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- **Revenue Growth**: Q3 2025 revenue up 17.8% YoY to $354.7M, driven by 34% VTE growth and 29.2% embolization/access expansion.
- **CAVT Innovation**: FDA clears Lightning Bolt 16 and Flash 3.0; STORM-PE trial validates CAVT superiority, spurring hospital protocol updates.
- **Margin Expansion**: Gross margin 67.8% (up 130bps YoY); targeting >70% by 2026. Operating income $48.8M (13.8% of revenue).
- **Guidance Update**: 2025 revenue raised to $1.375-$1.380B; U.S. thrombectomy growth 20-21%.
- **Pipeline Momentum**: Thunderbolt FDA review active; Flash 3.0 enhances case efficiency, Ruby XL stabilizes production.

**【CEO Summary Section】**
- Q3 2025 revenue reached $354.7 million, up 17.8% YoY, driven by 18.5% growth in U.S. thrombectomy and 29.2% in embolization/access. VTE franchise grew 34%, while U.S. embolization/access revenue rose 29.2%.
- FDA cleared Lightning Bolt 16 and Flash 3.0, enhancing CAVT portfolio for over 800,000 U.S. VTE patients. STORM-PE trial showed CAVT superior to anticoagulation alone, with faster recovery and safety profile.
- Gross margin expanded 130bps to 67.8%, targeting >70% by end-2026. Raised 2025 revenue guidance to $1.375-$1.380 billion, with U.S. thrombectomy growth of 20-21%.

**【CFO Financial Commentary】**
- Q3 GAAP revenue $354.7M, non-GAAP operating income $48.8M (13.8% of revenue). Gross margin 67.8%, up 180bps QoQ, driven by product and regional mix. Operating expenses $191.6M (54% of revenue), reflecting embolization team build-out.
- Adjusted EBITDA $66.7M (18.8% of revenue). Cash balance $470.3M, up $45.7M QoQ. Full-year guidance maintained for margin expansion.

**【Q&A Highlights】**
- **Thunderbolt Approval**: FDA review ongoing; no timeline provided, but team optimistic. Product launch readiness confirmed post-approval.
- **STORM-PE Impact**: Non-interventionalists updating protocols, accelerating CAVT adoption. Q4 and 2026 growth expected from procedural volume increase.
- **Margins**: Gross margin to expand >70% by 2026; operating expenses stabilize post-sales team build-out.
- **International Recovery**: China headwinds easing; rest-of-world growth 6.6% YoY. Focus on neurovascular innovation (e.g., Thunderbolt) to drive future growth.
- **Product Pipeline**: Lightning Flash 3.0 improves case times; Ruby XL stabilizes production, supporting margin accretion.

Penumbra, Inc. (PEN) Q3 2025 Earnings Call Transcript

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PEN

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