Guardant Health (GH) Q1 2026 Earnings Transcript

Image source: The Motley Fool.

DATE

Thursday, May 7, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

• Co-Founder & Co-CEO — Helmy Eltoukhy
• Co-Founder & Co-CEO — AmirAli Talasaz
• Chief Financial Officer — Michael Bell

TAKEAWAYS

• Total Revenue -- $302 million, up 48% year over year, marking the fastest annual growth rate in five years.
• Oncology Revenue -- $205 million, increasing 36%, with volume reaching approximately 86,000 tests for 47% growth fueled by strength across all products.
• Guardant360 Liquid Volume -- Grew 30% year over year, with average selling price stable between $3,000 and $3,100 per test.
• Guardant360 Tissue -- Identified as the second fastest-growing oncology product, with its revenue and volume both scaling above prior trends.
• Reveal Product Volume -- Exceeded 100% year-over-year growth, with adoption accelerating in MRD and expanded therapy response monitoring.
• Shield Revenue -- $42 million generated from approximately 44,000 tests, compared to $6 million and 9,000 tests the prior year, tracking closely to volume increases.
• Biopharma & Data Revenue -- $53 million, up 17%, supported by companion diagnostic projects, data products, and strategic partnerships.
• Non-GAAP Gross Margin -- 66%, compared to 65% in the prior period, led by lower sequencing cost per Guardant360 Liquid test and improved screening margins.
• Screening Gross Margin -- Improved to 56% from 18%, driven by a Shield cost-per-test reduction to $420 and higher ASP after Medicare’s fee update.
• Adjusted EBITDA Loss -- $59 million, unchanged from last year’s Q1 result.
• Free Cash Flow Burn -- $71 million, with a year-over-year increase attributed to a higher annual bonus payout; excluding this, burn declined by $12 million.
• Cash and Investments -- Approximately $1.2 billion at quarter end.
• 2026 Revenue Guidance -- Raised to a range of $1.30 billion to $1.32 billion, forecasting 32%-34% annual growth.
• Oncology Volume Guidance -- Management expects volume growth exceeding 35% and revenue growth between 28%-29% for the year.
• Screening Test Volume Guidance -- Revised to 230,000–245,000 Shield tests, up from prior guidance, with updated revenue outlook of $186 million–$198 million.
• 2026 Non-GAAP Operating Expenses -- Anticipated at $1.05 billion–$1.07 billion, representing 16%-18% year-over-year growth.
• Full-year Free Cash Flow Burn Guidance -- Projected at $185 million-$195 million, with the rest of the business (excluding Screening) expected to be free cash flow positive.
• FDA Submissions -- Data packages submitted to MolDx for Reveal reimbursement in breast cancer surveillance, immuno-oncology, and chemotherapy monitoring.
• CDx Approvals -- Two new FDA companion diagnostic approvals announced, bringing the franchise to 26 approvals across major markets.
• InfinityAI Usage -- Cited as key in generating findings for 25 out of 38 abstracts at AACR and supporting clinical utility expansion across products.
• Quest Diagnostics Collaboration -- National partnership initiated, expanding EMR connectivity and sales channel efficiency for Shield.
• Shield Adherence Rate -- Maintained at over 90%, distinguishing the product versus other noninvasive CRC screening options.
• FDA Approval of 2-Tube Shield Collection -- Regulatory clearance received to reduce required blood collection from four tubes to two, improving patient and provider experience.
• Shield Multi-Cancer Detection Launch -- Introduced in Asia via Manulife partnership, covering three initial markets: Hong Kong, the Philippines, and Singapore.
• Out-of-Period Revenue -- Accounted for $22 million, with $18 million from Oncology and $4 million from Screening; trend consistent with prior quarters.

Need a quote from a Motley Fool analyst? Email pr@fool.com

RISKS

• FDA approval of camizestrant for ESR1 monitoring is uncertain, as management stated, "the Oncologic Drugs Advisory Committee voted [ 6 to 3 ] against the claim that camizestrant demonstrated clinically meaningful benefit in HR-positive HER2-negative metastatic breast cancer. Ultimately, the FDA retains full discretion over its final decision."
• Management acknowledged Shield ASP will "tick down" through the remainder of the year as volume mix broadens to patients under 65, where commercial reimbursement remains limited.
• Year over year free cash flow burn increased due to a higher annual bonus payout, though operational burn excluding this item improved.

SUMMARY

Guardant Health (NASDAQ:GH) delivered record-setting revenue growth and test volume expansion, establishing new highs for both Oncology and Screening businesses and achieving broad-based gains across its product lines. Strategic progress was underscored by nationwide launches, impactful FDA and MolDx submissions, deeper AI-driven clinical differentiation, and incremental gross margin improvement through cost discipline and higher selling prices. The company substantially raised full-year revenue guidance, indicating management’s increased confidence based on Q1 momentum, and reiterated plans to reinvest profit gains into scale initiatives designed to expand commercial reach, product innovation, and operational efficiency.

• Management described Shield’s commercial execution as benefiting from a national DTC campaign, new EMR integrations, and collaboration with Quest Diagnostics, enabling rapid expansion into previously untapped health systems.
• InfinityAI data contributed to the first tumor-agnostic regulatory approval for Daiichi Sankyo’s ENHERTU in Japan, highlighting its integration into biopharma partner strategy and regulatory filings.
• Guardant Health obtained FDA authorization to reduce blood collection requirements for Shield, streamlining patient workflow and enhancing test accessibility.
• The company highlighted that "revenue guidance does not reflect any impact from the potential approval of camizestrant," positioning any such result as potential upside, not baked-in to the current forecast.
• Non-GAAP gross margin improvement was attributed to the ongoing transition to NovaSeq X in Guardant360 Liquid, with expected sequencing cost reductions to be fully realized in the coming quarter.
• Screening gross margin uplift was associated not only with ASP gains from Medicare’s rate change but also disciplined cost management that lowered Shield’s per-test expense by $100 year over year.
• According to management, customer engagement with the linked portfolio of G360 Liquid, Tissue, and Reveal products continues to rise, with many oncologists deploying multiple Guardant solutions per patient.
• Efforts to expand commercial infrastructure include not just sales force growth but active reinvestment of new gross profit in sales and marketing campaigns and ongoing hiring of increasingly high-quality representatives.

