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1 A specialty pharmaceutical in dermatology Mr Stan McLiesh, Chair Dr Philippe Wolgen, CEO Mr Darren Keamy, CFO DECEMBER 2014 ASX: XETRA DAX: ADR: CUV UR9 CLVLY

2 This release contains forward looking statements, which reflect the current beliefs and expectations of Clinuvel s management. Statements may involve a number of known and unknown risks that could cause our future results, performance or achievements to differ significantly from those expressed or implied by such forward looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialise pharmaceutical products, including our ability to develop, manufacture, market and sell biopharmaceutical products; competition for our products, especially SCENESSE afamelanotide 16mg ; our ability to achieve expected safety and efficacy results through our innovative R&D efforts;, the effectiveness of our patents and other protections for innovative products, particularly in view of national and regional variations in patent laws; our potential exposure to product liability claims to the extent not covered by insurance; increased government scrutiny in either Australia, the U.S. and Europe of our agreements with third parties and suppliers; our exposure to currency fluctuations and restrictions as well as credit risks; the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement; any failures to comply with any government payment system i.e. Medicare reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; any failure to retain or attract key personnel and managerial talent; the impact of broader change within the pharmaceutical industry and related industries; potential changes to tax liabilities or legislation; environmental risks; and other factors that have been discussed in our 2014 Annual Report. Forward looking statements speak only as of the date on which they are made and the Company undertakes no obligation, outside of those required under applicable laws or relevant listing rules of the Australian Securities Exchange, to update or revise any forward looking statement, whether as a result of new information, future events or otherwise.

3 CONCEPT EPP Orphan drug EU marketing authorisation Proof of Concept Reimbursement LABEL EXTENSIONS EPP PAEDIATRIC Key markets: EU CH US Japan VITILIGO Larger market Key markets: US ASIA STH AFRICA Systemic COMPLEMENTARY TREATMENT Rx Topical

4 Funds Raised A$m $40 $35 $30 $25 $20 $15 $10 $5 HISTORICAL SHARE PRICE ASX: CUV Nov 06 $35.2m Dec 05 $1m May 06 $5m Apr 07 $26m FUNDING ROUNDS JAN 06 MAY 14 9 Rounds Equity $86.9M Cash on hand $12.5M 09/30 Ave Monthly Burn $731k DEBT FREE Jun 12 $6.2m May 13 $6.3m May 14 $6.9m $14.00 $12.00 $10.00 $8.00 $6.00 $4.00 $2.00 Share price $A $ Dec 05 Dec 06 Dec 07 Dec 08 Dec 09 Dec 10 Dec 11 Dec 12 Dec 13 $ % of Issued Ordinary Shares 18% 16% 14% 12% 10% 8% 6% 4% 2% HISTORICAL AVERAGE DAILY TRADE VOLUMES 28 NOVEMBER 2014 Free float 14: 80% Volume traded 12 month: 12,989,742 Value traded 12month: A$36.1M 0% Q1 06 Q1 07 Q1 08 Q1 09 Q1 10 Q1 11 Q1 12 Q1 13 Q1 14 % Traded to Issued Cap *Excludes Sept 2008 off market transfer of major shareholder

5 Retail & Other 29.5% Institutions & Custodians 32.3% Asia Pacific 40.79% North America 29.21% EU/Switzerland 30.00% ADRs 9.8% Related parties 4.6% Sophisticated Investors & Brokers 23.8%

6 Clin. Dev. Expenses: Formulation: Regulatory: Marketing & Listing: Patents & Trademarks: Operations: Total Expenses: A$24.0m A$23.4m A$6.6m A$7.8m A$4.7m A$41.8m A$108.3m Others Ph1, 37% Expenses per indication Vitiligo, 8% EPP, 55%

7 A$ m Clinical development 3.5 Drug delivery, formulation 3.3 Regulatory Affairs 1.3 Personnel 10.0 Overheads, Marketing & Corporate 5.9 Total ** 23.9 * Expenditures foreseen subject to corporate progress ** excludes receipts, interest & R&D incentives

