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HeartFlowD
Nasdaq / Health Care Equipment & Services
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2026-08-16
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Investor releaseQuarter not tagged2026-08-16

HeartFlow (HTFL) Jumps On Q2 Results As Raised Outlook Leaves Shares Fully Valued

Simply Wall St.
Track your investments for FREE with Simply Wall St, the portfolio command center trusted by over 7 million individual investors worldwide. HeartFlow (HTFL) moved after its second quarter 2026 report, which paired higher sales with a continued net loss, along with a raised full year revenue outlook that lifted investor attention on the stock. See our latest analysis for HeartFlow. HeartFlow has seen sharp share price momentum around these results, with a 1 day share price return of 35.7% and a 30 day share price return of 69.1%, helping lift the stock to US$42.08 and contributing to a 35% 1 year total shareholder return. If the recent move in HeartFlow has you thinking about where else growth and AI in healthcare might show up next, it could be worth scanning 42 healthcare AI stocks After a surge like HeartFlow has just seen, some investors prefer to wait for a pullback while others lean into the momentum. So how does the current share price compare with the fundamentals and growth profile? HeartFlow’s most followed narrative places fair value at about $42.13, almost exactly in line with the recent $42.08 close. This puts the latest surge into context. Read the complete narrative. Want to see what kind of revenue ramp, margin shift and future earnings multiple sit behind that tight fair value band? The full narrative lays out those assumptions in detail. Result: Fair Value of $42.13 (ABOUT RIGHT) Have a read of the narrative in full and understand what's behind the forecasts. However, HeartFlow’s story still leans on assumptions about sustained coronary CT adoption and Plaque Analysis uptake, and any shortfall in either area could quickly challenge this fair value view. Find out about the key risks to this HeartFlow narrative. While the analyst narrative pegs HeartFlow at about fair value around $42.13, the current P/S ratio of 17.3x paints a more expensive picture. It sits well above the US Healthcare Services industry at 2.9x and a fair ratio estimate of 7.4x, which increases valuation risk if expectations ease even slightly. So which signal do you trust more right now? For a closer look at what the numbers imply about this pricing gap, See what the numbers say about this price — find out in our valuation breakdown. If the sentiment around HeartFlow so far feels finely balanced between promise and risk, it makes sense to move quickly and test the data for…Read full document

Track your investments for FREE with Simply Wall St, the portfolio command center trusted by over 7 million individual investors worldwide. HeartFlow (HTFL) moved after its second quarter 2026 report, which paired higher sales with a continued net loss, along with a raised full year revenue outlook that lifted investor attention on the stock. See our latest analysis for HeartFlow. HeartFlow has seen sharp share price momentum around these results, with a 1 day share price return of 35.7% and a 30 day share price return of 69.1%, helping lift the stock to US$42.08 and contributing to a 35% 1 year total shareholder return. If the recent move in HeartFlow has you thinking about where else growth and AI in healthcare might show up next, it could be worth scanning 42 healthcare AI stocks After a surge like HeartFlow has just seen, some investors prefer to wait for a pullback while others lean into the momentum. So how does the current share price compare with the fundamentals and growth profile? HeartFlow’s most followed narrative places fair value at about $42.13, almost exactly in line with the recent $42.08 close. This puts the latest surge into context. Read the complete narrative. Want to see what kind of revenue ramp, margin shift and future earnings multiple sit behind that tight fair value band? The full narrative lays out those assumptions in detail. Result: Fair Value of $42.13 (ABOUT RIGHT) Have a read of the narrative in full and understand what's behind the forecasts. However, HeartFlow’s story still leans on assumptions about sustained coronary CT adoption and Plaque Analysis uptake, and any shortfall in either area could quickly challenge this fair value view. Find out about the key risks to this HeartFlow narrative. While the analyst narrative pegs HeartFlow at about fair value around $42.13, the current P/S ratio of 17.3x paints a more expensive picture. It sits well above the US Healthcare Services industry at 2.9x and a fair ratio estimate of 7.4x, which increases valuation risk if expectations ease even slightly. So which signal do you trust more right now? For a closer look at what the numbers imply about this pricing gap, See what the numbers say about this price — find out in our valuation breakdown. If the sentiment around HeartFlow so far feels finely balanced between promise and risk, it makes sense to move quickly and test the data for yourself, then weigh up the 2 key rewards and 2 important warning signs. If HeartFlow has sharpened your focus on where to put new capital to work, now is a good time to scan fresh ideas before the next move passes you by. Spot potential value opportunities early and run your own comparisons using the 52 high quality undervalued stocks. Prioritise capital preservation by filtering for companies with steadier profiles through the 80 resilient stocks with low risk scores. Hunt for underfollowed stories that still show solid fundamentals with the screener containing 20 high quality undiscovered gems. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include HTFL. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Investor releaseQuarter not tagged2026-08-14

Heartflow, Inc. Common Stock Q2 2026 Earnings Call Summary

Moby
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Revenue growth of 48% was driven by the fastest acceleration in eight quarters, fueled by the rapid adoption of Plaque analysis and durable FFRCT utilization. The company is successfully leveraging its existing installed base to deploy new innovations, reaching 1,250 Plaque-activated accounts in two years compared to the eight years required for FFRCT. Management attributes competitive wins to market-leading accuracy and reproducibility, which are increasingly prioritized by clinical guidelines and independent scientific statements. Gross margin expansion to 83.3% resulted from a combination of volume leverage, a higher mix of high-margin Plaque revenue, and ongoing AI-driven production efficiencies. The breadth of the AI diagnostics platform, including Roadmap and PCI Navigator, is deepening clinical relationships and establishing HeartFlow as the 'operating system of record' for coronary artery disease. Strategic positioning is shifting toward a 'CT-first' pathway, with interventional cardiologists becoming key advocates for HeartFlow adoption within health systems. Full-year 2026 revenue guidance was raised to $246 million–$250 million, assuming steady sequential growth and typical second-half seasonality in the CCTA market. Management plans to expand the U.S. TAM from $5 billion to $11 billion by targeting high-risk asymptomatic patients through three new randomized controlled trials starting in late 2026. The 'Plaque Tracker' product and autonomous processing initiatives remain on track for 2027 rollouts, with the latter serving as a primary driver for the mid-term 85% gross margin target. Profitability remains projected for mid-2028, supported by a disciplined allocation of capital toward high-priority R&D and commercial expansion. Management expects Plaque pricing to step up more meaningfully in early 2027 as contractual schedules and clinical experience mature. Non-GAAP SG&A now excludes specific litigation-related expenses to provide better visibility into underlying operating performance during ongoing IP disputes. Management characterized the CMS proposal for AI-enabled software as a constructive multi-year process that aligns with their value proposition of improving clinical outcomes. Ongoing DO…Read full document

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Revenue growth of 48% was driven by the fastest acceleration in eight quarters, fueled by the rapid adoption of Plaque analysis and durable FFRCT utilization. The company is successfully leveraging its existing installed base to deploy new innovations, reaching 1,250 Plaque-activated accounts in two years compared to the eight years required for FFRCT. Management attributes competitive wins to market-leading accuracy and reproducibility, which are increasingly prioritized by clinical guidelines and independent scientific statements. Gross margin expansion to 83.3% resulted from a combination of volume leverage, a higher mix of high-margin Plaque revenue, and ongoing AI-driven production efficiencies. The breadth of the AI diagnostics platform, including Roadmap and PCI Navigator, is deepening clinical relationships and establishing HeartFlow as the 'operating system of record' for coronary artery disease. Strategic positioning is shifting toward a 'CT-first' pathway, with interventional cardiologists becoming key advocates for HeartFlow adoption within health systems. Full-year 2026 revenue guidance was raised to $246 million–$250 million, assuming steady sequential growth and typical second-half seasonality in the CCTA market. Management plans to expand the U.S. TAM from $5 billion to $11 billion by targeting high-risk asymptomatic patients through three new randomized controlled trials starting in late 2026. The 'Plaque Tracker' product and autonomous processing initiatives remain on track for 2027 rollouts, with the latter serving as a primary driver for the mid-term 85% gross margin target. Profitability remains projected for mid-2028, supported by a disciplined allocation of capital toward high-priority R&D and commercial expansion. Management expects Plaque pricing to step up more meaningfully in early 2027 as contractual schedules and clinical experience mature. Non-GAAP SG&A now excludes specific litigation-related expenses to provide better visibility into underlying operating performance during ongoing IP disputes. Management characterized the CMS proposal for AI-enabled software as a constructive multi-year process that aligns with their value proposition of improving clinical outcomes. Ongoing DOJ and patent litigation are described as multi-year processes that management does not currently view as a distraction to core operations. The exclusive selection as the plaque provider for the NIH-funded PREEMPT study is cited as a major validation of the platform's clinical utility in younger populations. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management noted that physician adoption metrics are at record levels, with utilization ramping as clinicians apply Plaque to a broader range of patients. Success is attributed to being on the 'right side of history' as CCTA penetrates the broader non-invasive testing market, currently at only 11% penetration. Management views the 2027 proposal as positive, noting that FFRCT and Plaque rates are stable while CCTA rates are increasing by nearly 12%. They believe the shift toward aligning payments with clinical outcomes favors their evidence-heavy platform, though full implementation is likely years away. FFRCT volumes significantly exceeded plans while ASPs were ahead of expectations due to favorable customer mix, which management believes is durable. Plaque ASPs benefited from contractual step-ups and a tilt toward higher-priced accounts, with further pricing increases anticipated in 2027. The product is currently offered without a fee to drive platform differentiation and engage interventional cardiologists as internal champions. The rollout is being phased to prioritize high-volume PCI hospitals without distracting the sales force from the primary Plaque launch.

Investor releaseQuarter not tagged2026-08-14

Heartflow Q2 Earnings Call Highlights

MarketBeat
Interested in Heartflow, Inc.? Here are five stocks we like better. Strong second-quarter growth: Revenue rose 48% year over year to $64.1 million, while global case volume increased 74% to 84,491, driven by Plaque Analysis, FFR-CT utilization and broader CCTA adoption. 2026 outlook raised: Heartflow now expects full-year revenue of $246 million to $250 million and plaque revenue of $29 million to $31 million. Non-GAAP gross margin reached 83.3%, and the company remains on track for cash-flow profitability by mid-2028. Product and market expansion: The company launched Plaque Staging, continues developing PCI Navigator and plans trials targeting high-risk asymptomatic populations that could expand its U.S. addressable market from roughly $5 billion to $11 billion. Heartflow (NASDAQ:HTFL) reported second-quarter revenue of $64.1 million, up 48% from a year earlier, as growth in its Plaque Analysis offering, durable FFR-CT utilization and continued expansion of the coronary CT angiography, or CCTA, market supported results. U.S. revenue rose 51% to $59.6 million, including $7.8 million from plaque revenue, while revenue outside the U.S. and other revenue totaled $4.5 million. Global revenue cases increased 74% to 84,491 during the quarter ended June 30. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be “Our year-over-year revenue growth accelerated for the second consecutive quarter, and we finished ahead of our expectations,” President and CEO John Farquhar said. He cited plaque adoption, FFR-CT utilization at existing accounts, new-account additions and growth in the underlying CCTA market as key drivers. Following the second-quarter performance, Heartflow raised its full-year revenue forecast to $246 million to $250 million, representing 40% to 42% year-over-year growth. The company also increased its 2026 plaque revenue outlook to $29 million to $31 million and now expects approximately 1,250 plaque-activated accounts by year-end. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand Chief Financial Officer Vikram Verghese said plaque revenue exceeded internal expectations, while results were broad-based across both plaque and FFR-CT. He said the company saw favorable seasonal demand in the second quarter, continued utilization growth at existing sites and contributions from recently added accounts. Heartflow said new ac…Read full document

