investor presentation - biocentury newsmakers for … · at the core of clinuvel’s business is...

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Company Announcement INVESTOR PRESENTATION - BIOCENTURY NEWSMAKERS CONFERENCE Melbourne, Australia, and New York, USA, 10 September 2018 CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) presented to the BioCentury NewsMakers conference in New York on Friday 07 September. A copy of the presentation and speaking notes is appended. – End – About CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY; XETRA- DAX: UR9) is a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic and skin disorders. As pioneers in photomedicine and understanding the interaction of light and human biology, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for photoprotection and repigmentation. These patient groups range in size from 5,000 to 45 million worldwide. CLINUVEL’s lead compound, SCENESSE ® (afamelanotide 16mg), was approved by the European Commission in 2014 for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). More information on EPP can be found at http://www.epp.care. Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Switzerland, the US and Singapore, with the UK acting as the EU distribution centre. For more information go to http://www.clinuvel.com. SCENESSE ® is a registered trademark of CLINUVEL PHARMACEUTICALS LTD. Media enquiries USA: Terri Clevenger, Continuum Health Communications, T +1 (203) 227-0209, [email protected] Europe: Lachlan Hay, CLINUVEL (UK) LTD. T +44 1372 860 765 [email protected] Investor enquiries [email protected] Forward-Looking Statements This release to the Australian Securities Exchange and to press may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause CLINUVEL’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward- looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that the FDA may require additional studies beyond the studies planned for product candidates or may not provide regulatory clearances, including for SCENESSE ® ; that the FDA may not provide regulatory approval for any use of SCENESSE ® or that the approval may be limited; that CLINUVEL may never file an NDA for SCENESSE ® regulatory approval in the US; that the Company may not be able to access adequate capital to advance its vitiligo For personal use only

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Page 1: INVESTOR PRESENTATION - BIOCENTURY NEWSMAKERS For … · At the core of CLINUVEL’s business is the concept of medicinal photoprotection, providing protection to skin from light

Company Announcement

INVESTOR PRESENTATION - BIOCENTURY NEWSMAKERS CONFERENCE Melbourne, Australia, and New York, USA, 10 September 2018 CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) presented to the BioCentury NewsMakers conference in New York on Friday 07 September. A copy of the presentation and speaking notes is appended. – End – About CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY; XETRA-DAX: UR9) is a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic and skin disorders. As pioneers in photomedicine and understanding the interaction of light and human biology, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for photoprotection and repigmentation. These patient groups range in size from 5,000 to 45 million worldwide. CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), was approved by the European Commission in 2014 for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). More information on EPP can be found at http://www.epp.care. Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Switzerland, the US and Singapore, with the UK acting as the EU distribution centre. For more information go to http://www.clinuvel.com. SCENESSE® is a registered trademark of CLINUVEL PHARMACEUTICALS LTD. Media enquiries USA: Terri Clevenger, Continuum Health Communications,

T +1 (203) 227-0209, [email protected] Europe: Lachlan Hay, CLINUVEL (UK) LTD.

T +44 1372 860 765 [email protected]

Investor enquiries [email protected] Forward-Looking Statements This release to the Australian Securities Exchange and to press may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause CLINUVEL’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that the FDA may require additional studies beyond the studies planned for product candidates or may not provide regulatory clearances, including for SCENESSE®; that the FDA may not provide regulatory approval for any use of SCENESSE® or that the approval may be limited; that CLINUVEL may never file an NDA for SCENESSE® regulatory approval in the US; that the Company may not be able to access adequate capital to advance its vitiligo

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programs; that the Company may not be able to retain its current pharmaceutical and biotechnology key personnel and knowhow for further development of its product candidates or may not reach favourable agreements with potential pricing and reimbursement agencies in Europe and the US; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE® which may lead to it being unable to supply its commercial markets and/or clinical trial programs. Level 6, 15 Queen Street T +61 3 9660 4900 www.clinuvel.com Melbourne, Victoria 3000 F +61 3 9660 4999 Australia

