HeartFlow Q4 2025 Earnings Call - Plaque ramp and AI-driven margin lift underpin $218M-$222M 2026 guide

Nick, Investor Relations, HeartFlow: Good afternoon, everyone, and welcome to the HeartFlow fourth quarter 2025 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 Q4 and 2025 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 will now turn the call over to John Farquhar, CEO.

John Farquhar, President and Chief Executive Officer, HeartFlow: Thanks, Nick, and good afternoon, everyone, and thank you for joining us. We’re pleased to host our fourth quarter call and close out a record year for HeartFlow. We’ve achieved outstanding financial performance driven by the sustained adoption of our HeartFlow platform and strong execution across our commercial, innovation, and clinical initiatives. Total fourth quarter revenue was $49.1 million, representing more than 40% year-over-year growth. Global cases grew nearly 53% year-over-year, driven by record installed base growth, consistent FFRct utilization, and strong CCTA market growth. We also achieved a record non-GAAP gross margin of nearly 80%, reaching our long-term target just over 7 months from our IPO. Based on this momentum and our confidence entering the year, we’re initiating full year 2026 revenue guidance in the range of $218 million-$222 million.

This represents a year-over-year growth of approximately 24%-26%. Embedded in this outlook is our expectation that full year 2026 plaque revenue reaches approximately $15 million-$17 million, reflecting continued progress across reimbursement, installed base expansion, and utilization. From a gross margin perspective, we’re initiating full year 2026 non-GAAP gross margin guidance of 80%-81%, representing approximately 300-400 basis points of expansion year-over-year, driven by continued volume leverage, AI-driven efficiencies, and the increased contribution of higher-margin plaque revenue. We’re also increasing our midterm non-GAAP gross margin target to 85%, up from our prior target of 80%. This represents sustained volume leverage, increasing plaque revenue contribution, and continued gains in AI-driven efficiencies.

Our financial targets reflect the strength of the underlying business, a solid foundation for continued growth, and a high degree of confidence in our ability to execute consistently. Now turning to our strategic pillars. As we look ahead, we remain focused on our three strategic pillars: driving commercial adoption, advancing our plaque innovation pipeline, and extending our clinical leadership. Starting with driving commercial adoption. 2025 was a record year of installed base expansion. We added 340 new accounts, closing the year with 1,465 US accounts, the strongest new account growth in the company’s history. FFRct utilization remains strong and durable. New accounts ramp to steady state within the first year and maintain those order patterns consistently over time. Turning to plaque.

We drove strong early momentum in Plaque account additions through 2025, closing the year with an installed base of 489 accounts. Feedback from customers has been very positive. They increasingly recognize HeartFlow Plaque Analysis as the most accurate AI-driven plaque assessment technology available. It remains the only AI-powered plaque solution supported by prospective published clinical evidence demonstrating 95% agreement with the invasive gold standard of IVUS. The reimbursement landscape has also materially strengthened. As of January 1, 2026, the Category One CPT code for Plaque is officially in effect, formally assigning RVUs and enabling physician reimbursement for the first time ever. Now, with Aetna recently joining UnitedHealthcare, Cigna, and Humana in covering our analysis, Plaque now has coverage across approximately 75% of U.S. covered lives. These payer wins are a testament to the clinical power of our DECIDE registry.

As the largest prospective study of its kind with over 22,000 patients, DECIDE demonstrated that the HeartFlow Plaque Analysis changed physician management plans 51% of the time compared to CCTA alone. With respect to plaque adoption trends, we’re encouraged by the strong initial plaque volume so far in the first quarter. We continue to expect plaque revenue will become more meaningful in the second half of the year as newly activated sites scale and physicians build clinical experience. Our conviction is high that plaque will be a strong contributor to both the top-line growth and margin expansion this year and beyond. Our second pillar is the continued advancement of our innovation pipeline. We continue to leverage our proprietary database of 160 million annotated CT images for innovation.

As you’ll remember, in late 2025, we launched our next-generation plaque algorithm and evolved an already market-leading product into one that’s even more precise. Now, in 2026, our proprietary database is again unlocking innovation, this time with the launch of PCI Navigator, the first and only AI-driven planning tool to integrate anatomy, plaque burden, and lesion-specific physiology in a single interface. PCI Navigator extends our AI platform deeper into the interventional suite, as interventional cardiologists will be able to plan complex interventions with unprecedented confidence. They can anticipate and plan for lesion complexity, selecting devices more intelligently, thereby enabling them to enter the cath lab with a clear procedural strategy. This is highly analogous to the pre-procedural planning that’s already standard for TAVR, mitral, and left atrial appendage.

