Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Shareholder Meeting (November 2015)
39 slides from Clinuvel Pharmaceuticals's shareholder meeting presentation, Nov 24, 2015
Slide 1: Annual General Meeting 2015
For personal use only SCENESSE® is acknowledged as a product for high specialty care, to be used exclusively in expert centres trained and accredited by Clinuvel. SCENESSE® is the world’s first systemic drug providing systemic photoprotection. The commercialisation process is being finalised by the
Slide 2: Forward-looking statements
For personal use only During this presentation of the Annual General Meeting 2015 held in Melbourne, the Company may make statements relating to future operations and events. Clinuvel is active in an area of risk, whereby a number of events may have an impact on the operations of the Company. 2
Slide 3: Topics and self-appraisal over 10 years
For personal use only The following topics will be discussed today, whereby the value construct will be central to the AGM. A self‐appraisal of the Company is presented based on operational and executional performance the past 10 years, the anniversary of this management. It as been 10 years since t
Slide 4: SCENESSE controlled-release implant development
For personal use only SCENESSE® has been developed during a decade between Clinuvel and – now – Evonik‐Brookwood in Birmingham, Alabama. It had been proven nearly impossible to engineer, according to Clinuvel’s specifications, a controlled‐release implant with specified time‐sequenced release. This
Slide 5: Clinical effect, IP and market exclusivity
For personal use only The clinical effect of SCENESSE® is unique in that Clinuvel arrived at formulating a product to solve targeted clinical problems. Clinuvel holds a suite of IP covering various formulations, chemistry, pharmacogenomics, plasma, methods of use and combination therapies of SCENESS
Slide 6: Blue Ocean strategy and platform
For personal use only In developing SCENESSE® from the very early days in 2006, a different approach was taken following the realisation that this product would be characterised unlike any other pharmaceutical ever developed. With innovation came the burden of developing an environment, platform and
Slide 7: Administration of SCENESSE video
For personal use only A short movie and animation is demonstrated for those who have never seen the administration of SCENESSE®. This video is part of the training material provided to European hospitals and insurance companies. 7
Slide 8: Erythropoietic protoporphyria (EPP)
For personal use only For those new shareholders who are less familiar with erythropoietic protoporphyria (EPP), this genetic disorder is characterised by the accumulation and storage of protoporphyrin IX which makes patients toxic to light sources. EPP is regarded as the highest order of intoleranc
Slide 9: Defining the clinical problem for stakeholders
For personal use only In developing SCENESSE® Clinuvel had to define the clinical problem and sequela for all stakeholders during 10 years of focused work. As a results of the phototoxicity , the impairment and handicap of EPP patients has gradually been communicated by the Company on behalf of pati
Slide 10: Impact of EPP on patients video
For personal use only For those new investors, we show a video illustrating the impact of the disease EPP on patients is shown ‐ as broadcast overseas in Europe and US during 2014‐2015. 10
Slide 11: Market capitalisation and value construct
For personal use only The frequent question posed by stakeholders to Board and management is whether Clinuvel’s current market capitalisation on the ASX is reflecting the fair value of the Company. Although the day to day valuation fluctuates with Clinuvel’s share price, many factors outside the con
Slide 12: Defining success
For personal use only Clinuvel defines success as minimising the risks for the team to achieve all objectives set in Q1 2006. 12
Slide 13: Risk management in the value construct
For personal use only Clinuvel’s management continuously scans the horizon for risks, general risks in pharmaceuticals. In Clinuvel’s case there were two specific risks associated with the Company, as seen below the dotted line. Developing the technology was only a minute part of the value construct
Slide 14: Fiscal risk and trial efficiency
For personal use only In addressing the fiscal risk, Clinuvel wished to improve the efficiency of trials. In this sense the Company maintains that it wishes to extract maximum information while expending minimal resources. In other words, more pilot trials, smaller trials and more meta analyses, for
Slide 15: Scenario 1: slow uptake
For personal use only The next three slides do not intend to provide financial guidance, but merely show how Clinuvel plans its budgets and contemplates its progress according to scenario analyses, in this case 3. In planning and projecting it often uses multiple scenarios while often taking the ‘wo
Slide 16: Scenario 2: faster European entry
For personal use only The next two slides do not intend to provide financial guidance, but merely show how Clinuvel plans its budgets and contemplates its progress according to scenario analyses, in this case 3. In this scenario one could imagine that the entry of the product in Europe would progres
Slide 17: Scenario 3: bullish uptake
For personal use only The next slide does not intend to provide financial guidance, but merely show how Clinuvel plans its budgets and contemplates its progress according to scenario analyses, in this case 3. In the most bullish projection, one could imagine that the uptake exceeds expectations and
Slide 18: Investor base and shareholder register
For personal use only Clinuvel has taken a different and rational approach to its investment base. In setting the objectives to attract investors with a long term investment horizon, similar outlook and objectives for Clinuvel, a mix of professional and institutional investors were contacted the pas
Slide 19: Share capital management and dilution
