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Melbourne, 28 November 2017
CLINUVEL PHARMACEUTICALS MANAGEMENT PRESENTATION
ASX: CUVADR: CLVLYXETRA: UR9
Today’sdiscussionoutlinestheCLINUVELBoard’sobjectivestoleadthegrowthoftheGroupby2020.TheemphasistodayisonthestrategicdirectionoftheGrouptowardsgrowthby2020.AudiencesunfamiliarwithCLINUVELareencouragedtoreviewthewebsiteatwww.clinuvel.com.ThreeelementshavedictatedCLINUVEL’sBoardstrategicconsiderations.CLINUVELintends:• tomaintain“situationalawareness”;• toleveragethemelanocortintechnology(SCENESSE®)/knowledge;and• tolendmorevisibilitytotheCLINUVELbrand.TheaudienceisaskedtokeepthesethreeelementsinmindwhentravellingintothefutureoftheCLINUVELGroup.
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Forward‐lookingstatements
This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. Statements may involve
a number of known and unknown risks that could cause our future results, performance or achievements to differ significantly from those expressed or
implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to
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 and efficacy results through our
innovative R&D efforts; the effectiveness of our patents and other protections for innovative products, particularly in view of national and regional variations
in patent laws; our potential exposure to product liability claims to the extent not covered by insurance; increased government scrutiny in either Australia,
the U.S., Europe and Japan of our agreements with third parties and suppliers; our exposure to currency fluctuations and restrictions as well as credit risks;
the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement; any failures to comply with any government payment system
(i.e. Medicare) reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways for the registration and approval of
biotechnology based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; any
failure to retain or attract key personnel and managerial talent; the impact of broader change within the pharmaceutical industry and related industries;
potential changes to tax liabilities or legislation; environmental risks; and other factors that have been discussed in our 2017 Annual Report. Forward-
looking statements speak only as of the date on which they are made and the Company undertakes no obligation, outside of those required under
applicable laws or relevant listing rules of the Australian Securities Exchange, to update or revise any forward-looking statement, whether as a result of new
information, future events or otherwise. More information on the forecasts and estimates is available on request. Past performance is not an indicator of
future performance.
YouareadvisedtoreadtheSafeHarbourStatement.
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Contents
1 Corporate Value
2 Financials
3 FDA
4 SCENESSE® EU Market Access & Reimbursement
5 Growth 2020
6 Milestones
7 SCENESSE® in EPP
Indexoftheseventopicstobecoveredtodaywhicheventuallywillleadtotheaudience’sunderstandingofCLINUVEL’sobjectivesandtheGroup’sintentionsby2020,pendingregulatoryclearancesandupcominglegislativechangesinEU‐US‐Asia,anddrugsafetyaspects.
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CLINUVEL’ssuccesstodayisowedtophysicians,patientsandallwhohavecontributed.Inretrospect,onecandistinguishinthevalueofCLINUVELtwokeyelements:1. consistencyinitscommunicationtoawidevarietyofstakeholders;2. followthroughonitscorporateactions.TheCLINUVELteamhasconsistentlycommunicatedduring12years toavarietyofstakeholdersapersistentobjectivetodevelopSCENESSE® forerythropoieticprotoporphyria[EPP]patients,whoarefrombirthonwardslifelongcondemnedtoanindoorexistence,leadingtosocialdeprivation.SCENESSE®
islicensedinEuropeforthepreventionofphototoxicityinadultpatientswithEPP.ThegeneticconditionEPP(FECHdeficiency)affectspatients’choicesinlife,theircareerchoicesduringformativeadolescentyearsandoftenchoiceofpartnersandfamily.FECHdeficienciesleadtoanaccumulationandstorageofthephototoxicmoleculeprotoporphyrinIXintheskin,liverandgallbladder.Importantly,EPPisauniquedisorder, notcomparabletoanyotheraffliction,inthatpatientsarephototoxicorintoleranttolightemittedalongthevisiblespectrumandoriginatingfromlightsources,includingLEDs,laptops,reflectivesurfaces,andthesun.Henceconventionaltherapiesandtopicalsunscreensdonotprotectthesepatients,sincetheemittedvisiblelightaffectstheaccumulatedprotoporphyrinmoleculesandexcitesthesetoahigherstatecausingoxidativedamage.Thesecondelementofachievementliesinfollowingthroughcorporateactionsandobjectives.
