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PALO ALTO, Calif.--(BUSINESS WIRE)--Nov 3, 2022--
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, 2022.
Recent Highlights
“Volume growth accelerated sequentially in clinical oncology, propelling us to new records in revenue and volumes. We made additional strides with Guardant Reveal, expanding its use into multiple cancer indications that now include colorectal, lung and breast cancers. In addition, Guardant Infinity, our first smart liquid biopsy offering, has seen a rapid uptake with our biopharma partners. That said, counter to our expectations earlier in the year, clinical volumes continue to be impacted by a challenging backdrop with lingering access restrictions and provider staffing shortages.” said Helmy Eltoukhy, co-founder and co-CEO.
“During the quarter we made great progress on the ECLIPSE study and are very close to locking our study database with about 70 CRCs. In parallel, our Shield LDT screening test continues to be well received by physicians and patients and has demonstrated outstanding levels of patient adherence,” said AmirAli Talasaz, co-founder and co-CEO. “This positive early response to Shield LDT gives us increased confidence in our ability to develop Shield into a leading non-invasive cancer screening methodology.”
Third Quarter 2022 Financial Results
Revenue was $117.4 million for the three months ended September 30, 2022, a 24% increase from $94.8 million for the three months ended September 30, 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 slightly decreased by 1%.
Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $76.9 million for the third quarter of 2022, an increase of $12.9 million from $64.0 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 66%, as compared to 67% for the corresponding prior year period.
Operating expenses were $221.5 million for the third quarter of 2022, as compared to $171.3 million for the corresponding prior year period, an increase of 29%. Non-GAAP operating expenses were $200.5 million for the third quarter of 2022, as compared to $135.1 million for the corresponding prior year period.
Net loss attributable to Guardant Health, Inc. common stockholders was $162.0 million for the third quarter of 2022, as compared to $107.5 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $1.58 for the third quarter of 2022, as compared to $1.06 for the corresponding prior year period. Non-GAAP net loss was $120.8 million for the third quarter of 2022, as compared to $70.5 million for the corresponding prior year period. Non-GAAP net loss per share was $1.18 for the third quarter of 2022, as compared to $0.70 for the corresponding prior year period.
Adjusted EBITDA loss was $112.8 million for the third quarter of 2022, as compared to a $65.2 million loss for the corresponding prior year period.
Cash, cash equivalents and marketable debt securities were $1.1 billion as of September 30, 2022.
2022 Guidance
Given the continued challenging backdrop and reimbursement delays impacting the clinical oncology business, Guardant Health now expects full year 2022 revenue to be in the range of $440 million to $450 million, representing growth of 18% to 20% compared to full year 2021. This compares to previous full year 2022 revenue guidance of $460 million to $470 million.
Webcast Information
Guardant Health will host a conference call to discuss the third quarter 2022 financial results after market close on Thursday, November 3, 2022 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 (benefit from) 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, 2021, and any current and periodic reports filed with 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 September 30, |
