HTFL

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

Good afternoon, everyone, 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 Verghese, our Chief Financial Officer. Today, we will walk you through our Q1 performance, share updates on our commercial momentum, innovation pipeline, and clinical programs, 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, 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. 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, combine 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. 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-$232 million, representing 29%-32% year-over-year growth. We're also increasing our Plaque-specific revenue outlook to $19 million-$21 million. Moving down to 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%. 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. 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 HeartFlow's 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 HeartFlow Plaque Analysis. Closer to the front lines, our recently expanded territory account manager sales force 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 Plaque revenue guidance, and we now expect our Plaque installed base to reach approximately 1,200 sites by the end of the year. We see a clear path to pricing expansion beginning later this year with more meaningful upside in 2027. 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, Plaque, 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 Plaque and PCI Navigator.

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. 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 phased rollout through 2026 with broader introduction in 2027. 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%. Finally, all of our innovation is enabled by our proprietary data set, an asset unmatched in our category. As of early May, we reached a 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 was 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 HeartFlow 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 HeartFlow 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. 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. 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 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.

Thanks, John, and good afternoon, everyone. Unless otherwise noted, my remarks reference the quarter ended March 31st, 2026. 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 first quarter was $52.6 million, up 41%. U.S. revenue grew to $48.3 million, up 42%, inclusive of $3.2 million of Plaque revenue. OUS and other revenue grew to $4.3 million. Total global revenue cases for the quarter were 67,443, representing 67% growth, driven by continued strength in U.S. FFRCT, strong contribution from accounts added in 2025, better than expected Plaque adoption, and continued expansion of the CCTA market.

We continue to see strong utilization in the quarter at both existing and new accounts, consistent with historical ramp dynamics we have described previously. New accounts continue to take about a year to ramp to near full FFRCT utilization, while existing accounts continue to demonstrate durable and consistent utilization patterns. As a reminder, FFRCT is applicable in approximately 33% of CCTAs, which means maximum FFRCT utilization in an account is approximately one-third of CCTA volume. We again saw particular volume strength in the clinic setting, which remains a rapidly growing and strategically important segment of the market, along with continued adoption of our volume-based rebate pricing structure. Finally, we continue to expand our install base at a rapid pace during the first quarter, driven by strong execution from our commercial organization and Plaque Analysis adoption that was ahead of expectations.

As a reminder, we provide install base metrics on an annual basis only. Turning to gross margin, first quarter gross margin reached 80.5% compared to 75.3% in the first quarter of 2025. The year-over-year improvement reflects volume leverage, increased production efficiency, 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. First quarter SG&A expenses were $38.3 million, driven by targeted investments in our commercial team to further drive adoption of the HeartFlow platform. Research and development expenses were $19.5 million as we continue to fund the innovation cadence John described, along with the clinical evidence required to support new product adoption and expand our addressable markets.

Non-GAAP operating expenses were 110% of revenue versus 116% a year ago. Non-GAAP operating loss was $15.5 million compared to $15 million last year, demonstrating improving operating leverage while we continue to invest for growth. Non-GAAP net loss was $13.3 million or a loss of $0.16 per share compared to a Non-GAAP net loss of $19.2 million or a loss of $3.11 per share in the first quarter of 2025. On a GAAP basis, net loss was $27.4 million or a loss of $0.32 per share. GAAP net loss includes a $7.5 million non-cash impairment charge associated with our facilities optimization and headquarters relocation to San Francisco.

Weighted average basic and diluted shares outstanding were $85.6 million in the quarter. Turning to the balance sheet. We ended the quarter with $254.9 million in cash equivalents, and investments. We continue to have high confidence that we are well-capitalized to fund operations through profitability while continuing to invest in R&D and commercial expansion. Turning to our updated outlook for 2026. Given the momentum in our core business and acceleration in Plaque, we are raising our expectations for the full year. We now expect total revenue of $228 million-$232 million, representing 29%-32% growth. We're increasing our Plaque-specific revenue outlook to $19 million-$21 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 1Q performance, we're also raising our full-year non-GAAP gross margin guidance to approximately 81%, up 400 basis points year-over-year. The drivers of our gross margin outlook include continued volume efficiencies, increased AI-enabled automation, and a higher mix of high-margin Plaque revenue. The midpoint of our revenue guidance implies approximately 37% gross profit growth in 2026. Finally, as John mentioned, we have remained committed to our midterm non-GAAP gross margin target of 85%. This reflects our confidence in continued AI-enabled production efficiencies through our autonomous processing initiative, scaling Plaque revenue, and sustained volume leverage as the platform grows. 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.