We anticipate PCI Navigator will not only strengthen engagement with interventional cardiologists but deepen provider support for the HeartFlow pathway and further increase the stickiness of our AI platform across health systems. We’re also pleased to announce that our product development team has executed ahead of schedule. We’re pulling forward the PCI Navigator launch to April 2026. This is earlier than the original plan that we had communicated for the second half of this year. In addition to customer-facing innovation, we’re also applying AI and our proprietary database further down the P&L to expand our gross margins. We’re excited to announce a major AI-driven efficiency initiative, HeartFlow Autonomous Processing. Built on over a decade of proprietary algorithm training, autonomous processing transitions our case processing into a highly automated single-step verification model.

With autonomous processing in place, our algorithms will autonomously manage intake, analysis, and output with the final human-in-the-loop quality check to preserve our gold standard accuracy. This initiative underwrites our confidence in our new midterm non-GAAP gross margin target of 85%, and it’s another proof point of how we convert our database and AI into long-term financial scale. Importantly, the rollout will follow a deliberate phased approach. We’ll start the initial rollout later this year, followed by a multiyear expansion beginning in 2027. Our third pillar is clinical leadership, and we continue to make great progress in this area. The goal of our strategy has always been the same: to create a new standard of care. In order to accomplish this, high-quality clinical evidence is paramount. In 2026, we’ll accelerate our evidence generation through prospective trials and peer-reviewed publications.

Earlier this week, we announced the first patient enrolled in our NAVIGATE-PCI registry. This prospective 5,000-patient study is designed to evaluate how PCI Navigator influences clinical strategy, enhances procedural efficiency, and bolsters physician confidence in the cath lab. To our knowledge, this is the industry’s first prospective registry that evaluates an AI planning tool for PCI. Now turning to plaque, at the American College of Cardiology meeting later this month, we’re presenting real-world data from a 15,000-patient registry from Mass General Brigham. This real-world evidence demonstrates that the HeartFlow Plaque Analysis is the most powerful CT-based predictor of MACE. Importantly, it also solidifies our plaque staging system as the most clinically validated system for personalized risk stratification, enabling clinicians to identify high-risk individuals beyond conventional metrics.

Finally, in the second half of the year, we plan to report one-year outcomes from approximately 13,000 patients within our landmark DECIDE registry. We believe that the addition of longitudinal outcomes data to DECIDE will shift the conversation from clinical utility to clinical impact and meaningfully expand the evidence base for plaque-guided care. Now moving to our expansion into the high-risk asymptomatic population, which we announced earlier this year. From the beginning, we’ve been methodical in our journey of bringing our technology to more patients, starting in the $5 billion symptomatic patient population, first with FFRCT and then moving to plaque. We view the high-risk asymptomatic population as the next logical step in this journey. We estimate this market represents an incremental $6 billion opportunity in the U.S. alone, expanding our total market opportunity to $11 billion.

Over the next 12 months, we plan to initiate three randomized controlled trials across targeted high-risk asymptomatic subpopulations. Patients with prior heart attack or PCI, patients with coronary calcium, and patients with prior symptoms and documented plaque. Targeting these subpopulations represents a de-risked approach that prioritizes a diagnostic pathway, focusing on patients already in the healthcare system who have known disease. We’re excited about these TAM expansion efforts and will share more details as the year progresses. It’s also worth noting that from a capital allocation standpoint, this is a very efficient approach. We believe we can achieve our clinical objectives with approximately 1,400 total patients combined across all three trials. In closing, we’ve executed extremely well against our core strategic pillars in 2025. In 2026, we expect this execution to continue with meaningful catalyst on each pillar on the horizon.

Our confidence in our 2026 guidance is high. It’s supported by continued growth in our core FFRct business, a meaningful second half ramp in plaque, strong install base expansion, and a rapidly growing CCTA market. We look forward to advancing our mission and transforming the standard of care in CAD. I’ll now turn the call over to Vikram for his financial review.

Vikram Verghese, Chief Financial Officer, HeartFlow: Thanks, John, and good afternoon, everyone. Unless otherwise noted, my remarks reference the quarter ended December 31, 2025. All financial metrics I refer to other than revenue will be non-GAAP, unless otherwise noted, and all growth rates will be year-over-year. Reconciliations to the comparable GAAP measure are in today’s earnings release. Total revenue for the fourth quarter was $49.1 million, up 40%. US revenue grew to $44.8 million, up 41%. All US and other revenue grew to $4.3 million. Total global revenue cases for the quarter were 57,776, representing 53% growth, driven by continued strength in our US FFRCT business. We also expanded our install base at a record pace during the year and the fourth quarter, bringing our year-end total to 1,465 accounts.

