0001576280false00015762802024-11-062024-11-06

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 6, 2024
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 Symbol(s)
Name of each exchange on which registered
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 2.02 Results of Operations and Financial Condition.
On November 6, 2024, Guardant Health, Inc. (the “Company”) issued a press release announcing financial results for the fiscal quarter ended September 30, 2024. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information furnished in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No.Description
99.1
104Cover 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 6, 2024By:
/s/ Michael Bell
Michael Bell
Chief Financial Officer
(Principal Accounting Officer and Principal Financial Officer)


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Guardant Health Reports Third Quarter 2024 Financial Results and Increases 2024 Revenue Guidance
Revenue growth of 34% driven by strong clinical and biopharma volume and Guardant360 ASP tailwinds
Shield received favorable Medicare pricing of $920
PALO ALTO, Calif. November 6, 2024 – Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today reported financial results for the quarter ended September 30, 2024.
Third Quarter 2024 Financial Highlights
•Recorded revenue of $191.5 million for the third quarter of 2024, an increase of 34% over the third quarter of 2023
•Reported 53,100 clinical tests (excluding Shield) and 10,500 biopharma tests in the third quarter of 2024, representing increases of 21% and 40%, respectively, over the third quarter of 2023
•Achieved Guardant360 ASP of over $3,000
•Raised 2024 annual guidance for revenue to a new range of $720 to $725 million, representing growth of 28% to 29%
•Improved free cash flow to $(55) million in the third quarter of 2024, compared to $(80) million in the prior year
•Revised annual free cash flow guidance to $(265) to $(275) million, an improvement of $70 to $80 million compared to 2023
Recent Operating Highlights
•Successfully launched Shield IVD with strong reception from physicians and patients
•Received Medicare pricing of $920 for Shield effective August 1, 2024
•CMS finalized its policy to remove cost-sharing for a follow-on colonoscopy after a blood-based screening test for Medicare beneficiaries
•Announced Medicare pricing for TissueNext will increase from $3,100 to $3,500 effective January 1, 2025
•Entered into laboratory partnership with Policlinico Gemelli in Italy, a leading European oncology center, to test advanced cancer patients locally
•Published data from SCRUM-Japan GOZILA study in Nature Medicine showing patients receiving Guardant360 CDx guided treatment survived twice as long
“We had another record quarter of revenue driven by significant Guardant360 reimbursement tailwinds and volume growth,” said Helmy Eltoukhy, co-founder and co-CEO. “With this momentum, we are raising revenue guidance for the third time this year and improving our free cash flow outlook for the full year. The upgrade of Guardant360 LDT to Smart Liquid Biopsy has already contributed to an increase in both breadth and depth of accounts, and we expect this to be a strong growth driver for our therapy selection business going forward.”
“Shield has received a very positive reception from physicians and patients in the first few months of commercial launch following FDA approval,” said AmirAli Talasaz, co-founder and co-CEO. “We were very pleased to see Shield receive a Medicare price of $920, which recognizes it as an important new class of CRC screening. We look forward to continuing to execute our commercial scale-up as we make Shield one of the most impactful products in the history of diagnostics.”
Third Quarter 2024 Financial Results
Revenue was $191.5 million for the third quarter of 2024, a 34% increase from $143.0 million for the corresponding prior year period. Precision oncology revenue grew 35%, to $180.6 million for the third quarter of 2024, from $133.4 million for the corresponding prior year period, driven by an increase in the volume of clinical tests (i.e., Guardant360, TissueNext, Response, and Reveal tests) and biopharma tests, which grew 21% and 40%, respectively, over the prior year period. The increase in precision oncology revenue was also attributable to an increase in reimbursement for our tests, due to an increase in Medicare reimbursement for our Guardant360 LDT test to $5,000, effective January 1, 2024; and an increase in both Medicare Advantage and commercial payer reimbursement. Development services and other revenue was $10.9 million for the third quarter of 2024, compared to $9.6 million for the corresponding prior year period.
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Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $117.0 million for the third quarter of 2024, an increase of $31.6 million from $85.4 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 61%, as compared to 60% for the corresponding prior year period. Precision oncology gross margin was 63% in the third quarter of 2024, as compared to 60% in the prior year period. Development services and other gross margin was 23% in the third quarter of 2024, as compared to 59% in the prior year period.
Non-GAAP gross profit was $121.1 million for the third quarter of 2024, an increase of $33.7 million, from $87.3 million for the corresponding prior year period. Non-GAAP gross margin was 63% for the third quarter of 2024, as compared to 61% for the corresponding prior year period.
