Conferencia de resultados del 2T de 2026 de HeartFlow (HTFL): los ingresos suben un 48% y eleva sus previsiones

HeartFlow Inc. (HTFL) presentó un crecimiento acelerado en el segundo trimestre de 2026, impulsado por la adopción de Plaque, la sólida utilización de FFRCT y la continua expansión del mercado de CCTA. La dirección elevó sus previsiones de ingresos anuales, ingresos de Plaque y margen bruto no GAAP.

Puntos clave

• Los ingresos del segundo trimestre aumentaron un 48% interanual hasta alcanzar los 64,1 millones de dólares, la tasa de crecimiento más rápida de la compañía en ocho trimestres. Los ingresos en Estados Unidos subieron un 51%, situándose en 59,6 millones de dólares.
• Los ingresos de Plaque alcanzaron los 7,8 millones de dólares. La dirección señaló que las activaciones de cuentas y la utilización por parte de los médicos superaron su plan interno.
• El margen bruto no GAAP se amplió en 770 puntos básicos hasta el 83,3%, impulsado por el apalancamiento del volumen, eficiencias en la producción, automatización mediante IA y una mayor contribución de los ingresos de Plaque.
• HeartFlow elevó sus previsiones de ingresos para 2026 a un rango de entre 246 millones y 250 millones de dólares, lo que implica un crecimiento del 40% al 42%. Las previsiones de ingresos de Plaque aumentaron a entre 29 millones y 31 millones de dólares.
• La empresa cerró el segundo trimestre con 246,8 millones de dólares en efectivo, equivalentes de efectivo e inversiones. La directiva reiteró su objetivo de alcanzar la rentabilidad de flujo de caja para mediados de 2028.

Principales resultados financieros

A partir del segundo trimestre, la presentación de los gastos SG&A no GAAP de HeartFlow excluye ciertos gastos relacionados con litigios de propiedad intelectual en curso. El ajuste también se aplicó con carácter retrospectivo a los resultados no GAAP de periodos anteriores.

Rendimiento comercial y operativo

Se acelera la adopción de Plaque

El crecimiento de Plaque se vio impulsado por la activación de nuevas cuentas, un mayor número de médicos solicitantes y el aumento del uso recurrente. La directiva elevó su objetivo de cuentas activadas con Plaque a aproximadamente 1.250 para finales de año y afirmó que la cobertura había alcanzado cerca del 78%.

Según la empresa, Plaque es aplicable a aproximadamente el 60% de los escáneres CCTA. La utilización actual se mantiene por debajo de ese nivel, pero la directiva señaló que la adopción en las cuentas activadas avanza más rápido de lo previsto inicialmente.

HeartFlow lanzó Plaque Staging en julio. La herramienta divide la carga personalizada de la enfermedad en cuatro etapas clínicas y ha sido validada utilizando datos de más de 23.000 pacientes con un seguimiento de hasta 16 años. La directiva prevé que impulse la adopción durante la segunda mitad de 2026 y a lo largo de 2027.

La compañía también fue seleccionada como proveedora exclusiva de análisis de placa para PREEMPT, un estudio financiado por los NIH en el que participan 1.500 pacientes. El estudio evaluará estrategias de prevención en pacientes más jóvenes y asintomáticos con enfermedad coronaria.

La utilización de FFRCT se mantiene sólida

FFRCT se benefició de una mayor utilización en las cuentas existentes y del continuo despliegue en nuevos centros. Las 340 cuentas incorporadas durante 2025 evolucionan en línea con las expectativas de la directiva, mientras que la utilización inicial entre la cohorte de cuentas de 2026 fue calificada de alentadora.

HeartFlow estima que FFRCT es aplicable a aproximadamente el 33% de los escáneres CCTA. Por lo general, las nuevas cuentas necesitan alrededor de un año para aproximarse a niveles de utilización maduros.

