Guardant Health Inc.
10/29/2025 | Press release | Distributed by Public on 10/29/2025 15:13
Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)
Management's Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with the unaudited condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q. This discussion and other parts of this Quarterly Report on Form 10-Q contain forward-looking statements that involve risk and uncertainties, such as statements of our plans, objectives, beliefs, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in Part I, Item 1A, "Risk Factors," of our Annual Report on Form 10-K for the year ended December 31, 2024 and in Part II, Item 1A, "Risk Factors" of this Quarterly Report on Form 10-Q.
Overview
We are a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. We are transforming patient care by providing critical insights into what drives disease through our advanced blood and tissue tests, and real-world data. Our tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and helping doctors select the best treatment for patients with advanced cancer. For patients with advanced-stage cancer, we offer the Guardant360 Liquid test, formerly known as the Guardant360 LDT test, and Guardant360 CDx test, the first comprehensive liquid biopsy test approved by the U.S. Food and Drug Administration, or the FDA, to provide tumor mutation profiling with solid tumors and to be used as a companion diagnostic in connection with non-small cell lung cancer, or NSCLC, and breast cancer. We also offer the Guardant360 Tissue test for advanced-stage cancer, Guardant Reveal blood test to detect residual and recurring disease in early-stage colorectal, breast and lung cancer patients, and Guardant360 Response blood test to predict patient response to immunotherapy or targeted therapy eight weeks earlier than current standard-of-care imaging.
We also collaborate with biopharmaceutical companies in clinical studies by providing the above-mentioned tests, as well as the GuardantINFINITY blood test, a next-generation Smart Liquid Biopsy that provides new, multi-dimensional insights into the complexities of tumor molecular profiles and immune response to advance cancer research and therapy development, and the GuardantOMNI blood test for advanced-stage cancer. Using data collected from our tests, we have also developed our GuardantINFORM platform to help biopharmaceutical companies accelerate precision oncology drug development through the use of this in-silico research platform to unlock further insights into tumor evolution and treatment resistance across various biomarker-driven cancers.
For early cancer detection, in May 2022, we launched the Shield LDT test to address the needs of individuals eligible for colorectal cancer screening. From a simple blood draw, Shield uses a novel multimodal approach to detect colorectal cancer signals in the bloodstream, including DNA that is shed by tumors. In December 2022, we announced that the ECLIPSE study, a registrational study evaluating the performance of our Shield blood test for detecting colorectal cancer in average-risk adults, met co-primary endpoints. In addition, in March 2023, we submitted a premarket approval application, or PMA, for our Shield blood test to the FDA. In July 2024, we received FDA approval of our Shield blood test for colorectal cancer screening in adults age 45 and older who are at average risk for the disease, and in August 2024, our Shield blood test became commercially available in the U.S. as the first blood test approved by the FDA for primary colorectal cancer screening, meaning healthcare providers can offer Shield in a manner similar to all other non-invasive methods recommended in screening guidelines. Shield is also the first blood test for colorectal cancer screening that meets coverage requirements by Medicare. In addition, in June 2025, the National Comprehensive Cancer Network included our Shield blood test in its updated colorectal cancer screening guidelines. We also expect to expand into lung cancer screening and multi-cancer detection, or MCD, with our Shield platform. In June 2025, the FDA granted Breakthrough Device designation to our Shield MCD test to provide patients and healthcare providers with timely access to medical devices by speeding up their development, assessment and review. In addition, in October 2025, we expanded our Shield blood test to include a MCD results report with a data collection effort to better understand the clinical impact of MCD results. Patients are now able to receive an MCD results report when they take a Shield colorectal cancer test by agreeing to participate in a clinical data collection initiative.
We currently perform clinical, research use only, and investigation use only tests in our laboratory located in Redwood City, California. Our Redwood City laboratory is licensed pursuant to the Clinical Laboratory Improvement Amendments of 1988, or CLIA, accredited by the College of American Pathologists, or CAP, permitted by the New York State Department of Health, or NYSDOH, and licensed in California and four other states. We also perform clinical tests in our laboratory located in Long Island City, New York, for which we have received a clinical laboratory license from New York State, and research use only tests in our laboratory located in San Diego, California. In addition, our Redwood City, San Diego and Palo Alto, California laboratories are currently operated as centers for our research and technology development, and our Palo Alto laboratory is also CLIA licensed.
We generated total revenue of $265.2 million and $191.5 million for the three months ended September 30, 2025, and 2024, respectively, and $700.8 million and $537.2 million for the nine months ended September 30, 2025, and 2024, respectively. We also incurred net losses of $92.7 million and $107.8 million for the three months ended September 30, 2025, and 2024, respectively, and $287.8 million and $325.4 million for the nine months ended September 30, 2025, and 2024, respectively. We have funded our operations to date principally from the sales of our common stock, issuances of convertible senior notes, and generation of our revenue. As of September 30, 2025, we had cash, cash equivalents and restricted cash of approximately $689.5 million.
Factors affecting our performance
We believe there are several important factors that have impacted and that we expect will impact our operating performance and results of operations, including:
•Testing volume, pricing, and product and customer mix. Our revenue and costs are affected by the volume of tests, and average selling price per sample and cost per sample in relation to the mix of products and customers from period to period. We evaluate the volume of tests performed both for patients on behalf of clinicians and for biopharmaceutical companies, including tests delivered by labs operated by our strategic partners. Our performance depends on our ability to retain and broaden adoption of our existing and new products, with existing customers, as well as attract new customers.
