Documentos de Académico
Documentos de Profesional
Documentos de Cultura
34th AnnualJ.P.MorganHealthcareConference
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ForwardLookingStatements
SPECIALNOTEREGARDINGFORWARDLOOKINGSTATEMENTS
Inadditiontohistoricalinformation,thispresentationcontainsforwardlookingstatementswithrespecttoourbusiness,capitalresources,
strategicinitiativesandgrowthreflectingthecurrentbeliefsandexpectationsofmanagementmadepursuanttothesafeharborprovisionsofthe
PrivateSecuritiesLitigationReformActof1995,includingregardingcontinuingadoptionof,andinterestin,Senza intheU.S.andinternational
markets;ourbeliefsregardingmarketsizeandshareforSenza;ourbeliefsregardingtheadvantagesofSenza andHF10therapy;ourexpectations
regardingourcommercializationefforts;ourexpectationsforU.S.,internationalandworldwiderevenueforthefourthquarterandfullyearof
2015;andourexpectationsforworldwiderevenueforthefullyear2016.Theseforwardlookingstatementsarebaseduponinformationthatis
currentlyavailabletousorourcurrentexpectations,speakonlyasofthedatehereof,andaresubjecttonumerousrisksanduncertainties,
includingourabilitytosuccessfullycommercializeourproducts;ourabilitytomanufactureourproductstomeetdemand;the leveland
availabilityofthirdpartypayor reimbursementforourproducts;ourabilitytoeffectivelymanageouranticipatedgrowth;ourabilitytoprotect
ourintellectualpropertyrightsandproprietarytechnologies;ourabilitytooperateourbusinesswithoutinfringingtheintellectualpropertyrights
andproprietarytechnologyofthirdparties;competitioninourindustry;additionalcapitalandcreditavailability;ourabilitytoattractandretain
qualifiedpersonnel;andproductliabilityclaims.Thesefactors,togetherwiththosethataredescribedingreaterdetailin ourAnnualReporton
Form10KfiledonMarch18,2015andourQuarterlyReportonForm10QfiledonNovember9,2015,aswellasanyreportsthatwemayfile
withtheSecuritiesandExchangeCommissioninthefuture,maycauseouractualresults,performanceorachievementstodiffermateriallyand
adverselyfromthoseanticipatedorimpliedbyourforwardlookingstatements.Weexpresslydisclaimanyobligation,exceptasrequiredbylaw,
orundertakingtoupdateorreviseanysuchforwardlookingstatements.Ourpreliminaryoperatingresultsforthequarterandfullyearended
December31,2015aresubjecttoadjustmentaswecompleteouryearendauditandotherprocessesandarenotnecessarilyindicativeofour
operatingresultsforanyfutureperiod.
LeadershipThroughInnovationTM
[ 2 ]
Nevro:ALeaderinNeuromodulation
ATTRACTIVEMarket
DIFFERENTIATEDTechnology
FIRSTinClassEvidence
Growing$1.5BMarket,
ExistingReimbursement,
PotentialtoTakeShareand
GrowExistingMarket
FirstSCStoDeliverSignificant&
SustainedBackPainRelief
FirstPivotalRCTwith
ComparativeEffectiveness
Data,AllPrimaryand
SecondaryEndpointsMet
EXECUTIONofU.S.CommercialLaunch
DEMONSTRATEDExecution
FDAApprovalSecuredinMay2015andNow
ExecutingonSuccessfulU.S.Launch
CommercialSuccessinEuropeand
Australia
6,000+ Patientsin17MARKETSOver5YEARS
LeadershipThroughInnovationTM
[ 3 ]
ProductandTherapyOverview
HF10Therapy
Frequency
AnatomicalLead
Placement
Waveform
Characteristics
Programming
LeadershipThroughInnovationTM
SenzaSCSSystem
SENZARCT
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Historically,LimitedDataExistedintheSCSSpace
PUBLISHEDRCTSTUDIESPRIORTONEVROSSENZARCT
Onlythreeprospectivestudieswithatleastsixmonthfollowuphadbeenpublished
Priorstudiesfocusedonlegpainastheprimaryendpoint
Ifreported,therewaslimitedefficacyforbackpain
LegPain
Trial
Success
Study
System
Patients
Schultz
2012
Medtronic
RestoreSensor
Predom
LegPain
NA
North
2005
Medtronic
Itrel
Predom
LegPain
17/24
71%
Kumar
2008
Medtronic
Synergy
Predom
LegPain
43/52
83%
VAS
Response
N
VAS
Response
N
VAS
Response
N
Base
6m
5.9
76
4.3
24
7.6
52
BackPain
12m
24m
Base
6m
12m
24m
4.4
38%
42
47%
