Guardant Health, Inc.

The following tables set forth the significant components of our results of operations for the periods presented.

(1)Amounts include stock-based compensation expense as follows:

In November 2020 and May 2021, we granted restricted stock units with certain performance metrics, or PSUs, consisting of a performance period of 4 years combined with an additional service period requirement of six months should the vesting criteria be met, with a grant date fair value of $113.40 per share and $148.19 per share, respectively. In the third quarter of 2024, the performance metrics of these PSUs were considered to be achieved; as such we recorded $24.8 million in stock-based compensation expense related to these PSUs, based on 219,161 shares granted with fair values of $113.40 per share and $148.19 per share, of which $2.4 million was recorded to cost of revenue, and $11.8 million, $6.5 million and $4.1 million was recorded as components of research and development expense, sales and marketing expense, and general and administrative expense, respectively.

Comparison of the Three Months Ended September 30, 2025 and 2024

Revenue

*Not meaningful

Total revenue was $265.2 million for the three months ended September 30, 2025, compared to $191.5 million for the three months ended September 30, 2024, an increase of $73.7 million, or 39%.

Oncology revenue was $184.4 million for the three months ended September 30, 2025, compared to $141.2 million for the three months ended September 30, 2024, an increase of $43.2 million, or 31%. This increase was driven primarily by an increase in oncology test volume to approximately 74,000 for the three months ended September 30, 2025 from approximately 53,100 for the three months ended September 30, 2024. This increase was also attributable to an increase in reimbursement for our oncology tests, partially offset by a reduction in revenue related to performance obligations satisfied in prior periods.

Biopharma and data revenue was $54.7 million for the three months ended September 30, 2025, compared to $46.5 million for the three months ended September 30, 2024, an increase of $8.2 million, or 18%. This increase was driven primarily by the achievement of certain milestones of our companion diagnostic development and regulatory approval service agreements.

Screening revenue was $24.1 million for the three months ended September 30, 2025, generated from the delivery of approximately 24,000 of our Shield screening tests.

Cost of revenue was $93.6 million for the three months ended September 30, 2025, compared to $74.5 million for the three months ended September 30, 2024, an increase of $19.1 million, or 26%. This increase in cost of revenue was driven primarily by an increase in costs associated with performing our oncology, biopharma and screening tests, which was attributable to an increase in sample volume, partially offset by reduced cost per sample of our oncology tests, including Guardant Reveal and Guardant360 Liquid; and reduced cost per sample of our Shield screening test.

Operating Expenses

Research and development expense

Research and development expenses were $90.0 million for the three months ended September 30, 2025, compared to $87.3 million for the three months ended September 30, 2024, an increase of $2.7 million, or 3%. This increase was related to continued investment in the development of our technologies and products, primarily including an increase of $3.9 million in outside services costs related to clinical studies, and an increase of $3.1 million in personnel costs; partially offset by a decrease of $5.2 million in stock-based compensation.

Sales and marketing expense

Sales and marketing expenses were $127.4 million for the three months ended September 30, 2025, compared to $97.9 million for the three months ended September 30, 2024, an increase of $29.5 million, or 30%. This increase was related to commercial team expansion and marketing activities to support the Shield product launch and existing product growth, primarily resulting in an increase of $22.0 million in personnel costs, and an increase of $7.9 million in marketing related costs; partially offset by a decrease of $2.0 million in stock-based compensation.

General and administrative expense

General and administrative expenses were $53.3 million for the three months ended September 30, 2025, compared to $49.1 million for the three months ended September 30, 2024, an increase of $4.1 million, or 8%, primarily driven by an increase of $2.7 million in information technology infrastructure costs.

Interest income was $7.4 million for the three months ended September 30, 2025, compared to $13.3 million for the three months ended September 30, 2024, a decrease of $5.9 million, or 44%. This decrease was primarily due to reduced investment balances and lower available market rates of return on our investment portfolio.

