Clinuvel Pharmaceuticals : Appendix 4E and Preliminary Financial Report

APPENDIX 4E

PRELIMINARY FINAL REPORT

CLINUVEL PHARMACEUTICALS LTD

A.B.N 88 089 644 119

1.	Reporting period: 1 July 2019 to 30 June 2020.
	Previous corresponding period: 1 July 2018 to 30 June 2019.
2.	Results for announcement to the market.
		Percentage change to 2019		Amount (AUD)
2.1	Revenues from ordinary activities.	Increased	5%	To	32,565,423
2.2	Profit from ordinary activities after tax attributable to	Profit has	8%	To	16,646,859
members.	decreased
2.3	Net profit for the period attributable to members.	Profit has	8%	To	16,646,859
decreased
2.4	An unfranked final dividend of $0.025 per ordinary share has been declared.
2.5	Record date for determining entitlements for the final dividend: 04 September 2020.
2.6	Refer to the Review of Operations and Financial Condition in the Directors Report to the Attachment to Appendix 4E for a brief explanation of the figures
reported above.
3.	Refer to the Attachment to Appendix 4E for the Statement of Profit or Loss and Other Comprehensive Income together with notes to the statement.
4.	Refer to the Attachment to Appendix 4E for the Statement of Financial Position together with notes to the statement.
5.	Refer to the Attachment to Appendix 4E for the Statement of Cash Flows together with notes to the statement.
6.	Refer to the Attachment to Appendix 4E for the Statement of Changes in Equity together with notes to the statement.
7.	The Directors have declared an unfranked final dividend of $0.025 per ordinary share to be paid on 18 September 2020.
8.	No dividend reinvestment plan.
9.	Net Tangible Assets per Security for Year Ended 30 June 2020: $1.3831.	Net Tangible Assets per Security for Year Ended 30 June 2019: $1.158.
10.	The control of entities which had control gained or lost: VALLAURIX MC SARL (Monaco) (May 2020)
11.	N/A
12.	No other significant information.
	Foreign entities:
	CLINUVEL, INC. (USA)
	CLINUVEL (UK) LTD (UK)
13.	CLINUVEL AG (Switzerland)		Australian Accounting Standards used

CLINUVEL SINGAPORE PTE LTD (Singapore)

VALLAURIX PTE LTD (Singapore)

CLINUVEL EUROPE LIMITED (Ireland)

VALLAURIX MC SARL (Monaco)

1 This has been adjusted to reflect the requirement of Australian Securities and Investments Commission to exclude right of use assets arising from the application of AASB 16 'Leases' from the calculations of net tangible assets.

14. COMMENTARY OF RESULTS

Commentary in respect of the financial results is provided in the Review of Operations and Financial Condition to the attached Directors Report.

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CONTENTS

CLINUVEL PHARMACEUTICALS LTD is the parent company of the CLINUVEL group of companies. In this report, unless otherwise stated, references to "CLINUVEL", "the Group", "the Company", "we", "our" and "us" refer to CLINUVEL PHARMACEUTICALS LTD and its controlled entities. In this report, references to the financial year refer to the period 1 July to 30 June unless otherwise stated.

All dollar figures are expressed in Australian dollars, unless otherwise stated

Directors' Report (including Remuneration Report)	3
Consolidated Statement of Profit or Loss and Other Comprehensive	28
Income
Consolidated Statement of Financial Position	29
Consolidated Statement of Cash Flows	30
Consolidated Statement of Changes In Equity	31
Notes To The Financial Statements	32
Directors' Declaration	50
Independent Auditor's Report	51
Auditor's Independence Declaration	55

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CLINUVEL PHARMACEUTICALS LTD - Consolidated Entity - A.B.N 88 089 644 119

DIRECTORS' REPORT

The Directors of the Board present their report on the Company for the financial year ended 30 June 2020 and the Auditor's Independence Declaration thereon.

DIRECTORS

The names of Directors in office during or since the end of the year are set out below.

WILLEM BLIJDORP

Non-Executive Director, Funda

Appointed 21 January 2015, Chair since 30

November 2019

Background

Mr Blijdorp is an internationally recongnised entrepreneur who has helped build the B&S Group, one of the largest global trading houses, in a period spanning three decades. Mr Blijdorp has led B&S's growth, with the Dutch group focused on specialty distribution services to difficult to serve markets. The B&S Group has global reach and is a leader in its market sector.