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CLINUVELStakeholders
IN
PA
EP
RGGM
LC
FM
ME
PO
GP
PR
SM
PI
RU
DI
GENERAL MEDICAL COMMUNITY
General PhysiciansMedical researchersMedical staff
EXPERT PHYSICIANS
EPP experts academicsPorphyria expertsPigmentation scientistsAlpha‐MSH scientistsVitiligo clinical experts, researchers
MEDIA
Industry pressFinancial pressGeneral pressAgencies, newswires
INVESTORS
Institutional investorsSophisticated, family officesRetail investors
PATIENT COMMUNITY
EPP Patients/AssociationsVitiligo patientsPhotodermatoses patientsGeneral patientsCarers
REGULATORS
EMA‐FDANational competent authoritiesEthics committeesAdvisory bodies
SUPPLIERS / MANUFACTURERS
PAYMENT & REIMBURSEMENT AGENCIES
Government advisory bodiesGovernment decision makersState/Private insurersMedical advisors
POLITICAL COMMUNITY
Government MPsCongressmen/senators
GENERAL PUBLIC
ConsumersRelated partiesNew recruits
PHARMACEUTICAL INDUSTRY / PEERS
PeersIndustry associations
FINANCIALMARKETS
Analysts US/EU/AS/ROWInvestment bankers
LEGAL COUNSEL
RESEARCH DEPARTMENT & UNIVERSITIES
DISTRIBUTORS
CLINUVELtransmitsmessagessimultaneouslyto15differentstakeholdergroups,andintoday’sworld,consistencyofmessagesisrequired.SomeofthesestakeholdersareuniquetoCLINUVEL. Obviously,thevariousstakeholdershavedifferentobjectives,incentivesandinterests.Examplesaregivenhowtheinterestsofstakeholdersmaybemisaligned.Inanindefectiblesystem,allCLINUVELstakeholdersoughttohavecommonobjectives.The15stakeholderscanbefurtherdifferentiatedin40varioussubgroups,abbreviatedineachhexagonshown.
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2005‐2008 2008‐2012 2012‐2014 2014‐2017
PA
IN
EP
RG
GM
LC
FMME
PO
GP
PR
SM
PI
2017‐2020PROOF OFPRINCIPLE
REGULATORY REVIEW
CLINUVEL ‘2020’
MARKET ACCESS
CLINICAL DEVELOPMENT
RU
DI
Insectioningthefivetemporalcorridorsfrom2005to2020,CLINUVELhasvarieditscommunicationchannelsastimepassedtoaddressthekeystakeholderswhoaremostrelevanttoeachperiod.Illustratedontheslideisanexampleofthehierarchyofaudiencesaddressedbyourcommunicationteamsbothinhouseandwithlocalagenciesduringtheseyears.
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2005‐2008 2008‐2012 2012‐2014
PA
IN
EPRG
GM
LC FM
ME
POGP
PR
SM
PI
2014‐2017 2017‐2020PROOF OFPRINCIPLE
CLINUVEL ‘2020’
MARKET ACCESS
REGULATORY REVIEW
CLINICAL DEVELOPMENT
RU
DI
From2008to2012,theyearsofclinicaldevelopment,obviouslypatientassociations,researchinstitutes,universities,regulatoryauthorities,expertphysicians,andnewlyattractedinvestorsrequiredprimaryattentionandcommunicationthroughCLINUVEL’spublicchannels.
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2005‐2008 2012‐2014 2014‐2017
PA
IN
EP
RG
GM
LC
FM
ME
PO
GP
PR
SM
PI
2017‐2020PROOF OFPRINCIPLE
REGULATORY REVIEW
MARKET ACCESS
CLINUVEL ‘2020’
2008‐2012CLINICAL
DEVELOPMENT
RU
DI
During2012to2014,theyearsofEuropeanregulatoryreview,thelongestinthehistoryoftheEMA,itbecameapparentthattheregulatorsrequiredconsistentcommunication.
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2005‐2008 2008‐2012 2012‐2014 2014‐2017PROOF OFPRINCIPLE
REGULATORY REVIEW
MARKET ACCESS
2017‐2020CLINICAL
DEVELOPMENTCLINUVEL ‘2020’
PA
IN
FM
PO
SM
PI
EP
RG
GP
GM
LCME
PR
RU
DI
During2014to2017,theyearsofapprovalandgainingmarketaccess,welearnedanentirelynewphenomenon:uncurated newsflowandcontentconsumption.
