8-K
Guardant Health, Inc. (GH)
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): August 5, 2021
GUARDANT HEALTH, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-38683 | 45-4139254 |
|---|---|---|
| (State or other jurisdiction<br><br>of incorporation or organization) | (Commission<br><br>File Number) | (I.R.S. Employer<br><br>Identification No.) |
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:
| ☐ | 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)) |
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. ☐
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, par value $0.00001 | GH | The Nasdaq Global Select Market |
Item 2.02 Results of Operations and Financial Condition.
On August 5, 2021, Guardant Health, Inc. (the “Company”) issued a press release announcing financial results for the fiscal quarter ended June 30, 2021. 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 | Press release of Guardant Health, Inc., datedAugust5, 2021 |
| 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: | August 5, 2021 | ||
| By: | /s/ Helmy Eltoukhy | ||
| Helmy Eltoukhy | |||
| Chief Executive Officer |
Document
Guardant Health Reports Second Quarter 2021 Financial Results
Achieved revenue of $92.1 million, driven by 52% year over year growth in clinical volume
REDWOOD CITY, Calif. August 5, 2021 – Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics, today reported financial results for the quarter ended June 30, 2021.
Recent Highlights
•Revenue of $92.1 million for the second quarter of 2021, an increase of 39% over the corresponding period of 2020
•Reported 20,830 tests to clinical customers and 3,653 tests to biopharmaceutical customers in the second quarter of 2021, representing an increase of 52% and 30%, respectively, over the second quarter of 2020
•Enrolled 10,000th patient in ECLIPSE trial and plans to launch a blood-based screening LDT in the first half of 2022
•Expanded Guardant360 portfolio with launch of TissueNext™ and Response™ tests
•Received FDA approvals for Guardant360 CDx as a companion diagnostic for LUMAKRAS and RYBREVANT in advanced non-small cell lung cancer
•Appointed Chris Freeman as Chief Commercial Officer of Oncology
“I am proud of our team’s execution this quarter as we continued to expand our product portfolio and establish our solutions as best-in-class in cancer testing,” said Helmy Eltoukhy, co-founder and CEO. “I am especially proud of the progress our clinical team has made running our ECLIPSE study during the pandemic and am excited to announce we have enrolled more than 10,000 patients to date. We are making great strides across our business to be a leader in cancer care and we are looking forward to continuing to make important progress in the second half of the year.”
Second Quarter 2021 Financial Results
Revenue was $92.1 million for the three months ended June 30, 2021, a 39% increase from $66.3 million for the three months ended June 30, 2020. Precision oncology revenue grew 42% driven predominantly by an increase in clinical testing revenue which grew 54% over the prior year period. There were 20,830 clinical tests and 3,653 biopharmaceutical tests performed during the second quarter of 2021. Development services and other revenue increased 27% primarily due to the timing of project milestones related to the receipt of regulatory approval for two of our companion diagnostic programs during the three months ended June 30, 2021 .
Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $62.2 million for the second quarter of 2021, an increase of $18.3 million from $43.9 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 68%, as compared to 66% for the corresponding prior year period.
Operating expenses were $159.8 million for the second quarter of 2021, as compared to $98.5 million for the corresponding prior year period, an increase of 62%. Non-GAAP operating expenses were $124.7 million for the second quarter of 2021, as compared to $72.9 million for the corresponding prior year period.
Net loss attributable to Guardant Health, Inc. common stockholders was $97.6 million for the second quarter of 2021, as compared to $54.6 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $0.96 for the second quarter of 2021, as compared to $0.57 for the corresponding prior year period. Non-GAAP net loss was $61.4 million for the second quarter of 2021, as compared to $23.5 million for the corresponding prior year period. Non-GAAP net loss per share was $0.61 for the second quarter of 2021, as compared to $0.25 for the corresponding prior year period.
Adjusted EBITDA loss was $56.4 million for the second quarter of 2021, as compared to a $25.1 million loss for the corresponding prior year period.
Cash, cash equivalents and marketable securities were $1.8 billion as of June 30, 2021.
