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Guardant Health (GH)

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 and individuals at a higher risk for developing cancer with early detection.

Company profile

Ticker
GH
Exchange
CEO
Helmy Eltoukhy
Employees
Incorporated
Location
Fiscal year end
SEC CIK
Subsidiaries
Guardant Health AMEA, Inc. • Guardant Health Pte. Ltd. • Guardant Health Japan Corp. • Guardant Holdings (Switzerland) GmbH • Bellwether Bio, Inc. ...
IRS number
454139254

GH stock data

Analyst ratings and price targets

Last 3 months

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

4 Aug 22
28 Sep 22
31 Dec 22
Quarter (USD) Jun 22 Mar 22 Dec 21 Sep 21
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD) Dec 21 Dec 20 Dec 19 Dec 18
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Cash burn rate (est.) Burn method: Change in cash Burn method: Operating income Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 215.34M 215.34M 215.34M 215.34M 215.34M 215.34M
Cash burn (monthly) 119.44M 60.3M 76.33M 46.5M 74.87M 33.19M
Cash used (since last report) 352.59M 177.99M 225.31M 137.25M 221.01M 97.98M
Cash remaining -137.25M 37.35M -9.97M 78.09M -5.67M 117.36M
Runway (months of cash) -1.1 0.6 -0.1 1.7 -0.1 3.5

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Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
9 Sep 22 Kumud Kalia COMMON STOCK Payment of exercise Dispose F No No 59.28 3,245 192.36K 23,260
9 Sep 22 Kumud Kalia COMMON STOCK Option exercise Acquire M No No 0 6,544 0 26,505
9 Sep 22 Kumud Kalia RSU COMMON STOCK Option exercise Dispose M No No 0 6,544 0 13,089
9 Sep 22 Saia John G. COMMON STOCK Payment of exercise Dispose F No No 59.28 302 17.9K 13,677
1 Sep 22 Kumud Kalia COMMON STOCK Payment of exercise Dispose F No No 49.07 1,409 69.14K 19,961
1 Sep 22 Kumud Kalia COMMON STOCK Option exercise Acquire M No No 0 2,840 0 21,370
1 Sep 22 Kumud Kalia RSU COMMON STOCK Option exercise Dispose M No No 0 2,840 0 8,523
1 Sep 22 Saia John G. COMMON STOCK Payment of exercise Dispose F No No 49.07 364 17.86K 13,979
1 Sep 22 Saia John G. COMMON STOCK Option exercise Acquire M No No 0 1,052 0 14,343
1 Sep 22 Saia John G. RSU COMMON STOCK Option exercise Dispose M No No 0 1,052 0 3,157
7.5% owned by funds/institutions
13F holders Current Prev Q Change
Total holders 330 350 -5.7%
Opened positions 52 43 +20.9%
Closed positions 72 84 -14.3%
Increased positions 113 108 +4.6%
Reduced positions 104 131 -20.6%
13F shares Current Prev Q Change
Total value 4.04B 6.7B -39.7%
Total shares 94.49M 95.28M -0.8%
Total puts 540K 360.1K +50.0%
Total calls 1.77M 1.22M +45.1%
Total put/call ratio 0.3 0.3 +3.3%
Largest owners Shares Value Change
FMR 14.76M $595.31M +55.1%
Vanguard 8.84M $356.66M +1.0%
Capital International Investors 5.58M $225.01M +9.8%
BLK Blackrock 5.21M $210.08M +2.1%
MS Morgan Stanley 5.16M $208M -6.4%
Viking Global Investors 4.48M $180.68M -22.9%
Clearbridge Advisors 3.24M $130.62M -3.5%
BEN Franklin Resources 2.77M $111.72M +6.0%
Khosla Ventures IV 2.67M $208.86M 0.0%
Capital Research Global Investors 2.15M $86.7M -46.4%
Largest transactions Shares Bought/sold Change
FMR 14.76M +5.24M +55.1%
Capital Research Global Investors 2.15M -1.86M -46.4%
Viking Global Investors 4.48M -1.33M -22.9%
Nuveen Asset Management 720.23K -1M -58.2%
American Century Companies 119.3K -938.58K -88.7%
Alyeska Investment 0 -709.78K EXIT
Pictet Asset Management 1.03M +697.28K +206.7%
Steadfast Capital Management 465.84K -548.69K -54.1%
GS Goldman Sachs 1.19M -504.25K -29.7%
SB Investment Advisers 0 -503.59K EXIT