Interested in Heartflow, Inc.? Here are five stocks we like better. Strong second-quarter growth: Revenue rose 48% year over year to $64.1 million, while global case volume increased 74% to 84,491, driven by Plaque Analysis, FFR-CT utilization and broader CCTA adoption. 2026 outlook raised: Heartflow now expects full-year revenue of $246 million to $250 million and plaque revenue of $29 million to $31 million. Non-GAAP gross margin reached 83.3%, and the company remains on track for cash-flow profitability by mid-2028. Product and market expansion: The company launched Plaque Staging, continues developing PCI Navigator and plans trials targeting high-risk asymptomatic populations that could expand its U.S. addressable market from roughly $5 billion to $11 billion. Heartflow (NASDAQ:HTFL) reported second-quarter revenue of $64.1 million, up 48% from a year earlier, as growth in its Plaque Analysis offering, durable FFR-CT utilization and continued expansion of the coronary CT angiography, or CCTA, market supported results. U.S. revenue rose 51% to $59.6 million, including $7.8 million from plaque revenue, while revenue outside the U.S. and other revenue totaled $4.5 million. Global revenue cases increased 74% to 84,491 during the quarter ended June 30. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be “Our year-over-year revenue growth accelerated for the second consecutive quarter, and we finished ahead of our expectations,” President and CEO John Farquhar said. He cited plaque adoption, FFR-CT utilization at existing accounts, new-account additions and growth in the underlying CCTA market as key drivers. Following the second-quarter performance, Heartflow raised its full-year revenue forecast to $246 million to $250 million, representing 40% to 42% year-over-year growth. The company also increased its 2026 plaque revenue outlook to $29 million to $31 million and now expects approximately 1,250 plaque-activated accounts by year-end. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand Chief Financial Officer Vikram Verghese said plaque revenue exceeded internal expectations, while results were broad-based across both plaque and FFR-CT. He said the company saw favorable seasonal demand in the second quarter, continued utilization growth at existing sites and contributions from recently added accounts. Heartflow said new accounts generally take about a year to approach full FFR-CT utilization. The company estimates FFR-CT is applicable to approximately 33% of CCTA scans, while plaque analysis is applicable to about 60% of scans. → On Holding's Price Stumble May Be an Opening for a Company Built to Run Farquhar said plaque activations were ahead of plan and that ordering-physician metrics, including both new and repeat orders, reached record levels. He added that the company had roughly 78% coverage for plaque. Non-GAAP gross margin reached 83.3% in the quarter, compared with 75.6% a year earlier. The expansion reflected volume leverage, production efficiencies, a higher mix of plaque revenue and progress in AI-enabled automation, according to Verghese. The company raised its full-year non-GAAP gross-margin outlook to approximately 82%, up 500 basis points year over year. It continues to target a midterm non-GAAP gross margin of 85%, with autonomous processing expected to become a more significant margin driver in 2027. Second-quarter non-GAAP operating expenses were 96% of revenue, down from 102% a year earlier. Non-GAAP operating loss narrowed to $7.9 million from $11.5 million, while non-GAAP net loss narrowed to $5.8 million, or $0.07 per share, from $17.6 million, or $2.79 per share. On a GAAP basis, net loss was $15.7 million, or $0.18 per share. Heartflow ended the quarter with $246.8 million in cash equivalents and investments and said it remained on track to achieve cash-flow profitability by mid-2028. At the Society of Cardiovascular Computed Tomography meeting in July, Heartflow launched Plaque Staging, a tool designed to classify disease burden into four stages to help physicians assess patient risk and guide medical management. Farquhar said the tool was validated in more than 23,000 patients with up to 16 years of follow-up. The company also said PCI Navigator, launched earlier in 2026, is gaining traction and remains on track for a broader rollout in 2027. The product combines lesion-specific FFR-CT and plaque information to help interventional cardiologists plan procedures. Heartflow does not currently charge for PCI Navigator and does not plan to seek reimbursement for it, Farquhar said, describing it as a platform differentiator intended to support adoption of a CT-first pathway. Heartflow presented eight new data sets involving more than 36,000 patients at SCCT. Among the findings cited by the company, a blinded prospective study published in the Journal of the American College of Cardiology showed minimal variability in repeat scans using Heartflow Plaque Analysis. Separately, an analysis of nearly 12,000 symptomatic patients in the DECIDE registry found that Plaque Staging reclassified half of patients with a zero calcium score into a higher-risk category by identifying non-calcified plaque. Heartflow said it plans to expand plaque analysis into high-risk asymptomatic populations, which it estimates could increase its U.S. total addressable market by roughly $6 billion to approximately $11 billion. A trial involving patients with coronary artery calcium is scheduled to begin enrollment in the fourth quarter of 2026. A study involving patients with prior myocardial infarction or PCI is also expected to begin enrollment in the fourth quarter. A trial involving patients with prior plaque is planned to begin enrollment in the first quarter of 2027. Farquhar said the studies would use the company’s existing technology and would evaluate changes in physician management and outcomes measured by changes in LDL cholesterol and soft plaque. He said Heartflow does not expect to need additional FDA clearance for these uses and aims to enter the markets with reimbursed technology before 2030. The company also said it was selected as the exclusive plaque provider for the PRE-EMPT Study, an NIH-funded 1,500-patient study examining whether direct measurement of coronary disease can improve prevention among younger asymptomatic patients. 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. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Heartflow Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Investor releaseQuarter not tagged2026-08-14

HeartFlow Inc (HTFL) (Q2 2026) Earnings Call Highlights: Revenue Surges 48% and Plaque Momentum ...

GuruFocus.com
This article first appeared on GuruFocus. Revenue: Total revenue of $64.1 million, up 48% year over year. US Revenue: $59.6 million, up 51% year over year. Plaque Revenue: $7.8 million in the second quarter. OUS and Other Revenue: $4.5 million. Total Global Revenue Cases: 84,491, up 74% year over year. Gross Margin: 83.3%, compared to 75.6% in the second quarter of 2025. SG&A Expenses: $37.8 million. R&D Expenses: $23.5 million. Non-GAAP Operating Loss: $7.9 million, compared to $11.5 million last year. Non-GAAP Net Loss: $5.8 million, or $0.07 per share, compared to a net loss of $17.6 million, or $2.79 per share, in the second quarter of 2025. GAAP Net Loss: $15.7 million, or $0.18 per share. Cash and Investments: $246.8 million at the end of the quarter. Full-Year 2026 Revenue Guidance: Raised to $246 million to $250 million, representing 40% to 42% growth. Full-Year 2026 Plaque Revenue Guidance: Raised to $29 million to $31 million. Full-Year 2026 Non-GAAP Gross Margin Guidance: Approximately 82%. Warning! GuruFocus has detected 3 Warning Signs with HTFL. Is HTFL fairly valued? Test your thesis with our free DCF calculator. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Revenue grew 48% year-over-year to $64.1 million, with US revenue up 51%, marking the fastest growth in eight quarters. Plaque revenue exceeded expectations at $7.8 million, with activations and utilization ahead of plan, supporting a raised full-year outlook. Gross margin expanded to 83.3%, up 770 basis points year-over-year, driven by AI efficiencies, volume leverage, and higher-margin Plaque mix. Launched Heartflow Plaque Staging, a clinically validated tool for risk stratification, expected to drive further adoption. Selected as exclusive Plaque provider for the NIH-funded PRE-EMPT study, highlighting clinical confidence in the technology. Non-GAAP operating loss of $7.9 million and net loss of $5.8 million persist, though improved year-over-year. FFRCT ASPs face pressure, with year-over-year declines expected to moderate only by 2027. Plaque adoption remains early, with utilization still far from the 60% applicability target. Ongoing IP litigation and CID investigation create potential legal and financial uncertainties. Full-year guidance implies only modest sequential revenue growth in H2, reflecting…Read full document

This article first appeared on GuruFocus. Revenue: Total revenue of $64.1 million, up 48% year over year. US Revenue: $59.6 million, up 51% year over year. Plaque Revenue: $7.8 million in the second quarter. OUS and Other Revenue: $4.5 million. Total Global Revenue Cases: 84,491, up 74% year over year. Gross Margin: 83.3%, compared to 75.6% in the second quarter of 2025. SG&A Expenses: $37.8 million. R&D Expenses: $23.5 million. Non-GAAP Operating Loss: $7.9 million, compared to $11.5 million last year. Non-GAAP Net Loss: $5.8 million, or $0.07 per share, compared to a net loss of $17.6 million, or $2.79 per share, in the second quarter of 2025. GAAP Net Loss: $15.7 million, or $0.18 per share. Cash and Investments: $246.8 million at the end of the quarter. Full-Year 2026 Revenue Guidance: Raised to $246 million to $250 million, representing 40% to 42% growth. Full-Year 2026 Plaque Revenue Guidance: Raised to $29 million to $31 million. Full-Year 2026 Non-GAAP Gross Margin Guidance: Approximately 82%. Warning! GuruFocus has detected 3 Warning Signs with HTFL. Is HTFL fairly valued? Test your thesis with our free DCF calculator. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Revenue grew 48% year-over-year to $64.1 million, with US revenue up 51%, marking the fastest growth in eight quarters. Plaque revenue exceeded expectations at $7.8 million, with activations and utilization ahead of plan, supporting a raised full-year outlook. Gross margin expanded to 83.3%, up 770 basis points year-over-year, driven by AI efficiencies, volume leverage, and higher-margin Plaque mix. Launched Heartflow Plaque Staging, a clinically validated tool for risk stratification, expected to drive further adoption. Selected as exclusive Plaque provider for the NIH-funded PRE-EMPT study, highlighting clinical confidence in the technology. Non-GAAP operating loss of $7.9 million and net loss of $5.8 million persist, though improved year-over-year. FFRCT ASPs face pressure, with year-over-year declines expected to moderate only by 2027. Plaque adoption remains early, with utilization still far from the 60% applicability target. Ongoing IP litigation and CID investigation create potential legal and financial uncertainties. Full-year guidance implies only modest sequential revenue growth in H2, reflecting conservative assumptions and seasonality. Q: Can you provide more detail on what is driving the strong adoption of Plaque and what differentiates HeartFlow from competitors in this space? A: John Farquhar (CEO) stated that Plaque momentum is significant and ahead of plan, with new account activations on track to reach 1,250 by year-end, a milestone that took eight years to achieve with FFRCT. He attributes the success to market-leading accuracy and reproducibility, validated in peer-reviewed studies, which aligns with ACC scientific standards. Physician adoption metrics are at record levels, with utilization ramping above initial expectations, and coverage is ahead of plan at approximately 78%. Customers are increasingly choosing HeartFlow, signaling strong market preference. Q: How should we think about the revenue beat in Q2, and was it driven more by FFRCT or Plaque? A: Vikram Verghese (CFO) clarified that Plaque handily beat expectations, with revenues of $7.8 million, approximately $4 million above plan. However, the overall performance was broad-based, with both FFRCT and Plaque contributing. FFRCT saw strong volume growth driven by improved utilization in existing sites and ramping new accounts. Plaque was a standout, with strong utilization trends, a record number of new ordering physicians, and existing physicians using the service more frequently. Q: Can you provide an update on the DECIDE one-year outcomes and how the data might influence physician behavior? A: John Farquhar (CEO) confirmed the one-year outcomes will be presented in Q4, focusing on changes in LDL. He noted that while clinical data is important for education, the most significant driver of adoption is physicians observing real-world changes in their patients' LDL levels after using Plaque analysis. This real-world evidence is expected to create a snowball effect that will further support Plaque adoption over the long term. Q: What are the timelines and next steps for the RCTs targeting the asymptomatic market, and is FDA approval required? A: John Farquhar (CEO) explained that the company is targeting three high-risk asymptomatic subpopulations: secondary prevention (prior MI/PCI), patients with calcium, and patients with Plaque. These trials will use existing technology, so no new FDA clearance is required. Each trial will enroll 300-500 patients, with endpoints measuring changes in physician management and outcomes (LDL and soft Plaque). Enrollment begins in Q4 2026 for the first two trials and Q1 2027 for the third. This approach is capital-efficient and leverages existing sales channels, with the goal of entering these markets with reimbursed technology before 2030. Q: Can you elaborate on the operating leverage seen in Q2 and the role of AI efficiency in future margin expansion? A: Vikram Verghese (CFO) highlighted that Q2 outperformance on the top line was reinvested with discipline into R&D, yet EBIT was roughly cut in half quarter-over-quarter. The company is leveraging durable revenue growth with strong margin expansion to invest in R&D and commercial initiatives. Key drivers for future margin expansion include the autonomous processing initiative, which reduces human touch, and the scaling of Plaque revenues. Despite investments, OpEx as a percentage of revenue is expected to improve by at least 5 points year-over-year, reinforcing the path to profitability by 2028. Q: How did pricing dynamics and revenue per case perform in Q2, and what is the outlook for ASPs? A: Vikram Verghese (CFO) noted that FFRCT volumes came in significantly above plan, with ASPs finishing modestly ahead of expectations due to favorable customer mix. This mix is considered durable, and consensus estimates for full-year FFRCT ASP are in the right ballpark. For Plaque, ASP favorability was driven by contractual step-ups that went into effect and a beneficial mix of higher-priced accounts. No further pricing changes are baked into the 2026 guidance, but a more meaningful step-up is expected in early 2027. Q: What is the pace of Plaque adoption at key accounts, and is there a halo effect between FFRCT and Plaque usage? A: John Farquhar (CEO) confirmed that while the maximum applicability for Plaque is 60% of CCTAs, the ramp towards that level is ahead of expectations, though still early. Initially, there was more overlap with FFRCT patients also receiving Plaque, but this is broadening as adoption increases. The company is pleased with the progress and the expanding use of Plaque across a wider range of patients. Q: Why does the full-year gross margin guidance not assume sequential improvement, and what are the key levers for expansion? A: Vikram Verghese (CFO) explained that the 82% gross margin guidance accounts for increased Plaque revenues, with about 75% of the Q2 beat driven by revenue outperformance. The remaining beat was due to headcount favorability and less R&D amortization. The architecture of margin expansion relies on AI-driven automation, Plaque revenue growth, and volume leverage. While there are puts and takes, including additional hiring in production and customer success, the autonomous processing initiative is expected to be a more significant driver in 2027, underpinning the mid-term target of 85%. Q: Can you provide an update on the PCI Navigator product and its commercialization strategy? A: John Farquhar (CEO) stated that PCI Navigator is currently not charged for, and there are no plans to pursue reimbursement. The strategy is to use it as a differentiator to engage interventional cardiologists as champions for the CT plus HeartFlow pathway. The rollout is phased, focusing on high-volume PCI hospitals first, to avoid distracting from the primary focus on Plaque. Early feedback has been very strong, and the company plans to expand availability throughout the year and into 2027. Q: What is the company's view on the recent CMS proposal for AI-enabled software reimbursement, and how might it impact HeartFlow? A: John Farquhar (CEO) viewed the proposal as a positive in the near term, noting that the 2027 hospital payment proposal keeps FFRCT and Plaque stable while increasing CCTA payments by nearly 12%, strengthening the economics of the HeartFlow pathway. Longer-term, the new framework for AI-enabled software is seen as constructive, as CMS acknowledges AI services differ from traditional medical devices. HeartFlow believes its clinical evidence aligns well with CMS's goal of better aligning payments with clinical outcomes, and the company looks For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-08-13

HeartFlow: Q2 Earnings Snapshot

Associated Press

MOUNTAIN VIEW, Calif. (AP) — MOUNTAIN VIEW, Calif. (AP) — HeartFlow Inc. (HTFL) on Thursday reported a loss of $15.7 million in its second quarter. On a per-share basis, the Mountain View, California-based company said it had a loss of 18 cents. Losses, adjusted for stock option expense and non-recurring costs, came to 7 cents per share. The results beat Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of 14 cents per share. The medical technology company posted revenue of $64.1 million in the period, which also beat Street forecasts. Five analysts surveyed by Zacks expected $56.7 million. HeartFlow expects full-year revenue in the range of $246 million to $250 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on HTFL at https://www.zacks.com/ap/HTFL

