Clinuvel Pharmaceuticals Annual Report 2023

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FY2023 Annual Report · Clinuvel Pharmaceuticals

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“A smooth sea never made
a skilled sailor”

Franklin D Roosevelt

CONTENTS

Key Achievements ���������������������� 6

Financial Highlights ��������������������� 8

Letter from the Chair �������������������� 10

Vison, Mission, and Values ����������������� 12

CLINUVEL’s ESG Practices ����������������� 14

Letter from the Managing Director �������������20

Operating and Financial Review ��������������26

1. Distribution of SCENESSE®

2. Pharmaceutical Product Development

and Clinical Programs

3. PhotoCosmetic Products

4. Financial Review

Plans 2024 and Beyond ������������������� 38

Directors’ Report ���������������������� 43

Remuneration Report �������������������� 57

Statement of Profit and Other Comprehensive Income �� 83

Statement of Financial Position ��������������84

Statement of Cash Flows ������������������ 85

Statement of Changes in Equity ��������������86

Notes To and Forming Part of the Financial Statements �� 87

Directors’ Declaration������������������� 111

Independent Auditor's Report �������������� 112

Auditor's Independence Declaration ����������� 115

Shareholder Information ����������������� 116

Market Performance ������������������� 120

Glossary �������������������������� 122

NAVIGATING
DIVERSIFICATION
ON TURBULENT
WATERS

The ocean is vast and unpredictable, yet it supports a diverse array
of life. CLINUVEL is navigating turbulent waters with a committed
team to diversify the Group in reaching multiple patient groups,
and underserved populations.

During the financial year ending 30 June 2023 (FY2023), CLINUVEL
continued to steer a defined course to maintain the commercial
distribution of SCENESSE® (afamelanotide 16mg) for patients with
erythropoietic protoporphyria (EPP). The Company’s melanocortin
drug portfolio has expanded, to include PRÉNUMBRA® Instant and
NEURACTHEL® Instant, to provide new treatment options for a range
of central diseases. The expanded clinical program was advanced,
specifically in DNA Repair, vitiligo, variegate porphyria, and arterial
ischaemic stroke.

CLINUVEL also started translation of its technological know-how
to a non-pharmaceutical sector. The first PhotoCosmetic product
CYACÊLLE, was launched in a pilot setting to targeted audiences in
need of polychromatic protection from Ultraviolet (UV) and High
Energy Visible (HEV) light. The overall plan is to launch a number
of product ranges belonging to PhotoCosmetics, with the innovative
melanocortin based products to assist DNA repair and MSH-response
for risk-free bronzing.

FY2023 marks the seventh consecutive year of positive revenues
growth, net cash inflow and profitability, and the declaration of a sixth
consecutive annual dividend. The balance sheet has been bolstered
by the highest cash reserves achieved in the history of the Company.
Like the directional movement of a strong ocean current, this dynamic
financial performance underpins CLINUVEL’s ability to advance its
diversification initiatives. The Company’s expansion trajectory will
continue into FY2024 and beyond to advance our objective to become
an integrated, diversified, and sustainable pharmaceutical group.

2023 ANNUAL REPORTKEY ACHIEVEMENTS

More SCENESSE® treatment
access changing lives

Ongoing supply of SCENESSE® to
EPP patients

Growth in treatment centres, patients,
prescriptions filled

Special access program launched in Canada

Application submitted for label expansion
to treat adolescent EPP patients (aged 12–17 years)

Start of adolescent patients treated

Melanocortin portfolio

PRÉNUMBRA® Instant
Developed, first use in second stroke study

NEURACTHEL® Instant
Instant formulation of ACTH progressed
to cGMP manufacture of validation batches
and preparation of Drug Master File

Afamelanotide in the clinic

DNA Repair
• Control study of healthy volunteers completed
• Two studies in xeroderma pigmentosum (XP)

underway

Arterial Ischaemic Stroke

• PRÉNUMBRA® study underway

Repigmentation

• Vitiligo monotherapy study

• Initial results of one XP study presented at the

underway

2023 American Academy of Dermatology Meeting
(reduction in key markers of photodamage)

• Large combination therapy study in planning

Variegate Porphyria

• Study underway

PhotoCosmetics

First polychromatic product CYACÊLLE,
pilot launched 1 March (EU)

Focus on highest risk audiences

Three product ranges in development –
radiant polychromatic protection, DNA-Repair
and melanogenesis

Financial performance

24% growth in revenues

Sixth consecutive annual dividend declared

Seventh consecutive annual profit

Controlled increase in expenses

Continued increase in cash reserves

Active communication of CLINUVEL’s story

57 company announcements

2 Strategic Updates – V and VI

6 Soirées and Investor Briefings

CUVA and CUVIP campaigns launched

6 Investor Conferences

Targeted social media posts

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORTFINANCIAL HIGHLIGHTS
Seven years of consecutive annual growth
in revenues, profit, and cash reserves

20172017

17.2m

10.1m

20182018

26.2m

13.3m

20192019

32.5m

20202020

33.9m

14.4m

22.4m

2021
2021

48.5m

22.7m

Total Revenues, Interest and Other income
Total Expenses

Revenues & expenses (A$m)

Revenues grew by 24% whilst expenses rose by 15% in FY2023.
The seven year compound annual growth rate of revenues of 42% more than doubled
growth of expenses of 20%.

2017

7.1m

2018

13.2m

12.9m

2019

18.1m

2020

15.1m

11.5m

2021

24.7m

25.7m

After Tax

Before Tax

Net profit (A$m)

2022
2022

67m

32.7m

2022

20.9m

34.3m

Earnings
per share

Return
on equity

Quick ratio

Debt

A$
0.62

19%

7:1

Nil

Key indicators of high performance

2023
2023

83m

2017

3.1m

2018

3.5m

2019

5.2m

28.6m

42.9m

62.3m

2020

9.5m

81.5m

2021

9.8m

108.6m

2022

18.4m

143.9m

37.4m

Assets

Liabilities

Assets & liabilities (A$m)

The balance sheet strengthened again in FY2023, with an increase of 31% in net assets.

Dividend
per share

A$
0.05

2023

29.1m

193.7m

2023
30.6m

45.6m

2017

2018

2019

2020

2021

2022

2023

36.2

54.3

23.8

66.7

82.7

121.5

156.8

Cash & cash equivalents (A$m)

Profits increased before and after tax by 33% (to A$45.6 million) and 47% (to A$30.6 million).
The seventh consecutive annual profit is the highest achieved to date.

A solid rise of 29% in cash reserves to A$157 million, further consolidating the capacity to self‑finance the
Group’s initiatives.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT
LETTER FROM THE CHAIR
CLINUVEL is staying the course to diversify the
business with self‑reliance and determination in
the face of ‘stormy conditions’.

"The financial result for
the year is excellent, with
continued growth of revenues,
net cash flow, and profit."

Dear Shareholders

Charting the Course

At times that the Company is performing, one can only be
proud to Chair the CLINUVEL Group as it continues to navigate a
pre-planned strategic course with full commitment from all teams.
A difficult operating environment continued to challenge most
life science companies during the past year, and it is possible that
we will face more ‘stormy conditions’. Inflation remained higher
than the range targeted by monetary authorities, seeing interest
rates increase with a consequent impact on the pace of economic
growth around the world. Ongoing global tensions contributed to
uncertainty in the markets, as securing timely supply remained
challenging.

Governance of the Board

The Board governs the adherence of the Group to its defined
strategy and, as intimated above, we are very satisfied with pro-
gress. The Board is also accountable to ensure CLINUVEL exhibits
responsible and ethical conduct in the pursuit of its wide ranging
activities. As Chair, I provide keen support to CLINUVEL’s Envi-
ronmental, Social and Governance (ESG) agenda and can report
that we maintained positive metrics and advanced key initiatives
in this area during the year. Whilst this is detailed in a feature on
this report, I can highlight:

• the ongoing safety profile of our products remains positive;
• no breaches of the Group’s code of conduct or

whistleblower reports;

• maintenance of peer leadership on multiple measures of

diversity; and

Expansion Strategy Achieving Results

• initiation of a new process to assess the adherence of key

CLINUVEL entered a phase of expansion – growing the distri-
bution of SCENESSE® for EPP patients, expanding a melanocor-
tin product portfolio, expanding a clinical program, and carefully
treading the field of PhotoCosmetics. By doing so, we launched a
rare initiative amongst pharmaceutical companies. We are trans-
forming the business to a diverse pharmaceutical with multiple
products for a range of patient and general population needs. This
strategy is an exciting one and it is unfolding in front of us.

The year has been marked by advances in the development of
new products, particularly PRÉNUMBRA® Instant, which is first
being evaluated in the second clinical study in arterial ischaemic
stroke, and the pilot launch in March 2023 of CYACÊLLE, the
Group’s first PhotoCosmetic product. Given the relevance of the
DNA Repair program to people with a deficiency in their natural
skin repair processes, I was pleased to see the initial results in
xeroderma pigmentosum, showing a reduction in key markers of
photodamage; these were presented by expert opinion leaders at
the 2023 American Academy of Dermatology Meeting.

The financial result for the year is excellent, with continued
growth of revenues, net cash flow, and profit. The diligence and
work by Mr Keamy and the finance team in the management and
support of controlled fiscal operations should be acknowledged
and received with appreciation. It is also my pleasure as Chair of
the Board to declare the sixth consecutive annual dividend provid-
ing returns to shareholders. In parallel, we continue to increase
our financial position, enabling us to pursue long-term plans for
the business while shielding the Company from short-term tumult.

suppliers to responsible ESG conduct.

Management

CLINUVEL distinguishes itself by an executive management
team that has developed together over a long period. It is tes-
tament to Dr Wolgen’s leadership that the core
team of executives has been kept in place for
more than a decade and a half, while he
has overseen the executive expansion to
nine, with more to come. Each executive
manager is allocated specific responsibil-
ities which collectively embrace all activi-
ties of the Group. I regard the benefit of
the growing tenure of the members of the
Board in a similar way. The Directors’
intimate knowledge of the Group’s
activities and joint view on building
the Group for the future gives us the
backbone of success.

Despite

intense competition
for talent, we have been able to
build out our team across several
global offices in the UK, Europe,
USA, Singapore, and Australia.
We offer a balanced mix of
remuneration and workforce
conditions to prevailing candi-

dates. We have found that talented people are interested in play-
ing a role in the fulfilment of CLINUVEL’s mission and developing
their careers in ways not readily available in other larger organisa-
tions. I witness a focused, motivated, and well co-ordinated team,
notwithstanding the fast growth.

Executive Remuneration

I specifically want to mention that the Board is acutely aware
that executive agreements with Mr Keamy and Dr Wolgen expire on
30 June 2024 and 2025, respectively. The executive remuneration
outlined in this report is designed to hold and incentivise executives
to this term.

With regard to retaining all executives, a new performance rights
plan is due at the end of a four-year cycle and seen as essential. The
Board is conscious of the need to search globally to secure a new
CEO post 30 June 2025 and wishes to assure shareholders that we
and Dr Wolgen are committed to an orderly and thorough transition
to a new CEO in the 2026 financial year, such that no disruption will
take place.

Our view is that it would be a real loss to the business if both
executives would leave before the Group would have achieved its
diversification plan of multiple products, markets, and communica-
tion strategies; therefore, I am spending much time seeking wider
consultation on what is best for CLINUVEL to take away any uncer-
tainty our existing and new shareholders may have on succession.

Outlook

improved conditions will benefit CLINUVEL’s continued advance
of key initiatives underway. The positive plans for 2024 and
beyond are outlined in this report and contribute collectively to
the ongoing transformation of the Group. The effective and wider
communication of CLINUVEL’s story and trajectory is the mission
of the Communications, Branding & Marketing team, as well as
Investor Relations.

Appreciation

I am conscious of the support from fellow shareholders. I hope
the dividend you will receive in September 2023 is welcomed in
this spirit. As a shareholder, I take encouragement from the rise
of 20% in the Company’s share price over the year, and over 60%
in the five years, to 30 June 2023. I remain optimistic that the
foundations of incremental value will ultimately be reflected in
the share price.

I wish to also thank all stakeholders for their support. I espe-
cially want to comment on our patients: your response to our
treatments is the sole reason we continue to operate, while your
support is a driving motivation for the CLINUVEL team. The past
year, we demonstrated that our commitment to ensure uninter-
rupted treatment is firm and unwavering.

Finally, I thank members of the Board for their support dur-
ing the year, and the management and entire CLINUVEL team for
their diligence and achievements.

I wish you all well as we continue navigate towards 2024 and

beyond to achieve our objectives.

Comment is due first on the operating environment and then
on the Group’s initiatives. We look at markets exhibiting increas-
ingly positive sentiments as the rate of inflation and interest rates
abate, and the pace of economic growth starts to improve. The

Willem Blijdorp
Chair
CLINUVEL Group

CORPORATE GOVERNANCE
CLINUVEL Pharmaceuticals Ltd and its Board are committed to establishing and achieving the highest standards of corporate governance.
The Company’s Corporate Governance Statement for the year ending 30 June 2023, based on the Australian Securities Exchange Corpo-
rate Governance Council’s (ASXCGC) Corporate Governance Principles and Recommendations, 4th Edition, can be found on our website at
https://www.clinuvel.com/people/#corporate-governance.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT
VISION
Delivering innovative
solutions for unmet patient
and healthcare needs.

MISSION

The CLINUVEL Group works to translate scientific
concepts and breakthroughs into commercial products
to prevent or treat acute and chronic medical
conditions where no alternatives exist.

We are determined in our desire to excel in scientific
research and development, building on our global
expertise to deliver longitudinal care and novel
products for patients and consumers.

The CLINUVEL Group puts its People and Environment
as central to the Group’s working practise. CLINUVEL
focuses its research and development on healthcare
problems not yet addressed, aiming to deliver
innovative medical and healthcare solutions.

E C H NOLOGY

E & ENVIRON

PEO P

A P P ROACH

VALUES
The CLINUVEL Group pledges to adhere to a principal
GEBUILD I N G
set of values which reflect how we operate and interact
with each other while expanding our business.

ECT&APP R E C I A

TIO N

H ARIN

People & Environment

Knowledge Building & Sharing

Respect & Appreciation

We work for those who have no alter-
natives: patients, physicians, and indi-
viduals at-risk. We are selective of with
whom we work, and invest time in the
talent we employ. We aspire to create an
environment where professionals are able
to develop and grow. We aim to present
skilled talent with early opportunities,
responsibilities, and accountability as part
of training the next generation. We strive
to build international teams and operate
on the basis of gender and ethnic equality.
We wish to set an example of excellence in
our industry.

Our expertise spans the fields of optical
physics, the interaction of light and human
biology, and the potential of melanocor-
tin drugs in acute care and life-threaten-
ing conditions. We specialise in skin and
brain disorders. We are proficient in our
understanding of acute, rare, and com-
plex disorders. We advance our ideas and
concepts and translate them into effective
and practical solutions. We aim to grow
our knowhow continuously and estab-
lish a learned community. Collaboratively
we seek to excel in a multifaceted field to
arrive at scientific breakthroughs.

We are conscious of the privilege to be
productive during our professional lives.
We appreciate the significance of being
able to function in good health and we
value this gift every day. We aim to be sin-
cere in our approach and represent data
and facts. We act respectfully and do not
harm others. We value our colleagues and
co-workers and cherish diversity, equality,
respect and harmony. We are passionate
towards our objectives and share empa-
thy and compassion for all those we work
to serve.

Approach

We aim to be innovative in our approach
and find solutions for unique, complex and
previously neglected healthcare problems.
We are determined to remain leaders in
our fields of expertise and be creative
and diligent in our endeavours. We admit
errors, recognise our shortfalls, evalu-
ate, analyse and learn to implement new
findings. In improving ourselves we strive
to enhance the lives and quality of life of
those we serve. We aim not to become
complacent and recognise that success
can only come from the identification and
mastering of obstacles. Our staff embrace
optimism and retain focus.

Technology

We create, develop, advance, and offer
pharmaceutical and healthcare products
which are driven by medical need, con-
sumer demand, and a lack of available solu-
tions. Our technologies aim to add value
beyond existing offerings. We acknowledge
that new technologies require regulatory
environments to be primed and markets
to be prepared for achieving widespread
acceptance and adoption.

E & ENVIRON

PEO P

LOGY

O
N
H
C
E
T

R
E

PRECIATI O N

A
C
H

G
N

R
A
H
S
&

U IL DING

NOWLED G E

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORTCLINUVEL'S
ESG PRACTICES
CLINUVEL is committed to an annual
statement of its Environmental, Social,
and Governance (ESG) practices. In order
to provide all stakeholders insights as to the
Company’s approach to and management of
ESG issues, this feature covers:

• the Company’s ESG framework;
• performance against a range of ESG
measures, particularly in the social
and governance fields; and

• a new initiative to assess the ESG

practices of key suppliers.

FRAMEWORK

ENVIRONMENTAL
Conscious of our World

SOCIAL
Fairness and Equity

GOVERNANCE
Responsibility and Compliance

Recognise climate change
Energy management
Safe and responsible materials handling
No adverse impact on global objectives
Supplier standards

Human rights
Freedom of association
Equal opportunity
Value diversity
Work-life balance
Training and education
Supplier standards

Honesty and integrity
Corporate governance
Compliance
Ethics
Supplier standards

CLINUVEL VALUES

CLINUVEL is a responsible adherent to the United Nations
(UN) tenets on ESG practices. The UN’s ten universal principles
guide our approach to ESG in the areas of human rights, labour
standards, environmental responsibility, and anti‑corruption1.
CLINUVEL’s ESG framework is detailed above, noting the key
focus in each of the ESG fields are underpinned by CLINUVEL’s
values, as detailed on page 13.

Environment

CLINUVEL is conscious of the impact of the activities of
humanity on the environment and takes a responsible approach
to managing its impact on the environment. CLINUVEL embraces
the UN definition of sustainability to meet the needs of the pres-
ent without compromising the ability of future generations to
meet their own needs.

Currently, CLINUVEL’s activities are conducted by a work-
force of less than 100 and does not manufacture its products.
The direct impact of CLINUVEL’s activities on the environment is
therefore assessed as low. Reflecting this, CLINUVEL’s focus is on
qualitative initiatives to manage its impact on the environment.
Management is accountable to ensure environmental responsi-
bility across all activities and specifically:

• handling and storage of materials and products;
• sourcing of key inputs and products from contract

manufacturers who adhere to World Health Organization
(WHO) Good Laboratory Practice (GLP) and the principles

of current Good Manufacturing Practice (cGMP), and
responsible ESG practices in general;

• conservation of resource and energy use in each of

our offices;

• minimisation and management of waste, particularly
in our Singapore based Research, Development &
Innovation Centre; and

• responsible product packaging.
With regard to product packaging, CLINUVEL adheres to the
environmental standards expected of cosmetic products in the
European countries of initial distribution of CYACÊLLE. In France,
for example, CLINUVEL is a member of CITEO which adheres to
the principle of Extended Producer Responsibility for household
paper and packaging to minimise the waste products produce. A
positive start has been made as the primary and secondary prod-
uct packaging of CYACÊLLE is glass and carton, respectively, and
only the cap is made of plastic.

In addition to these initiatives, a split home / office working
week in most locations serves to minimise the carbon footprint
of employees. Whilst we are now travelling more frequently to see
stakeholders in person, responsibility is vested in senior manage-
ment to review and approve travel within countries of operation and
internationally, to ensure sufficient tangible benefits are realised.

Quantitative measures or metricated targets are not set at this
time but will be assessed and introduced as the scale and size of
the business increases in the future. Given its low environmental

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORTYear Ended June

2020

2021

2022

2023

Up to 2 years

+2 and up to 5 years

+5 and up to 10 years

Over 10 years

Employee tenure (% of total employees)

Growth in employees
(% change year on year)
impact, CLINUVEL has received support for this approach from
a range of investors, including those institutions with an ESG
focus. We are aware of plans for mandatory climate-related finan-
cial disclosure requirements by companies in Australia. If imple-
mented, they would be phased-in from 2024/25 to 2027/28 based
on three groupings of companies meeting different reporting
thresholds (two out of three measures of size of employees, assets
and revenues)2.

Social

CLINUVEL has no adverse impact on UN social objectives.
Its key social contribution is the development and distribution of
products for unmet patient and healthcare needs. The paramount
focus of CLINUVEL in terms of social responsibility is on the
safety of its products and the wellbeing of patients and personnel.
We ensure our products are safe for human use through thor-
ough research and the minimum non-clinical and clinical studies
necessary to ensure safety of our products and obtain regulatory
approvals of pharmaceutical products in respective jurisdictions.
CLINUVEL is committed to the OECD Replacement Reduction
and Refinement Principles for non-human studies and ensure all
studies undertaken are responsibly designed and conducted by
laboratories certified by internationally recognised and respected
bodies. We use ethics committees for study approval, adhere to
OECD Testing Guidelines and the principles of GLP.

We ensure the manufacture of goods and distribution of
materials and products are undertaken responsibly and ethically.
CLINUVEL works with key suppliers that adhere to global regula-
tory standards (including GLP and GMP) to ensure the quality of
its products.

Afamelanotide, the active pharmaceutical ingredient in SCE-
NESSE®, the Company’s first therapeutic, has a positive safety
record from over 14,500 administrations over more than one and

16
a half decades. A rigorous pharmacovigilance program is also
maintained and reported to global regulatory authorities to con-
firm the real-world experience treating adult erythropoietic pro-
toporphyria (EPP) patients with SCENESSE®.

CLINUVEL respects the human rights of employees and free-
dom of association and exceeds the minimum labour standards
expected of an employer. The Company’s focus is to provide
employees with

1) a safe, positive, and flexible working environment to

support wellbeing, active interaction and productivity, and

2) competitive performance-based remuneration and

employment benefits that enable financial independence
and acceptable living standards. In addition, CLINUVEL
provides the opportunity for positive career development,
ensuring succession planning rewards performance and
endeavour.

Reflecting the safe working environment provided, there was
one minor injury and no time lost from workplace accidents in
FY2023 (Nil in FY2022).

CLINUVEL has been able to attract new employees in a com-
petitive market for talented people to support its growth and
expansion. The number of employees has increased by 95% over
the past four years. Reflecting the growth in employees, the pro-
portion of employees with tenure of less than 2 and 5 years has
averaged around 60% and 25%, respectively, over the past two
years, with most of the remainder of employees being with the
Company for more than 10 years.

CLINUVEL is committed to equality of opportunity which
applies to all human beings regardless of gender and gender
identification, sexual orientation, race and ethnicity, religion
and beliefs, disability, age, and socio-economic status and back-
ground. CLINUVEL’s commitment to, and track record in, treat-
ing all employees with equality extends to its interactions with

external stakeholders. Diversity in the workforce is a key indicator
of an equitable and fair approach to employees. Diversity is mon-
itored by the Board and is a key performance responsibility of the
Managing Director. CLINUVEL takes pride in its leadership on
diversity which is represented in gender, age, nationality, and use
of languages.

CLINUVEL recruits new employees from as diverse a pool of
candidates as possible and has been able to maintain its diversity
as it grows and expands.

The Company’s leadership in gender diversity is clear with:
• the 43% female quotient of the Board of Directors

exceeding the Australian Securities Exchange (ASX)
minimum expectation of women at Board level of 30%
(applicable to all listed companies in the ASX300 Index);

• the majority of the top seven salaried employees (excluding
the Chief Executive Officer) are females, exceeding the 40%
minimum expected by the ASX; and

• nearly two-thirds of all employees are females.
Multiple nationalities and linguistic abilities underly CLINUV-
EL’s diversity beyond gender. The age composition of employees
further highlights the diversity of the CLINUVEL team across sea-
soned and younger personnel at various stages of their careers.
All are committed to develop their skills and work together in a
highly collaborative way to achieve the objectives of the Company,
noting the ongoing stewardship of the Company is provided by
Generation X and Baby Boomers and the more experienced of the
Millennial generation.

Diversity (% female/male)2020Year Ended June202120222023Board (including MD)4357435750505050All employees (including BoD)6436653562386040Number of nationalities161915Employees with more than one language (%)40545161Age composition (%)Generation z (1997–2012)Generation y (1981–1996)Generation x (1965–1980)Baby boomers (1946–1964)Top 7 salaries (excluding MD)574357435743574322CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORTSUMMARY

The Company’s ESG practices are responsible and

sound. Performance in ESG management, particularly

against key social and governance measures, has been

maintained in FY2023. The new initiative to assess

the adherence of key suppliers to ESG practices is a

significant step forward to encourage and support wider

responsibility in each of the ESG fields. The Company’s

commitment is to continue to evolve and improve ESG
practices as an integral part of its focus on continuous

improvement and in line with the Company’s growth

and expansion.

Governance

The Board endorses the Company’s ESG framework and plays
a key governance role to ensure ongoing compliance with ESG
standards. Monthly reporting of ESG issues by management to
the Board was formalised in 2022. This complemented the already
heightened appreciation of ESG issues at Board level.

As mentioned above, the Group’s values (outlined on page
13) underpin the practices of the Company and its employees and
align to key ESG tenets. CLINUVEL has several formal policies
which support its adherence to responsible ESG practices. The
Corporate Governance Protocol and the annual Corporate Govern-
ance Statement set out the code of conduct and ethics and other
policies to ensure conflicts of interest are avoided and a culture
of honesty and integrity is maintained which concords with the
expectation of responsible management of ESG issues.

To extend this point, CLINUVEL adheres to a policy of ade-
quate and correct communication within the Group, stipulating
earnest and direct interaction with its staff and management.
Human Resource policies provide guidance on conflict resolution
and communication strategies to be deployed. CLINUVEL adheres
to communication guidelines which promote open dialogue with
those who seek to interact with CLINUVEL on relevant matters of
business, and those who act fairly and openly. However, to protect
the interest of CLINUVEL and the wellbeing of its staff and man-
agement, the Group reserves its rights to prosecute to the fullest
extent permitted by law those who intend harm and disseminate
falsified and untrue statements about the Company and its officers.
A Bribery and Corruption Policy prohibits illicit behaviour, and
a Whistleblower Policy protects employees who (and who are
encouraged to) report behaviours not aligned with the high stand-
ard of ethics and honesty embodied in CLINUVEL’s values and cul-

ture. There were no breaches in the Company’s Code of Conduct
or Whistleblower reports submitted in FY2023 and up to the date
of this Annual Report. CLINUVEL adheres to Disclosure UK, a
searchable database which records annual payments and benefits
in kind made by pharmaceutical companies to doctors, nurses,
and other health professionals, as part of a Europe-wide initiative
to increase transparency in the pharmaceutical-health sector.

Assessment of Key Suppliers

Supplier standards have relevance across each ESG area. This
is explicit in CLINUVEL’s ESG framework. CLINUVEL accepts the
responsibility to understand the ESG practices of its suppliers
and to use its relationship with them to influence changes to any
behaviours and activities considered necessary to avoid under-
performance against minimum ESG standards.

CLINUVEL’s suppliers are considered responsible and active
in their practice of ESG. CLINUVEL’s practice has been to assess
this on an ongoing basis from regular interactions and reviews of
relationships. During the past financial year, CLINUVEL initiated
a project to develop a new formal process to assess the adher-
ence of our key suppliers to responsible ESG practices. The initial
focus is on the largest 25 suppliers based on their ranking in CLI-
NUVEL’s annual expenses budget. The process has been finalised
and involves scheduled annual reviews by date by management
with senior executive sign-off and provision of regular briefings
of issues to the Board, in line with the monthly reporting prac-
tice formalised in 2022. If the assessment finds areas to rectify
or improve, actions are undertaken to discuss them with the sup-
plier and resolve, with formal sign-off by senior executives. This
process is effective from 1 July 2023.

1. For details on the UN’s ten principles and approach to ESG and sustainability, access to the United Nations website and particularly refer to United Nations Global Compact (2017), Progress

Report: Business Solutions to Sustainable Development, and United Nations Global Compact (2014), Guide to Corporate Sustainable Development.

2. Per the Australian Government - Treasury - Government ESG Consultation Paper, June 2023, reporting would commence from 2024/25 for large companies meeting two of three thresholds (over
500 employees, gross assets of at least A$1 billion or revenue of at least A$500 million); from 2026/27 for a second group of companies (meeting two of three thresholds - over 250 employees,
gross assets of at least A$500 million or revenue of at least A$200 million); and from 2027/28 for a third group of companies (meeting two of three thresholds - over 100 employees, gross assets
of at least A$25 million or revenue of at least A$50 million).

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORTLETTER FROM THE
MANAGING DIRECTOR
The most successful financial year in CLINUVEL’s history
has drawn to a close, and it is apparent that our team’s
steadfast resolve to advance has not been in vain. Step
by step, we are laying the foundation for further growth,
independence, and sustainability; our key objectives.

Dear Shareholders

On Course with a Clear Growth Strategy

The business relationship with hospitals and medical centres,
our customers, is a central element that has been the constant to
the Group’s progress. The direct distribution model maintained
both in Europe and the United States continued to provide bene-
fits in terms of just-in-time distribution and consistency of supply
terms, while direct interface with healthcare customers lay the
foundation for future markets we aim to establish.

I must acknowledge the resourcefulness, tenacity, and excep-
tional efforts of our team, held together by a drive and passion
to succeed in uncertain macro environments. The past year, we
enhanced our capacity and capabilities, and realised significant
growth of personnel. The Group remained on course with a clear
growth strategy to become a specialist in the development and
use of melanocortins. The Group’s strengthened balance sheet
indicates that we are well positioned to create further longer-term
value for our shareholders.

However, most revealing has been that more patients, and
an increasing number of centres, have gained access to SCE-
NESSE®, whereby demand for ongoing treatment remained a
key parameter we monitored. We managed to train more medical
centres and healthcare providers, providing direct access to drug
to our patients, shortening travel time. Feedback from prescribers
remained excellent, both on ease of administration of the drug
product, efficacy, and safety. In working towards one clinical goal
of making medical innovation available, I wish all patients and
their families a symptom-free existence enjoying full physical and
psychological freedom.

CLINUVEL’s future is crystal clear as we are establishing a mel-
anocortin specialty group, based on a core pharmaceutical and
a branch into PhotoCosmetics, a specialised consumer market.
Our research & development spans three pharmaceutical prod-

two

formulations

(controlled-release,

ucts (SCENESSE®, PRÉNUMBRA® Instant, and NEURACTHEL®
Instant),
immediate
release) to be administered in at least five diseases, and three
product lines to consumer markets, specialising in PhotoCos-
metics (CYACÊLLE, DNA-assisted repair, MSH-response). As the
Group increases in size and functions, the aim is to make each of
the new divisions profitable on their own merits, as products and
services are added.

Financial Year 2023

At the beginning of the year, we increased

the US team, lending assistance to patients
who had difficulty in overcoming the admin-
istrative burden imposed by their insurers.
Since many erythropoietic protoporphyria
(EPP) patients frequently turn to us for help
in wading through necessary paperwork
as a requirement to obtain insurance cover
under their existing plan, our teams steer
them such that physicians in turn
are properly set-up to apply for
treatment under Prior Author-
ization. The Assistance Pro-
gram in the US has supported
US patients in gaining access
to a life-altering treatment.

