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Digitalhealthcareforrespiratorydisease
TonyKeatingCEOandManagingDirector
InvestorPresentationApril2018
ASX:RAP
Disclaimer
This presentation has been prepared by ResApp Health Limited (“ResApp”). The information contained in this presentation is a professional opiniononly and is given in good faith. Certain information in this document has been derived from third parties and though ResApp has no reason tobelieve that it is not accurate, reliable or complete, it has not been independently audited or verified by ResApp. Any forward-looking statementsincluded in this document involve subjective judgment and analysis and are subject to uncertainties, risks and contingencies, many of which areoutside the control of, and may be unknown to, ResApp. In particular, they speak only as of the date of this document, they assume the success ofResApp’s strategies, and they are subject to significant regulatory, business, competitive and economic uncertainties and risks. Actual future eventsmay vary materially from the forward-looking statements and the assumptions on which the forward-looking statements are based. Recipients ofthis document (Recipients) are cautioned to not place undue reliance on such forward-looking statements. ResApp makes no representation orwarranty as to the accuracy, reliability or completeness of information in this document and does not take responsibility for updating anyinformation or correcting any error or omission which may become apparent after this document has been issued.
To the extent permitted by law, ResApp and its officers, employees, related bodies corporate and agents (Agents) disclaim all liability, direct, indirector consequential (and whether or not arising out of the negligence, default or lack of care of ResApp and/or any of its Agents) for any loss or damagesuffered by a Recipient or other persons arising out of, or in connection with, any use or reliance on this presentation or information.
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AllamountsinAustraliandollarsunlessstatedotherwise.
2
Digitalhealthcareforrespiratorydisease
§ Developingtheworld’sfirstclinically-tested,regulatory-clearedrespiratorydiseasediagnostictestandmanagementtoolsforsmartphones- Noadditionalhardwareneeded
§ Hugeglobalmarket,700million+doctorvisitsannuallyforrespiratorydisease1
§ Compellingclinicalevidencewith2,600+patientsenrolledinAustralianpediatricandadultstudies§ Well-fundedtoexecuteourongoingclinicalstrategy
- ExecutionissuesidentifiedinfirstUSpivotalstudy– notanaccurateevaluation- RevisedUSpediatricstudynowrecruiting,on-trackforcompletionmidCY2018- RecruitinginprospectiveAustralianstudies,resultsexpectedH1CY2018
§ Broadeningproductportfolio- Chronicrespiratorydiseasemanagement,at-homescreeningofobstructivesleepapnea
31.ResAppestimatebasedonOECDdoctorvisitspercapitadataandassuming10%ofvisitsareforrespiratorydisease(basedonUSdata)
Companyoverview
4
CapitalStructure(ASX:RAP)
MarketCap. AU$99M
SharePriceas of6April2018
AU$0.15
Shares onIssue 659M
Performance Shares1 93.75M
Options2 6.37M
IncentiveOptions3 51.45M
CashBalanceasof31December2017
AU$5.8M
1. IssuedonachievingAU$20Mofannualrevenueoronanacquisition2. 4.5M,exercisepriceof28c,expire29/4/19;1.87M,exercisepriceof
30c,expire29/4/193. Issuedtodirectors,staffandscientificadvisoryboard
