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1. Company Snapshot

1.a. Company Description

Amicus Therapeutics, Inc., a biotechnology company, focuses on discovering, developing, and delivering medicines for rare diseases.Its commercial product and product candidates include Galafold, an oral precision medicine for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene variant based on in vitro assay data.It also develops AT-GAA, a novel treatment paradigm for Pompe disease; enzyme replacement therapies for Pompe diseases; CLN3, which is in Phase 1/2 clinical study to evaluate the safety and efficacy of a single intrathecal administration of an AAV serotype AT-GTX-502 gene therapy in patients with CLN3; and CDKL5, a gene on the X-chromosome encoding the CDKL5 protein that regulates the expression of essential proteins for normal brain development.


The company has collaboration and license agreements with Nationwide Children's Hospital; University of Pennsylvania; and GlaxoSmithKline.Amicus Therapeutics, Inc.was incorporated in 2002 and is headquartered in Philadelphia, Pennsylvania.

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1.b. Last Insights on FOLD

Amicus Therapeutics' recent performance is driven by strong Q3 results, with revenue growing 19.5% year-over-year, fueled by robust sales growth of Galafold and Pombiliti + Opfolda. The company is progressing toward profitability and has reaffirmed its FY2025 guidance. Additionally, Amicus has added DMX-200 to its pipeline, targeting FSGS, a rare kidney disease. Wall Street analysts predict a potential upside of 58.5% (Zacks) to 76.3% (Nasdaq), citing a positive trend in earnings estimate revisions. AXQ Capital LP has also taken a new position in the company.

1.c. Company Highlights

2. Amicus Therapeutics' Q3 2025 Earnings: Strong Revenue Growth and Reaffirmed Guidance

Amicus Therapeutics reported a robust third quarter in 2025, with total revenue reaching $169.1 million, representing a 19% year-over-year increase. The company's GAAP profitability stood at $17.3 million, or $0.06 per share, surpassing estimates. The actual EPS came in at $0.17, beating the estimated $0.12. The two commercial products, Galafold and Pombiliti and Opfolda, drove this growth, with Galafold revenue at $138.3 million, up 12% at constant exchange rates, and Pombiliti and Opfolda revenue at $30.7 million, up 42% at constant exchange rates.

Publication Date: Nov -16

📋 Highlights
  • Revenue Growth:: Q3 2025 revenue hit $169.1M (+19% YoY) with GAAP net income of $17.3M ($0.06 EPS).
  • Product Performance:: Galafold revenue rose to $138.3M (+12% CER); Pombiliti/Opfolda surged to $30.7M (+42% CER).
  • Guidance Reaffirmed:: 2025 revenue growth forecast at 15–22%, with Pom-Op targeting 50–65% growth and Galafold 10–15%.
  • DMX-200 Pipeline:: Phase III ACTION3 trial (FSGS) over 90% enrolled; label expansions for Pompe disease anticipated by mid-2026 and 2028.
  • Financial Position:: Cash reserves reached $263.8M (+$32.8M Q3), with $1B combined sales target by 2028 for Galafold and Pom-Op.

Revenue Growth Drivers

The company highlighted that Galafold delivered 13% year-over-year patient growth, establishing itself as the standard of care in core countries, while Pombiliti and Opfolda showed significant momentum in both established and newly launched markets. The US was a significant contributor to the growth, with increased breadth and depth of prescriptions, and the company is seeing very strong adherence and compliance rates. The label for Pombiliti and Opfolda has been well-received, and the company is working towards expanding it to pediatric patients with late-onset Pompe disease and infantile onset patients.

Pipeline Progress and Future Expectations

Amicus Therapeutics is advancing the development of DMX-200, a first-in-class therapy in late-stage Phase III development for FSGS, with the ACTION3 pivotal study over 90% enrolled. The company anticipates that patients with higher MCP-1 levels will show more robust responses. For 2026, the company expects strong growth driven by switches from Nexviazyme in the US and more ex-US countries coming online, with Pombiliti and Opfolda potentially establishing a market share of over 50% at peak.

Valuation and Outlook

With a P/E Ratio of 147.13 and an EV/EBITDA of 88.62, the market seems to have priced in significant growth expectations. Analysts estimate next year's revenue growth at 19.0%, which is in line with the company's reaffirmed guidance for total revenue growth of 15% to 22% in 2025. The company's strong cash position, with $263.8 million in cash, cash equivalents, and marketable securities as of September 30, 2025, provides a solid foundation for its future plans.