INDUSTRY GLOSSARY

• MRD (Molecular Residual Disease): Detection of minimal cancer presence post-therapy to inform further treatment decisions within oncology.
• CDx (Companion Diagnostic): An in vitro diagnostic device providing information essential for the safe and effective use of a corresponding drug.
• Smart Apps: Proprietary AI-driven tools integrated within the Guardant platform to support enhanced clinical decision-making.
• InfinityAI: Guardant Health’s AI platform leveraging clinical and genomic data to accelerate product innovation, predictive analytics, and regulatory submissions.
• Shield (CRC & MCD): Guardant’s blood-based test for colorectal cancer screening (CRC), also marketed as a multi-cancer detection (MCD) platform.
• MolDx: The Molecular Diagnostics Program responsible for Medicare coverage determinations for molecular diagnostic tests in the U.S.
• NovaSeq X: Illumina’s advanced sequencing platform used to lower genomic sequencing costs per test.
• ADLT (Advanced Diagnostic Laboratory Test): U.S. Medicare classification enabling specific market-based pricing for novel clinical diagnostics.

Full Conference Call Transcript

Helmy Eltoukhy: Thanks, Zarak. Good afternoon, and thank you for joining our First Quarter 2026 Earnings Call. Starting on Slide 3, we entered 2026 with significant momentum that accelerated through Q1, driving a remarkable quarter for Guardant Health. These results validate our strategic vision of delivering increasingly more actionable insights to physicians and patients across the care continuum. Notably, our commercial flywheel has achieved a new level of velocity, delivering our fastest year-over-year percentage revenue growth in the last 5 years and surpassing the $1 billion trailing 12-month revenue milestone. This is a testament to the burgeoning scale and long-term durability of our business.

Before I share our results in more detail, I'd like to share a story that illustrates the real-world impact of our tests. A 77-year-old Atlanta resident recently completed a Shield CRC test. The results came back positive and the patient underwent a diagnostic colonoscopy during which a lesion was discovered and biopsied. The lesion was subsequently confirmed to be malignant by pathology. The patient then underwent surgical resection of the malignant lesion, which was confirmed to be highly localized. The patient welcomed this news from her oncologist and was further relieved that no additional treatment was necessary. Patient outcomes like this are one of the many reasons we have benefited from accelerating adoption and growth.

Turning to our revenue performance on Slide 4. We had a phenomenal start to 2026, delivering $302 million of revenue in Q1, representing 48% year-over-year growth. The growth was strong and broad-based across our Oncology, Biopharma & Data and Screening business lines. Taking a closer look at our oncology business on Slide 5. Oncology revenue growth accelerated to 36% year-over-year, driving Q1 revenue of $205 million. Oncology test volumes rose 47% to approximately 86,000 tests, up from 59,000 in the prior year period. This was the highest year-over-year percentage growth on oncology volume we've seen in nearly 3 years with strength across all products. We're excited to see the expanding role of our portfolio across the cancer care continuum.

Turning to Slide 6. Our 47% year-over-year volume growth reflects the increasing breadth of our portfolio across both therapy selection and MRD. Guardant360 Liquid delivered 30% volume growth year-over-year, while Guardant360 Tissue was our second fastest-growing product. Smart platform innovation continues to translate directly into volume growth for both products with InfinityAI powering a steady cadence of new clinical applications that are driving deeper adoption among oncologists. We have a strong pipeline of additional smart apps in development, and we look forward to continuing that cadence.

Reveal remained our fastest-growing product with volumes up over 100% year-over-year, reflecting strong adoption of Reveal in MRD across indications and enthusiasm for our new therapy response monitoring use case among our customers in its first full quarter post launch. Moving on to Slide 7. With each patient tested, our data treasury continues to deepen and diversify. Our data repository harnesses insights from over 1 million patient samples, 500,000 epigenetic profiles across more than 100 tumor types, and each new sample helps compound the breadth and uniqueness of what we can deliver over time.

By applying our InfinityAI learning engine to this expanding data moat, we uncover novel biological signatures, power new smart app development and accelerate therapeutic discovery for our biopharma partners. The result is a compounding flywheel wherein data drives better insights, which, in turn, fuels volume growth and strengthens our data advantage. Turning to Slide 8 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 and indications. We have submitted data packages to MolDx to support coverage in breast cancer surveillance, immuno-oncology monitoring and chemotherapy monitoring, and we are engaging constructively with MolDx through the Reveal process.

Each submission represents a potentially meaningful reimbursement catalyst, and we are excited about the ASP upside that favorable outcomes would unlock. We are also advancing our work towards the MolDx submission for CDK4/6 inhibitor monitoring. Looking further ahead, we have ongoing studies across more than 5 additional tumor types in both the adjuvant and surveillance settings. The breadth of this pipeline gives us real confidence in Reveal's trajectory and its expanding role across the cancer care continuum. Turning to Slide 9, we continue to make strong progress across the Guardant360 portfolio on multiple fronts. For Guardant360 Liquid, our FDA review remains on track.

When approved, Guardant360 Liquid will become the most comprehensive FDA-approved liquid biopsy for therapy selection on the market. Moreover, this development will help simplify ordering across our therapy selection portfolio and create better connectivity across our larger testing ecosystem. On the Tissue side, we are excited to announce our second major platform upgrade in less than a year, expanding RNA testing to whole transcriptome. This further builds on the genomic and epigenomic foundation of our Smart platform, and we believe reinforces Guardant360 Tissue's position as best-in-class in the tissue CGP market. We expect these upgrades to be a meaningful volume catalyst for both Liquid and Tissue, particularly as it opens the door to converting current nonusers. Turning to Slide 10.

