GH 10-K & 10-Q changes, risk factors and insider trading

We have incurred significant losses since our inception. For the years ended December 31, 2024,2025, 20232024 and 2022,2023, we incurred net losses of $436.4$416.3 million, $479.4$436.4 million and $654.6$479.4 million, respectively. As of December 31, 2024,2025, we had an accumulated deficit of $2.6$3.0 billion. To date, we have financed our operations principally from the sale of stock or convertible securities, and revenuegeneration fromof precisionour oncology testing, and development services and other.revenue. We have devoted substantially all of our resources to the development and commercialization of our current products and to research and development activities related to our future products, including clinical and regulatory initiatives to obtain marketing approval and sales and marketing activities. We will need to generate substantial revenue to achieve and then sustain profitability, and even if we achieve profitability, we cannot be sure that we will remain profitable for any period of time. Our failure to achieve or maintain profitability could negatively impact the valuetrading price of our common stock.

•the volume and customer mix of our precision oncology testingproducts;

Our development plan involves using data and analytical insights generated from our current products as a force multiplier of returns on research and development investment in our future products. However, if we are unable to generate additional or compatible data and insights, then we may not be able to advance our products under development as quickly, or at all, or without significant additional investment. In addition, we recently migrated some of our existing products to our Smart Liquid Biopsy platform.Platform. While we believe that this platform improves the tests and adds value, the tests may not perform as well as expected on the platform and the market might not accept the value proposition that we believe the platform provides.

Our success depends on the market’s confidence that we can provide reliable, high-quality precision oncology products that will improve clinical outcomes, lower healthcare costs and enable better biopharmaceutical development. We believe that patients, clinicians and biopharmaceutical companies are likely to be particularly sensitive to product defects and errors in the use of our products, including if our products fail to detect genomic alterations with high accuracy from samples or if we fail to list or inaccurately include certain treatment options and available clinical studies in our test reports, and there can be no guarantee that our products will meet their expectations. Furthermore, if our competitors’ products do not perform to expectations, it may result in lower confidence in our tests as well. As a result, the failure of our products to perform as expected could significantly impair our operating results and our reputation. In addition, we may be subject to legal claims arising from any defects or errors in our products.

As our volume of test sales grows, we will need to continue to increase our workflow capacity for sample intake, customer service, billing and general process improvements, expand our internal quality assurance program and extend our platform to support comprehensive genomic analysis at a larger scale within expected turnaround times. We will need additional certified laboratory scientists and other scientific and technical personnel to process higher volumes of our precision oncology products. Portions of our process are not automated and will require additional personnel to scale. We will also need to purchase additional equipment, some of which can take several months or more to procure, setup and validate, and increase our software and computing capacity to meet increased demand. There is no assurance that any of these increases in scale, expansion of personnel, equipment, software and computing capacities or process enhancements will be successfully implemented, if at all, or that we will have adequate space in our laboratory facility or be able to secure additional facility space to accommodate such required expansion.

In September 2018, we began to receive reimbursement from Medicare for claims submitted with respect to our precision oncology tests. Precision oncology revenue from clinical tests for patients covered and administered by Medicare represented approximately 39%, 43% and 45% of our precision oncology revenue from clinical customers for the years ended December 31, 2024, 2023 and 2022, respectively. Revenue attributable to Medicare accounted for more than 10% of our total revenue in each of the years ended December 31, 2024,2025, 20232024 and 2022.2023. In addition, pursuant to CMS regulations, we cannot bill Medicare directly for tests provided for Medicare beneficiaries in some situations. CMS adopted an exception to its laboratory date of service regulation, and if certain conditions are met, molecular pathology testing laboratories such as us can rely on that exception to bill Medicare directly, instead of seeking payment from the hospital. If this exception is repealed or curtailed by CMS, or the laboratory date of service regulation is otherwise changed to adversely impact our ability to bill Medicare directly, our revenue could be materially reduced.

Growing understanding of the importance of biomarkers linked with therapy selection, minimal residual disease detection, and early cancer screening is leading to more companies offering services in genomic profiling. The promise of liquid biopsy testing is also leading to more companies attempting to enter the space and compete with us. Over the last year, that has included new and accelerated development programs by a number of potential competitors, and increasing levels of merger and acquisition activity by both existing and new competitors. Currently, our main competition is from diagnostic companies with products and services to profile genes in cancers based on either single-marker or comprehensive genomic profile testing, based on next-generation sequencing in either blood or tissue. This may change over the next few years as a result of new competitors entering through investment and acquisition activity. For example, recent merger and acquisition activity includes both completed and potential transactions with new and larger participants, some with greater resources than our legacy competitors.

Our competitors within the liquid biopsy space for therapy selection include Foundation Medicine, Inc., which was acquired by Roche Holdings, Inc. in 2018; Caris Life ScienceSciences, Inc.; Tempus AI, Inc.; NeoGenomics Laboratories,NeoGenomics, Inc.; Exact Sciences Corp.Corporation; MyriadBillionToOne, Genetics,Inc.; Quest Diagnostics, Inc.; and Laboratory Corporation of America. In addition, Natera, Inc., Tempus AI, Inc., Exact Sciences Corp.,Corporation, Myriad Genetics, Inc., Caris Life Science,Sciences, Inc., Foundation Medicine, Inc., BillionToOne, Inc., Personalis, Inc. and Quest Diagnostics, Inc., among others, are our competitors in minimal residual disease detection. Additionally, our competitors in the early screening testing space include GRAIL, Inc., Exact Sciences Corp.,Corporation, Freenome Holdings, Inc., and Delfi Diagnostics.