19
4.4
40%
42
5.5
52
4.1
4.5
4.8
50
42
42
71
24
4
48%
50
Note:Blankcellsarenotreported
LeadershipThroughInnovationTM
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FirstPivotalStudyConductedforFDAApproval
FirstSCSstudytoreporton100%of
patientsto12months
Designedinconsultationwithand
monitoredbytheFDA
LeadershipThroughInnovationTM
2009
USFEASIBILITYSTUDY
PROSPECTIVE,
LONGTERM
Firstrandomizedstudywithback
painasaprimaryendpoint
2011
EUROPEAN
MULTICENTER,
24MONTHSTUDY
(SENZAEU)
FEASIBILITY
FirststudytodirectlycompareSCS
technologies
RANDOMIZED,
CONTROLLED
THELARGESTSTUDYINSCS
STEPWISEEVIDENCEGENERATION
HISTORYPROVIDING
2014
COMPARATIVELEVELIEVIDENCE
USPIVOTAL
STUDY
FORLEGANDBACKPAIN
(SENZARCT)
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SENZARCT:IndividualBackPainReduction
TraditionalSCSSubjects
IndividualSubjects(n=80)
IndividualSubjects (n=89)
HF10TherapySubjects
Responders(n=70)
79%
Responderrate
0%
20%
40%
60%
80% 100%
DecreaseinBackPainfromBaseline 12Months
51%
Responderrate
Nonresponders(n=39)
Nonresponders(n=19)
Responders(n=41)
20%
40%
60%
80% 100%
DecreaseinBackPainfromBaseline 12Months
Eachhorizontallinerepresentstheresponseofastudysubject
Respondersaredefinedassubjectsexperiencing50%orgreaterpain
relief
LeadershipThroughInnovationTM
0%
ResponderRates:P<0.001
Eachlinerepresentsapatient
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SENZARCT:IndividualBackPainReduction
HF10TherapySubjects
IndividualSubjects
TraditionalSCSSubjects
0%
20%
40%
60%
80% 100%
DecreaseinBackPainfromBaseline 12Months
Eachhorizontallinerepresentstheresponseofastudysubject
Respondersaredefinedassubjectsexperiencing50%orgreaterpain
relief
LeadershipThroughInnovationTM
ResponderRates:P<0.001
Eachlinerepresentsapatient
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SENZARCT:IndividualLegPainReduction
Responders(n=72)
81%
Responderrate
Nonresponders(n=17)
Responders(n=40)
50%
Responderrate
Nonresponders(n=40)
0%
DecreaseinLegPainfromBaseline 12Months
TraditionalSCSSubjects
IndividualSubjects(n=80)
IndividualSubjects (n=89)
HF10TherapySubjects
DecreaseinLegPainfromBaseline 12Months
Eachhorizontallinerepresentstheresponseofastudysubject
Respondersaredefinedassubjectsexperiencing50%orgreaterpain
relief
LeadershipThroughInnovationTM
0%
ResponderRates:P=0.003
Eachlinerepresentsapatient
[ 9 ]
SENZARCT:IndividualLegPainReduction
HF10TherapySubjects
IndividualSubjects
TraditionalSCSSubjects
0%
DecreaseinLegPainfromBaseline 12Months
Eachhorizontallinerepresentstheresponseofastudysubject
Respondersaredefinedassubjectsexperiencing50%orgreaterpain
relief
LeadershipThroughInnovationTM
ResponderRates:P=0.003
Eachlinerepresentsapatient
[ 10 ]
LargeandGrowingUnderservedMarket
LEGPAIN
LEGAND
LEG
AND BACKPAIN
TraditionalSCS
PrimarilyLegPain
$1.5Billion
BACKPAIN
EstablishedReimbursement
EstablishedClinicalPathways
SCSMarketToday
HF10Therapy
LeadershipThroughInnovationTM
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MultipleTherapyAdvantages
HF10TherapyAdvantages
SuperiorPainRelief
DurableResultsDemonstratedthrough24Months
SuperiorResponderRates
DurableResultsDemonstratedthrough24Months
BackPainEfficacy
Superiorefficacyintreatmentofbackpain
ParesthesiaFreePainRelief
Nouncomfortablestimulation
IntraoperativeWorkflowEfficiencies
Morepredictableproceduresduetolackofparesthesiamapping
(anatomicalplacement)
LeadershipThroughInnovationTM
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2015Highlights
FDAApproval&SuperiorityLabelingforHF10Therapy
12MonthPublicationinAnesthesiology
12MonthSENZARCTResultspublishedinAnesthesiology(titledNovel10KHzHighFrequencyTherapy
(HF10Therapy)IsSuperiortoTraditionalLowFrequencySpinalCordStimulationfortheTreatmentof
ChronicBackandLegPain:TheSENZARCTRandomizedControlledTrial
