Heartflow, Inc.

Good day, and thank you for standing by. Welcome to the Heart Flow first quarter, 2026 earnings call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Nick Lodico, Vice President of Investor Relations. Please go ahead.

Good afternoon, everyone, and welcome to the HeartFlow First Quarter 2026 Earnings Conference Call. Joining me today are John Farquhar, HeartFlow's President and Chief Executive Officer, and Vikram Virghese, our Chief Financial Officer. Today, we will walk you through our Q1 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 risks and uncertainties, and actual results may differ materially. Please note that both this live call and a digital replay will be available shortly after the call concludes. With that, I'll now turn the call over to John Farquhar, our CEO.

Thank you for joining us. HeartFlow entered 2026 with the strongest momentum in our history. and the first quarter demonstrated how quickly that momentum is translating into results. Our AI-powered platform, our deeply embedded commercial footprint, the world's largest database of annotated CCTA images, which is now over 200 million, combined to create an advantage that widens with every quarter. In the first quarter of 2026, revenue was $52.6 million, up 41% year over year, on 67% global case growth. Four factors drove the quarter. First, FFRCT utilization remains strong across the installed base. Second, the record class of new accounts that we added in 2025 is performing very well and ramping on schedule. Third, our plaque launch is outperforming expectations. And lastly, the broader CCTA market continued to expand, supported by guidelines and strong reimbursement. We also reached a meaningful milestone this quarter. HeartFlow has now helped physicians manage care of more than 650,000 patients worldwide. This scale of real world commercial experience is unmatched in our category and we continue to extend our leadership position with each quarter. The strength of our first quarter performance gives us confidence to raise our full year outlook. We now expect to deliver total revenue of $228 million to $232 million, representing 29% to 32% year-over-year growth. We're also increasing our plaque-specific revenue outlook to $19 million to $21 million. Moving down the P&L, we're raising our non-GAAP gross margin guidance to approximately 81%. This is the high end of our prior range, 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 approximately 37%. And finally, we remain committed to our midterm non-GAAP gross margin target of 85%. Now, turning to our three strategic pillars, commercial adoption, innovation, and clinical evidence. I'll walk through each, starting first with commercial adoption. Within this pillar, there's three themes that played out in Q1. First, as expected, our FFRCT business is healthy and performed well. Second, our emerging plaque business is accelerating ahead of expectations. And third, our platform strategy is taking hold. We're seeing it translate into deeper integration and increasing product utilization. Now, relative to FFRCT, the performance of our core FFRCT business remains remarkably strong, characterized by durable utilization across our established base of existing accounts as well as our new additions. Our cohort of legacy accounts is large and growing, delivering consistent, predictable volumes month over month. This is a result of our unique product differentiation. As the most accurate non-invasive test for CAD, and the only product with lesion-specific FFRCT values, our base business remains as strong as ever. Additionally, I'm very pleased with the performance of the accounts that we added into our installed base in 2025. This cohort of 340 accounts was the largest in HeartClose history and is ramping nicely in line with our expectations. Together, these factors reinforce my confidence in the long-term health and durability of our FFRCT business. Now turning to plaque, I'm pleased to report that adoption is ahead of our initial expectations, activation of new plaque accounts is ahead of schedule, and we're seeing strong early utilization trends. At a high level, the recently published ACC AHA scientific statement on plaque, the increasing payer coverage, and the outstanding clinical and economic evidence that we shared at ACC in March all contribute to growing awareness and demand for our heart flow plaque analysis. Closer to the front lines, our recently expanded Territory Account Manager Salesforce is trained, focused, and doing great work. These reps call directly on high-volume general cardiologists to raise awareness of our plaque technology and clinical data, as well as enable targeted medical education efforts. Everything we do in this regard underscores our proven accuracy and our clinical effectiveness. and is an important step in the journey of driving widespread adoption of this new technology. The scale of our medical education efforts is significant. Over the last 12 months, we've held over 1,000 medical education events focused on plaque, generating over 100,000 physician impressions. As our customers gain experience with plaque and see firsthand the value it can deliver for their patients, we're highly confident in the early trends we've seen in Q1 and that they'll translate to even better results longer term. Given this confidence, we've raised our 2026 PLAC revenue guidance, and we now expect our PLAC installed base to reach approximately 1,200 sites by the end of the year. Finally, we see a clear path to pricing expansion beginning later this year with more meaningful upside in 2027. Finally, a couple comments on our Heartflow platform. which we believe to be the most intelligent AI operating system in cardiovascular care and a very important component of our strategy. We're proud to be the only clinically validated