CLINUVEL
Pharmaceuticals
Annual Report 2021
CLINUVEL Pharmaceuticals | 2021 Annual Report
Targeted
Technology
Translation
As 2005 drew to a close, avenues were limited and prospects were at
a bare minimum; this point in time marks the birth of CLINUVEL, the
Company as we know it today. Twenty-five years wasted on execution
and intellectual property; a new reset was needed.
Fast forward, and the October 2019 approval of SCENESSE®
(afamelanotide 16mg) by the US Food and Drug Administration
(FDA) has been a catalyst to ‘unlock the door’ for CLINUVEL to
justify expansion of its research and development (R&D) programs
in melanocortins. The regulatory endorsement of the concept of
systemic photoprotection and use of melanocortins has followed
decades of unsuccessful attempts. The emphasis on the safety of
SCENESSE® provides the basis to translate CLINUVEL’s technology to
multiple technologies, new formulations, and new indications.
The 2021 financial year saw an expansion in R&D as part of the overall
strategy to make CLINUVEL’s proven technology available for more
patients with unmet medical needs, as well as broader targeted groups
at high risk from exposure to ultraviolet and high energy visible light.
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Key Events 2021 ������������������������������������������������������������������� 2
Financial Highlights 2021 ������������������������������������������������������������� 4
Mission, Vision & Values �������������������������������������������������������������� 8
Chair’s Letter ��������������������������������������������������������������������� 12
Managing Director’s Letter ������������������������������������������������������������ 16
The ‘Door’ Opens ������������������������������������������������������������������ 24
Divisional Expansion ��������������������������������������������������������������� 28
Growth of Commercial Operations ������������������������������������������������������ 30
Targeted Technology Translation ������������������������������������������������������� 32
Healthcare Solutions ��������������������������������������������������������������� 36
Directors’ Report ������������������������������������������������������������������ 42
Remuneration Report ��������������������������������������������������������������� 66
Statement of Comprehensive Income ���������������������������������������������������� 92
Statement of Financial Position �������������������������������������������������������� 93
Statement of Cash Flows ������������������������������������������������������������ 94
Statement of Changes in Equity �������������������������������������������������������� 95
Notes to the Financial Statements ������������������������������������������������������ 96
Directors’ Declaration �������������������������������������������������������������� 126
Independent Auditor’s Report �������������������������������������������������������� 127
Shareholder Information ������������������������������������������������������������ 131
Market Performance �������������������������������������������������������������� 134
Glossary ���������������������������������������������������������������������� 136
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CLINUVEL Pharmaceuticals | 2021 Annual Report Key Events
2021
Constructing CLINUVEL’s Future:
the Next Phase
The past year witnessed multiple key events
in CLINUVEL’s commercial operations,
research and development program,
Since the end of the financial year, and
financial performance, communications
in addition to the 2021 financial results
and analyst coverage, and advanced
and dividend announced in August 2021,
strategy which collectively, are forming
we have achieved further progress in the
the future of the Group.
R&D program.
Continued Strong Financial Performance
Annual Profit Delivered
4th
Annual Dividend Declared
5th
Annual Positive Cashflow
Wider Engagement
with the Investor
Community
Jefferies Australia Initiates Research Coverage of CUV
First Virtual AGM
Operations Update Webinar I
Wilsons Initiates Research Coverage of CUV
Strategic Update I
Strategic Update II
Chair’s Interview Series
2
CLINUVEL Pharmaceuticals | 2021 Annual Report Growth of CLINUVEL
Four Divisions Announced
Pharmaceuticals
Manufacturing
Healthcare
Solutions
Communications,
Branding & Marketing
Australian TGA
Approves SCENESSE® for EPP
Research, Development
& Innovation Centre
SCENESSE® Granted
Market Access Israel
First Full Year of Distribution