Cartera de productos y expansión del mercado

PCI Navigator se está introduciendo mediante un despliegue por fases enfocado inicialmente en hospitales con un alto volumen de intervenciones coronarias percutáneas (PCI). En la actualidad, HeartFlow no cobra por el producto ni tiene planes inmediatos de solicitar un reembolso independiente. La dirección lo considera un factor diferenciador de la plataforma que puede fortalecer las relaciones con los cardiólogos intervencionistas. Sigue previsto un despliegue más amplio para 2027.

Plaque Tracker, diseñado para medir los cambios en la placa mediante escáneres CTA seriados, también mantiene su lanzamiento programado para 2027. La iniciativa de procesamiento autónomo de HeartFlow avanza hacia una implantación más amplia en 2027 y se espera que ayude a alcanzar el objetivo de margen bruto de la empresa a medio plazo.

Para pacientes asintomáticos, la directiva estima que aplicar la tecnología Plaque existente podría añadir aproximadamente 6.000 millones de dólares al mercado direccionable de HeartFlow en Estados Unidos, elevándolo a unos 11.000 millones de dólares. La empresa prevé llevar a cabo tres ensayos controlados aleatorizados con poblaciones asintomáticas de alto riesgo. Se espera que cada ensayo cuente con unos 300-500 pacientes.

Se espera que la inclusión de pacientes en los estudios sobre calcio coronario y sobre aquellos con infarto de miocardio previo o PCI comience en el cuarto trimestre de 2026. Está previsto que la inscripción para un estudio con pacientes con placa previa comience en el primer trimestre de 2027. La directiva afirmó que se utilizará la tecnología existente y no se requerirá una autorización adicional de la FDA. La empresa tiene como objetivo acceder a estos mercados con tecnología reembolsada antes de 2030.

Previsiones de la dirección

En el punto medio de las previsiones de ingresos, la directiva espera que el beneficio bruto no GAAP crezca aproximadamente un 50% en 2026. HeartFlow mantuvo su objetivo de margen bruto no GAAP a medio plazo del 85% y su meta de alcanzar la rentabilidad de flujo de caja para mediados de 2028.

Las hipótesis de la dirección para la segunda mitad del año incluyen un crecimiento intertrimestral constante de los ingresos en el tercer y cuarto trimestre, continuas mejoras en la utilización de Plaque y aportaciones de las cuentas activadas recientemente. Las perspectivas también incorporan la estacionalidad habitual del mercado de CCTA, que resulta más relevante para FFRCT.

Riesgos y aspectos a vigilar

• Plaque se encuentra aún en la fase inicial de su ciclo de adopción, y su utilización se sitúa todavía muy por debajo del aproximadamente 60% de los escáneres CCTA que la dirección considera aptos.
• El rendimiento de FFRCT en el segundo semestre podría verse afectado por la estacionalidad habitual del mercado subyacente de CCTA.
• Las contrataciones adicionales en producción y atención al cliente podrían compensar parte de las ganancias en el margen bruto durante 2026. La directiva señaló que el procesamiento autónomo será un catalizador del margen principalmente de cara a 2027.
• Los CMS han propuesto un nuevo marco de pago hospitalario para el software impulsado por IA. HeartFlow considera que la orientación es constructiva, aunque la dirección prevé que se trate de un proceso de varios años que cobrará más relevancia probablemente hacia 2029.
• Se espera que los litigios sobre patentes y la solicitud de investigación civil de HeartFlow se prolonguen durante varios años. La directiva indicó que no hay novedades relevantes al respecto y afirmó que la empresa está colaborando con el proceso.

Puntos destacados del turno de preguntas y respuestas de los analistas

La dirección atribuyó el crecimiento del segundo trimestre a la solidez generalizada tanto de FFRCT como de Plaque. Los volúmenes de FFRCT se situaron significativamente por encima del plan interno de la empresa, mientras que los precios medios de venta superaron ligeramente las expectativas debido a la mezcla de clientes. HeartFlow prevé que las variaciones interanuales de precios de FFRCT se moderen a partir de 2027.