We rely on a limited number of suppliers or, in some cases, sole suppliers, including Illumina Inc., or Illumina, for certain sequencers, reagents, blood tubes and other equipment, software, instruments and materials that we use in our laboratory operations. An interruption in our laboratory operations could occur if we encounter delays or difficulties in securing these laboratory equipment, instruments or materials, and if we cannot then obtain an acceptable substitute. Any such interruption could significantly and adversely affect our business, financial condition, results of operations and reputation. We rely on Illumina as the sole supplier of the sequencers and as the sole provider of maintenance and repair services for these sequencers. Any disruption in operations of Illumina or other sole or limited suppliers or termination or suspension of our relationships with them could materially and adversely impact our supply chain and laboratory operations and thus our ability to conduct our business and generate revenue. These limited or sole suppliers could engage in diverse types of businesses, including selling products or providing services in competition with us, and there can be no assurance that we can continue to receive required equipment, software, instruments or materials from them.

We believe that there are only a limited number of other manufacturers that are capable of supplying and servicing the equipmentequipment, software, and materials necessary for our laboratory operations, including sequencers and various associated reagents, and potentially replacing our current suppliers. The use of equipment , software, or materials furnished by these replacement suppliers would require us to alter our laboratory operations. Transitioning to a new supplier would be time-consuming and expensive, may result in interruptions in our laboratory operations, could affect the performance specifications of our laboratory operations or could require that we revalidate our tests. There can be no assurance that we will be able to secure alternative equipment, reagents and other materials, bring such equipment, reagents and materials online, and revalidate our tests without experiencing interruptions in our workflow. In the case of an alternative supplier for Illumina, for example, there can be no assurance that replacement sequencers and various associated reagents will be available or will meet our quality control and performance requirements for our laboratory operations. If we should encounter delays or difficulties in securing, reconfiguring or integrating the equipment and reagents we require for our products or in revalidating our products, our business, financial condition, results of operations and reputation could be materially and adversely affected.

We currently derive the majority of our revenue from tests performed at a single laboratory facility located in Redwood City, California. Our facility and equipment could be harmed or rendered inoperable by natural or man-made disasters, including war, fire, earthquake, power loss, communications failure or terrorism, which may render itoperations difficult or impossible for our laboratory operations.facility. The inability to perform our tests or to reduce the backlog that could develop if our facility is inoperable, for even a short period of time, may result in the loss of customers or harm to our reputation, and we may be unable to regain those customers or repair our reputation. Furthermore, our facility and the equipment we use to perform our research and development work could be unavailable or costly and time-consuming to repair or replace. It would be difficult, time-consuming and expensive to rebuild our facility, to locate and qualify a new facility or enable a third party to practice our proprietary technology, particularly in light of licensure and accreditation requirements. Even if we are able to find a third party with such qualifications to perform our tests, the parties may be unable to agree on commercially reasonable terms.

•natural disasters, political and economic instability, including wars, terrorism, and political unrest, boycotts, tariffs, curtailment of trade and other business restrictions;

We market some of our tests, Guardant360,Guardant360 Liquid, Guardant360 Response, Guardant360 Tissue Next,Tissue, Guardant Reveal and Shield, as LDTs. LDTs are in vitro diagnostic tests that are intended for clinical use and are designed, manufactured, and used within a single laboratory. Although LDTs are classified as medical devices and the FDA has statutory authority to ensure that medical devices are safe and effective for their intended uses, the FDA has historically exercised enforcement discretion and has not enforced certain applicable FDA requirements, including premarket review, with respect to LDTs. While we believe that we are in material compliance with applicable laws and regulations, we cannot assure that the FDA will agree with us. If there are changes in FDA policy, or if the FDA disagrees that we are marketing our tests as LDTs within the scope of its policy of enforcement discretion, we may become subject to extensive regulatory requirements and may be required to stop selling our existing tests or launching any other tests we may develop and to conduct additional clinical studies or take other actions prior to continuing to market our tests. This could significantly increase the costs and expenses of conducting, or otherwise harm, our business.

These regulations introduced risk-based classification for IVDs and require notified body involvement for various high complexity devices including next generation sequencing tests such as Guardant360,Guardant360 Liquid, Guardant360 Response, Guardant360 Tissue Next,Tissue, and Guardant Reveal. Compliance with these requirements is a prerequisite to be able to affix the European Conformity, or CE, mark to our products, without which they cannot be sold or marketed in the EU. All medical devices placed on the market in the EU must fulfill the clinical evidence and post-market performance evidence requirements. In addition, the device must achieve the performances intended by the manufacturer and be designed, manufactured, and packaged in a suitable manner. To demonstrate compliance with the essential requirements we must demonstrate, among other things, on the evaluation of clinical data supporting the safety and performance of the products during normal conditions of use. Specifically, a manufacturer must demonstrate that the device achieves its intended performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and safety of the device are supported by suitable evidence.

Although we are a participating provider with some commercial payers, certain other large, national commercial payers, including Anthem, Aetna and Humana, have issued non-coverage policies that consider tissue and liquid CGP testing which are not FDA approved, including our Guardant360 and TissueNextTissue test, as experimental or investigational. If we are not successful in obtaining coverage from such payers, or if other payers issue similar non-coverage policies, our business and results of operations could be materially and adversely affected.

Medicare’s National Coverage Determination, or NCD, for Next Generation Sequencing, or NGS, first established in 2018 and subsequently updated in 2020 states that NGS tests, such as our Guardant360 test, are covered by Medicare nationally, when: (1) performed in a CLIA-certified laboratory, (2) ordered by a treating physician, (3) the patient meets certain clinical and treatment criteria, including having recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer, (4) the test is approved or cleared by the FDA as a companion in vitro diagnostic for an FDA approved or cleared indication for use in that patient’s cancer, and (5) results are provided to the treating physician for management of the patient using a report template to specify treatment options. Effective August 7, 2020, our Guardant360 CDx test obtained national coverage under the NGS NCD consistent with its FDA-approved indications.

