These risks and uncertainties include among others BioMarins success in the commercialization of102023 715 PM US Food and Drug Administration Approves BioMarins ROCTAVIAN valoctocogene roxaparvovecrvox the First and Only Gene Thera httpsinvestorsbiomarincom20230629USFoodandDrugAdministrationApprovesBioMarinsROCTAVIANTMvaloctocogeneroxaparvovecrvoxthe 1011Navigate AboutROCTAVIAN including achieving adequate market share and reimbursement levels whether ROCTAVIAN will have the impacts and benefits as anticipated the results and timing of current and planned preclinical studies and clinical trials of ROCTAVIAN and the release of data from those trials including continued monitoring of the participants in the clinical trials and postapproval studies BioMarins ability to successfully manufacture ROCTAVIAN for the clinical trials and commercially the content and timing of decisions by the FDA EU health authorities and other regulatory authorities regarding ROCTAVIAN and those factors detailed in BioMarins filings with the Securities and Exchange Commission SEC including without limitation the factors contained under the caption Risk Factors in BioMarins Quarterly Report on Form 10Q for the quarter year ended March 31 2023 as such factors may be updated by any subsequent reports