Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Shareholder Meeting (November 2014)
42 slides from Clinuvel Pharmaceuticals's shareholder meeting presentation, Nov 28, 2014
Slide 1: For personal use only
For personal use only The commercialisation of SCENESSE® is a long awaited dream of many scientists and patients around the world. For Clinuvel it marks the start of a new phase. 1
Slide 2: For personal use only
For personal use only Australia is the birthplace of a great number of inventions and innovations. As of 24 October SCENESSE® afamelanotide 16mg , developed from bench to bed by the Australian based company Clinuvel Pharmaceuticals, can be added to the list. In the process the Company optimised the
Slide 3: For personal use only
For personal use only Warning against speculative statements that may be made at today’s AGM, the public is requested to read the Forward Looking or ‘Safe Harbour’ Statement. 3
Slide 4: Four sections being discussed today
For personal use only There are four sections being discussed today. 4
Slide 5: For personal use only
For personal use only Clinuvel’s business plan was presented in 2005, consisting of involvement and engagement with the top academics worldwide. Nearly 10 years later the leading academic centers in the fields of interest have been involved in the development of SCENESSE®. Their feedback is incorpor
Slide 6: For personal use only
For personal use only In some disorders, patient organisations are fundamental to the success of a clinical program, since they represent the patients’ voices. Patient organisations will often communicate the patients’ feedback after a trial completion, the drawbacks of study designs and be the repr
Slide 7: For personal use only
For personal use only Clinuvel has built up considerable regulatory knowhow over the years, spanning several continents and many countries. 7
Slide 8: For personal use only
For personal use only Overall Clinuvel’s value lies in the aggregate elements, IP, specific knowhow, its registration dossier and manufacturing processes for its final product. 8
Slide 9: For personal use only
For personal use only It took nearly 10 years under Clinuvel’s management to develop SCENESSE® to a commercial product. This is the first time a systemic photoprotectant of the melanocortin family has obtained regulatory approval. The planning to further develop and commercialise new markets, indica
Slide 10: For personal use only
For personal use only The integral value of Clinuvel starts with SCENESSE®, the first drug used in an extreme disorder caused by daylight, UV. The initial risks in this business were high. Additionally there were unique risks associated with Clinuvel, some unduly assigned, some due to illegitimate m
Slide 11: For personal use only
For personal use only Erythropoietic protoporphyria was targeted it was understood that SCENESSE® could be of therapeutic benefit. Additional criteria, such as high unmet medical need, no alternative treatment and market exclusivity, were essential for the choice of EPP as Clinuvel’s lead indication
Slide 12: For personal use only
For personal use only Our European Marketing Authorisation provides confidence to expand the program into broader markets, with vitiligo the first target. Despite its high prevalence and significant impact on patients, there are no fully effective therapies for vitiligo. To date the mainstay of trea
Slide 13: For personal use only
For personal use only In parallel to the vitiligo program, the Company will seek broader application of SCENESSE®, with a commitment to focusing on paediatric EPP patients. Recent advances in our understanding and IP will allow us to expand our offering to complementary therapies. It must be noted,
Slide 14: For personal use only
For personal use only Clinuvel will now be able to capitalise on its in‐house expertise and lead the field of melanocortins, with topical formulations of alpha‐MSH analogues the next step in our development. 15
Slide 15: For personal use only
For personal use only 16
Slide 16: For personal use only
For personal use only The financials of Clinuvel reflect the quarterly statements and annual filings. The Company has been debt free and maintained a consistent burn over the past years. Purposefully, CUV required raised capital in nine rounds, whereby it is stressed that in the last three issuances
Slide 17: For personal use only
For personal use only The Company has sought to maintain a balanced register. 18
Slide 18: For personal use only
For personal use only The Company has invested the majority of its clinical expenditures to date in the lead program, EPP. Expenses include non‐cash adjustments. 19
Slide 19: For personal use only
For personal use only The Company is rapidly transforming from a pure R&D focused to a commercially driven entity. Relevant staff are being hired to succeed in the European distribution. 20
Slide 20: European Regulatory Review
u EUROPEAN REGULATORY REVIEW 21
Slide 21: For personal use only
For personal use only The progress of European regulatory review from beginning to approval was gradual. As more information about mode of action, disease, physicians’ experiences and patients’ benefit became known, the EMA arrived at a full understanding of the clinical use and benefit of SCENESSE®