En el caso de Plaque, los aumentos contractuales de precios y una mayor proporción de cuentas de tarifa prémium respaldaron los precios medios de venta del segundo trimestre. La directiva no contempla otro cambio de precios en lo que resta de 2026, pero prevé un incremento más significativo a principios de 2027.

En cuanto al margen bruto, la directiva identificó tres factores clave: la automatización mediante IA, una mayor contribución de Plaque y el apalancamiento del volumen. Cerca del 75% del margen bruto superior al plan interno en el segundo trimestre se atribuyó a los ingresos, especialmente de Plaque, mientras que el resto estuvo vinculado al control de plantilla y a una menor amortización de I+D en el coste de las ventas.

La dirección indicó que Plaque Staging está contemplado en las previsiones a través del crecimiento continuo de la utilización, más que por un salto repentino en la adopción. El enfoque de previsiones de la compañía se basa en una línea de partida de alta convicción diseñada para dar margen a un rendimiento aún superior.

Transcripción completa de la conferencia de resultados

Transcripción completa de la conferencia de resultados

Comentarios de la dirección

Operator

Thank you. Good day and thank you for standing by. Welcome to the HeartFlow Inc. second quarter 2026 earnings call. [Operator Instructions] Please be advised today's conference is being recorded. I would like to hand the conference over to your speaker today, [ Nick Ledeckle ]. Please go ahead.

Unknown Executive

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

John Farquhar

Thank you for joining us. Q2 is 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 8 quarters.

Four factors drove this performance. First, Plaque accelerated across new activations and physician utilization. Second, FFRCT utilization remained durable across our existing accounts. 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. And finally, the underlying CCTA market continued to expand, supported by guidelines and strong reimbursement and growing 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're now expected to deliver total revenue of $246 million to $250 million, representing 40% to 42% year-over-year growth.

We're also raising our full-year 2026 Plaque revenue outlook to a range of $29 million to $31 million. We're also raising our full-year guidance for Plaque-activated accounts to approximately 1,250. Looking 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%. And finally, we remain committed to our mid-term non-GAAP gross margin target of 85%. Now turning to our 3 strategic pillars, commercial adoption, innovation, and clinical evidence. I'll 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. 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're 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-based and technology platform and we believe the market appreciates this fact. Furthermore, we're 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 the program's and 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. 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. 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 4 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 in 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. 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. Most recently at SCCT's annual meeting in July, we presented 8 new data sets spanning more than 36,000 patients, further validating the accuracy, reproducibility, and clinical utility of the HeartFlow Plaque analysis. I'll highlight just 2. First, we demonstrated the precision and reproducibility of HeartFlow Plaque analysis. In a blinded prospective study recently published in the Journal of 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 0 into a higher risk category by identifying non-calcified plaque that calcium scoring cannot detect. This data gives physicians a more precise picture of their patients' 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 CTA scans and our Plaque analysis.

Importantly, tracking change only works if you can separate real changes in disease from noise. To do this, it takes best-in-class accuracy and reproducibility, which we believe is what our category-leading Plaque algorithm delivers. Our autonomous processing initiative, which we announced last quarter as a key driver underpinning our mid-term 85% gross margin target, is also progressing well and remains on track for a broader rollout in 2027. 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 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 build every market at HeartFlow, by leading with strong clinical evidence. Accordingly, we now have 3 RCTs targeted at 3 distinct high-risk asymptomatic populations that we will initiate over the next 3 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 the 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 enrolled in the fourth quarter. Lastly, for patients with prior plaque, this is a $2 billion TAM. 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. 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. Now I'll turn it over to Vikram for a review of our financial results and guidance.

Vikram Verghese

Thanks, John, and good afternoon, everyone. Unless otherwise noted, my remarks reference the quarter ended June 30th, 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. U.S. and other revenue increased to $4.5 million. Total global revenue increases for the quarter reached $84,491, up 74%. 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're seeing broader physician engagement, deepening utilization, and adoption across a larger share of eligible CCTAs. 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. 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.

