HeartFlow, Inc. (HTFL) Q4 2025 Earnings Call Transcript

Access earnings results, analyst expectations, report, slides, earnings call, and transcript.

Overview

The earnings call summary reflects strong U.S. revenue growth, improved operating leverage, and reduced losses. Management expressed high confidence in future guidance, driven by product adoption and competitive advantages. The Q&A section revealed positive sentiment towards growth drivers and strategic innovations. However, there was some avoidance of direct answers regarding Q1 consensus revenue, which slightly tempers the overall positive sentiment. The solid cash position supports continued investment, and the outlook for shareholder returns remains favorable, contributing to a positive stock price prediction.

Key Financial Performance

Total fourth quarter revenue $49.1 million, representing more than a 40% year-over-year growth. This growth was driven by the sustained adoption of the HeartFlow platform and strong execution across commercial, innovation, and clinical initiatives.

Global cases 57,776 cases, representing 53% year-over-year growth. This was driven by record installed base growth, consistent FFRCT utilization, and strong CCTA market growth.

Non-GAAP gross margin Nearly 80%, compared to 75.3% in the fourth quarter of 2024. The improvement reflects better-than-expected volume leverage and an increase in AI-driven efficiencies enabled by continuous training on the company's proprietary CCTA database.

U.S. revenue $44.8 million, up 41% year-over-year. This growth was attributed to the strength in the U.S. FFRCT business.

OUS and other revenue $4.3 million, showing growth year-over-year. Specific reasons for this growth were not detailed.

Operating loss $12.5 million, compared to $13.5 million last year, demonstrating improving operating leverage while continuing to invest for growth.

Non-GAAP net loss $9.8 million or a loss of $0.12 per share, compared to $18.6 million or a loss of $3.15 per share in the fourth quarter of 2024. This improvement reflects better operating leverage and reduced losses.

Cash, cash equivalents, and investments $280.2 million at the end of the quarter. This indicates strong capitalization to fund operations through profitability while continuing to invest in R&D and commercial expansion.

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Operating Highlights

HeartFlow Plaque Analysis: Achieved strong early momentum with 489 accounts by year-end 2025. Recognized as the most accurate AI-driven plaque assessment technology with 95% agreement with the invasive gold standard of IVUS. Category 1 CPT code for plaque effective January 1, 2026, enabling physician reimbursement. Coverage expanded to 75% of U.S. covered lives.

PCI Navigator: AI-driven planning tool integrating anatomy, plaque burden, and lesion-specific physiology. Launch pulled forward to April 2026. Aims to enhance procedural planning for interventional cardiologists.

HeartFlow Autonomous Processing: AI-driven efficiency initiative transitioning case processing to a single-step verification model. Expected to expand gross margins to 85% midterm. Initial rollout planned for late 2026.

High-risk asymptomatic population expansion: Targeting a $6 billion incremental market opportunity in the U.S., expanding total market opportunity to $11 billion. Plans to initiate 3 randomized controlled trials across targeted subpopulations.

Revenue Growth: Q4 2025 revenue reached $49.1 million, a 40% year-over-year growth. Full-year 2026 revenue guidance set at $218-$222 million, representing 24%-26% growth.

Gross Margin Improvement: Achieved a record non-GAAP gross margin of nearly 80% in Q4 2025. 2026 guidance set at 80%-81%, with a midterm target of 85% driven by AI efficiencies and plaque revenue.

Installed Base Expansion: Added 340 new accounts in 2025, ending the year with 1,465 U.S. accounts. Plaque analysis installed base reached 489 accounts.

Clinical Leadership: Launched NavIigAT-PCI registry, a 5,000-patient study to evaluate PCI Navigator's impact. Presented real-world data from a 15,000-patient registry demonstrating plaque analysis as a powerful predictor of MACE. Plans to report 1-year outcomes from 13,000 patients in the DECIDE registry.

Innovation Pipeline: Leveraging a proprietary database of 160 million annotated CT images for product advancements. Launched next-generation plaque algorithm in late 2025.

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Risk or Challenges

Market Adoption Challenges: While the company has seen strong adoption of its HeartFlow platform and plaque analysis, there is a dependency on new accounts ramping up to steady-state utilization within a year. Any delays or issues in this ramp-up process could impact revenue growth.

Regulatory and Reimbursement Risks: Although the reimbursement landscape has improved with the introduction of a Category 1 CPT code for plaque, any changes in reimbursement policies or delays in payer adoption could negatively affect revenue from plaque analysis.

Operational Execution Risks: The company is heavily reliant on AI-driven efficiencies and autonomous processing to achieve its gross margin targets. Any delays or failures in implementing these initiatives could hinder margin expansion.

Competitive Pressures: HeartFlow operates in a competitive market for AI-driven diagnostic tools. The launch of new products like PCI Navigator is critical, but failure to differentiate or gain traction could impact market share.

Economic and Market Conditions: The company’s growth is tied to the broader CCTA market and healthcare spending trends. Economic downturns or reduced healthcare budgets could adversely affect adoption rates.

Clinical Evidence and Adoption: The company’s strategy relies on generating high-quality clinical evidence to support its products. Any setbacks in clinical trials or failure to demonstrate significant clinical impact could hinder adoption.

