Aug 13, 2026 earnings call — Plaque adoption accelerates; guidance raised
Raised full-year revenue outlook to $246 million to $250 million.
Revenue $0.1B (est $0.1B) · EPS $-0.07 (est $-0.13) · Next-quarter revenue outlook $0.2B–$0.3B
Key quotes
"Activations were ahead of plan, highlighting the leverage of our installed base and our ability to deploy new innovation rapidly."
"At SCCT in July, we launched HeartFlow Plaque Staging, the most clinically validated tool for patient risk stratification."
"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."
Analyst Q&A 9
Why Plaque is winning; CMS proposal
Q (Robert Marcus · JPMorgan): Why is Plaque winning versus competitors and how are you driving adoption? Also, thoughts on the MedTech-as-a-service reimbursement proposal and its impact?
A: They said the Plaque launch has strong momentum: new account activations are ahead of plan and they expect 1,250 by year-end, utilization and ordering physicians are rising, and coverage is right around 78%. On the CMS proposal they view the near term as positive, believe CMS is recognizing AI services are different, and said the multi-year process is very much more likely in '29.
"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." — John Farquhar (CEO)
What drove the revenue beat
Q (Matthew O'Brien · Piper Sandler): Was the Q2 revenue beat mostly from FFRCT or Plaque? And why does the guide not assume more improvement in H2 given the momentum?
A: They said the beat was broad-based: Plaque revenues were $7.8 million and Plaque beat expectations by about $4 million, and FFRCT also saw strong volumes and improved utilization at existing sites. For guidance they used a steady sequential growth baseline, factored normal seasonality, and left room to outperform in H2.
"Plaque did handedly beat our expectations as well." — Vikram Verghese (CFO)
DECIDE 1-year results and competition
Q (Larry Biegelsen · Wells Fargo): When and what will you show from the DECIDE 1-year outcomes, and which endpoints could change payer or physician behavior? Also, what are you seeing on competition for FFRCT and Plaque?
A: They said the DECIDE 1-year outcomes will be presented in Q4 and will report 1-year change in LDL, following good 90-day results, and physician behavior may change as doctors see LDL changes in their patients. On competition they view the standard of care as their competitor, said CCTA penetration is low (~11%), acknowledged other players but said their metrics and market leadership look strong and are trending in the right direction.
"It'll be 1-year outcomes on change in LDL, that's what we're looking for." — John Farquhar (CEO)
Asymptomatic trials and NIH study
Q (Brandon Vazquez · William Blair): What are the plans and timing for RCTs in asymptomatic patients, and will you need FDA approval? Also, what is the NIH study about?
A: They will run three RCTs in high-risk asymptomatic subpopulations using existing technology and no FDA clearance is required; the trials target secondary prevention, patients with calcium, and patients with plaque, with endpoints including change in physician management and change in LDL and soft plaque. The NIH study is a U.S. study testing lipid-lowering and anti-inflammatory therapy, with a 2-year change in non-calcified Plaque volume on CTA as the primary endpoint.
"So to your question, no FDA clearance required." — John Farquhar (CEO)
Operating leverage and pricing dynamics
Q (Frederick Wise · Stifel): Can you update thinking on operating leverage, role of AI efficiency, and how price per case fared this quarter across FFRCT and Plaque?
A: They said Q2 outperformance was reinvested into R&D and the business showed strong efficiency; they plan measured commercial expansion and R&D spend (Plaque Tracker, autonomous processing), expect OpEx as a percent of revenue to improve by at least 5 points year-on-year, and for EBIT to meaningfully improve. On pricing, FFRCT volumes were above plan with ASPs modestly ahead, they expect ASP shifts to moderate starting in 2027, and Plaque ASPs benefitted from contractual step-ups and mix with no change baked into the rest of 2026 but a step-up expected in early 2027.
"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." — Vikram Verghese (CFO)
Plaque applicability and overlap with FFRCT
Q (Jakob Dodd · Morgan Stanley): You said 60% case applicability for Plaque long term. How fast are key accounts moving toward that level, and how much overlap is there with FFRCT on the same CCTA cases?
A: They said the ramp toward the 60% applicability is ahead of expectation but still far from the 60% maximum, and adoption takes time. On overlap they initially saw more overlap of FFRCT patients also getting Plaque, but that overlap is starting to broaden as adoption expands.
"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." — John Farquhar (CEO)
Gross margin drivers and Plaque Staging
Q (David Rescott · Wells Fargo): Should we expect gross margins to improve sequentially this year? And what tailwinds does Plaque Staging add and is that reflected in guidance?
A: They said gross margin expansion is driven by three levers: AI automation, Plaque revenue growth, and economies of scale; about 75% of the Q2 beat was revenue-driven (Plaque) and the 82% gross margin guide already factors increased Plaque, with upside if Plaque outperforms but some offset from production and customer success hiring. On Plaque Staging they said it is a strong differentiator, released at SCCT, the only Plaque product with staging and it is validated in a large dataset and pairs well with the DECIDE registry; guidance assumes continued Plaque utilization growth but not a step change.
"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." — John Farquhar (CEO)
Seasonality and legal updates
Q (William Plovanic · Canaccord): Is the Q3 sequential increase driven more by Plaque seasonality or FFRCT? Any updates on the DOJ CID or patent litigation?
A: They said it's fair to assume the sequential increase is Plaque-driven given seasonality patterns and their guidance sets a high-conviction baseline that leaves room to progress. On legal matters they said the patent litigation is multi-year, they are confident in their claims and will let the process play out, and there is no new CID update to share now.
"We think this matter, again, is going to play out over years, not months." — John Farquhar (CEO)
PCI Navigator charging plan
Q (Eugene Mannheimer · Freedom Holdings): Is PCI Navigator a paid product today and do you plan to start charging or seek reimbursement for it?
A: They said currently they do not charge for Navigator and there is no plan to pursue reimbursement today; the focus is to deploy it as a differentiator to build the platform and engage interventional cardiologists as champions. The rollout is phased this year to high-volume PCI hospitals, early feedback is very strong, and they plan broader deployment next year while keeping Plaque as the top priority.
"Currently, there's no plan to pursue reimbursement for it." — John Farquhar (CEO)