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, cash equivalents, and investments. 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 to $250 million, representing 40% to 42% growth. We are increasing our Plaque-specific revenue outlook to $29 million to $31 million. We continue to expect more material adoption in the second half of the year as clinicians gain clinical experience and broaden adoption.

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. From an operating expense perspective, we expect full-year non-GAAP operating expenses as a percentage of revenue to decline year-over-year. We remain disciplined in allocating incremental investment towards initiatives with a direct line of sight to revenue growth, product innovation, and addressable market expansion. The midpoint of our revenue guidance implies approximately 50% growth in gross profit in 2026. Finally, we remain committed to our mid-term non-GAAP gross margin target of 85%. We also remain on track to achieve cash flow profitability by mid-2028, consistent with our prior guidance of achieving profitability within 3 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. I would now like to turn it back to John for closing remarks.

John Farquhar

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

Operator

[Operator Instructions] Our first question comes from Robbie Marcus with JPMorgan. Your line is open.

Preguntas y respuestas

Robert Marcus

Thank you, and congratulations on a great quarter here. Two for 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, you know, 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 who drive such a strong start. And then I have a follow-up.

John Farquhar

Yes, sure. Thanks, Robbie. I appreciate the question. So yes, I mean relative to Plaque, and this came through in the prepared remarks, the launch is going very well. And 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. So the metrics, you know, the things that we sort of manage internally, the new account activations are ahead of plan. You know, we're on track now for 1,250 by the end of the year. And we've talked about, you know, 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. 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. So 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. And 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. So 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.

Robert Marcus

Great. Maybe as a follow-up question, and I imagine you've probably as one of the larger, you know, MedTech software 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. Um, you know, would love your thoughts on this. It's not something that's probably going to start for another 2 years, but, you know, any thoughts you have around this and how it might evolve from the CPT-1 codes that you're currently sliding into? Thanks a lot.

John Farquhar

Yes, sure. So this is, you know, this wasn't a surprise. You know, this direction is consistent with what CMS has signaled for years. I would say in the near term, we view this as a positive. You know, 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, it'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. 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 '29. Thanks a lot.

Operator

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

Matthew O'Brien

Good afternoon. Thanks for taking the questions. You know, 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, that is that allocation correct? If 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. I know there is a lot of momentum there, bigger sales force and et cetera, but what drove that uptick in FFRCT specifically? And then I do have a follow-up.

Vikram Verghese

Yes, Matt, this is Vikram. Thanks for the question. You know, Plaque did handedly beat our expectations as well. Plaque revenues were $7.8 million, which was more close to $4 million beat against expectations. I'd say it was broad-based momentum across both FFRCT and Plaque. We did see, you know, Q2 tends to be seasonally strong a quarter. That certainly played out across both segments of the business. For FFRCT, we continue to see strong volume, growth, demand.

We've driven by improving utilization in our existing sites. The new sites that we onboarded in the prior quarter were ramping at scale as well. And Plaque was certainly a standout for us. We continue to see strong utilization trends in our sites 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, so it was a combination of factors that led to the broad-based outpacing that we saw in the quarter.

Matthew O'Brien

Understood. Appreciate that, Vikram. I mean, you know, kind of following up on that, the second question is, is there a need, you know, when I looked 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 kind of a similar kind of question, not much, in terms of improvement in Plaque revenue in Q3, Q4. Is there anything to call out there? I don't know if there's anything on the pricing side that we need to be aware of or anything else outside of just traditional kind of conservatism on your part. Thanks so much.

Vikram Verghese

Yes, 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. You know, relative to phasing, what we'd say is we've assumed a steady sequential growth in both Q3 and Q4 of, you know, 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... 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.