•Payer coverage and reimbursement.Our revenue depends on achieving broad coverage and reimbursement for our tests from third-party payers, including both commercial and government payers. Our oncology and screening revenue is calculated based on our expected cash collections, using the estimated variable consideration. The variable consideration is estimated based on historical collection patterns as well as the potential for changes in future reimbursement behavior by one or more payers. Estimation of the impact of the potential for changes in reimbursement requires significant judgment and considers payers' past patterns of changes in reimbursement as well as any stated plans to implement changes. Any cash collections over the expected reimbursement period exceeding the estimated variable consideration are recorded in future periods based on actual cash received. Payment from commercial payers can vary depending on whether we have entered into a contract with the payers as a "participating provider" or do not have a contract and are considered a "non-participating provider". Payers often reimburse non-participating providers, if at all, at a lower amount than participating providers. Because we are not contracted with these payers, they determine the amount that they are willing to reimburse us for any of our tests and they can prospectively and retrospectively adjust the amount of reimbursement, adding to the complexity in estimating the variable consideration. When we contract with a payer to serve as a participating provider, reimbursements by the payer are generally made pursuant to a negotiated fee schedule and are limited to only covered indications or where prior approval has been obtained. Becoming a participating provider can result in higher reimbursement amounts for covered uses of our tests and, potentially, no reimbursement for non-covered uses identified under the payer's policies or the contract. As a result, the potential for more favorable reimbursement associated with becoming a participating provider may be offset by a potential loss of reimbursement for non-covered uses of our tests. Current Procedural Terminology, or CPT, coding plays a significant role in how our tests are reimbursed both from commercial and governmental payers. In addition, Z-Code Identifiers are used by certain payers, including under Medicare's Molecular Diagnostic Services Program, or MolDx, to supplement CPT codes for our molecular diagnostics tests. Changes to the codes used to report to payers may result in significant changes in its reimbursement. If their policies were to change in the future to cover additional cancer indications, we anticipate that our total reimbursement would increase.
In March 2021, the Centers for Medicare and Medicaid Services, or CMS, approved advanced diagnostic laboratory test, or ADLT, status to our Guardant360 CDx test, based on which Medicare paid us at the lowest available commercial rate per test, from April 1, 2021 to December 31, 2021. Effective January 1, 2022, Medicare started to reimburse Guardant360 CDx services at the median rate of claims paid by commercial payers. In March 2022, Palmetto GBA, the Medicare administrative contractor for MolDX, conveyed coverage for our Guardant360 Tissue test under the existing local coverage determination. The policy covers our Guardant360 Tissue test for Medicare fee-for-service patients with advanced solid tumor cancers. In July 2022, Palmetto GBA conveyed coverage for our Guardant Reveal test for fee-for-service Medicare patients in the United States with stage II or III colorectal cancer whose testing is initiated within three months following curative intent therapy, with an effective date of December 2021. In April 2023, Palmetto GBA conveyed coverage for our Guardant360 Response test for fee-for-service Medicare patients in the U.S. with metastatic or inoperable solid tumors who are on an immune checkpoint inhibitor therapy, tested four to ten weeks from therapy initiation. Effective January 1, 2024, Medicare has increased the reimbursement rate for our Guardant360 Liquid test to the same rate as our Guardant360 CDx test. In January 2025, Palmetto GBA granted coverage for our Guardant Reveal test to monitor disease recurrence in patients with colorectal cancer in the surveillance setting following curative intent therapy. This represents an expansion from the prior Medicare coverage of our Guardant Reveal test for colorectal cancer in the early post-surgical setting only. In May 2025, Palmetto GBA expanded coverage for our upgraded Guardant360 Tissue test to include both DNA and RNA testing.
In August 2024, following the FDA approval, our Shield blood test met the coverage requirements by Medicare based on the criteria established in its National Coverage Determination for blood-based colorectal cancer screening tests. The test is covered once every three years for eligible Medicare beneficiaries. In March 2025, CMS approved ADLT status for our Shield blood test for colorectal cancer screening, which initiated a specific, market-based approach to pricing the test for Medicare patients. In addition, in March 2025, our Shield blood test received coverage for patients receiving community care authorized by the U.S. Department of Veterans Affairs, or VA, as an in-network benefit, with no copay for average-risk individuals who are age 45 or older. Following Medicare coverage for our Shield blood test in August 2024, the VA network coverage is the first for individuals between the ages of 45 and 64.
Due to the inherent variability and unpredictability of the reimbursement landscape, including related to the amount that payers reimburse us for any of our tests, we estimate the amount of our oncology and screening revenue to be recognized at the time a test is provided and record revenue adjustments if and when the cash subsequently received differs from the revenue recorded. Due to this variability and unpredictability, previously recorded revenue adjustments are not indicative of future revenue adjustments from actual cash collections, which may fluctuate significantly. Additionally, if coding changes were to occur, payments for certain uses of our tests could be reduced, put on hold, or eliminated. This variability and unpredictability could increase the risk of future revenue reversal and result in our failing to meet any previously publicly stated guidance we may provide.
•Biopharmaceutical customers. Our revenue also depends on our ability to attract, maintain and expand relationships with biopharmaceutical customers. As we continue to develop these relationships, we expect to support a growing number of clinical studies globally and continue to have opportunities to offer our services to such customers, primarily including companion diagnostic development and regulatory approval, monitoring and maintenance, GuardantINFORM data services and GuardantConnect referral services.