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2005‐2008 2008‐2012 2012‐2014 2014‐2017PROOF OFPRINCIPLE
REGULATORY REVIEW
MARKET ACCESS
2017‐2020CLINICAL
DEVELOPMENTCLINUVEL ‘2020’
PA
IN
FM
SM
PI
EP
RG
GP
DIPO
GM
LCME
RU
PR
Media Coverage 2005 - Present
Online Traffic
Media Number of TitlesIndustry 679Magazine 36Newspaper 326Online 245TV 60Wire 123Grand Total 1469
Website visits (since 2008)
1,867,599
YouTube video views (since 2009)
1,058,609
TheglobalattentionforCLINUVELhassurpassedmanyofitspeers.Overthepast12years,wehaveseenintotal60TVprogramsonSCENESSE®,627industrypublications,326newspaperarticles,andoveronemillionYouTubehitsontheCompany’schannel.ThetablesillustratethesheeramountofnewsflowsurroundingCLINUVEL,anemergingpharmaceuticalcompanywithnoveltechnologyapplicableinauniverseofdiseases.MostoftheinformationontheCompanyisopenlyavailable.
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2005‐2008 2008‐2012 2012‐2014 2014‐2017PROOF OFPRINCIPLE
REGULATORY REVIEW
MARKET ACCESS
2017‐2020CLINICAL
DEVELOPMENTCLINUVEL ‘2020’
PA
FM
PO
EPGP
LC
PRPI
IN
SM
GM ME
RU
DI
RG
Media Coverage 2005 - Present
Online Traffic
Media Number of TitlesIndustry 679Magazine 36Newspaper 326Online 245TV 60Wire 123Grand Total 1469
Website visits (since 2008)
1,867,599
YouTube video views (since 2009)
1,058,609
Corporatevaluein2017andmostcertainlyby2020willrestonconsistentandmeasuredcommunication,andourabilitytofollowthroughourobjectives,wherebywewillremainawareofhowselectiveinformationonCLINUVELcanbeused.
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TheCompanyhasconsistentlysoughttoreviewitsfinancialpositionatAnnualGeneralMeetings,withreadersencouragedtofollowthethoughtprocesssince2006.
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Institutions 44.37%
Brokers 3.61%
Related parties 9.03%
ADRs2 11.54%
Other 16.25%
Below threshold of analysis 15.19%
Register analysis – CLINUVEL1
1 As at 15 September 20172 Sponsored American Depository Receipt, CLVLY
TheanalysisofCLINUVEL’sshareregisterisofimportancetocomprehendthechangingaudiencestheCompanyattracts,theinstitutionallevelofinterest,andtheotherpositionsovertime.
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Geographical distribution1
North America
EU / CHAustralia
Asia
Unanalysed / RoW
Institutions 44.37%
Brokers 3.61%
Related parties 9.03%
ADRs2 11.54%
Other 16.25%
Below threshold of analysis 15.19%
Register analysis – CLINUVEL1
1 As at 15 September 20172 Sponsored American Depository Receipt, CLVLY
WhenlookingatthegeographicaldistributionwehaveseenanincreaseofholdingsfromAsiaandNorthAmerica,withtheEUandSwitzerland(CH)slightlyontherise.
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ADRs2
CLVLY as % of total CLINUVEL holdings
2.00%
4.00%
6.00%
8.00%
10.00%
12.00%
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Institutions 44.37%
Brokers 3.61%
Related parties 9.03%
ADRs2 11.54%
Other 16.25%
Below threshold of analysis 15.19%
Register analysis – CLINUVEL1
1 As at 15 September 20172 Sponsored American Depository Receipt, CLVLY
Geographical distribution1
North America
InanalysingthenumberofAmericanDepositoryReceipts(ADRs)tradedandnewlyissued,theCompanygainssomeinsightastotheinterestfortheCLINUVELstoryfromNorthAmerica.SincetheNasdaqInternationalDesignationanincreaseinsponsoredADRs(CLVLY)hasbeenseen,nowat11.46%oftheentireCompany.
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Geographical distribution1
North America
Institutions 44.37%
Brokers 3.61%
Related parties 9.03%
ADRs2 11.54%
Other 16.25%
Below threshold of analysis 15.19%
Register analysis – CLINUVEL1
Traded value (A$)
$-
$10,000,000
$20,000,000
$30,000,000
$40,000,000
2012 2013 2014 2015 2016 2017
CUV
CLVLY
1 As at 15 September 20172 Sponsored American Depository Receipt, CLVLY
OfmostinterestistheanalysisofthevalueofthesponsoredADRs.