Interest expense was primarily related to the coupon interest, amortization of debt issuance costs, net of amortization of debt premium of our convertible senior notes for the three months ended September 30, 2025, and 2024. See Note 6, Debt to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on the convertible notes exchange transaction.

Other income (expense), net was immaterial for the three months ended September 30, 2025, and was a $3.0 million expense for the three months ended September 30, 2024, primarily attributable to $1.7 million of net unrealized and realized losses recorded for our marketable equity security investment in Lunit, Inc. during the period.

Provision for income taxes

Provision for income taxes was immaterial for the three months ended September 30, 2025, and 2024.

Comparison of the Nine Months Ended September 30, 2025 and 2024

Revenue

*Not meaningful

Total revenue was $700.8 million for the nine months ended September 30, 2025, compared to $537.2 million for the nine months ended September 30, 2024, an increase of $163.6 million, or 30%.

Oncology revenue was $493.6 million for the nine months ended September 30, 2025, compared to $397.2 million for the nine months ended September 30, 2024, an increase of $96.4 million, or 24%. This increase was driven primarily by an increase in oncology test volume to approximately 197,000 for the nine months ended September 30, 2025 from approximately 149,400 for the nine months ended September 30, 2024. This increase was also attributable to an increase in reimbursement for our oncology tests, partially offset by a reduction in revenue related to performance obligations satisfied in prior periods.

Biopharma and data revenue was $156.1 million for the nine months ended September 30, 2025, compared to $128.1 million for the nine months ended September 30, 2024, an increase of $28.1 million, or 22%. This increase was driven primarily by an increase in volume of our GuardantINFINITY test, as well as an increase in revenue derived from the achievement of certain milestones of our companion diagnostic development and regulatory approval service agreements.

Screening revenue was $44.6 million for the nine months ended September 30, 2025, generated from the delivery of approximately 49,000 of our Shield screening tests.

Licensing and other revenue was $6.4 million for the nine months ended September 30, 2025, compared to $10.9 million for the nine months ended September 30, 2024, a decrease of $4.5 million, primarily due to a one-time revenue recorded related to one of our partnership agreements for the nine months ended September 30, 2024.

Cost of revenue was $249.5 million for the nine months ended September 30, 2025, compared to $212.2 million for the nine months ended September 30, 2024, an increase of $37.3 million, or 18%. This increase in cost of revenue was driven primarily by an increase in costs associated with performing our oncology, biopharma and screening tests, which was attributable to an increase in sample volume, partially offset by reduced cost per sample of our oncology tests, including Guardant Reveal and Guardant360 Liquid; and reduced cost per sample of our Shield screening test.

Operating Expenses

Research and development expense

Research and development expenses were $265.9 million for the nine months ended September 30, 2025, compared to $254.2 million for the nine months ended September 30, 2024, an increase of $11.7 million, or 5%. This increase was related to continued investment in the development of our technologies and products, primarily including an increase of $6.0 million in material costs, an increase of $5.9 million in personnel costs, and an increase of $4.4 million in information technology infrastructure costs; partially offset by a decrease of $6.9 million in outside services costs related to clinical studies.

Sales and marketing expense

Sales and marketing expenses were $351.3 million for the nine months ended September 30, 2025, compared to $260.2 million for the nine months ended September 30, 2024, an increase of $91.1 million, or 35%. This increase was related to commercial team expansion and marketing activities to support the Shield product launch and existing product growth, primarily resulting in an increase of $50.2 million in personnel costs, an increase of $30.1 million in marketing related costs, an increase of $4.8 million in stock-based compensation, an increase of $3.1 million in information technology infrastructure costs, and an increase of $3.0 million in office and administrative costs.

General and administrative expense

General and administrative expenses were $150.5 million for the nine months ended September 30, 2025, compared to $128.2 million for the nine months ended September 30, 2024, an increase of $22.2 million, or 17%. This increase was primarily due to an increase of $12.8 million in stock-based compensation, and an increase of $9.0 million in information technology infrastructure costs.