•Research and development. A significant aspect of our business is our investment in research and development, including the development of new products. In particular, we have invested heavily in clinical studies as we believe these studies are critical to gaining physician adoption and driving favorable coverage decisions by payers. With respect to Guardant Reveal, in October 2021, we initiated a 1,000-patient prospective, observational, multi-center study, which we refer to as the ORACLE study, designed to evaluate the performance of our Guardant Reveal liquid biopsy test to predict cancer recurrence after curative intent treatment, across 11 solid tumor types. In addition, with respect to Guardant Reveal, in December 2022, we entered into a partnership with Susan G. Komen®, the world's leading breast cancer organization, to bring the patient perspective to the development of clinical studies that help identify early-stage breast cancer patients who are at high risk of disease recurrence and may benefit from additional monitoring or therapy. With respect to Shield, in December 2022, we announced that the ECLIPSE study, a registrational study evaluating the performance of our Shield blood test for detecting colorectal cancer in average-risk adults, met co-primary endpoints. The test demonstrated 83% sensitivity in detecting individuals with colorectal cancer. Specificity was 90% in both individuals without advanced neoplasia and in those who had a negative colonoscopy result. These results exceed the performance criteria set forth by the CMS for reimbursement. This test also demonstrated 13% sensitivity in detecting advanced adenomas. Based on these study results, in March 2023, we submitted a PMA to the FDA for our Shield blood test. In July 2024, we received FDA approval of our Shield blood test for colorectal cancer screening in adults age 45 and older who are at average risk for the disease, and in August 2024, our Shield blood test became commercially available in the U.S. as the first blood test approved by the FDA for primary colorectal cancer screening, meaning healthcare providers can offer Shield in a manner similar to all other non-invasive methods recommended in screening guidelines. Shield is also the first blood test for colorectal cancer screening that meets coverage requirements by Medicare. In addition, in June 2025, the National Comprehensive Cancer Network included our Shield blood test in its updated colorectal cancer screening guidelines. In July 2025, we initiated patient enrollment for the required Shield post FDA-approval study with the goal of assessing our Shield blood test performance, which we refer to as the SOLAR study. The SOLAR study will continue patient enrollment into 2026, and we aim to conclude the SOLAR study by 2031. To clinically validate the performance of our next-generation Shield blood test in lung cancer screening in high-risk individuals ages 50-80, in January 2022, we initiated a nearly 10,000-patient prospective, registrational study, which we refer to as the SHIELD LUNG study. In addition, in January 2025, our Shield multi-cancer detection, or MCD, test was selected for the Vanguard study funded by the National Cancer Institute, part of the National Institutes of Health. The Vanguard study is a four-year pilot study which initiated patient enrollment in June 2025 and will enroll up to 24,000 people to inform the design of a randomized controlled trial evaluating the use of MCD tests for cancer screening. In June 2025, the FDA also granted Breakthrough Device designation to our Shield MCD test to provide patients and healthcare providers with timely access to medical devices by speeding up their development, assessment and review. We have expended considerable resources, and expect to increase such expenditures over the next few years, to support our research and development programs with the goal of fueling further innovation.
•International expansion. A component of our long-term growth strategy is to expand our commercial footprint internationally, and we expect to increase our sales and marketing expense to execute on this strategy. We currently offer our tests in countries outside the United States primarily through distributor relationships, direct contracts with hospitals, and partnerships with local research organizations and laboratory companies.
In May 2018, we expanded our operations and commercialization of our products into Asia, the Middle East and Africa. In addition, in July 2023, Japan's Ministry of Health, Labour and Welfare granted national reimbursement approval for our Guardant360 CDx test for patients with advanced or metastatic solid tumor cancers in Japan.
In December 2020, we signed our first public private partnership agreement with Vall D'Hebron Institute of Oncology, or VHIO, one of Europe's leading cancer research institutions, and in May 2022, the first blood-based cancer testing services in Europe based on our digital sequencing platform became available at the VHIO testing facility in Spain. In October 2021, we signed a partnership agreement with The Royal Marsden NHS Foundation Trust, or Royal Marsden, a premier cancer center within the United Kingdom, or the UK, for patient care, research and teaching of all types of cancer, and in April 2023, the blood-based cancer testing services based on our digital sequencing platform became available at Royal Marsden testing facility in the UK. In September 2024, we signed a partnership agreement with the Agostino Gemelli University Polyclinic Foundation IRCCS, one of Italy's largest and most renowned hospitals known for its advanced oncology services, including diagnostics, treatment, and research, to establish an in-house liquid biopsy testing service within its hospital system.
In June 2022, we signed a strategic partnership agreement with Adicon Holdings Limited, or Adicon, a leading independent clinical laboratory company based in China, and in December 2023, the blood-based cancer testing services based on our digital sequencing platform became available at Adicon's testing facility, which offers our industry-leading comprehensive genomic profiling tests to biopharmaceutical companies to advance clinical research and the development of new cancer therapies in China.
The success of our international expansion strategy depends on a number of factors, including the internal and external constraints placed on our international laboratory partners and biopharmaceutical companies in the context of broader global, regional and U.S. economic and geopolitical conditions. For example, deterioration in the bilateral relationship between the United States and China may impact international trade, government spending, regional stability and macroeconomic conditions. The impact of these potential developments, including any resulting sanctions, export controls or other restrictive actions that may be imposed against governmental or other entities in, for example, China, may contribute to disruption of our international partnerships and instability and volatility in the global markets, which in turn could adversely impact our operations and weaken our financial results.
•Sales and marketing expense.Our financial results have historically, and will likely continue to, fluctuate significantly based upon the impact of our sales and marketing expense, increase in headcount, and in particular, our various marketing programs around existing and new product introductions.
•General and administrative expense. Our financial results have historically, and will likely continue to, fluctuate significantly based upon the impact of our general and administrative expense, and in particular, our stock-based compensation expense. Our equity awards, including performance-based restricted stock units, are intended to retain and incentivize employees to lead us to sustained, long-term superior financial and operational performance.
While each of these areas presents significant opportunities for us, they also pose significant risks and challenges that we must address. See Part I, Item 1A, "Risk Factors" of our Annual Report on Form 10-K for the year ended December 31, 2024, and Part II, Item 1A, "Risk Factors" of this Quarterly Report on Form 10-Q, for more information.
Components of results of operations
Revenue
We derive our revenue from four major sources, including oncology, biopharma and data, screening, and licensing and other.
Oncology.Oncology revenue was previously presented as precision oncology revenue from tests for clinical customers. Oncology revenue includes amounts derived from the delivery of our oncology tests for clinical customers, including hospitals, cancer centers, research institutions and patients, and oncology tests delivered by labs operated by our strategic partners. In the United States, we submit claims to Medicare and private payers for reimbursement for our Guardant360 CDx, Guardant360 Liquid, Guardant360 Tissue, Guardant Reveal and Guardant360 Response tests performed for qualifying patients.
Biopharma and data. Biopharma and data revenue includes amounts derived from the delivery of our tests for biopharmaceutical customers, previously presented as precision oncology revenue from tests for biopharmaceutical customers. Biopharma and data revenue also includes amounts derived from the performance of our service agreements with biopharmaceutical customers, previously presented as a component of development services and other revenue, primarily comprised of companion diagnostic development and regulatory approval, monitoring and maintenance, GuardantINFORM data services and GuardantConnect referral services.
