CLINUVEL PHARMACEUTICALS LTD
A.B.N. 88 089 644 119
1.
Reporting period:
1 July 2023 to 30 June 2024.
Previous corresponding period:
1 July 2022 to 30 June 2023.
2.
Results for announcement to the market.
Percentage change to 2024
Amount (A$)
2.1 Revenues from ordinary activities.
Increased 13%
To
88,178,308
2.2 Profit from ordinary activities before tax attributable to members.
Profit has increased 11%
To
50,678,978
2.3 Net profit for the period attributable to members.
Profit has increased 16%
To
35,636,359
2.4 A fully franked final dividend of $0.05 per ordinary share has been declared.
2.5 Record date for determining entitlements for the final dividend: 6 September 2024.
2.6 The CLINUVEL PHARMACEUTICALS LTD audited Annual Report for the year ended 30 June 2024 accompanies this announcement.
Additional Appendix 4E disclosure requirements, including the Operating and Financial Review for an explanation of the figures
reported above, are in the Directors’ Report of the attached Annual Report. Where applicable, the Annual Report includes
information per items 3 to 14 below:
3.
Refer to the Attachment to Appendix 4E for the Statement of Profit and Other Comprehensive Income together with notes to
the statement.
4.
Refer to the Attachment to Appendix 4E for the Statement of Financial Position together with notes to the statement.
5.
Refer to the Attachment to Appendix 4E for the Statement of Cash Flows together with notes to the statement.
6. Refer to the Attachment to Appendix 4E for the Statement of Changes in Equity together with notes to the statement.
7.
The Directors have declared a fully franked final dividend of $0.05 per ordinary share to be paid on 20 September 2024.
8.
No dividend reinvestment plan.
9.
Net Tangible Assets per Security for Year Ended
Net Tangible Assets per Security for Year Ended
30 June 2024: $4.015
30 June 2023: $3.290
10. The control of entities which had control gained or lost: N/A
11. Associates and joint venture entities: N/A
12. No other significant information.
13. Foreign entities: Australian Accounting Standards used.
CLINUVEL, INC. (USA), CLINUVEL (UK) LTD (UK), CLINUVEL AG (Switzerland), CLINUVEL SINGAPORE PTE LTD (Singapore), VALLAURIX PTE
LTD (Singapore), CLINUVEL EUROPE LIMITED (Ireland), VALLAURIX MC SARL (Monaco).
14. COMMENTARY OF RESULTS:
Commentary in respect of the financial results is provided in the Operating and Financial Review of the attached Annual Report.
P H A R M A C E U T I C A L S LTD
ANNUAL REPORT 2024
“When we build, let us
think that we build forever.”
John Ruskin
Plans 2025 and beyond
Financials
Advocacy
Chair’s letter
Vision
Mission
Values
Investor Relations Program
Management
Board
Managing
Director’s
letter
The role of melanocortins
Pharmaceutical products
Photocosmetic products
Operational overview
CONTENTS
Mission, Vision & Values
6
The Role of Melanocortins in Human Biology
10
Key Achievements
14
Advocacy of Key Opinion Leaders
16
Financial Highlights
18
Sustainability
20
Chair's Letter
26
Management and Board
30
Managing Director's Letter
42
Operating & Financial Review
50
1. Distribution of SCENESSE®
2. Pharmaceutical Product
Development and Clinical Programs
3. PhotoCosmetic Products
4. Financial Review
Plans 2025 and Beyond
66
Investor Relations Program
72
The Photomedicine Foundation
76
Directors’ Report
79
Remuneration Report
87
Statement of Profit and Other Comprehensive Income
116
Statement of Financial Position
117
Statement of Cash Flows
118
Statement of Changes in Equity
119
Notes to and Forming Part of the Financial Statements
120
Consolidated Entity Disclosure Statement
146
Directors’ Declaration
147
Independent Auditor's Report
148
Auditor's Independence Declaration
151
Shareholder Information
152
Market Performance
156
Glossary
158
BUILDING A
MELANOCORTIN
HOUSE
CLINUVEL's mission is to translate
its accumulated technology and
expertise on the melanocortin family
of hormones to wider audiences
with unmet needs through the
development of solutions for
conditions of skin and brain. We are
building a melanocortin house and
employing an integrated business
model to add incremental value to the
Company and become a sustainable,
diversified pharmaceutical group of
international significance.
ANNUAL REPORT 2024
CLINUVEL PHARMACEUTICALS LTD
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4
MISSION
D EL IVERIN G I NNOVAT I V E SO LU T I O NS
FOR U N M E T PAT I E NT A ND
HEA LT H C A R E NE E DS.
VISION
TH E CLIN UVE L GROUP WORKS TO
TRA N SL ATE SCIE N TIFIC CON CE PTS A N D
BRE A KTH ROUGH S IN TO COM M E RCIA L
PROD UCTS TO PRE VE N T OR TRE AT ACUTE
A N D CH RON IC M E D ICA L CON D ITION S
WH E RE N O A LTE RN ATIVE S E XIST.
WE A RE D E TE RM IN E D IN OUR D E SIRE
TO E XCE L IN SCIE N TIFIC RE SE A RCH A ND
D E VE LOPM E N T, BUILD IN G ON OUR GLOBAL
E XPE RTISE TO D E LIVE R LON GITUD IN AL
CA RE A N D N OVE L PROD UCTS
FOR PATIE N TS A N D CON SUM E RS.
TH E CLIN UVE L GROUP PUTS ITS PE OPL E
A N D E N VIRON M E N T A S CE N TRA L TO
TH E GROUP'S WORKIN G PRACTICE .
CLIN UVE L FOCUSE S ITS RE SE A RCH
A N D D E VE LOPM E N T ON H E A LTH CA RE
PROBLE M S N OT YE T A D D RE SSE D , A IM ING
TO D E LIVE R IN N OVATIVE M E D ICA L
A N D H E A LTH CA RE SOLUTION S.
ANNUAL REPORT 2024
CLINUVEL PHARMACEUTICALS LTD
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7
VALUES
T HE CL IN UVE L G R O U P PL E DG E S TO
AD HERE TO A PR I NC I PA L SE T O F VA LU E S
W HICH REF L ECT H OW W E O PE RAT E A ND
IN T ERACT W I T H E AC H OT H E R W H I L E
EXPAN D I NG O U R B USI NE SS.
People & Environment
We work for those who have no
alternatives: patients, physicians, and
individuals at-risk. We are selective 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.
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, evaluate,
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, consumer demand, and a lack of
available solutions. 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.
Knowledge Building & Sharing
Our expertise spans the fields of optical
physics, the interaction of light and
human biology, and the potential
of melanocortin drugs in acute care
and life-threatening conditions. We
specialise in skin and brain disorders.
We are proficient in our understanding
of acute, rare, and complex disorders.
We advance our ideas and concepts
and translate them into effective and
practical solutions. We aim to grow our
know-how continuously and establish a
learned community. Collaboratively we
seek to excel in a multifaceted field to
arrive at scientific breakthroughs.
Respect & Appreciation
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 sincere 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 empathy and compassion for all
those we work to serve.
ANNUAL REPORT 2024
CLINUVEL PHARMACEUTICALS LTD
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What are melanocortins?
Melanocortins are a group of small
protein hormones derived from
proopiomelanocortin (POMC). These
hormones modulate physiological
activity in the body by binding with
specific melanocortin receptors (MCRs)
on cells across the body. Five MCRs
have been identified: MC1R—MC5R.
POMC, the precursor molecule to all
naturally occurring melanocortins, is
widely expressed throughout the human
body, although has very little biological
THE ROLE OF
MELANOCORTINS
IN HUMAN BIOLOGY
Proopiomelanocortin (POMC)
241 Amino Acids
ACTH
24 / 39 Amino Acids
ꞵ-lipotropin
91 Amino Acids
MSH
13 Amino Acids
14 Amino Acids
ɣlipotropin
58 Amino Acids
ꞵ-endorphin
31 Amino Acids
13 Amino Acids
ꞵ-MSH
22 Amino Acids
ɣMSH
11 Amino Acids
activity. Cleaving POMC into smaller
peptides produces melanocortins which
are able to bind to receptors on cells and
exert their effects. Since these peptides
are tissue specific, the body can control
the release of specific melanocortins
from specific tissues to generate a
biologically relevant effect.
The key POMC-derived peptides are
α-MSH, beta-MSH, gamma-MSH and
ACTH. All share a key sequence of four
amino acids (-HFRW-) which allow them
to bind to the various melanocortin
receptors. α-MSH – the natural hormone
of which afamelanotide is an analogue
– is formed from the cleaving of ACTH
and known to play a role in cells across
the human body. Perhaps best known in
humans is the role of α-MSH in dermal
pigmentation: epidermal keratinocytes
produce and release α-MSH in response
to UV radiation exposure, with α-MSH
then binding to MC1R on melanocytes
to activate the synthesise of melanin.
This process is known as melanogenesis.
α-MSH is involved in a wide range of
other functions in the body, including
Melanocortin peptides, ACTH and α- β- γ-MSH derive from post-translational processing of POMC, which is also the
precursor for opioid peptides and CLIP (corticotropin-like intermediate lobe peptide)
PITUITARY GLAND
HYPOTHALAMUS
MCRs 1/4/5
MCRs 1/3/4/5
VASCULAR SYSTEM
MCRs 1/4
HEART
MCRs 1/4
LIVER
MCRs 1/4
INTESTINES
MCRs 1/3/4/5
GONADS
MCRs
FEMALE 4
MALE 1/4/5
ADRENAL GLANDS
MCRs 1/4/5
KIDNEYS
MCRs 1/3/4
M C 1R
TISSUE EXPRESSION
ANTI-INFLAMMATORY CELLS
HAIR FOLLICLE
MELANOMA CELLS
MELANOCYTES
PERIAQUEDUCTAL GREY
PITUITARY
SKIN GLANDS
TESTES
FUNCTION
INFLAMMATION
PIGMENTATION
AGONIST
α-MSH
M C 2R
TISSUE EXPRESSION
ADIPOCYTES
ADRENAL CORTEX
SKIN
FUNCTION
STEROIDOGENESIS
AGONIST
ACTH
M C 3R
TISSUE EXPRESSION
BRAIN
GUT
HEART
PLACENTA
TESTES
FUNCTION
ENERGY HOMEOSTASIS
SEXUAL BEHAVIOUR
AGONIST
α- β- AND γ-MSH
M C 4R
TISSUE EXPRESSION
ADIPOCYTES
BRAIN
FUNCTION
APPETITE REGULATION
AGONIST
α- AND β-MSH, ACTH
M C 5R
TISSUE EXPRESSION
ADIPOSE TISSUE
ADRENAL GLANDS
BRAIN
EXOCRINE TISSUES
KIDNEYS
LEUCOCYTES
LUNG
LYMPH NODES
MAMMARY GLANDS
MUSCLES
OVARIES
SKELETAL
TESTES
UTERUS
FUNCTION
EXOCRINE FUNCTION
AGONIST
α-MSH, ACTH
M ELA N OCO RT IN FAM ILY
ANNUAL REPORT 2024
CLINUVEL PHARMACEUTICALS LTD
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MC5R
MC5R functions are still being
researched, although evidence
suggests that MC5R plays a key role
in governing immune reaction and
DNA repair, immunomodulation,
anti‑inflammation, energy homeostasis,
reproductive system functions, and
exocrine gland secretion.
ACTH is the primary effector
hormone mediating the HPA
(hypothalamo‑pituitary-adreno)
axis, which regulates a wide range of
biological systems to meet day‑to‑day
metabolic needs of the body. Released
from the anterior pituitary gland,
ACTH binds to MC2R on the adrenal
glands, leading to release of the
glucocorticoid cortisol. ACTH also
binds to, and activates, all five known
human melanocortin receptors,
regulating immunomodulatory and
neuroprotective activity.
β-MSH and γ-MSH are cleaved from
the C-terminal and N-terminal ends of
POMC, respectively. In humans β-MSH
is thought to play a critical role in the
regulation of body weight in humans via
ERYTHROPOIETIC
PROTOPORPHYRIA (EPP)
A rare metabolic disorder
of the haem biosynthesis
pathway that causes severe,
phototoxic reactions to
visible and UV light.
SCENESSE®,
afamelanotide – MC1R
Stimulates the production
of eumelanin to provide
systemic photoprotection
from exposure to light and
resulting protoporphyrin
IX (PPIX) photoexcitation.
This prevents phototoxicity
in EPP, which is a result of
a deficiency of the enzyme
ferrochelatase (FECH) which
causes PPIX accumulation in
the body and skin.
VARIEGATE
PORPHYRIA (VP)
A rare metabolic disorder of the
haem biosynthesis pathway
that causes both phototoxicity
and acute attacks.
SCENESSE®,
afamelanotide – MC1R
Stimulates the production
of eumelanin to provide
systemic photoprotection
from exposure to light and
resulting PPIX photoexcitation.
This prevents phototoxicity
in VP, which is a result of
defects in the enzyme
protoporphyrinogen
oxidase (PPOX), which cause
protoporphyrinogen IX
accumulation (then oxidised
to PPIX) in the body and skin.
VITILIGO
A skin condition (believed to
be auto-immune) resulting
in a loss of pigment in the
skin, causing profound
psychological and social
impact.
SCENESSE®,
afamelanotide – MC1R
Stimulates melanocytes to
produce eumelanin, which
in conjunction with NB‑UVB
results in melanocyte
stem cell maturation and
migration into vitiligo
lesions, resulting in lesion
repigmentation.
XERODERMA
PIGMENTOSUM (XP)
A rare genetic disorder which
impairs the body's ability
to repair DNA damaged by
exposure to light; leads to
extreme risk of skin cancer.
SCENESSE®,
afamelanotide – MC1R
Protects the skin from UV
damage via multiple
mechanisms, including the
direct effects of increased
melanin levels in the skin,
antioxidative pathways
and enhanced UV radiation
repair mechanisms.
INFANTILE SPASMS (IS)
A rare and serious seizure
disorder in infants and young
children, which can lead to
developmental delay and
epilepsy in later life.
NEURACTHEL®,
ACTH – MC2R, MC3R, MC4R
Exerts antiepileptic
properties through a
combination of MC2R-
activated steroidogenesis
and MC3R/MC4R-mediated
anti-inflammation in the
central nervous system.
ARTERIAL ISCHAEMIC
STROKE (AIS)
An acute life-threatening
neurological dysfunction
following a blockage of
arterial blood flow.
PRÉNUMBRA®,
afamelanotide – MC1R,
MC3R, MC4R
Thought and evaluated on
its supportive role in the
reperfusion of brain tissue
via vasodilatory effects,
in addition to exerting
anti-inflammatory effects
and anti-oxidative effects
within tissue affected by the
stroke, potentially improving
post‑stroke recovery.
MULTIPLE SCLEROSIS (MS)
An auto-immune condition
of the central nervous system
which leads to impaired
neurological function,
including motor function.
NEURACTHEL®, ACTH
Exerts immunomodulation
by inhibiting the
inflammatory effects
of immune cells in the
central nervous system,
and generates an anti-
inflammatory effect by
reducing production of
pro-inflammatory cytokines
and inhibiting the activation
of nuclear factor (NF)‑κB,
the master driver of
inflammation.
PARKINSON'S DISEASE (PD)
A progressive
neurodegenerative condition
characterised by the death of
dopaminergic neurons in the
substantia nigra, accompanied
by accumulation of alpha-
synuclein (Lewy bodies).
PRÉNUMBRA®,
afamelanotide – MC1R
Generates neuroprotective
effects via attenuation
of α-synuclein-induced
dopaminergic neurotoxicity,
as well as upregulating anti-
inflammatory, anti-oxidative,
and DNA repair pathways
in a way which could slow
disease progression.
CLI N UVE L'S FOCUS ON CO N DI T I O N S O F S K I N A N D B RA I N
CLINUVEL's areas of interest are summarised below, highlighting the melanocortin technology applied for each condition,
the target MCR, and the mode of action that provides the therapeutic treatment of the condition.
its effect on the hypothalamus, while
γ-MSH is thought to regulate sodium
balance and blood pressure through
action on MC3R in the brain and kidneys.
Melanocortin Receptors
MCRs are found on cells across the
body. Their known distribution and
functions are illustrated on page 11.
MC1R
MC1R is well-known for mediating
adaptive tanning in human skin,
although its activation also leads to
regulation of a range of other effects,
including anti-inflammation, DNA repair
and immunomodulation. In addition to
melanocytes and keratinocytes in the
skin, MC1R is present on cells across
wide range of tissues including the liver,
brain and adrenal gland.
MC2R
MC2R, uniquely for the MCR group,
can be bound to and activated only by
ACTH. MC2R is predominantly found
in the adrenal glands where its action
leads to cortisol release as part of the
HPA axis, although like MC1R it is also
present in a wide range of tissues,
including skin, adipocytes, and bone.
MC3R
MC3R functions include regulation
of energy homeostasis, autonomic
functions, feeding behaviours, and
anti-inflammation. MC3R is normally
expressed in the brain, immune cells,
placenta, heart, thymus, gut and the eye.
MC4R
MC4R has a broad range of functions
that include energy homeostasis,
feeding behaviour, thermogenesis,
sexual function, cardiovascular
function, anti-inflammatory,
neuroprotection and pigmentation.
MC4R is normally expressed in the
brain, autonomic nervous system,
spinal cord, immune cells, and the eye.
ɑ-MSH
afamelanotide
[Nle4, D-Phe7]-ɑ-MSH
Ac-SER
TYR
SER
MET
GLU
HIS
L-PHE
ARG
TRP
GLY
LYS
PRO
VAL-NH2
Ac-SER
TYR
SER
NLE
GLU
HIS
D-PHE
ARG
TRP
GLY
LYS
PRO
VAL-NH2
1
2
3
4
5
6
7
8
9
10
11
12
13
Afamelanotide is an analogue of the naturally occuring α-MSH. Amino acids 4 and 7 in the chain are replaced, enhancing
the MCR1 binding and signalling mechanisms.
The peer review articles relevant to this feature are
listed at https://www.clinuvel.com/refs-melano-ar24/
inflammatory response, regulation of
sexual behaviour, thermoregulation,
and exocrine secretion. MC5R is
expressed ubiquitously in peripheral
tissues including adrenal glands, liver,
kidney, lung, lymph nodes, thymus,
spleen, mammary glands, testis, ovary,
uterus, skin, and exocrine glands.