Financial report summary

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Risks
  • We have incurred significant losses since inception, we may continue to incur losses in the future and we may not be able to generate sufficient revenue to achieve and maintain profitability.
  • We may not be able to generate sufficient revenue to achieve and maintain profitability and our current or future products may not achieve or maintain sufficient commercial market acceptance.
  • Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
  • New product development and commercialization involve a lengthy and complex process and we may be unable to develop or commercialize new products on a timely basis, or at all.
  • Our current revenue is primarily generated from sales of our tests and we are highly dependent on them for our success.
  • If our products, or our competitors’ products, do not meet the expectations of patients and our customers, our operating results, reputation and business could suffer.
  • If we are unable to support demand for our current and future products, including ensuring that we have adequate capacity to meet increased demand, or we are unable to successfully manage our anticipated growth, our business could suffer.
  • If we cannot maintain our current relationships, or enter into new relationships, with biopharmaceutical companies, our revenue prospects could be reduced.
  • Our payer concentration may materially adversely affect our financial condition and results of operations.
  • If we cannot compete successfully with our competitors, we may be unable to increase or sustain our revenue or to achieve and then sustain profitability.
  • The sizes of the markets for our current and future products have not been established with precision, and may be smaller than we estimate.
  • The precision oncology industry is subject to rapid change, which could make our Guardant Health Oncology Platform, our current products and any future products we may develop, obsolete.
  • We have experienced challenges attracting and retaining qualified personnel due to competitive labor markets and may continue to do so, and may be unable to manage our future growth effectively, all of which could make it difficult to execute our business strategy.
  • We may not be able to successfully market, sell or distribute our products, and if we are unable to expand our sales organization to adequately address our customers’ needs, our business may be adversely affected.
  • We rely on a limited number of suppliers or, in some cases, sole suppliers, for some of our laboratory instruments and materials and may not be able to find replacements or promptly transition to alternative suppliers.
  • If our existing laboratory facility becomes damaged or inoperable or we are required to vacate our existing facility, our ability to perform our tests and pursue our research and development efforts may be jeopardized.
  • We are exposed to risks associated with our joint venture with SoftBank, and may not realize the advantages we expect from it.
  • We could be adversely affected by violations of the FCPA and other anti-bribery laws.
  • We conduct business in a heavily regulated industry, and changes in regulations or violations of regulations may, directly or indirectly, reduce our revenue, adversely affect our results of operations and financial condition, and harm our business.
  • Certain of our tests are currently marketed as LDTs, and future changes in FDA enforcement discretion for LDTs could subject our operations to much more significant regulatory requirements.
  • There is no guarantee that the FDA will grant 510(k) clearance or a premarket approval of our products or that similar foreign authorities or notified bodies will grant premarket approval or certify our products and failure to obtain necessary clearances or approvals or certifications for our products would adversely affect our ability to grow our business.
  • Modifications to our FDA-cleared or approved products may require new 510(k) clearances or premarket approvals, or may require us to cease marketing or recall the modified products until clearances are obtained.
  • If third-party payers, including commercial payers and government healthcare programs, do not provide coverage of, or adequate reimbursement for, our tests, our business and results of operations will be negatively affected.
  • Our products may in the future be subject to product recalls. A recall of our products, either voluntarily or at the direction of the FDA or another governmental authority, or the discovery of serious safety issues with our products, could have a significant adverse impact on us.
  • Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and studies may not be predictive of future study results.
  • Our “research use only” and “investigational use only” products could become subject to more onerous regulation by the FDA or other regulatory agencies in the future, which could increase our costs and delay our commercialization efforts, thereby materially and adversely affecting our business and results of operations.
  • Even if we receive regulatory approval or certification of our products, we will continue to be subject to extensive regulatory oversight.
  • Failure to comply with federal, state and foreign laboratory licensing requirements and the applicable requirements of the FDA or any other regulatory authority, could cause us to lose the ability to perform our tests, experience disruptions to our business, or become subject to administrative or judicial sanctions.
  • We are subject to numerous federal and state healthcare statutes and regulations; complying with such laws pertaining to our business is an expensive and time-consuming process, and any failure to comply could result in substantial penalties and a material adverse effect to our business and results of operations.
  • If the validity of an informed consent from patients regarding our test was challenged, we could be forced to stop offering our products or using our resources, our business and results of operations will be negatively affected.
  • Our billing and claim processing are complex and time-consuming, and any delay in submitting claims or failure to comply with applicable billing requirements could hinder collection and have an adverse effect on our revenue.