Screening.Screening revenue, previously included in other revenue, includes amounts derived from the delivery of our Shield screening tests. In August 2024, following the FDA approval, our Shield screening test met the coverage requirements by Medicare, and we submit claims to Medicare for reimbursement for our Shield screening tests performed for qualifying patients. We also submit claims to private payers for reimbursement for qualifying patients covered under Medicare Advantage program. In addition, in March 2025, our Shield screening test received coverage for patients receiving community care authorized by the U.S. Department of VA, as an in-network benefit, with no copay for average-risk individuals who are age 45 or older. Following Medicare coverage for our Shield screening test in August 2024, the VA network coverage is the first for individuals between the ages of 45 and 64.
Licensing and other. We also derive revenue from licensing our technologies, previously included in other revenue.
Costs and operating expenses
Cost of revenue. Costs associated with performing our tests generally consists of cost of materials, including inventory write-downs; cost of labor, including employee benefits, bonus, and stock-based compensation; equipment and infrastructure expenses associated with processing test samples, such as sample preparation, library preparation, sequencing, and quality control analyses; freight; curation of test results for physicians; phlebotomy; and license fees due to third parties. Infrastructure expenses include depreciation of laboratory equipment, rent costs, depreciation of leasehold improvements and information technology costs. Costs associated with performing our tests are recorded as the tests are performed regardless of whether revenue was recognized with respect to the tests. We expect the costs associated with performing our tests to generally increase in line with the increase in the number of tests we perform, but we expect the cost per test to decrease modestly over time due to the efficiencies we may gain as test volume increases, and from automation and other cost reductions.
Cost of revenue also includes costs incurred for the performance of our service agreements and partnership agreements with biopharmaceutical customers and strategic partners, which comprise of labor and material costs. Costs associated with our service agreements and partnership agreements will vary depending on the nature, timing and scope of customer projects.
Research and development expense. Research and development expenses consist of costs incurred to develop technology and include salaries and benefits including stock-based compensation, reagents and supplies used in research and development laboratory work, infrastructure expenses, including facility occupancy and information technology costs, contract services, other outside costs and costs to develop our technology capabilities. Research and development expenses also include costs related to activities performed under contracts with biopharmaceutical companies before technological feasibility has been achieved. Research and development costs are expensed as incurred. Payments made prior to the receipt of goods or services to be used in research and development are deferred and recognized as an expense in the period in which the related goods are received or services are rendered. Costs to develop our technology capabilities are recorded as research and development unless they meet the criteria to be capitalized as internal-use software costs. We expect that our research and development expenses will continue to increase in absolute dollars as we continue to innovate and develop additional products, expand our genomic and medical data management resources and conduct our ongoing and new clinical studies.
Sales and marketing expense. Our sales and marketing expenses are expensed as incurred and include costs associated with our sales organization, including our direct sales force and sales management, client services, marketing and reimbursement, medical affairs, as well as business development personnel who are focused on our biopharmaceutical customers. These expenses consist primarily of salaries, commissions, bonuses, employee benefits, travel expenses and stock-based compensation, as well as marketing, sales incentives, and educational activities and overhead expenses. We expect our sales and marketing expenses to increase in absolute dollars as we expand our sales force, increase our presence within and outside of the United States, and increase our marketing activities to drive further awareness and adoption of our tests.
General and administrative expense. Our general and administrative expenses include costs for our executive, accounting and finance, information technology, legal and human resources functions. These expenses consist principally of salaries, bonuses, employee benefits, travel expenses and stock-based compensation, as well as professional services fees such as consulting, audit, tax and legal fees, and general corporate costs and overhead expenses. In addition, our general and administrative expenses also include severance costs related to workforce reduction. We expect that our general and administrative expenses will continue to increase as we incur additional costs to support the growth of our business. These expenses, though expected to increase in absolute dollars, are expected to decrease modestly as a percentage of revenue in the long term, though they may fluctuate as a percentage of revenue from period to period due to the timing and extent of these expenses being incurred.
Interest income
Interest income consists of interest earned on our cash, cash equivalents, restricted cash and marketable debt securities.
Interest expense
Interest expense consists of coupon interest expense and amortization of debt issuance costs, net of amortization of debt premium.
Other income (expense), net
Other income (expense), net consists of foreign currency exchange gains and losses, unrealized and realized gains and losses on marketable equity securities, gain on extinguishment of convertible notes, and impairment of non-marketable equity securities and other related assets. We expect our foreign currency gains and losses to continue to fluctuate in the future due to changes in foreign currency exchange rates.
Results of operations
The following tables set forth the significant components of our results of operations for the periods presented.
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Three Months Ended September 30, |
Nine Months Ended September 30, |
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| 2025 | 2024 | 2025 | 2024 | |||||||||||||||||||||||
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(unaudited)
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(in thousands)
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Revenue
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$ | 265,196 | $ | 191,476 | $ | 700,755 | $ | 537,202 | ||||||||||||||||||
| Costs and operating expenses: | ||||||||||||||||||||||||||
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Cost of revenue(1)
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93,587 | 74,489 | 249,515 | 212,206 | ||||||||||||||||||||||
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Research and development expense(1)
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89,957 | 87,306 | 265,927 | 254,210 | ||||||||||||||||||||||
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Sales and marketing expense(1)
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127,375 | 97,880 | 351,279 | 260,172 | ||||||||||||||||||||||
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General and administrative expense(1)
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53,266 | 49,129 | 150,477 | 128,243 | ||||||||||||||||||||||
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Total costs and operating expenses
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364,185 | 308,804 | 1,017,198 | 854,831 | ||||||||||||||||||||||
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Loss from operations
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(98,989) | (117,328) | (316,443) | (317,629) | ||||||||||||||||||||||
| Interest income | 7,391 | 13,257 | 24,063 | 42,038 | ||||||||||||||||||||||
| Interest expense | (943) | (646) | (2,717) | (1,936) | ||||||||||||||||||||||
| Other income (expense), net | (48) | (3,007) | 7,778 | (47,272) | ||||||||||||||||||||||
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Loss before provision for income taxes
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(92,589) | (107,724) | (287,319) | (324,799) | ||||||||||||||||||||||
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Provision for income taxes
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136 | 30 | 464 | 568 | ||||||||||||||||||||||
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Net loss
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$ | (92,725) | $ | (107,754) | $ | (287,783) | $ | (325,367) | ||||||||||||||||||
(1)Amounts include stock-based compensation expense as follows:
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Three Months Ended September 30, |
Nine Months Ended September 30, |
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| 2025 | 2024 | 2025 | 2024 | |||||||||||||||||||||||
| (unaudited) | ||||||||||||||||||||||||||
| (in thousands) | ||||||||||||||||||||||||||
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Cost of revenue
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$ | 2,501 | $ | 3,894 | $ | 7,444 | $ | 7,420 | ||||||||||||||||||
| Research and development expense | 13,478 | 18,643 | 39,788 | 38,413 | ||||||||||||||||||||||
| Sales and marketing expense | 11,185 | 13,215 | 32,458 | 27,633 | ||||||||||||||||||||||
| General and administrative expense | 15,644 | 14,017 | 43,337 | 30,579 | ||||||||||||||||||||||
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Total stock-based compensation expense
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$ | 42,808 | $ | 49,769 | $ | 123,027 | $ | 104,045 | ||||||||||||||||||
In November 2020 and May 2021, we granted restricted stock units with certain performance metrics, or PSUs, consisting of a performance period of 4 years combined with an additional service period requirement of six months should the vesting criteria be met, with a grant date fair value of $113.40 per share and $148.19 per share, respectively. In the third quarter of 2024, the performance metrics of these PSUs were considered to be achieved; as such we recorded $24.8 million in stock-based compensation expense related to these PSUs, based on 219,161 shares granted with fair values of $113.40 per share and $148.19 per share, of which $2.4 million was recorded to cost of revenue, and $11.8 million, $6.5 million and $4.1 million was recorded as components of research and development expense, sales and marketing expense, and general and administrative expense, respectively.
