Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Shareholder Meeting (November 2012)
15 slides from Clinuvel Pharmaceuticals's shareholder meeting presentation, Nov 20, 2012
Slide 1: Areas of expertise: melanogenesis and photoprotection
For personal use only The two areas of expertise of Clinuvel: melanogenesis and photoprotection of the skin. This positions the company uniquely in the area of specialised dermatology care. 2
Slide 2: Forward-looking statements
For personal use only This mandatory statement aims to protect from any forward‐looking statements that may be inferred from the presentation and that may differ from the actual development by Clinuvel. 3
Slide 3: The CUV team
For personal use only The CUV team has in‐depth knowledge of, and experience with, the financial, clinical and regulatory affairs essential to pharmaceutical development. Consistency in its strategy and persistence to achieve the company’s objectives are a hallmark of the CUV team. 4
Slide 4: Dr Agersborg's contributions
For personal use only Dr Agersborg’s contributions have enabled the company to reach its current point. His greatest wish has been to see through the drug on market for photo disorders. The CUV team will realise his life work. 5
Slide 5: CUV model and orphan route
For personal use only The CUV model is somewhat different from other pharmaceutical companies in that it hinges on retained knowhow in‐house and consistency of the team involved since 2005. Core managers have been retained while newer staff and rotation provides a balance in the team. The orphan rou
Slide 6: Market cap and shareholders
For personal use only Market cap at approximately A$64M for end stage development company. No significant changes to top 20 in the last 12 months. Quarterly spending has come down, and with a relatively small budget in pharma the company is making progress getting SCENESSE® to market in Europe. The
Slide 7: History and status overview
For personal use only An overview of the history and status is given as a reminder of the time and resource required in pharmaceutical development. 8
Slide 8: Key projects advanced in 2012
For personal use only The company’s key projects have advanced during the 2012 calendar year. In parallel the company has secured funding to ensure complete focus during the critical stages of the EMA review. Extending our ability to raise capital, if necessary, provides management with greater flex
Slide 9: Vitiligo program
For personal use only Vitiligo is a relatively common ‘pigmentation’ disorder which has a serious impact on patients’ Quality of Life. Advances in the medical understanding of vitiligo and its treatment in 2008‐2010 allowed Clinuvel to design and pursue trials for this difficult to treat disease. Re
Slide 10: Follicular repigmentation in CUV102
For personal use only A close image of follicular repigmentation in a vitiligo patient involved in the CUV102 study. This patient has undergone 55 NB‐UVB treatments and received four afamelanotide 16mg implants. The phenomenon of activating and increasing follicular repigmentation seems successful f
Slide 11: SCENESSE development and safety
For personal use only SCENESSE® has been developed over more than a decade as a controlled‐release formulation. Approximately A$30m has been invested in R$D formulatory work. The drug has maintained a good safety profile with the most common adverse events (AEs) seen in studies being minor and often
Slide 12: EMA review of marketing application
For personal use only The European Medicines Agency (EMA) is currently reviewing Clinuvel’s application for marketing authorisation, and feedback has been positive on a key number of issues. It is identify and important to stress the clinical meaningfulness of light and UV exposure to EPP patients’
Slide 13: Commercial planning for SCENESSE in EPP
For personal use only Commercial planning for SCENESSE® in EPP is underway. EPP distribution throughout the EU post‐approval can be executed by a relatively small team, given the small population of patients (orphan disease). The access programs in Italy and Switzerland have given valuable insight o
Slide 14: People and upcoming milestones
For personal use only The main asset are the professionals/people who make this all possible for patients; without the CUV staff the drug would not be developed in the way it has been. Retention of this group of professionals seven years after starting the program is the most important aspect of con
Slide 15: Gratitude to shareholders, Board and team
Clinuvel Pharmaceuticals Ltd Gratitude to loyal shareholders, and to CUV Board and unrelenting team Annual General Meeting, 20 November 2012 Dr Philippe Wolgen, CEO ASX: cuv XETRA-DAX: URS ADR: CLVLY
Clinuvel Pharmaceuticals — Shareholder Meeting (November 2012) on 6ix