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 start to 2026, and we continue to expect a milestone year. With that, I'll turn the call over to the operator for Q&A. Operator?

Thank you. Our first question comes from the line of Robbie Marcus with JPMorgan.

Hi, team. This is Alan on for Robbie. Just want to start off with Plaque and the updated guide. You know, clearly you began the year with, you know, a much stronger than expected quarter. I think relative to our expectations, sort of came in, double what we had been forecasting on a revenue perspective. You raised the guide by, you know, roughly $4 million. It looks like you're not pulling forward all of the upside. You know, how much of that reflects, you know, maybe a little bit of, you know, a faster start, a pull forward into the first quarter relative to, you know, the rest of the year? What are you seeing in, you know, second quarter that supports the rest of the guidance?

Yeah, sure. Thanks for the question. I'll give you some thoughts, and I'll let Vikram sort of speak to how that plays throughout the subsequent quarters. I would say, you know, from an adoption standpoint, the way we think about it, there's really three, you know, three drivers here, okay? The first is coverage, and we talked about this coming into the year, but we've made progress since then. As of the end of March, we're now at 75% total covered lives. That's a really good place to be, and we're happy with that. This is again, a function of us taking our DECIDE data, which is the largest prospective, you know, data set of its kind. We're taking that to payers to open and expand coverage. We still got work to do.

There's a fairly long tail of payers. I feel good about the team's execution and where we're sitting from a coverage standpoint. You know, the second piece is we need to get Plaque into our installed base. You know, I mentioned in the prepared remarks, we're now upping our guide relative to installed base. I've got high confidence we'll be at about 1,200 by the end of the year. This is a function of just, again, really strong market demand. I'm in the fortunate position where I can see the funnel moving forward, and I think the funnel looks really good. I feel good on where we're taking Plaque relative to our installed base.

You know, the third piece, probably the most important, is we need to get out with cardiologists, we need to help them understand how to use Plaque with their patients. Far and away, probably the number one question I get is this technology is amazing. It's really, you know, really interesting, how do I actually use it with my patients? We lean very hard into medical education. We've got a great stable of physician partners that speak on our behalf. Since last year, we've done over 1,000 events, we continue to do that. I would say across all of these dimensions, everything's performing really well. I think that sort of underscores the confidence in raising our guide.

Now I will say, you know, in spite of the optimism, we're still really early in the adoption cycle, you know. You think about the components of that, you know, first you need to get contracted with the account. You need to get the workflow up and running, you know, installed, et cetera. You've got to get confidence in the reimbursement. You know, accounts don't open the floodgates right away. They want to trust that payment is coming through, there's no denials, et cetera. Ultimately, physicians need to use it with their patients to help manage them medically. Those patients need to come back after a period of time.

Hopefully show some improvement. We're working that through that adoption cycle right now. I'm really happy with the team's execution. I've got really, you know, my optimism on the future of Plaque is as strong as it's ever been. With that, I'll let Vikram kind of speak to kinda how this plays out throughout the rest of the guide.

Thanks, John. I'll start with comments on Q1. It was a strong quarter for us. We did north of $3 million in revenue, and that was really driven by better utilization as well as stronger new account additions. Pricing was in line with expectations. Keep in mind the Category 1 CPT code for Plaque went live in early January, which supported the sequential step-up that we saw from 4Q to Q1. Relative to phasing of revenue, I wouldn't characterize this as a pull forward of any kind. It really shows sustained and strong momentum in the business. All of the metrics we track point to continued adoption momentum. Similar to our last guide, it's still early in the year, and this is a high conviction guide that sets us up well to outperform.

Then finally, I do wanna reinforce, we continue to expect Plaque to be back half weighted, and that really reflects the adoption curve that John described.

