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What were the key takeaways from Amicus Therapeutics’s earnings call?

- **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

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

Selling and Marketing Expenses

General and Administrative Expenses

Research and Development Expenses

Loss on Bad Debts

Loss on Impairment of Other Assets

Loss on Disposal of Assets

Other Operating Expenses

Operating Income

Non-Operating Income (Loss)

Income (Loss) from Affiliates

Income (Loss) from Associates

Income (Loss) from Joint ventures

Gain (Loss) on Other Investment

Gain (Loss) on Change in Fair Value

Gain (Loss) on Foreign Currency Exchange

Other Non-Operating Income (Loss)

Net Interest Expense

Interest Expense

Interest Income

Pretax Income From Continuing Operations

Income Tax Expense

Current Income Tax

Deferred Income Tax

Income Tax Adjustments

Net Income from Continuing Operations

Income from Discontinued Operations

Other Items Before Net Income

Net Income

Net Income Attributable to Minority Interests

Net Income Attributable to Owners of the Company

Preferred Stock Dividends

Other Adjustments

Net Income Attributable to Common Stockholders

Other Comprehensive Income

Total Comprehensive Income

Total Comprehensive Income Attributable to Minority Interests

Total Comprehensive Income Attributable to Owners of the Company

Basic EPS

Basic EPS from Continuing Operations

Basic EPS from Discontinued Operations

Diluted EPS

Diluted EPS from Continuing Operations

Diluted EPS from Discontinued Operations

FOLD

FOLD fundamentals

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