Equally in Europe, we saw
a rise in patient numbers,
frequency of drug doses,
and new centres being
trained.
In both conti-
nents, and without excep-

tion, prescribers are enthused about the drug since their patients
benefit from their effective care. At each bimonthly visit, patients,
partners, and families give a detailed description of newly found
lives, of the ability to participate in daily activities which had been
unimaginable. Concurrently, from data obtained we see that the
distribution of EPP patients shows a skewness, whereby the
pool of longer-term treated patients, between 10 and 15 years,
increases year on year. I have particular sympathy for our group
of patients, who have literally lived in the dark for the majority of
their existence. Facilitating “a full life in the light” for patients is
a reward to our entire team, it is the kind of motivation to keep
doing what we set out to.

All in all, clinical expansion and increased demand led to a
better than anticipated result of 24% increase in global revenues.
Tracking annual orders for SCENESSE®, we continued to see US
prescribers placing orders during the winter months. In contrast
to the belief of payors, porphyria patients need outdoors protec-
tion all year round, as the use of the drug in real world conditions
has shown, since light source exposure (including the visible
spectrum) will trigger phototoxic reactions. Therefore, coverage
during winter months appears necessary.

Profits before tax grew by 33%, while net profits after tax by
47%, results far exceeding our expectations, and beating consen-
sus. The Group remained debt free. Net assets increased by 31%
while cash reserves rose by 29%.

In keeping with our own projections shared in 2021 of
expenses up to A$175 million over 5 years, we steadily and delib-
erately increased the rate of reinvestments year on year. For the
year, overall expenses increased by 15%, while capital expendi-
tures were made towards facilities at the Singapore RDI Centre.
Resources have been made available towards new talent, clinical
studies, drug product and research activities.

Among many new staff, I mention the addition of several
engineers, a talented medically trained manager, the Group’s

first in-house lawyer, new financial staff, a new head of scientific
affairs, scientific staff, and an assistant to investor relations in
Europe. The Group grew by 19% over the past 12 months, facing
difficult labour markets.

Under guidance of Drs Wright and Bilbao, clinical progress
was made in the XP-DNA repair program, where first human
biopsy results showed novel and promising results. We started
a variegate porphyria program, evaluating the effects of afamel-
anotide in a group of patients with a different variant of porphyria
but akin to EPP, but who suffer from high degrees of skin fragil-
ity, seen as incapacitating wounds and blisters triggered by light
exposure.

With PRÉNUMBRA® Instant, we entered the second afamel-
anotide product in clinical trials, part of deliberate life cycle man-
agement. As we obtained good results from the first clinical trial
in ischaemic stroke (CUV801), we introduced this product in a
further study (CUV803) exposing mild to moderate, and mod-
erate to severe stroke patients. Our pharmacovigilance team
reviewed the first data on safe use of the product, the prerequisite
of CLINUVEL’s ongoing success, and we are enthused by the clin-
ical reports on the patients.

The scientific team led by Chief Scientific Officer (CSO), Dr
Wright and Dr Rizzitelli progressed the manufacturing of NEU-
RACTHEL® Instant, the ACTH product, adding to our suite of
melanocortins. Under Good Manufacturing Practices, we manu-
facture NEURACTHEL® batches for use in a clinical setting.

The backstop was provided by Dr Hamila and her quality and
pharmacovigilance team, ensuring that each porphyria patient
worldwide was followed up and data captured in a global registry.
Further advancements were made in formulation develop-
ment at VALLAURIX, our Singaporean facilities, and the first pilot
batch of our test product CYACÊLLE, a polychromatic screen, was
released on 1st March. Feedback was obtained before engaging
in scaled-up commercial manufacturing of a chosen formula-

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORTtion. Aiming to serve high risk populations, we start to realise the
ambition to establish a PhotoCosmetic market.

The CBM team grew in number and quality with Mrs Arrom
Bibiloni heading the division, providing guidance on global
branding and marketing activities for the years to come. While
Investor Relations is a separate discipline, we harmonised our
communications strategy such that similar messages and news
flow to various stakeholders would be ensured; Mr Bull contin-
ued the efforts to address domestic and international investors,
joined by Mrs Hardy.

The overall responsibility of the global operations was well
handled by Mr Hay, while local operations were presided by Mrs
Colucci and Dr Teng.

The Immediate Future: 2024‑2026

Direction. Often, I am asked to provide more colour on the
future of CLINUVEL, its direction and expectations. On various
occasions, I have expressed our strategy to build a sustainable
and diversified group, containing multiple divisions and attract-
ing diverse skills, turning CLINUVEL into an independent firm.
Actually, answers as to the chosen path are found in facts and
history, while business execution is multi-pronged and planned
for the long haul. Our approach is not axiomatic, but one which
has been contemplated for more than a decade of analyses, and
one that is within the realm of possibility. It is also apparent that
CLINUVEL will be the world’s first to launch a PhotoCosmetics
product range based on melanocortins.

The prospect of building a house from the brink of bankruptcy
to the status of being able to withstand the challenges of time is
exciting; many of us see this business case unfolding as a once-
in-a-lifetime opportunity, one created out of a unique long-term
strategy. What was once a dream has gradually turned into reality.
Let’s go back to the start. Mass demand for melanocortins was
provoked from 1980 onwards, and markets started to realise the
potential to chemically activate skin pigmentation by injection.

Various attempts by venture capitalists and pharmaceutical exec-
utives failed, which led to the Company facing insolvency in 2005.
The rest is known.

Nevertheless, insistence for melanogenesis, humans’ unique
defence mechanism to solar radiation, remained high among
the widest imaginable audiences, individual and professional
investors, banks, and consumers. However, the only strategy to
exhaust a regulatory authorisation for afamelanotide – the first
systemic photoprotective drug worldwide – and create value had
been via a pharmaceutical program spanning nearly two decades
of Phase I, II and III trials. We religiously followed a plan based on
compelling technology, while preparing for the second part of the
business to unfold.

There always remained the realisation that melanocortins,
expressed both in brain and skin, actually share neuroendocrine
end targets, in simpler terms both organs showing similar cellular
responses to these hormones. Logically, our CSO, Dr Wright and
technical staff followed a course of developing melanocortins for
brain diseases (acute stoke), as well as metabolic afflictions char-
acterised by severe light intolerance, phototoxicity, such as seen
in porphyria, and depigmentation – called vitiligo.

Vision. We had long formed the vision to make melanocortins
available for broader populations, aiding the repair of DNA-skin
damage provoked by UV. Data obtained earlier in the programs
drove us to sequentially execute a complex strategy. Besides,
the use of melanocortins as a DNA protective agent had always
remained a talking point for those seeking bronzing without
UV damage. To be able to ‘close the scientific loop’, we all too
well understood that safety of melanocortins used systemically
would be the requisite for its later translation into PhotoCosmetic
products, hence our decades-long public emphasis on safety, vig-
ilance, and analyses, all pre-empting our greater plans. Regula-
tory authorities required confirmation from abundant data sets to
quell their anxiety about the safety of melanocortins. We are near-
ing the moment of silencing any longer-term concern of safety
with more than 14,500 doses of SCENESSE® administered, and

patients followed-up for 17 consecutive years.

A successful establishment of a cosmetic business within
a core pharmaceutical one is unconventional, but in our case
makes much sense to progress. Therefore, as a first step, we
explored and engaged marketing consultants, advertising agen-
cies, branding and creative professionals, marketers and came to
the conclusion that the unique PhotoCosmetic products would
be better served by an in-house team of professionals coming
from the luxury goods sector, as well as experts in digital analyt-
ics. In 2021, we started to form the Communications, Branding
& Marketing (CBM) team in anticipation of the launch of Photo-
Cosmetics. In the year past, we attracted our preferred head of
creative, professionals in digital marketing, branding, and social
media managers, as well commercial and marketing specialists
with a background in cosmetics.

XP‑DNA damage repair and skin cancer prevention. It is
beyond question that from all factors contributing to skin cancers
and melanoma, solar radiation is a dominant one. The absence
of photodamage will seldom lead to any of the dermal cancers,
hence our mission to innovate in this area. Melanocortins have
long been shown to optimise the cellular signals needed to effec-
tively protect against UV-radiation, and enhancing these signals
gave us the ability to commercially launch the first melanocortin
afamelanotide as a systemic photoprotectant.

The unravelling of the puzzle came as it was discovered that
enhancement of cellular signalling in skin tissues led to assis-
tance in DNA reparative processes following UV radiation. To
effectively protect against solar damage, effective processes are
needed to mobilise complementation factors to recognise, excise
and replace DNA-damaged fragments. Melanocortins assist in
these processes, and our clinical studies in xeroderma pigmento-
sum and healthy controls aim to demonstrate the magnitude of
the role of these peptides.

problematic in the highest risk populations, XP patients, who
develop multiple skin cancers per year due to the lack of DNA-re-
parative processes.

Our teams are evaluating the extent of benefit melanocortins
provide to these XP patients, the percentage reduction of CPDs.
In the past year, we shared the first results of CUV156, and most
recently from CUV151 in healthy volunteers.

Vitiligo. The North American and European market for vitiligo
opened-up with the introduction of the first topical drug in July
2022, while US Food and Drug Administration (FDA) had made
a u-turn change in its views in March 2021. Since then, we have
answered the FDA’s request to conduct a small trial using afamel-
anotide as monotherapy (CUV104), while we prepare a larger viti-
ligo trial using the optimum combination of narrowband UVB and
afamelanotide. We had already shown the supremacy of the com-
bination therapy in 2014 (CUV102) and it had always been clear
that this combination would provide pigment thrust for thrust for
those who had lost skin colour. It has taken years of debate with
regulatory authorities for their representatives to understand the
effect of vitiligo on patients with darker skin complexion, and after
they had come around the necessity to prioritise these patients,
CLINUVEL’s pathway unfolded. The CUV105 trial will be the larg-
est held with 150 vitiligo patients to be recruited.

Brain disorders. A further arm of our pharmaceutical pro-
gram is the use of melanocortins in brain disorders. Since these
hormones are expressed both in skin and brain, the function of
melanocortins in neuroprotection is one long described by vari-
ous research groups, spanning decades. Our first neuro-program
targets an unaddressed population of stroke patients, those who
are ineligible to receive clot dissolution and clot removal therapy.
The results from study CUV801 were published during the past
12 months. These results provided the signal to advance the pro-
gram to CUV803, currently ongoing.

The origin of photodamage is found in the formation of chem-
ical bonds distorting DNA strands, and replication of defective
nucleotides increases the risk of skin cancers. This is even more

For diversification of the stroke program, we developed a
second afamelanotide formulation in PRÉNUMBRA® Instant,
giving physicians the option to increase acute doses. The results

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORTof CUV803 will ultimately determine the design of a larger ran-
domised clinical trial in stroke. The ability to assist patients who
suffered a stroke is a privilege and summarises our quest to
develop novel solutions.

PhotoCosmetics. The ability to translate pharmaceutical tech-
nologies to consumer products is in itself a rare opportunity, but
one that beckons from the specialty in melanocortins. Peptide
technology enables one to enter galenic research to arrive at user-
friendly products. However, many obstacles lay ahead to even
contemplate entry into consumer markets. The main one was
human safety of melanocortins. Here, we left no stone unturned,
and comprehensive analyses from 14,500 doses of SCENESSE®,
and longer-term monitoring of patients gave us the comfort in
2021 that regulatory authorities would no longer be able to object
to wider use. Since then, we have focused on the advancement of
the product lines containing melanocortins serving populations
in highest need of skin repair and protection.

With the two M-lines, we expect to change the way we think
and speak about solar damage, regeneration, and DNA-assisted
repair. We also intend to rewrite the notion of MSH-response
following UV exposure, as melanocortin-containing formulations
aim to accelerate the bronzing effect, melanisation of the skin to
reduce and prevent solar damage. In essence, we are closing the
circle, we are delivering on an expectation that came with the birth
of melanocortins, as these had first been introduced in 1980.

The circle came in three parts. Our pharmaceutical programs
in photo-induced diseases, patients characterised by absolute
light-intolerance, such as porphyria (EPP), showed the ability to
provide photoprotection. Second, clinical trials in XP and healthy
controls gave the scope to show reduction in photoproducts,

cyclobutane pyrimidine dimers (CPDs). Last, the vitiligo trials
(depigmentation), demonstrated our ability to use melanocort-
ins to repigment skin when exposed to UV-radiation. This triptych
is being translated in parallel in three PhotoCosmetic lines, one
P-line and two M-lines. The P-line offers new products providing
polychromatic (multiple wavelengths) protection under extreme
conditions, while the M-Lines contain the melanocortins. The
pilot launch of CYACÊLLE started on 1st March this year.

As far as our research has uncovered, there is no other pharma-
ceutical company which has endeavoured to translate its pharma-
ceutical programs from core technology into consumer focused
products. However, being first and novel has never daunted our
teams, someone has to do it. For this, we need a professional
team solely focussed on preparing global digital campaigns to
give visibility to our cause, preventing photodamage and skin
cancers in using melanocortins and thorough education.

Future expansion. The near-term goals are to advance man-
ufacturing of NEURACTHEL® Instant, complete the marketing
programs for PhotoCosmetics, and expand through an acqui-
sition. In the short-term, we will initiate manufacturing plans,
bringing in-house capacity to manufacture the next generation of
products. We aim for all our divisions, pharmaceuticals, health-
care solutions, and manufacturing to become profitable in time.
For this to occur, during the next period we will further invest in
R&D facilities, new formulation development at scale, and capital
equipment such that our research efforts be accelerated.

Summary

The clock is running to complete an ambitious program, since
I wish to see through the launch of several products before the

end of my engagement with CLINUVEL in 2025. My immediate
goals are aligned with the rest of our staff, and these are defined
as launching two new pharmaceuticals PRÉNUMBRA® Instant,
NEURACTHEL® Instant and a PhotoCosmetic range of three
product lines. Thereby, our Board’s objectives are to establish a
strong, independent group versed in many disciplines, and one
standing out in its management of personnel and intercompany
culture.

I place most emphasis on the true assets of this Group,
its people and therefore the longer-term careers we can offer.
Although we are doing well in this respect, it will improve to such
standards that CLINUVEL will position itself in the market as an
academy, able to outperform its peers in retention and attraction
of unique talent, and career development.

At the beginning of the calendar year, we shared our enthu-
siasm for the months ahead, and while we tend not to provide
financial guidance, there are no immediate reasons why CLINU-
VEL would not continue to grow at its current pace. In staying
with our own projections, we certainly prepare ourselves for
this by putting in place infrastructure and new systems, to spur
further growth. We plan for increase of staff in all disciplines,
back-office, finance, clinical, regulatory, investor relations, quality,
research, CBM, and business development; positions across all
functions will be added to the Group to a level of 120 over the
next 12 months.

In the next 12 months, we foresee that organic growth will be
complemented by acquisition(s) with an aim to turn these cash
neutral the first year. It is quite clear that to succeed in these ambi-

tions, we need discipline and focus across the Group. Guidelines
and policies and clear operating procedures are maintained while
we expand at high pace.

Against the ongoing successes, there are a number of busi-
ness domains we are turning our attention to, such that we can
say next year at the same time that we master not a number but
all disciplines of the decathlon.

My appreciation goes to all our physicians in Europe, Swit-
zerland, Israel and North-America for their devoted attention to
patients, and the independent analysts of CLINUVEL – Dr Stan-
ton and Mrs Thomson at Jefferies Australia, Mrs Mann at MA
Moelis Australia, Dr Benson, Dr Storey and Ms Williams at Wil-
sons Advisory, and last, but not least, the Bioshares team led by
Mark Pachacz – for their efforts and long hours of work put to
analyse CLINUVEL.

Philippe Wolgen
Managing Director
CLINUVEL Group

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORTOPERATING AND
FINANCIAL REVIEW

CLINUVEL is established to address unmet medical needs, with a particular

focus on patients with brain and skin disorders. One of the specialties of the

firm is photomedicine, serving populations at highest risk from UV and light

exposure.

The Company’s key operating activities encompass:

• the distribution of its novel pharmaceutical photoprotective

SCENESSE® (afamelanotide 16mg) for patients with
erythropoietic protoporphyria (EPP);

• the development of pharmaceutical products, including SCENESSE®,

PRÉNUMBRA® and NEURACTHEL®, and the conduct of clinical programs

for patients who require medical solutions; and

• the commercialisation of a range of PhotoCosmetic products to provide

healthcare solutions for people at highest risk of UV and light, DNA-damage

and requiring MSH-response as melanogenic (bronzing) protectant.

The review of operations details the key activities and developments

in each of these areas over the year ending 30 June 2023 (FY2023).

DISTRIBUTION
OF SCENESSE®

Only Approved Therapy for EPP

SCENESSE® is distributed for the treatment of adult EPP
patients in Europe, Switzerland, the USA, and Israel. During
the past year, access to Canadian patients was granted under a
special access program. The number of EPP patients receiving
treatment, total doses of SCENESSE®, and treatment centres
facilitating treatment all increased over the year.

In Europe, the number of EPP Expert Centres has increased,
with new centres opened in several countries, including Germany,
Italy, and Scotland. During the year, the English National Insti-
tute for Health and Care and Excellence (NICE) decided not to
recommend SCENESSE® for use on the English National Health
Service, despite NICE being twice found by its own Appeal Panel
to have breached the Equality Act and having acted unfairly in
its review of the drug. This decision has resulted in an ongoing
asymmetry of access for EPP patients in the UK, with Scottish
patients continuing to receive SCENESSE® treatment under a
patient access scheme.

April 2023 marked the third anniversary of the commence-
ment of commercial distribution of SCENESSE® for EPP patients
in the USA. CLINUVEL has established a network of over 50
Specialty Centers to facilitate patient treatment across 39 states
as of 30 June 2023. This advances CLINUVEL’s goal to reduce
the time and distance patients need to travel to receive their
bi-monthly treatment, with a network of 120 centers planned.
Over 100 national and local private insurers are reimbursing
SCENESSE®. Following the conclusion of FY2023, in July 2023,
the US Department of Veterans Affairs agreed to reimburse SCE-
NESSE®.

Canadian patients were first treated with SCENESSE® under
a Special Access Program in May 2023. CLINUVEL can supply
up to six doses of SCENESSE® per annum to adult EPP patients
through accredited Specialty Centers under insurance coverage.

Peer Reviewed Publications

During FY2023, a number of peer reviewed publications
were seen on the use of SCENESSE®. The medical publications
reported ongoing clinical benefit under real world conditions –
which was greater than that seen in clinical trials. Importantly,
during the year we saw the first analyses of the drug showing
a possible hepatoprotective effect, further investigations are
following.

Uniform Pricing

for
Uniquely, CLINUVEL maintained a uniform net price
SCENESSE® per jurisdiction, treating payors equally and in full trans-
parency.

SCENESSE® for Adolescents

CLINUVEL submitted a formal application to the European Med-
icines Agency (EMA) in September 2022 to expand the approved
indication for SCENESSE® (afamelanotide 16mg) to include the
treatment of adolescent patients aged 12-17. As part of global phar-
macovigilance, CLINUVEL has been closely monitoring the effects
of the drug in the adolescent patient population. Based on the
data received, the safety profile and clinical benefit of SCENESSE®
in these patients has been consistent with that seen in adults.
CLINUVEL continues to liaise with the EMA on the submission.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT2

PHARMACEUTICAL
PRODUCT DEVELOPMENT…

The product development pipeline is shown below:

PRINCIPLE PROGRAM

SCENESSE®

(afamelanotide 16mg) in adult EPP patients (EEA, UK, CH, USA, ISL, CAN, AUS)

SCENESSE®

(afamelanotide 16mg) in adolescent EPP patients

SCENESSE®

(afamelanotide 16mg) in adult VP patients

SCENESSE®

(afamelanotide 16mg) in XP patients / DNA repair

SCENESSE®

(afamelanotide 16mg) in vitiligo patients

PRENUMBRA®

Instant (afamelanotide) in arterial ischaemic stroke patients

MELANOCORTIN EXPANSION

CUV9900

PRECLINICAL

PHASE i

PHASE ii

PHASE iii

COMMERCIAL

Parvysmelanotide, phimelanotide

PRENUMBRA®

Modified release – to be confirmed

NEURACTHEL®

Instant – infantile spasms, mulitple sclerosis

NEURACTHEL®

Modified release – infantile spasms, mulitple sclerosis

In addition to SCENESSE®, CLINUVEL’s pipeline includes:

• PRÉNUMBRA® Instant, a liquid formulation of afamelanotide
which offers flexibility to personalise treatment and achieve
an effective clinical response. PRÉNUMBRA® has been first
used in the second clinical study in stroke (refer below),
which started in March 2023. PRÉNUMBRA® Modified
release is also under development.

• Instant and Modified release formulations of

adrenocorticotropic hormone (ACTH) under the brand
name NEURACTHEL®, with plans to develop these products
for the treatment of neurological, endocrinological,
and degenerative disorders. CLINUVEL plans to apply
NEURACTHEL® in the first instance to the treatment of
adult Multiple Sclerosis and Infantile Spasms.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT…AND CLINICAL PROGRAMS

CLINUVEL’s expertise in the role of melanocortins in the

function of the human body underpins the Company’s

expanded clinical development program. Specific

mention of each program is made below:

DNA Repair

Vitiligo

Arterial Ischaemic Stroke (AIS)

Variegate Porphyria (VP)

• Deffective DNA skin repair in >2 billion individuals.
• Initial focus on 1,000 xeroderma pigmentosum (XP) patients.
• Results CUV151 (n = 9), showed reduced skin damage,

statistically decreased UV-erythema dose response, increased
minimal erythema dose and skin pigmentation (one dose
of SCENESSE® following UV irradiation in disease free
individuals).

• Skin depigmentation disorder.
• Prevalence between 0.1-2% of global population.
• >250K darker skin type (IV-VI) patients in North America.
• Positive repigmentation in past studies CUV102 and CUV103.
• CUV104 (n = 6) underway with focus on SCENESSE® as a

monotherapy.

• CUV105 (n = 150) with combination NB-UVB and

• Initial results CUV156 (n = 6), presented to the 32nd

SCENESSE® therapy in design.

Meeting of the Photodermatology Society as part of the
2023 American Academy of Dermatology (AAD) Meeting,
showed afamelanotide reduced DNA photodamage.

• CUV152 (n = 6), ongoing.

• 15 million strokes annually, 80% ineligible for treatment.
• First study (CUV801) results (n=6) showed no safety

concerns and improved neurological function.

• Second study (CUV803) commenced March 2023 (n=12).
• Initial results of CUV803 showed improvement in three

• Light exposure causes skin fragility.
• No existing treatment.
• 3,000-4,000 patients US/EU.
• Study CUV040 (n = 6) commenced May 2023.
• SCENESSE® to reduce severity of phototoxicity

patients administered PRÉNUMBRA® Instant.

and skin disease.

• Study extended in May 2023 from patients with mild and

moderate strokes to patients with moderate-to-severe and
severe strokes.

Refer to the feature on “Plans 2024 and Beyond” on page 34 for the timelines to regulatory approval of each of these indications.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT"We raise awareness of photageing, photodamage and skin cancer.
Combat their effects with a truly new skincare category.
And will become a household name by 2026."
Marga Bibiloni, Director - Brand Strategy & Creative

CUVAs
Outdoor extreme

Immunocompromised

Skin Cancer susceptible

Jonathan Ferguson:
Through my partnership
with Clinuvel, we’re trying
to raise awareness about
skin cancer. Our team
is fuelled by passionate
outdoor athletes, skin
cancer survivors and
high risk groups with
autoimmune diseases like
me, who need to be extra
careful around the sun.
I’ve learned so much from
these ambassadors.

Jacqueline Fraser: Organ
transplantation isn’t a cure
either. It’s merely swapping
one set of medical issues
for another. Along with a
lifetime of anti rejection
medications which come
with their own side effects.
One being the increased
risk of skin cancer. There’s
a high mortality rate
around the 7 to 8 year
mark post transplant as
a result.

Paula Novotna: What is
my daily routine to protect
my skin? I try to wear
UV protective clothes to
cover my skin, and apply
sunscreen to my exposed
parts of my body.

Greta Hoeller: Living on
the oceans means we are
constantly exposed to the
sun. When @clinuveldna
reached out to ask us to be
their ambassador and raise
awareness of the damaging
effects of UV radiation
on our skin, it was a clear
yes. It gives us access to
scientific knowledge like
the Fitzpatrick skin types
to protect ourselves and all
of you from unintentionally
damaging our skin while
sailing.

CUVIPs

Kate Fitzpatrick:
Sometimes remembering
to apply sunscreen is
annoying. Sometimes
wearing long-sleeved swim
shirts is annoying. Who
wouldn’t rather be in a
cuter suit at the beach
or pool? But you know
what? Skin cancer surgery
is annoying too, to say the
least. And it only takes 21
days to develop a habit,
for better or for worse.

Matt Heywood: I’ve
learnt that there is always
more to learn, through
my relationship with sun/
light and the team @
clinuveldna, I have very
much realised that we are
only at the very start of
a journey, the individuals
that are protecting their
skin are a minority in
comparison.

Jaap van Zweden
@JaapVanZwedenOfficial
During my most recent trips I ensured that I was ade-
quately protected from the sun when exploring the city.
Working with @clinuvel_pharmaceuticals has highlighted
the importance of solar protection in order to minimise
the risk of skin cancer.

Cristina Ramos
@cristinaramos_ofc
Summer is coming and taking advantage of the fact that
May is Skin Cancer Awareness Month, I encourage you to
protect yourselves, because the sun at certain hours and
for a long time is harmful. Take care of your skin with care
to prevent diseases and its premature deterioration.

PHOTOCOSMETIC
PRODUCTS

CLINUVEL is translating its expertise and know-how in pho-
tomedicine and melanocortins,, accumulated over more than
two decades. It aims to assist the wellbeing of those at higher
risk from UV and HEV light exposure. The Company’s first Pho-
toCosmetic product line, the polychromatic screen CYACÊLLE,
was launched as part of a pilot in March 2023 in six European
countries. Second generation polychromatic screens and lines
for DNA repair and melanogenesis are under development at the
Group’s Singapore Research, Development & Innovation Centre.
The key focus in FY2023 was to complete the development and
initial limited launch of CYACÊLLE, which offers polychromatic
photoprotection to a wider range of light – incorporating UV and
HEV light – than currently provided by products in the market.
CYACÊLLE is also the Company’s second commercial product,
and it marks a milestone in the diversification of the Company’s
product range.

Prior to the initial pilot launch of CYACÊLLE on 1 March 2023,
the focus of the Communications, Branding & Marketing Division
(CBM) Division to raise awareness of the need for photprotec-
tion. The CBM team started campaigns through digital market-
ing, reaching new audiences. CLINUVEL Ambassadors (CUVAs)
were identified and engaged to progressively build awareness of
the need for photoprotection. CUVAs are leading and influential
individuals from each of the target audiences – fair skinned indi-
viduals with a history of skin cancer in their family, immunocom-
promised organ transplant patients, and people exposed under
extreme outdoors conditions due to their profession or recrea-
tional pursuits.

Two Intriguing Personalities (CUVIPs) were first engaged dur-
ing the year, as they shared common audiences. The two CUVIPS
aimed to first time raise CLINUVEL’s mission and story.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT2017

2018

2019

2020

2021

2022

2023

12/5/0.5

21/4/1

27/5/1

25/6/1

43/5/0.5

Commercial Sales

Special Access Scheme Reimbursements

Other Income

60/6/1

Growing revenues since initial launch (A$m)

72/6/5

The year saw the Group increasing the number of specialist
treatment centres to facilitate higher patient access and further
engagement with existing centres delivering a significant 19%
reported increase in revenue.

The compound annual growth rate in revenues from time of
first product launch in 2016 is 42%, clearly demonstrating the
sustained demand for the SCENESSE® implant over the long
term. On a constant currency basis, total revenues increased
13.75%. A weaker Australian dollar resulted in a $3.562 million
positive impact to the reported Total Revenue result for the year.

Total revenues include the initial pilot launch in March 2023
of CYACÊLLE, the Group’s first over-the-counter PhotoCosmetic
product. Distributed firstly free-of-charge, through hospitals
to patients suffering from EPP and XP1 as an adjuvant to SCE-
NESSE®, and secondly, through a dedicated e-commerce plat-
form to targeted audiences in six European countries. Sales from
the initial pilot launch was $0.009m.

US Revenues have grown through greater patient outreach
from expansion of the number of new treatment centers able to
administer SCENESSE® now exceeding 50 in number. Improved
geographic dispersion of centres is facilitating higher sales
orders. European orders have remained robust, reflecting ongo-
ing patient demand and more timely ordering earlier in the year
having a positive impact to current year revenues.

Expenditures increased to drive R&D pipeline
development, new product development; Net
operating profit continues to grow

Net profit after tax of $30.6 million (FY2022: $20.9 million)
reflects the performance of the Group in executing its objective to
provide its novel key pharmaceutical product in an underserved
market.

Adjusted for various non-cash and unrealised items, the
non-International Financial Reporting Standard ("non-IFRS")
financial metric of adjusted net profit after tax was $37.8 million
(FY2022 $27.9 million) – refer to the reconciliation of statutory
net profit after tax with adjusted net profit after tax on page 53.

Return on sales improved during the year to 58% in FY2023
(52% in FY2022) reflecting an improved rate of profitability. The
stronger financial performance has been achieved despite the
Group increasing expenditures to expand its product develop-
ment and clinical pipeline.

Internal resource capacity has been boosted to provide the
platform to support entering new markets with new products and
to prepare for future operational expansion.

The Group is now three years into its five-year business expan-
sion plan where it anticipated to commit to re-invest in its activ-
ities and to spend $175.0 million over the five years to 30 June
2025. The Total Expense result for the Group for FY2023 of $37.4

Total revenues, including interest and
other income increased by 24% in FY2023
to $83.0 million.

The growth in cash balances held
throughout FY2023 were complemented
by an increasing interest rate yield earned
on holding interest bearing term deposits
consistently throughout the year, averag-
ing 268 basis points higher year-on-year,
resulting in a robust increase in interest
received from funds held in bank accounts
and term deposits from $0.44 million in
FY2022 to $3.90 million in FY2023.

Commercial Sales,
incl. OTC

SAS Reimbursements,
Switzerland and Other

FY2023 Reported

FY2023 Constant*

FY2022 Reported

% change (Constant)

72.179

69.027

60.002

15.04%

Total

A$ million

78.321

74.759

65.722

6.142

5.732

5.720

0.21%

13.75%

% change (Reported)

20.29%

7.38%

19.17%

*FY2023 revenues converted to A$ monthly at the average conversion rate of the same month of FY2022

FINANCIAL REVIEW
The highlights of the Group’s financial result for the
12 months ended 30 June 2023 are summarised below:

Consolidated Entity

A$ million

Total Revenues, Interest and Other Income

$82.990

Total Expenses

Net Profit before income tax

Profit after income tax expense

Cash and Cash Equivalents

Basic Earnings per Share

Net Tangible Assets backing per Share

Dividend distribution per Share

$37.412

$45.579

$30.605

$156.814

$0.62

$3.29

$0.05

Change

Up 24%

Up 15%

Up 33%

Up 47%

Up 29%

Up 46%

Up 31%

Up 25%

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT
million is a 15% increase to FY2022’s total expense result of $32.7
million and is aligned with the anticipated financial commitments
of the five-year plan – (refer to Plans 2024 and Beyond on page
36 for more detail).

Key expenditure items:

Personnel-related expenses were $13.58 million (FY2022: $11.59
million). Average headcount was 7% higher than last year, new roles
created in Quality Assurance, in supply chain management and to
bolster the newly formed Communications, Branding and Market-
ing division with the goal to drive the continued expansion of the
business. Increases in remuneration rates were implemented to
maintain market competitiveness, reflected in the employee turno-
ver rate improving by 13% compared to FY2022.

