Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Shareholder Meeting (November 2019)
26 slides from Clinuvel Pharmaceuticals's shareholder meeting presentation, Nov 20, 2019
Slide 1: CLINUVEL AGM 20 November 2019
For personal use only CLINUVEL AGM 20 NOVEMBER 2019 PHILIPPE WOLGEN MANAGING DIRECTOR CLINUVEL PHARMACEUTICALS LTD ASX: CUV NASDAQ INT'L: CLVLY XETRA-DAX: UR9
Slide 2: Legal Notice
For personal use only LEGAL NOTICE This release contains forwards-looking statements, which reflect the and pharmaceutical pricing and reimbursement; any failures to comply current beliefs and expectations of CLINUVEL's management. with any government payment system (i.e. Medicare) reporting and Sta
Slide 3: Index
INDEX For personal use only 4 8 SHARE REGISTRY, TRENDS ADOPTION SCENESSE®, LANDSCAPE MCR 5 9 FINANCIALS STRATEGY I 6 10 DISTRIBUTION UPDATE SCENESSE® EU-US STRATEGY II 7 11 DISTRIBUTION, GLOBAL UNIFORM PRICE SUMMARY
Slide 4: Share Registry, Trends
SHARE REGISTRY, TRENDS For personal use only CUV REGISTER - GEOGRAPHICAL DISTRIBUTION 100% 90% 16% 14% 31% 28% 80% 70% 35% 36% 60% 28% 32% 50% 1% 1% 40% 13% 9% 30% 48% 48% 20% 28% 31% 10% 0% 2006 2010 2015 2019 Australia Asia-Pacific Europe North America
Slide 5: Financials
FINANCIALS For personal use only Mean quarterly cash burn $2.81m FINANCIAL MANAGEMENT - CURRENT RATIO 20 Mean annual cash burn $12.74m 15 Cumulative expenditure 2005-14 (EMA) A$139m 10 Cumulative expenditure 2005-19 (FDA) A$191m 5 0 2009/10 2010/11 2011/12 2012/13 2013/14 2014/15 2015/16 2016/17 201
Slide 6: SCENESSE Distribution Update EU-US
SCENESSE® DISTRIBUTION UPDATE EU-US For personal use only 2014 - CAGR 2015 29% 2016 59% INCREASE YOY 2017 87% - Treatment: 13% - Patients: 12.5% 2018 79% - Centres: 27% 2019 65% Retention rate >94% CLINUVEL’S DECISION MODEL: SELF-DISTRIBUTION VERSUS OUT-LICENSING • Upfront payments range from A$15M
Slide 7: SCENESSE Distribution – Global Uniform Price
SCENESSE® DISTRIBUTION – GLOBAL UNIFORM PRICE For personal use only CLINUVEL LEADS THE WAY WITH GLOBAL UNIFORM PRICING POLICY • Economic climate ripe, timely • Equitable treatment of all payors, hospitals • US politics: “no price rise higher than inflationary rate” [“Prescription Drug Pricing Reduct
Slide 8: Adoption SCENESSE, Landscape MCR Agents
ADOPTION SCENESSE®, LANDSCAPE MCR AGENTS use only MELANOCORTINS1 CYCLIC LINEAR >$250M SYN MCAP $323 FLOW OF SALES Cash $499 MCAP A$1,450 COMMERCIAL MS Burn $1,668 Cash A$58 $100 ‘DIAG’ Fund $565 Burn A$14 personal L $3,607 AFA - EPP Fund A$139 Dt $600 - 3RD P A$18 $25 BRE - FSD CHASM EARLY MCAP $180
Slide 9: Strategy I
STRATEGY I CLAIMS PIPELINE For personal use only • EPP NCAS >20 SCENESSE® • VITILIGO • 3rd INDICATION ETHICS >35 REPIGMENTATION SCENESSE® ENFANCE 1 (= MELANOGENESIS) EMA 2014 SYSTEMIC FDA 2019 PARVYSMELANOTIDE (VLRX001) 2 PHOTOPROTECTION TGA PHIMELANOTIDE (VLRX002) 3 PMDA (CUV9900) OTC
Slide 10: Strategy I
STRATEGY I CLAIMS PIPELINE For personal use only • EPP NCAS >20 SCENESSE® • VITILIGO • 3rd INDICATION ETHICS >35 REPIGMENTATION SCENESSE® ENFANCE 1 (= MELANOGENESIS) EMA 2014 SYSTEMIC FDA 2019 PARVYSMELANOTIDE (VLRX001) 2 PHOTOPROTECTION TGA PHIMELANOTIDE (VLRX002) 3 DNA REPAIR PMDA (CUV9900) OTC
Slide 11: Strategy I
STRATEGY I REPIGMENTATION (= MELANOGENESIS) For personal use only SYSTEMIC PHOTOPROTECTION DNA REPAIR I. MAIN CAUSES OF DNA DAMAGE • ROS → UVR → PHOTOPRODUCTS • GENETICALLY INHERITED DISORDERS II. DNA REPAIR MECHANISMS • RR • NER • BER • HR/EJ III. ROLE OF α-MSH / SCENESSE® IN NER = DNA REPAIR 1. EL
Slide 12: Strategy II
STRATEGY II RISK FACTORS TO SKIN CANCER For personal use only MC1R POLYMORPHISMS MELANIN DENSITY CELLULAR SIGNALLING UV EXPOSURE 16Q24.3 I. Increased risk of skin cancer – I. Lack of supranuclear protection I. Deficient, suboptimal I. UV photoproducts hierarchical regression II. Epidermal barrier fu
Slide 13: Strategy II: Alpha-MSH to Date – SCENESSE in Application
STRATEGY II ALPHA-MSH TO DATE – SCENESSE® IN APPLICATION For personal use only MC1R Polymorphisms 16q24.3 Melanin Density Cellular Signalling UV Exposure I. Ki (dissociation constant MC1R) I. Increase MD 0.35 MD units – 28 I. MC1R binding affinity I. Increased UV exposure without Ki MLN SCC BCC days
Slide 14: Strategy II: Alpha-MSH to Date – SCENESSE in Application
