Heartflow Q4 Earnings Call Highlights

HeartFlow reported Q4 revenue of $49.1 million (up 40% YoY) with non‑GAAP gross margin near 80%, and guided 2026 revenue of $218–$222 million (~24–26% growth) with 80–81% gross margin and ~$15–$17 million of plaque revenue weighted to H2. The company is seeing early but accelerating adoption of Plaque Analysis (489 accounts), benefited by a new Category One CPT code effective Jan. 1, 2026 and coverage across roughly 75% of U.S. covered lives, though management expects meaningful revenue contribution in the back half of 2026 as sites scale. HeartFlow is advancing its innovation pipeline—launching PCI Navigator in April 2026 and rolling out HeartFlow Autonomous Processing starting late 2026—leveraging a proprietary database of 160 million annotated CT images and underpinning a raise in midterm non‑GAAP gross margin target to 85%. Heartflow (NASDAQ:HTFL) executives highlighted record revenue, accelerating adoption of its platform, and expanding reimbursement support during the company’s fourth-quarter 2025 earnings call, while also initiating 2026 guidance and outlining product and clinical milestones expected over the next year. Fourth-quarter results and 2026 outlook HeartFlow reported fourth-quarter revenue of $49.1 million, up 40% year over year. U.S. revenue was $44.8 million, up 41%, while “all U.S. and other revenue” was $4.3 million. Global revenue cases totaled 57,776, representing 53% growth, which management attributed to continued strength in its U.S. FFRct business. Non-GAAP gross margin reached nearly 80% in the quarter, compared with 75.3% in the year-ago period. CFO Vikram Verghese said the improvement reflected better-than-expected volume leverage and increased AI-driven efficiencies enabled by continuous training on the company’s proprietary CCTA database. For 2026, management initiated revenue guidance of $218 million to $222 million, representing approximately 24% to 26% year-over-year growth. The outlook includes expected plaque revenue of approximately $15 million to $17 million, which the company said is weighted toward the second half of the year as newly activated sites scale and physicians build experience. HeartFlow also guided to 80% to 81% non-GAAP gross margin for 2026, representing roughly 300 to 400 basis points of year-over-year expansion. Installed base growth and commercialization priorities CEO John Farquhar said 2025 was a record year for installed base expansion, with 340 new accounts added and 1,465 U.S. accounts at year-end. Management emphasized that FFRct utilization has remained durable, with new accounts typically ramping to steady state within about a year and then maintaining consistent ordering patterns over time. Verghese noted that the company again saw particular volume strength in the clinic setting and continued adoption of its volume-based rebate pricing structure. On the first quarter of 2026, Verghese provided additional phasing commentary, stating the company expects growth in excess of 30% year over year in Q1 and typical seasonality benefiting Q2. He also said sequential growth could increase in the back half of 2026 as plaque revenue becomes more meaningful. Plaque Analysis: reimbursement, coverage, and adoption HeartFlow described “strong early momentum” in plaque adoption, ending 2025 with 489 Plaque Analysis accounts. Farquhar said customer feedback has been positive and positioned HeartFlow’s plaque offering as the only AI-powered plaque solution supported by prospective published clinical evidence demonstrating 95% agreement with the invasive gold standard of IVUS, based on his comments. Management also pointed to reimbursement improvements. Farquhar said that as of January 1, 2026, the Category One CPT code for plaque is in effect, assigning RVUs and enabling physician reimbursement “for the first time ever.” He added that with Aetna joining UnitedHealthcare, Cigna, and Humana in covering the company’s analysis, Plaque Analysis now has coverage across approximately 75% of U.S. covered lives. Executives repeatedly described the adoption curve as encouraging but not instantaneous. Farquhar said the company is seeing strong initial plaque volume in Q1, but expects plaque revenue to become more meaningful in the second half as sites scale. In response to questions about utilization, he said plaque’s total applicability is about 60% of all patients, compared to a “full utilization” range of about 30% to 33% for FFRct, while acknowledging plaque is still in the early innings. On pricing, Verghese said HeartFlow’s customer contracts include mechanisms that enable better pricing with broader coverage. He said the company underwrote modest ASP upside for plaque in 2026 and expects “more meaningful step-ups” in future years