Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Investor Presentation (March 2009)
26 slides from Clinuvel Pharmaceuticals's investor presentation, Mar 18, 2009
Slide 1: Leadership in Photoprotection
For personal use only Clinuvel Pharmaceuticals Ltd Leadership in Photoprotection March 2009 ASX: CUV; US ADR: CLVLY; XETRA/DAX: UR9 L11, 330 Collins St, Melbourne, Australia www.clinuvel.com
Slide 2: Safe Harbor Statement
SAFE HARBOR STATEMENT March 2009 Clinuvel is an Australian biopharmaceutical company focused on developing its leading drug candidate, afamelanotide, for a range of UV related For personal use only skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research an
Slide 3: Overview
Overview For personal use only • Clinuvel is an Australian biopharmaceutical company developing its photoprotective drug afamelanotide for the treatment of UV related skin disorders • With US, European, Swiss and Australian regulatory acknowledgement and A$43m in cash, the company is well placed to
Slide 4: Market value
Market value For personal use only $0.50 $0.40 $0.30 $0.20 Market cap: $62m Volume: 506,950/day $0.10 Cash on hand: $43m Value: $152,601/day Burn rate: $1.1m/month Share Price: $0.20 Shares on issue: 303,148,665 β: 1.21 $0.00 Dec-07 Feb-08 Apr-08 Jun-08 Aug-08 Oct-08 Dec-08 Feb-09
Slide 5: Progress 2006-2009
Progress 2006-2009 For personal use only • New management team reset the corporate strategy • Identified 5 medical uses for afamelanotide • Raised AUD$67M to fund clinical program • Strengthened patent position to 2024 • Granted Orphan Drug Designations (ODD) in Europe and US • Granted Investigation
Slide 6: Afamelanotide, our first-in-class drug
For personal use only Afamelanotide our first-in-class drug
Slide 7: Afamelanotide increases melanin density
Afamelanotide increases melanin density For personal use only Melanin is known for its photoprotective properties Normalised Abdomen Melanin Density vs Time 160 Skin types I-II Normalised melanin density (normally burns) 150 Skin types III-IV 140 (normally tans) 130 120 110 100 Day 0 Day 12 Day 30 D
Slide 8: Unique delivery technology
Unique delivery technology For personal use only • Subcutaneous absorbable implant formulation, 16 mg • Stimulates melanin production (melanogenesis) in the skin • Used to treat UV related skin disorders (photodermatoses)
Slide 9: Afamelanotide targets unmet medical needs
For personal use only Afamelanotide targets 5 unmet medical needs
Slide 10: Indications in the clinic
5 indications in the clinic For personal use only Indication Description 2006 US Clinical stage market est. US$m Erythropoietic Absolute sun intolerance 25 Phase III Protoporphyria 5,000 patients est. globally (EPP) Polymorphous Light Sun poisoning 40 Phase III Eruption (PLE) 10m patients est. globa
Slide 11: Erythropoietic Protoporphyria (EPP)
Erythropoietic Protoporphyria (EPP) For personal use only • A rare Orphan disease (2008 - EMEA, Swissmedic, FDA) • A serious and chronic condition with no methods of treatment • Clinuvel estimates around 5,000 sufferers worldwide • “It's like sticking your hands in boiling water and having 100 bees
Slide 12: EPP Phase III interim result
EPP Phase III interim result For personal use only • Positive results announced Jan 2009 • First 14 Swiss patients to complete 1 year trial • Maximum severity of phototoxicity reduced (p<0.001) • Total severity of phototoxic reactions reduced (p=0.028) • Skin melanin density increased (p=0.048) • No
Slide 13: Polymorphous Light Eruption (PLE)
Polymorphous Light Eruption (PLE) For personal use only • A seasonal dermatological disorder • Phototoxicity described as sun poisoning • Itching, rashes, unsightly • Global incidence around 10% of whom 10% are severe • Interim Phase III results 1H09 Afamelanotide aims to alleviate and reduce sympto
Slide 14: Skin cancer (AK/SCC) in OTRs
Skin cancer (AK/SCC) in OTRs For personal use only • Organ Transplant Recipients (OTRs) are vulnerable to skin cancer • OTRs are vulnerable for life due to immunosuppressive drugs • OTRs have 65x higher chance of skin cancer • US OTR population 447,515 • 30,000 new US patients pa (Source: Organ Proc
Slide 15: Solar Urticaria (SU)
Solar Urticaria (SU) For personal use only • Solar Urticaria (SU) is an acute anaphylactic reaction to sun • Following limited exposure to sunlight, sufferers experience rapid swelling and burning of the skin • Estimated <5,000 sufferers worldwide Afamelanotide aims to lower phototoxicity suffered b
Slide 16: Photodynamic Therapy (PDT)
Photodynamic Therapy (PDT) For personal use only • Systemic PDT is a surgical treatment for solid mass cancers (eg esophagus, pancreatic, gall bladder) • Systemic PDT patients treated with Photofrin photosensitiser suffer acute phototoxicity for 60 days after surgery • Phototoxic reactions mirror th
Slide 17: Regulatory progress and route to market
For personal use only Regulatory progress and route to market
Slide 18: Regulatory progress in the US
Regulatory progress in the US For personal use only • US FDA granted afamelanotide ODD status for treatment of EPP in Jul 2008 • US FDA granted afamelanotide IND status in Jan 2009 to treat EPP • First trial – a confirmatory pharmacokinetic • Followed by Phase II PDT and Phase III EPP trials Pathway
Slide 19: Regulatory progress in Europe
Regulatory progress in Europe For personal use only • Early support from physicians and regulators • Trials commenced in 2006 • Progressed well into Phase III • Over 40 clinics in trials • 450 patients treated • EMEA and Swissmedic granted afamelanotide ODD status for treatment of EPP in 2008 • ODD
Slide 20: Commercialization in sight
Commercialization in sight For personal use only Competition • No competitor in field of melanogenesis in clinical trials Distribution & pricing • Licensing & partnering options • Afamelanotide is the only systemic preventative UV treatment • Regional licensing potential in Eu/US/Aus • First mover a
Slide 21: Clinuvel expects first afamelanotide revenues in 2010
For personal use only Clinuvel expects first afamelanotide revenues in 2010
Slide 22: Appendix
For personal use only Appendix
Slide 23: Financials
Financials For personal use only Balance Sheet 2008 2007 2006 Capital $m raised # shares m Price raising Cash & Financial 50.8 62.3 10.6 Assets May 2006 $5.0 14.7 $0.34 placement Total Assets 55.0 67.8 17.0 Total Liabilities 3.1 2.4 3.0 Sep 2006 $35.2 91.4 $0.38 rights issue & Total Equity 51.8 65.4
Slide 24: Share ownership
Share ownership For personal use only • Shares on issue 303m • Top 20 shareholders own 42% • Substantial shareholders - JM Asset Management 6.9% • Total number of shareholders 3,780
Slide 25: Directors & Executives
Directors & Executives For personal use only • Dr Philippe Wolgen: CEO, Director • Ms Brenda Shanahan: Non-Executive Chair • Dr Hank Agersborg: CSO, Director • Dr Roger Aston: Director • Mr Stan McLiesh: Director • Mr Jack Wood: Director • Mr Darren Keamy: CFO • Dr Dennis Wright: VP Scientific Affai
Slide 26: Contact
Contact For personal use only Level 11, 330 Collins Street, Melbourne Ph +61 3 9660 4900 www.clinuvel.com investorrelations@clinuvel.com
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