For personal use only - ASX2016/10/18 · Digital healthcare for respiratory disease Tony Keang...
Transcript of For personal use only - ASX2016/10/18 · Digital healthcare for respiratory disease Tony Keang...
Digitalhealthcareforrespiratorydisease
TonyKea)ngChiefExecu)veOfficerandManagingDirector
TechKnowInvestRoadshowOctober2016
ASX:RAP
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DisclaimerThispresenta)onhasbeenpreparedbyResAppHealthLimited(“ResApp”).Theinforma)oncontainedinthispresenta)onisaprofessionalopiniononlyandisgiveningoodfaith.Certaininforma)oninthisdocumenthasbeenderivedfromthirdpar)esandthoughResApphasnoreasontobelievethatitisnotaccurate,reliableorcomplete,ithasnotbeenindependentlyauditedorverifiedbyResApp.Anyforward-lookingstatementsincludedinthisdocumentinvolvesubjec)vejudgmentandanalysisandaresubjecttouncertain)es,risksandcon)ngencies,manyofwhichareoutsidethecontrolof,andmaybeunknownto,ResApp.Inpar)cular,theyspeakonlyasofthedateofthisdocument,theyassumethesuccessofResApp’sstrategies,andtheyaresubjecttosignificantregulatory,business,compe))veandeconomicuncertain)esandrisks.Actualfutureeventsmayvarymateriallyfromtheforward-lookingstatementsandtheassump)onsonwhichtheforward-lookingstatementsarebased.Recipientsofthisdocument(Recipients)arecau)onedtonotplaceunduerelianceonsuchforward-lookingstatements.ResAppmakesnorepresenta)onorwarrantyastotheaccuracy,reliabilityorcompletenessofinforma)oninthisdocumentanddoesnottakeresponsibilityforupda)nganyinforma)onorcorrec)nganyerrororomissionwhichmaybecomeapparentaZerthisdocumenthasbeenissued.
Totheextentpermi[edbylaw,ResAppanditsofficers,employees,relatedbodiescorporateandagents(Agents)disclaimallliability,direct,indirectorconsequen)al(andwhetherornotarisingoutofthenegligence,defaultorlackofcareofResAppand/oranyofitsAgents)foranylossordamagesufferedbyaRecipientorotherpersonsarisingoutof,orinconnec)onwith,anyuseorrelianceonthispresenta)onorinforma)on.
Thispresenta)onisnotanoffer,invita)on,solicita)onorrecommenda)onwithrespecttothesubscrip)onfor,purchaseorsaleofanysecurity,andneitherthispresenta)onnoranythinginitshallformthebasisforanycontractorcommitmentwhatsoever.
AllamountsinAustraliandollarsunlessstatedotherwise.
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Digitalhealthcareforrespiratorydisease§ Developingtheworld’sfirstclinically-tested,regulatory-approvedrespiratorydisease
diagnos)ctestandmanagementtoolsforsmartphones- Noaddi'onalhardwareneeded
§ Hugeglobalmarket,700M+doctorvisitsannuallyforrespiratorydisease1
- Uniqueopportunitytointegrateintotelehealthproviders’exis)ngplaborms- Strongdemandalsoseenwithinclinics,emergencyroomsandoutpa)entfacili)es
§ Compellingclinicalevidencewith1,800+pa)entsenrolledinpediatricandadultstudies§ SuccessfulPre-Submissionmee)ngheldwithUSFDA,targe)ngUSapprovalinH12017§ PediatricUSFDAregistra)onstudytobeginshortlyatleadingUShospitals§ Strongbalancesheetwith$13.7Mcash
31.ResAppes)matebasedonOECDdoctorvisitspercapitadataandassuming10%ofvisitsareforrespiratorydisease(basedonUSdata)
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Companyoverview
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CapitalStructure(ASX:RAP)MarketCap. $307M
SharePriceasof14October2016
$0.47
SharesonIssue1 653M
PerformanceShares2 93.75M
Op)ons3 12.8M
StaffIncen)veOp)ons4 31M
CashBalanceasof30June2016
$13.7M
1. Includes59.6Mescrowedshares(un)l14/7/17)2. Issuedonachieving$20Mofannualrevenueoronanacquisi)on3. 6.4M,exercisepriceof2.6c,expire31/12/16;4.5M,exercisepriceof
28c,expire29/4/19;1.87M,exercisepriceof30c,expire29/4/194. Issuedtostaffandscien)ficadvisoryboard
BoardofDirectorsDrRogerAston Non-Execu)veChairman(ChairmanofOncosilMedicalLtd,formerlyCEOofMaynePharma,CambridgeAn)body,co-founderofpSividaCorp.)