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Page 3: INVESTOR PRESENTATION - BIOCENTURY NEWSMAKERS For … · At the core of CLINUVEL’s business is the concept of medicinal photoprotection, providing protection to skin from light

CLINUVELPHARMACEUTICALSLTD

NewYork,07September2018

ASX: CUVNASDAQINTERNATIONALDESIGNATIONADR: CLVLYXETRA: UR9

LachlanHayGeneralManagerCLINUVEL(UK)LTD

CLINUVEL has taken the timely opportunity to present its story internationally. As of Friday 07 September 2018, the ASX listed stock CUV been included in the S&P/ASX 300 Index.

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Page 4: INVESTOR PRESENTATION - BIOCENTURY NEWSMAKERS For … · At the core of CLINUVEL’s business is the concept of medicinal photoprotection, providing protection to skin from light

Forward‐looking statements,“safeharbor”

Thisreleasecontainsforward‐lookingstatements,whichreflectthecurrentbeliefsandexpectationsofCLINUVEL’smanagement.Statementsmayinvolveanumberofknownandunknownrisksthatcouldcauseourfutureresults,performanceorachievementstodiffersignificantlyfromthoseexpressedorimpliedbysuchforward‐lookingstatements.Importantfactorsthatcouldcauseorcontributetosuchdifferencesincluderisksrelatingto: ourabilitytodevelopandcommercialisepharmaceuticalproducts,includingourabilitytodevelop,manufacture,marketandsellbiopharmaceuticalproducts;competitionforourproducts,especiallySCENESSE® (afamelanotide16mg);ourabilitytoachieveexpectedsafetyandefficacyresultsthroughourinnovativeR&Defforts;theeffectivenessofourpatentsandotherprotectionsforinnovativeproducts,particularlyinviewofnationalandregionalvariationsinpatentlaws;ourpotentialexposuretoproductliabilityclaimstotheextentnotcoveredbyinsurance;increasedgovernmentscrutinyineitherAustralia,theU.S.,EuropeandJapanofouragreementswiththirdpartiesandsuppliers;ourexposuretocurrencyfluctuationsandrestrictionsaswellascreditrisks;the effectsofreformsinhealthcareregulationandpharmaceuticalpricingandreimbursement;thattheCompanymayincurunexpecteddelaysintheoutsourcedmanufacturingofSCENESSE®

whichmayleadtoitbeingunabletosupplyitscommercialmarketsand/orclinicaltrialprograms; anyfailurestocomplywithanygovernmentpaymentsystem(i.e.Medicare)reportingandpaymentobligations;uncertaintiessurroundingthelegislativeandregulatorypathwaysfortheregistrationandapprovalofbiotechnologybasedproducts;decisionsbyregulatoryauthoritiesregardingapprovalofourproductsaswellastheirdecisionsregardinglabelclaims;anyfailuretoretainorattractkeypersonnelandmanagerialtalent;theimpactofbroaderchangewithinthepharmaceuticalindustryandrelatedindustries;potentialchangestotaxliabilitiesorlegislation;environmentalrisks;andotherfactorsthathavebeendiscussedinour2017 AnnualReportand2018PreliminaryFinancialReport.Forward‐lookingstatementsspeakonlyasofthedateonwhichtheyaremadeandtheCompanyundertakesnoobligation,outsideofthoserequiredunderapplicablelawsorrelevantlistingrulesoftheAustralianSecuritiesExchange,toupdateorreviseany forward‐lookingstatement,whetherasaresultofnewinformation,futureeventsorotherwise.Moreinformationontheforecastsandestimatesisavailableonrequest.Pastperformanceisnotanindicatoroffutureperformance.

Thispresentermaymakeforwardlookingstatements.TheaudienceisforewarnedthroughthesafeharborstatementtoreadandunderstandtherisksofCLINUVEL’sbusiness.

