Core Viewpoint - Guardant Health is a significant player in precision oncology, focusing on blood tests for cancer detection and treatment, with recent positive ratings from analysts and mixed investor actions [1][5]. Investment Ratings - Raymond James upgraded Guardant Health to "Outperform" with a price target increase from $115 to $129, reflecting confidence in the company's future performance [1][5]. Investor Actions - Granite Investment Partners LLC reduced its stake in Guardant Health by 52.1%, now holding 185,301 shares valued at approximately $11.6 million, contrasting with other investors [2][5]. - Norges Bank acquired a new stake in Guardant Health worth around $64.1 million during the second quarter [3]. - Franklin Resources Inc. increased its investment by 78.2%, now holding 2,319,947 shares valued at $120.7 million after purchasing an additional 1,018,144 shares [3]. - Invesco Ltd. expanded its holdings by 27.3% during the undefined quarter [3]. Stock Performance - The current stock price for Guardant Health is approximately $100.42, reflecting a decrease of about 2.60%, with fluctuations between a low of $100.29 and a high of $103.58 [4]. - Over the past year, the stock has reached a high of $120.74 and a low of $34.88, with a market capitalization of approximately $13.04 billion and a trading volume of around 274,345 shares [4].

US biotech company Guardant Health (Nasdaq: GH) has acquired Israeli precise liquid biopsy company MetaSight Diagnostics for an immediate payment of $59 million and an additional $90 million in milestone payments. The acquisition was revealed in Guardant Health’s fourth quarter results. The milestone payments include receiving regulatory approvals and sales thresholds. The company has developed tests for accurate early diagnosis of cancer that could cost only a few dollars. MetaSight was founded by Prof. ...

Core Insights - Guardant Health reported revenue of $281.27 million for Q4 2025, a year-over-year increase of 39.4% [1] - The EPS for the same period was -$0.50, an improvement from -$0.62 a year ago, but below the consensus estimate of -$0.42, resulting in an EPS surprise of -18.12% [1] - The revenue exceeded the Zacks Consensus Estimate of $279.96 million by 0.47% [1] Financial Performance Metrics - Total oncology tests performed were 79,000, surpassing the average estimate of 75,360 from three analysts [4] - Revenue from oncology tests was $189.95 million, compared to the average estimate of $186.77 million from four analysts [4] - Revenue from licensing and other sources was $2.18 million, exceeding the estimated $2 million [4] - Revenue from screening reached $35.13 million, significantly higher than the average estimate of $27.31 million [4] - Revenue from biopharma and data was $54.01 million, compared to the average estimate of $50.47 million [4] Stock Performance - Over the past month, shares of Guardant Health have returned -7.2%, while the Zacks S&P 500 composite changed by -0.8% [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the broader market [3]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $281 million, representing a 39% year-over-year growth, while full-year revenue reached $982 million, a 33% increase year-over-year [9][31] - Non-GAAP gross margin improved to 66% in Q4 2025, up from 63% in the prior year, driven by a significant reduction in Reveal cost per test [32][33] - Adjusted EBITDA loss improved to $64.9 million in Q4 compared to $78.4 million in the prior year quarter [34] Business Line Data and Key Metrics Changes - Oncology revenue increased 30% to $190 million in Q4, with volumes growing 38% to approximately 79,000 tests [9][29] - Screening revenue totaled $35 million from approximately 38,000 Shield tests in Q4, reflecting strong sequential growth [19][30] - Biopharma and data revenue grew 18% year-over-year to $210 million in 2025 [16][17] Market Data and Key Metrics Changes - Guardant360 Liquid volumes increased nearly 30%, supported by expanding clinical utility from Smart apps launched over the past year [30] - Reveal continued to be the fastest-growing oncology product, benefiting from CRC surveillance reimbursement and early uptake for late-stage therapy response monitoring [12][30] - Shield's adherence rate reached 93% across the first 100,000 tests ordered, significantly higher than other screening modalities [22] Company Strategy and Development Direction - The company aims to expand Shield to include multi-cancer detection results, enhancing its market position [24] - Strategic collaborations with Quest Diagnostics and PathGroup are expected to broaden national reach and enhance commercial infrastructure [23] - The acquisition of MetaSyte Diagnostics is anticipated to enhance the oncology product portfolio and accelerate multi-disease detection capabilities [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2026, expecting revenue growth of 27%-30% and oncology revenue growth of 25%-27% [36][37] - The company is focused on achieving cash flow breakeven by the end of 2027, with expectations of positive free cash flow from the core business in 2026 [35][40] - Management highlighted the importance of reimbursement wins for therapy monitoring as a significant growth driver for the oncology business [46] Other Important Information - The company reported a significant increase in the commercial team, with approximately 300 sales representatives by the end of 2025 [21] - The ADLT reimbursement rate for Shield is set at $1,495, secured through December 2027, supporting healthy ASP and gross profit [25][39] - The company is actively pursuing FDA approvals for new products, including Guardant360 Liquid CDx for lung cancer [40] Q&A Session Summary Question: Can you elaborate on Reveal therapeutic monitoring and its opportunity? - Management expressed excitement about Reveal for therapy monitoring, emphasizing its synergy with Guardant360 for patient treatment decisions [44][46] Question: How should we think about oncology growth throughout the year? - Management is bullish about 2026, expecting at least 20% growth in Guardant360 volumes and strong performance from Reveal [50][51] Question: What is the expected burn for Shield in 2026? - The company anticipates a similar burn for screening as in 2025, around $220 million, while the rest of the business is expected to be cash flow positive [54][55] Question: What is the latest thinking on ADLT pricing for Guardant360? - Management indicated that no ADLT pricing is baked into the 2026 guidance, with expectations for FDA submission in H2 2026 [59][61] Question: Can you discuss the opt-in rate for MCED Shield and its potential for FDA approval? - Management reported good adoption rates for the MCED offering, with enthusiasm from providers and patients, but did not provide specific numbers [76][78]