Thanks. Then I just had a quick follow-up on the spend side. You know, good to see gross margin ticking up to the higher end of the range supported by that strong Plaque number. You know, I think operating spend did come in a touch higher than we had been expecting. I think previously we had been looking to, you know, $223 million-$224 million in OpEx for the year based on the 1st quarter run rate. It looks like you're going to be coming in a step above that. What really drove that spend in the 1st quarter, and should we use that as the right run rate for SG&A and R&D for the rest of the year going forward?

Thanks for the question there. You know, the first quarter OpEx, I would say, was increased sequentially, and that really was a reflection of the full quarter impact and investments were made in the fourth quarter. You know, we also made the conscious decision to front-load certain investments early in the year, particularly around medical education, given our expectations on Plaque, and the importance of supporting that effectively through the year. Importantly, I would say even with those investments, EBIT came in favorable to our expectations, you know, which reflects the continued discipline across the broader cost structure. Now to your question on 2026 OpEx.

For the full year 2026, you know, we continue to expect OpEx as a percentage of revenue, which is an important metric we track to decline year-over-year. There's some puts and takes within the cost base. On the clinical front, we'll have some favorable sequencing of costs. DECIDE related spend would phase out. We'll see that'll create capacity for the investments we wanna make in the asymptomatic RCT. We're also absorbing some incremental legal spend, but that's partially offset by the savings from the sublease of the facility. Net-net, we expect OpEx to increase modestly on a sequential basis through 2026. Combined with the continued margin expansion, you know, that should drive a meaningfully narrower loss, operating loss versus 2025.

All that being said, given the underlying drivers in the business, we continue to expect cash flow profitability, by that mid-2028 timeframe.

Thank you. Our next question comes from the line of Matthew O'Brien with Piper Sandler. Your line is now open.

Hi, this is Samantha on for Matt. Thank you so much for taking our question. Could you talk a little bit more about how the distribution of Plaque accounts is trending across the installed base? You know, started at large center first and now going broad. Just a little bit more depth there.

Yeah, sure. Thanks for the question. I think, you know, bottom line, I would say the distribution is fairly even across, you know, any cohort you wanna cut it. The biggest difference at this point that I see is more tilted towards our existing accounts, you know, being the first ones to get it, and then the new accounts are just now coming online. And, you know, the dynamic that drives that, just so you know, is these were all by and large contracts that were put in front of customers last year. As they move through the funnel, the first ones to go live are within our existing accounts.

Now moving forward, I would say from, you know, Q2 and beyond, we'll see more and more new accounts come in that will have the full platform from the get-go. You know, at the end of the day, we go where the demand is. I'm not reading too much into it one way or another on sort of an existing versus new standpoint. I think your question was probably a little bit more towards the size of the cohorts, large, medium, and small. I see that spread pretty evenly at this point, and I wouldn't expect that dynamic to change. As I mentioned, we've got good visibility in the funnel and it looks pretty relative that way.

Now we've still got, as I mentioned, we've got really good confidence that there's more accounts to go add. As we add more, as I mentioned, there'll be more new accounts coming in. That 1,200 kind of IB call for Plaque by the end of the year, that's a new one and we've got good confidence in that. I'd also just say relative to adding new accounts The total hunting ground, just as a reminder, is about 3,200. That's about 300 accounts more than there were last year. I think there's still a really good runway out there to continue to bring onto the franchise.

Thank you.

Thank you. Our next question comes from the line of Jon Young with Canaccord. Your line is now open.

Hey, John, Vikram. Thanks for taking the question tonight. Congratulations on the quarter. I just want to also touch on Plaque, if I can. On ASPs, could you just speak, you know, add a little bit more additional color on Plaque ASP expectations for this year? Generally, how long are existing contracts in terms of timing for ASP increases? Have you been able to take price? How should we think of the price point new accounts are being onboarded at relative to Plaque reimbursement today? Thanks.

Yeah. Yeah. Thanks for the question there, Jon. You know, I'd provide some commentary high level on how we look at pricing. Just by way of background, you know, many of our early Plaque contracts were really structured with attractive pricing for principally two reasons. First, to accelerate account activation and really drive early adoption, and I think we're doing a great job there. The second, because reimbursement was more limited at that time. It was really principally Medicare reimbursement. It's also worth noting that within our contracts with our customers, we do have mechanisms for price increases to step up over time. You may recall in the March earnings call, we had already increased our Plaque ASP expectations for 2026.

