Clinuvel Pharmaceuticals : Presentation Jefferies Virtual London Healthcare Conference

Diversification

and Growth

19 November 2020

Malcolm Bull

Head of Investor Relations

Jefferies Virtual London Healthcare Conference 17-19 November 2020

CLINUVEL Group
ASX:	CUV
Level 1 ADR (Nasdaq Int'l Designation):	CLVLY
XETRA-DAX:	UR9
clinuvel.com
news.clinuvel.com

Thank-you to Jefferies for inviting CLINUVEL to tell its story to the many investors attracted to this prestigious conference.

My objective today is to help you to get to know CLINUVEL and spark your interest to follow-up with us to learn more about our dynamic company and its potential to continue to build incremental value for shareholders.

For those who already know CLINUVEL - like Jefferies and Dr David Stanton who commenced coverage of us in October 2019 - I hope this presentation provides new insights and existing investors affirm their commitment to CLINUVEL.

www.clinuvel.com

Legal Notice

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 commercialize pharmaceutical products, the COVID-19 pandemic affecting the supply chain for a protracted period of time, 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., Europe, China and Japan 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; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE® which may lead to it being unable to supply its commercial markets and/or clinical trial programs; 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 and consumer 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 2020 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. More information on the forecasts and estimates is available on request. Past performance is not an indicator of future performance.

Your attention is drawn to our legal notice which we provide at the start of every presentation. Please keep in mind that I will make forward looking statements in this presentation and there are many risks that can materialise and impact their achievement.

www.clinuvel.com

CLINUVEL Group

Phases of Evolution

• Formation and strategy to 2005
• 2005-2020- drug development and commercialisation
• 2020 onward - targeted translation of technology, growth and expansion

From medicinal therapies…

• to universal skin care products for DNA Repair

CLINUVEL's evolution can be understood across three distinct phases:

The first phase is from formation and the initial strategy to 2005: The core technology of the Company

is afamelanotide, a synthetic peptide which mimics the naturally occurring alpha-melanocyte stimulating hormone (α-MSH). Afamelanotide was invented at the University of Arizona in the late 1980s and was acquired by CLINUVEL in 1999. The peptide stimulates the production of eumelanin which provides photoprotection to UV light and in doing so, tans the skin. The period to 2005 sought to apply the technology to develop a tanning preparation. This more cosmetic than medicinal strategy did not garner support from medical practitioners and regulators. The Company's strategy was unsupported and needed to change.

The second phase is drug development and commercialisation: Dr Philippe Wolgen became CEO late 2005 and formed a new management team, a new vision and new strategy. From 2005 to 2020 the focus was on the development and commercialisation of a novel drug for an unmet medical need. During this period, SCENESSE® (afamelanotide 16mg) was developed as a controlled release subcutaneous injectable implant, erythropoietic protoporphyria (EPP) was selected as the lead indication. We progressed clinical studies, regulatory applications and approvals, and commercialised SCENESSE® as the world's first systemic photoprotective.

The European Medicines Agency and US Food and Drug Administration (FDA) approved SCENESSE® for adult EPP patients in 2014 and 2019, respectively. Commercial distribution commenced in the European Union in June 2016 and the USA in April 2020. After four years of commercial operations, we have built a viable business generating positive cashflow and profitability with a strong balance sheet and cash reserves sufficient to finance planned organic growth.

The third, current and most exciting phase of CLINUVEL's evolutionis to expand access to SCENESSE® in EPP and to translate the technology to new targeted indications and healthcare solutions for broader audiences. CLINUVEL is well positioned to grow and diversify, despite the challenging operating environment.

www.clinuvel.com

CLINUVEL Group
Functional Divisions
Healthcare Solutions		Communications/
Pharmaceuticals	Branding/Marketing
	Research, Development & Innovation Centre
	VALLAURIX [SG]

The CLINUVEL Group is headquartered in Australia with operations in Europe, Singapore, and the USA. Listed on the Australian Securities Exchange in 2001, we also trade, since 2004, on the Xetra-Dax in Germany (as UR9) and the OTC securities market in the USA (as CLVLY) as a Level One American Depositary Receipt. We have grown to eight subsidiaries and have recently organised the Group across three Divisions.

The Pharmaceuticals Division is CLINUVEL's core business, focussed on developing and delivering drugs for patients with an unmet medical need. The business model is geared towards seeking medical solutions for disorders for which there is no satisfactory therapy.

The Healthcare Solutions Division concentrates on non-prescription products derived from the knowhow and active ingredients used in the Pharmaceuticals Division.

The Communications, Branding & Marketing Division prepares communications to wider differentiated audiences, to relay the unique product attributes and benefits.

Last, underlying the divisional structure, the Research, Development & Innovation Centre in Singapore performs fundamental research on molecular science, biology, and follow-on formulations, and actively engages with all three divisions.

The illustration shows the inter-connections between the Divisions which provides our professionals the broadest possible exposure to other disciplines, a distinctive feature of working for the CLINUVEL Group. Before providing more detail on the divisions of the Group and our forward plans, I would like to explain more about the technology developed and our story to date.

www.clinuvel.com