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- **YORVIPATH Growth**: €143.1M Q3 revenue, 4,250+ U.S. patients, 70% approval rate, Japan launch, and 30+ European markets.
- **SKYTROFA Expansion**: AGHD approval, €50.7M Q3 revenue, Phase III trial for additional growth disorders.
- **TransCon CNP Update**: FDA PDUFA date November 30, 2025; Phase II combo trial shows 3x linear growth, Phase III planned for Q4 2025.
- **Financial Health**: €214M total revenue, €11M operating profit, €539M cash, and 9% cash growth.

**【CEO Summary Section】**
- **YORVIPATH Global Launch Momentum**: Q3 revenue of €143.1 million, with over 4,250 U.S. patients prescribed and 2,000 unique prescribers. Japan launched commercially in August, and Europe expanded to 30+ countries. U.S. approval rate for new patients is ~70%, expected to improve over time.
- **SKYTROFA Expansion**: U.S. approval for adult growth hormone deficiency (AGHD) in July, Q3 revenue €50.7 million. Phase III basket trial initiated for additional growth disorders (ISS, SHOX deficiency, Turner syndrome).
- **TransCon CNP Regulatory Progress**: FDA priority review with PDUFA date November 30, 2025. Phase II COACH trial shows 3x linear growth in achondroplasia when combined with TransCon GH, with plans for Phase III trial in Q4 2025.

**【CFO Financial Commentary】**
- **Q3 2025 Financials**: Total revenue €214 million (YORVIPATH: €143.1M, SKYTROFA: €50.7M, collaboration: €20M). Operating profit €11 million (vs. loss €12.5M in Q3 2024). Cash balance €539 million, up 9% from Q2 2025.
- **Expense Management**: R&D expenses down 9% to €66.9 million, SG&A up 63% to €113.4 million due to global commercial expansion.

**【Q&A Highlights】**
- **Patient Retention**: >95% of patients stay on YORVIPATH after 4-6 weeks, driven by once-weekly dosing and stable calcium management.
- **TransCon CNP Labeling**: FDA in late-stage discussions, with focus on linear growth and safety (no hypotension, low injection site reactions). Phase III trial design expected to align with 1-year data requirement.
- **International Expansion**: Japan launch underway, Europe targeting 30+ countries, and U.S. SKYTROFA label expansion for AGHD.

Ascendis Pharma A/S (ASND) 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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Loss on Bad Debts

Loss on Impairment of Other Assets

Loss on Disposal of Assets

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Operating Income

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Net Income from Continuing Operations

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Net Income

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Total Comprehensive Income Attributable to Owners of the Company

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ASND

ASND fundamentals

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