Amicus Therapeutics Reports Unaudited Preliminary Sales Results for the Full Year 2018; Provides Revenue Guidance for the Year 2019
January 07, 2019 at 07:00 am
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Amicus Therapeutics reported unaudited preliminary sales results for the full year 2018. The company recorded approximately $91 million (preliminary and unaudited) in full-year 2018 revenue from commercial sales and reimbursed expanded access programs for Galafold.
For the full-year 2019, the company anticipates total Galafold revenue of $160 million to $180 million. Prescription growth in 2018 was largely driven by EU and other countries outside the U.S. and Japan. Growth in 2019 is expected to be driven by continued growth in EU markets, further geographic expansion, and further success from the first full year of launch in the U.S. and Japan.
Amicus Therapeutics, Inc. is a biotechnology company, which is focused on discovering, developing, and delivering novel medicines for rare diseases. Its two marketed therapies are Galafold, the first oral monotherapy for people living with Fabry disease who have amenable genetic variants, and Pombiliti + Opfolda, a novel treatment designed to improve uptake of active enzyme into key disease relevant tissues for adults living with late-onset Pompe disease. As an orally administered monotherapy, Galafold is designed to bind to and stabilize an endogenous alpha-galactosidase A (alpha-Gal A) enzyme in those patients with genetic variants identified as amenable in a Good Laboratory Practice (GLP) cell-based amenability assay. Pombiliti + Opfolda consists of a uniquely engineered rhGAA enzyme, cipaglucosidase alfa-atga, with an optimized carbohydrate structure to enhance lysosomal uptake, administered in combination with miglustat that functions as an enzyme stabilizer.