This reflects strong execution by our commercial organization and continued growth in interest around Plaque Analysis. As a reminder, we provide installed-based metrics on an annual basis only. We continue to see strong utilization at both existing and new accounts in line with historical trends. New accounts continue to ramp to steady-state FFRCT utilization in about a year, while existing accounts consistently maintain that utilization. We again saw particular volume strength in the clinic setting, a rapidly growing segment of the market, as well as continued adoption of our volume-based rebate pricing structure. Turning to gross margin. Fourth quarter gross margin reached nearly 80% compared to 75.3% in the fourth quarter of 2024. The year-over-year margin improvement reflects better than expected volume leverage and an increase in AI-driven efficiencies enabled by continuous training on the company’s proprietary CCTA database. Operating expenses reflect disciplined growth investments.

Fourth quarter SG&A expenses were $34.6 million, driven by investments in headcount and the expansion of our TAM sales force to further drive adoption of the HeartFlow platform. Research and development expenses were $17.1 million, driven by investments in technology to advance our innovation pipeline and in clinical research to expand our evidence base. Operating expenses were 105% of revenue versus 114% a year ago. Operating loss was $12.5 million compared to $13.5 million last year, demonstrating improving operating leverage while we continue to invest for growth.

Non-GAAP net loss was $9.8 million, or a loss of $0.12 per share compared to non-GAAP net loss of $18.6 million, or a loss of $3.15 per share in the fourth quarter of 2024. On a GAAP basis, net loss was $24.4 million or a loss of $0.29 per share. The GAAP result includes a $9.3 million non-cash charge from the remeasurement of our common stock warrant liability, driven by higher share price during the quarter. In October of 2025, the warrant holder net exercised all warrants, so Q4 will be the last quarter with any warrant remeasurement impact. Weighted average basic and diluted shares outstanding were 84.8 million in the quarter. Turning to the balance sheet.

We ended the quarter with $280.2 million in cash equivalents, and investments. We continue to have high confidence. We are well capitalized to fund operations through profitability while continuing to invest in R&D and commercial expansion. Looking ahead to 2026, I’m pleased to provide our guidance for the full year. We are initiating total revenue guidance for the full year 2026 to be in a range of $218 million-$222 million, representing approximately 24%-26% growth. This outlook includes plaque revenues of approximately $15 million-$17 million, weighted towards the back half as clinicians build clinical experience. We are also initiating non-GAAP gross margin guidance of 80%-81%, representing 300-400 basis points of expansion.

Drivers of our gross margin guide include volume efficiencies, increased AI-driven efficiencies, and high-margin plaque revenues in the second half of the year. The midpoints of our revenue and gross margin guidance imply approximately 31% gross profit growth in 2026. As John mentioned, we are also increasing our midterm non-GAAP gross margin target from 80% to 85%. This reflects high confidence in further AI-driven efficiencies driven by our autonomous processing initiative, scaling plaque revenues, and continued volume leverage. We also remain on track to achieve cash flow profitability within three years of our IPO. I would now like to turn it back to John for summary closing remarks.

John Farquhar, President and Chief Executive Officer, HeartFlow: 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 a new standard of care for detecting, diagnosing, managing, and treating coronary artery disease. We’re excited about the progress we’ve made in a record 2025, and we look forward to a milestone year in 2026. With that, I’ll turn the call over to the operator for Q&A. Operator?

Operator: Thank you so much. As a reminder to ask a question, press star one one on your telephone and wait for your name to be announced. To remove yourself, press star one one again. One moment while we compile the Q&A roster. Our first question. Stand by. Comes from Robbie Marcus with JPM. Please proceed.

Robbie Marcus, Analyst, JPMorgan Chase (JPM): Great. Thanks for taking the questions. Congrats on a good closing quarter. Two questions from me. Wanted to start first with 2026 guidance came in above the street, and I believe that plaque number is also above where consensus sits. Love to just hear the confidence in the building blocks, particularly any extra commentary you have on plaque so far in first quarter and feedback on the launch and the assumptions underpinning FFRct, and then I have a follow-up.

