10-KPeriod: FY2021

Guardant Health, Inc. Annual Report, Year Ended Dec 31, 2021

Filed February 24, 2022For Securities:GH

Summary

Guardant Health, Inc. (GH) reported a strong increase in total revenue for the year ended December 31, 2021, reaching $373.7 million, a 30% increase from the prior year. This growth was driven primarily by a 29% increase in precision oncology testing revenue, which reached $304.3 million, fueled by higher sample volumes and an improved average selling price for certain tests. The company also saw a significant 38% increase in development services and other revenue, primarily from companion diagnostic development services and milestone payments. Despite revenue growth, Guardant Health continued to incur substantial net losses, with a loss of $384.8 million for 2021, compared to $246.3 million in 2020. This widening loss reflects significant investments in research and development (up 76% to $263.2 million) and sales and marketing (up 80% to $191.9 million) to support product development, clinical studies, and commercial expansion. The company ended the year with a substantial cash and cash equivalents and marketable securities balance of approximately $1.6 billion, providing ample runway for ongoing operations and strategic investments.

Financial Statements
Beta
Revenue$373.65M
R&D Expenses$263.22M
Operating Expenses$784.65M
Operating Income-$411.00M
Interest Expense$2.58M
Net Income-$405.67M
EPS (Basic)$-4.00
EPS (Diluted)$-4.00
Shares Outstanding (Basic)101.31M
Shares Outstanding (Diluted)101.31M

Key Highlights

  • 1Total revenue increased by 30% to $373.7 million in 2021, driven by strong growth in precision oncology testing.
  • 2Precision oncology testing revenue grew 29% to $304.3 million, supported by increased sample volumes and higher average selling prices.
  • 3Development services and other revenue increased by 38% to $69.3 million, primarily due to companion diagnostic development services and milestone payments.
  • 4Significant investments in Research & Development (+76%) and Sales & Marketing (+80%) reflect the company's focus on innovation and market expansion.
  • 5Net loss widened to $384.8 million in 2021 from $246.3 million in 2020, primarily due to increased operating expenses.
  • 6The company ended 2021 with a robust liquidity position, holding approximately $1.6 billion in cash, cash equivalents, and marketable securities.
  • 7Guardant Health launched Guardant Reveal for residual and recurring cancer detection and Guardant360 TissueNext and Guardant360 Response for advanced cancer patients in 2021, expanding its product portfolio.

Frequently Asked Questions

Guardant Health is a precision oncology company focused on developing and commercializing proprietary tests and advanced analytics to help conquer cancer. Its primary revenue streams are from precision oncology testing services provided to clinicians and biopharmaceutical companies, and development services, which include services related to companion diagnostic development and clinical studies for biopharmaceutical partners.

In 2021, Guardant Health reported total revenue of $373.7 million, a 30% increase year-over-year. Precision oncology testing revenue grew 29% to $304.3 million, while development services and other revenue increased 38% to $69.3 million. However, the company incurred a net loss of $384.8 million, reflecting significant investments in R&D and sales & marketing, compared to a net loss of $246.3 million in 2020. Despite the net loss, the company maintained a strong cash position with approximately $1.6 billion in cash, cash equivalents, and marketable securities at year-end.

Guardant Health's growth is driven by the increasing adoption of its liquid biopsy tests across the cancer care continuum, from advanced stage cancer treatment selection to early detection and recurrence monitoring. Key strategies include expanding clinical utility and reimbursement for its products, strengthening customer relationships with biopharmaceutical companies, and leveraging its Guardant Health Oncology Platform to develop new products, particularly in early cancer detection with its Guardant SHIELD test.

Key risks and challenges include the company's ongoing history of net losses and the need to achieve profitability, potential delays or failures in new product development and commercialization, intense competition within the genomic profiling and liquid biopsy markets, reliance on third-party payers for coverage and reimbursement, and the complex and evolving regulatory landscape for diagnostic tests. The company also faces risks related to supply chain dependencies and potential cybersecurity threats.