Materials and related expenses were $12.06 million (FY2022:
$5.40 million). In FY2023 a series of manufacturing campaigns were
undertaken with the Group’s contract manufacturer of the SCE-
NESSE® implant to meet imminent clinical, and term commercial
demand, resulting in a significant investment in associated mate-
rials. Investment in the development and manufacture of product
formulations by the Healthcare Solutions Division, in the expanded
formulation development programs targeting NEURACTHEL® and
PRÉNUMBRA® Instant, along with supplies and materials for the
Singapore RDI Centre to progress their development of other for-
mulations, were incurred to ensure the Group continued its path of
becoming the global melanocortin leader.

Increases across commercial distribution, finance and admin-
istration, legal and insurance, and Communications, Branding &
Marketing (CBM) were incurred in FY2023:

1) Commercial distribution expenses were $3.15 million

(FY2022: $2.49 million)

2) Legal, Insurance and IP expenses were $1.32 million

(FY2022: $1.15 million)

3) Finance, Corporate and General expenses were $3.19

million (FY2022: $2.27 million)

4) CBM expenses were $0.75 million (FY2022: $0.29 million)
The Group saw the cost of several essential activities increase
throughout FY2023 as the business pursues its growth objectives.
It experienced increased regulatory interaction connected to dos-
sier changes and regulatory audits and inspections of systems
including the use of external assistance to support these activi-
ties. There was increased freight, manufacturing royalties, prod-
uct handling and distribution of product from higher volumes to
support commercial sales and special access arrangements.

Lower insurance costs from risk protection were offset legal

assistance to address several matters throughout FY2023, includ-
ing the Group’s responses to various pricing negotiations in the
UK, and Europe, as well as the protracted legal proceedings sur-
rounding the breach by University of Muenster filing patent appli-
cations on technology and knowledge proprietary to the Group.
The impact of heightened international staff travel across the
Group, higher professional services fees, and a first-time recog-
nition for expected credit losses arising from the US commercial
distribution market, were all important factors during FY2023.

The Group has invested in resources to expand its visibility
and to engage with new audiences and some of these activities
included developing promotional content for the PhotoCosmetic
product lines, engaging with selected ambassadors to build
awareness for the need for photoprotection across digital market-
ing channels and conducting roadshow presentations and inves-
tor soirées to select stakeholders.

The non-cash accounting charge for share-based payments
was $8.99 million (FY2022: $6.12 million). Performance rights are
an effective tool in promoting employee retention and to encour-
age participants be aligned with the interests of the owners of the
Group. In early FY2022, the Group issued 743,174 unlisted perfor-
mance rights to staff of the CLINUVEL group of companies and
at the end of FY2023 a further 255,750 unlisted performance rights
were issued to staff. The FY2023 result reflects:

• the first full year of expensing of the FY2022 issue of

performance rights, and

• reassessing the probability of achieving certain non-market

conditions for performance rights held by certain staff
previously considered unlikely to be met as the vesting
date draws nearer.

Clinical and non-clinical development fees were $1.27 mil-
lion (FY2022: $1.23 million). The deliberate increase reflects the
Group’s strategy to advance its research and development initia-
tives into new products and new formulations as well as expand-
ing the use of afamelanotide using new and existing formulations
as a potentially new therapy for indications beyond EPP. Expense
towards the DNA Repair program, investigating afamelanotide as
a potential first-line therapy for XP, and the vitiligo program to
evaluate the safety and efficacy of afamelanotide as a monother-
apy in vitiligo patients with darker skin complexions (CUV104),
were largely offset by temporary reductions in the cost of pre-clin-
ical studies to support the Group’s strategic focus to develop new
and alternative formulations and in regulatory-related fees to pre-
pare dossier applications for review in new jurisdictions that was
incurred in FY2022.

47%
Cash Held

420%

Inventories

37%

Trade
Receivables

133%

Trade
Payables

121%
Income Tax
Payables

No Equity Raised
Since 2016

No Debt Financing

Balance Sheet Highlights

Income tax expense was $14.97 million (FY2022: $13.44 mil-
lion) reflecting the impact on corporate taxes from the growth in
taxable profit year-on-year. The result was aided by movements
in the deferred tax position of the Australian business along with
benefits received from utilising unused tax losses.

Significant growth in cash balance, maintained
consistent annual spend in operating activities

Cash and cash equivalents of $156.81 million as at June 2023
(FY2022: $121.51 million), the 29% growth in cash held exclusively
generated from operations and without reliance on debt or equity
financing activities.

Operating cash inflows primarily consisted of receipts from
the global distribution of SCENESSE® under relevant mar-
ket authorisations and access arrangements of $74.88 million
(FY2022: $66.4 million). Cash inflows also comprise $2.73 million
from interest earned on cash held, reflecting higher yields earned
from higher cash deposits throughout the financial year.

Operating cash outflows included payments to suppliers and
employees of $33.23 million (FY2022: $27.35 million) and taxes
paid of $7.74 million (FY2022: $Nil).

Net cash used in investing activities was $1.03 million to
strengthen the infrastructure of the Group’s Singapore RDI Cen-
tre to develop novel PhotoCosmetic and pharmaceutical formu-
lations.

Dividends distributed to shareholders during FY2023 was
$1.98 million, an increase in dividends per share from $0.025
on FY2021 earnings to $0.04 on FY2022 earnings, reflecting the
commitment of the Company to return value to shareholders.

Highly liquid balance sheet, free of debt financing

A key objective of the Group is to ensure a financially strong
Balance Sheet, allowing the optionality for future re- investing in
the business and/or to acquire new assets and businesses to be
absorbed within the Group. Additionally, a robust Balance Sheet
with liquid assets provides a financial buffer to withstand unex-
pected adverse events. The Company has been successful to both
grow and preserve its cash and cash equivalents without need-
ing to seek further funding, and in doing so diluting shareholder
returns, nor has it raised debt capital.

The increasing financial strength of the Group is reflected in
the growth of its net assets to $164.6 million (FY2022: $125.56
million). The Company continues to hold no long-term debt. The
ratio of the Company’s overall debt to equity increased to 18%
(FY2022: 15%).

Trade and other receivables at 30 June 2023 of $22.21 million

(FY2022: $16.20 million), reflect the overall growth in distribution.

Inventories increased to $9.52 million (FY2022: $1.83 million) to
meet expected commercial demand and imminent clinical demand.
Trade and other payables of $7.65 million (FY2022: $3.28 mil-
lion), with the increase driven by timing of payments to support
product manufacturing initiatives and supply chain commitments.

Income taxes payable increased to $16.09 million (FY2022: $7.28
million), driven by a higher taxable profit result to meet Australian
corporate income tax obligations as well as tax obligations in other
relevant jurisdictions.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORTPLANS 2024
AND BEYOND
CLINUVEL’s strategic
objective is to transform into
a sustainable pharmaceutical
group and diversify its
activities establishing an
integrated business.

Long‑term Value of Integration and Diversification

CLINUVEL’s business model strives to build and retain key
pharmaceutical functions in-house, rather than outsource to
external business partners and suppliers. The overall aim is to fur-
ther integrate functions while diversifying revenue streams. The
rationale of this approach is found in the Company’s objectives
for independence with self-determination and control of quality,
costs and supply, reflecting the Company’s resourceful culture.
CLINUVEL undertakes several functions in-house:

• Formulation R&D, including select pre-clinical

development;

• Design and conduct of clinical studies;
• Regulatory affairs, pharmacovigilance and quality assurance

activities, including key manufacturing activities;

• Direct distribution of SCENESSE® to European EPP Expert

Centres and US Specialty Centers;

• Pricing and reimbursement functions, including patient
support and the SCENESSE® Assistance Program in the
USA;

• Finance, facilitated by preservation of cash balances

to allow for planned organic and inorganic growth and
expansion; and

• Communications, branding and marketing, and investor

relations.

Plans to diversify the Company are being executed and aim
to result in new revenue streams as treatments are provided for
indications with larger patient populations than EPP. In other
words, the firm’s efforts go towards spreading the Company’s
activities, products and markets. This strategy is one to diversity
revenue streams, part of a risk management plan. The risk of the
chosen strategy lies in its implementation, which is mitigated by
a deliberate and thorough approach of the Company to expand
its activities based on its existing expertise in melanocortins

and photomedicine, and central nervous system. The Group has
increased its workforce to support its activities accordingly.

SCENESSE® for other indications. Work continues to provide treat-
ment access for all US EPP patients.

Infrastructure and Know‑How to Support Expansion

Other Jurisdictions

CLINUVEL has built enhanced infrastructure and know-how in

The Company is committed to gaining market access for SCE-

support of its expansion plans.

NESSE® in other jurisdictions around the world.

With this overview of CLINUVEL’s strategic approach in mind,
more specific plans in EPP patient treatment, drug development
and indications, and PhotoCosmetics, are outlined below.

Enabling EPP Patient Treatment

CLINUVEL continues to focus on the distribution of SCE-
NESSE® for EPP patients in existing jurisdictions to meet patient
and physician demand. In this regard, work with external contract
manufacturers and raw material suppliers continues to ensure
product supply at current Good Manufacturing Practice standard.

Europe

As part of the conditions attached to European marketing
authorisation, CLINUVEL will maintain its commitment to the
European EPP Disease Registry to monitor the long-term safety
of SCENESSE®.

The Company recognises the impact of EPP on patients under
the age of 18 and the potential for SCENESSE® as a treatment
for adolescent patients. CLINUVEL subsequently proposed an
expansion of the drug’s label to the European Medicines Agency
(EMA) to include adolescent patients and expect to provide an
update later in 2023.

USA

CLINUVEL aims to establish a network of 120 Specialty Centers
across the US to provide greater treatment access for EPP patients.
This network may also play a role in the clinical development of

Melanocortin Drug Development

CLINUVEL is a world leader in melanocortins, evaluating a
number of melanocortin-based pharmaceuticals for a range of
patient groups with unmet need.

CLINUVEL expects progress across several clinical programs

with afamelanotide:

• DNA Repair Program – results of the first two XP studies

(CUV156 and CUV152) and the study on healthy volunteers
(CUV151) are expected in FY2024. Subject to these results,
additional studies will be undertaken with the objective of
completing a dossier of patient results of sufficient gravitas
to present to the EMA to extend the approved label of
SCENESSE® to XP patients.

• Vitiligo – the results of CUV104 will be available in FY2024

and CUV105, a new, larger study, using SCENESSE® in
combination with NB-UVB phototherapy, will commence
as soon as design and ethics approvals are received. The
objective is to submit a dossier to the US FDA to consider
approval to extend the label of SCENESSE® to vitiligo
patients.

• Variegate porphyria – first efficacy results of CUV040 are

expected in 2024. After assessing the results, the next steps
will be determined, including the need for another study,
with a view to substantiate a submission to the EMA to
extend the label of SCENESSE® to VP patients in Europe.

• Stroke – first efficacy results of CUV803 are expected in

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORTFY2024. The path to regulatory approval of afamelanotide
for Stroke is a longer term one. Additional and larger studies
will need to be undertaken before regulatory approvals can
be sought and a timeframe to commercialisation of at least
5 years is considered likely.

Acquisitions

CLINUVEL has long expressed an interest in acquiring assets
to augment the planned organic growth of the Company. An
acquisition needs to fit several criteria:

• An existing management team with complementary skills

Clinical studies in other indications are planned to be

and willingness to integrate within the Group;

announced in 2024 and 2025.

PhotoCosmetic Products

CLINUVEL is establishing a new category of products as Pho-
toCosmetics, with the objective of making the brand a household
name by 2026.

CYACÊLLE is planned for wider launch in new jurisdictions,
particularly the USA. The PhotoCosmetic products for DNA repair
and melanogenesis will continue to be developed by the Research,
Development & Innovation Centre in Singapore, for planned
launch in 2024 and 2025, respectively.

Regular Bulletins from the CBM team, addressing different
aspects of CLINUVEL’s brand architecture, will be issued to pro-
vide updates to stakeholders.

Cumulative Expenses Plan

We have provided a five-year projection of expenses we expect
to incur to aim for our objectives. Excluding capital expendi-
tures and marketing expenses on the PhotoCosmetics initiative,
expenses of $175.0 million are planned over the five years to the
end of FY2025.To date, expenses incurred in FY2021 to FY2023
total $92.8 million, or 53% of the expenses plan. The chart below
shows the indicative path to achieve this projection.

• Scope to add value from its experience and expertise;
• Complement or add to our activities;
• In either a late clinical stage biotech; and/or a
• Manufacturer that advances our objectives.
CLINUVEL does not rule out recourse to external finance –
whether this be bank debt and/or a capital raising – to acceler-
ate or complete one or more acquisitions. The option to secure
finance to allow for an acquisition is one of several avenues to
grow the Group inorganically. The ongoing monitoring and
assessment of opportunities does not engage more management
time and effort than warranted by the potential value add of the
appropriate incorporation.

Primary Listing of the Company

The primary listing of CLINUVEL is the Australian Securi-
ties Exchange (ASX) – since 2001. We have made it explicit in
our recent communications that consideration would be given
to a primary listing elsewhere if the benefits to the Group and
stakeholders are compelling. We have also stated that we are not
inclined to a dual listing due to the duplication of compliance and
reporting costs, and dilution of trading volume. Therefore, our
approach is to either remain on the ASX or move to a listing in
another country, if opportunities are sufficiently compelling. The
implications of a change in listing will be thoroughly assessed
such that shareholders benefit and do not lose out or suffer neg-
ative consequences.

Five-year Plan to 30 June 2025 (A$m)

180

160

140

120

100

FY2021

FY2022

FY2023

FY2024

FY2025

Cumulative Expenses

Indicative Path of Cumulative Expenses

SUMMARY

CLINUVEL is on the path towards a highly integrated and

diversified pharmaceutical company. Its transformation

will be reflected in four pharmaceutical products for eight

indications – four in photomedicine and four in CNS

conditions – and three PhotoCosmetic product lines which

will make CLINUVEL a household name. CLINUVEL will

be recognised as an expert in melanocortins and their

therapeutic role in managing conditions of the skin and

brain. The benefit of this integration and diversity will be

a sustainable business able to perform with resilience

and dynamism over the long-term.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORTANNUAL RESULTS
Financial Year Ending 30 June 2023

Directors report

The Directors of the Board present their report on the Company for the financial year ended 30 June 2023
and the Auditor’s Independence Declaration thereon.

Directors’ Report

“Since the launch of SCENESSE® in 2016, we have pursued
clear and ambitious objectives for CLINUVEL, with a strong
financial foundation and consistent performance being central.
It is undeniable that – with seven years of growing revenues
and profitability, continued R&D investment, and a formidable
balance sheet to navigate uncertainty – we are meeting our
long-term objectives and setting a standard for the future
of the Group.

In parallel, strong cash inflows have enabled the Board to declare
a sixth consecutive annual dividend for shareholders, recognising
their long-term support. We will continue the strategy to
translate our technology to the benefit of patients and the
general population at high risk of DNA damage.”

Mr Darren Keamy, Chief Financial Officer, CLINUVEL Group

WILLEM BLIJDORP
Non-Executive Director, Chair since 30 November 2019, Funda
Appointed 21 January 2015

Committee Membership
Chair of the Remuneration Committee
Chair of the Nomination Committee
Member of the Audit and Risk Committee

Current Directorships and Other Interests
None

Other Listed Company Directorships (last 3 years)
None

Relevant Interest in Shares and Performance Rights
Shares 1,743,118

Performance Rights –

Relevant Skills

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

Background

Mr Blijdorp is an entrepreneur recognised for having established 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 serve markets. The B&S Group has worldwide reach and is a leader in its market sector. Formerly B&S Group’s CEO,
and former member of its Supervisory Board, Mr Blijdorp is a majority shareholder of B&S, 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 received acknowledgment for his expertise in mergers 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 valuable knowhow and contributed by setting the
Group’s long-term strategy for product commercialisation, growth, and plans to diversify CLINUVEL. He provides guidance on
business and tax restructuring of the Company, as well as assist in setting up distribution channels for CLINUVEL’s business in
photocosmetic products serving a specialised consumer market

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

PHILIPPE WOLGEN
Chief Executive Officer, MBA, MD
Appointed to Board 1 October 2005, appointed Chief Executive Officer 28 November 2005

Committee Membership
None

Current Directorships and Other Interests
None

Other Listed Company Directorships (last 3 years)
None

Relevant Interest in Shares and Performance Rights
Shares 3,122,247

Performance Rights 1,513,750

Relevant Skills

• pharmaceutical R&D, commercialisation
• clinical expertise
• commercial & entrepreneurial outlook
• executive management, corporate turnarounds
• finance and capital markets
• experienced in listed company Directorships

Background

Under Dr Wolgen’s leadership, 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 systems were established to self-distribute the prescriptive product 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 through a controlled
distribution system set up by the Company. SCENESSE® is the world’s first systemic photoprotective 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, and 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 different and unique within the sector.
He is currently leading the Group’s expansion, both based on organic and inorganic strategies. His focus has been to establish
a professional management team executing corporate objectives of establishing a sustainable, and profitable group diversified
from its core pharmaceutical base, to cosmetics and other services within an integrated model.

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..

BRENDA SHANAHAN, AO

Non-Executive Director, BComm, FAICD, ASIA
Appointed 6 February 2007

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
Chair, SG Hiscock Medtech Advisory Board
Director of DMP Asset Management Ltd
Director of Rock Art Australia

Other Listed Company Directorships (last 3 years)
Phoslock Water Solutions Ltd (ASX: PHK, since 2017)

Relevant Interest in Shares and Performance Rights
Shares 196,577

Performance Rights –

Relevant Skills

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

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 Water Solutions Ltd. 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. In 2021, Mrs Shanahan was recognised as an Officer in the General Division of the Order of Australia.

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.
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) and Challenger Limited (ASX: CGF). Mrs Shanahan has
also served 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.

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.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

KAREN AGERSBORG

Non-Executive Director, MD
Appointed 29 January 2018

Committee Membership
Member of the Remuneration Committee
Member of the Nomination Committee

Current Directorships and Other Interests
Fellow of the American Association of Clinical Endocrinologists

Other Listed Company Directorships (last 3 years)
None

Relevant Interest in Shares and Performance Rights
Shares 5,500

Performance Rights –

Relevant Skills

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

SUSAN (SUE) SMITH

Non-Executive Director, Dipl ClinRisk
Appointed 23 September 2019

Committee Membership
Member of the Remuneration Committee
Member of the Nomination Committee

Current Directorships and Other Interests
Director of HCA Hope Fund UK
Board Chair of The Evewell Group Ltd

Other Listed Company Directorships (last 3 years)
None

Relevant Interest in Shares and Performance Rights
Shares 420

Performance Rights –

Relevant Skills

leadership and strategy setting in complex environments

• executive healthcare management
•
• risk management and governance
• customer relations

Background

Dr Agersborg is a Clinical Endocrinologist with diverse and extensive practice experience in Pennsylvania and New Jersey,
USA. She is Board Certified in both Internal Medicine and Endocrinology, Diabetes & Metabolism and holds specific expertise
on the class of melanocortins.

Her career has included inpatient, outpatient, and hospitalist positions across a number of prominent medical institutions.

She is an Associate Professor of Medicine, teaching medical students and residents in endocrinology.

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 regulatory and commercial
strategy, resulting in the US FDA’s approval of SCENESSE® in October 2019 and the subsequent market launch in 2020.

Mrs Smith manages an established consultancy business, providing advisory services to a range of healthcare organisations,
investors and boards of directors. She has led 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 practising physicians within
the UK independent healthcare sector.

Her past experience Is now successfully translating into a diverse portfolio with non-executive director appointments. She is
currently Board Chair of The Evewell Group Ltd which operates fully integrated medical centres of excellence dedicated to
caring for, and protecting, all aspects of fertility and gynaecological health. Mrs Smith is also a Director of HCA Hope Fund UK,
a charity providing financial aid and resources to its healthcare worker members to help them start rebuilding after an extended
illness, injury, environmental disasters, or other extraordinary situations. In the face of the ever-changing healthcare market
Mrs Smith fosters first class relationships with a wide range of healthcare stakeholders to provide care of excellence to patients.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

JEFFREY ROSENFELD, AC, OBE

Non-Executive Director MBBS MS MD FRACS
Appointed 26 November 2019

Committee Membership
Member of the Audit and Risk Committee
Member of the Nomination Committee

Current Directorships and Other Interests
Board Member, Connectivity TBI Ltd
Board Chair, New Medical Education Australia Ltd
Representative Honorary Colonel, Royal Australian Army Medical Corps
Emeritus Professor, Monash University

Board Member, Spirit of Australia Foundation

Other Listed Company Directorships (last 3 years)
None

Relevant Interest in Shares and Performance Rights
Shares 3,148

Performance Rights –

Relevant Skills

lifetime experience in providing healthcare

•
• clinical research and development
• board and committee oversight and governance
•

leadership and management

Background

Prof Rosenfeld is an internationally recognised neurosurgeon with extensive experience in senior healthcare and medical
research executive roles and a distinguished and decorated career in the Australian Army. He is a retired Major General and a
former Surgeon General, Australian Defence Force-Reserves. He has served on eight deployments to Rwanda, Iraq, Solomon
Islands, Bougainville and East Timor. He was the Founding Director of Monash University Institute of Medical Engineering
(MIME)-Melbourne. He is developing a bionic vision device to restore vision in people without eyesight, and he is also a leader
in brain injury research. Prof Rosenfeld was Director of Neurosurgery at the Alfred Hospital for fifteen years, concurrently
holding Professor and Head of the Department of Surgery at Monash University for nine years. Prof Rosenfeld is active in many
community organisations and champions various charitable causes. Prof Rosenfeld has been an active volunteer for the
Australian-Aid funded Pacific Islands Project which transfers clinical skills and knowledge to healthcare professionals in Papua
New Guinea, Fiji and the Solomon Islands.

In 2018, Prof Rosenfeld was awarded the Companion of the Order of Australia, which is Australia’s highest civilian honour,
the Meritorious Service Medal of the United States of America in 2017 and Officer in the Order of the British Empire in 2013.
Prof Rosenfeld became an Emeritus Professor at Monash University in January 2021.

SIR ANDREW LIKIERMAN

Non-Executive Director, MA, FCMA, FCCA
Appointed 4 April 2022

Committee Membership
Member of the Nomination Committee

Current Directorships and Other Interests
Professor of Management Practice at the London Business School

Other Listed Company Directorships (last 3 years)
Beazleys PLC (London Stock Exchange) – to 2021

Relevant Interest in Shares and Performance Rights
Shares 1,000

Performance Rights –

Relevant Skills

• cross-border financial and commercial acumen
• public sector experience
• board and committee oversight and governance
•

leadership and management

Background

Sir Andrew’s long and accomplished career sees him alternating between public, private and academic positions.
Sir Andrew is Professor of Management Practice at the London Business School and was its Dean from 2009 to 2017. He is
currently working on the role of good judgement in management, with his work used extensively by many organisations and
recently incorporated in guidance issued by the UK financial regulator.

In the private sector, Sir Andrew served as non-executive Director of Times Newspaper Holdings Ltd, Monument Bank,
Barclays Bank plc, quoted insurance Lloyds underwriter Beazley plc, Applied Intellectual Capital plc, and market research firm
MORI Ltd.

Among many roles in the public sector, Sir Andrew worked in the UK Cabinet Office, and spent 11 years as Head of the UK
Government Financial Management Service, during five of which he was also the Chief Financial Officer of the UK Treasury
(Finance Ministry). In this period, he led the nine-year project which changed the basis of government planning, control, and
reporting. He was knighted for public service in 2001. He has also served as non-executive Director at the Bank of England and
non-executive Chair of the (UK) National Audit Office.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

Information on Company Secretary

Principal Objectives and Activities

CLINUVEL PHARMACEUTICALS LTD (CLINUVEL) is a global specialty biopharmaceutical company focused on developing
and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening, disorders, as well as
healthcare solutions for the general population. As pioneers in photomedicine and the development of melanocortin peptides,
CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for
systemic photoprotection, DNA repair, repigmentation and acute conditions which lack alternatives.

CLINUVEL’s lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA,
Israel and Australia as the world’s first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid
reactions and burns) in adult patients with erythropoietic protoporphyria (EPP).

The principal activities of the Group during the 12 months to 30 June 2023 (FY2023) were to:
• manufacture and commercially distribute its leading drug candidate SCENESSE® in the European Union (EU) and the

USA for the treatment of the rare, genetic metabolic disorder, erythropoietic protoporphyria (EPP);

• research and develop SCENESSE® and the liquid formulation PRÉNUMBRA® (afamelanotide) as medicinal therapies to
treat a range of severe disorders, including vitiligo, variegate porphyria, xeroderma pigmentosum (XP), acute arterial
ischaemic stroke (AIS), DNA repair and other disorders;

• develop and manufacture NEURACTHEL® (adrenocorticotropic hormone; ACTH) in different formulations, to target

neurological, endocrinological, and degenerative disorders;

• research, develop, manufacture and commercialise non-prescription, PhotoCosmetic products for individuals and

populations at highest risk of exposure to ultraviolet (UV) and high energy visible (HEV) light, and in need of assistance
in DNA repair and melanogenesis of the skin;

• develop new pharmaceutical formulations containing afamelanotide and melanocortin analogues for the treatment of a

range of disorders;

• research and develop various pharmaceutical formulations of melanocortin analogues for the treatment of a range of

disorders.

There was no significant change in the nature of the Group’s activities during the financial year.
The long-term financial objective of the Group is to maximise company value through the distribution of treatments to
patients and special populations in society, focusing on those who are unattended or unaddressed. The key to long-term
sustainable performance is to continue targeted research and development of a portfolio of assets centred around its key drug
candidate SCENESSE® and its melanocortin derivatives; their successful commercialisation, manufacture, and distribution; and
the maintenance of ongoing financial discipline and stability.

DARREN KEAMY

Company Secretary, Chief Financial Officer, BComm, CPA, GradDip ACG.

Mr Keamy, a Certified Practicing Accountant and Company Secretary, joined CLINUVEL in November 2005 and became Chief
Financial Officer of the Group in 2006. He has previously worked in key management accounting and commercial roles in Amcor
Limited and has experience working in Europe in financial regulation and control within the banking and retail pharmaceutical
industries.

He has overseen the financial management of the Group since 2005, played a role in raising A$95 million in capital, and
assisted the steering of the Group from a loss-making, pre-revenue position to a commercially focussed profitable enterprise,
recording six consecutive years of growth.

Meeting of Directors

The following table summarises the number of and attendance at all meetings of Directors during the financial year:

Director

Board

Audit & Risk
Committee

Remuneration
Committee

Nomination
Committee

Mrs. B. M. Shanahan

Dr. P. J. Wolgen

Mr. W. Blijdorp

Dr. K. A. Agersborg

Mrs. S. E. Smith

Prof J. V. Rosenfeld

Prof. J. A. Likierman

Column A indicates the number of meetings held during the period the Director was a member of the Board and/or Board Committee.
Column B indicates the number of meetings attended during the period the Director was a member of the Board and/or Board Committee.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

• Adrenocorticotropic hormone (ACTH) being developed as Instant and

Non-IFRS financial measures should be viewed in addition to, and not as a substitute for, the Group’s statutory results. These

Operating and Financial Review

Highlights of the Company’s key activities and operational outcomes are summarised below:

SCENESSE® - World’s First
Photoprotective Drug
• More patients treated, more implants

administered and expanded expert treatment
centre network.

• April 2023 marked the third anniversary of
treatment of EPP patients in the USA.

• Uniform pricing per jurisdiction maintained.

• First treatment of EPP patient in Canada in

May 2023 under special access arrangements.

• Application to EMA to treat adolescents
submitted September 2022 and is under
ongoing consideration.

Melanocortin – Drug Pipeline
• PRÉNUMBRA® Instant (afamelanotide):

• Developed to offer flexibility to personalise treatment and achieve faster

clinical responses.

• First use in the second clinical study on stroke, commenced March 2023.

• NEURACTHEL® (ACTH)

Modified-Release products.

• Initial focus on treatment of adult Multiple Sclerosis and Infantile Spasms.

• Ongoing work with partner to validate batches of NEURACTHEL®

manufactured under current Good Manufacturing Practice (cGMP) and
prepare Drug Master File for submission to the US FDA.

Clinical Programs – Advanced

• DNA Repair with focus on xeroderma pigmentosum (XP):

- Study CUV156 (n=6) ongoing, positive preliminary results reported,

presented at global conferences.

- Study CUV152 (n=6) ongoing.
- Study CUV151 (n=9) in disease free volunteers reduced DNA

photodamage.

• Variegate Porphyria (VP):

- Study CUV040 (n=6) commenced May 2023.

• Vitiligo:

- Monotherapy study CUV104 (n=6) commenced.
- Combined treatment with narrow-band UVB study CUV105 (n=150)

being designed.

• Arterial Ischaemic Stroke (AIS):

- Study CUV803 (n=12), commenced March 2023, using

PRÉNUMBRA® Instant.

PhotoCosmetic – Products
• First polychromatic screen product CYACÊLLE
launched in pilot phase in March 2023, initial
distribution limited to hospitals and people at
highest risk through e-commerce in Europe.

• CUVAs and CUVIPs engaging targeted highest risk
communities on the impact of UV exposure and
the benefits of photoprotection.

• Three product lines communicated:
- Polychromatic photoprotection;

- DNA Repair;

- Melanogenesis.

• Development of the second and third product lines

continued at the Singapore Research,
Development & Innovation Centre.

The financial highlights of the Company for the year ended 30 June 2023 are presented in the following table:

Consolidated Entity

Total Revenues, Interest and Other Income

Total Expenses

Net Profit before income tax

Profit after income tax expense

Cash and Cash Equivalents

Basic Earnings per Share

Net Tangible Assets backing per Share

Dividend distribution per Share

A$ million

Change

$82,990

Up 24%

$37.411

Up 14%

$45.578

Up 33%

$30.605

Up 47%

$156.814

Up 47%

$0.619

Up 47%

$3.29

$0.05

Up 31%

Up 25%

A review of the Company’s operations and information on the financial results is contained in the feature on pages 26-37 of

this Annual Report.

Reconciliation of Net Profit after Tax with Adjusted Net Profit after tax

The Group’s net profit after tax and earnings per share are prepared in accordance with Australian Accounting Standards.
The Group has prepared a financial measure titled “Adjusted Net Profit after Tax” which provides for a number of non-
International Financial Reporting Standard (“non-IFRS”) financial measures including “Adjusted Total Revenue, Interest and
Other Income”, “Adjusted Expenses”, “Adjusted Net Profit Before Tax” and “Adjusted Net Profit After tax”.
The Directors believe non-IFRS financial measures assist in providing meaningful information about,
1)
2) period-to-period comparability,
by adjusting for non-recurring, non-cash or unrealised items that may be of a material nature which may affect the Group’s

the performance of the business, and

statutory results.

measures may also differ from non-IFRS measures used by other companies.

Non-IFRS financial measures are not subject to audit or review. The Group’s non-IFRS financial measures are presented with
reference to the Australian Securities & Investment Commission (“ASIC”) Regulatory Guide 230 Disclosing non-IFRS financial
information.