Comparison of the Three Months Ended September 30, 2025 and 2024
Revenue
| Three Months Ended September 30, |
Change
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| 2025 | 2024 |
$
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%
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(unaudited)
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(in thousands)
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Oncology
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$ | 184,402 | $ | 141,197 | $ | 43,205 | 31 | % | |||||||||||||||
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Biopharma and data
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54,731 | 46,547 | 8,184 | 18 | % | ||||||||||||||||||
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Screening
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24,112 | 1,003 | 23,109 | * | |||||||||||||||||||
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Licensing and other
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1,951 | 2,729 | (778) | (29) | % | ||||||||||||||||||
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Total revenue
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$ | 265,196 | $ | 191,476 | $ | 73,720 | 39 | % | |||||||||||||||
*Not meaningful
Total revenue was $265.2 million for the three months ended September 30, 2025, compared to $191.5 million for the three months ended September 30, 2024, an increase of $73.7 million, or 39%.
Oncology revenue was $184.4 million for the three months ended September 30, 2025, compared to $141.2 million for the three months ended September 30, 2024, an increase of $43.2 million, or 31%. This increase was driven primarily by an increase in oncology test volume to approximately 74,000 for the three months ended September 30, 2025 from approximately 53,100 for the three months ended September 30, 2024. This increase was also attributable to an increase in reimbursement for our oncology tests, partially offset by a reduction in revenue related to performance obligations satisfied in prior periods.
Biopharma and data revenue was $54.7 million for the three months ended September 30, 2025, compared to $46.5 million for the three months ended September 30, 2024, an increase of $8.2 million, or 18%. This increase was driven primarily by the achievement of certain milestones of our companion diagnostic development and regulatory approval service agreements.
Screening revenue was $24.1 million for the three months ended September 30, 2025, generated from the delivery of approximately 24,000 of our Shield screening tests.
Cost of Revenue
| Three Months Ended September 30, |
Change
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| 2025 | 2024 |
$
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%
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(unaudited)
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(in thousands)
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Cost of revenue
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$ | 93,587 | $ | 74,489 | $ | 19,098 | 26 | % | |||||||||||||||
Cost of revenue was $93.6 million for the three months ended September 30, 2025, compared to $74.5 million for the three months ended September 30, 2024, an increase of $19.1 million, or 26%. This increase in cost of revenue was driven primarily by an increase in costs associated with performing our oncology, biopharma and screening tests, which was attributable to an increase in sample volume, partially offset by reduced cost per sample of our oncology tests, including Guardant Reveal and Guardant360 Liquid; and reduced cost per sample of our Shield screening test.
Operating Expenses
Research and development expense
| Three Months Ended September 30, |
Change
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| 2025 | 2024 |
$
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%
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(unaudited)
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(in thousands)
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Research and development expense
|
$ | 89,957 | $ | 87,306 | $ | 2,651 | 3 | % | |||||||||||||||
Research and development expenses were $90.0 million for the three months ended September 30, 2025, compared to $87.3 million for the three months ended September 30, 2024, an increase of $2.7 million, or 3%. This increase was related to continued investment in the development of our technologies and products, primarily including an increase of $3.9 million in outside services costs related to clinical studies, and an increase of $3.1 million in personnel costs; partially offset by a decrease of $5.2 million in stock-based compensation.
Sales and marketing expense
| Three Months Ended September 30, |
Change
|
||||||||||||||||||||||
| 2025 | 2024 |
$
|
%
|
||||||||||||||||||||
|
(unaudited)
|
|||||||||||||||||||||||
|
(in thousands)
|
|||||||||||||||||||||||
|
Sales and marketing expense
|
$ | 127,375 | $ | 97,880 | $ | 29,495 | 30 | % | |||||||||||||||
Sales and marketing expenses were $127.4 million for the three months ended September 30, 2025, compared to $97.9 million for the three months ended September 30, 2024, an increase of $29.5 million, or 30%. This increase was related to commercial team expansion and marketing activities to support the Shield product launch and existing product growth, primarily resulting in an increase of $22.0 million in personnel costs, and an increase of $7.9 million in marketing related costs; partially offset by a decrease of $2.0 million in stock-based compensation.
General and administrative expense
| Three Months Ended September 30, |
Change
|
||||||||||||||||||||||
| 2025 | 2024 |
$
|
%
|
||||||||||||||||||||
|
(unaudited)
|
|||||||||||||||||||||||
|
(in thousands)
|
|||||||||||||||||||||||
|
General and administrative expense
|
$ | 53,266 | $ | 49,129 | $ | 4,137 | 8 | % | |||||||||||||||
General and administrative expenses were $53.3 million for the three months ended September 30, 2025, compared to $49.1 million for the three months ended September 30, 2024, an increase of $4.1 million, or 8%, primarily driven by an increase of $2.7 million in information technology infrastructure costs.