Non-GAAP gross profit excluding cost of screening was $124.0 million for the third quarter of 2024, an increase of $34.3 million, from $89.7 million for the corresponding prior year period. Non-GAAP gross margin excluding cost of screening was 65% for the third quarter of 2024, as compared to 63% for the corresponding prior year period.
Operating expenses were $234.3 million for the third quarter of 2024, as compared to $199.0 million for the corresponding prior year period. Non-GAAP operating expenses were $187.3 million for the third quarter of 2024, as compared to $177.3 million for the corresponding prior year period.
Net loss was $107.8 million for the third quarter of 2024, as compared to $86.1 million for the corresponding prior year period. Net loss per share was $0.88 for the third quarter of 2024, as compared to $0.73 for the corresponding prior year period. The year-over-year increase in net loss was primarily due to a $18.3 million increase in net unrealized and realized losses recorded for our investment in Lunit, Inc.
Non-GAAP net loss was $55.0 million for the third quarter of 2024, as compared to $79.2 million for the corresponding prior year period. Non-GAAP net loss per share was $0.45 for the third quarter of 2024, as compared to $0.67 for the corresponding prior year period.
Adjusted EBITDA loss was $56.2 million for the third quarter of 2024, as compared to a $79.7 million loss for the corresponding prior year period.
Free cash flow for the third quarter of 2024 was $(55.3) million, as compared to $(80.2) million for the corresponding prior year period. Cash, cash equivalents, restricted cash and marketable debt securities were $1.0 billion as of September 30, 2024.
2024 Guidance
Guardant Health now expects full year 2024 revenue to be in the range of $720 to $725 million, representing growth of 28% to 29% compared to full year 2023. This compares to the prior range of $690 to $700 million, representing growth of 22% to 24%. Guardant Health continues to expect full year 2024 non-GAAP gross margin excluding screening to be in the range of 61% to 63% and total non-GAAP operating expenses to be in the range of $720 to $730 million, representing a flat to 1% decrease compared to 2023. Guardant Health now expects free cash flow to be in the range of $(265) to $(275) million in 2024, representing an improvement of $70 million to $80 million compared to 2023.
Webcast Information
Guardant Health will host a conference call to discuss the third quarter 2024 financial results after market close on Wednesday, November 6, 2024 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A webcast of the conference call can be accessed at http://investors.guardanthealth.com. The webcast will be archived and available for replay for at least 90 days after the event.
Non-GAAP Measures
Guardant Health has presented in this release certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis, including non-GAAP cost of precision oncology testing, non-GAAP cost of development services and other, non-GAAP cost of screening, non-GAAP gross profit, non-GAAP gross profit excluding cost of screening, non-GAAP research and development expense, non-GAAP sales and marketing expense, non-GAAP general and administrative expense, non-GAAP loss from operations, non-GAAP net loss, non-GAAP net loss per share, basic and diluted, adjusted EBITDA, and free cash flow.
We define our non-GAAP measures as the applicable GAAP measure adjusted for the impacts of stock-based compensation and related employer payroll tax payments, contingent consideration, amortization of intangible assets, unrealized and realized gains and losses on marketable equity securities, impairment of non-marketable equity securities and other related assets, and other non-recurring items.
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Adjusted EBITDA is defined as net loss adjusted for interest income; interest expense; other income (expense), net; provision for income taxes; depreciation and amortization expense; stock-based compensation expense and related employer payroll tax payments; contingent consideration; and other non-recurring items. Free cash flow is defined as net cash used in operating activities in the period less purchase of property and equipment in the period.
We believe that the exclusion of certain income and expenses in calculating these non-GAAP financial measures can provide a useful measure for investors when comparing our period-to-period core operating results, and when comparing those same results to that published by our peers. We exclude certain items because we believe that these income and expenses do not reflect expected future operating performance. Additionally, certain items are inconsistent in amounts and frequency, making it difficult to perform a meaningful evaluation of our current or past operating performance. We use these non-GAAP financial measures to evaluate ongoing operations, for internal planning and forecasting purposes, and to manage our business.
These non-GAAP financial measures are not intended to be considered in isolation from, as substitute for, or as superior to, the corresponding financial measures prepared in accordance with GAAP. There are limitations inherent in non-GAAP financial measures because they exclude charges and credits that are required to be included in a GAAP presentation, and do not present the full measure of our recorded costs against its revenue. In addition, our definition of the non-GAAP financial measures may differ from non-GAAP measures used by other companies.
