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| 2 Forward-Looking Statements Thispresentationcontains"forward-lookingstatements"withinthemeaningofthePrivateSecuritiesLitigationReformActof1995relatingtopreclinicalandclinicaldevelopmentofourproductcandidates,thetimingandreportingofresultsfrompreclinicalstudiesandclinicaltrials,theprospectsandtimingofthepotentialregulatoryapprovalofourproductcandidates,commercializationplans,manufacturingandsupplyplans,financingplans,andtheprojectedrevenues,expenses,cashposition,andfutureprofitabilityfortheCompany.Theinclusionofforward-lookingstatementsshouldnotberegardedasarepresentationbyusthatanyofourplanswillbeachieved.Anyoralloftheforward-lookingstatementsinthispressreleasemayturnouttobewrongandcanbeaffectedbyinaccurateassumptionswemightmakeorbyknownorunknownrisksanduncertainties.Forexample,withrespecttostatementsregardingthegoals,progress,timing,andoutcomesofdiscussionswithregulatoryauthorities,andinparticularthepotentialgoals,progress,timing,andresultsofpreclinicalstudiesandclinicaltrials,includingastheyareimpactedbyCOVID-19relateddisruption,arebasedoncurrentinformation.ThepotentialimpactonoperationsfromtheCOVID-19pandemicisinherentlyunknownandcannotbepredictedwithconfidenceandmaycauseactualresultsandperformancetodiffermateriallyfromthestatementsinthisrelease,includingwithoutlimitation,becauseoftheimpactongeneralpoliticalandeconomicconditions,includingasaresultofeffortsbygovernmentalauthoritiestomitigateCOVID-19,suchastravelbans,shelterinplaceordersandthird-partybusinessclosuresandresourceallocations,manufacturingandsupplychaindisruptionsandlimitationsonpatientaccesstocommercialorclinicalproduct.InadditiontotheimpactoftheCOVID-19pandemic,actualresultsmaydiffermateriallyfromthosesetforthinthisreleaseduetotherisksanduncertaintiesinherentinourbusiness,including,withoutlimitation:thepotentialthatresultsofclinicalorpreclinicalstudiesindicatethattheproductcandidatesareunsafeorineffective;thepotentialthatitmaybedifficulttoenrollpatientsinourclinicaltrials;thepotentialthatregulatoryauthorities,includingtheFDA,EMA,andPMDA,maynotgrantormaydelayapprovalforourproductcandidates;thepotentialthatwemaynotbesuccessfulincommercializingGalafoldinEurope,Japan,theUSandothergeographies orourotherproductcandidatesifandwhenapproved;thepotentialthatpreclinicalandclinicalstudiescouldbedelayedbecauseweidentifyserioussideeffectsorothersafetyissues;thepotentialthatwemaynotbeabletomanufactureorsupplysufficientclinicalorcommercialproducts;andthepotentialthatwewillneedadditionalfundingtocompleteallofourstudies,manufacturingandlaunchpreparations.Further,theresultsofearlierpreclinicalstudiesand/orclinicaltrialsmaynotbepredictiveoffutureresults.WithrespecttostatementsregardingprojectionsoftheCompany'srevenue,expenses,cashposition,andfutureprofitability,actualresultsmaydifferbasedonmarketfactorsandtheCompany'sabilitytoexecuteitsoperationalandbudgetplans.Inaddition,allforward-lookingstatementsaresubjecttootherrisksdetailedinourAnnualReportonForm10-KfortheyearendedDecember31,2021andForm10-QforthequarterendedSeptember30,2022.Youarecautionednottoplaceunduerelianceontheseforward-lookingstatements,whichspeakonlyasofthedatehereof.Allforward-lookingstatementsarequalifiedintheirentiretybythiscautionarystatement,andweundertakenoobligationtoreviseorupdatethisnewsreleasetoreflecteventsorcircumstancesafterthedatehereof. Non-GAAPFinancialMeasuresInadditiontofinancialinformationpreparedinaccordancewithU.S.GAAP,thispresentationalsocontainsadjustedfinancialmeasuresthatwebelieveprovideinvestorsandmanagementwithsupplementalinformationrelatingtooperatingperformanceandtrendsthatfacilitatecomparisonsbetweenperiodsandwithrespecttoprojectedinformation.Theseadjustedfinancialmeasuresarenon-GAAPmeasuresandshouldbeconsideredinadditionto,butnotasasubstitutefor,theinformationpreparedinaccordancewithU.S.GAAP.WetypicallyexcludecertainGAAPitemsthatmanagementdoesnotbelieveaffectourbasicoperationsandthatdonotmeettheGAAPdefinitionofunusualornon-recurringitems.Othercompaniesmaydefinethesemeasuresindifferentways.Whenweprovideourexpectationfornon-GAAPoperatingexpensesonaforward-lookingbasis,areconciliationofthedifferencesbetweenthenon-GAAPexpectationandthecorrespondingGAAPmeasuregenerallyisnotavailablewithoutunreasonableeffortduetopotentiallyhighvariability,complexityandlowvisibilityastotheitemsthatwouldbeexcludedfromtheGAAPmeasureintherelevantfutureperiod,suchasunusualgainsorlosses.Thevariabilityoftheexcludeditemsmayhaveasignificant,andpotentiallyunpredictable,impactonourfutureGAAPresults. |