2021 Guidance
Due to continued uncertainty around the global COVID pandemic, Guardant Health is maintaining its previous 2021 revenue guidance. The Company continues to expect full year 2021 revenue to be in the range of $360 million to $370 million, representing 26% to 29% growth over full year 2020. Clinical volumes for 2021 are expected to be greater than 90,000 tests, growing at least 42% over 2020.
Webcast Information
Guardant Health will host a conference call to discuss the second quarter 2021 financial results after market close on Thursday, August 5, 2021 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 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 attributable to Guardant Health, Inc., common stockholders, non-GAAP net loss per share attributable to Guardant Health, Inc. common stockholders, basic and diluted, and Adjusted EBITDA.
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; changes in estimated fair value redeemable noncontrolling interest; contingent consideration; acquisition related expenses, amortization of intangible assets, and other non-recurring items.
Adjusted EBITDA is defined as net loss attributable to Guardant Health, Inc. common stockholders adjusted for interest income; interest expense; other income (expense), net, provision for (benefit from) income taxes; depreciation; and amortization expense; stock-based compensation expense and related employer payroll tax payments; adjustments relating to non-controlling interest and contingent consideration and, if applicable in a reporting period, acquisition-related expenses and other non-recurring items.
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 other items because we believe that these income (expenses) do not reflect expected future operating expenses. 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 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 liquid biopsy-based 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 Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including statements relating to Guardant Health’s future results, 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, 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:
Anna Czene
press@guardanthealth.com
Guardant Health, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||
|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2021 | 2020 | |||||
| Revenue: | ||||||||
| Precision oncology testing | $ | 72,604 | $ | 50,991 | $ | 136,333 | $ | 111,237 |
| Development services and other | 19,497 | 15,344 | 34,433 | 22,608 | ||||
| Total revenue | 92,101 | 66,335 | 170,766 | 133,845 | ||||
| Costs and operating expenses: | ||||||||
| Cost of precision oncology testing | 24,887 | 17,809 | 48,477 | 36,000 | ||||
| Cost of development services and other | 5,040 | 4,626 | 10,197 | 6,941 | ||||
| Research and development expense | 63,724 | 36,319 | 119,232 | 73,335 | ||||
| Sales and marketing expense | 47,716 | 25,015 | 82,054 | 50,130 | ||||
| General and administrative expense | 48,376 | 37,186 | 116,311 | 56,971 | ||||
| Total costs and operating expenses | 189,743 | 120,955 | 376,271 | 223,377 | ||||
| Loss from operations | (97,642) | (54,620) | (205,505) | (89,532) | ||||
| Interest income | 1,037 | 2,640 | 2,588 | 5,958 | ||||
| Interest expense | (644) | (10) | (1,290) | (22) | ||||
| Other income (expense), net | (243) | 2,285 | (533) | 2,076 | ||||
| Loss before provision for income taxes | (97,492) | (49,705) | (204,740) | (81,520) | ||||
| Provision for income taxes | 83 | 34 | 193 | 48 | ||||
| Net loss | (97,575) | (49,739) | (204,933) | (81,568) | ||||
| Adjustment of redeemable noncontrolling interest | — | (4,900) | (2,300) | (800) | ||||
| Net loss attributable to Guardant Health, Inc. common stockholders | $ | (97,575) | $ | (54,639) | $ | (207,233) | $ | (82,368) |
| Net loss per share attributable to Guardant Health, Inc. common stockholders, basic and diluted | $ | (0.96) | $ | (0.57) | $ | (2.05) | $ | (0.87) |
| Weighted-average shares used in computing net loss per share attributable to Guardant Health, Inc. common stockholders, basic and diluted | 101,172 | 96,011 | 101,064 | 95,196 |
Guardant Health, Inc.