BoardofDirectorsDr RogerAston Non-Executive Chairman(ChairmanofRegeneus,PharmAust and Immuron,Non-Exec. DirectorofOncosilMedical,formerlyCEOofMaynePharma,CambridgeAntibody,co-founderofpSivida)
Dr TonyKeating Managing DirectorandCEO(formerlyDirector,CommercialEngagement atUniQuest,engineeringmanagementroleswithExa Corporation)
Mr NathanBuzza Non-ExecutiveDirector(formerly founderof Commtech Wireless,EVPAzureHealthcareandnon-executivedirectorofAlcidion)
Mr ChrisNtoumenopoulos Non-ExecutiveDirector(ManagingDirectoratTwenty1Corporate,Non-Exec.DirectoratRaceOncology,formerlyatCitigroup,IndianOceanCapitalandCPSCapital)
SubstantialShareholdersFidelityInternational:9.23%FreemanRoad:6.84%IanFrancisReynolds:5.60%
Diagnosisofrespiratorydiseaseisthemostcommonoutcomefromavisittothedoctor
5
AcuteconditionsURTI,influenza,bronchitis,bronchiolitis,pneumonia,pertussis,croup,reactiveairwaysdisease
Chronicconditionsasthma,COPD,cysticfibrosis,bronchiectasis
§ 700M+ doctorvisitsp.a.globally1 forrespiratorydisease→ 125M inUS2 (10%ofallvisits)→ 6-8M inAustralia3
§ Mostcommonreasonsforhospitaladmission4→ Bronchiolitis(infants)→ Asthmaandpneumonia(children)
§ US$10.5Bp.a.directUShospitalcostsforpneumonia5
§ HighprevalenceandgrowthinAsia
1.ResApp estimatebasedonOECDdoctorvisitspercapitadataandassuming10%ofvisitsareforrespiratorydisease(basedonUSdata)2.Ambulatorycasevisits,NationalAmbulatoryMedicalCareSurvey20103.AustralianLungFoundation4.HCUPStatisticalBrief#1485.HCUPStatisticalBrief#160
Diagnosedtodayusingstethoscope,imaging(x-ray,CT),spirometry,bloodand/orsputumtests→Timeconsuming,expensive,subjectiveandnotveryaccurate
Easytouse,instantdiagnosisusingonlyasmartphone§ Machinelearningtechnology developedbyAssociate
ProfessorAbeyratne atTheUniversityofQueensland- Usessignaturesincoughsoundstoinstantlydifferentially
diagnoserespiratorydisease- Abletoautomaticallyimproveperformanceandlearnnew
diseasesfromnewclinicaldatasets§ Usesthebuilt-inmicrophoneinmodernsmartphones
- Noadditionalhardware/accessoriesrequired- Real-timeon-deviceanalysis,noconnectivity/cloudneeded
§ Growingpatentportfolioanddataassets- CorepatentinnationalphaseexaminationinUS,Australia,
Europe,China,Japan,SouthKorea;threepatentapplications- Proprietarydataset,over3,800patients’(includingUS
SMARTCOUGH-Cdata)coughandbreathingsoundsandmatchingclinicalsigns,symptomsanddiagnosis
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Verifiedbycompellingpediatricclinicalevidence
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Breathe-EasyPediatric Study(populationofpatientswithbroadrespiratorysymptoms)
Positive PercentAgreement
NegativePercentAgreement
PrimaryUpperRespiratoryTractInfection(n=53) 92%(95%CI, 82-98) 89%(95%CI,86-91)
Croup(n=57) 100%(95%CI, 94-100) 96%(95%CI, 94-97)
Lower RespiratoryTractDisease(n=492) 90%(95%CI, 87-93) 92%(95%CI, 86-96)
Asthma/ReactiveAirwaysDisease(n=234) 92%(95%CI,88-95) 89%(95%CI,85-92)
Bronchiolitis(n=101) 95%(95%CI, 89-98) 94%(95%CI, 92-96)
Pneumonia(n=123) 89%(95%CI,82-94) 79%(95%CI,75-83)
Breathe-EasyPediatricStudy(2015-)Joondalup HealthCampusandPrincessMargaretHospital,PerthAustralia1,127patients(continuing)- Latestanalysis(announced22/6/17)optimised tomatchdesignofUSSMARTCOUGH-Cstudy- Comparisontoclinicaldiagnosis(incl.CXR,labtests)- Achieved90-100%PPAand89-96%NPAforURTI,croup,LRTD,asthmaandbronchiolitis- Achieved89%PPAand79%NPAforpneumonia
AsperFDAguidance,positiveandnegativepercentagreement(ratherthansensitivityandspecificity)areusedwhenanewtestiscomparedtoanon-referencestandardsuchasaclinicaldiagnosis.