Investor releaseQuarter not tagged2026-08-13

Heartflow Reports Second Quarter 2026 Financial Results and Raises Full Year 2026 Guidance

GlobeNewswire
SAN FRANCISCO, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for diagnosing coronary artery disease (CAD), today reported financial results for the second quarter ended June 30, 2026. Second Quarter 2026 Highlights Total revenue of $64.1 million, a 48% increase year-over-year Gross margin of 83.0%, non-GAAP gross margin of 83.3% Net operating loss of $17.9 million; non-GAAP net operating loss of $7.9 million 2026 Annual Guidance Total revenue of $246 million to $250 million (approximately 40% to 42% growth year-over-year), compared to previous guidance of $228 million to $232 million (approximately 29% to 32% growth year-over-year) Non-GAAP gross margin of approximately 82%, compared to previous guidance of approximately 81% "The second quarter reflects the growing strength of Heartflow's category leadership and unique AI technology platform for identifying, diagnosing, managing and treating coronary artery disease," said John Farquhar, President and CEO of Heartflow. "The CCTA market for detecting CAD continues to grow rapidly and remains significantly under-penetrated, providing a strong backdrop for continued growth. Our FFRCT business remains strong and durable, while Plaque is rapidly emerging as a meaningful second growth engine — helping us win new accounts, deepen physician utilization and expand the value of the Heartflow platform for our customers. At the same time, record gross margin and improving operating leverage demonstrate the increasing scalability of our model, giving us greater confidence in long-term, profitable growth." Second Quarter 2026 Financial ResultsTotal revenue was $64.1 million, a 48% increase year-over-year. U.S. revenue was $59.6 million, a 51% increase year-over-year. International and other revenue was $4.5 million, a 12% increase year-over-year. The year-over-year increase in total global revenue was primarily attributable to an increase in total U.S. FFRCT revenue case volume and an increase in total U.S. Plaque revenue case volume. Gross profit was $53.2 million, compared to $32.8 million in the prior year period. Non-GAAP gross profit was $53.4 million, compared to $32.8 million in the prior year period. Gross margin was 83.0%, compared to 75.5% in the prior year period. Non-GAAP gross margin was 83.3%, compared to 75.6% in the prior year period. The year-over…Read full document

SAN FRANCISCO, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for diagnosing coronary artery disease (CAD), today reported financial results for the second quarter ended June 30, 2026. Second Quarter 2026 Highlights Total revenue of $64.1 million, a 48% increase year-over-year Gross margin of 83.0%, non-GAAP gross margin of 83.3% Net operating loss of $17.9 million; non-GAAP net operating loss of $7.9 million 2026 Annual Guidance Total revenue of $246 million to $250 million (approximately 40% to 42% growth year-over-year), compared to previous guidance of $228 million to $232 million (approximately 29% to 32% growth year-over-year) Non-GAAP gross margin of approximately 82%, compared to previous guidance of approximately 81% "The second quarter reflects the growing strength of Heartflow's category leadership and unique AI technology platform for identifying, diagnosing, managing and treating coronary artery disease," said John Farquhar, President and CEO of Heartflow. "The CCTA market for detecting CAD continues to grow rapidly and remains significantly under-penetrated, providing a strong backdrop for continued growth. Our FFRCT business remains strong and durable, while Plaque is rapidly emerging as a meaningful second growth engine — helping us win new accounts, deepen physician utilization and expand the value of the Heartflow platform for our customers. At the same time, record gross margin and improving operating leverage demonstrate the increasing scalability of our model, giving us greater confidence in long-term, profitable growth." Second Quarter 2026 Financial ResultsTotal revenue was $64.1 million, a 48% increase year-over-year. U.S. revenue was $59.6 million, a 51% increase year-over-year. International and other revenue was $4.5 million, a 12% increase year-over-year. The year-over-year increase in total global revenue was primarily attributable to an increase in total U.S. FFRCT revenue case volume and an increase in total U.S. Plaque revenue case volume. Gross profit was $53.2 million, compared to $32.8 million in the prior year period. Non-GAAP gross profit was $53.4 million, compared to $32.8 million in the prior year period. Gross margin was 83.0%, compared to 75.5% in the prior year period. Non-GAAP gross margin was 83.3%, compared to 75.6% in the prior year period. The year-over-year gross margin expansion was primarily attributable to an increase in total revenue case volume, an increase in total U.S. Plaque revenue case volume, and improved production team productivity driven by AI efficiency initiatives, partially offset by the hiring and training of production team personnel. Total operating expenses were $71.1 million, or 111% of total revenue, compared to $46.5 million, or 107% of total revenue, in the prior year period. Non-GAAP total operating expenses were $61.3 million, or 96% of total revenue, compared to $44.3 million, or 102% of total revenue, in the prior year period. The year-over-year operating expense increase was primarily attributable to increased investment in sales personnel and related expenses, as well as increased investments in technology and clinical research. Net operating loss was $17.9 million, compared to $13.7 million in the prior year period. Non-GAAP net operating loss was $7.9 million, compared to $11.5 million in the prior year period. Net loss was $15.7 million, or ($0.18) net loss per share, compared to $9.2 million, or ($1.46) net loss per share, in the prior year period. Non-GAAP net loss was $5.8 million, or ($0.07) non-GAAP net loss per share, compared to $17.6 million, or ($2.79) non-GAAP net loss per share, in the prior year period. Adjusted EBITDA was ($6.7) million, compared to ($10.1) million in the prior year period. Cash, cash equivalents and investments totaled $246.8 million as of June 30, 2026. For additional information regarding non-GAAP financial measures, see “Use of Non-GAAP Measures,” “Heartflow GAAP to Non-GAAP Reconciliations” and “Reconciliation of GAAP Net Loss to Adjusted EBITDA” below. Webcast and Conference Call DetailsHeartflow will host a conference call today, August 13, 2026, at 1:30 p.m. PT / 4:30 p.m. ET to discuss its second quarter 2026 financial results. Those interested in listening to the conference call should register online using this link. Once registered, participants will receive dial-in numbers and a unique PIN to join the call. Participants are encouraged to register more than 15 minutes prior to the start of the call. A live and archived webcast of the event will also be available on the “Investor Relations” section of the Heartflow website at https://ir.heartflow.com. The archived version will be available for 12 months following completion of the live call. About Heartflow’s Technology and ResearchHeartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,800 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by American College of Cardiology and American Heart Association (ACC/AHA) guidelines and supported by more than 625 peer-reviewed publications, Heartflow has redefined how clinicians manage care for more than 750,000 patients worldwide.1 Key benefits include: Unmatched Proprietary data pipeline: Built from the world’s largest database of more than 200 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations. Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 200 studies assessing over 365,000 patients. Heartflow is the only AI platform prospectively validated against invasive gold standards and demonstrated through real-world evidence to improve patient outcomes.2,3,4,5 Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%. Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay. Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001. About Heartflow, Inc.Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com. Use of Non-GAAP MeasuresTo supplement its consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company discloses non-GAAP gross profit and non-GAAP gross margin, non-GAAP total operating expenses, non-GAAP research and development expense, non-GAAP selling, general and administrative expense, non-GAAP net operating loss, non-GAAP net loss, non-GAAP net loss per share, basic and diluted, and Adjusted EBITDA (collectively, the “Non-GAAP Measures”) in this press release. As used by the Company, these measures are adjusted to exclude stock-based compensation expense from the comparable GAAP financial measure. Non-GAAP net loss and non-GAAP net loss per share, basic and diluted, are also adjusted for change in fair value of common stock warrant liability, change in fair value of derivative liability, certain litigation expenses and asset impairment charge. In addition, Adjusted EBITDA is calculated by adding back to net loss or excluding, as appropriate, interest income and expense, provision for income taxes, certain litigation expenses, and charges for depreciation and amortization and is further adjusted by adding back in or excluding, stock-based compensation and, as appropriate, other income and expense items that are not reflective of the Company’s underlying continuing operating performance. Reconciliations of the Non-GAAP Measures to their most directly comparable GAAP financial measures are provided in the financial statement tables included at the end of this press release, and investors are encouraged to review the reconciliations. The Company believes the presentation of the Non-GAAP Measures, when shown in conjunction with the corresponding GAAP measures, provides useful information to investors as it provides visibility to the Company’s underlying continuing operating performance from period to period by excluding the impact of stock-based compensation and certain other items that are not reflective of the Company’s ongoing operations. Because of the variety of equity awards used by companies, the varying methodologies for determining stock-based compensation expense, the subjective assumptions used in those determinations, and the volatility in valuations that can be driven by market conditions outside the Company’s control, we believe excluding stock-based compensation expense enhances the ability of management and investors to understand and assess the underlying performance of our business over time and compare it against our peers, a majority of whom also exclude stock-based compensation expense from their non-GAAP results. With respect to the presentation of Adjusted EBITDA, the Company believes it is a useful measure to evaluate the Company’s operating performance and it is used by the Company to evaluate ongoing operations and for planning and forecasting purposes. Adjusted EBITDA is also a measure frequently used by analysts, investors and other interested parties to evaluate companies in our same industry. The Company’s definition of the Non-GAAP Measures may differ from similarly titled measures used by others. The Non-GAAP Measures should be considered only as a supplement to, and not as a substitute for, or superior to, their most directly comparable GAAP financial measures. Because the Non-GAAP Measures exclude the effect of items that increase or decrease the Company’s reported results of operations, management strongly encourages investors to review the reconciliations to the most comparable GAAP financial measures at the end of this press release and, when they become available, the Company’s consolidated financial statements and publicly filed Securities and Exchange Commission (“SEC”) reports in their entirety. The Company is not able to provide a reconciliation without unreasonable efforts of its forward-looking guidance related to non-GAAP gross margin to the most directly comparable GAAP financial measure due to the unknown effect of stock-based compensation that is material to the comparable GAAP financial measure. Forward-Looking StatementsThis press release contains express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release, including statements regarding our strategy, market conditions, expected market growth and financial guidance, are forward-looking statements. These forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements, including, but not limited to: we may not be able to achieve or sustain profitability; our dependence on the success of our two products, Heartflow FFRCT Analysis and Heartflow Plaque Analysis, healthcare providers may be unwilling to change their standard practice regarding the evaluation of coronary artery disease; adoption of the Heartflow Platform by healthcare providers may be negatively impacted if third-party payors, including government payors, do not cover or provide adequate reimbursement; the concentration of our customer base; the significant competition we face in an environment of rapid technological change; the commercialization of Heartflow Plaque Analysis is nascent; risks associated with our use and development of AI models; risks related to failing to properly manage our future growth; disruption by catastrophic events; risks associated with our dependence on our information technology systems; security breaches that we cannot anticipate or successfully defend; extensive regulatory requirements we face to bring our products to market; and third parties could develop and commercialize technology and products similar or identical to ours. For a more extensive description of these and other risks and uncertainties that could materially affect our results, you should read our filings with the SEC, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as such filings may be amended, supplemented or superseded from time to time by other reports Heartflow files with the SEC. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and we undertake no obligation to update the forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law. Investor ContactNick [email protected] Media ContactElliot [email protected] ____________________1Gulati, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation & Diagnosis of Chest Pain. J Am Coll Cardiol2 Narula, et al. EHJ CVI 20243 Danad, et al. JAMA Cardiol 20174 Fairbairn et al. Coronary CT Angiography Plaque as a Predictor of Death, Cardiovascular Death and Myocardial Infarction. Presented at AHA 2025. (Real-world study with n=7,899 patients, higher TPV results in increased cardiovascular death and MI)5 Madsen KT, et al. ADVANCE-DK 7-year. Presented at TCT Scientific Sessions 2024 (n=900 patients determined a 2.5x increase in cardiovascular events or deaths at 7 years)

TranscriptFY2026 Q22026-08-13

FY2026 Q2 earnings call transcript

Earnings source - 90 paragraphs
Operator

Please be advised today's conference is being recorded. I would now like to hand the conference over to your speaker today, Nick Laudico. Please go ahead.

Nick Laudico

Good afternoon, everyone, and welcome to the HeartFlow Second Quarter 2026 Earnings Conference Call. Joining me today are John Farquhar, HeartFlow's President and Chief Executive Officer, and Vikram Verghese, our Chief Financial Officer. Today we will walk you through our Q2 performance, share updates on our commercial momentum, innovation pipeline, and clinical programs, and provide financial guidance. A live Q&A session will follow. The earnings release accompanying today's discussion is available on our investor relations website at ir.heartflow.com. During this call, we will refer to certain non-GAAP financial measures. Reconciliations to the most comparable GAAP figures can be found in today's earnings release. I'd like to remind everyone that certain statements made on this call are forward-looking within the meaning of federal securities laws. These statements are based on management's current expectations and beliefs, involve certain risks and uncertainties, and actual results may differ materially.

Nick Laudico

Please note that both this live call and a digital replay will be available shortly after the call concludes. With that, I will now turn the call over to John Farquhar, our CEO.

John Farquhar

Thank you for joining us. Q2 was an outstanding quarter for HeartFlow, and the momentum that we entered 2026 with is accelerating. Our year-over-year revenue growth accelerated for the second consecutive quarter, and we finished ahead of our expectations. A credit to our expanding category leadership and the continued strong growth of the CCTA market. It's also a credit to the outstanding efforts of the HeartFlow team and their continued dedication to the patients we serve. Thank you all for your hard work and commitment. In the second quarter, revenue was $64.1 million, up 48% year-over-year, with U.S. revenue up 51%. This was our fastest revenue growth in eight quarters. Four factors drove this performance. First, plaque accelerated across new activations and physician utilization. Second, FFR-CT utilization remained durable across our existing accounts.

