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- **Revenue Surge**: Q3 2025 revenue up 90% YoY to $8.1 million, driven by 160% YoY growth in new patient shipments and 150% YoY installed base expansion.
- **DTC Dominance**: DTC marketing generated 300% YoY patient leads, accounting for 60% of new patients, with social media spending key to growth.
- **Margin Expansion**: Gross profit $3.5 million (up 750% YoY), with 2025 gross margin 35-40% and 2026 target >50%.
- **Strategic Transition**: 90% of Ascensia U.S. CGM employees transitioned to Senseonics, with European transition in H1 2026.
- **Pipeline Momentum**: CE mark for Eversense 365 expected Q4 2025, Sequel's twiist pump integration launching Q1 2026.

**【CEO Summary Section】**
- **Revenue Growth**: Q3 2025 revenue reached $8.1 million, up 90% YoY, driven by Eversense 365 adoption. New patient shipments increased 160% YoY, with 150% YoY growth in installed base.
- **DTC Success**: Direct-to-consumer (DTC) marketing led to 300% YoY increase in patient leads, accounting for 60% of new patients. Social media spending directly contributed to prescriber referrals.
- **Eon Care Expansion**: Eon Care insertions now represent 25% of total insertions, with 75 new trained inserters added in Q3 (140% YoY growth).
- **Transition with Ascensia**: 90% of U.S. CGM employees from Ascensia have joined Senseonics, with European transition planned for H1 2026. Full commercial control begins January 1, 2026.
- **Product Pipeline**: CE mark for Eversense 365 expected by end-2025, with U.S. launch of Sequel's twiist insulin pump integration in Q1 2026. Gemini IDE submission planned for Q4 2025, targeting late 2026 approval.

**【CFO Financial Commentary】**
- **Revenue Breakdown**: U.S. revenue $6.4 million (80% of total), international $1.7 million. Office consignment sales now 50% of global revenue, with 100% revenue recognition post-Ascensia transition.
- **Gross Profit**: $3.5 million (up $7.5 million YoY) due to Eversense 365 margins. Full-year 2025 gross margin expected 35-40%, rising to >50% in 2026.
- **Expenses**: R&D $7.8 million (down 27% YoY), SG&A $15.3 million (up 81% YoY) due to DTC marketing. Net loss $19.5 million (-18% YoY).
- **Cash Position**: $111.3 million as of Q3, with $60 million annual cash utilization.

**【Q&A Highlights】**
- **Patient Demographics**: 90% of new patients switch from Dexcom/Libre, 2/3 commercial payers, 1/3 Medicare. Switchers drive 60% of demand.
- **Twiist Integration**: First patients expected Q1 2026, with ramp constrained by pump availability. Joint marketing with Sequel underway.
- **Eon Care Growth**: Target 100 inserters by end-2026, expanding access to primary care settings.
- **Private Payer Trends**: United Healthcare and Kaiser moving to bundled payments, aligning with CMS. Consignment sales expected to grow 2026.
- **European Launch**: CE mark on track, with own sales force launching H1 2026. Ascensia employees transitioning Q1 2026.

Senseonics Holdings, Inc. (SENS) Q3 2025 Earnings Call Transcript

- **Revenue Growth**: Q2 2025 revenue up 37% YoY to $6.6M, driven by Eversense 365 new patient starts (+79% YoY).
- **DTC Marketing Impact**: Expanded DTC spend and 12 new sales reps boost leads (+100% YoY) and conversion.
- **Partnership Innovation**: Integration with Sequel's twiist pump to simplify diabetes management for basal insulin users.
- **Pipeline Progress**: Gemini IDE study to begin late 2025, with U.S. launch in late 2026; Freedom program targeting 2027.
- **Financial Strength**: $126.7M cash post-equity raise, supporting $10M DTC spend over next 2 quarters.
- **Shareholder Engagement**: Proposed reverse stock split to improve investor access and index inclusion.