DrTonyKea)ng ManagingDirectorandCEO(formerlyDirector,CommercialEngagementofUniQuest,engineeringmanagementroleswithExaCorpora)on)
MrBrianLeedman Execu)veDirectorandVP(ChairofAusBiotech-WA,Non-Execu)veDirectorofAlcidionLtd,co-founderofImugeneLtdandOncosilMedicalLtdandformerlyVP,IRatpSividaCorp.)
MrChrisNtoumenopoulos Non-Execu)veDirector(ManagingDirectoratTwenty1Corporate,Non-Execu)veDirectoratRaceOncology,formerlyatCi)group,IndianOceanCapitalandCPSCapital)
Substan)alShareholdersFreemanRoad:6.84%FidelityInterna)onal:6.15%F
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Diagnosisofrespiratorydiseaseisthemostcommonoutcomefromavisittothedoctor
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Acutecondi'onsURTIs,influenza,bronchi)s,bronchioli)s,pneumonia,pertussis,croupChronicCondi'onsAsthma,COPD,cys)cfibrosis,bronchiectasis
§ 700M+doctorvisitsp.a.globally1forrespiratorydisease→ 125MinUS2(10%ofallvisits)→ 6-8MinAustralia3
§ US$10.5Bp.a.UShospitalcostsforpneumonia4
§ HighprevalenceandgrowthinAsia
1.ResAppes)matebasedonOECDdoctorvisitspercapitadataandassuming10%ofvisitsareforrespiratorydisease(basedonUSdata)2.Ambulatorycasevisits,Na)onalAmbulatoryMedicalCareSurvey20103.AustralianLungFounda)on4.HCUPSta)s)calBrief#160
Currentlydiagnosedusingstethoscope,imaging(x-ray,CT),bloodand/orsputumtests➝Timeconsuming,expensiveandnotveryaccurate
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Easytouse,instantdiagnosisusingonlyasmartphone§ Exclusiveworldwidelicensetomachinelearning
technologydevelopedbyAssociateProfessorUdanthaAbeyratneatTheUniversityofQueensland
§ Usessignaturesincoughsoundstodiagnosedisease§ Ini)aldevelopmentfundedbyTheGatesFounda)onto
reducethe1Mchilddeathsp.a.duetopneumoniainthedevelopingworld
§ Patentapplica)onfiledinUS,Australia,Europe,China,JapanandSouthKorea
§ Usesthemicrophonesintoday’ssmartphones
→ Noaddi'onalhardwarerequired
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Verifiedbycompellingpediatricclinicalevidence
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2013Study Sensi'vity Specificity Accuracy
Pneumoniavs.allrespiratory1 94% 100% 96%
Asthmavs.pneumonia2 100% 80% 90%
1. Abeyratneetal.,AnnalsofBiomedicalEngineering,20132. Kosashietal.,IEEETransac)onsinBiomedicalEngineering,20153. ResAppPressRelease30September2015,211subjectdataset4. ResAppPressRelease10November2015,338subjectdataset5. ResAppPressRelease31March2016,524subjectdataset
2015StudyPreliminaryResults Sensi'vity Specificity Accuracy
Pneumoniavs.norespiratory4 100% 95% 97%
Asthmavs.norespiratory3 97% 92% 95%
Bronchioli'svs.norespiratory4 100% 100% 100%
Croupvs.norespiratory4 94% 100% 99%
URTIvs.norespiratory4 100% 95% 96%
Pneumonia,crouporbronchioli'svs.URTI4 89-100% 90-95% 89-98%
Differen'aldiagnosisofpneumonia,croup,URTIandbronchioli's5
91-99% 89-98% 89-98%
2013PediatricProof-of-ConceptStudy
SardijtoHospital,Indonesia
91pediatricpa)entsenrolled
2015/16AustralianPediatricStudy
976pediatricpa)entsenrolledtodate
JoondalupHealthCampusandPrincessMargaretHospital
FundedbytheBillandMelindaGatesFounda)on
LatestresultsreleasedMarch2016Enrolmentandanalysiscon)nuing
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Buildingstrongclinicalevidenceinadults
