Guardant Health, Inc.

Guardant Health, Inc. is a precision oncology company focused on improving cancer care through advanced blood and tissue tests, real-world data, and AI analytics. The company's products span the full continuum of patient care, including screening for early cancer detection, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. Guardant Health's strategy emphasizes increasing product awareness, expanding clinical utility and reimbursement, strengthening customer relationships, and broadening its product portfolio. The company operates in a heavily regulated industry, subject to federal and state laboratory licensing requirements, FDA regulations for medical devices and companion diagnostics, and various healthcare fraud and abuse laws.

Guardant Health generates revenue from four primary sources: oncology, biopharma and data, screening, and licensing and other. Oncology revenue is derived from the delivery of oncology tests to clinical customers, including hospitals, cancer centers, research institutions, and patients, as well as tests delivered by strategic partners' labs. Biopharma and data revenue comes from tests provided to biopharmaceutical customers and services such as companion diagnostic development, regulatory approval, monitoring and maintenance, GuardantINFORM data services, and GuardantConnect referral services. Screening revenue is generated from the Shield blood test for colorectal cancer screening. Licensing and other revenue is derived from technology licensing arrangements.

For the fiscal year ended December 31, 2025, Guardant Health reported total revenue of $982.0 million ¹. This represents a 33% increase from the $739.0 million ² reported in 2024. The company incurred a net loss of $416.3 million ³ in 2025, compared to a net loss of $436.4 million ⁴ in 2024 and $479.4 million ⁵ in 2023. As of December 31, 2025, the accumulated deficit stood at $3.0 billion ⁶. Cash, cash equivalents, restricted cash, and marketable debt securities totaled approximately $1.3 billion ⁷ at year-end 2025.

Oncology revenue increased by $140.8 million ⁸, or 26%, to $683.6 million ⁹ in 2025 from $542.8 million ¹⁰ in 2024. This growth was primarily driven by an increase in oncology test volume to approximately 276,000 ¹¹ in 2025, up from approximately 206,700 ¹² in 2024. Biopharma and data revenue rose by $32.6 million ¹³, or 18%, to $210.1 million ¹⁴ in 2025 from $177.6 million ¹⁵ in 2024, mainly due to increased volume of the GuardantINFINITY test and revenue from companion diagnostic development and data services. Screening revenue, which was $5.1 million ¹⁶ in 2024, significantly increased to $79.7 million ¹⁷ in 2025, generated from approximately 87,000 ¹⁸ Shield screening tests. Licensing and other revenue decreased by $4.9 million ¹⁹, or 37%, to $8.6 million ²⁰ in 2025 from $13.5 million ²¹ in 2024, primarily due to nonrecurring milestone revenue in 2024.

Cost of revenue increased by $59.2 million ²², or 20%, to $349.0 million ²³ in 2025 from $289.8 million ²⁴ in 2024, driven by higher sample volume across oncology, biopharma, and screening tests, partially offset by reduced cost per sample for Guardant Reveal, Guardant360 Liquid, and Shield screening tests. Research and development expenses increased by $16.4 million ²⁵, or 5%, to $364.2 million ²⁶ in 2025 from $347.8 million ²⁷ in 2024, reflecting continued investment in technology and product development, including a $9.6 million ²⁸ increase in personnel costs, a $6.7 million ²⁹ increase in material costs, and a $3.8 million ³⁰ increase in information technology infrastructure costs, partially offset by a $6.5 million ³¹ decrease in outside services for clinical studies.

Sales and marketing expenses increased by $129.7 million ³², or 36%, to $494.7 million ³³ in 2025 from $364.9 million ³⁴ in 2024, primarily due to commercial team expansion and marketing activities for the Shield product launch and existing products. This included a $77.0 million ³⁵ increase in personnel costs, a $35.1 million ³⁶ increase in marketing activity-related costs, an $8.2 million ³⁷ increase in stock-based compensation, a $4.8 million ³⁸ increase in office and administrative costs, and a $4.7 million ³⁹ increase in information technology infrastructure costs. General and administrative expenses increased by $31.3 million ⁴⁰, or 17%, to $211.4 million ⁴¹ in 2025 from $180.1 million ⁴² in 2024, mainly due to a $15.9 million ⁴³ increase in stock-based compensation and a $13.9 million ⁴⁴ increase in information technology infrastructure costs, partially offset by a $5.6 million ⁴⁵ decrease in legal expenses.