In March 2022, Palmetto GBA established coverage for our Guardant360 TissueNextTissue test under an existing LCD. The coverage, which is also applicable to Noridian, covers our Guardant360 TissueNextTissue test for Medicare fee-for-service patients with advanced solid tumor cancers. In July 2022, Palmetto GBA established coverage under an existing LCD 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. This coverage, which also applies to Noridian, has an effective date of December 2021. In April 2023, Palmetto GBA established coverage for Guardant360 Response under an existing LCD for tracking patient response to immunotherapy after an initial Guardant therapy selection test. This coverage also applies to Noridian.

Separately, in response to the global COVID-19 pandemic, the FDA postponed most inspections of domestic and foreign manufacturing facilities at various points. Even though the FDA has since resumed standard inspection operations of domestic facilities where feasible, the FDA has continued to monitor and implement changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as it adapts to the evolving COVID-19 pandemic,regulates, and any resurgence of the virus or emergence of new variants may lead to further inspectional delays. Other regulatory authorities may adopt similar restrictions or other policy measures in response to the COVID-19 pandemic. If a prolonged government shutdown occurs, or if global health concerns continue to prevent the FDA or other regulatory authorities from conducting business as usual or conducting inspections, reviews or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

In the EU, notified bodies must be officially designated to certify products and services in accordance with the IVDR. Only a few notified bodies have been designated to date. Without IVDR designation, notified bodies may not yet start certifying devices in accordance with the new Regulation.regulation. As only a few notified bodies hashave been IVDR-designated to date, they are facing a heavy workload and their review times have lengthened. This situation could impact the way we are conducting or intend to conduct our business in the EU and the EEA.

In addition, the coding procedure used by third-party payers to identify various procedures, including our test, during the billing process is complex, does not adapt well to our tests and may not enable coverage and adequate reimbursement rates. Third-party payers usually require us to identify the test for which we are seeking reimbursement using a Current Procedural Terminology, or the CPT code. CPT coding plays a significant role in how our Guardant360 test is reimbursed both from commercial and governmental payers. The CPT code set is maintained by the American Medical Association, or AMA. In cases where there is not a specific CPT code to describe a test, the test may be billed under an unlisted molecular pathology procedure code or through the use of a combination of single gene CPT codes, depending on the payer. The Protecting Access to Medicare Act, or PAMA authorized the adoption of new, temporary billing codes and unique test identifiers for FDA-cleared or approved tests as well as advanced diagnostic laboratory tests. The AMA has created a new section of CPT codes, Proprietary Laboratory Analyses codes or PLA, to facilitate implementation of this section of PAMA. In addition, CMS maintains the Healthcare Common Procedure Coding System, or HCPCS, and may assign unique level II HCPCS code to tests that are not already described by a unique CPT code. New CPT "Category I" codes are issued annually and new PLA and level II HCPCS codes are issued as frequently as quarterly. Payers’ acceptance of the new code could be delayed, and transition to the new code could result in a decrease in reimbursement for our tests, both of which could potentially reduce revenue from commercial and government 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 molecular diagnostics tests such as our Guardant360 test. Following the FDA approval of our Guardant360 CDx test, a new Z-Code Identifier was issued in August 2020. In January 2021, a CPT PLA code was issued for our Guardant360 CDx test with an effective date in April 2021. Additionally, based on this new PLA code, we applied to the CMS for our Guardant360 CDx test to become an advanced diagnostic laboratory test, or ADLT. In March 2021, CMS approved ADLT status for the Guardant360 CDx test, based on which Medicare paid us at the actual list charge 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 and this rate will update annually based on the previous year’s private payer data submission. In April 2022, a CPT PLA code was issued for Guardant360 with an effective date in July 2022. In July 2022, a CPT PLA code was issued for Guardant360 TissueNextTissue with an effective date in October 2022. In October 2023, a CPT PLA code was issued for Guardant360 Response with an effective date in January 2024. Effective January 1, 2024, Medicare has increased the reimbursement rate for our Guardant360 LDTLiquid test to the same rate as our Guardant360 CDx test. 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 revenue to be recognized at the time a test is provided and record revenue adjustments if and when the cash subsequently received for a test differs from the revenue recorded for the test. 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.

Further, various states, such as California and Massachusetts, have implemented similar privacy laws and regulations, such as the California Confidentiality of Medical Information Act, that impose restrictive requirements regulating the use and disclosure of health information and other personally identifiable information. Laws in all 50 states require businesses to provide notice to individuals whose personally identifiable information has been disclosed as a result of a data breach. The laws are not consistent, and compliance in the event of a widespread data breach is costly. States are also constantly amending existing laws, and creating new data privacy and security laws, requiring attention to frequently changing regulatory requirements. For example, the California Consumer Privacy Act, or CCPA went into effect on January 1, 2020, andCCPA, creates certain data privacy rights for California residents. The CCPA increases the privacy and security obligations of entities handling certain personal information, and provides for civil penalties for violations, as well as a private right of action for data breaches that has increased the likelihood of, and risks associated with data breach litigation. Further, the California Privacy Rights Act, or CPRA, generally went into effect in January 2023, and imposes additional data protection obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk data, and opt outs for certain uses of sensitive data. It has also created a new California data protection agency authorized to issue substantive regulations and could result in increased privacy and information security enforcement. Additional compliance investment and potential business process changes may be required. Similar laws have passed in Virginia, Colorado, Connecticut, and Utah and haveor been proposed in other states and at the federal level, reflecting a trend toward more stringent privacy legislation in the United States. These laws and regulations are not necessarily preempted by HIPAA, particularly if a state affords greater protection to individuals than HIPAA. Where state laws are more protective, we may have to comply with the stricter provisions. In addition to fines and penalties imposed upon violators, some of these state laws also afford private rights of action to individuals who believe their personal information has been misused. The interplay of federal and state laws may be subject to varying interpretations by courts and government agencies, creating complex compliance issues for us and our clients, and potentially exposing us to additional expense, adverse publicity and liability. Further, as regulatory focus on privacy issues continues to increase and laws and regulations concerning the protection of personal information expand and become more complex, these potential risks to our business could intensify. Changes in laws or regulations associated with the enhanced protection of certain types of sensitive data, such as PHI, or personally identifiable information along with increased demands for enhanced data security infrastructure, could greatly increase our costs of providing our services, decrease demand for our services, reduce our revenue and/or subject us to additional risks.