**【CEO Summary Section】**
- **Eversense 365 Launch Momentum**: Q2 new patient starts increased 79% YoY and 37% QoQ, with June leads up 50% vs. prior 3-month average. Expanded DTC marketing and 12 new inside sales reps are driving growth.
- **Partnership with Sequel**: Integration of Eversense 365 with Sequel's twiist pump to simplify diabetes management for users on basal insulin. Expected launch later this year.
- **Product Pipeline**: 
  - **Gemini**: Self-powered sensor with swipe and CGM modes, targeting type 2 diabetes. Pivotal IDE study to begin late 2025, with U.S. launch in late 2026.
  - **Freedom**: Invisible CGM with no on-body components. Development to follow Gemini, targeting 2027 launch.
- **Eon Care Network Expansion**: 40+ providers now handle ~20% of insertions, with plans to reach 100 providers by end-2026.
- **Reimbursement Progress**: CMS updated Medicare fee schedule to cover full year of Eversense, with commercial payers transitioning to bundled payments.

**【CFO Financial Commentary】**
- **Q2 2025 Results**: 
  - Revenue: $6.6M (37% YoY growth), with U.S. at $4.9M and OUS at $1.7M.
  - Gross Profit: $3.1M (vs. $0.3M YoY), driven by 365-day product margins and one-time VAT recovery.
  - R&D: $7.7M (down 27% YoY due to completed 365 trials).
  - SG&A: $9.7M (7% YoY increase due to sales commissions).
- **2025 Outlook**: 
  - Revenue: $34-38M, with 2/3 of annual revenue in H2 (majority in Q4 from reorders).
  - Gross Margin: 32.5%-37.5%.
  - Cash Utilization: ~$60M, supporting DTC marketing (~$10M over next 2 quarters).
  - Cash Position: $126.7M post-$78M equity raise, including $20M from Abbott.
- **Reverse Stock Split**: Proposed 10:1 to 20:1 split to address investor access barriers, with shareholder vote in fall.

**【Q&A Highlights】**
- **Retention Rates**: Historical 75% (sensor 1→2), 85% (2→3), 95% (3+). Expect higher retention for 365-day product.
- **Consignment Channel**: 40% of Q2 revenue, growing as payers adopt bundled payments. ASPs 2x higher than direct-to-Ascensia channel.
- **Type 2 Diabetes Growth**: 75% of new patients are type 2 on basal insulin, driven by 1-year sensor convenience.
- **Gemini Study Design**: Validate flash functionality in pivotal study, leveraging existing 365-day sensor technology.
- **Eon Care Contribution**: Low single-digit revenue impact, but growing as network expands.


Senseonics Holdings, Inc. (SENS) Q2 2025 Earnings Call Transcript

- **365 Launch Momentum**: Q1 revenue +24% to $6.3M, with 365-day product driving 18% gross margin. European launch on track for H2 2025.
- **Strategic Partnerships**: First AID integration with Sequel's twiist system set for Q3 launch. Virtual CGM monitoring with SweetSpot expands healthcare access.
- **Pipeline Progress**: Gemini IDE submission expected by year-end; Freedom Bluetooth CGM in development.
- **Financial Health**: $64.6M cash runway to mid-2026. 2025 revenue guidance $34-38M, targeting 25-30% full-year gross margin.
- **Reimbursement Expansion**: Medicare 2025 fee schedule covers full 365-day sensor. >50% commercial payers transitioned to 365-day coverage, with >90% expected by Q3.

**【CEO Summary Section】**
- Launched Eversense 365 integration with Sequel's twiist AID system, enabling real-time CGM data for automated insulin delivery. Joint launch expected in Q3 2025.
- Filed CE Mark application for European launch of Eversense 365 in H2 2025, targeting single-product offering by end-2025.
- Expanded healthcare partnerships: 
  - Collaborated with SweetSpot for virtual CGM monitoring in endocrinology practices.
  - Paused Mercy Health Systems RPM project due to organizational restructuring, but maintained momentum with 365 launch.
- Pipeline progress: 
  - Gemini (1-year sensor with swipe testing) IDE submission expected by year-end.
  - Freedom (invisible CGM with Bluetooth) in development.

