Business Wire | Aug 5, 2021 04:03PM EDT

Guardant Health Reports Second Quarter 2021 Financial Results

Aug. 05, 2021

REDWOOD CITY, Calif.--(BUSINESS WIRE)--Aug. 05, 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(tm) and Response(tm) 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(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 June Six Months Ended June 30, 30,

2021 2020 2021 2020



Revenue:

Precision oncology $ 72,604 $ 50,991 $ 136,333 $ 111,237 testing

Development services and 19,497 15,344 34,433 22,608 other

Total revenue 92,101 66,335 170,766 133,845

Costs and operating expenses:

Cost of precision 24,887 17,809 48,477 36,000 oncology testing

Cost of development 5,040 4,626 10,197 6,941 services and other

Research and development 63,724 36,319 119,232 73,335 expense

Sales and marketing 47,716 25,015 82,054 50,130 expense

General and 48,376 37,186 116,311 56,971 administrative expense

Total costs and 189,743 120,955 376,271 223,377 operating expenses

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), (243 ) 2,285 (533 ) 2,076 net

Loss before provision (97,492 ) (49,705 ) (204,740 ) (81,520 )for income taxes

Provision for income 83 34 193 48 taxes

Net loss (97,575 ) (49,739 ) (204,933 ) (81,568 )

Adjustment of redeemable - (4,900 ) (2,300 ) (800 )noncontrolling interest

Net loss attributable toGuardant Health, Inc. $ (97,575 ) $ (54,639 ) $ (207,233 ) $ (82,368 )common stockholders

Net loss per shareattributable to GuardantHealth, Inc. common $ (0.96 ) $ (0.57 ) $ (2.05 ) $ (0.87 )stockholders, basic anddiluted

Weighted-average sharesused in computing netloss per shareattributable to Guardant 101,172 96,011 101,064 95,196 Health, Inc. commonstockholders, basic anddiluted

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.

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, 2021and December 31, 2020; 101,265,100 and 1 1 100,213,985 shares issued and outstanding as ofJune 30, 2021 and December 31, 2020, respectively

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 $ 2,291,885 $ 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 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

)

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 Selected GAAP Measures to Non-GAAP Measures

(unaudited)

(in thousands)

Three Months Ended June Six Months Ended June 30, 30,

2021 2020 2021 2020



GAAP cost of precision $ 24,887 $ 17,809 $ 48,477 $ 36,000 oncology testing

Amortization of (149 ) (141 ) (297 ) (141 )intangible assets

Stock-based compensationexpense and related (888 ) (394 ) (1,687 ) (716 )employer payroll taxpayments

Non-GAAP cost ofprecision oncology $ 23,850 $ 17,274 $ 46,493 $ 35,143 testing



GAAP research and $ 63,724 $ 36,319 $ 119,232 $ 73,335 development expense

Amortization of - (43 ) - (43 )intangible assets

Stock-based compensationexpense and related (4,659 ) (2,557 ) (9,050 ) (5,029 )employer payroll taxpayments

Acquisition related - - - (8,500 )expenses

Non-GAAP research and $ 59,065 $ 33,719 $ 110,182 $ 59,763 development expense



GAAP sales and marketing $ 47,716 $ 25,015 $ 82,054 $ 50,130 expense

Stock-based compensationexpense and related (3,493 ) (2,065 ) (6,427 ) (3,995 )employer payroll taxpayments

Non-GAAP sales and $ 44,223 $ 22,950 $ 75,627 $ 46,135 marketing expense



GAAP general and $ 48,376 $ 37,186 $ 116,311 $ 56,971 administrative expense

Amortization of (336 ) (349 ) (669 ) (578 )intangible assets

Stock-based compensationexpense and related (25,735 ) (20,651 ) (75,110 ) (22,562 )employer payroll taxpayments

Change in fair value of (875 ) - (875 ) 190 contingent consideration

Acquisition related - - - (1,207 )expenses

Non-GAAP general and $ 21,430 $ 16,186 $ 39,657 $ 32,814 administrative expense



GAAP loss from $ (97,642 ) $ (54,620 ) $ (205,505 ) $ (89,532 )operations

Amortization of 485 533 966 762 intangible assets

Stock-based compensationexpense and related 34,775 25,667 92,274 32,302 employer payroll taxpayments

Change in fair value of 875 - 875 (190 )contingent consideration

Acquisition related - - - 9,707 expenses

Non-GAAP loss from $ (61,507 ) $ (28,420 ) $ (111,390 ) $ (46,951 )operations



GAAP net loss $ (97,575 ) $ (49,739 ) $ (204,933 ) $ (81,568 )

Amortization of 485 533 966 762 intangible assets

Stock-based compensationexpense and related 34,775 25,667 92,274 32,302 employer payroll taxpayments

Change in fair value of 875 - 875 (190 )contingent consideration

Acquisition related - - - 9,707 expenses

Non-GAAP net loss $ (61,440 ) $ (23,539 ) $ (110,818 ) $ (38,987 )



GAAP net lossattributable to Guardant $ (97,575 ) $ (54,639 ) $ (207,233 ) $ (82,368 )Health, Inc. commonstockholders

Amortization of 485 533 966 762 intangible assets

Stock-based compensationexpense and related 34,775 25,667 92,274 32,302 employer payroll taxpayments

Change in fair value of 875 - 875 (190 )contingent consideration

Acquisition related - - - 9,707 expenses

Adjustments relating to - 4,900 2,300 800 non-controlling interest

Non-GAAP net lossattributable to Guardant $ (61,440 ) $ (23,539 ) $ (110,818 ) $ (38,987 )Health, Inc. commonstockholders



GAAP net loss per shareattributable to GuardantHealth, Inc., common $ (0.96 ) $ (0.57 ) $ (2.05 ) $ (0.87 )stockholders, basic anddiluted

Non-GAAP net loss pershare attributable toGuardant Health, Inc., $ (0.61 ) $ (0.25 ) $ (1.10 ) $ (0.41 )common stockholders,basic and diluted

Weighted-average sharesused in computing GAAPand Non-GAAP net loss 101,172 96,011 101,064 95,196 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 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

)

View source version on businesswire.com: https://www.businesswire.com/news/home/20210805006034/en/

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

CONTACT: Media Contact: Anna Czene press@guardanthealth.com