Aspecialtypharmaceuticalindermatology

Mr StanMcLiesh,ChairDr PhilippeWolgen,CEOMr DarrenKeamy,CFO

DECEMBER2014

ASX: CUVXETRA‐DAX: UR9ADR: CLVLYF

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This release contains forward‐looking statements, which reflect the current beliefs andexpectations of Clinuvel’s management. Statements may involve a number of known andunknown risks that could cause our future results, performance or achievements to differsignificantly from those expressed or implied by such forward‐looking statements. Importantfactors that could cause or contribute to such differences include risks relating to: our abilityto develop and commercialise pharmaceutical products, including our ability to develop,manufacture, market and sell biopharmaceutical products; competition for our products,especially SCENESSE® afamelanotide 16mg ; our ability to achieve expected safety andefficacy results through our innovative R&D efforts;, the effectiveness of our patents and otherprotections for innovative products, particularly in view of national and regional variationsin patent laws; our potential exposure to product liability claims to the extent not covered byinsurance; increased government scrutiny in either Australia, the U.S. and Europe of ouragreements with third parties and suppliers; our exposure to currency fluctuations andrestrictions as well as credit risks; the effects of reforms in healthcare regulation andpharmaceutical pricing and reimbursement; any failures to comply with any governmentpayment system i.e. Medicare reporting and payment obligations; uncertaintiessurrounding the legislative and regulatory pathways for the registration and approval ofbiotechnology based products; decisions by regulatory authorities regarding approval of ourproducts as well as their decisions regarding label claims; any failure to retain or attract keypersonnel and managerial talent; the impact of broader change within the pharmaceuticalindustry and related industries; potential changes to tax liabilities or legislation;environmental risks; and other factors that have been discussed in our 2014 Annual Report.Forward‐looking statements speak only as of the date on which they are made and theCompany undertakes no obligation, outside of those required under applicable laws orrelevant listing rules of the Australian Securities Exchange, to update or revise any forwardlooking statement, whether as a result of new information, future events or otherwise.F

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EPPOrphandrug

EUmarketingauthorisationProofofConcept √Reimbursement2010‐2014 √

Keymarkets: EU‐CH‐US‐Japan

CONCEPT

VITILIGOLargermarketKeymarkets:US‐ASIA‐STH AFRICA

LABELEXTENSIONS

EPPPAEDIATRIC

COMPLEMENTARYTREATMENTRx

Systemic

Topical

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0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

Q106 Q107 Q108 Q109 Q110 Q111 Q112 Q113 Q114

%TradedtoIssuedCap

Shareprice$AFundsR

aisedA$m

May‐13$6.3m

Jun‐12$6.2m

Apr‐07$26m

Nov‐06$35.2m

May‐06$5m

HISTORICALSHAREPRICEASX:CUV

HISTORICALAVERAGEDAILYTRADEVOLUMES

%ofIssuedOrdinaryShares

*ExcludesSept2008off‐markettransferofmajorshareholder

May‐14$6.9m

Dec‐05$1m

28NOVEMBER2014Freefloat’14: 80%Volumetraded12month: 12,989,742Valuetraded12month: A$36.1M

FUNDINGROUNDSJAN‘06– MAY‘149RoundsEquity $86.9MCashonhand$12.5M 09/30AveMonthlyBurn‘12‐’14$731kDEBTFREE

$‐

$2.00

$4.00

$6.00

$8.00

$10.00

$12.00

$14.00

$‐

$5

$10

$15

$20

$25

$30

$35

$40

Dec‐05 Dec‐06 Dec‐07 Dec‐08 Dec‐09 Dec‐10 Dec‐11 Dec‐12 Dec‐13

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Retail&Other29.5%

ADRs9.8%

Relatedparties4.6%

SophisticatedInvestors&Brokers23.8%

Institutions&Custodians32.3%

Asia‐Pacific 40.79%North America 29.21%EU/Switzerland 30.00%

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Clin.Dev.Expenses: A$24.0m

Formulation: A$23.4m

Regulatory: A$6.6m

Marketing&Listing: A$7.8m

Patents&Trademarks: A$4.7m

Operations: A$41.8m

TotalExpenses: A$108.3m

Expensesperindication

EPP,55%

OthersPh1,37%

Vitiligo,8%

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*Expendituresforeseensubjecttocorporateprogress**excludesreceipts,interest&R&Dincentives

A$ m

Clinicaldevelopment 3.5

Drug delivery,formulation 3.3

RegulatoryAffairs 1.3

Personnel 10.0

Overheads,Marketing&Corporate 5.9

Total** 23.9

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QUALITY OUTSET OUTCOME

Drugsubstance– manufacture/qualitycontrol

Drugproduct– manufacture/qualitycontrol

NONCLINICALPharmacology

Toxicology

CLINICALPharmacology – modeofaction

Clinicalsafety

Clinicalefficacy

Prescribinginformation/riskmanagementplan

CONVERGENCEINKNOWLEDGEIN947DAYSOFREVIEW

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2010AIFA648/96

2011SWISSMEDIC

2014115EPPPATIENTS

• 21PORPHYRIAEXPERTSATTESTTOEFFICACY• SCEPTICAL PHYSICIANSCONVERTED• 94%OFTRIALPATIENTSREQUESTCONTINUOUSTREATMENT

WITHSCENESSE®• ALLPATIENTADVOCACYGROUPSINSUPPORT• 8PARA/‐MEDICALLYQUALIFIEDEPPPATIENTS

n 1st EP 2nd EPCUV010 5 pain,tolerancetoλ

p 0.0069melanindensity

CUV017 100 painp 0.0023/0.0017

tolerancetoλ

CUV030 77 exposuretoλp 0.036/0.025

pain,QoL

CUV029 74 exposuretoλp 0.005

pain,QoL

CUV039 93 exposuretoλp 0.107

QoL

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12345678910111213

AcSerTyrSerNleGluHisDpheArgTrpGlyLysProValNH2

• Theoreticalpropertiesofmelanocortins:1. melanogenic2 anti‐inflammatory3anti‐carcinogenic

• Humanpharmacology,bioresponse andsafetydeterminecommercialvalue

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“ThissummerIhavehadtodealwithpaindailyandIcan’taffordtotaketimeoffwork,asIhavebillstopay,foodtobuyjustlikeeveryoneelse…pleaseallowmethisopportunitytolivewhatIbelievetobeanormallife”

‐ AustralianEPPpatient

• Lightdeprivation/starvationsincechildhood• Socialisolationaffectingchildhooddevelopment• Impactprofessionaloptions• Moodaffectivedisorders• ‘Pain’isnon‐responsivetoanalgesics

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SEVERITY

CHRONIC

Hemophilia

ChronicLumbarPain RefractiveHNP

ACUTE

CerebrovascularAccident

MyocardialInfarction

DiabeticFootUlcers

MS

Crohn’s/UC

ClusterHeadaches

LymphEdema

AcuteLymphoblasticLeukemia

STAGEIMARKETRESEARCHONSCENESSE®FORTHEPREVENTIONOFEPP

ProstateCancer

AcuteMacularDegeneration

ActinicKeratosis

EPP

Source:ThirdpartymarketresearchcommissionedbyCUV

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REIMBURSEMENTOFSCENESSE®PRIORTOEMAAPPROVALSAS*

SAS 2010 2011 2012 2013 2014ITA 1 1 1 1 4CH n/a n/a 12 14 14EU‐ other 0 0 1 3 6

TOTAL 1 1 14 18 24

*SpecialAccessScheme

PREVALENCEEPP 1:140,000CONTINUATIONAFTERTRIAL 94%DISCONTINUATIONAFTER5YEARSOFSPECIALACCESSSCHEMES

22.6%

COSTOFTRAVEL/RELOCATION 10.4%DESIRETOSTARTFAMILY 4.3%OTHER 7.9%

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• FDAacknowledgesrationaleofproposedtreatmentSCENESSE®• 10%bodyinvolvement• DarkskincomplexionFitzpatrickIV‐VI• 3trials,2pivotal comb.NB‐UVB‐ SCENESSE® n 600• USfirstmarketofentry,MEA*&Asianmarketssecond• Globalprevalence1‐2%ofglobalpopulation

ProjectedUSpenetrationrateSCENESSE®‐ commercialphase

*SubmissionformarketingauthorisationinMiddleEast,Africa

0.00%

2.00%

4.00%

Year1 Year2 Year3

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Day0Baseline

Day27After9NB‐UVBtreatments

Day55After15NB‐UVBtreatments,1implant

Day111After27NB‐UVBtreatments,3implants

Day176After40NB‐UVBtreatments,4implants

• ImagesareasoriginallysuppliedbytheclinicalcenterandIDnumbershavebeenremovedtomaintainpatientprivacy,theimagesareotherwiseunaltered.

