【持续性肾脏替代治疗CRRT英文课件】Renal-Disease-Overview

(Symbol:XCPL)Rodman&Renshaw9thAnnualHealthcareConferenceNovember7,2007(Symbol:XCPL)1Forward-LookingStatementsExceptforstatementsofhistoricalfact,themattersdiscussedinthispresentation are forward looking and pursuant to the safe harborprovisions of the private Securities Litigation Reform Act of 1995.Theseforward-lookingstatementsreflectnumerousassumptionsandinvolveavarietyofriskanduncertainties,manyofwhicharebeyondthecompanyscontrolthatmaycauseactualresultstodiffermateriallyfromstatedexpectations.Theseriskfactorsinclude,amongothers,limited operating history,difficulty in developing,exploiting,andprotectingproprietarytechnologies,theriskthatourtechnologymaynotbeeffective,uncertaintyastotheoutcomeoflegalproceedings,intensecompetition,andsubstantialregulationinthemedicaldeviceand healthcare industries,as discussed in the Companys periodicreportsfiledwiththeSecuritiesandExchangeCommission,availableonitswebsiteathttp:/www.sec.gov.2Forward-LookingStatementsExc2CompanyOverviewMedicaldevicecompanyDevelopingandcommercializingextra-corporealmedicaldevicesthatwillreplacethefunctionoffailingorfailedorgansInnovativeplatformtechnologybelievedtobesuperiortothosecurrentlyinuseFocusingonthreerenalreplacementtherapyapplicationsarisingfromplatformtechnology3CompanyOverviewMedicaldevice3【持续性肾脏替代治疗CRRT英文课件】Renal-Disease-Overview4【持续性肾脏替代治疗CRRT英文课件】Renal-Disease-Overview5PortableHemodialysisDeviceforHospitalCRRT/AcuteHemodialysis6PortableHemodialysisDevice6AcuteRenalFailure-HospitalPrevalence200,000/yearintheU.S.with50%mortality;majorityhospitalizedinICUsGrowingat10%peryearduetoagingpopulationandincreasingseverityofhospitalizedpatientsContinuousRenalReplacementTherapy(CRRT)isemergingtherapyofchoice24hour/7daytherapymimicsnormalkidneySlowandgentletherapy(Nosuddenvolumeshifts)AdoptionofCRRTlimitedbyLaborintensivetherapyExpensivereplacementfluid7AcuteRenalFailure-HospitalPr7XcorporealsHospitalRenalReplacementDeviceSmaller,trulyportabledevice(30-40lbs)MultifunctionalCRRT&IntermittentHDSorbent-baseddialysateregenerationDecreaseWorkloadforICUstaffNoplumbingrequirementsorbaggeddialysateSimpletouseoperatorinterfaceSnap-indisposableunitSimpleset-up,teardownCosteffectiveDecreaseinmedicalstafftime(nurse,pharmacist)Noneedforbaggeddialysate($180/treatment)8XcorporealsHospitalRenalR8PortableHemodialysisDeviceforHomeRenalReplacementTherapy9PortableHemodialysisDevice9ChronicRenalFailure75MAmericansatriskofdevelopingCRF9thleadingcauseofdeathintheUSNo“cure”andtherapyfocusesonslowingprogressiontoend-stagerenaldiseaseEnd-StageRenalDisease350,000patientsreceivingdialysisHealthcareExpenditures$32b/yrin20040.2%populationbut7%ofMedicarebudgetMature,cost-constrainedindustry10ChronicRenalFailure75MAmeri10HemodialysisforESRD90%ESRDpts.onHDMajorityofpatientsundergotherapy3x/wkatanoutpatientclinicfor3-4hours/sessionHighmorbidity:12-14dinthehospitalperyearMortalityintheUSremainshighestintheworld,24%inYear1Totalcost=$100k/yr11HemodialysisforESRD90%ESRD11WhyanOpportunityforXcorporeal?RecognitionthatmorehemodialysistreatmentsproducebetterpatientoutcomesReducesmeds,e.g.erythropoietins(WWsales$5B)ReduceshospitalizationsImprovesqualityoflifeInsurancecompanypotentialnetsavingsof25%Hemodialysisclinicsareexpensivetobuild,$1.5Mfora20station,120patientunitMajorefficienciesalreadyachievedwithintheindustryconsolidation,verticalintegrationCost-constraints,pricecompressionCapitation:singlereimbursementrateBundlingofallservicesincludingmeds.onthehorizon12WhyanOpportunityforXcorpor12HomeHemodialysisisasignificantGrowthOpportunityinESRDPatientBenefitsIncreasedtimeonhemodialysiswithimprovedoutcomesPotentialfordailydialysisImprovedqualityoflife:diet,sleep,timeProviderBenefitsDecreasedneedfornurses/techsIncreaseinrevenueswithoutneedforadditionalinfrastructureDecreasedneedforexpensivemedications13HomeHemodialysisisasignifi13ComparableNxStageMedical,Inc.Emerginggrowthhemodialysiscompany“SystemOne”deviceHomehemodialysis:1,615patients;0.5%marketHospitalCRRTforacuterenalfailureFinancialMetrics$517Mmarketcapitalization10/25/07(Pro-forma)16.7xtrailingtwelvemonthsrevenues13.0 xannualizedQ2,2007revenuesQuarterendedJune30,2007financialhighlights$53Mincash$17Moperatingexpenses$13.5Moperatingloss14ComparableNxStageMedical,14WhywillXcorporealsHomeHemodialysisDeviceSucceed?MarketforcesdrivinghomehemodialysisPricecompressionMarketingeffortsofNxStageSmaller,portabledevice(30-40lbs)ImprovedflowratesrelativetoNxStageOpportunityforpatientswithhighBodyMassIndexCosteffectiveNowaterpurificationsystem($100K/center)Noneedforbaggeddialysate($360/month/patient)SimpletouseSimpleuserinterfaceSimplesetup,teardown15WhywillXcorporealsHomeHem15ComparisonofHomeHemodialysisDevices16Fresenius 2008KRenal SolutionsNxStageXcorpBlood Flow Rates20-600150-40050-60010-600Dialysate Flow Rates100-800200-40050-20010-500Dialysate/4-hr(Liters)120620-302-4Dialysate RegenerationNoYesNoYesDry Weight(lbs)1601958030-40Size(cu ft)161651.5PortableNoNoPartialYesDrainage RequiredYesNoYesNoInstallation CostHighLowLowLow ComparisonofHomeHemodialysi16WearableArtificialKidney17WearableArtificialKidney1717WearableArtificialKidney“Disruptive”technologyWearable,light-weightdeviceBatteryoperatedFullyautomated,simpletouseDialysateregenerationwithsorbents24hrs/7daystherapywithpotentialtorevolutionizecareofESRDpatients18WearableArtificialKidney“Dis18WearableArtificialKidneyInitialclinicalstudyconductedwithaprototypedeviceatTheRoyalFreeHospital,London8ESRDsubjectsdialyzedformeanof6.4hrsClearancesofcreatinine,urea,andbeta-2-microglobulinachievedNoadverseeventsreportedSubjectsambulatedbothuntetheredandw/oimpactondeviceperformanceCompellingdatapresentedatASNNovember5,2007Publicationsubmittedtopeerreviewjournal19WearableArtificialKidneyInit19RegulatoryStrategyDeviceU.S.E.U.ClinicalTrialsCRRT/AcuteHD510(k)CENoneHomeHemodialysis 510(k)CE30-40patientsWearableArtificialKidneyPMACE100-200patients20RegulatoryStrategyCRRT/Acute20XcorporealsProductsAnticipatedApprovalDatesDeviceE.U.U.S.PortableHemodialysisDevice-CRRT/AcuteHemodialysisQ408Q109PortableHemodialysisDevice-HomeHemodialysis-ESRDQ408Q209WearableArtificialKidney-HomeHemodialysis-ESRD2010201221XcorporealsProductsAnticipa21ReimbursementCodes(CMS/Medicare)areEstablishedProcedureCodeAmount