| Nine Months Ended September 30, | ||||||||||||
| 2022 |
| 2021 |
| 2022 |
| 2021 | ||||||||
|
|
|
|
|
|
|
| ||||||||
Revenue: |
|
|
|
|
|
|
| ||||||||
Precision oncology testing | $ | 102,054 |
|
| $ | 79,272 |
|
| $ | 278,252 |
|
| $ | 215,605 |
|
Development services and other |
| 15,350 |
|
|
| 15,507 |
|
|
| 44,395 |
|
|
| 49,940 |
|
Total revenue |
| 117,404 |
|
|
| 94,779 |
|
|
| 322,647 |
|
|
| 265,545 |
|
Costs and operating expenses: |
|
|
|
|
|
|
| ||||||||
Cost of precision oncology testing |
| 39,434 |
|
|
| 29,665 |
|
|
| 104,493 |
|
|
| 78,142 |
|
Cost of development services and other |
| 1,062 |
|
|
| 1,151 |
|
|
| 4,711 |
|
|
| 11,348 |
|
Research and development expense |
| 100,017 |
|
|
| 70,968 |
|
|
| 267,229 |
|
|
| 190,200 |
|
Sales and marketing expense |
| 80,370 |
|
|
| 50,228 |
|
|
| 218,405 |
|
|
| 132,282 |
|
General and administrative expense |
| 41,121 |
|
|
| 50,055 |
|
|
| 126,068 |
|
|
| 166,366 |
|
Total costs and operating expenses |
| 262,004 |
|
|
| 202,067 |
|
|
| 720,906 |
|
|
| 578,338 |
|
Loss from operations |
| (144,600 | ) |
|
| (107,288 | ) |
|
| (398,259 | ) |
|
| (312,793 | ) |
Interest income |
| 1,754 |
|
|
| 689 |
|
|
| 3,919 |
|
|
| 3,277 |
|
Interest expense |
| (644 | ) |
|
| (644 | ) |
|
| (1,933 | ) |
|
| (1,934 | ) |
Other income (expense), net |
| (18,389 | ) |
|
| (187 | ) |
|
| (18,059 | ) |
|
| (720 | ) |
Fair value adjustments of noncontrolling interest liability |
| — |
|
|
| — |
|
|
| (99,785 | ) |
|
| — |
|
Loss before provision for income taxes |
| (161,879 | ) |
|
| (107,430 | ) |
|
| (514,117 | ) |
|
| (312,170 | ) |
Provision for income taxes |
| 115 |
|
|
| 96 |
|
|
| 537 |
|
|
| 289 |
|
Net loss |
| (161,994 | ) |
|
| (107,526 | ) |
|
| (514,654 | ) |
|
| (312,459 | ) |
Adjustment of redeemable noncontrolling interest |
| — |
|
|
| — |
|
|
| — |
|
|
| (2,300 | ) |
Net loss attributable to Guardant Health, Inc. common stockholders | $ | (161,994 | ) |
| $ | (107,526 | ) |
| $ | (514,654 | ) |
| $ | (314,759 | ) |
Net loss per share attributable to Guardant Health, Inc. common stockholders, basic and diluted | $ | (1.58 | ) |
| $ | (1.06 | ) |
| $ | (5.04 | ) |
| $ | (3.11 | ) |
Weighted-average shares used in computing net loss per share attributable to Guardant Health, Inc. common stockholders, basic and diluted |
| 102,289 |
|
|
| 101,420 |
|
|
| 102,065 |
|
|
| 101,184 |
|
Guardant Health, Inc. Condensed Consolidated Balance Sheets (unaudited) (in thousands, except share and per share data) | |||||||
| September 30, 2022 |
| December 31, 2021 | ||||
ASSETS |
|
|
| ||||
Current assets: |
|
|
| ||||
Cash and cash equivalents | $ | 158,310 |
|
| $ | 492,202 |
|
Short-term marketable debt securities |
| 799,727 |
|
|
| 440,546 |
|
Accounts receivable, net |
| 86,200 |
|
|
| 97,652 |
|
Inventory, net |
| 63,047 |
|
|
| 30,674 |
|
Prepaid expenses and other current assets, net |
| 23,565 |
|
|
| 53,052 |
|
Total current assets |
| 1,130,849 |
|
|
| 1,114,126 |
|
Long-term marketable debt securities |
| 156,741 |
|
|
| 698,034 |
|
Property and equipment, net |
| 168,007 |
|
|
| 124,461 |
|
Right-of-use assets, net |
| 178,747 |
|
|
| 189,443 |
|
Intangible assets, net |
| 12,417 |
|
|
| 14,207 |
|
Goodwill |
| 3,290 |
|
|
| 3,290 |
|
Other assets, net |
| 51,728 |
|
|
| 60,938 |
|
Total Assets | $ | 1,701,779 |
|
| $ | 2,204,499 |
|
LIABILITIES, REDEEMABLE NONCONTROLLING INTEREST AND STOCKHOLDERS’ EQUITY |
|
|
| ||||
Current liabilities: |
|
|
| ||||
Accounts payable | $ | 40,911 |
|
| $ | 17,580 |
|
Accrued compensation |
| 57,423 |
|
|
| 42,496 |
|
Accrued expenses |
| 63,367 |
|
|
| 45,285 |
|
Noncontrolling interest liability |
| — |
|
|
| 78,000 |
|
Deferred revenue |
| 13,423 |
|
|
| 11,326 |
|
Total current liabilities |
| 175,124 |
|
|
| 194,687 |
|
