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Companyhighlights
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• 12thconsecu,vequarterofgrowthachievedsincefirstrevenues
• Valuableandinnova>veproductpor@oliowithFDA-cleared,TGA-clearedandCE-Markedproducts
• DyeVertistheonlydevicewithanFDAclearedclaimfordyereduc,onwithoutcompromisedimagequality
• Productswithdyeminimiza>onandmonitoringendorsedbycardiologysocietyguidelines
• US$1.8billiontotaladdressablemarketforDyeVertandnewproductDyeTect
• Top>erBoardandmanagementteam,investedinOsprey’ssuccess
• Strongbalancesheetposi>onedforgrowth
Ospreyisaccelera,ngcommercialisa,onofitsproducts
Recenttradingupdate
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Osprey’stradinghasreturnedtonormalfollowingimpactofHurricanesHarveyandIrma
ImpactofHurricanesonUS ImpactonOsprey
• InlateAugust2017,Texas,GeorgiaandFloridawereaffectedbyHurricanesHarveyandIrma
• HarveyandIrmaweretwoofthecostliestUSnaturaldisastersonrecordwithcombineddamageofgreaterthanUS$200billion
“Stormrelateddisrup0onsandrebuildingwillaffecteconomicac0vityintheneartermbutpastexperiencesuggeststhatthestormsareunlikelytomateriallyalterthecourseofthena0onaleconomyoverthemediumterm.”–USFederalReserve
• Achieved12thconsecu>vequarterofgrowthdespitesubstan>aldisrup>ontokeysalesterritoriesfromthehurricanes
• Con>nuedtomaintainstrongleadingindicatorsforfuturegrowth,with52hospitalsnowintheevalua>on-to-purchasephase
“DespitethesevereimpactofHurricanesHarveyandIrmaonSouthernTexas,FloridaandGeorgia,wewereencouragedbycon0nuedstronggrowthinunaffectedterritoriesandpleasedthatouroverallsalesgrowthwasposi0ve.Wehaveseenastrongstarttothecurrentquarterandlookforwardtoresumingourstronggrowthtrajectory.”-MikeMcCormick(OspreyPresidentandCEO)
Ospreyisdedicatedtoprotec,ngkidneys
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Ospreyspecialisesinthecommercialisa,onofproprietarytechnologiesdesignedtoprotectkidneysfromtheharmfuleffectsofdye
Commonlyperformedimagingproceduresfortheheartandlegsrequiretheinjec,onofx-raydye,whichisthenclearedbythekidney
• Theharmfuleffectsofdyecancausedamagetopa>ents’kidneys,knownasContrastInducedAcuteKidneyDamage(CI-AKI)
• DyeVertandDyeVertPlusareproprietarydyereduc>onandmonitoringtechnologiesdesignedtoprotectthekidneysofpa>entswithchronickidneydisease,whoaremostatriskofCI-AKI
Pa,entImpactFromCI-AKI
CI-AKIisagrowingproblemassociatedwithpoorpa,entoutcomesaVercoronaryangiographyorinterven,on
Tsai TT, Patel UD, Chang TI et al. Contemporary Incidence, Predictors, and Outcomes of Acute Kidney Injury in Patients Undergoing Percutaneous Coronary Interventions: Insights from the NCDR Cath-PCI Registry. J Am Coll Cardiol Intv 2014;7:1-9.
AKI incidence: population incidence of acute kidney injury among cardiac cath. and PCI patients in the United States from 2001 to 2011. AKI indicates acute kidney injury. Brown J et al. J Am Heart Assoc. 2016;5:e002739.