Larry Biegelsen

Good afternoon. Thanks for taking the question. Congrats on the good quarter here. John, two for me. I wanted to start with the DECIDE 1-year outcomes. Have you, you know, determined which conference that's going to be at, I assume TCT, and, you know, which endpoints, you know, do you think will, you know, actually change, you know, payer or physician behavior in that one follow-up?

John Farquhar

Yes, hey Larry, it'll be in Q4. Beyond that, probably nothing to share. It'll be 1-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 1 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 whether or not their LDLs are changing in their clinical practice. The more that snowball rolls downhill, I think the more Plaque will be supported as we go through the long term.

Larry Biegelsen

That's helpful. And 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.

John Farquhar

Yes, sure. So first thing I'll say, and I've said this before, you know, we view our competition as the standard of care. So when we wake up and, you know, get going every morning, it is to create a new standard of care. And the way we're going to win moving forward is by sourcing volumes from traditional non-invasive tests. And we really think we're on the right side of history in doing this. CCTA is only penetrated about 11% against the total non-invasive testing market, and all signs point towards continued strong category growth. Now, obviously we're not the only player that recognizes this is an attractive space. But 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, and none of this is slowing us down. So bottom line, I think we're winning in the field, I think we're winning every day, both with Plaque and with FFRCT, all of those metrics are trending in the right direction. They're extremely strong. And 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.

Operator

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

Brandon Vazquez

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

John Farquhar

Yes, sure. Thank you for the question. So, yes, I mean, the asymptomatic opportunity is arguably the biggest opportunity in all of cardiovascular diagnostics, okay? And we are very excited about what this could mean for our business, but equally importantly, what this can mean for patients. So we're going to approach this in a very similar fashion to how we've approached the symptomatic market. We're going to start with patients at the most risk, okay? So with that, we're targeting 3 high-risk subpopulations that we can access with the right clinical studies, and this will use our existing technology. So to your question, no FDA clearance required. The 3 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. Okay, 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's only between call it 300 and 500 patients in each trial. And also this is going to be very synergistic to our revenue. It leverages the same call points that we're already calling on, the same sales channel, the same technology stack. So we're really excited on what the future holds and we think we can be in these markets with reimbursed technology before 2030.

Brandon Vazquez

Great. And 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? I mean, correct me if I'm wrong, I don't think you have great market access in the U.K. yet. And so just curious if you can talk a little bit about the genesis of that program and what the next steps are there.

John Farquhar

Yes, 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.

Brandon Vazquez

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

Operator

One moment for our next question. Our next question comes from Rick Wise of Stifel.

Frederick Wise

Good afternoon, everybody. I thought it would be interesting to get your thoughts, I'd like 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. I mean, you had an outstanding quarter, sales up $12 million sequentially and SG&A is down. How do we, and maybe as part of answering that question, you can talk about importance of this AI efficiency and the role it's going to play going forward. So just any additional perspectives, and particularly as we start trying to think about the second half and into 2027?

Vikram Verghese

Yes, thanks for the question, Rick. You know, I'll start by saying in Q2, we outperformed on the top line and we suddenly reinvested that with discipline back into R&D. Even with the higher OPEX, EBIT was roughly cut in half quarter-over-quarter. And 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. And we're really leveraging this dynamic to invest across both R&D and commercial at a disciplined pace. A few areas worth mentioning. You know, 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. 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, and EBIT, which is also an important metric we track, should meaningfully improve year-over-year. Ultimately, it's the combination, the durability of the growth profile, the Plaque proof points, and the mid-term gross margin targets of 85% that reinforce a conviction of getting the company to profitability in that 2028 timeframe.

Frederick Wise

Thank you, Vikram. And 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 fair 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. And I know pricing is complicated because of the, I'm sorry, revenue per case. I'm sorry, I misspoke. But I know with greater price pressure, perhaps on the FFRCT side, more positive contribution from Plaque, but now FFRCT outperforming is a long question, but just how do we think about that mix of dynamics if you could help us, I'd appreciate it. Thank you.