Slide 22: For personal use only
For personal use only The end points from both studies show how SCENESSE® was clinically evaluated over five studies involving around 350 patients. Decisions to continue the EPP program were based on both trial results – safety and efficacy – as well as ongoing regulatory, physician and patient feed
Slide 23: Valuation, Benchmarks
VALUATION, BENCHMARKS 24
Slide 24: For personal use only
For personal use only EPP is a poorly understood disorder. Due to the fear of debilitating skin reactions to UV/light, patients become deprived of light exposure and the ability to lead a ‘normal’ life. For most EPP patients the disease dictates many life decisions and can lead to anxiety and depres
Slide 25: For personal use only
For personal use only Independently evaluated against other disorders, EPP is considered to be a severe, chronic disorder in need of annual treatment. 26
Slide 26: For personal use only
For personal use only Reviewing the pharmaceutical landscape, recent trends reflect a premium for orphan drugs. 27
Slide 27: For personal use only
For personal use only In benchmarking SCENESSE® against other orphan drugs developed, and viewing returns on investment, a number of observations are being made. The most recent numbers on drug development are US$1b for the entire program, Clinuvel’s A$120M holds up well as one of the most economica
Slide 28: For personal use only
For personal use only In the clinical phase and commercial phase both on overseas’ markets and Nasdaq there are few ‘orphan drug’ pharmaceuticals at US$200M. Benchmarking CUV against peers provides some insight in market valuations. 29
Slide 29: For personal use only
For personal use only Italy and Switzerland have given more than two years of ‘conditions of use’ and five years of special access scheme SAS data in EPP patients. The table shows reimbursement for SCENESSE® by insurers and regional authorities in these two countries, and in recent times, also from
Slide 30: For personal use only
For personal use only EU distribution is in preparation following the EMA ‘approval’ on 23 October 2014 morning 24 Oct Melbourne . 31
Slide 31: For personal use only
For personal use only The first key strategic markets for EPP had been identified by Clinuvel. The markets in blue are under consideration. 32
Slide 32: For personal use only
For personal use only Modelling EPP by analysts and peers presumes a number of variables. Once pricing is established in EU, an adequate market size can be estimated. In Clinuvel’s case the 5 years of experience during the ‘Special Access Schemes’ provides data for modelling. 33
Slide 33: For personal use only
For personal use only Vitiligo attracts much attention in North America given the magnitude of the clinical problem most apparent in patients of colour due to the contrast between vitiligo and non‐vitiliginous lesions. 34
Slide 34: For personal use only
For personal use only Penetration rates in a low case scenario is being discussed, given the demographics and patient population known. 35
Slide 35: For personal use only
For personal use only Patients of skin colour who lose their pigmentation often see a gradual progression of disease. It causes much distress and sense of helplessness. Patients who lose a large surface area of pigmentation present such as the patient in Day 0 left hand side . This patient’s de‐pigm
Slide 36: For personal use only
For personal use only Close up reveals the follicular pattern repigmentation ‘islands’ throughout the epidermis. The Day 176 images are particularly important as rate and depth of repigmentation is assessed. 37
Slide 37: For personal use only
For personal use only A further close up shows individual ‘islands’ of pigment developing. 38
Slide 38: For personal use only
For personal use only These islands represent the melanocyte stem cells near a hair follicle. The maturation of melanocytes enables the first pigmentation to become visible. 39
Slide 39: For personal use only
For personal use only Clinuvel is known as the company which treats vitiligo in darker skin populations, whereby VIP catch the eye of the imagination. Many of the industry publications focus on the positive results from CUV102. 40
Slide 40: Summary
SUMMARY 3 EMA approval validated SCENESSE® and melanocortins SCENESSE® preparing for market entry Spring 2015 Value of integrity of SCENESSE® and derivatives Focus EPP on 3 strategic markets Vitiligo focus on North-America Asia& Middle-East North Africa 41
Slide 41: For personal use only
For personal use only Support from Clinuvel Board, investors and staff have been fundamental to Clinuvel’s success. The greatest assets of the Company are its people. 42
Slide 42: Clinuvel Pharmaceuticals
oS eS Clinuvel CLINUVEL PHARMACEUTICALS A specialty pharmaceutical in dermatology COMMERCIALISATION OF SCENESSE® Mr Stan McLiesh, Chair ASX: CUV Dr Philippe Wolgen, CEO 2 XETRA-DAX: URS ADR: CLVLY NOVEMBER 2014 aes — 43
Clinuvel Pharmaceuticals — Shareholder Meeting (November 2014) on 6ix