The Group’s statutory net profit after tax for FY2023 was $30.605 million, up 47% from FY2022. The Group’s adjusted net
profit after tax for FY2023 was $37.838 million, up 36% from FY2022’s adjusted net profit after tax result. The adjusted result
considers various non-cash and unrealised items, including the non-cash charge for share-based payments attached to the prior
grant of performance rights to the Managing Director and other staff which are typically valued at their grant dates and
expensed over time, even if certain performance conditions attached to the performance rights are unmet.

Total Revenues

Total Interest Income

Total Other Income

30 June 2023

30 June 2022

Statutory

Non-IFRS

Statutory

Non-IFRS

78,321,318

65,722,292

3,905,856

763,082

444,071

821,152

444,071

821,152

Total Revenue, Interest Income and Other Income

82,990,256

66,987,515

Adjust for:

Unrealised gain on restating foreign currency balances and
currencies held

Adjusted Total Revenue, Interest Income and Other Income

Total Expenses

Adjust for:

Share-based payments

Unrealised loss on restating foreign currency balances and
currencies held

Adjusted Expenses

Net Profit before Tax

(659,901)

82,330,355

(604,317)

66,383,197

37,411,533

32,666,600

(8,989,788)

28,421,745

(6,120,977)

26,545,623

45,578,723

34,320,915

Adjusted Net Profit before Tax

53,908,610

39,837,574

Income Tax

Adjust for:

tax on above adjustments

tax on Unrealised gains/losses including loans to subsidiaries

Net Profit after Tax

Adjusted Net Profit after tax

14,974,157

13,442,450

(167,070)

1,263,081

(179,454)

(1,284,691)

30,604,566

20,878,465

37,838,442

27,859,269

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

Material Business Risks

Dividends Paid or Recommended

The following specific business risks are periodically reviewed by the Board and management, as these have the potential
to affect the Group’s business strategy, financial position or future performance. It is not possible to identify every risk that
could affect the Group’s business, and the actions taken to mitigate these risks cannot provide absolute assurance that risks
will not materialise This list is not exhaustive.

Declared & paid in 2022/23

Cents
per
Share

Amount

Date of Payment

Final

4.00

$1,976,414

21 September 2022

Risk

Description

Mitigation Strategies

On 28 August 2023, the Board of Directors declared a fully-franked dividend of $0.05 per ordinary share in relation to the full year ended 30 June 2023.

Technology

Despite obtaining marketing authorisations, the approved
products may ultimately prove not to be safe and/or of
clinical or other benefit.

The Company has established a comprehensive pharmacovigilance system and
conducts intense and continuous safety monitoring, evidenced by the risk
management commitments agreed with the European Medicines Agency for
the long-term follow-up of patients treated with SCENESSE®. The Group works
with key opinion leaders to ensure it responds to any evidence supporting a
change to the clinical relevance or change to the safety profile.

Supply

Manufacturing processes may result in product batches
not meeting minimum specifications, raw material
components not being sourced to specification. The
manufacturing process may encounter process issues
not previously identified and controlled, and there may be
non-controllable disruptions to the operations of the
products’ contract manufacturers. These factors may lead
to delay nor non-supply of product and/or adverse
regulatory outcomes.

This risk has a high degree of non-controllability, and the switching costs
comes with potentially long lead times and significant expense. The Company
works very closely with its suppliers to ensure scheduling fits forecast
requirements and that the manufacturing processes are actively managed.
New suppliers are subject to due diligence processes and key relationships
are developed with regulatory agencies to support the Company in the event of
supply chain disruption. Insurance protection for stock loss is in place.
In FY2023 the Company increased its inventory levels to meet pending demand
and to ensure supply chain risk is managed.

Clinical &
Regulatory

Clinical trials may not yield the expected and desired
results for the investigational medicinal product(s) to
obtain further regulatory approvals.

Every clinical trial undergoes a rigorous design process involving third party
experts, primary investigators, and the Company’s R&D experts to give each
trial the best opportunity to deliver valuable outcomes. A framework is in place
to ensure all clinical trials are actively monitored, the sites are adequately
trained and supported, patients are recruited and retained, and data is
efficiently and accurately analysed. In FY2023, less reliance on third-party
providers was sought by bringing data analytical functions in-house.

Market
Competition

New entrants could enter the same market to directly
compete against CLINUVEL's products. CLINUVEL’s
business could be adversely impacted if new products to
the market claim or are proven to be safer and/or more
effective and are priced lower than CLINUVEL’s products.

The Company is investing in its R&D to investigate and develop new
formulations and make improvements to the existing formulation. To de-risk
its reliance on one market segment it is investigating afamelanotide and
related molecules as a potential therapy in new markets.

Drug Pricing

Third-party payors may not provide insurance coverage
or not be willing to accept the prices agreed with other
third-party payors, adversely affecting revenues and
profitability. Furthermore, changes in government
insurance programs may result in lower prices for our
products and could materially adversely affect our ability
to operate profitably.

To address this risk, the Company ensures as part of its drug pricing
negotiations that it can demonstrate the value of the clinical benefit of the drug
and its impact on a patient’s quality of life, supported by benchmarking
analysis and health economic assessments. External assistance is also used
where necessary.
This risk could be exacerbated by new market entrants (see above) which
would likely see further pressure to lower prices.

Intellectual
Property

Funding

Future sales could be impacted to the extent there is not
sufficiently robust patent protection across the Group’s
product portfolio to prevent competitors from entering
the marketplace with ‘generic’ versions of the Group’s
approved products. Also, competitors infringing the
Group’s IP rights may adversely impact the Group’s
ability to maximise the value to be made from product
commercialisation.

The Company has created a portfolio of patents and trademarks across various
jurisdictions and has utilised regulatory laws enabling market exclusivity that
has enabled a relatively strong IP protection. It works closely with experienced
specialists and advisors internationally over many years and it continues to
fortify its portfolio through applying for new patents arising from new
knowledge gained during its research and development.

Cash outflows from its operations over the long-term
may be higher than cash inflows over the long-term.
Therefore, the ability of the Group to successfully bring
its products to market and achieve consistent positive
cash flow is dependent on its ability to maintain a revenue
stream and to access sources of funding while containing
its expenditures.

The ability to access additional funding through debt and capital markets and
the competitive terms to obtain the funding can be dependent on
macroeconomic and other factors outside the Company’s control, however the
Directors believe additional funding could be obtained if necessary. Should
additional funding not occur, other measures could be deployed as appropriate,
including reducing the scope of business operations. Additional information on
the management of its foreign currency and credit risk can be found in Note 22
to the financial statements.

Management

The corporate strategy could be impacted adversely if the
Group was not able to retain its specialised knowledge
and areas of expertise, key management, members of
staff and/or Board.

The Company continually reviews its remuneration, reward, and training to
ensure it is a competitive employer in a tight labour market, and an attractive
place to work. Strategies to promote staff retention include eligibility to
participate in LTI Plans after a period of service has passed, and specialist
training programs are available to career develop performing staff. Staff
benefits are constantly reviewed to ensure market competitiveness.

Cyber
Security

A breach of the Company’s IT systems has the potential to
disrupt critical business processes, leading to a loss in
privacy, loss in commercially sensitive data and/or
reputational damage to the Company.

This risk cannot be comprehensively eliminated; however the Company has in
place safeguards to restrict access to the Company’s operating systems
including multifactor authentication, firewalls, phishing identification software,
cloud hosted solutions and regular data back-ups.

Changes in The State of Affairs

The Directors are not aware of any matter or circumstance not otherwise dealt with in this report that has significantly or

may significantly affect the operations of the Group.

Significant Events after the Reporting Date

There has not been any matter, other than reference to the financial statements that has arisen since the end of the financial

year that has affected or could significantly affect the operations of the Group, other than:

• In July 2023, the Group purchased a commercial property located in Egham, UK to support its expanding European-

based workforce for a cash consideration, net of fees, of £2,500,000; and

• On 28 August 2023, the Board of Directors declared a franked dividend of $0.05 per ordinary share.

Likely Developments and Expected Results

The Company is on an expansion path to transform into a highly integrated and diversified pharmaceutical group. This is
expected to result in a company with the ability to sustain greater long-term profitability and performance for the benefit of all
stakeholders.

The likely developments to expect on the integration and diversification of the Group are:

Integration

Diversification

• Maintenance and development of existing in-house functions

• Advancement of the product development program

• Continued advance of the activities of the Communications,

• Continuation of existing clinical programs and release of

Branding & Marketing Division

results

• Assessment of options for self-manufacturing, including

acquisitions

• Announcements of new indications of focus and clinical
programs necessary to achieve regulatory approvals

The “Operating and Financial Review” (on pages 26-37) in this Annual Report details the type of developments and outcomes
that occurred in FY2023 as the Company advanced its expansion plans. The feature on the “Plans 2024 and Beyond” (on pages
38-41) in this Annual Report sets out in greater detail the likely developments and outcomes expected in FY2024 and beyond
as the expansion continues.

Environmental Regulation and Performance

The Group’s operations are not regulated by any significant environmental regulation under a law of the Commonwealth, or
of a State or Territory, or of any other jurisdiction. CLINUVEL is conscious of the impact of mankind on the environment and is
a responsible corporate citizen adhering to sound practices on Environmental, Social and Governance (ESG) matters. An update
on these practices is provided in the feature on pages 14-19 of the Annual Report.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

Rounding of Amounts

The Group is a type of company referred to in ASIC Corporations (Rounding in Financial/Directors’ Reports) Instrument
2016/91 and therefore the amounts contained in this report and in the financial report may have been rounded to the nearest
$1,000,000 or in most other cases, to the nearest dollar.

Indemnification and Insurance of Directors and Officers

During or since the end of the financial year the Group has given or agreed to indemnify, or paid or agreed to pay, insurance
premiums to insure each of the Directors against liabilities for costs and expenses incurred by them in defending any legal
proceedings arising from their conduct while acting in the capacity of Director of the Group, other than conduct involving wilful
breach of duty in relation to the Group. Details of the amount of the premium paid in respect of insurance policies are not
disclosed as such disclosure is prohibited under the terms of the contract.

Directors’ Benefits and Interest in Contracts

Since the end of the previous financial year no Director has received or become entitled to receive a benefit (other than a
benefit included in the total amount of emoluments received or due and receivable by Directors shown in the financial
statements and the Remuneration Report), because of a contract that the Director or a firm of which the Director is a member,
or an entity in which the Director has a substantial interest has made with a controlled entity.
Further information on these contracts is included in Note 20 to the financial statements.

Remuneration Report

The Remuneration Report, which forms part of the Directors’ Report, provides information about the remuneration of the Directors of

CLINUVEL PHARMACEUTICALS LTD and Other Key Management Personnel for the year ended 30 June 2023.

Key Management Personnel (‘KMP’) has the meaning given in the Accounting Standard AASB 124 and who together have the authority and

responsibility for planning, directing and controlling the activities of the Group, being:

Name

Position

Term as KMP

Non-Executive Directors

Mrs. B. M. Shanahan

Non-Executive Director

Mr. W. A. Blijdorp

Non-Executive Director

Dr. K. A. Agersborg

Non-Executive Director

Mrs. S. E. Smith

Non-Executive Director

Prof. J. V. Rosenfeld

Non-Executive Director

Prof. J. A. Likierman

Non-Executive Director

Full Year

Executive KMP

Dr. P. J. Wolgen

Dr. D. J. Wright

Mr. D. M. Keamy

Managing Director and Chief Executive
Officer (CEO)

Full Year

Chief Scientific Officer (CSO)

Full Year

Chief Financial Officer and Company
Secretary (CFO)

Full Year

The remuneration report is set out under the following main headings:

A. Introduction by the Chair of the Remuneration Committee
B. Remuneration Governance
C. Executive Remuneration
D. Non-Executive Remuneration
E. Service Agreements FY2023
F. Share Based Remuneration
G. Details of Remuneration
H. Description of Performance Conditions to Performance Rights expiring 20 November 2023

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

A. Introduction by the Chair of the Remuneration Committee

Chairman of the Remuneration Committee

Dear Shareholder,

On behalf of the Remuneration Committee (Committee), I am pleased to present the
Remuneration Report for the year ended 30 June 2023. This introduction to the Report covers:

• the Company’s approach to remuneration of Executive KMP and Directors;
• key achievements of the past year, and CLINUVEL’s longer-term objectives;
• FY2023 remuneration outcomes for Executive KMP and Directors: and
• our intentions on remuneration into FY2024 and beyond.

Remuneration framework

As part of our remuneration framework, we strive to be and remain an attractive group to work for. We place high emphasis
on keeping skills and talent under one roof. Since we invest resources and time on improving specialized professionals, retention
has become key.

In a global talent market, and given the maturity of the Company, it is more important than ever to offer competitive
remuneration packages. As a company operating on several continents, and being aware of an ever-changing working
environment, luring specialized talent in the pharmaceutical sector has become a global aspiration of many.

Competitors in the sector are seeking similar skills, and in a unique working environment, we intend to balance financial and
non-financial benefits, and provide a long-term career path. Fundamental to our current success remain our strong values,
which have proven a definite factor the past year in attracting employees. With an increase of 95% of staff numbers over the
four financial years to 30 June 2023, we have been able to build around a core executive team of new professionals. Retention
of skills has equally proven beneficial to shareholders, with the executive team showing an average tenure of 16 years.

The value of having an experienced team, replenished with new managers coming through, is immense and cannot be

overplayed.

In Section C of the Report, the remuneration framework links the Group’s mission and strategy to executive remuneration,

and contains the following key components:

A. fixed base remuneration, and non-monetary benefits (health insurance, accommodation, relocation, travel and statutory

benefits);

B. short-term incentives (STIs); and
C. long-term incentives (LTIs, equity participation through conditional performance rights).
As an international company commercially operating outside Australia, limiting its peer benchmarking of its executive
remuneration to Australian peers only is not considered to be a fair comparison. For this reason, the Committee commissions
annually analyses of its executive remuneration, benchmarking against comparable peers in terms of complexity and innovative
focus, scope and scale, technical and specialised skills, market capitalisation, achievements, and risk profile, operating on either
an Australian or UK market exchange. For FY2023, the peer group consists of 26 companies, 22 which are US-listed, and four
listed in Australia – refer to pages 66-69. The CEO’s total remuneration package is lower than the median of peers, albeit higher
on fixed remuneration and percentage potential on STI, but much lower on long term incentives, whilst the reverse is the case
for the CFO. The variation in the components is assessed by the Remuneration Committee to be reasonable based on the
leading performance and achievements of the business.

Key achievements of the past year

In an environment of increasing inflationary pressures globally, CLINUVEL entered the financial year in a strong financial
position. It joined a select group of biopharmaceuticals companies who avoided the need to rely on external funding. The ability
to access both capital and credit markets had changed dramatically the past year, and we witnessed the phenomena midway
through the year of more than 180 US listed companies trading below cash levels.

It became clear that consistent financial management had given us the opportunity to focus on the diversification of activities,
on further research and preparing the new consumer focussed business, PhotoCosmetics. As the year passed, the Group
continued to increase its profitability through this uncertain environment, demonstrated by the release of the December half
year results, reporting a 93.9% increase to after-tax profit.

We reinvested in 2023 in further highly skilled personnel, we expanded the EPP market in Europe and US, and progressed

new pharmaceutical products. Specifically, we saw news on:

• PRÉNUMBRA® Instant, completed development, and administered for the first time in the clinic;
• the development of NEURACHTEL®;
• key clinical programs advanced – XP and DNA Repair, variegate porphyria, vitiligo and acute ischaemic stroke; and
• the first PhotoCosmetic product, CYACÉLLE, entered its pilot phase (first polychromatic screen).

At the end of book year 2023, the Company had enhanced its financial position, the highlights are:

Total Revenues & Other Income:

Up 24% to A$83.0 million

NPBT :

NPAT :

EPS :

ROE:

Dividend

Up 33% to A$45.6 million

Up 47% to A$30.6 million

Up 47% to 62 cents

Increased from 16.6% to 18.6%

5.0 cents per share, 6th consecutive year of distribution

The Board is closely involved in the Company’s operations, its developments and is across the unique challenges posed on
innovation in melanocortins. It therefore greatly appreciates the work our teams have delivered over the past year. These
outcomes overall have exceeded our expectations set at the beginning of the financial year, and do not come without
considerable commitment and effort from all involved. Keeping a team of professionals together and highly motivated has made
a real difference to patients’ lives. From the many stories of families and caretakers, we know how much we are improving the
lives of patients.

Overseeing this year, I owe all Clinuvellians a big “thank you” for what has been achieved the past year.

Remuneration outcomes FY2023

The tables in Section G of the Report set out the remuneration outcomes for Executive KMP and non-executive Directors

for FY2023.

The lower Australian dollar affected components of the total remuneration reported, for those executives who reside outside
Australia and are paid in non-Australian dollar currency. Inflationary adjustments had an impact to salaries in FY2023 and this
was combined with an average headcount increase of 7% when compared to the FY2022 average headcount for the Company.

For the financial year, the Managing Director received:
• gross fixed base remuneration of $1,593,117 - a modest increase of 6.9% compared to FY2022;
• STI – award is 60% of the maximum opportunity;
• LTI. As of 30 June 2023, 15% of the maximum number of the 1,513,750 performance rights granted to the CEO have been
assessed to have hit their performance condition, and we are anticipating up to 21% to be achieved by their vesting date.
I must add that the relatively low number of performance conditions achieved truly reflects the significant ‘stretch targets’
embodied in the performance rights plan designed and set by the Committee in 2019. The 15% percent performance conditions
achieved by the Managing Director is also well below the expectations of those who expressed concerns at the time of grant of
the performance rights, and who may have voted against the grant.

The Committee sets ambitious objectives for the performance conditions such that these are at “highest threshold”; the
challenging objectives at the time of grant in November 2019 was considered a novel approach in Australia at the time. Ahead
of the next AGM, we expect to inform our shareholders as to the future challenges we have set for our executives.

Yours sincerely,

Willem Blijdorp
Chairman of the Remuneration Committee

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

B. Remuneration Governance

(i) Remuneration Committee

The Board has provided a mandate to the Remuneration Committee to assist and advise on determining an appropriate
remuneration framework and policies for its KMP over time, taking into account the relationship between pay and performance,
and the results of any evaluations or review processes. The Board has also provided a mandate to the Remuneration Committee
to provide advice on setting salaries and fees, short- and long-term incentives and employment terms and conditions for its key
executives, and on non-executive director fees.

The objectives of the Remunerations Committee’s responsibilities are to ensure that:

• remuneration of the Company’s KMP is aligned with the interests of the Company and its shareholders within an

appropriate control framework, taking into account the Company’s strategies but also its risks.

• the level and composition of remuneration attract, motivate and retain professionals of high calibre and with unique

specialist industry knowledge to work towards the long-term growth and success of the Company.

• the role that total fixed remuneration and short- and long-term incentives play is clearly defined and provides a clear

relationship between performance and remuneration.

• the levels and structure of remuneration are benchmarked against relevant international peers and considered against

global employment market conditions.

• the Company gives due consideration to applicable legal requirements and appropriate standards of governance.
The methods used by the Remuneration Committee to assess Board performance is disclosed in the Corporate Governance

Protocol.

(ii) Remuneration Recommendations

Under the provisions of the Committee’s Charter, the Committee may engage the assistance and advice from external
remuneration firms which could include legal specialists and proxy advisors. Any recommendations made by remuneration
consultants are provided directly to members of the Committee to ensure no undue influence is exerted by any executive.

For the year ended 30 June 2023, the Remuneration Committee secured the services of remuneration advisors to provide
comparable peer company market data and advice on LTI plans. However, under the definition of the Corporations Act, no
remuneration recommendations were obtained during the financial year.

(iii) Voting and feedback at the Company’s last Annual General Meeting

In the 2022 Annual General Meeting (AGM), the Company obtained 81.47% of the proxy votes (including votes at the proxy’s
discretion) in favour of adopting the 2021/22 Remuneration Report, and this resolution was carried in favour by poll with 81.46%
of votes cast. A question was raised regarding the vesting of performance rights held by the Managing Director, otherwise the
Company did not receive any further specific feedback at the AGM on its remuneration practices.

C. Executive Remuneration

(iv) Executive Remuneration Framework

The following diagram links each of the executive remuneration components to the Company’s mission and strategy.

The Company’s reward framework has historically provided for a mix of fixed and variable pay. The variable pay is structured

to incentivise:

• short-term generally payments in the form of performance-based incentives awarded as a percentage of base salary.
•
long-term generally based upon the issuance of performance rights to acquire shares in the Company to secure and
recognise ongoing commitment.

The inherent risk of failure within pharmaceutical development and innovation is high and this risk is amplified for the
Company due to its history of implementing a specialised and narrow focus on developing and commercialising novel, first-in-
class and first-in-line therapies in diseases where there is an unmet clinical need.

The current progress and success of the Company needs to be set against previously unsuccessful managerial attempts to
develop melanocortin technologies for commercial use. To mitigate risk and to provide a strong platform to achieve meaningful
progress, the Board has followed a distinct business model where most operational skills are retained in-house, where possible,
and many management responsibilities are concentrated between the Managing Director, the CSO, and the CFO. The
Managing Director has the responsibility of guiding and overseeing the execution of the overall corporate strategy and has
global responsibility for the safety aspects of the lead’s drug technology.

The CSO is responsible for pre-clinical programs, toxicology, the manufacturing of the drug delivery program, clinical
programs and setting the regulatory strategies in close coordination with the Board of Directors. As the business evolves and
progresses through its development path, this centralised management model will continue to evolve, and key management
responsibilities are being shared across existing and new senior management who have been brought into the Company.

The CFO is responsible for the overall financial management and administration of the Group. The CFO is critical in assisting
the Board and Managing Director in its resource allocation and reinvestment decisions of cash and working capital, while
representing the Company to existing and new investors.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

The Board recognizes that experience, processes and the unique interaction between the three executive KMP and its

executive staff, as critical factors underlying the financial performance of the Company.

The Managing Director’s remuneration structure is reviewed every three years to ensure:
• a maximum level of incentivisation is in place to lead and advance the Company’s programs from its current stages of
development and commercial growth, in taking into account the unique risk and complexity of the chosen business
model; and
it is competitive in international markets to attract and retain specific skillsets.

•
In 2021/22 the Managing Director’s service agreement was renewed for a further three years, from 1 July 2022 to 30 June
2025. In determining the level and structure of the remuneration agreed with the Managing Director, the Remuneration
Committee considered the following criteria:

longevity of his 17+ years of service as CEO compared against the average tenure of local and international peers;

•
• track record, integrity, and professional qualifications to excel in the role;
• the enterprise value created since first employment;
• capability to sustain the Company’s focus to maximise profitability following market access;
• the demonstrated ability to maintain the solidarity of the business and management team over the long term; and
• communication of a longer-term vision to establish a diversified Group.

(v) Executive Remuneration Structure Financial year 2023

1. Fixed Base Remuneration Salary and Non-Monetary Benefits

In assessing the Managing Director’s STI for FY2023, the Remuneration Committee considered a variety of factors that
impacted the reporting period, and Dr Wolgen’s guidance was shown to navigate critical issues and challenges facing the
Company. The Remuneration Committee considered such factors including rising supply constraints and costs, inflationary
pressures, as well as the re-rating of life science companies globally, negotiations in key commercial and pricing contracts,
decision making and overall management and growth of the Group. The Committee assessed the treatment of patients across
Europe and the United States with uninterrupted supply, working with the centres to increase patient access, the challenges in
achieving and maintaining operating margins, and the progress made to expand the existing porphyria markets under pending
clinical, investigational settings. It viewed the overall progress of research, clinical and regulatory development, and the start of
a photocosmetic consumer-oriented business.

Additional objectives were taken into consideration when assessing other executive KMP performance by the Remuneration

Committee, which were considered an essential element of achieving individual performance.

However, some of these are considered commercially sensitive and are not disclosed.
The Managing Director’s STI performance outcomes for FY2023 are tabled below, as aligned with the CLINUVEL strategy.
An STI rating of 60.0% of the maximum potential opportunity for the Managing Director was achieved for FY2023 (FY2022: 42.5%).

STI Outcomes

Year Ended 30 June 2023

STIs summarised into
Strategic Grouping for Year

Managing Director

Weighting

Rating

Outcome

Fixed base remuneration (FBR) comprises base fees, superannuation and may include non-monetary benefits including health

R&D, Manufacturing

30%

Medium

insurance, accommodation, relocation, travel and statutory benefits.

FBR is set at a level to attract and retain talent with the requisite capabilities to deliver longer-term on CLINUVEL’s
objectives, taking into account a range of factors including, seniority, qualifications, skill, experience, length of service,
leadership, industry knowledge and level of strategic oversight.

FBR is tested annually for market competitiveness by reference to appropriate benchmarks recommended and provided by

Growth

25%

Low

external consultants and comparing to industry-relevant local and international peer companies.

FBR may be adjusted each year for changes to CPI. Any adjustments above CPI are in response to individual performance or

change in job scope and reviewed by the Remuneration Committee.

2. Short-Term Incentives

Short-Term Incentives (STIs) are annual payments to reward executives for achieving certain regulatory, development,

commercial and operational outcomes which are expected to contribute to increasing intrinsic and shareholder value.

Details of the STI arrangements are as follows:

Managing Director

Other Executive KMP

Setting and Assessment

Are reset at the start of each financial year by the
Remuneration Committee and are assessed at the
end of the financial year.

Are reset at the start of each financial year by the Managing
Director and are recommended to the Remuneration Committee
for their review and approval.

Maximum Opportunity

100% of Fixed Base Remuneration

Cessation of
employment

STIs will be evaluated for the current performance
period on a pro-rata basis.

Performance hurdles

Can be a mix of financial and non-financial targets.
All targets are set having regard to the
achievements and performance of the prior year,
market conditions and internal forecasts.

Chief Financial Officer: 20.5% of Fixed Base Remuneration
Chief Scientific Officer: 9% of Fixed Base Remuneration

Must be employed by the Company and not serving a period of
notice prior to the end of the relevant financial year. It will not be
paid pro-rata should the other KMP leave employment during the
relevant financial year.

Can be a mix of financial and non-financial targets. All targets are
set having regard to the achievements and performance of the
prior year, market conditions and internal forecasts.

In the year following the year of achievement.

The Company’s policy is not to disclose
commercially sensitive information, consistent with
best practice disclosure obligations but will provide
information on achieving the performance hurdles to
the extent commercially practicable. See the section
titled “Relationship between Remuneration and
Performance” on pages 69 and 70.

The Company’s policy is not to disclose commercially sensitive
information, consistent with best practice disclosure obligations
but will provide information on achieving the performance hurdles
to the extent commercially practicable. See the section titled
“Relationship between Remuneration and Performance” on pages
69 and 70.

Payment

Disclosure of
Performance

Development of the second afamelanotide formulation PRÉNUMBRA® INSTANT,
completed and now in clinical use
Progress in new pharmaceutically targeted formulations at pre-clinical stage
Advancement in NEURACTHEL manufacturing
Progress in establishing centres for clinical trial participation across multiple studies,
first results announced

Diligence conducted on a range of potential targets, public and private company
opportunities
Pilot launch of first dermatocosmetic product
Maintained strength in intellectual property protection; IP patent position defended

Increased total revenues in both major markets, complemented by disciplined,
controlled growth in expenditure base
Generated positive cash flows to increase cash reserves, enabling further reinvestment
Continued avoidance of external funding sources
Ongoing optimisation program to support future expansion

Financial Performance

30%

High

General Management & New
Initiatives

15%

Medium

Increased the size of the executive team
reduction to employee turnover rate
Progress made to receive approval to expand the use of SCENESSE® in adolescents

Total

100%

60.0%

Ratings Legend, Low = STIs are not met or marginally met, Medium = STIs are partially met, High = STIs are largely or wholly met

For the year ended 30 June 2023, the Remuneration Committee assessed overall performance for the 2022/23 year against
the Short-Term Incentives, which were recommended by the Managing Director, and who approved following assessments
against the maximum Short-Term Incentives:

Chief Scientific Officer – 100%
Chief Financial Officer – 85%

3. Long Term Incentives (equity-based incentives)

Long term incentives (LTIs) are generally offered in the form of performance rights, being an option to acquire ordinary shares
of CLINUVEL PHARMACEUTICALS LTD. Since 2010, the Company has issued LTIs to the Managing Director and to other
Executive KMPs on only three occasions. At the risk of forfeiting the performance rights, executives are generally required to
remain employed during the entire length of the vesting term before the performance rights can be exercised into ordinary
shares.

The LTIs are acquired at nil exercise price, and are offered to executive KMP and to staff from time to time to:
• support, attract and retain key executives;

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

• align their interests with CLINUVEL’s business strategy and maturity; and
• reward executives from improving long-term business performance and shareholder returns, and
• considering international and Australian best practices.
The Company does not issue LTIs annually to the Managing Director and executive KMPS, unlike many peer companies, but
instead sets longer-term objectives to align executives within the group to predetermined objectives. Due to setting these long-
term objectives, performance conditions have historically been based on a mix of financial and commercial objectives, and
operational targets strongly linked to shareholder value, such as, revenue growth and regulatory approvals.

Under the existing performance rights plan of 2014, and applicable to the performance rights issued to the Managing Director
in 2020, to other executive KMP in 2021, performance rights have a vesting end date of 20 November 2023.The achievement of
a performance condition is assessed and approved by the Board when it is considered satisfied, or the condition has otherwise
been waived by the Board. To date, no condition has been waived by the Board.

The Company may, at the sole discretion of the Board, determine that any ordinary shares exercised from vested performance
rights be acquired by a Plan Trustee and then, from time to time, transferred to the Executive KMP and other participants of
the Performance Rights Plan. The Company may determine and conclude agreements with the Plan Trustee and enforce or
prosecute any rights and obligations under such agreements, without reference or recourse to a participant under the Plan.

The performance conditions attached to performance rights previously issued to executive KMPs which are unvested at any

time during 2022/23 relate to long-term (multi-year) strategic, non-financial objectives.

At the 2019 Annual General Meeting, shareholders approved the grant of 1,513,750 Performance Rights to the Managing
Director and these Performance Rights were offered and issued to the Managing Director, who accepted the offer on 26 August
2020. Prior to this, the Managing Director was last issued Performance Rights five years previously, in the 2014/15 financial year.
These performance rights have a vesting period of up to four years from date of shareholder approval. If the performance
conditions are not achieved by 20 November 2023, these shall be forfeited and will lapse. On the reporting date the Group has
assessed the probability of the underlying performance conditions attached to the performance rights being achieved by their
vesting date to be 21% of the 1,513,750 performance rights granted to the Managing Director

Maximum LTI Opportunity

The Remuneration Committee outlines in its framework an annual maximum LTI opportunity as a percentage of fixed base
remuneration for executives. The maximum annual LTI opportunity for the Managing Director is assessed in context of two
factors:

•
•

the relative weightings between fixed base remuneration, STI and LTI as part of the overall package
desired positioning of each element relative to international markets.

The underlying conditions for the performance rights issued to the Managing Director and other Executive KMP are

presented in the “Description of Performance Conditions”, and tabled below:

Performance
Condition

Rationale

PC1

PC2

PC3

PC4

PC5

PC6

PC7

PC8

• to promote growth in Company value

• to diversify the Group whilst maintaining profitability

• to ensure conscious and risk-free financial management for further Company growth
• to provide for financial stability to protect Shareholder value and to act as a counter cyclical buffer during adverse

economic conditions

• to increase the revenue base

• to build further value from internal product development

• to expand its existing pharmaceutical product into a new market and increase commercial opportunities

• to expand new products in new or existing markets and increase potential revenue base

• to incentivise and reward for unanticipated commercial opportunities which are demonstrably value accretive

The market capitalisation targets defined in PC (i) to (v) continue to apply and were not replaced with performance targets in case of a recession for 2 consecutive quarters during the
vesting period.
A summary of the performance conditions granted to the Managing Director in respect of the Performance Rights approved by shareholders at the 2019 AGM are set out in pages 80 to 81.