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Enlargedimageofleftthighshowinggeneralisedfollicularrepigmentation

Day0Baseline

Day55After15NB‐UVBtreatments,1implantdose

Day176After40NB‐UVBtreatments,4implantdoses

• ImagesareasoriginallysuppliedbytheclinicalcenterandIDnumbershavebeenremovedtomaintainpatientprivacy,theimagesareotherwiseunaltered.

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Aspecialtypharmaceuticalindermatology

Mr StanMcLiesh,ChairDr PhilippeWolgen,CEOMr DarrenKeamy,CFO

DECEMBER2014

ASX: CUVXETRA‐DAX: UR9ADR: CLVLYF

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InvestorupdatepresentationspeakingnotesMelbourne,AustraliaandZug,Switzerland,December4,2014Slide1:INVESTORUPDATEThisservesasaninvestorupdateattheendofthecalendaryear2014summarisinganumberofcorporateeventsand,mostimportantly,theEMAapprovalofSCENESSE®onOctober23.Slide2:FORWARDLOOKINGSTATEMENTSForward looking statements may be made during the presentation but the safe harbour statement serves toforewarn the reader or any speculative investor against the risk associatedwith pharmaceutical development,distribution,pricingandreimbursement.Slide3:DOWNSTREAMVALUEOFSCENESSE®The integral value of Clinuvel originates from the research and development, and marketing authorisation ofSCENESSE®asthefirstsystemictreatmentof lightdisordersandpigmentarydiseases.AfteradecadeofcarefulpreparationthedownstreamvalueofSCENESSE®willflowfromitsuseinotherindications,aswellastheuseofassociatedmelanocortinstocomplementSCENESSE®invitiligo.The topical formulation is being developed and progresswill bemade as relevant data become available. Thecombined use of SCENESSE® systemic and “SCENESSE® topical” will add to the value of Clinuvel. The firstregulatoryapprovalbytheEMAwasnecessarytoobtainclinicalandfinancialendorsementforfurtherdownstreamdevelopment.Slide4:FINANCIALS‐CLINUVELThefundingofClinuvelwascarefullyplannedthroughaseriesoffundingroundsduringtheclinicalandregulatorydevelopmentstagesofSCENESSE®.Thepastdecadethepurposewastosecurefundingsufficienttoobtainthefirstessential regulatory approval in Europewhileminimising the dilution for shareholders. To that effect, Clinuvelraisedsmallerequityinjectionsatpremiumtomarketprices(2012‐2014).LiquidityinClinuvelhasincreasedduring2014andhasbeensufficientforthoseinvestorsinterestedinbuildingasignificantstakeinthecompany.Thefreefloatover2014hasbeenapproximately80%‐higherthanpreviousyears.Slide5:CUVSHAREREGISTERCompared topreviousyearsClinuvel’s share registerhas shownan increase inUS investorswho seem tohavediscoveredtheCompany’suniquedrugandplatform.TheAsia‐Pacificinvestorsremain,with40.79%,thelargestgeographicallyfollowedbyEurope/SwitzerlandandtheUS.Morespecialisedlife‐sciencefundsandfamilyofficesrequestinformationontheCompanyasalong‐terminvestmentprospect.Slide6:EXPENSES‘05‐’14Theexpendituresover thepastnineyearshavebeencarefullymanagedwhereby the lion’s shareof costswereallocated towards EPP as the first indication for which Clinuvel was developed to European market. OtherindicationstestedservedtoprovideessentialsafetydataontheuseofSCENESSE®giventhelargerpopulationsavailable (other thanEPP).Aproportionate, large sumwent into thedevelopmentof theunique formulation, acontrolled‐releaseimplant;thistechnologyisthusfartheonlyoneavailablecommerciallyandprovidesClinuvel10yearsofmarketexclusivity.Expensesincludenon‐cashadjustments.Slide7:PROJECTEDEXPENDITURESCY2015‐2016*AsthecompanytransitionsfromR&Dtoafullcommercialentity,approximately40%ofitsprojectedexpenditureswillbeallocatedtowardsnewprofessionalstaffandmanagementinordertosuccessfullydistributeSCENESSE®intheEuropeanUnion.TheforecastaboveissubjecttomanychangesandcoverstheperiodfromJanuary2015toDecember2016,anymaterialchangeswillbemadepublicontheASX.

