Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Shareholder Meeting (November 2009)
25 slides from Clinuvel Pharmaceuticals's shareholder meeting presentation, Nov 18, 2009
Slide 1: Clinuvel Pharmaceuticals Annual General Meeting 2009
For personal use only Clinuvel Pharmaceuticals Ltd Annual General Meeting 2009 Melbourne, Australia Wednesday 18th November, 2009 Dr Philippe Wolgen, CEO ASX: CUV XETRA-DAX: UR9 ADR: CLVLY
Slide 2: Global Financial Crisis
Global Financial Crisis For personal use only Chart courtesy of ASX November 16, 2009 B. Shanahan: Chair
Slide 3: Australia and Skin Cancer
Australia and Skin Cancer For personal use only • Melanoma: 9,524 new cases annually1 • Melanoma: 1,270 deaths annually2 • Skin Cancer: 1,700+ deaths annually2 • 2 in 3 Australians will be diagnosed with skin cancer by the age of 703 1. Australian Institute of Health and Welfare (AIHW) & Australasia
Slide 4: Clinuvel Is Unique
Clinuvel Is Unique For personal use only • New preventative therapy for patients UV Skin • Exporting afamelanotide cross-border • Impressive corporate turnaround B. Shanahan: Chair
Slide 5: Clinuvel Pharmaceuticals Annual General Meeting 2009
For personal use only Clinuvel Pharmaceuticals Ltd Annual General Meeting 2009 Melbourne, Australia Wednesday 18th November, 2009 Dr Philippe Wolgen, CEO ASX: CUV XETRA-DAX: UR9 ADR: CLVLY
Slide 6: Safe harbor statement
Safe harbor statement For personal use only Clinuvel is an Australian biopharmaceutical company focused on developing its leading drug candidate, afamelanotide, for a range of UV- related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and developm
Slide 7: Risk Assessment
Risk Assessment For personal use only • Financial management Sufficient funding, control of burn rate D • Executional • Clinical/regulatory program ‘05-’09 Competition D None Illegal/untested counterfeit presents false claims D • Clinical Safely administered 600 patients, 10 years Endpoints/protocol
Slide 8: World's First – Medicinal Photoprotection
World’s First – Medicinal Photoprotection For personal use only Afamelanotide, 1st in class; inherent novelty as a: I New chemical entity (NCE) II Concept of medicinal (Rx) photoprotection III Controlled-release formulation IV Prophylactic therapeutic treatment in orphan diseases (EPP/SU) V Seasonal
Slide 9: Financials
Financials For personal use only • Shares on issue 303,148,665 c/s • Fully diluted basis ~320M c/s • Market cap ~A$85m • Cash burn rate (FY09) <A$1.2m/month • Projected cash burn rate (FY10) <A$1.7m/month • Reserves (Sep 30 ’09) A$35.5m • Projected gross expenditures (Dec 1 ’09 - Dec 31 ’10) A$24.6m
Slide 10: Value Proposition
For personal use only Value Propostion
Slide 11: Clinuvel Scorecard
Clinuvel Scorecard Internal Performance Measures For personal use only
Slide 12: Clinuvel Scorecard
Clinuvel Scorecard Internal Performance Measures For personal use only
Slide 13: Clinuvel Scorecard
Clinuvel Scorecard Internal Performance Measures For personal use only
Slide 14: The operational scale of developing afamelanotide across continents
The operational scale of developing afamelanotide across 3 continents For personal use only
Slide 15: The operational scale of developing afamelanotide across continents
The operational scale of developing afamelanotide across 3 continents For personal use only
Slide 16: The operational scale of developing afamelanotide across continents
The operational scale of developing afamelanotide across 3 continents For personal use only
Slide 17: The operational scale of developing afamelanotide across continents
The operational scale of developing afamelanotide across 3 continents For personal use only
Slide 18: Regulatory Processes 2009 - 2010
Regulatory Processes 2009 - 2010 For personal use only
Slide 19: Commercialisation Strategy Afamelanotide
Commercialisation Strategy Afamelanotide For personal use only
Slide 20: Global Distribution Afamelanotide
Global Distribution Afamelanotide For personal use only I Partnering • Co-development • Co-marketing • License • Territorial/global II Clinuvel • National roll-out • EU, AUS, CH, US 1. Disruptive technology to serve orphan diseases 2. Fully developed market
Slide 21: Market Size
Market Size For personal use only Indication Global Europe USA EPP >5000 ±2000 ±2000 SU 3-4 : 100,000 ~15,000 ~10,000 PDT (systemic) >5000 PLE 10-15% of Caucasians ~5m ~2m OTR <1m >150,000 >175,000 Mean average use of afamelanotide [4x] = seasonal prescriptions Pricing studies ongoing in EU
Slide 22: Alpha-MSH and Afamelanotide formulations
Alpha-MSH | | | Afamelanotide Afamelanotide Controlled-Release Formulation Additional Formulations Rx Rx Paracrine Local Effect Dermis Local Effect Dermis = Non-Systemic Photoprotection Immuno-modulation Photodermatoses (6) Inflammatory Disorders Dermoprotection Domain 1 Domain 2 © Melanocytes, MC1R
Slide 23: Upcoming Clinical and Regulatory Milestones
Upcoming Clinical and Regulatory Milestones For personal use only
Slide 24: Gratitude to all staff
For personal use only Gratitude to all staff for your time and effort over the years YOU are now part of the asset
Slide 25: Clinuvel Pharmaceuticals Annual General Meeting 2009
For personal use only Clinuvel Pharmaceuticals Ltd Annual General Meeting 2009 Melbourne, Australia Wednesday 18th November, 2009 Dr Philippe Wolgen, CEO ASX: CUV XETRA-DAX: UR9 ADR: CLVLY
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