Expansion Risks: The company’s plans to expand into the high-risk asymptomatic population involve new clinical trials. Any delays or failures in these trials could impact the timeline and success of market expansion.

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Guidance & Outlook

2026 Revenue Guidance: HeartFlow projects full-year 2026 revenue in the range of $218 million to $222 million, representing a year-over-year growth of approximately 24% to 26%. Plaque revenue is expected to contribute approximately $15 million to $17 million, with significant growth anticipated in the second half of the year.

2026 Gross Margin Guidance: Non-GAAP gross margin is projected to be 80% to 81%, reflecting a 300 to 400 basis point expansion year-over-year. This improvement is attributed to volume leverage, AI-driven efficiencies, and higher-margin plaque revenue contributions.

Midterm Gross Margin Target: HeartFlow has increased its midterm non-GAAP gross margin target to 85%, up from the prior target of 80%. This reflects sustained volume leverage, increasing plaque revenue contribution, and continued gains in AI-driven efficiencies.

PCI Navigator Launch: The launch of PCI Navigator, an AI-driven planning tool, has been pulled forward to April 2026. This tool integrates anatomy, plaque burden, and lesion-specific physiology to enhance procedural planning for interventional cardiologists.

Autonomous Processing Initiative: HeartFlow plans to roll out its AI-driven autonomous processing initiative later in 2026, transitioning case processing to a highly automated model. A multiyear expansion is planned beginning in 2027, supporting the midterm gross margin target of 85%.

High-Risk Asymptomatic Population Expansion: HeartFlow plans to initiate three randomized controlled trials in 2026 targeting high-risk asymptomatic subpopulations. This market represents an incremental $6 billion opportunity in the U.S., expanding the total market opportunity to $11 billion.

Clinical Evidence and Trials: In 2026, HeartFlow will accelerate evidence generation through prospective trials and peer-reviewed publications. Key initiatives include the NavIigAT-PCI registry and reporting 1-year outcomes from the DECIDE registry.

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Shareholder Return Plan

The selected topic was not discussed during the call.

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Key Q&A

Q:What is the confidence level in the 2026 guidance, particularly regarding Plaque and FFRCT?

A:Management expressed high confidence in the 2026 guidance, describing it as a 'high conviction forecast.' They highlighted three drivers: the ability to sign up new accounts (340 accounts added last year), predictable utilization of FFRCT technology, and the growing adoption of CCTA as a frontline test for coronary artery disease. For Plaque, they expect to reach 1,000 accounts by the end of the year, with early trends showing positive volume. However, they noted that material volume growth is expected in the back half of the year.

Q:How does the company view its competitive moat against AI companies?

A:The company believes its moat is highly defensible due to its proprietary CT database with over 160 million annotated images, extensive clinical evidence with over 600 peer-reviewed publications, and its status as a regulated medical device. They also emphasized their integration into physicians' workflows and a strong global patent portfolio.

Q:What product innovations have been introduced recently, and how have they impacted workflow?

A:Recent innovations include the next-generation plaque algorithm and the PCI Navigator, which is launching soon. The plaque algorithm was enhanced using their proprietary database, while the PCI Navigator helps interventional cardiologists plan procedures. These innovations aim to improve functionality and integration into clinical workflows, but no significant changes to workflow were noted.

Q:What is the pricing strategy for Plaque in 2026 and beyond?

A:The company has underwritten modest ASP (average selling price) upside for Plaque in 2026, with more meaningful price increases expected in future years. Current pricing is around $350 per case, with potential for upward mobility as commercial payer coverage expands.

Q:What are the expectations for Q1 2026 performance?

A:Management expects Q1 2026 growth to exceed 30% year-over-year, with sequential improvement of 1% to 2%. They anticipate seasonality benefits in Q2 and more sequential growth in the back half of the year as Plaque adoption increases.

Q:What is the utilization trend for Plaque compared to FFRCT?

A:Plaque has a total applicability of 60% of patients, but current utilization is below this as it is still in the early stages. FFRCT, being more mature, sees utilization close to its full range of about 30%-33%. Management expects Plaque to eventually surpass FFRCT in business size.

Q:How is the company supporting accounts in utilizing Plaque analysis?

A:The company is heavily focused on medical education to help physicians understand how to use Plaque with their patients. They are also presenting data at conferences like AHA and plan to release 1-year outcomes from the DECIDE study in the second half of the year.

Q:What is the current adoption level of CCTA, and how does it impact growth?

A:CCTA adoption is around 10%-12% of the standard of care in the U.S., with significant room for growth. The number of accounts with active CCTA programs is expected to grow from 3,200 to 3,500 this year. Management sees durable trends supporting CCTA adoption, which benefits the company.

Q:How does the company view competition from other AI vendors?

A:The company views the standard of care as its primary competition and believes having more players in the category is beneficial. They compete on the quality of their data and product rather than price, emphasizing their prospective, published accuracy and continuous product improvements.

Q:Review of Unclear Management Responses

A:Management avoided directly addressing the question about Q1 consensus revenue of $46.9 million and whether they are extremely comfortable with that number. They provided general guidance for Q1 growth exceeding 30% year-over-year but did not explicitly confirm or deny the consensus figure.

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HTFL Transcript

HeartFlow, Inc. (HTFL) Q4 2025 Earnings Call Transcript

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