Guardant Health Reports Fourth Quarter and Full Year 2022 Financial Results and Provides 2023 Outlook

Q4 clinical and biopharma volumes up 41% and 24% year over year

PALO ALTO, Calif.--()--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 and full year ended December 31, 2022.

Fourth Quarter 2022 Financial Highlights

  • Revenue of $126.9 million for the fourth quarter of 2022, an increase of 17% over the fourth quarter of 2021.
  • Reported 36,000 tests to clinical customers and 8,200 tests to biopharmaceutical customers in the fourth quarter of 2022, representing an increase of 41% and 24%, respectively, over the fourth quarter of 2021.

Full Year 2022 Financial Highlights

  • Revenue of $449.5 million for the full year 2022, an increase of 20% over the full year 2021.
  • Reported 124,800 tests to clinical customers and 26,000 tests to biopharmaceutical customers in the full year 2022, representing an increase of 42% and 40%, respectively, over the full year 2021.

Recent Highlights

  • Demonstrated 83% sensitivity and 90% specificity in pivotal ECLIPSE study evaluating Shield for colorectal cancer detection. Separately, Guardant Shield LDT has shown greater than 90% adherence in real world settings.
  • Announced FDA approval for Guardant360 CDx as companion diagnostic for ORSERDU for treatment of patients with ESR1 mutations in ER+, HER2- advanced or metastatic breast cancer.
  • Obtained coverage for Guardant360 CDx tests in lung and breast cancer from United Healthcare.
  • Introduced Guardant Galaxy suite of advanced AI analytics in partnership with Lunit to enhance our portfolio of cancer tests starting with the Guardant360 TissueNext PD-L1 test, shown to improve biomarker detection by >20% in NSCLC.

“2022 marked another year of great progress at Guardant Health. We achieved record revenues and volumes during the year, launched new offerings in minimal residual disease with multi cancer Reveal and expanded market access for our tests. We also launched our Smart Liquid Biopsy platform, which we believe will drive the next chapter of growth for our oncology business and enable significant R&D efficiency and operating leverage. With the approval of our first companion diagnostic in breast cancer and expanded payor coverage, we are poised for continued strong growth in the year ahead,” said Helmy Eltoukhy, co-founder and co-CEO.

“In December, we reported successful results in our pivotal ECLIPSE study for colorectal cancer screening with 83% sensitivity at 90% specificity. With over 90% of individuals completing the blood-based screening test, Shield significantly improves adherence rates and adds an important new option for patients and healthcare providers to boost screening rates, detect more cancers and save countless lives,” said AmirAli Talasaz, co-founder and co-CEO. “We intend to complete our submission to FDA in the first quarter of 2023 as we continue our research and development efforts in screening for lung and additional cancers.”

Fourth Quarter 2022 Financial Results

Revenue was $126.9 million for the three months ended December 31, 2022, a 17% increase from $108.1 million for the three months ended December 31, 2021. Precision oncology revenue grew 28%, driven predominantly by an increase in clinical testing volume and biopharma sample volume, which grew 41% and 24%, respectively, over the prior year period. Development services and other revenue decreased by 33%, primarily due to a one-time catch-up royalty payment that was recognized in the fourth quarter of 2021.

Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $79.8 million for the fourth quarter of 2022, an increase of $5.1 million from $74.7 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 63%, as compared to 69% for the corresponding prior year period.

Operating expenses were $225.9 million for the fourth quarter of 2022, as compared to $172.9 million for the corresponding prior year period, an increase of 31%. Non-GAAP operating expenses were $201.2 million for the fourth quarter of 2022, as compared to $146.2 million for the corresponding prior year period.

Net loss attributable to Guardant Health, Inc. common stockholders was $139.9 million for the fourth quarter of 2022, as compared to $90.9 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $1.36 for the fourth quarter of 2022, as compared to $0.89 for the corresponding prior year period. Non-GAAP net loss was $119.6 million for the fourth quarter of 2022, as compared to $70.4 million for the corresponding prior year period. Non-GAAP net loss per share was $1.17 for the fourth quarter of 2022, as compared to $0.69 for the corresponding prior year period.