of SCENESSE® in the USA
Exp a n d i n g R&D
PRENUMBRA® Second Afamelanotide Formulation
Opening of VALLAURIX RD&I Facility in Singapore
DNA Repair Program Announced
First XP Patient Dosed in DNA Repair Program
First Global Human Trial in an XP-C Patient, Evaluating the Effects on DNA Repair
Arterial Ischaemic Stroke Program Announced
SCENESSE® in DNA Repair Approved for Healthy Volunteers
DNA Repair Program Extended to XP-V Variant Patients
First Stroke Patient Treated with Afamelanotide
Advancement OTC Product Lines
3
Enabling Patientsto AccessTreatmentCLINUVEL Pharmaceuticals | 2021 Annual Report Financial
Highlights
2021
Cash & Cash Equivalents (A$m)
Assets & Liabilities (A$m)
110
90
70
50
30
10
2017
2018
2019
2020
2021
2017
2018
2019
2020
2021
Revenue & Expenses (A$m)
50
40
30
20
10
-10
-20
-30
2017
2018
2019
2020
2021
80
60
40
20
0
4
CLINUVEL Pharmaceuticals | 2021 Annual Report Net Profit (A$m)
30
25
20
15
10
5
0
2017
2018
2019
2020
2021
Strong Foundation for Growth:
Five Consecutive Years of Positive Cash and Profit
Commercial operations commenced in June 2016
in 2020 to support key growth initiatives with an
with the first post-authorisation distribution of
SCENESSE® in Europe. CLINUVEL’s direct distribution
model has been implemented effectively with cautious
abatement of growth in 2021 due to the timing of
planned expenditures on the expansion of the research
and development program. A net profit for the fifth
cost control. We have established a track record of
consecutive year in a difficult operating environment
positive cash flow and profitable outcomes over five
points to the sustainability of commercial operations.
consecutive years to provide a strong foundation to
support the growth and sustainability of the Group.
Assets have grown strongly with the accumulation of
cash reserves sufficient to finance planned organic
Revenues have grown over the last five years with
growth. Liabilities are at a minimum and are composed
the start of sales in the USA reflected in the 2021
of trade payables and leases of operating assets.
outcome. Expenses have been well controlled, rising
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CLINUVEL Pharmaceuticals | 2021 Annual Report Key Indicators FY 2021
Return on Equity 25%
Net increase
in cash held
A$16.9m
Current
ratio 11.8x
EPS A$ 0.50
KEY INDICATORS
CLINUVEL’s liquidity is very strong due to high cash reserves
(which make up most of the current assets), relative to modest
liabilities, mainly composed of trade creditors.
Company debt is minimal, consisting of leased operating assets.
There is no long-term debt.
Due to ongoing profitability, the Company’s return on equity and
earnings per share are positive and are rising year on year.
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CLINUVEL Pharmaceuticals | 2021 Annual Report CUV Share Price & Key Indices
CUV
XJO
XHJ
NBI
130
120
110
100
90
80
70
Jun 20
Jul 20
Aug 20
Sep 20
Oct 20
Nov 20
Dec 20
Jan 21
Feb 21 Mar 21
Apr 21 May 21
Jun 21
SHARE PRICE
CUV’s share price trended downwards in the first half of the 2021 financial year.
Following the announcement of the December 2020 half year results in February 2021,
the share price rose strongly and ended the year with a rise of 19.7%. This is in line with
the 19.8% rise in the Nasdaq Biotech Index (NBI) and exceeds the 5% increase in the
S&P/ASX 200 Healthcare Index (XHJ). The broader S&P/ASX 200 Index of the largest
capitalised listed companies in Australia rose 24% in the 2021 financial year.
The indices above are based as at 30 June 2020 = 100 to show their absolute and
comparative movements during the 2021 financial year.
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CLINUVEL Pharmaceuticals | 2021 Annual Report Mission
Vision
& Values
Delivering innovative
solutions for unmet patient
and healthcare needs.
8
VISIONVALUESMISSIONCLINUVEL Pharmaceuticals | 2021 Annual Report The CLINUVEL Group works to translate scientific concepts
and breakthroughs into commercial products.
We are determined in our desire to excel scientific research
and development, building on our global expertise to deliver
lifelong care and novel products for patients and consumers.
The CLINUVEL Group places much emphasis on its People
and Environment as central to the Group’s working practise.
CLINUVEL focuses its research and development on
healthcare problems not yet addressed, aiming to deliver
innovative medical solutions. Our products seek to prevent
or treat acute and chronic medical conditions where no
alternatives exist.
