Amicus Therapeutics Reports Strong 2024 Revenue and Outlines 2025 Strategic Outlook

Amicus Therapeutics (Nasdaq: FOLD), a global biotechnology company focused on developing and commercializing novel medicines for rare diseases, recently announced its preliminary 2024 revenue and provided a strategic outlook for 2025. The company reported a remarkable year, marked by significant revenue growth and full-year non-GAAP profitability.



2024 Revenue Highlights:

* Total revenue reached $528.5 million, representing a 32% increase year-over-year, reflecting strong operational growth of 32% at constant exchange rates (CER).
* Galafold (migalastat) net product sales were $458.2 million, up 18% year-over-year, or 18% at CER, driven by continued strong demand and market leadership.
* Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) net product sales were $70.3 million, with a successful first full year of commercial launch, treating or scheduling 220 patients with commercial product.
* The company raised its full-year 2024 revenue growth guidance for Galafold to +16% to +18% on a constant currency basis (CER) and for Pombiliti + Opfolda to $69 million to $71 million on a constant currency basis (CER).



2025 Strategic Outlook:

* Amicus anticipates total revenue growth of 17-24% at CER, with Galafold revenue growth of 10-15% at CER and Pombiliti + Opfolda revenue growth of 65-85% at CER.
* The company plans to advance ongoing studies to broaden labels and scientific leadership in Fabry and Pompe diseases.
* Amicus aims to achieve positive GAAP Net Income during H2 2025, driven by strong revenue growth and continued financial discipline.

Key Milestones and Regulatory Updates:

* Amicus reached a settlement with Teva on the Galafold U.S. patent litigation, ensuring the company can continue to support the Fabry community with Galafold for many years to come.
* The company secured multiple Pombiliti + Opfolda pricing and reimbursement agreements in late 2024 and early 2025, with first commercial patients from these countries anticipated to begin treatment over the first half of 2025.
* Amicus anticipates new regulatory decisions in Australia, Canada, and Japan in 2025, as well as additional reimbursement agreements throughout the year.



Amicus Therapeutics' strong 2024 performance and strategic outlook for 2025 demonstrate the company's commitment to delivering great medicines for people living with rare diseases and creating significant value for shareholders. With a focus on sustainable revenue growth, expanding its portfolio, and achieving profitability, Amicus is well-positioned to become one of the leading rare disease companies in the coming years.