Formerly B&S Group's CEO, Mr Blijdorp now serves on its Supervisory Board and is a majority shareholder, focussing on the Group's development and expansion strategy. He led and oversaw the Group's initial public offering on Euronext Amsterdam in March 2018.

In 2014 Mr Blijdorp was recognised for his expertise in merger and acquisitions and commercial leadership as the Ernst & Young Entrepreneur of the Year in the Netherlands, and runner-up in its European Union awards.

Since becoming a director of CLINUVEL in 2015, Mr Blijdorp has provided a valuable contribution to setting the Group's long-term strategy for product commercialisation, growth, and future plans to further diversify CLINUVEL.

Relevant Skills

• entrepreneurship, commercial prowess
• general management
• financial management
• experienced in listed company Directorships

Committee Membership

Chair of the Remuneration Committee

Chair of the Nomination Committee

Member of the Audit and Risk Committee

Current Directorships and other interests

Director of the Supervisory Board of the B&S Group (the Netherlands)

Other listed company Directorships (last 3 years)

None

Relevant interest in Shares and performance rights

Shares: 1,743,118

Performance Rights: -

PHILIPPE WOLGEN

Chief Executive Officer, MBA, MD

Appointed to Board 1 October 2005, appointed Chief Executive Officer 28 November 2005

Background

Under Dr Wolgen's leadership since late 2005, a long-term strategy for CLINUVEL was devised. The lead product SCENESSE® (afamelanotide 16mg) was reformulated, its medical application

identified, European marketing authorisation was obtained in 2014 and distributed in the European Economic Area from June 2016. Dr Wolgen oversaw the submission of the scientific dossier to the US Food & Drug Administration (FDA) under a New Drug Application, which was approved in October 2019. First treatment of US patients commenced in April 2020. SCENESSE® is the first melanocortin drug to have completed a clinical trial program and obtain marketing authorisation in two major markets.

Dr Wolgen has been instrumental in the Company's corporate turnaround, rebuilding a share register of long-term professional and institutional investors. He led CLINUVEL to attract more than AU$110 million in investments, his international contacts and network contribute to the strategic support CLINUVEL enjoys globally.

Under his tenure a business model was adopted to develop and launch SCENESSE®, guiding the Group through a complex pharmaceutical product development program. His overall business execution and exact financial management is viewed as exemplary within the life sciences industry and the funding strategy he led is considered unique within the sector.

Dr Wolgen is currently leading the Group's expansion, with an immediate focus on the US and the further development of the product pipeline for various market segments. His focus has been to establish a professional management team to execute the corporate objectives set and prepare the next generation of managers.

Dr Wolgen's long track record speaks to a strongly focussed, competitive and conscientious professional who is known to persevere in meeting challenging business objectives. He holds an MBA from Columbia University, NY. Trained as a craniofacial surgeon, Dr Wolgen obtained his MD from the University of Utrecht, the Netherlands.

Relevant Skills

• pharmaceutical research & development, commercialisation
• clinical expertise
• commercial knowhow, entrepreneurial outlook
• executive management, corporate turnarounds
• financial management
• capital market understanding
• experienced in listed company Directorships

Current Directorships and other interests

None

Other listed company Directorships (last 3 years)

None

Relevant interest in Shares and performance rights

Shares: 3,504,696

Performance Rights: 1,513,750*

*Performance Rights were issued to Dr Wolgen on 26 August 2020, consequent to shareholder approval at the 2019 AGM

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CLINUVEL PHARMACEUTICALS LTD - Consolidated Entity - A.B.N 88 089 644 119

BRENDA SHANAHAN	Background
Dr Agersborg is a Board-Certified Endocrinologist in Pennsylvania,
Non-Executive Director, BComm,	USA, currently serving as Clinical Endocrinologist at Easton
Hospital, Steward Health, specialising in Endocrinology, Diabetes
FAICD, ASIA	& Metabolism. Dr Agersborg had previously worked at Reading
Appointed 6 February 2007	Hospital, West Reading and at Suburban Hospital, Norristown
	as Clinical Endocrinologist and served as Chief, Endocrinology,
	Diabetes, Metabolism at Chestnut Hill Hospital.