as coverage broadens. Innovation pipeline: PCI Navigator and autonomous processing HeartFlow emphasized its proprietary database of 160 million annotated CT images as a driver of innovation. Farquhar said the company launched a next-generation plaque algorithm in late 2025, improving precision without requiring workflow changes for customers. He also referenced an updated user interface introduced a little over two years ago that integrated plaque and FFRct with risk profile information in a single interface. For 2026, the company announced the upcoming launch of PCI Navigator, which it described as an AI-driven planning tool integrating anatomy, plaque burden, and lesion-specific physiology for interventional cardiologists. Management said the product launch has been pulled forward to April 2026, earlier than a previously communicated second-half timeframe. While executives said PCI Navigator could strengthen engagement with interventional cardiologists and potentially drive additional activity, Verghese said the 2026 forecast does not assume incremental upside from PCI Navigator and framed it as a longer-duration growth vector rather than a near-term financial driver. Separately, HeartFlow outlined an AI-driven efficiency initiative called HeartFlow Autonomous Processing, which Farquhar said is intended to transition case processing to a highly automated single-step verification model, while maintaining a final human-in-the-loop quality check. He said rollout will be phased, starting with an initial rollout later in 2026 and a multiyear expansion beginning in 2027. Management said this initiative supports its decision to raise its midterm non-GAAP gross margin target to 85% from 80%. Clinical programs and market expansion plans On clinical evidence generation, Farquhar said HeartFlow will accelerate prospective trials and publications in 2026. He noted the first patient has been enrolled in the NAVIGATE-PCI registry, a prospective 5,000-patient study designed to evaluate how PCI Navigator influences clinical strategy, procedural efficiency, and physician confidence in the cath lab. HeartFlow also previewed upcoming data presentations and readouts tied to its plaque program: ACC meeting (later in the month): real-world data from a 15,000-patient registry from Mass General Brigham, which management said shows HeartFlow Plaque Analysis is a powerful CT-based predictor of MACE and supports its plaque staging system for risk stratification. Second half of the year: planned reporting of one-year outcomes from approximately 13,000 patients within the DECIDE registry. Management also discussed expanding into a high-risk asymptomatic population. Farquhar said HeartFlow estimates this represents an incremental $6 billion U.S. opportunity, expanding total market opportunity to $11 billion. Over the next 12 months, the company plans to initiate three randomized controlled trials across targeted subpopulations, with approximately 1,400 total patients combined across the trials, according to his remarks. On competitive positioning, Farquhar said the company’s primary “competition” is the existing standard of care, and he argued HeartFlow’s differentiation is rooted in its proprietary data set, clinical evidence base (including more than 600 peer-reviewed publications as cited on the call), regulated medical device requirements, integration into clinical workflows, and its global patent portfolio. He said the company competes on product quality rather than price and added that other AI vendors in the category have not slowed HeartFlow’s progress. From a financial position standpoint, Verghese said HeartFlow ended the quarter with $280.2 million in cash, equivalents, and investments and said the company is “well capitalized” to fund operations through profitability while continuing to invest in R&D and commercial expansion. He also said HeartFlow remains on track to achieve cash flow profitability within three years of its IPO. About Heartflow (NASDAQ:HTFL) HeartFlow, Inc (NASDAQ: HTFL) is a medical technology company that develops non-invasive diagnostic solutions for coronary artery disease. The company's core offering translates coronary CT angiography (CTA) data into a patient-specific, three-dimensional physiological model of the coronary arteries. Using advanced image processing and computational modeling, HeartFlow's analysis estimates fractional flow reserve (FFR) values throughout the coronary tree to identify ischemia-producing lesions without the need for invasive pressure-wire measurements. HeartFlow's cloud-based service integrates with clinical workflows: clinicians submit coronary CTA images and receive a detailed, color-coded 3D map and report that highlights lesion-specific FFR values and physiological impact.