3. NewsRoom

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Wall Street Analysts Think Amicus Therapeutics (FOLD) Could Surge 58.46%: Read This Before Placing a Bet

Nov -26

Source: zacks.com

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AXQ Capital LP Makes New $290,000 Investment in Amicus Therapeutics, Inc. $FOLD

Nov -25

Source: defenseworld.net

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Amicus Therapeutics: Moving Towards Consistent Profitability

Nov -11

Source: seekingalpha.com

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Amicus Therapeutics, Inc. (FOLD) Presents at UBS Global Healthcare Conference 2025 Transcript

Nov -10

Source: seekingalpha.com

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Wall Street Analysts Believe Amicus Therapeutics (FOLD) Could Rally 76.32%: Here's is How to Trade

Nov -10

Source: zacks.com

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Bet on These 4 Top-Performing Liquid Stocks to Maximize Returns

Nov -07

Source: zacks.com

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Amicus' Q3 Earnings Beat, Higher Product Sales Drive Y/Y Revenues

Nov -05

Source: zacks.com

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Compared to Estimates, Amicus Therapeutics (FOLD) Q3 Earnings: A Look at Key Metrics

Nov -05

Source: zacks.com

4. Business Breakdown

4.a. Revenues by Country

4.b. Revenues by Segment

5. Expected revenues mid-term growth (11.30%)

6. Segments

Advanced Therapies

Expected Growth: 11.3%

Amicus Therapeutics' Advanced Therapies segment growth of 11.3% is driven by increasing adoption of its gene therapies, particularly AT-GAA for Pompe disease, and strong demand for its Fabry disease treatment, Galafold. Additionally, the company's expanding commercial presence, strategic partnerships, and ongoing R&D investments in novel gene therapies contribute to its growth momentum.

7. Detailed Products

Galafold

Galafold is a pharmacological chaperone therapy for the treatment of Fabry disease, a rare genetic disorder caused by the deficiency of the alpha-galactosidase A enzyme.

AT-GAA

AT-GAA is a gene therapy for the treatment of Pompe disease, a rare genetic disorder caused by the deficiency of the acid alpha-glucosidase enzyme.

CLN6

CLN6 is a gene therapy for the treatment of Batten disease, a rare genetic disorder caused by the deficiency of the CLN6 protein.

ATB200/AT220

ATB200/AT220 is a pharmacological chaperone therapy for the treatment of Pompe disease, a rare genetic disorder caused by the deficiency of the acid alpha-glucosidase enzyme.

8. Amicus Therapeutics, Inc.'s Porter Forces

Forces Ranking

Threat Of Substitutes

The threat of substitutes for Amicus Therapeutics, Inc. is medium due to the presence of alternative treatments and therapies for rare genetic diseases. While there are some substitutes available, they may not be as effective or convenient as Amicus' products.

Bargaining Power Of Customers

The bargaining power of customers for Amicus Therapeutics, Inc. is low due to the specialized nature of its products and the lack of alternative treatments for rare genetic diseases. Patients and healthcare providers have limited bargaining power.

Bargaining Power Of Suppliers

The bargaining power of suppliers for Amicus Therapeutics, Inc. is medium due to the presence of multiple suppliers for raw materials and manufacturing services. However, the company's dependence on a few key suppliers for certain components may give them some bargaining power.

Threat Of New Entrants

The threat of new entrants for Amicus Therapeutics, Inc. is low due to the high barriers to entry in the biotechnology industry, including the need for significant investments in research and development, manufacturing, and regulatory approvals.

Intensity Of Rivalry

The intensity of rivalry for Amicus Therapeutics, Inc. is high due to the presence of several established competitors in the biotechnology industry, as well as the potential for new entrants. The company operates in a highly competitive market with many players vying for market share.

9. SWOT Analysis

Strength

Weaknesses

Opportunities

Threats

10. Capital Structure

10.a. Balance Sheet

10.b. Weighted Average Cost of capital

Value
Debt Weight 71.21%
Debt Cost 7.92%
Equity Weight 28.79%
Equity Cost 7.92%
WACC 7.92%
Leverage 247.34%

11. Quality Control: Amicus Therapeutics, Inc. passed 4 out of 9 key points

12.a Historical Valuation

12.b Price/Earnings Ratio

12.c Margin Valuation

12.d Peers Valuation

Peers Group Analysis

Stock-Card
PTC Therapeutics

A-Score: 5.8/10

Value: 7.8

Growth: 5.6

Quality: 8.6

Yield: 0.0

Momentum: 9.5

Volatility: 3.3

1-Year Total Return ->

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Rhythm Pharma

A-Score: 4.5/10

Value: 6.0

Growth: 5.1

Quality: 3.8

Yield: 0.0

Momentum: 9.5

Volatility: 2.7

1-Year Total Return ->

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Ionis Pharmaceuticals

A-Score: 4.2/10

Value: 6.0

Growth: 1.1

Quality: 4.5

Yield: 0.0

Momentum: 10.0

Volatility: 3.7

1-Year Total Return ->

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Stock-Card
Amicus Therapeutics

A-Score: 3.6/10

Value: 4.4

Growth: 7.6

Quality: 3.8

Yield: 0.0

Momentum: 1.0

Volatility: 5.0

1-Year Total Return ->

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Stock-Card
Celldex Therapeutics

A-Score: 3.4/10

Value: 6.6

Growth: 3.0

Quality: 5.0

Yield: 0.0

Momentum: 3.0

Volatility: 3.0

1-Year Total Return ->

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Stock-Card
Denali Therapeutics

A-Score: 3.3/10

Value: 6.8

Growth: 3.7

Quality: 6.2

Yield: 0.0

Momentum: 0.5

Volatility: 2.3

1-Year Total Return ->

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Peers Metrics

12.e Scoring Insights

12.f DCF BETA

Parameters

Short Term Growth

Short term Time

Long-Term Growth

WACC

Target Price

9.9$

Current Price

9.9$

Potential

-0.00%

Expected Cash-Flows