Heartflow — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue for the quarter ended September 30, 2026, was $72.9 million, representing a 57% year-over-year increase.
• U.S. revenue was $67.9 million, a 60% year-over-year increase; International and other revenue was $4.9 million, a 29% year-over-year increase.
• Gross profit was $60.9 million compared to $35.4 million in the prior year period; non-GAAP gross profit was $61.1 million compared to $35.5 million.
• Gross margin was 83.6% compared to 76.5% in the prior year period; non-GAAP gross margin was 83.8% compared to 76.8%.
• Total operating expenses were $74.8 million (103% of revenue) compared to $50.5 million (109% of revenue) in the prior year period; non-GAAP operating expenses were $66.1 million (91% of revenue) compared to $46.7 million (101% of revenue).
• Net operating loss was $13.8 million compared to $15.1 million in the prior year period; non-GAAP net operating loss was $5.0 million compared to $11.1 million.
• Net loss was $11.5 million ($0.13 per share) compared to $50.9 million ($1.04 per share) in the prior year period; the prior year included a $32.1 million noncash warrant liability charge, a $4.8 million derivative liability benefit, and a $6.4 million loss on debt extinguishment.
• Non-GAAP net loss was $2.7 million ($0.03 per share) compared to $13.2 million ($0.27 per share) in the prior year period.
• Adjusted EBITDA was ($3.6) million compared to ($9.8) million in the prior year period.
• Cash, cash equivalents, and investments totaled $253.0 million as of September 30, 2026.

Guidance and Future Outlook:

• Full-year 2026 total revenue guidance was raised to $262 million to $264 million, implying approximately 49% to 50% year-over-year growth, compared to previous guidance of $246 million to $250 million (40% to 42% growth).
• Full-year 2026 non-GAAP gross margin guidance was raised to approximately 82.5%, compared to previous guidance of approximately 82%.
• Management expressed confidence in the path to profitability, citing continued momentum and a scaling business.

Business Segments and Product Lines:

• The core FFR_(CT) business remains durable with an expanding installed base.
• Activations of Heartflow Plaque Analysis are ramping ahead of plan with utilization broadening across a wider share of applicable CCTAs.
• The increase in total global revenue was primarily driven by increased U.S. FFR_(CT) and U.S. Plaque revenue case volumes.
• Gross margin expansion was driven by increased case volumes, improved production team productivity from AI efficiency initiatives, and partially offset by hiring and training costs.
• Operating expense increases were driven by investments in sales personnel, technology, and clinical research.
• Heartflow technology is adopted by more than 1,800 institutions globally and has been used to manage care for over 800,000 patients.

Market and Competitive Landscape:

• The CCTA market continues to grow rapidly and remains significantly underpenetrated.
• U.S. revenue grew at its fastest pace in 11 quarters.
• Heartflow is the only AI platform prospectively validated against invasive gold standards with coronary CTA image acceptance rates exceeding 97%.
• The company's data foundation is built from the world's largest database of more than 250 million annotated CTA images.

Risks and Challenges:

• Risks include the potential inability to achieve or sustain profitability and dependence on the success of the two primary products: Heartflow FFR_(CT) Analysis and Heartflow Plaque Analysis.
• Risks exist regarding healthcare providers' willingness to change standard practices and third-party payor coverage or reimbursement adequacy.
• Challenges include significant competition in an environment of rapid technological change and the nascent commercialization of Heartflow Plaque Analysis.
• Risks related to AI model development, IT system dependence, security breaches, and extensive regulatory requirements are noted.

Management Commentary and Tone:

• John Farquhar, President and CEO, described the third quarter as "excellent," highlighting revenue acceleration for the third consecutive quarter.
• Management cited disciplined execution of commercial, innovation, and clinical initiatives as drivers for raising guidance.
• The tone was confident regarding the company's market leadership position and path to profitability.

Other Key Points:

• The company fully prepaid its term loan in August 2025, resulting in a $6.4 million loss on extinguishment of debt in the prior year period.
• Heartflow meets or exceeds international standards including HITRUST r2, SOC 2 Type 2, MDSAP, ISO 13485, and ISO 27001.
• The company's technology is supported by more than 625 peer-reviewed publications and backed by ACC/AHA guidelines.
• A conference call was hosted on November 12, 2026, to discuss the results.