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Overview

• Specialtypharmaceuticalcompany• Longevity(14years)– ManagementandBoard• Nocompetition,noalternativetreatmenttoSCENESSE® (afamelanotide16mg)

• EUapprovedproduct,awaitingPDUFAdatefororphanindicationporphyria(EPP)

• SocialresponsibilitytotreatEPPchildrenanddepigmentedpatients

• Growth throughorganic/inorganicexpansion• Twoadditionalindications• 2nd generationproducts– Rx• OTCproductsforlargeraudience

• Profitable since2017,firstdividenddeclared2018

For14yearsCLINUVELhasfocuseditsdevelopmentononeproduct,SCENESSE®(afamelanotide16mg)inoneorphanindication,EPP.SCENESSE®isapprovedintheEuropeanUnionforthepreventionofphototoxicityinadultpatientsdiagnosedwithEPP.Moreinformationonthiscanbefoundonourwebsite.InJune2018CLINUVELfiledSCENESSE®under“rollingreview”withtheUSFoodandDrugAdministration(FDA).TheFDArecentlyissuedadditionalquestionsaspartofthedialoguebetweenapplicantandagency.BeyondadultEPPpatients,CLINUVELintendstodevelopinnovativesolutionsforchildrenwithEPP,aswellasworkingtoaddressthedepigmentationdisordervitiligo.SCENESSE®alsoprovidesafoundationfortheCompanytogrow,boththroughorganicandinorganicopportunities.

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CLINUVEL’sbusiness ‐ systemicphotoprotection

• Geneticmetabolicdisorder(s)• Intoleranttolightemission(blue‐green/UVB/UVA)• Highunmetmedicalneed(s)• Noalternativetherapy,nobenchmark• Afamelanotide16mg,familyofmelanocortins(POMC)• Rx/SCENESSE® approvedbyEMA’14

• World’sfirstsystemicphotoprotectivedrug

������������������������ ������� ����������������� ��

AtthecoreofCLINUVEL’sbusinessistheconceptofmedicinalphotoprotection,providingprotectiontoskinfromlight.Thisisanovelconceptnothavingbeenexploredbyanyotherpharmaceuticalcompanythusfar.Duetotheaccumulationandstorageofaphototoxicchemicalreactant(protoporphyrinIX,PPIX)inEPPpatients,absolutelightintolerancewilloccursincePPIXwillreactwithphotonsemittedalongthevisiblespectrumoflight.Thelightemittedalongtheblueandgreenwavelengthsisthesourcewhichmakesthesepatientsveryill.Therefore–asidefromSCENESSE®– noothertherapytodateiseffective,asitdoesnotprotectbeyond400nanometersinwavelength.CLINUVELhaschosentoaddressthisdisorderastherearenoalternativetherapiesavailableforpatientsandahighunmetmedicalneed.

Afamelanotide,theactivechemicalentityinthefinalproductSCENESSE®‐ theinjectablecontrolledreleasesubcutaneousresolvableimplant‐ isanewmolecularentitybelongingtotheclassofproopiomelanocortins(POMCs).Thedrugmimicsthebody’sownresponsetoUVlightbyreleasingthehormoneharbouring specificpropertiesaswellasactivatingmelanin(pigmentation)oftheskin.TheEuropeanMedicinesAgency(EMA)approvedSCENESSE®in2014asthe world’sfirstsystemicphotoprotectivedrug.

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Medicinalphotoprotection– medicalinnovation/breakthrough

Proofofconceptinporphyrias(EPP)• Systemicprotectiontovisiblelight(>408nm)• Raredisorder1:140,000• Globaldiseaseregistry

Photoprotection,DNArepair

Systemicrepigmentation(totalbody)• Firstpharmacompanytoaddresslossofpigmentation• Positiveearlysafety/efficacydata

Systemic&topicalphotoprotection• 2nd generationmelanocortins• Additionalindications• Complementaryproductlines– OTC

EPP

2nd indicationQ4’18

Vitiligo

Generalpopulation

HavingdevelopeditsfirstinnovativeproductwithSCENESSE®,managementhasdesignedaclearplantogrowthebusinesstohelpserveotherpatientswithunmetneedandabroaderconsumerbase.LaterthisyeartheCompanyexpectstoannounceanewclinicalprogramfocusedonphotoprotectionandevaluatingthedrug’sabilitytorepairDNAdamagefollowinglightandUVexposure.