STRATEGY II ALPHA-MSH TO DATE – SCENESSE® IN APPLICATION For personal use only MC1R Polymorphisms 16q24.3 Melanin Density Cellular Signalling UV Exposure I. REDUCING PROBABILITY OF SUNBURN (APOPTOSIS) II. REDUCING PHOTOPRODUCTS T-T, (CPD/6-4PP) III. DNA REPAIR EFFICIENCY REDUCING RISK OF SKIN CANCER
Slide 15: Summary: CLINUVEL's Portfolio
SUMMARY CLINUVEL’S PORTFOLIO For personal use only EPP – EU SCENESSE® EPP – USA EPP – AUS EPP – JPN CUV104 VITILIGO CUV105 CUV150 3RD Indication – USA CUV151 SCENESSE® ENFANCE EPP – EU EPP – USA EPP – AUS EPP – JPN 3rd Indication – USA PARVYSMELANOTIDE PHIMELANOTIDE VITILIGO CUV9900 OTC LINES PREVEN
Slide 16: CLINUVEL AGM November 2019
CLINUVEL AGM For personal use only 20 NOVEMBER 2019 APPRECIATION OF CLINUVEL BOARD, MANAGEMENT, STAFF, PATIENTS, EXPERT PHYSICIANS AND INVESTORS PHILIPPE WOLGEN MANAGING DIRECTOR CLINUVEL PHARMACEUTICALS LTD ASX: CUV NASDAQ INT'L: CLVLY XETRA-DAX: UR9
Slide 17: CEO's Presentation to the Annual General Meeting
Company Announcement ASX: CUV Nasdaq International Designation: CLVLY XETRA-DAX: UR9 For personal use only CEO’s Presentation to the Annual General Meeting Melbourne, Australia, 20 November 2019 WELCOME Good morning ladies & gentlemen, members of the Company, We welcome the international audience at
Slide 18: Share Registry and Trends
SHARE REGISTRY AND TRENDS Annually, we share with you the make-up of CUV’s register as we pay close attention to the changes occurring each quarter. We call your attention to the stability in ownership segmentation, whereby the register – including the decline of For personal use only ADRs – consist
Slide 19: For personal use only
our sector between revving up expenses to create value ahead of demonstrating economic viability. The contrary is true, whereby never-ending equity and debt financing in pharmaceutical R&D decreases the probability of being able to generate meaningful returns on the total investment, other than hopi
Slide 20: For personal use only
In simple terms, is it economically of benefit to let someone else distribute one’s product or should one do it him/herself? CLINUVEL – perhaps unconventionally to some investors but not the majority of our followers – decided to distribute itself. In sharing with you our optional license analyses,
Slide 21: For personal use only
With the nominations for the US elections in 2020 gathering momentum, we can surely say that CLINUVEL’s policy fits the current political debate on drug pricing in the US, precisely at the time that SCENESSE® is entering the US market. A Global Uniform Pricing Policy implies that SCENESSE® is to com
Slide 22: For personal use only
At the right-hand side, one sees a matrix of – along the horizontal axis – a distinction between orphan or mainstream addressable diseases, while on the vertical axis one sees the demarcation between clinical and commercial stage products belonging to the family of melanocortins. Although these are
Slide 23: Strategy I (A)
STRATEGY I (A) If one critically views the Company’s performance the past 14 years, an opportune question is whether there are other companies which would deliver equivalent or better shareholder returns. The answer is affirmative, of course there are. However, this management started a mission and
Slide 24: Strategy I (C)
What does this mean? On the right-hand side, one sees CLINUVEL’s pipeline of products, derivatives of SCENESSE®, all providing similar effectiveness as the mother technology or molecule, but to be used by us in different formulations and applications, the next generation of our products with a simil
Slide 25: CLINUVEL's Portfolio
3. increasing DNA reparative efficiency. The missing link for CLINUVEL to provide through the use of SCENESSE® – and which would have had limited or no value without the acknowledgement of the technology and its scientific data by the most recent FDA approval – is to demonstrate in 20 healthy human
Slide 26: Investor Enquiries and Forward-Looking Statements
SCENESSE® is a registered trademark of CLINUVEL PHARMACEUTICALS LTD. Head of Investor Relations Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD Investor enquiries For personal use only https://www.clinuvel.com/investors/contact-us Forward-Looking Statements This release contains forward-looking statem
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