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Institutions 44.37%
Brokers 3.61%
Related parties 9.03%
ADRs2 11.54%
Other 16.25%
Below threshold of analysis 15.19%
Register analysis – CLINUVEL1
Shares on Issue
12 month low-high
47,735,227
A$5.91-$9.44
MCAP A$437m
12 month traded volume 4,771,470
Investment to date 2001-17 A$172m
Register: Geographical breakdown1
North America
EU / CH
Australia
Asia
Unanalysed / RoW
1 As at 15 September 20172 Sponsored American Depository Receipt, CLVLY
Dilution 2005-17 187%
Currentlythereare47,735,227ordinarysharesonissue,andnodilutionhasoccurredsincelastyear.Theviewerisshownthatthepercentageofdilutionis187%over12years,ametricthefinanceteamcloselymonitors.
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QuarterlyCashflow[2006– 2017]
$4,000,000
$3,000,000
$2,000,000
$1,000,000
0
- $1,000,000
- $2,000,000
- $3,000,000
- $4,000,000Q106
Q206
Q306
Q406
Q107
Q207
Q307
Q407
Q108
Q208
Q308
Q308
Q109
Q209
Q309
Q409
Q110
Q210
Q310
Q410
Q111
Q211
Q311
Q411
Q112
Q212
Q312
Q412
Q113
Q213
Q313
Q413
Q114
Q214
Q314
Q414
Q115
Q215
Q315
Q415
Q116
Q216
Q316
Q416
Q117
Q217
Q317
Cashflow per quarter A$
Illustratedis47quartersofcashflowsincemanagementstartedtheSCENESSE®program.In43ofthesequartersthecashflowswerenegative,infourofthefivemostrecentquartersCLINUVELhasbecomecashflowpositive.AnepitomehasbeenthemaidenprofitpostedbytheCompanyattheendofFY2017.
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QuarterlyCashflow[2006– 2017]Scenario 3 – High
(CUV internal scenario presented at AGM 2015)
-$4,000,000
-$2,000,000
$0
$2,000,000
$4,000,000
2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
$-
$10,000,000
$20,000,000
$30,000,000
$40,000,000
$50,000,000
$60,000,000
$70,000,000 Projected inflows as per CUV internal scenario presented at AGM 2015
Actual outflows
Actual inflows
A$
A$
CLINUVELiscurrentlynotinthepositiontoprovidefinancialguidance,howeverasanexpressionofCLINUVEL’sambitions,ithadsharedthreeinternalscenariosduringthe2015AGM.TheaudienceisshownCLINUVEL’sperformancetodateagainstthethird,“High”,scenario,trackedto2020.
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PROOF OF PRINCIPLE
CLINICAL DEVELOPMENT
REGULATORY REVIEW
MARKET ACCESS
CLINUVEL 2020
Market cap Equity Assets at Risk
0
10,000,000
20,000,000
30,000,000
40,000,000
50,000,000
60,000,000
0
50,000,000
100,000,000
150,000,000
200,000,000
250,000,000
300,000,000
350,000,000
400,000,000
450,000,000
500,000,000
Dec-05 Dec-06 Dec-07 Dec-08 Dec-09 Dec-10 Dec-11 Dec-12 Dec-13 Dec-14 Dec-15 Dec-16 Dec-17 Dec-18 Dec-19 Dec-20
Date
Sha
res
on I
ssue
$A
23 July 2010Positive results of
CUV017 studyFebruary 2005
FDA rejects afamelanotide IND
17 May 2010Afamelanotide
prescribed under Italian law 648/96
22 December 2014EMA marketing authorisation for
SCENESSE®
ThewhitelinehighlightsthehurdlestheCLINUVELteamhadtoovercometoarriveattoday’sjuncture.AtquiteanumberofmomentstheteamwasatcrossroadsgiventhelegacyoftheCompany,andhadtosurmountresistance.Inmanywaysthewhitelinesymbolisesthepersistenceoftheteam.Thisslidealsoshowskeymilestones,withfoureventshighlighted.Intotal,thoserepresentedbyyellowmarkersare:28Nov2005– NewCLINUVELmanagementstructure01May2006– PrivateplacementraisesA$5.0m01Nov2006– RaiseofA$35.2mviaRightsIssue&PrivatePlacement22Feb2007– PositiveresultsofCUV010study(PhaseIIEPP)26Apr2007– CompletionofA$26mPrivatePlacement17May2010– AfamelanotideprescribedunderItalianlaw648/9623Jul2010– PositiveresultsofCUV017(PhaseIIIEPP)study03Nov2011– PositiveresultsofCUV030(PhaseIIEPP)study06Feb2012– EMAmarketingauthorisationapplicationforSCENESSE®