In addition, the interpretation and application of consumer, health-related, and data protection laws, especially with respect to genetic samples and data, in the United States, European Economic Area, or EEA, and elsewhere are often uncertain, contradictory, and in flux. We operate or may operate in a number of countries outside of the United States whose laws may in some cases be more stringent than the requirements in the United States. For example, EEA member states have specific requirements relating to cross-border transfers of personal data to certain jurisdictions, including to the United States where our laboratory resides. In addition, some countries have stricter consumer notice and/or consent requirements relating to personal data collection, use or sharing, more stringent requirements relating to organizations’ privacy programs and provide stronger individual rights. Moreover, international privacy and data security regulations may become more complex and have greater consequences. For instance, the General Data Protection Regulation, or GDPR, went into effect in May 2018 and imposes stringent data protection requirements for the processing of personal data of persons within the EEA. The GDPR applies to any company established in the EEA as well as to those outside the EEA if they collect and use personal data in connection with the offering of goods or services to individuals in the EEA or the monitoring of their behavior. The GDPR imposes strict data protection compliance requirements including: providing detailed disclosures about how personal data is collected and processed; demonstrating that an appropriate legal basis is in place or otherwise exists to justify data processing activities; granting rights for data subjects in regard to their personal data; introducing the obligation to notify data protection regulators or supervisory authorities (and in certain cases, affected individuals) of significant data breaches; defining pseudonymized (i.e., key-coded) data; imposing limitations on retention of personal data; maintaining a record of data processing; and complying with the principal of accountability and the obligation to demonstrate compliance through policies, procedures, training and audit. The GDPR provides that EEA member states may make their own further laws and regulations limiting the processing of personal data, including genetic, biometric or health data, which could limit our ability to use and share personal data or could cause our costs could increase, and harm our business and financial condition. Failure to comply with the requirements of GDPR and the applicable national data protection laws of the EEA member states may result in fines of up to €20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financial year, whichever is higher, and other administrative penalties. Failure to comply with the GDPR and other applicable privacy or data security-related laws, rules or regulations could result in material penalties imposed by regulators, affect our compliance with client contracts and have an adverse effect on our business, financial condition and results of operations.

European data protection law also imposes strict rules on the transfer of personal data out of the EU to the United States. These obligations may be interpreted and applied in a manner that is inconsistent from one jurisdiction to another and may conflict with other requirements or our practices. In addition, these rules are constantly under scrutiny. For example, in July 2020, the Court of Justice of the EU, or the CJEU, limited how organizations could lawfully transfer personal data from the EEA to the United States by invalidating the Privacy Shield for purposes of international transfers and imposing further restrictions on use of the standard contractual clauses, or SCCs. In March 2022,While the United States and EU announcedhave asince new regulatory regime intended to replace the invalidated regulations; In October 2022, President Biden signed an executive order to implementadopted the EU-U.S. Data Privacy Framework, which serves as a replacement to the Privacy Shield.Shield, Theit Europeanis Commissionuncertain adoptedwhether this framework will be overturned in court like the adequacyprevious decisiontwo onEU-U.S. Julybilateral 10,cross-border 2023.transfer frameworks. As supervisory authorities issue further guidance on personal data export mechanisms, including circumstances where the SCCs cannot be used, and/or start taking enforcement action, we could suffer additional costs, complaints and/or regulatory investigations or fines, and/or if we are otherwise unable to transfer personal data between and among countries and regions in which we operate, it could affect the manner in which we provide our services, the geographical location or segregation of our relevant systems and operations, and could adversely affect our financial results.

Assuming that other requirements for patentability are met, prior to March 16, 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent. On or after March 16, 2013, under the Leahy-Smith America Invents Act, or the America Invents Act, enacted in September 16, 2011, the United States transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will beis entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. A third party that files a patent application in the USPTO on or after March 16, 2013, but before us could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by such third party. This will requirerequires us to be cognizant of the time from invention to filing of a patent application. Since patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we or our licensors were the first to either (i) file any patent application related to our product candidates or (ii) invent any of the inventions claimed in our or our licensor’s patents or patent applications.

•volume and customer mix for our precision oncology testingproducts;

In 2020, we sold $1,150,000,000$1.15 billion aggregate principal amount of 0% convertible senior notes due 2027, or the 2027 Notes. In February 2025, we issued $600 million aggregate principal amount of 1.25% convertible senior notes due 2031, or the 2031 Notes (together with the 2027 Notes, the Notes) in exchange for the retirement of approximately $659.3 million aggregate principal amount of the 2027 Notes, or the Note Exchange. In November 2025, we sold $402.5 million aggregate principal amount of 0% convertible senior notes due 2033, or the 2033 Notes (together with the 2027 Notes and 2031 Notes, the Notes). We may also incur additional indebtedness to meet future needs. Our indebtedness could have significant negative consequences for our security holders, business, results of operations and financial condition by, among other things:

In the event the conditional conversion features of the Notes are triggered, holders of the Notes will be entitled to convert their Notes into shares of our common stock upon the occurrence of certain events. If one or more holders of the Notes elect to convert their Notes, unless we satisfy our conversion obligation by delivering only shares of our common stock, we would be required to settle all or a portion of our conversion obligation through the payment of cash, which could adversely affect our financial condition. In the event the conditional conversion feature of the Notes is triggered, the conversion of some or all of the Notes will dilute the ownership interests of our existing stockholders to the extent we deliver shares of our common stock upon such conversion. The 2027 Notes, the 2031 Notes and the 20312033 Notes may become in the future convertible at the option of the holders thereof prior to August 15, 2027 and2027, November 15, 2030,2030 and February 15, 2033, respectively, under certain circumstances as provided in the respective indentures. Any sales in the public market of shares of our common stock issuable upon such conversion could adversely affect the price of our common stock. In addition, the existence of the Notes may encourage short selling by market participants because the conversion of the Notes could be used to satisfy short positions, and even anticipated conversion of the Notes into shares of our common stock could depress the price of our common stock.

