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Digital healthcare for respiratory disease Tony Kea)ng Chief Execu)ve Officer and Managing Director [email protected] 12 th Bioshares Biotech Summit 29-30 July 2016 ASX: RAP For personal use only

Transcript of For personal use only - asx.com.au · PDF fileTarge)ng mul)ple market segments 13 Telehealth...

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Digitalhealthcareforrespiratorydisease

TonyKea)ngChiefExecu)veOfficerandManagingDirector

[email protected]

12thBiosharesBiotechSummit29-30July2016

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)nganyerrororomissionwhichmaybecomeapparenta^erthisdocumenthasbeenissued.

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)ngplaforms-  Strongdemandalsoseenwithinclinics,emergencyroomsandoutpa)entfacili)es

§  Compellingclinicalevidencewith1,430pa)entsenrolledinpediatricandadultstudies§  SuccessfulPre-Submissionmee)ngheldwithUSFDA,targe)ngUSapprovalinearly2017§  USclinicalstudytobegininQ32016,Massachuse_sGeneralHospitalannouncedasfirstsite§  Strongbalancesheetwith$12.5MraisedinMarch2016

31.ResAppes)matebasedonOECDdoctorvisitspercapitadataandassuming10%ofvisitsareforrespiratorydisease(basedonUSdata)

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Companyoverview

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CapitalStructure(ASX:RAP)MarketCap. $240M

SharePriceasof25July2016

$0.37

SharesonIssue1 650M

PerformanceShares2 93.75M

Op)ons3 15.5M

StaffIncen)veOp)ons4 25M

CashBalanceasof29April2016

$14.9M

1.  Includes57.2Mescrowedshares(un)l14/7/17)2.  Issuedonachieving$20Mofannualrevenueoronanacquisi)on3.  10M,exercisepriceof2.6c,expire31/12/16;4.5M,exercisepriceof

28c,expire29/4/19;1.87M,exercisepriceof30c,expire29/4/194.  IssuedtoMD,5Mop)onsatexercisepriceof2.5c,5Mat5cand10M

at10c,5yearexpiry;IssuedtoDrAbeyratne,3Mat5cand2Mat10c

BoardofDirectorsDrRogerAston Non-Execu)veChairman(ChairmanofOncosil,formerCEOofMaynePharma,CambridgeAn)body,cofounderofpSividaCorp)

DrTonyKea)ng ManagingDirectorandCEO(formerDirector,CommercialEngagementofUniQuest,engineeringmanagementroleswithExaCorpora)on)

MrBrianLeedman Execu)veDirectorandVP(ChairofAusBiotech-WA,co-founderofImugeneLtdandOncosilMedicalLtd,formerVP,IRatpSividaCorp.andGroupMarke)ngManageratE&Y-WA)

MrChrisNtoumenopoulos Non-Execu)veDirector(14+yearsinvestmentbanking,AssociateDirectoratCPSCapital,formerlyatCi)group,IndianOceanCapital)

Substan)alShareholdersFreemanRoad:6.84%FidelityInterna)onal:5.06%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

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Revolu)onarytooltodiagnoserespiratorydiseasebasedonsoundsignatures

§  ExclusiveworldwidelicensetomachinelearningtechnologydevelopedbyAssociateProfessorAbeyratneatTheUniversityofQueensland

§  Usessignaturesincoughingandbreathingsoundstodiagnosedisease

§  Ini)aldevelopmentatUQfundedbyTheGatesFounda)ontoreducethe1Mchilddeathsp.a.duetopneumoniainthedevelopingworld

§  Patentapplica)onfiledinUS,Australia,Europe,China,JapanandSouthKorea

§  Usesthemicrophonesintoday’ssmartphones→  Noaddi'onalhardwarerequired

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Cough Spectra too is different

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Cough Spectra too is different

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Easytouse,instantdiagnosisusingonlyasmartphone

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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

2015AustralianPediatricStudy

880pediatricpa)entsenrolledtodate

JoondalupHealthCampusandPrincessMargaretHospital

FundedbytheBillandMelindaGatesFounda)on

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Buildingstrongclinicalevidenceinadults

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AdultStudyPreliminaryResults Sensi'vity Specificity Accuracy

COPDvs.norespiratory 100% 93-98% 96-99%

Asthmavs.norespiratory 92-100% 92-93% 92-95%

Pneumoniavs.norespiratory 100% 100% 100%

AsthmaorCOPDvs.norespiratory 94-96% 93-94% 94-95%

Asthmavs.COPD 96% 95% 96%

Pneumoniavs.Asthma 94% 96% 95%

2015AustralianAdultStudyJoondalupHealthCampusandWesleyHospital510adultpa)entsenrolledtodate

