Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Shareholder Meeting (November 2017)
46 slides from Clinuvel Pharmaceuticals's shareholder meeting presentation, Nov 28, 2017
Slide 1: Clinuvel Pharmaceuticals Management Presentation
For personal use only Melbourne, 28 November 2017 CLINUVEL PHARMACEUTICALS MANAGEMENT PRESENTATION ASX: CUV ADR: CLVLY XETRA: UR9 Today’s discussion outlines the CLINUVEL Board’s objectives to lead the growth of the Group by 2020. The emphasis today is on the strategic direction of the Group towards
Slide 2: Forward-looking statements
Forward‐looking statements 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 significantl
Slide 3: Contents
Contents 1 Corporate Value 4 SCENESSE® EU Market Access & Reimbursement For personal use only 2 Financials 5 Growth 2020 3 FDA 6 Milestones 7 SCENESSE® in EPP Index of the seven topics to be covered today which eventually will lead to the audience’s understanding of CLINUVEL’s objectives and the Gro
Slide 4: For personal use only
1 For personal use only CLINUVEL’s success today is owed to physicians, patients and all who have contributed. In retrospect, one can distinguish in the value of CLINUVEL two key elements: 1. consistency in its communication to a wide variety of stakeholders; 2. follow through on its corporate actio
Slide 5: CLINUVEL Stakeholders
CLINUVEL Stakeholders GENERAL MEDICAL REGULATORS POLITICAL GM COMMUNITY RG PO COMMUNITY EMA‐FDA General Physicians National competent authorities Government MPs Medical researchers Ethics committees Congressmen/senators Medical staff Advisory bodies SUPPLIERS / EXPERT PHYSICIANS FINANCIAL SM MANUFAC
Slide 6: For personal use only
2005‐2008 2008‐2012 2012‐2014 2014‐2017 2017‐2020 PROOF OF CLINICAL REGULATORY MARKET CLINUVEL PRINCIPLE DEVELOPMENT REVIEW ACCESS ‘2020’ IN RG EP PA RU For personal use only GM ME FM SM LC PI GP PO PR DI In sectioning the five temporal corridors from 2005 to 2020, CLINUVEL has varied its communicat
Slide 7: For personal use only
2005‐2008 2008‐2012 2012‐2014 2014‐2017 2017‐2020 PROOF OF CLINICAL REGULATORY MARKET CLINUVEL PRINCIPLE DEVELOPMENT REVIEW ACCESS ‘2020’ PA RU EP RG IN GM For personal use only ME PR PI LC FM SM PO GP DI From 2008 to 2012, the years of clinical development, obviously patient associations, research
Slide 8: For personal use only
2005‐2008 2008‐2012 2012‐2014 2014‐2017 2017‐2020 PROOF OF CLINICAL REGULATORY MARKET CLINUVEL PRINCIPLE DEVELOPMENT REVIEW ACCESS ‘2020’ RG PR PA EP LC For personal use only PI SM GM IN RU ME DI FM PO GP During 2012 to 2014, the years of European regulatory review, the longest in the history of the
Slide 9: For personal use only
2005‐2008 2008‐2012 2012‐2014 2014‐2017 2017‐2020 PROOF OF CLINICAL REGULATORY MARKET CLINUVEL PRINCIPLE DEVELOPMENT REVIEW ACCESS ‘2020’ PA EP PR SM GM For personal use only IN RU RG ME PO LC DI PI FM GP During 2014 to 2017, the years of approval and gaining market access, we learned an entirely ne
Slide 10: For personal use only
2005‐2008 2008‐2012 2012‐2014 2014‐2017 2017‐2020 PROOF OF CLINICAL REGULATORY MARKET CLINUVEL PRINCIPLE DEVELOPMENT REVIEW ACCESS ‘2020’ Media Coverage 2005 - Present PA Media Number of Titles EP Industry 679 Magazine 36 PR Newspaper 326 SM GM Online 245 TV 60 For personal use only Wire 123 IN RU R
Slide 11: For personal use only
2005‐2008 2008‐2012 2012‐2014 2014‐2017 2017‐2020 PROOF OF CLINICAL REGULATORY MARKET CLINUVEL PRINCIPLE DEVELOPMENT REVIEW ACCESS ‘2020’ Media Coverage 2005 - Present PA GP Media Number of Titles Industry 679 EP Magazine 36 Newspaper 326 IN GM ME Online 245 TV 60 For personal use only Wire 123 Gran
