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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): November 14, 2023
GUARDANT HEALTH, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-38683 | 45-4139254 | ||
| (State or other jurisdiction of incorporation or organization) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
3100 Hanover Street
Palo Alto, California 94304
(Address of principal executive offices) (Zip Code)
855-698-8887
(Registrant’s telephone number, include area code)
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:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading |
Name of each exchange |
||
| Common Stock, $0.00001 par value per share | GH | The Nasdaq Global Select Market |
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. ☐
| Item 8.01 | Other Events. |
On November 14, 2023, after a trial in the U.S. District Court for the District of Delaware in the matter of TwinStrand Biosciences, Inc. v. Guardant Health, Inc., C.A. No. 21-1126-GBW-SRF, a jury verdict was entered in favor of plaintiffs, TwinStrand Biosciences, Inc. and the University of Washington (the “Plaintiffs”), and against Guardant Health, Inc. (the “Company”). The jury found that the Company willfully infringed U.S. Patent Nos. 10,287,631 and 10,760,127, and awarded Plaintiffs $83.4 million in damages, representing a 6% royalty on past sales. The Company expects that the district court will enter judgment on the jury’s verdict in the coming weeks, after which the Company will file post-trial motions to overturn the jury’s verdict, seek a new trial, and/or amend the judgment. The Plaintiffs may seek to enhance the damages award up to three times based on the jury’s finding of willful infringement. The Company disagrees strongly with the jury’s findings and plans to vigorously contest the verdict and judgment through post-trial motions in the district court, and through appeal to the U.S. Court of Appeals for the Federal Circuit. The Company does not expect the verdict to materially impact its business, but it may have an impact on future expenses if the verdict is upheld on appeal, as the court may require royalty payments on the Company’s future sales.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit No. |
Description |
|
| 99.1 | Press release of Guardant Health, Inc., dated November 15, 2023. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
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.
| GUARDANT HEALTH, INC. | ||||||
| Date: November 15, 2023 | By: | /s/ John G. Saia |
||||
| John G. Saia | ||||||
| Chief Legal Officer and Corporate Secretary | ||||||
Exhibit 99.1
PRESS RELEASE
Guardant Health to Appeal Federal District Court Verdict
PALO ALTO, Calif. - (BUSINESS WIRE) - (November 15, 2023) – Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced it intends to appeal yesterday’s verdict in the U.S. District Court for the District of Delaware related to intellectual property claims brought against Guardant by TwinStrand Biosciences, Inc. and University of Washington.
“We strongly disagree with this decision and will vigorously appeal for its overturn,” said Helmy Eltoukhy, Guardant Health co-founder and co-CEO. “We believe the ruling ignores the strengths and merits of our R&D and intellectual property, which we painstakingly developed for over a decade.”
Guardant remains confident that it did not infringe the asserted patents, and the company expects to file additional motions with the U.S. District Court for the District of Delaware and appeal to the U.S. Court of Appeals for the Federal Circuit.
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 GuardantINFINITY™ tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening. For more information, visit guardanthealth.com and follow the company on LinkedIn and Twitter (X).
Forward-Looking Statements
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, 2022, and any current and periodic reports filed with or furnished to the Securities and Exchange Commission thereafter.
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:
investors@guardanthealth.com
Media Contact:
Matt Burns
press@guardanthealth.com
+1 518 423 5907