Heartflow (HTFL) Wells Fargo 21st Annual Healthcare Conference summary

Business overview and market opportunity

• Focused on AI-driven diagnosis of coronary artery disease, targeting a $5B symptomatic market with significant growth potential and low current penetration.

• Plaque Analysis is the current growth driver, with a $2B TAM, while FFRCT addresses a $3B TAM; both are supported by strong clinical data and reimbursement.

• Adjacent $6B TAM in high-risk asymptomatic patients is being targeted through upcoming clinical trials, aiming for market entry before 2030.

• Over 625 peer-reviewed publications and a proprietary database of 200M+ annotated CT images support ongoing AI development and clinical credibility.

• Commercial adoption is accelerating, with Plaque Analysis revenue expected to grow from $1.5M last year to $30M this year.

Product innovation and clinical strategy

• Launched Plaque Analysis staging tool and integrated a PCI Navigator for interventional cardiologists, enhancing pre-procedure planning and efficiency.

• PCI Navigator combines lesion-specific FFR and plaque mapping, aiming to become standard of care in cath labs.

• DECIDE registry tracks 23,000 patients, providing long-term data on risk stratification and outcomes.

• Three randomized controlled trials (RCTs) will address high-risk asymptomatic subpopulations, focusing on decision-making, LDL management, and plaque progression over 18 months.

• Clinical evidence strategy mirrors previous successful playbooks, emphasizing decision impact and secondary markers over hard outcomes.

Commercial execution and financial performance

• Commercial team of 300+ FTEs covers sales, account management, and customer success, supporting integration and adoption.

• Plaque Analysis adoption is rapidly increasing, with covered lives at 78% and expected to rise to mid-80s as Anthem and regional payers come online.

• Plaque Analysis ASPs are rising with expanded coverage, with another contractual step-up expected in early 2027.

• Q2 revenue exceeded $64M, up 48% YoY, with gross margin expanding by 30 points over five years; company is well-capitalized with $250M on the balance sheet.

• Profitability targeted for mid-2028, with continued investment in sales, marketing, and R&D while narrowing EBIT losses.