Technology
Approach
People & Environment
Knowledge Building & Sharing
Respect & Appreciation
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VISIONVALUESMISSIONThe CLINUVEL Group works to translate scientific concepts and breakthroughs into commercial products.We are determined in our desire to excel scientific research and development, building on our global expertise to deliver lifelong care and novel products for patients and consumers.The CLINUVEL Group places much emphasis on its People and Environment as central to the Group’s working practise. CLINUVEL focuses its research and development on healthcare problems not yet addressed, aiming to deliver innovative medical solutions. Our products seek to prevent or treat acute and chronic medical conditions where no alternatives exist.CLINUVEL Pharmaceuticals | 2021 Annual Report The CLINUVEL Group pledges to
adhere to a principal set of values,
which reflect how we operate and
expand our business.
These fall into five main categories;
Technology, Approach, People
and Environment, Knowledge
Building and Sharing, and
Respect and Appreciation.
Technology
Approach
We create, develop, advance,
We aim to be innovative in our
and offer healthcare products
approach and find solutions for
which are driven by medical
unique, complex and previously
need, consumer demand and
neglected healthcare problems.
a lack of available solutions.
We are determined to remain
Our technologies aim to add
leaders in our fields of expertise
value beyond existing offerings.
and be creative and diligent in all
We acknowledge that new
our endeavours. We admit errors,
technologies require regulatory
recognise our shortfalls, evaluate,
environments to be primed
analyse and learn to implement
and markets to be prepared for
new findings. In improving
achieving widespread acceptance
ourselves we strive to enhance the
and adoption.
lives and quality of life of those
we serve. We are vigilant not to
become complacent and recognise
that success can only come from
the identification and mastering of
obstacles. Our staff are optimistic
and focused.
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CLINUVEL’s ValuesCLINUVEL Pharmaceuticals | 2021 Annual Report Technology
Approach
People &
Environment
Knowledge
Building &
Sharing
Respect &
Appreciation
People & Environment
We work for those who have no
alternatives: patients, physicians,
at-risk individuals, and our
stakeholders. We are selective 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
Knowledge Building
& Sharing
We are experts in optical physics,
the interaction of light and human
biology and acute and life-
threatening conditions. We are
proficient in our understanding of
rare disorders and skin care. 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
equality. We wish to set an example
scientific breakthroughs.
of excellence in our industry.
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.
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CLINUVEL Pharmaceuticals | 2021 Annual Report Clinuvel Pharmaceuticals | 2021 Annual Report
Chair’s Letter
Dear Shareholders,
Strategy Drives Value
CLINUVEL’s history demonstrates that a long vision will eventually lead to value for
society and shareholders.The CLINUVEL Board has long supported an often difficult
strategy to reach its goals, and the plan is just starting to unwind as new shareholders
are discovering our consistent approach to the business. I am positive that further focus
will lead to more growth and results and my task is to see that we can keep and add to
our existing team of managers. This is CLINUVEL’s story where many successes and
even some setbacks have taken us to present successes.
As Chair, my mandate is to guide the turnaround and viability of the Company, and since the strategic reset
from late 2005 our primary focus has shifted to growth and expansion of skills, services and products. As we
progressed the Company’s strategy, there were many problems that needed to be solved and many errors that
have been avoided. The successful progression of our strategic path required an entrepreneurial mindset, being
prepared to take calculated risks to benefit patients and shareholders.
As a Board, we are united by the desire to contribute to society in particular to patients who have an unmet
medical need. The commercialisation of the drug over the past five financial years and the track record of
the team has driven performance that is enviable amongst life-science companies. The Board have overseen
critical decisions taken by a committed team of professionals. Now, we find ourselves again at a decision
moment after a difficult but successful year.
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An Excellent Financial Year
The financial year ending June 2021 is a record year for total revenues and the achievement of profit under
the most demanding COVID conditions. Top revenues of A$48.451 million and profit before tax of A$25.713
million are excellent outcomes and marks the Company’s fifth consecutive year of profit and growth.
During the past financial year, the CLINUVEL team in various locations around the world have had to
communicate, co-ordinate and progress their work remotely and worked in scheduled shifts in the
laboratories. We saw an increase in the number of EPP patients receiving care and prudently managed our
supply chain to meet rising patient demand. We have advanced our research and development initiatives to
underpin the diversification and sustainability of the Company for the future. In addition, we have excelled
in capital and financial management, maintaining our share capital. We have no debt and have declared the
payment of a dividend four years in a row to again show our appreciation of shareholders, particularly those
who directly funded the development of the Company over many years.
