Heartflow Q2 2026 Earnings Call Transcript

Quartr
Provided by Quartr
August 13, 2026

Key Takeaways

  • Positive Sentiment: Q2 revenue rose 48% year over year to $64.1 million, with U.S. revenue up 51%, supported by durable FFRCT utilization, accelerating Plaque adoption, new account additions, and continued CCTA market growth.
  • Positive Sentiment: HeartFlow raised its 2026 outlook to $246 million–$250 million in revenue, 40%–42% growth, while increasing Plaque revenue guidance to $29 million–$31 million and projected Plaque-enabled accounts to approximately 1,250.
  • Positive Sentiment: Profitability metrics improved materially, with non-GAAP gross margin reaching 83.3% versus 75.6% a year ago and non-GAAP net loss shrinking to $5.8 million; management maintained its targets of roughly 85% gross margin and cash-flow profitability by mid-2028.
  • Positive Sentiment: The company highlighted multiple growth catalysts, including Plaque Staging, PCI Navigator, Plaque Tracker planned for 2027, autonomous processing, and three clinical trials targeting high-risk asymptomatic patients that could expand the U.S. addressable market by approximately $6 billion.
  • Neutral Sentiment: HeartFlow said its patent litigation and government civil investigative demand remain multi-year matters, with no material updates provided; management stated it is cooperating and does not view either issue as disrupting operations.
AI Generated. May Contain Errors.
Earnings Conference Call
Heartflow Q2 2026
00:00 / 00:00

There are 13 speakers on the call.

Operator

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

Speaker 1

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

Speaker 1

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

Speaker 2

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

Speaker 2

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

Speaker 2

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

Speaker 2

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

Speaker 2

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

Speaker 2

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

Speaker 2

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

Speaker 2

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

Speaker 2

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

Speaker 2

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

Speaker 2

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

Speaker 2

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

Speaker 2

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

Speaker 2

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

Speaker 3

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

Speaker 3

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

Speaker 3

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

Speaker 3

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

Speaker 3

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

Speaker 3

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

Speaker 3

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

Speaker 3

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

Speaker 2

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

Operator

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

Speaker 4

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

Speaker 2

Yeah, sure. Thanks, Robbie, I appreciate the question. I mean, relative to Plaque, and this came through in the prepared remarks, the launch is going very well. I think as we moved through the quarter, the momentum built, and I would categorize it from a momentum standpoint as significant. So far this year, Q1 was a good first start, initial start. But coming out of Q2, these trends give me really higher confidence. The metrics, the things that we sort of manage internally, the new account activations are ahead of plan. We're on track now for 1,250 by the end of the year, and we've talked about historically it took us 8 years to get to 1,000 with FFRCT. We'll get to 1,250 in 2 with Plaque. The physician adoption metrics all look really good.

Speaker 2

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

Speaker 4

Great. Maybe as a follow-up question, and I imagine you've probably as one of the larger MedTech-as-a-Service providers, had discussions with the FDA about this. But I think we all saw the MedTech-as-a-Service reimbursement proposal come out last month, a couple of weeks ago. I'm losing it, sorry. Would love your thoughts on this. It's not something that's probably going to start for another 2 years, but any thoughts you have around this and how it might evolve from the CPT Category I codes that you're currently sliding into? Thanks a lot.

Speaker 2

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

Speaker 2

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

Speaker 4

Thanks a lot.

Operator

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

Speaker 5

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

Speaker 3

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

Speaker 3

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

Speaker 5

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

Speaker 3

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

Operator

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

Speaker 6

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

Speaker 2

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

Speaker 6

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

Speaker 2

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

Speaker 2

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

Speaker 6

All right. Got it. Thank you.

Operator

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

Speaker 7

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

Speaker 2

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

Speaker 2

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

Speaker 7

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

Speaker 2

Yeah. Just to be clear, it's a U.S. study, National Institutes of Health. It will study lipid-lowering and anti-inflammatory therapy to see what slows plaque progression, or if any do, slow plaque progression in lower-risk adults that already have some form of coronary artery disease. So it's younger patients in plaque. The primary endpoint will be a 2-year change in non-calcified plaque volume on a CTA versus the baseline.

Speaker 7

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

Speaker 2

No, good question. Thank you.

Operator

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

Speaker 8

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

Speaker 3

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

Speaker 3

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

Speaker 8

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

Speaker 3

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

Speaker 3

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

Speaker 8

Great. Thanks again.

Operator

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

Speaker 9

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

Speaker 2

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

Operator

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

Speaker 10

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

Speaker 3

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

Speaker 3

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

Speaker 10

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

Speaker 2

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

Speaker 3

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

Operator

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

Speaker 11

Hello?

Operator

Your line is now open, William.

Speaker 11

Can you hear me?

Operator

Yeah, we can hear you now.

Speaker 11

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

Speaker 3

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

Speaker 11

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

Speaker 2

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

Speaker 2

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

Speaker 11

Great. Appreciate it.

Operator

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

Speaker 12

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

Speaker 2

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

Speaker 2

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

Speaker 12

Thank you.

Operator

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

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