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GH · Guardant Health, Inc.

8 filings

10-K

GH 10-K Annual Reports

Guardant Health, Inc. - 8 annual reports

Filing record · 2018–202610-K810-Q248-K99

2025
Guardant Health, Inc. Annual Report, Year Ended Dec 31, 2025
Guardant Health, Inc. (GH) has filed its 10-K for the fiscal year ending December 31, 2025. The company reported total revenue of $982.0 million, a significant increase of 33% from the prior year, driven by strong growth in both its Oncology and Biopharma & Data segments. Despite this revenue growth, Guardant Health continued to incur substantial net losses, reporting a net loss of $416.3 million for the year, which is an improvement from the $436.4 million net loss in 2024. The company's expansion of its sales and marketing efforts, particularly for its Shield blood test for colorectal cancer screening, contributed to increased operating expenses, with sales and marketing expenses rising 36% year-over-year. Guardant Health remains focused on its strategic objectives of expanding clinical utility, increasing reimbursement, and strengthening customer relationships across its product portfolio, which spans therapy selection, minimal residual disease detection, and early cancer screening. Financially, the company ended the year with a strong cash position of approximately $1.3 billion in cash, cash equivalents, and marketable debt securities, providing ample runway. Key developments include the FDA approval and commercial availability of the Shield blood test for colorectal cancer screening, and continued investment in R&D to expand its technology platform. However, the company continues to face significant risks related to its profitability, ongoing losses, reimbursement uncertainties from payers, competitive pressures, and potential regulatory changes.
Feb 19, 2026
2024
Guardant Health, Inc. Annual Report, Year Ended Dec 31, 2024
Guardant Health, Inc. (GH) presented its 2024 Annual Report on Form 10-K, highlighting significant revenue growth driven by its precision oncology testing business, which increased by 34% year-over-year to $687.9 million. This growth was fueled by a 34% rise in clinical testing revenue, attributed to increased sample volumes and improved reimbursement rates, particularly from Medicare for its Guardant360 LDT test. Biopharmaceutical revenue also saw a 31% increase. Despite top-line growth, the company continues to incur substantial net losses, with the 2024 net loss at $436.4 million, a slight improvement from $479.4 million in 2023. The company ended the year with a strong liquidity position, holding $944.2 million in cash, cash equivalents, restricted cash, and marketable debt securities, providing ample runway for continued investment in research and development, clinical studies, and commercial expansion. The company achieved a major milestone with the FDA approval and subsequent commercial launch of its Shield blood test for colorectal cancer screening in August 2024, making it the first FDA-approved blood test for primary colorectal cancer screening that also meets Medicare coverage requirements. This positions Guardant Health to address the critical early cancer detection market. Looking ahead, Guardant Health remains focused on expanding clinical utility, securing broader payer coverage and reimbursement, and growing its global commercial footprint. However, investors should remain aware of the significant risks outlined, including the ongoing unprofitability, dependence on reimbursement decisions, competitive pressures, and potential regulatory changes, particularly concerning Laboratory Developed Tests (LDTs).
Feb 20, 2025
2023
Guardant Health, Inc. Annual Report, Year Ended Dec 31, 2023
Guardant Health, Inc. reported a total revenue of $563.9 million for the year ended December 31, 2023, a 25% increase year-over-year, driven primarily by a 31% rise in precision oncology testing revenue. Despite this top-line growth, the company continued to incur significant net losses, amounting to $479.4 million for the year. The company has a substantial cash and cash equivalents balance of $1.1 billion as of December 31, 2023, which it believes is sufficient to fund its operations for more than 12 months. The company is focused on expanding its product portfolio and market adoption, particularly with its Shield test for early cancer detection, for which a PMA was submitted to the FDA. However, significant risks remain, including the company's ongoing unprofitability, dependence on third-party payer coverage and reimbursement, and intense competition in the precision oncology market. A recent jury verdict in a patent infringement case resulted in an $83.4 million liability accrual, which is a significant concern for investors.
Feb 22, 2024
2022
Guardant Health, Inc. Annual Report, Year Ended Dec 31, 2022
Guardant Health, Inc. (GH) presented its 2022 Form 10-K filing, highlighting significant revenue growth driven by its precision oncology testing services, which increased by 29% year-over-year to $392 million. Despite this growth, the company continues to incur substantial net losses, with a reported net loss of $654.6 million for the year, indicating ongoing investments in research and development and commercial expansion. The company's core strategy revolves around expanding the clinical utility and reimbursement of its liquid biopsy tests across all cancer stages, from early detection to recurrence monitoring. Key product launches and study results, such as the positive efficacy data from the ECLIPSE study for its Shield blood test for colorectal cancer screening, underscore the company's commitment to innovation. However, significant risks remain, including continued operational losses, intense competition, and ongoing regulatory scrutiny, particularly concerning laboratory-developed tests (LDTs) and reimbursement policies from third-party payers.
Feb 23, 2023
2021
Guardant Health, Inc. Annual Report, Year Ended Dec 31, 2021