Slide 12: For personal use only
2 For personal use only The Company has consistently sought to review its financial position at Annual General Meetings, with readers encouraged to follow the thought process since 2006. 12
Slide 13: Register analysis – CLINUVEL
Register analysis – CLINUVEL1 Institutions 44.37% Brokers 3.61% For personal use only Related parties 9.03% ADRs2 11.54% Other 16.25% Below threshold of analysis 15.19% 1 As at 15 September 2017 2 Sponsored American Depository Receipt, CLVLY The analysis of CLINUVEL’s share register is of importance
Slide 14: Register analysis – CLINUVEL
Register analysis – CLINUVEL1 Institutions 44.37% Brokers 3.61% Related parties 9.03% ADRs2 11.54% Other 16.25% Below threshold of analysis 15.19% Geographical distribution1 Unanalysed / RoW For personal use only North America Asia Australia EU / CH 1 As at 15 September 2017 2 Sponsored American Dep
Slide 15: Register analysis – CLINUVEL
Register analysis – CLINUVEL1 Institutions 44.37% Brokers 3.61% Related parties 9.03% ADRs2 11.54% Other 16.25% Below threshold of analysis 15.19% ADRs2 Geographical distribution1 CLVLY as % of total CLINUVEL holdings For personal use only 12.00% North America 10.00% 8.00% 6.00% 4.00% 2.00% 2005 200
Slide 16: Register analysis – CLINUVEL
Register analysis – CLINUVEL1 Institutions 44.37% Brokers 3.61% Related parties 9.03% ADRs2 11.54% Other 16.25% Below threshold of analysis 15.19% Geographical distribution1 Traded value (A$) $40,000,000 For personal use only North America $30,000,000 $20,000,000 CUV $10,000,000 CLVLY $- 2012 2013 2
Slide 17: Register analysis – CLINUVEL
Register analysis – CLINUVEL1 Register: Geographical breakdown1 Institutions 44.37% Unanalysed / RoW Brokers 3.61% North America Related parties 9.03% Asia ADRs2 11.54% Other 16.25% Below threshold of analysis 15.19% Australia EU / CH Shares on Issue 47,735,227 For personal use only 12 month low-hig
Slide 18: Quarterly Cashflow [2006 – 2017]
Quarterly Cashflow [2006 – 2017] Cashflow per quarter A$ $4,000,000 $3,000,000 $2,000,000 For personal use only $1,000,000 0 - $1,000,000 - $2,000,000 - $3,000,000 - $4,000,000 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q3 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1
Slide 19: Quarterly Cashflow [2006 – 2017]
Quarterly Cashflow [2006 – 2017] Scenario 3 – High A$ (CUV internal scenario presented at AGM 2015) $70,000,000 Projected inflows as per CUV internal scenario presented at $60,000,000 AGM 2015 $50,000,000 $40,000,000 $30,000,000 For personal use only $20,000,000 Actual inflows $10,000,000 Actual out
Slide 20: For personal use only
PROOF OF CLINICAL REGULATORY MARKET CLINUVEL PRINCIPLE DEVELOPMENT REVIEW ACCESS 2020 500,000,000 60,000,000 22 December 2014 450,000,000 EMA marketing 23 July 2010 authorisation for February 2005 Positive results of SCENESSE® 50,000,000 400,000,000 FDA rejects CUV017 study afamelanotide IND 350,000
Slide 21: For personal use only
For personal use only 3 21
Slide 22: FDA
FDA 2017 2016 NDA FILING ON ROLLING BASIS 2016 END‐OF‐PHIII MEETING 2015 For personal use only PILOT 1ST FDA WORKSHOP ON EPP 2014 AD HOC MEETING EPP PATIENTS – FDA 2012 GCP INSPECTION 2011 AD HOC MEETING EPP PATIENTS ‐ FDA 2010 APPROVAL PHIII CUV039 2008 APPROVAL PHII CUV030 2007 ODD 2003 APPROVAL I
Slide 23: FDA filing pathway
FDA CLINICAL DATA EC726 / 2004 Exceptional circumstances – no scientific tools Post-Authorisation Study – safety data For personal use only 2nd Annual Report EMA – Dec 2017 Validation 60 days Feb 2018 analyses P Priority Rev. Standard Rev. 2017-18 D U <6m 9-12m DDDP F Advisory Committee 9 voting mem