In connection with the sale of the 2027 Notes, we entered into convertible note hedge, or the 2027 Note Hedge, transactions with certain financial institutions, or option counterparties, certain of which are expected to bewere cancelled in connection with the Note Exchange. The remaining 2027 Note Hedge transactions are expected generally to reduce the potential dilution upon any conversion of the 2027 Notes and/or offset any cash payments we are required to make in excess of the principal amount of converted 2027 Notes.

The option counterparties are financial institutions, and we will beare subject to the risk that any or all of them may default under the 2027 Note Hedge transactions. Our exposure to the credit risk of the option counterparties will not be secured by any collateral. If an option counterparty becomes subject to insolvency proceedings, we will become an unsecured creditor in those proceedings, with a claim equal to our exposure at that time under our transactions with that option counterparty. Our exposure will depend on many factors but, generally, an increase in our exposure will be correlated to an increase in the market price and in the volatility of our common stock. In addition, upon a default by an option counterparty, we may suffer adverse tax consequences and more dilution than we currently anticipate with respect to our common stock. We can provide no assurances as to the financial stability or viability of the option counterparties.

As a result of adverse geopolitical and macroeconomic developments, including tariffs and other trade actions and economic inflation and the responses by central banking authorities to control such inflation, the global credit and financial markets have experienced extreme volatility and disruptions and there has been increasing uncertainty about economic stability. If the equity and credit markets remain depressed or further deteriorate as a result of this global uncertainty, it may make any necessary debt or equity financing more difficult, more costly and more dilutive. Any of the above events could significantly harm our business, prospects, financial condition and results of operations and cause the price of our common stock to decline.

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, real-world data and real-worldAI data.analytics. Our tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and helpingtreatment doctors select the best treatmentselection for patients with advanced cancer. For patients with advanced-stage cancer, we haveoffer commercially launchedthe Guardant360 laboratory developedLiquid test, orformerly LDT,known as the Guardant360 LDT test, and the Guardant360 CDx,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, colorectal cancer and breast cancer. We have also launchedoffer the Guardant360 TissueNext tissueTissue test for advanced-stage cancer,cancer and the Guardant Reveal blood test to detect residual and recurring disease in early-stage colorectal, breast and lung cancer patients,patients. andWe Guardant360have Responsealso bloodexpanded the Guardant Reveal test to predictinclude patientlate-stage therapy response monitoring for patients with solid tumors. Our product portfolio is now powered by our Smart Platform, which utilizes methylation technology with genomic, epigenomic, and RNA-based data, to immunotherapyunlock ormulti-modal targetedbiology therapywith eightproprietary weekschemistry, earlieradvanced thanalgorithms currentand standard-of-careour imaging.InfinityAI learning engine.

We also collaborate with biopharmaceutical companies in clinical studies by providing the above-mentioned tests, as well as the GuardantOMNI blood test for advanced-stage cancer, and the GuardantINFINITY blood test, aalso next-generationpowered by our Smart LiquidPlatform, Biopsy thatwhich provides new, multi-dimensional insights into the complexities of tumor molecular profiles and immune response to advance cancer research and therapy development.development, and the GuardantOMNI blood test for advanced-stage cancer. Using data collected from our tests,tests and through AI-enabled analytical tools, 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.

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 certifiedlicensed 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.development, and our Palo Alto laboratory is also CLIA licensed.

We generated total revenue of $739.0$982.0 million, $563.9$739.0 million and $449.5$563.9 million for the years ended December 31, 2024,2025, 20232024 and 2022,2023, respectively. We also incurred net losses of $436.4$416.3 million, $479.4$436.4 million and $654.6$479.4 million in the years ended December 31, 2024,2025, 20232024 and 2022,2023, respectively. We have funded our operations to date principally from the salesales of our common stock, issuances of convertible senior notes, and revenue from our precision oncology testing and development services and other. In May 2023, we completed a follow-on underwritten public offering, in which we issued and sold 14,375,000 sharesgeneration of our commonrevenue. stockSee atNote a7, price of $28.00 per share,Debt, and receivedNote net10, proceedsCommon ofStock, $381.4to millionthe afterconsolidated deductingfinancial underwritingstatements discountsincluded elsewhere in this Annual Report on Form 10-K for additional information on our convertible senior notes and commissions and other offering costs of $21.1 million. In December 2023, we completed a registered direct offering with an investment management firm, in which we issued and sold 3,387,446 shares of our common stock at a price of $26.77 per share, and received net proceeds of $90.6 million.stock. As of December 31, 2024,2025, we had cash, cash equivalents, restricted cash and marketable debt securities of approximately $944.2$1.3 million.billion.

•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. PrecisionOur oncology and screening revenue from tests for clinical customers 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 TissueNextTissue test under the existing local coverage determination. The policy covers our Guardant360 TissueNextTissue 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 LDTLiquid 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, the coverage for our upgraded Guardant360 Tissue test was expanded by Medicare to include both DNA and RNA testing.

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 platformservices to such customerscustomers, for development services,primarily including companion diagnostic development, novel target discoverydevelopment and validation,regulatory asapproval, wellmonitoring asand clinicalmaintenance, studyGuardantINFORM enrollment.data Forservices example,and ourGuardantConnect testsreferral are being developed as companion diagnostics under collaborations with biopharmaceutical companies.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 oncology and screening 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 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 theFondazione Policlinico Universitario Agostino Gemelli UniversityIRCCS, Polyclinicor FoundationPoliclinico IRCCS,Gemelli, 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.system, and in December 2025, the liquid biopsy testing service based on our proprietary Guardant360® CDx technology became available at the Policlinico Gemelli facility in Italy.