8 CONVERGENCE IN KNOWLEDGE IN 947 DAYS OF REVIEW QUALITY OUTSET OUTCOME Drug substance manufacture/quality control Drug product manufacture/quality control NONCLINICAL Pharmacology Toxicology CLINICAL Pharmacology mode of action Clinical safety Clinical efficacy Prescribing information/risk management plan

9 n 1 st EP 2 nd EP CUV010 5 pain, tolerance to λ p CUV pain p / CUV exposure to λ p 0.036/0.025 CUV exposure to λ p CUV exposure to λ p melanin density tolerance to λ pain, QoL pain, QoL QoL 2010 AIFA 648/ SWISSMEDIC EPP PATIENTS 21 PORPHYRIA EXPERTS ATTEST TO EFFICACY SCEPTICAL PHYSICIANS CONVERTED 94% OF TRIAL PATIENTS REQUEST CONTINUOUS TREATMENT WITH SCENESSE ALL PATIENT ADVOCACY GROUPS IN SUPPORT 8 PARA/ MEDICALLY QUALIFIED EPP PATIENTS

10 Ac Ser Tyr Ser Nle Glu His Dphe Arg Trp Gly Lys Pro Val NH2 Theoretical properties of melanocortins: 1. melanogenic 2 anti inflammatory 3 anti carcinogenic Human pharmacology, bioresponse and safety determine commercial value

11 Light deprivation/starvation since childhood Social isolation affecting childhood development Impact professional options Mood affective disorders Pain is non responsive to analgesics This summer I have had to deal with pain daily and I can t afford to take time off work, as I have bills to pay, food to buy just like everyone else please allow me this opportunity to live what I believe to be a normal life Australian EPP patient

12 STAGE I MARKET RESEARCH ON SCENESSE FOR THE PREVENTION OF EPP SEVERITY Cerebrovascular Accident Acute Lymphoblastic Leukemia Myocardial Infarction Acute Macular Degeneration Prostate Cancer EPP Chronic Lumbar Pain Refractive HNP MS Hemophilia Crohn s/uc Lymph Edema Actinic Keratosis Diabetic Foot Ulcers Cluster Headaches ACUTE Source: Third party market research commissioned by CUV CHRONIC

13 REIMBURSEMENT OF SCENESSE PRIOR TO EMA APPROVAL SAS* SAS ITA CH n/a n/a EU other TOTAL PREVALENCE EPP 1:140,000 CONTINUATION AFTER TRIAL 94% DISCONTINUATION AFTER 5 YEARS OF SPECIAL ACCESS 22.6% SCHEMES COST OF TRAVEL/RELOCATION 10.4% DESIRE TO START FAMILY 4.3% OTHER 7.9% *Special Access Scheme

14 FDA acknowledges rationale of proposed treatment SCENESSE 10% body involvement Dark skin complexion Fitzpatrick IV VI 3 trials, 2 pivotal comb. NB UVB SCENESSE n 600 US first market of entry, MEA* & Asian markets second Global prevalence 1 2% of global population Projected US penetration rate SCENESSE commercial phase 4.00% 2.00% 0.00% Year 1 Year 2 Year 3 * Submission for marketing authorisation in Middle East, Africa

15 Day 0 Baseline Day 27 After 9 NB UVB treatments Day 55 After 15 NB UVB treatments, 1 implant Day 111 After 27 NB UVB treatments, 3 implants Day 176 After 40 NB UVB treatments, 4 implants Images are as originally supplied by the clinical center and ID numbers have been removed to maintain patient privacy, the images are otherwise unaltered.

16 Enlarged image of left thigh showing generalised follicular repigmentation Day 0 Baseline Day 55 After 15 NB UVB treatments, 1 implant dose Day 176 After 40 NB UVB treatments, 4 implant doses Images are as originally supplied by the clinical center and ID numbers have been removed to maintain patient privacy, the images are otherwise unaltered.

