Amicus Therapeutics(US:FOLD)2022-08-04 15:19Galafold Performance and Outlook - Galafold achieved $80.7 million in revenue for 2Q22[10], contributing to $1594 million in 1H22 revenue, representing a 109% reported growth[11] and 178% operational growth at CER[11] - The company is reiterating FY22 Galafold revenue guidance of $350 million to $365 million at CER, indicating a 15% to 20% growth at CER[4, 8, 10, 12] - The company anticipates near-term growth to $500 million, driven by continued penetration into existing markets, expansion into new geographies, and broadening of labels[13] AT-GAA Development and Launch - AT-GAA is under global regulatory reviews, with a U S PDUFA date in 2H2022 and a CHMP opinion expected late 2022[4, 20, 21] - Over 175 people living with Pompe disease are currently receiving AT-GAA through clinical extension studies and expanded access programs[20] - Phase 3 PROPEL study results showed greater improvement with AT-GAA vs alglucosidase alfa in ERT-naïve and ERT-experienced patients[18] Financial Position and Strategy - The company reported $386.8 million in cash as of June 30, 2022[4] - The company is focused on prudent expense management to achieve profitability in 2023[4, 5, 39] - 2Q22 operating expenses increased, reflecting manufacturing costs for AT-GAA launch and non-recurring expenses related to gene therapy portfolio reprioritization[37] - The company's 2022 non-GAAP operating expense guidance is $470 million to $485 million[39]