John Farquhar

Third, we had another strong quarter for new account additions and the record cohort of 340 accounts we added in 2025 continued to ramp in line with our expectations. Finally, the underlying CCTA market continued to expand, supported by guidelines and strong reimbursement and growing interest in CT as a frontline diagnostic test for suspected CAD. The strength of our second quarter performance gives us confidence to raise our full-year outlook again. We now expect to deliver total revenue of $246 million-$250 million, representing 40%-42% year-over-year growth. We are also raising our full-year 2026 plaque revenue outlook to a range of $29 million-$31 million. We are also raising our full-year guidance for plaque activated accounts to approximately 1,250.

John Farquhar

Moving down the P&L, we are raising our non-GAAP gross margin guidance to approximately 82%, driven by ongoing AI efficiencies, volume leverage, and a higher mix of high-margin plaque revenue. At the midpoint of our revenue guidance, this implies year-over-year non-GAAP gross profit growth of nearly 50%. Finally, we remain committed to our mid-term non-GAAP gross margin target of 85%. Now turning to our three strategic pillars, commercial adoption, innovation, and clinical evidence. I will walk you through each, starting first with commercial adoption. Our installed base of accounts continues to grow rapidly. We had another very strong quarter of new account additions, and we continue to win at a high-rate, strengthening our growing category leadership and ability to drive broader platform utilization. Now turning to plaque, performance was again ahead of our expectations with accelerating activations and utilizations.

John Farquhar

Activations were ahead of plan, highlighting the leverage of our installed base and our ability to deploy new innovation rapidly. Trends in physician utilization are very strong and give me high confidence in our continued momentum. Time and time again, we are winning at the point of sale with plaque, and there are many reasons for this, but none more important than accuracy and reproducibility. HeartFlow Plaque Analysis has demonstrated in peer-reviewed prospective studies market-leading accuracy and reproducibility across our research and independent clinical studies. ACC's scientific statement on industry standards for the use of quantitative plaque analysis underscores that independently validated accuracy and reproducibility are foundational for clinical use. These standards align directly with HeartFlow's differentiated evidence base and technology platform, and we believe the market appreciates this fact.

John Farquhar

Furthermore, we are proud to share that HeartFlow was recently selected as the exclusive plaque provider for the PRE-EMPT Study, an NIH-funded 1,500-patient study evaluating whether directly measuring coronary disease can improve prevention in younger asymptomatic patients. We believe this selection reflects the clinical community's confidence in our plaque technology's accuracy and reproducibility. Bottom line, our plaque performance in Q2 supports both our higher 2026 outlook and long-term conviction. Shifting now to FF-RCT. Performance in Q2 also exceeded our expectations. Utilization remains durable across our existing accounts, and the record 2025 cohort of 340 accounts continues to ramp in line with our expectations. So far this year, early utilization trends from our 2026 new account cohort is also encouraging. As is the case with plaque, these results are also enabled by meaningful product differentiation.

John Farquhar

Not only is FF-RCT the most accurate non-invasive test for CAD, it's also the only product with lesion-specific FF-RCT values and the only test with published prospective validation against the invasive gold standard. Importantly, the recently updated expert consensus guidelines from SCCT and endorsed by ACC underscored the importance of lesion-specific FF-RCT in identifying coronary lesions that may warrant an intervention. Lastly, I'd be remiss if I didn't also recognize the power of our platform in these results. Our clinical evidence and technology differentiation is second to none. The breadth of our AI diagnostics platform across RoadMap, Plaque, FF-RCT, and PCI Navigator deepens our clinical relationships and makes HeartFlow increasingly important to their clinical workflows, creating a durable strategic advantage. In Q2, this dynamic is reflected in our strong results, and I'm confident it will continue in Q3 and beyond. Now turning to our second pillar, innovation.

John Farquhar

Our investments in R&D continue to produce market-leading innovation. At SCCT in July, we launched HeartFlow Plaque Staging, the most clinically validated tool for patient risk stratification. Plaque Staging translates the personalized disease burden itself into four clinically distinct stages that help physicians assess the severity and guide medical management. It's validated in more than 23,000 patients with up to 16 years follow-up, with significant separation in events by stage after adjusting for traditional risk factors and stenosis. We expect it to be another tailwind for Plaque adoption in the second half of 2026 and into 2027. PCI Navigator launched earlier this year and is gaining strong traction and remains on track for a broader rollout in 2027. Interventional cardiologists are gaining a level of pre-procedural certainty they simply did not have before.

John Farquhar

With PCI Navigator, they can now enter the cath lab with a more informed procedural plan already in hand. Navigator is uniquely differentiated by HeartFlow's lesion-specific FF-RCT and rich plaque information, bringing together the insights needed to plan a PCI with greater precision. Importantly, Navigator is also strengthening our position within new accounts. Interventional cardiologists are an influential constituency in health systems, and their advocacy for a CT-first pathway into their cath lab helps accelerate HeartFlow adoption and new account acquisition. Now turning to our third pillar, clinical evidence. The breadth and quality of evidence supporting the HeartFlow platform remains unmatched in the category. As I mentioned on last quarter's call, we have more than 625 peer-reviewed publications and over 200 clinical studies, and we continue to build on this foundation.

John Farquhar

Most recently at SCCT's annual meeting in July, we presented eight new data sets spanning more than 36,000 patients, further validating the accuracy, reproducibility, and clinical utility of the HeartFlow Plaque Analysis. Let me highlight just two. First, we demonstrated the precision and reproducibility of HeartFlow Plaque Analysis. In a blinded prospective study recently published in the Journal of the American College of Cardiology, we demonstrated minimal variability in repeat scans. This data gives physicians further confidence that changes in plaque measured over time accurately reflects true changes in a patient's actual disease. Second, we demonstrated how HeartFlow Plaque Analysis provides a more complete assessment of disease burden than a calcium score alone. In a DECIDE registry analysis of nearly 12,000 symptomatic patients, HeartFlow Plaque Staging reclassified half of patients with a calcium score of zero into a higher risk category by identifying non-calcified plaque that calcium scoring cannot detect.

John Farquhar

This data gives physicians a more precise picture of their patient's actual disease burden to help optimize treatment. As excited we are about the progress we've made in the second quarter, we're even more enthusiastic about what the future holds. From a new product perspective, the development of Plaque Tracker remains on track to launch in 2027. HeartFlow Plaque Tracker measures a patient's plaque changes over time using serial CCTA scans and our Plaque Analysis. Importantly, tracking change only works if you can separate real changes in disease from noise. To do this, it takes best-in-class accuracy and reproducibility, which we believe is what our category-leading plaque algorithm delivers. Our autonomous processing initiative, which we announced last quarter as a key driver underpinning our mid-term 85% gross margin target, is also progressing well and remains on track for a broader rollout in 2027.

John Farquhar

Both Plaque Tracker and the autonomous processing initiative are enabled by our proprietary data set of more than 200 million CCTA images, diverse and precisely annotated. From a TAM expansion perspective, our next major opportunity is applying our current plaque technology to the asymptomatic market, which is one of the biggest unmet needs in cardiovascular diagnostics. HeartFlow today primarily serves symptomatic patients. However, the vast majority of coronary disease develops silently, often for years, before symptoms emerge or a first cardiovascular event occurs. Our initial entry into this market will focus on asymptomatic patients with the highest risk. Expanding into this market will increase our U.S. TAM by roughly $6 billion to approximately $11 billion. We plan to develop this market the same way we've built every market at HeartFlow, by leading with strong clinical evidence.

John Farquhar

Accordingly, we now have three RCTs targeted at three distinct high-risk asymptomatic populations that we will initiate over the next three quarters. The first is for patients with coronary artery calcium. This is a $3 billion TAM. This trial is intended to prove that our Plaque Analysis can improve outcomes as measured by changes in LDL and soft plaque beyond just a calcium score alone. Enrollment in this trial begins in the fourth quarter of 2026. The second is for patients with a prior MI or PCI. This is a $1 billion TAM. This trial is intended to prove that Plaque Analysis in this population will help physicians optimize medical therapy post-PCI to improve outcomes, again, as measured by changes in LDL and soft plaque. This study is also enrolling in the fourth quarter. Lastly, for patients with prior plaque, this is a $2 billion TAM.

John Farquhar

This trial is intended to prove that serial plaque assessments will better track disease, measure treatment response, and optimize medical therapy. Enrollment in this trial will begin in the first quarter of 2027. Taken together, these RCTs will allow HeartFlow to take our plaque technology upstream to help even more patients, and we're confident we'll access these TAMs with reimbursed technology before the end of the decade. In closing, our second quarter results reflect the power of our platform and the most clinically validated diagnostic AI products in the industry. Plaque is accelerating, FF-RCT is durable, and we're rapidly becoming the AI operating system of record for CAD. Our next wave of growth in the high-risk asymptomatic market is approaching, and we're confident in our plan to enter this market before 2030. These trends give us high confidence in our increased full-year revenue guidance and our multi-year growth trajectory.

John Farquhar

We remain focused on our mission to transform the detection, diagnosis, management, and treatment of coronary artery disease. The future is bright, and I'm grateful to the HeartFlow team for their continued dedication to the patients we serve and for all of their hard work. I now turn it over to Vikram for a review of our financial results and guidance.

Vikram Verghese

Thanks, John, and good afternoon, everyone. Unless otherwise noted, my remarks reference the quarter ended June 30, 2026. All financial metrics other than revenue are presented on a non-GAAP basis, unless otherwise noted, and all growth rates are year-over-year. Reconciliations to the comparable GAAP measures are included in today's earnings release. Our second quarter results demonstrated the increasing strength of the HeartFlow financial model. 48% revenue growth, 770 basis points of gross margin expansion, and a 600 basis point improvement in operating expenses as a percentage of revenue. Total revenue for the second quarter was $64.1 million, up 48%. U.S. revenue grew 51% to $59.6 million, including $7.8 million of plaque revenue. OUS and other revenue increased to $4.5 million. Total global revenue cases for the quarter reached 84,491, up 74%.

Vikram Verghese

Performance was broad-based with continued strength in U.S. FF-RCT, plaque adoption ahead of our expectations, and continued expansion of the CCTA market. We saw strong FF-RCT utilization across both existing and new accounts, consistent with the historical ramp dynamics we have described previously. New accounts continue to take about a year to ramp to near full FF-RCT utilization, while existing accounts demonstrate durable and consistent utilization patterns. The relevant denominator for assessing FF-RCT utilization is the eligible CCTA population. FF-RCT is applicable in approximately 33% of CCTAs, establishing a mature utilization opportunity of roughly one-third of an account's total CCTA volume. Plaque utilization also strengthened during the quarter, driven by both new account activations and expanding use within accounts already live. As clinicians gain experience with the product, we are seeing broader physician engagement, deepening utilization, and adoption across a larger share of eligible CCTAs.

Vikram Verghese

Plaque is applicable to approximately 60% of CCTAs, providing a substantially broader eligible utilization opportunity within each account. While plaque remains early in its adoption curve, the breadth and progression of utilization during the quarter increased our confidence in its near and long-term growth trajectory. Finally, we expanded our install base at a rapid pace during the second quarter, driven by strong execution from our commercial organization and plaque analysis adoption that was ahead of expectations. We are winning new accounts at a very high rate and remain confident in the durability of this momentum. As a reminder, we provide install-based metrics on an annual basis only. Turning to gross margin. Second quarter gross margin reached 83.3%, compared to 75.6% in the second quarter of 2025.

Vikram Verghese

The year-over-year improvement reflects volume leverage, increased production efficiency, increased plaque revenues, and continued progress in AI-enabled automation. Supported by ongoing training on our proprietary CCTA image database, operating expenses reflect disciplined investment behind our highest priority growth initiatives. Second quarter SG&A expenses were $37.8 million, driven by targeted investments in our commercial team to further expand adoption of the HeartFlow platform. Beginning this quarter, non-GAAP SG&A expenses exclude the impact of certain litigation-related expenses associated with our ongoing IP litigation. We believe this presentation provides investors with greater visibility into the underlying operating performance of the business. We have also applied this adjustment retrospectively to prior-period results in the non-GAAP financial tables included in today's earnings release.

Vikram Verghese

Research and development expenses were $23.5 million, as we continue to fund the innovation cadence John described, together with the clinical evidence required to support new product adoption and expand our addressable markets. Non-GAAP operating expenses were 96% of revenue versus 102% a year ago. Non-GAAP operating loss was $7.9 million compared to $11.5 million last year, demonstrating greater operating efficiency as we invest behind durable growth. Non-GAAP net loss was $5.8 million, or $0.07 per share, compared to non-GAAP net loss of $17.6 million, or $2.79 per share in the second quarter of 2025. This represents an approximately two-thirds reduction in net loss. On a GAAP basis, net loss was $15.7 million or $0.18 per share. Weighted average basic and diluted shares outstanding were 86.4 million in the quarter. Turning to the balance sheet, we ended the quarter with $246.8 million in cash equivalents, and investments.

Vikram Verghese

We remain highly confident that our balance sheet provides the capital to fund operations through profitability, while sustaining investment in R&D and commercial expansion. Turning to our updated outlook for 2026, the strength of our second quarter performance and the momentum across both FF-RCT and plaque support a meaningful increase in our full-year expectations. We now expect total revenue of $246 million-$250 million, representing 40%-42% growth. We are increasing our plaque-specific revenue outlook to $29 million-$31 million. We continue to expect more material adoption in the second half of the year as clinicians gain clinical experience and broaden adoption. Based on our 2Q performance, we're also raising our full-year non-GAAP gross margin guidance to approximately 82%, up 500 basis points year-over-year. The drivers of our gross margin outlook include continued volume efficiencies, increased AI-enabled automation, and a higher contribution from plaque.

Vikram Verghese

From an operating expense perspective, we expect full-year non-GAAP operating expenses as a percentage of revenue to decline year-over-year. We remain disciplined in allocating incremental investment towards initiatives with a direct line of sight to revenue growth, product innovation, and addressable market expansion. The midpoint of our revenue guidance implies approximately 50% growth in gross profit in 2026. Finally, we remain committed to our mid-term non-GAAP gross margin target of 85%. We also remain on track to achieve cash flow profitability by mid-2028, consistent with our prior guidance of achieving profitability within three years of our IPO. The second quarter strengthened each of the core elements of our financial model: durable revenue growth, expanding gross margins, increasing operating leverage, and a well-capitalized balance sheet. We enter the second half with substantial momentum and a clear path towards sustained profitable growth.