The Board regarded each performance hurdle for the performance conditions at the time of issue to be extremely challenging
and this is now widely recognised by remuneration consultants, proxy advisors, and shareholders. This is currently
demonstrated in the number of Performance Rights whose underlying performance conditions have not yet been met since
their date of grant at the 2019 AGM. As at 30 June 2023, of the 1,513,750 granted to the Managing Director at the 2019 AGM,
1,197,500 performance rights, or 79% of the amount granted, are currently assessed as not likely to be probable of meeting
their underlying performance condition by the date of vesting of 20 November 2023. Overall, the Managing Director is expected
to meet just 21% of the performance hurdles set in 2019, indicating that these thresholds were set at ‘maximum stretch’.

The performance conditions attached to the Performance Rights granted to the other executive KMP are a mix of the same
performance conditions attached to performance rights granted to the Managing Director at the 2019 AGM, ensuring total
alignment with the Group’s long-term strategy, as well as role-specific performance conditions which are also linked to
enhancing corporate value and to promoting longer term retention of skills and knowledge.

For CFO and CSO, the relative percentage of LTIs awarded during the past four years and their probability of vesting is

highlighted in the table below:

Other Executive KMP

# Performance Rights

PC1-8

Role Specific PCs

Likely to be met by Vesting Date

CSO

CFO

75,813

339,875

69%

60%

31%

40%

26%

39%

No performance rights were issued to other executive KMP for the financial year ended 30 June 2023. For the financial year
ended 30 June 2022, the other executive KMP were issued in total 415,688 Performance Rights, to vest 20 November 2023, as
part of the remuneration reward framework to further align their interests with shareholders, to act as a key retention tool for
and to provide further incentivisation to build company value. Prior to the 2021/22 year, the other executive KMP were last
issued performance rights in the 2015/16 financial year.

4. Long Term Incentives - Future Issues to Executive KMP

The performance rights currently held by the executive KMP, including the Managing Director, vest on 20 November 2023.
After this date, the remuneration structure for the executive KMP will no longer contain a long-term, equity-based component
intended to provide the requisite level of motivation and incentivisation for the executive KMP to work towards the long-term
growth and success of the Company. After this date, the absence of equity-based LTI’s will not be in alignment with the reward
framework set by the Committee.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

the Company’s remuneration structure to remain competitive against international benchmarks to attract and retain existing
executive talent at the highest managerial calibre. The Board firmly acknowledges that it cannot limit its benchmarking and
consequent setting of the level and structure of its executive remuneration against local Australian peer companies only. The
selection criteria for these companies are broadly based on comparison of businesses and sectors:

a) of similar complexity and innovative nature;
b) of similar scope and scale;
c) requiring highly technical and specialised skills;
d) of similar value, reflected in market capitalisation;
e) which have demonstrated similar progress in achieving business outcomes; and
f) with a comparable risk profile.
During the year the Managing Director’s remuneration was benchmarked against four Australian and 22 US life science peer
companies with different profiles, since there are few profitable bio-technology companies globally serving as benchmark,
(except for the mix of medical device, human and animal health prescriptive and over-the-counter pharmaceutical product,
healthcare solutions and diagnostic focussed companies) using the following criteria:

Benchmarking Criteria

Australian Companies

US Companies

Market Capitalisation:

Between A$100 million and A$3 billion

Between US$300 million and US$5 billion

Generating Product Revenues:

Yes

Financial Status:

Positive EBITDA

The financial performance of the Company measured over 7 consecutive years, being the time from first commercial product

launch of its approved drug SCENESSE® has seen it rank strongly against revenue growth, EPS, and TSR amongst its peers.

In consultation with proxy advisors, remuneration and legal specialists, the Committee is designing a new long-term incentive
plan, in the form of performance rights that in the near term will be offered to the executive KMP, and in relation to the
Managing Director, will require shareholder approval prior to granting. Consistent with prior issues of performance rights, to
encourage retention, the next issue of performance rights will have a multi-year vesting period and will only be exercisable upon
the holder of the performance rights remaining in employment at the expiration of the vesting period. Various factors will be
considered when setting the amount of performance rights to be granted to the executive KMP, including:

length of time served;

•
• volume weighted average share price (VWAP) at time of issue;
• the level of fixed base remuneration;
• market trends among international peer companies;
• responsibility within the Group;
• potential impact on share dilution; and
• characterisation of vesting conditions attached to the issue of performance rights.
Given the context of the Company’s distinct operations, as well as the practices of its peers, the nature of the performance
conditions attached to future grants of performance rights to executive KMP, including the Managing Director, is expected to
be a mix of market and non-market conditions. The Committee acknowledges a change to the Company’s share price is not
solely determined by the financial performance achieved by management but can be influenced by the achievement of key
strategic objectives, and a mix of financial and strategic targets linked to the long-term reward structure would be the best fit
for the Company. The performance conditions could be linked to share price or other financial performance, clinical and
regulatory outcomes, business expansion, the growth in the photocosmetic consumer line and achievements not foreseen at
the time of grant due to a change in business direction. The Committee acknowledges the risk of changing business
circumstances during a long-term vesting period which may result in a deviation away from those performance conditions based
on strategic and operational outcomes. Accordingly, a future issue of performance rights will most likely have a discretionary
element attached to it to reward the participant in the event a change in business strategy that was unforeseen at the time of
grant is assessed as creating value.

Future issues of performance rights which may extend beyond the executive KMP and to be offered to other staff and

management will most likely incorporate common elements aligning the global team i with achieving its objectives.

5. Business Generation Incentive (BGI)* and Discretionary Payments

Since 2021, the Company no longer includes cash-based BGIs in executive service agreements, and it considers LTIs a better

instrument to ensure longer term value for shareholders.

BGIs are Individual longer-term cash incentive components based on specified performance-based targets which remain for

the term of an executive’s service agreement. BGIs had aimed to:

1) reward exceptional business outcomes that contribute to creating significant corporate value without shareholder

dilution through equity remuneration; and

2) to act as a key retention tool.
The Managing Director does not receive BGIs, no BGIs form part of the Managing Director’s service agreement. Only the

CFO has currently two BGIs remaining in his current service agreement, linked to:

1) expansion of the Company through acquisition and integration of a new entity with demonstrated positive cash flows of

the acquired entity post-acquisition; and

2) participation in an equity or debt funding event if deemed necessary to meet the business needs of the Company.

No BGIs were achieved by the Chief Financial Officer for the years ended 30 June 2023, or 30 June 2022

The Managing Director may be eligible to receive a discretionary cash payment only in the event of exceptional performance,
innovation, expansion, acquisitions, manufacturing and business development which do not form part of the STI or not
otherwise anticipated at the time of execution of the service agreement.

No discretionary payments have been made in 2023 or 2022.

(vi) Executive Remuneration – Peer Benchmarking

One of the Remuneration Committee’s responsibilities is to ensure that the level and structure of remuneration of staff are
benchmarked against relevant peers and considered against global employment market conditions. CLINUVEL refers to a select
group of publicly listed companies on the ASX and, more relevant, to international securities exchanges for the purpose of peer
group analyses.

CLINUVEL is a company operating globally with all commercial activities taking place outside Australia, and the bulk of its
operations and financial exposure falling within North America and the European Economic Area. It is considered critical for

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

For the past 7 years, the Company ranks:
• 5th amongst its peers for TSR performance;
• 4th among its peers for growth in earnings per share; and
• 2nd among its peers (above 90th percentile) in the compound annual growth of its total revenues.

Conversely, the CFO’s fixed base remuneration was found to be positioned below the median level, whereas the LTIs were
valued above the median level. The Board considers the level of fixed base remuneration to be appropriate, considering the
long-term outperformance of the Company and the relatively unusually long-term tenure of the Managing Director and CFO
who has led the restructure of the Company since 2005, building a profitable and sustainable business whilst delivering higher
shareholder return. The Board intends to address the LTIs to be awarded to the Managing Director to establish a comparable
level with CLINUVEL’s peers.

(vii)

Relationship Between Remuneration and Performance

The Group has dedicated its resources to the ongoing research, development and commercialisation of its unique and
medically beneficial technology. The remuneration and incentive framework, which has been put in place by the Committee,
has ensured executive personnel are remunerated such that they are focussed on both maximising short-term operating
performance and long-term strategic growth leading to shareholder value. A mix of metrics are used to assess achievement of
regulatory, development, commercial and operational outcomes, where financial metrics in isolation are not necessarily an
appropriate measure of executive performance.

Specifically, the Committee looks at relations between overall performance, strategic targets and progress of the Group, and

overall shareholder returns.

The table shows the development progress made during the year:

Throughout FY2023 CLINUVEL has been trading at a price earnings ratio above its Australian peers and above the majority
of its US peers, indicating a higher than fair value attributed to the Company. Ending the FY2023 year with a 20% growth in
share price.

In comparing FY2023 executive remuneration to the peer group remuneration for FY2022, the Managing Director’s fixed
base remuneration was found to be positioned above the median level, whereas the LTIs valued were below the median level.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

Analyses of CLINUVEL’s share price performance against main life science indices shows an equally positive outcome, both
in the shorter term (for the 12 months to 30 June 2023) and across the long-term (for the past seven years, consistent with the
period of time from first commercial product launch). However, the Board is cognizant that there may not always be a relation
between CLINUVEL’s volume weighted average share price (VWAP) and performance of the Company, as has been frequently
demonstrated.

6. Executive Remuneration Pay Mix

The Board believes the remuneration mix aligns the other executive KMP and Managing Director to shareholder interest.

The remuneration mix for 2022/23 is demonstrated as follows:

Position

Fixed Remuneration

STI Cash

LTI Cash1

LTI Equity1

Managing Director

100%

47% of Base Salary

None

191% of Base Salary

Other Executive KMP

CFO

CSO

100%

17.5% of Base Salary

None

633% of Base Salary

9% of Base Salary

None

89% of Base Salary

1. Shown as total value of performance rights calculated under AASB2 divided by 4 years (CEO) and 2.4 years (CFO and CSO) being the vesting period of the performance rights held
during the year.

The table below shows the share price and some of the key milestones the past year.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

D. Non-Executive Remuneration

E. Service Agreements FY2023

The Board seeks an appropriate combination of skills, diversity, experience, attitude and specific attributes to steward the
Company’s success. The Remuneration Committee recommends to the Board individual Non-Executive Director fee levels to
attract and retain those with the forementioned attributes, having regard to global employment market conditions and
consultation with specialist remuneration consultants with experience in the healthcare and biotechnology industries.

7. Non-Executive Director Fees

Non-Executive Director fees consist of base fees and committee fees and are inclusive of superannuation and all other

contributions.

There are no further retirement benefits. The fees are outlined in the table below:

Annual Non-Executive Director fees (inclusive of superannuation):

Chair

Non-Executive Director

Committee Chair

Committee Member

Board Fees

115,000

70,000

Audit & Risk
Committee

Remuneration
Committee

Nomination
Committee

15,000

5,000

15,000

5,000

* The Chair of the Board is a member of all Committees but does not receive any additional Committee fees in addition to the base fee.
** The CEO does not receive Board fees for his membership as director.

Under the Company’s Constitution, the maximum aggregate remuneration available for division among the Non-Executive
Directors is to be determined by the shareholders in a General Meeting and was set at $700,000 at the 2019 AGM. This amount
(or some part of it) is to be divided among the Non-Executive Directors as determined by the Board. The aggregate amount
paid to Non-Executive Directors for the year ended 30 June 2023 was $495,000.

8. Non-Executive Director Long-Term Incentive – Equity Compensation

The long-term equity remuneration was formerly provided to Non-Executive Directors via the CLINUVEL Conditional Rights
Plan and the Performance Rights Plan. Any issue of Performance Rights to Non-Executive Directors requires shareholder
approval.

It is not planned for Non-Executive Directors to participate in long-term equity compensation plans. No Non-Executive

Director holds performance rights as at 30 June 2023.

Remuneration and other terms of employment for the Managing Director and executive KMP are formalised by a service
agreement determined by the Remuneration Committee and accepted by the Board of Directors. The agreement provides for
fixed base remuneration, short- and long-term incentives, other benefits and participation, when eligible, in the CLINUVEL
Performance Rights Plan.

The Managing Director, in consultation with the Remuneration Committee, oversees the service agreements entered into
with other executive KMP, providing for base salary, incentives, other benefits and participation, when eligible, in the
CLINUVEL Performance Rights Plan.

On appointment to the Board, all Non-Executive Directors enter into a service agreement with the Company in the form of
a letter of appointment. The letter summarises the Board’s policies, the Director’s responsibilities and compensation for holding
office.

In the prior financial year 2022 the service agreements for key Executives Dr Wolgen and Mr Keamy were extended for a

further three years and two years respectively.

The details of the service agreements to the Managing Director and Executive KMP are:

Name

Dr Philippe Wolgen

Dr Dennis Wright

Mr Darren Keamy

Duration of contract

3 years

No fixed term

2 years

Notice Period (from Company)

12 months

3 months

12 months

Notice Period (from Managing Director)

12 months

Notice Period (from Executive KMP)

Termination Payment without Cause

12 months

Termination Payment with Cause

None

3 months

None

12 months

None

Contract End Date

30 June 2025

not applicable

30 June 2024

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

F. Equity-Based Awards

G. Details of Remuneration

The Group has an ownership-based scheme not only for Directors and other executive KMP but also for employees and select

consultants of the Company, which is designed to provide long-term incentives to deliver long-term value.

10. KMP remuneration of the Company for the years ended 30 June 2023 and 30 June 2022– Cash Based Benefits

9. Performance Rights:

All Performance Rights that have been issued fall under two Performance Rights plans:
• the CLINUVEL Conditional Performance Rights Scheme (2009); and
• the CLINUVEL Performance Rights Plan (2014).

a) Conditional Performance Rights Scheme (2009)

The Conditional Performance Rights Scheme (2009) has been available to eligible employees of the Company. Any issue of
rights to Directors requires shareholder approval in accordance with ASX Listing Rules. All Performance Rights convert to one
ordinary share of the Group and are issued for nil consideration, have no voting rights, are non-transferable and are not listed
on the ASX. These can be converted to ordinary shares at any time once the vesting conditions attached to the rights have been
achieved, whereby these will be held in a Scheme Trust on behalf of the eligible employee for up to seven years.

The eligible employee can request for shares to be transferred from the Scheme Trust after seven years or at an earlier date
if the eligible employee is no longer employed by the Company or all transfer restrictions are satisfied or waived by the Board
in its discretion. It is no longer intended to issue Performance Rights under the 2009 Plan.

As at 30 June 2023, 38,333 Performance Rights issued under the 2009 Scheme remain unvested.

b) Performance Rights Plan (2014)

The Performance Rights Plan (2014) is available to eligible persons of the Company. Any issue of rights to Directors requires
shareholder approval in accordance with ASX Listing Rules. Since 2020, the Company policy is for Non-Executive Directors to
not receive performance rights or other equity securities in the Company. All rights convert to one ordinary share of the Group
and are issued for nil consideration, have no voting rights, are not listed on the ASX and are non-tradeable (other than with
prior written Board consent). They can be converted to ordinary shares at any time once all vesting conditions attached to the
rights have been achieved. The Company may, at the sole discretion of the Board, determine that any shares exercised from
vested performance rights be acquired by a Plan Trustee and then, from time to time, transferred to participants to the
Performance Rights Plan. Unless the performance rights are granted with a shorter vesting period, performance rights under
this plan lapse after seven years from grant date.

Performance rights are valued for financial reporting purposes only, using either a Monte Carlo simulation pricing model or a
probability-adjusted binomial valuation pricing model and are represented as accounting values only in the financial statements.
Holders of performance rights may or may not receive a benefit from these amounts, either in the current or future reporting
periods. The value of all performance rights granted, exercised and lapsed during the financial year is detailed in the tables
within the Remuneration Report.

On June 29, 2023, the Company issued 255,750 performance rights to non-Key Management Personnel. Each performance
right entitles the holder to receive one fully paid ordinary share in CLINUVEL, subject to achieving certain time-served and
company performance-based vesting conditions. Unless the Board determines otherwise, each staff member must be employed
by CLINUVEL on the expiry date in order to exercise those performance rights that have met their performance conditions.

2,591,860 performance rights are issued under the 2014 Performance Rights Plan. 420,607 (16.3%) performance rights have

met their underlying performance condition but will not vest until the end of their vesting period.

Year

Gross
Salary ³

Short
Term
Incentive

Retention
Award4

Other¹

Superannuati
on/ Pension
Fund

Subtotal

Leave
Entitlements
Paid Out,
(Exceptional)

Total
(Excluding
Share-Based
Payments)

2023

1,593,117

898,244

286,314

2022

1,490,048

560,113

101,731

198,128

2,777,675

2,350,020

1,314,157

3,664,177

2023

76,923

2022

77,273

2023

115,000

2022

115,000

2023

75,000

2022

75,000

2023

75,000

2022

75,000

2023

67,874

2022

68,182

2023

70,000

2022

17,051

2023

289,182

26,026

2022

278,059

25,025

2023

331,737

58,054

2022

331,737

46,443

12,000

8,077

85,000

7,727

85,000

115,000

75,000

7,126

75,000

6,818

75,000

70,000

17,051

25,292

340,500

23,568

326,652

25,292

415,083

23,568

413,748

2023

2,693,833

982,324

286,314

65,787

4,028,258

85,000

115,000

75,000

70,000

17,051

340,500

326,652

415,083

413,748

4,028,258

Dr. P. J. Wolgen2

Mrs. B. M. Shanahan

Mr. W. A. Blijdorp

Dr. K. A. Agersborg

Mrs. S. E. Smith

Prof. J. V. Rosenfeld

Prof J. A. Likierman

Dr. D. J. Wright

Mr. D. M. Keamy

Total

2022

2,527,350

631,581

113,731

198,128

61,681

3,532,471

1,314,157

4,846,628

1) ‘Other’ includes health insurance, housing and other allowances that may be subject to fringe benefits tax.
2) Dr Wolgen’s salary is paid in Euro currency.
3) Does not include movement in annual leave and long service leave provisions.

4) In FY2022 Retention Awards were removed from executive service agreements.
For Mr Keamy and Dr Wright, the movement to their aggregate annual leave and long service leave entitlements was $11,206 accretive and $24,693 reduction respectively (year ending
30 June 2022: $39,991 and $9,698 increase respectively).

For Dr Wolgen the accretive movement to his aggregate annual leave and long service leave entitlements for year ending 30 June 2023 was $149,280.

FY2022 Leave Entitlements Paid Out

Paid annual leave and long-service leave are considered compensation as defined by Australian Accounting Standards Board AASB 119 Employee Benefits and the Corporations
Regulations 2001 - REG 2M.3.03. During the year a management review was undertaken to address the increase in the Group’s current and non-current employee provisions over time.
As a result of the review, to assist in reducing the value of employee entitlements appearing on the Group Balance Sheet, the Board of Directors approved the payment of all unused,
accrued annual leave and long service leave owed to the Managing Director from employment start in November 2005 up to 30 June 2021. The payout was made in lieu of the Managing
Director consuming the employee entitlements through taking an enforced, extended leave of absence from his duties as Chief Executive Officer and Managing Director.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

KMP remuneration of the Company for the years ended 30 June 2023 and 30 June 2022 – Non-Cash
Benefits

Share-based payments (accounting charge only)¹

Remuneration Performance Rights holdings of KMP – 2023

Balance at
Start of Year

Issued as
Compensation

Exercised

Lapsed and
Expired

Balance at
End of Year

Perform Condition met,
not exercisable until
end Vesting Period*

Total (Excluding
Share-Based
Payments)

Performance
Rights
(for accounting
purposes only)

Total (Including
Share-Based
Payments, for
accounting
purposes only)

%
Performance-
based

2,777,675

3,612,426

6,390,101

3,664,177

3,448,463

7,112,640

71%

56%

85,000

115,000

75,000

70,000

17,051

340,500

326,652

296,352

176,165

85,000

115,000

75,000

70,000

17,051

636,852

502,817

415,083

2,674,581

3,089,664

413,748

1,196,205

1,609,953

4,028,258

6,583,359

10,611,617

4,846,628

4,820,833

9,667,461

51%

40%

88%

77%

Year

2023

2022

2023

2022

2023

2022

2023

2022

2023

2022

2023

2022

2023

2022

2023

2022

2023

2022

2023

2022

Dr. P. J. Wolgen

Mrs. B. M. Shanahan

Mr. W. A. Blijdorp

Dr. K. A. Agersborg

Mrs. S. E. Smith

Prof. J. V. Rosenfeld

Prof J. A. Likierman

Dr. D. J. Wright

Mr. D. M. Keamy

Total

1. As these values represent accounting values the KMP may or may not actually receive any benefit from these amounts, either in the current or future reporting periods. Any
benefit obtained by the KMP is contingent upon the Company achieving certain performance conditions and the employee remaining in employment to a fixed date. The value of
all performance rights and share options granted, exercised and lapsed during the financial year is detailed in the following tables within the Remuneration Report. Performance
rights were priced using either the Monte Carlo simulation pricing model or a binomial pricing model. The amount expensed each reporting period includes adjustments to the
life-to-date expense of the grants based on the reassessed estimate of achieving non-market performance criteria.

Directors

Dr. P. J. Wolgen

1,513,750

Mrs. B. M. Shanahan

Mr. W. A. Blijdorp

Dr. K. A. Agersborg

Mrs. S. E. Smith

Prof. J. V. Rosenfeld

Prof. J. A. Likierman

Other KMP

Dr. D. J. Wright

Mr. D.M. Keamy

93,938

347,235

1,513,750

227,000

93,938

347,235

11,328

86,400

*The underlying performance-based conditions have been met, but performance rights will not vest until the end of the vesting period. All Performance Rights held at the end of the year
are unvested.

Shares held by KMP

The number of ordinary shares in the Company during the 2022/23 reporting period held by each of the Group’s KMP,

including their related parties, is set out below:

Year Ended 30 June 2023

Personnel

Dr. P. J. Wolgen

Mrs. B. M. Shanahan

Mr. W. A. Blijdorp

Dr. K. A. Agersborg

Mrs. S. E. Smith

Prof. J. V. Rosenfeld

Prof. J. A. Likierman

Other KMP

Dr. D. J. Wright

Mr. D. M. Keamy

Balance at
Start of Year

Granted as
Remuneration

Received
on Exercise

Other Changes

Held at the End of
Reporting Period

3,120,715

196,577

1,743,118

5,500

420

2,848

1,000

256,874

313,588

1,532

3,122,247

300

196,577

1,743,118

5,500

420

3,148

1,000

(100,000)

156,874

(135,000)

178,588

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

Terms and conditions of each grant of rights affecting remuneration in the current or future
reporting periods

Entity

Number
of Rights
Granted

Value per
Right on
Grant Date

Class

Grant Date

Issue date

Expiry Date

Perform Condition met,
not exercisable until
end Vesting Period

Exercisable
Date

CLINUVEL

450,000

$10.86

Ordinary

20/11/2019

26/08/2020

20/11/2023

45,000

20/11/2023

CLINUVEL

1,063,750

$26.87

Ordinary

20/11/2019

26/08/2020

20/11/2023

182,000

20/11/2023

Remuneration details of cash incentives

Cash Incentives

Name

Max Potential Opportunity (%)

STI Awarded (%)*

STI Forfeited (%)

Total Granted ($)

Dr. P. J. Wolgen

Dr. D. J. Wright

Mr. D. M. Keamy

100%

20.5%

56%

100%

85%

53%

15%

898,244

26,026

58,054

CLINUVEL

37,976

$8.97

Ordinary

24/12/2020

20/11/2023

3,798

20/11/2023

* For the Managing Director, the STI Awarded in the functional currency on his base salary was 60.0%

Loans to Directors and Executives

No loans were granted to Directors or executives for the years ended 30 June 2023 and 30 June 2022.
Signed in accordance with a resolution of the Board of Directors pursuant to s.298(2) of The Corporations Act 2001.

CLINUVEL

94,524

$20.73

Ordinary

24/12/2020

20/11/2023

31,543

20/11/2023

CLINUVEL

133,440

$18.74

Ordinary

26/08/2021

20/11/2023

24,901

20/11/2023

CLINUVEL

598,484

$26.22

Ordinary

26/08/2021

20/11/2023

123,566

20/11/2023

CLINUVEL

22,500

$12.87

Ordinary

05/05/2022

20/12/2024

For each STI incentive and right(s) granted, the percentage of the available grant or STI that was paid or vested in the financial
year, and the percentage forfeited due to unmet milestones (including service length), is set out below. STIs are paid in the year
following the period of performance.

Remuneration details of Equity Incentives (Performance Rights)

Equity Incentives (Performance Rights)

Name

Year Granted

Latest Year of
Vesting

Vested in Year

Lapsed &
Forfeited in
Year

Dr. P. J. Wolgen

2019/20 *

2023/24

Mrs. B. M. Shanahan

Mr. W. A. Blijdorp

Dr. K. A. Agersborg

Mrs. S. E. Smith

Prof. J. V. Rosenfeld

Prof J. A. Likierman

Other KMP

Dr. D. J. Wright

2011/12

no limitation

2021/22

2023/24

Mr. D. M. Keamy

2011/12

no limitation

2021/22

2023/24

Max Value of Right
at
Grant Date Yet to
Vest

8,226,311

12,853

466,723

5,219

3,169,166

On exercise, each Performance Right entitles the KMP to one fully paid ordinary share in the Company. The share price of the Company at the time of exercise is not known. The
minimum value of unvested performance rights is $Nil. The exercise price for those Rights granted between 2010/11 and 2021/22 was $Nil.
* At the 2019 Annual General Meeting, shareholders approved the grant of 1,513,750 performance rights to the Managing Director and these performance rights were issued on 26
August 2020. At 30 June 2023, it is assessed that 21% of these performance rights are considered probable to be met by their vesting date of 20 November 2023..

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

H. APPENDIX

Details of performance rights issued to Managing Director,
expiring 20 November 2023

PC1 Performance Rights granted to Managing Director – 450,000

Executive management and staff succeeding in steering the Company to a:

Performance Condition
met, not exercisable
until end Vesting Period
(20 November 2023)

(i) Market capitalisation of a minimum A$1,700,000,000 - as measured by a minimum of 15 trading days

üü

during the vesting period - 10% of the performance rights under PC1 shall vest,

(ii) Market capitalisation of a minimum A$2,100,000,000 - as measured by a minimum of 15 trading days

during the vesting period - 15% of the performance rights under PC1 shall vest,

(iii) Market capitalisation of a minimum A$2,700,000,000 - as measured by a minimum of 15 trading days

during the vesting period - 25% of the performance rights under PC1 shall vest,

(iv) Market capitalisation of a minimum A$5,000,000,000 - as measured by a minimum of 15 trading days

during the vesting period - 25% of the performance rights under PC1 shall vest,

(v) Market capitalisation of a minimum A$7,500,000,000 - as measured by a minimum of 15 trading days

during the vesting period - 25% of the performance rights under PC1 shall vest.

Only in case of a recession in the country of the Company’s primary market exchange (recession defined by a
contraction of gross domestic product for 2 consecutive quarters) when the Company’s market capitalisation
may be adversely impacted by conditions outside management control, that the market capitalisation targets
defined in PC1 (i) to (v) above will be replaced by the following performance targets:

(i) The Company’s growth in share price outperforms either the Nasdaq Biotech Index or ASX Healthcare

Index for 1 quarter - after the country has entered a recession - by more than 3.0%, 10% of the
performance rights under PC1 shall vest,

(ii) The Company’s growth in share price outperforms either the Nasdaq Biotech Index or ASX Healthcare

Index for 1 quarter - after the country has entered a recession - by more than 4.0%, 15% of the
performance rights under PC1 shall vest,

(iii) The Company’s growth in share price outperforms either the Nasdaq Biotech Index or ASX Healthcare

Index for 1 quarter - after the country has entered a recession - by more than 5.0%, 25% of the
performance rights under PC1 shall vest,

(iv) The Company’s growth in share price outperforms either the Nasdaq Biotech Index or ASX Healthcare

Index for 1 quarter - after the country has entered a recession - by more than 7.0%, 25% of the
performance rights under PC1 shall vest,

(v) The Company’s growth in share price outperforms either the Nasdaq Biotech Index or ASX Healthcare

Index for 1 quarter - after the country has entered a recession - by more than 9.0%, 25% of the
performance rights under PC1 shall vest.

When the country of the Company’s primary market exchange is no longer in recession, this performance
condition reverts back to the original market capitalisation conditions.

PC2 Performance Rights granted to Managing Director – 105,000

(i) Upon quarterly reporting of A$60 million in cash and cash equivalents held for 2 consecutive quarters,

15% of PC2 shall vest,

(ii) Upon quarterly reporting of A$70 million in cash and cash equivalents held for 2 consecutive quarters, a

further 20% of PC2 shall vest,

(iii) Upon quarterly reporting of A$80 million in cash and cash equivalents held for 2 consecutive quarters, a

further 30% of PC2 shall vest,

üü

(iv) Upon quarterly reporting of more than A$150 million in cash and cash equivalents held for 2 consecutive

quarters, a further 35% of PC2 will be achieved.

Dividends paid out during the vesting period shall be added back to the calculation of the cash reserves. At
any time during the vesting period, the ratio between cash and cash equivalents internally generated from
the Company’s operations and any debt and/or equity financing which increases cash and cash equivalents
must be at minimum 2:3 ratio for any of the 5 performance targets under PC2 to be achieved.

PC3 Performance Rights granted to Managing Director – 105,000

Successful acquisition of a business entity, defined by:

(i) The acquired entity must have generated sales revenue within 6 months of transaction, 50% of PC3 shall

vest,

(ii) CUV Group becomes or remains profitable within 3 years (plus variability of one year) of transaction as
measured by two successive quarters reporting profitability of the two or more combined entities, 50%
of PC3 shall vest.

For PC3 to be achieved, the acquisition must be considered synergistic to the Company’s business
operations at the time of acquisition.

PC4 Performance Rights granted to Managing Director – 87,500

(i) Upon receipt of first US revenues under the US post-marketing authorization for SCENESSE®, 34% of

PC4 shall vest,

(ii) US revenues in year 3 to exceed revenues by a minimum of 10% in year 2, a further 33% of PC4 shall vest,

(iii) US revenues greater than US$10,000,000 in a 12-month period leads to vesting of 33% of PC4.

PC5 Performance Rights granted to Managing Director – 175,000

(i) Market launch of first non-pharmaceutical (‘OTC’) product(s) line developed by the VALLAURIX

subsidiary entity, 15% of PC5 shall vest,

(ii) Total revenues from OTC product lines developed by the VALLAURIX subsidiary entity achieving

greater than A$250,000 in accumulated gross sales, a further 30% of PC5 shall vest,

üü

(iii) First topical melanogenic formulation to be used either in animal or in human testing, a further 25% of

PC5 shall vest,

(iv) Upon the completion of the first clinical study of a SCENESSE® paediatric formulation (being the

completion of a final clinical study report), a further 30% of PC5 shall vest.