•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 market-based and performance-based restricted stock units, are intended to retain and incentivize employees to lead us to sustained, long-term superior financial and operational performance.

•Other operating expense. Our financial results might fluctuate significantly based upon the impact of our other operating expense, and in particular, our legal settlement costs,reserves, which could potentially decrease or increase significantly.

We derive our revenue from twofour sources:major (i)sources, precisionincluding oncologyoncology, testing,biopharma and (ii)data, developmentscreening, servicesand licensing and other.

Cost of precisionrevenue. oncologyCosts testing.associated Costwith ofperforming precisionour oncology testingtests 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 accessioning,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. WhileWe expect the costs associated with performing our tests to generally increase in line with the increase in the number of tests we doperform, notbut believewe expect the technologiescost underlyingper test to decrease modestly over time due to the third-party licenses are necessary to permit us to provide our tests,efficiencies we domay believegain theseas technologiestest arevolume potentially valuableincreases, and offrom possibleautomation strategicand importanceother tocost us or our competitors.reductions.

Cost of developmentrevenue services and other. Cost of development services and other primarilyalso includes costs incurred for the performance of development services requested by our biopharmaceuticalservice customers,agreements and costs associated with our partnership agreements with biopharmaceutical customers and deliverystrategic of Shield screening tests,partners, which comprise of labor and material costscosts. includingCosts anyassociated inventorywith write-downs.our Forservice development of new products, costs incurred before technological feasibility has been achieved are reported as researchagreements and developmentpartnership expenses, while costs incurred thereafter are reported as cost of revenue. Cost of development services and otheragreements 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.

Interest expense consists primarily of chargescoupon relatinginterest toexpense and amortization of debt issuance costs.costs, net of amortization of debt premium.

Other income (expense), net consists of foreign currency exchange gains and losses, unrealized and realized gains and losses ofon 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.

Provision for (benefit from) income tax

Our tax positions are subject to income tax audits. We recognize the tax benefit of an uncertain tax position only if it is more likely than not that the position is sustainable upon examination by the taxing authority, based on the technical merits. The tax benefit recognized is measured as the largest amount of benefit which is more likely than not to be realized upon settlement with the taxing authority. We recognize interest accrued and penalties related to unrecognized tax benefits in its tax provision. We evaluate uncertain tax positions on a regular basis. The evaluations are based on a number of factors, including changes in facts and circumstances, changes in tax law, correspondence with tax authorities during the course of the audit, and effective settlement of audit issues. The provision for (benefit from) income taxes includes the effects of any accruals that we believe are appropriate, as well as the related net interest and penalties.

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. Before 2024, no compensation expense for these PSUs had been recorded since the achievement of the performance metrics did not meet the criteria for accrual. In 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 development services and other,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. In the first quarter of 2025, these PSUs were vested after the additional six months service requirements were fulfilled.

Precision oncology testingScreening revenue increasedwas to $687.9$79.7 million for the year ended December 31, 2024,2025, generated from $514.2 million for the year ended December 31, 2023, an increasedelivery of $173.7approximately million,87,000 orof 34%.our Shield screening tests.

Research and development expenses were $364.2 million for the year ended December 31, 2025, compared to $347.8 million for the year ended December 31, 2024, comparedan to $367.2 million for the year ended December 31, 2023, a decreaseincrease of $19.4$16.4 million, or 5%. This decreaseincrease was primarily duerelated to acontinued decreaseinvestment in the development of $31.8our technologies and products, primarily including an increase of $9.6 million in outsidepersonnel servicescosts, costsan primarily driven by a reduction in the ECLIPSE clinical study costs as the study nears completion, a decreaseincrease of $9.7$6.7 million in material costs, and aan decreaseincrease of $3.7$3.8 million in information technology infrastructure costs; partially offset by ana increasedecrease of $15.9$6.5 million in stock-basedoutside compensation,services primarilycosts related to theclinical PSUs of $11.8 million discussed in the Results of operations section above; and an increase of $10.0 million in other personnel costs.studies.

Sales and marketing expenses were $494.7 million for the year ended December 31, 2025, compared to $364.9 million for the year ended December 31, 2024, compared to $295.2 million for the year ended December 31, 2023, an increase of $69.7$129.7 million, or 24%.36%. This increase was related to commercial team expansion and marketing activities to support existing products andboth the Shield product launch,launch and existing products growth, primarily resulting in an increase of $34.1$77.0 million in other personnel costs;costs, an increase of $14.9$35.1 million in marketing activity related costs;costs, an increase of $11.7$8.2 million in stock-based compensation, includingan $6.5increase of $4.8 million related to the PSUs discussed in theoffice Resultand ofadministrative operations section above;costs, and an increase of $10.5$4.7 million in information technology infrastructure costs.

General and administrative expenses were $211.4 million for the year ended December 31, 2025, compared to $180.1 million for the year ended December 31, 2024, compared to $155.8 million for the year ended December 31, 2023, an increase of $24.3$31.3 million, or 16%.17%. This increase was primarily due to an increase of $19.2$15.9 million in stock-based compensation, includingan $4.1increase of $13.9 million related to the PSUs discussed in theinformation Resultstechnology ofinfrastructure operation section above;costs, and an increase of $12.4$4.0 million in otheroutside personnelservice costs; partially offset by a decrease of $7.5 million in severance costs related to a workforce reduction in the first quarter of 2023, and a decrease of $3.1$5.6 million in legal expenses.

Interest income was $34.1 million for the year ended December 31, 2025, compared to $53.7 million for the year ended December 31, 2024, compareda to $35.4 million for the year ended December 31, 2023, an increasedecrease of $18.3$19.6 million, or 52%,36%. This decrease was primarily attributabledue to higherreduced average investment balances and lower available market rates of return on our investments.investment portfolio.

