FOLD - Amicus Therapeutics FY 2020 top line up 43%
Amicus Therapeutics ([[FOLD]] -3.7%) FY results:Revenues: $260.88M (+43.2%).Net loss: ($276.9M) (+22.3%); loss/share: ($1.07) (+27.7%); Quick Assets: $483.3M (+6.8%).2021 guidance: Galafold revenue: $300M - 315M, to be driven by continued operational growth and commercial execution across all major markets including the U.S., EU, U.K. and Japan ; non-GAAP operating expense of $410M - 420M, driven by continued investment in the global Galafold launch, AT-GAA clinical studies and pre-launch activities, and advancing the gene therapy pipeline.Key Strategic Priorities: Complete BLA submission in 1H2021 and the EU MAA submission to be completed in 2H2021.To achieve continued double-digit growth and Galafold revenue of at least $300M for FY 2021.Advance clinical development, manufacturing and regulatory discussions for CLN6 Batten disease gene therapy program and commence dosing additional patients with GMP grade material.Phase 1/2 study data to be reported from the CLN3 Batten disease. Further advance manufacturing and regulatory discussions, and submit protocol for next clinical study.Progress IND-enabling work in both Pompe and Fabry gene therapy.Previously
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Amicus Therapeutics FY 2020 top line up 43%