Interest income was $24.1 million for the nine months ended September 30, 2025, compared to $42.0 million for the nine months ended September 30, 2024, a decrease of $18.0 million, or 43%. This decrease was primarily due to reduced investment balances and lower available market rates of return on our investment portfolio.

Interest expense was primarily related to the coupon interest, amortization of debt issuance costs, net of amortization of debt premium of our convertible senior notes for the nine months ended September 30, 2025, and 2024. See Note 6, Debt to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for additional information on the convertible notes exchange transaction.

Other income (expense), net was a $7.8 million income for the nine months ended September 30, 2025, primarily attributable to a gain on extinguishment of convertible notes of $13.7 million related to the convertible notes exchange transaction completed in February 2025, partially offset by an impairment of $5.0 million recorded for one of our non-marketable equity security investments. Other income (expense), net was a $47.3 million expense for the nine months ended September 30, 2024, primarily attributable to $47.2 million of net unrealized and realized losses recorded for our marketable equity security investment in Lunit, Inc. during the period.

Provision for income taxes

Provision for income taxes was immaterial for the nine months ended September 30, 2025, and 2024.

Liquidity and capital resources

We have incurred losses and negative cash flows from operations since our inception, and as of September 30, 2025, we had an accumulated deficit of $2.9 billion. We expect to incur additional operating losses in the near future and our operating expenses will increase as we continue to invest in clinical studies and develop new products, expand our sales organization, and increase our marketing efforts to drive market adoption of our tests. As demand for our tests are expected to continue to increase from physicians and biopharmaceutical companies, we anticipate that our capital expenditure requirements could also increase if we require additional laboratory capacity.

We have funded our operations to date principally from the sales of our common stock, issuances of convertible notes and generation of our revenue. As of September 30, 2025, we had cash, cash equivalents and restricted cash of $689.5 million. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to provide liquidity while ensuring capital preservation.

Based on our current business plan, we believe our current cash, cash equivalents and restricted cash and anticipated cash flows from operations, will be sufficient to meet our anticipated cash requirements for more than 12 months from the date of this Quarterly Report on Form 10-Q. We may consider raising additional capital to expand our business, to pursue strategic investments, to take advantage of financing opportunities or for other reasons. As our revenue is expected to grow long-term, we expect our accounts receivable and inventory balances to increase. Any increase in accounts receivable and inventory may not be completely offset by increases in accounts payable and accrued liabilities, which could impact our working capital balances.

If our available cash, cash equivalents and restricted cash and anticipated cash flows from operations are insufficient to satisfy our liquidity requirements because of lower demand for our products as a result of lower than currently expected rates of reimbursement from our customers or other risks described in this Quarterly Report on Form 10-Q and in our Form 10-K for the year ended December 31, 2024, we may seek to sell additional common or preferred equity or convertible debt securities, enter into a credit facility or another form of third-party funding or seek other debt financing. The sale of equity and convertible debt securities may result in dilution to our stockholders and, in the case of preferred equity securities or convertible debt, those securities could provide for rights, preferences or privileges senior to those of our common stock. The terms of debt securities issued or borrowings pursuant to a credit agreement could impose significant restrictions on our operations. If we raise funds through collaborations and licensing arrangements, we might be required to relinquish significant rights to our platform technologies or products or grant licenses on terms that are not favorable to us. Additional capital may not be available to us on reasonable terms, or at all.

At-The-Market Offering Program

In August 2024, we entered into an Open Market Sales Agreement, or the Sales Agreement, with Jefferies LLC, or the Agent, with respect to an at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of our common stock, having aggregate gross proceeds of up to $400.0 million through the Agent, subject to the terms and conditions of the Sales Agreement. As of September 30, 2025, no shares of our common stock have been sold under the Sales Agreement.