Inaddition,CLINUVELwillbeoneofthefirstpharmaceuticalcompaniestoaddresstheneedsofpatientswiththepigmentationlossdisordervitiligo.Earlyclinicaltrials(PhaseIIa)haveindicatedthatSCENESSE®iswelltoleratedbythesepatientswhenusedinacombinationtherapywithnarrowbandUVBphototherapy.FurtherresultsarebeinganalysedfromastudyinvitiligopatientsinSingapore.DecisionstofurtherthisprogramrestontheCompany’songoingdiscussionswiththeFDA,reviewingtheuseofthedrug,doseregimenandproductcharacteristics.CLINUVELundertakesitsfundamentalresearchinSingapore,withinthewhollyownedsubsidiaryVALLAURIXPTELTD,whereworkonsecondgenerationproductsisongoing.TheCompanyisalsoactivelyevaluatingfurtheropportunitiesinordertoestablishasustainablebusinesshingingonmultipleproducts,variousindicationsanduseofproducts,andspecificknowhowtoservelargergroupsofpatientsandthegeneralpublicinthefuture,aspartofCLINUVEL’s2020strategydisclosedin2017.Thisslideshowsthedevelopmentfromapextobase,verymuchkeepinmindtheburdenofproofforanypioneerembarkingonchangingmedicalconventions.

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Clinicalexperience – afamelanotideextensivelytested

• 1991‐2018 34clinicaltrials>975patients>7,900afamelanotidedosestodate>5,700SCENESSE® implants

• SAFETY Mostcommon“sideeffects”:nausea,headache,bruisingatinjectionsite,fatigue,flushingNonewsafetysignalstodatePositivesafetyprofile

• Doseregimen 1resorbableimplantformulationSubcutaneousinjectionevery60days

Thereisextensiveclinicaldataandexperiencefromtheuseofafamelanotidesince1991,anddatacontinuestobecapturedundertheEuropeanpost‐authorisationprogramme.Mostimportantly,ascanbeexpectedfromregulatorsandfromapplicantsdevelopingnovelproductspreviouslynotusedinhumansnorpatients,theCompanyemphasisesitscommitmenttomonitorpatientsandsafetyoftheproductfromlong‐termuse(pharmacovigilance).Inpioneeringinpharmaceuticaldevelopment,thereisaclearunderstandingfromCLINUVEL’steamstofocusonsafetylong‐term.ForthistheCompanycontrolsitsdevelopment,distributionandqualitymanagementsystemsinEurope(andshortlyintheUSfollowingCLINUVEL’sintentionstomakethedrugavailableintheUS).Manyoftheresultsfromafamelanotidehavebeenpublished,includingtheCompany’sphaseIIIclinicalresultsinEPPwhichwerepublishedintheNewEnglandJournalofMedicine.

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Effectivenessandpatientimpact ‐ SCENESSE®

LeadindicationEPP• Inabilitytoexposetolightsources(visible/invisibleλ)

• Conditionedsincebirthtoavoidlight(ingrainedanxiety)

• Phototoxicity,anaphylactoidreactions

AfamelanotidehasradicallychangedthewayIapproachmydailylife…ThismedicinehasfreedmefromthedebilitatingconsequencesofEPPandfromfearofsufferingthem.

Swisserythropoieticprotoporphyria(EPP)patientrepresentativeof98%treatmentcontinuation

Phototoxic reaction in an EPP patient. Image courtesy of the Koerner family.

