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- **IBTROZI Launch Success**: 204 new patients in Q3 (15/week), 50-month DOR in TKI-naive patients, surpassing competitor performance. 
- **Financial Strength**: $13.1M Q3 revenue, $549M cash, no guidance but $55M annualized run rate from Q3 patients. 
- **Strategic Wins**: Japan approval with $25M milestone, advanced Europe partnership, avoided $100M study cost. 
- **Pipeline Momentum**: TRUST-IV adjuvant trial initiated, safusidenib high-grade glioma trial on track, NUV-1511 data pending. 
- **Market Leadership**: 80% payer coverage, 98% territory engagement, fastest ROS1 launch in history. 


**【CEO Summary Section】**
- Launched IBTROZI in Q3 2025, achieving 204 new patient starts (15/week), surpassing competitor Augtyro's first 3-month performance (34 patients). 
- Updated data shows median duration of response (DOR) of 50 months in TKI-naive patients, up from 44 months. 
- Submitted supplemental NDA for label update with new DOR data and planning 2026 medical conference update.
- TRUST-IV Phase III study initiated for adjuvant therapy in early-stage ROS1+ NSCLC.
- Secured Japan regulatory approval and expects reimbursement approval Q4 2025 with $25M milestone payment.

**【CFO Financial Commentary】**
- Q3 2025 total revenue: $13.1M (including $7.7M net product revenue from IBTROZI). 
- Gross to net ratio ~20%, stable with 80% payer coverage. 
- Cash balance: $549M, sufficient for operations through profitability. 
- No guidance on net revenue but 204 Q3 patients represent $55M annualized run rate. 
- Avoided $100M head-to-head study cost by focusing on high-grade glioma trial. 
- European partnership discussions advanced, potential Q4 2025 update. 

**【Commercial Update】**
- 98% of 47 sales territories engaged, 80% payer coverage, 75% academic/community center prescriptions. 
- Free trial program converts patients in weeks, highlighting IBTROZI's tolerability. 
- 50% of new patients in second-line due to competitor limitations; expect shift to first-line as durability data solidifies. 
- Potential 16,000+ patients by Q4 2029 based on 50-month DOR and RNA testing expansion. 

**【Q&A Highlights】**
- No sales guidance; Q3 2025 net revenue growth driven by new patients, not channel stocking. 
- Market share leadership confirmed by 5x faster patient starts vs. Augtyro. 
- Japan reimbursement approval imminent, Europe partnership details Q4 2025. 
- Safusidenib high-grade glioma trial completion expected 2029; no low-grade head-to-head study due to cost. 
- NUV-1511 Phase I data update pending, potential new modality in targeted therapy. 


Nuvation Bio Inc. (NUVB) Q3 2025 Earnings Call Transcript

Revenue

Sales and Services Revenue

Financing Services Revenue

Other Revenue

Cost of Revenue

Cost of Goods and Services

Cost of Financing Services

Other Cost

Gross Profit

Other Operating Income

Operating Expenses

Selling, General and Administrative Expenses

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Research and Development Expenses

Loss on Bad Debts

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Loss on Disposal of Assets

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Operating Income

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Other Non-Operating Income (Loss)

Net Interest Expense

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Interest Income

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Net Income from Continuing Operations

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Net Income

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Net Income Attributable to Owners of the Company

Preferred Stock Dividends

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Other Comprehensive Income

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Total Comprehensive Income Attributable to Owners of the Company

Basic EPS

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Diluted EPS from Discontinued Operations

NUVB

NUVB fundamentals

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