Background

Mrs Shanahan is a pioneer in the Australian finance community. The first female stockbroker, Mrs Shanahan has also spent more than two decades working and investing in medical R&D and commercialisation. She is currently a non-executive director of Phoslock Environmental Technologies Ltd (ASX: PET). Mrs Shanahan is also a non-executive director of DMP Asset Management Ltd and SG Hiscock Ltd, a director of the Kimberly Foundation of Australia Ltd, and Chair of the Aikenhead Centre for Medical Discovery in Melbourne.

Previously Mrs Shanahan was a member of the Australian Stock Exchange and an executive director of a stockbroking firm, a fund management company and an actuarial company. Until 2017, she was Chair of St Vincent's Medical Research Institute and also a non-executive director of Challenger Limited (ASX: CGF). Mrs Shanahan was formerly Chair of Challenger Listed Investments Ltd, the reporting entity for four ASX listed firms and formerly a non-executive director of Bell Financial Group (ASX: BFG). Mrs Shanahan also has served on and chaired various Audit and Risk Committees throughout her career, including Challenger Financial Services Group Ltd, Bell Financial Group, Victoria University, JM Financial Group Ltd, SA Water, AWB International Ltd, BT Financial Group and V/Line Passenger. She is the current Chair of of the Audit Committee for Phoslock Environmental Technologies Ltd (ASX: PET).

Mrs Shanahan joined CLINUVEL in 2007, and was Non-Executive Chair of the Board from late 2007 until July 2010. Her depth of experience across global markets and medical research provides significant value to the current Board and Group.

Dr Agersborg had an extensive career in managing commercial sales & distribution at Wyeth Pharmaceuticals (formerly Ayerst Laboratories). Dr Agersborg has played an integral role in setting the CLINUVEL Group's US commercial strategy, resulting in the US FDA's approval of SCENESSE® in October 2019.

Relevant Skills

• pharmaceutical research & development, commercialisation
• relevant knowledge on melanocortins, clinical expertise
• commercial knowhow in US pharmaceuticals
• general management
• experience in private company Directorships

Committee Membership

Member of the Remuneration Committee

Member of the Nomination Committee

Current Directorships and other interests

Member of the American Osteopathic Association

Fellow of the American Association of Clinical Endocrinologists Fellow of the American College of Osteopathic Internists. Doctorate of Osteopathic Medicine

Other listed company Directorships (last 3 years)

None

Relevant interest in Shares and performance rights

Shares: 5,500

Performance Rights: -

Relevant Skills

• research & development in life sciences
• capital market understanding
• executive management
• experienced in listed company Directorships

Committee Membership

Chair of the Audit and Risk Committee

Member of the Nomination Committee

Current Directorships and other interests

Chair of the Aikenhead Centre for Medical Discovery, Melbourne Director of SG Hiscock Ltd

Director of DMP Asset Management Ltd Director of Kimberly Foundation of Australia Ltd

Other listed company Directorships (last 3 years) Phoslock Environmental Technologies Ltd (ASX: PET, since 2017) Bell Financial Group (ASX: BFG, from 2012 to 2018)

Challenger Limited (ASX: CGF, from 2014 to 2017)

Relevant interest in Shares and performance rights

Shares: 258,969

Performance Rights: 25,000

KAREN AGERSBORG

Non-Executive Director, MD

Appointed 29 January 2018

SUSAN (SUE) SMITH

Non-Executive Director, Dipl ClinRisk

Appointed 23 September 2019

Background

Mrs Smith manages an established consultancy business, providing advisory services to a range of healthcare organisations, investors and boards of directors. Mrs Smith has also hadled a distinguished career, serving for 14 years as Chief Executive Officer of The Princess Grace Hospital, London, and 11 years as the Chief Executive Officer of The Portland Hospital for Women and Children, London. Mrs Smith's specific expertise is in the implementation of operational strategies within complex and acute care environments, and in the interaction with healthcare authorities and UK regulators. Her most recent role was as the Chief Executive Officer of the Independent Doctors Federation, a membership organisation representing practicing physicians within the UK independent healthcare sector.

Her past experience is now successfully translating into a diverse portfolio with non-executive director appointments having been successful in completing the Financial Times Non-Executive Director Advanced Professional Diploma. She is Board Chair of the Evewell (Harley St) Ltd, a fully integrated centre of medical excellence dedicated to caring for and protecting all aspects of fertility and gynaecological health. She also sits on an Advisory Board for Sweettree Home Care Services providing the bridge between hospital and community care. In the face of the ever-changing healthcare market Mrs Smith fosters first class relationships with a wide range of healthcare stakeholders to build first class services for patients.

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