PC6 Performance Rights granted to Managing Director – 262,500

(i) Upon start (being the closure of recruitment period) of a Phase IIb vitiligo study in North America, 20%

of PC6 shall vest,

(ii) Upon disclosure to the securities exchange of the results to the Phase IIb vitiligo study in North

America, 20% of PC6 shall vest,

(iii) After the completion of the Phase IIb vitiligo study in North America and prior to the subsequent Phase

IIb/III study, upon holding a Type-C meeting (FDA) and acceptance of study protocol for the Phase IIb/III
vitiligo study in North America, a further 20% of PC6 shall vest,

(iv) Upon start (being the closure of recruitment period) of the subsequent Phase IIb/III vitiligo study in

North America, a further 20% of PC6 shall vest,

(v) Upon disclosure to the securities exchange of the results to the subsequent Phase IIb/III vitiligo study in

North America, 20% of PC6 shall vest.

PC7 Performance Rights granted to Managing Director – 212,500

(i) Upon the regulatory submission to either of EMA, FDA, TGA, PMDA and Swissmedic to approve

SCENESSE® or any other molecule or product enhancing the pharmaceutical product line-only offerings
of the Company, 25% of PC7 shall vest,

(ii) Upon the regulatory approval by either of EMA, FDA, TGA, PMDA and Swissmedic of SCENESSE® or any
other molecule constituting a successful evaluation of a scientific dossier, a further 75% of PC7 shall vest.

PC8 Performance Rights granted to Managing Director – 116,250

The Board to use its discretion to award performance rights depending on the extraordinary nature of the
corporate event(s) achieved and the significant impact on the Company's value. It is not certain that these
performance rights will be issued during the fixed term of the Conditional Rights Plan, and hence these need
to be regarded as a reserve pool enabling the Company to grant in the event of exceptional and unexpected
performances which was unanticipated at the time of business planning.

These corporate events shall include, but are not limited to, business generation in new markets without the
Company engaging in merger and acquisition activity.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

END OF AUDITED REMUNERATION REPORT

Shares Provided Upon Exercise of Rights

Details of Shares issued during the financial year as a result of exercise of rights

Entity

Number of shares issued

Issue Price for Shares

Class

CLINUVEL PHARMACEUTICALS LTD

Nil

$Nil

Ordinary

Unissued shares under option

Entity

Number of
Shares under
Rights

Exercise Price

Class

Expiry Date

CLINUVEL PHARMACEUTICALS LTD

2,630,193

$Nil

Ordinary

Upon achievement of specific
performance and time-based
milestones or upon cessation of
employment

Total as at date of Directors Report

2,630,193

Auditor’s Independence Declaration

The auditor’s independence declaration as required by s.307C of the Corporations Act 2001 is included in page 115 of this

Annual Report, and forms part of this Directors’ Report.

Proceedings On Behalf Of the Company

No person has applied for leave of Court to bring proceedings on behalf of the Company or intervene in any proceedings to
which the Company is party for the purpose of taking responsibility on behalf of the Company for all or any part of those
proceedings.

The Company was not party to any such proceedings during the year.

Dr. Philippe Wolgen, MBA MD
Director
Dated this 29th day of August, 2023

Statement of Profit and Other Comprehensive Income
for the Year Ended 30 June 2023

Revenues

Commercial sales of goods

Sales reimbursements

Total revenues

Interest income

Total interest income

Other income

Unrealised gain on restating foreign currency balances and currencies held

Realised foreign currency gain on transactions

Government grants and other income

Total other income

Total expenses

Personnel-related

Materials and related expenses

Share-based payments

Finance, corporate and general

Commercial distribution

Legal, insurance and IP

Clinical and non-clinical development

Depreciation and amortisation

Communication, branding and marketing

Note

Consolidated Entity
2022
$

2023
$

72,179,047

60,002,220

6,142,271

5,720,072

78,321,318

65,722,292

3,905,856

659,901

79,364

23,817

763,082

444,071

604,317

216,835

821,152

13,576,951

11,590,661

12,063,281

8,989,788

3,192,713

3,145,355

1,323,383

1,268,456

789,408

749,769

5,401,679

6,120,977

2,274,357

2,494,361

1,147,199

1,232,989

757,826

291,772

Changes in inventories of raw materials, work in progress and finished goods

(7,687,571)

1,354,779

Total expenses

Profit before income tax

Income tax on income

Current

Deferred

Income tax expense

Operating profit after income tax

Net profit for the year

Other comprehensive income

37,411,533

32,666,600

45,578,723

34,320,915

16,382,733

(1,408,576)

7,367,889

6,074,561

14,974,157

13,442,450

3(a)

17(b)

30,604,566

20,878,465

30,604,566

20,878,465

Items that may be re-classified subsequently to profit or loss

Exchange differences of foreign exchange translation of foreign operations

(1,454,160)

(1,057,433)

Other comprehensive loss for the period, net of income tax

Total comprehensive income for the period

Basic earnings per share - cents per share

Diluted earnings per share - cents per share

The accompanying notes form part of these financial statements.

(1,454,160)

(1,057,433)

29,150,406

19,821,032

61.9

59.1

42.3

40.3

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

Statement of Financial Position as at 30 June 2023

Statement of Cash Flows for the Year Ended 30 June 2023

Current assets

Cash and cash equivalents

Trade and other receivables

Inventories

Other assets

Total current assets

Non-current assets

Property, plant and equipment

Right-of-use assets

Intangible asset

Deferred tax assets

Total non-current assets

Total assets

Current liabilities

Trade and other payables

Income tax payables

Provisions

Lease Liabilities

Total current liabilities

Non-current liabilities

Deferred tax liabilities

Lease Liabilities

Provisions

Total non-current liabilities

Total liabilities

Net assets

Equity

Contributed equity

Reserves

Accumulated losses

Total equity

The accompanying notes form part of these financial statements.

Note

Consolidated Entity

2023

2022

Cash flows from operating activities

Receipts from customers

17(a)

156,813,537

121,509,282

Payments to suppliers and employees

22,214,646

16,201,937

9,519,462

1,831,891

1,070,153

1,039,453

189,617,798

140,582,563

Income taxes paid

Interest received

GST and VAT refunds

Government grants

2,017,861

1,540,702

Cash flows from investing activities

833,326

1,159,642

Payments for property, plant and equipment

185,030

Net cash used in investing activities

3(c)

1,059,541

481,600

Cash flows from financing activities

4,095,758

3,366,974

193,713,556

143,949,537

Dividends paid

Payment of lease liabilities

Payment of interest

7,649,572

3,277,857

Net cash used in financing activities

16,094,178

7,279,449

Net increase in cash held

Note

Consolidated Entity
2022
$

2023
$

74,877,720

66,399,524

(33,230,793)

(27,352,186)

(7,744,922)

2,727,126

248,999

260,923

358,687

22,009

217,258

(1,027,532)

(434,438)

(1,027,532)

(434,438)

(1,976,414)

(1,235,265)

(263,718)

(268,492)

(2,240,132)

(1,503,757)

33,644,399

37,934,087

121,509,282

82,690,982

Net cash provided by operating activities

17(b)

36,912,063

39,872,282

1,450,120

2,859,828

300,843

315,068

25,494,713

13,732,202

3(c)

2,757,516

3,615,281

699,022

941,463

131,162

101,548

3,587,700

4,658,292

29,082,413

18,390,494

164,631,143

125,559,043

151,849,375

22,556,044

12,112,096

(9,774,276)

(38,402,428)

164,631,143

125,559,043

Cash and cash equivalents at beginning of the year

Effects of exchange rate changes on foreign currency held

1,659,856

884,213

Cash and cash equivalents at end of the year

17(a)

156,813,537

121,509,282

The accompanying notes form part of these financial statements.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

Statement of Changes in Equity for the Year Ended 30 June 2023

Share Capital

Performance
Rights
Reserve

Foreign
Currency
Translation
Reserve

Retained
Earnings

Total Equity

Balance at 30 June 2021

151,849,375

4,343,422

674,405

(58,129,768)

98,737,434

Exercise of performance rights under share-
based payment

Employee share-based payment options

6,036,836

84,141

6,120,977

Dividends paid

(1,235,266)

Transactions with owners

151,849,375

10,380,258

674,405

(59,280,893)

103,623,145

Profit for the year

20,878,465

Other comprehensive income:

Exchange differences of foreign exchange
translation of foreign operations

Total other comprehensive income

1,057,433

Balance at 30 June 2022

151,849,375

10,380,258

1,731,838

(38,402,428)

125,559,043

Exercise of performance rights under share-
based payment

Employee share-based payment options

8,989,788

Dividends paid

(1,976,414)

Transactions with owners

151,849,375

19,370,046

1,731,838

(40,378,842)

132,572,417

Profit for the year

Other comprehensive income:

Exchange differences of foreign exchange
translation of foreign operations

Total other comprehensive income

30,604,566

1,454,160

Balance at 30 June 2023

151,849,375

19,370,046

3,185,998

(9,774,276)

164,631,143

Notes To And Forming Part Of The Financial Statements
For The Year Ended 30 June 2023

1. Basis Of Preparation

The financial report is a general purpose financial report that has been prepared in accordance with Australian Accounting
Standards, other authoritative pronouncements of the Australian Accounting Standards Board and the Corporations Act 2001.
Compliance with Australian Accounting Standards ensures the consolidated financial statements and notes of the consolidated
entity with International Financial Reporting Standards (“IFRS”). CLINUVEL PHARMACEUTICALS LTD is a for-profit entity
for the purposes of reporting under Australian Accounting Standards.

The financial report has been prepared on an accruals basis and is based on historical costs and does not take into account
changing money values or, except where stated, current valuations of financial assets. Cost is based on the fair values of the
consideration given in exchange for assets. The accounting policies have been consistently applied, unless otherwise stated.

Both the functional and presentation currency of the Group and its Australian controlled entities is Australian dollars. The
functional currency of certain non-Australian controlled entities is not Australian dollars. As a result, the results of these entities
are translated to Australian dollars for presentation in the CLINUVEL PHARMACEUTICALS LTD financial report.

In applying Australian Accounting Standards management must make judgements regarding carrying values of assets and
liabilities that are not readily apparent from other sources. Assumptions and estimates are based on historical experience and
any other factor that are believed reasonable in light of the relevant circumstances. These estimates are reviewed on an ongoing
basis and revised in those periods to which the revision directly affects.

All accounting policies are chosen to ensure the resulting financial information satisfies the concepts of relevance and

reliability.

a) Principles Of Consolidation

The consolidated financial statements are prepared by combining the financial statements of all the entities that comprise
the consolidated entity, being the Company (the parent entity) and its subsidiaries as defined in Australian Accounting Standard
Board (AASB) 10. Consistent accounting policies are employed in the preparation and presentation of the consolidated financial
statements.

The consolidated financial statements include the information and results of each subsidiary from the date on which the
Company obtains control and until such time as the Company ceases to control such entity. In preparing the consolidated
financial statements, all intercompany balances and transactions, and unrealised profits arising within the consolidated entity
are eliminated in full.

All the Group’s subsidiaries are wholly-owned. There are no longer non-controlling interests with ownership interests in any

of the Group’s subsidiaries.

b) Going Concern

The financial statements of the consolidated entity have been prepared on a going concern basis. The consolidated entity’s
operations are subject to risk factors that could materially impact the financial performance and position of the consolidated
entity.

The going concern basis assumes that, if required, future capital raisings will be available to enable the consolidated entity to
acquire new entities with projects of interest and to undertake the research, development and commercialisation of existing
projects and that the subsequent commercialisation of products will be successful. The consolidated entity has successfully
raised additional working capital in past years. Should cash flows from its commercialisation activities not provide adequate
funding to finance potential acquisitions or sustain its research, development and commercialisation projects in the coming
financial year, the Directors would consider the need to bring in additional funds from various funding sources. The Company
has sufficient amounts of cash to be able to continue as a going concern and therefore will be able to realise its assets and
extinguish its liabilities in the normal course of business and at the amounts stated in the financial statements.

c) Income Tax

Current Tax

Current tax is calculated by reference to the amount of income tax payable or recoverable in respect of the taxable profit or
loss for the period. It is calculated using tax rates and tax laws that have been enacted or substantially enacted by reporting
date. Current tax for current and prior periods is recognised as a liability to the extent it is unpaid.

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

Deferred Tax

Deferred tax is accounted for using the comprehensive balance sheet liability method in respect of temporary differences
arising from differences between the carrying amount of assets and liabilities in the financial statements and corresponding tax
base of those items.

In principle, deferred tax liabilities are recognised on all taxable differences. Deferred tax assets are recognised for deductible
temporary differences and unused tax losses to the extent that it is probable that sufficient unused tax losses and tax offsets
can be utilised by future taxable profits. However, deferred tax assets and liabilities are not recognised if the temporary
differences giving rise to them arise from the initial recognition of assets and liabilities (other than as a result of a business
combination) which affect neither taxable income nor accounting profit. Furthermore, a deferred tax liability is not recognised
in relation to taxable temporary differences arising from goodwill.

Deferred tax liabilities are recognised for taxable temporary differences arising on investments in subsidiaries, except where
the consolidated entity is able to control the reversal of the temporary differences and it is probable that the temporary
differences will not reverse in the foreseeable future. Deferred tax assets arising from deductible temporary differences
associated with these investments and interests are only recognised to the extent that it is probable that there will be sufficient
taxable profits against which to utilise the benefits of the temporary differences and they are expected to reverse in the
foreseeable future.

Deferred tax assets and liabilities are measured at the tax rates that are expected to apply to the period(s) when the asset
and liability giving rise to them are realised or settled, based on tax rates (and tax laws) that have been enacted or substantially
enacted by reporting date. The measurement of deferred tax liabilities and assets reflects the tax consequences that would
follow from the manner in which the consolidated entity expects, at the reporting date, to recover or settle the carrying amount
of its assets and liabilities.

Deferred tax assets and liabilities are offset when they relate to income taxes levied by the same taxation authority and the

Company/consolidated entity intends to settle its current tax assets and liabilities on a net basis.

Tax Consolidation

The Company and its wholly-owned Australian entities are part of a tax-consolidation group under Australian taxation law.

CLINUVEL PHARMACEUTICALS LTD is the head entity of the tax-consolidation group.

Current And Deferred Tax For The Period

Current and deferred tax is recognised as an expense or income in the Statement of Profit or Loss and Other Comprehensive
Income, except when it relates to items credited or debited directly to equity, in which case the deferred tax is also recognised
directly in equity, or where it arises from the initial accounting for a business combination, in which case it is taken into account
in the determination of goodwill or discount on acquisition.

The deferred tax asset has been recognised as at 30 June 2023 and 30 June 2022 after management judgement was applied

to assess whether its unused tax losses and tax offsets could be utilised by future taxable profits. It was determined:

• The consolidated entity has experienced consecutive years of profitability and revenue growth;
• Current pricing agreements with European and US payors are not expected to change in the next financial year;
• An increase to consolidated entity revenues are expected in the near term from making SCENESSE® available in the USA

and UK;

• Whilst internal targets continue to expect ongoing profitability in the near term, there is uncertainty around expected

future taxable income in the longer term as part of the business strategy to expand the Company.

d) Cash And Cash Equivalents

Cash and cash equivalents comprise of cash on hand, at call and term deposits with banks or financial institutions, bank bills
and investments in money market instruments where it is easily convertible to a known amount of cash and subject to an
insignificant risk of change in value.

Cash at bank earns floating rates based on daily bank deposit rates. The carrying amounts of cash and cash equivalents
represent fair value. Cash equivalents are held for the purpose of meeting short-term cash commitments rather than for
investment or other purposes. The term deposits are readily convertible to cash within 31 days’ notice and after a market-
related rate reduction to the interest on the term deposit principal is applied.

e) Inventories

Raw materials, work in progress and finished goods are stated at the lower of cost or net realisable value. Cost comprises,
direct material and labour. Costs are assigned to individual items of inventory on the basis of weighted average costs. Net
realisable value is the estimated selling price in the ordinary course of business less the estimated costs of completion and the
estimated costs necessary to make the sale.

f) Other Current Assets

Other current assets comprise prepayments of drug peptide still in development stage and yet to be used in the Group’s R&D
program and prepayments for certain insurances yet to expire, along with other general prepayments. The expenditures
represent an unused expense and therefore a decrease in future economic benefit has yet to be incurred.

g) Property, Plant And Equipment

Plant and equipment are stated at cost less accumulated depreciation and impairment. Cost includes expenditure that is
directly attributable to the acquisition of the item. In the event that settlement of all or part of the purchase consideration is
deferred, cost is determined by discounting the amounts payable in the future to their present value as at the date of acquisition.
Depreciation is calculated on diminishing value so as to write off the net cost of each asset over its expected useful life to its
estimated residual value. The estimated useful lives, residual values and depreciation method are reviewed at the end of each
annual reporting period and adjusted if appropriate. An asset’s carrying amount is written off immediately to its recoverable
amount if the asset’s carrying amount is greater than its estimated recoverable amount.

The following diminishing value percentages are used in the calculation of depreciation:
• Computers and software: 40%
• Leasehold improvement: 40%
• All other assets: 7.5% to 33.3%
Gains and losses on disposal of assets are determined by comparing proceeds upon disposal with the asset’s carrying amount.

These are included in the Profit or Loss.

h) Leases

The Group considers whether a contract is, or contains, a lease. A lease is defined as ‘a contract, or part of a contract, that
conveys the right to use an asset (the underlying asset) for a period of time in exchange for consideration’. To apply this
definition, the Group assesses whether the contract meets three key evaluations which are whether:

• the contract contains an identified asset, which is either explicitly identified in the contract or implicitly specified by

being identified at the time the asset is made available to the Group;

• the Group has the right to obtain substantially all of the economic benefits from use of the identified asset throughout

the period of use, considering its rights within the defined scope of the contract; or

• the Group has the right to direct the use of the identified asset throughout the period of use. The Group assess whether

it has the right to direct ‘how and for what purpose’ the asset is used throughout the period of use.

At lease commencement date, the Group recognises right-of-use assets and lease liabilities on the balance sheet. The right-
of-use asset is measured at cost, which is made up of the initial measurement of the lease liability, any initial direct costs
incurred by the Group, an estimate of any costs to dismantle and remove the asset at the end of the lease, and any lease
payments made in advance of the lease commencement date (net of any incentives received).

The Group depreciates the right-of-use assets on a straight-line basis from the lease commencement date to the earlier of
the end of the useful life of the right-of-use assets or the end of the lease term which is currently between two to six years.
Instead of performing an impairment review on the right-of-use assets at the date of initial application, the Group has relied on
its historic assessment as to whether leases were onerous immediately before the date of initial application of AASB 16. The
Group also assesses the right-of-use assets for impairment when such indicators exist.

Lease payments included in the measurement of the lease liability are made up of fixed payments (including in substance
fixed), variable payments based on an index or rate, amounts expected to be payable under a residual value guarantee and
payments arising from options reasonably certain to be exercised.

Subsequent to initial measurement, the liability will be reduced for payments made and increased for interest. It is

remeasured to reflect any reassessment or modification, or if there are changes in in-substance fixed payments.

The Group has elected to account for short-term leases and leases of low-value assets using the practical expedients. Instead
of recognising a right-of-use asset and lease liability, the payments in relation to these are recognised as an expense in profit or
loss on a straight-line basis over the lease term.

i) Intangible Assets – Trademarks And Patents

Trademarks and patents have a finite useful life and are recorded at cost less accumulated amortisation and impairment
losses. Amortisation is charged on a straight-line basis over the shorter of the relevant agreement or useful life. The trademarks
and patents had been fully amortised.

j) Investments And Other Financial Assets

Recognition And Derecognition

Financial assets and financial liabilities are recognised when the Group becomes a party to the contractual provisions of the
financial instrument and are measured initially at fair value adjusted by transactions costs, except for those carried at fair value

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

through profit or loss, which are measured initially at fair value. Subsequent measurement of financial assets and financial
liabilities are described below.

Financial assets are derecognised when the contractual rights to the cash flows from the financial asset expire, or when the
financial asset and substantially all the risks and rewards are transferred. A financial liability is derecognised when it is
extinguished, discharged, cancelled or expired.

Classification And Initial Measurement Of Financial Assets

Except for those trade receivables that do not contain a significant financing component and are measured at the transaction
price in accordance with AASB 15, all financial assets are initially measured at fair value adjusted for transaction costs (where
applicable).

Subsequent Measurement Of Financial Assets

For the purpose of subsequent measurement, financial assets, other than those designated and effective as hedging

instruments, are classified into the following categories upon initial recognition:

• financial assets at amortised cost;
• financial assets at fair value through profit or loss (FVPL);
• debt instruments at fair value through other comprehensive income (FVOCI); and
• equity instruments at FVOCI.
Classifications are determined by both:
• the entity’s business model for managing the financial assets; and
• the contractual cash flow characteristics of the financial assets.
All income and expenses relating to financial assets that are recognised in profit or loss are presented within finance costs,
finance income or other financial items, except for impairment of trade receivables which is presented within Finance, Corporate
and General expenses.

Financial Assets At Amortised Cost

Financial assets are measured at amortised cost if the assets meet the following conditions (and are not designated as FVPL):
• they are held within a business model whose objective is to hold the financial assets and collect its contractual cash

flows; and

Intangible assets with indefinite useful lives and intangible assets not yet available for use are tested for impairment annually
and whenever there is an indication that the asset may be impaired. Recoverable amount is the higher of fair value less costs
to sell and value in use. In assessing value in use, the estimated future cash flows are discounted to their present value using a
pre-tax discount rate that reflects current market assessments of the time value of money and the risk specified to the asset
for which the estimates of future cash flows have not been adjusted.

If the recoverable amount of an asset (or cash-generating unit) is estimated to be less than its carrying amount, the carrying
amount of the asset (cash-generating unit) is reduced to its recoverable amount. An impairment loss is recognised in the Profit
or Loss immediately.

Where an impairment loss subsequently reverses, the carrying amount of the asset (cash-generating unit) is increased to the
revised estimate of its recoverable amount, but only to the extent that the increased carrying amount does not exceed the
carrying amount that would have been determined had no impairment loss been recognised for the asset (cash-generating unit)
in prior years. A reversal of an impairment loss is recognised in the Profit or Loss immediately.

l) Payables

Trade payables and other accounts payable are recognised when the consolidated entity becomes obliged to make future

payments resulting from the purchase of goods and services, incurred prior to the end of the financial year.

m) Employee Benefits

Provision is made for benefits accruing to employees in respect of wages and salaries, loyalty payment, annual leave and long

service leave when it is probable that settlement will be required and they are capable of being measured reliably.

Provisions made in respect of employee benefits expected to be settled within 12 months, are measured at their nominal

values using the remuneration rate expected to apply at the time of settlement.

Provisions made in respect of employee benefits which are not expected to be settled within 12 months are measured as the
present value of the estimated future cash outflows to be made by the consolidated entity in respect of services provided by
employees up to reporting date. The discount rate used to estimate future cash flows is per the Australian high quality corporate
bond rates.

n) Provisions

Provisions are recognised when a present obligation to the future sacrifice of economic benefits becomes probable, and the

• the contractual terms of the financial assets give rise to cash flows that are solely payments of principal and interest on

amount of the provision can be measured reliably.

the principal amount outstanding.

After initial recognition, these are measured at amortised cost using the effective interest method. Discounting is omitted
where the effect of discounting is immaterial. The Group’s cash and cash equivalents, trade and most other receivables fall into
this category of financial instruments.

Impairment Of Financial Assets - Trade And Other Receivables

The Group makes use of a simplified approach in accounting for trade and other receivables and records the loss allowance
at the amount equal to the expected lifetime credit losses. In using this practical expedient, the Group uses its historical
experience, external indicators and forward-looking information to calculate the expected credit losses.

The Group assess impairment of trade receivables on a collective basis as they possess credit risk characteristics based on

the days past due.

Classification And Measurement of Financial Liabilities

The Group’s financial liabilities include trade and other payables.
Financial liabilities are initially measured at fair value, and, where applicable, adjusted for transaction costs unless the Group

designated a financial liability at fair value through profit or loss.

Subsequently, financial liabilities are measured at amortised cost using the effective interest method except for derivatives
and financial liabilities designated at FVPL, which are carried subsequently at fair value with gains or losses recognised in profit
or loss (other than derivative financial instruments that are designated and effective as hedging instruments).

All interest-related charges and, if applicable, changes in an instrument’s fair value that are reported in profit or loss are

included within finance costs or finance income.

k) Impairment Of Assets

At each reporting date, the consolidated entity reviews the carrying amounts of its tangible and intangible assets to determine
whether there is any indication that those assets have suffered an impairment loss. If any such indication exists, the recoverable
amount of the asset is estimated in order to determine the extent of the impairment loss (if any). Where the asset does not
generate cash flows that are independent from other assets, the consolidated entity estimates the recoverable amount of the
cash-generating unit to which the asset belongs.

The amount recognised as a provision is the best estimate of the consideration required to settle the present obligation at
reporting date, taking into account the risks and uncertainties surrounding the obligation. Where a provision is measured using
the cash flows estimated to settle the present obligation, its carrying amount is the present value of those cash flows.

When some or all of the economic benefits required to settle a provision are expected to be recovered from a third party, the
receivable is recognised as an asset if it is virtually certain that recovery will be received, and the amount of the receivable can
be measured reliably.

o) Share Capital

Ordinary share capital is recognised at the fair value of the consideration received by the Company.
Any transaction costs arising on the issue of ordinary shares are recognised directly in equity as a reduction of the share

proceeds received.

p) Earnings Per Share

Basic Earnings Per Share

Basic earnings per share is determined by dividing net profit after income tax attributable to members of the Company,
excluding any costs of servicing equity other than ordinary shares, by the weighted average number of ordinary shares
outstanding during the financial year, adjusted for bonus elements in ordinary shares issued during the year.

Diluted Earnings Per Share

Diluted earnings per share adjusts the figures used in the determination of basic earnings per share to take into account the
after income tax effect of interest and other financing costs associated with dilutive potential ordinary shares and the weighted
average number of shares assumed to have been issued for no consideration in relation to dilutive potential ordinary shares.

q) Revenue And Other Income

Revenue Arises From The Sale Of SCENESSE® Implants

The Group’s revenue from contracts with customers arise from the commercial sales of goods and sales reimbursements.
Commercial sales of goods are the commercial sales of SCENESSE® implants in Europe and USA. Sales reimbursements are the

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

distribution of SCENESSE® under special access reimbursement schemes. The special access reimbursement scheme provides
for the import and supply of an unapproved therapeutic good to patients, often on a case-by-case basis.

To determine whether to recognise revenue, the Group follows a five-step process:
1) identifying the contract with a customer;
2) identifying the performance obligations;
3) determining the transaction price;
4) allocating the transaction price to the performance obligations; and
5) recognising revenue when/as performance obligation(s) are satisfied.
Based on the above revenue recognition process and the nature of all revenue streams from contracts with customers, the
Group recognises revenues as earned from commercial sales of goods and sales reimbursements (constrained by variable
considerations, which include return and rebates) when performance obligations are satisfied at a point in time, which is when
control of the goods passes to the customer or generally upon receipt of shipment, at an amount that reflects the consideration
to which the Group expects to be entitled in exchange for the goods.

Due to patients seeking treatment in the spring, summer and autumn months, there remains a seasonal demand for

SCENESSE®. As such, fluctuations caused by seasonal demand impact the cash flows to the Group’s operations.

Note 21 provides additional disclosures disaggregating revenue by geographical market.

Interest

Interest income is recognised on a proportional basis that takes into account the effective yield on the financial asset.

Government R&D Tax Incentive

The Company formerly received other income through a refundable tax offset as part of the Australian government R&D tax
incentive program. Other income would be recognised when it has been established that the conditions of the tax incentive
have been met and that the expected amount of tax incentive can be reliably measured.

Government Grant

Government grants represents the Research Incentive Scheme for Companies provided by the Singapore Economic
Development Board, along with the Job Growth Incentive and Progressive Wage Credit Scheme Payout from Singaporean
government. Government grants are recognised in the financial statements at their fair values when there is a reasonable
assurance that the Consolidated Entity will comply with the requirements and that the grant will be received.

r) Research And Development Expenditure

Expenditure on research activities is recognised as an expense in the period in which it is incurred. Where no internally
generated intangible asset can be recognised, development expenditure is recognised as an expense in the period as incurred.
An intangible asset arising from development (or from the development phase of an internal project) is recognised if, and only
if, all of the following is demonstrated:

• the technical feasibility of completing the intangible asset so that it will be available for use or sale;
• the intention to complete the intangible asset and use or sell it;
• the ability to use or sell the intangible asset;
• how the intangible asset will generate probable future economic benefits;
• the availability of adequate technical, financial and other resources to complete the development and to use or sell the

intangible asset; and

• the ability to measure reliably the expenditure attributable to the intangible asset during its development.
The consolidated entity uses its critical judgement in continually assessing whether development expenditures meet the

recognition criteria of an intangible asset.

Whilst at the end of the financial year the consolidated entity had received European and US regulatory approval and
launched a European and US product the above criteria have not been fully satisfied to support the recognition and generation
of an internally generated intangible asset.

s) Goods And Services Tax/Value Added Tax (GST)

Revenues, expenses and assets are recognised net of the amount of ‘goods and services tax’ or ‘valued added tax’ as it is

known in certain jurisdictions (GST), except:

• where the amount of GST incurred is not recoverable from the taxation authority, it is recognised as part of the costs of

acquisition of an asset or as part of an item of expense; or

• for receivables and payables which are recognised inclusive of GST.
The net amount of GST recoverable from, or payable to, the taxation authority is included as part of receivables or payables.
Cash flows are included in the Statement of Cash Flow on a gross basis. The GST component of cash flows arising from investing
and financing activities which is recoverable from, or payable to, the taxation authority is classified as operating cash flows.

t) Comparatives

Where necessary, comparatives have been reclassified and repositioned for consistency with current year disclosure.

u) Foreign Currency Transactions And Balances

All foreign currency transactions during the financial year are brought to account using the exchange rate in effect at the
date of the transaction. Foreign currency monetary items at reporting date are translated at the exchange rate existing at
reporting date. Non-monetary assets and liabilities carried at fair value that are denominated in foreign currencies are
translated at the rates prevailing at the date when the fair value was determined. Exchange differences are recognised in profit
or loss in the period in which they arise as defined in AASB 121.

Foreign subsidiaries that have a functional currency different from the presentation currency are translated into the

presentation currency as follows:

• At the spot rate at reporting date for assets and liabilities; and
• At average monthly exchange rates for income and expenses.
Resulting differences are recognised within equity in a foreign currency translation reserve.

v) Share-Based Payment Transactions

Benefits are provided to employees of the Group in the form of share-based payment transactions, whereby employees

render services in exchange for shares or rights over shares (“equity-settled transactions”).

The cost of these equity-settled transactions with employees is measured by reference to the fair value at the date at which
they are granted. The fair value of conditional performance rights is measured by a Monte Carlo simulation pricing model for
those performance rights with market capitalisation hurdles and either a binomial or a trinomial model for those performance
rights not linked to the price of the shares of CLINUVEL PHARMACEUTICALS LTD (“non-market vesting conditions”). It is
determined at grant date and expensed on a straight-line basis over the vesting period. In valuing equity-settled transactions,
no account is taken of any performance conditions, other than conditions linked to the price of the shares of CLINUVEL
PHARMACEUTICALS LTD (“market conditions”).

The cost of equity-settled transactions is recognised, together with a corresponding increase in equity, over the period in
which the performance conditions are fulfilled, ending on the date on which the relevant employees become fully entitled to
the award (“vesting date").

