-cancer results report, which includes findings for 9 of the most common cancers in addition to CRC. With each positive MCD finding, the report includes a cancer site of origin or CSO color, 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 Quest and 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 sales phase Shield into select markets 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 MetaSight 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.

Thanks, AmirAli. Turning to Slide 20. I'll review select financial highlights for the quarter and full year ended December 31, 2025. Unless otherwise noted, all growth rates are year-over-year. Total revenue in the fourth quarter 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 the 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 to $3,100, Guardant360 Tissue approximately $2,000 and Reveal between $600 and $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 fourth quarter of 2025, including approximately $3 million related to screening. This was in line with prior periods compared to approximately $17 million in both the third quarter of 2025 and the fourth quarter 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 second half 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 2 Q4 items. Firstly, an increase in accrual for the 2025 company bonus plan, which reflects the strong performance in the year across financial, regulatory and commercial milestones. Secondly, 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 AmirAli mentioned, in December, we acquired MetaSight 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 MetaSight 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 entered 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 to $1.28 billion, representing growth of 27% to 30%. This outlook reflects sustained 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% to 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 to $174 million, driven by 210,000 to 225,000 tests, a meaningful growth from approximately $80 million revenue and 87,000 tests in 2025. As in 2025, we expect sequential increases in Shield volumes every quarter with the increases expected to be greater towards 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 margin to be in the range of 64% to 65%, reflecting ongoing operational improvements, volume growth and expected product mix. We expect non-GAAP operating expenses of $1.03 billion to $1.05 billion, representing 14% to 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 to $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 following FDA approval, our ESR 1 monitoring test and Reveal Ultra. In addition, we expect to release additional apps driven by our Smart Platform and advanced 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.

The first question comes from Dan Leonard with UBS.

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.

Yes. We're very excited about Reveal for therapy monitoring. We think it's an important opportunity to really solidify and work synergistically with Guardant360. If you think about it, all the volume we have with 360 patients are being tested in terms of therapy selection. And then this idea of coupling that with Reveal for essentially monitoring how those patients are doing on therapy is really exciting. And then the nice thing about that is, unfortunately, as some of those patients progress, they're going to need a new therapeutic decision in terms of 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.

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

The first one, Helmy, for you. When you look at the strong growth that you've seen in oncology, maybe could you elaborate 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 important drivers like the camizestrant launch and other things that you mentioned are actually still not in the guide. So just trying to think about sort of how should we think about both of these products volume growth throughout the year.

Yes. Maybe I'll start and I'll let Mike sort of jump in. We're very bullish about '26 in terms of the progress we've made in '25 and what we're seeing at the beginning of the year here. So I would say that we think it's going to be another strong year for 360, something around at least 20% growth in terms of volumes. And then obviously, another very strong year for Reveal. It will continue to be our fastest-growing product. We think we'll see some acceleration, obviously, with Reveal for therapy monitoring as well on top of that. So I think we're well underway for sort of LRP Investor Day projections in 2028.

Yes. Well, maybe just to add because we didn't talk about tissue. I think 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 there's getting the FDA approval for Guardant360 during the year also could potentially have a pull-through impact on Guardant360 tissue as well. So yes, we're feeling bullish about all of the products across oncology.

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

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 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 where do you think the sales force should be at year-end?

Do you want to start with that?

Yes, I can address the question regarding screening burn, Doug. For 2025, our total burn for the company was $233 million, with approximately $220 million attributed to screening. We set a target of $220 million and worked hard to achieve that, especially towards the end of the year, as we aimed to leverage our first-mover advantage. On the call, we noted that excluding screening, the rest of the business was actually cash flow positive in both Q3 and Q4. Looking ahead to 2026, we anticipate a similar level of burn for screening as in 2025, around $220 million. We will continue to make significant investments in our commercial infrastructure, and 2026 is expected to remain a year of investment for screening, while 2027 should mark a turning point where we begin to experience considerable operating leverage from that infrastructure.

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 going to continue to build out that commercial organization in 2026. I'm not going to 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 we can think about it, we will continue to invest our incremental gross profit that we are going to 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.

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

I want to start off on one of the bigger topics on ADLT pricing. What is your latest thinking? And what have you baked into the guide, if anything, for G360? And then overall, you are guiding for a decel in volumes 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 the outlook on oncology?

