What is the revenue and EPS growth rate for Amicus Therapeutics year over year?

What guidance did Amicus Therapeutics's management provide for the next earnings period?

What does Amicus Therapeutics do and what are its main business segments?

What is Amicus Therapeutics's latest dividend and current dividend yield?

What factors drove the changes in Amicus Therapeutics's revenue and profit?

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

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

- **Record Growth**: 17th consecutive quarter of double-digit revenue growth (22% YoY) driven by Galafold (+16%) and Pombiliti/Opfolda (+58%).
- **$1B Sales Target**: Pombiliti/Opfolda on track to reach $1B by 2028; Galafold maintains $1B+ peak potential.
- **Pipeline Momentum**: DMX-200 Phase III enrollment >75% complete; U.S. manufacturing for Pombiliti to begin H2 2025.
- **Profitability Outlook**: GAAP net income expected in H2 2025; 2026 launch pipeline includes Japan and 5 new EU markets.

**【CEO Summary Section】**
- Achieved 17th consecutive quarter of double-digit revenue growth, driven by Galafold (13% YoY patient growth) and Pombiliti/Opfolda (58% YoY revenue growth). 
- Reaffirmed $1 billion sales target for Pombiliti/Opfolda by 2028 and Galafold's $1 billion+ peak potential.
- On track for GAAP profitability in H2 2025, with DMX-200 Phase III enrollment on track for year-end.

**【CFO Financial Commentary】**
- Q2 2025 revenue: $154.7M (+22% YoY), with Galafold ($128.9M, +16% YoY) and Pombiliti/Opfolda ($25.8M, +58% YoY) leading growth.
- GAAP net loss: $24.4M (-$0.08/share), vs. $15.7M (-$0.05/share) in Q2 2024. Non-GAAP net income: $1.9M (+$0.01/share).
- Full-year guidance: 15-22% total revenue growth, 10-15% Galafold growth, 50-65% Pombiliti/Opfolda growth.

**【Q&A Highlights】**
- **Manufacturing Strategy**: U.S. drug product manufacturing with Sharp to begin in H2 2025, complementing Ireland facility. No tariff impact on 2025 P&L.
- **IP Confidence**: Strong defense of Galafold IP; majority of generic challenges historically resolve in favor of innovators.
- **DMX-200 Regulatory Path**: FDA aligned on proteinuria as Phase III primary endpoint; Phase III enrollment >75% complete.
- **2026 Launch Plan**: Targeting 10+ new countries for Pombiliti/Opfolda, including Japan and 5 EU markets.


Amicus Therapeutics, Inc. (FOLD) Q2 2025 Earnings Call Transcript

- **Double-digit growth continuity**: 11 straight quarters of +10% revenue growth in core therapies.
- **$30M Dimerix deal**: Adds Phase III kidney disease asset with $1B+ peak potential.
- **2025 guidance adjustment**: Pom-Op growth lowered to 50-65% due to UK rebate and launch delays.
- **Profitability milestone**: GAAP net income expected in H2 2025, cash balance >$250M.
- **DMX-200 progress**: Phase III 65% enrolled, FDA-aligned primary endpoint, 2025 interim analysis planned.

**【CEO Opening Remarks】**
- **Core Business Growth**: 11 consecutive quarters of double-digit revenue growth in Pompe and Fabry therapies. 
- **Strategic Collaboration**: $30M upfront deal with Dimerix for DMX-200, a Phase III kidney disease therapy with blockbuster potential.
- **Supply Chain Resilience**: Onshored Pombiliti manufacturing in US and diversified drug substance production in Ireland.
- **Long-Term Ambition**: Target $1B annual revenue by 2028 for Galafold and Pombiliti combined.

**【CFO Financial Highlights】**
- **Q1 2025 Results**: $125.2M revenue (+13% YoY), Non-GAAP net income $9M, cash balance $251M.
- **Updated Guidance**: Full year revenue growth 15-22% (down from 17-24%), Pom-Op growth 50-65% (vs prior 65-85%).
- **Profitability Outlook**: GAAP net income expected in H2 2025, gross margin ~85% for the year.

**【Key Product Updates】**
- **Galafold**: Q1 revenue $104.2M (+6% ex-Rate), 14% new patient starts, 69% global market share.
- **Pom-Op**: Q1 revenue $21M (+92% ex-Rate), US sales 45% of total, 2025 guidance adjusted to 50-65% growth.
- **DMX-200**: Phase III enrollment 65% complete, FDA-aligned proteinuria endpoint, $30M upfront cost included in 2025 R&D spend.

**【Q&A Highlights】**
- **UK rebate impact**: 22% VPAG rate vs 15% guidance, one-time 2025 hit but offset by patient growth.
- **Switch dynamics**: 65% of Pom-Op new starts from Nexviazyme, 90%+ adherence rates.
- **Regulatory strategy**: Leveraging real-world evidence, seeking FDA alignment on rare disease endpoints.