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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KEY
ACHIEVEMENTS
CLIN UVEL CON T IN U ED ITS A DVA NC E TOW A R D S
A DIV ERSIF IED B IOP HARM AC E U T I C A L
IN THE J U N E 20 24 F IN AN C I A L Y E A R
F IN AN C IAL
PE R FO R M AN C E
• Growth in revenues
• Controlled increase in expenses
• Eighth consecutive annual profit
• Seventh consecutive annual dividend declared
• Continued increase in cash reserves
M E LAN O CO RT IN
PR O D U CT PO RT FO L IO
• PRÉNUMBRA® in use in clinic for stroke patients
• NEURACTHEL® development continued
ST E ADY PR O G R E SS
S C E N E SS E ® ACC E SS
IN E PP
• Increased patients, treatment centres and frequency
of dosage
• Partnership commenced with Valentech Pharma
in Latin America
• Adolescent study CUV052 expanded and underway
AFAM E LAN OTI DE
IN T HE C L IN IC
• VP – Phase II study CUV040 completed; European Orphan
Drug Designation (ODD) granted
• DNA Repair – CUV151 in healthy volunteers completed;
CUV152 and CUV156 continue; European ODD granted
for XP
• Vitiligo – recruitment Phase III study CUV105 commenced
• AIS – Phase II study CUV803 underway
• Parkinson's – clinical program CUV901 announced
PHOTO CO S M ETI CS
• Continued formulation work at the Singapore Research,
Development & Innovation Centre
• Increased awareness of audiences of the need for
photoprotection
• Prelaunch of CYACÊLLE Radiant
R E AC HIN G M ORE
IN V E STO RS A N D
N E W AU D IE N C ES
• Broadening of communications
• Novel use of social media
• Informative investor briefings
• Increased analyst coverage
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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Day 134 – 7 implants, 39 NB-UVB sessions
Day 0 – baseline
Case study on use of afamelodtide in vitiligo - presented to American Academy of Dermatology, March 2024.
ADVOCACY OF
KEY OPINION
LEADERS
K EY OPIN ION L EAD ERS S P E A K A B O U T
T HE BE N EF ITS OF AFAM EL A NOT I D E
“Afamelanotide is a convincing
enriching, sometimes off‑label,
treatment option that
physicians should take
advantage of, however in
diseases beyond EPP the
further studies on a larger group
of patients with long‑term
efficacy evaluation
should be considered.”
“This study highlights a dramatic clinical benefit of afamelanotide
in relation to light tolerance and QoL in protoporphyria”
“…afamelanotide was safe,
well tolerated and showed
possible reduction in infarct core
volume in our safety and feasibility
study involving small sample of
AIS patients. Potent MSH analogues
such as afamelanotide have
high therapeutic potential in AIS.
Further large, randomized
studies are required.”
“Afamelanotide has revolutionized my life.
With whispers of this treatment in the pipeline for so long,
I am delighted that it has been made available in my lifetime.”
Polańska, A., Wegner, J., Nutbohm, P., Staubach, P., Żaba, R., Dańczak-Pazdrowska, A., & Jenerowicz, D. (2024).
Afamelanotide in protoporphyria and other skin diseases: A review. Advances in Dermatology and Allergology, 41(2), 149–154.
Leaf, R. K. (2004). Afamelanotide for Treatment of the Protoporphyrias: Impact on Quality of Life and Laboratory Parameters in a US Cohort. Life, 14(6), 689.
Stanislaus, V., Kam, A., Murphy, L., Wolgen, P., Walker, G., Bilbao, P., & Cloud, G. C.
(2023). A feasibility and safety study of afamelanotide in acute stroke patients—An
open label, proof of concept, phase IIa clinical trial. BMC Neurology, 23(1), 281.
O’Reilly, M., McGuire, V. A., & Dawe, R. S. (2024).
Erythropoietic protoporphyria and afamelanotide: A patient's perspective.
Clinical and Experimental Dermatology, 49(2), 186–187.
ANNUAL REPORT 2024
CLINUVEL PHARMACEUTICALS LTD
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FINANCIAL
HIGHLIGHTS
ST RO N G P ERFORM AN CE CO NT I NU E D: E I G H T H CO NSE CU T I V E
ANN UA L P ROF IT W IT H G ROW T H I N R E V E NU E S A ND
CA S H RES ER VES
A$0.72
E AR NI NG S PER S HA R E
A$0.05
D IV ID E N D PE R S HAR E
18%
R ET U R N ON EQU I TY
NIL
D E BT
Total Expenses
Total Revenues, Interest and Other income
48.5
2021
22.7
67
2022
32.7
83
2023
37.4
95.3
44.6
33.9
2020
22.4
2024
RE VE NUES & EX PEN S ES (A$m)
Growth of revenues
and expenses were
15% and 19%,
respectively in
FY2024.
Over the eight
years since
commencement
of commercial
operations, the
compound annual
growth rate for
revenues is 38%
and 20% for
expenses.
Before Tax
After Tax
2023
45.6
30.6
2022
34.3
20.9
2021
25.7
24.7
2020
11.5
15.1
2024
50.7
35.6
NE T P ROFIT (A$m)
The Company continued to maintain a range of
key indicators of high performance in FY2024
Net profit
increased before
tax and after tax
by 11% to A$50.7
million and 16%
to A$35.6 million,
respectively.
FY2024 marks the
eighth consecutive
year of profit.
2020
9.5
81.5
2021
9.8
108.6
2022
18.4
143.9
2023
29.1
193.7
Assets
Liabilities
2024
28.1
231.1
ASS E TS & L IAB IL IT IE S (A$m)
The balance sheet
strengthened
again in FY2024,
with an increase
of 23% in net
assets.
2023
156.8
2024
183.9
2022
121.5
2021
82.7
2020
66.7
C AS H R E S E RV E S (A$m)
Cash reserves
increased strongly
by 17% to A$183.9
million which
enables the self-
financing of the
Group's expansion
initiatives with
a buffer to
absorb adverse
fluctuations in
the operating
environment.
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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ENVIRONMENTAL
CONSCIOUS OF OUR WORLD
SOCIAL
FAIRNESS
AND EQUITY
GOVERNANCE
RESPONSIBILITY AND COMPLIANCE
CLINUVEL
VALUES
Recognise climate change
Energy management
Safe and responsible materials handling
No adverse impact on global objectives
Supplier standards
Honesty and integrity
Corporate governance
Compliance
Ethics
Supplier standards
Human rights
Freedom of association
Equal opportunity
Value diversity
Work-life balance
Training and education
Supplier standards
E S G F RAM E WO R K
SUSTAINABILITY
SUSTA INAB IL ITY EN CAPS U L AT E S C L I NUV E L'S
RE S PON S IB L E AP P ROACH TO T H E M A NAG E M E NT
OF EN VIRON M EN TAL , S OC I A L A ND G OV E R NA NC E
( E S G) RIS KS . B U IL D IN G ON T H E DE TA I L E D E SG
STAT EMEN T CON TAIN ED IN T H E 2 0 2 3 A NNUA L
RE PORT, W E S U M M ARIS E H E R E , C L I NUV E L'S
A PPROAC H AN D P RACT ICE S, A ND
HOW WE M EAS U RE T HE P R O G R E SS
ACHIEVED IN F Y 2 02 4.
CLI NUVEL'S ESG A P PROACH & PRACTI CES
GENERAL
DETAIL
Responsible corporate citizenship
The ESG Framework covers environmental, social and governance practices
and policies, underpinned by the Company's values
Adhere to the United Nations (UN)
Global Compact ten principles
of sustainability
The ten principles cover human rights (2), labour (4), environment (3) and
anti‑corruption (1) (see diagram and tables on pages 22–25)
We assess our activities have low
direct environmental impact
A range of qualitative policies support minimisation of resource use and waste
(refer to page 23)
Aligned with UN Sustainable
Development Goals
The Company distributes a quality-assured product with a positive safety
record assisting the quality of life of patients with no other treatment options
Social practices and policies
consistent with the tenets of the
UN Global Compact
We champion equal opportunity, diversity, inclusion and people development -
refer to social measures on page 24
Active management by Executives
and governance by the Board
Executives accountable to report monthly to the Board on ESG issues in their area
of responsibility
Reviews of key suppliers undertaken
on their ESG practices
Initiated 1 July 2023; reviews completed to date are acceptable to the Company
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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21
ANTI-CORRUPTION
10
Businesses should work
against corruption in
all its forms, including
extortion and bribery
HUMAN RIGHTS
1
Businesses should
support and respect
the protection of
internationally
proclaimed
human rights
2
Make sure that
they are not
complicit in
human rights
abuses
ENVIRONMENT
7
Businesses
should support
a precautionary
approach to
environmental
challenges
8
Undertake
initiatives to
promote greater
environmental
responsibility
9
Encourage the
development
and diffusion of
environmentally
friendly
technologies
LABOUR STANDARDS
3
Businesses should
uphold the freedom
of association and the
effective recognition
of the right to
collective bargaining
4
The elimination
of all forms
of forced and
compulsory
labour
5
The
effective
abolition
of child
labour
6
The elimination
of discrimination
in respect of
employment
and occupation
The Ten Principles of the UN Global Compact are derived from the Universal Declaration of
Human Rights, the International Labour Organization’s Declaration on Fundamental Principles
and Rights at Work, the Rio Declaration on Environment and Development, and the
United Nations Convention Against Corruption.
UN GLO B A L CO M PACT
TEN P RINCIP LE S OF S USTA I N A BI LI TY
ENVI R O NMENT
KEY AREAS
HOW WE MEASURE PROGRESS
Conscious of the human impact
on the environment
Follow UN Global Compact definition of sustainability
We assess the Company's direct
environmental impact as low
• Less than 100 employees as of 30 June 2024
• Product manufacturing outsourced
A range of qualitative measures are
in place to minimise resource use
and waste
• Responsible product packaging
• Responsible waste management and materials handling in the laboratory
• Electronic over paper files – Investor Relations use QR codes for presentations
• Split home / office working week
• Executive approval required for travel
Environmental and climate targets
not set
Targets will be appropriate as the scale of activities increase and planned
regulatory reporting applies
ANNUAL REPORT 2024
CLINUVEL PHARMACEUTICALS LTD
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22
GOVER NA NCE
SOCI AL
KEY AREAS
HOW WE MEASURE PROGRESS
Responsible corporate citizenship
• Safety record of SCENESSE® (afamelanotide 16mg) in over 16,000
administrations to EPP patients
• Regular pharmacovigilance reporting of patient experience to regulators
Clinical testing involving humans, as
required to obtain regulatory approval
of pharmaceutical products
• Adhere to OECD Testing Guidelines and principles of Good Laboratory
Practices
• Privacy of study participants maintained
• Ethics committees approve studies
• PhotoCosmetic products tested on humans only
Clinical testing involving non-humans
• Adhere to OECD Replacement, Reduction and Refinement Principles
• Laboratories used meet international standards and certifications
Facilitate a safe working environment
• CLINUVEL's premsies are high quality and designed to enable active
interation and collaboration
Facilitate a positive working
environment
• Competitive performance-based remuneration and employment benefits
• HR policies support employee well-being, with leave for illness, including
stress and post-menopausal care, maternity, paternity and family care
Respect human rights
• Support freedom of association and binary / non-binary designation
Equal opportunity and
people development
• Policy of no tolerance in relation to discrimination
• Focus on career development through Individual Development Plans (all
employees) and advanced development through the CLINUVEL Academy
Leader in diversity – refer FY2024
metrics
• Gender: Female / Male quotient (%): All employees (69/31%); Executives (Top
seven excluding MD 57/43%); and Board (including MD 60/40%)
• Nationalities: 30
• Linguistics: 63% of employees speak more than one language
• Age: Generation Z (born 1997-2012) 19%; Generation Y, Millennials (1981-
1996) 58%; Generation X (1965-1980) 19%; Baby Boomers (1946-1964) 4%
• Tenure: % of total employees; Up to 2 years 59%; +2 and up to 5 years 25%;
+5 and up to 10 years 8%; Over 10 years 8%
KEY AREAS
HOW WE MEASURE PROGRESS
General Board oversight
Diligence actively maintained
Monthly reporting to Board
Achieved FY2024
HR Policies
Govern behaviours and have supported positive, productive relationships in FY2024
Code of Conduct and Corporate Values
Emphasise honesty and integrity; Nil breaches reported FY2024
Bribery & Corruption Policy prohibits
illicit behaviour
No instances of identified corruption in FY2024
Whistleblower Policy
No reports or need to protect against reprisals in FY2024
Public disclosure of payments
to health professionals
Practised in all jurisdictions; signatory of Disclosure UK
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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25
• In the US, we extended
reimbursement of the cost of
treatment to US veterans and
their families and continued the
expansion of Specialty Centers from
over 50 to 85, as we head towards
120 centers by the end of 2025. This
network is being put in place to treat
both EPP and vitiligo patients, ahead
of the completion of clinical studies
on vitiligo.
• In vitiligo, we formed an expert
medical panel, commenced the
recruitment of patients for the Phase
III study CUV105 in October 2023,
and in March 2024 saw positive
results experienced by a new patient
presented at the American Academy
of Dermatology.
• In DNA Repair, we provided readouts
for CUV151 showing afamelanotide
reduced DNA damage in a healthy
population and continued the
studies on XP.
• The CUV803 study looking to
address arterial ischaemic stroke
is also ongoing.
• We announced Parkinson's disease
in June as a new indication
with a Phase IIa study, CUV901
commencing later this calendar year,
involving 6 patients receiving 11
doses of afamelanotide over a study
period of 56 days.
• In June we initiated a soft launch
of CYACÊLLE Radiant, a new
polychromatic product providing
photoprotection that paves the
way for the melanocortin product
Dear Shareholders
Focus on the Mission
I was pleased to assume the role of
Chair of the CLINUVEL Group mid-
way through the 2024 financial year,
a year marked by our ongoing focus
to advance a range of initiatives to
build a house of melanocortin based
treatments for long-term sustainability.
Our expertise in targeted receptor
melanocortins is being applied to
conditions of the skin and brain which
have unmet medical needs. We are
also translating this technology into
PhotoCosmetic products for people
in the general population to benefit
from photoprotection, DNA repair and
re-pigmentation (bronzing).
Achievements FY2024
Let's review the year and the advances
made across the range of initiatives:
• The distribution of SCENESSE® for EPP
continued to grow in terms of number
of patients, prescribing doctors, and
centres administering treatment.
• We commenced a partnership with
Valentech, enabling important
access to treat EPP patients in Latin
America, but ceased our partnership
in China, until greater certainty over
IP protection prevails.
• We expanded the CUV052 study
to n=28, covering adolescent and
adult patients >50 kg in weight to
support the submission for the
label expansion of SCENESSE® for
adolescent EPP patients.
range under development for the
preservation and bronzing of the skin.
Our strong financial performance
continued with increased revenues,
profit, and net cash inflow achieved for
the eighth consecutive financial year.
We are pleased with the 15% growth
in revenues and ongoing prudent
management of expenses achieved in
FY2024. Cash reserves* accumulated
further this year from $156.8 million to
$183.9 million and enable us to finance
organic expansion, the share buy-back
program, and the flexibility to manage
external events and circumstances.
The Board was proud to declare a
A$95.3m
REV ENUES & I N COM E
18%
R O E
A$0.72
EPS
A$35.6m
P R OFI T
A$183.9m
CASH RESERVES*
CHAIR'S LETTER
Vitiligo case study presented to the
American Academy of Dermatology
CYACÊLLE Radiant
*Cash reserves as stated in a non-IFRS measure
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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seventh consecutive annual dividend to
shareholders, which will be paid to
shareholders in September.
People
We have thoughtfully increased
staff numbers in recent years to
support the expansion of the Group.
We are fortunate to have attracted
well-credentialed professionals in
a highly competitive international
labour market to advance CLINUVEL's
objectives over the past years.
The Executive management team has
changed and expanded in FY2024. We
were pleased to re-engage Dr Emilie
Rodenburger in the position of Director,
Global Clinical Affairs in April. As of
1 July 2024, Mr Peter Vaughan took
over as Chief Financial Officer (CFO)
from Mr Darren Keamy, CLINUVEL's
leading finance executive for 19 years.
We thank Darren very much for his
dedicated service to the Company
and wish him well as he takes a well-
earned sabbatical. In August 2024, we
appointed Ms Claire Newstead-Sinclair
as Company Secretary (CS). Previously
this role was undertaken by Mr Keamy,
but the Board decided that the CFO
and CS roles should be separate,
particularly as the complexity and
breadth of the business has increased.
Reflecting this, the CS role will assume
responsibility for the risk management
of environmental, social and governance
risks as part of the Company's drive to
responsible sustainability. We welcome
Dr Rodenburger and Mr Vaughan to
the Executive management team
to help collectively advance our
strategic initiatives.
I am also pleased that we secured a
one-year extension to the services of
Dr Wolgen as Managing Director (MD)
and Chief Executive Officer (CEO) to
30 June 2026, providing the assurance
of the continuity and advancement of
our wide-ranging initiatives under his
leadership. This now enables the Board
to follow a process of putting longer-
term succession in place.
Board
We acknowledge the service of Mr
Willem Blijdorp, who served just over
four years as Chair.
As the new Chair, I instigated a full
Governance Review and Board
Strategy Review guided by experienced
external consultants. These have been
completed and have been valuable in
the Board's operations.
Since my appointment as Chair
on 1 January, I have been actively
overseeing the recruitment of new Non-
Executive Directors to the Board.
We aim to formalise the recruitment of
two to three Non-Executive Directors
to the Board in the coming months,
following an international search.
There have been no adverse issues
from a governance perspective over the
past year, further extending CLINUVEL's
record of operating at the highest
ethical and professional standard.
I am sincerely grateful to my fellow
Board members for their support and
effort over the past year and thank all
CLINUVELLIANS for their steadfast focus
on the objectives of the Company.
Shareholders
We actively engage shareholders on
their views of the Company and take
them into account in our decisions and
communications. Let me provide you a
few examples:
• Last October, ex-Chair Willem
Blijdorp together with investor
relations spoke to shareholders
in Australia, New Zealand, Europe
and the USA and their feedback
is reflected in the extension of
the CEO's contract to June 2026,
mentioned above.
