Guardant Health (GH) is expected to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price.The earnings report, which is expected to be released on April 30, 2025, might help the stock move higher if these key numbers are better than ex ...

Guardant Health, Inc. (NASDAQ: GH ) is a biopharma company working on liquid biopsy tests for several illnesses, but mostly with a focus on oncology applications. Basically, their approach relies on genomic and digital technology to analyze patients' DNA samples andMy name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree in computer science from Ohio University, Athens, OH, USA, a graduate ...

On Tuesday, the Centers for Medicare & Medicaid Services (CMS) approved the Advanced Diagnostic Laboratory Test (ADLT) status for Guardant Health, Inc.’s GH Shield blood test for colorectal cancer (CRC) screening.The U.S. Food and Drug Administration (FDA) approved Shield in July 2024 as the first blood test for primary CRC screening.Medicare already covers the test.For Medicare patients beginning April 1, the Shield test will be reimbursed at $1,495 during the initial nine-month ADLT period.Also Read: What ...

The Medical group has plenty of great stocks, but investors should always be looking for companies that are outperforming their peers. Is Guardant Health (GH) one of those stocks right now? By taking a look at the stock's year-to-date performance in comparison to its Medical peers, we might be able to answer that question.Guardant Health is one of 1009 companies in the Medical group. The Medical group currently sits at #2 within the Zacks Sector Rank. The Zacks Sector Rank considers 16 different sector grou ...

Call Start: 16:30 January 1, 0000 5:31 PM ET Guardant Health, Inc. (NASDAQ:GH) Q4 2024 Earnings Conference Call February 20, 2025 4:30 PM ET Company Participants Zarak Khurshid - Vice President, IR Helmy Eltoukhy - Co-Chief Executive Officer AmirAli Talasaz - Co-Chief Executive Officer Mike Bell - Chief Financial Officer Conference Call Participants Puneet Souda - Leerink Partners Bill Bonello - Craig-Hallum Tycho Peterson - Jefferies Dan Brennan - TD Cowen Subbu Nambi - Guggenheim Mark Massaro - BTIG Pa ...

Conquering Cancer with Data Q4 2024 & Full Year 2024 Earnings Call February 20, 2025 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 and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance ...

Core Insights - Guardant Health reported a strong revenue growth of 30% year-over-year, reaching $201.8 million, surpassing analysts' expectations of $192 million [2][3] - The company experienced a non-GAAP loss of $0.62 per share, which was better than the anticipated loss of $0.75 per share, while the net loss narrowed to $111 million [2][3][6] Business Overview and Focuses - Guardant Health specializes in precision oncology, focusing on advanced blood tests for cancer detection and management, particularly through liquid biopsies [4] - The company is prioritizing product innovation and strategic partnerships to enhance research capabilities and market access, with a focus on securing payer reimbursement [4][8] Quarterly Highlights and Developments - The precision oncology segment saw a 30% increase in sales, contributing $184.6 million to total revenue, aided by new Medicare reimbursement rates [5] - Operating expenses rose to $250.2 million, primarily due to increased spending on R&D, sales, and marketing, although the net loss was reduced due to the absence of a prior-year legal expense [6] Regulatory and Strategic Collaborations - Guardant Health achieved regulatory approvals, including Medicare coverage for its Guardant Reveal Smart Liquid Biopsy, enhancing its service offerings [7] - Collaborations with industry leaders like Boehringer Ingelheim and ConcertAI support the company's research initiatives and commitment to innovation [7] Future Projections - For 2025, Guardant Health anticipates revenue growth of 15% to 16%, projecting revenues between $850 million and $860 million, with oncology revenue expected to grow by approximately 15% [9] - The company aims to stabilize its non-GAAP gross margin between 62% and 63% and plans to control cash burn, projecting $225 million to $235 million for the year [9][10]

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]