2013PediatricProof-of-ConceptStudySardijto Hospital,Indonesia- 91patients- FundedbytheBill&MelindaGatesFoundation- Achieved>90%accuracyfordiagnosisofpneumoniaandasthmavspneumonia
2013 PediatricProof-of-Concept Sensitivity Specificity Accuracy
Pneumoniavs.allrespiratory 94% 100% 96%
Asthmavs.pneumonia 100% 80% 90%Publishedinpeer-reviewpublications:Abeyratne etal.,AnnalsofBiomedicalEngineering(2013)andKosashi etal.,IEEETransactionsinBiomedicalEngineering(2015)
Buildingstrongclinicalevidenceinadults
8
Breathe-EasyAdultStudy(2015-)Joondalup HealthCampus,PerthAustraliaandWesleyHospital,BrisbaneAustralia1,387adultpatients(continuing)- Latestanalysistargetedintendeduse
populationstoprepareforpivotalstudies- Achievedhighlevelsofaccuracyindiagnosis
ofpneumoniaandacuteasthma- DiagnosisofCOPDandchronicasthma
comparedtothegoldstandardofLFT
Breathe-EasyAdultStudy(comparedtoclinicaldiagnosis,populationofpatientswithbroadrespiratorysymptoms)
Positive PercentAgreement
NegativePercentAgreement
Community-acquiredpneumonia(n=360) 90%(95%CI, 86-93) 88%(95%CI,83-92)
Acuteasthma(n=54) 91%(95%CI, 80-97) 88%(95%CI, 85-91)
Breathe-EasyAdultStudy(comparedtolungfunctiontesting,populationofpatientsreferredtolungfunctiontesting) Sensitivity Specificity
COPD(n=41) 89%(95%CI, 74-96) 87%(95%CI,79-92)
Chronicasthma(n=34) 87%(95%CI, 73-97) 90%(95%CI, 83-95)
Achievingbreakthroughperformanceindiagnosis§ Lowerrespiratorytractdiseasediagnosis
- Effectivetreatmentneedsidentificationoflowerrespiratorytractinvolvement- Correctlydetectedlowerrespiratorytractinvolvementin97%ofcasesinitially“missed”byexperienced
cliniciansusingastethoscope
§ Causeofpneumoniadiagnosis“Weneedfaster,less-expensivediagnostictestsfordoctorstoaccuratelydiagnosethecauseof
pneumonia sotheycaneffectivelytreatit”USCDC(2015)1
- Incorrectdiagnosisleadstounnecessaryandineffectiveantibioticuse- Identifyingthecausetodayistimeconsuming,costlyandonlyavailableintertiaryhospitals- Preliminaryresultsdemonstratedseparationofbacterialandatypicalfromviralpneumoniawith89%-90%
accuracy
91. USDepartmentofHealthandHumanServicesPressRelease,Feb25,2015
(http://www.cdc.gov/media/releases/2015/p0225-pneumonia-hospitalizations.html)
Uniqueopportunitytodeployalongsidetelehealth,oneofthefastestgrowingtrendsinhealthcare§ UStelehealthislarge,andgrowingrapidly§ Providesbenefitsacrossthehealthcaresystem:payors,patientsandhealthcareproviders
§ 30-50%oftelehealthconsultsareforrespiratorydisease4- Todaythereisnoabilitytouseastethoscopeandnoaccurateremotediagnosistoolsavailable
§ ResApp’s testcanbedeliveredanywhere,anytimewhileretainingaclinician’sinput
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75Mconsultsp.a.
(UStelehealth ‘evisits’in2014estimatedbyDeloitte)1
US$12BUSTAM
(GoldmanSachsUStotaladdressablemarketestimate)3
56%growth
(Growthrateuntil2018estimatedbyIHS)2
1. Deloitte,eVisits:the21st centuryhousecall (August2014)2. IHS,WorldMarketforTelehealth (2014)3. GoldmanSachsEquityResearch,TheDigitalRevolutionComestoUSHealthcare(June2015)4. Uscher-PinesandMehrotra (HealthAffairs,2014)andUnitedHealthcare Presentation
Pursuingatrulyglobaltelehealthopportunity§ SignificantgrowthintelehealthinEuropeandAustralia
- PlantofileforCEMarkinCY2018
§ HugepotentialinAsiaPacificwherethereareover1billionsmartphoneusers1
- HighprevalenceofrespiratorydiseaseandnationwideshortageofdoctorsinChina2
- Chinesemobileonlinemedicalconsultationexamples:
§ Activediscussionsinallregions
111. ForresterResearch2. “DearthofDoctorsinChinaSaidtoPutChildren’sHealthatRisk,CaixinOnline,http://english.caixin.com/2016-01-21/100902234.html3. http://www.hkexnews.hk/app/SEHK/2018/2018012901/Documents/SEHK201801290023.pdf
92Mactiveusers229questionsperminute
Raised$183Min2016Chunyuyisheng(SpringRainDoctors)
PingAnHaoyisheng(GoodDoctor)
192.8Mregisteredusers370,000onlineconsultationsperday
ListingonHKEXin20183RaisedUS$500Min2016
Targetingmultiplemarketsegments
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Telehealth Clinical use Developingworld Directtoconsumer
Marketsize
• 22.5Mrespiratory-relatedUStelehealth consultsp.a.