• The Capital Markets Briefing in May
in Sydney was a good opportunity for
me as a newly elected Chair to talk
to institutional investors and I was
pleased with their understanding of
the depth and promise of the pipeline.
• I have also received correspondence
from many shareholders and
exchanged views on the Company
and its progress.
Despite the strong financial
performance of the Company, the
commercial progress of SCENESSE®
and the potential of the pipeline,
CLINUVEL's market value was lower
in the past year. This is below what
we regard as fair value, and given
the sufficiency of cash reserves,
we implemented a share buy-
back program in March to provide
some support to the share price.
Many shareholders expressed their
appreciation of this initiative.
It is important that the Company's
course remains steady and focused
on our objectives. At this year's
Annual General Meeting, I am
looking for shareholders to support
the uninterrupted direction of the
Company to execute our diversification
initiatives. The risk of disruption will
not be in the interests of shareholders.
Outlook
Looking to the future, we are actively
executing our vision of a strategic house
of melanocortins, maintaining focus
on the commercial efforts in EPP, and
investing to drive pipeline initiatives.
These encompass the drug products,
PRÉNUMBRA® and NEURACTHEL®,
clinical programs in vitiligo, variegate
porphyria, DNA Repair, stroke and
Parkinson's, and the development of a
range of PhotoCosmetic products.
CLINUVEL is on the path to transform
its operating and financial profile
through expanded product offerings for
unmet needs. All stakeholders can see
the incremental value being built. For
example, the first few years of treatment
of vitiligo has the potential to generate
significant revenues. This is also the case
for the distribution of NEURACTHEL® and
shareholders have also recognised the
potential of our PhotoCosmetic product
range. For investors, the rationale
for their investment in CLINUVEL is
compelling as we strive to advance the
strategic priorities to fruition over the
coming years.
I wish all stakeholders good health
and look forward with you to the
advancement of our objectives in the
2025 financial year and beyond.
Professor Jeffrey Rosenfeld
Chair
CLINUVEL Group
CORPORATE GOVERNANCE
CLINUVEL PHARMACEUTICALS LTD and its Board are committed to establishing and achieving the highest standards of corporate govern-
ance. The Company's Corporate Governance Statement for the year ending 30 June 2024, based on the Australian Securities Exchange
Corporate Governance Council's (ASXCGC) Corporate Governance Principles and Recommendations, 4th Edition, can be found on our
website at https://www.clinuvel.com/clinuvel/company-overview/corporate-governance.
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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MANAGEMENT
TEN E XECU T IVES , IN CLU D I NG T H E M A NAG I NG
DIRECTOR, CON ST IT U T E T H E E X E CU T I V E
MA NAGEM EN T T EAM OF CL I NUV E L .
Malcolm Bull
Head of Australian Operations
and Investor Relations
Joined 2019
BEc (Hons, University of Adelaide)
MEc (Monash University)
Mr Malcolm Bull joined CLINUVEL in January 2019 and
initially built out the Company's investor relations program
with a focus on analyst and Australian institutional
engagement. Recognising the need for greater operational
support in Australia amidst the COVID-19 pandemic, Mr Bull's
role with CLINUVEL evolved in 2021 to the remit of Head of
Australian Operations and Investor Relations. Previously
an economist within the Australian Federal Government
and private sector, Mr Bull then spent more than two
decades in banking across credit, business development
and strategy, and relationship management, working with
Commonwealth Bank of Australia, Bank of Western Australia,
National Australia Bank, and ANZ. This included time in
general management for ANZ in the Philippines and as part
of the Victorian state management team for CBA Corporate.
Mr Bull has managed to attract six sell-side analysts since his
arrival and increased institutional ownership of CLINUVEL
from 25% to 35% of issued capital.
Antonella Colucci
VP, Commercial Affairs
Joined 2011
MA (European Studies and Global Affairs, Catholic University
of the Sacred Heart)
MA (Modern Languages, IULM Milan)
Mrs Antonella Colucci is responsible for commercial matters
ex-North America while working closely with the US team
to ensure continuity of business. Having spent many years
working within the medical industry in Italy, Mrs Colucci was
instrumental in the expansion of CLINUVEL's Italian 648/96
program and subsequent Swiss special access scheme.
These two programs – which facilitated subsidised
reimbursement of the drug prior to its marketing
authorisation – provided CLINUVEL with commercial
proof-of-concept for SCENESSE® and laid the foundations
for Mrs Colucci to lead the Company's successful commercial
activities since 2016. With responsibilities across pricing,
compliance, and distribution, Mrs Colucci is currently
focused on expanding the Company's commercial reach
in both new and existing regions.
“The investor relations team
loves telling CLINUVEL's
dynamic story to stakeholders,
particularly assisting new
shareholders to discover the
long-term incremental value
being built.”
“The positive impact
of SCENESSE ® on the
lives of EPP patients
spurs my team every day
to work to extend its use
to new patients.”
As Managing Director, Dr Wolgen sees his role as the
conductor of the orchestra – keeping rhythm and discipline
while ensuring the best possible ensemble is in place to
do justice to the ‘score’. As the complexity of the business
increases, it is imperative to have the right people in place
for the multitude of tasks ahead, and the executive team
is expected to grow accordingly. The executive team has
and will become more visible as they communicate their
activities and outcomes to stakeholders.
ANNUAL REPORT 2024
CLINUVEL PHARMACEUTICALS LTD
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Darren Keamy
CFO & Company Secretary
Joined 2005 – to 1 July 2024
BComm (Accounting, La Trobe University)
CPA
GradDip Applied Corporate Governance
(Governance Institute of Australia)
Mr Keamy held the dual role of Chief Financial Officer and
Company Secretary from 2005 to 1 July 2024. For 19 years, he
ensured the Company operated with a high level of financial
discipline while maintaining a strong focus on governance
and compliance. From early in his time with CLINUVEL, Mr
Keamy was responsible for maintaining strict controls to
enable the Company to achieve profitability and reinvest
in long-term growth. As the business evolved, Mr Keamy
oversaw the addition of new entities and structures to both
enable commercial sales as well as maintain tax efficiencies.
Mr Keamy provided counsel to the Board across his role as
well as maintaining corporate governance structures for the
Group and leading global compliance. A qualified CPA, Mr
Keamy previously held roles with global packaging specialists
Amcor in Australia, as well as Salomon Smith Barney (now
part of Citigroup) and Superdrug Stores in the UK.
Reflecting the complexities of the business, the Chief
Financial Officer and Company Secretary roles have now
been separated.
Dr Rose Quadbeck-Diel
Snr VP Regulatory Affairs
Joined 2012
BSc (Nutrition, Justus Liebig-Universität)
PhD (Biochemistry, Johann-Wolfgang Goethe-University)
Having spent over 30 years in global regulatory affairs and
quality assurance in large and mid-sized pharmaceutical
entities in Germany and Switzerland – including Baxter
Oncology, Asta Medica, and Mundipharma – Dr Rose
Quadbeck-Diel ensures CLINUVEL is compliant with, and
able to adapt to, a changing regulatory landscape. In her
time with CLINUVEL this has included navigating marketing
authorisation filings and compliance, shaping the Company's
Brexit response, and implementing new European regulatory
initiatives such as the falsified medicines regulations.
In recent years Dr Quadbeck-Diel has worked to expand
CLINUVEL's regulatory team to prepare long-term regulatory
projects and new marketing filings.
“I am proud to have played a
leading role as CFO and
Company Secretary, in
CLINUVEL's progression from
an R&D based enterprise to a
profitable commercial operation,
expanding for the future.”
“It is satisfying to meet
the challenge to gain
marketing authorisations
and subsequently, to meet
all of the regulatory re-
porting requirements
to maintain them.”
Lachlan Hay
Chief Operations Officer
Joined 2007
BA (Media Comms, University of Melbourne)
MA (International Relations, Freie Universität Berlin)
As Director of Global Operations, Mr Lachlan Hay supports
the executive and senior management teams as well as
maintaining responsibility for the delivery of key business
objectives. Having joined the business in a corporate
communications role in Australia, Mr Hay then assumed
roles in Europe and Asia. He was the first General Manager
of the UK business, overseeing the introduction of
SCENESSE® into European markets since 2016, and
assumed a broader operational position in response to
the needs of the business. On 1 July 2024, Mr Hay assumed
the position of Chief Operations Officer, providing him more
responsibilities. He is also completing his law degree (LLM).
Dr Azza Hamila
Head of Quality Assurance and Drug Safety
Joined 2015
BPharm (University Claude Bernard)
MPharm (University Paris Descartes)
Dr Azza Hamila has played a central role in CLINUVEL's
commercial scale-up, establishing new internal standards
in GxP, with a focus on manufacturing, distribution, and
pharmacovigilance. Her work has enabled the Company to
achieve long-standing compliance, giving authorities comfort
that CLINUVEL conforms to strict international regulations
and can maintain the licences necessary to perform critical
manufacturing and distribution functions in-house. Dr
Hamila's position encompasses both Responsible Person
and Qualified Person roles in various jurisdictions within the
quality management system, as well as being responsible for
supplier management and patient safety. She has previously
held quality assurance roles with Orphan Europe (Recordati),
Sanofi Aventis, and Roche before joining CLINUVEL in 2015.
“We pride ourselves on
vigilance to quality and
the standards that are
essential to ensure the
smooth performance of the
business.”
“Managing the strate-
gic expansion and daily
operations of this interna-
tional biopharmaceutical
group provides our teams
an ongoing professional
challenge.”
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Dr Dennis Wright
Chief Scientific Officer
Joined 2005
BPharm (University of Sydney)
MSc (University of Sydney)
PhD (University of Sydney)
GradCert Health Economics (Monash University)
Dr Dennis Wright has been at the core of the Company's
clinical program and regulatory affairs for nearly two decades
in the role of Chief Scientific Officer. A pharmacist with a PhD
in xenobiotic metabolism, Dr Wright has a pharmaceutical
career spanning more than 40 years with Nicholas Kiwi,
Faulding/Mayne, CSL and CLINUVEL.
During this time, he worked across basic and clinical
research, regulatory affairs, pharmacovigilance, business
development, in-licensing, and marketing. It is from this
diverse background that he has led CLINUVEL's late-stage
clinical development program for EPP as well as steering
successful regulatory filings for SCENESSE® in Europe, the
USA, Australia, and Israel. His role has extended in recent
years to facilitate new clinical programs for afamelanotide
as well as overseeing new product development and
scientific affairs.
Peter Vaughan
Chief Financial Officer
Joined April 2024
BBus (Acc) (Swinburne University)
Snr. Exec. MBA (Melbourne University – Business School)
Member, Institute of Chartered Accountants ANZ
GAICD, AGIA
Cert. Climate Change: Financial Risks and Opportunities
(Imperial College, London)
Mr Peter Vaughan joined CLINUVEL in April 2024 and
assumed the Chief Financial Officer role on 1 July 2024.
Mr Vaughan has over 20 years of experience in listed and
unlisted companies in Australia, the USA, Europe, and Asia.
Most recently with Toys “R” Us ANZ Limited as a strategic
financial advisor, he has previously held CFO and Company
Secretary roles at Titomic (ASX:TTT), Immuron (ASX:IMC,
NASDAQ:IMRN), Amaero (ASX:A3D) and Respiri (ASX:RSH),
among others. He has led capital raisings, M&A and licensing
deals within life science companies, as well as the dual
listing of two Australian companies on the Nasdaq (Immuron
Limited and Prima Biomed Limited (now Immutep)). Mr
Vaughan is a Chartered Accountant, with a BBus (Accounting)
from the Swinburne University of Technology and a Senior
Executive MBA from Melbourne Business School. He is also
a member of Australian Institute of Company Directors and
Governance Institute of Australia.
“Applying melanocortin
products to treat indications
of the skin and brain with
unmet needs is exciting. This
mission underlies everything
we do in the clinical and
scientific area of the business.”
“I’m excited to join the high
performing CLINUVEL
team, and lead the disciplined
financial stewardship as
we build the foundations of
new revenue streams for
future growth.”
Dr Linda Teng
Director of North American Operations
Joined 2007
BPharm (National Taiwan University)
Doctor of Health Administration (Medical University of
South Carolina)
As Director of North American Operations, Dr Linda Teng has
established the Company's commercial presence, building
a network of Specialty Centers and commercial programs
enabling EPP patients to receive treatment in both the USA
and Canada. With a background in clinical pharmacy and
clinical pharmaceutical development – at BioMarin and
for more than 16 years at CLINUVEL – Dr Teng also heads
the vitiligo program in North America. The US team has
grown quickly over the past 18 months to incorporate new
functions, including patient support and in-house counsel,
adding complexity but greater bandwidth to the operations
under Dr Teng's purview.
Dr Emilie Rodenburger
Director, Global Clinical Affairs
Joined April 2024
PharmD (Paris Descartes University, France)
MSc (Paris-Sud University, France)
Dr Emilie Rodenburger rejoined CLINUVEL in April 2024 as
Director Clinical Affairs. Returning to CLINUVEL after four
years with Roche in senior clinical roles, Dr Rodenburger
oversees CLINUVEL's global clinical program, evaluating
melanocortin based drugs for a range of disorders of the
skin and brain. Her immediate focus will be to ensure full
enrolment and analyses of the CUV105 study of SCENESSE®
in vitiligo (loss of pigmentation). A pharmacist (PharmD)
with a master's degree in cancer biology, Dr Rodenburger
previously worked with the CLINUVEL Group for over a
decade in clinical development roles in Australia, the USA
and Europe. During this time, she led the Company's first
vitiligo trials as well as being one of two clinical managers
completing the EPP program resulting in the successful
approval and commercialisation of SCENESSE® as the first
systemic photoprotective therapy.
“I am thrilled to re-join
CLINUVEL and advance
its expanded clinical
programs, particularly
in vitiligo.”
“Since April 2020, we’ve
built a strong foundation
with EPP in the US. Now,
we’re excited to expand our
treatment to vitiligo and
other unmet needs.”
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BOARD
SU MMMARIES OF T HE S KIL LS A ND E X PE R I E NC E O F
THE CLINUVEL B OARD
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.
Non-Executive Director,
AC, OBE, MBBS, MS, MD, FRACS
Appointed 26 November 2019,
Chair since 1 January 2024
Relevant Skills
• lifetime experience in providing
healthcare
• clinical research and development
• board and committee oversight
and governance
• leadership and management
J E F F R E Y R O S E N F E L D AC , OBE
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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.
Non-Executive Director,
BComm, FAICD, ASIA
Appointed 6 February 2007
Relevant Skills
• research & development in life
sciences
• capital market understanding
• executive management
• experienced in listed company
directorships
Background
Under Dr Wolgen's leadership, a long-term strategy for
CLINUVEL was devised. The lead product SCENESSE® 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.
Chief Executive Officer,
MBA, MD
Appointed to Board 1 October 2005,
appointed Chief Executive Officer 28
November 2005
Relevant Skills
• pharmaceutical R&D,
commercialisation
• clinical expertise
• commercial & entrepreneurial
outlook
• executive management, corporate
turnarounds
• finance and capital markets
• experienced in listed company
directorships
B R E N DA S HAN AHAN AO
P HI L I PP E WOLG EN
CLINUVEL PHARMACEUTICALS LTD
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Background
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.
Non-Executive Director,
Dipl ClinRisk
Appointed 23 September 2019
Relevant Skills
• executive healthcare management
• leadership and strategy setting in
complex environments
• 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.
Non-Executive Director,
MD
Appointed 29 January 2018
Relevant Skills
• pharmaceutical research &
development, commercialisation
• relevant knowledge on
melanocortins, clinical expertise
• commercial knowhow in US
pharmaceuticals
• general management
• experience in private company
directorships
S US AN ( S U E ) S M IT H
KAR E N AG ERS BORG
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increased the pace of development
of treatments for vitiligo, DNA repair,
stroke, porphyrias, Parkinson’s disease
and other healthcare products. We have
achieved our primary goal, which was
ensuring that both patients and early
investors benefit from these actions.
Now we find ourselves in the secondary
stage of financing this project, as this
letter explains. I will share the rationale
behind our approach to finance,
development and expansion over the
last 12 months.
Unexpectedly, this period has been
overshadowed by the tragic loss in
August of our esteemed colleague and
a dedicated supporter of CLINUVEL,
Professor Marcus Maurer, Chair of the
Dermatology Department at Berlin’s
renowned Charité University Hospital.
I would like to pay tribute to Marcus,
taking the moment to express my
longstanding admiration for a person
who was larger-than-life, optimistic,
light-hearted and always stood above
the matter. I only wish I had done this
during his lifetime.
Dear Shareholders,
Success in biopharmaceuticals involves
exploring unchartered territories while
working out an attitude to risk. It is
a balancing act that requires a team
with a certain disposition who have a
clear philosophy to follow. Our core
technology has been fined-tuned
over the space of 43 years. To put
our industry in context, in that time
three companies have abandoned
their attempts to clinically develop
melanocortin technology.
That is to say, our scientists, physicians
and managers have faced daunting
challenges in their efforts to turn
chemical novelty into economic reality.
And yet, they have achieved that goal.
Today, CLINUVEL is comprised of a
global team that works cohesively across
seven locations. These individuals
devote their time and energy to build a
profitable group that solves healthcare
problems, while striving to become a
global brand. That is the mission we
have set ourselves and which we have an
unwavering commitment to fulfil. Now
to the future: how and when to propel
the Company towards the next phase of
growth and valuation?
One of our core beliefs is that many
minds working together will solve
problems related to melanocortin
technologies more quickly. Technology
is subordinate to the calibre of staff.
My main priority has been to position
CLINUVEL among the handful of
biopharmaceutical companies that
are financially independent. Less
than 9% of such firms make money
and we are one of them. Unfettered
by fundraising constraints, we have
Marcus was one of the first physicians
I contacted back in 2004, as part of
lengthy diligence on CLINUVEL (at the
time, Epitan). Marcus immediately
understood the potential of
SCENESSE® in treating EPP and various
photodermatoses. He accompanied
our managers to Germany’s BfArM,
the European Medicines Agency, and
reimbursement authorities (GBA,
GKV), and spoke about afamelanotide
at numerous conferences. Not only
was Marcus one of the most ethical
professionals one could meet, but
he also radiated charisma and
demonstrated an innate compassion for
patients and staff alike. He was, he is, a
luminous being.