Theimage– kindlyprovidedtousbythisyoungpatient’sfamily– showsapatientapproximately24hoursafteraphototoxicreaction,withsevereswelling,exudation(waterformation)andgeneraldiseasefollowingsun/lightexposedskin.Tragicallyinthisdiseasepatientsareforcedtolearnfromanearlyage,eveniftheyremainundiagnosed,theimpactofphototoxicityandanaphylactoidreactionsfromshortlightexposure,andpatientsovertheyearswithdrawfromsociety.

ThereisnoequivalentdisordertodescribetheordealofEPP,therearenoadequatetoolstomeasuretheimpactofdisease,andthereisnoprecedenttocomparethecomplexityofEPP.CLINUVEL’smotivationtofurtherassistthesepatientsstemsfromtheoverwhelminglypositiveresponsefrompatientsandexpertsphysiciansovertheyearssinceSCENESSE®wasmadeavailableduringclinicaltrials.Withoutbiasandsimulation,bothphysiciansandpatientsstartedtoreportdramaticeffectivenessandchangetotheirlives,assumingalifewhichhadnotbeenpossiblepriortoSCENESSE®treatment.

Inmanyways,launchinganovelmodeofactionanddrugtherapyforcesanapplicanttoexplainindetailtostakeholders,regulators,andadvisorybodiesthatconventionalapproachestomedicalproblemscannotbeappliedinthecaseofEPP.InEuropethisledtheEMAtoapprovethedrugwithoverwhelmingmajorityofvotes,andledtheEuropeaninsurersinmanycountriestoreimbursethedrug.

Treatmentwithafamelanotidehassoughtnotonlytoprotectpatientsfromlight,butimprovepatients’existence,addressingalifelongconditionedbehaviortoavoidlightexposure.Thisconditionedbehaviourtohidefromlight,andverywellknowingtheconsequencesofaphotoreaction,isbestcomparedtoareflextofire:nobodycanbeforcedtoputherorhishandintoburningflames.

TheretentionrateofpatientsandprescriptionrateofSCENESSE®inEuropeandSwitzerlandisover95%overtheyears,ameasureofeffectiveness.

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CLINUVEL’s operations Howdowedoit?Specialaccesssince2010SCENESSE® commerciallydistributedsince2016Direct,controlledEUdistributiontoEPPexpertcentresEMArisk managementplan,globaldiseaseregistry,“PASS”

Resultstodate66.1%increaseinpatienttreatments2016to201798%treatmentcontinuationratereportedinEU/CHUSpatientsflyingtoSwitzerlandtoseektreatment

Alternative effective therapy1 None

Listing price range

(Lauer-Taxe)2

€ 0 €25,000 €50,000 €75,000 €100,000

1No alternative effective therapy exists for SCENESSE®

2Price in Lauer-Taxe is published by IFA GmbH

SCENESSE® UniformPrice

CLINUVEL’sEuropeandistributionofSCENESSE®originatesfromourteam’sfocusedapproach.ThemapshowsavailableEPPexpertcentresinEurope.Ourfirstdistributionexperiencehadbeendevelopedduringclinicaltrialsandspecialaccessprogrammeswhichfirstcommencedin2010inItaly,then2012inSwitzerland.FirstcommercialdistributionundertheEUmarketingauthorisationcommencedin2016.TheCompanyhasanagreedcomprehensiveriskmanagementplanwiththeEMAandcontrolsdirectdistributionoftheproducttoexpertcentres(nothirdpartydistributors).Datacontinuestobecapturedonthedrug’ssafetyandeffectivenessthroughaglobaldiseaseregistryandthroughapost‐authorisationsafetystudy(PASS).Treatmentuptakeandcontinuationratesareencouraging,andweareawareofagrowingnumberofEPPpatientscrossingtheAtlantictoseektreatmentwhoarepreparedtopay,andinsomecasesreceivealreadyreimbursementfromUShealthcareinsurers.AuniformEuropeanpricehasbeenestablished,withtheexamplehereprovidedaspublishedintheGermanLauer‐Taxe,alistavailabletohospitalpharmacistsseekingtoorderSCENESSE®.