John Farquhar, President and Chief Executive Officer, HeartFlow: Yeah, sure. Thanks, Robbie. Great to hear your voice. So yeah, thinking about 26, I mean, I’ll start by saying, I’ve never been more confident in this business and what we’re setting up to deliver here. I think there is fundamental demand out there, and I could not be happier with our team’s track record of execution. I wanna compliment the team for continuing to deliver. The way I would kinda categorize this guide is, I’d put it as a healthy starting point. We’ve talked about our, you know, our guidance philosophy previously. We wanna provide very high conviction guides that set us up well, you know, for quarters down the road. Okay. That’s at a high level.

You know, first, around FFRCT and the base business, I’ve got great confidence here, okay? There’s really kind of three drivers underwriting it. You know, we have proven our ability to go out into the market and sign up new accounts. Okay? We just did the biggest year ever. We did 340 last year, as you’re aware of. I think our go-to-market model has proven our ability to go get it, okay? That number incidentally grows. The number of accounts we can go get grows by about 300 every year. Okay? One, we can go get the account. Two, once they’re in, we’ve got very predictable performance, you know, relative to utilization.

We see physicians ramping and using our FFRCT technology very predictably, so they become healthy in that regard. Then lastly, there’s this kind of underlying factor out there relative to CCTA in and of itself, you know. That, you know, I like to think of that genie is not gonna get put back in the bottle. CCTA as a frontline test for diagnosing coronary artery disease is in the guidelines, not just in the U.S., but around the world. I think we’re on the right side of history here, and that’s gonna continue to sort of fuel growth moving forward. That’s the core business. Then what makes 26 really exciting is plaque, you know. I think we did a great job last year.

You know, we signed up close to 500 accounts by the end of 2025. You know, we’re well into Q1 here, right now, and, you know, we’ve had some strong activations that have continued. I have visibility, obviously into the funnel, so I’ve got high confidence that, by the end of this year, we’ll be in 1000 accounts. Again, just as, you know, frame of reference, it took us 8 years to get into 1000 accounts with our FFRCT business. We’ll do it in less than 2, with plaque. And then, you know, the accounts that are live now, the early trends are very positive relative to volume. Okay. So I’m very, you know, happy about that. Now, I will say, I don’t think this is gonna be a light switch moment.

I still think, as Vikram mentioned, you know, the material volume’s gonna come in the back half. We’ve got some catalysts out there. We’ve got the one-year DECIDE data reading out in the second half of this year. Physicians really need to experience it, experience outcomes with their individual patients to get into a more kinda higher utilization rate. But all that being said, very confident. Again, I’d say this is a high conviction forecast that we’re giving you.

Vikram Verghese, Chief Financial Officer, HeartFlow: Yeah. I’ll probably add some commentary to that. You know, again, this is a high confidence baseline that really sets a solid foundation to allow for quarterly progression. Additionally, there’s, you know, pockets of, you know, incremental pockets of potential upside. I’ll start with FFRCT. Again, a high conviction guide, but not factored in any utilization tailwinds from the Navigator launch, so that’ll be upside. The feedback from physician community has been incredibly positive. Now focusing on plaque and, you know, you had a very specific question there, Robbie. We’ll point out that again, this is highly de-risked given the early volume data that we’re seeing in Q1. If the adoption curve were to steepen more quickly, it provides an additional catalyst for growth.

Second, you know, we referenced 1,000 accounts by the end of the year. We’ve got strong funnel with good visibility, so any outperformance there would also be, you know, beyond the range we provided for guidance. You know, stepping back, the framework here is straightforward. We’ve been conservative around optionality and realistic around execution assumptions. The overall skew in our view is to the upside.

Robbie Marcus, Analyst, JPMorgan Chase (JPM): Great. Just as a follow-up, you know, a lot of software companies have come under pressure from fears around AI that they could, you know, do it better and faster. Obviously, there’s a lot of moats you have with your data and, you know, tech and med tech are very different sectors for a reason. I’d love to get just on record your view of your moat around the business, you know, versus some of the AI companies that are hitting software and how you feel your defenses and things you’re doing to, you know, stay ahead of all the competition. Appreciate it.

John Farquhar, President and Chief Executive Officer, HeartFlow: Yeah. Yeah, sure, Robbie. I think that question makes a lot of sense given some of the recent, you know, headlines. You know, I’ll say, I mean, I would characterize our moat as highly defensible, okay? I think there’s a couple of components that sort of, you know, to make it up here. The first is, I think, as everybody’s aware, you know, an AI model is only as good as the training set and the data that that model is trained on. We have, and we’re very proud of it, what we believe to be the world’s largest proprietary CT database of annotated CT images. Okay? We’ve got over 160 million images.

