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CLINUVEL PHARMACEUTICALS LTD is a global biopharmaceutical company focused on developing and commercialising treatments for patients with genetic, metabolic, and life-threatening disorders, as well as healthcare solutions for the general population.

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CLINUVEL is listed on the Australian
Securities Exchange under the ticker code CUV.

CLINUVEL

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Announcements Calendar 2021

MANDATORY ANNOUNCEMENTS TO THE AUSTRALIAN SECURITIES EXCHANGE DUE DATE
Appendix 4C – Quarterly Cash Flow
29 January 2021
Appendix 4D – Half Yearly Report
26 February 2021
Appendix 4C – Quarterly Cash Flow
30 April 2021
Appendix 4C – Quarterly Cash Flow
30 July 2021
Appendix 4E – Full Year Results
31 August 2021
Appendix 4C – Quarterly Cash Flow
29 October 2021

Except for scheduled announcements to the Australian Securities Exchange, the timing of announcements is subject to change by the Company.

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Company Snapshot

CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY; XETRA-DAX: UR9) is a global and diversified biopharmaceutical company focused on developing and commercialising treatments for patients with genetic, metabolic, and life-threatening disorders, as well as healthcare solutions for the general population. As pioneers in photomedicine and understanding the interaction of light and human biology, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprotection, DNA repair and acute or life-threatening conditions. These patient groups range in size from 5,000 to 45 million worldwide. CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), was approved by the European Commission in 2014, the US Food and Drug Administration in 2019 and the Australian Therapeutic Goods Administration in 2020 for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP).

More information on EPP can be found at https://www.epp.care.

Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Switzerland, the US and Singapore.

SCENESSE® and PRÉNUMBRA® are registered trademarks of CLINUVEL PHARMACEUTICALS LTD.

Fact ASX Listed 2001 Shares on Issue 49,410,338
Conditional performance rights 1,784,583
52 week price range (27/08/21) $19.53 - $34.90
Market cap (27/08/21) A$1,704m
Locations Melbourne, Australia Company headquarters
Zug, Switzerland Swiss operational office
Dublin, Ireland EU operational office
Leatherhead, UK UK operational office
Singapore VALLAURIX Research, Development & Innovation Centre
Burlingame, US US operational office
www.clinuvel.com
Stock Listings ASX CUV
Xetra-DAX UR9
Level 1 ADR CLVLY
Key Financial Statistics
FY June 2021
Total revenue A$48.5m
Net profit A$24.7m
Net cash increase A$16.9m
Cash A$82.7m
Total assets A$108.6m
Equity A$98.7m
Products

SCENESSE® (afamelanotide 16mg implant)
First-in-class photoprotective and repigmentation drug with EMA, US FDA and Australian TGA approvals for rare disease EPP. Phase IIb trial completed in Singapore for vitiligo. Trial programs for stroke and DNA Repair.

CUV9900
An alpha-Melanocyte Stimulating Hormone (alpha-MSH) analogue in early development.

Parvysmelanotide (VLRX001)
An alpha-Melanocyte Stimulating Hormone (alpha-MSH) analogue in early development.

PRÉNUMBRA®
PRÉNUMBRA® is a liquid (non-solid) injectable formulation of afamelanotide designed for administration by a healthcare professional and intended to provide a flexible dose of afamelanotide, a synthetic analogue of natural α-melanocyte stimulating hormone.

People Willem Blijdorp Non-Executive Chair
Dr Philippe Wolgen CEO, Managing Director
Brenda Shanahan Non-Executive Director
Dr Karen Agersborg Non-Executive Director
Susan Smith Non-Executive Director
Professor Jeffrey V. Rosenfeld Non-Executive Director
Darren Keamy CFO, Company Secretary
Dr Dennis Wright Chief Scientific Officer
Lachlan Hay Director of Global Operations

Financial
overview

CLINUVEL’s end of financial year is 30 June.