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Slide8:POSITIVECHMPEVALUATION23OCTOBER2014TheintroductionofnovelSCENESSE®(afamelanotide16mg)metmuchregulatoryresistanceatthebeginningofthe reviewprocess, as seen in the left columnof thebalance score card. It couldhavebeen expected fromanypharmaceutical company to withdraw the application for marketing authorisation given the EMA regulatoryresistance.Clinuvel’smanagementhadbeenconvincedof thesafetyandclinicalefficacyofSCENESSE®andhadtaken intoaccounttheunusuallystrongpatients’demandandpositivefeedbackfromexpertphysiciansandacademics.HenceClinuvel’smanagementpersistedintheregulatoryreviewandhadnotconsideredthewithdrawaloftheapplicationatanystage,sincenewdatageneratedinanadditionaltrialwouldnotprovideadditionalusefulinformation.Towardstheendofthereviewprocess–thelongestinthehistoryoftheEMAwith947days–theAgencyconvergedtowardsfullacceptanceoftheclinicalefficacyandsafetyofSCENESSE®.Thead‐hocmeetingandplenarysessionoftheCHMPprovidedtheEMAtwoopportunitiestospeaktoEPPpatientsandphysicians,expertsinthefield.TheinvolvementofEPPpatientsandexpertphysicianshadbeenrequestedbyClinuvelsince2008.ThepositiveoutcomeonOctober23confirmedClinuvel’slong‐standingviewsontheclinicaluseofSCENESSE®inEPP.Slide9:EPPREGULATORYDECISIONMODELClinuvel’s Board and management considered many risks inherent to the R&D of disruptive and innovativetechnology,SCENESSE®.AgainstthelowoddsofsuccessanddespitethechallengesofevaluatingtheefficacyofSCENESSE®throughconventionalmethodology,anumberofsignpostsalongthejourneyclearlyindicatedclinicalefficacyandsafetyoftheproduct.Theresponsibilityofmanagementwastomaketherightcallsateachjunctureofdevelopment.AnumberoffactorsfacilitatedthedecisiontodevelopSCENESSE®inEPP,suchastheinclusionofthedruginItaly’sspecialaccessscheme,Swissreimbursement,patientdemandforcontinuoustreatment,physicians’consistentpositivefeedbackandtheresponsefrompatientadvocacygroups.Notunimportantly, sixoutofeightpara/medicallyqualifiedEPPpatientshadreportedsignificant improvementfollowingtheuseofSCENESSE®.Slide10:SCENESSE®(AFAMELANOTIDE16MG)As extensively known, melanocortins exert a number of activities which have all been published. Structuralconfiguration, dose, plasma concentration, bioavailability and other factors determine how, andwhen, to use amelanocortin.Additionally,atalltimes,safetyconsiderationsdominatethechoicesofhowtoclinicallyuseoneofthesemolecules. InthecaseofSCENESSE®Clinuvelhadconsideredalloftheparametersandtogetherwiththemedical communityhad arrived at a uniformconclusionofhow tobestmakeSCENESSE®available to a targetpatientpopulationwhilesecuringanoptimumsafetyprofile.Whiletheoreticallyanumberofusesareconceivable,many research groups and companies in the world have failed over the past decades to develop any of themelanocortinscommerciallyduetothecomplexityofbalancingallparametersforementioned.Clinuvel has now successfully launched the first systemic photoprotective drug – SCENESSE® – to provideprotection against light and light sources for those patients in extreme need of therapy for erythropoieticprotoporphyria(EPP).Slide11:ERYTHROPOIETICPROTOPORPHYRIA(EPP)EPPpatientssufferfromanextremeformofphototoxicityagainstanylightsource,specificallythevisiblebandof408nm.Asapoorlycharacteriseddisorder,EPPcanbestbedescribedasageneticdisordercausinglifelonglightdeprivationandstarvation.It is well known from literature, clinical experiments, penitentiary institutions and human rights what lightstarvation,long‐term,doestohumanbiology.Forallstakeholderstheabilitytoofferamedicalsolutiontoadultsfirst(andchildrenlater)toassistandfacilitateinleadinganormallifewhichhadnotbeenknownorpossiblebeforetreatmentisatrulyuniqueopportunity.Theresponsefrompatientsworldwidehasbeennothinglessthanamazingandoneofgratitude.Slide12:HEALTHECONOMICASSESSMENTPERDISORDERDuringclinicalmarketresearchitbecameapparentthatEPPwastobeviewedasasevereandchronicdisorder,perhapsbestcomparedorbenchmarkedagainsthaemophilia(bleedingdisorders).PositioningEPPandthereforeSCENESSE®isnecessarytofullyunderstandthevaluethatcanbebuilt inClinuvel.AsEPPisadisorderofhighunmetclinicalneedforwhichthereisnopriororalternativetherapy,propercharacterisationandpositioningaidesinthediscussionswithpayorsandreimbursementagencies.