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HospitalImpactFromCI-AKI
Hospitalcostsincreaseforpa,entswithCI-AKIasmostprocedure-relatedpooroutcomesaretheresponsibilityofthehospital
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1SubramanianS,etal.EconomicBurdenofCIN:Implica>onsforPreven>onStrategies.JournalofMedicalEconomics.2007;10:119-134.1PfunterA,etal.AgencyforHealthcareResearchandQualitySta>s>calBrief#168.December2013.hips://www.hcup-us.ahrq.gov/reports/statbriefs/sb168-Hospital-Costs-United-States-2011.pdf2CenterofMedicareandMedicaidServicesWebsite:hip://www.cms.gov/Medicare-Fee-for-Service-Payment/AcuteInpa>entPPS/Readmissions-Reduc>onpProgram.html2AmericanHospitalAssocia>onFactsheet:HospitalReadmissionReduc>onProgram.April14,2014.hip://www.aha.org/content/13/fs-readmissions.pdf3AmericanCollegeofCardiologyCMSReleasesProposed2018MedicareQPPRulehip://www.acc.org/latest-in-cardiology/ar>cles/2017/06/20/17/40/cms-releases-proposed-2018-medicare-qpp-rule
1.Increasedlengthofstay1
2.Increased30-dayreadmissions2
3.Increasedbundledpaymentrisk3
Osprey’ssolu,on:DyeVertPlusSystem
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Easytosetup,anddoesnotdisruptpa,entflowandrequiresnochangefromstandardphysiciantechnique
With Osprey dye reduction
Without Osprey dye reduction
Compellingeconomicargument
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CI-AKIincreaseshospitalcoststhroughincreasedlengthofstayand30-dayreadmissions–Osprey’sDyeVerthelpsmi,gatetheserisks
• CI-AKIpa>entsaverage4daysofextendedhospitaliza>on1-3
• Addi>onalhospitaliza>oncosts~$12,000foreachCI-AKIpa>ent4
• Extendedhospitaliza>onnega>velyimpactshospitalandphysicianqualityscores(highlyrelevantforhospitalinUShealthsystem)
1PfunterA,etal.AgencyforHealthcareResearchandQualitySta>s>calBrief#168.December2013.hips://www.hcup-us.ahrq.gov/reports/statbriefs/sb168-Hospital-Costs-United-States-2011.pdf.2ChertowGM,etal.AcuteKidneyInjury,Mortality,LengthofStay,andCostsinHospitalizedPa>ents.JAMSocNephrol.2005,16:3365-3370.3LiangosO,etal.EconomicBurdenofCIN:Implica>onsforPreven>onStrategies.JournalofMedicalEconomics.2007;10:119-134.4SubramanianS,etal.EconomicBurdenofCIN:Implica>onsforPreven>onStrategies.JournalofMedicalEconomics.2007;10:119-134.5KoulouridisI,etal.Hospital-AcquiredAcuteKidneyInjuryandHospitalReadmissions:ACohortStudy.AmKidneyDis.2015;65(2):275-282.
15xCI-AKIpa,entsare15,mesmorelikelytobehospitalizedover4days
37%CI-AKIpa,entshavea37%increasein30-dayreadmissions
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ProvenCustomerAdop,on
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Keycustomeradop,onmetricsshowstrongproductperformancetoaddressunmetclinicalneedforCI-AKIreduc,on
Quarterlyunitsalesgrowth
TotalhospitalspurchasingDyeVert
Strongpipelineofhospitals
178%unitsalesgrowthinQ32017,ascomparedtoQ32016
144%increaseinnewhospitalspurchasingyearoveryear
52hospitalsatendofQ32017inthesample-to-purchaseprocess
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Quarterlyproductunitsalessinceincep,on
0
200
400
600
800
1,000
1,200
1,400
4Q141Q152Q153Q154Q151Q162Q163Q164Q161Q172Q173Q17
AVERTsales DyeVertsales
Focusedcommercialisa,onapproach
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Ospreyfollowsatwo-stepsalesprocessinallterritories
Sample-to-purchase(approx.3-4months)• SalesrepsdirectlyapproachkeyphysicianstosampleDyeVert• 90%ofphysiciansapproachedprogresstoevalua>ngtheproduct• Thesephysiciansthensupporttheproduct’spurchasewiththe
hospitalValua>onAssessmentCommiiee
Increasingpenetra>onwithinhospitals• Onceahospitalisapprovedtopurchase,thefocusshiqsto
expandingtheproduct’sreachtoallphysicians• Increasedpenetra>onwithinpurchasinghospitalsensures
thatallpa>entswithpoorkidneyfunc>onarecoveredbyDyeVert
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Pillarsofsalesgrowthstrategy
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Aggressivecommercializa,onstrategyfocusesonnewsalesrepresenta,vesandincreasingawarenessabouttheimportanceofkidneyprotec,on
SalesterritoryexpansionFocusonaddingnewhighlyexperiencedsalesrepsinterritorieswiththehighestratesofpoorkidneyfunc>on
Podiumpresenta,onsandphysicianadvocatesFocusonkeyopinionleadingphysicianswhoadvocateforthebenefitsofOsprey’sproductsatkeyindustryconferences
Marke,ngkidneyprotec,onFocusonmarke>ngthebenefitsofOsprey’sproductsinprotec>ngpa>ents’kidneysandtheirabilitytohelphospitalsadheretona>onalguidelinesarounddyesavings
ImprovementsandnewtechnologiesandplabormsConstantinnova>onfocusedonimprovingpa>entoutcomesandreducinghospitalcosts.