Now, with the visibility we have, we continue to see upside to current consensus, with really more favorable pricing becoming visible, in 2027 and beyond.

Okay. Great. Thanks. Just as a follow-up too, our survey work has been suggesting there's some strong unawareness in the clinical community still about Plaque reimbursement. Do you see that as well, and are there any plans for education to overcome this hurdle? Thanks again for taking our questions.

Yeah. I think you said you said you heard that in your survey. That doesn't surprise me. You know, depending on where you are in the market, I think that's fair that could be the case. I think in general, I would describe awareness of Plaque as low. I mean, that's part of this kind of category creation effort under which we're undertaking. A large part of that is clinical education, as I mentioned, another part of that is, you know, the reimbursement that comes with it. You know, I mentioned this dynamic, you know, customers need to understand the Category 1. They need to understand the payment dynamic in their ZIP code.

They need to trust that the payment is gonna come through after a submission, and there's not gonna be a denial, what have you. All of that is part and parcel of the work we do to help the develop the category. My expectation is that was probably the case earlier this quarter. It'll probably still be the case, you know, in future quarters, just to a lesser degree as we continue to do our work.

Thank you.

Thank you. Our next question comes from the line of Rick Wise with Stifel. Your line is now open.

Good afternoon, John, and congratulations on a really another outstanding, if not brilliant quarter. In that spirit, you've given us you beat street numbers, you beat our numbers, and you raised by more than these. I feel slightly embarrassed, but not so embarrassed I'm not gonna ask. When I think back and look back over the last couple of years, you've been growing 40%, if you know, kind of character or better. The midpoint of the guide, the new guide is, I think I'm right in saying sort of, 30% or so.

Maybe just help us think through in a little more detail, I'll call it your conservatism in light, not just the past performance, but the really impressive continued rollout of innovation, as you said, adding new accounts, expanding reimbursement, Plaque moving faster. Maybe just help us put that in context going. It's clear that the even looking at the 2027, the outlook is extremely positive. Maybe just talk about how we should think about it and maybe where the drivers of upside could come from. Thank you.

Yeah. Sure, Rick. Thanks, and thanks for the question. I think you're, you know, you're probably familiar with our guidance philosophy at this point, but, you know, when we give guidance, we want it to be a high conviction guidance. Okay? I would certainly characterize this one within the same light. I've got really high confidence in this raise. When I think about sort of the biggest drivers of it, you know, number one is our FFRCT business continues to be strong and durable and predictable. You know, we talked about in 2025, we had the biggest year ever in terms of bringing on new accounts. We brought on 340 new accounts. Those accounts are really starting to pay off well. Okay?

They are ramping on schedule, and I've got really high confidence that they'll get up to sort of that higher utilization range that we historically see. I feel good in that regard. You know, you mentioned Plaque. You know, Plaque is this sort of next layer of the cake, you know, growth, so to speak. Every metric we track internally is ahead of plan, okay? Doesn't mean we're where we wanna be, but I'm very, very pleased with it, you know? That's both relative to volumes, as well as new accounts coming through. You know, that underscores our, you know, the guide that Vikram mentioned, that underscores that 1,200 account install base by the end of the year.

We're still really early, but I feel better now than I ever have relative to Plaque. I should also say qualitatively, you know, when I'm out in the market with customers, the feedback is outstanding. It's just working through this kind of adoption cycle that we've discussed, and that's, you know, that's hard to rush. The last piece is just, you know, the wind at the sails of the overall CCTA category. You know, I think we like to say we're on the right side of history here as this structural shift from, you know, older modalities for non-invasive testing towards a CT first pathway. We think that's a multi-year tailwind, and that's certainly a component as well.

From that standpoint, I've got, you know, I've got good confidence in this guide and, you know, relative to the guiding philosophy, Vikram, I don't know if you have anything to add on that.

Yeah. Yeah. Thanks, John. I'll just reinforce from my perspective again, to what John said, this is a high conviction starting point that really preserves room for operational upside as the year unfolds. And relative to the FFRCT business, you know, we meaningfully outperformed our expectations on both volumes and revenues in 1Q. Based on that performance and the visibility we have, we immediately increased our volume and growth assumptions versus the March guide. We also have a clear path here to further strengthen the growth outlook as the year progresses. Now, second, on Plaque, you know, I would characterize this as a de-risked guide based on the early trends we're seeing in Q1.