Interest expense was primarily attributablerelated to the coupon interest, amortization of debt issuance costscosts, relatednet toof amortization of debt premium of our convertible senior notes issued in November 2020, for the years ended December 31, 2024,2025, and 2023.2024. See Note 7, Debt to the consolidated financial statements included elsewhere in this Annual Report on Form 10-K for additional information on our convertible senior notes.

Our business, financial condition and operating results are affected by a number of factors, whether currently known or unknown, including risks specific to us or the healthcare industry as well as risks that affect businesses in general. In addition to the information set forth in this Quarterly Report on Form 10-Q, you should consider carefully the factors discussed in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 19, 2026. The risks and uncertainties disclosed in such Annual Report and in this Quarterly Report could materially adversely affect our business, financial condition, cash flows or results of operations and thus our stock price. During the firstsecond quarter of fiscal 2026, there were no material changes to our previously disclosed risk factors.

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, real-world data and AI analytics. Our tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For patients with advanced-stage cancer, we offer the Guardant360 Liquid test and the 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, colorectal cancer and breast cancer. In addition, in the second quarter of 2026, we received FDA approval of our Guardant360 Liquid CDx test, advancing blood-based comprehensive genomic testing by the integration of genomic and epigenomic insights. We also offer the Guardant360 Tissue test for advanced-stage cancer and the Guardant Reveal test to detect residual and recurring disease in early-stage colorectal, breast and lung cancer patients. We have also expanded the Guardant Reveal test to include late-stage therapy response monitoring for patients with solid tumors. Our product portfolio is now powered by our Smart Platform, which utilizes methylation technology with genomic, epigenomic, and RNA-based data, to unlock multi-modal biology with proprietary chemistry, advanced algorithms and our InfinityAI learning engine.

For early cancer detection, we offer the Shield blood test for colorectal cancer screening in adults age 45 and older who are at average risk for the disease. Shield is the first blood test approved by the FDA for primary colorectal cancer screening and also the first blood test for colorectal cancer screening that meets coverage requirements by Medicare. In addition, our Shield blood test is included in the National Comprehensive Cancer Network and American Cancer Society colorectal cancer screening guidelines. We also expect to expand into lung cancer screening and multi-cancer detection, or MCD, with our Shield platform. The FDA has 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, we have expanded our Shield blood test to include an MCD results report with a data collection effort to better understand the clinical impact of MCD results in the United States. And we have launched the Shield MCD test in multiple markets in Asia.

We generated total revenue of $301.7$335.0 million and $203.5$232.1 million for the three months ended MarchJune 31,30, 2026, and 2025, respectively, and $636.6 million and $435.6 million for the six months ended June 30, 2026, and 2025, respectively. We also incurred net losses of $112.1$120.1 million and $95.2$99.9 million for the three months ended MarchJune 31,30, 2026, and 2025, respectively, and $232.2 million and $195.1 million for the six months ended June 30, 2026, and 2025, 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. See Note 7, Debt, and Note 10, Common Stock, to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on our convertible senior notes and common stock. As of MarchJune 31,30, 2026, we had cash, cash equivalents, and restricted cash and marketable securities of approximately $1.2 billion.

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. 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, the coverage for our upgraded Guardant360 Tissue test was expanded by Medicare to include both DNA and RNA testing. In the second quarter of 2026, following the FDA approval, our Guardant360 Liquid CDx test met the coverage requirements by Medicare based on the criteria established in its National Coverage Determination for molecular diagnostic tests.

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 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. In July 2026, UnitedHealth Group updated its policy to provide coverage of our Shield blood test for eligible members with an effective date of August 1, 2026, making it the first major commercial insurer to provide coverage for adults age 45 or older at average risk of colorectal cancer.

Oncology. 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 Liquid CDx, Guardant360 Tissue, and Guardant Reveal tests performed for qualifying patients.

Screening. Screening 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, our Shield blood test has received coverage for patients receiving community care authorized by the U.S. Department of Veterans Affairs with no copay for average-risk individuals ages 45 and older.older, and coverage from UnitedHealth Group for eligible members age 45 and older at average risk of colorectal cancer.

Other income (expense), net consists of foreign currency exchange gains and losses, gain on extinguishment of convertible notes, and impairment of non-marketable equity securities and other related assets.securities. We expect our foreign currency gains and losses to continue to fluctuate in the future due to changes in foreign currency exchange rates.

Comparison of the Three Months Ended MarchJune 31,30, 2026 and 2025

Total revenue was $301.7$335.0 million for the three months ended MarchJune 31,30, 2026, compared to $203.5$232.1 million for the three months ended MarchJune 31,30, 2025, an increase of $98.2$102.9 million, or 48%.44%.

Oncology revenue was $205.0$219.1 million for the three months ended MarchJune 31,30, 2026, compared to $150.6$158.7 million for the three months ended MarchJune 31,30, 2025, an increase of $54.4$60.4 million, or 36%.38%. This increase was driven primarily by an increase in oncology test volume to approximately 86,000104,000 for the three months ended MarchJune 31,30, 2026 from approximately 59,00064,000 for the three months ended MarchJune 31,30, 2025, and an increase in reimbursement for our oncology tests.2025.

Biopharma and data revenue was $53.0$60.9 million for the three months ended MarchJune 31,30, 2026, compared to $45.4$56.0 million for the three months ended MarchJune 31,30, 2025, an increase of $7.6$4.9 million, or 17%.9%. This increase was driven primarily by the achievement of certain milestones within our companion diagnostic development and regulatory approval service agreements, and revenue derived from our data services and the delivery of our tests for biopharmaceutical customers.agreements.

Screening revenue was $41.6$52.9 million for the three months ended MarchJune 31,30, 2026, compared to $5.7$14.8 million for the three months ended MarchJune 31,30, 2025, an increase of $35.9$38.1 million, or 633%.257%. The increase was driven primarily by an increase in our Shield screening test volume to approximately 44,00066,000 for the three months ended MarchJune 31,30, 2026 from approximately 9,00016,000 for the three months ended MarchJune 31,30, 2025, which was the second full quarter following the FDA approval of our Shield screening test. The increase was also attributable to an increase in reimbursement for our Shield screening test.2025.