Salesterritories
1. Shadingonthemapreflectspopula>ondensity
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CA-South
TX-EastTX-South
Southeast
FL-Central
Carolinians
TX-North
FL-South
CA-North
St.Louis
Chicago LongIsland/JerseyShore
Cincinna,
Arizona/LasVegas
CT/NJ
FL-Tampa
Minnesota
Existing Sales Territories 18
Next Planned Sales Territories 3
Existing Clinical Specialist 5
Pihsburgh
MI
LouisianaArkansas
Next Planned Clinical’s 2
Colorado/Utah
Highqualitysalesrepsstrategicallyposi,onedinareaswithhigherinstancesofkidneydamage,withplanstogrowsaleshires
Marke,ngkidneyprotec,on
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“BeKindtoKidneys”campaignisdrivingadop,onoftheDyeVertSystembyincreasingawarenessforthena,onaldyesavingsguidelines
Theproblem Theguidelines Osprey’sproducts
Onlyproductclearedforcontrastreduc>on
• Screenforrisk
• Increasehydra>on
• Minimizecontrast
Podiumpresenta,ons
Ospreyiscommihedtosuppor,ngkeyscien,ficconferencesandresearch
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AmericanCollegeofCardiology(ACC)Dr.PrasadpresentedonDyeVertPlusatInnova>onSymposiuminMarch2017
CardioRenalConnec,onsTwopodiumpresenta>onsonDyeVertPlusinApril2017
EmoryPrac,calInterven,onCourse(EPIC)Mee>ngsponsorwithfocusedmessageonDyeVertPlus
SocietyforCardiovascularAngiographyandInterven,ons(SCAI)Threepodiumpresenta>onsonDyeVertatbreakfastsymposium
ComplexCardiovascularCatheterTherapeu,cConference(C3)Dr.RichardHauserpresentedonAKIreduc>onstrategies,includingDyeVert
Na,onalCardiovascularDataRegistry(NCDR)Onlymedicaldeviceexhibi>ng,focusedmessage“BeKindtoKidneys”
TranscatheterCardiovascularTherapeu,cs(TCT)Co-sponsoredluncheonandCI-AKISymposiumwithmul>pleDyeVertpresenta>ons
Clinicalresearch
Post-approvalclinicalresearchac,vi,es
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Ospreysponsoredtrials• DyeVertPlusmul>centertrial,primaryendpointdyesavings,secondaryadverseeventstoincludeCI-AKI
Physicianini,atedQualityImprovementtrials• AHA/ACCguidelinesplusDyeTect™orDyeVertPlus• Datacollec>onincludesACCNCDRCath-PCIregistry• OutcomesincludeAKIreduc>onanddyereduc>on
Physicianini,atedhighriskpa,entpopula,ontrials• CTO-primaryendpointcontrastvolumevs.ProgressCTORegistry• STEMI-primaryendpointcontrastvolumesavings
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Latestresearchpublishedinleadingmedicaljournalsupportsgreateradop,onofOsprey’sproducts
Posi,vedatahighlysuppor,veofOsprey’sproductswasrecentlypublishedintheJournaloftheAmericanMedicalAssocia,on(JAMA)
• JAMAisthemostwidelycirculatedmedicaljournalglobally,publishedsince1883
• JAMA’srecentpublica>onanalyseddatafromNCDRdatabase
ü Concludedthatdyereduc>onwasnecessarytominimizeAKI1
ü DyeVertistheonlydevicewithanFDAclearedclaimfordyereduc>onwithoutcompromisedimagequality
Researchfindingsaresuppor,veoffutureadop,onofDyeVertandDyeVertPlus,theonlyproductswithFDAclearancefordyereduc,on
“AKIratesvarygreatlyamongphysicians,whoalsovarymarkedlyintheiruseof
contrastanddonotusesubstan>allylesscontrastinpa>entswithhigherriskforAKI.
