Achieved record revenue of $94.8 million

Growth of 35% and 58% year over year in clinical and biopharma volumes, respectively

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 September 30, 2021.

Recent Highlights

Revenue of $94.8 million for the third quarter of 2021, an increase of 27% over the corresponding period of 2020
Reported 22,806 tests to clinical customers and 4,839 tests to biopharmaceutical customers in the third quarter of 2021, representing an increase of 35% and 58%, respectively, over the third quarter of 2020
Initiated ORACLE study to evaluate performance of Guardant Reveal™ to predict recurrence across eleven early-stage cancers
Presented data at ACG showing LUNAR-2 blood test is highly sensitive in detecting early-stage colorectal cancer
Announced SHIELD study to validate the performance of blood-based assay in lung cancer screening, with enrollment beginning in December of 2021
Added Myrtle Potter, CEO of Sumitovant Biopharma, to Board of Directors

"We delivered solid results this quarter as we continue to build on our strong foundation as the liquid biopsy leader in oncology, despite the continued impact of COVID," said Helmy Eltoukhy, co-founder and co-CEO. "We have continued our strong cadence of data supporting our Guardant360® products and are making solid progress towards our multi-cancer goal for MRD with the initiation of our ORACLE study. We are dedicated to offering healthcare providers a complete portfolio of oncology products that will provide clinically actionable information to guide patient care."

"At Guardant, we are focused on developing a highly accurate blood test to screen for multiple cancers where lives can be saved," said AmirAli Talasaz, co-founder and co-CEO. "Guardant's differentiated core technology platform has the potential to significantly improve our ability to detect many cancers at their earliest stages. Successful readouts of ECLIPSE and SHIELD, as well as future studies, will unlock the tremendous opportunity for blood-based cancer screening."

Third Quarter 2021 Financial Results

Revenue was $94.8 million for the three months ended September 30, 2021, a 27% increase from $74.6 million for the three months ended September 30, 2020. Precision oncology revenue grew 31% driven predominantly by an increase in clinical testing revenue which grew 27% over the prior year period. There were 22,806 clinical tests and 4,839 biopharmaceutical tests performed during the third quarter of 2021. Development services and other revenue increased 9% primarily due to progression of collaboration projects from biopharmaceutical customers for companion diagnostic development services during the three months ended September 30, 2021.

Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $64.0 million for the third quarter of 2021, an increase of $10.6 million from $53.4 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 67%, as compared to 72% for the corresponding prior year period.

Operating expenses were $171.3 million for the third quarter of 2021, as compared to $127.6 million for the corresponding prior year period, an increase of 34%. Non-GAAP operating expenses were $135.1 million for the third quarter of 2021, as compared to $71.8 million for the corresponding prior year period.

Net loss attributable to Guardant Health, Inc. common stockholders was $107.5 million for the third quarter of 2021, as compared to $77.7 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $1.06 for the third quarter of 2021, as compared to $0.78 for the corresponding prior year period. Non-GAAP net loss was $70.5 million for the third quarter of 2021, as compared to $15.4 million for the corresponding prior year period. Non-GAAP net loss per share was $0.70 for the third quarter of 2021, as compared to $0.15 for the corresponding prior year period.

Adjusted EBITDA loss was $65.2 million for the third quarter of 2021, as compared to a $14.1 million loss for the corresponding prior year period.

Cash, cash equivalents and marketable securities were $1.7 billion as of September 30, 2021.

2021 Guidance

Guardant Health expects full year 2021 revenue to be in the range of $360 million to $370 million, representing 26% to 29% growth over full year 2020.

Webcast Information

Guardant Health will host a conference call to discuss the third quarter 2021 financial results after market close on Thursday, November 4, 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 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.

