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- **Revenue Surge**: ORLADEYO up 37% YoY to $159.1M, with U.S. sales dominating at 89%. Full-year guidance raised to $590-600M. 
- **Strategic Wins**: European sale & debt repayment; $400M Astria acquisition for navenibart. 
- **Pipeline Momentum**: BCX17725 skin penetration in healthy volunteers; DME program to be spun/partnered. 
- **Financial Strength**: $269M cash pre-close; 2025 non-GAAP net income positive. 
- **Pediatric Play**: 500 diagnosed pediatric HAE patients; PDUFA mid-Dec with payer alignment intact.

**【CEO Summary Section】**
- **ORLADEYO Revenue Growth**: Q3 revenue of $159.1M, up 37% YoY, driven by U.S. sales ($141.6M, 89% of total). Full-year guidance raised to $590-600M, with $1B peak by 2029. 
- **Strategic Transactions**: Sold European business, repaid $200M Pharmakon debt, and announced Astria acquisition (navenibart) for $400M in Q1 2026. 
- **Pipeline Progress**: BCX17725 (Netherton) shows skin penetration in healthy volunteers; DME program to be spun/partnered post-Q1 data. 
- **Leadership Transition**: Charlie Gayer to CEO, Ron Dullinger to lead U.S. commercial team.

**【CFO Financial Commentary】**
- **Financial Highlights**: Non-GAAP net income $35.6M (EPS $0.17), up 107% YoY. Cash $269M (pre-close of European sale). 
- **Cost Efficiency**: Operating expenses $118M (up 28% YoY), with R&D investment. 2025 guidance: $430-440M OpEx, positive cash flow. 
- **Liquidity**: $294M post-European sale; targeting $1B cash by 2029. 

**【Q&A Key Highlights】**
- **ORLADEYO Competition**: Retention rate stable at 60%, with 64 new prescribers Q3. Gross-to-net ~15%, stable through 2026. 
- **Pediatric Launch**: 500 diagnosed pediatric HAE patients, 40% untreated. PDUFA date mid-Dec; payer alignment similar to adult. 
- **DME Program**: Decision to de-prioritize due to cost and expertise; Phase I data pending. 
- **Netherton Progress**: BCX17725 shows skin penetration; Q1 2026 data from 10+ patients. SubQ/IV dosing exploration ongoing. 
- **Regulatory Updates**: FDA interactions stable despite shutdown; no PDUFA delay anticipated.

BioCryst Pharmaceuticals, Inc. (BCRX) Q3 2025 Earnings Call Transcript

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