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AdultStudyPreliminaryResults Sensi'vity Specificity Accuracy
COPDvs.norespiratory 100% 96-100% 98-100%
Asthmavs.norespiratory 91% 91-93% 91-92%
Pneumoniavs.norespiratory 97-100% 100% 98-100%
URTIvs.norespiratory 100% 100% 100%
AsthmaorCOPDvs.norespiratory 91-93% 91-93% 91-93%
Asthmavs.COPD 93% 96% 94%
Pneumoniavs.Asthma 92% 81% 88%
Pneumoniavs.COPD 92% 92% 92%
2015/16AustralianAdultStudyJoondalupHealthCampusandWesleyHospital772adultpa)entsenrolledtodate
LatestresultsreleasedOctober2016Enrolmentandanalysiscon)nuing
1. ResAppPressRelease3October2016
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Achievingbreakthroughperformanceindiagnosis§ Lowerrespiratorytractdiseasediagnosis
- Effec)vetreatmentneedsiden)fica)onoflowerrespiratorytractinvolvement- Correctlydetectedlowerrespiratorytractinvolvementin97%ofcasesini'ally“missed”by
experiencedcliniciansusingastethoscope
§ Causeofpneumoniadiagnosis“Weneedfaster,less-expensivediagnos@ctestsfordoctorstoaccuratelydiagnosethe
causeofpneumoniasotheycaneffec@velytreatit”USCDC(2015)1- Incorrectdiagnosisleadstounnecessaryandineffec)vean)bio)cuse- Iden)fyingthecausetodayis)meconsuming,costlyandonlyavailableinter)aryhospitals- Preliminaryresultsdemonstratedsepara'onofbacterialandatypicalfromviralpneumoniawith
89%and90%accuracy
91. USDepartmentofHealthandHumanServicesPressRelease,Feb25,2015
(h[p://www.cdc.gov/media/releases/2015/p0225-pneumonia-hospitaliza)ons.html)
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Uniqueopportunitytodeployalongsidetelehealth,oneofthefastestgrowingtrendsinhealthcare§ UStelehealthisalreadylarge,andgrowingrapidly§ Telehealthbenefitsall:payors,pa)entsandhealthcareproviders
§ 30-50%oftelehealthconsultsforrespiratorydisease4,noaccurateremotediagnosisavailable§ ResApp’stestcanbedeliveredanywhere,any'mewhileretainingaclinician’sinput
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75Mconsultsp.a.
(UStelehealth‘evisits’in2014es)matedbyDeloi[e)1
US$12BUSTAM
(GoldmanSachsUStotaladdressablemarketes)mate)3
56%growth
(Growthrateun)l2018es)matedbyIHS)2
1. Deloi[e,eVisits:the21stcenturyhousecall(August2014)2. IHS,WorldMarketforTelehealth(2014)3. GoldmanSachsEquityResearch,TheDigitalRevolu)onComestoUSHealthcare(June2015)4. Uscher-PinesandMehrotra(HealthAffairs,2014)andUnitedHealthcarePresenta)on
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Pursuingatrulyglobalopportunity§ SignificantgrowthintelehealthinEuropeandAustralia
- PlantofileforCEMarkinearly2017inparallelwithFDAsubmission
§ Hugepoten)alinAsiaPacificwherethereareover1billionsmartphoneusers1
- Highprevalenceofrespiratorydiseaseandna)onwideshortageofdoctorsinChina2
- Chinesemobileonlineconsulta)onexamples:
§ Ac'vepartnershipdiscussionsinallregions
111. ForresterResearch2. “DearthofDoctorsinChinaSaidtoPutChildren’sHealthatRisk,CaixinOnline,h[p://english.caixin.com/2016-01-21/100902234.html
92Mac)veusers229ques)onsperminute
Chunyuyisheng PingAnHaoyisheng
25Mac)veusers95,000appointmentsperday
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Targe)ngmul)plemarketsegments
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Telehealth Clinicaluse Developingworld Directtoconsumer
Marketsize
• 22.5Mrespiratory-relatedUStelehealthconsultsp.a.
