8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): December 31, 2021

GUARDANT HEALTH, INC.

(Exact name of registrant as specified in its charter)

505 Penobscot Dr.

Redwood City, California 94063

(Address of principal executive offices) (Zip Code)

855-698-8887

(Registrant’s telephone number, include area code)

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

On December 31, 2021, Guardant Health, Inc. (the “Company”) entered into a Settlement and License Agreement (the “Settlement Agreement”) with Foundation Medicine, Inc. (“FMI,” now a subsidiary of Roche Holdings, Inc.), consistent with the binding term sheet entered into by the parties on May 13, 2021 and announced in a Form 8-K filed by the Company with the Securities and Exchange Commission (the “SEC”) on May 17, 2021. Under the terms of the Settlement Agreement, FMI will pay the Company $25 million as well as future royalties for the remaining term of the licensed patents, while the Company will grant FMI a non-exclusive license to a defined subset of the Company’s patents. As a result of the Settlement Agreement, all pending patent litigation between the parties will be dismissed.

On January 7, 2022, the Company issued a press release announcing the Settlement Agreement. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of federal securities laws, such as statements about final court approval of the settlement and entry into a definitive settlement agreement. These statements are based on current expectations and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. Additional risks and uncertainties that could cause actual results to differ materially from those indicated by the forward-looking statements made in this Current Report on Form 8-K include those discussed under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 and in its other reports filed with the SEC. The forward-looking statements in this Current Report on Form 8-K are based on information available to the Company as of the date hereof, and the Company disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this Current Report on Form 8-K.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

EX-99.1

Exhibit 99.1

Guardant Health and Foundation Medicine Reach Settlement in Digital Sequencing Technology Litigation

REDWOOD CITY, Calif. January 7, 2022 – Guardant Health, Inc. (Nasdaq: GH) today announced that it has reached an agreement to settle all pending litigation concerning the company’s digital sequencing technology patents with Foundation Medicine, Inc. Pursuant to the settlement agreement, Foundation Medicine will pay Guardant Health $25 million as well as future royalties for the remaining term of the licensed digital sequencing technology patents. In turn, Guardant Health will grant Foundation Medicine a non-exclusive license to a defined subset of its digital sequencing technology patents. As a result of this settlement, all pending patent litigation between Foundation Medicine and Guardant Health will be dismissed.

“We are pleased with the Foundation Medicine settlement agreement as it recognizes the importance of our scientific discoveries and validates the strong intellectual property rights we have built as a company,” said Helmy Eltoukhy, Guardant Health Co-CEO.

About Guardant Health

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360^®^, Guardant360 CDx, Guardant360 TissueNext^™^, Guardant360 Response^™^, and GuardantOMNI^®^ tests for advanced stage cancer patients, and Guardant Reveal^™^ for early-stage cancer patients. These tests fuel development of its LUNAR screening program, which aims to address the needs of asymptomatic individuals eligible for cancer screening.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press

release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2020 and in its other reports filed with the Securities and Exchange Commission. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

Investor Contact:

Carrie Mendivil

investors@guardanthealth.com

Media Contact:

Michele Rest

press@guardanthealth.com