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,
	2021			2020			2021			2020

Revenue:
Precision oncology testing	$	79,272		$	60,384		$	215,605		$	171,621
Development services and other	15,507			14,185			49,940			36,793
Total revenue	94,779			74,569			265,545			208,414
Costs and operating expenses:
Cost of precision oncology testing	29,665			16,699			78,142			52,699
Cost of development services and other	1,151			4,488			11,348			11,429
Research and development expense	70,968			36,245			190,200			109,580
Sales and marketing expense	50,228			25,095			132,282			75,225
General and administrative expense	50,055			66,294			166,366			123,265
Total costs and operating expenses	202,067			148,821			578,338			372,198
Loss from operations	(107,288		)	(74,252		)	(312,793		)	(163,784		)
Interest income	689			2,313			3,277			8,271
Interest expense	(644		)	(8		)	(1,934		)	(30		)
Other income (expense), net	(187		)	345			(720		)	2,421
Loss before provision for income taxes	(107,430		)	(71,602		)	(312,170		)	(153,122		)
Provision for income taxes	96			68			289			116
Net loss	(107,526		)	(71,670		)	(312,459		)	(153,238		)
Adjustment of redeemable noncontrolling interest	—			(6,000		)	(2,300		)	(6,800		)
Net loss attributable to Guardant Health, Inc. common stockholders	$	(107,526	)	$	(77,670	)	$	(314,759	)	$	(160,038	)
Net loss per share attributable to Guardant Health, Inc. common stockholders, basic and diluted	$	(1.06	)	$	(0.78	)	$	(3.11	)	$	(1.66	)
Weighted-average shares used in computing net loss per share attributable to Guardant Health, Inc. common stockholders, basic and diluted	101,420			99,554			101,184			96,659

Guardant Health, Inc.
Condensed Consolidated Balance Sheets (unaudited)
(in thousands, except share and per share data)

	September 30, 2021			December 31, 2020
ASSETS
Current assets:
Cash and cash equivalents	$	832,370		$	832,977
Short-term marketable securities	653,601			961,903
Accounts receivable, net	60,744			53,299
Inventory	24,739			22,716
Prepaid expenses and other current assets, net	21,958			17,466
Total current assets	1,593,412			1,888,361
Long-term marketable securities	250,226			246,597
Property and equipment, net	106,156			62,782
Right-of-use assets	196,436			37,343
Intangible assets, net	14,698			16,155
Goodwill	3,290			3,290
Other assets, net	61,316			17,253
Total Assets	$	2,225,534		$	2,271,781
LIABILITIES, REDEEMABLE NONCONTROLLING INTEREST AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	15,674		$	7,340
Accrued compensation	38,838			28,280
Accrued expenses	40,475			22,639
Deferred revenue	7,317			8,550
Total current liabilities	102,304			66,809
Convertible senior notes, net	1,134,180			806,292
Long-term operating lease liabilities	216,806			41,565
Other long-term liabilities	3,424			1,520
Total Liabilities	1,456,714			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 September 30, 2021 and December 31, 2020; 101,623,257 and 100,213,985 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively	1			1
Additional paid-in capital	1,626,926			1,902,389
Accumulated other comprehensive income	(593		)	2,697
Accumulated deficit	(916,914		)	(606,592		)
Total Stockholders' Equity	709,420			1,298,495
Total Liabilities, Redeemable Noncontrolling Interest and Stockholders' Equity	$	2,225,534		$	2,271,781

Guardant Health, Inc.
Reconciliation of Selected GAAP Measures to Non-GAAP Measures
(unaudited)
(in thousands)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2021			2020			2021			2020

GAAP cost of precision oncology testing	$	29,665		$	16,699		$	78,142		$	52,699
Amortization of intangible assets	(152		)	—			(449		)	(141		)
Stock-based compensation expense and related employer payroll tax payments	(762		)	(450		)	(2,449		)	(1,166		)
Non-GAAP cost of precision oncology testing	$	28,751		$	16,249		$	75,244		$	51,392

GAAP research and development expense	$	70,968		$	36,245		$	190,200		$	109,580
Amortization of intangible assets	—			—			—			(43		)
Stock-based compensation expense and related employer payroll tax payments	(4,624		)	(2,474		)	(13,674		)	(7,503		)
Acquisition related expenses	—			—			—			(8,500		)
Non-GAAP research and development expense	$	66,344		$	33,771		$	176,526		$	93,534

