- **Q3 Record Performance**: $249M revenue (+15% YoY), 54% gross margin, and return to positive EBITDA. 
- **Strategic Growth Drivers**: 2026 targets include 60%+ gross margin, 15% direct intl. sales, and Mobi Tubeless launch. 
- **Innovation Momentum**: Mobi Android, t:slim Libre 3 integration, and Type 2 diabetes expansion driving pipeline. 
- **Pharmacy Channel Acceleration**: 5% Q3 pharmacy sales, with t:slim supplies now available and 40% U.S. coverage. 
- **Operational Efficiency**: $3M Q3 restructuring costs to support 2026 margin expansion. 


**【CEO Summary Section】**
- **Record Q3 Sales**: Achieved $249 million, driven by U.S. ASP increases and international growth. Pump shipments met expectations, with September as the strongest month. 
- **Commercial Transformation**: U.S. sales productivity improving; direct European operations launching in 2026 (UK, Switzerland, Austria). 
- **Innovation Highlights**: 
  - Mobi Android app awaiting FDA clearance to expand global addressable market. 
  - t:slim X2 with Abbott FreeStyle Libre 3 Plus integration now fully available in the U.S. 
  - Mobi Tubeless (extended wear patch pump) in final testing stages for 2026 launch. 
- **Type 2 Diabetes Expansion**: Full commercial launch of Control-IQ+ for Type 2 patients, doubling U.S. addressable market. 
- **Pharmacy Channel Growth**: 5% of U.S. sales via pharmacy in Q3, with t:slim supplies now available. Early uptake driven by affordability and convenience. 

**【CFO Financial Commentary】**
- **Q3 Financials**: 
  - Revenue: $249 million (+15% YoY). 
  - Gross Margin: 54% (+3ppt YoY). 
  - Adjusted EBITDA: Returned to positive. 
  - Free Cash Flow: Positive for the quarter. 
- **2025 Guidance**: 
  - Full-year revenue: ~$1 billion (U.S. $700M, international $300M). 
  - Gross margin: 53-54% (Q4 expected to be all-time high in mid-50s). 
  - Adjusted EBITDA: -5% of sales. 
- **2026 Outlook**: 
  - Gross margin target: ≥60% in Q4 2026. 
  - Direct international sales to contribute ~15% of international revenue. 
  - Cost optimization initiatives (e.g., $3M restructuring costs in Q3) expected to yield savings. 

**【Q&A Highlights】**
- **Mobi Tubeless Priority**: 510(k) submission nearing completion; expected to launch ahead of SteadySet. 
- **Pharmacy Channel Dynamics**: 40% of U.S. lives covered by Mobi pharmacy benefit; 2026 focus on scaling supply revenue via t:slim. 
- **Gross Margin Drivers**: ASP increases (+5% YoY in Q3), Mobi cost scaling, and pharmacy channel expansion. 
- **Competitive Position**: Leading in U.S. pump market with >70% renewal capture rate; international end-user placements growing double-digit YoY. 
- **Fully Closed-Loop Progress**: Pivotal study for UVA-developed algorithm planned for 2026. 


TNDM

TNDM fundamentals

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