Vikram Verghese

Yes, 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. And this was really driven by more favorable customer mix. Given the visibility we have to these customers, the volumes and the predictable utilization rate that we have with FFRCT, 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. And then second, we did see benefited mix as well. Volume 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 '26. That said, we do expect pricing to step up more meaningfully in early '27.

Operator

Great. Thanks again. One moment for our next question. Our next question comes from [ Jacob Dodd ] with Morgan Stanley.

Unknown Analyst

Good afternoon. Thanks for taking the question. Maybe a two-parter, both related to Plaque utilization. I'll 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 degree of overlap or any halo effect you're seeing in these real-world cases between FFRCT and Plaque used on the same CCTA cases? Thank you very much.

John Farquhar

Yes, sure. Thanks, Jacob. So, yes, you're right. The maximum utilization rates or applicability is 60%. We're seeing in our accounts, the ramp towards that is ahead of expectation. It's still nowhere near 60%. It takes a while to get there. It's performing very well and it's 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're very pleased that's starting to broaden as adoption takes place.

Operator

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

David Rescott

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

Vikram Verghese

Thanks for the question, David. Zooming out, the architecture of our gross margin expansion is quite clear. It will be principally driven by 3 levers. One is that 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 and the rest was headcount favorability and less R&D amortization which hits cost of revenue. Now looking at 2026 there's 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. Longer-term autonomous processing is certainly an initiative we're very excited about and underpins our mid-term gross margin target of 85%, but that is more of a 2027 driver.

David Rescott

Okay, that's helpful. And then 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 and into 2027. So wondering if you could expand on that a little bit, as well as any incremental color on, you know, what, if at all, is contemplated in the Plaque guide for the year as it relates to some of these tailwinds on the Plaque Staging side. Thank you.

John Farquhar

Yes, I'll let Vikram speak to some of the what's contemplated. Staging, you know, we're excited about it. It's a strong differentiator for us. We released that just recently at SCCT. We're the only Plaque product with staging in it. This is a staging system that's validated in over 23,000 patients with up to 16 years follow-up, which marries very well with our DECIDE registry, that's 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 aligned very well with how we're helping to educate the market on using Plaque to take care of their patients. Relative to your question on what's in the guide, I don't know, Vikram, if you have anything.

Vikram Verghese

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 kind of guide, there'll likely be upside.

Operator

One moment for our next question. Our next question comes from [ William ] with Canaccord Genuity. [ William ], if your line is open, you can ask your question. One moment. Hello? Your line is now open, [ William ].

Unknown Analyst

Can you hear me? We can hear you now. Okay, great. Thanks. Great. Thanks for taking the question. So, the first question is on the FFRCT and one of the comments that typically a little seasonality in that business. So as we think of the guide with the increase from Q3, from Q2, is that more of a Plaque-based comment that that would be the driver for that sequential increase?

Vikram Verghese

Yes, that's a fair assumption, Bill. Obviously, with the raise, which is greater than 2x the beat, we wanted to anchor these, the data guide appropriately and setting a high conviction baseline that leaves room for quarterly progression was important. And 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.

Unknown Analyst

Okay. And then given that basically all the financial questions have been asked at this point, I guess any update on the CID or the patent litigation that we should think about? Just updates, milestones, key events coming up, anything of that nature. And thanks for taking my questions.

John Farquhar

Yes, 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. 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.

Operator

One moment for our next question. Next question comes from [ Gene Mannheimer ] with Freedom Capital Markets. Your line is open.

Unknown Analyst

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. You know, that seems like a very strong value proposition for the interventional cardiologist. Is that a product you charge for currently, and do you anticipate a moment when you will begin to charge for that product? Thank you.

John Farquhar

Yes, thanks for the question. And you're right, we're very excited about Navigator. Currently we don't charge currently. We 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. So that's what we're doing right now. Early feedback has been very, 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. So we're taking this mostly to high-volume PCI hospitals first. But the early trends and what we're hearing is really strong. So 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.

Operator

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