Guardant Health (NasdaqGS:GH) Q4 2025 Earnings call February 19, 2026 04:30 PM ET Company ParticipantsAmirAli Talasaz - Co-CEOCasey Woodring - Vice President of Equity ResearchDaniel Markowitz - VPEric Hershey - VP of Investor RelationsHelmy Eltoukhy - Co-CEOJack Meehan - Partner- Life Science Tools & DiagnosticsLuke Sergott - Director of Healthcare Equity ResearchMichael Ryskin - Managing DirectorMike Bell - CFOConference Call ParticipantsAndrew Brackmann - Research AnalystBill Bonello - Senior Research An ...

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $281.3 million, representing a 39% year-over-year growth, while full-year revenue reached $982.0 million, a 33% increase year-over-year [7][28]. - Non-GAAP gross margin improved to 66% in Q4 2025, up from 63% in the prior year, and for the full year, it increased from 62% in 2024 to 66% [29][30]. - Adjusted EBITDA loss improved to $64.9 million in Q4 compared to $78.4 million in the prior year, and for the full year, the loss was $220.9 million versus $257.5 million in 2024 [31]. Business Line Data and Key Metrics Changes - Oncology revenue increased by 30% to $189.9 million in Q4, with approximately 79,000 tests conducted, reflecting a 38% volume growth [25][28]. - Screening revenue totaled $35.1 million from approximately 38,000 Shield tests in Q4, with an average selling price (ASP) of approximately $850 [27][30]. - Biopharma and data revenue grew 9% to $54.0 million, aligning with expectations [27]. Market Data and Key Metrics Changes - The company received Medicare coverage for colorectal cancer (CRC) surveillance in early 2025, which has positively impacted the adoption of Reveal [5]. - The Shield test has shown strong adherence rates of 93% among patients, significantly higher than traditional screening methods [18]. Company Strategy and Development Direction - The company aims to expand its multi-cancer detection capabilities through the Shield platform, which includes a new multi-cancer detection results report [21]. - Strategic partnerships with Quest Diagnostics and PathGroup are expected to enhance national reach and operational capabilities in 2026 [19][20]. - The acquisition of MetaCyte Diagnostics is anticipated to enhance the company's R&D capabilities and accelerate its multi-disease detection pipeline [32]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued strong growth in oncology, projecting a 25%-27% growth rate for oncology revenue in 2026, supported by volume growth of approximately 30% [33]. - The company expects to achieve free cash flow positivity for the core business in 2026, excluding screening, and aims for company-wide cash flow breakeven by the end of 2027 [32][36]. - Management highlighted the importance of reimbursement wins for therapy monitoring as a significant growth driver for the oncology business [42]. Other Important Information - The company has established a robust pipeline of ongoing companion diagnostics (CDx) programs, with 25 approvals to date across various regions [14]. - The company is focused on improving gross margins through ASP optimization and operational efficiencies, with expectations of non-GAAP gross margins in the range of 64%-65% for 2026 [36]. Q&A Session Summary Question: Can you elaborate on Reveal therapeutic monitoring and its opportunity? - Management expressed excitement about Reveal for therapy monitoring, emphasizing its synergy with Guardant360 for patient monitoring and therapeutic decisions [40][42]. Question: How should we think about oncology growth throughout the year? - Management is bullish about 2026, expecting at least 20% growth in Guardant360 volumes and strong performance from Reveal, which is anticipated to remain the fastest-growing product [46][48]. Question: What is the expected burn for Shield in 2026? - The company anticipates a similar burn level for screening as in 2025, around $220 million, while the rest of the business is expected to be free cash flow positive [50][52]. Question: What is the latest on ADLT pricing for Guardant360? - Management indicated that no ADLT pricing is baked into the 2026 guidance, with expectations for FDA submission progress in the second half of the year [58][59]. Question: Can you discuss the opt-in rate for MCED Shield and potential FDA submissions? - Management noted good adoption rates for the MCED offering, with enthusiasm from providers and patients, but did not provide specific numbers [76][78].

