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- **$220M China Sale**: Extended cash runway to 2028, reducing debt by $75M and receiving $6.4M of $10M holdback.
- **FG-3246 Milestones**: Phase II trial initiated with G-CSF prophylaxis; IST combo data due Q1 2026, interim Phase II results H2 2026.
- **Roxadustat Path**: FDA-aligned Phase III protocol for lower-risk MDS; $50-60M trial cost, exploring partner funding.
- **Financial Health**: Q3 2025 operating expenses down 86% YoY; $121.1M U.S. cash, no near-term liabilities beyond optional Phase III.

**【CEO Summary Section】**
- Completed sale of FibroGen China to AstraZeneca for $220M, extending cash runway to 2028 and paying off $75M term loan.
- Initiated Phase II monotherapy trial for FG-3246 in mCRPC with 75 patients, targeting optimal dose with G-CSF prophylaxis.
- Expected top-line results from FG-3246/enzalutamide IST in Q1 2026 and interim Phase II data in H2 2026.
- FDA-aligned Phase III protocol for roxadustat in lower-risk MDS with high transfusion burden, aiming for submission by end-2025.

**【CFO Financial Commentary】**
- Q3 2025 cash balance: $121.1M (U.S. only), with total operating costs reduced 86% YoY to $6.5M.
- Full-year 2025 operating expenses guidance: $50-60M, excluding potential Phase III trial costs ($50-60M).
- Received $6.4M of $10M holdback from China sale, with remaining $4M due Q2 2026.

**【Q&A Highlights】**
- Roxadustat Phase III cost: $50-60M, could reduce cash runway to mid-2027 if self-funded; exploring partnerships.
- FG-3246: 10.2-month rPFS in Ib IST combo trial; correlation between CD46/PSMA expression to be assessed in Phase II.
- No additional milestones for FG-3246 beyond $80M Phase III option; no royalty obligations post-approval.
- Decision on roxadustat trial path expected Q2 2026, with potential FDA-exclusivity supporting economic opportunity.

FibroGen, Inc. (FGEN) 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

Loss on Impairment of Other Assets

Loss on Disposal of Assets

Other Operating Expenses

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Income (Loss) from Associates

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Other Non-Operating Income (Loss)

Net Interest Expense

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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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Total Comprehensive Income Attributable to Owners of the Company

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FGEN

FGEN fundamentals

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