One very occasionally meets someone
who makes an immediate impact,
leaves an indelible impression and
whose energy makes collaborating
joyful and exciting. Marcus was this very
person. He leaves behind his partner
and three children, and his departure
from this world leaves us with an
ineffable void. Our clinical research
with Charité must continue in his name,
that is the way Marcus had wanted
it. CLINUVEL’s work will stand on his
shoulders, a giant in dermatology.
Risk Management & Efficiencies
The past year reminded us once again
of the steep development and financial
risks posed by the relatively high number
of Complete Response Letters issued by
the FDA, as well as the many drugs that
leading insurance companies rejected,
owing to concerns about new molecular
entities (NMEs). It is worth noting that
developing and commercialising novel
hormones for untreated diseases—as
CLINUVEL has chosen to do—is a
MANAGING
DIRECTOR'S
LETTER
In memory of
Professor Marcus Maurer
“a revolutionary thinker in
dermatology, an inspiration
and statue of optimism for
all who had met Marcus”
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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positions to suit the brightest
individuals. To increase retention
and incentives for long careers at
the Company, we established the
CLINUVEL Academy in 2024. The
initiative offers eligible managers a
structured training program, post-
graduate education, and advanced
learning opportunities, in return for
long-term service.
The Next Phase of Growth: 2024–2026
For the last decade, our financial
planning has been centred around
establishing a Group that remains
at the vanguard of pharmaceutical
development, giving shape to the next
set of melanocortin technologies.
To make this a reality, we came up
with a business model in which
longer-term development would
be self-financed. Now with our
melanocortin portfolio (SCENESSE®,
PRÉNUMBRA®, NEURACTHEL®) and the
PhotoCosmetics ranges (CYACÊLLE®
and CYACÊLLE® RADIANT), we are
on the cusp of translating peptide
technologies to help a host of rare
or untreated diseases; realising a
future of new delivery methods; and
reformulating our technology to suit
consumer healthcare.
by diversifying its pipeline early on,
would have left CLINUVEL dependent
on equity investors or debt financing.
We estimate this would have diluted
shareholders’ ownership of CLINUVEL
by more than 1,600% (assuming we
would have secured funding at all).
So, we took a different path.
Once management and majority
shareholders agreed to aim for
economic sovereignty, we focused our
resources on limiting drug development
and set out to self-distribute our lead
product, SCENESSE®. Thanks to this
strategy, CLINUVEL’s financial metrics
have strengthened year-on-year. Our
robust balance-sheet has enabled us to
seize promising growth opportunities
by developing our portfolio of
melanocortin technologies and pursing
new ventures which will result in new
revenue streams.
In parallel to our attention to risk, we
have sought operational efficiencies.
We first set annual agendas,
aligning all parts of the business
and establishing key performance
indicators for staff. These included
working in cross-functional teams to
cross-pollinate expertise; assigning
To combat this trend, we are on
a perpetual search for the next
generation of technical and business
talent. The Group continually
conducts interviews to identify
promising candidates and shape
much riskier endeavour than it is for
biosimilars, radiopharmaceuticals,
generics, diagnostics, devices and
managed care.
All medical technologies and services
developed by listed life-science
companies will eventually be collated
in a life-science index. On closer
inspection however, these distinct
businesses are incomparable in such
a pared-back format, owing to their
differing objectives and risk profiles.
Dotmatics, an analysis firm that
aggregates biochemical and clinical
data, recently revealed that the costs
of drug development have surpassed
US$1.5 billion over the last decade.
Meanwhile regulatory and commercial
success rates remain steady, at less
than 10%. Higher spending does not
guarantee fixed results.
I felt strongly that CLINUVEL, as a
leading specialist in developing
NMEs, needed to be insulated
from operational and financial
risks, particularly given increased
volatility in global markets. Managing
the Company’s development in
a conventional manner, with less
focus to funding requirements and
We are embracing novel thinking
on financial systems, distribution
networks, artificial intelligence,
branding activities, social
media, broader ambassadors’
communication and ERP, distribution,
and market access. We are preparing
the Company to integrate new skills
in engineering, bio-analytics, and
formulation development, while also
diversifying our offering and markets
by targeting both pharmaceutical and
consumer healthcare.
Over the last year, we have increased
the number of trained and accredited
North American Specialty Centres
from 67 to 87 (with two now active in
Canada), in anticipation of entering the
North American vitiligo market. We aim
to add another 33 such centres by the
end of 2025. These centres will prescribe
SCENESSE®, according to the conditions
of the drug’s use for vitiligo patients who
have lost pigmentation in their skin, and
in many cases, their identity.
Dr Linda Teng has done a remarkable
job of converting sceptical physicians
in North America into keen followers
and long-term prescribers, thanks
to years of persistence by her team.
regional responsibilities; and
integrating research & development
and innovation output. Over the last
year, we rolled out a multi-weighted
model to guide clinical and regulatory
decision-making. The aim was to
provide our managers with a blueprint
to secure efficacy and commercial
viability of new drug candidates. The
model aims to save considerable
sums by avoiding costly clinical and
regulatory programmes which do not
meet the commercial criteria down
the line. New systems will be added in
2025 too. ERP¹, CRM² systems, eQMS³
and intelligence platforms will ensure
that data and information are readily
available across the Group.
At CLINUVEL, we all understand the
need to deliver results and meet
deadlines. Those who embrace the
Group culture, being enthusiastic
and motivated to solve problems,
build a meaningful career. At the
same time, we are swimming against
tides in the post-pandemic labour
market. Recruitment agencies such as
Randstad report up to a 30% turnover
in pharmaceuticals, a number that
raises concerns about the retention of
key knowledge.
15%
GROW TH YOY
SCEN ESSE®
P R É N U M BRA ®
N E U RACT HE L ®
CYAC Ê L L E ®
M 1
M 2
CLINUVEL PHARMACEUTICALS LTD
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Against these achievements, how do
we measure the eighth consecutive
year of growth in earnings, a continuum
carefully planned to facilitate our
ambitions? We have built up a hefty
vault of cash—currently A$183.9m in
cash reserves, an increase of 17% the
past financial year—and an annual
compounded growth rate over seven
years of 34%. This enables us to
more rapidly able to integrate new
technologies and companies. We are
always on the lookout for acquisition
opportunities when the time is right
and when we can sufficiently mitigate
integration risk. This would continue
the Group’s expansion and subsequent
growth of the management team.
Investor & Public Relations,
Communications
New Australian institutions have
purchased over 3% in aggregate of
CLINUVEL’s shares (CUV) over the last 12
months. Existing institutional investors
also increased their holdings over
the same period, taking institutional
ownership of CUV to 35% of issued
capital. Retail stakeholders (including
high-net-worth individuals and family
offices) also expanded their stake, to
Across the Atlantic, Mrs Antonella
Colucci has successfully headed
European and Swiss market
access, distribution, and logistics.
Over 90% of patients continue
treatment with SCENESSE® and
the therapy is in demand. Patients
express high levels of satisfaction
and report an improved quality of
life, as two new papers illustrate:
“Afamelanotide for Treatment of the
Protoporphyrias: Impact on Quality
of Life and Laboratory Parameters
in a US Cohort” from Massachusetts
General Hospital; and “Association
of quality of life measures with
afamelanotide treatment in patients
with erythropoietic protoporphyria
and x-linked protoporphyria: A
retrospective cohort study”, from Henry
Ford Hospital in Detroit.
Our patient registry makes these
studies possible. It contains
uninterrupted follow-up data on
patients worldwide which in turn, fuels
the growth in the number of centres,
prescribers, patients and treatments
administered. This makes more doctors
and patients aware of the therapy’s
long-term benefits.
40% of issued capital. We are buoyed
by our supporters’ optimism. One
high-net-worth investor in the United
States recently grew their holdings to
one million shares, or 2% of issued
capital. Given the ebullient interest in
North America, we have recruited our
first investor relations manager for this
market, Mr Myles Clouston, who is an
experienced analytics expert in the life
sciences sector.
In October 2023 we welcomed Bell
Potter, one of Australia’s largest
financial advisory firms, commencing
research on the Company for their
client base which spans individuals,
institutions and corporations. This
was followed by Morgans Financial
and Morningstar initiating coverage
a month later. Mr Malcolm Bull, who
leads our Investor Relations (IR) efforts,
has attracted six sell-side analysts and
acts as the point of liaison with our new
Australian institutional investors.
Our consumer-facing communications
have also progressed in leaps and
bounds. This year we made a first low-
cost foray into social media, engaging
specialised ambassadors with their
We are focusing on raising brand
awareness ahead of the launch of the
M1 and M2 lines in 2026, transdermal
formulations containing melanocortins.
These will be a world first. The Annual
Meeting of the American Academy of
Dermatology in Orlando next spring
presents another opportunity to
promote the Company’s industry-
defining technologies and bold moves
into consumer skincare. We look
forward to seeing you there.
One of the year’s digital highlights
was the event in February hosted by
Ms Stefani Germanotta (whom you may
know as Lady Gaga) and Mr Michael
Polansky at their home in Los Angeles.
At this star-studded, intimate evening
we presented CLINUVEL’s pioneering
technology and future ambitions
to Silicon Valley’s investor
community and professionals
in the entertainment industry.
The night yielded dazzling results.
Content from the evening reached
3.4m people in the days following the
event, boosted by Ms Germanotta’s
influential profile and mega-influencers
own histories of solar damage and skin
cancers to raise awareness of the first
PhotoCosmetic product CYACÊLLE®.
We also recruited our first professional
writer, a journalist formerly of The
Economist, to create content and
opinion pieces for targeted online
audiences. A strategic goal remains to
deliver articles and engaging, relevant
content in digital formats. In the next 24
months, we intend to identify additional
influential ambassadors (CUVAs) who
can share the CLINUVEL story.
We started the CUVIPs program,
engaging intriguing personalities with
a public profile and communicating
our story with their “followers” in
both the virtual and digital worlds.
Bringing novel healthcare products
to a consumer market requires a
long runway. Time and patience
are key. Two aims drive our global
branding campaign: first, a desire to
achieve household name recognition
within the next two years. Second,
to make CLINUVEL known as a brand
synonymous with world-leading
innovation in both photomedicine
and PhotoCosmetics.
such as Ms Dylan Mulvaney. It was
proof that a combination of high-
profile events, curated social-media
campaigns and broader exposure
outside pharmaceutical circles will
launch CLINUVEL into new, valuable
conversations. From here onwards, it
is about repetition of messages and
having a presence at key global events.
Collaboration Post-pandemic
By now, the world has endured seven
million deaths from COVID-19 and a
total of 776 million confirmed cases
(refer World Health Organisation), with
many more undocumented. Among
other things, the pandemic created
seismic shifts in working habits. By Q1
2023 we were well adapted to a new
reality of Zoom calls at kitchen tables.
After this new-found freedom, it was
clear that we would not revert to the
pre-pandemic norm of five days in the
office per week. We posed ourselves two
questions: how to maintain productivity
and where would work suffer without
daily interactions? A year on, we have
settled into a new rhythm. Teams
working in offices tend to come in two
or three times a week, in line with the
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global average for the post-pandemic
workplace. CLINUVEL staff who require
a physical laboratory have no option
other than to attend full time, however.
I believe that tempting professionals
back the office will require employers to
rethink their offer to workers. This will
entail disrupting the former notion of
“office” and presenting an entirely novel
concept to staff. Flexibility is essential:
commuting outside peak traffic; state-
of-the-art facilities that include wellness
and meditation rooms; a nursery for
children; and cooking facilities. In sum,
creating an environment of privilege
may incentivise valued staff back to the
office. In Britain, we took advantage
of a depressed commercial real-estate
market to purchase a highly-valued
office close to London. Once the refit of
our premises is complete, we anticipate
that the Britain-based team will
reevaluate the inconvenience of leaving
home, considering the benefits offered
at the new facilities.
Research & Development, Innovation
Direct investment in research,
development and innovation amounts
to more than 40% of our net profits. Our
Board and senior personnel are acutely
aware of the risks associated with
innovating melanocortins. And yet, we
are confident that it is a gamble worth
taking. It would pay off handsomely, in
the shape of the competitive position
that CLINUVEL would attain at the end
of successfully developing a drug for
untreated diseases. A case-in-point is
the market for porphyria, a new venture
that has generated returns on equity
of more than 24% on average since we
started commercialising.
We have invested resources into
the VALLAURIX Singapore team this
year, adding new skills, new capital
expenditures and new analytical
methods with an eye to advancing
three pharmaceutical products and
the three PhotoCosmetic lines. We are
continuously evaluating whether these
investments in melanocortin-based
technologies increase long-term value,
or whether the funds would be more
usefully spent elsewhere. Time versus
output remains a critical metric of how
we assess resource allocation. Thus far,
we are compelled to develop the next
melanocortin products, serving unmet,
lucrative markets.
Finally, in February this year we
launched the Photomedicine
Foundation, an important, worthy
initiative which donates the fruits of
R&D to underprivileged communities.
African patients with xeroderma
pigmentosum will receive treatment
and skin-protecting PhotoCosmetics
funded by the Foundation. We will focus
on patients with darker skin, children
and those handicapped by light.
Board and Management Composition
We acknowledge the contributions of
Willem Blijdorp, who served nine years
as a Board member and four years as
Chairman. He gave commercial input
at critical moments in CLINUVEL’s
history. His business acumen and wider
commercial views are missed. I also
wish to thank Andrew Likierman for
serving during an interim period, and
for kindly providing his financial views
when they were needed. As this letter
goes to print, we are poised to welcome
new members who will bring diverse
skills to the Board.
Across the Group, our priority is building
a team with complementary experience
and skills. We are also committed to
achieving gender parity and increasing
ethnic diversity. Our current ratio of
female to male employees is 69:31. We
are striving to maintain a minimum
of 40% female representation on the
Board (the current make-up is 60:40
female:male). Other measures of
diversity are detailed in the feature on
Sustainability in this Annual Report.
At the same time, we are establishing
a skills-based organisation where we
employ and develop professionals
who can meet both current and future
objectives. These range from R&D to
clinical, analytics, commercial, consumer
health, branding and communications.
In the meantime, succession planning
for the executive team is progressing
well. In July Mr Peter Vaughan replaced
Mr Darren Keamy as Chief Financial
Officer after 19 years at the Group;
and new executives are being added
to the team of ten, with Mr Lachlan
Hay stepping up to the role of Chief
Operations Officer on 1 July. The aim is
to appoint a new Chief Executive Officer
prior to my departure in June 2026,
giving sufficient time for an orderly
handover. The Company will continue
its trajectory with new management in
place by 2026. That presses us to realise
all ambitions in less than 24 months.
Summary
This past year has been defined by
exciting advances, supported by
activities to consolidate and realise
these strides forwards. CLINUVEL ranks
among the few financially independent
biopharmaceuticals on a solid growth
trajectory. This has attracted numerous
new investors to CLINUVEL, drawn by
our fundamentals, long-term approach
and risk management. To our delight,
retail investors in Germany reached
more than 1,900 in the past 12 months
and their interest in the Company
was warmly received during an over-
subscribed meeting in Düsseldorf last
March. German-speaking countries
will receive further investor relations
attention in the year ahead.
We are bullish on the outlook for
SCENESSE®. The market for the
therapy is expanding year-on-year
and insurers have already started to
reimburse teenagers aged 15 and
older. Eventually, we will add the
adolescent population to our total pool
of patients—a true milestone. With the
new talent and specific skills that have
entered the Company, we have also
begun gearing up to enter the North
American vitiligo market. This will
reap significant rewards.
The bold combination of
pharmaceuticals and healthcare is
already lending the Company global
exposure. We have laid the foundations
for developing, manufacturing and
distributing the first PhotoCosmetic
products, while preparing for the
flagship M-lines. Of course, we remain
aware that two distinct businesses
compound risks. Yet we possess the
funds to take calculated risks, and we
are confident in our ability to succeed.
Our leadership continues to evolve,
protecting CLINUVEL’s core identity as
we innovate. Of the executive team of
ten, eight have been with the Company
for more than 15 years, and we
welcome a new tier of talented senior
managers. We have seen the addition
of Mr Benson Chao (Legal Counsel), Ms
Claire Newstead-Sinclair (Company
Secretary), Mr Vaughan (CFO), and
the return of Dr Emilie Rodenburger
(Director, Global Clinical Affairs). We
are pleased to have Mr Clouston join us
to build an IR program in the US; and
Ms Marga Arrom-Bibiloni to lead the
branding activities for the consumer
healthcare branch of the business.
There are many new prodigies and
emerging stars within the Group.
Our task is to design programmes for
individuals destined to have a long and
rewarding career with us, under the
umbrella of the CLINUVEL Academy.
I am convinced these investments
are worthwhile and that they will pay
off in the long-term. I look back at a
year where a valuable team carried
out quality and pharmacovigilance;
regulatory; R&DI; clinical; finance and
compliance; investor relations; public
relations; a CBM team performed
with creative talent; and strong
general management.
The avid reader and biopharma
investor will also know that CLINUVEL
only discloses a fraction of our
activities, as it is not in our interest
to feed competitors with valuable
knowledge. With the bulk of our work
below the surface, we look forward
to the days when we can reveal our
value accretive technologies to enter
new markets, protected by intellectual
property patents.
The key objective for me now is to
fulfil a life’s ambition: to leave behind
a prosperous biopharmaceutical
company, which houses unique
individuals, talents and personalities
collectively doing good for those who
benefit from our medical innovations.
The journey to realising this goal has
brought with it humility, shared by all
who are associated with CLINUVEL
from new Board members to our
experienced executive team. This
is a robust foundation which we
can build upon.
That only leaves me to thank the
CLINUVEL team for delivering great
financials and you, for staying with us.
