Core Insights - Heartflow, Inc. reported a strong financial performance for Q4 2025, achieving a 40% year-over-year revenue growth, concluding a record year for the company [3][4][13] - The company anticipates continued growth in 2026, projecting total revenue between $218 million and $222 million, representing approximately 24% to 26% growth year-over-year [11] Financial Performance - Total revenue for Q4 2025 was $49.1 million, a 40% increase from $34.98 million in Q4 2024 [4][28] - U.S. revenue reached $44.8 million, up 41% year-over-year, while international revenue was $4.3 million, a 35% increase [4] - Gross profit for Q4 2025 was $39.1 million, compared to $26.3 million in the prior year, with a gross margin of 79.5% [5][6] - Total operating expenses were $56.8 million, or 116% of total revenue, down from 121% in the prior year [7][16] - The net loss for Q4 2025 was $24.4 million, or ($0.29) per share, significantly improved from a net loss of $33 million, or ($5.59) per share, in Q4 2024 [9][10] Annual Overview - For the full year 2025, Heartflow reported total revenue of $176 million, a 40% increase from $125.8 million in 2024 [13][28] - The gross margin for the full year was 76.8%, up from 75.1% in the previous year [15] - The net loss for 2025 was $116.8 million, or ($3.17) per share, compared to a net loss of $96.4 million, or ($17.98) per share, in 2024 [17] Market Position and Growth Strategy - Heartflow's technology is being adopted by over 1,800 institutions globally, with a focus on expanding its commercial presence [20] - The company has made significant progress in scaling account activations and driving early physician adoption of Heartflow Plaque Analysis [3] - Aetna's coverage of Heartflow Plaque Analysis has increased the total U.S. covered lives for Plaque to approximately 75% [11] Future Outlook - Heartflow's 2026 guidance reflects strong business fundamentals and confidence in consistent execution, with commercial, innovation, and clinical catalysts anticipated [3] - The company expects non-GAAP gross margin to be between 80% and 81% for 2026 [11]

Core Insights - Heartflow, Inc. is advancing its AI technology for coronary artery disease (CAD) management, presenting new clinical evidence and launching the NAVIGATE-PCI Registry to enhance patient care and outcomes [1][3][10] Group 1: Clinical Evidence and Registry Launch - Heartflow presented new clinical evidence at the American College of Cardiology (ACC) Annual Scientific Session, establishing Heartflow Plaque Analysis as a leading tool for early identification of high-risk CAD patients [1][4] - The NAVIGATE-PCI Registry has enrolled its first patient, marking a significant effort to evaluate the real-world impact of AI-driven insights on clinical strategy and procedural efficiency in PCI planning [2][10] Group 2: Heartflow Plaque Analysis - Heartflow Plaque Analysis is highlighted for its long-term validation in risk stratification and its effectiveness in lipid management, reinforcing its role as a personalized and cost-effective solution for CAD [4][5] - A study tracking over 15,000 patients demonstrated that extensive plaque volume is a strong predictor of major adverse cardiovascular events (MACE), with patients facing a fourfold higher risk [5][6] Group 3: Comparative Effectiveness and Economic Impact - An analysis involving nearly 3,800 patients showed that management guided by Heartflow's Plaque Analysis led to a higher initiation of lipid-lowering therapy and achievement of LDL goals compared to traditional methods [7] - A budget impact analysis indicated that Heartflow's Plaque Analysis achieves cost-effectiveness within two years, with total population savings of $140 million, emphasizing the economic sustainability of the technology [8] Group 4: Future Directions and Technology Integration - The NAVIGATE-PCI Registry aims to generate evidence on how pre-procedural insights can influence clinical decisions and enhance PCI procedures, improving efficiency and outcomes for patients [10][12] - Heartflow's technology is positioned to redefine precision cardiovascular care, with over 1,400 institutions adopting its solutions globally, supported by extensive clinical validation [16][17]

Core Insights - Heartflow, Inc. is expanding its GAMEFILM Registry to include retired NBA and NHL players, enhancing its initiative to monitor heart health in professional athletes [1][4] - The registry aims to enroll up to 300 former athletes to study cardiovascular disease prevalence and risk factors, building on its initial success with NFL players [3][5] Company Overview - Heartflow is a leader in AI technology for coronary artery disease, utilizing advanced imaging and AI to provide non-invasive assessments of heart health [1][6] - The company has been adopted by over 1,400 institutions globally and has supported the care of over 500,000 patients [6][7] Technology and Research - Heartflow's technology transforms coronary CTA images into personalized 3D heart models, offering insights into plaque characteristics and blood flow effects [7][9] - The GAMEFILM Registry employs advanced coronary computed tomography angiography (CCTA) imaging to identify plaque types and assess their risk for cardiac events [3][4] Health Impact - Cardiovascular disease is a leading cause of death, particularly among professional athletes, where underlying issues may be overlooked due to high physical demands [2][5] - The initiative aims to provide proactive heart care and improve understanding of how high-performance sports affect long-term heart health [4][5]

Investor Presentation January 2026 Disclaimers Forward-Looking Statements This presentation includes express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our strategy, future financial condition, future operations, projected costs, prospects, plans, objectives of management ...