Financial Performance - The company has incurred significant losses since inception and may continue to do so, with uncertainty about achieving and maintaining profitability[22]. - The reimbursement landscape is variable and unpredictable, which may lead to revenue adjustments and impact future financial guidance[74]. - The company anticipates ongoing proposals at federal and state levels to reduce healthcare costs and improve coverage, which may impact pricing and reimbursement for its tests[162]. Product Offerings - The Guardant360 CDx test is a 74-gene liquid biopsy test approved by the FDA, providing tumor mutation profiling for cancer patients, and is the market leader in its category[33]. - The Shield blood test is the first FDA-approved blood test for primary colorectal cancer screening, meeting Medicare coverage requirements, and included in the National Comprehensive Cancer Network guidelines[25]. - The company expects to expand its Shield platform into lung cancer screening and multi-cancer detection (MCD), with the Shield MCD test receiving Breakthrough Device designation from the FDA[41]. - The Guardant Reveal test has been expanded to include late-stage therapy response monitoring, leveraging proprietary technology to predict therapy response across all classes[35]. - The Guardant360 Liquid test measures over 740 genes and supports guideline-recommended biomarkers, providing advanced cancer patients with personalized therapy options[34]. - GuardantINFINITY test provides a comprehensive molecular profile of tumors with genotyping coverage of over 800 genes, enhancing biomarker discovery and clinical research[43]. - GuardantOMNI test covers 500 genes and has achieved superior sensitivity for detecting clinically actionable biomarkers compared to the Guardant360 Liquid test[45]. - GuardantINFORM database offers longitudinal biological insights into tumor evolution and clinical outcomes, supporting drug discovery and clinical research[46]. - The Smart Platform enhances research and development efficiencies, driving faster turnaround times and cost savings while providing industry-leading sensitivity[48]. Market Expansion and Partnerships - The company aims to strengthen relationships with biopharmaceutical companies to enhance revenue prospects and support product adoption[27]. - The company is focused on expanding global market access through strategic partnerships and investments in clinical utility[30]. - The company has expanded its international commercial efforts, establishing partnerships in Europe and Asia, including a CE mark for the Guardant360 CDx test[57][58]. - In Japan, the Guardant360 CDx test received national reimbursement approval for patients with advanced or metastatic solid tumor cancers[58]. - The company is actively working to expand coverage among commercial payers, which may lead to increased average revenue per test performed[64][65]. Regulatory Environment - The company currently markets its Guardant360 CDx test and the Shield test under an approved PMA, which is more demanding than the 510(k) premarket notification process[110]. - The PMA process generally takes between one and three years, but may take significantly longer depending on the complexity of the application[112]. - The FDA has 180 days to review a filed PMA, although the review often occurs over a longer period[112]. - The FDA may require post-approval studies or post-market surveillance as a condition of PMA approval to ensure ongoing safety and effectiveness[114]. - The 510(k) clearance process requires manufacturers to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device[104]. - The FDA is required to complete its review of a 510(k) notification within 90 days, but clearance often takes longer[105]. - Class III devices, which pose the greatest risk, are subject to the more rigorous PMA process, which is generally more costly and time-consuming than the 510(k) process[103]. - The FDA may impose significant regulatory fines or penalties for failure to submit the requisite applications for device modifications[108]. - The FDA has proposed reforms to the 510(k) clearance process, which could include increased requirements for clinical data and a longer review period[109]. - 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[120]. - The FDA may require simultaneous approval of companion diagnostics with therapeutic products, ensuring that diagnostics are adequately evaluated for safety and effectiveness[125]. - The EU's new In Vitro Diagnostic Regulation (IVDR) will strengthen market placement rules and enhance post-market surveillance, becoming applicable five years after its publication on May 26, 2022[139]. - Compliance with the essential requirements of the EU In Vitro Diagnostic Medical Devices Directive (IVDD) is necessary for obtaining the CE mark, which is required for marketing in the EU[132]. - The FDA has broad post-market regulatory enforcement powers, including unannounced inspections and potential sanctions for non-compliance, which can significantly impact operational costs[127]. - Legislative proposals regarding the regulation of laboratory developed tests (LDTs) may lead to increased regulatory requirements, potentially affecting the development and commercialization of new tests[122]. - The FDA's enforcement discretion generally applies to in vitro diagnostics used within a single laboratory, but future regulations could impose additional compliance costs[121]. - The EU medical device vigilance system mandates reporting of incidents and corrective actions to mitigate risks associated with in vitro diagnostic medical devices already on the market[134]. - The IVDR introduces a unique identification number for medical devices to improve traceability and facilitate efficient recalls in case of safety risks[139]. Employee and Workforce Diversity - As of December 31, 2025, the company had 2,506 employees, with 2,490 being full-time and approximately 2,278 located in the U.S.[163]. - The workforce was approximately 51% racially/ethnically diverse and 53% female as of December 31, 2025[165]. - For leadership positions, 32% self-identified as racially/ethnically diverse and 40% self-identified as women[165]. - Women held 33% of the independent director seats on the company's Board as of December 31, 2025[165]. - The company is committed to recruiting and retaining a diverse team aligned with its values[166]. Compliance and Legal Matters - The company is subject to federal fraud and abuse laws, including the Anti-Kickback Statute and the False Claims Act, which impose significant compliance obligations[150][154]. - In January 2022, the company received a civil investigative demand from the U.S. Attorney for the Northern District of California regarding billing for its genetic tests[157]. - The company is subject to evolving data privacy and security laws that govern the collection and protection of health-related personal information[158]. Financial Position - As of December 31, 2025, the company had cash, cash equivalents, restricted cash, and marketable debt securities totaling $1.3 billion[535]. - The majority of the company's revenue is generated in the United States, with an insignificant amount from foreign currencies as of December 31, 2025[536]. - A hypothetical 10% change in foreign currency exchange rates would not be material to the company's financial condition or results of operations[536]. - The company has not entered into any hedging arrangements regarding foreign currency risk to date[536]. - A hypothetical 100 basis point increase or decrease in interest rates would have resulted in an immaterial decline or increase in the fair value of the company's investments[535]. Employee Engagement and Compensation - Employee engagement surveys are regularly utilized to assess the effectiveness of employee development and compensation programs[166]. - The company offers a comprehensive total rewards package, including market-competitive pay, equity grants, and various insurance benefits[167]. - The compensation programs are evaluated with an independent consultant to ensure competitiveness and fairness across the workforce[166]. - The company maintains a focus on strategic alignment of talent and performance rewards while managing costs[167].