ThesefindingssuggestanimportantopportunitytoreduceAKIbyreducingthe
varia,onincontrastvolumesacrossphysiciansandloweringitsuseinhigher-risk
pa,ents.”1
DrAmitAmin
1. “Varia>oninContrastVolumewithAcuteKidneyInjuryinPa>entsUndergoingPercutaneousCoronaryInterven>on”–DrAmitAmin,JournalofAmericanMedicalAssocia0onCardiology,publishedonline5July2017
Recentsuppor,veresearch
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Newproductpipelineexpandsmarketpoten,alforkidneyprotec,on
ApprovedbykeyregulatorsinUSandEU
LeveragestechnologyfromDyeVertPlus
Increasesaddressablemarketby40%
Newproductpipeline
CEMarkexpected2Q,FDA4Q2017
Offersdyesavingsforpowerusers
Approximately25%ofUSangiographymarket
Inmarketwithini-allaunchphase,receivingvaluableclinicianfeedback
Osprey’saddressablemarketnow$1.8bn
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LaunchofDyeTectincreasesOsprey’saddressablemarketby40%toUS$1.8billionbyaddinganaddi,onal3.5millionrelevantprocedures
DyeVertPlusmarketopportunityof3.2millionproceduresperyearintheUSAandWesternEU‒ CKD:1.3millionproceduresperyear‒ Diabetes:1.0millionproceduresperyear‒ STEMI:440Kproceduresperyear‒ Peripheral:450Kproceduresperyear
DyeTectmarketopportunityof3.5millionproceduresperyearintheUSAandWesternEU‒ Coronary:3.1millionproceduresperyear‒ Peripheral:476Kproceduresperyear
AveragesellingpriceofDyeVertisUS$355ExpectedlistpriceofDyeTectisUS$149
Totalmarketopportunity$1.8billion
Keydriversofshareholdervalue
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Ospreyremainsfirmlyfocusedonsalestodriveshareholderreturns
SALESGROWTHGrowsalesteamandterritories
• OngoingquarteronquartersalesgrowthofDyeVertisexpectedtocon>nuewithincreasingawarenessandagrowingsalesteam
• PilotsalesterritoryunderwayinGermanyandJapan
ECONOMICSCapitalizeonnewlegisla0on
• Takeadvantageofmandatorydyesavingsguidelines• Capitaliseontheshiqofhospital/physicianpaymentsbasedon
“procedurevolume”to“improvingquality”
• FirstinHumanExperienceDyeVertPlus,pendingpublica0oninJIC• DyeVertRCT,submissioncompletedexpectpublica0on4Q2017• Contrast-InducedAKI:Preven>veMeasuresthatWork.TCT2017• FirstinHumanExperience,DyeTect.Submissionplanned
PODIUMScien0ficpresenta0ons
R&DDevelopmentofR&DporYolio
• Powerinjector-compa,bleDyeVertindevelopment• WorkingwithkeyPhysiciansonspeciallydesignedDyeVertPlusthat
willbeop>mizedforChronicTotalOcclusionsandSTEMI
Companyoverview
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Osprey’sposi,vesharepricemomentumissupportedbystrongsalesgrowthandreflec,veofitsexci,ngpipelineoffuturecustomers
Topshareholders CDIs %
BrandonCapitalPartners 91.4m 26.9%
CMCapitalVT 34.0m 10.0%
JCPInvestmentPartners 17.4m 5.1%
Financialinforma,on
Shareprice(1-Dec-17) A$0.43
52weeklow/high A$0.34/A$0.51
Numberofshares(m) 339.4
Marketcapitalisa,on A$145.9m
Cash(30-Sep-17) US$36.1m/A$27.3m
Debt(30-Sep-17) Nodebt
Enterprisevalue A$118.6m
• Inaddi>on,Kine>cInvestmentPartnersLtdhasinterestsinapproximately7%oftheissuedcapitalofOsprey
Note:Greyshadingrepresentssubstan>alholdingsassociatedwithOspreyBoardmembers,ChrisNaveandAndyJane
Note:AssumesAUDUSDexchangerateof0.75
SharepriceperformanceAcps Volume
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Volume OSPcloseprice
This presenta>on has been prepared by Osprey Medical, Inc. (“Osprey” or the “Company”) for the sole purpose of providing general and backgroundinforma>ononOsprey.Thispresenta>ondoesnotcontainallinforma>onnecessarytomakeaninvestmentdecision.