AI platform to span the full continuum of care across coronary artery disease, from detection to diagnosis to management and treatment planning. Our platform is comprised of four tools, Roadmap, PLAC, FFRCT, and now PCI Navigator. all powered by AI to independently provide precision and unique clinical insights, and all working together as a unified solution. Now, I can't underscore this enough. Our customers are busy and operate in complex environments. In many cases, they're forced to make decisions and share information across settings of care and subspecialties. Simply stated, their job is hard. They do not want separate, discrete, ad hoc point solution. For true adoption, they demand what our platform uniquely delivers, a unified clinical solution that provides both precision and seamless coordination across the continuum of care. Further, our platform strengthens as it expands. With each new technology we introduce, the flywheel of adoption accelerates. This is happening right now with the launches of PLAC and PCI Navigator. And lastly, I'd be remiss if I didn't also mention that we integrate seamlessly into our customers' workflow, effectively becoming the operating system of record for CAD across their hospitals, clinics, and health systems. Now turning to our second pillar, innovation. In April, we launched PCI Navigator, and the feedback from interventional cardiologists has exceeded our expectations. For the first time, ICs can walk into the cath lab with a fully informed procedural plan already in hand, a level of pre-procedural certainty that simply did not exist before. The tool runs on any computer and reduces procedural planning to minutes. We're executing a phase rollout through 2026 with broader introduction in 2027. Now, innovation doesn't just impact the top line. Our autonomous processing initiative, which we highlighted on our last earnings call, is progressing well and is on track. We entered the pilot phase in the first quarter and continue to expect a gradual rollout through the back half of 2026 and a multi-year impact beginning in 2027. The program underpins our midterm non-GAAP gross margin target of 85%. And finally, all of our innovation is enabled by a proprietary data set, an asset unmatched in our category. As of early May, we reached the defining milestone. This data set now exceeds over 200 million annotated CCTA images. It's large, diverse, and precisely annotated, and serves as the foundation for everything we do with respect to innovation. We've spent over 10 years training algorithms, and it supports our leading accuracy and reproducibility. It also enables our consistent cadence of innovation, as evidenced by our track record of delivering at least one major launch each year. Clinical evidence is our third pillar, and it remains central to our leadership in this category. We've built what we believe to be the deepest and most rigorous evidence base in this space, with over 625 peer-reviewed publications and more than 200 clinical studies and trials. The breadth and depth of clinical validation spanning accuracy, clinical utility, cost effectiveness, and outcomes shapes how we develop and commercialize our technologies and continues to strengthen the trust we've earned with the physicians we serve. Our leadership is on full display at the American College of Cardiology annual scientific session this year. Our educational dinner was standing room only. Our mobile CCTA plus heart flow program where physicians received a live personalized analysis was oversubscribed. We view this level of engagement as part of the broader rising tide of interest in CCTA, with heart flow increasingly being at the center of the discussion. Building on our body of clinical evidence, our 5,000 patient Navigate PCI registry is now ramping, with sites activating and enrollment building. This study will generate one of the first large-scale prospective data sets evaluating how an AI-driven pre-procedural planning tool influences PCI strategy and cath lab efficiency, and it will extend our impact beyond diagnosis into treatment planning. Beyond symptomatic disease, we're now advancing into the asymptomatic population, which we view as the next frontier of this category. To lead this expansion, we remain on track to initiate two randomized controlled trials in the second half of 2026, one for patients with prior MI or PCIs and another for patients with elevated calcium scores. A third RCT will focus on patients with prior plaque and will initiate in the first half of 2027. These studies are designed to expand our U.S. addressable market by approximately $6 billion, bringing our total total addressable market to $11 billion over time. This clinical path not only builds on the depth of evidence for our platform, but it also puts us on a clear trajectory to begin accessing the incremental TAM before the end of the decade. In closing, the first quarter of 2026 translated our platform vision into financial results. FFRCT and plaque analysis working together are driving sustained volume growth deeper clinical integration, and more durable account-level adoption. Plaque remains early, but it's ramping ahead of our expectations. With PCI Navigator now in the market, HeartFlow spans the full continuum of coronary artery disease from diagnosis through treatment planning, positioning us as an indispensable partner to the cardiovascular service line. This performance supports our increased guidance and reinforces our confidence in the trajectory of the business. We remain focused on our mission to transform the detection, diagnosis, and management of coronary artery disease, and I'm grateful to the HeartFlow team for their continued dedications to the patients we serve and for all of their hard work. I'll now turn it over to Vikram to review our financial results and guidance.