Guardant had another strong showing at AACR this year. Together with our independent collaborators, 38 abstracts were presented spanning our entire oncology portfolio. The depth of the Smart App data was remarkable. 25 of the abstracts featured InfinityAI generated findings, which speaks to how rapidly this platform is maturing. We were particularly encouraged to see concrete evidence of InfinityAI enabling therapeutic response prediction and improving detection of clinically challenging alterations like ALK-fusions and MTAP deletions. These are exactly the kind of insights unlocked by our data treasury and epigenomic capabilities that truly differentiate our platform. Shifting gears to our Biopharma & Data business on Slide 11. We delivered another strong quarter with revenue growing 17% year-over-year to $53 million.

The last few months have been highly productive with respect to our CDx strategy, which included Guardant360 CDx FDA approval for Pfizer's Braftovi in BRAF V600E-mutant metastatic colorectal cancer and this week's CDx FDA approval with Arvinas and Pfizer's VEPPANU for ER-positive, HER2-negative, ESR1-mutated advanced breast cancer. Our CDx franchise now spans 26 approvals across the U.S., Japan and Europe, backed by a robust pipeline across multiple partnerships with leading biopharma companies. In the quarter, real-world evidence generated from InfinityAI as supplemental data alongside clinical findings contributed to the first tumor-agnostic approval of Daiichi Sankyo's ENHERTU in Japan.

We also saw further strengthening of our relationships with leading biopharma companies, including a multiyear agreement with Merck to develop companion diagnostics and commercialize novel therapies as well as last week's announced collaboration with Nuvalent to develop companion diagnostics with an initial focus on Guardant360 Tissue. Together, these developments reflect the growing strategic value of our smart platform and InfinityAI to leading biopharma companies and reinforce our confidence in sustained growth in this business. With that, I'll now turn the call over to AmirAli for an update on screening.

AmirAli Talasaz: Thanks, Helmy. Moving on to Slide 12. Q1 was another strong quarter for Shield. We delivered $42 million of Shield testing revenue driven by approximately 44,000 tests compared to $6 million revenue and approximately 9,000 tests in Q1 of 2025. Revenue growth has closely tracked volume growth, reflecting favorable collections and a disciplined focus on reimbursable lives. Now roughly 18 months into the commercial launch, we continue to break records and look forward to sustained strong growth throughout the remainder of 2026. Moving to Slide 13 for a closer look at Q1 screening highlights.

We saw strong volume throughout the quarter and exited the quarter with accelerated momentum in March, which gives us real confidence in our trajectory for the remainder of the year. Our growth was fueled by continued improvement in sales rep productivity and amplified by a series of marketing initiatives that came together in the quarter. We launched our DTC and influencer campaigns in conjunction with colorectal cancer awareness month, including our national campaign with Patrick Dempsey, which I will cover on the next slide. Our Quest collaboration launched nationwide in late Q1, and we are pleased with the early signals.

Quest is already opening doors for us in health systems and physician practices where we did not previously have a strong direct presence. Shield continues to demonstrate a high adherence rate of over 90%, which is one of the key differentiators of Shield versus other noninvasive modalities. Finally, we launched Shield Multi-Cancer Detection in Asia through our partnership with Manulife, extending our reach into an important new market segment. Taking a closer look at our direct-to-consumer programs on Slide 14. Q1 marked our first comprehensive DTC campaign spanning TV, digital and influencer channels and the results exceeded our expectations. Together, these efforts generated over 1 billion impressions.

The centerpiece was our partnership with Patrick Dempsey, actor and a cancer advocate, who shared his personal experience using Shield during colorectal cancer awareness month. We saw a meaningful step-up in consumer engagement, including website traffics and consumer-initiated provider engagements, which we expect to translate into greater adoption of Shield. Turning to Slide 15. Complementing our DTC program, we have expanded our healthcare provider marketing initiatives, which drove record HCP engagement in Q1. Our March campaign featured targeted messaging to about 200,000 HCPs emphasizing that many millions of Americans remain unscreened, and that Shield is the only FDA-approved blood test for CRC screening with Medicare coverage. Also, we continue to make great progress to enhance physician and patient experience.

We are rapidly expanding the number of accounts with direct integration into their Epic eClinicalWorks and Athenahealth EMR systems. Moreover, we officially launched our collaboration with Quest Diagnostics nationwide in late Q1, which has fast tracked our EMR connectivity to more than 650,000 HCPs. We expect this to meaningfully increase depth of ordering among connected physicians. Quest national sales team has now started actively promoting Shield. While still early days, we are pleased with positive contributions we are seeing. Finally, our patient navigation team is actively helping practices connect patients to convenient phlebotomy access, utilizing our nationwide network of 40,000 phlebotomists as well as Quest 8,000 patient service centers. Turning to Slide 16.

At Guardant Health, we are dedicated to continuous improvement of our products and patient experience. We are excited to report that we recently received FDA approval to reduce the amount of blood collected from patients to process Shield test to 2-tubes from the original 4-tube kit. We applaud the FDA for their continuous collaboration and dedication to strong patient outcomes. Moving to Slide 17. 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. When a physician orders Shield for CRC screening, they can opt in to receive multi-cancer detection results report.

The Shield MCD report is available to Shield CRC patients who authorized the release of their medical records to Guardant. The launch of this initiative establishes a scalable platform for clinical data generation, enables assessment of the utilization of MCD results in patient care and provides a new avenue to expand patient access to Multi-Cancer Detection. The MCD report covers finding across 9 additional cancer types behind CRC, including lung, breast, ovarian, pancreatic and others. We are encouraged by HCP and patient response to this data collection initiatives and the strong opt-in that we are seeing.

As a result, we believe we are building what will quickly become the largest clinical database of Multi-Cancer Detection outcomes from patients in the United States. Now on to Slide 18. During Q1, we announced the expansion of Shield multi-cancer detection in Asia through our partnership with Manulife. Manulife serves more than 13 million customers across Asia. We initially launched in 3 key markets: Hong Kong, the Philippines and Singapore. This is a differentiated go-to-market strategy, which leverages a direct channel to a large member base within those markets. With that, I will now turn the call over to Mike for more detail on our financials.