Philippe Wolgen
Managing Director
CLINUVEL Group
1. Enterprise Resource Planning; 2. Customer Relationship Management; 3. Electronic Quality Management System
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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49
OPERATING &
FINANCIAL REVIEW
IN-HOUSE COMMERCIAL TEAM
DIRECT DISTRIBUTION
2019–2024
5% new institutional investors attracted
15%
5%
5%
R&D Pipeline Development
Vitiligo CUV105 - 75% Recruitment
DNA repair – Full Recruitment of XP CUV152-156
Stroke – Full Results in CUV803
New indication announced
20%
0%
0%
0%
5%
General Management Initiatives
Recruit Key Personnel in R&D
Recruit Key Personnel in Operations
Initiatives to expand/add value to Clinuvel
10%
2.5%
2.5%
2.5%
TOTAL
100%
60%
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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v) Long-term retention
KMP (except the MD) and all other employees are eligible to receive LTI in the form of PRs awarded for long-term service to
the Group. The vesting period of the long-term service PRs is three years from grant date whereby risk of forfeiture exists until
the last day of employment at the end of the 36 months.
During the FY2024 financial year, only the Group’s CFO was eligible to receive retention awards, payable in cash and
conditional to having remained employed at the last day of the respective employment terms. The Group CFO, Mr Darren
Keamy, received a long-term retention award of $28,198 during the FY2024 financial period.
i Long-term Incentives (PRs, equity awards) to KMP (excluding MD)
KMP receive periodically receive equity awards in the form of PRs every four years assessed upon value-generating performance
conditions. The most recent PRs were awarded to KMP in November 2019 and vested or expired in November 2023.
As of 1 January 2024, newly employed KMP are annually awarded PRs on tenure of service set to secure retention for time
served. In contrast, existing KMP were eligible to receive PRs with a vesting period of four years.
For the CFO (Darren Keamy resigned 1 July 2024) and CSO, the relative percentage of LTIs are highlighted in the table below:
Executive KMP
# Performance Rights
on Issue 1 July 2023
# Performance Rights
Vested and Exercises
# Performance Rights
Lapsed and Expired
Deemed Achieved at
Vesting Date
CSO
75,813
31,938
43,875
42%
CFO
339,875
184,302
155,575
54.2%
During the financial year ended 30 June 2024, a total of 216,240 of the potential 415,688 PRs issued to KMP in the 30 June
2022 financial year were deemed to have been achieved by 20 November 2023 and were subsequently converted to shares on
27 November 2023. No PRs were issued to KMP during the financial year ended 30 June 2024.
ii Long-term incentives (PRs, equity awards) to MD
PRs were last awarded to the MD in 2019 where at the 2019 AGM, shareholders approved the grant of 1,513,750 PR to the MD and
these PRs were offered and granted to the MD, who accepted the offer on 26 August 2020. These PRs had a vesting period of up to
four years from date of shareholder approval. Several of the performance conditions were deemed to have been achieved which
amounted to an issuance of 301,125 shares (20%) with the remaining performance conditions not achieved by 20 November
2023 amounting to 1,212,625 PRs (80%) being forfeited and lapsed. As at 30 June 2024, the MD has no PRs outstanding.
Whilst the employment agreement of the MD has been extended by one further year to 30 June 2026 (refer ASX
announcement 28 June 2024), following advice from external remuneration consultants, proxy advisors, and counsel, the
Remuneration Committee has deemed to not award the MD any new PRs or equity incentives beyond the expiry of the
existing PRs in November 2023. Accordingly, the MD has not received any equity incentives in FY2024 and will currently not
receive PRs in either of the next two financial years, FY2025 and FY2026.
To secure the ongoing services of Dr Wolgen as MD for the extension period to 30 June 2026, the Committee implemented a
Retention Payment, subject to Dr Wolgen remaining with the business through until 30 June 2026, may entitle him to receive
a Retention Payment equivalent to 200% of FBR, subject to the executive satisfying certain conditions. Dr Wolgen will forfeit
any entitlement to a Retention Payment where he resigns (for reasons other than fundamental change) or is terminated for
cause but will retain the entitlement if his employment is terminated without cause or he resigns for fundamental change.
3) Benefits
The Board strives to offer the Group’s employees competitive benefits comparable to pay scales within the country and
region of residence.
The total incentive package of an employee may include pension contributions, health insurance contributions, healthcare
plans or private healthcare insurance, telephone and IT contributions as well as a laptop and professional software licenses,
or other such benefits.
Total incentive packages may differ between regions and market conditions at the time of entering an employment agreement.
4) Claw back provisions
The Remuneration Committee adheres to a process of retaining the right to claw back and seek recovery of benefits paid to
KMP if adverse activities or events have occurred which were detrimental to the Group resulting in financial loss or value. The
Remuneration Committee may elect to claw back a previously provided retention award and / or LTI. The Board of Directors,
in its discretionary capacity, may elect to reduce, cancel in part or in full, or pursue a claw process for incentives previously
provided to any employee, including any former employees, where misconduct or adverse activities have occurred.
If an employee of the Group has acted dishonestly or failed to act in a way that one would expect according to CLINUVEL’s
Code of Conduct and corporate governance, the Board may decide to claw back and retrieve part or total of the retention
award or equity provisions from the employee.
E. EQUITY BASED AWARDS
1) Performance Rights:
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.
All PRs that have been issued fall under two Performance Rights plans:
a) the CLINUVEL Conditional Performance Rights Scheme (2009); and
b) the CLINUVEL Performance Rights Plan (2014).
i) 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 rights 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 PRs be acquired by a Plan Trustee and then, from time to
time, transferred to participants to the Performance Rights Plan. Unless the PRs are granted with a shorter vesting period, PRs under
this plan lapse after seven years from grant date. It is no longer intended to issue PRs under the 2009 Plan.
As at 30 June 2024, 29,082 PRs issued under the 2009 Scheme remain unvested.
ii) 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. Any issue of rights to Directors requires shareholder approval in
accordance with ASX Listing Rules by since 2020, the Company policy is for NED to not receive PRs or other equity securities in the
Company. All rights 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 PRs be acquired by a Plan Trustee and then, from time to time, transferred to participants to the Performance Rights Plan.
Unless the PRs are granted with a shorter vesting period, PRs under this plan lapse after seven years from grant date.
PRs 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 PRs may or may not receive a benefit from these amounts, either in the current or future reporting periods. The
value of all PRs granted, exercised, and lapsed during the financial year is detailed in tables within this Remuneration Report.
Of the 2,591,860 Performance Rights on issue on 1 July 2023 which had been previously issued under the 2014 Performance
Rights Plan to both KMP and non-KMP employees, 716,932 (27.7%) PRs were deemed to have achieved the performance
conditions by the 20 November 2023 vesting date and were exercised. 1,637,678 (63.2%) performance rights were deemed to
have not achieved the performance criteria by the vesting date and lapsed. It indicates how the Committee has set
performance conditions at maximum stretch.
At the Company’s Annual General Meeting held on 31st October 2023, shareholders approved the renewal of the 2014
Performance Rights Plan for a further 3 years. Under the renewed plan, up to a maximum of 2.25% of the Company’s issued
share capital may be issued as new PRs, though this maximum number is not intended to be a prediction of the actual
number of securities to be issued by the Company under the Plan, as assessed from past conditions met.
As at 30 June 2024, 237,250 PRs issued under the 2014 Performance Right Plan remain outstanding, of which an estimated
200,854 of the PRs (85%) are likely to achieve the underlying performance condition but will not vest until the end of their
respective vesting dates if the employee is still employed at that time by the Company.
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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F. REMUNERATION COMPONENTS BENCHMARKED
Benchmarking the remuneration packages of KMP and management occurs annually through the selection of comparable
international peer companies according to the selection criteria outlined below. In conjunction with remuneration
consultants, external counsel, and taking into account feedback from proxy advisors, the Remuneration Committee arrives at
a selection of comparable companies in setting the FBR and total incentive package for KMP, including the MD.
A number of critical components underpin the remuneration practices of the Group whereby the benchmarking of its FBR and
STI is compared against the pay scales of peer companies. It is considered critical for 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.
International publicly listed companies with the same or similar R&D and commercial risks, have been deemed the most
appropriate comparable peer group measure given the Group generates all its revenues from Europe, North America and the
Middle-East. In addition, over 82% of the total employees of the Group reside and are employed outside Australia.
Accordingly, any remuneration benchmarking should also be compared against international pay-scales and practices.
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.
Selection criteria
Commentary
Bio-pharmaceuticals
Bio-pharmaceutical development is regarded as comprising
the highest R&D, clinical, regulatory, and commercial risk.
Peers are selected internationally on comparable
technologies.
Platform technologies
Preference is to select those companies which have
translational technology, and or ability to utilise technology
in multiple indications, and formulations.
NME/NCE¹
New molecular, chemical entities bear the highest risk due
to the novelty and lack of prior art. Peers are identified on
the basis of comparable NME/NCE strategies.
Revenue generating
Comparison is drawn with independently operating and
mature bio-pharmaceutical companies, which are debt free
and not dependent on equity funding.
Profitable
Selected are the peers which are profitable and demonstrate
a CAGR.
Annual Growth
Identified are bio-pharmaceutical companies which
illustrate annual growth in pipeline and activities through
self-funding.
Longevity, tenure
Benchmarked against executive management with a
minimum tenure of 3 years, with a proven track record in the
industry.
Qualification, background
Selection and benchmarking of management with dual or
multiple academic qualifications, with a background in life
sciences and proven track of operating in capital markets.
Responsibility, risks
Benchmarked against peer companies, where management
bears executive responsibility and proven to manage
operational, clinical, regulatory and financial risks longer
term.
¹ New molecular or new chemical entity, indicating complexity and length of R&D
During the year, the MD’s remuneration was benchmarked against 12 Australian and 22 US life science peer companies with
different profiles, since there are few profitable bio-technology companies globally serving as a benchmark, (except for the
mix of medical device, human and animal health prescriptive and over-the-counter pharmaceutical products, healthcare
solutions and diagnostic focused companies) using the following criteria:
The financial performance of the Company measured against this peer group ranks strongly on TSR, EPS and revenues
growth, and ROE criteria. The Company ranks:
• 10th amongst its peers for TSR performance over 7 years;
• 8th among its peers for growth in earnings per share over 5 years;
• 5th among its peers in the compound annual growth of total revenues over 7 years; and
• 6th amongst its peers for ROE performance.
Benchmarking Criteria
Australian Companies
US Companies
Market Capitalisation:
Between A$450 million and A$2.7 billion
Between US$500 million and US$1.7 billion
Industry Segment:
Pharmaceutical, Biotech, Medical companies
Biopharma companies
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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In comparing FY2024 KMP remuneration to the peer group remuneration for FY2023, the MD’s FBR was found to be positioned
above the median level, whereas the overall remuneration package was below the median level. The Board considers the
level of FBR to be appropriate, considering the long-term outperformance of the Company, the relatively unusually long-term
tenure of the MD to lead the restructure of the Company since 2005, building a profitable and sustainable business, his deep
knowledge of the targeted technologies, whilst delivering high shareholder returns.
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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103
G. 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:
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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105
Analysis of CLINUVEL’s share price performance against main life science indices shows an equally positive outcome over the
long-term (the past seven years). However, the Board is cognisant that there may not be a relation between CLINUVEL’s
volume weighted average share price (VWAP) and performance of the Company, as has been frequently seen. This was the
case in FY2024 as CLINUVEL’s share price declined by 14.5%, whilst the Company has grown and some recovery was evident
in key biotech indices.
The graphs below show the share price over the past year and seven years compared to key indices and the share price over
the longer term with some of the key milestones that have been achieved.
The Board believes the remuneration mix aligns the other executive KMP and MD to shareholder interest. The remuneration
mix for 2023/24 is demonstrated in the table below.
The Board intends to award PR, or LTIs, to the KMP (except the current MD) in the coming financial year. The current CFO is
eligible to receive PRs at the end of the vesting period.
H. NON-EXECUTIVE REMUNERATION
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 NED 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.
1) Non-Executive Director Fees
NED 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 NED fees (inclusive of superannuation):
Board Fees
Audit & Risk
Committee
Remuneration
Committee
Nomination
Committee
Chair
115,000
-
-
-
Non-Executive Director
70,000
-
-
-
Committee Chair
-
15,000
15,000
-
Committee Member
-
5,000
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 NEDs 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 allocated to NEDs as determined by the Board. The aggregate amount paid to NEDs for the year ended 30 June
2024 was $437,084 (2023: $495,000).
2) Non-Executive Director Long-Term Incentive – Equity Compensation
Long-term equity remuneration was formerly provided to NEDs via the CLINUVEL Conditional Rights Plan and the
Performance Rights Plan. Any issue of PRs to NEDs requires shareholder approval. It is not planned for NEDs to participate in
long-term equity compensation plans. No NED holds PRs as of 30 June 2024.
Position
Fixed Remuneration
STI Cash
LTI Cash1
LTI Equity
Managing Director
100%
46% of Base Salary
None
None
Other Executive KMP
CFO
100%
7% of Base Salary
None
None
CSO
100%
7% of Base Salary
None
None
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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I. SERVICE AGREEMENTS
Remuneration and other terms of employment for the MD and KMP are formalised by a service agreement determined by the
Remuneration Committee and accepted by the Board of Directors. The agreement provides for FBR, STI, LTI, other benefits,
and participation, when eligible, in the Group’s Performance Rights Plan.
The MD makes recommendations to the Remuneration Committee on the service agreements entered into with other KMP,
providing for base salary, incentives, other benefits and participation, when eligible, in the Group’s Performance Rights Plan.
On appointment to the Board, all NEDs enter into a service agreement with the Company in the form of a letter of
appointment which outlines the Board’s policies, the Director’s responsibilities, and compensation for holding office.
On 28 June 2024, the service agreement for the MD, Dr Wolgen, was extended for one further year to 30 June 2026.
Due to the resignation of Mr Keamy, effective from 1 July 2024, his service agreement for the roles of Company Secretary and
CFO were not renewed beyond the 1 July 2024 expiration date.
The details of the service agreements to the MD and KMP are:
Name
Dr Philippe Wolgen
Dr Dennis Wright
Duration of contract
24 months (terminating 30
June 2026)
No fixed term
Notice Period (from Company)
12 months
3 months
Notice Period (from Managing Director)
12 months
-
Notice Period (from Executive KMP)
-
3 months
Termination Payment without Cause
12 months
3 months
Termination Payment with Cause
None
None
Contract End Date
30 June 2026
not applicable
J. DETAILS OF REMUNERATION
1) KMP remuneration of the Company for the years ended 30 June 2024 and 30 June 2023 –
Cash Based Benefits
Year
Gross
Salary ³
Short Term
Incentive
Retention
Award
Other¹
Superannuati
on/ Pension
Fund
Total
(Excluding Share-
Based Payments)
$
$
$
$
$
$
Dr. P. J. Wolgen2
2024
1,765,068
941,046
-
283,454
-
2,989,568
2023
1,593,117
898,244
-
286,314
-
2,777,675
Mrs. B. M. Shanahan
2024
76,577
-
-
-
8,424
85,001
2023
76,923
-
-
-
8,077
85,000
Mr. W. A. Blijdorp
2024
82,083
-
-
-
-
82,083
2023
115,000
-
-
-
-
115,000
Dr. K. A. Agersborg
2024
75,000
-
-
-
-
75,000
2023
75,000
-
-
-
-
75,000
Mrs. S. E. Smith
2024
80,000
-
-
-
-
80,000
2023
75,000
-
-
-
-
75,000
Prof. J. V. Rosenfeld
2024
82,583
-
-
-
9,084
91,667
2023
67,874
-
-
-
7,126
75,000
Prof J. A. Likierman
2024
23,333
-
-
-
-
23,333
2023
70,000
-
-
-
-
70,000
Dr. D. J. Wright
2024
305,086
21,966
-
-
27,399
354,451
2023
289,182
26,026
-
-
25,292
340,500
Mr. D. M. Keamy
2024
361,594
26,035
30,736
-
27,399
445,764
2023
331,737
58,054
-
-
25,292
415,083
Total
2024
2,851,324
989,047
30,736
283,454
72,305
4,226,867
2023
2,693,833
982,324
-
286,314
65,787
4,028,258
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.
For Mr Keamy and Dr Wright, the movement in their annual leave and long service leave entitlements was $22,519 accretive and $28,447 accretive respectively (year ending 30 June 2023:
$11,206 accretive and $24,693 reduction respectively).
For Dr Wolgen, the movement in his aggregate annual leave and long service leave entitlements for year ending 30 June 2024 decreased by $11,787 (2023: $232,054).
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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109
3) KMP remuneration of the Company for the years ended 30 June 2024 and 30 June 2023 –
Non-Cash Benefits
Share-based payments (accounting charge only)¹
Year
Total
(Excluding Share-
Based Payments)
Performance
Rights
(for accounting
purposes only)
Total
(Including Share-
Based Payments,
for accounting
purposes only)
Performance-
based
$
$
$
%
Dr. P. J. Wolgen
2024
2,989,568
752,844²
3,742,412
20%
2023
2,777,675
3,612,426
6,390,101
57%
Mrs. B. M. Shanahan
2024
85,001
-
85,001
-
2023
85,000
-
85,000
-
Mr. W. A. Blijdorp
2024
82,083
-
82,083
-
2023
115,000
-
115,000
-
Dr. K. A. Agersborg
2024
75,000
-
75,000
-
2023
75,000
-
75,000
-
Mrs. S. E. Smith
2024
80,000
-
80,000
-
2023
75,000
-
75,000
-
Prof. J. V. Rosenfeld
2024
91,667
-
91,667
-
2023
75,000
-
75,000
-
Prof J. A. Likierman
2024
23,333
-
23,333
-
2023
70,000
-
70,000
-
Dr. D. J. Wright
2024
354,451
428,162
782,613
55%
2023
340,500
296,352
636,852
47%
Mr. D. M. Keamy
2024
445,764
2,218,120
2,663,884
83%
2023
415,083
2,674,581
3,089,664
87%
Total
2024
4,226,867
3,399,126
7,625,993
-
2023
4,028,258
6,583,359
10,611,617
-
¹As 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 PRs and
share options granted, exercised and lapsed during the financial year is detailed in the following tables within the Remuneration Report. PRs 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.
² The value of the PRs assigned to the MD, as awarded on achieving 20% of the PRs granted at the AGM 2019. Dr Wolgen is no longer eligible for PR or any form of equity.