Adjusted EBITDA loss was $109.8 million for the fourth quarter of 2022, as compared to a $64.6 million loss for the corresponding prior year period.

Full Year 2022 Financial Results

Revenue was $449.5 million for the year ended December 31, 2022, a 20% increase from $373.7 million for the year ended December 31, 2021. Precision oncology revenue grew 29%, driven predominantly by an increase in clinical testing volume and biopharma sample volume, which grew 42% and 40%, respectively, over the prior year period. Development services and other revenue decreased by 17%, primarily due to the change in collaboration projects with biopharmaceutical customers for companion diagnostic development and regulatory approval services, and discontinuation of our Guardant-19 tests in August 2021, partially offset by revenues earned from licensing our technologies, and providing data services during the year ended December 31, 2022.

Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $293.2 million for 2022, an increase of $42.5 million from $250.7 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 65%, as compared to 67% for the corresponding prior year period.

Operating expenses were $837.6 million for 2022, as compared to $661.7 million for the corresponding prior year period, an increase of 27%. Non-GAAP operating expenses were $736.6 million for 2022, as compared to $506.8 million for the corresponding prior year period.

Net loss attributable to Guardant Health, Inc. common stockholders was $654.6 million for 2022, as compared to $405.7 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $6.41 for 2022, as compared to $4.00 for the corresponding prior year period. Non-GAAP net loss was $435.4 million for 2022, as compared to $251.7 million for the corresponding prior year period. Non-GAAP net loss per share was $4.26 for 2022, as compared to $2.48 for the corresponding prior year period.

Adjusted EBITDA loss was $403.4 million for 2022, as compared to a $231.5 million loss for the corresponding prior year period.

Cash, cash equivalents and marketable debt securities were $1.0 billion as of December 31, 2022.

2023 Guidance

Guardant Health expects full year 2023 revenue to be in the range of $525 million to $540 million, representing growth of 17% to 20% compared to full year 2022.

We expect full year 2023 operating expenses to be below full year 2022, and free cash outflow to be approximately $350 million in 2023.

Webcast Information

Guardant Health will host a conference call to discuss the fourth quarter and full year 2022 financial results after market close on Thursday, February 23, 2023 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 of noncontrolling interest liability, adjustments relating to redeemable noncontrolling interest, contingent consideration, acquisition related expenses, amortization of intangible assets, fair value adjustments on marketable equity securities, impairment of other 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 income taxes; depreciation and amortization expense; stock-based compensation expense and related employer payroll tax payments; changes in estimated fair value of noncontrolling interest liability; adjustments relating to redeemable noncontrolling 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. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of 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, 2022, 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.

Guardant Health, Inc.

Condensed Consolidated Statements of Operations

(unaudited)

(in thousands, except per share data)

 

 

 

 

 

 

 

 

 

Three Months Ended December 31,

 

Twelve Months Ended December 31,

 

2022

 

2021

 

2022

 

2021

 

 

 

 

 

 

 

 

Revenue:

 

 

 

 

 

 

 

Precision oncology testing

$

113,797

 

 

$

88,707

 

 

$

392,049

 

 

$

304,312

 

Development services and other

 

13,094

 

 

 

19,401

 

 

 

57,489

 

 

 

69,341

 

Total revenue

 

126,891

 

 

 

108,108

 

 

 

449,538

 

 

 

373,653

 

Costs and operating expenses:

 

 

 

 

 

 

 

Cost of precision oncology testing

 

43,706

 

 

 

32,254

 

 

 

148,199

 

 

 

110,396

 

Cost of development services and other

 

3,415

 

 

 

1,168

 

 

 

8,126

 

 

 

12,516

 

Research and development expense

 

106,578

 

 

 

73,021

 

 

 

373,807

 

 

 

263,221

 

Sales and marketing expense

 

81,423

 

 

 

59,599

 

 

 

299,828

 

 

 

191,881

 

General and administrative expense

 

37,888

 

 

 

40,274

 

 

 

163,956

 

 

 

206,640

 

Total costs and operating expenses

 

273,010

 

 

 

206,316

 

 

 

993,916

 

 

 

784,654

 

Loss from operations

 

(146,119

)

 

 

(98,208

)

 

 

(544,378

)

 

 

(411,001

)

Interest income

 