Guardant Health, Inc. (GH) reported a strong increase in total revenue for the year ended December 31, 2021, reaching $373.7 million, a 30% increase from the prior year. This growth was driven primarily by a 29% increase in precision oncology testing revenue, which reached $304.3 million, fueled by higher sample volumes and an improved average selling price for certain tests. The company also saw a significant 38% increase in development services and other revenue, primarily from companion diagnostic development services and milestone payments. Despite revenue growth, Guardant Health continued to incur substantial net losses, with a loss of $384.8 million for 2021, compared to $246.3 million in 2020. This widening loss reflects significant investments in research and development (up 76% to $263.2 million) and sales and marketing (up 80% to $191.9 million) to support product development, clinical studies, and commercial expansion. The company ended the year with a substantial cash and cash equivalents and marketable securities balance of approximately $1.6 billion, providing ample runway for ongoing operations and strategic investments.
Feb 24, 2022
2020
Guardant Health, Inc. Annual Report, Year Ended Dec 31, 2020
Guardant Health's FY2020 10-K shows a company still in hyper-growth and deep investment mode. Total revenue rose 34% to $286.7 million in 2020 (from $214.4 million), driven by precision oncology testing (up 31% to $236.3 million) and development services (up 49% to $50.4 million). Clinical test volume grew to 63,254 from 49,926, while biopharma test volume fell to 15,983 from 20,643 due to clinical trial timing and COVID-19 disruption. Gross margin improved modestly to 68%. Profitability worsened sharply. The net loss attributable to common stockholders widened to $253.8 million from $75.7 million, and Adjusted EBITDA was negative $85.2 million. Much of the increase came from $144.1 million of stock-based compensation, including $111.9 million tied to market-based restricted stock units granted to the CEO and President/COO. R&D rose 74% to $149.9 million and G&A rose 214% to $192.8 million. The accumulated deficit reached $606.6 million. The balance sheet was strengthened substantially. Cash, cash equivalents and marketable securities reached about $2.0 billion after a $1.15 billion 0% convertible senior notes offering due 2027 and a $354.6 million follow-on equity raise. Management states that existing resources fund operations for at least 12 months. Key risks include heavy reliance on Guardant360 volumes, payer reimbursement and Medicare billing transitions (including the pending CDx pricing change), LDT regulatory exposure, IP litigation against Foundation Medicine, and the SoftBank joint venture put/call arrangement, which could require significant cash outflows.
Feb 25, 2021
2019
Guardant Health, Inc. Annual Report, Year Ended Dec 31, 2019
Guardant Health's FY2019 10-K (filed March 2, 2020) shows a company scaling rapidly as it pursues a precision oncology strategy built on blood-based liquid biopsy. Total revenue rose 137% to $214.4 million in 2019 from $90.6 million in 2018, driven by precision oncology testing (up 130% to $180.5 million) and development services (up 177% to $33.9 million). Clinical test volume grew to 49,926 from 29,238, and biopharmaceutical test volume to 20,643 from 10,370. Net loss narrowed to $67.9 million from $84.3 million, though the company is still unprofitable with an accumulated deficit of $352.8 million. Operating cash burn was modest at $47.1 million, supported by $791.6 million in cash and marketable securities after a $350.4 million follow-on offering in May 2019. The key investor debates center on reimbursement and the LUNAR early-detection pipeline. Medicare coverage for Guardant360 expanded through a December 2019 Palmetto GBA LCD, with a Noridian LCD expected but with uncertain timing. Several large commercial payers, including Anthem, Aetna and Humana, maintain non-coverage policies, and about 44% of U.S. clinical tests were for NSCLC. Revenue concentration is significant, with the top five biopharma customers at 38% of revenue and AstraZeneca alone at 26%. The Guardant360 PMA submission to the FDA in Q4 2019 and February 2020 is a potential catalyst for companion diagnostic status and coverage. Risks also include the SoftBank joint venture's put-call structure, pending patent litigation against Foundation Medicine and Personal Genome Diagnostics, and the LDT regulatory environment. For investors, the thesis is a high-growth diagnostics platform with strong revenue momentum and a substantial cash cushion, against which must be weighed reimbursement uncertainty, customer concentration, continuing losses, and the long development horizon for early-cancer-detection products.
Mar 2, 2020
2018
Guardant Health, Inc. Annual Report, Year Ended Dec 31, 2018
Guardant Health's first 10-K as a newly public company (IPO October 2018) shows rapid top-line growth alongside continued heavy losses. Total revenue rose 82% to $90.6 million in 2018 from $49.8 million, driven by a 86% increase in precision oncology testing revenue ($78.4 million) and 58% growth in development services ($12.2 million). Clinical test volume reached 29,238 and biopharmaceutical test volume 10,370. Gross economics on testing improved as revenue scaled, but the company still posted a net loss of $84.3 million (EPS of -$2.80), with an accumulated deficit of $280.8 million. Operating expense growth outpaced revenue. R&D rose 98% to $50.7 million, sales and marketing rose 65% to $53.5 million, and G&A was roughly flat at $36.2 million after a large 2017 stock-repurchase compensation charge. Medicare coverage became a meaningful catalyst: a July 2018 MolDx LCD for Guardant360 in NSCLC led to first Medicare payments in October 2018 at $3,500 per test. Medicare represented about 38% of U.S. clinical test volume, and the company's largest commercial payer and largest biopharma customer concentration remain material risks. Balance sheet strength is a key positive. Cash, cash equivalents and marketable securities totaled $496.5 million at year-end, following net IPO proceeds of about $249.5 million and a $41 million SoftBank contribution to the Japan-focused joint venture. Management states current resources fund operations for at least 12 months. Risks investors should weigh include revenue recognized largely on a cash basis for clinical customers, a single laboratory in Redwood City, dependence on Illumina as sole sequencer supplier, a July 2018 phishing-related security incident affecting about 1,700 individuals with an open HHS OCR inquiry, and pending patent litigation against Foundation Medicine and Personal Genome Diagnostics.
Mar 19, 2019