Slide 24: For personal use only
4 For personal use only ® CLINUVEL has established SCENESSE® as the standard of care for adult EPP patients in Europe. Work continues to enable access to the treatment for patients with an unmet medical need. 24
Slide 25: For personal use only
For personal use only A media excerpt is shown of a Swiss insurer and a patient representative debating unequal access to treatment, as well as the tripling of the price of the drug while the Company made the drug available to Swiss patients free of charge and at a subsidised level, while not postin
Slide 26: SCENESSE EU Market Access & Reimbursement
SCENESSE® EU Market Access & Reimbursement 22 Dec 2014 2015‐2022 EMA – EC 726 / 2004 14 (8) EPP Pharmacovigilance For personal use only MA under ‘Exceptional Circumstances’ EPP Disease Registry 1 Orphan product A Safety data No scientific instruments available 2 to quantify effectiveness B Rate of c
Slide 27: SCENESSE EU Market Access & Reimbursement
SCENESSE® EU Market Access & Reimbursement Germany 2017 IQWIG GBA For personal use only GKV (PKV) ‐ AMNOG (§130 V SG) 15/09/15 Clinical benefit Outcomes CoA Germany (25) Alternative Tx Comparable Tx Price setting Retract from market 7/25 = 28% Appeal final price setting 7/10 = 70% Court of Arbitrati
Slide 28: SCENESSE Eligible expert centres in Europe
SCENESSE® Eligible expert centres in Europe 66.1% increase in patient treatments 2016 to 2017 5 US patients treated in 2017 SCENESSE® Uniform Price For personal use only Alternative effective therapy1 None Listing price (Lauer-Taxe)2 € 0 €25,000 €50,000 €75,000 €100,000 1No alternative effective the
Slide 29: For personal use only
5 For personal use only CLINUVEL seeks sustainability. A number of key elements of sustainability are described as part of the foundations of the business. 29
Slide 30: Expertise
EXPERTISE financial management melanocortins – GCPR - physics / optics – structured project finance peptide chemistry – analytical clinical – regulatory – PV – QA endocrinology – haematology – gastroenterology – dermatology For personal use only distribution – market access – pricing There are key f
Slide 31: Communication – Media Strategy
COMMUNICATION – MEDIA STRATEGY For personal use only repositioning company ‘branding’ CLINUVEL medical community increase visibility general public investment community EXPERTISE The elements ‘timely visibility’, and ‘relevance to a widest possible audience’, requires more work towards reaching: a.
Slide 32: Financial Targets
FINANCIAL TARGETS reinvest in R&D cross subsidise - ROCE increase assets ROE For personal use only COMMUNICATION - MEDIA EXPERTISE The Company seeks to reinvest in R&D. 32
Slide 33: Values-Mission-Vision
VALUES-MISSION-VISION innovative solutions for complex medical problems translate scientific breakthroughs to commercial products For personal use only attitude, respect, appreciation, knowledge-based culture ‘persistence of objectives beyond what can be expected from staff’ FINANCIAL TARGETS COMMUN
Slide 34: SCENESSE EU and US
SCENESSE® EU US EMA FDA CUV DRIVES HARMONISATION PAYORS PAYORS For personal use only regulatory dossier registry PVS/QMS DISTRIBUTION DISTRIBUTION market access, reimbursement controlled distribution “PASS” pharmacovigilance expand EU access 8 states 1-2 registries VALUES - VISION FINANCIAL TARGET
Slide 35: SCENESSE applications EU US