Amicus Therapeutics, Inc. (FOLD) Q1 2025 Earnings Call Transcript

- **Revenue Growth**: 32% YoY to $528 million, driven by Galafold (19% growth) and Pom-Op ($70M launch year).
- **2025 Outlook**: 17-24% total revenue growth, with Pom-Op targeting 65-85% expansion into 10 new markets.
- **Profitability**: Full-year non-GAAP profit in 2024; GAAP net income expected positive in H2 2025.
- **Strategic Moves**: AI diagnostic pilot, 2025 market expansion, and disciplined cost control to fuel growth.

**【CEO Summary Section】**
- Total revenue for 2024 reached $528 million, a 32% year-over-year increase, driven by strong performance of Galafold and Pombiliti/Opfolda.
- Galafold revenue grew 19% YoY to $458 million, with 2,700+ patients globally. Projected 10-15% growth in 2025.
- Pombiliti/Opfolda generated $70 million in 2024, with 220 patients treated. Expected 65-85% growth in 2025.
- Strategic focus on expanding into 10 new markets in 2025, targeting 650+ late-onset Pompe disease patients.
- Full-year non-GAAP profitability achieved in 2024, with GAAP net loss reduced to $56 million.

**【CFO Financial Commentary】**
- 2024 GAAP net loss: $56 million ($0.18 per share), compared to $152 million ($0.51) in 2023.
- Non-GAAP net income: $74 million ($0.24 per share), up from $39 million ($0.13) in 2023.
- Operating expenses: $450 million (GAAP) and $348 million (non-GAAP), reflecting disciplined cost management.
- 2025 guidance: Total revenue growth 17-24%, Galafold 10-15%, Pombiliti/Opfolda 65-85%.
- Gross margin expected in mid-80s%, with GAAP net income positive in the second half of 2025.

**【Q&A Highlights】**
- **FX Impact**: 1% USD exchange rate change could affect revenue by $4 million. No hedging plans.
- **Pom-Op Switch Dynamics**: 40% of US Nexviazym patients will reach 2-year mark in 2025, driving potential switches.
- **AI Diagnostic Collaboration**: Pilot with OM1 at Penn identifies top 100 high-risk Fabry patients; results expected mid-2025.
- **Market Expansion**: Launches in Netherlands, Italy, Japan (Q4), and 10+ countries by year-end.
- **R&D Strategy**: Focus on leverageable infrastructure, late-stage assets, and adjacent rare disease opportunities.

Amicus Therapeutics, Inc. (FOLD) Q4 2024 Earnings Call Transcript

Amicus Therapeutics (FOLD)-6 Nov 24-2024 Q3 Earnings call transcript

Amicus Therapeutics (FOLD)-8 Aug 24-2024 Q2 Earnings call transcript

Amicus Therapeutics (FOLD)-9 May 24-2024 Q1 Earnings call transcript

Amicus Therapeutics (FOLD)-28 Feb 24-2023 Q4 Earnings call transcript

- **Galafold Growth Accelerates**: Q3 revenue up 19% YoY, full-year guidance raised to 16-18%.
- **Pompe Launch Momentum**: 60+ patients on commercial Pombiliti/Opfolda, 66% U.S. patients submitting PRFs.
- **Profitability Achievable**: Non-GAAP breakeven expected in Q4 2023.
- **Pipeline Prudent Expansion**: Gene therapy and next-gen chaperone programs progressing with financial discipline.

**【CEO Summary Section】**
- Galafold revenue grew 19% YoY in Q3 2023 (constant currency), driving full-year guidance to 16-18% growth. 
- Pombiliti and Opfolda launched in the U.S., Germany, and U.K., with over 60 patients on commercial therapy as of early November.
- Company on track for non-GAAP profitability in Q4 2023, supported by $430M debt refinancing with Blackstone.

**【CFO Financial Commentary】**
- Q3 2023 total revenue: $103.5M (+27% YoY), with 63% ex-U.S. and 37% U.S. contribution.
- Non-GAAP operating expenses: $90M (+5% YoY), driven by commercial expansion.
- Cash balance: $280M as of September 30, 2023.

**【Q&A Highlights】**
- 66% of U.S. Pompe patients have submitted PRFs for Pombiliti/Opfolda, with conversions from ERTs already occurring.
- Regulatory submissions for Pombiliti/Opfolda in over 12 countries expected by year-end.
- Long-term focus on next-gen Fabry chaperone and gene therapy pipeline, with judicious investment to maintain profitability.

Actual												-0.35	-0.2	-0.25	-0.27	-0.25	-0.19	-0.19	-0.29	-0.3	-0.21	-0.12	-0.19	-0.18	-0.15	-0.07	-0.11	-0.16	-0.05	-0.02	0.05	-0.07	-0.08	0.06
Forecast												-0.2834	-0.2595	-0.2124	-0.2297	-0.2422	-0.2161	-0.1757	-0.1564	-0.2547	-0.2109	-0.1887	-0.1172	-0.1368	-0.1139	-0.0759	-0.0578	-0.0644	-0.0549	0.0012	0.0124	-0.0542	-0.1177	0.0386
Surprise	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	0.00%	-23.50%	+22.93%	-17.70%	-17.54%	-3.22%	+12.08%	-8.14%	-85.42%	-17.79%	+0.43%	+36.41%	-62.12%	-31.58%	-31.69%	+7.77%	-90.31%	-148.45%	+8.93%	-1766.67%	+303.23%	-29.15%	+32.03%	+55.44%

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