4) Remuneration Performance Rights holdings of KMP – 2024
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*
Directors
Dr. P. J. Wolgen
1,513,750*
-
(301,125)
(1,212,625)
-
-
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
93,938
-
(31,938)
(43,875)
18,125
-
Mr. D.M. Keamy
347,235
-
(184,302)
(155,575)
7,358
-
* A listing of the Performance Conditions for the Performance Rights vested and exercised are shown at section XXX.
5) Shares held by KMP
The number of ordinary shares in the Company during the 2023/24 reporting period held by each of the Group’s KMP,
including their related parties, is set out below:
Year Ended 30 June 2024
Personnel
Balance at
Start of Year
Granted as
Remuneration
Received
on Exercise
Other Changes
Held at the End of
Reporting Period
Dr. P. J. Wolgen
3,122,247
-
301,125
1,850
3,425,222
Mrs. B. M. Shanahan
196,577
-
-
-
196,577
Mr. W. A. Blijdorp
1,743,118
-
-
-
1,743,118
Dr. K. A. Agersborg
5,500
-
-
-
5,500
Mrs. S. E. Smith
420
-
-
-
420
Prof. J. V. Rosenfeld
3,148
-
-
-
3,148
Prof. J. A. Likierman
1,000
-
-
(1,000)
-
Other KMP
Dr. D. J. Wright
156,874
-
31,938
-
188,812
Mr. D. M. Keamy
178,588
-
184,302
-
362,890
6) Terms and conditions of each grant of rights affecting remuneration in the current or future
reporting periods
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.
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
7,500
$12.87
Ordinary
05/05/2022
05/05/2022
20/12/2024
-
20/12/2024
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
110
111
7) Remuneration details of Equity Incentives (Performance Rights)
8) Remuneration details of cash incentives
Loans to Directors and Executives
No loans were granted to Directors or executives for the years ended 30 June 2024 and 30 June 2023.
Signed in accordance with a resolution of the Board of Directors pursuant to s.298(2) of The Corporations Act 2001.
Equity Incentives (Performance Rights)
Name
Year Granted
Latest Year of Vesting
Vested in Year
Lapsed &
Forfeited in Year
Max Value of Right at
Grant Date Yet to Vest
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
2011/12
no limitation
-
-
$12,853
Mr. D. M. Keamy
2011/12
no limitation
-
-
$5,219
On exercise, each PR 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 PRs is $Nil. The exercise price for the PRs granted between in 2010/11 was $Nil.
Cash Incentives
Name
Max Potential Opportunity (%)
STI Awarded (%)*
STI Forfeited (%)
Total Granted ($)
Dr. P. J. Wolgen
100%
53%
47%
941,046
Dr. D. J. Wright
9%
80%
20%
21,966
Mr. D. M. Keamy
20.5%
35%
65%
26,035
* For the MD, the STI Awarded in the functional currency on his base salary was 60.0%
K. DETAILS OF PERFORMANCE RIGHTS
1) Managing Director Performance Rights Vested on 20 November 2023
Details of Performance Rights issued to Managing Director
Performance
Condition Met
Number of Rights
Vested
PC1
Performance Rights granted to Managing Director – 450,000
Executive management and staff succeeding in steering the Company to a:
(i) Market capitalisation of a minimum A$1,700,000,000 - as measured by a minimum of 15 trading days
during the vesting period - 10% of the performance rights under PC1 shall vest,
45,000
(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,
X
-
(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,
X
-
(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,
X
-
(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.
X
-
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,
15,750
(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,
21,000
(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,
31,500
(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.
36,750
* The Board ad Remuneration Committee deemed Cash and Cash Equivalents to pertain to cash assets of the business held in Cash and Cash Equivalents together with Cash Held in Term
Deposits.
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,
X
-
(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.
X
-
For PC3 to be achieved, the acquisition must be considered synergistic to the Company’s business operations at the time of acquisition.
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
112
113
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,
29,750
(ii) US revenues in year 3 to exceed revenues by a minimum of 10% in year 2, a further 33% of PC4 shall vest,
28,875
(iii) US revenues greater than US$10,000,000 in a 12-month period leads to vesting of 33% of PC4.
28,875
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,
X
-
(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,
X
-
(iii) First topical melanogenic formulation to be used either in animal or in human testing, a further 25%
of PC5 shall vest,
X
-
(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.
X
-
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,
5,500
(10.5% of full target)
(ii) Upon disclosure to the securities exchange of the results to the Phase IIb vitiligo study in North
America, 20% of PC6 shall vest,
X
-
(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,
X
-
(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,
X
-
(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.
X
-
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,
X
-
(i) 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.
X
-
PC8 Performance Rights granted to Managing Director – 116,250
(i) 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.
58,125
(50% of full target)
These corporate events shall include, but are not limited to, business generation in new markets without the Company
engaging in merger and acquisition activity.
Total Performance Rights Vested and Exercised by Managing Director
301,125
– 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
Unissued shares under option
Auditor’s Independence Declaration
The auditor’s independence declaration as required by s.307C of the Corporations Act 2001 is included on page 151 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, 2024
Entity
Number of shares issued
Issue Price for Shares
Class
CLINUVEL PHARMACEUTICALS LTD
716,932
Nil$
Ordinary
Entity
Number of Shares
under Rights
Exercise Price
Class
Expiry Date
CLINUVEL PHARMACEUTICALS LTD
266,332
Nil$
Ordinary
Upon achievement of specific
performance and time-based
milestones or upon cessation of
employment
Total as at date of Directors Report
266,332
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
114
115
Statement of Profit and Other Comprehensive Income
for the year ended 30 June 2024
Consolidated Entity
2024
2023
$
$
Revenues
Commercial sales of goods
19
81,218,146
72,179,047
Sales reimbursements
19
6,960,162
6,142,271
Total revenues
88,178,308
78,321,318
Interest income
7,324,871
3,905,856
Total interest income
7,324,871
3,905,856
Other income
Unrealised (loss)/gain on restating foreign currency balances and currencies held
(745,764)
659,901
Government grants and other income
562,936
23,817
Realised foreign currency (loss)/ gain on transactions
(14,614)
79,364
Total other income (loss)
(197,442)
763,082
Total revenues, interest and other income
95,305,737
82,990,256
Expenses
Personnel-related
18,917,924
13,576,951
Share-based payments
6,107,272
8,989,788
Materials and related expenses
5,201,364
12,063,281
Finance, corporate and general
4,454,292
3,192,713
Commercial distribution
3,638,897
3,145,355
Clinical and non-clinical development
2,348,296
1,268,456
Communication, branding and marketing
2,180,489
749,769
Legal, insurance and IP
1,743,050
1,323,383
Depreciation and amortisation
1,142,326
789,408
Changes in inventories of raw materials, work in progress and finished goods
(1,107,151)
(7,687,571)
Total expenses
44,626,759
37,411,533
Profit before income tax
50,678,978
45,578,723
Income tax
Current
3(a)
15,532,461
16,382,733
Deferred
3(a)
(489,842)
(1,408,576)
Income tax expense
3(a)
15,042,619
14,974,157
Operating profit after income tax
15(b)
35,636,359
30,604,566
Net profit for the year
35,636,359
30,604,566
Other comprehensive income
Items that may be re-classified subsequently to profit or loss
Exchange differences of foreign exchange translation of foreign operations
138,945
(1,454,160)
Other comprehensive loss for the period, net of income tax
138,945
(1,454,160)
Total comprehensive income for the period
35,775,304
29,150,406
Basic earnings per share - cents per share
14
71.5
61.9
Diluted earnings per share - cents per share
14
69.8
59.1
The accompanying notes form part of these financial statements.
Statement of Financial Position as at 30 June 2024
Consolidated Entity
Note
2024
2023 Restated
$
$
Current assets
Cash and cash equivalents
1(e) and 15(a)
35,200,751
31,893,021
Cash held in term deposits
1(f)
148,667,720
124,920,516
Trade and other receivables
4
26,238,297
22,214,646
Inventories
5
10,626,613
9,519,462
Other current assets
1,330,461
1,070,153
Total current assets
222,063,842
189,617,798
Non-current assets
Property, plant and equipment
6
6,982,337
2,017,861
Right-Of-Use assets
7
737,788
833,326
Intangible asset
185,030
185,030
Deferred tax assets
3(c)
1,020,344
1,059,541
Lease bonds
134,208
-
Total non-current assets
9,059,707
4,095,758
Total assets
231,123,549
193,713,556
Current liabilities
Trade and other payables
9
7,109,053
7,649,572
Income tax payables
15,851,385
16,094,178
Provisions
10
1,881,898
1,450,120
Lease liabilities
7
369,861
300,843
Total current liabilities
25,212,197
25,494,713
Non-current liabilities
Deferred tax liabilities
3(d)
2,226,104
2,757,516
Lease liabilities
7
509,923
699,022
Provisions
10
163,959
131,162
Total non-current liabilities
2,899,986
3,587,700
Total liabilities
28,112,183
29,082,413
Net assets
203,011,366
164,631,143
Equity
Contributed equity
11
168,802,368
151,849,375
Reserves
12
4,245,371
22,556,044
Retained earnings/(accumulated losses)
29,963,627
(9,774,276)
Total equity
203,011,366
164,631,143
The accompanying notes form part of these financial statements.
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
116
117
Statement of Cash Flows for the Year Ended 30 June 2024
Consolidated Entity
Note
2024
2023 Restated
$
$
Cash flows from operating activities
Receipts from customers
84,020,937
74,877,720
Payments to suppliers and employees
(39,749,125)
(33,230,793)
Income taxes paid
(15,648,111)
(7,744,922)
Interest received
7,633,046
2,727,126
Government grants
344,394
22,009
GST and VAT refunds
244,147
260,923
Proceeds from insurance claims
208,594
-
Net cash provided by operating activities
15(b)
37,053,882
36,912,063
Cash flows from investing activities
Investments in cash held in term deposits
(23,457,711)
(30,820,516)
Payments for property, plant and equipment
(5,576,215)
(1,027,532)
Net cash used in investing activities
(29,033,926)
(31,848,048)
Cash flows from financing activities
Issuance of shares related to employee share schemes
4,155,010
-
Payments related to employee share schemes
(4,155,010)
-
Dividends paid
(2,470,227)
(1,976,414)
Payments for share buy back
(754,236)
-
Payments of lease liabilities
(347,344)
(263,718)
Net cash used in financing activities
(3,571,807)
(2,240,132)
Net increase in cash held
4,448,149
2,823,883
Cash and cash equivalents at beginning of the year
31,893,021
27,409,282
Effects of exchange rate changes on foreign currency held
(1,140,419)
1,659,856
Cash and cash equivalents at end of the year
15(a)
35,200,751
31,893,021
The accompanying notes form part of these financial statements.
Statement of Changes in Equity for the Year Ended 30 June 2024
Share
Capital
Performance
Rights
Reserve
Foreign
Currency
Translation
Reserve
Retained
Earnings/
(Accumulated
Losses)
Total Equity
$
$
$
$
$
Balance at 30 June 2022
151,849,375
10,380,258
1,731,838
(38,402,428)
125,559,043
Employee share-based payment options
-
8,989,788
-
-
8,989,788
Dividends paid
-
-
-
(1,976,414)
(1,976,414)
Exercise of performance rights
under share-based payment
-
-
-
-
-
Transactions with owners
151,849,375
19,370,046
1,731,838
(40,378,842)
132,572,417
Profit for the year
-
-
-
30,604,566
30,604,566
Other comprehensive income:
Exchange differences of foreign exchange
translation of foreign operations
-
-
1,454,160
-
1,454,160
Total other comprehensive income
-
-
1,454,160
-
1,454,160
Balance at 30 June 2023
151,849,375
19,370,046
3,185,998
(9,774,276)
164,631,143
Exercise of performance rights
under share-based payment
17,707,229
(17,707,229)
-
-
-
Lapsed, forfeited rights
-
(6,571,771)
-
6,571,771
-
Employee share-based payment options
-
6,107,272
-
-
6,107,272
Share buy back
(754,236)
-
-
-
(754,236)
Dividends paid
-
-
-
(2,470,227)
(2,470,227)
Transactions with owners
168,802,368
1,198,318
3,185,998
(5,672,732)
167,513,952
Profit for the year
35,636,359
35,636,359
Other comprehensive income:
Exchange differences of foreign exchange
translation of foreign operations
-
-
(138,945)
-
(138,945)
Total other comprehensive income
-
-
(138,945)
-
(138,945)
Balance at 30 June 2024
168,802,368
1,198,318
3,047,053
29,963,627
203,011,366
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
118
119
Notes To And Forming Part Of The Financial Statements For
The Year Ended 30 June 2024
1. Summary Of Other Potentially Material Accounting Policies
This note provides a list of other potentially material accounting policies adopted in the preparation of these consolidated
financial statements to the extent they have not already been disclosed in the other notes below. These policies have been
consistently applied to all the years presented, unless otherwise stated. The financial statements are for the group consisting
of CLINUVEL PHARMACEUTICALS LTD and its subsidiaries.
a) 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 complies 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 material 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 factors 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 material accounting policies are chosen to ensure the resulting financial information satisfies the concepts of relevance
and reliability.
b) 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 material 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.
c) 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.
d) 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.
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.
A deferred tax asset has been recognised as at 30 June 2024 and 30 June 2023 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;
• 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.
Private Tax Ruling
During the 2024 financial year, Clinuvel applied for, and received, a Private Tax Ruling from the Australian Taxation Office
(ATO) to affirm its entitlement to deduct an amount under section 8-1 of the Income Tax Assessment Act 1997 (Cth) (ITAA
1997) for irretrievable cash contributions it makes to CPU Share Plans Pty Limited (the Trustee) of the Clinuvel
Pharmaceuticals Limited Employee Share Plan Warehouse Trust (the Trust) to fund the subscription for, or acquisition on-
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market of, fully paid ordinary shares in the Company (Shares), to satisfy employee share scheme (ESS) interests issued
pursuant to the 2014 Performance Rights Plan as updated in September 2023 and renewed by the Company’s shareholders at
the 2023 Annual General Meeting.
e) Cash and Cash Equivalents
Cash and cash equivalents comprise of cash on hand and at call deposits held with banks or financial institutions. The cash at
bank amounts earns floating rates based on daily bank account interest 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.
f) Cash Held in Term Deposits
Cash held in term deposits include cash in term deposits with banks or financial institutions. The Company’s policy is to place
surplus cash in term deposits to earn competitive interest income while maintaining liquidity. As of 30 June 2024, the term
deposits are readily convertible to cash upon Clinuvel providing 31 days’ prior notice to the institution following which a
market-related rate reduction to the interest payable for the early withdrawal is applied.
The average effective interest rate on cash held in term deposits was 5.28% (2023: 3.33%). These deposits have an average
maturity date of 251 days (2023: 252 days).
Reclassification of comparative amounts
The Group has restated its consolidated Statement of Financial Position as at 30 June 2023 to reclassify cash term deposits
with maturity dates beyond 90 days from their acquisition date, from cash and cash equivalents to cash held in term deposits.
This is after a review of its accounting policy and how it is applied to term deposits considered readily convertible to a known
amount of cash and subject to an insignificant risk of changes in value.
The accounting treatment has been changed by reclassifying each of the affected financial statement line items for the prior
period as follows:
Statement of Financial Position (extract)
30 June 2023
Increase/(Decrease)
30 June 2023 (Restated)
Cash and cash equivalents
156,813,537
(124,920,516)
31,893,021
Cash held in term deposits
-
124,920,516
124,920,516
Total assets
193,713,556
-
193,713,556
The comparative amount for the consolidated Statement of Cash Flows for the year ended 30 June 2023 has been restated to
present the movement of cash into cash in term deposits as a net cash flow from investing activity.
The treatment has been changed by reclassifying each of the affected financial statement line items for the prior period as
follows:
Statement of Cash Flows (extract)
30 June 2023
Increase/ (Decrease)
30 June 2023
(Restated)
Investments in cash held in term deposits
-
(30,820,516)
(30,820,516)
Net cash used in investing activities
(1,027,532)
(30,820,516)
(31,848,048)
Net increase in cash held
33,644,399
(30,820,516)
2,823,883
Cash and cash equivalents at beginning of the year
121,509,282
(94,100,000)
27,409,282
Effects of exchange rate changes on foreign currency held
1,659,856
-
1,659,856
Cash and cash equivalents at end of the year
156,813,537
(124,920,516)
31,893,021
g) 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.
h) Property, Plant and Equipment
Property, 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.
Building is depreciated using the straight-line method over the estimated useful lives of assets up to 50 years. Land is not
depreciated.
Plant and equipment 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 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.
i) 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.
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 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.
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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).
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
• the contractual terms of the financial assets give rise to cash flows that are solely payments of principal and interest on
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.
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, retention 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
amount of the provision can be measured reliably.
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 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:
a) Identifying supply conditions laid down in a contract with a customer;
b) identifying the performance obligations;
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c) determining the transaction price;
d) allocating the transaction price to the performance obligations; and
e) 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 19 provides additional disclosures disaggregating revenue by geographical markets.
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 represent 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) Comparatives
Where necessary, comparatives have been reclassified and repositioned for consistency with current year disclosure.
t) 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.
u) 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.
v) 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 21. 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 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.
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Key Judgements – Tax Losses
Given the Company’s and each individual entity’s 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).
w) Segment Reporting
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 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 19. The Group has one operating segment within the definition of AASB 8 Operating Segments.
x) 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 any 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
2024.