Michael Bell: Thanks, AmirAli. Moving to Slide 19, I'll now review our first quarter 2026 financial results. Unless otherwise noted, all growth rates are year-over-year. Total revenue in Q1 increased 48% to $302 million, reflecting strong growth and continued momentum across Oncology, Biopharma & Data and Screening. Starting with Oncology. Revenue increased 36% to $205 million. We reported approximately 86,000 oncology tests in the quarter, representing 47% volume growth with broad-based strength across the portfolio. Guardant360 Liquid volumes grew 30%, supported by expanding clinical utility and continued traction of our Smart Apps. Guardant360 Tissue also continued to scale and remains our second fastest-growing oncology product.

Reveal remains our fastest-growing oncology product with volume growth exceeding 100%, reflecting strong adoption in MRD and continued expansion in therapy response monitoring following its Q4 2025 launch. Average selling prices were stable sequentially with Guardant360 Liquid in the range of $3,000 to $3,100, Guardant360 Tissue above $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. Favorable outcomes from these submissions will provide upside to Reveal ASP. Biopharma & Data revenue was $53 million, up 17%, reflecting sustained demand and continued strength across sample testing, companion diagnostic projects and data products.

In Screening, Q1 revenue was $42 million compared to $6 million in the prior year period. The increase was primarily driven by approximately 44,000 Shield tests in the quarter compared to approximately 9,000 in the prior year period. Volume tracked in line with expectations through January and February. And following the launch of our Quest partnership and successful HCP and DTC programs during colorectal cancer awareness month, we saw clear momentum build through March and exited the quarter strongly. Shield ASPs increased significantly year-over-year, reflecting the Medicare rate step-up from $920 to $1,495 that went into effect on April 1, 2025, following Shield's ADLT designation.

As a reminder, after the initial 9-month period of list price-based reimbursement, Shield transitioned to market-based pricing at the start of 2026. Based on Commercial and Medicare Advantage payments received in 2025, the $1,495 Medicare fee-for-service rate is now established for 2026 and 2027. Out-of-period revenue in Q1 was broadly consistent with quarterly trends over the past year and totaled $22 million, which consisted of $18 million Oncology revenue and $4 million Screening revenue. Turning to Slide 20. Non-GAAP gross margin was 66% in Q1 2026, up from 65% in the prior year period. The improvement was primarily driven by lower Guardant360 Liquid cost per test reflecting the ongoing transition to NovaSeq X, which will be completed in May 2026.

The transition reduced Guardant360 Liquid sequencing cost per test by nearly $200 versus Q1 2025. We also benefited from improved screening gross margins, which I'll discuss on the next slide. Non-GAAP operating expenses were $268 million, an increase of 34%, primarily driven by commercial investment. While R&D and G&A saw modest year-over-year increases, sales and marketing expense rose to $154 million in Q1 2026 compared to $94 million in the prior year period. This reflects continued investment in building out our screening sales infrastructure, advancing Shield HCP and DTC marketing programs and supporting ongoing oncology revenue growth. Adjusted EBITDA loss in Q1 was $59 million compared to a loss of $59 million in the first quarter of 2025.

Free cash flow burn in Q1 2026 was $71 million compared to $67 million in the prior year period. The year-over-year change reflects an increase in the company-wide annual bonus payout in Q1 2026 compared to Q1 2025. Excluding this impact, free cash flow burn decreased by approximately $12 million year-over-year. We remain focused on disciplined cash management and are on track to decrease full year 2026 free cash flow burn compared to 2025. We ended the quarter with approximately $1.2 billion in cash and investments. Turning to Slide 21. Over the past year, Screening non-GAAP gross margin improved from 18% in Q1 2025 to 56% in Q1 2026.

This improvement has been driven by an increase in Shield ASP, as I outlined earlier, and a decrease in Shield non-GAAP cost per test from $520 in Q1 2025 to $420 in Q1 2026, which is a result of higher volumes, disciplined cost management and efficient lab operations. As a reminder, we continue to expect Shield cost per test to decline to approximately $200 at scale, driven by further volume growth as well as workflow efficiencies and automation, which we expect to implement in 2027. Turning to Slide 22.

Based on our strong first quarter performance and increased visibility, we are raising our full year 2026 revenue guidance to a range of $1.30 billion to $1.32 billion, representing growth of 32% to 34%. Oncology revenue is now expected to grow 28% to 29% with volume growth of greater than 35%. Demand fundamentals remain strong across the portfolio. Guardant360 Liquid should continue to benefit from Smart App adoption, while Guardant360 Tissue is building on recent upgrades and strong commercial execution. Reveal is expected to remain our fastest-growing oncology product, driven by MRD and therapy monitoring. Our oncology guidance does not include potential upside from FDA approval of Guardant360 Liquid or the launch of Reveal Ultra.

We continue to expect Biopharma & Data to grow in the low double-digit range, supported by recent strategic partnerships, continued progress in our CDx pipeline and a combination of ongoing collaborations and new program starts. Given the momentum exiting Q1, the impact we're seeing from our DTC and HCP campaigns and the launch of our Quest collaboration, we now expect Screening revenue of $186 million to $198 million, driven by Shield volume of approximately 230,000 to 245,000 tests. Note that this improved outlook does not include upside from ACS guideline inclusion, which we continue to expect in the near term.

We continue to expect full year non-GAAP gross margin in the range of 64% to 65%, which reflects ongoing improvements to Guardant360 Liquid and Shield cost per test, balanced with changes to product mix as Shield and Reveal test volumes scale rapidly. Given the strength and momentum we're seeing with Shield, we plan to continue reinvesting incremental screening gross profit to support commercial expansion during the year. Accordingly, we now expect 2026 non-GAAP operating expenses to be in the range of $1.05 billion to $1.07 billion, representing growth of 16% to 18% compared to 2025. We continue to expect full year free cash flow burn to be in the range of $185 million to $195 million, representing an improvement year-over-year.

