Amicus Therapeutics(US:FOLD)2023-03-01 19:16Galafold Performance and Outlook - Galafold achieved revenue of $329 million in 2022, with a 16% operational growth at Constant Exchange Rates (CER)[17, 37] - Q4 2022 Galafold revenue reached $88 million[14] - The company anticipates Galafold revenue growth of 12-17% at CER in 2023[3, 9, 25] - Galafold has treated over 2,000 individuals globally[18, 20] AT-GAA Development and Regulatory Status - AT-GAA is under global regulatory review for Pompe disease[3] - Regulatory approvals for AT-GAA in the three largest Pompe markets are anticipated in 2023[31] - The European Commission (EC) decision for Pombiliti™ (cipaglucosidase alfa) is expected in Q1 2023, with a CHMP opinion for Miglustat expected in Q2 2023 and an EC decision in Q3 2023[31] - FDA approval for AT-GAA is anticipated in Q3 2023[31] Financial Goals and Profitability - The company is focused on prudent expense management and aims to achieve non-GAAP profitability in the second half of 2023[3, 25, 39] - 2023 non-GAAP operating expense guidance is set at $340 million to $360 million[25] - Cash as of December 31, 2022, was $294 million[3] AT-GAA Clinical Data - Approximately 200 people living with Pompe disease are currently receiving AT-GAA through extension studies and expanded access programs[23]