**【CFO Financial Commentary】**
- Q1 2025 revenue: $6.3M (+24% YoY), driven by 365-day product margins. U.S. revenue $4.5M, OUS $1.8M.
- Gross profit: $1.5M (+400% YoY), margin ~18% (including prior R&D costs). Full-year gross margin target 25-30%.
- R&D expenses: $7.3M (-31% YoY) due to completion of 365-day trials.
- SG&A: $7.7M (-5% YoY) from cost management.
- Net loss: $14.3M (-25% YoY), narrowing to $0.02 per share.
- Cash: $64.6M (including $27M ATM issuance). Debt reduced to $35M post-note repayment.
- 2025 guidance: $34-38M revenue, ~100% patient growth, 2/3 revenue in H2 due to seasonality.

**【Q&A Highlights】**
- **Guidance Confidence**: Offset Mercy pause with 365 launch momentum and OUS expansion. U.S. DTC campaigns driving 13% consignment program revenue.
- **DTC Strategy**: Targeting Medicare patients via Facebook, TikTok, Instagram. Medicare 2025 fee schedule retroactive to Jan 1 covers full 365-day sensor.
- **Twiist Integration**: Sequel leading pump-side verification/validation. Q3 launch on track with joint sales team engagement.
- **Reimbursement Progress**: >50% commercial payers transitioned to 365-day coverage. Expect >90% conversion by Q3 2025.

Senseonics Holdings, Inc. (SENS) Q1 2025 Earnings Call Transcript

- **Eversense 365 Dominance**: 56% patient growth, 81% switchers from competitors, and 73% prescriber increase highlight strong US adoption.
- **European Expansion**: CE Mark filing sets stage for 2H 2025 launch, targeting European market expansion.
- **Pipeline Momentum**: Gemini feasibility study nearing completion; Freedom Bluetooth sensor in development, positioning for future growth.
- **Financial Outlook**: 2025 revenue $34M-$38M, 25%-30% gross margins, with 2/3 revenue in 2H due to insurance seasonality.
- **Reimbursement Update**: Medicare MAX pricing under negotiation, expected resolution Q2 2025 to enable full reimbursement.

**【CEO Summary Section】**
- **Eversense 365 Launch Success**: Achieved 56% patient growth to 6,000 global patients in 2024, with 81% switching from competitive CGMs. US prescribers increased 73% to 2,400, and direct-to-consumer leads doubled post-launch.
- **European Expansion**: Filed for CE Mark for Eversense 365, targeting a 2H 2025 launch in Europe, leveraging Ascensia's distribution network.
- **Pipeline Progress**: Gemini (1-year sensor with battery) feasibility study nearing completion; Freedom system (Bluetooth-enabled sensor) in development. Both leverage Eversense 365's approved technology.
- **Strategic Partnerships**: Expanded with Mercy Health for system-wide access and integrated with SweetSpot for clinical support. Actively discussing insulin pump integration to enable wireless insulin delivery.

**【CFO Financial Commentary】**
- **Q4 2024 Financials**: Net revenue $8.3M (vs. $8M prior year), US revenue $6.2M, non-US $2.1M. Gross profit $4M (up from $1.1M), driven by 365-day product margins. Net loss $15.5M (-$0.02 EPS) vs. $17.2M (-$0.03 EPS) prior year.
- **Full Year 2024**: Revenue $22.5M (flat vs. 2023), gross profit $0.5M (down from $3.1M) due to $4.8M one-time transition costs. R&D expenses $41.1M (down $7.6M), SG&A $34.2M (up $4.3M).
- **2025 Guidance**: Global revenue $34M-$38M, with 2/3 in 2H due to insurance deductible seasonality. Gross margins 25%-30%, cash utilization $50M-$60M.

**【Q&A Key Highlights】**
- **OUS Launch Dynamics**: Europe will see gradual inventory build vs. US, with CE Mark approval pending. Expect conservative stocking to align with demand.
- **Prescriber Base Growth**: 2,400 annual US prescribers in 2024, half from direct-to-consumer leads. Primary care physicians (Type 2 diabetes) driving expansion beyond endocrinologists.
- **Reimbursement Progress**: Medicare G-codes published, but MAX pricing under negotiation. Anticipate resolution in Q2 2025 to enable full reimbursement.
- **Expense Cadence**: SG&A linear with slight increases in sales commissions. R&D to rise post-Gemini pivotal trial approval (targeted for year-end 2025).

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