Excluding Screening, we expect the remainder of the business to be free cash flow positive for the full year 2026, and we remain committed to achieving company-wide cash flow breakeven by the end of 2027. Turning to Slide 23, we are executing well against our key 2026 priorities. In Oncology, we will complete the Guardant360 Liquid NovaSeq X transition this month and expect multiple product launches, including Reveal Ultra, FDA-approved Guardant360 Liquid and continued expansion of the Smart platform. Guardant360 Liquid ESR1 monitoring launch is dependent on FDA approval of camizestrant. Last week, the Oncologic Drugs Advisory Committee voted [ 6 to 3 ] against the claim that camizestrant demonstrated clinically meaningful benefit in HR-positive HER2-negative metastatic breast cancer.

Ultimately, the FDA retains full discretion over its final decision, and we look forward to that outcome in the coming months. Importantly, the committee's discussion reinforced the broader consensus that ctDNA companion diagnostic therapy monitoring represents the future of precision oncology care. Furthermore, our revenue guidance does not reflect any impact from the potential approval of camizestrant. If it does receive FDA approval, this could represent a meaningful source of upside to Guardant360. In Biopharma & Data, we're advancing CDx programs and expanding strategic partnerships, including recent additions with leading biopharma companies and continue to scale our InfinityAI platform. In Screening, we've launched our Quest collaboration and expanded Shield into Multi-Cancer Detection markets in Asia through our partnership with Manulife.

Overall, the business is delivering very strong growth, and we remain focused on disciplined execution as we scale. With that, we'll now open the call for questions.

Operator: [Operator Instructions] First question is from the line of Mark Massaro with BTIG.

Mark Massaro: Congrats on the strong beat and raise. I'll stick with the Shield question. So it's nice to see both volumes and revenue come in above my expectations. And you talked about volumes accelerated momentum in March. I was curious if you could just speak to your confidence around April. I would assume that, that is tracking well since you raised the guide. And can you just give us a sense for why you raised the volume guide up for Shield? If I remember this correctly, I believe the prior outlook excluded benefit from Quest. So how much of this might be adding Quest into the calculus versus any other drivers that you're seeing?

AmirAli Talasaz: Thank you, Mark. Yes, we are very proud of what we did in Q1 in terms of Shield volume. January and February went as we expected. But as we entered March, really we saw such a huge momentum that was way better than actually what we expected. The root cause of it, like multiple things worked all at the same time hand to hand. We talked about launching our DTC campaign, influencer campaigns, Quest went live at the same time, that EMR connectivity actually helped in a very meaningful way. And we saw that actually continue.

So based on the trends that we've seen in March, and it's -- we don't want to get into Q2 commentary, but based on everything that we've seen, gives us a lot of good confidence of what we can deliver in this year. And still, we don't want to get ahead of our skis and be too excited with maybe what we've seen. But we are very confident of this new guide that we put out there. In terms of Quest contribution, we need to capture more data on how much really Quest is helping us incrementally. What we are seeing in terms of early indications are positive.

So we are counting on some of that in our new guide, but again, in a very thoughtful way, and we are going to monitor how it goes in the months to come, and we've set the expectation accordingly.

Operator: Next question is from the line of Subbu Nambi with Guggenheim.

Subhalaxmi Nambi: Congratulations on the print. Helmy, G360, despite being on the market for over a decade, is growing 30% year-over-year. While you have previously said there is no one reason for this outsized growth, could you give us additional color on what is driving this? Is it CRC now starting to adopt Liquid? Is it G360 Testing or something else? And then as we look to full year guidance, how much of the guide raise is attributed to G360 outlook?

Helmy Eltoukhy: Sure. Thanks for the question. Yes, we're very pleased with how, as you said, in its 10th year, Guardant360 continues to grow very nicely. I think a lot of it -- I think when we launched the smart liquid biopsy platform a few years ago, I think a lot of people sort of brushed it off as just a sort of marginal addition to the liquid biopsy space. But this is a fundamental step change in terms of the power of liquid biopsy and its capabilities, allowing us to see phenotype, allowing us to have all these different capabilities that were never possible with liquid biopsy before.

And I think you're seeing us lean into that, and you're seeing the adoption begin to grow and grow. So I think it's -- when we dig in and we peel down another layer, there's certainly, I would say, in this inning, a lot of share gains that are happening. There is greater depth and greater breadth as well in terms of physicians that haven't traditionally used liquid biopsy for certain tumor types. But I think all in all, the growth is very broad-based.

And I think what's even more exciting is that we're still very much in the early innings of the platform's capabilities in terms of what we can do on the Smart App side as well as the longitudinal testing. I mean we're still not testing at every progression, still very underpenetrated. And so that's the exciting part is that we're very confident that the growth continue not only in the short term, but the medium to long term as well.

Operator: The next question is from the line of Patrick Donnelly with Citi.

Patrick Donnelly: Helmy, maybe one for you on the Reveal side. I think you talked about over 100% growth there. Can you just talk about what you're seeing in the market, the key drivers there? And then I know you mentioned you submitted a few data packages to MolDx on breast cancer surveillance, some of the monitoring pieces. Maybe just talk about the catalyst set on that front on the reimbursement side, what we should be looking for on the Reveal front?

Helmy Eltoukhy: Yes. We're very excited with how fast Reveal is growing, how much depth we're seeing there. Part of the drivers are -- we're still continuing to see really good growth in CRC, breast and lung cancers and the surveillance setting. But therapy monitoring has also been a great addition to the portfolio, and we're seeing, I think, great traction there. I think what that shows is really the brands that we've built over the last 12 years in oncology. And when we launch something new, we tend to see, I think, outsized traction maybe versus, let's say, a new competitor in the market. And then we're making progress with our MolDX submissions.