Preliminaryresultsreleasedon21June2016usingini)al143pa)entdatasetExpec)ngfurtherresultsinQ3andQ42016

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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

101.  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%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)

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Pursuingatrulyglobalopportunity§  SignificantgrowthintelehealthinEuropeandAustralia

-  PlantofileforCEMarkinQ42016

§  Hugepoten)alinAsiaPacificwherethereareover1billionsmartphoneusers1

-  Highprevalenceofrespiratorydiseaseandna)onwideshortageofdoctorsinChina2

-  Chinesemobileonlineconsulta)onexamples:

§  Ac'vepartnershipdiscussionsinallregions

121. 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)ngplaforms

✓  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

§  Clinicalcollabora'onstobeannouncedshortly

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1. TheGlobalAsthmaReport2014(GlobalAsthmaNetwork)2. USCDC3. EuropeanLungWhiteBook4. AsthmaAustralia

5. WHO6. Interna)onalStudyofAsthmaandAllergiesinChildhood7. COPDFounda)on

1in7childrenhasasthma6

1in5adultsover45hasCOPD7

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Anoutstanding12monthsofachievements

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¨  Ini)atedandenrolled880pa)entsinmul)-sitepediatricclinicalstudy¨  Releasedpreliminaryresultsfrompediatricstudy(Q32015,Q42015and2xQ12016)¨  Demonstratedsuperioritytostethoscopeforlowerrespiratorydiseasediagnosis(Q12016)¨  Reportedpreliminaryresultsforsepara)onofviral,bacterialandatypicalpneumonia(Q12016)¨  Ini)atedandenrolled510pa)entsinmul)-siteadultclinicalstudy¨  Releasedpreliminaryresultsfromadultstudy(Q22016)¨  AnnouncedMassachuse_sGeneralHospitalasfirstUSclinicalstudysite(Q32016)

¨  Appointedbest-in-classFDAregulatoryconsultant–ExperienGroup(Sunnyvale,CA)¨  FiledPre-SubmissionpackagewiththeUSFDA(Q42015)¨  HeldPre-Submissionmee)ngwiththeUSFDA(Q12016)

¨  RaisedAU$4MandlistedontheASX(Q32015)¨  RaisedAU$12.5Mfromins)tu)onalinvestorstoexpandmarketopportunity(Q12016)¨  Securedpartnershipwithglobalhumanitarianorganisa)onfordevelopingworldtrial(Q12016)¨  Builtuptheteamwithfournewhires(so^waredevelopment,clinical/regulatoryopera)ons)

Regulatory

Clinical

Corporate

✓✓

✓✓

✓✓

✓✓

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PivotalmilestonesleadinguptofirstFDAapproval

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¨  Announceaddi)onalUSpediatricclinicalstudysites(Q32016)¨  Ini)ateUSpivotalpediatricclinicalstudy(Q32016)

•  TobesupportedintheUSbyINCResearch,aleadingglobalCRO

¨  Announceclinicalcollabora)onsforasthmaandCOPDmanagement(Q32016)¨  Releaseupdatedandexpandedadultclinicalstudyresults(Q3andQ4,2016)¨  ReleaseresultsfromUSpivotalpediatricclinicalstudy(earlyQ42016)¨  FiledenovopremarketsubmissionwithFDAforfirstResAppproduct(earlyQ42016)¨  FileforCEMarkinEurope(Q42016)¨  FDAmarke)ngapprovalforfirstResAppproduct(early2017)¨  Ini)atepivotaladultclinicalstudyinUS(early2017)

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Summary§  Revolu)onarytechnology–diagnosisandmanagementofrespiratorydiseasewithouttheneedfor

addi)onalhardware§  Compellingclinicalevidence

-  Veryhighaccuracyfrommul)plepaediatricclinicalstudies,over800pa)entsenrolledtodate-  Breakthroughresults:Detec)nglowerrespiratorytractinvolvementwhichmaybemissedbyausculta)onand

diagnosingthecauseofpneumonia(viral,bacterialoratypical)-  Posi)vepreliminaryresultsfromadultclinicalstudy

§  ClearUSregulatorypathway-  HeldsuccessfulUSFDAPre-Submissionmee)nginQ12016-  ConfirmeddenovoregulatorypathwayasClassIIMedicalDevice-  CommencingUSclinicalstudytosupportdenovosubmissioninQ32016

§  USmarketentryinearly2017-  LaunchviaUStelehealthpartnertoreachmillionsofpa)entsquickly-  Poten)alEuropean,AustralianandAsianmarketentryinparalleltoUS-  Deploymenttolowresourceareasviapartnershipswithhumanitarianorganisa)ons

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