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- **Revenue Growth**: Q3 revenue up 19% to $169.1M, driven by 13% Galafold patient growth and 45% Pompe revenue increase.
- **Profitability Milestone**: First quarter of GAAP net income ($17.3M) and positive cash flow generation.
- **Pompe Momentum**: 50-65% full year growth guidance, with 4x patient switch rate in U.S. vs. 2024.
- **Pipeline Progress**: DMX-200 Phase III >90% enrolled, targeting FSGS approval.
- **Strategic Targets**: $1B combined Galafold/Pompe sales by 2028, >50% Pompe market share at peak.

**【CEO Opening Remarks】**
- Q3 revenue growth driven by 13% patient increase for Galafold and strong momentum in Pompe therapies (Pombiliti/Opfolda). 
- Reaffirmed $1 billion combined sales target for Galafold and Pompe therapies by 2028.
- Highlighted GAAP net income of $17.3 million, marking first quarter of GAAP profitability.
- Emphasized strategic focus on rare disease expertise, commercial execution, and pipeline expansion (e.g., DMX-200 for FSGS).

**【Commercial Update (Sebastien Martel)】**
- **Galafold**: 
  - Q3 revenue $138.3M (+15% YoY), with 13% patient demand growth.
  - 69% global market share of treated Fabry patients with amenable mutations.
  - 65% naive patients, 35% switches, reflecting improved diagnosis rates.
  - U.S. "Finding Fabry" campaign targeting late-onset patients.
- **Pompe (Pombiliti/Opfolda)**: 
  - Q3 revenue $30.7M (+45% YoY), with 59% ex-U.S. growth.
  - 15 countries with reimbursement, including Japan, Belgium, Ireland.
  - 50-65% full year 2025 revenue growth guidance.
  - 4x patient switch rate from Myozyme to PomOp in U.S. vs. 2024.

**【Clinical & Pipeline Update (Jeffrey Castelli)】**
- **Pompe Evidence**: 
  - 4-year PROPEL data shows durable muscle function improvements.
  - U.K. real-world study shows PomOp superior to Nexviazyme in motor function.
- **DMX-200 (FSGS)**: 
  - Phase III ACTION3 trial >90% enrolled, targeting proteinuria as primary endpoint.
  - FDA alignment on regulatory pathway for approval.

**【Financial Results (Simon Harford)】**
- Q3 2025: 
  - Total revenue $169.1M (+19% YoY).
  - GAAP net income $17.3M (vs. loss in Q3 2024).
  - Non-GAAP EPS $0.18 (vs. $0.10 prior year).
  - Cash position $263.8M (+$32.8M QoQ).
- Full Year 2025 Guidance: 
  - Total revenue +15-22% YoY.
  - Galafold +10-15%, Pompe +50-65%.
  - Gross margin 83-87%.
  - Positive GAAP net income for H2 2025.

**【Q&A Highlights】**
- **Pom-Op U.S. Adoption**: 
  - 43% U.S. revenue share, with strong adherence rates >90%.
  - Real-world evidence (e.g., U.K. study) driving physician confidence in switching.
- **Label Expansion**: 
  - Adolescent Pompe label expansion expected mid-2026.
  - Infantile onset Pompe trial (ROSELLA) targeting 2027 submission.
- **Supply Chain**: 
  - Ireland manufacturing facility approved in Europe, U.S. approval pending.
  - BIOSECURE 2.0 legislation not impacting U.S. supply security.
- **Market Share Ambition**: 
  - Target >50% Pompe market share at peak.
  - Galafold aiming for 85-90% share in mature markets.


Amicus Therapeutics, Inc. (FOLD) Q3 2025 Earnings Call Transcript

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