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USFDA timeline

APPROVALIND

ODD

APPROVALPHIICUV030

APPROVALPHIIICUV039

POSITIVEPHIIIRESULTSCUV039

CLINICALDATAPACKAGEAGREEDFORSUBMISSION

FASTTRACKDESIGNATION

20072008

20102011

20132016

20162016

2016

PILOT1ST FDAWORKSHOPONEPP

NDAFILING,“ROLLINGREVIEW”

2018

PRE‐NDAMEETING

2019‐20

NDAOUTCOME/RISK‐BENEFIT

OurUSapproachwillbesimilartothattakeninEurope.AnumberofUSexpertcentreshavebeenidentified.WorktomakeSCENESSE®availableintheUSstartedalongtimeago.TheFDA’sinterestinSCENESSE®wasfirstreceivedin2006,whileproactivelytheUSFDAhostedthefirsteverscientificworkshopinSilverSpringin2016tobetterunderstandtheEPPpatientexperience.Transcriptsfromthisworkshopcanbefoundonline.TherollingreviewoftheSCENESSE®newdrugapplication(NDA)isongoing,withtheCompanyaskedrecentlytoprovideadditionalinformationtotheFDAaspartoftheprocess.TheCompanyhasfiledforPriorityReviewintheUS,andoncetheFDAhasfiledallitsfinalquestionstowhichourteamsprovideallsatisfactoryanswers,anoutcomeastoPriorityReviewandPDUFAdatecanbeexpectedfromtheDivisionofDermatologyandDentalProducts.

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FinancialsI CLINUVEL’sDNA

• Disciplinedfinancialmanagement2005‐2018• Debt‐free• Expertiseinhouse

$0

$1

$2

$3

$4

$5

Q105 Q106 Q107 Q108 Q109 Q110 Q111 Q112 Q113 Q114 Q115 Q116 Q117 Q118

A$m

QuarterlyOperatingCashOutflows

CLINUVELhasapproacheditsfinancialmanagementdifferentlyfrommostofitspeers.Itsfocusedattitudetowardsmelanocortinsandonedrugtobedevelopedforonediseaseentityinitially,meantthatcostcontrolandresponsibilitieswerehighlyprioritisedduringtheyearsoffinancingtheprogramme.OvertheyearsCLINUVELusedstraightequityissuance,oftenatapremiumtomarket,whileselectingitsinvestorswithacommonlong‐termviewtogeneratevalue.TheCompanyhasnottakenondebtfinancenorengagedinschemestofactoritsrevenuesorroyalties.Importantly,CLINUVEL’scurrentsuccesshingesonretentionoftalentandprovidingcontinuitywithoutoutsourcingmanyofitsfunctions.ForpivotalworktheCompanyutilisestheservicesofthirdparties,serviceprovidersandresearchorganisations,butagainwithalong‐termviewtousethesamekeypersonnelinalltheseactivitiesspanningmorethanadecade.

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FinancialsII P&L– disruptivetechnologySCENESSE®

TotalfundscommittedtoSCENESSE® programtodate: A$172m

Industrystandarddevelopmentcosts US$600‐800m

Profitaftertax(FY18) A$13.224m

Unfrankeddividendperordinaryshare(FY18) $A0.02

TheCompany’sP&LhistorysawaninflectionpointresultinginthefirsttwoyearsofprofitinFY2017andFY2018.HighlightedherearefirstrevenuesfromtheItalianspecialaccessprogrammein2010,andincreasedexpendituretofacilitatepost‐approvalscaleupfrom2014.Comparedtotheindustrystandard,evenfororphandrugs,CLINUVELhasdeliveredaninnovativeproductforafractionoftheexpectedcost.Thisfactorisincreasinglyimportantforinsurersandpayorsworldwide,howdidaCompanymanageitsresourcesandatwhatcostdiditdevelopnewtechnology?

