Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Shareholder Meeting (November 2016)
28 slides from Clinuvel Pharmaceuticals's shareholder meeting presentation, Nov 28, 2016
Slide 1: Welcome to CLINUVEL's Annual General Meeting
For personal use only Good morning and welcome to CLINUVEL’s Annual General Meeting. The challenges ahead for 2017 are to reconcile the asymmetry in knowledge with regulators, governmental advisory bodies, payors, medical community and press on CLINUVEL’s innovative technology SCENESSE® (afamelanoti
Slide 2: Safe Harbour and speculation caution
For personal use only CLINUVEL forewarns against any speculative comments, suggestions or perceived guidance provided during this session and dissuades any member of the public to speculate, trade and act on the information obtained. The audience is advised to read the Safe Harbour Statement provide
Slide 3: Investor motives for investing in CLINUVEL
For personal use only CLINUVEL’s major active investors have made their investment motives known, why they invested and remain invested in CLINUVEL over sometimes more than five years, some even more than 11 years. We share the four broad categories of how shareholders have consistently expressed th
Slide 4: Four investment motives and stakeholder priorities
For personal use only In the four investment motives expressed, CLINUVEL and its shareholders seem aligned, we just have taken the liberty to adhere to a sequence of priorities for the sake of our primary stakeholders: patients, physicians, and ultimately those who funded the Company the past 12 yea
Slide 5: 2017 focus topics
For personal use only The calendar year 2017 is marked by a focused number of topics providing an indication of CLINUVEL’s current thinking and direction of the CLINUVEL GROUP: I Ensuring continuation of the POWDER SNOW strategy II Expansion of the distribution of SCENESSE® in the European Economic
Slide 6: Press perception of pharmaceutical companies and R&D focus
Global popular press is influencing public opinion on pharmaceutical companies as has been seen during 2015 and continuing in 2016. Four US companies the past 12 months have managed to attract negative attention from press, politicians and public for their marketing and pricing practices for pharmac
Slide 7: Positioning SCENESSE in current medicine
For personal use only How to view SCENESSE® in current medicine and what is the relevance to all stakeholders of CLINUVEL? Whereas breakthrough technology transforms a sector or the way we dramatically apply knowledge or suddenly change the way we undertake things, disruptive strategies and technolo
Slide 8: Continuing strategy in Europe and US, vitiligo
and SCENESSE® will continue in 2017, both in Europe and the US. In the future we expect that the same approach will be adopted when introducing the technology to a wider audience for the treatment of vitiligo. Clearly there is a cost to entering an ‘untouched domain’ however it also provides a maide
Slide 9: From isolation to visible handicap
For personal use only From isolation to visible handicap. Patients have lost the courage to participate in social activities and can only do so when fully covered and remain stigmatised in life. The shared patients’ experiences have become more prominent through online communities. 7
Slide 10: SCENESSE European rollout and market access
For personal use only SCENESSE® is the first pharmaceutical treatment approved for EPP patients, with a centralised European Medicines Agency marketing authorisation. A gradual roll out per country is being pursued while patients await the treatment. Discussions with each National Competent Authorit
Slide 11: National reference centres and treatment
For personal use only In each country there is typically one National Reference Centre for porphyria or rare metabolic disorders. Sometimes there are satellite centres acting as a supporting treatment hub. These centres require training and accreditation according to strict protocol and requiring re
Slide 12: EPP and vitiligo regulatory strategies
For personal use only In CLINUVEL’s programs of EPP and vitiligo it is imperative to gain knowledge on the common features which influence the regulatory strategies and filings. 10
Slide 13: FDA strategy for SCENESSE
For personal use only The FDA strategy to reintroduce the to US has been planned for years, safety dictated CLINUVEL’s program. CLINUVEL had identified that SCENESSE® would pose a new concept for regulatory agencies in EU and US. The one drug would be used as a systemic injectable as a periodic solu
Slide 14: Differentiation of CLINUVEL
For personal use only In current economic turmoil in the EU and US differentiation of CLINUVEL is desired to make all stakeholders understand that this unique company has focused all its resources on one innovative technology in one rare disorder at considerably lower expenditures than its peers. Po
Slide 15: Share price performance
For personal use only CLINUVEL’s share price has outperformed most indices and Australian peers. This follows the positive news flow from the Company during 2016. 13
Slide 16: Average share price and equity dilution
For personal use only CLINUVEL has consistently aimed to minimise costs to arrive at a finished product for distribution to EU-US EPP patients. At an average price of AUD$3.59 per share shareholders would have been able to calculate their returns over the years, that is if their equity holdings coul
Slide 17: Investment in research and development
For personal use only Contrary to other pharmaceutical companies mentioned in US & EU press, CLINUVEL does genuinely invest in research and development to grow the Company. 15
Slide 18: Tracking against hypothetical commercial scenarios
For personal use only This slide does not intend to provide financial guidance, but merely shows how CLINUVEL is tracking commercially against three hypothetical scenarios discussed at the 2015 AGM (reference is made to 2015 AGM presentation). The graph here shows financial year data (July 1-June 30
Slide 19: Publications on drug, disease and CLINUVEL
For personal use only Traditionally the company summarises the number of publications on drug, disease and CLINUVEL over the past calendar year: 94 to date, a relatively large reach for a small size pharmaceutical entity with one product. 17
Slide 20: TV broadcasts in Switzerland, Netherlands and UK
For personal use only A summary of TV broadcast in Switzerland, Netherlands and UK is shown. 18
Slide 21: Alpha-MSH research and linear compounds
For personal use only Physiologic alpha MSH has attracted much scientific attention resulting in more than 6,000 articles. CLINUVEL opts to work with compounds of linear structure given its relatively benign safety profile. Toxicology and safety drives our objectives. 19
Slide 22: Melanocortin research groups and companies
For personal use only A competitive breakdown of research groups and companies active in melanocortins is discussed. In using alpha-MSH analogues in melanogenesis CLINUVEL is the furthest down the development path compared to competitors. 20
Slide 23: Focus on unmet diseases and five core strengths
For personal use only CLINUVEL focuses on unmet diseases with high severity, EPP and vitiligo fit this criterion. Five core strengths have characterised CLINUVEL over the years. 21
Slide 24: Leader in photomedicine and melanogenesis
For personal use only CLINUVEL will expand its position as leader in photomedicine and melanogenesis and also will enter the market of non-prescriptive products to add to its portfolio. 22
Slide 25: Social mandate to treat patients of colour
For personal use only A strong social mandate has emerged, CLINUVEL being the first company to treat patients of Caucasian skin (EPP) and patients of darker skin colour (vitiligo). The conscious direction to treat patients of colour fulfils a social objective of the CLINUVEL GROUP to do good for pat
Slide 26: Looking to 2017
For personal use only There is much work ahead, but we look with much optimism and energy to 2017. 24
Slide 27: Patient community and media exposure
For personal use only As a function of CLINUVEL’s continuous R&D investments as well as the patient associations’ long term efforts to aggregate patients with common disease have resulted in a number of unintended phenomenon. During the past year many reports have emerged from the exposure by media,
Slide 28: Thanks to shareholders
For personal use only On behalf of patients, physicians and staff we thank all shareholders for their continuous support. Without the belief in the Company, SCENESSE® would not have reached EPP patients. The gratitude of patients is at times overwhelming and makes our team realise that the fundament
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