Vikram Verghese

I would now like to turn it back to John for closing remarks.

John Farquhar

Thank you, Vikram, and thank you all for joining us today. We appreciate your continued interest and your support as we work to advance the HeartFlow AI platform as the new standard of care for detecting, diagnosing, managing, and treating coronary artery disease. We're excited about the remainder of 2026, and with that, I'll turn the call over to the operator for Q&A. Operator?

Operator

Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star one one on your telephone. If your question has been answered and you wish to remove yourself from the queue, please press star one one again. We'll pause for a moment while we compile our Q&A roster. Our first question comes from Robbie Marcus with JPMorgan. Your line is open.

Robbie Marcus

Thank you, and congratulations on a great quarter here. Two from me. Maybe first, you talked about this a little bit in the prepared remarks, but you're doing a phenomenal job driving adoption in plaque. You spoke to the clinical data as one key driver of differentiation, but would just love a little more word off the street of how you're winning, why you're winning, and what you think you're doing differently than some of the competitors out there to drive such a strong start. Then I have a follow-up.

John Farquhar

Yeah, sure. Thanks, Robbie, I appreciate the question. I mean, relative to Plaque, and this came through in the prepared remarks, the launch is going very well. I think as we moved through the quarter, the momentum built, and I would categorize it from a momentum standpoint as significant. So far this year, Q1 was a good first start, initial start. But coming out of Q2, these trends give me really higher confidence. The metrics, the things that we sort of manage internally, the new account activations are ahead of plan. We're on track now for 1,250 by the end of the year, and we've talked about historically it took us eight years to get to 1,000 with FF-RCT. We'll get to 1,250 in 2 with Plaque. The physician adoption metrics all look really good.

John Farquhar

The ordering physicians are at a record level, both new orders as well as repeat, so I feel great on that. Utilization is ramping really well and above our initial expectations. This tells me that as physicians start to apply Plaque, they're doing it to a broader range of patients as their clinical experience deepens. So I feel good on that front. Then again, on coverage, I think we're a little north of 78% or right around 78% coverage right now. So we're ahead of plan on that. Overall, I'm very bullish on the future of Plaque. I'm pleased with the momentum heading into the second half of the year and beyond that, and I think all of these results are a signal that customers are voting, and they're voting for HeartFlow increasingly here. So I feel really good about it.

Robbie Marcus

Great. Maybe as a follow-up question, and I imagine you've probably as one of the larger MedTech software-as-a-service providers, had discussions with the FDA about this. But I think we all saw the MedTech-as-a-Service reimbursement proposal come out last month, a couple of weeks ago. I'm losing it, sorry. Would love your thoughts on this. It's not something that's probably going to start for another two years, but any thoughts you have around this and how it might evolve from the CPT I codes that you're currently sliding into? Thanks a lot.

John Farquhar

Yeah, sure. This wasn't a surprise. This direction is consistent with what CMS has signaled for years. I would say in the near-term, we view this as a positive. In the hospital setting, as you know, the majority of our business is in the hospital setting. We really like the 2027 proposal. FF-RCT and Plaque are stable. CCTA is up nearly 12%. So the economics of the HeartFlow pathway are very strong. So we like that. In the physician fee schedule, that's also in line with expectations. FF-RCT and Plaque are relatively stable there. So in the near-term, this is certainly a positive. Longer-term, as you know, CMS proposed a new framework for AI-enabled software in the hospital setting, and we think this is constructive. Okay?

John Farquhar

We think CMS is acknowledging something obvious, which is AI services are different than a traditional medical device, and we agree with them on that. They've stated they want to better align payments with clinical outcomes, and we think these goals align very well with our value proposition, and we certainly have the clinical evidence to substantiate that. So we look forward to collaborating with CMS, and I think as you mentioned, this is going to be a multi-year process, very much more likely in 2029.

Robbie Marcus

Thanks a lot.

Operator

One moment for our next question. Our next question comes from Matthew O'Brien with Piper Sandler. Your line is open.

Matthew O'Brien

Good afternoon. Thanks for taking the question. Looking at the Q2 results, you beat our model by about $8 million, and it doesn't sound like the lion's share of that beat was Plaque. I guess, first of all, is that allocation correct? That more of the beat was on the FF-RCT side versus the Plaque side? And then if that is the case, it would signal that you had your biggest incremental improvement in FF-RCT we've seen in quite a while. So I know there is a lot of momentum there, bigger sales force and cetera, but what drove that uptick in FF-RCT specifically? And then I do have a follow-up.

Vikram Verghese

Yeah, Matt, this is Vikram. Thanks for the question. Plaque did handedly beat our expectations as well. Plaque revenues were $7.8 million, which was more close to a $4 million beat against expectations. I'd say it was broad-based momentum across both FF-RCT and Plaque. We did see Q2 tends to be seasonally a stronger quarter. That certainly played out across both segments of the business. For FF-RCT, we continue to see strong volume growth driven by improving utilization in our existing sites. The new sites that we onboarded in the prior-quarter were ramping at scale as well. Plaque was certainly a standout for us. We continue to see strong utilization trends in our accounts. John touched on some of the key metrics relative to utilization, the number of new ordering physicians improving, existing physicians utilizing the service more.

Vikram Verghese

It was a combination of factors that led to the broad-based outpacing that we saw in the quarter.

Matthew O'Brien

Understood. Appreciate that, Vikram. Kind of following up on that, the second question is, when I look at the guide for the year, it doesn't assume in the back half much improvement in terms of revenue versus Q2. If you just annualize Q2, you kind of get the same numbers for Q3 and Q4. Given that momentum, especially in Plaque, and it's a similar kind of question, not much in terms of improvement in Plaque revenue in Q3, Q4. Is there anything to call out there? I don't know if there's anything on the pricing side that we need to be aware of or anything else outside of just traditional kind of conservatism on your part. Thanks so much.

Vikram Verghese

Yeah, Matt, I think you touched on it there. This is again consistent with our guidance philosophy. We want to leave enough room to outperform in the second half. Relative to phasing, what we'd say is, we've assumed a steady sequential growth in both Q3 and Q4 off a relatively strong base that's in Q2. The progression in the second half is really underpinned by those factors we talked about, continued growth from existing accounts, ongoing contributions from these new accounts that have come live, and we had a record quarter in new onboards in Q2, and then continued expansion that we're seeing in Plaque utilization. We've factored in normal seasonality in second half, and that's typical in the underlying CCTA market, and we have incorporated that into the FF-RCT outlook.

Operator

One moment for our next question. Our next question comes from Larry Biegelsen with Wells Fargo. Your line is open.

Larry Biegelsen

Good afternoon. Thanks for taking the question. Congrats on the good quarter here. John, two for me. I wanted to start with the DECIDE one-year outcomes. Have you determined which conference that's going to be at? I assume TCT. Which endpoints do you think will actually change pay or physician behavior? I have one follow-up.

John Farquhar

Yeah. Hey, Larry. It'll be in Q4. Beyond that, probably nothing to share. It'll be one-year outcomes on change in LDL. That's what we're looking for. Obviously, we have very good results on that at the 90-day, and we'll see what the data says at one year. How this impacts physician behavior, I think as we're in the early innings of the Plaque launch, certainly clinical data and educating physicians is an important piece of it. But probably the most important piece of that is physicians are starting to get their patients to come back after they've given their initial Plaque Analysis, and they're seeing how whether or not their LDLs are changing in their clinical practice. So the more that snowball rolls downhill, I think the more Plaque will be supported as we go through the launch here.

Larry Biegelsen

That's helpful. Secondly, can you please talk about what you're seeing from a competitive standpoint in FF-RCT and Plaque? Any estimates you could provide on your respective shares and how you're thinking about competition going forward? Thank you.

John Farquhar

Yeah, sure. First thing I will say, and I have said this before, we view our competition as the standard of care. When we wake up and get going every morning, it is to create a new standard of care, and the way we are going to win moving forward is by sourcing volume from traditional non-invasive tests. We really think we are on the right side of history in doing this. CCTA has only penetrated about 11% against the total non-invasive testing market, and all signs point towards continued strong category growth. Obviously, we are not the only player that recognizes this. This is an attractive space. That being said, I feel better than ever about our competitive position and our market leadership. Competition in this space is not a new dynamic. Some of these other vendors have been around for going on 10 years now.

John Farquhar

None of this is slowing us down. Bottom-line, I think we are winning in the field. I think we are winning every day, both with Plaque and with FF-RCT. All of those metrics are trending in the right direction. They are extremely strong. Ultimately, the results that we put out, I think today speaks for themselves, and I think the guidance speaks towards the confidence that we have for the remainder of the year.

Larry Biegelsen

All right. Got it. Thank you.

Operator

One moment for our next question. Our next question comes from Brandon Vazquez with William Blair. Your line is open.

Brandon Vazquez

Hey, thanks for taking the question. First, I wanted to ask on, you gave a little bit more timelines around the asymptomatic populations and those RCTs. Maybe just, if you can, spend a minute on any other details like expectations for time of enrollment. What are kind of the next steps after this? Remind us if you need to get FDA approval after the RCTs for asymptomatic patients, or is this really just RCTs going after the payers and what timelines might look like there?

John Farquhar

Yeah, sure. Thank you for the question. The asymptomatic opportunity is arguably the biggest opportunity in all of cardiovascular diagnostics. We are very excited about what this could mean for our business, but equally importantly, what this could mean for patients. We are going to approach this in a very similar fashion to how we have approached the symptomatic market. We are going to start with patients at the most risk. With that, we are targeting three high-risk subpopulations that we can access with the right clinical studies, and this will use our existing technology. To your question, no FDA clearance required. The three populations, the first is secondary prevention, so this is prior MIs or prior PCIs. The second is patients with calcium, and then the third is patients with plaque.

John Farquhar

In all of these trials, the endpoints will be change in physician management and change in outcomes as measured by change in LDL and soft plaque. We really like this approach. We think this is a very capital-efficient trial structure. It is only between call it 300 and 500 patients in each trial. Also, this is going to be very synergistic to our revenue. It leverages the same call points that we are already calling on, the same sales channel, the same technology stack. So we are really excited on what the future holds, and we think we can be in these markets with reimbursed technology before 2030.

Brandon Vazquez

Great. Interestingly, on a similar note, the NIH study that you had mentioned, can you just talk a little bit about the genesis of that program? Correct me if I am wrong, I do not think you have great market access in the U.K. yet. Just curious if you can talk a little bit about the genesis of that program and what the next steps are there.

John Farquhar

Yeah. Just to be clear, it's a U.S. study, National Institutes of Health. It will study lipid-lowering and anti-inflammatory therapy to see what slows plaque progression, or if any do, slow plaque progression in lower-risk adults that already have some form of coronary artery disease. So it's younger patients in plaque. The primary endpoint will be a two-year change in non-calcified plaque volume on a CTA versus the baseline.

Brandon Vazquez

Thanks, guys. Sorry about that. I mistook that.

John Farquhar

No, good question. Thank you.

Operator

One moment for our next question. Our next question comes from Rick Wise of Stifel. Your line is open.

Rick Wise

Good afternoon, everybody. I thought it would be interesting to hear a little bit more, just maybe your updated thinking about the operating leverage that we saw in the quarter and how you're thinking going forward or how we should be thinking about it going forward. You had an outstanding quarter, sales up $12 million sequentially, and SG&A is down. Maybe as part of answering that question, you can talk about the importance of this AI efficiency and the role it's going to play going forward. Just any additional perspectives, and particularly as we start trying to think about the second half and into 2007.

Vikram Verghese

Yeah. Thanks for the question, Rick. I'll start by saying in Q2, we outperformed on the top-line, and we certainly reinvested that with discipline back into R&D. Even with the higher OpEx, EBIT was roughly cut in half quarter-over-quarter. That really speaks to the strength and the efficiency of the underlying business model. The notion of durable, predictable revenue growth paired with strong margin expansion. We're really leveraging this dynamic to invest across both R&D and commercial at a disciplined pace. A few areas worth mentioning. R&D carries the largest increase for us as we advance the innovation pipeline that John had outlined. Plaque Tracker, to your question on margin expansion, autonomous processing initiative is an example of where we are removing or reducing the human touch and thereby expanding gross margins.

Vikram Verghese

We've got the TAM expansion clinical trials as well, which will start later this year. Of note, medical education is also recorded within R&D, and that is pivotal as we think of expanding the reach of plaque. On the commercial side, given the strength in the plaque ramp, we plan to expand field capacity in a measured and disciplined way. Despite these investments, we expect OpEx as a percentage of revenue for the full-year to improve by at least 5 points year-on-year. EBIT, which is also an important metric we track, should meaningfully improve year-over-year. Ultimately, it's the combination, the durability of the growth profile, the plaque proof points, and the mid-term gross margin targets of 85% that reinforce a conviction of getting the company to profitability in that 2028 timeframe.

Rick Wise

Thank you, Vikram. Just as a follow-up, maybe you can just sort of update us to the extent that you want to on the call about how price per case, how pricing dynamics fared this quarter. I think you were down, I'm saying this from memory, I don't know if I'm right, down 10% last quarter. I know pricing is complicated because of the, I'm sorry, revenue per case. I'm sorry. I misspoke. I know with greater price pressure, perhaps on the FFR side, more positive contribution from plaque, but now FFR outperforming. This is a long question, but just how do we think about that mix of dynamics? If you could help us, I'd appreciate it. Thank you.