The cumulative expense recognised for equity-settled transactions at each reporting date until vesting date reflects (i) the
extent to which the vesting period has expired and (ii) the number of awards that, in the opinion of the Directors of the Group,
will ultimately vest. This opinion is formed based on the best available information at reporting date. No adjustment is made
for the likelihood of market performance conditions being met as the effect of these conditions is included in the determination
of fair value at grant date.

Where the terms of an equity-settled award are modified, as a minimum an expense is recognised as if the terms had not
been modified. In addition, an expense is recognised for any increase in the value of the transaction as a result of the
modification, as measured at the date of modification. Where an equity-settled award is cancelled, it is treated as if it had vested
on the date of cancellation, and any expense not yet recognised for the award is recognised immediately.

However, if a new award is substituted for the cancelled award and designated as a replacement award on the date that it is
granted, the cancelled and new award are treated as if they were a modification of the original award, as described in the
previous paragraph.

The dilutive effect, if any, of outstanding options is reflected as additional share dilution in the computation of earnings per

share.

w) Critical Accounting Estimates And Judgement

The Directors evaluate estimates and judgements incorporated into the financial report based on historical knowledge and
best available current information. Estimates assume a reasonable expectation of future events and are based on current trends
and economic data, obtained both externally and within the Group.

Key Estimates – Share-Based Payments Transactions

The Group measures the cost of equity-settled transactions with employees by reference to the fair value of the equity
instruments at the date at which they are granted. The fair value is determined using either a Monte Carlo simulation pricing
model for market conditions, or a Binomial Options Valuation pricing model for non-market conditions, using the assumptions
detailed in Note 23. The total expense is brought to account over the vesting period which for some instruments requires the
group to form judgements associated with the timing and probability of vesting conditions.

Key Judgements – Trade Debtors

In applying the Group’s accounting policy to trade debtors, significant judgement is involved in assessing the expected credit
loss of trade debtors amounts. The Group uses ageing of trade debtors and use judgement to assess the expected credit loss of

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

Consolidated Entity

2023
$

2022
$

16,382,733

(1,408,576)

7,367,889

6,074,561

14,974,157

13,442,450

(497,571)

(911,005)

(1,408,576)

4,425,880

1,648,682

6,074,562

45,578,723

13,673,617

34,320,915

10,296,275

1,229,465

71,075

1,836,293

1,735,845

14,974,157

13,868,413

- (425,963)

14,974,157

13,442,450

trade debtors taking into account historical loss experience and other forward-looking factors specific to the debtors and the
economic environment. The value of trade debtors is included in Note 4.

3. Income Tax Expense

Key Judgements – Tax Losses

Given the Company’s and each individual entities’ history of losses, the Group has recognised a deferred tax asset with regard
to unused tax losses and other temporary differences. The Directors have determined the Group will generate sufficient taxable
income against which the unused tax losses and other temporary differences can be utilised. The value of tax losses both
recognised and not recognised is included in Note 3.

Uncertainty Over Income Tax Treatments

The Group assesses whether it is ‘probable’ that a taxation authority will accept an uncertain tax treatment. This assessment
takes into account that, for certain jurisdictions in which the Group operates, a local tax authority may seek to open a group’s
books as far back as inception of the group. Where it is probable, the Group has determined tax balances consistently with the
tax treatment used or planned to be used in its income tax filings. Where the Group has determined that it is not probable that
the taxation authority will accept an uncertain tax treatment, the most likely amount or the expected value has been used in
determining taxable balances (depending on which method is expected to better predict the resolution of the uncertainty).

x) Segment Reporting

(a) Income tax expense

Current

Deferred

Income tax expense

Deferred tax included in income tax expense (benefit) comprises:

Increase/Decrease in deferred tax assets

Increase/Decrease in deferred tax liabilities

(b) Numerical

Profit before income tax expense

Tax at the statutory tax rates of 30% in 2023 and 2022

A segment is a component of the consolidated entity that earns revenues or incurs expenses whose results are regularly

Tax effect amounts which are not deductible/(taxable) in calculating taxable income:

reviewed by the chief operating decision makers and for which discrete financial information is prepared.

The Group has identified its operating segments based on the internal reports that are reviewed and used by the Chief
Executive Officer (the Chief Operating Decision Maker) in assessing performance and in determining the allocation of
resources. The consolidated entity has formed four Divisions – Pharmaceuticals, Healthcare Solutions, Communications
Branding & Marketing, and Manufacturing but operates in a single operating segment, being the biopharmaceutical sector, and
the majority of its activities continue to be concentrated on researching, developing and commercialising a sole asset in the
biopharmaceutical sector, being its leading drug candidate. Accordingly, the consolidated entity has one operating segment
within the definition of AASB 8. The Group’s consolidated total assets are the total reportable assets of the operating segment.
The Group has established entities in more than one geographical area. The non-current assets that are not held within
Australia are immaterial to the Group. The revenues earned from external customers by geographical location is detailed in
Note 21.

y) New Australian Accounting Standards Issued But Not Yet Effective

The Group has not adopted any new accounting standards or interpretations that are issued but not yet effective. The Group
is yet to undertake a detailed assessment of the impact of new accounting standards or interpretation. However, based on the
Group’s preliminary assessment, new accounting standards or interpretations are not expected to have a material impact on
the transactions and balances recognised in the consolidated financial statements for the year ended 30 June 2023.

2. Profit/(Loss) From Continuing Operations

Profit/(loss) before income tax includes the following specific expenses

2023

2022

Employee benefits expense

12,960,543

10,825,178

Consolidated Entity

Operating lease expense – minimum lease payments

Amortisation of right-of-use assets

Depreciation on property, plant & equipment

Bank charges

Loss on sale of property, plant and equipment

306,830

343,642

397,260

38,671

324,124

289,888

426,700

38,069

27,380

Non-deductible share-based payments

Other non-deductible expenses for tax purposes

Recognition of DTA on carry forward tax losses at year end

Income tax expense

Tax losses not recognised

Unused tax losses for which no deferred tax asset has been recognised

18,899,558

20,325,477

Carry forward tax losses

Intangibles

Provisions

Accrued Expenses

Lease liabilities

Reconciliation to the Statement of Financial Position

Total deferred tax assets

1,011,871

553,282

233,280

61,700

10,642

381,050

513,469

271,869

145,729

33,957

1,870,775

1,346,074

1,870,775

1,346,074

Set-off of deferred tax liabilities that are expected to reverse in the same period

(811,234)

(864,474)

Movements

Opening balance

Deferred tax assets utilised

Carry forward tax losses

Intangibles

Lease liabilities

Accrued Expenses

Provisions

Unrealised foreign exchange gains

Accrued income

Right-of-use assets

Intangibles

Reconciliation to the Statement of Financial Position

Total deferred tax liabilities

Set-off of deferred tax assets that are expected to reverse in the same period

1,059,541

481,600

1,346,074

5,762,262

(5,042,930)

630,821

39,813

(23,314)

(84,030)

(38,589)

381,050

79,747

(14,763)

118,933

61,775

1,870,775

1,346,074

(3,142,445)

(420,888)

(10,108)

4,691

(4,238,456)

(218,641)

(33,275)

10,617

(3,568,750)

(4,479,755)

(3,568,750)

(4,479,755)

811,234

864,474

(2,757,516)

(3,615,281)

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

Movements

Opening balance

Unrealised foreign exchange gains

Right-of-use assets

Accrued income

Intangibles

(4,479,755)

1,096,011

23,167

(202,247)

(5,926)

(2,831,074)

(1,464,144)

15,920

(201,854)

1,397

(3,568,750)

(4,479,755)

6. Other Assets

Prepayments

Total

Deferred tax assets include US and UK deferred tax assets that cannot be offset with Australian deferred tax liabilities. The tax rates used in this report are the Australian corporate tax
rate of 30% in 2023 and 2022, income tax rate of 21% for US entity in 2023 and 2022 and income tax rate of 25% for UK entity in 2023.

7. Property, Plant and Equipment

4. Trade and Other Receivables

Current
Trade debtors

Interest receivables

Sundry debtors

Less: Provision for expected credit losses

Total

Consolidated Entity

2023
$

2022
$

20,807,909

15,898,020

1,438,696

134,199

259,633

44,284

(166,158)

22,214,646

16,201,937

Trade debtors are recognised initially at the amount of consideration that is unconditional, when they are recognised at fair value. They are subsequently measured at amortised cost
using the effective interest method and due to their short-term nature their carrying amount is considered to be the same as their fair value.

A provision for expected credit losses (ECL) is recognised based on the difference between the contractual cashflows due in accordance with the contract and all the cash flows that the
Group expects to receive. The Group applies a simplified approach in calculating ECLs. Therefore, the Group does not track changes in credit risk, but instead recognises a loss allowance
based on lifetime ECLs at each reporting date. The Group has established a provision matrix that is based on its historical credit loss experience, adjusted for forward-looking factors
specific to the debtors and the economic environment.

As at 30 June 2023, the Group had a provision for expected credit loss of $166,158 (2022: $Nil).

Plant and equipment

At cost

Less: accumulated depreciation

Sub-total

Furniture and fittings

At cost

Less: accumulated depreciation

Sub-total

Leasehold improvements

At cost

Less: accumulated amortisation

Sub-total

Total property, plant and equipment

Consolidated Entity

2023
$

2022
$

1,070,153

1,039,453

1,070,153

1,039,453

Consolidated Entity

2023

2022

1,487,388

(490,012)

997,376

45,603

(26,387)

19,216

1,888,048

(886,779)

1,001,269

2,017,861

1,289,490

(343,245)

946,245

41,935

(22,575)

19,360

1,253,373

(678,276)

575,097

1,540,702

Opening balance as at 1 July 2022

Provision for expected credit loses

Closing balance at 30 June 2023

5. Inventories

Current

Raw materials – at cost

Consolidated Entity

2023
$

166,158

2022
$

Consolidated Entity

2023
$

2022
$

514,812

519,393

Less: Provision for obsolescence – raw materials

(51,655)

(159,712)

Work in progress – at cost

Finished goods – at cost

Total

A provision for obsolescence of $108,057 was written off in 2023 (2022: $Nil).

7,466,396

1,589,909

9,519,462

1,176,227

295,983

1,831,891

Movements in Carrying Amounts – Property, Plant and Equipment

Movements in the carrying amounts for each class of property, plant and equipment between the beginning and the end of

the financial year.

Carrying amount at 30 June 2021

Additions

Disposals

Depreciation written back on disposals

Depreciations expense

Carrying amount at 30 June 2022

Additions

Disposals

Depreciation written back on disposals

Depreciations expense

Carrying amount at 30 June 2023

Consolidated Entity

Plant And
Equipment
$
483,267

615,183

(101,018)

72,464

Furniture And
Fittings
$
22,448

Leasehold
Improvements
$
878,707

1,306

Total

$
1,384,422

616,489

(101,018)

72,464

(123,651)

(4,394)

(303,610)

(431,655)

946,245

197,898

19,360

3,668

575,097

634,675

1,540,702

836,241

(146,767)

(3,812)

(208,503)

(359,082)

997,376

19,216

1,001,269

2,017,861

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

Carrying amount at 30 June 2021

Additions

Amortisation

Currency translation differences

Carrying amount at 30 June 2022

Additions

Amortisation

Currency translation differences

Carrying amount at 30 June 2023

Lease liabilities

Lease liabilities - Current

Lease liabilities - Non-current

Total lease liabilities

8. Right-of-Use Assets and Lease Liabilities

10. Interests in Subsidiaries

Consolidated Entity

2023
$

2022
$

Name of Entity

Parent entity

1,782,946

1,775,894

CLINUVEL PHARMACEUTICALS LTD

Australia

Country of Incorporation

Ownership Interest

Right-of-use assets
At cost

Less: accumulated depreciation

(949,620)

(616,252)

Total right-of-use assets

833,326

1,159,642

Movements in Carrying Amounts – Right-Of-Use Assets

Movements in the carrying amounts for right-of-use assets between the beginning and the end of the financial year.

Consolidated Entity

Right-of-use Assets

1,218,721

236,965

(289,888)
1,159,642
(6,156)
7,052

(343,642)

10,274

833,326

Australia

United Kingdom

United States of America

Switzerland

Singapore

Ireland

Monaco

Controlled entities

A.C.N. 108 768 896 PTY LTD

CLINUVEL (UK) LTD

CLINUVEL, INC.

CLINUVEL AG

CLINUVEL SINGAPORE PTE LTD

VALLAURIX PTE LTD

CLINUVEL EUROPE LIMITED

VALLAURIX MC SARL

All transactions with subsidiaries have been eliminated on consolidation.

11. Trade and Other Payables

Current

Unsecured trade creditors

Sundry creditors and accrued expenses

2023

2022

100%

Consolidated Entity

2023

2,791,672

4,857,900

7,649,572

2022

259,199

3,018,658

3,277,857

910,574

564,667

Consolidated Entity

Total

(a) Aggregate amounts payable to:

Directors and Director-related entities

2023
$

300,843

699,022

999,865

2022
$

315,068

941,463

1,256,531

(b) Australian dollar equivalents of amounts payable in foreign currencies not effectively hedged by natural hedges and included in
Trade and Sundry creditors:

Danish Krona

Canadian dollars

Other

16,791

The Group has leases primarily in relation to offices and laboratory facility ranging from 3 to 6 years. Lease liability is measured at the present value of the lease payments unpaid at that
date, discounted using the interest rate implicit in the lease if that rate is readily available or the Group’s incremental average borrowing rate of 6.4% in 2023 and 5.5% in 2022.
Please refer to Note 22 for a maturity analysis of the Group’s lease liabilities.

Total

9. Intangible asset

Goodwill

At cost

Less: impairment

Total

Consolidated Entity

2023
$

2022
$

185,030

Goodwill is not amortised but is measured at cost less any accumulated impairment losses. Impairment occurs when a cash-generating unit’s recoverable amount falls below the carrying
value of its net assets. The results of the impairment test show that the cash-generating unit’s recoverable amount exceeds the carrying value of its net assets, inclusive of goodwill.
Consequently, there is no goodwill impairment as at 30 June 2023.

For an analysis of the sensitivity of trade and other payables to foreign currency risk refer to Note 22.
(c) Terms and conditions: Trade and sundry creditors are non-interest bearing and normally settled on 30 day terms.

100

101

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

12. Provisions

14. Reserves

Current

Employee benefits

Total

Non-current

Employee benefits

Other provisions

Total

13. Contributed Equity

(a) Issued And Paid Up Capital

Consolidated Entity

2023

2022

1,450,120

2,859,828

56,573

74,589

131,162

31,643

69,905

101,548

Conditional Performance Rights reserve:

Balance at the beginning of period

Share-based payment

Transfer to share capital

Lapsed, forfeited rights

Balance at the end of period

Consolidated Entity

2023
$

2022
$

10,380,258

8,989,788

4,343,422

6,120,977

(84,141)

19,370,046

10,380,258

The Conditional Performance Rights reserve arises on the grant of conditional performance rights to eligible employees under the Conditional Performance Rights Plan. Amounts are
transferred out of the reserve and into issued capital when the rights are exercised and to retained earnings when rights lapse.

Foreign currency translation reserve:

Balance at the beginning of period

Translating foreign subsidiary to current rate at reporting date

Balance at the end of period

Total reserves

Consolidated Entity

2023
$

2022
$

15. Short-Term Lease Commitments

49,410,338 fully paid ordinary shares (2022: 49,410,338)

151,849,375

Ordinary shares have the right to receive dividends as declared and, in the event of winding up the Company, to participate in the proceeds from the sale of all surplus assets in
proportion to the number of and amounts paid up on shares held. Ordinary shares entitle their holder to one vote, either in person or by proxy, at a meeting of the Company. The
Company does not have a limited amount of authorised capital and issued shares do not have a par value.

(b) Movements In Ordinary Share Capital

Operating lease commitments
Non-cancellable operating leases contracted for but not capitalised under
AASB 16 as they are short-term or low value and are payable as follows:

not later than 1 year

Low value item later than 1 year but not later than 5 years

No.

2023
$

No.

2022
$

Operating leases comprises commitments for limited license agreement of furnished office accommodation and office equipment.
The limited license agreement has no contingent rental clauses and contains renewal options.

Consolidated Entity

Total

At the beginning of the financial year

49,410,338

151,849,375

49,410,338

151,849,375

Issued during the year

Conditional rights issues and transferred from conditional
rights reserve

Less: transaction costs

Balance at the end of the financial year

49,410,338

151,849,375

49,410,338

151,849,375

During the year the following conditional performance rights were exercised, resulting in the issue of fully paid ordinary shares:

Expiry date

Exercise Price

Number of Securities

Upon achievement of various performance milestones

$Nil

As at 30 June 2023, the year the following conditional performance rights existed which if exercised, resulting in the issue of fully
paid ordinary shares:

Expiry date

Exercise Price

Number of Conditional Rights

Upon achievement of various performance milestones

$Nil

2,630,193

16. Earnings Per Share (EPS)

(a) Basic earnings per share (cents per share)

(a) Diluted earnings per share (cents per share)

(b) The Weighted Average Number of Ordinary Shares (WANOS) used in the
calculation of basic earnings per share

(b) Weighted average number of performance rights on issue in respect of
share based payments during the year

(b) The Weighted Average Number of Ordinary Shares (WANOS) used in the
calculation of diluted earnings per share

30,604,566

20,878,465

There have been no other transactions involving ordinary shares or potential ordinary shares that would significantly change the number of ordinary shares outstanding between the
reporting date and the date of the completion of this financial report.

102

103

1,731,838

674,405

1,454,160

1,057,433

3,185,998

1,731,838

22,556,044

12,112,096

Consolidated Entity

2023
$

2022
$

43,207

1,350

44,557

27,867

2,731

30,598

Consolidated Entity

2023
$

61.9

59.1

2022
$

42.3

40.3

49,410,338

2,405,659

2,366,106

51,815,997

51,776,444

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

17. Cash Flow Information

19. Auditor’s Remuneration

(a) Reconciliation of cash
Cash at the end of the financial year as shown in the Statement of Cash Flows is reconciled to the related items in the balance sheet
as follows:

Consolidated Entity

2023
$

2022
$

Cash at bank

Cash on hand

Deposits on call

Term deposits

Security bonds

22,883,205

22,849,846

774

617,759

132,946,316

365,483

259

4,215,543

94,100,000

343,634

Total cash and cash equivalents

156,813,537

121,509,282

(b) Reconciliation of cash flows from operating activities with operating profit (loss)

Operating profit after income tax

30,604,566

20,878,465

Non cash flows in operating profit after income tax:

Depreciation expense on property, plant & equipment

Amortisation expense on right-of-use assets

397,260

343,642

Exchange rate effect on foreign currencies held

(1,659,855)

Share-based payment expense

Unrealised loss (gain) on foreign exchange translation

Loss on sale of non-current assets

Changes in assets and liabilities:

(Increase)/decrease in receivables

(Increase)/decrease in inventories

Increase in other assets

(Increase)/decrease in deferred tax assets

Increase/(decrease) in payables

Increase in income tax payables

Decrease in provisions

Increase/(decrease) in deferred tax liabilities

Net cash used in operating activities

8,989,788

1,454,160

(6,012,709)

(7,687,571)

(30,700)

(577,941)

4,514,552

8,814,729

(1,380,093)

(857,765)

426,700

289,888

(884,213)

6,120,977

1,057,434

27,379

(113,410)

1,354,779

(157,418)

2,449,588

(1,563,412)

7,184,398

(814,154)

3,615,281

36,912,063

39,872,282

Cash at bank earns floating rates based on daily bank deposit rates. The carrying amounts of cash and cash equivalents represent fair value.
The effective interest rate on short-term deposits was 3.33% (2022: 0.64%). These deposits have an average maturity date of 252 days (2022: 249 days).

18. Key Management Personnel

Short-term employee benefits

Post-employment benefits

Long-term benefits

Share-based payments

Total

No loans or other transactions existed with key management personnel.

Consolidated Entity

2023

3,962,471

65,787

6,583,359

10,611,617

2022

4,225,617

61,681

559,330

4,820,833

9,667,461

Consolidated Entity

2023
$

2022
$

246,154

179,000

246,154

179,000

Amounts received or due and receivable by Grant Thornton for:

Audit services and review

Total

No non-audit services were provided by Grant Thornton during the year (FY2022$Nil).

20. Related Party Disclosures

Wholly-Owned Group Transactions

Loans

The loan receivable by CLINUVEL PHARMACEUTICALS LTD from A.C.N. 108 768 896 Pty Ltd is non-interest bearing. A
provision for non-recovery has been raised in the accounts of CLINUVEL PHARMACEUTICALS LTD where a deficiency in net
assets exists in A.C.N. 108 768 896 Pty Ltd. On 1 July 2022, CLINUVEL PHARMACEUTICALS LTD issued a Deed of Loan
Forgiveness to A.C.N. 108 768 896 Pty Ltd. The loan to A.C.N. 108 768 896 Pty Ltd as at 30 June 2023 is $0 (2022: $4,370,640).
The loan receivable by CLINUVEL PHARMACEUTICALS LTD from CLINUVEL, INC. is interest bearing at average of 4.6%
in 2023 and 2.1% in 2022. Repayment of the loan has commenced upon commercialisation of the Company’s drug candidate. A
provision for non-recovery has been raised in the accounts of CLINUVEL PHARMACEUTICALS LTD where a deficiency in net
assets exists in CLINUVEL, INC. The loan to CLINUVEL, INC. as at 30 June 2023 is $21,681,805 (2022: $23,381,365).

The loan receivable by CLINUVEL PHARMACEUTICALS LTD from CLINUVEL AG is non-interest bearing. Repayment of
the loan will commence upon commercialisation of the Company’s drug candidate. A provision for non-recovery has been raised
in the accounts of CLINUVEL PHARMACEUTICALS LTD where a deficiency in net assets exists in CLINUVEL AG. During the
year, CLINUVEL PHARMACEUTICALS LTD entered into a Deed of Loan Forgiveness to CLINUVEL AG effective 1 July 2022.
The loan to CLINUVEL AG as at 30 June 2023 is $188,531 (2022: $13,985,963).

The loan receivable by CLINUVEL PHARMACEUTICALS LTD from CLINUVEL SINGAPORE PTE LTD is non-interest bearing.
Repayment of the loan will commence upon commercialisation of the Company’s drug candidate. A provision for non-recovery has
been raised in the accounts of CLINUVEL PHARMACEUTICALS LTD where a deficiency in net assets exists in CLINUVEL
SINGAPORE PTE LTD. The loan to CLINUVEL SINGAPORE PTE LTD as at 30 June 2023 is $625,133 (2022: $629,876 ).

The loan receivable by CLINUVEL PHARMACEUTICALS LTD from CLINUVEL (UK) is interest bearing at average of 4.6% in
2023. Repayment of the loan will commence upon commercialisation of the Company’s drug candidate. A provision for non-
recovery has been raised in the accounts of CLINUVEL PHARMACEUTICALS LTD where a deficiency in net assets exists in
CLINUVEL (UK) LTD. The loan to CLINUVEL (UK) LTD as at 30 June 2023 is $2,053,783 (2022: $7,383,677).

The loan receivable by CLINUVEL PHARMACEUTICALS LTD from VALLAURIX PTE LTD is non-interest bearing.
Repayment of the loan will commence upon commercialisation of VALLAURIX PTE LTD’s product(s). A provision for non-
recovery has been raised in the accounts of CLINUVEL PHARMACEUTICALS LTD where a deficiency in net assets exists in
VALLAURIX PTE LTD. The loan to VALLAURIX PTE LTD as at 30 June 2023 is $10,475,621 (2022: $7,127,994).

The loan receivable by (payable by) CLINUVEL PHARMACEUTICALS LTD from VALLAURIX MC SARL is non-interest
bearing. Repayment of the loan will commence upon commercialisation of the Company’s drug candidate. A provision for non-
recovery has been raised in the accounts of CLINUVEL PHARMACEUTICALS LTD where a deficiency in net assets exists in
VALLAURIX MC SARL. The loan to (from) VALLAURIX MC SARL as at 30 June 2023 is $6,339,501 (2022: $2,958,807 payable).
The loan receivable by CLINUVEL PHARMACEUTICALS LTD from CLINUVEL EUROPE LIMITED is non-interest bearing.
Repayment of the loan will commence upon commercialisation of CLINUVEL EUROPE LIMITED’s product(s). A provision for
non-recovery has been raised in the accounts of CLINUVEL PHARMACEUTICALS LTD where a deficiency in net assets exists
in CLINUVEL EUROPE LIMITED. The loan to CLINUVEL EUROPE LIMITED as at 30 June 2023 is $9,675,165 (2022:
$1,984,059).

104

105

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

Director Related And Key Management Personnel Transactions And Entities:

There are no loan transactions and relationships in existence as at 30 June 2023 between Directors and the Company and its

related entities.

21. Segment Information

A segment is a component of the consolidated entity that earns revenues or incurs expenses whose results are regularly

reviewed by the chief operating decision makers and for which discrete financial information is prepared.

The Group has established entities in more than one geographical area. The non-current assets that are not held within
Australia are immaterial to the Group. The revenues earned from external customers by geographical location is detailed below.
The consolidated entity has one operating segment within the definition of AASB 8.
The Group’s revenue disaggregated by primary geographical markets is as follows:

FY2023

FY2022

Commercial
sales of goods

Sales
reimbursements

Commercial
sales of goods

Sales
reimbursements

Europe & USA

Switzerland,
Others

Total

$’000

72,179

$’000

Total

$’000

104

72,283

6,038

6,142

6,038

78,321

$’000

60,002

$’000

Total

$’000

139

60,141

5,581

5,720

5,581

65,722

The Group has a number of customers to which it provides its leading drug candidate. Two customers each comprise 15%

and 13% of external total revenue (2022: Two customers each comprising 12% of external total revenue).

22. Financial Instruments

CLINUVEL PHARMACEUTICALS LTD and consolidated entities have exposure to the following risks from its use in financial

instruments:

• Market Risk
• Credit Risk
• Liquidity Risk
The Board of Directors oversees and reviews the effectiveness of the risk management systems implemented by
management. The Board has assigned responsibility to the Audit and Risk committee to review and report back to the Board in
relation to the Company’s risk management systems.

a) Market Risk
Market risk is the risk of changes to market prices of foreign exchange purchases, interest rates and/or equity prices resulting
in a change in value of the financial instruments held by the consolidated entity. The objective to manage market risk is to
ensure exposures are contained within acceptable parameters, to minimise costs and to stabilise existing assets.

Foreign Currency Risk

The consolidated entity is exposed to foreign currency risk on future commercial transactions and recognised assets and
liabilities that are denominated in a currency other than the functional currency of each of the Group’s entities, primarily US
dollars (USD), Euros (EUR), Swiss francs (CHF), Singapore dollars (SGD) and Great British pounds (GBP). The parent entity is
exposed to the risk of its cash flows being adversely affected by movements in exchange rates that will increase the Australian
dollar value of foreign currency payables. It is also exposed to the risk of movements in foreign currency exchange rates for
those currencies which sales and reimbursement receipts are received.

The consolidated entity’s policy of managing foreign currency risk is to hold foreign currencies equivalent to the cash outflow
projected over minimum 30 days by the placement of market orders or have in place forward exchange contracts to achieve a
target rate of exchange, with protection floors in the event of a depreciating Australian dollar exchange rate, to run for the time
between recognising the exposure and the time of payment. In the event of an appreciating Australian dollar, the amount of
foreign currency held is minimised at a level to only meet short-term obligations in order to maximise gains in an appreciating
Australian currency. CLINUVEL does not engage in speculative transactions in its management of foreign currency risk. No
forward exchange contracts had been entered into as at 30 June 2023 and as at 30 June 2022.

The Consolidated Entities Exposure To Foreign Currency Risk At 30 June 2023

Consolidated Entity

Cash
and Cash
Equivalents

Trade
Debtors
and Other
Assets

Trade, Other
Payables
and
Provisions

Cash
and Cash
Equivalents

TOTAL

Trade
Debtors
and Other
Assets

Trade, Other
Payables
and
Provisions

2023

2022

TOTAL

USD

12,016,211

7,719,647

(2,249,199)

17,486,659

7,932,297

7,452,124

(422,710)

14,961,711

EUR

CHF

GBP

SGD

CAD

DKK

SEK

ILS

9,658,588

5,157,824

(2,403,905)

12,412,507

5,876,623

2,650,122

(2,252,650)

6,274,095

1,406,750

1,184,729

558,588

(93,231)

1,313,519

554,736

579,272

(128,874)

1,005,134

(396,064)

(241,557)

788,665

317,031

(14,744)

297,972

149,530

(258,288)

989,697

238,264

(302,720)

189,214

925,241

(206)

429,225

(100)

Sensitivity Analysis

During the financial year the Company had a principal foreign currency transaction risk exposure to the Euro currency.
Assuming all other variables remain constant, a depreciation in the Australian dollar is advantageous to the consolidated entity
as sales receipts received in Euro foreign currency allows for conversion to a higher amount of Australian dollars.

For the consolidated entity, a 8.7% appreciation of the Australian dollar against the Euro currency would have decreased
profit and loss and equity by $2,147,985 for the year ended 30 June 2023 (2022: $1,661,459 decrease), on the basis that all other
variables remain constant. 8.7% is considered representative of the market volatility in the Australian dollar/Euro rate for the
period.

For the consolidated entity, a depreciation of the Australian dollar against the Euro currency would have an equal but opposite

effect to the above, on the basis that all other variables remain constant.

The Group’s exposure to other foreign currency movements is not considered as material.

Interest Rate Risk

The consolidated entity holds fixed interest-bearing assets therefore exposure to interest rate risk exists. It does not hold

interest bearing liabilities.

The consolidated entity currently finances its operations through reserves of cash and liquid resources and does not have a
borrowing requirement. In order to be protected from, and to take advantage of, interest rate movements it is the consolidated
entity’s policy to place cash into term deposits and other financial assets at both fixed and variable (floating) rates. The Board
monitors the movements in interest rates in combination with current cash requirements to ensure the mix and level of fixed
and floating returns is in the best interests of the consolidated entity.

Sensitivity Analysis

For the consolidated entity, at 30 June 2023, if interest rates had changed by +/- 325 basis points from the year-end rates (a
movement considered reflective of the level of interest rate movements throughout the course of the financial year), with effect
from the beginning of the year, profit and equity would be $4,564,433 higher/lower (2022: $3,247,999 higher/ lower). This
analysis assumes all other variables are held constant.

106

107

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

Price Risk

CLINUVEL PHARMACEUTICALS LTD and its consolidated entities was formerly exposed to price risk in its investments in
income securities classified in the Statement of Financial Position as held for trading. Neither the consolidated entity nor the
parent is exposed to commodity price risk.

Contractual Maturities Of Financial Assets As At 30 June 2023

b) Credit Risk

Credit risk arises from the potential failure of counterparties to meet their contractual obligations, resulting in a loss to the

Cash and cash equivalents

consolidated entity.

Credit risk in relation to the consolidated entity is the cash and cash equivalents deposited with banks, trade and other
receivables. Exposure to credit risk in trade debtors is limited to over forty counterparties across German, Italian, Swiss, Dutch,
US and other medical institutions who are reimbursed by government or private insurance payors.

