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