26Apr2012– SwissinsurersfirstagreetoreimburseSCENESSE®
24Jun2012– RaiseofA$6.2m06May2013– RaiseofA$6.3m11Nov2013– PositiveresultsofCUV039(PhaseIIIEPP)study20May2014– RaiseofA$6.9m28Jul2014– HostiletakeoverbidfromRetrophin22Dec2014– EMAmarketingauthorisationforSCENESSE®
02July2015– NEJMpublishespivotalphaseIIISCENESSE® studies15May2016– RaiseofA$8.3m22Jun2016– SCENESSE® launchedinEurope09Nov2016– AgreementwithFDAonNewDrugApplicationtimelines12Apr2017– AgreementreachedonGermanSCENESSE® pricing
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3
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FDA
APPROVAL IND
ODD
APPROVAL PHII CUV030
APPROVAL PHIII CUV039
AD HOC MEETING EPP PATIENTS ‐ FDA
GCP INSPECTION
AD HOC MEETING EPP PATIENTS – FDA
PILOT 1ST FDA WORKSHOP ON EPP
END‐OF‐PHIII MEETING
REJECTION IND
EPITAN
CUV
2007
2008
2010
2011
2012
2014
2015
2016
2016
2003
2017
NDA FILING ON ROLLING BASIS
AnoverviewofFDAmilestonestodateisgiven.
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FDA
EC726 / 2004 Exceptional circumstances – no scientific tools
Post-Authorisation Study– safety data
CLINICAL DATA
2017-18
2nd Annual Report EMA – Dec 2017Feb 2018 analyses
PDUFA
V
Validation 60 days
Priority Rev. Standard Rev.
<6m 9-12m
Advisory Committee
Further information
Market Authorization – Complete Response Letter
DDDP
9 voting members
Expert physicians
Patient advocacy
Company
ThepathwayoftheFDAfilingandrationaleisexplained.Thepossibleoutcomesarehighlightedandare:• MarketingAuthorization;• CompleteResponseLetter.Theprocessisdescribed.
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®
4
CLINUVELhasestablishedSCENESSE® asthestandardofcareforadultEPPpatientsinEurope.Workcontinuestoenableaccesstothetreatmentforpatientswithanunmetmedicalneed.
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AmediaexcerptisshownofaSwissinsurerandapatientrepresentativedebatingunequalaccesstotreatment,aswellasthetriplingofthepriceofthedrugwhiletheCompanymadethedrugavailabletoSwisspatientsfreeofchargeandatasubsidisedlevel,whilenotpostingprofitsduringthatperiod.Themoderatorconcludesbystatingthatthetreatmentismeanwhileavailableinothercountries.AstillimageofnewsclipsisshownoftheheadlinesonCLINUVELandthedistributionofSCENESSE®.
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SCENESSE® EUMarketAccess&Reimbursement
EMA – EC 726 / 2004 14 (8)
MA under ‘Exceptional Circumstances’
1 Orphan product
2 No scientific instruments available to quantify effectiveness
3 Unethical to subject EPP patients to further clinical trials
22 Dec 2014
EPP Pharmacovigilance
EPP Disease Registry
A Safety data
B Rate of continuity Rx
C Inventory of Daily Activities
2015‐2022
SCENESSE® wasgrantedmarketingauthorisationbytheEMAin2014underExceptionalCircumstancesduetotheuniquenatureofEPPandthelackofscientifictoolsavailabletoquantifythediseaseoratreatment.SinceapprovalCLINUVEL’steamshaveestablishedacompliantpharmacovigilancesystemtomonitordrugsafety,andthefirsteverinternationalEPPdiseaseregistrytocollectlongtermsafetyandeffectivenessoutcomesendpoints.PseudonymiseddataarecollectedfrompatientsreceivingthedrugatEuropeanEPPExpertCentres.
