Business Wire | Nov 4, 2021 04:05PM EDT

Guardant Health Reports Third Quarter 2021 Financial Results

Nov. 04, 2021

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Nov. 04, 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 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(tm) 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(r) 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(r), Guardant360 CDx, Guardant360 TissueNext(tm), Guardant360 Response(tm), and GuardantOMNI(r) tests for advanced stage cancer patients, and Guardant Reveal(tm) 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 Nine Months Ended September 30, 30,

2021 2020 2021 2020



Revenue:

Precision $ 79,272 $ 60,384 $ 215,605 $ 171,621 oncology testing

Developmentservices and 15,507 14,185 49,940 36,793 other

Total revenue 94,779 74,569 265,545 208,414

Costs andoperating expenses:

Cost ofprecision 29,665 16,699 78,142 52,699 oncology testing

Cost ofdevelopment 1,151 4,488 11,348 11,429 services andother

Research anddevelopment 70,968 36,245 190,200 109,580 expense

Sales andmarketing 50,228 25,095 132,282 75,225 expense

General andadministrative 50,055 66,294 166,366 123,265 expense

Total costs andoperating 202,067 148,821 578,338 372,198 expenses

Loss from (107,288 ) (74,252 ) (312,793 ) (163,784 ) operations

Interest income 689 2,313 3,277 8,271

Interest expense (644 ) (8 ) (1,934 ) (30 )

Other income (187 ) 345 (720 ) 2,421 (expense), net

Loss beforeprovision for (107,430 ) (71,602 ) (312,170 ) (153,122 ) income taxes

Provision for 96 68 289 116 income taxes

Net loss (107,526 ) (71,670 ) (312,459 ) (153,238 )

Adjustment ofredeemable - (6,000 ) (2,300 ) (6,800 ) noncontrollinginterest

Net lossattributable toGuardant Health, $ (107,526 ) $ (77,670 ) $ (314,759 ) $ (160,038 ) Inc. commonstockholders

Net loss pershareattributable toGuardant Health, $ (1.06 ) $ (0.78 ) $ (3.11 ) $ (1.66 ) Inc. commonstockholders,basic anddiluted

Weighted-averageshares used incomputing netloss per shareattributable to 101,420 99,554 101,184 96,659 Guardant Health,Inc. commonstockholders,basic anddiluted

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.

Condensed Consolidated Balance Sheets (unaudited)

(in thousands, except share and per share data)

September 30, December 31, 2021 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, 21,958 17,466 net

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 pershare; 350,000,000 shares authorized as ofSeptember 30, 2021 and December 31, 2020; 1 1 101,623,257 and 100,213,985 shares issued andoutstanding as of September 30, 2021 andDecember 31, 2020, respectively

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 $ 2,225,534 $ 2,271,781 Interest and Stockholders' Equity

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 Selected GAAP Measures to Non-GAAP Measures

(unaudited)

(in thousands)



Three Months Ended September Nine Months Ended September 30, 30,

2021 2020 2021 2020



GAAP cost ofprecision $ 29,665 $ 16,699 $ 78,142 $ 52,699 oncology testing

Amortization ofintangible (152 ) - (449 ) (141 ) assets

Stock-basedcompensationexpense and (762 ) (450 ) (2,449 ) (1,166 ) related employerpayroll taxpayments

Non-GAAP cost ofprecision $ 28,751 $ 16,249 $ 75,244 $ 51,392 oncology testing



GAAP researchand development $ 70,968 $ 36,245 $ 190,200 $ 109,580 expense

Amortization ofintangible - - - (43 ) assets

Stock-basedcompensationexpense and (4,624 ) (2,474 ) (13,674 ) (7,503 ) related employerpayroll taxpayments

Acquisition - - - (8,500 ) related expenses

Non-GAAPresearch and $ 66,344 $ 33,771 $ 176,526 $ 93,534 developmentexpense



GAAP sales andmarketing $ 50,228 $ 25,095 $ 132,282 $ 75,225 expense

Stock-basedcompensationexpense and (4,127 ) (2,379 ) (10,554 ) (6,374 ) related employerpayroll taxpayments

Non-GAAP salesand marketing $ 46,101 $ 22,716 $ 121,728 $ 68,851 expense



GAAP general andadministrative $ 50,055 $ 66,294 $ 166,366 $ 123,265 expense

Amortization ofintangible (339 ) (503 ) (1,008 ) (1,081 ) assets

Stock-basedcompensationexpense and (26,044 ) (50,397 ) (101,154 ) (72,959 ) related employerpayroll taxpayments

Change in fairvalue of (970 ) (70 ) (1,845 ) 120 contingentconsideration

Acquisition - - - (1,207 ) related expenses

Non-GAAP generaland $ 22,702 $ 15,324 $ 62,359 $ 48,138 administrativeexpense



GAAP loss from $ (107,288 ) $ (74,252 ) $ (312,793 ) $ (163,784 ) operations

Amortization ofintangible 491 503 1,457 1,265 assets

Stock-basedcompensationexpense and 35,557 55,700 127,831 88,002 related employerpayroll taxpayments

Change in fairvalue of 970 70 1,845 (120 ) contingentconsideration

Acquisition - - - 9,707 related expenses

Non-GAAP loss $ (70,270 ) $ (17,979 ) $ (181,660 ) $ (64,930 ) from operations



GAAP net loss $ (107,526 ) $ (71,670 ) $ (312,459 ) $ (153,238 )

Amortization ofintangible 491 503 1,457 1,265 assets

Stock-basedcompensationexpense and 35,557 55,700 127,831 88,002 related employerpayroll taxpayments

Change in fairvalue of 970 70 1,845 (120 ) contingentconsideration

Acquisition - - - 9,707 related expenses

Non-GAAP net $ (70,508 ) $ (15,397 ) $ (181,326 ) $ (54,384 ) loss



GAAP net lossattributable toGuardant Health, $ (107,526 ) $ (77,670 ) $ (314,759 ) $ (160,038 ) Inc. commonstockholders

Amortization ofintangible 491 503 1,457 1,265 assets

Stock-basedcompensationexpense and 35,557 55,700 127,831 88,002 related employerpayroll taxpayments

Change in fairvalue of 970 70 1,845 (120 ) contingentconsideration

Acquisition - - - 9,707 related expenses

Adjustmentsrelating to - 6,000 2,300 6,800 non-controllinginterest

Non-GAAP netlossattributable to $ (70,508 ) $ (15,397 ) $ (181,326 ) $ (54,384 ) Guardant Health,Inc. commonstockholders



GAAP net lossper shareattributable toGuardant Health, $ (1.06 ) $ (0.78 ) $ (3.11 ) $ (1.66 ) Inc., commonstockholders,basic anddiluted

Non-GAAP netloss per shareattributable toGuardant Health, $ (0.70 ) $ (0.15 ) $ (1.79 ) $ (0.56 ) Inc., commonstockholders,basic anddiluted

Weighted-averageshares used incomputing GAAPand Non-GAAP net 101,420 99,554 101,184 96,659 loss per share,basic anddiluted

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

)

View source version on businesswire.com: https://www.businesswire.com/news/home/20211104006257/en/

CONTACT: Investor Contact: Carrie Mendivil investors@guardanthealth.com

CONTACT: Media Contact: Michele Rest press@guardanthealth.com

CONTACT: Julie Johnson julie.johnson@uncappedcommunications.com