Vikram Verghese

Yeah. Yeah. Thanks again, Rick. I'll unpack that across FF-RCT and plaque. On the FF-RCT side, at a high level, volumes came in significantly above plan, while ASPs finished modestly ahead of expectations. This was really driven by more favorable customer mix. Given the visibility we have to these customers, their volumes, and the predictable utilization rate that we have with FFR, that mix looks durable. Therefore, net-net consensus is in the right ballpark on full-year ASP for FF-RCT. Now, looking ahead, these pricing trends certainly reinforce our view that year-over-year ASP shifts will moderate beginning in 2027. Now, shifting gears to plaque, two factors drove ASP favorability in the quarter. First, some of those contractual step-ups that we had highlighted previously, they went into effect in the quarter. Second, we did see benefit of mix as well.

Vikram Verghese

Volumes skewed a bit higher towards higher priced accounts. Now looking ahead on plaque ASPs, given what we see in the contractual schedules, we're not baking in a change in pricing for the rest of 2026. That said, we do expect pricing to step up more meaningfully in early 2027.

Rick Wise

Great. Thanks again.

Operator

One moment for our next question. Our next question comes from Jacob Dodd with Morgan Stanley. Your line is open.

Jacob Dodd

Good afternoon. Thanks for taking the question. Maybe a two-parter, both related to plaque utilization. I will ask them both up front. I heard you reiterate the approximate expectation for 60% case applicability for plaque. Could you maybe speak to the pace of adoption at key accounts where you onboarded plaque at the beginning of this year on their way to that long-term level? And then related to that, could you quantify for us in any way the degree of overlap or any halo effect you are seeing in these real-world cases between FF-RCT and plaque used on the same CCTA cases? Thank you very much.

John Farquhar

Yeah, sure. Thanks, Jacob. So yeah, you are right. The maximum utilization rates, or applicability, is 60%. We are seeing in our accounts, the ramp towards that is ahead of expectation. It is still nowhere near 60%. It takes a while to get there, but it is performing very well and it is ramping very well. Your second question is around the overlap. Initially, we saw more of an overlap on FF-RCT patients also getting plaque. But we are very pleased that is starting to broaden as adoption takes place.

Operator

One moment for our next question. Our next question comes from David Rescott with Baird. Your line is open.

David Rescott

Great. Thanks for taking the question and congrats on the really strong results here. I want to follow-up a little bit on some of the commentary around price and gross margins. If you look at the guide for the year versus what you just delivered in the quarter, it does not seem to be baking in any type of sequential or flattish type quarter-over-quarter gross margin number for the year. It sounds like a lot of the drivers on the gross margin front are continuing to progress through the year. Just trying to get a sense for, on the gross margin side, why or why not should we assume that gross margins, at least on a sequential basis, should or should not improve through the rest of the year? Then I have a follow-up as well.

Vikram Verghese

Yeah, thanks for the question, David. Zooming out, the architecture of our gross margin expansion is quite clear. It will be principally driven by three levers. One is the AI-driven automation of our algorithm, second is the emergence of plaque revenues, and third is economies of scale or volume leverage. Relative to our performance in Q2, about 75% of that beat was driven by revenue outperformance, specifically on the plaque side. The rest was headcount favorability and less R&D amortization, which hits cost of revenue. Looking at 2026, there are puts and takes. Our 82% guide takes into account our increased plaque numbers. Should we outperform on plaque, you would see upside to the gross margin forecast as well. This will be offset by some additional hiring on both the production side as well as parts of customer success, which hit cost of revenue.

Vikram Verghese

Longer-term, autonomous processing is certainly an initiative we are very excited about and underpins our mid-term gross margin target of 85%, but that is more of a 2027 driver.

David Rescott

Okay, that is helpful. Maybe on Plaque Staging, I think some of the prepared remarks talked about additional tailwinds to plaque adoption from Plaque Staging in the second half of 2026 into 2027. So wondering if you could expand on that a little bit, as well as any incremental color on what, if at all, is contemplated in the plaque guide for the year as it relates to some of these tailwinds on the Plaque Staging side. Thank you.

John Farquhar

Yeah. I will let Vikram speak to some of what is contemplated. Staging, we are excited about it. It is a strong differentiator for us. We released that just recently at the SCCT, we are the only plaque product with staging in it. This is a staging system that is validated in over 23,000 patients with up to 16 years follow-up, which marries very well with our DECIDE registry. That is the largest prospective registry of its kind. So with the two, as physicians look to learn how to use plaque, we feel like we have tools that are not only differentiated, but align very well with how we are helping to educate the market on using plaque to take care of their patients. Relative to your question on what is in the guide, I do not know, Vikram, if you have anything to add.

Vikram Verghese

Yeah, I'd probably reiterate what I stated earlier, David. No deviation from our guidance philosophy. We want to take a high conviction baseline, show steady sequential growth, and that gives us room to outperform. We've assumed continued growth in plaque utilization. We're not assuming a step change, but if history is any guide, there'll likely be upside.

Operator

One moment for our next question. Our next question comes from William Plovanic with Canaccord. Your line is open. William, your line is open. You can ask your question. One moment.

William Plovanic

Hello?

Operator

Your line is now open, William.

William Plovanic

Can you hear me?

Operator

Yeah, we can hear you now.

William Plovanic

Okay, great. Thanks. Great. Thanks for taking the question. The first question is on the FF-RCT and one of the comments that typically a little more seasonality in that business. As we think of the guide with the increase from Q3 from Q2, is that more of a plaque-based comment that that would be the driver for that sequential increase?

Vikram Verghese

Yeah, that's a fair assumption. Well, obviously with the raise, which is greater than 2x the beat, we wanted to anchor the guide appropriately and setting a high conviction baseline that leaves room for the quarterly progression was important. Given the scale of the business on plaque, those seasonality comments, which we've seen historically in the underlying CCTA market, are much more relevant to FF-RCT.

William Plovanic

Okay. Given that basically all the financial questions have been asked at this point, I guess any update on the DOJ or the patent litigation that we should think about, just updates, milestones, key events coming up, anything of that nature. Thanks for taking my questions.

John Farquhar

Yeah, I'll take that. Appreciate the question. On the patent side, I think as you know, this type of litigation typically follows a multi-year path. We're very confident in our claims. The complaint's public. I'm sure you've read it. If not, it's out there. I think it speaks for itself. We've got high confidence in our legal position, but we'll let the process play out and obviously we're staying focused on running the business as we do that. On the other topic, on the CID, we don't have any update beyond what's already been shared. When we do have something material to share, we'll share it. We think this matter again, is going to play out over years, not months. We don't find it to be a distraction.

John Farquhar

It's not slowing us down in any way, and it goes without saying, we're fully cooperating, and we'll let the process play out.

William Plovanic

Great. Appreciate it.

Operator

One moment for our next question. Our next question comes from Gene Mannheimer with Freedom Holdings. Your line is open.

Gene Mannheimer

Thanks. Good afternoon, and congrats as well on the great numbers. Most of my questions have been answered, but I did want to ask about PCI Navigator. That seems like a very strong value proposition for the interventional cardiologist. Is that a product you charge for currently, and do you anticipate a moment when you will begin to charge for that product? Thank you.

John Farquhar

Yeah. Thanks for the question. You're right, we're very excited about Navigator. We don't charge currently. There's no plan to pursue reimbursement for it. Our thinking, coming into this year is the value proposition is so strong relative to building out our platform. The right thing to do is get it in the market as a differentiator, and we can engage interventional cardiologists as champions for the CT + HeartFlow pathway. That's what we're doing right now. Early feedback has been very strong. I will say this is a rollout and a phased approach this year. Again, that's by design. Our number one focus is plaque, and we don't want to take away from the team's focus on this. We're taking this mostly to high volume PCI hospitals first. But the early trends and what we're hearing is really strong.

John Farquhar

They certainly like it, and we look forward to taking this technology to more customers throughout the year and in a greater degree next year as well.

Gene Mannheimer

Thank you.

Operator

I am not showing any further questions at this time. As such, this does conclude today's presentation. We thank you for your participation. You may now disconnect, and have a wonderful day.

Investor releaseQuarter not tagged2026-08-12

HeartFlow Inc (HTFL) Q2 2026 Earnings Report Preview: What To Expect

GuruFocus.com

This article first appeared on GuruFocus. HeartFlow Inc (NASDAQ:HTFL) is set to release its Q2 2026 earnings on Aug 13, 2026. The consensus estimate for Q2 2026 revenue is 56.64 million, and the earnings are expected to come in at -0.18 per share. The full year 2026's revenue is expected to be $230.07 million and the earnings are expected to be $-0.73 per share. More detailed estimate data can be found on the Forecast page Warning! GuruFocus has detected 3 Warning Signs with HTFL. Is HTFL fairly valued? Test your thesis with our free DCF calculator. Revenue estimates for HeartFlow Inc (NASDAQ:HTFL) have increased from $220.41 million to $230.07 million for the full year 2026 and increased from $272.56 million to $283.22 million for 2027 over the past 90 days. Earnings estimates for HeartFlow Inc (NASDAQ:HTFL) have declined from $-0.61 per share to $-0.73 per share for the full year 2026 and declined from $-0.38 per share to $-0.52 per share for 2027 over the past 90 days. In the previous quarter of 2026-03-31, HeartFlow Inc's (NASDAQ:HTFL) actual revenue was $52.59 million, which beat analysts' revenue expectations of $49.71 million by 5.80%. HeartFlow Inc's (NASDAQ:HTFL) actual earnings were $-0.32 per share, which missed analysts' earnings expectations of $-0.20 per share by -60.00%. After releasing the results, HeartFlow Inc (NASDAQ:HTFL) was down by -12.17% in one day. Based on the one-year price targets offered by 7 analysts, the average target price for HeartFlow Inc (NASDAQ:HTFL) is $36.86 with a high estimate of $40.00 and a low estimate of $34.00. The average target implies an upside of 24.77% from the current price of $29.54. Based on the consensus recommendation from 9 brokerage firms, HeartFlow Inc's (NASDAQ:HTFL) average brokerage recommendation is currently 1.80, indicating an "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

Investor releaseQuarter not tagged2026-07-23

Heartflow to Report Second Quarter 2026 Financial Results on August 13, 2026

GlobeNewswire
SAN FRANCISCO, July 23, 2026 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced it will release financial results for the second quarter of 2026 after market close on Thursday, August 13, 2026. Management will host a conference call to discuss financial results beginning at 1:30 p.m. PT / 4:30 p.m. ET on August 13, 2026. Those interested in listening to the conference call should register online using this link. Once registered, participants will receive dial-in numbers and a unique PIN to join the call. Participants are encouraged to register more than 15 minutes prior to the start of the call. A live and archived webcast of the event will also be available on the “Investor Relations” section of the Heartflow website at https://ir.heartflow.com. The archived version will be available for 12 months following completion of the live call. About Heartflow’s Technology and Research Heartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,800 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by American College of Cardiology and American Heart Association (ACC/AHA) guidelines and supported by more than 625 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 650,000 patients worldwide.1 Key benefits include: Unmatched Proprietary data pipeline: Built from the world’s largest database of more than 200 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations. Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 200 studies assessing over 365,000 patients. Heartflow is the only AI platform prospectively validated against invasive gold standards and demonstrated through real-world evidence to improve patient outcomes.2,3,4,5 Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%. Seamless clinical integration via upgraded wo…Read full document

SAN FRANCISCO, July 23, 2026 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced it will release financial results for the second quarter of 2026 after market close on Thursday, August 13, 2026. Management will host a conference call to discuss financial results beginning at 1:30 p.m. PT / 4:30 p.m. ET on August 13, 2026. Those interested in listening to the conference call should register online using this link. Once registered, participants will receive dial-in numbers and a unique PIN to join the call. Participants are encouraged to register more than 15 minutes prior to the start of the call. A live and archived webcast of the event will also be available on the “Investor Relations” section of the Heartflow website at https://ir.heartflow.com. The archived version will be available for 12 months following completion of the live call. About Heartflow’s Technology and Research Heartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,800 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by American College of Cardiology and American Heart Association (ACC/AHA) guidelines and supported by more than 625 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 650,000 patients worldwide.1 Key benefits include: Unmatched Proprietary data pipeline: Built from the world’s largest database of more than 200 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations. Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 200 studies assessing over 365,000 patients. Heartflow is the only AI platform prospectively validated against invasive gold standards and demonstrated through real-world evidence to improve patient outcomes.2,3,4,5 Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%. Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay. Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001. About Heartflow, Inc. Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com Investor ContactNick [email protected] Media ContactElliot [email protected] ____________________________1 Gulati, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation & Diagnosis of Chest Pain. J Am Coll Cardiol2 Narula, et al. E HJ CVI 20243 Danad, et al. JAMA Cardiol 20174 Fairbairn et al. Coronary CT Angiography Plaque as a Predictor of Death, Cardiovascular Death and Myocardial Infarction. Presented at AHA 2025. (Real-world study with n=7,899 patients, higher TPV results in increased cardiovascular death and MI)5 Madsen KT, et al. ADVANCE-DK 7-year. Presented at TCT Scientific Sessions 2024 (n=900 patients determined a 2.5x increase in cardiovascular events or deaths at 7 years)