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SCENESSE® EUMarketAccess&Reimbursement
IQWIG
Germany 2017
GBA
GKV (PKV) ‐ AMNOG (§130 V SG)
Clinical benefitAlternative TxComparable TxPrice setting
Court of Arbitration 31/03/17
SCENESSE® reviewed by CoAEU price establishedNo rebates payableGKV/PKV pay uniform EU priceTreatment benefit unquantifiable
15/09/15
Outcomes CoA Germany (25)
Retract from marketAppeal final price setting
7/25 = 28%7/10 = 70%
AnexampleisgivenofthenegotiationswiththeGermangovernmentreimbursementbody,GKV‐Spitzenverband,whicheventuallyledtoaformalCourtofArbitrationinMarch2017.SCENESSE® isnowthestandardofcareforEPPinGermany.
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SCENESSE® EligibleexpertcentresinEurope
66.1% increase in patient treatments 2016 to 20175 US patients treated in 2017
Alternative effective therapy1 None
Listing price
(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® Uniform Price
Thereare42EuropeanEPPExpertCentreswhohaveindicatedawillingnesstoprescribeSCENESSE® fortheirpatients.Increasinglywehaveseenmovementacrossbordersaspatientsseekaccesstotreatment,includingfiveUSpatientswhohavereceivedtreatmentinEuropein2017.CLINUVELestablishedauniformpriceforSCENESSE® withallnationstreatedequally.
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CLINUVELseekssustainability.Anumberofkeyelementsofsustainabilityaredescribedaspartofthefoundationsofthebusiness.
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EXPERTISE
financial management– structured project finance
clinical – regulatory – PV – QA
distribution – market access – pricing
melanocortins – GCPR - physics / optics
peptide chemistry – analytical
endocrinology – haematology – gastroenterology – dermatology
TherearekeyfoundationsnowinplacefromwhichwearegrowingtheGroup.PartsoftheassetsnotfoundonthebalancesheetbutvitaltothelongevityofCLINUVELresidein:1. abilitytomaintainfinancialdiscipline;2. abilitytoseethroughcomplexity.TheteamhasbuiltaspecificsetofskillstoprogressSCENESSE® tomarket.‐‐Definitions:GCPR:G‐coupledproteinreceptorsPV:PharmacovigilanceQA:QualityAssurance
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COMMUNICATION – MEDIA STRATEGY
repositioning company ‘branding’ CLINUVEL increase visibility
medical communitygeneral publicinvestment community
EXPERTISE
Theelements‘timelyvisibility’,and‘relevancetoawidestpossibleaudience’,requiresmoreworktowardsreaching:a. medicalcommunityb. generalpublicc. investmentcommunityandarepartofthegrowthstrategy.
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FINANCIAL TARGETS
reinvest in R&D cross subsidise - ROCE ROEincrease assets
EXPERTISE
COMMUNICATION - MEDIA
TheCompanyseekstoreinvestinR&D.
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VALUES-MISSION-VISION
innovative solutions for complex medical problems
translate scientific breakthroughs to commercial products
attitude, respect, appreciation, knowledge-based culture
‘persistence of objectives beyond what can be expected from staff’
EXPERTISE
COMMUNICATION - MEDIA
FINANCIAL TARGETS
ThereisaconsistencyacrosstheGroupwhichreflectsourcorevaluesandwhatweexpectfromstaff.Bymakingthesecentraltenetsofoperationswearebestpositionedtogrow.