The maximum credit exposure is the carrying value of the cash and cash equivalents deposited with banks, trade and other

Carrying amount

6 months or less

Greater than 6 months

Total

debtors and foreign, wholly-owned subsidiaries.

c) Liquidity Risk

Liquidity risk is the risk the consolidated entity will not be able to meets its financial obligations when they fall due. It is the
policy of the consolidated entity to ensure there is sufficient liquidity to meet is liabilities when due without incurring
unnecessary loss or damage. The consolidated entity holds cash and cash equivalents in liquid markets. It does not hold financing
facilities, overdrafts or borrowings.

Fair Value Estimation

The fair value of financial assets and financial liabilities must be estimated for recognition and measurement for disclosure

purposes.

The fair value of financial instruments traded in active markets is based on quoted market prices at reporting date. The quoted
market price for the consolidated entity is the bid price. For longer-term debt instruments held by the consolidated entity,
dealer quotes are used to determine fair value. The consolidated entity formerly held investments in income securities classified
in the Statement of Financial Position as held for trading. These financial instruments were traded in active markets and based
on quoted market prices.

The carrying value of trade payables is assumed to approximate their fair values due to their short-term nature.
The consolidated entity manages its liquidity needs by carefully identifying expected operational expenses by month and ensuring
sufficient cash is on hand, across appropriate currencies, in the day-to-day bank accounts for a minimum 30 day period. When further
liquidity is required, the consolidated entity draws down on its cash under management to service future liquidity needs.

Contractual Maturities Of Financial Liabilities As At 30 June 2023

Trade and other payables

Carrying amount

6 months or less

Greater than 6 months

Total

Lease liabilities

Carrying amount

6 months or less

Greater than 6 months

Total

Capital Risk Management

Consolidated Entity

2023

7,649,572

7,645,178

4,394

2022

3,277,857

3,273,492

4,365

7,649,572

3,277,857

999,865

161,018

838,847

999,865

1,358,214

170,979

1,187,235

1,358,214

The consolidated entity’s equity is limited to shareholder contributions, supported by the cash inflows received from
providing SCENESSE® to EPP patients under both the full cost special access reimbursement programs such as in Switzerland
and from commercial sales currently in the European Economic Area and USA. Its capital management objectives are limited
to ensuring the equity available to the Company will allow it to continue as a going concern and to realise adequate shareholder
return by progressing in its developmental research of SCENESSE®, to file for successful marketing authorisation in new
jurisdictions and achieving a status whereby revenues will consistently exceed expenditure.

Consolidated Entity

2023
$

2022
$

156,813,537

121,509,282

109,213,537

84,709,282

47,600,000

36,800,000

156,813,537

121,509,282

22,214,646

16,201,937

20,959,240

15,142,670

1,255,406

1,059,267

22,214,646

16,201,937

Other financial assets (includes trade and other receivables)

Carrying amount

6 months or less

Greater than 6 months

Total

23. Share-Based Payments

The consolidated entity has two conditional performance rights schemes which are ownership based for key management
personnel and select consultants (including Directors) of the Company. The number of rights granted is subject to approval by
the Remuneration Committee. Rights currently have specific terms and conditions, being the achievement of performance and
time-based milestones set by the Directors of the consolidated entity.

Conditional Performance Rights Plan (2009)

The Conditional Performance Rights Plan (2009) was available to eligible employees of the Company. Any issue of rights to
executive Directors requires shareholder approval in accordance with ASX Listing Rules. All rights convert to one ordinary share
of the consolidated entity are issued for nil consideration, have no voting rights, are non-transferable and are not listed on the
ASX. They can be converted to ordinary shares at any time once the vesting conditions attached to the rights have been
achieved, whereby they will be held by a Scheme Trustee on behalf of the eligible employee for up to seven years. The eligible
employee can request for shares to be transferred from the Scheme Trust after seven years or at an earlier date if the eligible
employee is no longer employed by the Company or all transfer restrictions are satisfied or waived by the Board in its discretion.

The Company does not intend to issue further performance rights under the 2009 Plan.

Performance Rights Plan (2014)

The Performance Rights Plan (2014) is available to eligible persons of the Company. Any issue of rights to Executive Directors
requires shareholder approval in accordance with ASX Listing Rules. All rights convert to one ordinary share of the consolidated
entity are issued for nil consideration, have no voting rights, are not listed on the ASX and are non-tradeable (other than with
prior written Board consent). They can be converted to ordinary shares at any time once the vesting conditions attached to the
rights have been achieved, whereby, only at the discretion of the Board, they may be held by a Scheme Trustee on behalf of the
eligible person. The eligible person cannot trade in the shares held by the Scheme Trust without prior written Board consent
until the earlier of seven years from grant date of performance right, when the eligible person ceases employment or when all
transfer restrictions are satisfied or waived by the Board in its discretion. Performance Rights under this plan lapse after seven
years from grant date.

As at 30 June 2023, the Company via its wholly owned subsidiary A.C.N. 108768896 Pty Ltd acting in its capacity as trustee

for the 2009 Scheme Trust and the 2014 Plan Trust, holds Nil shares (2022: 2,214,810 shares).

108

109

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

The Following Share-Based Payment Arrangements Were In Existence At 30 June 2023

Holdings Of All Issued Conditional Performance Rights – 2022

Performance
Rights Series

Number Grant date

Expiry Date

Exercise
Price

Fair Value
at Grant Date

Issued

16/09/2011

38,333

16/09/2011

The earlier of achievement of specific
performance milestones and cessation
of employment/directorship

Issued

26/08/2020

1,513,750

20/11/2019 20/11/2023

Issued

24/12/2020

132,500

24/12/2020 20/11/2023

Issued

26/08/2021

682,360

26/08/2021 20/11/2023

$ Nil

between
$0.55 and $0.72

$ Nil

between
$10.86 & $26.87 *

between
$8.98 & $20.74 *

between
$18.73 & $26.22

Issued

5/05/2022

7,500

5/05/2022

20/12/2024

$ Nil $12.87

Issued

29/06/2023

111,500

29/06/2023 30/06/2025

Issued

29/06/2023

144,250

29/06/2023 30/06/2026

$ Nil

between
$9.16 & $14.26 *

* These performance rights are a mixture of market and non-market conditions, the fair values applied to those performance rights expected to vest from the time of grant

Holdings Of All Issued Conditional Performance Rights – 2023

Granted as
Compensation

Exercised

Expired
& Lapsed

Balance at
End of Year

Performance
Condition Met,
not exercisable
until end
Vest Period

Performance
Condition
Not Met,
not exercisable
until end
Vest Period

Performance
Rights Series

Balance at
Start of
Year

Issued 16/09/2011

38,333

Issued 26/08/2020

1,513,750

Issued 24/12/2020

132,500

Issued 26/08/2021

731,924

Issued 05/05/2022

22,500

Issued 29/06/2023

255,750

(15,000)

7,500

255,750

Total

2,439,007

255,750

(64,564)

2,630,193

418,431

2,211,762

Weighted average
exercise price

$Nil

For Performance Rights issued in 2011
Performance Rights were priced using either a binomial or trinomial pricing model. There is no limitation on the life of the right. Expected volatility of each right is based on the historical
share price for the approximate length of time for the expected life of the rights. It is assumed that the consolidated entity will not pay any dividends during the life of the option, and
the risk free rate used in the pricing model is assumed to be the yield on ranging from 1 year to 10 year Government bonds. The exercise conditions are non-marketable and a discount
for lack of marketability was applied to the pricing model.

For Performance Rights Issued in 2020 to 2023
Performance Rights were priced using either a Monte Carlo simulation pricing model for market conditions, or a Binomial Options Valuation pricing model for non-market conditions,
taking into account factors specific to the Performance Rights Plan, such as the vesting period. For non-market conditions, the value of each performance right is multiplied by the
number of performance rights expected to vest to arrive at a valuation. The performance rights expire the earlier of 7 years from date of grant of rights or at a pre-defined date.
Expected volatility of each right is based on the historical share price for the approximate length of time for the expected life of the rights. The exercise conditions are non-marketable.
For the Performance Rights issued on and after 24 December 2020, an illiquidity discount was applied to the pricing model.

110

Granted as
Compensation

Exercised

Balance at
Start of
Year

113,335

25,000

1,513,750

132,500

743,174

22,500

Performance
Condition Met,
not exercisable
until end
Vest Period

Performance
Condition
Not Met, not
exercisable
until end
Vest Period

38,333

Expired
& Lapsed

Balance at
End of Year

(75,002)

38,333

(25,000)

1,513,750

200,750

1,313,000

132,500

11,731

120,769

(11,250)

731,924

63,942

667,982

22,500

1,784,585

765,674

(111,252)

2,439,007

276,423

2,162,584

$Nil

Performance
Rights Series

Issued

Total

Weighted average
exercise price

For Performance Rights Issued in 2020 to 2022
Performance Rights were priced using either a Monte Carlo simulation pricing model for market conditions, or a Binomial Options Valuation pricing model for non-market conditions,
taking into account factors specific to the Performance Rights Plan, such as the vesting period. For non-market conditions, the value of each performance right is multiplied by the
number of performance rights expected to vest to arrive at a valuation. The performance rights expire the earlier of 7 years from date of grant of rights or at a pre-defined date.
Expected volatility of each right is based on the historical share price for the approximate length of time for the expected life of the rights. The exercise conditions are non-marketable.
For the Performance Rights issued on and after 24 December 2020, an illiquidity discount was applied to the pricing model.

24. CLINUVEL PHARMACEUTICALS LTD

Assets

Current assets

Non-current assets

Total assets

Liabilities

Current liabilities

Non-current liabilities

Total liabilities

Equity

Issued equity

Share–based payments reserve

Accumulated losses

Total equity

Financial performance

Net profit for the year

Total comprehensive income

CLINUVEL PHARMACEUTICALS LTD

2023

2022

152,351,411

117,142,670

47,683,856

29,199,431

200,035,267

146,342,101

19,899,692

2,785,053

9,010,574

3,667,875

22,684,745

12,678,449

151,849,375

19,370,046

10,380,258

6,131,101

(28,565,981)

177,350,522

133,663,652

32,720,668

22,294,578

111

38,333

1,513,750

227,000

1,286,750

Parent Company Information

132,500

35,341

97,159

(49,564)

682,360

156,090

526,270

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

a) Guarantees Entered Into By The Parent Entity

The Parent entity provides certain financial guarantees to its subsidiaries. No liability is recognised in relation to this
guarantee as the fair value of the guarantee is considered immaterial. These guarantees are related to the subsidiaries’ abilities
to meet their obligations to their employees.

The Parent entity provides financial commitments for certain subsidiaries for the amount necessary to enable those entities

to meet their obligations as and when they fall due.

b) Contingent Liability

Directors’ Declaration

In the opinion of the Directors:

1) the financial statements and notes of the consolidated entity are in accordance with the Corporations Act 2001,

including:
a) giving a true and fair view of the consolidated entity’s financial position as at 30 June 2023 and of its performance for

The Parent entity did not have any material contingent liabilities as at 30 June 2023 and 2022.

the year ended on that date;

c) Contractual Commitments For The Acquisition Of Property, Plant And Equipment

The Parent entity did not have any material contractual commitments for the acquisition of property, plant and equipment

as at 30 June 2023 and 2022.

25. Subsequent Events

There have not been any matters financial in nature, other than reference to the financial statements that has arisen since
the end of the financial year that has affected or could significantly affect the operations of the consolidated entity, other than:

• On 28th August 2023, the Board of Directors declared an unfranked dividend of $0.05 per ordinary share; and
• In July 2023, the Group purchased a commercial property located in Egham, UK to support its expanding European-

based workforce for a cash consideration, net of fees, of £2,500,000.

26. Additional Company Information

CLINUVEL PHARMACEUTICALS LTD is a listed public company incorporated and operating in Australia.

The Registered office is:

Level 11, 535 Bourke Street
Melbourne VIC 3000
Ph: (03) 9660 4900

b) complying with Accounting Standards; and
c) complying with International Financial Reporting Standards as disclosed in Note 1.

2) there are reasonable grounds to believe that the Company will be able to pay its debts as and when they become due

and payable; and

3) the audited remuneration disclosures set out in pages 57 to 82 of the Directors’ Report comply with Section 300A of the

Corporations Act 2001.

This declaration is made in accordance with a resolution of the Board of Directors. The Directors have been given the
declarations by the Chief Executive Officer and Chief Financial Officer required by Section 295A of the Corporations Act
2001.

Dr. Philippe Wolgen, MBA MD
Director
Dated this 29th day of August, 2023

112

113

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

Grant Thornton Audit Pty Ltd
Level 22 Tower 5
Collins Square
727 Collins Street
Melbourne VIC 3008
GPO Box 4736
Melbourne VIC 3001

T +61 3 8320 2222

Independent Auditor’s Report

To the Members of Clinuvel Pharmaceuticals Limited

Report on the audit of the financial report

Opinion

We have audited the financial report of Clinuvel Pharmaceuticals Limited (the Company) and its subsidiaries
(the Group), which comprises the consolidated statement of financial position as at 30 June 2023, the
consolidated statement of profit or loss and other comprehensive income, consolidated statement of
changes in equity and consolidated statement of cash flows for the year then ended, and notes to the
consolidated financial statements, including a summary of significant accounting policies, and the Directors’
declaration.

In our opinion, the accompanying financial report of the Group is in accordance with the Corporations Act
2001, including:

giving a true and fair view of the Group’s financial position as at 30 June 2023 and of its performance
for the year ended on that date; and

complying with Australian Accounting Standards and the Corporations Regulations 2001.

Basis for opinion

We conducted our audit in accordance with Australian Auditing Standards. Our responsibilities under those
standards are further described in the Auditor’s Responsibilities for the Audit of the Financial Report section
of our report. We are independent of the Group in accordance with the auditor independence requirements
of the Corporations Act 2001 and the ethical requirements of the Accounting Professional and Ethical
Standards Board’s APES 110 Code of Ethics for Professional Accountants (including Independence
Standards) (the Code) that are relevant to our audit of the financial report in Australia. We have also fulfilled
our other ethical responsibilities in accordance with the Code.

We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our
opinion.

Key audit matters

Key audit matters are those matters that, in our professional judgement, were of most significance in our audit of
the financial report of the current period. These matters were addressed in the context of our audit of the financial
report as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these
matters.

www.grantthornton.com.au
ACN-130 913 594

Grant Thornton Audit Pty Ltd ACN 130 913 594 a subsidiary or related entity of Grant Thornton Australia Limited ABN 41 127 556 389 ACN 127 556 389.
‘Grant Thornton’ refers to the brand under which the Grant Thornton member firms provide assurance, tax and advisory services to their clients and/or
refers to one or more member firms, as the context requires. Grant Thornton Australia Limited is a member firm of Grant Thornton International Ltd (GTIL).
GTIL and the member firms are not a worldwide partnership. GTIL and each member firm is a separate legal entity. Services are delivered by the member
firms. GTIL does not provide services to clients. GTIL and its member firms are not agents of, and do not obligate one another and are not liable for one
another’s acts or omissions. In the Australian context only, the use of the term ‘Grant Thornton’ may refer to Grant Thornton Australia Limited ABN 41 127
556 389 ACN 127 556 389 and its Australian subsidiaries and related entities. Liability limited by a scheme approved under Professional Standards
Legislation.

112

114

Key audit matter

Income taxes (Note 3)

The Group holds significant tax balances at 30 June 2023,
including deferred tax assets of $1,059,541, deferred tax
liabilities of $2,757,516, and income tax payable of
$16,094,178.

There are also $18,899,558 of unused carry-forward tax
losses from its foreign subsidiaries not recognised on the
balance sheet.

Deferred tax assets are recognised to the extent that there are
sufficient taxable profits relating to the same taxation authority
against which the unused tax losses can be utilised. The
Group also operates globally and is therefore subject to tax
regimes and legislation administered by tax authorities in a
number of jurisdictions.

This area is a key audit matter due to:
•

The degree of judgement required in assessing
Management’s estimates of future taxable profits to
enable the asset to be realised;

•

The Group undertaking transactions in a number of tax
jurisdictions which require the Group to make significant
judgments about the interpretation of tax legislation and
the application of accounting standards; and

The nature of cross-border tax arrangements and our
need to involve taxation specialists with cross-border
transactions experience and expertise in transfer pricing
in key jurisdictions.

Share-based payments (Note 14 & Note 23)

The Group has material share-based payment arrangements
in place for key management and employees, with the
expense for the year being $8,989,788.

These arrangements include a combination of both market
and non-market conditions, with the expense being incurred
during the year being heavily impacted by the probabilities
determined by management of the specific performance
milestones being met, which contain a high degree of
judgement.

Under AASB 2, Management are required to value the
performance rights and assess the expected vesting date for
achievements of the milestones.

This area is a key audit matter due to the degree of judgement
required in valuing the performance rights, as well as
determining estimates of the vesting dates, relating to both the
probability and likely timing of achieving specific non-market
conditions.

How our audit addressed the key audit matter

Our procedures included, amongst others:

• Holding discussions with Management to obtain an

understanding of the policy applied for the recognition of
deferred tax and assessment of profitability of the group in
the near future;

•

Evaluating Management’s forecast of future taxable
income by assessing the key underlying assumptions such
as future taxable income against historic performance and
market trends;

Assessing the competence and objectivity of
Management’s tax expert used, to assist in the preparation
of the valuation of the tax balances;

Utilising our internal taxation specialists to assess that
carry-forward losses are available for use;

Checking the accuracy of input data and evaluate formulas
and assumptions applied in the computation of the
deferred tax asset;

Utilising our transfer pricing specialists to assist in our
assessment of the cross-border transactions made
between Group entities in different tax jurisdictions;

Utilising our internal taxation specialists to assist in the
assessment of the determination of the tax bases; and

Assessing the adequacy of the group’s disclosure in
relation to the carrying value of deferred tax assets.

Our procedures included, amongst others:

• Reviewing the relevant agreements to obtain an

understanding of the contractual nature of the share-based
payment arrangements;

•

Obtaining Management's option valuations and associated
share-based payment support;

Holding discussions with Management to understand the
share-based payment arrangements in place;

Assessing the allocation of the share-based payment
expense over the relevant vesting period (assessing
appropriateness of the vesting period);

Evaluating Management’s forecasts, holding discussions
with management and corroborating achievement of
performance conditions attached to the share-based
payments to external evidence to validate consistency and
appropriateness of vesting dates for performance
conditions; and

Assessing the adequacy of the disclosures in the financial
report.

Information other than the financial report and auditor’s report thereon

The Directors are responsible for the other information. The other information comprises the information included
in the Group’s annual report for the year ended 30 June 2023, but does not include the financial report and our
auditor’s report thereon.

Our opinion on the financial report does not cover the other information and we do not express any form of
assurance conclusion thereon.

Grant Thornton Audit Pty Ltd

113

115

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

In connection with our audit of the financial report, our responsibility is to read the other information and, in doing
so, consider whether the other information is materially inconsistent with the financial report, or our knowledge
obtained in the audit or otherwise appears to be materially misstated.

If, based on the work we have performed, we conclude that there is a material misstatement of this other
information, we are required to report that fact. We have nothing to report in this regard.

Responsibilities of the Directors for the financial report

The Directors of the Company are responsible for the preparation of the financial report that gives a true and fair
view in accordance with Australian Accounting Standards and the Corporations Act 2001 and for such internal
control as the Directors determine is necessary to enable the preparation of the financial report that gives a true
and fair view and is free from material misstatement, whether due to fraud or error.

In preparing the financial report, the Directors are responsible for assessing the Group’s ability to continue as a
going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of
accounting unless the Directors either intend to liquidate the Group or to cease operations, or have no realistic
alternative but to do so.

Auditor’s responsibilities for the audit of the financial report

Our objectives are to obtain reasonable assurance about whether the financial report as a whole is free from
material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our opinion.
Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance
with the Australian Auditing Standards will always detect a material misstatement when it exists. Misstatements
can arise from fraud or error and are considered material if, individually or in the aggregate, they could
reasonably be expected to influence the economic decisions of users taken on the basis of this financial report.

A further description of our responsibilities for the audit of the financial report is located at the Auditing and
Assurance Standards Board website at: http://www.auasb.gov.au/auditors_responsibilities/ar1_2020.pdf.This
description forms part of our auditor’s report.

Report on the remuneration report

Opinion on the remuneration report

We have audited the Remuneration Report included in pages 57 to 82 of the Directors’ report for the year
ended 30 June 2023.

In our opinion, the Remuneration Report of Clinuvel Pharmaceuticals Limited, for the year ended
30 June 2023 complies with section 300A of the Corporations Act 2001.

Responsibilities

The Directors of the Company are responsible for the preparation and presentation of the Remuneration Report
in accordance with section 300A of the Corporations Act 2001. Our responsibility is to express an opinion on the
Remuneration Report, based on our audit conducted in accordance with Australian Auditing Standards.

Grant Thornton Audit Pty Ltd
Level 22 Tower 5
Collins Square
727 Collins Street
Melbourne VIC 3008
GPO Box 4736
Melbourne VIC 3001

T +61 3 8320 2222

Auditor’s Independence Declaration

To the Directors of Clinuvel Pharmaceuticals Limited

In accordance with the requirements of section 307C of the Corporations Act 2001, as lead auditor for the audit
of Clinuvel Pharmaceuticals Limited for the year ended 30 June 2023, I declare that, to the best of my knowledge
and belief, there have been:

no contraventions of the auditor independence requirements of the Corporations Act 2001 in relation to
the audit; and

no contraventions of any applicable code of professional conduct in relation to the audit.

Grant Thornton Audit Pty Ltd
Chartered Accountants

M A Cunningham
Partner – Audit & Assurance

Melbourne, 29 August 2023

Grant Thornton Audit Pty Ltd
Chartered Accountants

M A Cunningham
Partner – Audit & Assurance

Melbourne, 29 August 2023

114

116

Grant Thornton Audit Pty Ltd

www.grantthornton.com.au
ACN-130 913 594

115

117

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT

SHAREHOLDER
INFORMATION
As at 15 August 2023

Additional information as at 15 August 2023 required by the Australian Securities Exchange not shown else-
where in this report is as follows:

1. Shareholding

a) Distribution of shareholder numbers

Ordinary fully paid shares

e) Largest shareholders

Total holders

Units

% Of issued capital

Position

Name

2.53

4.38

2.25

8.70

82.14

100.00

Units

3,709

Category (size of
holding)

1-1,000

1,001-5,000

5,001-10,000

10,001-100,000

100,001 & Over

Total

4,381

951

152

163

5,672

1,249,177

2,164,496

1,111,802

4,297,291

40,587,572

49,410,338

b) Shareholdings held in less than marketable parcels

Total

Minimum parcel size

Holders

Minimum $500.00 parcel at $20.32 per unit

422

c) Substantial shareholdings

Name

No. Ordinary shares & American Depository Receipts

The Bank of New York Mellon Corporation1

Dr Philippe Wolgen2

Ender 1 LLC3

4,296,472

3,122,247

2,340,824

1. As disclosed in substantial holder notice dated 24 May 2022.
2. As disclosed in director’s interest notice dated 28 June 2023. Actual shareholding on 15 August 2023 is 3,122,247.
3. As disclosed in substantial holder notice dated 16 September 2013. Actual shareholding on 15 August 2023 is 2,590,824.

d) Voting rights

The voting rights attaching to each class of equity securities are set out below:

(i) Ordinary shares: Ordinary shares entitle their holder to one vote, either in person or by proxy,

at a meeting of the Company.

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

20.

HSBC Custody Nominees (Australia) Ltd

BNP Paribas Nominees Pty Ltd ACF Clearstream

BNP Paribas Nominees Pty Ltd

J P Morgan Nominees Australia Pty Ltd

Dr Philippe Jacques Wolgen

Citicorp Nominees Pty Ltd

Ender 1 LLC

BNP Paribas Nominees Pty Ltd

Emilino Group Pty Ltd

National Nominees Ltd

Dr Mark Edwin Badcock

Mr David William Trevorrow

Mr David John Lewis

HSBC Custody Nominees (Australia) Ltd - a/c 2

Mr Trent Sheldon Redding

Mr Darren Michael Keamy

Rusty Hammer Pty Ltd

Dr Dennis Wright

Mr Simon John Bown

BNP Paribas Noms (NZ) Ltd

Totals: Top 20 holders of ordinary fully paid shares (total)

Number of
ordinary
fully paid
shares held

11,280,990

5,679,762

5,312,764

4,390,776

3,122,247

3,014,759

2,590,824

1,482,356

603,447

548,371

440,085

229,600

187,000

180,199

179,480

178,588

156,892

156,874

146,000

130,710

40,011,724

9,398,614

% held of issued
ordinary capital

22.83

11.50

10.75

8.89

6.32

6.10

5.24

3.00

1.22

1.11

0.89

0.46

0.38

0.36

0.32

0.30

0.26

80.97

19.03

(i) Performance rights: Performance Rights have no voting rights.

Total remaining holders balance

118

119

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT2. Company Secretary
The name of the Company Secretary is: Darren Keamy

6. Restricted Securities
Restricted securities on issue at 30 June, 2023: Nil.

3. Registered Office
The principle registered office in Australia is:
Level 11, 535 Bourke Street

Melbourne, VIC 3000, Australia

Telephone: +61 3 9660 4900

Fax: +61 3 9660 4999

Email: mail@clinuvel.com

Website: https://www.clinuvel.com

4. Register Of Securities
Computershare Investor Services Pty Ltd

Yarra Falls, 453 Johnston St, Abbotsford,

VIC 3067, Australia

Telephone: +61 3 9415 4000

7. Directory
Non-Executive Chair
Willem Blijdorp

Non-Executive Directors
Brenda Shanahan, Dr Karen Agersborg, Susan Smith,

Prof Jeffrey Rosenfeld, Sir Andrew Likierman

Managing Director And Chief Executive Officer
Dr Philippe Wolgen

Chief Scientific Officer
Dr Dennis Wright

Chief Financial Officer And Company Secretary
Darren Keamy

Auditor
Grant Thornton Audit Pty Ltd

5. Australian Securities
Exchange Limited
Quotation has been granted for all the ordinary shares on

all Member Exchanges of the Australian Securities Exchange Limited

(ASX):

• ASX: CUV.

The Company’s shares are also traded on:

• Börse Frankfurt, Germany, under the code UR9; and

• Over-the-Counter Market, USA, as a Level 1, American Depositary

Receipt (ADR), under the code CLVLY. Each ADR of the Company

Collins Square, Tower 5, Level 22, 727 Collins Street, Melbourne,

VIC 3008, Australia

Banker
National Australia Bank (NAB)

Western Branch, 460 Collins St, Melbourne, VIC 3000, Australia

Legal Counsel
Arnold Bloch Leibler

Level 21, 333 Collins St, Melbourne, VIC 3000, Australia

Sidley Austin LLP

Woolgate Exchange, 25 Basinghall Street, London, EC2V 5HA,

United Kingdom

IP Lawyer
Dipl.-Ing Peter Farago

is equivalent to one ordinary share of the Company, as traded on

Baadestr 3, Munich 80, Germany

the ASX. The Bank of New York Mellon is the depositary bank for

CLVLY.

120

CLINUVEL Pharmaceuticals Ltd MARKET PERFORMANCE

1,200,000

1,000,000

800,000

600,000

400,000

200,000

2022
JUL

AUG

SEP

OCT

NOV

DEC

2023
JAN

FEB

MAR

APR

MAY

JUN

2022
JUL

AUG

SEP

OCT

NOV

DEC

2023
JAN

FEB

MAR

APR

MAY

JUN

ASX:CUV – Share Price (A$)

ASX:CUV – Daily Trading Volume (No.)

122

123

CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORTGLOSSARY

Alpha-melanocyte stimulating hormone (α-msh)
A peptide hormone which activates or stimulates the production
and release of (eu)melanin in the skin (melanogenesis).

Melanin
The dark pigment synthesised by melanocytes; responsible for
skin pigmentation.

Dermatocosmetics
Specially formulated products designed to assist skin health
with a focus on anti-aging, and repair and regeneration of the
skin. Dermatocosmetics combine a dermatological action to
treat the skin and a cosmetic action to cleanse, moisturise, and
alter the appearance of an individual’s skin.

European Medicines Agency (EMA)
The decentralised body of the European Union regulating medi-
cal drugs and devices.

Eumelanin
A black or brown pigment mainly concerned with the pro-
tection of the skin by absorbing incoming uv radiation. This
protective ability warrants melanin to be termed a photopro-
tectant (a substance capable of providing protection against
radiation from the sun). α-msh acts specifically to stimulate
(eu)melanin synthesis.

Food and Drug Administration (FDA)
The usa’s regulatory agency for food, tobacco, medicines,
and medical devices.

Melanocortins
Melanocortins are a group of peptide hormones, consisting
of adrenocorticotropin hormone (ACTH), α-melanocyte
stimulating hormone (α-MSH), beta-melanocyte-stimulating
hormone (β-MSH), and gamma-melanocyte-stimulating hor-
mone (γ-MSH) which are derived from proopiomelanocortin
(POMC) in the pituitary gland.

Melanocortin receptors
Melanocortins exert their effects by binding to and activating
melanocortin receptors, a family of five (MC1R to MC5R) sev-
en-transmembrane g-protein coupled receptors (GPCRS) that
affect different body functions. The receptors are widespread
throughout the body, exhibiting myriad ligand affinities, tissue
and cell distribution, and downstream effects.

Melanogenesis
The process whereby melanin is produced in the body
Narrowband Ultraviolet B (NB-UVB) phototherapy
Therapy which utilises an ultraviolet b light source
to activate melanin in vitiliginous lesions of the skin.

High Energy Visible (HEV) light
A particularly high-frequency, high-energy light in the blue/violet
band, ranging from 450 to 450 nm in the visible light spectrum.
HEV generates oxidative stress, accelerates skin aging and
increases hyperpigmentation.

Phase i
The first trials of a new drug candidate in humans, phase i trials
are designed to evaluate how a new drug candidate should
be administered, to identify the highest tolerable dose and to
evaluate the way the body absorbs, metabolises and eliminates
the drug.

Phase ii
A phase ii trial is designed to continue to test the safety of the
drug candidate, and begins to evaluate whether, and how well,
the new drug candidate works (efficacy). Phase ii trials often
involve larger numbers of patients.

Phase iib/phase iii
Advanced-stage clinical trials that should conclusively demon-
strate how well a therapy based on a drug candidate works.
Phase iii trials can be longer and typically much larger than
phase ii trials, and frequently involve multiple test sites. The
goal is statistically determining whether a therapy clinically
improves the health of patients undergoing treatment while
remaining safe and well tolerated.

Pharmacodynamics
The study of the time course of a drug’s actions in the body.

Pharmacokinetics
The part of pharmacology that studies the release and availabili-
ty of a molecule and drug in the human body.

PhotoCosmetics
CLINUVEL’s product range of dermatocosmetics.
Photodermatoses
Photodermatoses are a variety of skin conditions that develop as
a result of exposure to ultraviolet radiation or visible light.

Photoprotection
Protection from light and ultraviolet radiation. Melanin provides
natural photoprotection to skin, whilst sunscreens provide artifi-
cial photoprotection.

Subcutaneous
Underneath the skin.

Sustained release/controlled‑release
Process whereby a drug is released from a formulation over a
period of time.

Therapeutic Goods Administration (TGA)
Australia’s regulatory agency for medicinal products
and devices.

Ultraviolet (UV) radiation
Part of the electromagnetic spectrum at wavelengths below 400
nanometers, also called the invisible portion of light. There are
three sub-types of UV: UVC <280 nm; UVB 280–320 nm; UVA
320–400 nm.

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