CURRENT REPORT UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K GUARDANT HEALTH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38683 45-4139254 (State or other jurisdiction of incorporation or organization) Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): January 13, 2025 (Commission File Number) (IRS Employer Identification No.) 3100 Hanover Street Palo Alto, California 94304 ( ...

Guardant Health (GH) shares rallied 6.3% in the last trading session to close at $35.88. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 8.4% loss over the past four weeks.The company’s blood test, Shield, is approved by the FDA for colorectal cancer (CRC) screening in adults aged 45 and older who are at average risk for the disease. According to Guardant Health, Shield provides an easy, convenient and pleasa ...

Biotechnology stock Guardant Health (GH) is trading at 15-month highs today, last seen up 7% at $38.28. Shares have added 107.7% over the last nine months, and now stand nearly 42% higher in 2024. Plus, a bullish signal now flashing suggests GH’s rally could still have legs, if past is precedent.Guardant Health stock’s recent highs coincide with historically low implied volatility (IV) — a combination that has been bullish for the security in the past. According to data from Schaeffer's Senior Quantitative ...

| --- | --- | --- | |------------------------------------------------------------------|-------|-------| | | | | | | | | | | | | | Transforming Cancer Care Q3 2024 Earnings Call November 6, 2024 | | | Safe harbor and non-GAAP disclosures Certain statements in this presentation and the accompanying oral commentary are forward-looking statements within the meaning of federal securities laws. These statements relate to future events or Guardant Health, Inc. (the "Company")'s future results and involve known an ...

Financial Data and Key Metrics - Total revenue grew 34% to a record $191.5 million in Q3 2024, driven by precision oncology revenue, which increased 35% to $180.6 million [11][39] - Clinical test volume grew 21% year-over-year and 7% quarter-over-quarter, reaching 53,100 tests in Q3 2024 [12][40] - Biopharma test volume increased 40% year-over-year to a record 10,500 tests in Q3 2024 [13][41] - Guardant360 ASP reached $3,000 in Q3 2024, achieving the long-term goal four years ahead of schedule [17][43] - Non-GAAP gross margin excluding screening was 65% in Q3 2024, with adjusted EBITDA loss improving to $56.2 million [46][48] - Free cash flow improved to negative $55.3 million in Q3 2024, with $1 billion in cash on hand [49][50] Business Line Performance - Guardant360 LVT upgrade expanded the number of genes by nearly tenfold, improved sensitivity for tumor burden detection by a factor of 10, and introduced methylation tech stack features [14][15] - Guardant360 LVT on smart liquid biopsy was the strongest contributor to year-over-year and sequential volume growth in Q3 2024 [17] - Reveal continues to see strong growth, with clinical validity studies for additional cancers such as lung, pancreatic, and gastric planned for 2025 [24][25] - Shield, the first FDA-approved blood test for colorectal cancer screening, launched in August 2024 with a Medicare price of $920 [29][34] Market Performance - The company partnered with Policlinico Gemelli in Rome to implement on-site processing of Guardant360 CDx tests, marking one of the first dedicated liquid biopsy testing facilities in Italy [19] - Strong momentum in China with a growing pipeline of biopharma samples [22] - Shield received a Medicare price of $920, with expectations to secure an ADLT designation and a more favorable Medicare price of $14.95 in 2025 [34] Strategic Direction and Industry Competition - The company aims to achieve greater than 60% gross margins for its MRD business, with Reveal expected to be gross margin positive in 2025 [26][27] - Shield is positioned to become a leading multi-cancer detection blood test, with plans to upgrade to Shield V2 in 2025 [37] - The company expects oncology clinical volume growth to accelerate above 20% in 2025, driven by Guardant360, Reveal, and TissueNext [54] Management Commentary on Operating Environment and Future Outlook - Management highlighted the significant survival benefits of using Guardant360 CDx in the SCRUM-Japan GOZILA study, with 24% of patients receiving personalized targeted treatment based on Guardant360 CDx [20] - The company is optimistic about the potential inclusion of Shield in American Cancer Society guidelines and expects to secure ADLT status in 2025 [37] - Management reiterated confidence in achieving cash flow breakeven by 2028, with the potential to bring forward the target date due to the early achievement of Guardant360 ASP goals [50] Other Important Information - The company increased its full-year 2024 revenue guidance to $720 million to $725 million, representing growth of approximately 28% to 29% compared to 2023 [51] - Shield's initial post-launch volume was ahead of expectations, with strong momentum continuing into Q4 2024 [33] - The company expects to report Shield revenue and volume separately in Q4 2024 as they become material to the numbers [42] Q&A Session Summary Question: Shield's Medicare pricing and sales strategy [56] - The company remains committed to a disciplined investment approach for Shield, with a maximum spend of $200 million in the following years [57] - While USPSTF recommendations are seen as a major milestone, the company believes there is significant market depth to mine in the covered patient population [60] Question: Shield's performance and market feedback [63] - Shield's initial volume post-launch was ahead of expectations, with strong momentum continuing into Q4 2024 [65] - The company plans to report Shield volume and revenue contribution in Q4 2024 [65] Question: Therapy selection TAM and repeat testing [71] - The market for therapy selection is expected to grow significantly, with potential for patients to receive multiple tests over their lifetime [72] - The company sees liquid biopsy as uniquely positioned to capture this market due to its ability to perform repeat testing easily [73] Question: Reveal's potential upside and ASP [74] - The company expects an acceleration in Reveal volume growth in 2025, driven by CRC surveillance reimbursement and cost reduction initiatives [76] - ASP for Reveal is expected to increase with CRC surveillance reimbursement, though the exact uptick is difficult to quantify at this stage [76] Question: Shield's market penetration and V2 data [78] - Shield V2 data is expected in 2025, with potential for an upgrade to the test [79] - The company assumes a 60% market share in blood-based CRC screening in its long-term projections [80] Question: Core revenue growth and Shield reordering rates [83] - Prior period cash upsides contributed approximately $20 million to revenue growth, with the remainder driven by clinical volume growth, Guardant360 ASP increases, and biopharma performance [84] - Reordering rates for Shield are not yet measurable, as the recommended interval for retesting is every three years [85] Question: Clinical volume growth acceleration and Shield lab setup [87] - Clinical volume growth is expected to accelerate above 20% in 2025, driven by Guardant360, TissueNext, and Reveal [89] - The company has incorporated learnings from the LDT launch into the Shield commercial launch, with 15% of orders coming from accounts with full EMR integration [91] Question: Reveal's contribution and COSMOS progress [94] - Reveal contributed to sequential growth in Q3 2024, with the company expecting 2025 to be a pivotal year for the product [98] - The company is making progress on CRC surveillance reimbursement and expects to submit breast data for publication soon [96] Question: International growth and Reveal acceleration [100] - The main growth driver for clinical volume acceleration in 2025 is expected to be Guardant360 in the U.S., with international growth playing a smaller role [101] - Reveal volume acceleration is expected regardless of CRC surveillance reimbursement, though reimbursement will allow for more aggressive growth [103] Question: Japan market and lab closure [105] - The closure of the Shonan Research Center in Japan was unrelated to market progress and was a cost-cutting measure [106] - The ramp in Japan has been slower than expected due to reimbursement structures, but the company remains optimistic about future growth [107] Question: Guidance increase and Shield volume estimation [109] - The increase in full-year revenue guidance was driven by prior period cash upsides, Guardant360 ASP increases, biopharma revenue growth, and Shield revenue contribution [113] - Shield's cost per test has decreased below $1,000, with further reductions expected as volume scales [115]

