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Guardant Health Reports First Quarter 2021 Financial Results

Nachrichtenquelle: Business Wire (engl.)
06.05.2021, 22:05  |  143   |   |   

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, today reported financial results for the quarter ended March 31, 2021.

Recent Highlights

  • Revenue of $78.7 million for the first quarter of 2021, an increase of 17% over the corresponding period of 2020
  • Reported 18,390 tests to clinical customers and 3,522 tests to biopharmaceutical customers in the first quarter of 2021, representing an increase of 21% and a decrease of 33%, respectively, over the first quarter of 2020
  • Successfully launched Guardant Reveal, the first blood-only test with a 7-day turnaround time, for residual disease and recurring monitoring in patients with early-stage colorectal cancer and received positive early feedback from oncologists
  • Received Advanced Diagnostic Laboratory Test (ADLT) status for the Guardant360 CDx test to be reimbursed at a rate of $5,000 effective April 1, 2021, for all Medicare patients
  • Study led by Massachusetts General Hospital Cancer Center and published in Clinical Cancer Research demonstrated that Guardant Reveal identifies patients most likely to recur with high clinical accuracy
  • Appointed Dr. Craig Eagle as Chief Medical Officer

“I am proud of our team for their continued hard work this quarter. Despite continuing impacts of COVID, we achieved record revenue and solid growth in our clinical business, and continued to progress our product pipeline,” said Helmy Eltoukhy, PhD, co-founder and CEO. “I am so excited about what is ahead for Guardant and believe 2021 will be a pivotal year for us as we expand our product portfolio and invest across our business to build the foundations for complete cancer testing across the continuum of care.”

First Quarter 2021 Financial Results

Revenue was $78.7 million for the three months ended March 31, 2021, a 17% increase from $67.5 million for the three months ended March 31, 2020. Precision oncology revenue grew 6% driven predominantly by an increase in clinical testing revenue which grew 31% over the prior year period. There were 18,390 clinical tests and 3,522 biopharmaceutical tests performed during the first quarter of 2021. Development services and other revenue increased 106% primarily related to the timing of project related milestones for companion diagnostic development programs.

Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $49.9 million for the first quarter of 2021, an increase of $2.9 million from $47.0 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 63%, as compared to 70% for the corresponding prior year period.

Operating expenses were $157.8 million for the first quarter of 2021, as compared to $81.9 million for the corresponding prior year period, an increase of 93%. Non-GAAP operating expenses were $100.7 million for the first quarter of 2021, as compared to $65.9 million for the corresponding prior year period.

Net loss attributable to Guardant Health, Inc. common stockholders was $109.7 million for the first quarter of 2021, as compared to $27.7 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $1.09 for the first quarter of 2021, as compared to $0.29 for the corresponding prior year period. Non-GAAP net loss was $49.4 million for the first quarter of 2021, as compared to $15.4 million for the corresponding prior year period. Non-GAAP net loss per share was $0.49 for the first quarter of 2021, as compared to $0.16 for the corresponding prior year period.

Adjusted EBITDA loss was $45.4 million for the first quarter of 2021, as compared to a $15.5 million loss for the corresponding prior year period.

Cash, cash equivalents and marketable securities were $1.9 billion as of March 31, 2021.

2021 Guidance

Guardant Health now 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. 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 first quarter 2021 financial results after market close on Thursday, May 6, 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 blood tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched liquid biopsy-based Guardant360, Guardant360 CDx, 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 March 31,

 

2021

 

2020

 

 

 

 

Revenue:

 

 

 

Precision oncology testing

$

63,729

 

 

$

60,246

 

Development services and other

14,936

 

 

7,264

 

Total revenue

78,665

 

 

67,510

 

Costs and operating expenses:

 

 

 

Cost of precision oncology testing

23,590

 

 

18,191

 

Cost of development services and other

5,157

 

 

2,315

 

Research and development expense

55,508

 

 

37,016

 

Sales and marketing expense

34,338

 

 

25,115

 

General and administrative expense

67,935

 

 

19,785

 

Total costs and operating expenses

186,528

 

 

102,422

 

Loss from operations

(107,863)

 

 

(34,912)

 

Interest income

1,551

 

 

3,318

 

Interest expense

(646)

 

 

(12)

 

Other expense, net

(290)

 

 

(209)

 

Loss before provision for income taxes

(107,248)

 

 

(31,815)

 

Provision for (benefit from) income taxes

110

 

 

14

 

Net loss

(107,358)

 

 

(31,829)

 

Adjustment of redeemable noncontrolling interest

(2,300)

 

 

4,100

 

Net loss attributable to Guardant Health, Inc. common stockholders

$

(109,658)

 

 

$

(27,729)

 

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

$

(1.09)

 

 

$

(0.29)

 

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

100,955

 

 

94,382

 

Guardant Health, Inc.

