10-KPeriod: FY2018

Guardant Health, Inc. Annual Report, Year Ended Dec 31, 2018

Filed March 19, 2019For Securities:GH

Summary

Guardant Health, Inc. (GH) filed its 2018 10-K on March 19, 2019, detailing its financial performance and strategic initiatives. The company, a leader in precision oncology, reported significant revenue growth, driven by its Guardant360 and GuardantOMNI liquid biopsy tests. Total revenue for 2018 reached $90.6 million, an 82% increase from the prior year, reflecting strong adoption among both clinical and biopharmaceutical customers. Despite revenue growth, Guardant Health continued to incur substantial net losses, totaling $84.3 million in 2018, a slight increase from $83.2 million in 2017. This is attributed to significant investments in research and development, sales and marketing, and general administrative expenses, reflecting the company's strategy to drive innovation and market penetration. The company's strong cash position, bolstered by a successful IPO in October 2018, provides ample runway to fund operations and future growth initiatives. Management believes current cash reserves are sufficient for at least the next 12 months, though they may seek additional capital to fund expansion or strategic investments.

Financial Statements
Beta
Revenue$90.64M
R&D Expenses$50.71M
Operating Expenses$183.58M
Operating Income-$92.94M
Interest Expense$1.25M
Net Income-$84.26M
EPS (Basic)$-2.80
Shares Outstanding (Basic)30.40M

Key Highlights

  • 1Revenue grew 82% year-over-year to $90.6 million in 2018, primarily driven by an 86% increase in precision oncology testing revenue, signaling strong market demand for Guardant360 and GuardantOMNI tests.
  • 2Net loss for 2018 was $84.3 million, a slight increase from $83.2 million in 2017, reflecting substantial investments in R&D (up 98%) and Sales & Marketing (up 65%) to support product development and commercial expansion.
  • 3The company completed its Initial Public Offering (IPO) in October 2018, raising $254.0 million in net proceeds, significantly strengthening its cash position to $496.5 million in cash, cash equivalents, and marketable securities as of December 31, 2018.
  • 4Guardant360 and GuardantOMNI tests received Breakthrough Device Designation from the FDA, indicating their potential to address unmet medical needs and potentially expedite regulatory review.
  • 5The company is actively pursuing reimbursement from Medicare and commercial payers, with a local coverage determination (LCD) for Guardant360 in Non-Small Cell Lung Cancer (NSCLC) expected to cover approximately 75% of Medicare patients.
  • 6Guardant Health operates as an 'emerging growth company' (EGC), allowing it to take advantage of certain regulatory and reporting exemptions, but it is expected to transition out of EGC status by the end of 2019 if its non-affiliate market capitalization exceeds $700 million.
  • 7The company has established a joint venture with SoftBank to accelerate international commercialization, particularly in Asia, the Middle East, and Africa, with an initial focus on Japan.

Frequently Asked Questions

Guardant Health's primary revenue source is precision oncology testing, which includes its Guardant360 and GuardantOMNI liquid biopsy tests. In 2018, this segment generated $78.4 million, an increase of 86% from $42.1 million in 2017. Overall total revenue grew 82% to $90.6 million in 2018.

No, Guardant Health is not currently profitable. The company reported a net loss of $84.3 million in 2018, an increase from $83.2 million in 2017. This is due to significant investments in research and development, sales, and marketing to drive growth and product innovation. The company's financial outlook is focused on continued revenue growth and market expansion, supported by a strong cash position from its recent IPO.

Key risks include reliance on regulatory approvals and payer coverage for reimbursement, intense competition in the liquid biopsy market, the need for continued significant investment in R&D, potential patent litigation, and the possibility of future stock sales by existing shareholders impacting the stock price. The company also faces risks associated with its status as an emerging growth company and its dependence on management's estimates and judgments for financial reporting.

Guardant Health significantly strengthened its financial position by completing an initial public offering (IPO) in October 2018, which raised approximately $254.0 million in net proceeds. This, combined with previous equity financings, resulted in a robust cash and marketable securities balance of $496.5 million as of December 31, 2018, providing substantial liquidity for future operations and strategic initiatives.