Investor releaseQuarter not tagged2026-05-15

Heartflow Q1 Earnings Call Highlights

MarketBeat
Interested in Heartflow, Inc.? Here are five stocks we like better. Heartflow beat expectations in Q1, with revenue up 41% year over year to $52.6 million and global case volume rising 67%. The company also raised its full-year 2026 revenue outlook to $228 million-$232 million. Plaque Analysis is gaining traction faster than planned, with adoption ahead of expectations, Plaque coverage reaching 75% of covered lives, and full-year Plaque revenue guidance increased to $19 million-$21 million. Management expects the installed base to reach about 1,200 sites by the end of 2026. The core FFRCT business and broader platform expansion remain major growth drivers, supported by strong utilization from existing accounts, ramping new accounts, and the launch of PCI Navigator. Heartflow also highlighted its growing clinical evidence base and new studies aimed at expanding its addressable market over time. Heartflow (NASDAQ:HTFL) reported a sharply higher first-quarter revenue total and raised its full-year 2026 outlook, citing strength in its core FFRCT business, faster-than-expected adoption of its Plaque Analysis product and continued expansion of the coronary CT angiography, or CCTA, market. President and Chief Executive Officer John Farquhar said HeartFlow entered 2026 with “the strongest momentum in our history,” with first-quarter revenue rising 41% year over year to $52.6 million. Global case volume increased 67% to 67,443 cases, according to Chief Financial Officer Vikram Verghese. → Micron Investors Face a High-Stakes Moment After the Latest Rally Farquhar said four factors drove the quarter: continued FFRCT utilization across the installed base, a record group of new accounts added in 2025 that is ramping as expected, stronger-than-expected Plaque adoption and broader CCTA market growth supported by clinical guidelines and reimbursement. The company also said it has now helped physicians manage care for more than 650,000 patients worldwide. Farquhar said HeartFlow’s database now includes more than 200 million annotated CCTA images, which he described as a proprietary asset supporting the company’s artificial intelligence development and automation efforts. → How Bad Could Tesla’s Cybertruck Recall Be for Shares? HeartFlow raised its full-year 2026 revenue forecast to a range of $228 million to $232 million, representing expected year-over-year growth of 29% to…Read full document

Interested in Heartflow, Inc.? Here are five stocks we like better. Heartflow beat expectations in Q1, with revenue up 41% year over year to $52.6 million and global case volume rising 67%. The company also raised its full-year 2026 revenue outlook to $228 million-$232 million. Plaque Analysis is gaining traction faster than planned, with adoption ahead of expectations, Plaque coverage reaching 75% of covered lives, and full-year Plaque revenue guidance increased to $19 million-$21 million. Management expects the installed base to reach about 1,200 sites by the end of 2026. The core FFRCT business and broader platform expansion remain major growth drivers, supported by strong utilization from existing accounts, ramping new accounts, and the launch of PCI Navigator. Heartflow also highlighted its growing clinical evidence base and new studies aimed at expanding its addressable market over time. Heartflow (NASDAQ:HTFL) reported a sharply higher first-quarter revenue total and raised its full-year 2026 outlook, citing strength in its core FFRCT business, faster-than-expected adoption of its Plaque Analysis product and continued expansion of the coronary CT angiography, or CCTA, market. President and Chief Executive Officer John Farquhar said HeartFlow entered 2026 with “the strongest momentum in our history,” with first-quarter revenue rising 41% year over year to $52.6 million. Global case volume increased 67% to 67,443 cases, according to Chief Financial Officer Vikram Verghese. → Micron Investors Face a High-Stakes Moment After the Latest Rally Farquhar said four factors drove the quarter: continued FFRCT utilization across the installed base, a record group of new accounts added in 2025 that is ramping as expected, stronger-than-expected Plaque adoption and broader CCTA market growth supported by clinical guidelines and reimbursement. The company also said it has now helped physicians manage care for more than 650,000 patients worldwide. Farquhar said HeartFlow’s database now includes more than 200 million annotated CCTA images, which he described as a proprietary asset supporting the company’s artificial intelligence development and automation efforts. → How Bad Could Tesla’s Cybertruck Recall Be for Shares? HeartFlow raised its full-year 2026 revenue forecast to a range of $228 million to $232 million, representing expected year-over-year growth of 29% to 32%. The company also increased its Plaque-specific revenue outlook to $19 million to $21 million. Verghese said U.S. revenue in the first quarter grew 42% to $48.3 million, including $3.2 million of Plaque revenue. Outside the U.S. and other revenue increased to $4.3 million. → Reading the Stripes: Is The Industrial Recession Over? Non-GAAP gross margin improved to 80.5% from 75.3% in the prior-year quarter. Management raised its full-year non-GAAP gross margin guidance to approximately 81%, citing volume efficiencies, AI-enabled automation and a higher mix of Plaque revenue. Farquhar said the company remains committed to a midterm non-GAAP gross margin target of 85%. First-quarter non-GAAP operating loss was $15.5 million, compared with $15 million a year earlier. Non-GAAP net loss was $13.3 million, or $0.16 per share, compared with a non-GAAP net loss of $19.2 million, or $3.11 per share, in the first quarter of 2025. On a GAAP basis, net loss was $27.4 million, or $0.32 per share, including a $7.5 million non-cash impairment charge related to facilities optimization and the company’s headquarters relocation to San Francisco. HeartFlow ended the quarter with $254.9 million in cash, cash equivalents and investments. Verghese said the company believes it is well-capitalized to fund operations through profitability while continuing to invest in research and development and commercial expansion. He reiterated the company’s expectation of reaching cash flow profitability within three years of its IPO, pointing to a mid-2028 timeframe during the Q&A session. Farquhar said Plaque Analysis adoption is ahead of the company’s initial expectations, with account activation ahead of schedule and strong early utilization trends. He pointed to a recently published ACC/AHA scientific statement on plaque, increasing payer coverage and clinical and economic evidence presented at the American College of Cardiology meeting in March as factors supporting awareness and demand. During the Q&A portion of the call, Farquhar said Plaque coverage had reached 75% of total covered lives as of the end of March. He said the company continues to use its DECIDE data with payers to expand coverage, while also focusing on adding Plaque to its installed base and educating cardiologists on how to use it in patient care. Farquhar said HeartFlow has held more than 1,000 medical education events focused on Plaque over the last 12 months, generating more than 100,000 physician impressions. He said the company now expects its Plaque installed base to reach approximately 1,200 sites by the end of 2026. Verghese said the first-quarter Plaque revenue performance was not a pull-forward of future demand, but reflected sustained momentum. He added that Plaque revenue is still expected to be weighted toward the back half of the year as adoption broadens. On pricing, Verghese said many early Plaque contracts were structured with attractive pricing to accelerate activation and because reimbursement was more limited at the time. He said existing contracts include mechanisms for price increases over time, with more favorable pricing becoming visible in 2027 and beyond. Management said the core FFRCT business remained strong, with durable utilization among established customers and healthy ramping from new accounts added in 2025. Farquhar said the 340 accounts added last year represented the largest annual cohort in HeartFlow’s history and are ramping in line with expectations. Verghese said new accounts generally take about a year to ramp to near full FFRCT utilization, while existing accounts continue to show durable and consistent utilization patterns. He noted that FFRCT is applicable in roughly 33% of CCTAs, meaning maximum FFRCT utilization in an account is approximately one-third of CCTA volume. The company also reported continued volume strength in the clinic setting, which Verghese described as a rapidly growing and strategically important market segment. He said HeartFlow continues to see adoption of its volume-based rebate pricing structure, which supports higher volume growth even as mix and rebates affect average selling prices. Farquhar said HeartFlow’s platform now includes four tools: RoadMap, Plaque, FFRCT and PCI Navigator. He described the platform as a unified AI solution spanning coronary artery disease detection, diagnosis, management and treatment planning. HeartFlow launched PCI Navigator in April. Farquhar said feedback from interventional cardiologists has exceeded expectations, adding that the tool allows physicians to enter the catheterization lab with a pre-procedural plan. He said the company is executing a phased rollout through 2026, with a broader introduction planned in 2027. In response to an analyst question, Farquhar said HeartFlow is initially targeting the largest PCI hospitals and is not yet disclosing specific adoption metrics for PCI Navigator. He said the company believes the product can make the platform “stickier” and more compelling over time. Management also discussed its autonomous processing initiative, which entered a pilot phase in the first quarter. Farquhar said the company expects a gradual rollout through the back half of 2026, with a multi-year impact beginning in 2027. The initiative is expected to support HeartFlow’s gross margin expansion targets. Farquhar said HeartFlow has built an evidence base that includes more than 625 peer-reviewed publications and more than 200 clinical studies and trials. He said the company’s 5,000-patient NAVIGATE-PCI Registry is ramping, with sites activating and enrollment building. The study is designed to evaluate how an AI-driven pre-procedural planning tool influences PCI strategy and cath lab efficiency. The company also plans to begin two randomized controlled trials in the second half of 2026 focused on asymptomatic populations: one for patients with prior myocardial infarction or PCI, and another for patients with elevated calcium scores. A third trial focused on patients with prior Plaque is expected to begin in the first half of 2027. Farquhar said these studies are intended to expand HeartFlow’s U.S. addressable market by approximately $6 billion over time, bringing the total addressable market to $11 billion. He said the company expects this clinical path to help it begin accessing the incremental market opportunity before the end of the decade. In closing, Farquhar said the first quarter demonstrated that HeartFlow’s platform strategy is translating into financial results, with FFRCT and Plaque Analysis driving volume growth and deeper account-level adoption. Verghese said the updated outlook reflects momentum in the core business and acceleration in Plaque, while management maintained that the company will continue investing in commercial expansion, clinical evidence and product innovation. 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. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Heartflow Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Investor releaseQuarter not tagged2026-05-15

HeartFlow Inc (HTFL) Q1 2026 Earnings Call Highlights: Robust Revenue Growth and Raised ...

GuruFocus.com
This article first appeared on GuruFocus. Revenue: $52.6 million, up 41% year-over-year. US Revenue: $48.3 million, up 42%, including $3.2 million from Plaque revenue. Global Revenue Cases: 67,443, representing 67% growth. Non-GAAP Gross Margin: 80.5%, up from 75.3% in Q1 2025. Non-GAAP Operating Loss: $15.5 million, compared to $15 million last year. Non-GAAP Net Loss: $13.3 million or $0.16 per share, compared to $19.2 million or $3.11 per share in Q1 2025. GAAP Net Loss: $27.4 million or $0.32 per share, including a $7.5 million non-cash impairment charge. Cash Equivalents and Investments: $254.9 million at the end of the quarter. Full-Year Revenue Guidance: Raised to $228 million to $232 million, representing 29% to 32% growth. Plaque-Specific Revenue Guidance: Increased to $19 million to $21 million. Full-Year Non-GAAP Gross Margin Guidance: Raised to approximately 81%. Warning! GuruFocus has detected 3 Warning Signs with HTFL. Is HTFL fairly valued? Test your thesis with our free DCF calculator. Release Date: May 14, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. HeartFlow Inc (NASDAQ:HTFL) reported a 41% year-over-year revenue increase in Q1 2026, reaching $52.6 million, driven by 67% global case growth. The company raised its full-year revenue guidance to $228 million to $232 million, representing 29% to 32% year-over-year growth. HeartFlow's Plaque Analysis product is outperforming expectations, leading to an increased revenue outlook of $19 million to $21 million for 2026. The company achieved a significant milestone by helping manage the care of over 650,000 patients worldwide, reinforcing its leadership position. HeartFlow's non-GAAP gross margin guidance was raised to approximately 81%, driven by AI efficiencies, volume leverage, and a higher mix of high-margin Plaque revenue. Despite strong performance, HeartFlow Inc (NASDAQ:HTFL) remains in the early stages of Plaque adoption, with a need for continued medical education and market development. Operating expenses increased, with SG&A expenses reaching $38.3 million, reflecting investments in commercial expansion and medical education. The company reported a non-GAAP net loss of $13.3 million, or $0.16 per share, indicating ongoing financial challenges despite revenue growth. HeartFlow's GAAP net loss was $27.4 million, including a $7.5…Read full document

This article first appeared on GuruFocus. Revenue: $52.6 million, up 41% year-over-year. US Revenue: $48.3 million, up 42%, including $3.2 million from Plaque revenue. Global Revenue Cases: 67,443, representing 67% growth. Non-GAAP Gross Margin: 80.5%, up from 75.3% in Q1 2025. Non-GAAP Operating Loss: $15.5 million, compared to $15 million last year. Non-GAAP Net Loss: $13.3 million or $0.16 per share, compared to $19.2 million or $3.11 per share in Q1 2025. GAAP Net Loss: $27.4 million or $0.32 per share, including a $7.5 million non-cash impairment charge. Cash Equivalents and Investments: $254.9 million at the end of the quarter. Full-Year Revenue Guidance: Raised to $228 million to $232 million, representing 29% to 32% growth. Plaque-Specific Revenue Guidance: Increased to $19 million to $21 million. Full-Year Non-GAAP Gross Margin Guidance: Raised to approximately 81%. Warning! GuruFocus has detected 3 Warning Signs with HTFL. Is HTFL fairly valued? Test your thesis with our free DCF calculator. Release Date: May 14, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. HeartFlow Inc (NASDAQ:HTFL) reported a 41% year-over-year revenue increase in Q1 2026, reaching $52.6 million, driven by 67% global case growth. The company raised its full-year revenue guidance to $228 million to $232 million, representing 29% to 32% year-over-year growth. HeartFlow's Plaque Analysis product is outperforming expectations, leading to an increased revenue outlook of $19 million to $21 million for 2026. The company achieved a significant milestone by helping manage the care of over 650,000 patients worldwide, reinforcing its leadership position. HeartFlow's non-GAAP gross margin guidance was raised to approximately 81%, driven by AI efficiencies, volume leverage, and a higher mix of high-margin Plaque revenue. Despite strong performance, HeartFlow Inc (NASDAQ:HTFL) remains in the early stages of Plaque adoption, with a need for continued medical education and market development. Operating expenses increased, with SG&A expenses reaching $38.3 million, reflecting investments in commercial expansion and medical education. The company reported a non-GAAP net loss of $13.3 million, or $0.16 per share, indicating ongoing financial challenges despite revenue growth. HeartFlow's GAAP net loss was $27.4 million, including a $7.5 million non-cash impairment charge related to facilities optimization. The company faces challenges in expanding awareness and adoption of its Plaque Analysis product, with ongoing efforts needed to educate the clinical community and secure payer coverage. Q: How did the strong start to the year for Plaque impact the updated guidance, and what are the expectations for the rest of the year? A: John Farquhar, CEO, explained that the strong start was driven by three factors: increased coverage, integration into the installed base, and medical education efforts. They have reached 75% coverage of total lives and expect to have Plaque in 1,200 sites by year-end. Despite early success, they are still in the early adoption phase, and the guidance reflects sustained momentum rather than a pull-forward of revenue. Vikram Verghese, CFO, added that Q1 revenue was strong due to better utilization and new account additions, and they expect Plaque revenue to be back half-weighted. Q: Can you provide more details on the operating expenses and whether the first quarter run rate should be expected for the rest of the year? A: Vikram Verghese, CFO, noted that Q1 OpEx was higher due to investments made in Q4 and front-loaded investments in medical education. Despite this, EBIT was favorable to expectations. For 2026, they expect OpEx as a percentage of revenue to decline year-over-year, with some favorable cost sequencing and incremental legal spend. Overall, they anticipate modest sequential increases in OpEx, with continued margin expansion driving a narrower operating loss compared to 2025. Q: How is the distribution of Plaque accounts trending across the installed base? A: John Farquhar, CEO, stated that the distribution is fairly even across cohorts, with existing accounts being the first to adopt Plaque. Moving forward, more new accounts will come online with the full platform. The demand is strong, and they have visibility into the funnel, expecting to reach 1,200 Plaque accounts by year-end. Q: What are the expectations for Plaque ASPs this year, and how are existing contracts structured for price increases? A: Vikram Verghese, CFO, explained that early Plaque contracts had attractive pricing to accelerate adoption and due to limited reimbursement. Contracts include mechanisms for price increases over time. They have already increased Plaque ASP expectations for 2026 and see more favorable pricing in 2027 and beyond. Q: How is the rapid accumulation of annotated CCTA images impacting HeartFlow's platform and margins? A: John Farquhar, CEO, highlighted that surpassing 200 million annotated images strengthens their competitive advantage. This data set drives innovation, customer-facing improvements, and gross margin expansion. It supports their track record of annual major launches and efficiency improvements, contributing to their growth strategy. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-05-15