Interest income
| Three Months Ended September 30, |
Change
|
||||||||||||||||||||||
| 2025 | 2024 |
$
|
%
|
||||||||||||||||||||
|
(unaudited)
|
|||||||||||||||||||||||
|
(in thousands)
|
|||||||||||||||||||||||
|
Interest income
|
$ | 7,391 | $ | 13,257 | $ | (5,866) | (44) | % | |||||||||||||||
Interest income was $7.4 million for the three months ended September 30, 2025, compared to $13.3 million for the three months ended September 30, 2024, a decrease of $5.9 million, or 44%. This decrease was primarily due to reduced investment balances and lower available market rates of return on our investment portfolio.
Interest expense
| Three Months Ended September 30, |
Change
|
||||||||||||||||||||||
| 2025 | 2024 |
$
|
%
|
||||||||||||||||||||
|
(unaudited)
|
|||||||||||||||||||||||
|
(in thousands)
|
|||||||||||||||||||||||
|
Interest expense
|
$ | (943) | $ | (646) | $ | (297) | 46 | % | |||||||||||||||
Interest expense was primarily related to the coupon interest, amortization of debt issuance costs, net of amortization of debt premium of our convertible senior notes for the three months ended September 30, 2025, and 2024. See Note 6, Debtto the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on the convertible notes exchange transaction.
Other income (expense), net
| Three Months Ended September 30, |
Change
|
||||||||||||||||||||||
| 2025 | 2024 |
$
|
%
|
||||||||||||||||||||
|
(unaudited)
|
|||||||||||||||||||||||
|
(in thousands)
|
|||||||||||||||||||||||
|
Other income (expense), net
|
$ | (48) | $ | (3,007) | $ | 2,959 | (98) | % | |||||||||||||||
Other income (expense), net was immaterial for the three months ended September 30, 2025, and was a $3.0 million expense for the three months ended September 30, 2024, primarily attributable to $1.7 million of net unrealized and realized losses recorded for our marketable equity security investment in Lunit, Inc. during the period.
Provision for income taxes
| Three Months Ended September 30, |
Change
|
||||||||||||||||||||||
| 2025 | 2024 |
$
|
%
|
||||||||||||||||||||
|
(unaudited)
|
|||||||||||||||||||||||
|
(in thousands)
|
|||||||||||||||||||||||
|
Provision for income taxes
|
$ | 136 | $ | 30 | $ | 106 | 353 | % | |||||||||||||||
Provision for income taxes was immaterial for the three months ended September 30, 2025, and 2024.
Comparison of the Nine Months Ended September 30, 2025 and 2024
Revenue
| Nine Months Ended September 30, |
Change
|
||||||||||||||||||||||
| 2025 | 2024 |
$
|
%
|
||||||||||||||||||||
|
(unaudited)
|
|||||||||||||||||||||||
|
(in thousands)
|
|||||||||||||||||||||||
| Oncology | $ | 493,646 | $ | 397,214 | $ | 96,432 | 24 | % | |||||||||||||||
| Biopharma and data | 156,127 | 128,067 | 28,060 | 22 | % | ||||||||||||||||||
| Screening | 44,603 | 1,003 | 43,600 | * | |||||||||||||||||||
| Licensing and other | 6,379 | 10,918 | (4,539) | (42) | % | ||||||||||||||||||
| Total revenue | $ | 700,755 | $ | 537,202 | $ | 163,553 | 30 | % | |||||||||||||||
*Not meaningful
Total revenue was $700.8 million for the nine months ended September 30, 2025, compared to $537.2 million for the nine months ended September 30, 2024, an increase of $163.6 million, or 30%.
Oncology revenue was $493.6 million for the nine months ended September 30, 2025, compared to $397.2 million for the nine months ended September 30, 2024, an increase of $96.4 million, or 24%. This increase was driven primarily by an increase in oncology test volume to approximately 197,000 for the nine months ended September 30, 2025 from approximately 149,400 for the nine months ended September 30, 2024. This increase was also
attributable to an increase in reimbursement for our oncology tests, partially offset by a reduction in revenue related to performance obligations satisfied in prior periods.
Biopharma and data revenue was $156.1 million for the nine months ended September 30, 2025, compared to $128.1 million for the nine months ended September 30, 2024, an increase of $28.1 million, or 22%. This increase was driven primarily by an increase in volume of our GuardantINFINITY test, as well as an increase in revenue derived from the achievement of certain milestones of our companion diagnostic development and regulatory approval service agreements.
Screening revenue was $44.6 million for the nine months ended September 30, 2025, generated from the delivery of approximately 49,000 of our Shield screening tests.
Licensing and other revenue was $6.4 million for the nine months ended September 30, 2025, compared to $10.9 million for the nine months ended September 30, 2024, a decrease of $4.5 million, primarily due to a one-time revenue recorded related to one of our partnership agreements for the nine months ended September 30, 2024.
Cost of Revenue
| Nine Months Ended September 30, |
Change
|
||||||||||||||||||||||
| 2025 | 2024 |
$
|
%
|
||||||||||||||||||||
|
(unaudited)
|
|||||||||||||||||||||||
|
(dollars in thousands)
|
|||||||||||||||||||||||
|
Cost of revenue
|
$ | 249,515 | $ | 212,206 | $ | 37,309 | 18 | % | |||||||||||||||
Cost of revenue was $249.5 million for the nine months ended September 30, 2025, compared to $212.2 million for the nine months ended September 30, 2024, an increase of $37.3 million, or 18%. This increase in cost of revenue was driven primarily by an increase in costs associated with performing our oncology, biopharma and screening tests, which was attributable to an increase in sample volume, partially offset by reduced cost per sample of our oncology tests, including Guardant Reveal and Guardant360 Liquid; and reduced cost per sample of our Shield screening test.