2,150

 

 

 

653

 

 

 

6,069

 

 

 

3,930

 

Interest expense

 

(644

)

 

 

(643

)

 

 

(2,577

)

 

 

(2,577

)

Other income (expense), net

 

5,281

 

 

 

25,898

 

 

 

(12,778

)

 

 

25,178

 

Fair value adjustments of noncontrolling interest liability

 

 

 

 

 

 

 

(99,785

)

 

 

 

Loss before provision for income taxes

 

(139,332

)

 

 

(72,300

)

 

 

(653,449

)

 

 

(384,470

)

Provision for income taxes

 

602

 

 

 

11

 

 

 

1,139

 

 

 

300

 

Net loss

 

(139,934

)

 

 

(72,311

)

 

 

(654,588

)

 

 

(384,770

)

Adjustment of redeemable noncontrolling interest

 

 

 

 

(18,600

)

 

 

 

 

 

(20,900

)

Net loss attributable to Guardant Health, Inc. common stockholders

$

(139,934

)

 

$

(90,911

)

 

$

(654,588

)

 

$

(405,670

)

Net loss per share attributable to Guardant Health, Inc. common stockholders, basic and diluted

$

(1.36

)

 

$

(0.89

)

 

$

(6.41

)

 

$

(4.00

)

Weighted-average shares used in computing net loss per share attributable to Guardant Health, Inc. common stockholders, basic and diluted

 

102,516

 

 

 

101,697

 

 

 

102,178

 

 

 

101,314

 

Guardant Health, Inc.

Condensed Consolidated Balance Sheets (unaudited)

(in thousands, except share and per share data)

 

 

December 31, 2022

 

December 31, 2021

ASSETS

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

141,647

 

 

$

492,202

 

Short-term marketable debt securities

 

869,584

 

 

 

440,546

 

Accounts receivable, net

 

97,256

 

 

 

97,652

 

Inventory, net

 

51,598

 

 

 

30,674

 

Prepaid expenses and other current assets, net

 

31,509

 

 

 

53,052

 

Total current assets

 

1,191,594

 

 

 

1,114,126

 

Long-term marketable debt securities

 

 

 

 

698,034

 

Property and equipment, net

 

167,920

 

 

 

124,461

 

Right-of-use assets, net

 

174,001

 

 

 

189,443

 

Intangible assets, net

 

11,727

 

 

 

14,207

 

Goodwill

 

3,290

 

 

 

3,290

 

Other assets, net

 

61,453

 

 

 

60,938

 

Total Assets

$

1,609,985

 

 

$

2,204,499

 

LIABILITIES, REDEEMABLE NONCONTROLLING INTEREST AND STOCKHOLDERS’ EQUITY

 

 

 

Current liabilities:

 

 

 

Accounts payable and accrued liabilities

 

175,817

 

 

 

105,361

 

Noncontrolling interest liability

 

 

 

 

78,000

 

Deferred revenue

 

17,403

 

 

 

11,326

 

Total current liabilities

 

193,220

 

 

 

194,687

 

Convertible senior notes, net

 

1,137,391

 

 

 

1,134,821

 

Long-term operating lease liabilities

 

210,015

 

 

 

226,053

 

Other long-term liabilities

 

9,179

 

 

 

3,933

 

Total Liabilities

 

1,549,805

 

 

 

1,559,494

 

Stockholders’ equity:

 

 

 

Common stock, par value of $0.00001 per share; 350,000,000 shares authorized as of December 31, 2022 and December 31, 2021; 102,619,383 and 101,767,446 shares issued and outstanding as of December 31, 2022 and December 31, 2021, respectively

 

1

 

 

 

1

 

Additional paid-in capital

 

1,742,114

 

 

 

1,657,593

 

Accumulated other comprehensive loss

 

(19,522

)

 

 

(4,764

)

Accumulated deficit

 

(1,662,413

)

 

 

(1,007,825

)

Total Stockholders’ Equity

 

60,180

 

 

 

645,005

 

Total Liabilities and Stockholders’ Equity

$

1,609,985

 

 

$

2,204,499

 

Guardant Health, Inc.