Core Insights - Heartflow, Inc. has received comprehensive coverage for its AI-powered Heartflow Plaque Analysis from Aetna, marking a significant milestone in expanding access to this technology for coronary artery disease [1][3] - Aetna is the fourth major national commercial insurer to provide this coverage, following similar decisions by Humana, Cigna, and UnitedHealthcare, which enhances the accessibility of Heartflow Plaque Analysis across the United States [1][3] - The new Category I CPT payment code 75577 for Heartflow Plaque Analysis, effective January 1, 2026, establishes a reimbursement structure that supports the financial viability of this service [2][4] Coverage and Policy Changes - Aetna's updated policy became effective on December 23, 2025, allowing coverage for patients with acute or stable chest pain and mild-to-moderate coronary artery narrowing [3] - The policy aims to facilitate earlier diagnosis and personalized management of coronary artery disease through AI-driven plaque analysis [3][4] Clinical Validation and Impact - The DECIDE Registry data indicates that over 50% of patients had their medical management altered when Heartflow Plaque Analysis was utilized, demonstrating its clinical impact [5] - Heartflow Plaque Analysis has been validated through over 100 studies involving more than 365,000 patients, showcasing its effectiveness in real-world clinical practice [7][8] Technological Advancements - Heartflow's technology is the only FDA-cleared AI-powered plaque quantification tool, achieving 95% agreement with the gold standard, IVUS [6] - The platform utilizes a proprietary data pipeline built from over 160 million annotated CTA images, enhancing the accuracy and reproducibility of insights [7] Market Presence and Adoption - Heartflow has been adopted by more than 1,400 institutions globally, indicating a strong commercial presence and commitment to expanding access to its innovative solutions [7] - The company aims to redefine cardiovascular care by transforming coronary artery disease management through early detection and personalized treatment strategies [9]

Core Insights - Heartflow, Inc. has been recognized for its AI technology in coronary artery disease (CAD) management, with new scientific statements from the American College of Cardiology (ACC) and the American Heart Association (AHA) supporting the prognostic value of coronary plaque quantification [1][3][4] Group 1: Scientific Statements and Recommendations - The ACC's consensus recommendations emphasize the importance of quantitative plaque assessment and the adoption of AI-powered Heartflow Plaque Analysis for personalized cardiac care [1][4] - The AHA statement highlights that plaque burden and composition are critical in managing nonobstructive CAD, indicating that such patients should not be considered low-risk [3][4] - Both ACC and AHA statements advocate for the integration of AI technology in clinical practice to enhance risk stratification and preventive treatment in CAD management [4][5] Group 2: Heartflow's Technology and Validation - Heartflow Plaque Analysis is the only FDA-cleared AI-powered plaque quantification tool, achieving 95% agreement with the gold standard, IVUS [2] - The technology has been validated through extensive clinical evidence, with over 100 studies involving more than 365,000 patients, demonstrating high accuracy and reproducibility [11] - The DECIDE registry indicates that over 50% of patients had their medical management altered when Plaque Analysis was included, compared to management based solely on CCTA [6][11] Group 3: Clinical Integration and Future Directions - Heartflow's technology allows for seamless clinical integration, providing instant quality-reviewed analyses upon order, which facilitates timely clinical decision-making [11] - The company aims to redefine precision cardiovascular care by leveraging its extensive coronary imaging dataset and AI capabilities [8][11] - Heartflow's commitment to rigorous validation and standardization aligns with the ACC and AHA's guidance, positioning the company as a leader in the evolving landscape of CAD management [5][11]

Core Insights - Heartflow, Inc. reported a strong third quarter for 2025, with total revenue increasing by 41% year-over-year to $46.3 million, driven by growth in its FFRCT business and an expanding installed base [3][4][9] - The company is experiencing heightened physician interest in its Heartflow Plaque Analysis, which is expected to contribute to future growth following broader commercial payor coverage [3][9] - Heartflow's gross margin improved to 76.5%, up from 75.7% in the prior year, attributed to increased revenue case volume and enhanced production efficiency [5][9] Financial Performance - Total revenue for Q3 2025 was $46.3 million, a 41% increase from $32.9 million in Q3 2024 [4][22] - U.S. revenue reached $42.5 million, reflecting a 42% year-over-year growth, while international revenue was $3.8 million, a 24% increase [4][22] - Gross profit was $35.4 million, compared to $24.9 million in the same period last year, with a gross margin of 76.5% [5][22] - Operating expenses totaled $50.5 million, representing 109% of total revenue, down from 121% in the prior year [6][22] - The net loss for Q3 2025 was $50.9 million, or ($1.04) per share, compared to a net loss of $19.1 million, or ($3.43) per share, in Q3 2024 [8][22] Operational Highlights - Heartflow launched its next-generation Heartflow Plaque Analysis with an updated algorithm and advanced visualization features [9] - The DECIDE real-world prospective registry indicated that Heartflow Plaque Analysis led to medical management changes in over half of patients beyond coronary computed tomography angiography (CCTA) alone [9] - Major payors, including UnitedHealthcare and Cigna, began coverage of Heartflow Plaque Analysis on October 1, 2025, enhancing market access [9] Future Outlook - Heartflow anticipates total revenue for the full year 2025 to be in the range of $173.0 million to $173.5 million, indicating a year-over-year growth of approximately 37.5% to 38.0% [12]