Operating Expenses
Research and development expense
| Nine Months Ended September 30, |
Change
|
||||||||||||||||||||||
| 2025 | 2024 |
$
|
%
|
||||||||||||||||||||
|
(unaudited)
|
|||||||||||||||||||||||
|
(in thousands)
|
|||||||||||||||||||||||
|
Research and development
|
$ | 265,927 | $ | 254,210 | $ | 11,717 | 5 | % | |||||||||||||||
Research and development expenses were $265.9 million for the nine months ended September 30, 2025, compared to $254.2 million for the nine months ended September 30, 2024, an increase of $11.7 million, or 5%. This increase was related to continued investment in the development of our technologies and products, primarily including an increase of $6.0 million in material costs, an increase of $5.9 million in personnel costs, and an increase of $4.4 million in information technology infrastructure costs; partially offset by a decrease of $6.9 million in outside services costs related to clinical studies.
Sales and marketing expense
| Nine Months Ended September 30, |
Change
|
||||||||||||||||||||||
| 2025 | 2024 |
$
|
%
|
||||||||||||||||||||
|
(unaudited)
|
|||||||||||||||||||||||
|
(in thousands)
|
|||||||||||||||||||||||
|
Sales and marketing
|
$ | 351,279 | $ | 260,172 | $ | 91,107 | 35 | % | |||||||||||||||
Sales and marketing expenses were $351.3 million for the nine months ended September 30, 2025, compared to $260.2 million for the nine months ended September 30, 2024, an increase of $91.1 million, or 35%. This increase was related to commercial team expansion and marketing activities to support the Shield product launch and existing product growth, primarily resulting in an increase of $50.2 million in personnel costs, an increase of $30.1 million in marketing related costs, an increase of $4.8 million in stock-based compensation, an increase of $3.1 million in information technology infrastructure costs, and an increase of $3.0 million in office and administrative costs.
General and administrative expense
| Nine Months Ended September 30, |
Change
|
||||||||||||||||||||||
| 2025 | 2024 |
$
|
%
|
||||||||||||||||||||
|
(unaudited)
|
|||||||||||||||||||||||
|
(in thousands)
|
|||||||||||||||||||||||
|
General and administrative
|
$ | 150,477 | $ | 128,243 | $ | 22,234 | 17 | % | |||||||||||||||
General and administrative expenses were $150.5 million for the nine months ended September 30, 2025, compared to $128.2 million for the nine months ended September 30, 2024, an increase of $22.2 million, or 17%. This increase was primarily due to an increase of $12.8 million in stock-based compensation, and an increase of $9.0 million in information technology infrastructure costs.
Interest income
| Nine Months Ended September 30, |
Change
|
||||||||||||||||||||||
| 2025 | 2024 |
$
|
%
|
||||||||||||||||||||
|
(unaudited)
|
|||||||||||||||||||||||
|
(in thousands)
|
|||||||||||||||||||||||
|
Interest income
|
$ | 24,063 | $ | 42,038 | $ | (17,975) | (43) | % | |||||||||||||||
Interest income was $24.1 million for the nine months ended September 30, 2025, compared to $42.0 million for the nine months ended September 30, 2024, a decrease of $18.0 million, or 43%. This decrease was primarily due to reduced investment balances and lower available market rates of return on our investment portfolio.
Interest expense
| Nine Months Ended September 30, |
Change
|
||||||||||||||||||||||
| 2025 | 2024 |
$
|
%
|
||||||||||||||||||||
|
(unaudited)
|
|||||||||||||||||||||||
|
(in thousands)
|
|||||||||||||||||||||||
|
Interest expense
|
$ | (2,717) | $ | (1,936) | $ | (781) | 40 | % | |||||||||||||||
Interest expense was primarily related to the coupon interest, amortization of debt issuance costs, net of amortization of debt premium of our convertible senior notes for the nine months ended September 30, 2025, and 2024. See Note 6, Debtto the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on the convertible notes exchange transaction.
Other income (expense), net
| Nine Months Ended September 30, |
Change
|
||||||||||||||||||||||
| 2025 | 2024 |
$
|
%
|
||||||||||||||||||||
|
(unaudited)
|
|||||||||||||||||||||||
|
(in thousands)
|
|||||||||||||||||||||||
|
Other income (expense), net
|
$ | 7,778 | $ | (47,272) | $ | 55,050 | (116) | % | |||||||||||||||
Other income (expense), net was a $7.8 million income for the nine months ended September 30, 2025, primarily attributable to a gain on extinguishment of convertible notes of $13.7 million related to the convertible notes exchange transaction completed in February 2025, partially offset by an impairment of $5.0 million recorded for one of our non-marketable equity security investments. Other income (expense), net was a $47.3 million expense for the nine months ended September 30, 2024, primarily attributable to $47.2 million of net unrealized and realized losses recorded for our marketable equity security investment in Lunit, Inc. during the period.
Provision for income taxes
| Nine Months Ended September 30, |
Change
|
||||||||||||||||||||||
| 2025 | 2024 |
$
|
%
|
||||||||||||||||||||
|
(unaudited)
|
|||||||||||||||||||||||
|
(in thousands)
|
|||||||||||||||||||||||
|
Provision for income taxes
|
$ | 464 | $ | 568 | $ | (104) | (18) | % | |||||||||||||||
Provision for income taxes was immaterial for the nine months ended September 30, 2025, and 2024.
Liquidity and capital resources
We have incurred losses and negative cash flows from operations since our inception, and as of September 30, 2025, we had an accumulated deficit of $2.9 billion. We expect to incur additional operating losses in the near future and our operating expenses will increase as we continue to invest in clinical studies and develop new products, expand our sales organization, and increase our marketing efforts to drive market adoption of our tests. As demand for our tests are expected to continue to increase from physicians and biopharmaceutical companies, we anticipate that our capital expenditure requirements could also increase if we require additional laboratory capacity.
We have funded our operations to date principally from the sales of our common stock, issuances of convertible notes and generation of our revenue. As of September 30, 2025, we had cash, cash equivalents and restricted cash of $689.5 million. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to provide liquidity while ensuring capital preservation.