TheCompany’sfirsteverdividendwasdeclaredthisyear.

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$6.00

$8.00

$10.00

$12.00

$14.00

$16.00

Sep‐17 Nov‐17 Jan‐18 Mar‐18 May‐18 Jul‐18 Sep‐18

$AFinancialsIII ASX:CUV– 12months

Sharesonissue: 47,824,427

Avedailytradingvolume(3months) 54,381

The12‐monthsharepricegraphreflectsongoingprogressofthebusinessasmoreforeign(non‐Australian)shareholdersfindtheCompanyontheASX,Level1ADROTCprogram(NasdaqInternationalDesignation)orXetra.Increasedstockliquidityhasbeenseenthepasttwoyears.

TheCompany’sofficersareregularlyaskedwhethertheASXcanrecognisethefullvalueofthepharmaceuticalsuccessstories,andthisquestionispartofvariousconsiderationsBoardandmanagementmakeinevaluatingthevariousexchanges.

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CLINUVELGroup ownershipASX:CUV

XETRA‐DAX:UR9ADR:CLVLY(NasdaqInternationalDesignation)

Board, managementandstaff 8.87%

Lagoda InvestmentManagement 7.12%

FILInvestmentManagement 5.45%

Ender1LLC 5.43%

FamilyofficesSwitzerland/Germany 11%

PrivateinvestorsUK/Netherlands/Austria ~5%

MarketCap(07September) A$735.5m

52weekhigh‐low A$6.36‐$15.40

Australia28.4%

Europe22.8%

NorthAmerica27.4%

Asia8.8%

RestofWorld/Unanalyzed12.7%

CLINUVELhasbeenselectiveinbuildingitsregistersuchthatinvestorsunderstandtheCompany’slong‐termgoals.SomewhatdifferenttomanyASX‐listedcompanies,alargepercentageofCLINUVEL’sshareholdersarebasedoutsideofAustralia.

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Conclusions

• Specialtypharmaceuticalcompany• Longevity(14years)– ManagementandBoard• Nocompetition,noalternativetreatmenttoSCENESSE®

• EUapprovedproduct,awaitingPDUFAdatefororphanindicationporphyria(EPP)

• SocialresponsibilitytotreatEPPchildrenanddepigmentedpatients

• Growth throughorganic/inorganicexpansion• Twoadditionalindications• 2nd generationproducts– Rx• OTCproductsforlargeraudience

• Profitable since2017,firstdividenddeclared2018

CLINUVELhasanumberofimportanteventsincomingmonths,withthenear‐termgoalofenablingtreatmentaccessforUSpatients,andlonger‐termgoalsoftreatingothergroupsforwhomtherearenoalternatives.TheongoingsuccessoriginatingfromourmanagementofSCENESSE®needstoleadtofurtherdevelopmentandhopefullytofurtherregulatoryapprovals.

Inconclusion,thestatusofCLINUVELisbeinghailedinAustraliaascomingfromateamwhichhastakenafocused,selectiveapproachandonewhichintendstocontinuetobuildthebusinessinlinewithourcorevalues.Oftenheardbutseldomfullyrealisedandfollowedthrough,wemaintainatCLINUVELthatpeoplemakeproducts.Productsandtechnologyaloneareinsufficienttobuildacompany.

Inourbusinessmodel,profitsarenowbeingreinvestedintoR&D,withvaluebeingrealisedtoourlong‐terminvestors.

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Page 17: INVESTOR PRESENTATION - BIOCENTURY NEWSMAKERS For … · At the core of CLINUVEL’s business is the concept of medicinal photoprotection, providing protection to skin from light

Q&A

LachlanHayGeneralManagerCLINUVEL(UK)[email protected]+441372860765

Iwelcomequestionsfromtheroom.

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