Interest income decreased by $19.6 million ⁴⁶, or 36%, to $34.1 million ⁴⁷ in 2025 from $53.7 million ⁴⁸ in 2024, primarily due to reduced average investment balances and lower market rates of return. Interest expense increased by $1.3 million ⁴⁹, or 51%, to $3.9 million ⁵⁰ in 2025 from $2.6 million ⁵¹ in 2024, related to convertible senior notes. Other income (expense), net, was a $10.5 million ⁵² expense in 2025, primarily from an $18.6 million ⁵³ impairment on non-marketable equity security investments, partially offset by a $13.7 million ⁵⁴ gain on extinguishment of convertible notes. In 2024, other income (expense), net, was a $42.6 million ⁵⁵ expense, mainly due to $44.4 million ⁵⁶ in net unrealized and realized losses on marketable equity security investment in Lunit, Inc.

Significant operational developments in 2025 include the vesting of performance-based restricted stock units after fulfilling additional six-month service requirements in the first quarter. In January 2025, Palmetto GBA granted expanded Medicare coverage for the Guardant Reveal test to monitor disease recurrence in colorectal cancer patients in the surveillance setting. In May 2025, Medicare coverage for the upgraded Guardant360 Tissue test was expanded to include both DNA and RNA testing. In March 2025, CMS approved ADLT status for the Shield blood test for colorectal cancer screening, initiating a market-based pricing approach for Medicare patients. Also in March 2025, the Shield blood test received coverage for patients receiving community care authorized by the U.S. Department of Veterans Affairs, and in January 2026, it received coverage for active-duty service members and their families through TRICARE. In July 2025, patient enrollment began for the required Shield post-FDA approval SOLAR study, aiming for conclusion by 2031. In June 2025, the FDA granted Breakthrough Device designation to the Shield MCD test. In December 2025, the liquid biopsy testing service based on Guardant360® CDx technology became available at the Policlinico Gemelli facility in Italy, following a partnership agreement signed in September 2024.

Guardant Health expects to incur additional operating losses in the near future as operating expenses are projected to increase due to continued investment in clinical studies and the development of new products, expansion of the sales organization, and increased marketing efforts to drive market adoption of its tests. The company anticipates that capital expenditure requirements could also increase if additional laboratory capacity is needed to meet the expected growing demand for its tests from physicians and biopharmaceutical companies.

A significant growth area for Guardant Health is the expansion of its product portfolio, particularly in early cancer detection and minimal residual disease (MRD) monitoring. The company initiated patient enrollment for the required Shield post-FDA approval SOLAR study in July 2025, with the goal of assessing the Shield blood test's performance, and aims to conclude this study by 2031. Additionally, in January 2022, Guardant Health initiated the SHIELD LUNG study, a nearly 10,000-patient ⁵⁷ prospective, registrational study, to clinically validate the performance of its next-generation Shield blood test in lung cancer screening for high-risk individuals aged 50-80. The FDA granted Breakthrough Device designation to the Shield MCD test in June 2025, which is expected to provide patients and healthcare providers with timely access to medical devices by expediting their development, assessment, and review. In January 2025, the Shield MCD test was selected for the Vanguard study, funded by the National Cancer Institute, which initiated patient enrollment in June 2025 and will enroll up to 24,000 ⁵⁸ people to inform the design of a randomized controlled trial evaluating the use of MCD tests for cancer screening.

Another key growth area is the continued expansion of payer coverage and reimbursement for its tests. In January 2025, Palmetto GBA granted coverage for the Guardant Reveal test to monitor disease recurrence in patients with colorectal cancer in the surveillance setting following curative intent therapy, expanding from prior Medicare coverage in the early post-surgical setting. In May 2025, Medicare coverage for the upgraded Guardant360 Tissue test was expanded to include both DNA and RNA testing. Following FDA approval in August 2024, the Shield blood test met Medicare coverage requirements for primary colorectal cancer screening, covering the test once every three years ⁵⁹ for eligible beneficiaries. In March 2025, CMS approved ADLT status for the Shield blood test, initiating a specific, market-based approach to pricing for Medicare patients. Furthermore, in March 2025, the Shield blood test received coverage for patients receiving community care authorized by the U.S. Department of Veterans Affairs, and in January 2026, it received coverage for active-duty service members and their families through TRICARE.

Operationally, Guardant Health expects its cost of revenue to generally increase in line with the increase in the number of tests performed, but anticipates the cost per test to decrease modestly over time due to efficiencies gained from increased test volume, automation, and other cost reductions. Research and development expenses are expected to continue to increase in absolute dollars as the company continues to innovate and develop additional products, expand genomic and medical data management resources, and conduct ongoing and new clinical studies. Sales and marketing expenses are also expected to increase in absolute dollars as the company expands its sales force, increases its presence within and outside the United States, and intensifies marketing activities to drive further awareness and adoption of its tests. General and administrative expenses are projected to increase in absolute dollars to support business growth, but are expected to decrease modestly as a percentage of revenue in the long term, although they may fluctuate from period to period.

