NeuroPace Earnings Call Transcripts
Fiscal Year 2026
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The company reported strong 2025 growth, reaching $100 million in revenue and expanding its patient base. Key initiatives include FDA submission for IGE indication, AI-driven product enhancements, and a broadened sales force. 2026 is expected to be transformational, with further market and clinical expansion.
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Growth is driven by increased adoption at epilepsy centers, improved referral management, and commercial investments. NAUTILUS trial data support a major new indication, with FDA review ongoing and a large untapped patient population. Commercial rollout will be phased as payer coverage expands.
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Strong 2025 results included $100 million in revenue and 25% growth, driven by expanding adoption of the RNS System and disciplined execution. Strategic focus remains on core business growth, indication expansion, and leveraging proprietary data for AI-driven product development. Guidance for 2026 projects continued robust growth and margin improvement.
Fiscal Year 2025
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Q4 and full-year 2025 saw strong revenue growth, improved margins, and positive adjusted EBITDA, driven by RNS adoption and disciplined execution. 2026 guidance projects continued double-digit growth, with new AI tools and potential IGE indication expansion as key catalysts.
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Record Q3 revenue and positive adjusted EBITDA were achieved, driven by strong RNS growth and broad-based adoption. Full-year guidance for revenue and gross margin was raised, with the RNS segment expected to sustain 20%+ growth as DIXI winds down.
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The company is expanding access to its responsive neurostimulation device for drug-resistant epilepsy, leveraging regulatory approvals, data-driven insights, and partnerships to address unmet needs. Clinical trials support indication expansion, and strong financial growth is projected.
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Record Q2 revenue and gross margin led to raised full-year guidance. RNS System growth, Project CARE expansion, and debt refinancing drove strong results, while Dixi Medical sales will phase out. NAUTILUS and pediatric markets offer future growth opportunities.
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Preliminary NAUTILUS trial data show the RNS System is safe and offers robust efficacy, especially in patients with lower baseline seizure frequency. The company maintains its 2025 guidance and long-term growth strategy, with plans to submit full data to the FDA in the second half of 2025.
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Q1 2025 revenue grew 24% year-over-year to $22.5M, driven by strong RNS System adoption and Project CARE. Gross margin improved to 77%, and 2025 revenue guidance was raised to $93–$97M. SEEG distribution will be wound down, focusing on higher-margin RNS growth.
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Strong 2024 revenue growth and disciplined expense management position the business for continued expansion, with RNS therapy demonstrating superior clinical outcomes and moving earlier in the treatment continuum. Growth strategies include expanding access through Project CARE, new indications, and AI-driven product enhancements.
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The company reported strong 2024 growth driven by expanded adoption in core and new centers, with Project CARE and incremental sales force expansion fueling momentum. NAUTILUS trial for generalized epilepsy is on track for a 2025 data readout and FDA submission, targeting a significant unmet need.
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Over the next three years, the company targets over 20% CAGR, expanding indications into generalized and pediatric epilepsy, launching AI-powered tools, and achieving cash flow break-even by 2027. 2025 revenue is guided at $92–$96 million, with continued growth from care centers and DTC strategies.
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Focused on closing the treatment gap in drug-resistant epilepsy, the RNS System has driven strong revenue growth and clinical outcomes. Expansion into new indications and care sites, along with disciplined investment and strategic partnerships, positions the business for continued momentum in 2025.
Fiscal Year 2024
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Revenue grew 22% in 2024 to $79.9M, driven by RNS System and Dixie Medical sales, with record Q4 results. 2025 guidance projects 15–20% revenue growth, continued margin strength, and investments in commercial expansion, new indications, and AI-enabled tools.
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Q3 2024 saw record revenue of $21.1M (up 28% YoY), driven by RNS System sales and Project CARE expansion. Gross margin remained strong, cash burn improved, and 2024 revenue guidance was raised to $78–$80M. Growth is expected to continue with expanded market access and new indications.
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RNS therapy offers individualized, data-driven treatment for drug-resistant epilepsy, with best-in-class efficacy and lower adverse events. Growth strategy focuses on expanding access through new sites, broader indications, and leveraging clinical data, with key trials and partnerships underway.
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The company is executing a three-part growth strategy focused on expanding access to its RNS System for drug-resistant epilepsy, with strong first-half 2024 growth and disciplined financial management. Project CARE and the Nautilus trial are key drivers, with broader rollout and new indications expected in 2025.
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Q2 2024 saw 17% revenue growth to $19.3M, gross margin expansion, and improved net loss, driven by RNS System and DIXI sales. 2024 revenue guidance was raised to $76M–$78M, with continued investment in commercial expansion and strategic programs.