For the quarter ended September 2024, Guardant Health (GH) reported revenue of $191.48 million, up 33.9% over the same period last year. EPS came in at -$0.45, compared to -$0.73 in the year-ago quarter.The reported revenue represents a surprise of +12.72% over the Zacks Consensus Estimate of $169.87 million. With the consensus EPS estimate being -$0.55, the EPS surprise was +18.18%.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wa ...

Guardant Health (GH) came out with a quarterly loss of $0.45 per share versus the Zacks Consensus Estimate of a loss of $0.55. This compares to loss of $0.73 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 18.18%. A quarter ago, it was expected that this provider of oncology testing services would post a loss of $0.57 per share when it actually produced a loss of $0.48, delivering a surprise of 15.79%.Over the last four quarte ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 _____________________ FORM 10-Q _____________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38683 _____________________ GUARDANT HEALTH, INC. (Exact Name of Registrant as Sp ...

Guardant Health Reports Third Quarter 2024 Financial Results and Increases 2024 Revenue Guidance Revenue growth of 34% driven by strong clinical and biopharma volume and Guardant360 ASP tailwinds Shield received favorable Medicare pricing of $920 PALO ALTO, Calif. November 6, 2024 – Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today reported financial results for the quarter ended September 30, 2024. Third Quarter 2024 Financial Highlights • Recorded revenue of $191.5 million fo ...

Wall Street analysts forecast that Guardant Health (GH) will report quarterly loss of $0.55 per share in its upcoming release, pointing to a year-over-year increase of 24.7%. It is anticipated that revenues will amount to $169.87 million, exhibiting an increase of 18.8% compared to the year-ago quarter.Over the last 30 days, there has been an upward revision of 1.8% in the consensus EPS estimate for the quarter, leading to its current level. This signifies the covering analysts' collective reconsideration o ...