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20 A specialty pharmaceutical in dermatology Mr Stan McLiesh, Chair Dr Philippe Wolgen, CEO Mr Darren Keamy, CFO DECEMBER 2014 ASX: XETRA DAX: ADR: CUV UR9 CLVLY

21 Investor update presentation speaking notes Melbourne, Australia and Zug, Switzerland, December 4, 2014 Slide 1: INVESTOR UPDATE This serves as an investor update at the end of the calendar year 2014 summarising a number of corporate events and, most importantly, the EMA approval of SCENESSE on October 23. Slide 2: FORWARD LOOKING STATEMENTS Forward looking statements may be made during the presentation but the safe harbour statement serves to forewarn the reader or any speculative investor against the risk associated with pharmaceutical development, distribution, pricing and reimbursement. Slide 3: DOWNSTREAM VALUE OF SCENESSE The integral value of Clinuvel originates from the research and development, and marketing authorisation of SCENESSE as the first systemic treatment of light disorders and pigmentary diseases. After a decade of careful preparation the downstream value of SCENESSE will flow from its use in other indications, as well as the use of associated melanocortins to complement SCENESSE in vitiligo. The topical formulation is being developed and progress will be made as relevant data become available. The combined use of SCENESSE systemic and SCENESSE topical will add to the value of Clinuvel. The first regulatory approval by the EMA was necessary to obtain clinical and financial endorsement for further downstream development. Slide 4: FINANCIALS CLINUVEL The funding of Clinuvel was carefully planned through a series of funding rounds during the clinical and regulatory development stages of SCENESSE. The past decade the purpose was to secure funding sufficient to obtain the first essential regulatory approval in Europe while minimising the dilution for shareholders. To that effect, Clinuvel raised smaller equity injections at premium to market prices ( ). Liquidity in Clinuvel has increased during 2014 and has been sufficient for those investors interested in building a significant stake in the company. The free float over 2014 has been approximately 80% higher than previous years. Slide 5: CUV SHARE REGISTER Compared to previous years Clinuvel s share register has shown an increase in US investors who seem to have discovered the Company s unique drug and platform. The Asia Pacific investors remain, with 40.79%, the largest geographically followed by Europe/Switzerland and the US. More specialised life science funds and family offices request information on the Company as a long term investment prospect. Slide 6: EXPENSES The expenditures over the past nine years have been carefully managed whereby the lion s share of costs were allocated towards EPP as the first indication for which Clinuvel was developed to European market. Other indications tested served to provide essential safety data on the use of SCENESSE given the larger populations available (other than EPP). A proportionate, large sum went into the development of the unique formulation, a controlled release implant; this technology is thus far the only one available commercially and provides Clinuvel 10 years of market exclusivity. Expenses include non cash adjustments. Slide 7: PROJECTED EXPENDITURES CY * As the company transitions from R&D to a full commercial entity, approximately 40% of its projected expenditures will be allocated towards new professional staff and management in order to successfully distribute SCENESSE in the European Union. The forecast above is subject to many changes and covers the period from January 2015 to December 2016, any material changes will be made public on the ASX.

