clinuvel pharmaceuticals management presentation · 11/28/2017 · online traffic media number of...

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


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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REGULATORY REVIEW

MARKET ACCESS

2017‐2020CLINICAL


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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REGULATORY REVIEW

MARKET ACCESS

2017‐2020CLINICAL


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%


ADRs2 11.54%

Other 16.25%




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%


ADRs2 11.54%

Other 16.25%





North America

InanalysingthenumberofAmericanDepositoryReceipts(ADRs)tradedandnewlyissued,theCompanygainssomeinsightastotheinterestfortheCLINUVELstoryfromNorthAmerica.SincetheNasdaqInternationalDesignationanincreaseinsponsoredADRs(CLVLY)hasbeenseen,nowat11.46%oftheentireCompany.

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North America

Institutions 44.37%

Brokers 3.61%


ADRs2 11.54%

Other 16.25%



Traded value (A$)

$-

$10,000,000

$20,000,000

$30,000,000

$40,000,000

2012 2013 2014 2015 2016 2017

CUV

CLVLY


OfmostinterestistheanalysisofthevalueofthesponsoredADRs.

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Institutions 44.37%

Brokers 3.61%


ADRs2 11.54%

Other 16.25%



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


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


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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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


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


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


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


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


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


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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


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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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clinuvel pharmaceuticals management presentation · 11/28/2017 · online traffic media number of...

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