Based on our current business plan, we believe our current cash, cash equivalents and restricted cash and anticipated cash flows from operations, will be sufficient to meet our anticipated cash requirements for more than 12 months from the date of this Quarterly Report on Form 10-Q. We may consider raising additional capital to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons. As our revenue is expected to grow long-term, we expect our accounts receivable and inventory balances to increase. Any increase in accounts receivable and inventory may not be completely offset by increases in accounts payable and accrued liabilities, which could impact our working capital balances.
If our available cash, cash equivalents and restricted cash and anticipated cash flows from operations are insufficient to satisfy our liquidity requirements because of lower demand for our products as a result of lower than currently expected rates of reimbursement from our customers or other risks described in this Quarterly Report on Form 10-Q and in our Form 10-K for the year ended December 31, 2024, we may seek to sell additional common or preferred equity or convertible debt securities, enter into a credit facility or another form of third-party funding or seek other debt financing. The sale of equity and convertible debt securities may result in dilution to our stockholders and, in the case of preferred equity securities or convertible debt, those securities could provide for rights, preferences or privileges senior to those of our common stock. The terms of debt securities issued or borrowings pursuant to a credit agreement could impose significant restrictions on our operations. If we raise funds through collaborations and licensing arrangements, we might be required to relinquish significant rights to our platform technologies or products or grant licenses on terms that are not favorable to us. Additional capital may not be available to us on reasonable terms, or at all.
At-The-Market Offering Program
In August 2024, we entered into an Open Market Sales Agreement, or the Sales Agreement, with Jefferies LLC, or the Agent, with respect to an at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of our common stock, having aggregate gross proceeds of up to $400.0 million through the Agent, subject to the terms and conditions of the Sales Agreement. As of September 30, 2025, no shares of our common stock have been sold under the Sales Agreement.
Cash flows
The following table summarizes our cash flows for the periods presented:
| Nine Months Ended September 30, | |||||||||||
| 2025 | 2024 | ||||||||||
|
(unaudited)
|
|||||||||||
|
(in thousands)
|
|||||||||||
| Net cash used in operating activities | $ | (158,387) | $ | (175,345) | |||||||
| Net cash provided by (used in) investing activities | $ | 277,865 | $ | (271,838) | |||||||
| Net cash (used in) provided by financing activities | $ | (60,895) | $ | 1,939 | |||||||
Operating activities
Cash used in operating activities during the nine months ended September 30, 2025, was $158.4 million, which resulted from a net loss of $287.8 million, and changes in our operating assets and liabilities of $46.7 million, partially offset by reconciliation adjustments of $176.1 million. Reconciliation adjustments primarily consisted of $123.0 million of stock-based compensation, $29.7 million of depreciation and amortization, $25.0 million of operating lease costs, $7.7 million of interest income received on marketable debt securities, and $5.0 million of impairment on non-marketable equity security investments, partially offset by $13.7 million of gain on extinguishment of convertible notes. The changes in our operating assets and liabilities were primarily the results of a $28.0 million payment of operating lease liabilities net of receipt of tenant improvement allowance, a $19.4 million increase in inventory, net, a $8.6 million increase in prepaid expenses and other current assets, net, and a $6.0 million increase in accounts receivable, net, partially offset by a $15.5 million increase in deferred revenue.
Cash used in operating activities during the nine months ended September 30, 2024 was $175.3 million, which resulted from a net loss of $325.4 million, and changes in our operating assets and liabilities of $58.0 million, partially offset by reconciliation adjustments of $208.1 million. Reconciliation adjustments primarily consisted of $104.0 million of stock-based compensation, $47.2 million of net unrealized and realized losses on marketable equity security investment in Lunit, Inc., $31.9 million of depreciation and amortization, and $23.4 million of operating lease costs. The changes in our operating assets and liabilities were primarily the result of a $27.0 million payment of operating lease liabilities net of receipt of tenant improvement allowance, a $19.8 million decrease in accounts payable and accrued liabilities, a $10.3 million increase in inventory, net, and a $9.2 million increase in prepaid expenses and other current assets, net, partially offset by a $9.6 million increase in deferred revenue.
Investing activities
Cash provided by investing activities during the nine months ended September 30, 2025, was $277.9 million, which resulted primarily from maturities of marketable debt securities of $307.3 million, partially offset by purchases of property and equipment of $20.5 million, and purchases of non-marketable equity securities of $9.0 million.
Cash used in investing activities during the nine months ended September 30, 2024, was $271.8 million, which resulted primarily from purchases of marketable debt securities of $307.3 million, purchases of property and equipment of $16.2 million, and purchase of non-marketable equity securities of $2.5 million, partially offset by maturities of marketable debt securities of $35.0 million, and sales of marketable equity security investment in Lunit, Inc. of $19.2 million.
Financing activities
Cash used in financing activities during the nine months ended September 30, 2025, was $60.9 million, which was primarily attributable to repurchase of treasury stock of $45.0 million, employee taxes paid related to net share settlement of restricted stock units of $25.2 million, and payment of debt issuance costs of $12.3 million, partially offset by proceeds from issuances of common stock under our employee stock purchase plan of $7.7 million, proceeds from exercise of stock options of $6.0 million, and proceeds from unwinding of convertible note hedges of $5.0 million.
Cash provided by financing activities during the nine months ended September 30, 2024, was $1.9 million, which was primarily attributable to proceeds from issuances of common stock under our employee stock purchase plan of $7.2 million, and proceeds from exercise of stock options of $2.6 million, partially offset by employee taxes paid related to net share settlement of restricted stock units of $7.7 million.
Critical accounting policies and estimates
We have prepared our consolidated financial statements in accordance with accounting principles generally accepted in the United States of America, or GAAP. Our preparation of these consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, expenses and related disclosures at the date of the consolidated financial statements, as well as revenue and expenses recorded during the reporting periods. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results could therefore differ materially from these estimates under different assumptions or conditions.
Our significant accounting policies are described in more detail in Note 2 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q and in Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations", in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024. During the three and nine months ended September 30, 2025, there were no material changes to our critical accounting policies from those discussed previously.
Recent accounting pronouncements
See Note 2, Summary of Significant Accounting Policies, to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for more information.
Guardant Health Inc. published this content on October 29, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on October 29, 2025 at 21:14 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]