Convertible senior notes, net |
| 1,136,748 |
|
|
| 1,134,821 |
|
Long-term operating lease liabilities |
| 216,174 |
|
|
| 226,053 |
|
Other long-term liabilities |
| 6,988 |
|
|
| 3,933 |
|
Total Liabilities |
| 1,535,034 |
|
|
| 1,559,494 |
|
Stockholders’ equity: |
|
|
| ||||
Common stock, par value of $0.00001 per share; 350,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 102,413,638 and 101,767,446 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively |
| 1 |
|
|
| 1 |
|
Additional paid-in capital |
| 1,716,075 |
|
|
| 1,657,593 |
|
Accumulated other comprehensive loss |
| (26,852 | ) |
|
| (4,764 | ) |
Accumulated deficit |
| (1,522,479 | ) |
|
| (1,007,825 | ) |
Total Stockholders’ Equity |
| 166,745 |
|
|
| 645,005 |
|
Total Liabilities and Stockholders’ Equity | $ | 1,701,779 |
|
| $ | 2,204,499 |
|
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, | ||||||||||||
| 2022 |
| 2021 |
| 2022 |
| 2021 | ||||||||
|
|
|
|
|
|
|
| ||||||||
GAAP cost of precision oncology testing | $ | 39,434 |
|
| $ | 29,665 |
|
| $ | 104,493 |
|
| $ | 78,142 |
|
Amortization of intangible assets |
| (285 | ) |
|
| (152 | ) |
|
| (582 | ) |
|
| (449 | ) |
Stock-based compensation expense and related employer payroll tax payments |
| (1,377 | ) |
|
| (762 | ) |
|
| (3,782 | ) |
|
| (2,449 | ) |
Non-GAAP cost of precision oncology testing | $ | 37,772 |
|
| $ | 28,751 |
|
| $ | 100,129 |
|
| $ | 75,244 |
|
|
|
|
|
|
|
|
| ||||||||
GAAP research and development expense | $ | 100,017 |
|
| $ | 70,968 |
|
| $ | 267,229 |
|
| $ | 190,200 |
|
Stock-based compensation expense and related employer payroll tax payments |
| (7,256 | ) |
|
| (4,624 | ) |
|
| (18,857 | ) |
|
| (13,674 | ) |
Contingent consideration |
| (355 | ) |
|
| — |
|
|
| (2,652 | ) |
|
| — |
|
Non-GAAP research and development expense | $ | 92,406 |
|
| $ | 66,344 |
|
| $ | 245,720 |
|
| $ | 176,526 |
|
|
|
|
|
|
|
|
| ||||||||
GAAP sales and marketing expense | $ | 80,370 |
|
| $ | 50,228 |
|
| $ | 218,405 |
|
| $ | 132,282 |
|
Amortization of intangible assets |
| (67 | ) |
|
| — |
|
|
| (201 | ) |
|
| — |
|
Stock-based compensation expense and related employer payroll tax payments |
| (6,643 | ) |
|
| (4,127 | ) |
|
| (18,267 | ) |
|
| (10,554 | ) |
Non-GAAP sales and marketing expense | $ | 73,660 |
|
| $ | 46,101 |
|
| $ | 199,937 |
|
| $ | 121,728 |
|
|
|
|
|
|
|
|
| ||||||||
GAAP general and administrative expense | $ | 41,121 |
|
| $ | 50,055 |
|
| $ | 126,068 |
|
| $ | 166,366 |
|
Amortization of intangible assets |
| (339 | ) |
|
| (339 | ) |
|
| (1,007 | ) |
|
| (1,008 | ) |
Stock-based compensation expense and related employer payroll tax payments |
| (5,955 | ) |
|
| (26,044 | ) |
|
| (31,042 | ) |
|
| (101,154 | ) |
Contingent consideration |
| (390 | ) |
|
| (970 | ) |
|
| (4,195 | ) |
|
| (1,845 | ) |
Non-GAAP general and administrative expense | $ | 34,437 |
|
| $ | 22,702 |
|
| $ | 89,824 |
|
| $ | 62,359 |
|
|
|
|
|
|
|
|
| ||||||||
GAAP loss from operations | $ | (144,600 | ) |
| $ | (107,288 | ) |
| $ | (398,259 | ) |
| $ | (312,793 | ) |
Amortization of intangible assets |
| 691 |
|
|
| 491 |
|
|
| 1,790 |
|
|
| 1,457 |
|
Stock-based compensation expense and related employer payroll tax payments |
| 21,231 |
|
|
| 35,557 |
|
|
| 71,948 |
|
|
| 127,831 |
|
Contingent consideration |
| 745 |
|
|
| 970 |
|
|
| 6,847 |
|
|
| 1,845 |
|
Non-GAAP loss from operations | $ | (121,933 | ) |
| $ | (70,270 | ) |
| $ | (317,674 | ) |
| $ | (181,660 | ) |
|
|
|
|
|
|
|
| ||||||||
GAAP net loss | $ | (161,994 | ) |
| $ | (107,526 | ) |
| $ | (514,654 | ) |
| $ | (312,459 | ) |
Amortization of intangible assets |
| 691 |
|
|
| 491 |
|
|
| 1,790 |
|
|
| 1,457 |
|
Stock-based compensation expense and related employer payroll tax payments |
| 21,231 |