I think the nice thing is the volume is sort of leading indicator. You can't generate revenue without the volume. And hopefully when we get over the finish line with some of the submissions, they will really be in a good spot from a revenue and sort of overall ASP for the MRD business that we have.

Operator: Next question is from the line of Doug Schenkel with Wolfe Research.

Colleen Babington: This is Colleen on for Doug. We've got a question on Shield ASPs expectations. So it looks like ASP is holding up a little bit better than we had expected. And if we're doing the math right, it looks like you're expecting full year '26 Shield ASPs a bit north of $800 per test. If possible, could you share what percentage of Shield volume came from CMS in the quarter and how you expect that to evolve over the year?

Michael Bell: Yes, I can take that. Q1 was pretty consistent with what we saw towards the back end of last year with a pretty high proportion of Shield tests being either Medicare -- fee-for-service or Medicare Advantage. And so that's what's been driving that strong ASP over the last few quarters. As we look out for the remainder of the year, we're expecting to sort of broaden the reach to patients under 65. And of course, we're not covered yet on the commercial side.

And so I think our sort of expectation and our guide sort of implies a tick down in the ASP for the remainder of the year as we build out that commercial patient volume and getting ahead of when we start to get the reimbursement. So yes, today, it's been strong. It's predominantly Medicare, Medicare Advantage, but that sort of mix is going to skew a little bit more to [ under 65s ] throughout the year.

Operator: Next question is from the line of Casey Woodring with JPMorgan.

Sebastian Sandler: This is Sebastian Sandler on for Casey. Can you dig a little more into the G360 Tissue growth you're seeing? You're growing well above the market. So it seems like you're taking some share there. I'm just curious how sustainable maybe some of these share gains are? And then can you talk about the pathway to ASP upside from this whole transcriptome addition? I would expect that would be more than the $300 benefit you saw from the initial RNA element.

Helmy Eltoukhy: Yes. Great question. Yes, obviously, we're very pleased with the growth we're seeing in Tissue. And we think one of the things that will sort of further accelerate that growth is as we get FDA approval for our Guardant360 Liquid test. And we think that will really streamline the portfolio, allow simplified ordering between the 2 products and really help move everything on to the Smart platform. And so yes, we believe this growth is sustainable. But right now, sort of the trajectory is being led by Guardant360 Liquid in terms of just how advanced those capabilities are. But the nice thing is that G360 Tissue will also have a lot of the same Smart Apps over time.

And so we think essentially Tissue can just draft behind really, I think, amazing growth we're seeing with our Liquid portfolio. In terms of old transcriptome, maybe if we take a step back, I think the overall sort of trajectory or pathway we're seeing with G360 Tissue is that obviously, that will go through its own regulatory pathway. We'll submit that to the FDA at some point. And we believe we can qualify for essentially ADLT status there as well, which should improve ASP further substantially.

Operator: The next question is from the line of Puneet Souda with Leerink Partners.

Puneet Souda: First one on Shield, 90% adherence rate, that is impressive, something, AmirAli, you've been pointing out for some time, just as you were pointing out FDA approval of Shield and both of those obviously coming to fruition here. So I really like the consistency and insight here. But could you talk about the Shield volume cadence through the year? How should we think about the next 3 quarters just given the momentum you're seeing and the effort around the key ads and the marketing and all of that you're putting, DTC that you're putting behind Shield? And on the oncology side, Helmy, G360 repeat use is an important driver. Cami AdCom was resoundingly positive for G360 and ctDNA use.

But the problem was the trial design not the assay. Going forward, how should we think about the repeat use from 1.3 average? How does that go higher in the future?

AmirAli Talasaz: Thank you, Puneet. So our guide for this year now for Shield, when you do the calculation, it kind of implies an average of about maybe a little bit over 10,000 sequential growth like Q-over-Q. And as I mentioned earlier, we feel very confident about this new guidance. And we'll see how it goes. Again, we didn't want to get ahead of our skis. We want to capture more data of how our DTC campaigns are going to continue to impact our volume, how Quest is going to contribute, how much more we can see the rep productivity is going to go up. We continue to hire reps. We have that element, too.

But currently, this new guide, I think, is the right guide that we feel very confident of a little bit over 10,000 Q-over-Q growth.

Helmy Eltoukhy: In terms of the 1.3 average that you mentioned on G360, I think -- what we see is that there are multiple shots on goal to getting, I think, this feature that everyone believes in, which is going from biopsies and scans to just using the power of smart liquid biopsy and blood to monitor patients adaptively and dynamically. And so there are multiple shots on goal there. And I think the primary one is going to be using really the 1, 2 punch of Guardant360 Liquid and Reveal for monitoring.

And then as Reveal ebbs and flows, it will be a much simpler way to reflex patients to essentially a G360 test in those patients if and when those patients progress. And so we think this feature will happen. It's starting to happen now with the launch of Reveal for therapy monitoring, which we're seeing exciting traction for. And we're very confident that regardless of how camizestrant turns out, the future of oncology and the future of therapy switching will involve ctDNA.

Operator: The next question is from the line of Dan Arias with Stifel.

Daniel Arias: Helmy, on that point, on the camizestrant AdCom, some of the folks on the committee seem to suggest that the vote for them would have been a yes if there was an overall survival benefit. From where you sit, are the trials that might be on deck here set up endpoint-wise to show that? What do we have coming to us in terms of evidence generation and getting over the hump there on what these folks might need to see?

Helmy Eltoukhy: Yes. I mean, obviously, we don't want to comment on the specifics of any one trial. But yes, we're very confident that over time there are other trials that I think are going to sort of push the envelope. It's always hard for the first paradigm shift. And there's always a mountain of evidence that's required from -- moving from one paradigm from one modality to another one. But once that dam is broken, it's very hard to go back to the previous paradigm. And so it's just a matter of when, not if, and we're very confident we'll get there over the next few years, if not sooner.

Operator: The next question is from the line of Kyle Mikson with Canaccord.