Heartflow Reports First Quarter 2026 Financial Results and Raises Full Year 2026 Guidance

GlobeNewswire
SAN FRANCISCO, May 14, 2026 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today reported financial results for the first quarter ended March 31, 2026. First Quarter 2026 Highlights Total revenue of $52.6 million, a 41% increase year-over-year Gross margin of 80.2%, non-GAAP gross margin of 80.5% Net operating loss of $29.5 million, including a $7.5 million non-cash impairment charge associated with facilities optimization and headquarters relocation to San Francisco. Non-GAAP net operating loss was $15.5 million 2026 Annual Guidance Total revenue of $228 million to $232 million (approximately 29% to 32% growth year-over-year), compared to previous guidance of $218 million to $222 million (approximately 24% to 26% growth year-over-year) Non-GAAP gross margin of approximately 81%, compared to previous guidance of 80% to 81% “Heartflow entered 2026 with unprecedented momentum, expanding the category leadership we established over the last several years,” said John Farquhar, President and CEO of Heartflow. “Our AI-driven platform, deeply embedded commercial footprint, and the world’s largest database that recently expanded to over 200 million annotated CCTA images combine to create a foundational advantage that grows stronger with every quarter. The growth of our core FFRCT business remains durable, and adoption of Heartflow Plaque Analysis is ramping ahead of schedule. Most importantly, by helping physicians guide the care of over 650,000 patients worldwide, Heartflow has achieved an unrivaled scale of real-world experience. As the architects of this category, we continue to extend our leadership position, becoming the AI operating system of record for the detection, diagnosis, management, and treatment planning of coronary artery disease.” First Quarter 2026 Financial Results Total revenue was $52.6 million, a 41% increase year-over-year. U.S. revenue was $48.3 million, a 42% increase year-over-year. International and other revenue was $4.3 million, a 34% increase year-over-year. The year-over-year increase in total global revenue was primarily attributable to an increase in total U.S. FFRCT volume. Gross profit was $42.2 million, compared to $27.9 million in the prior year period. Non-GAAP gross profit was $42.3 million, compared to $28.0 million in the prior year period. Gross m…Read full document

SAN FRANCISCO, May 14, 2026 (GLOBE NEWSWIRE) -- Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today reported financial results for the first quarter ended March 31, 2026. First Quarter 2026 Highlights Total revenue of $52.6 million, a 41% increase year-over-year Gross margin of 80.2%, non-GAAP gross margin of 80.5% Net operating loss of $29.5 million, including a $7.5 million non-cash impairment charge associated with facilities optimization and headquarters relocation to San Francisco. Non-GAAP net operating loss was $15.5 million 2026 Annual Guidance Total revenue of $228 million to $232 million (approximately 29% to 32% growth year-over-year), compared to previous guidance of $218 million to $222 million (approximately 24% to 26% growth year-over-year) Non-GAAP gross margin of approximately 81%, compared to previous guidance of 80% to 81% “Heartflow entered 2026 with unprecedented momentum, expanding the category leadership we established over the last several years,” said John Farquhar, President and CEO of Heartflow. “Our AI-driven platform, deeply embedded commercial footprint, and the world’s largest database that recently expanded to over 200 million annotated CCTA images combine to create a foundational advantage that grows stronger with every quarter. The growth of our core FFRCT business remains durable, and adoption of Heartflow Plaque Analysis is ramping ahead of schedule. Most importantly, by helping physicians guide the care of over 650,000 patients worldwide, Heartflow has achieved an unrivaled scale of real-world experience. As the architects of this category, we continue to extend our leadership position, becoming the AI operating system of record for the detection, diagnosis, management, and treatment planning of coronary artery disease.” First Quarter 2026 Financial Results Total revenue was $52.6 million, a 41% increase year-over-year. U.S. revenue was $48.3 million, a 42% increase year-over-year. International and other revenue was $4.3 million, a 34% increase year-over-year. The year-over-year increase in total global revenue was primarily attributable to an increase in total U.S. FFRCT volume. Gross profit was $42.2 million, compared to $27.9 million in the prior year period. Non-GAAP gross profit was $42.3 million, compared to $28.0 million in the prior year period. Gross margin was 80.2%, compared to 75.1% in the prior year period. Non-GAAP gross margin was 80.5%, compared to 75.3% in the prior year period. The year-over-year gross margin expansion was primarily attributable to an increase in revenue case volume and improved production team productivity driven by AI efficiency initiatives, partially offset by the hiring and training of production team personnel. Total operating expenses were $71.7 million, or 136% of total revenue, compared to $45.4 million, or 122% of total revenue, in the prior year period. GAAP operating expenses also included a $7.5 million non-cash impairment charge related to the right-of-use asset for our Mountain View, California facility. The Company optimized its facilities footprint and relocated its headquarters to San Francisco. Non-GAAP total operating expenses were $57.8 million, or 110% of total revenue, compared to $43.0 million, or 116% of total revenue, in the prior year period. The year-over-year operating expense increase was primarily attributable to increased investment in sales personnel and related expenses, as well as increased investments in technology and clinical research. Net operating loss was $29.5 million, compared to $17.5 million in the prior year period. Non-GAAP net operating loss was $15.5 million, compared to $15.0 million in the prior year period. Net loss was $27.4 million, or ($0.32) net loss per share, compared to $32.3 million, or ($5.25) net loss per share, in the prior year period. Non-GAAP net loss was $13.3 million, or ($0.16) non-GAAP net loss per share, compared to $19.2 million, or ($3.11) non-GAAP net loss per share, in the prior year period. Adjusted EBITDA was ($14.0) million, compared to ($13.6) million in the prior year period. Cash, cash equivalents and investments totaled $254.9 million as of March 31, 2026. For additional information regarding non-GAAP financial measures, see “Use of Non-GAAP Measures,” “Heartflow GAAP to Non-GAAP Reconciliations” and “Reconciliation of GAAP Net Loss to Adjusted EBITDA” below. Webcast and Conference Call Details Heartflow will host a conference call today, May 14, 2026, at 1:30 p.m. PT / 4:30 p.m. ET to discuss its first quarter 2026 financial results. Those interested in listening to the conference call should register online using this link. Once registered, participants will receive dial-in numbers and a unique PIN to join the call. Participants are encouraged to register more than 15 minutes prior to the start of the call. A live and archived webcast of the event will also be available on the “Investor Relations” section of the Heartflow website at https://ir.heartflow.com. The archived version will be available for 12 months following completion of the live call. About Heartflow’s Technology and Research Heartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,800 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by American College of Cardiology and American Heart Association (ACC/AHA) guidelines and supported by more than 625 peer-reviewed publications, Heartflow has redefined how clinicians manage care for nearly 650,000 patients worldwide.1 Key benefits include: Unmatched Proprietary data pipeline: Built from the world’s largest database of more than 200 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations. Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 200 studies assessing over 365,000 patients. Heartflow is the only AI platform prospectively validated against invasive gold standards and demonstrated through real-world evidence to improve patient outcomes.2,3,4,5 Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%. Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay. Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001. About Heartflow, Inc. Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com. Use of Non-GAAP Measures To supplement its consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company discloses non-GAAP gross profit and non-GAAP gross margin, non-GAAP total operating expenses, non-GAAP research and development expense, non-GAAP selling, general and administrative expense, non-GAAP net operating loss, non-GAAP net loss, non-GAAP net loss per share, basic and diluted, and Adjusted EBITDA (collectively, the “Non-GAAP Measures”) in this press release. As used by the Company, these measures are adjusted to exclude stock-based compensation expense from the comparable GAAP financial measure and, in the case of non-GAAP total operating expenses, non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share, basic and diluted, and an asset impairment charge. Non-GAAP net loss and non-GAAP net loss per share, basic and diluted, are also adjusted for change in fair value of common stock warrant liability, change in fair value of derivative liability, and asset impairment charge. In addition, Adjusted EBITDA is calculated by adding back to net loss or excluding, as appropriate, interest income and expense, provision for income taxes, and charges for depreciation and amortization and is further adjusted by adding back in or excluding, stock-based compensation and, as appropriate, other income and expense items that are not reflective of the Company’s underlying continuing operating performance. Reconciliations of the Non-GAAP Measures to their most directly comparable GAAP financial measures are provided in the financial statement tables included at the end of this press release, and investors are encouraged to review the reconciliations. The Company believes the presentation of the Non-GAAP Measures, when shown in conjunction with the corresponding GAAP measures, provides useful information to investors as it provides visibility to the Company’s underlying continuing operating performance from period to period by excluding the impact of stock-based compensation and certain other items that are not reflective of the Company’s ongoing operations. Because of the variety of equity awards used by companies, the varying methodologies for determining stock-based compensation expense, the subjective assumptions used in those determinations, and the volatility in valuations that can be driven by market conditions outside the Company’s control, we believe excluding stock-based compensation expense enhances the ability of management and investors to understand and assess the underlying performance of our business over time and compare it against our peers, a majority of whom also exclude stock-based compensation expense from their non-GAAP results. With respect to the presentation of Adjusted EBITDA, the Company believes it is a useful measure to evaluate the Company’s operating performance and it is used by the Company to evaluate ongoing operations and for planning and forecasting purposes. Adjusted EBITDA is also a measure frequently used by analysts, investors and other interested parties to evaluate companies in our same industry. The Company’s definition of the Non-GAAP Measures may differ from similarly titled measures used by others. The Non-GAAP Measures should be considered only as a supplement to, and not as a substitute for, or superior to, their most directly comparable GAAP financial measures. Because the Non-GAAP Measures exclude the effect of items that increase or decrease the Company’s reported results of operations, management strongly encourages investors to review the reconciliations to the most comparable GAAP financial measures at the end of this press release and, when they become available, the Company’s consolidated financial statements and publicly filed Securities and Exchange Commission (“SEC”) reports in their entirety. The Company is not able to provide a reconciliation without unreasonable efforts of its forward-looking guidance related to non-GAAP gross margin to the most directly comparable GAAP financial measure due to the unknown effect of stock-based compensation that is material to the comparable GAAP financial measure. Forward-Looking Statements This press release contains express or implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release, including statements regarding our strategy, expected market growth and financial guidance, are forward-looking statements. These forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements, including, but not limited to: we may not be able to achieve or sustain profitability; our dependence on the success of our one product, Heartflow FFRCT Analysis; healthcare providers may be unwilling to change their standard practice regarding the evaluation of coronary artery disease; adoption of the Heartflow Platform by healthcare providers may be negatively impacted if third-party payors, including government payors, do not cover or provide adequate reimbursement; the concentration of our customer base; the significant competition we face in an environment of rapid technological change; the commercialization of Heartflow Plaque Analysis is nascent; risks associated with our use and development of AI models; risks related to failing to properly manage our future growth; disruption by catastrophic events; risks associated with our dependence on our information technology systems; security breaches that we cannot anticipate or successfully defend; extensive regulatory requirements we face to bring our products to market; and third parties could develop and commercialize technology and products similar or identical to ours. For a more extensive description of these and other risks and uncertainties that could materially affect our results, you should read our filings with the SEC, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as such filings may be amended, supplemented or superseded from time to time by other reports Heartflow files with the SEC. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and we undertake no obligation to update the forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law. Investor Contact Nick Laudico [email protected] Media Contact Elliot Levy [email protected] 1 Gulati, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation & Diagnosis of Chest Pain. J Am Coll Cardiol 2 Narula, et al. E HJ CVI 2024 3 Danad, et al. JAMA Cardiol 2017 4 Fairbairn et al. Coronary CT Angiography Plaque as a Predictor of Death, Cardiovascular Death and Myocardial Infarction. Presented at AHA 2025. (Real-world study with n=7,899 patients, higher TPV results in increased cardiovascular death and MI) 5 Madsen KT, et al. ADVANCE-DK 7-year. Presented at TCT Scientific Sessions 2024 (n=900 patients determined a 2.5x increase in cardiovascular events or deaths at 7 years)

As of 2026-08-22 • Updated weeklySource: Earnings sourceIngestion runbook