NI
NeuroPace Inc (NPCE)·Q3 2025 Earnings Summary
Executive Summary
- Record quarter: revenue $27.35M (+30% YoY), gross margin 77.4%, operating loss narrowed to ($2.6)M; net loss per share improved to ($0.11) .
- Clear beat vs Street: revenue $27.35M vs $24.63M estimate (+$2.72M), EPS ($0.11) vs ($0.195) estimate; EBITDA modest beat; drivers were broad-based RNS System adoption, Project CARE, and manufacturing/pricing mix tailwinds . Consensus figures marked with * retrieved from S&P Global.
- Guidance raised: FY25 revenue to $97–$98M (from $94–$98M), gross margin to 76–77% (from 75–76%), OpEx to $94–$95M (from $92–$95M). Q4 mix guided to RNS $20–$21M, DIXI ~$3M, services ~$0.75M .
- Strategic catalysts: NAUTILUS PMA supplement for IGE on track to submit by year-end (180-day review implies mid-2026), SeizureID AI tool submitted to FDA; pediatric indication via real‑world evidence pushed beyond 2025 .
What Went Well and What Went Wrong
What Went Well
- RNS System momentum: $22.6M revenue (+31% YoY), with “all sales regions” exceeding plans; prescribers, accounts, and utilization reached all-time highs .
- Margin quality: total gross margin 77.4% (vs 73.2% LY; 77.1% Q2), with RNS margin “above 80%” on manufacturing efficiency and favorable pricing .
- Operating leverage and adjusted EBITDA: operating loss improved to ($2.6)M; adjusted EBITDA turned positive ~$0.1M for the first time, reflecting disciplined expense management and mix .
- CEO: “We delivered record revenue growth with strong gross margin… advancing key clinical and product development initiatives” .
What Went Wrong
- DIXI drag and tariffs: lower-margin DIXI products (slightly below 50% GM) and incremental tariffs diluted overall margins; DIXI winds down through Q1’26 .
- OpEx tick-up: Q3 OpEx rose to $23.8M (+21% YoY), driven by sales overperformance and higher variable compensation; FY OpEx guide raised to $94–$95M .
- Pediatric timing extended: real‑world evidence submission timing “extends beyond 2025,” delaying a potential incremental growth lever .
Financial Results
Quarterly Performance (Actuals)
Q3 2025 vs Wall Street Consensus
Consensus values marked with * retrieved from S&P Global.
Segment Revenue (Q3 2025)
Selected KPIs and Operating Metrics
- Cash, cash equivalents and short-term investments: $60.0M; long-term borrowings: $58.7M (as of 9/30/25) .
- Free cash flow (Q3): approximately ($2.0)M; adjusted EBITDA: +$0.1M (ex‑SBC) .
- Prescribers, accounts, utilization: all-time highs (qualitative) .
Guidance Changes
Earnings Call Themes & Trends
Management Commentary
- CEO: “We delivered record revenue growth with strong gross margin, operating and cash discipline while advancing key clinical and product development initiatives… establishing the RNS System as the standard of care in drug-resistant epilepsy” .
- CFO: “Adjusted EBITDA turned positive, reflecting scalability and disciplined expense management… we are raising both full-year revenue and gross margin guidance” .
- On NAUTILUS: “We believe the safety and effectiveness profile supports a favorable benefit-risk… PMA supplement on track to submit before year-end” .
- On SeizureID: “Designed to improve clinical outcomes and accelerate iEEG review… making RNS more accessible and improving efficiency” .
Q&A Highlights
- 2026 outlook: Company reiterates confidence in 20%+ RNS growth baseline, with DIXI substantially complete by end-2025; 2026 should be modeled as an RNS-only business .
- Q4 dynamics: RNS off to a “solid start” with pipeline strength; overall gross margin implied step-down largely mix-related (potential DIXI sales variability) .
- Pediatric submission: timing extends beyond 2025; focus on fit-for-purpose RWE design to align with FDA, with potential for time savings post-submission .
- Replacements: currently <10% of revenue, mid-single-digit by quarter; initial implants remain the focus .
- Partnerships: Rapport collaboration extended; new UCB collaboration; service revenue ~$0.77M in Q3; monetization opportunities with high-margin data services .
Estimates Context
- Q3 beats: revenue $27.35M vs $24.63M estimate; EPS ($0.11) vs ($0.195) estimate; EBITDA ($2.546M) vs ($2.656M) estimate. Outperformance driven by stronger RNS volumes across regions, prescriber/base expansion, and margin tailwinds from product mix and manufacturing efficiencies .
- Q4 setup: guidance mix implies total revenue ~$23.75–$24.75M, broadly bracketing consensus ~$24.35M; Street EPS estimate ($0.186)* .
- Consensus values marked with * retrieved from S&P Global.
Key Takeaways for Investors
- Operational momentum: RNS growth and margin quality are accelerating, with adjusted EBITDA positive—suggesting improving path to profitability as mix shifts away from DIXI .
- Guidance credibility: Raised FY revenue and margin ranges, plus detailed Q4 mix components, provide clearer modeling guardrails and reduce uncertainty .
- Near‑term catalysts: NAUTILUS PMA-S submission by YE25 and SeizureID FDA review—both can expand utilization and support narrative on personalized neuromodulation .
- 2026 margin baseline: With DIXI exit, model gross margin ≥80% on RNS-only mix; replacement cycle remains small near term (<10%) .
- Watch pediatric RWE timing: extended beyond 2025; eventual approval could broaden addressable market and accelerate growth .
- Data monetization optionality: Partnerships (Rapport, UCB) and services revenue provide high-margin ancillary streams; scale of proprietary EEG dataset is a competitive moat .
- Trading implications: The beat-and-raise and positive adjusted EBITDA should be supportive; mid-2026 IGE timeline and AI submissions are the next catalysts. Near term, Q4 mix (DIXI) may modestly pressure consolidated margins, but RNS strength remains intact .
Note: Consensus estimates denoted with * are values retrieved from S&P Global.