Condensed Consolidated Balance Sheets (unaudited)
(in thousands, except share and per share data)
| June 30, 2021 | December 31, 2020 | |||
|---|---|---|---|---|
| ASSETS | ||||
| Current assets: | ||||
| Cash and cash equivalents | $ | 938,590 | $ | 832,977 |
| Short-term marketable securities | 853,072 | 961,903 | ||
| Accounts receivable, net | 53,667 | 53,299 | ||
| Inventory | 26,494 | 22,716 | ||
| Prepaid expenses and other current assets, net | 19,236 | 17,466 | ||
| Total current assets | 1,891,059 | 1,888,361 | ||
| Long-term marketable securities | 55,368 | 246,597 | ||
| Property and equipment, net | 89,737 | 62,782 | ||
| Right-of-use assets | 200,958 | 37,343 | ||
| Intangible assets, net | 15,189 | 16,155 | ||
| Goodwill | 3,290 | 3,290 | ||
| Other assets, net | 36,284 | 17,253 | ||
| Total Assets | $ | 2,291,885 | $ | 2,271,781 |
| LIABILITIES, REDEEMABLE NONCONTROLLING INTEREST AND STOCKHOLDERS’ EQUITY | ||||
| Current liabilities: | ||||
| Accounts payable | $ | 21,399 | $ | 7,340 |
| Accrued compensation | 34,735 | 28,280 | ||
| Accrued expenses | 31,998 | 22,639 | ||
| Deferred revenue | 8,480 | 8,550 | ||
| Total current liabilities | 96,612 | 66,809 | ||
| Convertible senior notes, net | 1,133,539 | 806,292 | ||
| Long-term operating lease liabilities | 211,783 | 41,565 | ||
| Other long-term liabilities | 2,486 | 1,520 | ||
| Total Liabilities | 1,444,420 | 916,186 | ||
| Redeemable noncontrolling interest | 59,400 | 57,100 | ||
| Stockholders’ equity: | ||||
| Common stock, par value of $0.00001 per share; 350,000,000 shares authorized as of June 30, 2021 and December 31, 2020; 101,265,100 and 100,213,985 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively | 1 | 1 | ||
| Additional paid-in capital | 1,597,419 | 1,902,389 | ||
| Accumulated other comprehensive income | 33 | 2,697 | ||
| Accumulated deficit | (809,388) | (606,592) | ||
| Total Stockholders’ Equity | 788,065 | 1,298,495 | ||
| Total Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Equity | $ | 2,291,885 | $ | 2,271,781 |
Guardant Health, Inc.
Reconciliation of Selected GAAP Measures to Non-GAAP Measures
(unaudited)
(in thousands)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||
|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2021 | 2020 | |||||
| GAAP cost of precision oncology testing | $ | 24,887 | $ | 17,809 | $ | 48,477 | $ | 36,000 |
| Amortization of intangible assets | (149) | (141) | (297) | (141) | ||||
| Stock-based compensation expense and related employer payroll tax payments | (888) | (394) | (1,687) | (716) | ||||
| Non-GAAP cost of precision oncology testing | $ | 23,850 | $ | 17,274 | $ | 46,493 | $ | 35,143 |
| GAAP research and development expense | $ | 63,724 | $ | 36,319 | $ | 119,232 | $ | 73,335 |
| Amortization of intangible assets | — | (43) | — | (43) | ||||
| Stock-based compensation expense and related employer payroll tax payments | (4,659) | (2,557) | (9,050) | (5,029) | ||||
| Acquisition related expenses | — | — | — | (8,500) | ||||
| Non-GAAP research and development expense | $ | 59,065 | $ | 33,719 | $ | 110,182 | $ | 59,763 |
| GAAP sales and marketing expense | $ | 47,716 | $ | 25,015 | $ | 82,054 | $ | 50,130 |
| Stock-based compensation expense and related employer payroll tax payments | (3,493) | (2,065) | (6,427) | (3,995) | ||||
| Non-GAAP sales and marketing expense | $ | 44,223 | $ | 22,950 | $ | 75,627 | $ | 46,135 |
| GAAP general and administrative expense | $ | 48,376 | $ | 37,186 | $ | 116,311 | $ | 56,971 |
| Amortization of intangible assets | (336) | (349) | (669) | (578) | ||||
| Stock-based compensation expense and related employer payroll tax payments | (25,735) | (20,651) | (75,110) | (22,562) | ||||