2. Profit/(Loss) From Continuing Operations
Consolidated Entity
Profit/(loss) before income tax includes the following specific expenses
2024
2023
Employee benefits expense
17,861,812
12,960,543
Depreciation on property, plant & equipment
753,184
397,260
Operating lease expense – minimum lease payments
339,011
306,830
Amortisation of right-of-use assets
331,932
343,642
Bank charges
41,562
38,671
3. Income Tax Expense
Consolidated Entity
2024
2023
$
$
(a) Income tax expense
Current
15,532,461
16,382,733
Deferred
(489,842)
(1,408,576)
Income tax expense
15,042,619
14,974,157
Deferred tax included in income tax benefit comprises:
Decrease/(Increase) in deferred tax assets
(110,542)
497,571
Increase/(Decrease) in deferred tax liabilities
(379,300)
911,005
(489,842)
1,408,576
(b) Numerical
Profit before income tax expense
50,678,977
45,578,723
Tax at the statutory tax rates of 30% in 2023 and 2022
15,203,693
13,673,617
Tax effect amounts which are not deductible/(taxable) in calculating taxable income:
Other non-deductible (deductible) expenses for tax purposes
(161,074)
71,075
Non-deductible share-based payments
-
1,229,465
Income tax expense
15,042,619
14,974,157
Tax losses not recognised
Unused tax losses for which no deferred tax asset has been recognised
18,301,957
18,899,558
(c) Deferred tax assets
Carry forward tax losses
856,768
1,011,871
Intangibles
572,581
553,282
Provisions
256,668
233,280
Accrued Expenses
225,869
61,700
Lease liabilities
71,804
10,642
1,983,690
1,870,775
Reconciliation to the Statement of Financial Position
Total deferred tax assets
1,983,690
1,870,775
Set-off of deferred tax liabilities that are expected to reverse in the same period
(963,346)
(811,234)
1,020,344
1,059,541
Movements
Opening balance
1,870,775
1,346,074
Carry forward tax losses
(155,103)
630,821
Intangibles
19,299
39,813
Lease liabilities
61,162
(23,314)
Accrued Expenses
164,169
(84,030)
Provisions
23,388
(38,589)
1,983,690
1,870,775
(d) Deferred tax liabilities
Unrealised foreign exchange gains
(2,744,331)
(3,142,445)
Accrued income
(339,133)
(420,888)
Right-of-use assets
(124,435)
(10,108)
Intangibles
18,449
4,691
(3,189,450)
(3,568,750)
Reconciliation to the Statement of Financial Position
Total deferred tax liabilities
(3,189,450)
(3,568,750)
Set-off of deferred tax assets that are expected to reverse in the same period
963,346
811,234
(2,226,104)
(2,757,516)
Movements
Opening balance
(3,568,750)
(4,479,755)
Unrealised foreign exchange gains
398,113
1,096,011
Right-of-use assets
(114,327)
23,167
Accrued income
81,756
(202,247)
Intangibles
13,758
(5,926)
(3,189,450)
(3,568,750)
Deferred tax assets include US 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 2024 and 2023, income tax rate of 21% for US entity in 2024 and 2023 and income tax rate of 25% for UK entity in 2024 and 2023.
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4. Trade and Other Receivables
Consolidated Entity
2024
2023
$
$
Current
Trade debtors
25,162,556
20,807,909
Interest receivables
1,130,444
1,438,696
Sundry debtors
94,803
134,199
Expected credit losses
(149,506)
(166,158)
Total
26,238,297
22,214,646
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 2024, the Group had a provision for expected credit loss of $149,506 (2023 $166,158)
Consolidated Entity
2024
2023
$
$
Opening balance as at 1 July
(166,158)
-
Reversal of/(provision for) expected credit losses
16,652
(166,158)
Closing balance as at 30 June 2024
(149,506)
(166,158)
5. Inventories
Consolidated Entity
2024
2023
$
$
Current
Raw materials – at cost
571,169
514,812
Provision for obsolescence – raw materials
-
(51,655)
Work in progress – at cost
7,026,835
7,466,396
Finished goods – at cost
3,028,609
1,589,909
Total
10,626,613
9,519,462
A provision for obsolescence of $51,655 was written off in 2024 (2023 : $108,057)
6. Property, Plant and Equipment
Consolidated Entity
2024
2023
$
$
Land
347,744
-
Building
At cost
4,620,025
-
Less: accumulated depreciation
(76,327)
-
Sub-total
4,543,698
-
Plant and equipment
At cost
1,849,823
1,487,388
Less: accumulated depreciation
(758,157)
(490,012)
Sub-total
1,091,666
997,376
Furniture and fittings
At cost
92,293
45,603
Less: accumulated depreciation
(35,639)
(26,387)
Sub-total
56,654
19,216
Leasehold improvements
At cost
1,987,000
1,888,048
Less: accumulated amortisation
(1,044,425)
(886,779)
Sub-total
942,575
1,001,269
Total property, plant and equipment
6,982,337
2,017,861
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.
Consolidated Entity
Land
Building
Plant And
Equipment
Furniture And
Fittings
Leasehold
Improvements
Total
$
$
$
$
Carrying amount at 30 June 2022
-
-
946,245
19,360
575,097
1,540,702
Additions
-
-
197,898
3,668
634,675
836,241
Disposals
-
-
-
-
-
-
Depreciation written back on disposals
-
-
-
-
-
-
Depreciations expense
-
-
(146,767)
(3,812)
(208,503)
(359,082)
Carrying amount at 30 June 2023
-
-
997,376
19,216
1,001,269
2,017,861
Additions
347,744
4,620,025
379,071
46,690
98,951
5,492,481
Disposals
-
-
(16,635)
-
-
(16,635)
Depreciation written back on disposals
-
-
14,133
-
-
14,133
Depreciations expense
-
(76,327)
(282,279)
(9,252)
(157,645)
(525,503)
Carrying amount at 30 June 2024
347,744 4,543,698
1,091,666
56,654
942,575
6,982,337
CLINUVEL PHARMACEUTICALS LTD
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7. Right-of-Use Assets and Lease Liabilities
Consolidated Entity
2024
2023
$
$
Right-of-use assets
At cost
1,762,660
1,782,946
Less: accumulated depreciation
(1,024,872)
(949,620)
Total right-of-use assets
737,788
833,326
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
$
Carrying amount at 30 June 2022
1,159,642
Additions
7,052
Amortisation
(343,642)
Currency translation differences
10,274
Carrying amount at 30 June 2023
833,326
Additions
284,945
Disposals
(52,682)
Amortisation
(331,932)
Currency translation differences
4,131
Carrying amount at 30 June 2024
737,788
Consolidated Entity
2024
2023
$
$
Lease liabilities
Lease liabilities - Current
369,861
300,843
Lease liabilities - Non-current
509,923
699,022
Total lease liabilities
879,784
999,865
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 6.26 % in 2024 and 6.4% in 2023.
8. Interests in Subsidiaries
Name of Entity
Type of Entity
Ownership Interest
Country of Incorporation
2024
2023
Parent entity
CLINUVEL PHARMACEUTICALS LTD Body Corporate
-
-
Australia
Controlled entities
A.C.N. 108 768 896 PTY LTD
Body Corporate
100%
100%
Australia
CLINUVEL (UK) LTD
Body Corporate
100%
100%
United Kingdom
CLINUVEL, INC.
Body Corporate
100%
100%
United States of America
CLINUVEL AG
Body Corporate
100%
100%
Switzerland
CLINUVEL SINGAPORE PTE LTD
Body Corporate
100%
100%
Singapore
VALLAURIX PTE LTD
Body Corporate
100%
100%
Singapore
CLINUVEL EUROPE LIMITED
Body Corporate
100%
100%
Ireland
VALLAURIX MC SARL
Body Corporate
100%
100%
Monaco
9. Trade and Other Payables
Consolidated Entity
2024
2023
$
$
Current
Unsecured trade creditors
2,345,436
2,791,672
Sundry creditors and accrued expenses
4,763,617
4,857,900
Total
7,109,053
7,649,572
(a) Aggregate amounts payable to:
Directors and Director-related entities
952,653
910,574
(b) Australian dollar equivalents of amounts payable in foreign currencies not effectively hedged and included in Trade and Sundry
creditors:
British Pounds
85,880
-
Canadian dollars
3,750
16,791
Other
603
-
Total
90,233
16,791
For an analysis of the sensitivity of trade and other payables to foreign currency risk refer to Note 20. (c) Terms and conditions: Trade and sundry creditors are non-interest bearing and
normally settled on 30 day terms.
10. Provisions
Consolidated Entity
2024
2023
$
$
Current
Employee benefits
1,881,898
1,450,120
Total
1,881,898
1,450,120
Non-current
Employee benefits
84,721
56,573
Other provisions
79,238
74,589
Total
163,959
131,162
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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133
11. Contributed Equity
(a) Issued And Paid Up Capital
Consolidated Entity
2024
2023
$
$
50,077,780 fully paid ordinary shares (2023: 49,410,338)
168,802,368
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
Consolidated Entity
2024
2023
No.
$
No.
$
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
716,932
17,707,229
-
-
Share buy back1
(49,490)
(754,236)
-
-
Less: transaction costs
-
-
-
-
Balance at the end of the financial year
50,077,780
168,802,368 49,410,338 151,849,375
1 During the year ended 30 June 2024, shares purchased under the share buy back program were cancelled.
(c) Conditional Performance Rights
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$
716,932
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$
266,332
12. Reserves
Consolidated Entity
2024
2023
$
$
Conditional Performance Rights reserve:
Balance at the beginning of period
19,370,046
10,380,258
Share-based payment
6,107,272
8,989,788
Transfer to share capital
(17,707,229)
-
Lapsed, forfeited rights
(6,571,771)
-
Balance at the end of period
1,198,318
19,370,046
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
3,185,998
1,731,838
Translating foreign subsidiary to current rate at reporting date
(138,945)
1,454,160
Balance at the end of period
3,047,053
3,185,998
Total reserves
4,245,371
22,556,044
13. Short-Term Lease Commitments
Consolidated Entity
2024
2023
$
$
Operating lease commitments
Non-cancellable operating leases contracted for but not capitalised under AASB 16 as
they are short-term and are payable as follows:
not later than 1 year
66,942
43,207
later than 1 year but not later than 5 years
-
1,350
Total
66,942
44,557
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.
14. Earnings Per Share (EPS)
Consolidated Entity
2024
2023
$
$
(a) Basic earnings per share (cents per share)
71.5
61.9
(a) Diluted earnings per share (cents per share)
69.8
59.1
(b) The Weighted Average Number of Ordinary Shares (WANOS) used in the
calculation of basic earnings per share
49,834,035
49,410,338
(b) Weighted average number of performance rights on issue in respect of share
based payments during the year
1,192,679
2,405,659
(b) The Weighted Average Number of Ordinary Shares (WANOS) used in the
calculation of diluted earnings per share
51,026,713
51,815,997
(c) The numerator used in the calculation of basic earnings per share ($)
35,636,359
30,604,566
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.
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
134
135
15. Cash Flow Information
Consolidated Entity
2024
2023 Restated
$
$
(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 Statement of Financial Position as follows:
Cash at bank
18,102,718
22,883,205
Cash on hand
1,818
774
Deposits on call
16,874,047
617,759
Term deposits
-
8,025,800
Security bonds
222,168
365,483
Total cash and cash equivalents
35,200,751
31,893,021
(b) Reconciliation of cash flows from operating activities with operating profit (loss)
Operating profit after income tax
35,636,359
30,604,566
Non cash flows in operating profit after income tax:
Executive share option expense
6,107,272
8,989,788
Exchange rate effect on foreign currencies held
808,148
(1,659,855)
Depreciation expense on property, plant & equipment
753,184
397,260
Amortisation expense on right-of-use assets
331,932
343,642
Unrealised loss (gain) on foreign exchange translation
(138,945)
1,454,160
Changes in assets and liabilities:
(Increase)/decrease in receivables
(4,023,652)
(6,012,709)
(Increase)/decrease in inventories
(1,107,151)
(7,687,571)
(Increase)/decrease in other current assets
(260,308)
(30,700)
(Increase)/decrease in deferred tax assets
39,197
(577,941)
(Increase)/decrease in lease bonds
(134,208)
-
Increase/(decrease) in payables
(648,316)
4,514,552
Increase/(decrease) in income tax payables
(242,793)
8,814,729
Increase/(decrease) in provisions
464,574
(1,380,093)
Increase/(decrease) in deferred tax liabilities
(531,411)
(857,765)
Net cash used in operating activities
37,053,882
36,912,063
Cash at bank earns floating rates based on daily bank deposit rates. The carrying amounts of cash and cash equivalents represent fair value.
16. Key Management Personnel
Consolidated Entity
2024
2023
$
$
Short-term employee benefits
4,123,825
3,962,471
Post-employment benefits
72,306
65,787
Long-term benefits
30,736
-
Share-based payments
3,399,126
6,583,359
Total
7,625,993
10,611,617
No loans or other transactions existed with key management personnel.
17. Auditor’s Remuneration
Consolidated Entity
2024
2023
$
$
Amounts received or due and receivable by Grant Thornton Audit Pty Ltd for:
Audit services and review
249,126
246,154
Total
249,126
246,154
18. 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 2024 is $Nil (2023: $Nil).
The loan receivable by CLINUVEL PHARMACEUTICALS LTD from CLINUVEL, INC. is interest bearing at average of 5.81% in 2024
and was 4.6% in 2023. 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 2024 is $20,499,042 (2023: $21,681,805).
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 2023
financial 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 2024 is $91,828 (2023: $188,531).
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 2024 is $503,705 (2023: $625,133).
The loan receivable by CLINUVEL PHARMACEUTICALS LTD from CLINUVEL (UK) is interest bearing at average of 5.81% in 2024
and was 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 2024 is $3,753,911 (2023: $2,053,783).
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 2024 is $13,333,126 (2023: $10,475,621).
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 VALLAURIX MC SARL as at 30 June 2024 is $5,208,319 (2023: $6,339,501).
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 2024 is $9,205,322 (2023: $9,675,165).
Foundation
The Photomedicine Foundation (Foundation), a Not For Profit entity, was incorporated on 7 February 2024 under the State of
California USA. The purpose of the Foundation is to support individuals affected by ultraviolet and visible light through access
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
136
137
to equipment, medical care, treatments or other means to improve the individual’s health. The Foundation is currently
dormant and not actively engaged in any activities.
Director Related And Key Management Personnel Transactions And Entities:
There are no loan transactions and relationships in existence as at 30 June 2024 between Directors and the Company and its
related entities.
19. Segment Information
A segment is a component of the Group 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 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 Group operates in a single operating segment, being the biopharmaceutical sector, and the majority of its
activities are concentrated on researching, developing and commercialising a sole asset, being its leading drug candidate.
Accordingly, 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
above. The Group has one operating segment within the definition of AASB 8 Operating Segments.
The Group’s revenue disaggregated by primary geographical markets is as follows:
FY2024
FY2023
Europe & USA
Switzerland,
Others
Total
Europe & USA
Switzerland,
Others
Total
($’000)
($’000)
($’000)
($’000)
($’000)
($’000)
Commercial sales of goods
81,218
-
81,218
72,179
-
72,179
Sales reimbursements
265
6,695
6,960
104
6,038
6,142
Total revenues
81,483
6,695
88,178
72,283
6,038
78,321
Total expenses
(44,627)
(37,412)
Net profit before tax
50,679
45,579
Income tax
(15,043)
(14,974)
Net profit after tax
35,636
30,605
Total asset
231,124
193,714
Total liability
28,112
29,082
The Group has a number of customers to which it provides its leading drug candidate. Two customers each comprise 12% of
external total revenue (2023: Two customers each comprise 15% and 13% of external total revenue).
20. 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 2024 and as at 30 June 2023.
The Consolidated Entities Exposure To Foreign Currency Risk At 30 June 2024
Consolidated Entity
2024
2023 Restated
Cash and Cash
Equivalents
Cash Held
In Term
Deposits
Trade
Debtors
and Other
Assets
Trade, Other
Payables and
Provisions
TOTAL
Cash and
Cash
Equivalents
Cash Held
In Term
Deposits
Trade
Debtors
and Other
Assets
Trade,
Other
Payables
and
Provisions
TOTAL
USD
1,600,443
20,000,000
9,213,442
(1,588,919)
29,224,966
3,516,211
8,500,000
7,719,647
(2,249,199)
17,486,659
EUR
4,907,251
-
6,755,698
(2,458,873)
9,204,076
7,658,588
2,000,000
5,157,824
(2,403,905)
12,412,507
SEK
-
-
971,172
-
971,172
-
-
-
-
-
CHF
1,016,656
-
28,451
(122,923)
922,184
1,406,750
-
-
(93,231)
1,313,519
SGD
527,674
-
155,324
(272,159)
410,839
558,588
-
-
(241,557)
317,031
GBP
376,258
-
211,781
(574,237)
13,802
1,184,729
-
-
(396,064)
788,665
CAD
-
-
-
(3,433)
(3,433)
-
-
-
(14,744)
(14,744)
BRL
-
-
-
(2,114)
(2,114)
-
-
-
-
-
ILS
-
-
-
(89)
(89)
-
-
-
-
-
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 2.2% appreciation of the Australian dollar against the Euro currency would have decreased
profit and loss and equity by $622,563 for the year ended 30 June 2024 (2023: $2,147,985 decrease), on the basis that all other
variables remain constant. 2.2 % 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.
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
138
139
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 2024, 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 $5,234,216 higher/lower (2023: $4,564,433 higher/lower).
This analysis assumes all other variables are held constant.
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.
b) Credit Risk
Credit risk arises from the potential failure of counterparties to meet their contractual obligations, resulting in a loss to the
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
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 2024
Consolidated Entity
2024
2023
$
$
Trade and other payables
Carrying amount
7,109,053
7,649,572
6 months or less
7,082,494
7,645,178
Greater than 6 months
26,559
4,394
Total
7,109,053
7,649,572
Lease liabilities
Carrying amount
879,784
999,865
6 months or less
178,694
161,018
Greater than 6 months
701,090
838,847
Total
879,784
999,865
Capital Risk Management
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 Canada 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.
Contractual Maturities Of Financial Assets As At 30 June 2024
Consolidated Entity
2024
2023 Restated
$
$
Cash and cash equivalents
Carrying amount
35,200,751
31,893,021
6 months or less
35,200,751
31,893,021
Total
35,200,751
31,893,021
Cash held in term deposits
Carrying amount
148,667,720
124,920,516
6 months or less
65,125,316
77,320,516
Greater than 6 months
83,542,404
47,600,000
Total
148,667,720
124,920,516
Other financial assets (includes trade and other receivables)
Carrying amount
26,238,297
22,214,646
6 months or less
25,799,352
20,959,240
Greater than 6 months
438,945
1,255,406
Total
26,238,297
22,214,646
Cash at bank and cash held in term deposits 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.
21. 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
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
140
141
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 Directors requires
shareholder approval in accordance with ASX Listing Rules. Any issue of rights to Directors requires shareholder approval in
accordance with ASX Listing Rules. Since 2020, the Company policy is for NED to not receive PRs or other equity securities in
the Company. All rights 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 PRs be acquired by a Plan Trustee and then, from time to time, transferred to participants
to the Performance Rights Plan. Unless the PRs are granted with a shorter vesting period, PRs under this plan lapse after
seven years from grant date.