This data is effectively ground truth data, and it does not exist in the public domain. There’s no large data set out there that somebody very quickly could go acquire and start training a model on. Okay. We’ve been training this model, and we’ve been building this data set for over 10 years. Not only is it very large at 160 million annotated CT images, it’s also super diverse, you know, ’cause it’s got all sorts of different types of anatomy and types of CT capital feeding into it. Okay. The last thing I’ll say on it is right now, we’re already connected, and this is sort of at the end of or the start of this year. We’re connected to 60% of the market CCTAs.

Every day, as the category grows, we’re growing disproportionately with it. Okay? This would be a very difficult catch-up game if somebody were to try to start a race here. That’s the data that the algorithms are trained on, but that works hand-in-hand with clinical evidence, you know. We like to say, you know, you can’t code your way into clinical trust. Clinical trust with a physician comes by delivering high-quality clinical data. HeartFlow as a company has been investing in this regard for over 10 years. We have over 600 peer-reviewed publications. We’ve got a couple randomized controlled trial. This is high-quality clinical data, and you can’t fast-forward that. There’s no way to rush that.

This is an incredible lead that we have, and we’ll continue to invest and build on that. Now that clinical data works hand-in-hand with the fact that we’re med tech. You know, in med tech, you can’t have an AI hallucination the way you can in, you know, consumer technology. We are a regulated medical device. You need clinical data first to get FDA clearance, but then you need to operate within a regulated quality system. We have just that. Of course, we have our human in the loop that ensures our, you know, our accuracy remains incredibly high. The last thing I’ll say is, you know, we are software and, you know, software is useless if it’s not integrated into a doctor’s everyday practice.

We are effectively the proven operating system, if you will, in over 15 hospitals and clinics right now. Okay. We work really hard to integrate in and meet our physicians where they are. We help them do their job easier. We don’t ask them to adapt and do it with us. That can be a tough row to sort of hoe, you know, initially it takes over a year to get into these, some of these hospitals. Once you’re in, we’re pretty sticky, okay. Being the kind of operating system of choice, we think is a great advantage for us. Lastly, underscoring all this, we’ve got a great strong global patent portfolio that we think is very defensible as well.

Robbie Marcus, Analyst, JPMorgan Chase (JPM): Appreciate it. Thanks a lot.

Vikram Verghese, Chief Financial Officer, HeartFlow: Thank you. As a reminder, if you do have a question, simply press star one one to get in the queue. We have a question from the line of William Plovanic with Canaccord Genuity. Please proceed.

William Plovanic, Analyst, Canaccord Genuity: Hey, great. Thanks for taking my questions. Good evening. I’d like to ask just on the product itself. I mean, you guys are innovating rather quickly, and so you’ve had significant changes to both FFRct and plaque, I think, over the last 3-6 months. Just, I was wondering if you could just kind of maybe highlight some of those changes and how they’ve impacted the workflow to help us understand. My follow-up is on the PCI Navigator. Just initial feedback, future data, product innovations. You know, we saw the first patient go into the registry. Just love to hear more on that. It sounds like, you know, you’re using that as one of your competitive moats as well. Thanks.

John Farquhar, President and Chief Executive Officer, HeartFlow: Yeah, sure. Good to hear your voice, Bill. On kind of the product innovation piece, you know, last year, we introduced our next generation plaque algorithm, okay. That was, again, we’re going into this proprietary database that we have. We’re training the algorithms to get smarter, and we took what was already a really good plaque algorithm, and we enhanced it. Okay. From a customer standpoint, there’s no changes to the workflow per se. We’re always doing behind the scenes work that I don’t think is really. You know, it’s not material enough for a call such as this to, you know, take out steps and improve functionality of our product. 2 years ago, a little over 2 years ago, we launched our new.

Another example is we launched our new user interface, which incorporated both plaque and FFRct co-registered with our risk profile, our nomogram information into a singular user interface. Now physicians can use that to interrogate the entire coronary tree. This year, we’re really excited, we’re launching it actually next month. The team did a good job pulling it forward. We’re launching our PCI Navigator, and we’re really excited about that. You know, we’ve talked about, you know, the strength of the platform matters, and PCI Navigator expands our platform, okay? We really think for interventional cardiologists, this can be a pretty attractive tool for their toolkit.