Cost of revenue was $104.9$115.9 million for the three months ended MarchJune 31,30, 2026, compared to $74.7$81.2 million for the three months ended MarchJune 31,30, 2025, an increase of $30.2$34.7 million, or 40%.43%. This increase in cost of revenue was driven primarily by an increase in sample volume, partially offset by reduced cost per sample of our oncology tests, including Guardant360 Liquid;tests and reduced cost per sample of our Shield screening test.

Research and development expenses were $91.0$96.5 million for the three months ended MarchJune 31,30, 2026, compared to $88.5$87.4 million for the three months ended MarchJune 31,30, 2025, an increase of $2.5$9.1 million, or 3%.10%. This increase was related to continued investment in the development of our technologies and products.

Sales and marketing expenses were $169.1$190.0 million for the three months ended MarchJune 31,30, 2026, compared to $104.3$119.6 million for the three months ended MarchJune 31,30, 2025, an increase of $64.8$70.4 million, or 62%.59%. This increase was related to commercial infrastructure expansion and marketing activities to support our Shield and oncology growth, primarily resulting in an increase of $33.4$35.1 million in personnel costs,costs; and an increase of $21.5$27.6 million in marketing activity related costs.

General and administrative expenses were $57.9$61.7 million for the three months ended MarchJune 31,30, 2026, compared to $47.0$50.3 million for the three months ended MarchJune 31,30, 2025, an increase of $11.0$11.4 million, or 23%, primarily driven by an increase of $7.1 million in legal and other outside service costs, and $5.3$9.5 million in stock-based compensation.

Interest income was $11.2$10.2 million for the three months ended MarchJune 31,30, 2026, compared to $9.1$7.6 million for the three months ended MarchJune 31,30, 2025, an increase of $2.0$2.6 million, or 22%.35%. This increase was primarily due to increased average investment balances, partially offset by lower available market rates of return on our investment portfolio.

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 MarchJune 31,30, 2026, and 2025. See Note 7, Debt to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on our convertible senior notes.

Provision forOther income taxes(expense), net was immaterial for the three months ended MarchJune 31,30, 2026,2026 and 2025.

We have incurred losses and negative cash flows from operations since our inception, and as of MarchJune 31,30, 2026, we had an accumulated deficit of $3.1$3.2 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 MarchJune 31,30, 2026, we had cash, cash equivalents, and restricted cash and marketable securities of $1.2 billion. 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. Additionally, we have investments held in marketable securities consisting primarily ofin commercial paper and U.S. treasury securities that can be immediately liquid.

Based on our current business plan, we believe our current cash, cash equivalents, restricted cash and marketable securitiesinvestments, 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, restricted cash and marketable securitiesinvestments, 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, 2025, 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. See Note 7, Debt, and Note 10, Common Stock, to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on our convertible senior notes and common stock.

Cash used in operating activities during the threesix months ended MarchJune 31,30, 2025,2026, was $62.7$123.4 million, which resulted from a net loss of $95.2$232.2 million, and changes in our operating assets and liabilities of $23.3$37.5 million, partially offset by reconciliation adjustments of $55.8$146.3 million. Reconciliation adjustments primarily consisted of $37.8$105.3 million of stock-based compensation, $10.2$19.0 million of depreciation and amortization, $7.9$17.1 million of operating lease costs, $7.7and $13.1 million of interest income received on marketable securities, and $5.0 million of impairment on non-marketable equity security investments, partially offset by $13.7$8.0 million of gainamortization of discount on extinguishmentmarketable of convertible notes.securities. The changes in our operating assets and liabilities were primarily the result of a $9.6$24.2 million increase in prepaid expenses and other current assets, net, a $19.6 million increase in inventory, net, a $17.9 million payment of operating lease liabilities net of receipt of tenant improvement allowance, a $6.2$8.0 million increasedecrease in inventory,deferred net,revenue, and a $6.1$5.9 million increase in accounts receivable, net, and a $3.1 million increase in prepaid expenses and other current assets, net, partially offset by a $2.4$36.1 million increase in deferredaccounts revenue.payable and accrued liabilities.

Cash provided by investing activities during the threesix months ended MarchJune 31,30, 2026, was $699.4$800.9 million, which resulted primarily from proceeds from marketable securities of $954.9$1.1 million,billion, partially offset by purchases of marketable securities of $249.9 million, and purchases of property and equipment of $5.6$17.3 million.

Cash provided by investing activities during the threesix months ended MarchJune 31,30, 2025, was $302.9$292.2 million, which resulted primarily from proceeds from marketable securities of $307.3 million, partially offset by purchases of property and equipment of $4.5$10.1 million, and purchase of non-marketable equity securities of $5.0 million.

Cash usedprovided inby financing activities during the threesix months ended MarchJune 31,30, 2026, was $21.6$1.4 million, which was primarily attributable to proceeds from exercise of stock options of $21.6 million, and proceeds from issuances of common stock under our employee stock purchase plan of $10.4 million, partially offset by employee taxes paid related to net share settlement of restricted stock units of $20.7 million, partially offset by proceeds from exercise of stock options of $3.7$29.0 million.

Cash used in financing activities during the threesix months ended MarchJune 31,30, 2025, was $66.9$65.2 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 $15.5$22.9 million, and payment of debt issuance costs of $12.1$12.3 million, partially offset by proceeds from issuances of common stock under our employee stock purchase plan of $7.7 million, proceeds from unwinding of convertible note hedges of $5.0 million, and proceeds from exercise of stock options of $2.3 million.

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, 2025. During the three and six months ended MarchJune 31,30, 2026, there were no material changes to our critical accounting policies from those discussed previously.