Yes. In terms of ADLT, 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 second half of this year and then potentially sets up second sort of next ADLT pricing rate for 360 at the beginning of '27. So nothing is baked in, in terms of ADLT pricing for 360 for 2026. In terms of the second part of your question, I'll let...

Yes. I mean maybe on the volumes, 2025 was an incredibly strong year, particularly with Guardant360 and the Smart apps driving the volume. But we see 2026 as just continuing that trend. Our guidance is for 30% growth in oncology volume, which we think is very strong. This growth is expected across the entire portfolio. Helmy mentioned it earlier, but we still anticipate strong traction with Guardant360, with Reveal being the fastest-growing product and tissue continuing to accelerate. So yes, we're feeling really positive about the guidance we've provided for oncology growth this year.

Okay, Mike. And then just a follow-up on speak of conservatism, you're also guiding for Shield ASPs to be down relative to where you exited '25. What's the thought process there? And also, what are you baking in for international? I know you flagged that as incremental.

Yes. We've observed a consistent trend in Shield ASP over the last few quarters, focusing primarily on the Medicare population and reimbursable tests, where we've excelled. However, we are also noticing significant demand from individuals under 65. We anticipate that this demand will continue to grow in 2026, increasing the mix of commercial versus Medicare. This is a key factor in our expectations for ASP movement. We plan to maintain the ADLT rate at $14.95 for 2026 and 2027. We're receiving strong reimbursement from Medicare Advantage payers, which has led to some out-of-period adjustments. The ASP for Medicare Advantage is improving steadily. Ultimately, the dynamics will reflect a mix between Medicare and non-Medicare. Regarding the international aspect, if the question pertains to Shield, we've noted a minor contribution from Abu Dhabi in 2025 and expect this to remain limited in 2026, with most of the volume and growth coming from the U.S. in 2026.

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

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?

Yes. We're excited about Reveal Ultra, 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 the 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 going to 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.

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

AmirAli, 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?

Yes, I believe we're discussing the recent MCED deal that has just passed. As I mentioned in my earlier remarks, we are pleased to see this legislation move forward as it benefits the entire field. However, in the short term, it is not expected to significantly impact our business based on our current business plan. While it may create opportunities in the future, particularly as we consider midterm developments and broader testing with Shield, we do not anticipate it to be a meaningful driver for us in the near term.

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

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 RSE approval? I know it doesn't matter to the core story, but just trying to figure out as we think about upside.

Yes. Thanks for this important question. When we are thinking about the data that now we are generating with this MCD offering for Shield when the physician and 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 in 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 exact number of it. It's trending up, but so far, so good. So far, so good, and we are very excited with it.

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

This is Aaron on for Mike. Can you talk a little bit more about the puts and takes of the Shield guide? Obviously, 4Q saw the 14,000 sequential volume growth. But should we 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 thinking about Quest and PathGroup, those look like upsides to the guidance. And so how should we be thinking about the timing of those impacts of those tailwinds as we head through the year?

Yes, we are very excited about the guidance of approximately 87,000 volume moving to a midpoint of 217,000, which indicates significant revenue growth. However, it's important to remember that we are still in the early stages of this launch; this is only the second year since we started. We want to be careful with our guidance and not get overly enthusiastic based on just one quarter's performance. The trends are looking positive, and we are looking forward to how 2026 will develop for us. In our prepared remarks, we mentioned some typical seasonality in PCP offices for the first quarter, which is expected. We are optimistic about the guidance we provided and see some potential upside. For ACS guidelines, we believe they should be released soon, but they are not included in our guidance until updates are made. Regarding Quest and PathGroup, their contribution is expected to be minor. We anticipate some advantages from the EMR connectivity related to the integration with Quest and PathGroup, though we are not factoring in any volume contributions from co-promotion or sales by Quest's sales team. We'll keep a close watch on this to see how beneficial it actually is.

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

I wanted to ask about Shield. So for AmirAli, one of the key factors in the success of Cologuard was their direct-to-consumer TV launch. How are you planning your spending in 2026? Will it lean more towards Select digital, or do you expect to allocate some budget for TV? Additionally, I wanted to clarify the access for Quest salespeople to promote Shield. Are these representatives incentivized for this? Also, could you give us an idea of where the Shield test fits in their portfolio compared to the other products they are selling?

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, yes, 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 with the accounts. So again, we are going to 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.