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Slide13:EUROPEANDISTRIBUTIONSCENESSE®Datacollectedovertheyearsfromcompassionateuseprogramsandspecialaccessschemesprovidefertilegroundforunderstandingmarketing and sales throughout theEuropeanUnion.Distribution through the special accessschemesinItalyandSwitzerlandareillustratedinthefirsttableaboveanditisapparentthatthenumberofregionsinItaly,thenumberofpayorsinSwitzerlandand,since2012,thenumberofGermaninsurershaveincreased.Tounderstandpatients’willingnessandeagernesstoreceiveSCENESSE®treatmentClinuvellookedatcontinuationrateandreasonsfordiscontinuingdruguse.Modellingthisknowledge–expressedinpercentages–greatlyassistsinforecastingthesizeoftheEPPmarketinEurope,US,andotherpartsoftheworld.Slide14:VITILIGOPATHTOCOMMERCIALISATIONIndeterminingthepriceforEPPthecommercialworkonvitiligohasstarted.WhereasthetreatmentforEPPisseenasapreventativeforphototoxicsymptomsonanannualbasis,thetreatmentofvitiligoisofcurativenaturewherebyitisestimatedthatseveninjectionsofSCENESSE®willbesufficienttorepigmentthesepatientscompletely.Thislastestimateissubjecttofurtherclinicaltrials.Slide15:REPIGMENTATIONPATTERN–VITILIGO(CUV102)Fordecadesthetreatmentofvitiligowasoneoflittleprogressandsuccess.WiththeintroductionofnarrowbandUVBsomefollicularresponseandrepigmentationwasseen inaselectgroupofpatients,butmostlyresulting indeficientandpartialclinicalrepigmentation.Thisresponseisdeemedunsatisfactoryandclinicallydeficientbytheleadingvitiligoexpertsintheworld.BasedontheCUV102resultsandthefeedbackfromtheleadingvitiligoexperts,SCENESSE®seemstobeofferingvitiligopatientsofcolour(darkerskincomplexions,FitzpatrickSkinTypesIV‐VI)aneffectivetherapyachievingacompleteandlastingrepigmentation.Slide16:FOLLICULARREPIGMENTATION–VITILIGO(CUV102)As seen in the centre image, SCENESSE® is extremely effective in activating a follicular pigmentary responseresulting,afteranumberofdoses,incompleteconfluentrepigmentationoftheskin(thirdimage).TheresultsofCUV102havebeenpublishedinanumberofjournalsandpresentedtoconferencesglobally.ThegroundbreakingworkreceivedanawardfromtheAmericanAssociationofDermatologyin2012PublicationsandpublicpresentationsonSCENESSE®invitiligo:Agbai,A(2012).SafetyandEfficacyofAfamelanotideImplantsandNB‐UVBversusNB‐UVBAloneintheTreatmentofNonsegmental Vitiligo: Preliminary Results Detroit. Skin of Color Society, San Diego.Recipient:BestResident/FellowPresentationAward

Lim, H (2012). Combination therapy SCENESSE® (afamelanotide 16mg) and NB‐UVB in vitiligo: The DetroitExperiencePreliminaryResults(CUV102).RCD,Manila

Agbai,A(2013).SafetyandEfficacyofAfamelanotideImplantsandNB‐UVBversusNB‐UVBAloneintheTreatmentofNonsegmentalVitiligo.AAD,Miami.