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SCENESSE®
EU US
EMA FDA
PAYORS
DISTRIBUTION
PAYORS
DISTRIBUTION
“PASS”
expand EU access
pharmacovigilance
8 states
1-2 registries
CUV DRIVES HARMONISATION
regulatory dossierregistry PVS/QMSmarket access, reimbursementcontrolled distribution
EXPERTISE
COMMUNICATION - MEDIA
FINANCIAL TARGETS
VALUES - VISION
TheleaddrugSCENESSE®,asystemicphotoprotectiveagent,formsthebasisforgrowth.Anumberofkeylearningshavebeenderivedfromthedevelopmentofthedruganditspathtomarketingauthorisation.WhiletheEMAapprovalofSCENESSE® hastakensometimetofindawaytograntthedrugmarketingauthorisation,theUSdoesnotyethavesimilarpathways,althoughregulatoryreformsareunderway.InmanywaystheSCENESSE® casedrivesharmonisationbetweenthetwoleadingagenciesand,fromaperspectiveofregulatoryandcostefficiency,commonandlogicalpathwaysmakesense.CLINUVEL’ssequentialregulatoryfilingsofclinicaltrialdataandEuropeandatafromconditionsofuseareasteptowardsfacilitatingsimilarscientificconsiderationsbyvariousagencies.‐‐Definitions:EMA:EuropeanMedicinesAgencyFDA:USFoodandDrugAdministrationSmPC:EuropeanSummaryofProductCharacteristicsPhIIb/III:PhaseIIborIIIclinicaltrialsPVS:PharmacovigilanceSystemQMS:QualityManagementSystem
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EPP
EPP US 1:140,000 prevalence
EPP Japan, Australia +/- 500 known
Label extension – ‘cutaneous porphyrias’ FDA orphan designation
Dosing increase 4 to 6 per annum SmPC to be reviewed
New orphan indication – high unmet need IP filed
Vitiligo Ph IIb/III US trials North America
EU US
EMA FDA
PAYORS
DISTRIBUTION
PAYORS
DISTRIBUTION
“PASS”
Expand EU access
Pharmacovigilance
8 stages
1-2 registries
CUV DRIVES HARMONISATION
Regal dossierRegistry PVMarket access, reimbursementControlled Distribution
SCENESSE®
EXPERTISE
COMMUNICATION - MEDIA
FINANCIAL TARGETS
VALUES - VISION
SCENESSE® onceapprovedintheUSwilllikelyhaveseveralapplications– pendingregulatoryapproval –in:1. EPPEurope(adults)2. EPPUSA(adults)3. adultEPPpatientsacrossvariousjurisdictionswhereknownpatientpopulationsexist(Australia‐
Japan)throughlabelextensionin:4. othercutaneousporphyrias(orphanindication)through5. anincreaseinprescriptionfrom4to6dosesperannum6. athird(new)orphanindication7. vitiligoaffectingNorthAmericanpatientsofdarkercomplexion(FitzpatricktypesIV‐VI).
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SCENESSE®
RESEARCH & DEVELOPMENT
EXPERIMENTAL LAB
ANALYTICAL LAB
SMALL MOLECULES Rx
CUV9900
VLRX001
CLINUVEL-VALLAURIX
VALLAURIX joint venture
second laboratory Singapore - CUV
topical Rx skin inflammatory D.
DNA repair & regeneration.
systemic, 2nd generation MC.
ANALYTICAL METHODS
fully equipped, GLPmaximum capacity
SUSTAINABILITY
• PROPRIETARY TECHNOLOGY• PRODUCT LIFECYCLE MGMT• COMPETITIVE ADVANTAGE• BARRIERS TO ENTRY• “CUSTOMERS” DEMAND
PAEDIATRIC PRODUCT
SCENESSE® ENFANCE dosing < 18 years
EXPERTISE
COMMUNICATION - MEDIA
FINANCIAL TARGETS
VALUES - VISION
Essentialtolongtermgrowthistechnologicaladvancementviacontinuousresearch&development.CLINUVELhasamajoritystakeinanexperimentallaboratoryinSingapore,whereanumberofnovelprojectsarebeingprogressed,andwillleadtotheclinicaldevelopmentof:8. CUV99009. VLRX001bothastopicalandsecond‐generationmelanocortin(MC)products.Followingtherequestbytheregulatoryauthorities,theteamsarealsoworkingonthedevelopmentof10. SCENESSE® ENFANCEforchildrendiagnosedwithEPP.SCENESSE® ENFANCEwillbeevaluatedforEuropeanandNorthAmericanEPPpatients.Sustainabilityisbeingreiteratedinlightoftheresearchanddevelopment.‐‐Definitions:GLP:GoodLaboratoryPracticeMC:Melanocortin
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GROWTH 2020
RESEARCH & DEVELOPMENT
ACQUISITION(S)- LICENSING
synergies – existing expertise same user basefully integratedprofitable short-term
SCENESSE®
EXPERTISE
COMMUNICATION - MEDIA
FINANCIAL TARGETS
VALUES - VISION
TheCompanywillfurtherexpandthroughthelicensingofaproductand/oranacquisition.Theobjectiveistoincreasetheproductofferings.
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CUVGrowth2020
BUSINESS STRATEGY
A. DIVERSIFY CUV
B. SPREAD RISK
C. USE/EXPAND EXPERTISE
D. PRODUCT CYCLE
E. MC INCREASE RELEVANCE
F. LONGEVITY CUV
FINANCIAL STRATEGY
A. CAGR
B. FINANCE CONTROLLED GROWTH
C. REINVEST IN R&D
D. INCREASE RETURN ON EQUITY
Thefocusonmelanocortins,financialmanagement,execution,retentionoftalent,andtheabilitytopersisttowardsaclearobjectivebytheCLINUVELteamareallsomeofthekeyfactorsofsuccess.ThiscomplementarystrategytothepharmaceuticaldevelopmentwilllendCLINUVELgreatervisibilityandrelevancetoabroaduserbase.Attheendof2020CLINUVELwillneedtohavetransformedintoaGroupwithgreaterdiversification,productcyclemanagement,addressingapaediatricpopulation,greaterproductmix,reductionofassetriskandenhancedvisibilityamongageneralmedicalcommunity,andabroaduserbase.