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

On the MetaSight acquisition, interesting to see that. Most of the consideration is tied to future commercial performance and the regulatory approval of the technology. So first one, wondering what the path is to noncancer launch is? And then second, it seems like they use mass spec, how does that factor into your NGS heavy platform?

Yes. So we are very actually excited about this acquisition to bring a very high-quality world experts 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 technology talking again. So let us make more progress, and we will talk about it at the right time.

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

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? I think that, that comment would imply a sizable step down sequentially. And then I guess, on the ACS commentary you made, if that hits in the first half 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?

Yes. I'll begin with the ACS aspect. We should expect updates in the near future. There are around a dozen states with mandates requiring even younger patients to access the test. The screening market currently consists of approximately 40% of those aged 65 and older, but there is significant potential among the younger patient group. This could serve as a valuable growth driver for us as we expand our commercial testing initiatives in those states. First, we need to wait for their guideline updates before proceeding. Regarding Q1, there is indeed some seasonality in primary care physician offices affecting screenings. However, our team has effectively rescheduled impacted appointments and we are on track to screen more patients in Q1 than in any previous quarter since launch. We’ll see how the rest of the quarter unfolds, and we will address this further in our next earnings call.

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

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

This news just came out, so I'm not fully aware of all the details. We've been on this call together. However, when considering the field of multi-cancer detection, the crucial aspect is the ability to identify early-stage cancers. We believe that our technology for Shield shows promising early-stage detection performance, particularly in colorectal cancer, which could have a significant impact. Additionally, it emphasizes our efforts to gather comprehensive clinical evidence and medical records from patients undergoing MCD testing in the U.S., helping to establish the utility of this testing on a large scale. We anticipate benefits from the commercial scale of Shield, allowing us to compile that evidence efficiently and cost-effectively. Overall, we are feeling increasingly optimistic about our approach to the screening business and the progress of our MCED offering.

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

So on the Shield demand and after you guys have had this for 1.5 years now, but this is like the first full year of launch has 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?

Yes. Demand is primarily coming from PCP physicians regarding patient types. We are particularly focused on the unscreened patient population. Recent data indicates that around 90% of patients screened by Shield had not been screened in the last five years when we accessed their medical records and claims. This means our messaging is effective, and we are increasing overall screening rates. There are still care gaps and opportunities ahead of us. We need to qualify for quality scores, and Shield is currently not there. Achieving HEDIS compliance would be a significant growth driver for us. Therefore, the care gap program is not part of our current growth strategy.

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

Appreciate all the color on the screening investments you're making. I was wondering if you could share color on the oncology side, specifically, just the 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 year is that taking place? And any way you can quantify level of savings you expect?

Yes. So I think obviously, as Mike said, we reached cash flow positivity on the oncology side last year. And obviously, we'll 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 revenue per rep sort of grow, we saw tooth around a healthy number in terms of a matter of course, expansion of the team. And 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.

Yes, we successfully transitioned Reveal to NovaSeq X just over a year ago, which also improved workflow efficiencies. We observed a significant reduction in the cost per test for Reveal. For Guardant360, we initiated that transition as well, and it will take some time to implement fully. I expect that by around the middle of the year, all Guardant360 liquid tests will be using NovaSeq X. We anticipate a notable improvement in our cost per test. Currently, our gross margin for Guardant360 is in the high 60s, and after we complete the transition to NovaSeq X and everything is functioning well, I expect to see an improvement of about 200 basis points, pushing the gross margins for Guardant360 into the low 70% range. We are feeling very positive about this switch, and we believe it will positively affect our P&L.

Operator, one more question please.

Our last question comes from the line of Bill Bonello with Craig-Hallum.

So this one is probably for Helmy. If I understand correctly, the FDA approval would allow physicians to order both tissue and blood tests from Guardant at the same time. I'm curious about your thoughts on the demand for using both tests upfront and any potential reimbursement challenges you foresee if that becomes more common.

Yes, guidelines are increasingly recommending that for patients at the outset, particularly those with lung cancer and breast cancer, which are our two largest indications for Guardant360. One of the challenges is that the way LDT is reimbursed does not allow for concurrent ordering. This has been somewhat of an obstacle but will likely turn into an advantage once we receive FDA approval for Guardant360. We see this as a potential driver for our business. It's important that we ensure it's utilized in cases where it has clinical utility for patients and provides value for treatment selection. We're confident this will serve as a significant catalyst for our tissue business moving forward.

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.