What it allows them to do is really plan ahead before a PCI procedure, so they can walk into that procedure knowing the right device, the devices to select, the complexity of the anatomy, et cetera. That’s very analogous to what they’re already doing, you know, with TAVR and mitral et cetera. We’re excited to that. We haven’t, and Vikram can speak to this if there’s interest, we haven’t necessarily baked in FFRct upside as a result of this, but we do think it’s possible. We think having an interventional cardiologist who’s an important part of the CV ecosystem, if you will, really advocate strongly for CT, you know, CT and HeartFlow pathway, that helps us. Certainly using HeartFlow on every case that comes in helps us as well.

We’re super excited about that. Vikram, I don’t know if you wanna talk about-

Vikram Verghese, Chief Financial Officer, HeartFlow: Yeah. I’ll quickly underscore. You know, our current forecast really does not assume any incremental upside from PCI Navigator. To the extent Navigator drives incremental activity, it’ll really flow through FFRct volumes as each case is anchored to an FFRct order. Then, you know, we’re highly encouraged by the early feedback we’ve received on the product and the early potential we see, but we would frame PCI Navigator as a longer duration growth vector for us than a real near-term driver of financial performance.

John Farquhar, President and Chief Executive Officer, HeartFlow: Yeah. The last thing.

William Plovanic, Analyst, Canaccord Genuity: Yeah. Vikram-

John Farquhar, President and Chief Executive Officer, HeartFlow: Oh, sorry. Go ahead, Bill. Oh, go ahead.

William Plovanic, Analyst, Canaccord Genuity: I was just gonna say, from my understanding, you’re not charging for PCI Navigator. I just wanted to circle up with, you know, just on the consensus on Robbie’s question, Q1 consensus, I think it’s $46.9 million. That’s up 26% year-over-year. You’re guiding $24-$26 million. How do we think about, you know, that first quarter? I mean, you’re two weeks away from closing it. You know, how, you know, are you extremely comfortable with that current number? Do you think it’ll be higher, or how should we think of Q1? Thanks.

Vikram Verghese, Chief Financial Officer, HeartFlow: Yeah. In terms of phasing, generally, Bill, what I would say is, you know, our full year guide reflects a midpoint of 25% year-over-year. For the first quarter, and this is specific to your comment there, we expect growth in excess of 30% year-over-year, and that bakes in about a sequential improvement of 1%-2%, full cognizance of where we are, you know, relative to the end of the quarter. Moving into Q2, for what it’s worth, we typically benefit from a little bit of seasonality, and we expect that pattern to hold true in 2026 as well. Then as plaque starts to really materialize in 2026 towards the back half of the year, you’ll see more sequential growth relative to where consensus is at.

Again, plaque, you know, should plaque outperform, that’s, you know, the principal upside to the back half phasing assumptions.

William Plovanic, Analyst, Canaccord Genuity: Thank you.

John Farquhar, President and Chief Executive Officer, HeartFlow: Hey, Bill, just to round out your question on innovation a little bit. Obviously, Navigator is, you know, what we’re discussing today. I would describe our pipeline of new products as really strong, and we’ll have more news in future quarters of other innovations that are coming.

Operator: One moment for our next question, please. It comes from Matthew O’Brien with Piper Sandler. Please proceed.

Matthew O’Brien, Analyst, Piper Sandler: All right, thanks for taking the questions. Just for starters, on the plaque side, should we continue to assume $350 per case for plaque here in 2026? Is there any, you know, upward mobility to that revenue per case going forward?

John Farquhar, President and Chief Executive Officer, HeartFlow: Yeah, maybe I’ll say a couple of comments on plaque, and then Vikram, you can speak to the specifics of the model. I mean, first thing, Matt, I’ll say, I mean, I’ve said this before, but it’s worth saying again. I could not be more excited about what plaque is gonna mean, full stop. I think it’s gonna mean a lot for patients, most importantly, but I also think it’s gonna transform this business. Now, over time, we’ve got to be a little judicious in how we call it, given we’re still in the early innings. As we monitor uptake every quarter, we’ll be able to adjust going forward. Part of that uptake, to your question, is pricing, and I’ll let Vikram speak to that.

Vikram Verghese, Chief Financial Officer, HeartFlow: Yeah, happy to, John. So Matt, relative to your question, you know, given that we have and now you know commercial payers coming online, Aetna being the latest one, that gets us to about 75% covered lives in the U.S., we now have clearer line of sight to pricing improvements over time. Our contracts with our customers have built-in mechanisms that enable better pricing with broader coverage. Consequently, in our 2026 base plan, we have underwritten modest ASP upside in the 2026 plan, and then more meaningful step-ups in future years.