• 13.4MUSEDvisitsforrespiratorydiseasep.a.1(~4.6Mforchildren)
• 1Mchilddeathsduetopneumoniap.a.3• 151Mcasesofpneumoniaindevelopingcountriesp.a.3
• 400MiPhoneusers4• 1.6BAndroidusers4• mHealthappmarketexpectedtogrowto$25Bbyendof20175
Valueproposi'on
✓ Theonlyremoteclinically-accuratediagnos)ctoolavailable
✓ Easilyintegratedintoexis)ngplaborms
✓ Reducecosts(<$10vs>$200forx-ray)
✓ Reduce)me(x-rayadds~30mins,culturescantakedays)
✓ Lowcost,accurate&fast✓ Usablebynon-medical
personnel✓ IntegratesintoIMCI
framework
✓ Convenience✓ Lowcost✓ Consumer
empowerment
Commercialstrategy
Partnerwithtelehealthproviderstoreach10sofmillionsofpa)ents
Ini)aluseinemergencydepartments(ED),extendingtoregularclinics
Partnerwithleadinginterna)onalaidagenciestoequipfieldpersonnel
Directtoconsumerviaappstorestotargetgrowthinconsumer-ledhealth
Revenuemodel B2Bpertestfee(<$10)fromtelehealthproviders
B2Bpertestfee(<$10)fromhealthcarepayors
B2Bannualsubscrip)onfromaidagencies
B2Cdownloadandpertestfeedirectfromconsumers
1. ResAppes)matebasedonOECDpercapitadata2. NHAMCS(2011)3. WHOes)mate
4. Sta)sta(2014es)mates)5. Research2guidancemHealthAppDeveloperEconomics(2014)
700MdoctorvisitsinOECDforrespiratorydiseasep.a.1
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Improvingchronicrespiratorydiseasemanagement§ 334Mpeoplehaveasthma1
- 17.7MinUS2,30MinEurope3,2.3MinAustralia4
- $30B+p.a.USeconomicburden2
- Pa)entadherencetoasthmamedica)onsisgenerallyverypoor
§ 65MpeoplehavemoderatetosevereCOPD5
- Emphysemaandchronicbronchi)s,primarycausedbysmoking- 3M+peoplediedofCOPDin2012,6%ofalldeathsglobally5
§ HighprevalenceofasthmaandCOPDinChina
§ OpportunitytomeasuretheseverityofasthmaandCOPD,withoutthecostofaddi)onalhardwareortheneedtocarryanextradevice
§ ExploratoryclinicalstudiesunderwayatJoondalupHealthCampusandtheWesleyHospital
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1. TheGlobalAsthmaReport2014(GlobalAsthmaNetwork)2. USCDC3. EuropeanLungWhiteBook4. AsthmaAustralia
5. WHO6. Interna)onalStudyofAsthmaandAllergiesinChildhood7. COPDFounda)on
1in7childrenhasasthma6
1in5adultsover45hasCOPD7
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PivotalmilestonesleadinguptofirstFDAapproval
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H22016¨ Clinicalcollabora)onsforasthmaandCOPD
management¨ Addi)onalAustralianadultstudyresults¨ Startfieldevalua)onwithhumanitarianorg.¨ StartSMARTCOUGH-C,pivotalUSpediatricstudy¨ Addi)onalAustralianpediatricstudyresults
H12017¨ Addi)onalAustralianadultstudyresults¨ StartpivotalUSadultclinicalstudy¨ PrimarydatafromSMARTCOUGH-C¨ FiledenovopremarketsubmissionwithFDAfor
leadResAppproduct(pediatric)¨ FileforCEMarkinEurope¨ FDAmarke)ngapprovalforleadResAppproduct
✓
✓
SMARTCOUGH-CstudyProspec)ve,mul)-site,double-blindstudywithprimaryendpointsofdiagnosisofchildhoodpneumonia
SecondaryendpointsofdiagnosisofURTI,croup,bronchioli)s,asthma/viralwheezeandlowerrespiratorytractinvolvement
ThreeconfirmedUSsites:1. Massachuse[sGeneralHospital2. Unnamed,top-)eracademicmedicalcenter3. Unnamed,top-)erchildren’shospital
SupportedbyINCResearch,agloballeadingCRO
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Summary§ Revolu)onarytechnology–diagnosisandmanagementofrespiratorydiseasewithouttheneedforaddi)onalhardware
§ Compellingclinicalevidence- Veryhighaccuracyfrommul)pleadultandpaediatricclinicalstudies,over1,800pa)entsenrolledtodate- Breakthroughresults:Detec)nglowerrespiratorytractinvolvementwhichmaybemissedbyausculta)onand
diagnosingthecauseofpneumonia(viral,bacterialoratypical)
§ ClearUSregulatorypathway- HeldsuccessfulUSFDAPre-Submissionmee)nginQ12016- ConfirmeddenovoregulatorypathwayasClassIIMedicalDevice- CommencingpivotalUSclinicalstudy,SMARTCOUGH-C,attop-)erhospitalstosupportdenovosubmission
§ USmarketentryin2017- LaunchviaUStelehealthpartnertoreachmillionsofpa)entsquickly- Poten)alEuropean,AustralianandAsianmarketentryinparalleltoUS- Deploymenttolowresourceareasviapartnershipswithhumanitarianorganisa)ons
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