Kyle Mikson: Congrats on the quarter. Mike, on the ASP for Shield, and this was touched on earlier, but it looks like the rest of the year ASP implied in the guide, the new guide is like high 500s. I'm just curious what you're assuming in terms of mix and why would it be that low? That's quite obviously. And then secondly, on -- maybe just a broader question, perhaps Helmy can answer this. So we have this acquisition today of an AI-based kind of diagnostics company.

Is this -- I mean I know it's like one example, but are you guys thinking about ways to kind of step up your AI game and offer AI-based companion diagnostics or anything of that sort?

Michael Bell: Yes, Kyle, I'll take the Shield ASP question first. Now actually, if you look at our guide on the volume increase and the revenue increase, what it implies is for Q2 through Q4, on average, the ASP is around $775, which is effectively the same sort of guide that we gave for that part of the year back in February. So there's no change. And yes, as I mentioned before, what's driving that tick down from Q1, which is very strong, is going to be just the mix of Medicare, Medicare Advantage versus commercial patients where we're not getting paid now.

Helmy Eltoukhy: Yes. In terms of the AI question, I feel like we've been leading the pack, frankly, in terms of real AI that has that actionable insight. There's a lot of talk about AI in the space, but I think you can see physicians voting with their feet when they're using our products much more than others in the space right now. And we were one of the -- we are the first to bring AI pathology to the oncology space with the Lunit collaboration we did a few years ago. You're seeing what we're doing with InfinityAI. I think we'll be one of the first to amass an exabyte of data.

And data is really the raw fuel that's required to use AI to have truly actionable insights. And so we built an architecture that's purpose-built from the ground up to be really deployed and utilized and worked with AI in, I think, very fruitful way. And yes, you're going to see, I would say, over the coming quarters us really sharing a lot more in terms of all the exciting things that we're building with AI and with the enormous treasury of data that we have inside the company.

Operator: Next question is from the line of Tycho Peterson with Jefferies.

Tycho Peterson: A couple of quick ones. I guess you've had a couple on SERENA-6. Just a different angle, though. How does this change your time lines for establishing therapy monitoring as a standard billable event versus just therapy selection? Does this kind of extend the adoption curve and other lessons learned from this trial as we think about other high-volume areas like lung and CRC surveillance. So that's one question. Second is consolidation that came up in an earlier question. There's been a lot. How are you thinking about competitive landscape? I mean now you've got Roche with Saga. Obviously, Abbott with Exact. Just curious if that changes your thoughts on size of sales channel, go-to-market strategy at all?

And then for Mike, was there any weather impact? I've had a few people asking if there's going to be any catch-up in 2Q. Obviously, you grew through it, but was there any headwind from PCP visit cancellations?

Helmy Eltoukhy: In terms of the SERENA-6 question, our primary shots on goal there are frankly, the Reveal therapy monitoring we just launched and the reimbursement packages we have on deck in terms of IO therapy monitoring, chemotherapy monitoring, which are really the primary modalities and tools and the therapies in oncology therapy space right now. And so with those 2 over the finish line, I think we'll be in a very, very good spot from a therapy monitoring point of view. And as we said, things like SERENA-6 and specific trials are frankly, upside really to that primary pathway.

In terms of consolidation, we look at almost, I think every company in the space always thinking about balancing organic growth with inorganic growth. But as you can see, the bar is very high in terms of what we built organically inside the company, the growth rates, the quality of our products and so on. And so it really has to be something that is accretive to what we built here. But yes, I think it will happen at some point.

Michael Bell: Yes. And then with respect to the weather impact, I mean, in Q1, we saw the normal seasonal impact related to sort of PCP footfall as well as weather. That was expected. That was in our original guide. And so the start of the year came in, yes, again, as we expected. So no, we don't anticipate any catch-up. I think what we saw in the start of the year was just what we would normally expect to see every year.

Operator: Next question is from the line of Bill Bonello with Craig-Hallum.

William Bonello: I have maybe a slightly bigger picture question, but that's just sort of getting at the importance of the portfolio that you've built out. Just curious if you can give us some sense of the percentage of customers that are ordering multiple products, so say, G360 Liquid and Tissue and Reveal. And then maybe along with that, with this growth, how much of it is sort of competitive takeaway versus docs that might be using some of these products, let's say, de novo?

Helmy Eltoukhy: Yes, it's a great question. Those are numbers that keep going up every single quarter in terms of the depth of ordering, not just the number of patients that the physician may have where they're ordering, let's say, a single product from us, but really the number of essentially linked products we have where there may be a CDx cluster tissue and then the physician may be sort of monitoring those patients or they may be using an MRD product from us for another patient subset. And that is really the power of the platform really this idea that all these products are all linked.

And I think that is why having such a comprehensive portfolio is so important because essentially any one of those products with their best-in-class can help convert those users and those physicians to Guardant evangelist. And I would say that for the -- like de novo versus the sort of users, we have something like, I think, 10,000, 11,000 oncologists who order from us certainly on a quarterly kind of basis. And so it's very hard to sort of gain shares in terms of de novo physicians at this point. So it's mostly that.

I would say it's a balance of greater depth in terms of percentage of patients that are sort of Guardant360 or Guardant products are being utilized and then certainly, share gains as well. And then I think the exciting part is, obviously, there's a longitudinal aspect that we're barely penetrated and which I think will lead to, I think, growth for the coming years across the portfolio.

Operator: Next question is from the line of Michael Ryskin with Bank of America.

Michael Ryskin: Congrats on the quarter again. Maybe sort of a big picture one. There's been a little bit of a land grab among some of your competitors on the market access in terms of expanding sales force building out as they launch new products and as they try to scale their existing products. Just curious what your internal plans are for commercial sales force, where you're expanding, where you're investing and just sort of across the portfolio, if you could walk us through the rest of the year, where you see some of that incremental OpEx going?