Condensed Consolidated Balance Sheets (unaudited)

(in thousands, except share and per share data)

 

March 31, 2021

 

December 31,
2020

ASSETS

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

869,372

 

 

$

832,977

 

Short-term marketable securities

1,071,078

 

 

961,903

 

Accounts receivable, net

48,039

 

 

53,299

 

Inventory

28,876

 

 

22,716

 

Prepaid expenses and other current assets, net

15,679

 

 

17,466

 

Total current assets

2,033,044

 

 

1,888,361

 

Long-term marketable securities

 

 

246,597

 

Property and equipment, net

71,765

 

 

62,782

 

Right-of-use assets

205,671

 

 

37,343

 

Intangible assets, net

15,674

 

 

16,155

 

Goodwill

3,290

 

 

3,290

 

Other assets, net

17,297

 

 

17,253

 

Total Assets

$

2,346,741

 

 

$

2,271,781

 

LIABILITIES, REDEEMABLE NONCONTROLLING INTEREST AND STOCKHOLDERS’ EQUITY

 

 

 

Current liabilities:

 

 

 

Accounts payable

$

22,318

 

 

$

7,340

 

Accrued compensation

37,180

 

 

28,280

 

Accrued expenses

27,643

 

 

22,639

 

Deferred revenue

8,360

 

 

8,550

 

Total current liabilities

95,501

 

 

66,809

 

Convertible senior notes, net

1,132,899

 

 

806,292

 

Long-term operating lease liabilities

210,244

 

 

41,565

 

Other long-term liabilities

1,651

 

 

1,520

 

Total Liabilities

1,440,295

 

 

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 March 31, 2021 and December 31, 2020; 101,085,653 and 100,213,985 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively

1

 

 

1

 

Additional paid-in capital

1,557,954

 

 

1,902,389

 

Accumulated other comprehensive income

904

 

 

2,697

 

Accumulated deficit

(711,813)

 

 

(606,592)

 

Total Stockholders’ Equity

847,046

 

 

1,298,495

 

Total Liabilities, Redeemable Noncontrolling Interest and Stockholders’ Equity

$

2,346,741

 

 

$

2,271,781

 

Guardant Health, Inc.

Reconciliation of Selected GAAP Measures to Non-GAAP Measures

(unaudited)

(in thousands)

 

 

 

Three Months Ended March 31,

 

2021

 

2020

 

 

 

 

GAAP cost of precision oncology testing

$

23,590

 

 

$

18,191

 

Amortization of intangible assets

(148)

 

 

 

Stock-based compensation expense and related employer payroll tax payments

(799)

 

 

(322)

 

Non-GAAP cost of precision oncology testing

$

22,643

 

 

$

17,869

 

 

 

 

 

GAAP research and development expense

$

55,508

 

 

$

37,016

 

Stock-based compensation expense and related employer payroll tax payments

(4,391)

 

 

(2,472)

 

Acquisition related expenses

 

 

(8,500)

 

Non-GAAP research and development expense

$

51,117

 

 

$

26,044

 

 

 

 

 

GAAP sales and marketing expense

$

34,338

 

 

$

25,115

 

Stock-based compensation expense and related employer payroll tax payments

(2,934)

 

 

(1,930)

 

Non-GAAP sales and marketing expense

$

31,404

 

 

$

23,185

 

 

 

 

 

GAAP general and administrative expense

$

67,935

 

 

$

19,785

 

Amortization of intangible assets

(333)

 

 

(229)

 

Stock-based compensation expense and related employer payroll tax payments

(49,375)

 

 

(1,911)

 

Change in fair value of contingent consideration

 

 

190

 

Acquisition related expenses

 

 

(1,207)

 

Non-GAAP general and administrative expense

$

18,227

 

 

$

16,628

 

 

 

 

 

GAAP loss from operations

$

(107,863)

 

 

$

(34,912)

 

Amortization of intangible assets

333

 

 

229

 

Stock-based compensation expense and related employer payroll tax payments

56,700

 

 

6,313

 

Change in fair value of contingent consideration

 

 

(190)

 

Acquisition related expenses

 

 

9,707

 

Non-GAAP loss from operations

$

(50,830)

 

 

$

(18,853)

 

 

 

 

 

GAAP net loss

$

(107,358)

 

 

$

(31,829)

 

Amortization of intangible assets

481

 

 

229

 

Stock-based compensation expense and related employer payroll tax payments

57,499

 

 

6,635

 

Change in fair value of contingent consideration

 

 

(190)

 

Acquisition related expenses

 

 

9,707

 

Non-GAAP net loss

$

(49,378)

 

 

$

(15,448)

 

 

 

 

 

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

$

(109,658)

 

 

$

(27,729)

 

Amortization of intangible assets

481

 

 

229

 

Stock-based compensation expense and related employer payroll tax payments

57,499

 

 

6,635

 

Change in fair value of contingent consideration

 

 

(190)

 

Acquisition related expenses

 

 

9,707

 

Adjustments relating to non-controlling interest

2,300

 

 

(4,100)

 

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

$

(49,378)

 

 

$

(15,448)

 

 

 

 

 

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

$

(1.09)

 

 

$

(0.29)

 

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

$

(0.49)

 

 

$

(0.16)

 

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

100,955

 

 

94,382

 

Guardant Health, Inc.

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

(unaudited)

(in thousands)

 

Three Months Ended March 31,

 

2021

 

2020

 

 

 

 

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

$

(109,658)

 

 

$

(27,729)

 

Interest income

(1,551)

 

 

(3,318)

 

Interest expense

646

 

 

12

 

Other expense, net

290

 

 

209

 

Provision for (benefit from) income taxes

110

 

 

14

 

Depreciation and amortization

5,010

 

 

3,304

 

Stock-based compensation expense and related employer payroll tax payments

57,499

 

 

6,635

 

Change in fair value of contingent consideration

 

 

(190)

 

Acquisition related expenses

 

 

9,707

 

Adjustments relating to non-controlling interest

2,300

 

 

(4,100)

 

Adjusted EBITDA

$

(45,354)

 

 

$

(15,456)

 

 

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Disclaimer

Guardant Health Reports First Quarter 2021 Financial Results Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, today reported financial results for the quarter …

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