Reconciliation of Selected GAAP Measures to Non-GAAP Measures

(unaudited)

(in thousands, except per share data)

 

 

 

 

 

Three Months Ended December 31,

 

Twelve Months Ended December 31,

 

2022

 

2021

 

2022

 

2021

 

 

 

 

 

 

 

 

GAAP cost of precision oncology testing

$

43,706

 

 

$

32,254

 

 

$

148,199

 

 

$

110,396

 

Amortization of intangible assets

 

(351

)

 

 

(152

)

 

 

(933

)

 

 

(601

)

Stock-based compensation expense and related employer payroll tax payments

 

(1,793

)

 

 

(1,174

)

 

 

(5,575

)

 

 

(3,623

)

Non-GAAP cost of precision oncology testing

$

41,562

 

 

$

30,928

 

 

$

141,691

 

 

$

106,172

 

 

 

 

 

 

 

 

 

GAAP research and development expense

$

106,578

 

 

$

73,021

 

 

$

373,807

 

 

$

263,221

 

Stock-based compensation expense and related employer payroll tax payments

 

(8,071

)

 

 

(5,696

)

 

 

(26,928

)

 

 

(19,370

)

Contingent consideration

 

(2,577

)

 

 

 

 

 

(5,229

)

 

 

 

Non-GAAP research and development expense

$

95,930

 

 

$

67,325

 

 

$

341,650

 

 

$

243,851

 

 

 

 

 

 

 

 

 

GAAP sales and marketing expense

$

81,423

 

 

$

59,599

 

 

$

299,828

 

 

$

191,881

 

Amortization of intangible assets

 

 

 

 

 

 

 

(201

)

 

 

 

Stock-based compensation expense and related employer payroll tax payments

 

(7,399

)

 

 

(5,208

)

 

 

(25,666

)

 

 

(15,762

)

Non-GAAP sales and marketing expense

$

74,024

 

 

$

54,391

 

 

$

273,961

 

 

$

176,119

 

 

 

 

 

 

 

 

 

GAAP general and administrative expense

$

37,888

 

 

$

40,274

 

 

$

163,956

 

 

$

206,640

 

Amortization of intangible assets

 

(339

)

 

 

(339

)

 

 

(1,346

)

 

 

(1,347

)

Stock-based compensation expense and related employer payroll tax payments

 

(6,240

)

 

 

(14,951

)

 

 

(37,282

)

 

 

(116,105

)

Contingent consideration

 

(110

)

 

 

(535

)

 

 

(4,305

)

 

 

(2,380

)

Non-GAAP general and administrative expense

$

31,199

 

 

$

24,449

 

 

$

121,023

 

 

$

86,808

 

 

 

 

 

 

 

 

 

GAAP loss from operations

$

(146,119

)

 

$

(98,208

)

 

$

(544,378

)

 

$

(411,001

)

Amortization of intangible assets

 

690

 

 

 

491

 

 

 

2,480

 

 

 

1,948

 

Stock-based compensation expense and related employer payroll tax payments

 

23,503

 

 

 

27,029

 

 

 

95,451

 

 

 

154,860

 

Contingent consideration

 

2,687

 

 

 

535

 

 

 

9,534

 

 

 

2,380

 

Non-GAAP loss from operations

$

(119,239

)

 

$

(70,153

)

 

$

(436,913

)

 

$

(251,813

)

 

 

 

 

 

 

 

 

GAAP net loss

$

(139,934

)

 

$

(72,311

)

 

$

(654,588

)

 

$

(384,770

)

Amortization of intangible assets

 

690

 

 

 

491

 

 

 

2,480

 

 

 

1,948

 

Stock-based compensation expense and related employer payroll tax payments

 

23,503

 

 

 

27,029

 

 

 

95,451

 

 

 

154,860

 

Contingent consideration

 

2,687

 

 

 

535

 

 

 

9,534

 

 

 

2,380

 

Unrealized (gains) losses on marketable equity securities

 

(5,437

)

 

 

 

 

 

7,793

 

 

 

 

Impairment of other assets

 

 

 

 

 

 

 

5,261

 

 

 

 

Fair value adjustments of noncontrolling interest liability

 

 

 

 

 

 

 

99,785

 

 

 

 

Non-recurring other income

 

