Amicus Therapeutics(FOLD) Newsfilter·2025-01-12 21:00Company Overview - Amicus Therapeutics is a global biotechnology company focused on developing and commercializing novel medicines for rare diseases [1] - The company is dedicated to advancing a pipeline of first- or best-in-class medicines for rare diseases [1] - Amicus Therapeutics is committed to delivering high-quality medicines for patients with rare diseases [1] Financial Performance - Total revenue in 2024 reached $528.5 million, representing a year-over-year increase of 32% [7] - Fourth quarter total revenue was $149.9 million [7] - The company anticipates total revenue growth of 17-24% on a constant currency basis for 2025 [7] - Galafold net product sales in 2024 were $458.2 million, a year-over-year increase of 18% [7] - Pombiliti + Opfolda net product sales in 2024 were $70.3 million [7] - The company anticipates achieving positive GAAP Net Income during H2 2025 [7] Product Highlights - Galafold is an oral pharmacological chaperone for the treatment of Fabry disease in adults with amenable GLA variants [14] - Pombiliti + Opfolda is a two-component therapy for the treatment of late-onset Pompe disease [17] - As of the end of 2024, there were ~2,730 patients living with Fabry disease on Galafold [7] - There were ~220 patients treated or scheduled with Pombiliti + Opfolda as of the end of 2024 [7] Strategic Priorities - The company is focused on delivering significant long-term revenue growth and anticipates surpassing $1 billion in total sales by 2028 [7] - Amicus is advancing ongoing studies to broaden labels and scientific leadership in Fabry and Pompe diseases [7] - The company reached a settlement with Teva on the Galafold U.S. patent litigation, preventing Teva from commercializing generic migalastat in the U.S. until Jan 2037 [7] Market Expansion - Multiple Pombiliti + Opfolda pricing and reimbursement agreements were achieved in Italy, Sweden, Switzerland, and Czech Republic [7] - The company anticipates new regulatory decisions in Australia, Canada, and Japan in 2025 [7] - Additional reimbursement agreements are expected throughout 2025 [7] Corporate Updates - Bradley Campbell, President and CEO, highlighted the company's significant revenue growth and non-GAAP profitability in 2024 [5] - The company's strong intellectual property position and global rare disease organization are expected to enable sustainable revenue growth [5] - Mr. Campbell will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025 [21]