Conquering Cancer with Data Q4 2025 & Full Year 2025 Earnings Call February 19, 2026 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 - Apogee Therapeutics (NASDAQ:APGE) is identified as one of the 17 biotechnology stocks with more than 50% upside potential, with a current price target of $95 set by Citi analyst Geoff Meacham, indicating a potential upside of over 37% [1] - RBC Capital analyst Brian Abrahams downgraded Apogee Therapeutics from Outperform to Sector Perform, while raising the price target from $70 to $83, suggesting nearly 20% upside [2] - The market reaction to the release of Sanofi's Phase 3 amlitelimab data is viewed as an overreaction, with Meacham asserting that it does not negatively impact the prospects for Apogee's APG279 candidate [1] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for treating inflammatory and immune diseases, including atopic dermatitis, asthma, chronic obstructive pulmonary disease, and eosinophilic esophagitis [4] - The company's pipeline includes several candidates at different clinical trial stages, such as APG777, APG279, APG990, APG333, and APG808 [4] Market Context - The segment in which Apogee operates is becoming increasingly competitive, with established players posing challenges despite the potential of its primary drug, zumilokibart, as a long-acting IL-13 treatment for atopic dermatitis [3] - The share price of Apogee has surged by 108% over the past year, which may limit the potential for further gains [3]

Core Insights - Guardant Health, in collaboration with Mayo Clinic, published the largest study to date on circulating tumor DNA (ctDNA) for minimal residual disease (MRD) detection in resected stage III colon cancer patients, indicating that ctDNA detection is a better predictor of recurrence and overall survival compared to standard staging [1][2] Group 1: Study Findings - Approximately 20% of patients in the phase III trial had detectable ctDNA post-surgery, with Guardant Reveal identifying a four-to-six-fold higher rate of disease recurrence or reduced survival [2] - Patients with smaller tumors or fewer affected lymph nodes also showed over a six-fold higher rate of events when ctDNA was detected, supporting the integration of ctDNA testing into routine postoperative management [2][4] Group 2: Clinical Implications - The amount of ctDNA, known as tumor fraction, further distinguishes patients at the highest risk of early recurrence and worse survival, aiding clinicians in prioritizing intensive surveillance or alternative therapies [3][4] - ctDNA testing enhances the accuracy of estimating cancer recurrence risk, allowing for more tailored recommendations for adjuvant chemotherapy and follow-up monitoring [4] Group 3: Company Overview - Guardant Health is a leading precision oncology company focused on providing insights into disease drivers through advanced blood and tissue tests, real-world data, and AI analytics, aiming to improve outcomes across all stages of cancer care [5] - The company has expanded its Reveal test to support late-stage therapy response monitoring, reinforcing its clinical utility in molecular residual disease and personalized care [4]