earnings
confidence high
sentiment positive
materiality 0.80
Protalix FY2022 net loss narrows to $14.9M; CHMP positive opinion for PRX-102; FDA PDUFA May 9
Protalix BioTherapeutics, Inc.
2022-FY EPS reported
-$0.31
revenue$47,638,000
- Net loss of $14.9M ($0.31/share) vs $27.6M ($0.62/share) in FY2021; revenue from goods up 51% to $25.3M.
- EMA CHMP adopted positive opinion recommending marketing authorization for PRX-102 (pegunigalsidase alfa) for Fabry disease; EC decision expected May 2023.
- FDA accepted resubmitted BLA for PRX-102 with PDUFA action date of May 9, 2023; milestone payment from Chiesi if approved.
- Cash and equivalents $22.2M at Dec 31, 2022; voluntary delisting from Tel Aviv Stock Exchange effective March 22, 2023.