SCENESSE® EU US EMA FDA EPP CUV DRIVES PAYORS PAYORS HARMONISATION EPP US 1:140,000 prevalence For personal use only EPP Japan, Australia +/- 500 known Regal dossier Registry PV Market access, reimbursement DISTRIBUTION DISTRIBUTION Controlled Distribution “PASS” Expand EU access Pharmacovigilance
Slide 36: Research & Development
RESEARCH & DEVELOPMENT CLINUVEL-VALLAURIX ANALYTICAL METHODS ANALYTICAL LAB SUSTAINABILITY fully equipped, GLP second laboratory Singapore - CUV maximum capacity • PROPRIETARY TECHNOLOGY For personal use only • PRODUCT LIFECYCLE MGMT SMALL MOLECULES Rx • COMPETITIVE ADVANTAGE topical Rx skin inflamm
Slide 37: Growth 2020
GROWTH 2020 ACQUISITION(S)- LICENSING synergies – existing expertise same user base fully integrated For personal use only profitable short-term SCENESSE® RESEARCH & DEVELOPMENT VALUES - VISION FINANCIAL TARGETS COMMUNICATION - MEDIA EXPERTISE The Company will further expand through the licensing of
Slide 38: CUV Growth 2020
CUV Growth 2020 BUSINESS STRATEGY FINANCIAL STRATEGY A. DIVERSIFY CUV A. CAGR B. SPREAD RISK B. FINANCE CONTROLLED GROWTH C. USE/EXPAND EXPERTISE C. REINVEST IN R&D For personal use only D. PRODUCT CYCLE D. INCREASE RETURN ON EQUITY E. MC INCREASE RELEVANCE F. LONGEVITY CUV The focus on melanocortin
Slide 39: For personal use only
6 For personal use only All intended strategic considerations shared are subject to the ongoing safety of SCENESSE®, material changes to the CLINUVEL business due to unexpected events, and changes geopolitically, economically and force majeure. Timelines are given per continent. 39
Slide 40: Upcoming Milestones – Europe & Australia
Upcoming Milestones – Europe & Australia 2018 2019 2020 File with TGA For personal use only Company SCENESSE ® 1st PK trial in children positioning new in EPP n =5, 11‐18 years website & SCENESSE® ENFANCE communication 2nd Annual Report EMA Label extension Rx from 4 to 6 doses CUV103 vitiligo result
Slide 41: Upcoming Milestones – Asia
Upcoming Milestones – Asia 2018 2019 2020 For personal use only Analytical lab Singapore • Analytical • Regulatory support SE‐Asia Filing SCENESSE® in EPP, Japan • SCENESSE® ENFANCE PMDA CUV9900 Launch CLINUVEL PK Study skincare solutions Topical Rx First results CUV9900 2 distribution channels All
Slide 42: Upcoming Milestones – USA
Upcoming Milestones – USA 2018 2019 2020 For personal use only FDA PDUFA V NDA or CRL* EMA 2nd NDA: first US EPP patient Annual treated* Report to FDA decision on FDA Priority Review* Type C meeting FDA vitiligo protocol* FDA starts validation SCENESSE® NDA* All intended strategic considerations sha
Slide 43: CUV Growth 2020
CUV Growth 2020 4 CONTINENTS - EU, US, ASIA, AUS 4 INDICATIONS - EPP, LABEL EXT, ORPHAN INDICATION, VITILIGO 2 PRODUCTS – TOPICAL + SYSTEMIC 1 PAEDIATRIC PRODUCT For personal use only RELEVANT TOPICAL PRODUCT LINE ADDITIONAL ASSET INCREASE VISIBILITY – WIDER RELEVANCE As the slide shows, knowledge,
Slide 44: For personal use only
7 For personal use only ® An overview of SCENESSE® in EPP is given for those unfamiliar with the Company’s story. 44
Slide 45: SCENESSE – Erythropoietic Protoporphyria
SCENESSE® – Erythropoietic Protoporphyria Erythropoietic protoporphyria SCENESSE® (afamelanotide 16mg) For personal use only Gene defect: chromosome 18q21.3 World’s first systemic photoprotective drug Burns, anaphylactoid reactions (phototoxicity) EU approval for the prevention of phototoxicity in a
Slide 46: For personal use only
For personal use only CLINUVEL would like to thank all of its Board of Directors, worldwide staff and shareholders 46
CLINUVEL Pharmaceuticals — Shareholder Meeting (November 2017) on 6ix