AMICUS THERAPEUTICS (FOLD) Company Report

Amicus Therapeutics expects Galafold (Fabry disease) revenue to exceed $500 million this year, growing 10%-15%, and Pombiliti/Opfolda (Pompe disease) sales to surpass $100 million with 50%-65% growth.
The company achieved GAAP profitability for the first time in Q3 and holds over $260 million in cash on its balance sheet.
Amicus licensed DMX-200 for FSGS, a late-phase 3 asset, with U.S. commercial rights and anticipates top-line data in early 2028, with the FDA agreeing that proteinuria could serve as a primary endpoint and indicating potential for an accelerated path.

Nov 18, 2025, 4:30 PM

Transcript

Amicus Therapeutics Reports Strong Product Growth and Q3 2025 GAAP Profitability

FOLD

Revenue Acceleration/Inflection

New Projects/Investments

Guidance Update

Amicus Therapeutics expects Galafold revenue to exceed $500 million this year, growing at 10%-15%, and anticipates Pombiliti and Opfolda (POMOP) revenue growth of 50%-65% to over $100 million this year. The company achieved GAAP profitability in Q3 2025.
Galafold, for Fabry disease, continues to see double-digit growth driven by patient finding initiatives and a growing market, with patent protection expected until 2037.
The Pombiliti and Opfolda (POMOP) launch for Pompe disease is showing accelerating momentum in the U.S., with Q2 and Q3 2025 being the largest commercial quarters, and strong progress in Europe.
Amicus licensed DMX-200 for FSGS, a rare kidney disease, securing U.S. commercial rights for a late-phase III asset with a potential $1 billion+ opportunity. Top-line data for the two-year proteinuria endpoint is anticipated in early 2028.
The company maintains a strong financial foundation with over $260 million in cash on its balance sheet and is committed to full-year profitability, with a business development strategy focused on late-stage, de-risked assets.

Nov 18, 2025, 4:30 PM

Transcript

Amicus Provides Business Update and Program Timelines at UBS Global Healthcare Conference

FOLD

Guidance Update

New Projects/Investments

Legal Proceedings

Amicus, a rare disease company, anticipates passing $600 million in revenue this year and $1 billion by 2028, with profitability expected in the second half of 2025.
Galafold (Fabry disease) is projected for 10-15% growth this year, exceeding $500 million in sales, with IP protection into the 2040s and a key patent trial outcome expected in Q2 2026.
Pombiliti Opfolda (Pompe disease) is experiencing 50-65% growth this year, expected to surpass $100 million in sales, driven by strong patient additions and geographic expansion, with a pediatric label expansion anticipated in mid-2026.
The DMX-200 program for FSGS, a potential blockbuster, is nearing completion of Phase 3 enrollment by end of 2025, with top-line data expected in early 2028 and discussions for potential accelerated approval in H1 2026.
Amicus is mitigating potential tariff impacts by transitioning Pompe manufacturing from China to Ireland by 2027 and anticipates muted effects from MFN due to a likely rare disease carve-out.

Nov 10, 2025, 7:45 PM

Transcript

Amicus Provides Business Update, Highlights Product Growth, and Pipeline Progress

FOLD

Guidance Update

Product Launch

New Projects/Investments

Amicus is on track to become profitable in the second half of the year, with over $600 million in revenue this year and a target of $1 billion by 2028. The company holds over $260 million in cash and generated over $30 million in cash in Q3.
Galafold is projected to achieve 10-15% growth and over $500 million in sales this year, with patent protection extending into the 2040s and IP litigation resolution expected in H1 next year.
Pombiliti Opfolda, an early-launch product, is anticipated to grow 50-65% this year, surpassing $100 million in sales, driven by strong patient additions and geographic expansion into eight new countries. A pediatric label expansion is expected mid-next year.
The company acquired US rights to DMX-200 for FSGS, a potential blockbuster opportunity. Its Phase 3 trial enrollment is over 90% complete and expected to close by year-end, with top-line data anticipated two years after the last patient randomization. Conversations for potential accelerated approval are expected in H1 next year.
Manufacturing for Pompe is transitioning from China to Ireland, with supply expected to shift throughout next year and primarily from Ireland by 2027, aiming to mitigate tariff impacts.

Nov 10, 2025, 7:45 PM

Transcript

Amicus Therapeutics Reports Strong Q3 2025 Revenue Growth and GAAP Profitability

FOLD

Earnings

Guidance Update

Revenue Acceleration/Inflection

Amicus Therapeutics reported Q3 2025 total revenue of $169.1 million, a 19% increase over Q3 2024, and achieved GAAP net income of $17.3 million, or $0.06 per share, marking its first profitable quarter in 2025.
Galafold revenue reached $138.3 million, growing 15% (12% at constant exchange rates) with 13% year-over-year patient growth.
Pombiliti and Opfolda revenue was $30.7 million, an increase of 45% (42% at constant exchange rates), driven by strong launch momentum and expansion into 15 countries.
The company reiterated its full-year 2025 guidance, expecting total revenue growth of 15%-22% and Pombiliti and Opfolda revenue growth of 50%-65% at constant exchange rates, and anticipates positive GAAP net income for the second half of 2025.
Amicus remains confident in achieving $1 billion in combined sales for Galafold and Pombiliti/Opfolda by 2028 and is advancing the DMX-200 Phase III study for FSGS, which is over 90% enrolled.

