Regulatory Approvals and Compliance - The Shield blood test for colorectal cancer screening received FDA approval in July 2024 and became commercially available in August 2024, marking it as the first FDA-approved blood test for this purpose[37]. - The Guardant360 CDx test received CE mark for commercialization in the EU, with partnerships established in Spain and the UK for blood-based cancer testing services[53]. - In Japan, Guardant360 CDx test received regulatory approval as a companion diagnostic and national reimbursement approval for advanced solid tumor cancers[55]. - The FDA regulates medical devices under the Federal Food, Drug, and Cosmetic Act, requiring either a 510(k) clearance or PMA approval for new or significantly modified devices[95]. - Compliance with the EU In Vitro Diagnostic Medical Devices Directive (IVDD) is necessary for CE marking, which allows in vitro diagnostic medical devices to be marketed in the EU[128]. - The EU's new Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) aims to enhance public health protection and is directly applicable across EU member states[134]. - The FDA may require approval of companion diagnostics at the same time as therapeutic products, ensuring adequate evaluation and performance characteristics[122]. - The MHRA has become the regulatory authority for Great Britain, requiring medical devices to be registered with them before market placement[139]. - Effective July 1, 2023, all medical devices in Great Britain require a UKCA mark for compliance[139]. - The IVDR will become applicable on May 26, 2027, strengthening market placement rules and enhancing device surveillance[135]. - Companion diagnostics will require conformity assessment by a notified body under the new IVDR classification system[137]. Product Performance and Development - The Shield test demonstrated 83% sensitivity in detecting colorectal cancer and 90% specificity in individuals without advanced neoplasia, exceeding performance criteria set by CMS for reimbursement[37]. - The company plans to expand into lung cancer screening and multi-cancer detection with the Shield platform, initiating a nearly 10,000-patient prospective study for lung cancer screening[38]. - The Guardant360 CDx test is the market-leading comprehensive liquid biopsy test, providing tumor mutation profiling for cancer patients with solid tumors[30]. - The Guardant Reveal test aims to improve early detection of recurrence in early-stage cancers, with the potential to identify high-risk patients more effectively than current methods[34]. - The Guardant360 Response test predicts treatment response eight weeks earlier than standard imaging scans, providing critical insights for treatment decisions[32]. - GuardantINFINITY test provides a comprehensive molecular profile of tumors with genotyping coverage of over 800 genes, enhancing biomarker discovery and clinical research[40]. - GuardantOMNI test covers 500 genes, achieving comparable analytical performance to the Guardant360 LDT test while improving sensitivity for detecting clinically actionable biomarkers[42]. - GuardantINFORM database offers longitudinal biological insights into tumor evolution and clinical outcomes, supporting drug discovery and clinical research[43]. - GuardantConnect software solution aims to connect patients with actionable alterations to relevant clinical studies, addressing the need for clinical study matching in oncology[44]. - The Smart Liquid Biopsy platform enhances research and development efficiencies, supporting cost savings and improved turnaround time for testing[45]. Financial Performance and Risks - The company has incurred significant losses since inception and may continue to do so, raising concerns about future profitability[22]. - The company relies heavily on a limited number of suppliers for laboratory instruments and materials, which poses risks to its operations[22]. - The reimbursement landscape is inherently variable, and future changes could adversely affect revenue and increase costs[70]. - The company anticipates that changes in payer policies could significantly increase total reimbursement for its tests[65]. - The company is actively working to broaden coverage among commercial payers, which may lead to increased average revenue per test performed[62]. - As of December 31, 2024, the company had cash, cash equivalents, restricted cash, and marketable debt securities totaling $944.2 million as of December 31, 2024[514]. - A hypothetical 100 basis point change in interest rates would have resulted in an immaterial change in the fair value of the company's investments[514]. - The majority of the company's revenue is generated in the United States, with insignificant revenue from foreign currencies as of December 31, 2024[515]. - A hypothetical 10% change in foreign currency exchange rates would not materially affect the company's financial condition or results of operations[515]. Employee and Diversity Initiatives - As of December 31, 2024, the company had 2,021 employees, with 1,999 being full-time[159]. - As of December 31, 2024, the company employed a workforce that was 55% racially/ethnically diverse and 54% female[161]. - For leadership positions, 32% self-identified as racially/ethnically diverse and 40% self-identified as women[161]. - Women held 30% of the independent director seats on the company's Board as of December 31, 2024[161]. - The company maintains an inclusive culture that values diversity and aims to drive innovation for the benefit of employees and the community[160]. - The company regularly utilizes employee engagement surveys to assess the effectiveness of its employee development and compensation programs[162]. - The total rewards package includes market-competitive pay, equity grants, and various benefits such as medical and retirement plans[163]. Legal and Regulatory Challenges - The company is subject to federal fraud and abuse laws, including the Anti-Kickback Statute and the False Claims Act[146]. - A civil investigative demand was received in January 2022 regarding billing for the Guardant360 panel of genetic tests[153]. - The company relies on a combination of patents and trade secrets to protect its intellectual property, with patents expected to expire between 2026 and 2041[85]. - Compliance with CLIA and state laboratory licensing requirements is critical, with potential enforcement actions for non-compliance including suspension or revocation of licenses[93]. - Clinical studies must comply with FDA's investigational device exemption regulations, and significant risk devices require an IDE application prior to human studies[113][114]. - The FDA's acceptance of an IDE application does not guarantee that the data will support the safety and effectiveness of the device[115]. - The FDA's Breakthrough Devices Program aims to expedite the development and review of medical devices that provide more effective treatment for life-threatening conditions, allowing for more timely access to qualifying devices[116]. - The FDA finalized a rule in May 2024 requiring LDTs to undergo premarket review as medical devices, set to be implemented in spring 2025, but this has faced legal challenges[120].

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 ( ...

Company Overview - Guardant Health is a diagnostics company focused on cancer detection and monitoring through blood-based tests that provide molecular information about cancer, representing a market opportunity exceeding $100 billion [1] Investment Strategy - Narweena, an asset manager led by Richard Durant, seeks to identify market dislocations caused by misunderstandings of long-term business prospects, aiming for excess risk-adjusted returns by focusing on companies with secular growth opportunities in markets with entry barriers [1] - The investment approach emphasizes company and industry fundamentals to uncover unique insights, with a preference for smaller cap stocks and markets where competitive advantages are not immediately apparent [1] Market Dynamics - The aging population, low population growth, and stagnating productivity growth are expected to create new investment opportunities distinct from historical trends, with some industries facing stagnation or secular decline, potentially improving business performance due to reduced competition [1] - Conversely, certain businesses may encounter rising costs and diseconomies of scale, while economies increasingly favor asset-light businesses, leading to a decline in infrastructure investment needs over time [1] - A significant amount of capital is pursuing a limited set of investment opportunities, resulting in rising asset prices and compressed risk premia [1] Leadership Background - Richard Durant holds undergraduate degrees in engineering and finance from the University of Adelaide and an MBA from Nanyang Technological University, along with having passed the CFA exams [1]

Shares of Guardant Health (GH) have been struggling lately and have lost 6.7% over the past week. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road.The formation of a hammer pattern is considered a technical indication of nearing a bottom with likely subsiding of selling pressure. But this is not the only factor that makes a bullish case for t ...

The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. Guardant Health (GH) is a stock that can certainly grab the attention of many investors, but do its recent returns compare favorably to the sector as a whole? Let's take a closer look at the stock's year-to-date performance to find out.Guardant Health is one of 1013 companies in the Medical group. The Medical group currently sits at #3 within the Zacks Sector Rank. The Zacks ...

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 ...