IPRPatentChallengeVictory
U.S.PatentandTrademarkOfficedeniedBostonScientificPetitionsforInterPartes ReviewofU.S.Patent
No.8,359,102
CMSApprovalofTransitionalPassThroughPayment
CentersforMedicare&MedicaidServices(CMS)ApprovesaTransitionalPassThroughPaymentfor
HighFrequencyStimulationundertheMedicareHospitalOutpatientProspectivePaymentSystem
EffectiveBeginningJanuary1,2016
ConsistentInternationalPerformance
~70%YoYgrowthin1Q15,~80%growthin2Q15and~50%growthin3Q15onaconstantcurrencybasis
SuccessfulUSLaunch
GrowingnumberofclinicsacrosstheU.S.arecontinuingtoadoptHF10therapyandoutcomesin
commercialuseareconsistentwithclinicaloutcomesfromSENZARCT
LeadershipThroughInnovationTM
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CMSApprovesTransitionalPassThroughPayment
forOutpatientUseofSenza SCSSystem
EffectiveJanuary1,2016
CMShasdeterminedthatHF10therapyhasfulfilleditsSubstantial
ClinicalImprovementcriteriabasedonNevros SENZARCTpivotal
studydata
ThispassthroughpaymenttofacilitiesforHF10therapyforMedicare
patientswillbeinadditiontotheestablishedreimbursementforspinal
cordstimulationdevices
Inthepast10years,HF10therapyis1ofonly11 medicaldevicesto
begrantedoutpatientpassthroughpaymentstatusbyCMS
LeadershipThroughInnovationTM
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ExecutingonU.S.LaunchStrategy
RESPONSIBLYROLLINGOUTHF10THERAPY
LEVERAGING INTERNATIONALEXPERIENCE&CLINICALEVIDENCE
HIRING EXCEPTIONALTALENT&PROVIDINGRIGOROUSTRAINING
DELIVERING CONSISTENT&SUPERIORCLINICALOUTCOMES
EDUCATING THEMARKETONTHEPIVOTALRCTDATA
ESTABLISHING NEVROASTHELEADERINNEUROMODULATION
LeadershipThroughInnovationTM
[ 15 ]
U.S.SalesOrganization
RepsTrained&InField
RepProductivityGoals
100
92
100fullytrained
salesrepsasof
YE2015
70
Steadystaterep
productivitygoalof
$1.3to$1.5million
52
Steadystate
achievementin18to
24months
AtLaunch
5/8/15
LeadershipThroughInnovationTM
Q2
Q3
YE15
[ 16 ]
NevroIsPenetratingAND GrowingtheSCSMarket
PainDistributionofHF10TreatedPatients
U.S.LaunchthroughJan1,2016
~5%
PredominantBack
PredominantLeg
~30%
Back&Leg
Other
~50%
~15%
LeadershipThroughInnovationTM
[ 17 ]
2015QuarterlyRevenueRamp
$inMillions(unaudited)
FY15PreliminaryEstimatedRevenue:$69.1M $69.6M
U.S.Revenue
4Q15E
InternationalRevenue
~$32.6
U.S.Range:$19.5M $19.8M
IntlRange:$13.1M $13.3M
~$19.5
$15.4
$9.7
$11.4
$0.1
$11.3
$9.7
1Q15
2Q15
$4.5
$10.9
3Q15
~$13.1
4Q15E
FY16PreliminaryWorldwideRevenueGuidance:$145.0M $155.0M
LeadershipThroughInnovationTM
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MultiplePotentialLabelExpansionOpportunities
RefractoryChronicMigraine
ChronicIntractableNeckand
UpperExtremityPain
FOCUSEDONPAIN&
PAINSPECIALISTS
LeadershipThroughInnovationTM
NonSurgicalLowBackPain
[ 19 ]
Nevro:ALeaderinNeuromodulation
ATTRACTIVEMarket
DIFFERENTIATEDTechnology
FIRSTinClassEvidence
Growing$1.5BMarket,
ExistingReimbursement,
PotentialtoTakeShareand
GrowExistingMarket
FirstSCStoDeliverSignificant&
SustainedBackPainRelief
FirstPivotalRCTwith
ComparativeEffectiveness
Data,AllPrimaryand
SecondaryEndpointsMet
EXECUTIONofU.S.CommercialLaunch
DEMONSTRATEDExecution
FDAApprovalSecuredinMay2015andNow
ExecutingonSuccessfulU.S.Launch
CommercialSuccessinEuropeand
Australia
6,000+ Patientsin17MARKETSOver5YEARS
LeadershipThroughInnovationTM
[ 20 ]
ExperiencedIndustryLeadership
MICHAELDEMANE
Chairman&CEO
RAMIELGHANDOUR
President
ANDREWGALLIGAN
CFO
DOUG ALLEAVITCH
VPQuality&Operations
MICHAELENXING
VPSales
ANDREWALKER
Sr.VPR&D
DAVIDCARAWAY,MD,PHD
ChiefMedicalOfficer
RICHCARTER
VPFinance
BRADGLINER
VPClinical& Regulatory
MIKE HALL
GeneralCounsel
TAMARAROOK
VPHE&R
LeadershipThroughInnovationTM
Centerfor
PainRelief
RelativeValueScale
UpdateCommittee(RUC)
[ 21 ]
JANUARY2016
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