5 Year Financial Summary

PROFIT & LOSS
2021
2020
2019
2018
2017
2016
Revenues
A$m
48.5
33.9
32.5
26.2
17.2
7.2
Expenses
A$m
22.7
22.4
14.4
13.3
10.1
10.4
Net Profit / (Loss)
A$m
24.7
15.1
18.1
13.2
7.1
(3.2)
PROFIT & LOSS
2021
2020
2019
2018
2017
2016
Cash & Cash equivalents
A$m
82.7
66.7
54.3
36.2
23.8
13.8
Total Assets
A$m
108.6
81.5
62.3
42.9
28.6
20.1
Total Liabilities
A$m
9.8
9.5
5.2
3.5
3.1
2.3
Equity
A$m
98.7
72.1
57.2
39.4
25.4
17.8
CASH FLOW
2021
2020
2019
2018
2017
2016
Cashflow (used in ) operating activities
A$m
19.3
14.2
18.4
11.7
9.9
(5.0)
Net increase in cash held
A$m
16.9
11.8
17.2
11.6
9.9
3.3
KEY VARIABLES
2021
2020
2019
2018
2017
2016
Basic Earnings per Share
Cents
50.0
30.6
37.6
27.7
14.9
(7.0)
Net Tangible Assets Backing
A$ per share
1.9
1.4
1.2
0.8
0.5
0.4
Return on Equity
%
25
21
32
34
28.0

Some figures in the table may vary slightly to CLINUVEL’s reporting due to rounding.
Click here to see our Annual Reports.

Please refer to the Announcements Calendar for planned financial releases.

CLINUVEL has raised over A$95.0 million since 2006 to fund its clinical programme for afamelonotide

Capital Raisings

* Represented at post-consolidated basis after capital re-organisation
November 2010 (10:1 Reverse Stock Split).

Shareholder
Information

ASX Shareholders

CLINUVEL maintains its ASX shareholder registry with Computershare. For all enquiries related to your shareholding, contact:

The Registrar
Computershare Investor Services Pty Limited
GPO Box 2975
Australia
(Aus) 1300 555 159
(International) +61 (0)3 9415 4062

Shareholders are able to access the company’s share registry with Computershare online and  perform the following tasks:

View Your Security Holdings
-Account Details
-Balances
-Communication Details

Change your Shareholdings Records
Click here to go to the Computershare website.

American Depository Receipts holders

CLINUVEL’s stock is available as a Level I OTC-traded ADR sponsored by the Bank of New York Mellon with the symbol CLVLY. CLINUVEL is also a member of the Nasdaq International Designation program. For more information, please see this announcement.

For all enquiries related to ADR ownership, contact:
BNY Mellon Shareowner Services
P.O. Box 358516
Pittsburgh, PA 15252-8516
USA (USA) 1888 BNY ADRS or – 1888 269 2377 (toll free)
(International) +1 201 680 6825
Email: shrrelations@bnymellon.com
Website: www.adrbnymellon.com