For personal use only By setting the coordinates early on, Clinuvel looked at maximising information from minimal resources with a strict focus on one or, maximum, two indications. Secondly, Clinuvel looked at minimising dilution while maximising the yield per equity issued. At the peak of the marke
Slide 20: Healthcare companies listed on the ASX
For personal use only There are 148 biotechnology, pharmaceutical and healthcare equipment companies listed on the ASX in Australia, 74 of whom can be considered pharma/biotech, 70 of those are going concern. If one looks at companies below a market cap of A$3bn ‐ the combined market cap of all 134
Slide 21: ASX biotech companies
For personal use only In total 69 biotech companies only according to ASX (excluding CSL). 21
Slide 22: Benchmarking peers in R&D
For personal use only We chose 3 companies in R&D to benchmark CUV against as a first step to assess peer value and arrive at comparables in our sector further differentiated. 22
Slide 23: Selecting comparable companies
For personal use only The frequent value most Australian companies ask themselves, are we getting sufficient value on the ASX or are there better exchanges to realise shareholder value? Clinuvel goes through the same process, and the challenge is to seek comparable companies in Australia. Unfortunat
Slide 24: Dilution and market cap versus peers
Bloomberg, Google Finance, Annual Reports 2006‐2015 and ASX announcements. Errors can not be excluded in the reporting of these company data. Clinuvel incurred a dilution of 168% over 10 years and almost tripled its market capitalisation, while taking SCENESSE® to market on A$87 million in funding (
Slide 25: Valuation of pre-revenue pharma and NASDAQ IPO comparison
For personal use only The question often posed is whether Clinuvel is properly valued on the ASX? Clinuvel has no answer to this question, but rather looks at peers and tries to draw analogies, find comparables and think in scenarios. Various factors play a role when assessing the enterprise value o
Slide 26: Special Access Scheme patient data
For personal use only The data from the two countries where SCENESSE® is distributed through Special Access Schemes assist in making fair projections on 1. Rate of Continuation. Of the 27 patients who discontinued treatment, 13 resumed treatment after a period of 12 or more months without treatment.
Slide 27: Cumulative doses over time
For personal use only The cumulative number of doses is illustrated in this graph whereby it is seen year‐ on‐year that patients continue treatment. The longer the program in Italy and Switzerland continues, the higher the number of injections patients seem to receive. 26
Slide 28: Media coverage of EPP and Clinuvel
For personal use only Clinuvel has established systematically and consistently a platform for media to become interested in the topics of EPP and light intolerance, Clinuvel’s decision models, its development program and EPP as a complex orphan disorder. The past year Clinuvel received a record numb
Slide 29: Publication in the New England Journal of Medicine
For personal use only The highlight of the year was undoubtedly the publication of the results of two EPP trials in the New England Journal of Medicine. This journal is regarded as the pinnacle of medicine when it comes to the acknowledgement of innovative therapies. It has the highest citation inde
Slide 30: US and EU broadcast summary
For personal use only A summary of the US and EU broadcast over 2014‐2015 is shown. 29
Slide 31: Commercial distribution and PRAC release
For personal use only The commercial distribution has been in preparation for more than two years. Frustratingly, Clinuvel had to await the product release by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency. Long negotiations about the post‐marketing commitmen
Slide 32: European distribution by country
For personal use only Thus far clinical demand for SCENESSE® has been sizeable. In a specific sequence, Clinuvel will address the countries where the number of patients is the highest and where it has already conducted its clinical trial program. These centres are already familiar with SCENESSE®, an
Slide 33: Post-marketing commitments and EPP registry
For personal use only The European marketing authorisation for SCENESSE® comes with strict post‐ marketing commitments to provide clinical data for life. Under a post‐authorisation safety study protocol, the Company had to establish a European EPP Disease Registry, an electronic platform. Each indiv
Slide 34: Vitiligo strategy and development program
For personal use only The strategy for vitiligo is taking shape and will depend on the results from CUV103 and the FDA’s requirement to complete an animal study, mimicking the future human dosing in vitiligo. This animal study is foreseen to complete by the end of March 2016, while final results are
Slide 35: Complementary products for vitiligo
For personal use only The exciting venture focusing on the complementary products for SCENESSE® in vitiligo is making strides. In 2016, news flow will unveil some of the progress made on the next products. It is apparent that the medical community anticipates Clinuvel and its partners and subsidiari
Slide 36: Pricing pressure and R&D spending
For personal use only The Chief Executive of the UK National Institute of Health and Care Excellence, Sir Andrew Dillon stated recently in public that pharmaceutical companies ought to look at themselves and question the need to spend large sums on R&D. It indicates that advisory bodies to the gover
Slide 37: Summary of today's discussion
For personal use only A summary of today’s discussion is presented in 5 points. 36
Slide 38: Thanks to shareholders
For personal use only The active investors and shareholders in the Company are acknowledged and thanked for their support to Clinuvel. 37
Slide 39: Acknowledgement of human capital
For personal use only Clinuvel without its main constructors, human capital, assets would not exist today. 38
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