Nov 4, 2025, 1:30 PM

Transcript

Amicus Therapeutics Reports Strong Q3 2025 Results and Reaffirms Full-Year Guidance

FOLD

Earnings

Guidance Update

Revenue Acceleration/Inflection

Amicus Therapeutics (FOLD) reported Q3 2025 revenue of $169 million, marking a 17% increase at constant exchange rates (CER), with non-GAAP net income reaching $54.2 million.
Product performance highlights include Galafold revenue of $138.3 million (+12% at CER) and Pombiliti + Opfolda revenue of $30.7 million (+42% at CER) for Q3 2025.
The company reiterated its FY 2025 financial guidance, anticipating total revenue growth of 15% to 22% and positive GAAP net income in H2 2025.
Pombiliti + Opfolda expanded its global reach with regulatory approvals in Australia, Canada, and Japan in 2025, and is now reimbursed in 15 countries, adding 10 new countries this year.

Nov 4, 2025, 1:30 PM

Presentation

Amicus Therapeutics Reports Strong Q3 2025 Revenue Growth and GAAP Profitability

FOLD

Earnings

Guidance Update

Revenue Acceleration/Inflection

Amicus Therapeutics reported total revenue of $169.1 million for Q3 2025, representing a 19% increase over the same period in 2024.
The company achieved GAAP net income of $17.3 million, or $0.06 per share, in Q3 2025, marking its first quarter of positive GAAP net income for the year.
Galafold revenue reached $138.3 million, up 15% (12% at constant exchange rates) in Q3 2025, driven by 13% year-over-year patient growth.
Pombiliti and Opfolda revenue was $30.7 million, growing 45% (42% at constant exchange rates) in Q3 2025, with significant momentum in both established and newly launched markets.
Amicus reiterated its full-year 2025 financial guidance, including total revenue growth of 15%-22% at constant exchange rates, and anticipates positive GAAP net income for the second half of 2025. The Phase III ACTION3 pivotal study for DMX-200 is over 90% enrolled.

Nov 4, 2025, 1:30 PM

Transcript

Amicus Therapeutics Reports Strong Q3 2025 Results with Revenue Growth and GAAP Profitability

FOLD

Earnings

Revenue Acceleration/Inflection

Guidance Update

Amicus Therapeutics reported total revenue of $169.1 million for Q3 2025, a 19% increase over the same period in 2024.
The company achieved GAAP net income of $17.3 million, or $0.06 per share, in Q3 2025, marking its first quarter of positive GAAP net income in 2025.
Galafold saw 13% year-over-year patient growth, and Pombiliti and Opfolda revenue reached $30.7 million, up 45% in Q3 2025.
Full-year 2025 guidance was reaffirmed, projecting total revenue growth of 15%-22% and anticipating positive GAAP net income for the second half of 2025.
Cash, cash equivalents, and marketable securities increased by $32.8 million during Q3 2025, reaching $263.8 million as of September 30, 2025.

Nov 4, 2025, 1:30 PM

Transcript

Amicus Therapeutics Announces Strong Q3 2025 Financial Results and Reaffirms 2025 Guidance

FOLD

Earnings

Guidance Update

Revenue Acceleration/Inflection

Amicus Therapeutics reported Q3 2025 total revenue of $169 million, reflecting a 17% increase at constant exchange rates (CER), and achieved GAAP net income of $17 million.
The company's cash, cash equivalents, and marketable securities increased by $33 million in Q3 2025, reaching $264 million as of September 30, 2025.
Net product sales for Galafold were $138.3 million (up 15%) and for Pombiliti + Opfolda were $30.7 million (up 45%) in Q3 2025.
Amicus Therapeutics reiterated its 2025 financial guidance, projecting total revenue growth of 15% to 22% at CER and positive GAAP net income during H2 2025 ,.
The company anticipates surpassing $1 billion in total sales in 2028 and is on track for up to 10 new launch countries for Pombiliti + Opfolda in 2025 ,.

Nov 4, 2025, 12:39 PM

8-K

Amicus Therapeutics Reports Strong Q3 2025 Financial Results

FOLD

Earnings

Guidance Update

Revenue Acceleration/Inflection

For the third quarter ended September 30, 2025, Amicus Therapeutics reported total revenues of $169.1 million, an increase of 17% at constant exchange rates.
The company achieved GAAP net income of $17.3 million, or $0.06 per share basic and diluted, for Q3 2025, a significant improvement from a GAAP net loss in the third quarter of 2024.
Cash, cash equivalents, and marketable securities increased to $263.8 million as of September 30, 2025.
Amicus Therapeutics anticipates surpassing $1 billion in total sales in 2028 and reiterated its 2025 financial guidance, which includes projected total revenue growth of 15% to 22%.

Nov 4, 2025, 12:00 PM

Press Release

Earnings Transcripts

Quarterly earnings call transcripts for AMICUS THERAPEUTICS.

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