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6
AllintendedstrategicconsiderationssharedaresubjecttotheongoingsafetyofSCENESSE®,materialchangestotheCLINUVELbusinessduetounexpectedevents,andchangesgeopolitically,economicallyandforcemajeure.Timelinesaregivenpercontinent.
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UpcomingMilestones– Europe&Australia
2018 2019 2020
Company positioning new website & communication
CUV103 vitiligo results n = 18Asian phenotype
EPP expert meetingSCENESSE® evaluation
Pilot ‐ physician initiated cutaneous porphyrias
2nd Annual Report EMA
File with TGASCENESSE ®
in EPP
Label extension Rxfrom 4 to 6 doses
1st PK trial in childrenn =5, 11‐18 yearsSCENESSE® ENFANCE
AllintendedstrategicconsiderationssharedaresubjecttotheongoingsafetyofSCENESSE®,materialchangestotheCLINUVELbusinessduetounexpectedevents,andchangesgeopolitically,economicallyandforcemajeure.Timelinesaregivenpercontinent.
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UpcomingMilestones– Asia
2018 2019 2020
Analytical lab Singapore• Analytical• Regulatory support
SE‐Asia• SCENESSE® ENFANCE
Launch CLINUVEL skincare solutions2 distribution channels
Filing SCENESSE® in EPP, Japan PMDA
CUV9900PK StudyTopical Rx First results CUV9900
AllintendedstrategicconsiderationssharedaresubjecttotheongoingsafetyofSCENESSE®,materialchangestotheCLINUVELbusinessduetounexpectedevents,andchangesgeopolitically,economicallyandforcemajeure.Timelinesaregivenpercontinent.
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UpcomingMilestones– USA
2018 2019 2020
EMA 2nd
Annual Report to FDA
FDA decision on Priority Review*
Type C meeting FDA vitiligo protocol*
FDA PDUFA V NDA or CRL*
NDA: first US EPP patient treated*
FDA starts validation SCENESSE® NDA*
AllintendedstrategicconsiderationssharedaresubjecttotheongoingsafetyofSCENESSE®,materialchangestotheCLINUVELbusinessduetounexpectedevents,andchangesgeopolitically,economicallyandforcemajeure.Timelinesaregivenpercontinent.*Possiblescenariosshown.
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CUVGrowth20204 CONTINENTS - EU, US, ASIA, AUS
4 INDICATIONS - EPP, LABEL EXT, ORPHAN INDICATION, VITILIGO
2 PRODUCTS – TOPICAL + SYSTEMIC
1 PAEDIATRIC PRODUCT
ADDITIONAL ASSET
RELEVANT TOPICAL PRODUCT LINE
INCREASE VISIBILITY – WIDER RELEVANCE
Astheslideshows,knowledge,expertise,andIPflowingdownstreamfromtheR&DonSCENESSE® andonclinicaluseleadtocomplementaryproductsforabroaderuserbase.
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®
7
AnoverviewofSCENESSE® inEPPisgivenforthoseunfamiliarwiththeCompany’sstory.
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SCENESSE® – ErythropoieticProtoporphyria
Erythropoietic protoporphyria
Gene defect: chromosome 18q21.3
Burns, anaphylactoid reactions (phototoxicity)
Lifelong light deprivation, nocturnal existence
SCENESSE® (afamelanotide 16mg)
EU approval for the prevention of phototoxicity in adult EPP patients
Novel controlled release injectable subcutaneous formulation, once every two months
World’s first systemic photoprotective drug
“we have not been taken serious by society throughout our lives, now there is treatment available and we are noticed and given due attention”
SCENESSE® isapprovedinEuropeforthepreventionofphototoxicityinadultpatientswithEPP.Formoreinformation,includingcopiesofproductinformation,pleaseseeCLINUVEL’swebsite,www.clinuvel.com.
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CLINUVELwouldliketothankallofitsBoardofDirectors,worldwidestaffandshareholders
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