PRs 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 PRs may or may not receive a benefit from these amounts, either in the current or future reporting periods. The
value of all PRs granted, exercised and lapsed during the financial year is detailed in tables within this Remuneration Report.
Of the 2,591,860 Performance Rights on issue on 1 July 2023 which had been previously issued under the 2014 Performance
Rights Plan to both KMP and non-KMP employees, 716,932 (27.6%) PRs were deemed to have achieved the performance
conditions by the 20 November 2023 vesting date and were exercised. 1,611,678 (72.4%) performance rights were deemed to
have not achieved the performance criteria by the vesting date and lapsed.
At the Company’s Annual General Meeting held on 31st October 2023, shareholder approved the renewal of the 2014
Performance Rights Plan for a further 3 years. Under the renewed plan, up to a maximum of 2.25% of the Company’s issued
share capital may be issued as new Performance Rights, though this maximum number is not intended to be a prediction of
the actual number of securities to be issued by the Company under the Plan.
As at 30 June 2024, 237,250 performance rights issued under the 2014 Performance Right Plan remain outstanding, of which
and estimated 200,854 of the PRs (85%) are likely to achieve the underlying performance condition but will not vest until the
end of their respecting vesting dates if the employee is still employed at that time by the Company.
The Company, via its wholly owned subsidiary A.C.N. 108 768 896 Pty Ltd, previously acted as trustee for the 2009 Scheme
Trust and the 2014 Plan Trust. The entity currently holds NIL shares (2023: NIL shares).
The Following Share-Based Payment Arrangements Were In Existence At 30 June 2024
Performance Rights Series
Number
Grant date
Expiry Date
Exercise
Price
Fair Value at Grant Date
Issued
16/09/2011
29,082
16/09/2011
The earlier of achievement of
specific performance milestones
and cessation of employment/
directorship
$ Nil
Between $0.55 and $0.72
Issued
5/05/2022
7,500
5/05/2022
20/12/2024
$ Nil
$12.87
Issued
29/06/2023
94,500
29/06/2023
30/06/2025
$ Nil
Between $9.16 & $14.26 *
Issued
29/06/2023
135,250
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 – 2024
Performance
Rights Series
Balance at
Start of Year
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
Issued 16/09/2011
38,333
-
-
(9,251)
29,082
-
29,082
Issued 26/08/2020
1,513,750
-
(301,125)
(1,212,625)
-
-
-
Issued 24/12/2020
132,500
-
(61,146)
(71,354)
-
-
-
Issued 26/08/2021
682,360
-
(354,661)
(327,699)
-
-
-
Issued 05/05/2022
7,500
-
-
-
7,500
1,250
6,250
Issued 29/06/2023
255,750
-
-
(26,000)
229,750
184,271
45,479
Total
2,630,193
-
(716,932)
(1,646,929)
266,332
185,521
80,811
Weighted average
exercise price
$Nil
$Nil
$Nil
$Nil
$Nil
$Nil
$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.
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
142
143
Holdings Of All Issued Conditional Performance Rights – 2023
Performance
Rights Series
Balance at
Start of Year
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
Issued 16/09/2011
38,333
-
-
-
38,333
-
38,333
Issued 26/08/2020
1,513,750
-
-
-
1,513,750
227,000
1,286,750
Issued 24/12/2020
132,500
-
-
-
132,500
35,341
97,159
Issued 26/08/2021
731,924
-
-
(49,564)
682,360
156,090
526,270
Issued 05/05/2022
22,500
-
-
(15,000)
7,500
-
7,500
Issued 29/06/2023
-
255,750
-
-
255,750
-
255,750
Total
2,439,007
255,750
-
(64,564)
2,630,193
418,431
2,211,762
Weighted average
exercise price
$Nil
$Nil
$Nil
$Nil
$Nil
$Nil
$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.
22. CLINUVEL PHARMACEUTICALS LTD
Parent Company Information
CLINUVEL PHARMACEUTICALS LTD
2024
2023
$
$
Assets
Current assets
184,283,878
152,351,411
Non-current assets
55,207,108
47,683,856
Total assets
239,490,986
200,035,267
Liabilities
Current liabilities
18,960,091
19,899,692
Non-current liabilities
2,420,996
2,785,053
Total liabilities
21,381,087
22,684,745
Equity
Issued equity
168,802,380
151,849,375
Share–based payments reserve
1,198,628
19,370,046
Accumulated losses
48,108,891
6,131,101
Total equity
218,109,899
177,350,522
Financial performance
Net profit for the year
39,507,563
32,720,668
Total comprehensive income
39,507,563
32,720,668
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
The Parent entity did not have any material contingent liabilities as at 30 June 2024 and 2023.
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 2024 and 2023.
23. 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 2024, the Board of Directors declared a fully franked dividend of $0.05 per ordinary share; and
24. Additional Company Information
CLINUVEL PHARMACEUTICALS LTD is a listed public company incorporated and operating in Australia.
The Registered office is:
Level 22, 535 Bourke Street
Melbourne VIC 3000
Ph: (03) 9660 4900
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
144
145
Consolidated Entity Disclosure Statement as at 30 June 2024
The Australian Government passed a Treasury Laws Amendment (Making Multinationals Pay Their Fair Share – Integrity and
Transparency) Act 2024 such that the Corporations Act now requires Australian public companies to disclose the following
information regarding each of its subsidiary entities in the annual financial reports for financial year commencing on or after
1 July 2023:
Name of Entity
Type of Entity
Trustee
Partner
or Participant
in JV
% of Share
Capital
Place of business/
Country of
incorporation
Australian
resident or foreign
resident
Foreign
jurisdiction(s) of
foreign residents
Parent entity
CLINUVEL PHARMACEUTICALS LTD
Body Corporate
-
100%
Australia
Australia
Australia
Controlled entities
A.C.N. 108 768 896 PTY LTD
Body Corporate
-
100%
Australia
Australia
Australia
CLINUVEL (UK) LTD
Body Corporate
-
100%
United Kingdom
Foreign
United Kingdom
CLINUVEL, INC.
Body Corporate
-
100%
United States
of America
Foreign
United States
of America
CLINUVEL AG
Body Corporate
-
100%
Switzerland
Foreign
Switzerland
CLINUVEL SINGAPORE PTE LTD
Body Corporate
-
100%
Singapore
Foreign
Singapore
VALLAURIX PTE LTD
Body Corporate
-
100%
Singapore
Foreign
Singapore
CLINUVEL EUROPE LIMITED
Body Corporate
-
100%
Ireland
Foreign
Ireland
VALLAURIX MC SARL
Body Corporate
-
100%
Monaco
Foreign
Monaco
Consolidated Entity Disclosure Statement – Basis of preparation
Basis of Preparation
This Consolidated Entity Disclosure Statement (CEDS) has been prepared in accordance with the Corporations Act 2001 and
includes required information for each entity that was part of the consolidated entity as at the end of the financial year.
Consolidated entity
This CEDS includes only those entities consolidated as at the end of the financial year in accordance with AASB 10
Consolidated Financial Statements (AASB10).
Determination of Tax Residency
Section 295 (3A) of the Corporations Act 2001 defines tax residency as having the meaning in the Income Tax Assessment Act
1997. The determination of tax residency involves judgment as there are currently several different interpretations that could
be adopted, and which could give rise to a different conclusion on residency.
In determining tax residency, the consolidated entity has applied the following interpretations:
• Australian tax residency
The consolidated entity has applied current legislation and judicial precedent, including having regard to the Tax
Commisioner’s public guidance.
• Foreign tax residency
Where necessary, the consolidated entity has used independent tax advisers in foreign jurisdictions to assist in its
determination of tax residency to ensure applicable foreign tax legislation has been complied with.
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 2024 and of its performance for
the year ended on that date;
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.
3) the audited remuneration disclosures set out in pages 87 to 114 of the Directors’ Report comply with Section 300A of the
Corporations Act 2001.
4) 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.
5) the consolidated entity disclosure statement on page 146 is true and correct.
The Company was not party to any such proceedings during the year.
Dr. Philippe Wolgen, MBA, MD
Director
Dated this 29th day of August, 2024
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
146
147
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
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.
Independent Auditor’s Report
To the Members of Clinuvel Pharmaceuticals Limited
Report on the audit of the financial report
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.
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 2024, 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 material accounting policy information, the consolidated entity
disclosure statement and the directors’ declaration.
In our opinion, the accompanying financial report of the Group is in accordance with the Corporations Act
2001, including:
a
giving a true and fair view of the Group’s financial position as at 30 June 2024 and of its performance
for the year ended on that date; and
b
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.
Grant Thornton Audit Pty Ltd
Key audit matter
How our audit addressed the key audit matter
Share-Based Payments (Note 21)
The Group has material share-based payment
arrangements in place for key management and
employees, with the expense for the year being
$6,107,272 (2023: $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 Share-Based Payments, 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.
Our procedures included, amongst others:
For newly issued performance rights:
•
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;
•
Utilising our internal valuation specialist to
review the valuation performed by
management’s expert;
•
Reviewing management’s determination of fair
value of the share-based payments issued,
considering the appropriateness of the
valuation model used and assessing the
valuation inputs; and
•
Holding discussions with management to
understand the share-based payment
arrangements in place.
For both newly issued and existing performance rights:
•
Evaluating management’s assessment of the
likelihood of meeting the performance
conditions attached to the share-based
payments;
•
Assessing the allocation of the share-based
payment expense over the relevant vesting
period (and the appropriateness of the vesting
period);
•
Evaluating management’s forecasts to validate
consistency of vesting dates for performance
milestones;
•
Determining whether performance rights
cancelled or lapsed during the year have been
correctly accounted for; 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 2024 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.
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.
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
148
149
Grant Thornton Audit Pty Ltd
Responsibilities of the Directors for the financial report
The directors of the Company are responsible for the preparation of:
a) the financial report that gives a true and fair view in accordance with Australian Accounting Standards
and the Corporations Act 2001 (other than the consolidated entity disclosure statement); and
b) the consolidated entity disclosure statement that is true and correct in accordance with the Corporations
Act 2001, and
for such internal control as the directors determine is necessary to enable the preparation of:
i. the financial report that gives a true and fair view and is free from material misstatement, whether due to
fraud or error; and
ii. the consolidated entity disclosure statement that is true and correct and is free of 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
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
Chartered Accountants
M A Cunningham
Partner – Audit & Assurance
Melbourne, 29 August 2024
Opinion on the remuneration report
We have audited the Remuneration Report included in pages 87 to 114 of the Directors’ report for the year
ended 30 June 2024.
In our opinion, the Remuneration Report of Clinuvel Pharmaceuticals Limited, for the year 30 June 2024
complies with section 300A of the Corporations Act 2001.
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
www.grantthornton.com.au
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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 2024, I declare that, to the best of my knowledge
and belief, there have been:
a
no contraventions of the auditor independence requirements of the Corporations Act 2001 in relation to the
audit; and
b
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 2024
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
150
151
SHAREHOLDER
INFORMATION
AS AT 15 AU G UST 20 24
Additional information as at 15 August 2024 required by the Australian Securities
Exchange not shown elsewhere in this report is as follows:
1 – SHA REHOLDIN G
a. DISTRIBUTION OF SHAREHOLDER NUMBERS
Ordinary fully paid shares
Category (size of holding)
Total holders
Units
% Of issued capital
1-1,000
4,282
1,273,323
2.54
1,001-5,000
1,024
2,336,641
4.67
5,001-10,000
160
1,188,167
2.37
10,001-100,000
170
4,316,697
8.62
100,001 & Over
26
40,962,952
81.80
Total
5,662
50,077,780
100.00
b. SHAREHOLDINGS HELD IN LESS THAN MARKETABLE PARCELS
Total
Minimum parcel size
Holders
Units
Minimum $500.00 parcel at $13.96 per unit
36
627
11,049
c. SUBSTANTIAL SHAREHOLDINGS
Name
No. Ordinary shares & American Depository Receipts
The Bank of New York Mellon Corporation1
4,296,472
Dr Philippe Wolgen2
3,425,222
Ender 1 LLC3
2,340,824
1. As disclosed in substantial holder notice dated 24 May 2022.
2. As disclosed in director's interest notice dated 27 November 2023. Actual shareholding on 15 August 2024 is 3,425,222.
3. As disclosed in substantial holder notice dated 16 September 2013. Actual shareholding on 15 August 2024 is 2,590,824.
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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153
2 – COM PA N Y SECRETA RY
The name of the Company Secretary is:
Claire Newstead-Sinclair
3 – REGISTERED OFFICE
The principle registered office in Australia is:
Level 22, 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 SECU RITIES
Computershare Investor Services Pty Ltd
Yarra Falls, 453 Johnston St, Abbotsford,
VIC 3067, Australia
Telephone: +61 3 9415 4000
5 – AUSTRA LIA N SECU RITIES
EXCHA N GE 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 is equivalent to one ordinary share of the
Company, as traded on the ASX. The Bank of New York
Mellon is the depositary bank.
6 – RESTRICTED SECU RITIES
Restricted securities on issue at 30 June, 2024:
Nil.
7 – DIRECTORY
Non-Executive Chair
Prof. Jeffrey Rosenfeld.
Non-Executive Directors
Brenda Shanahan, Dr Karen Agersborg, Susan Smith.
Managing Director And Chief Executive Officer
Dr Philippe Wolgen.
Chief Scientific Officer
Dr Dennis Wright.
Chief Financial Officer
Peter Vaughan.
Auditor
Grant Thornton Audit Pty Ltd
Collins Square, Tower 5, Level 22,
727 Collins Street, Melbourne,
VIC 3008, Australia
Bankers
National Australia Bank (NAB)
Western Branch, 460 Collins St,
Melbourne, VIC 3000, Australia
J. P. Morgan Chase & Co. (JPM)
85 Castlereagh Street, Sydney,
NSW 2000, 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
Baadestr 3, Munich 80, Germany
8 – A N N UA L GEN ERA L MEET IN G
CLINUVEL PHARMACEUTICALS LTD (“Company”) provides
notice for its 2024 Annual General Meeting (AGM) of
shareholders, which is scheduled to take place on
Wednesday 16 October 2024 commencing at 10.00 am
(AEDT).
The Notice of Meeting will be lodged with the ASX no later
than Friday 13 September 2024. Details in relation to the
AGM, including shareholder participation, will be included in
the Notice of Meeting and accompanying materials.
In accordance with ASX Listing Rule 3.13.1, the Closing Date for
receipt of Director nominations is Thursday 5 September 2024.
d. VOTING RIGHTS
The voting rights attaching to each class of equity securities are set out below:
Ordinary shares: Ordinary shares entitle their holder to one vote, either in person or by proxy, at a meeting of the Company.
Performance rights: Performance Rights have no voting rights.
e. LARGEST SHAREHOLDERS
Position
Name
Number of ordinary
fully paid shares held
% held of issued
ordinary capital
1.
HSBC Custody Nominees (Australia) Ltd
10,225,972
20.42
2.
BNP Paribas Nominees Pty Ltd ACF (Clearstream)
5,685,193
11.35
3.
BNP Paribas Nominees Pty Ltd
4,988,645
9.96
4.
J P Morgan Nominees Australia Pty Limited
3,629,550
7.25
5.
Dr Philippe Jacques Wolgen
3,425,222
6.84
6.
Citicorp Nominees Pty Limited
3,416,310
6.82
7.
Ender 1 LLC
2,590,824
5.17
8.
BNP Paribas Nominees Pty Ltd (IB AU Noms Retail Client)
2,207,904
4.41
9.
HSBC Custody Nominees (Australia) Ltd A/C2
922,480
1.84
10.
Emilino Group Pty Ltd (Emilino Super Fund)
601,447
1.20
11.
National Nominees Limited
548,778
1.10
12.
Mr Darren Michael Keamy
362,890
0.72
13.
Dr Mark Edwin Badcock
346,772
0.69
14.
Mr David William Trevorrow
229,600
0.46
15.
BNP Paribas Nominees Pty Ltd (Agency Lending A/C)
229,044
0.46
16.
Dr Dennis Wright
188,812
0.38
17.
Mr David John Lewis
185,000
0.37
18.
Mr Trent Sheldon Redding
177,370
0.35
19.
Rusty Hammer Pty Ltd (Archipelago Holdings SF A/C)
150,722
0.30
20.
Mr Simon John Bown
146,000
0.29
Totals: Top 20 holders of ordinary fully paid shares (total)
40,258,535
80.39
Total remaining holders balance
9,819,245
19.61
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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155
2023
2024
JUL
AUG
SEP
OCT
NOV
DEC
JAN
FEB
MAR
APR
MAY
JUN
5
10
15
20
25
30
ASX:CUV – Share Price (A$)
200,000
300,000
400,000
600,000
500,000
2023
2024
JUL
AUG
SEP
OCT
NOV
DEC
JAN
FEB
MAR
APR
MAY
JUN
ASX:CUV – Daily Trading Volume (No.)
MARKET
PERFORMANCE
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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157
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.
GLOSSARY
Alpha-melanocyte stimulating
hormone (α-MSH)
A peptide hormone which activates
or stimulates the production and
release of (eu)melanin in the skin
(melanogenesis).
Dermatocosmetics
Specially formulated products
designed to assist skin health
with a focus on anti-ageing, 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 medical
drugs and devices.
Eumelanin
A black or brown pigment mainly
concerned with the protection of
the skin by absorbing incoming UV
radiation. This protective ability
warrants melanin to be termed a
photoprotectant (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.
High Energy Visible (HEV) light
A particularly high-frequency, high-
energy light in the blue/violet band,
ranging from 400 nm to 480 nm in the
visible light spectrum. HEV generates
oxidative stress, accelerates skin ageing
and increases hyperpigmentation.
Melanin
The dark pigment synthesised by
melanocytes; responsible for skin
pigmentation.
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 hormone
(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) seven-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.
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 demonstrate
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 availability 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 artificial
photoprotection.
CLINUVEL PHARMACEUTICALS LTD
ANNUAL REPORT 2024
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“Each new situation requires
a new architecture.”
Jean Nouvel
CLINUVEL PHARMACEUTICALS LTD
160
CLIN UV EL. COM
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