Media Coverage

AUTHORPUBLISHERDATEAUTHOR BIOPUBLISHER PROFILE
David Koch & Nadine
Blayney & Daniel Weiner
Ausbiz18 June 2020
23 April 2020
02 April 2020
David Koch is a prominent financial journalist, co-host of a national television breakfast program, co-founder of ausbiz and host of The Call program. CLINUVEL has been interviewed by ausbiz co-anchors Nadine Blayney who has covered business and media since 2005, and Daniel Weiner who joined ausbiz after a career as a trader in global financial markets.Ausbiz is a business and financial news, live streaming and on demand, service which commenced in March 2020. The Call is a daily program on ausbiz.
Kate O'BrienThe Motley Fool15 June 2020Kate O’Brien writes for The Motley Fool on consumer product, healthcare, finance, and legal matters and has worked as an analyst and consultant in the finance industry. Nick Sundich is an experienced financial journalist focused on corporate strategy and market trends. He writes predominately for Stockhead and holds Commerce and Arts degrees from University of Sydney.The Motley Fool was established in 1993 and provides investment and financial advice to its large membership
Nick SundichStockhead10 June 2020
23 April 2020
23 March 2020
Nick Sundich is an experienced financial journalist focused on corporate strategy and market trends. He writes predominately for Stockhead and holds Commerce and Arts degrees from University of Sydney.Stockhead Australia draws on a team of contributing journalists to report online daily on emerging small and micro listed stocks. It is owned by AG Media Investments
Jessica De FreitasThe Market Herald23 April 2020Jessica De Freitas has a digital marketing background with a Bachelor of Arts in communications and media. She writes on market news, specialising in real estate and consumer trends.The Market Herald is a Perth based, leading source of Australian stock market news for self-directed investors.
Tim BorehamThe New Criterion02 April 2020Tim Boreham is a freelance business journalist with more than 30 years of experience writing on business for major publications, including The Australian. Sectors covered by Tim include banking, accounting, technology, property, and life sciences. Tim authors The New Criterion and Dr Boreham’s Crucible.The New Criterion is published weekly online and focuses on small- to mid-capitalised stocks for Independent Investment Research which was established in 2004 and specialises in the analysis of high-quality commissioned research for brokers, family offices and fund managers.
Louise WeihartMergemarket31 March 2020Louise Weihart is an experienced journalist who understands business issues and has reported for Mergermarket for nearly 15 years. She is a graduate of the University of Witwatersrand.Mergermarket is an Acuris company and distributes specialist M&A intelligence drawn from 500 correspondents worldwide to 175,000 subscribers interested in corporate strategy.
Will BoggsM./D. Alert27 March 2020Will Boggs is a physician and freelance journalist based in the United States and covers life sciences for media outlets, including Reuters, Business Insider, HuffPost, The Globe and Mail, Scientific American, and M.D./alert.M.D./alert is focused on informing physicians in all specialities about developments in healthcare.
Michael BaileyThe Australian
Financial Review
23 March 2020Michael Bailey writes on entrepreneurship and the arts and edits the Australian Financial Review’s Rich Lists. Michael has also been an editor in Fairfax Media.The Australian Financial Review is an Australian business and finance newspaper which reports the latest news on business, investment, and politics.
Team KalkineKalkine Media02 March 2020Team Kalkine is a team of journalists that review the latest developments across equity markets, debt markets, currency markets and commodity markets.Kalkine Media is an independent equities research firm founded by Kunal Sawhney to provide recommendations to subscribers on stocks to buy, sell or hold.
Patrick McLoughlinYouth Investment
Group Australia
28 February 2020Patrick McLoughlin has been a senior manager at Youth Investment Group Australia since August 2019 and holds business and law qualifications from the University of Technology Sydney.Youth Investment Group Australia was founded by Tyger Fitzpatrick with the aim to educate young investors of the power of financial knowledge.
James MickleboroThe Motley Fool26 February 2020James Mickleboro has contributed to The Motley Fool on business and finance since late 2015 and is also a Financial Analyst at ATI Wealth. James has written articles on Australian equities for The Motley Fool, Yahoo Finance and Seeking AlphaThe Motley Fool was established in 1993 and provides investment and financial advice to its large membership.

Analyst coverage

CLINUVEL does not provide financial guidance on its earnings and financial performance. CLINUVEL does not endorse, confirm or express a view as to the accuracy of the analyst reports and the forecasts contained within them and does not make any representation that its earnings will fall within the range of the analyst’s forecasts. CLINUVEL does not induce, incentivise or remunerate analysts and journalists to publish and recommend CLINUVEL in their reports or mainstream media channels.