Grimes,P(2013).Afamelanotideinvitiligo–presentationontheCUV102studypreliminaryresults.AAD,Miami.

Lim,H(2013).Phototherapyinvitiligo.AAD,Miami.

Grimes,P(2014).Newperspectivesinmedicaltherapies.AAD,Colorado

Hamzavi,I(2014).PhotodermatologyInSkinOfColor,Melasma&Pigmentation.AAD,Colorado

Lebwohl,M(2014).Afamelanotideinvitiligo:Thefirstexperience.MSHSocietyMeeting,Amsterdam.

Lim,H(2014).NewCombinationTreatments.AAD,Colorado.Slide17:FOLLICULARREPIGMENTATION–VITILIGO(CUV102)Inclose‐upthefollicularrepigmentationispronouncedindarkerskincomplexions(FitzpatrickIV‐VI)andshowsahomogenous pattern across all affected skin sites. The use of SCENESSE® in the US trial CUV102 showed anaccelerationanddepthofrepigmentationinpatientstreatedwithnarrowbandUVBandthedrug.Theimageaboveillustrates the early signs of follicular activity in vitiligo patients after receiving the first or second dose ofSCENESSE®.Slide18:FOLLICULARREPIGMENTATION–VITILIGO(CUV102)Graphicallyonecould imagine the follicular repigmentationarising from the “factoryofpigment”, thebulge (orniche)adjacenttothehairfollicle.

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Slide19:SUMMARYNonotes.‐End‐AboutClinuvelPharmaceuticalsLimitedClinuvelPharmaceuticalsLtd(ASX:CUV;XETRA‐DAX:UR9;ADR:CLVLY)isaglobalbiopharmaceuticalcompanyfocusedondevelopingdrugs for the treatmentof a rangeof severe skindisorders.With itsuniqueexpertise inunderstandingtheinteractionoflightandhumanskin,thecompanyhasidentifiedpatientpopulationswithaclinicalneedforphotoprotectionandanotherpopulationwithaneedforrepigmentation.Thesepatientgroupsrangeinsizefrom 5,000 to 45 million. Clinuvel’s lead compound, SCENESSE® (afamelanotide 16mg), a first‐in‐class drugtargetingerythropoieticprotoporphyria(EPP),hascompletedPhaseIIandIIItrialsintheUSandEurope,andhasbeen recommended for marketing authorisation under exceptional circumstance by the European MedicinesAgency.BasedinMelbourne,Australia,ClinuvelhasoperationsinEurope,theUSandSingapore.Formoreinformationgotohttp://www.clinuvel.com.ClinuvelisanAustralianbiopharmaceuticalcompanyfocussedondevelopingitsphotoprotectivedrug,SCENESSE®(afamelanotide)forarangeofUV‐relatedskindisordersresultingfromexposureoftheskintoharmfulUVradiation.Pharmaceuticalresearchanddevelopmentinvolveslongleadtimesandsignificantrisks.Therefore,whileallreasonableeffortshavebeenmadebyClinuveltoensurethatthereisareasonablebasisforallstatementsmadeinthisdocumentthatrelatetoprospectiveeventsordevelopments(forward‐lookingstatements),investorsshouldnotethefollowing:

actualresultsmayandoftenwilldiffermateriallyfromtheseforward‐lookingstatements; noassurancescanbegivenbyClinuvelthatanystatedobjectives,outcomesortimeframesinrespectofitsdevelopmentprogrammeforSCENESSE®

canorwillbeachieved; noassurancescanbegivenbyClinuvelthat,evenifitsdevelopmentprogrammeforSCENESSE®issuccessful,itwillobtainregulatoryapprovalfor

itspharmaceuticalproductsorthatsuchproducts,ifapprovedforuse,willbesuccessfulinthemarketplaceLevel14/190QueenStreet T+61396604900 www.clinuvel.comMelbourne,Victoria3000 F+61396604999Australia

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