Helmy Eltoukhy: On the oncology side, this has been a matter, of course, now for a number of years where we look at revenue per territory per rep. And as long as there's no saturation in that territory, we may split it, we may add additional reps, additional support staff. And so that's just a matter of good hygiene for us, and we'll continue to do that where we see positive ROI. But I would say that I think we've prided ourselves on fairly high, maybe industry best sales efficiency. And so we will always try to do it in the most efficient way. But yes, we're not going to sort of skim on sales and marketing where there's positive ROI.

AmirAli Talasaz: On the Screening side, as we talked about it before, any additional gross profit in terms of year-over-year is getting reinvested in building the S&M function. They have a very good traction that goes into hiring additional sales force now is going towards these marketing campaigns like DTC campaign that we talked about earlier. It's kind of very interesting, in fact, I heard from our Head of Sales, and we are continuing to hire this year, too, that even the quality of the reps that we are hiring continues to go up. So we are very excited with what we are seeing right now.

Operator: The next question is from the line of Dan Brennan with TD Cowen.

Daniel Brennan: Maybe one on G360 and just one on multi-cancer. So on G360, really nice quarter, 30% volume growth, well above expectations. I know there was a comment question or 2 earlier, but just can you speak to a little bit again like what was better than you thought to drive that kind of volume growth? And then b, kind of implicit within the new 35% oncology volume growth, how are you thinking about G360? And then just on multi-cancer, can you just remind us of the strategy there? When we'll learn more? You're obviously having the ability to have patients opt in. What's the timetable at which we will get some clarity on the regulatory plan there?

I know you've been bullish about the number of samples you'll be collecting, but just wondering how we think about the path forward there.

Helmy Eltoukhy: In terms of G360, I don't think there was anything that kind of completely surprised us. I mean I think we know that the test is really best-in-class offers a lot of capabilities that, frankly, are not available in the market. And I think we're just continuing to lean into that. When we think about the rest of the year, I think beginning, we said something like 20% year-over-year growth for G360. That's obviously with a strong quarter inching up. And we're going to continue pushing the Vision G360 out there. The FDA approval of G360 should be another major catalyst that hopefully will be even upside to this current forecast.

AmirAli Talasaz: On the MCD front, this option rate is going strong. And with the strategy that we have, we are on track to have the biggest clinical database of MCD testing and the value on the patient from U.S. patient population in near future. So still we have a couple of milestones to hit to build that database. So let us get there and then we would set the right expectation for the timing of the regulatory milestones. But we are pleased with what we are seeing today.

Operator: The next question is from the line of Brandon Couillard with Wells Fargo.

Brandon Couillard: A couple on Shield. How many reps do you expect to have on board exiting the year at this point in the context of the higher revenue guide? Number two, do you expect only needing 2 blood tubes to be a volume driver? And number three, on ACS guidelines, why don't you think they've been published yet? Are you able to share any feedback from maybe some of your interactions with the organization?

AmirAli Talasaz: Yes. So we entered this year with like the 300 reps that we talked about. And as I mentioned, this incremental gross profit that we're going to have this year is going to get reinvested back. We are not planning to just give like pipe-by-pipe kind of updates on the size of the sales team as the field is becoming competitive, and that's commercially sensitive information. But based on this high-level guide, I think you guys are well positioned to have some estimation of how many people we are going to have by end of, let's say, 2026.

In terms of 2-tubes, on one side, we didn't hear any kind of issue with 4-tube, but we always want to have the best-in-class, easiest customer experience with Guardant products. As a result, we worked on studies to reduce the 4-tubes even to 2-tube, and we are very pleased that we got the approval from FDA, and we are going live with that updated kit in very near future. In terms of ACS guideline, I know you guys are hearing from me. It's coming. It's coming now probably for over a year. And my answer is the same. I think it's going to come any day, but I've been kind of a broken record on it.

Our conversation with them continues to be actually pretty positive, and looks like everything is done. So we are just waiting for the finalized guidelines to be published. So it should be any day, but we'll see.

Helmy Eltoukhy: Last question, please.

Operator: Final question is from the line of Bradley Bowers with Mizuho.

Bradley Bowers: Just wanted to maybe double-click on where you're kind of seeing the Reveal volume growth. The pricing doesn't lend itself to be in Medicare CRC, but maybe I'm wrong. But just based on KOL checks, that area may be preferring Tissue. Just wanted to see where you're kind of seeing some of the volume growth ahead of expectation and maybe what the expectations for volume and price lift should be post-breast?

Helmy Eltoukhy: Yes. I would say we're seeing growth, frankly, across the board. CRC, breast has been very strong for us, lung. And then obviously, new indication of therapy monitoring has been relatively strong for us as well. So yes, I think the market really has, I would say, sort of 2 parts to it. The consumer-informed sort of MRD subset and then certainly market as well that is very, very sizable. Right now we're the far and away leader in tissue-free MRD, and we're continuing to lean into that. And obviously we'll be excited when we dip our toes into more informed with Reveal coming later this year. I'll let maybe Mike talk about ASP.

Michael Bell: Yes. No, ASP continues to be in this range, $600 to $700. I think we're excited hopefully to get incremental MolDx coverage in the near future with the breast and IO and chemo submissions that we've made. So obviously, getting Medicare coverage for each of those is going to have a nice positive impact. So definitely, breast is a large portion of the volume now. And so if we get that, it will definitely take us beyond the current range that we're in and sort of move us step-by-step closer to the $1,000 target that we set for 2028. So I think getting that coverage is going to be very positive for us.

Operator: No additional questions waiting at this time. So I'll pass the call back to management for any closing remarks.

Helmy Eltoukhy: That's it. Thank you, Matt.

Operator: That concludes the conference call. Thank you for your participation. You may now disconnect your lines.

This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. Parts of this article were created using Large Language Models (LLMs) based on The Motley Fool's insights and investing approach. It has been reviewed by our AI quality control systems. Since LLMs cannot (currently) own stocks, it has no positions in any of the stocks mentioned. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability.

The Motley Fool has positions in and recommends Guardant Health. The Motley Fool has a disclosure policy.