22 Slide 8: POSITIVE CHMP EVALUATION 23 OCTOBER 2014 The introduction of novel SCENESSE (afamelanotide 16mg) met much regulatory resistance at the beginning of the review process, as seen in the left column of the balance score card. It could have been expected from any pharmaceutical company to withdraw the application for marketing authorisation given the EMA regulatory resistance. Clinuvel s management had been convinced of the safety and clinical efficacy of SCENESSE and had taken into account the unusually strong patients demand and positive feedback from expert physicians and academics. Hence Clinuvel s management persisted in the regulatory review and had not considered the withdrawal of the application at any stage, since new data generated in an additional trial would not provide additional useful information. Towards the end of the review process the longest in the history of the EMA with 947 days the Agency converged towards full acceptance of the clinical efficacy and safety of SCENESSE. The ad hoc meeting and plenary session of the CHMP provided the EMA two opportunities to speak to EPP patients and physicians, experts in the field. The involvement of EPP patients and expert physicians had been requested by Clinuvel since The positive outcome on October 23 confirmed Clinuvel s long standing views on the clinical use of SCENESSE in EPP. Slide 9: EPP REGULATORY DECISION MODEL Clinuvel s Board and management considered many risks inherent to the R&D of disruptive and innovative technology, SCENESSE. Against the low odds of success and despite the challenges of evaluating the efficacy of SCENESSE through conventional methodology, a number of signposts along the journey clearly indicated clinical efficacy and safety of the product. The responsibility of management was to make the right calls at each juncture of development. A number of factors facilitated the decision to develop SCENESSE in EPP, such as the inclusion of the drug in Italy s special access scheme, Swiss reimbursement, patient demand for continuous treatment, physicians consistent positive feedback and the response from patient advocacy groups. Not unimportantly, six out of eight para/medically qualified EPP patients had reported significant improvement following the use of SCENESSE. Slide 10: SCENESSE (AFAMELANOTIDE 16MG) As extensively known, melanocortins exert a number of activities which have all been published. Structural configuration, dose, plasma concentration, bioavailability and other factors determine how, and when, to use a melanocortin. Additionally, at all times, safety considerations dominate the choices of how to clinically use one of these molecules. In the case of SCENESSE Clinuvel had considered all of the parameters and together with the medical community had arrived at a uniform conclusion of how to best make SCENESSE available to a target patient population while securing an optimum safety profile. While theoretically a number of uses are conceivable, many research groups and companies in the world have failed over the past decades to develop any of the melanocortins commercially due to the complexity of balancing all parameters forementioned. Clinuvel has now successfully launched the first systemic photoprotective drug SCENESSE to provide protection against light and light sources for those patients in extreme need of therapy for erythropoietic protoporphyria (EPP). Slide 11: ERYTHROPOIETIC PROTOPORPHYRIA (EPP) EPP patients suffer from an extreme form of phototoxicity against any light source, specifically the visible band of 408nm. As a poorly characterised disorder, EPP can best be described as a genetic disorder causing lifelong light deprivation and starvation. It is well known from literature, clinical experiments, penitentiary institutions and human rights what light starvation, long term, does to human biology. For all stakeholders the ability to offer a medical solution to adults first (and children later) to assist and facilitate in leading a normal life which had not been known or possible before treatment is a truly unique opportunity. The response from patients worldwide has been nothing less than amazing and one of gratitude. Slide 12: HEALTHECONOMIC ASSESSMENT PER DISORDER During clinical market research it became apparent that EPP was to be viewed as a severe and chronic disorder, perhaps best compared or benchmarked against haemophilia (bleeding disorders). Positioning EPP and therefore SCENESSE is necessary to fully understand the value that can be built in Clinuvel. As EPP is a disorder of high unmet clinical need for which there is no prior or alternative therapy, proper characterisation and positioning aides in the discussions with payors and reimbursement agencies.