About Guardant Health
Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including statements relating to Guardant Health’s future results, regulatory approval for products or regarding the potential benefits and advantages of Guardant Health’s platforms, assays and tests, which involve risks and uncertainties that could cause Guardant Health’s 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, 2023, 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:
Zarak Khurshid
investors@guardanthealth.com
Media Contact:
Melissa Marasco
press@guardanthealth.com
+1 650-647-3711
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Guardant Health, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except per share data)
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Revenue:
Precision oncology testing
$180,604 $133,423 $503,351 $372,060 
Development services and other10,872 9,607 33,851 36,834 
Total revenue
191,476 143,030 537,202 408,894 
Costs and operating expenses:
Cost of precision oncology testing 66,095 53,648 191,116 148,111 
Cost of development services and other8,394 3,966 21,090 16,424 
Research and development expense 87,306 93,851 254,210 277,338 
Sales and marketing expense 97,880 68,934 260,172 216,100 
General and administrative expense 49,129 36,174 128,243 118,135 
Total costs and operating expenses
308,804 256,573 854,831 776,108 
Loss from operations
(117,328)(113,543)(317,629)(367,214)
Interest income
13,257 11,690 42,038 21,477 
Interest expense
(646)(644)(1,936)(1,933)
Other income (expense), net (3,007)16,885 (47,272)56,490 
Loss before provision for income taxes (107,724)(85,612)(324,799)(291,180)
Provision for income taxes 30 490 568 1,226 
Net loss $(107,754)$(86,102)$(325,367)$(292,406)
Net loss per share, basic and diluted $(0.88)$(0.73)$(2.66)$(2.66)
Weighted-average shares used in computing net loss per share, basic and diluted123,051 117,736 122,406 109,791 
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 Guardant Health, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands, except share and per share data)
September 30, 2024December 31, 2023
ASSETS
Current assets:
Cash, cash equivalents and restricted cash
$688,368 $1,133,537 
Short-term marketable debt securities
310,701 35,097 
Accounts receivable, net
88,465 88,783 
Inventory, net
72,298 61,948 
Prepaid expenses and other current assets, net
66,883 27,741 
Total current assets
1,226,715 1,347,106 
Property and equipment, net
125,169 145,096 
Right-of-use assets, net
144,964 157,616 
Intangible assets, net
7,251 8,979 
Goodwill
3,290 3,290 
Other assets, net
31,338 124,334 
Total Assets
$1,538,727 $1,786,421 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable$15,473 $51,741 
Accrued compensation80,647 72,736 
Accrued expenses
71,671 63,475 
Deferred revenue
29,554 17,965 
Total current liabilities
197,345 205,917 
Convertible senior notes, net1,141,901 1,139,966 
Long-term operating lease liabilities
170,131 185,848 
Other long-term liabilities
89,446 96,006 
Total Liabilities
1,598,823 1,627,737 
Stockholders’ equity:
Common stock, par value of $0.00001 per share; 350,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 123,158,418 and 121,629,861 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively
1 1 
Additional paid-in capital
2,410,416 2,304,220 
Accumulated other comprehensive loss
(3,284)(3,675)
Accumulated deficit
(2,467,229)(2,141,862)
Total Stockholders’ (Deficit) Equity
(60,096)158,684 
Total Liabilities and Stockholders’ (Deficit) Equity
$1,538,727 $1,786,421 

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Guardant Health, Inc.