• 13.4MUSEDvisitsforrespiratorydiseasep.a.1(~4.6Mforchildren)
• 1M childdeathsduetopneumoniap.a.3• 151Mcasesofpneumoniaindevelopingcountriesp.a.3
• 400MiPhoneusers4• 1.6BAndroidusers4• mHealth appmarketexpectedtogrowto$25Bbyendof20175
Valueproposition
✓ Theonlyremoteclinically-accuratediagnostictool available
✓ Easilyintegratedintoexistingplatforms
✓ Reducecosts(<$10vs >$200forx-ray)
✓ Reducetime(x-rayadds~30mins,culturescantakedays)
✓ Lowcost,accurate&fast✓ Usablebynon-medical
personnel✓ IntegratesintoIMCI
framework
✓ Convenience✓ Low cost✓ Consumer
empowerment
Commercialstrategy
Partnerwithtelehealthproviderstoreach10sofmillionsofpatients
Initialuseinemergencydepartments(ED),extendingtoregularclinics
Partnerwithleadinginternationalaidagencies toequipfieldpersonnel
Directtoconsumerviaappstorestotargetgrowthinconsumer-ledhealth
Revenuemodel $5-$10pertestfeefromtelehealth providers
$5-$10pertestfeefromhealthcarepayors
annualsubscriptionfromaidagencies
downloadandpertestfeedirectfromconsumers
1. ResApp estimatebasedonOECDpercapitadata2.NHAMCS(2011)3.WHOestimate
4. Statista (2014estimates)5. Research2guidancemHealth AppDeveloperEconomics(2014)
700MdoctorvisitsinOECDforrespiratorydiseasep.a.1
SMARTCOUGH-Cstudy
13
§ Prospective,multi-site,double-blindUSstudywithendpointsofURTI,bronchiolitis,asthma/reactiveairwaysdisease,pneumoniaandlowerrespiratorytractinvolvement- Top-tierUShospitals:MassachusettsGeneralHospital,ClevelandClinic&TexasChildren’sHospital- Recruited1,245patientsaged29daysto12years(December2017– June2017)- Detailsonwww.clinicaltrials.gov (NCT0973282)
§ Top-lineanalysisshowedpredefinedendpointsnotmet§ Studyexecutionissuesidentifiedasskewingtop-lineresults
- Patientstreatedbeforecoughrecordingmade(particularimpactoncroupandasthma/RAD)- Pooraudiorecordingquality(non-patientcoughs,backgroundnoiseandmachinenoiseinterference)- Materialvarianceinfinalclinicaldiagnoses
Aclearpathforward
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§ RevisedUSpediatricstudy,SMARTCOUGH-C-2underway- Detailsonwww.clinicaltrials.gov (NCT03392363)- Recruitingupto1,667patientsaged29daysto12years- SamerecruitmentsitesatSMARTCOUGH-C- Upgradedrecordingapp andtraining,on-sitedataverification- Centralised,independentclinicaladjudication- 640patientsrecruitedasof9th ofMarch2018- AudioQAshowinghighqualityaudio,on-trackforcompletioninmid
CY2018
§ Broadenedpediatricstrategywithprospective,double-blindAustralianstudyunderwaytosupportCEandTGAfilings
§ Prospective,double-blindAustralianadultclinicalstudyunderway(USadultstudiesplanned)
Proof-of-concept Large-scalestudies Pivotalstudies Regulatory submissions Commercialisation
Acuterespiratorydisease
Chronicrespiratorydisease
Otherindications
Broadeningproductportfolio
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Pediatric
Adult
ChronicObstructivePulmonaryDisease
Asthma
ObstructiveSleepApnea
AUstudytocompleteH1CY2018USstudytocompletemidCY2018
AUstudytocompleteendCY2018
AUstudytocompleteendCY2018
AUstudytocompleteendCY2018