It's still early in the fiscal year, and we continue to believe Plaque revenues will be back half weighted. You know, John talked about the conviction behind the 1,200 Plaque counts by the year-end, and that's really supported by the funnel and the high visibility we have on the commercial front. Finally, we also did outperform expectations on new site additions, which we believe is a strong indicator of continued interest in the HeartFlow pathway. In sum, you know, I would characterize this guide as a durable base case, with really multiple paths to drive performance about the top end of the range.

Yeah, it's exciting to hear. Just another topic I'm hoping you're gonna expand on a little bit is what I, what I sort of my reaction was the tsunami of annotated CCTA images you're accumulating and rapidly building now over 200 million. Back in January, I think you were talking about over 160 million. I don't know whether this number makes any sense, but it feels like you could be at, I don't know, 300 million by the end of this year or early next year. Regardless of that number, can you talk through the implications for HeartFlow, the multifaceted implications from this really rapid accumulation of these images relative to the speed of the platform, to the adoption, to the implications for your COGS, your margins?

Maybe just any updated thinking and color and perspective there. Thank you so much.

Yeah, sure. Thanks. Good question. We've passed the 200 million annotated image threshold, now we're just a bit, you know, north of that, and that's really a function of the model that we've put in place. For every CCTA that one of our customers does, that comes into our cloud. We annotate it. It's got precise annotations, and we can use that to drive innovation, both that drives, you know, customer-facing innovation with physicians and new clinical insights and gross margin expansion. We absolutely see this as a competitive advantage that is getting stronger each and every day. It really is the bedrock for all we do, you know, relative to innovation.

We've talked about historically, we've got a very strong track record of putting at least one, you know, one material new launch into the market every year. We've got Plaque tracking coming out next year. Obviously, this year we have PCI Navigator. Obviously, we've got more in the RoadMap beyond that we'll share with you on future calls. I feel great with this as an asset, so to speak. More broadly, you know, we try to innovate across three vectors. We go deep, this is all about making our existing products better. Just last year when we launched our next generation Plaque algorithm, that's a good example of that. That came from that same, you know, data set of annotated CCTA image. We innovate around breadth.

You know, we expand the platform, we can do more. You know, a couple of years ago, we launched RoadMap. This year we're launching PCI Navigator. Next year we're launching Plaque, that's another example, real-world example of that. We, you know, we use the same data set for efficiency. A lot of that efficiency is expanding our gross margins. We talked about our autonomous processing initiative that's now underway. We continue to use that same data to do that. This is core to who we are as a company. It's core to our, you know, our engine that helps drive growth. I think, you know, as we've discussed, it's only getting stronger as, you know, as each quarter goes on.

Thank you, John.

Thank you. Our next question comes from the line of Larry Biegelsen with Wells Fargo.

Hi, this is Nahtan Treybeck back on for Larry. Can you talk about how accounts with Plaque Analysis are utilizing it? Is it broad across the addressable patient population or is it in specific patient cohorts?

Yeah, sure. Thanks, Nathan. Good question. I think it's still early to tell. I think anecdotally we have a direction, but we don't know, you know, objectively at this point. I think, you know, most of our early users are using it in patients with more disease first. I think that's not surprising to hear that feedback. I think as they get confidence that folks, that patients that they have with a higher Plaque burden come back with better adherence, better, you know, better outcomes and, you know, LDL lowering, et cetera, I think that will broaden over time. My only comment on that is I'd put an asterisk on it. That's an anecdotal kind of pulse of the market that's not based on any data.

I'm sure there's instances where patients with lower Plaque burden are using it, are getting it as well.

Okay. Thanks for that. In terms of how Plaque utilization is trending, you know, as we think about new accounts, how is it trending in the new accounts relative to how, you know, FFRCT trended on utilization when it was launched?

I think, good question, and thanks for asking it. I think we're kind of talking about two different parts of history. I mean, when FFRCT was launched, that was pre-guidelines. That was on older, you know, an older base of CT capital that was in the market. The awareness was quite a bit lower. You know, this is a new world. You know, I think, you know, CT plus AI is much higher awareness right now. I don't know if we can kind of compare the utilization to the same degree. I will say we're very confident in FFRCT's ability to, in our understanding of ramping over time, FFRCT will go to the full extent of the range. We have not seen that yet in Plaque. We're too early in the adoption curve.