Reconciliation of Selected GAAP Measures to Non-GAAP Measures
(unaudited)
(in thousands, except per share data)
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
GAAP cost of precision oncology testing$66,095 $53,648 $191,116 $148,111 
Amortization of intangible assets(151)(151)(450)(448)
Stock-based compensation expense and related employer payroll tax payments(1,505)(1,120)(4,092)(3,563)
Non-GAAP cost of precision oncology testing $64,439 $52,377 $186,574 $144,100 
GAAP cost of development services and other$8,394 $3,966 $21,090 $16,424 
Amortization of intangible assets— (201)(267)(603)
Stock-based compensation expense and related employer payroll tax payments(2,412)(437)(3,409)(1,391)
Non-GAAP cost of development services and other$5,982 $3,328 $17,414 $14,430 
GAAP gross profit$116,987 $85,416 $324,996 $244,359 
Amortization of intangible assets151 352 717 1,051 
Stock-based compensation expense and related employer payroll tax payments3,917 1,557 7,501 4,954 
Non-GAAP gross profit$121,055 $87,325 $333,214 $250,364 
GAAP cost of screening $5,320 $2,992 $12,108 $10,023 
Amortization of intangible assets— (201)(267)(603)
Stock-based compensation expense and related employer payroll tax payments(2,412)(437)(3,409)(1,391)
Non-GAAP cost of screening $2,908 $2,354 $8,432 $8,029 
Non-GAAP gross profit excluding cost of screening$123,963 $89,679 $341,646 $258,393 
GAAP research and development expense$87,306 $93,851 $254,210 $277,338 
Stock-based compensation expense and related employer payroll tax payments(18,750)(8,611)(38,815)(25,877)
Contingent consideration(190)(531)(675)(1,632)
Non-GAAP research and development expense$68,366 $84,709 $214,720 $249,829 
GAAP sales and marketing expense$97,880 $68,934 $260,172 $216,100 
Stock-based compensation expense and related employer payroll tax payments(13,287)(5,137)(27,874)(18,657)
Non-GAAP sales and marketing expense$84,593 $63,797 $232,298 $197,443 
GAAP general and administrative expense$49,129 $36,174 $128,243 $118,135 
Amortization of intangible assets(340)(339)(1,011)(1,006)
Stock-based compensation expense and related employer payroll tax payments(14,068)(6,794)(30,891)(18,017)
Contingent consideration(340)(220)(760)(230)
Non-GAAP general and administrative expense$34,381 $28,821 $95,581 $98,882 
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Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
GAAP loss from operations$(117,328)$(113,543)$(317,629)$(367,214)
Amortization of intangible assets491 691 1,728 2,057 
Stock-based compensation expense and related employer payroll tax payments50,022 22,099 105,081 67,505 
Contingent consideration530 751 1,435 1,862 
Non-GAAP loss from operations$(66,285)$(90,002)$(209,385)$(295,790)
GAAP net loss $(107,754)$(86,102)$(325,367)$(292,406)
Amortization of intangible assets491 691 1,728 2,057 
Stock-based compensation expense and related employer payroll tax payments50,022 22,099 105,081 67,505 
Contingent consideration530 751 1,435 1,862 
Unrealized and realized losses (gains) on marketable equity securities1,686 (16,634)47,225 (84,513)
Impairment of non-marketable equity securities and other related assets— — — 29,054 
Non-GAAP net loss $(55,025)$(79,195)$(169,898)$(276,441)
GAAP net loss per share, basic and diluted$(0.88)$(0.73)$(2.66)$(2.66)
Non-GAAP net loss per share, basic and diluted$(0.45)$(0.67)$(1.39)$(2.52)
Weighted-average shares used in computing GAAP and Non-GAAP net loss per share, basic and diluted123,051 117,736 122,406 109,791 


Reconciliation of GAAP Net Loss to Adjusted EBITDA
(unaudited)
(in thousands)
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
GAAP net loss $(107,754)$(86,102)$(325,367)$(292,406)
Interest income (13,257)(11,690)(42,038)(21,477)
Interest expense 646 644 1,936 1,933 
Other expense (income), net 3,007 (16,885)47,272 (56,490)
Provision for income taxes 30 490 568 1,226 
Depreciation and amortization10,598 11,037 31,933 32,013 
Stock-based compensation expense and related employer payroll tax payments50,022 22,099 105,081 67,505 
Contingent consideration530 751 1,435 1,862 
Adjusted EBITDA$(56,178)$(79,656)$(179,180)$(265,834)

Reconciliation of Free Cash Flow to Net Cash Used in Operating Activities
(unaudited)
(in thousands)
Three Months Ended September 30,Nine Months Ended September 30,
2024202320242023
Net cash used in operating activities$(51,059)$(77,791)$(175,345)$(246,247)
Purchases of property and equipment (4,199)(2,372)(16,210)(16,409)
Free cash flow$(55,258)$(80,163)$(191,555)$(262,656)
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v3.24.3
Document and Entity Information Document
Nov. 06, 2024
Cover [Abstract]  
Document Type 8-K
Document Period End Date Nov. 06, 2024
Entity Registrant Name GUARDANT HEALTH, INC.
Entity Central Index Key 0001576280
Amendment Flag false
Entity Incorporation, State or Country Code DE
Entity File Number 001-38683
Entity Tax Identification Number 45-4139254
Entity Address, Address Line One 3100 Hanover Street
Entity Address, City or Town Palo Alto
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94304
City Area Code 855
Local Phone Number 698-8887
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company false
Title of 12(b) Security Common Stock, $0.00001 par value per share
Trading Symbol GH
Security Exchange Name NASDAQ
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