(1,100

)

 

 

(26,100

)

 

 

(1,100

)

 

 

(26,100

)

Non-GAAP net loss

$

(119,591

)

 

$

(70,356

)

 

$

(435,384

)

 

$

(251,682

)

 

 

 

 

 

 

 

 

GAAP net loss attributable to Guardant Health, Inc. common stockholders

$

(139,934

)

 

$

(90,911

)

 

$

(654,588

)

 

$

(405,670

)

Amortization of intangible assets

 

690

 

 

 

491

 

 

 

2,480

 

 

 

1,948

 

Stock-based compensation expense and related employer payroll tax payments

 

23,503

 

 

 

27,029

 

 

 

95,451

 

 

 

154,860

 

Contingent consideration

 

2,687

 

 

 

535

 

 

 

9,534

 

 

 

2,380

 

Non-recurring other income

 

(1,100

)

 

 

(26,100

)

 

 

(1,100

)

 

 

(26,100

)

Unrealized (gains) losses on marketable equity securities

 

(5,437

)

 

 

 

 

 

7,793

 

 

 

 

Impairment of other assets

 

 

 

 

 

 

 

5,261

 

 

 

 

Fair value adjustments of noncontrolling interest liability

 

 

 

 

 

 

 

99,785

 

 

 

 

Adjustment of redeemable noncontrolling interest

 

 

 

 

18,600

 

 

 

 

 

 

20,900

 

Non-GAAP net loss attributable to Guardant Health, Inc. common stockholders

$

(119,591

)

 

$

(70,356

)

 

$

(435,384

)

 

$

(251,682

)

 

 

 

 

 

 

 

 

GAAP net loss per share attributable to Guardant Health, Inc., common stockholders, basic and diluted

$

(1.36

)

 

$

(0.89

)

 

$

(6.41

)

 

$

(4.00

)

Non-GAAP net loss per share attributable to Guardant Health, Inc., common stockholders, basic and diluted

$

(1.17

)

 

$

(0.69

)

 

$

(4.26

)

 

$

(2.48

)

Weighted-average shares used in computing GAAP and Non-GAAP net loss per share, basic and diluted

 

102,516

 

 

 

101,697

 

 

 

102,178

 

 

 

101,314

 

Guardant Health, Inc.

Reconciliation of GAAP Net Loss Attributable to Guardant Health, Inc. Common Stockholders

to Adjusted EBITDA

(unaudited)

(in thousands)

 

 

Three Months Ended December 31,

 

Twelve Months Ended December 31,

 

2022

 

2021

 

2022

 

2021

 

 

 

 

 

 

 

 

GAAP net loss attributable to Guardant Health, Inc. common stockholders

$

(139,934

)

 

$

(90,911

)

 

$

(654,588

)

 

$

(405,670

)

Interest income

 

(2,150

)

 

 

(653

)

 

 

(6,069

)

 

 

(3,930

)

Interest expense

 

644

 

 

 

643

 

 

 

2,577

 

 

 

2,577

 

Other (income) expense, net

 

(5,281

)

 

 

(25,898

)

 

 

12,778

 

 

 

(25,178

)

Provision for income taxes

 

602

 

 

 

11

 

 

 

1,139

 

 

 

300

 

Depreciation and amortization

 

10,169

 

 

 

6,090

 

 

 

35,962

 

 

 

22,271

 

Stock-based compensation expense and related employer payroll tax payments

 

23,503

 

 

 

27,029

 

 

 

95,451

 

 

 

154,860

 

Contingent consideration

 

2,687

 

 

 

535

 

 

 

9,534

 

 

 

2,380

 

Fair value adjustments of noncontrolling interest liability

 

 

 

 

 

 

 

99,785

 

 

 

 

Adjustment of redeemable noncontrolling interest

 

 

 

 

18,600

 

 

 

 

 

 

20,900

 

Adjusted EBITDA

$

(109,760

)

 

$

(64,554

)

 

$

(403,431

)

 

$

(231,490

)

 

Contacts

Investor Contact:

investors@guardanthealth.com

Media Contact:

press@guardanthealth.com

Contacts

Investor Contact:

investors@guardanthealth.com

Media Contact:

press@guardanthealth.com