FIRM / INSTITUTIONANALYSTDATE OF PUBLICATIONANALYST PROFILEFIRM / INSTITUTION PROFILE
BiosharesDavid Blake
& Mark Pachacz
Latest coverage: No. 901, 08 September 2021
Initial coverage: No. 195, 01 December 2006
Prior to co-founding Bioshares, David Blake was a housing market analyst for the Victorian Government. He holds a Bachelor of Arts from the University of Queensland and Graduate Diplomas from the University of Melbourne and the Securities Institute of Australia. Mark Pachacz is co-founder and co-editor of Bioshares. He is a chemical engineer by training and a graduate of Monash University and the Securities Institute of Australia.Bioshares is published by Blake Industry and Market Analysis Pty Ltd. Since 2000, Bioshares has cemented a reputation for highly knowledgeable, insightful, and independent coverage of life sciences, pharmaceutical and healthcare companies.
Intelligent InvestorGraham WitcombLatest coverage: 27 August 2021
Initial coverage: 15 June 2020
Graham Witcomb is a senior analyst focused on the healthcare, gambling, and transport infrastructure sectors. He is a graduate in psychology from the University of Sydney and a Chartered Financial Analyst charterholder.Intelligent Investor is part of the InvestSMART Group which offers financial services to over 673,00 members through diversified and single asset class investments.
Jefferies AustraliaDavid StantonLatest coverage: 27 August 2021
Initial coverage: 13 October 2020
Dr Stanton is Head of Healthcare Equity Research Australia at Jefferies Australia Pty Ltd. He is a qualified Medical Specialist, holds a Master of Business Administration, and is an experienced and well regarded healthcare analyst. Dr Stanton has followed CLINUVEL’s development program since 2007. With Jefferies since September 2019, he has held senior analytical roles over 15 years with CSLA, Nomura, and ABN Amro.Jefferies Financial Group Inc. (NYSE:JEF) is a leading international financial services company offering a range of investment banking, equities, fixed income, asset and wealth management products and services through subsidiaries worldwide, see https://www.jefferies.com. Healthcare is one of the firm’s 12 focus areas, with Jefferies maintaining a dedicated global healthcare research team which issues analyst coverage on over 270 companies in the sector. The annual Jefferies Global Healthcare Conference is recognised as the largest life sciences investment event in Europe.
Lonsec ResearchChad TrojaLatest coverage: 30 August 2021
Initial coverage: 17 June 2020
Chad Troja is a senior equity analyst, experienced in portfolio management, equity markets and foreign exchange trading. He holds a Master of Applied Finance from Macquarie University and Bachelor of Business Administration from Monash University.Lonsec Research provides investment research, portfolio consulting and managed accounts to financial advisers, fund managers, superfunds, and DIY investors.
Moelis Australia
Securities
Sarah MannLatest coverage: 26 August 2021
Initial coverage: 17 April 2019
Sarah Mann is a prominent analyst focused on the healthcare sector. With Moelis Australia since mid-2016, Sarah was previously an analyst at Credit Suisse. She holds a Bachelor of Liberal Studies from the University of Sydney with an undergraduate thesis in Immunology. At Moelis Australia, Sarah covers a number of companies across the healthcare and consumer sectors listed on the Australian Securities Exchange (ASX).Moelis Australia Securities Ltd is a financial services group listed on the ASX, specialising in asset management, corporate advisory, and transaction services. They have a team of over 200, research 58 ASX-listed companies, manage funds of A$4.9bn and have advised on transactions worth over A$110bn since their launch in 2009. Moelis Australia commenced as a joint venture with the New York Securities Exchange (NYSE)-listed Moelis & Company, a leading global independent investment bank and Australian executives.
Wilsons AdvisoryShane Storey & Melissa BensonLatest Coverage: 27 August 2021
Initial coverage: 26 April 2021
Dr Storey has covered the healthcare sector at Wilsons for more than a decade and previously held positions in drug development, R&D project management, and venture capital. Dr Benson joined Wilsons in September 2020 after gaining experience in both industry and academia, primarily in clinical research and drug commercialisation roles. Australian-based firm Wilsons offers services in private wealth management, corporate finance, research and investment strategy, and institutional sales. The group is focused on investment opportunities in emerging and mid-cap markets, and undertakes in-depth research on the healthcare, technology, financial services, consumer, food, and agriculture sectors. Wilsons currently covers 23 listed companies in Australia.

Each research report is issued by a holder of an Australian Financial Services Licence. CLINUVEL does not distribute the original or copies of the analyst reports in observance of copyrights.

Annual Reports

Download CLINUVEL’s Annual Reports from previous years by clicking the links.

International Listings

CLINUVEL stock is available in the USA as a level 1 ADR (CLVLY) through the Bank of New York Mellon with the symbol CLVLY. Click here for the CLVLY price (third party site). CLINUVEL stock is available in Europe through the Xetra listing UR9. CLINUVEL does not issue stock directly to investors. Please contact a financial advisor for more investing information.

Investor
enquiries

Investor enquiries

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