Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Corporate Update (January 2013)
15 slides from Clinuvel Pharmaceuticals's corporate update, Jan 21, 2013
Slide 1: Clinuvel Pharmaceuticals Corporate Update
For personal use only Clinuvel Pharmaceuticals SCENESSE® European pre-marketing phase Corporate Update January 2013 Darren Keamy, CFO Philippe Wolgen, CEO ASX: CUV XETRA-DAX: UR9 ADR: CLVLY
Slide 2: Safe harbor
Safe harbor Clinuvel is an Australian biopharmaceutical company focused on For personal use only 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 development involv
Slide 3: Key personnel
Key personnel Mr Stan McLiesh, BEd For personal use only Non-Executive Chairman, >30 yrs pharma experience – commercialisation, M&A Mrs Brenda Shanahan, Mr Jack Wood, Mr Elie Ishag Non-Executive Directors, broad background in finance, healthcare, pharma deal making Dr Philippe Wolgen, MD, MBA Chief
Slide 4: Share price and company milestones
$12.00 Share price CUV $AUD For personal use only $9.00 Shares on issue: 34,715,374 Share Price (Jan ‘12): A$2.25 $6.00 Market cap: A$78M $3.00 $‐ Jan‐06 Jan‐07 Jan‐08 Jan‐09 Jan‐10 Jan‐11 Jan‐12 Jan‐13 Clinical & Regulatory Finance Commercial 2006 EU Ph II EPP results New management 2007 EU Ph III1
Slide 5: Capital raisings and spend
$4.0 Spend $AUDM Raising $AUDM $50 For personal use only Sep 2006 rights issue & placement $35.2M $40 Raising ($AUDM) Spend ($AUDM) $3.0 $30 Apr 2007 placement $26M $2.0 Jun 2007 share purchase plan $0.4M $20 $1.0 May 2006 placement $5M June 2012 placement $6M $10 $‐ $0 Q1 06 Q1 07 Q1 08 Q1 09 Q1 10
Slide 6: Shareholder composition
For personal use only • Top 20 own 68% • Retail 51% : Non-Retail 49% • Aus 44% : EU 28% : US/RoW 28% • ADR: 8.7% • Staff and management ownership interests 3%-4.3%
Slide 7: Erythropoietic protoporphyria (EPP)
Erythropoietic protoporphyria (EPP) – absolute light intolerance For personal use only Est. global incidence: up to 11,000 assessable patients (4,000 EU/4,000 US) • Rare (‘orphan’) lifelong genetic disorder • No effective treatment/preventative – unmet clinical need • SCENESSE® safe, effective in Ph
Slide 8: Vitiligo
Vitiligo – acquired depigmentation disorder For personal use only Est. global incidence: 45 million patients • Progressive, psychologically devastating disease • No effective treatment to date • SCENESSE® used as combination repigmentation therapy • Phase IIa (CUV102) results excellent Depigmentatio
Slide 9: Spend by business function
For personal use only Business Function $AUDM R&D (includes cost of clinical study and drug delivery programs, direct R&D staffing) $4,843 Toxicology & Regulatory $1,053 Business, Marketing & listing $376 General operations $3,481 Total $9,753
Slide 10: European marketing application status
For personal use only • First Marketing Authorisation Application (EPP) filed Feb 2012, decision expected Q1/Q2 2013 • EU reimbursement discussions underway • High level physician and patient support • Solo distribution vs partnership under consideration
Slide 11: In-house capabilities
For personal use only In-house capabilities • Clinical trial development, execution and monitoring • Data collation, analysis • Small scale distribution – Italian + Swiss program • Regulatory, ethics strategy & submissions • Academic relations strong – patients, physicians, payors • Communications,
Slide 12: Italian and Swiss reimbursement programs
For personal use only • Italian law allows prescription of SCENESSE® to EPP patients, reimbursement for supply by Italian government • Swiss law allows prescription of SCENESSE® to EPP patients, reimbursement for supply by insurance companies • Agreed pharmacoeconomic benefit with national reimburse
Slide 13: Target markets: Asia and USA
Singapore/Asia For personal use only • Estimated >5M vitiligo patients • National healthcare system • High level NB-UVB penetration USA - EPP • 4,000 EPP patients USA - vitiligo • Up to 6M vitiligo patients • Insurance coverage NB-UVB
Slide 14: SCENESSE (afamelanotide)
For personal use only • Activates melanin in skin to provide natural umbrella • First-in-class drug (New Molecular Entity) • An analogue of the naturally occurring melanocortin alpha-MSH • Systemic photoprotection, repigmentation • Patented injectable 16mg resorbable formulation – Size grain of rice
Slide 15: Summary
For personal use only • Unique drug with multiple indications • EMA EPP filing outcome expected Q1/Q2 ‘13 • Safety profile SCENESSE® excellent • Vitiligo phase II trial endpoints met • Longevity: Clinuvel team kept intact for 7 years
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