CommentsUltrafiltrationAquapheresis36514$720/txCodeforplasmapheresisAcuteHD90935$406/txCRRT90935$406/txHomeHD9092590921$1800/moIncludesallHDsuppliesOutpatientHD9092590921$96-123/txVariesdependingonregion22ReimbursementCodes(CMS/Medic22RenalReplacementTherapyMarketOpportunity$in millionsUSEuropeAsiaTotalHospital Renal Replacement Device:Disposables$968$660$484$2,112Device$465$465$232$1,162TotalHospitalRRDevice$1,433$1,125$716$3,274ESRD-Home Renal Replacement Device and Wearable Artificial Kidney:TotalHomeRRDandWAK$7,074$7,146$3,537$17,757Total All Devices$8,507$8,271$4,253$21,031 23RenalReplacementTherapyMark23ManagementTeamTerrenPeizerExecutiveChairmanWinsonTang,MD,FACPChiefOperatingOfficerVictorGura,MDChiefMedicalOfficerRobertWeinstein,CPA,MBAChiefFinancialOfficerCEO,Chairman&FounderHythiamAmgen,Vertex,Tularik,Isis,PacificCapitalGrpCedars-SinaiMedCntr,AssocClinProf,UCLACitiPrivateEquity,AbleLabs,GECapital24ManagementTeamTerrenPeizerC24ManagementTeamNinaPeled,PhD,MBASVP-Quality&RegulatoryJamesBraig,MSMESVP-ProductDevBarryFulkersonVP-HardwareSystemsRussJoseph,MSVP-DisposableEngineerHansen,Cygnus,Amira,Lumenis,i-STAT,BMOptiscan,SquareOneTech,OhioMedicalNxStage,COBE(Prisma,CS3),GambroGishBiomedical,Sorin,BaxterHealthcare25ManagementTeamNinaPeled,PhD25ProductDevelopmentTeamInternalteamofengineerswithexpertiseindialysisequipmentanddisposableswhopreviouslyworkedatCobe,Gambro,Aksys,NxStageandBaxterContractProductDevelopmentGroupinSouthernCaliforniatoleveragetheexpertiseofanadditional10-15engineersManufacturingtobeoutsourced26ProductDevelopmentTeamIntern26SelectedBoardMembersandScientificAdvisorsHansPolaschegg,PhDDanGoldberger,MSMEKellyMcCrann,MBAFresenius-(A1008D,2008D,2008H)Chairman,ExtracorpCir&InfusionTechComGlucon,OSISystems,Optiscan,NellcorDaVita,PacificCare,ProfDentalAssoc,KPMG,McKinsey27SelectedBoardMembersandSci27SelectedFinancialInformation($inmillions)BalanceSheetJune30,2007:-CashandMarketableSecurities$23.0-Totalassets$23.3-Totalliabilities$1.9-Totalstockholdersequity$21.5-Workingcapital$21.4Other:-SharesOutstanding-14.4million-MarketCapitalization-$124millionat10/25/07-PrivatePlacement-Q406,NetProceeds$27.3M-$1.0millionmonthlycashburnrate28SelectedFinancialInformation28CompanyMilestonesCRRT/AcuteIntermittentHemodialysisDeviceEngineeringPrototypeQ4,2007510(k)submissionQ3,2008CommercializationtargetQ1,2009HomeHemodialysisDeviceValidationPrototypeQ2,2008ClinicalstudiesQ1,2009510(k)submissionQ3,2009WearableArtificialKidneyASNpresentationNov.5,200729CompanyMilestonesCRRT/AcuteI29XcorporealAdvantagesExperiencedmanagementteamMultipleproductsMinimaltolowriskImproved“NextGeneration”devicesARF&ESRDPrototypedevicetestedsuccessfullyinhumansWelldefinedregulatoryapprovalstrategyWelldelineatedreimbursementcodesUScommercializationoffirstdevicetargetedQ1,09Multi-billiondollarmarketsWearableArtificialKidney“Disruptive”Technology30XcorporealAdvantagesExperienc30