Matthew O’Brien, Analyst, Piper Sandler: A little above $350 to start and then maybe going up more.

Vikram Verghese, Chief Financial Officer, HeartFlow: That’s right.

Matthew O’Brien, Analyst, Piper Sandler: In 2027, 2028. Is that fair?

Vikram Verghese, Chief Financial Officer, HeartFlow: That’s right.

Matthew O’Brien, Analyst, Piper Sandler: Got it. Then Vikram, just sticking with the numbers here a little bit. I wanted to get into gross margin because that was so good, but trying to keep it to two here. Was the FFRCT case number per site similar to what you saw in Q3? Because, you know, given the number of hospitals you added, that’s really good. Then, you know, I think it’s kinda, you know, to the guidance question. If you assume. Well, when I’m looking at the FFRCT revenue, that’s factored in when you think about, you know, the plaque growth plus, you know, OUS, it’s the lowest level that we’ve seen from you guys or would see from you guys over the last three years.

Is there something in there that we should be aware of, again, given all the momentum that we’re seeing in the core FFRCT business, or is it just back to kinda what John was saying to start with? Like, look, we’re just trying to be very judicious with how we’re guiding early in the year, and then we’ll kinda reflect back as things progress. Thanks.

Vikram Verghese, Chief Financial Officer, HeartFlow: Yeah, thanks for the question, Matt, again. You know, relative to cases per site, we did outperform despite the heavy onboard number. We were about 15% higher on a cases per site basis in 4Q 2025, relative to where consensus came at. That’s really, you know, driven by the strength of that market shift that’s happening here with CCTA ultimately on its way to becoming standard of care. With respect to guidance, you know, I’d say we’ve, you know, it’s part law of large numbers, as well as a part guidance philosophy. You know, we’re lapping an exceptionally strong year in 2025, and when you start with that kind of elevated base, you know, the growth rates really start to normalize.

The second piece, you know, to underscore what John said, you know, this is core to our guidance philosophy. The framework we’ve put forward for 2026 still assumes very strong underlying demand from a nominal volume perspective, with a fair amount of conservatism. I would really view this guide as an earlier framework that intentionally leaves sufficient room for quarterly progression.

Matthew O’Brien, Analyst, Piper Sandler: Got it. Thanks so much.

Operator: Thank you. Ladies and gentlemen, as a reminder, if you have a question, press star one one to get in the queue. We have a question from Larry Biegelsen with Wells Fargo. Please proceed.

Nathan Treybeck, Analyst, Wells Fargo: Hi, this is Nathan Treybeck on for Larry. Thanks for taking the question. Can you talk about the utilization that you’re seeing for Plaque Analysis in your FFRct accounts? How does the utilization compare to FFRct, and how do you envision utilization trending throughout 2026? Thanks.

John Farquhar, President and Chief Executive Officer, HeartFlow: Yeah, thanks, Nathan. Again, we’re at the early innings, but I think what we’re seeing so far is positive. Okay. Now, you need to remember the total applicability for plaque is 60% of all patients. Okay. We’re nowhere near 60% right now because we’ve just kinda got out the gates here. Over time, there’s plenty of upside to ramp, but what we’ve seen is, you know, very positive and I think leads to sort of the bullishness that you’re hearing from me today. Relative to FFRCT obviously is a more mature therapy. Or, sorry, more mature diagnostic. Once an account is up and running, we see FFRCT being utilized pretty close to the full range.

That’s the good news, but the full range is about half of what it is on plaque. FFRCT is about a 30% or 33% full utilization, and we get pretty close to that with most of our accounts. I think over time, there’s certainly an opportunity to see plaque really in a material way take off here. I think long term, I’ve got really high confidence plaque is gonna be a bigger business than FFRCT. I think where we have to sort of you know, wait and see and kind of measure it every you know, every week, every month is what does that ramp look like. We’re in the early innings there, but again, so far pretty positive.

Nathan Treybeck, Analyst, Wells Fargo: Okay, thanks for that. Can you talk about how you’re helping your accounts to better understand how to utilize Plaque Analysis? I guess what’s next for Plaque from a clinical data standpoint?

