Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — FINSIA Life Sciences Showcase June 2008
20 slides from Clinuvel Pharmaceuticals's conference presentation, Jun 11, 2008
Slide 1: Clinuvel Pharmaceuticals Ltd - Photo Protection
For personal use only Clinuvel Pharmaceuticals Ltd PHOTO PROTECTION The route from New Molecular Entity to Marketing Authorization FINSIA Life Sciences Showcase - June 2008 ASX:CUV Xetra: UR9 US ADR: CLVLY Colin Mackie, Head of Corporate Development
Slide 2: Safe harbor statement
Safe harbor statement Clinuvel is an Australian biopharmaceutical company focused on developing its For personal use only leading drug candidate, CUV1647, for a range of UV- related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and development in
Slide 3: Global environment pharma productivity declining
Global environment pharma’ productivity declining For personal use only US$m $45,000 $40,000 $35,000 $30,000 $25,000 Global R&D $20,000 NME Approved $15,000 $10,000 $5,000 $0 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 Spending more money – finding fewer New Molecular Entities FDA**
Slide 4: Global environment pharma revenue under threat
Global environment pharma revenue under threat 2007 2008 2009 2010 For personal use only Norvasc - hyprtens Advair - asthm Prevacid – ulcer Cozaar – hprtens Ambien - insom Effexor – depr Lexapro - depr Abilify - schiz Zyrtec - allrg Risperidal- schiz Topamax – epilp Aricept – Alzh Lotrel - hprtens F
Slide 5: Australian pharma pipeline attractive
Australian pharma pipeline attractive For personal use only 8 companies expected to file for NDA in 2009: Clinuvel EU, Swiss, Aus Pharmaxis Aus, EU Acrux US Peplin US Alchemia US Chemgenex US Halcygen US QRxPharma US Australian sector maturing Commercialization prospects closer than ever
Slide 6: Clinuvel Pharmaceuticals (CUV)
Clinuvel Pharmaceuticals (CUV) For personal use only • Clinuvel is an Australian biopharmaceutical company • Developing its photo protective drug, CUV1647, for a range of light related skin conditions • CUV1647 is a ‘first-in-class’ drug - exclusivity • Two Phase III trials - well advanced • Recentl
Slide 7: Share price AUD$
Share price AUD$ For personal use only $0.00 $0.20 $0.40 $0.60 $0.80 $1.00 $1.20 $1.40 Feb-01 Aug-01 Feb-02 Aug-02 Feb-03 Aug-03 Feb-04 Close Aug-04 Feb-05 Aug-05 EPT1647 Lifestyle use Feb-06 Medical indication focus from late 2005 Aug-06 Feb-07 Aug-07 Feb-08 CUV1647 Medicinal use
Slide 8: CUV1647
CUV1647 For personal use only • CUV1647 has ability to stimulate and increase one’s natural pigment in the skin: MELANIN • MELANIN is known to offer biologic photo protection against skin damage from visible & invisible light • Visible effect from MELANIN is darkening of the skin, most prominent in
Slide 9: CUV1647 provides photoprotection
CUV1647 provides photoprotection For personal use only Skin melanin density in fair skinned Australians with 0-1% melanin have seven times greater relative risk of malignant melanoma or basal cell carcinoma than men with >3% melanin**. ** Dwyer et al; 2002
Slide 10: CUV1647 treats medical indications
CUV1647 treats 5 medical indications For personal use only Medical Indication Description Erythropoietic Protoporphyria Absolute sun intolerance (EPP) Polymorphic Light Eruption Sun poisoning (PLE) Actinic Keratosis (AK) and OTPs have a high risk to precursor Squamous Cell Carcinoma (SCC) in to skin
Slide 11: Route to market in EU/Aus/Sui
Route to market in EU/Aus/Sui For personal use only Medical Phase I Phase II Phase III Marketing Drug indications Authorization Registration Application EPP ODD ODD 2009 sun intolerance ODD ODD PLE 2010 sun poisoning AK 2010-2011 precursor to skin cancer SU anaphylactic reaction to sun PDT photo-sen
Slide 12: US Market size
US Market size For personal use only EPP US$25m Sun intolerance PLE US$40m Sun allergy OTP US$240m Transplant recipients SU US$12m Anaphylactic reaction Other US$200m Includes PDT Total US$517m Per Implant selling price: range $300 - $1,000 Source: IMS Primary Market Research 2006
Slide 13: 2008 Plan
For personal use only 2008 Plan 16 Nov’ 07 1 Jan’ 08 Mar’ 08 July’ 08 1 Oct’ 08 1 Dec ‘08 1 Jan’ 09 AGM - 2 x Orphan Drug Designations from EMEA - WHO Generic name CUV1647 AGM - Brand name CUV1647 - Start SCC Ph II RMH (Melbourne) - Start SU Ph II EU Interim Results EPP Ph III trials EU/AUS - Start
Slide 14: Clinuvel's high value strategy
Areas where CUV can add value Clinuvel’s high value strategy For personal use only PHOTO PROTECTION BALLAST ONCOLOGY TRANSPLANT MEDICINE HAEMATOLOGY DERMATOLOGY VALUE TRAP Decreasing risk of value destruction
Slide 15: Challenging pathway
Challenging pathway For personal use only • First-in-Class (FiC) = educate photo protection • CMC + delivery = formulation “controlled” • Protocol design = novel • Regulatory acknowledgement • Orphan Designation = recruit & retain
Slide 16: Reducing Risk
Reducing Risk For personal use only Technology = CUV1647 Management = Execution • SAFETY √ • STRATEGY clinical/regulatory √ • EFFICACY ‘08/’09 • FUNDING √ • Chemistry, Manufact, Controls √ • HR √ • Drug Delivery • Increasing Awareness = √ • IP √ GLOBAL PROBLEM UV/SUN-SKIN REGULATORY APPROVALS [EMEA/
Slide 17: CUV Financials
CUV Financials For personal use only • No of shares on issue: 302,148,665 • Market Cap: A$105m AU$0.35/share • Cash on deposit: AU$50M AU$0.17/share • Average Daily Volume 12 months (ASX): 163,171 • Current monthly spend of <$1.0m
Slide 18: Market capitalisation underpinned by strong cash
Market capitalisation underpinned by strong cash For personal use only AU$m 300 Cash 250 200 150 100 50 0 Financial Yr Jun-01 Jun-02 Jun-03 Jun-04 Jun-05 Jun-06 Jun-07 Jun-08
Slide 19: Quarterly cash flow reflects cost focus
personal For Net use Operating Cashflow $m only $0.0 -$4.5 -$4.0 -$3.5 -$3.0 -$2.5 -$2.0 -$1.5 -$1.0 -$0.5 Dec-03 Mar-04 Jun-04 Sep-04 Dec-04 Mar-05 Jun-05 Sep-05 Dec-05 Mar-06 Jun-06 Sep-06 Dec-06 Mar-07 Jun-07 Quarterly cash flow reflects cost focus Sep-07 Dec-07 Mar-08
Slide 20: Summary and Outlook
Summary and Outlook For personal use only • Clinical success and commercialization is our focus • Our program is fully funded • Success expected within two years • Future value drivers Complete clinical trials Obtain Registration/Regulatory approvals Manufacturing agreements/commercial decisions Par
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