This presenta>on does not cons>tute an offer, invita>on, solicita>on or recommenda>on by any person to sell or apply for securi>es in Osprey in anyjurisdic>on,andnoneofthispresenta>ondocumentoritscontentsshallformthebasisofanycontractorcommitment.Thispresenta>onisnotintendedtocons>tutelegal,taxoraccoun>ngadviceoropinion,orfinancialproductadviceandshouldnotberelieduponasarepresenta>onofanymaierthatapersonshouldconsiderinevalua>ngOsprey. Youmustnotrelyonthepresenta>onprovidedbutmakeyourownindependentassessmentofthepresenta>onandseekandrelyuponyourownindependenttaxa>on,legal,financialorotherprofessionaladviceinrela>ontothepresenta>on.Thispresenta>ondoesnottakeintoaccountanyourinvestmentobjec>ves,taxa>onsitua>on,financialsitua>onorneeds.Ospreyisnotlicensedtoprovidefinancialproductadviceinrespectofitssecuri>esoranyotherfinancialproducts.Coolingoffrightsdonotapplytotheacquisi>onofOspreysecuri>es.
None of Osprey, its officers, directors, employees and agents, nor any other personmakes any representa>on orwarranty, express or implied, as to, orendorsementof,Osprey,theaccuracyorcompletenessofany informa>on,statementsorrepresenta>onscontained inthispresenta>onandnoneofthemacceptsanyresponsibilityorliabilityforanyerrorsoromissionsinthispresenta>onwhatsoever.
Theinforma>oninthispresenta>onissubjecttochangewithoutno>ceandOspreydoesnothaveanyresponsibilityorobliga>ontoinformyouofanymaierarisingorcomingto theirno>ce,aqer thedateof thispresenta>on,whichmayaffectanymaier referredto in thispresenta>on. Thedistribu>onof thispresenta>onmayberestrictedbylawandyoushouldobserveanysuchrestric>ons.
Thispresenta>oncontainscertainforwardlookingstatementswhichinvolveknownandunknownrisks,uncertain>es,andotherfactorswhichmaycausetheactualresultsorperformanceofOspreytobemateriallydifferentfromtheresultsorperformanceexpressedorimpliedbysuchforwardlookingstatements.Past performance is not necessarily a guide to future performance and no representa>on or warranty is made as to the likelihood of achievement orreasonablenessofanyforwardlookingstatementsorotherforecast.
Allfigures in thepresenta>onareA$ thousandsonaconstantcurrencybasisbasedonanexchange ratesofA$1:US$0.75unless statedotherwiseandallmarketsharesarees>matesonly.Thepro-formahistoricalfinancialinforma>onincludedinthispresenta>ondoesnotpurporttobeincompliancewithAr>cle11ofRegula>onS-Xoftherulesandregula>onsoftheUSSecuri>esandExchangeCommission.Thispresenta>onmaycontaincertainfinancialdatathatis"non-GAAPfinancialmeasures"underRegula>onGundertheU.S.Securi>esExchangeActof1934,asamended.Thedisclosureofsuchnon-GAAPfinancialmeasuresinthemannerincludedinthispresenta>onwouldnotbepermissibleinaregistra>onstatementundertheSecuri>esAct.Thesenon-GAAPfinancialmeasuresdonothaveastandardisedmeaningprescribedbyAIFRSand, therefore,maynotbecomparabletosimilarly>tledmeasurespresentedbyotheren>>es,norshould theybeconstruedasanalterna>vetootherfinancialmeasuresdetermined inaccordancewithAIFRS.Althoughwebelieve thesenon-GAAPfinancialmeasuresprovideusefulinforma>ontousersinmeasuringthefinancialperformanceandcondi>onofourbusinessforthereasonssetoutinthispresenta>on,youarecau>onednottoplacedunduerelianceonanynon-GAAPfinancialmeasuresandra>onsincludedinthispresenta>on.
DyeVert™,DyeVert Plusand DyeTect SystemsRegulatory Status:Europe – CEMark obtained;Australia – TGA approval obtained;United States – 510(k)cleared.
IC0012Rev.A
Disclaimer
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