GAAP sales and marketing expense	$	50,228		$	25,095		$	132,282		$	75,225
Stock-based compensation expense and related employer payroll tax payments	(4,127		)	(2,379		)	(10,554		)	(6,374		)
Non-GAAP sales and marketing expense	$	46,101		$	22,716		$	121,728		$	68,851

GAAP general and administrative expense	$	50,055		$	66,294		$	166,366		$	123,265
Amortization of intangible assets	(339		)	(503		)	(1,008		)	(1,081		)
Stock-based compensation expense and related employer payroll tax payments	(26,044		)	(50,397		)	(101,154		)	(72,959		)
Change in fair value of contingent consideration	(970		)	(70		)	(1,845		)	120
Acquisition related expenses	—			—			—			(1,207		)
Non-GAAP general and administrative expense	$	22,702		$	15,324		$	62,359		$	48,138

GAAP loss from operations	$	(107,288	)	$	(74,252	)	$	(312,793	)	$	(163,784	)
Amortization of intangible assets	491			503			1,457			1,265
Stock-based compensation expense and related employer payroll tax payments	35,557			55,700			127,831			88,002
Change in fair value of contingent consideration	970			70			1,845			(120		)
Acquisition related expenses	—			—			—			9,707
Non-GAAP loss from operations	$	(70,270	)	$	(17,979	)	$	(181,660	)	$	(64,930	)

GAAP net loss	$	(107,526	)	$	(71,670	)	$	(312,459	)	$	(153,238	)
Amortization of intangible assets	491			503			1,457			1,265
Stock-based compensation expense and related employer payroll tax payments	35,557			55,700			127,831			88,002
Change in fair value of contingent consideration	970			70			1,845			(120		)
Acquisition related expenses	—			—			—			9,707
Non-GAAP net loss	$	(70,508	)	$	(15,397	)	$	(181,326	)	$	(54,384	)

GAAP net loss attributable to Guardant Health, Inc. common stockholders	$	(107,526	)	$	(77,670	)	$	(314,759	)	$	(160,038	)
Amortization of intangible assets	491			503			1,457			1,265
Stock-based compensation expense and related employer payroll tax payments	35,557			55,700			127,831			88,002
Change in fair value of contingent consideration	970			70			1,845			(120		)
Acquisition related expenses	—			—			—			9,707
Adjustments relating to non-controlling interest	—			6,000			2,300			6,800
Non-GAAP net loss attributable to Guardant Health, Inc. common stockholders	$	(70,508	)	$	(15,397	)	$	(181,326	)	$	(54,384	)

GAAP net loss per share attributable to Guardant Health, Inc., common stockholders, basic and diluted	$	(1.06	)	$	(0.78	)	$	(3.11	)	$	(1.66	)
Non-GAAP net loss per share attributable to Guardant Health, Inc., common stockholders, basic and diluted	$	(0.70	)	$	(0.15	)	$	(1.79	)	$	(0.56	)
Weighted-average shares used in computing GAAP and Non-GAAP net loss per share, basic and diluted	101,420			99,554			101,184			96,659

Guardant Health, Inc.
Reconciliation of GAAP Net Loss Attributable to Guardant Health, Inc. Common Stockholders
to Adjusted EBITDA
(unaudited)
(in thousands)

	Three Months Ended September 30,						Nine Months Ended September 30,
	2021			2020			2021			2020

GAAP net loss attributable to Guardant Health, Inc. common stockholders	$	(107,526	)	$	(77,670	)	$	(314,759	)	$	(160,038	)
Interest income	(689		)	(2,313		)	(3,277		)	(8,271		)
Interest expense	644			8			1,934			30
Other (income) expense, net	187			(345		)	720			(2,421		)
Provision for income taxes	96			68			289			116
Depreciation and amortization	5,544			4,353			16,181			11,462
Stock-based compensation expense and related employer payroll tax payments	35,557			55,700			127,831			88,002
Change in fair value of contingent consideration	970			70			1,845			(120		)
Acquisition related expenses	—			—			—			9,707
Adjustments relating to non-controlling interest	—			6,000			2,300			6,800
Adjusted EBITDA	$	(65,217	)	$	(14,129	)	$	(166,936	)	$	(54,733	)

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Guardant Health Reports Third Quarter 2021 Financial Results