| Change in fair value of contingent consideration | (875) | — | (875) | 190 | ||||
| Acquisition related expenses | — | — | — | (1,207) | ||||
| Non-GAAP general and administrative expense | $ | 21,430 | $ | 16,186 | $ | 39,657 | $ | 32,814 |
| GAAP loss from operations | $ | (97,642) | $ | (54,620) | $ | (205,505) | $ | (89,532) |
| Amortization of intangible assets | 485 | 533 | 966 | 762 | ||||
| Stock-based compensation expense and related employer payroll tax payments | 34,775 | 25,667 | 92,274 | 32,302 | ||||
| Change in fair value of contingent consideration | 875 | — | 875 | (190) | ||||
| Acquisition related expenses | — | — | — | 9,707 | ||||
| Non-GAAP loss from operations | $ | (61,507) | $ | (28,420) | $ | (111,390) | $ | (46,951) |
| GAAP net loss | $ | (97,575) | $ | (49,739) | $ | (204,933) | $ | (81,568) |
| Amortization of intangible assets | 485 | 533 | 966 | 762 | ||||
| Stock-based compensation expense and related employer payroll tax payments | 34,775 | 25,667 | 92,274 | 32,302 | ||||
| Change in fair value of contingent consideration | 875 | — | 875 | (190) | ||||
| Acquisition related expenses | — | — | — | 9,707 | ||||
| Non-GAAP net loss | $ | (61,440) | $ | (23,539) | $ | (110,818) | $ | (38,987) |
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||
|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2021 | 2020 | |||||
| GAAP net loss attributable to Guardant Health, Inc. common stockholders | $ | (97,575) | $ | (54,639) | $ | (207,233) | $ | (82,368) |
| Amortization of intangible assets | 485 | 533 | 966 | 762 | ||||
| Stock-based compensation expense and related employer payroll tax payments | 34,775 | 25,667 | 92,274 | 32,302 | ||||
| Change in fair value of contingent consideration | 875 | — | 875 | (190) | ||||
| Acquisition related expenses | — | — | — | 9,707 | ||||
| Adjustments relating to non-controlling interest | — | 4,900 | 2,300 | 800 | ||||
| Non-GAAP net loss attributable to Guardant Health, Inc. common stockholders | $ | (61,440) | $ | (23,539) | $ | (110,818) | $ | (38,987) |
| GAAP net loss per share attributable to Guardant Health, Inc., common stockholders, basic and diluted | $ | (0.96) | $ | (0.57) | $ | (2.05) | $ | (0.87) |
| Non-GAAP net loss per share attributable to Guardant Health, Inc., common stockholders, basic and diluted | $ | (0.61) | $ | (0.25) | $ | (1.10) | $ | (0.41) |
| Weighted-average shares used in computing GAAP and Non-GAAP net loss per share, basic and diluted | 101,172 | 96,011 | 101,064 | 95,196 |
Guardant Health, Inc.
Reconciliation of GAAP Net Loss Attributable to Guardant Health, Inc. Common Stockholders to Adjusted EBITDA
(unaudited)
(in thousands)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||
|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2021 | 2020 | |||||
| GAAP net loss attributable to Guardant Health, Inc. common stockholders | $ | (97,575) | $ | (54,639) | $ | (207,233) | $ | (82,368) |
| Interest income | (1,037) | (2,640) | (2,588) | (5,958) | ||||
| Interest expense | 644 | 10 | 1,290 | 22 | ||||
| Other (income) expense, net | 243 | (2,285) | 533 | (2,076) | ||||
| Provision for income taxes | 83 | 34 | 193 | 48 | ||||
| Depreciation and amortization | 5,627 | 3,805 | 10,637 | 7,109 | ||||
| Stock-based compensation expense and related employer payroll tax payments | 34,775 | 25,667 | 92,274 | 32,302 | ||||
| Change in fair value of contingent consideration | 875 | — | 875 | (190) | ||||
| Acquisition related expenses | — | — | — | 9,707 | ||||
| Adjustments relating to non-controlling interest | — | 4,900 | 2,300 | 800 | ||||
| Adjusted EBITDA | $ | (56,365) | $ | (25,148) | $ | (101,719) | $ | (40,604) |
7