RegulatorysubmissionbyendofCY2018Prospectivestudyunderway
Improvingchronicrespiratorydiseasemanagement§ 334Mpeoplehaveasthma1
- 17.7MinUS2,30MinEurope3,2.3MinAustralia4
- $30B+p.a.USeconomicburden2
- Patientadherencetoasthmamedicationsisgenerallyverypoor
§ 65MpeoplehavemoderatetosevereCOPD5
- Emphysemaandchronicbronchitis,primarilycausedbysmoking- 3M+peoplediedofCOPDin2012,6%ofalldeathsglobally5
§ OpportunitytomeasuretheseverityofasthmaandCOPD,withoutthecostofadditionalhardwareortheneedtocarryanextradevice- Demonstrated94%accuracyinidentifyingasthmapatientswhorequireadditionaltreatment- IdentifiedinfectiveexacerbationsinCOPDpatientsat91%(95%CI,84-96)PPAand90%(95%CI,80-96)NPA
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1. TheGlobalAsthmaReport2014(GlobalAsthmaNetwork)2. USCDC3. EuropeanLungWhiteBook4. AsthmaAustralia
5. WHO6. InternationalStudyofAsthmaandAllergiesinChildhood7. COPDFoundation
1in7childrenhasasthma6
1in5adultsover45hasCOPD7
Sleepapneaisthemostcommonsleepbreathingdisorderandissignificantlyunderdiagnosed§ Morethan3in10men,andnearly2in10womenhavesleep
apnea1
§ 80%withmoderateorseveresleepapneaareundiagnosed2
§ Untreated,sleepapneahasbeenlinkedtoheartdisease,strokeandtype2diabetes
§ Majorbarrierstodiagnosis:
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Sleeplaboratorypolysomnography(PSG)
RequiresreferralLongwaittimes$600-$5,000pertestUncomfortable&unfamiliarenvironment
Homesleeptesting(HST)
Requires referral&trainingUpto18%failurerate$150-$500pertestUncomfortable
1. Peppard etal.,AmJEpidemiol (2013)2. AmericanAcademyofSleepMedicine
Convenient,at-homescreeningofobstructivesleepapnea
§ ReplacetheHSTdevicewithasmartphone onthebedsidetable
§ Easytouseandcomfortable,nocables§ Software-only,simpleappdownload
- Usesaudiosignaturesinovernightbreathingandsnoringsoundstoidentifysleepapnea
§ Proof-of-conceptclinicalstudy- Comparedtosimultaneous,in-laboratoryPSG- 731patients,62%male,meanageof53years
(range:18-87),meanahiof24(range:0-196)- 86%sensitivity,83%specificity,0.91AUCROC
§ ProspectivestudyunderwaywithregulatorysubmissionplannedbyendofCY2018
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Summary§ Revolutionarytechnology– diagnosisandmanagementofrespiratorydiseasewithouttheneedfor
additionalhardware§ CompellingclinicalevidencefromAustralianstudiesof2,600+patients§ Multipleclinicalprogramsunderway
- RevisedUSpediatricclinicalstudyrecruitingwell,on-tracktocompletemidCY2018- Australianprospectivepediatricandadultstudiesrecruiting,expectingpediatricresultsinH1CY2018
§ Wellunderstoodregulatorypathway- HeldUSFDAPre-SubmissionmeetinginQ1CY2016,confirmeddenovoregulatorypathwaystrategy- FDAsubmissionfollowingUSpediatric studycompletion- CE(Europe)andTGA(Australia)submissionsfollowingAustralianprospectivestudycompletion
§ Broadenedproductportfolio- Chronicrespiratorydisease(asthma,COPD)management- At-homescreeningofobstructivesleepapnea,regulatorysubmissionbyendofCY2018
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