I think physicians need to use Plaque, have patients come back, understand how it's helping them manage it. We're not at that point yet.

Thank you. Our next question comes from the line of Kallum Titchmarsh with Morgan Stanley. Your line is now open.

Great. Thanks for taking the question, guys. I'll be unoriginal and stick with Plaque for one. You described the upcoming DECIDE one-year outcomes as a potential inflection point for Plaque. Can you maybe just give us a sense of what specific endpoints or metrics you expect will resonate most with payers and physicians? Are you still on track for the readout in H2? Thanks a lot.

Yeah, sure. We use, you know, DECIDE obviously in a lot of what we do relative to, you know, to educating the market. We use that with both, payers, to get the coverage, as well as more importantly with physicians to help them understand. The 90-day readout showed a 51% change in management, meaning when a physician have the Plaque Analysis, they change their management plan with patients and a 19-point reduction in LDL. Okay. The one-year data that comes out later this year, we'll see each of those. Obviously, I don't know what they, what that will be yet. And we'll have about 13,000 patients in that readout. We certainly expect that will help with Plaque adoption.

I think the most important thing that's gonna help with Plaque adoption is this first round of patients that get it are gonna come back to see their cardiologists and, those outcomes will become very personal. I think as that cardiologist, and physician experiences that's when the flywheel, I think will just get stronger.

Great. You know, now that the PCI Navigator's been in the market for about a month, again, realize it's early days, but any early observations on adoption patterns? You know, how many sites have activated it? You know, you seen any early sign of incremental FFRCT pull through from kind of interventional cardiologists? I guess if not now, then when are you expecting that to take place? Thanks a lot.

Yeah, sure. Navigator, you know, we're super excited about it. The feedback is really strong. There's lots and lots of interventional cardiologists asking for it, asking how they can get it, et cetera. We are gonna be like everything we do, we're gonna be very planful in the rollout. You know, what's most important is the cardiologists have a good experience with it, you know. We believe the ability to have a plan for a PCI before the patient, you know, before the physician is in the cath lab, is really important. Okay? This is gonna allow physicians to plan ahead. They can plan both relative to the complexity of the lesion as well as the approach that they're gonna take.

They'll be able to hopefully select devices more intelligently. They can walk in with a clear procedural plan. You know, I've had an interventional cardiologist tell me recently the cath lab should be for executing the plan, not deciding the plan. That's exactly what happens with TAVR and mitral and left atrial appendage, and we think one day PCI will go there. So we're really excited about that. We think it makes our platform, our platform more, you know, stickier, more compelling. We're right now, we're targeting the largest PCI hospitals first. That's where, you know, given our strategy, that's where we're targeting. We'll roll through that, and we'll make sure that, you know, all initial experiences are strong.

At this point, we're not disclosing any metrics more specifically for that, but I will say I'm very, I'm very excited about Navigator and what it does for our platform this year.

Thank you. Our next question comes from the line of Brandon Vazquez with William Blair. Your line is now open.

Hey, everyone. Thanks for taking the question, and I'll echo congrats on a nice quarter here. John, maybe I'll start with a higher-level picture. You'd used this phrase that there was a flywheel effect going on as you start to see adoption of kind of all the different solutions within the portfolio here at HeartFlow. Maybe expand on that a little bit. What do you mean by you're seeing a flywheel effect? Where you know, what metrics give you excitement and optimism to come on the call and start talking about flywheel effects, and how does that build over time? What metrics do you think we'll see that in the model?

Thanks, Brandon, for the question. I, you know, I link it back to, you know, to two things. One, the power of the platform, and then two, the power of the database that I mentioned earlier on the call. You know, relative to the platform, you know, we believe the stronger the HeartFlow platform, the stronger the business, you know. We back everything we do with clinical data from detection to diagnosis to management and treatment. The more we expand our platform, and that's core to our strategy, the more we see, and we believe utilization and adoption will occur. This year, you know, introducing Plaque, introducing Navigator. This is obviously a big year for the platform.