|
|
| 35,557 |
|
|
| 71,948 |
|
|
| 127,831 |
|
Contingent consideration |
| 745 |
|
|
| 970 |
|
|
| 6,847 |
|
|
| 1,845 |
|
Unrealized losses on marketable equity securities |
| 13,230 |
|
|
| — |
|
|
| 13,230 |
|
|
| — |
|
Impairment of other assets |
| 5,261 |
|
|
| — |
|
|
| 5,261 |
|
|
| — |
|
Fair value adjustments of noncontrolling interest liability |
| — |
|
|
| — |
|
|
| 99,785 |
|
|
| — |
|
Non-GAAP net loss | $ | (120,836 | ) |
| $ | (70,508 | ) |
| $ | (315,793 | ) |
| $ | (181,326 | ) |
|
|
|
|
|
|
|
| ||||||||
GAAP net loss attributable to Guardant Health, Inc. common stockholders | $ | (161,994 | ) |
| $ | (107,526 | ) |
| $ | (514,654 | ) |
| $ | (314,759 | ) |
Amortization of intangible assets |
| 691 |
|
|
| 491 |
|
|
| 1,790 |
|
|
| 1,457 |
|
Stock-based compensation expense and related employer payroll tax payments |
| 21,231 |
|
|
| 35,557 |
|
|
| 71,948 |
|
|
| 127,831 |
|
Contingent consideration |
| 745 |
|
|
| 970 |
|
|
| 6,847 |
|
|
| 1,845 |
|
Unrealized losses on marketable equity securities |
| 13,230 |
|
|
| — |
|
|
| 13,230 |
|
|
| — |
|
Impairment of other assets |
| 5,261 |
|
|
| — |
|
|
| 5,261 |
|
|
| — |
|
Fair value adjustments of noncontrolling interest liability |
| — |
|
|
| — |
|
|
| 99,785 |
|
|
| — |
|
Adjustment of redeemable noncontrolling interest |
| — |
|
|
| — |
|
|
| — |
|
|
| 2,300 |
|
Non-GAAP net loss attributable to Guardant Health, Inc. common stockholders | $ | (120,836 | ) |
| $ | (70,508 | ) |
| $ | (315,793 | ) |
| $ | (181,326 | ) |
|
|
|
|
|
|
|
| ||||||||
GAAP net loss per share attributable to Guardant Health, Inc., common stockholders, basic and diluted | $ | (1.58 | ) |
| $ | (1.06 | ) |
| $ | (5.04 | ) |
| $ | (3.11 | ) |
Non-GAAP net loss per share attributable to Guardant Health, Inc., common stockholders, basic and diluted | $ | (1.18 | ) |
| $ | (0.70 | ) |
| $ | (3.09 | ) |
| $ | (1.79 | ) |
Weighted-average shares used in computing GAAP and Non-GAAP net loss per share, basic and diluted |
| 102,289 |
|
|
| 101,420 |
|
|
| 102,065 |
|
|
| 101,184 |
|
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, | ||||||||||||
| 2022 |
| 2021 |
| 2022 |
| 2021 | ||||||||
|
|
|
|
|
|
|
| ||||||||
GAAP net loss attributable to Guardant Health, Inc. common stockholders | $ | (161,994 | ) |
| $ | (107,526 | ) |
| $ | (514,654 | ) |
| $ | (314,759 | ) |
Interest income |
| (1,754 | ) |
|
| (689 | ) |
|
| (3,919 | ) |
|
| (3,277 | ) |
Interest expense |
| 644 |
|
|
| 644 |
|
|
| 1,933 |
|
|
| 1,934 |
|
Other (income) expense, net |
| 18,389 |
|
|
| 187 |
|
|
| 18,059 |
|
|
| 720 |
|
Provision for income taxes |
| 115 |
|
|
| 96 |
|
|
| 537 |
|
|
| 289 |
|
Depreciation and amortization |
| 9,807 |
|
|
| 5,544 |
|
|
| 25,793 |
|
|
| 16,181 |
|
Stock-based compensation expense and related employer payroll tax payments |
| 21,231 |
|
|
| 35,557 |
|
|
| 71,948 |
|
|
| 127,831 |
|
Contingent consideration |
| 745 |
|
|
| 970 |
|
|
| 6,847 |
|
|
| 1,845 |
|
Fair value adjustments of noncontrolling interest liability |
| — |
|
|
| — |
|
|
| 99,785 |
|
|
| — |
|
Adjustment of redeemable noncontrolling interest |
| — |
|
|
| — |
|
|
| — |
|
|
| 2,300 |
|
Adjusted EBITDA | $ | (112,817 | ) |
| $ | (65,217 | ) |
| $ | (293,671 | ) |
| $ | (166,936 | ) |
View source version on businesswire.com:https://www.businesswire.com/news/home/20221103005971/en/
CONTACT: Investor Contact:
investors@guardanthealth.comMedia Contact:
press@guardanthealth.com
KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: ONCOLOGY MEDICAL SUPPLIES MEDICAL DEVICES HEALTH PHARMACEUTICAL BIOTECHNOLOGY
SOURCE: Guardant Health, Inc.
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PUB: 11/03/2022 04:05 PM/DISC: 11/03/2022 04:07 PM
http://www.businesswire.com/news/home/20221103005971/en