John Farquhar, President and Chief Executive Officer, HeartFlow: Well, we lean very heavily into education, and I think as we talked about before, you know, one important unlock is coverage and, you know, we’re making great progress there. That’s super easy to measure, so to speak. Medical education is a little more nuanced, okay? In the FFRct journey, it was a much simpler story. You just needed to prove accuracy versus invasive FFR, and then everybody knew what to do with a, you know, with a whatever 0.7 FFR value. Plaque is much more nuanced, and we are leaning in very heavily to help physicians understand how to use plaque with their specific patients, okay? We do a lot of medical education.

I would say moving forward, and we’re at AHA just this next week in New Orleans, and far and away, you know, the lion’s share of everything we’re talking about, there will be plaque. In the second half of this year, the big data that we’ll share is the one-year data on DECIDE, where we’ll have one-year outcomes there, and that’ll be another piece that’s really important to bring to our physicians. Ultimately, what we’re trying to do is shift it from, you know, clinical utility, you know, question number one is first, how do you use it, to actual clinical management. That’s the journey that we’re on with our physicians right now.

Operator: One moment for our next question, please. It comes from the line of Rick Wise with Stifel. Please proceed.

John, Analyst, Stifel: Hi, John and team. This is John on for Rick today. A couple quick questions for me. First, I just wanted to ask about the broader role of CCTA for HeartFlow and how that’s impacting growth today. I remember back in the IPO, you gave a couple metrics about how penetrated and utilized CCTA is for non-invasive coronary tests. I was just hoping for a general update on where CCTA adoption stands, how much are you benefiting from it and how much more do we have to go in terms of uptake there in your view?

John Farquhar, President and Chief Executive Officer, HeartFlow: Yeah, sure. Thanks, John. Appreciate the question. Again, we’re trying to create a new standard of care here, and it’s well documented that the existing standard of care is suboptimal. Patients are being misdiagnosed, way too many false positives, way too many false negatives, okay? CT plus HeartFlow addresses that issue, and we’re trying to create a new one. The first piece of that is CCTA being adopted. At the end of 2021, CCTA in the U.S. came in as a level 1 A test ahead of all other alternatives. Okay. We like to say we’re on the right side of history here, but we have a lot of upside. It’s around 10%-12%, I think, penetrated relative to the whole standard of care.

There’s lots of ways to go before we get there. I, you know, as I said earlier, I don’t think the genie is gonna get put back in the bottle there. I think it’s just a matter of time, you know, between the guidelines, the stronger reimbursement, more and more readers, you know, are raising their hand, becoming CTA readers. Plaque is coming on board, so that makes the utility even that much greater. All of those trends in my mind are durable, and there’s a high ceiling for us to, you know, aspire to go hit. Now from what I’m seeing in the data, I’m not seeing anything slowing us down. You know, we’re seeing more and more accounts join the category, so to speak.

You know, at the start of this year, there’s 3,200 accounts with active CTA programs. We expect that number will be 3,500 before the year’s out. Right now, the majority of volume coming off a CT scanner is not CCTA. It’s for another modality. More and more accounts can start adding slots to it before they even have to tap into kind of a longer uptick of a capital, you know, capital cycle. There’s lots of tailwinds into this story, and we continue to lean into them.

John, Analyst, Stifel: Thanks. That’s helpful. Just wanted to also ask about competition quickly here. I’m just curious what you’re seeing in terms of win rates or when you’re going head-to-head against peers. Are you getting any pushback on price if they come below you? Just curious about how the broader HeartFlow ecosystem factors into the competitive positioning when you go up against others. Thanks.

John Farquhar, President and Chief Executive Officer, HeartFlow: Yeah, sure. First thing I’ll say, and I remind the team of this often, our competition is the standard of care. Okay? When we wake up every morning, we are trying to convert volume from the existing standard of care into CT plus HeartFlow. When we do that, we will be successful and patients will be better off, and we’re continuing to focus on changing those practice patterns and bringing physicians into kind of a CT plus HeartFlow pathway. Now your question I think is more specifically around other AI vendors. This is not a new dynamic. Some of these vendors have been around since 2018, 2017. None of that is slowing us down. I think if anything, having more competitors or players in the category is actually good for the category.

We don’t compete on price. We compete on the quality of our data, which we’re extremely proud of. We’re prospective, we’re published, we lean into that, we prove our accuracy, and we compete on the quality of our product. We continue to improve our product just like we’re doing this year and expanding our platform with PCI Navigator. We don’t publish win rates and things like that, but I think our results are very positive and I feel good about the way the team is competing and how we’re winning in the market.

John, Analyst, Stifel: That’s helpful. Thanks for taking my questions.

Operator: With that, we conclude our Q&A session and conference for today. We want to thank everyone for participating. You may now disconnect.