Core Insights - The FISH&CHIPS study confirms total plaque volume (TPV) as a significant independent predictor of long-term cardiovascular events, enhancing the understanding of coronary artery disease (CAD) management through AI technology [1][2][7] Company Overview - Heartflow, Inc. is a leader in AI technology for CAD, with its Heartflow Plaque Analysis and Plaque Staging framework being the most clinically validated for actionable CAD care [1][4] - The company has been adopted by over 1,400 institutions globally and has supported nearly 500,000 patients, backed by ACC/AHA guidelines and over 600 peer-reviewed publications [4][9] Study Findings - The retrospective analysis involved nearly 8,000 symptomatic patients, marking the largest validation of the Heartflow Plaque Staging framework based on TPV measurement [2] - Key findings indicate that patients in the highest TPV stage have over a 5x greater risk of major cardiovascular events compared to those in the lowest stage, with a hazard ratio of 5.10 [7] - The study suggests that accurate plaque measurement can help cardiologists personalize treatment, potentially preventing future heart attacks or deaths [2][3] Clinical Impact - Changes in medical management guided by Heartflow Plaque Staging resulted in an average reduction of LDL cholesterol by 18.7 mg/dL at 90 days, indicating a 15% decrease in the risk of cardiac events [2] - Heartflow's AI-driven solutions have been validated through over 100 studies involving more than 365,000 patients, demonstrating high accuracy and reproducibility in clinical practice [8]

Core Insights - Heartflow, Inc. has presented new data from the FISH&CHIPS Study at the AHA Scientific Sessions 2025, reinforcing the effectiveness of its AI-powered Heartflow Plaque Analysis and Plaque Staging framework for coronary artery disease (CAD) [1][2] Group 1: Study Findings - The retrospective analysis involved nearly 8,000 symptomatic patients, marking the largest validation of the Heartflow Plaque Staging framework based on total plaque volume (TPV) measurement [2] - The study indicates that TPV-based staging is a strong predictor of future heart attacks or cardiovascular death, allowing for personalized treatment to prevent adverse outcomes [2][4] - Patients in the highest TPV stage faced over a 5x greater risk of major cardiovascular events compared to those in the lowest stage, with a hazard ratio of 5.10 [4] Group 2: Clinical Impact - The DECIDE Registry data showed that Heartflow Plaque Analysis with Plaque Staging led to changes in medical management for over 50% of patients, resulting in an average LDL cholesterol reduction of 18.7 mg/dL at 90 days [2] - Management changes guided by Heartflow Plaque Staging are expected to result in a 15% decrease in the risk of cardiac events [2] Group 3: Technology and Adoption - Heartflow's technology is redefining precision cardiovascular care through clinically-proven AI and a large coronary imaging dataset, adopted by over 1,400 institutions globally [3][5] - The company has validated its AI-driven solutions through over 100 studies involving more than 365,000 patients, achieving a coronary CTA image acceptance rate exceeding 96% [5] Group 4: Regulatory and Compliance - Heartflow's quality system meets or exceeds international standards, including HITRUST, SOC 2 Type 2, GDPR, HIPAA, CCPA, ISO 13485, and ISO 27001, ensuring patient data integrity and security [6]

Core Insights - Heartflow, Inc. is set to present new data on the clinical and economic value of its AI-powered Heartflow Plaque Analysis at the AHA Scientific Sessions 2025, emphasizing its role in predicting long-term cardiovascular outcomes [1][2]. Company Developments - Heartflow will showcase seven abstracts at the AHA Scientific Sessions, reinforcing the scientific foundation for its Plaque Analysis as a significant advancement in cardiovascular risk prediction and personalized treatment [3]. - The company continues to invest in clinical research to validate its Plaque Analysis technology, which aids cardiologists in personalizing treatment plans using non-invasive methods [4]. Research Highlights - Key presentations at the AHA will include studies on coronary CT angiography as a predictor of death and myocardial infarction, improvements in cardiovascular risk assessment, and the cost-effectiveness of AI-enabled coronary plaque analysis [5][8]. - The FISH&CHIPS study, which will be presented by Dr. Timothy Fairbairn, focuses on plaque volume burden and its implications for cardiovascular risk [2][6]. Technology and Impact - Heartflow's technology utilizes AI to convert coronary CTA images into personalized 3D heart models, providing actionable insights into plaque characteristics and their impact on blood flow [14]. - The company has been adopted by over 1,400 institutions globally and has supported the management of nearly 500,000 patients, demonstrating its significant impact on cardiovascular care [13][14].