Next year, we'll have our Plaque tracker out there. As I mentioned, we've got other ones down the road that we'll share. That provides stickiness. That provides utility. Everything we do across the platform is co-registered. You get concordance across all of it. Just wherever you are in the continuum of taking care of a patient with Coronary Disease, we have our clinically backed AI technology to help you with that. Relative to the other data set that I mentioned, that gets bigger and bigger as well, right? For every patient we serve, for every account we open, we're adding more into our proprietary database.

The more we have in our database, the more diverse it is, and the more we'll be able to develop, you know, new innovation along the lines of what I previously spoke about.

Got it. As a follow-up, maybe I'll ask two here, one, John, for you and one for Vikram. Part of this flywheel, John, is it fair to say, do you guys see in accounts that are adopting the entire portfolio, are they seeing higher utilization levels across the board? I think that's part of what I'm trying to understand a little bit too, is there a flywheel or a halo effect of the entire portfolio in the accounts?

Then Vikram, on that note, maybe talk to us a little bit about, I know you guys don't give specifics on the ASPs or the volumes, every quarter, but talk a little bit as you think about the increased guidance relative to what you had the prior guidance at, how much of that is coming from volume versus better than expected pricing. Thanks, guys.

Yeah. Short answer right now, Brandon, it's too soon to tell. We anticipate, over time, when successful, certainly that to be the case. I think the more, the more components of the platform, the more value we're delivering. With that, you would expect, you know, stronger utilization. At this point, it's too soon to tell.

Brandon, to your question, it's really driven by volumes. You know, we expect on the Plaque side, ASPs to be in line with consensus in 2026. On FFRCT, as we have talked about previously, you know, we do have the dynamic of two dynamics specifically, both of them are volume-enabling dynamics. First is our use of volume-based rebates. You know, this worked to our advantage in Q1. Our volume growth in Q1 approached 50%. As volumes come in ahead of plan, the ASPs obviously reflect that level of outperformance. Second is the mix shift, you know, to the clinic site of service, which carries with it lower ASPs, but is again fundamentally volume enabling.

You know, against that backdrop of ASP shifts, we continue to drive towards profitable growth. Gross profit in Q1 increased about 10 points faster than revenue to about 51%. It was in fact higher than unit growth as well. You know, with respect to the guide, we assume these dynamics will continue through the balance of the year on FFRCT.

Thank you. I'm currently showing no further questions at this time. Thank you all for your participation. This does conclude today's conference. You may now disconnect.

Good afternoon, everyone, and welcome to the HeartFlow Q4 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.

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 Q4 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 seven 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 to $222 million.

This represents a year-over-year growth of approximately 24% to 26%. Embedded in this outlook is our expectation that full year 2026 plaque revenue reaches approximately $15 million to $17 million, reflecting continued progress across reimbursement, installed base expansion, and utilization. From a gross margin perspective, we're initiating FY2026 non-GAAP gross margin guidance of 80%-81%, representing approximately 300 to 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 U.S. 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.

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%. U.S. revenue grew to $44.8 million, up 41%. All U.S. 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 U.S. FFRCT business. We also expanded our install base at a record pace during the year and the Q4, 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 Q4 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 Q4 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 to $222 million, representing approximately 24% to 26% growth. This outlook includes plaque revenues of approximately $15 million to $17 million, weighted towards the back half as clinicians build clinical experience. We are also initiating non-GAAP gross margin guidance of 80% to 81%, representing 300 to 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.

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?

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 J.P.M. Please proceed.

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.

Yeah, sure. Thanks, Robbie. Great to hear your voice. So yeah, thinking about 2026, 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 eight years to get into 1000 accounts with our FFRCT business. We'll do it in less than two, 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.

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.

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.

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.

Appreciate it. Thanks a lot.

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.

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 three to six 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.

Yeah, sure. Good to hear your voice, Will. 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. two years ago, a little over two 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-

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.

Yeah. The last thing.

Yeah. Vikram-

Oh, sorry. Go ahead, Will. Oh, go ahead.

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 to $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.

Yeah. In terms of phasing, generally, Will, 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% to 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.

Thank you.

Hey, Will, 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.

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

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?

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.

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.

A little above $350 to start and then maybe going up more.

That's right.

In 2027, 2028. Is that fair?

That's right.

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.

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.

Got it. Thanks so much.

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.

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.

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.

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?

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.

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

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?

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.

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.

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.

That's helpful. Thanks for taking my questions.

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