Guardant Health's capital allocation plans include continued investment in research and development programs, particularly in clinical studies, which are considered critical for physician adoption and favorable payer coverage decisions. The company also plans to increase sales and marketing expenses to execute its international expansion strategy. As of December 31, 2025, Guardant Health had cash, cash equivalents, restricted cash, and marketable debt securities of approximately $1.3 billion ⁶⁰, which is believed to be sufficient to meet anticipated cash requirements for more than 12 months ⁶¹. The company may consider raising additional capital in the future through equity or convertible securities, credit facilities, or other debt financing to fund business expansion, strategic investments, or other needs.

The company has identified several structural headwinds and execution risks. The variability and unpredictability of the reimbursement landscape, including the amount payers reimburse for tests, could lead to significant fluctuations in revenue adjustments and potentially cause the company to fail to meet publicly stated guidance. Changes in coding, such as CPT or Z-Code Identifiers, could reduce, put on hold, or eliminate payments for certain test uses. The success of international expansion depends on factors including internal and external constraints on international laboratory partners and biopharmaceutical companies, and broader global, regional, and U.S. economic and geopolitical conditions. Deterioration in bilateral relationships, such as between the United States and China, may impact international trade, government spending, regional stability, and macroeconomic conditions, potentially disrupting international partnerships and weakening financial results.

Guardant Health faces material risks including significant losses since inception, with net losses of $416.3 million ⁶², $436.4 million ⁶³, and $479.4 million ⁶⁴ for the years ended December 31, 2025, 2024, and 2023, respectively, and an accumulated deficit of $3.0 billion ⁶⁵ as of December 31, 2025. The company's ability to achieve and maintain profitability is uncertain, as commercial market acceptance of its products is not assured. Operating results may fluctuate significantly due to factors such as demand, R&D investment, product mix, and payer coverage, making future results difficult to predict. New product development is lengthy and complex, with no assurance of timely commercialization or market acceptance, particularly for early cancer detection products. The company is highly dependent on sales of its existing tests, which accounted for 94% ⁶⁶, 94% ⁶⁷, and 91% ⁶⁸ of revenue in 2025, 2024, and 2023, respectively, and failure to maintain or increase market acceptance would materially harm the business. Customer dissatisfaction due to product defects or errors could impair operating results and reputation. Inability to support increased demand or manage growth, including attracting and retaining qualified personnel in competitive labor markets, could lead to delays, higher costs, and declining quality. Reliance on a limited number of sole suppliers for laboratory instruments and materials, such as Illumina, Inc., poses supply chain risks. International expansion exposes the company to business, regulatory, political, operational, financial, and economic risks, including conflicting laws, difficulties in obtaining regulatory approvals, and foreign currency fluctuations. The company is subject to extensive federal and state healthcare regulations, including CLIA, FDA medical device regulations, and fraud and abuse laws like the AKS, EKRA, Stark Law, and FCA. Changes in FDA enforcement discretion for LDTs could subject products to more significant regulatory requirements. Failure to obtain or maintain adequate third-party payer coverage and reimbursement, including from commercial and government programs like Medicare, could negatively affect revenue, especially given that Medicare accounted for more than 10% ⁶⁹ of total revenue in each of the years ended December 31, 2025, 2024, and 2023. Billing and claim processing complexities, including potential retrospective adjustments and clawbacks, can hinder collections. Intellectual property protection is critical, but patents may be challenged, found invalid or unenforceable, or insufficient to prevent competition. The price of common stock has fluctuated substantially, and sales of large blocks of shares could depress prices. The company's indebtedness, including convertible senior notes, could increase vulnerability to adverse conditions and dilute existing stockholders. Cybersecurity incidents, including security breaches and data loss, could compromise sensitive information and expose the company to substantial liability. Increasing reliance on artificial intelligence technologies may expose the company to operational, regulatory, legal, and reputational risks, including inaccurate outputs, integration challenges, and evolving legal landscapes.

Management's message to shareholders emphasizes Guardant Health's commitment to transforming patient care by providing critical insights through advanced blood and tissue tests, real-world data, and AI analytics, with the overarching objective of guarding wellness and giving every person more time free from cancer. The company's strategic priorities for the period ahead include increasing awareness of its product portfolio across all stages of care, expanding clinical utility and increasing reimbursement for its products by working with payers and investing in clinical and real-world evidence, strengthening relationships with customers by demonstrating product utility and expanding lab capabilities, and expanding its product portfolio through disciplined research and development, leveraging its Smart Platform and data insights. Management highlighted the FDA approval of the Shield blood test for colorectal cancer screening in adults age 45 and older who are at average risk for the disease in July 2024, and its subsequent commercial availability in August 2024, as a significant milestone. Furthermore, the Shield blood test was included in the National Comprehensive Cancer Network colorectal cancer screening guidelines in June 2025, and CMS approved ADLT status for the Shield blood test in March 2025, initiating a specific, market-based approach to pricing for Medicare patients.