23 Slide 13: EUROPEAN DISTRIBUTION SCENESSE Data collected over the years from compassionate use programs and special access schemes provide fertile ground for understanding marketing and sales throughout the European Union. Distribution through the special access schemes in Italy and Switzerland are illustrated in the first table above and it is apparent that the number of regions in Italy, the number of payors in Switzerland and, since 2012, the number of German insurers have increased. To understand patients willingness and eagerness to receive SCENESSE treatment Clinuvel looked at continuation rate and reasons for discontinuing drug use. Modelling this knowledge expressed in percentages greatly assists in forecasting the size of the EPP market in Europe, US, and other parts of the world. Slide 14: VITILIGO PATH TO COMMERCIALISATION In determining the price for EPP the commercial work on vitiligo has started. Whereas the treatment for EPP is seen as a preventative for phototoxic symptoms on an annual basis, the treatment of vitiligo is of curative nature whereby it is estimated that seven injections of SCENESSE will be sufficient to repigment these patients completely. This last estimate is subject to further clinical trials. Slide 15: REPIGMENTATION PATTERN VITILIGO (CUV102) For decades the treatment of vitiligo was one of little progress and success. With the introduction of narrowband UVB some follicular response and repigmentation was seen in a select group of patients, but mostly resulting in deficient and partial clinical repigmentation. This response is deemed unsatisfactory and clinically deficient by the leading vitiligo experts in the world. Based on the CUV102 results and the feedback from the leading vitiligo experts, SCENESSE seems to be offering vitiligo patients of colour (darker skin complexions, Fitzpatrick Skin Types IV VI) an effective therapy achieving a complete and lasting repigmentation. Slide 16: FOLLICULAR REPIGMENTATION VITILIGO (CUV102) As seen in the centre image, SCENESSE is extremely effective in activating a follicular pigmentary response resulting, after a number of doses, in complete confluent repigmentation of the skin (third image). The results of CUV102 have been published in a number of journals and presented to conferences globally. The groundbreaking work received an award from the American Association of Dermatology in 2012 Publications and public presentations on SCENESSE in vitiligo: Agbai, A (2012). Safety and Efficacy of Afamelanotide Implants and NB UVB versus NB UVB Alone in the Treatment of Nonsegmental Vitiligo: Preliminary Results Detroit. Skin of Color Society, San Diego. Recipient: Best Resident /Fellow Presentation Award Lim, H (2012). Combination therapy SCENESSE (afamelanotide 16mg) and NB UVB in vitiligo: The Detroit Experience Preliminary Results (CUV102). RCD, Manila Agbai, A (2013). Safety and Efficacy of Afamelanotide Implants and NB UVB versus NB UVB Alone in the Treatment of Nonsegmental Vitiligo. AAD, Miami. Grimes, P (2013). Afamelanotide in vitiligo presentation on the CUV102 study preliminary results. AAD, Miami. Lim, H (2013). Phototherapy in vitiligo. AAD, Miami. Grimes, P (2014). New perspectives in medical therapies. AAD, Colorado Hamzavi, I (2014). Photodermatology In Skin Of Color, Melasma & Pigmentation. AAD, Colorado Lebwohl, M (2014). Afamelanotide in vitiligo: The first experience. MSH Society Meeting, Amsterdam. Lim, H (2014). New Combination Treatments. AAD, Colorado. Slide 17: FOLLICULAR REPIGMENTATION VITILIGO (CUV102) In close up the follicular repigmentation is pronounced in darker skin complexions (Fitzpatrick IV VI) and shows a homogenous pattern across all affected skin sites. The use of SCENESSE in the US trial CUV102 showed an acceleration and depth of repigmentation in patients treated with narrowband UVB and the drug. The image above illustrates the early signs of follicular activity in vitiligo patients after receiving the first or second dose of SCENESSE. Slide 18: FOLLICULAR REPIGMENTATION VITILIGO (CUV102) Graphically one could imagine the follicular repigmentation arising from the factory of pigment, the bulge (or niche) adjacent to the hair follicle.

24 Slide 19: SUMMARY No notes. End About Clinuvel Pharmaceuticals Limited Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA DAX: UR9; ADR: CLVLY) is a global biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders. With its unique expertise in understanding the interaction of light and human skin, the company has identified patient populations with a clinical need for photoprotection and another population with a need for repigmentation. These patient groups range in size from 5,000 to 45 million. Clinuvel s lead compound, SCENESSE (afamelanotide 16mg), a first in class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe, and has been recommended for marketing authorisation under exceptional circumstance by the European Medicines Agency. Based in Melbourne, Australia, Clinuvel has operations in Europe, the US and Singapore. For more information go to Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, SCENESSE (afamelanotide) for a range of UV related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and development involves long lead times and significant risks. Therefore, while all reasonable efforts have been made by Clinuvel to ensure that there is a reasonable basis for all statements made in this document that relate to prospective events or developments (forward looking statements), investors should note the following: actual results may and often will differ materially from these forward looking statements; no assurances can be given by Clinuvel that any stated objectives, outcomes or timeframes in respect of its development programme for SCENESSE can or will be achieved; no assurances can be given by Clinuvel that, even if its development programme for SCENESSE is successful, it will obtain regulatory approval for its pharmaceutical products or that such products, if approved for use, will be successful in the market place Level 14 / 190 Queen Street T Melbourne, Victoria 3000 F Australia

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