Cash flows

The following table summarizes our cash flows for the periods presented:

Operating activities

Cash used in operating activities during the nine months ended September 30, 2025, was $158.4 million, which resulted from a net loss of $287.8 million, and changes in our operating assets and liabilities of $46.7 million, partially offset by reconciliation adjustments of $176.1 million. Reconciliation adjustments primarily consisted of $123.0 million of stock-based compensation, $29.7 million of depreciation and amortization, $25.0 million of operating lease costs, $7.7 million of interest income received on marketable debt securities, and $5.0 million of impairment on non-marketable equity security investments, partially offset by $13.7 million of gain on extinguishment of convertible notes. The changes in our operating assets and liabilities were primarily the results of a $28.0 million payment of operating lease liabilities net of receipt of tenant improvement allowance, a $19.4 million increase in inventory, net, a $8.6 million increase in prepaid expenses and other current assets, net, and a $6.0 million increase in accounts receivable, net, partially offset by a $15.5 million increase in deferred revenue.

Cash used in operating activities during the nine months ended September 30, 2024 was $175.3 million, which resulted from a net loss of $325.4 million, and changes in our operating assets and liabilities of $58.0 million, partially offset by reconciliation adjustments of $208.1 million. Reconciliation adjustments primarily consisted of $104.0 million of stock-based compensation, $47.2 million of net unrealized and realized losses on marketable equity security investment in Lunit, Inc., $31.9 million of depreciation and amortization, and $23.4 million of operating lease costs. The changes in our operating assets and liabilities were primarily the result of a $27.0 million payment of operating lease liabilities net of receipt of tenant improvement allowance, a $19.8 million decrease in accounts payable and accrued liabilities, a $10.3 million increase in inventory, net, and a $9.2 million increase in prepaid expenses and other current assets, net, partially offset by a $9.6 million increase in deferred revenue.

Investing activities

Cash provided by investing activities during the nine months ended September 30, 2025, was $277.9 million, which resulted primarily from maturities of marketable debt securities of $307.3 million, partially offset by purchases of property and equipment of $20.5 million, and purchases of non-marketable equity securities of $9.0 million.

Cash used in investing activities during the nine months ended September 30, 2024, was $271.8 million, which resulted primarily from purchases of marketable debt securities of $307.3 million, purchases of property and equipment of $16.2 million, and purchase of non-marketable equity securities of $2.5 million, partially offset by maturities of marketable debt securities of $35.0 million, and sales of marketable equity security investment in Lunit, Inc. of $19.2 million.

Financing activities

Cash used in financing activities during the nine months ended September 30, 2025, was $60.9 million, which was primarily attributable to repurchase of treasury stock of $45.0 million, employee taxes paid related to net share settlement of restricted stock units of $25.2 million, and payment of debt issuance costs of $12.3 million, partially offset by proceeds from issuances of common stock under our employee stock purchase plan of $7.7 million, proceeds from exercise of stock options of $6.0 million, and proceeds from unwinding of convertible note hedges of $5.0 million.

Cash provided by financing activities during the nine months ended September 30, 2024, was $1.9 million, which was primarily attributable to proceeds from issuances of common stock under our employee stock purchase plan of $7.2 million, and proceeds from exercise of stock options of $2.6 million, partially offset by employee taxes paid related to net share settlement of restricted stock units of $7.7 million.

Critical accounting policies and estimates

We have prepared our consolidated financial statements in accordance with accounting principles generally accepted in the United States of America, or GAAP. Our preparation of these consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets, liabilities, expenses and related disclosures at the date of the consolidated financial statements, as well as revenue and expenses recorded during the reporting periods. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results could therefore differ materially from these estimates under different assumptions or conditions.

Our significant accounting policies are described in more detail in Note 2 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q and in Item 7, “Management's Discussion and Analysis of Financial Condition and Results of Operations”, in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024. During the three and nine months ended September 30, 2025, there were no material changes to our critical accounting policies from those discussed previously.

Recent accounting pronouncements

See Note 2, Summary of Significant Accounting Policies, to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q for more information.