  • Changes in healthcare laws, regulations and policies could increase our costs, decrease our sales and revenues and negatively impact reimbursement for our tests.
  • Our collection, use and disclosure of personally identifiable information, including patient and employee information, is subject to privacy and security laws and regulations, and our failure to comply with those laws and regulations or to adequately secure the information in our possession could result in significant liability or reputational harm.
  • If we are unable to obtain and maintain sufficient intellectual property protection for our technology, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop, manufacture and commercialize products, services or technology similar or identical to ours, and our ability to successfully develop, manufacture or commercialize our products, services or technology may be impaired.
  • Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.
  • Issued patents covering our products, services or technology could be found invalid or unenforceable if challenged.
  • We rely on licenses from third parties, and if we lose these licenses then we may be subjected to future litigation. If we cannot license and maintain rights to use third-party intellectual property rights on reasonable terms, we may not be able to successfully develop, manufacture and/or commercialize our products, services or technology. Our licensed intellectual property rights may lose value or utility over time.
  • We may not be able to protect or enforce our intellectual property rights adequately throughout the world.
  • If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business could be harmed.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed trade secrets of their former employers.
  • We may not be able to protect and enforce our trademarks and we could infringe others’ trademarks.
  • We may be subject to claims challenging the inventorship or ownership of our owned or licensed intellectual property.
  • We are and may continue to be involved in litigation and other legal proceedings related to intellectual property, which could be time-intensive and costly and may adversely affect our business, operating results or financial condition.
  • Obtaining and maintaining our patent protection depends on compliance with various required procedures, document submissions, fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Patent terms may be inadequate to protect our competitive position for an adequate amount of time.
  • The price of our common stock has fluctuated substantially and may do so in the future, and you may not be able to resell shares of our common stock at or above the price at which you purchased them.
  • The convertible note hedge may affect the value of the 2027 Notes and our common stock.
  • Provisions in our corporate charter documents and under Delaware law could make a change in control of us more difficult and may prevent attempts by our stockholders to replace or remove our current management.
Management Discussion
  • Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
  • You should read the following discussion and analysis of our financial condition and results of operations together with the consolidated financial statements and related notes included elsewhere in this Annual Report on Form 10-K. This discussion and other parts of this Annual Report on Form 10-K contain forward-looking statements that involve risk and uncertainties, such as statements of our plans, objectives, beliefs, expectations and intentions. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in Part I, Item 1A, “Risk Factors,” of this Annual Report on Form 10-K.
  • We are a leading precision oncology company focused on helping conquer cancer globally through use of our proprietary tests, vast data sets and advanced analytics. Today our proprietary tests are helping to realize the full potential of precision oncology by providing patients and their doctors critical insights that can inform decisions at all stages of the disease, from screening, to monitoring cancer recurrence, to treatment decisions. We believe that the key to conquering cancer is unprecedented access to its molecular information throughout all stages of the disease, which we intend to enable by our tests. By looking at the unique dimensions of cancer found in blood, including genomic alterations, methylation, and fragmentomics, we are unlocking insights that can increasingly help patients across all stages of cancer, including at its earliest, when it’s most treatable. To help identify cancer at the earliest stages, we are developing Guardant SHIELD, a blood test for cancer screening in average-risk adults without symptoms, that detects very early signs of cancer by interrogating genomic alterations, methylation, and fragmentomic signals from a simple blood draw. In pursuit of our goal to manage cancer across all stages of the disease, we provide our Guardant360, Guardant360 LDT, Guardant360 CDx and GuardantOMNI liquid biopsy-based tests for advanced stage cancer. Our Guardant360 CDx test was the first comprehensive liquid biopsy test approved by the U.S. Food and Drug Administration, or the FDA, to provide tumor mutation profiling with solid tumors and to be used as a companion diagnostic in connection with non-small cell lung cancer, or NSCLC. In February 2021, we launched our Guardant Reveal liquid biopsy-based tests for residual and recurring cancer to first address the need in Stage II-III colorectal cancer. In June 2021, we launched Guardant360 TissueNext, our first tissue-based test which will be used to identify patients with advanced cancer who may benefit from biomarker-informed treatment, and Guardant360 Response which will be used to measure early indications to patients' response to treatment up to eight weeks earlier than response evaluation criteria in solid tumors. We have also developed our GuardantINFORM platform to further accelerate precision oncology drug development by biopharmaceutical companies by offering them an in-silico research platform to unlock further insights into tumor evolution and treatment resistance across various biomarker-driven cancers.

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