New Divisions to Support Expanded Operations
We now maintain operations in seven countries. Operations in Australia, the United States, United Kingdom,
Switzerland, and Singapore have been enhanced by new operations in Ireland, and following Brexit most
recently, Monaco. During the year, we positioned our Company for the future with four divisions:
• Pharmaceuticals, the core of our business;
• Healthcare Solutions, for dermatocosmetic non-prescription products;
• Communications, Branding & Marketing, to communicate our activities
and reach new audiences; and
• Manufacturing, to improve our self-reliance.
These Divisions are underpinned by the Singapore based Research, Development & Innovation Centre,
commissioned in August 2020 to progress new product development opportunities for the Group.
Pipeline & Development
CLINUVEL has expanded its research and development program over the past year:
• We have commenced a clinical study in acute stroke, specifically arterial ischaemic
stroke (AIS), which has a high unmet need;
• The DNA Repair Program is underway with clinical studies in xeroderma
pigmentosum (XP) patients set to commence;
• A new topical product is under development to add to our medical product portfolio;
• We continue the development of a formulation of afamelanotide for the treatment
of children; and
• PRÉNUMBRA®, a liquid formulation of afamelanotide, is in development.
13
CLINUVEL Pharmaceuticals | 2021 Annual Report Incremental Value
Many of us have invested in CLINUVEL because we want to see something good for
particular patient groups who have no other medical choice. The pursuit of this objective has
resulted in significant incremental value to shareholders over the years and, in many ways,
FY2021 has been an important year to commence the next phase of CLINUVEL’s progress.
In staying with a specific strategy, we have seen CLINUVEL’s
market performance improve over the years. Shareholder returns
based on the change in the CUV share price are impressive.
The increase over the last five years (30 June 2016 to 30 June
2021) in CLINUVEL’s market capitalisation is 645.8%.
To continue this performance, I believe it is critical that we retain the
people who have proven their worth in building the business over the
Shareholder returns
15 years
10 years
5 years
1 year
692%
1,487%
591%
28%
years and in continuing to attract new talent. We have increased our staff significantly over
the last few years to support the expanding activities of the Group. A very high percentage
of our staff become integrated and perform at high standard. Despite some attrition with
a demanding workload, we generally select personnel with a positive attitude to winning,
consistent with CLINUVEL’s culture. The best talent requires not just a positive environment
and inspirational objectives, they also see their remuneration and incentives grow over the
years as they contribute meaningfully to the Company’s success.
CLINUVEL has taken a lead in setting incentives at the executive leadership level to
encourage entrepreneurship, measured risk taking at highest level, a behaviour close to
my heart, and one which, I believe, enables the best and most effective results. I cannot be
clearer that the retention of key personnel from the CEO and senior executives, through
to personnel of the Company at all levels, is essential for this Company to come through
the lows and achieve the highs. The Board, through the Remuneration Committee,
which I continue to lead as Chair, have reviewed and improved further the Company’s
remuneration arrangements. Together with remuneration consultants and the legal team,
we undertake annually analysis of peer groups of comparative companies resulting in the
remuneration of executive management detailed in the Remuneration Report.
We also recognise and accept as a Board that the minority voting can influence the direction
of the Company with the majority of shareholders not taking the time to vote for resolutions
proposed to them. In the worst case, the voting outcome can have an impact on the
longevity of management and the stability of the Company. During the year, the Board has
supported initiatives to communicate in more varied ways, to reach more shareholders,
and to assist a broader understanding of the Company. The Chair’s Letters, issued in
November 2020, March 2021, and May 2021, provided insights into the Company’s plans,
the role of entrepreneurship and how this links to our approach to executive retention and
remuneration. Regular and more detailed News Communiqués were issued on the progress
14
CLINUVEL Pharmaceuticals | 2021 Annual Report of the Company on its many initiatives, and these continued to be translated to German
for shareholders in Switzerland, Austria, and Germany. We also launched new initiatives in
public communications during the year to assist general understanding of the Company.
We provided shareholders the opportunity to learn about the Company through:
• An Operations Update Webinar hosted by Mr Bull of investor relations, engaging
Mr Keamy and Mr Hay on financial and operational issues;
• Strategic Updates I and II with the CEO’s video in the second update attracting much
positive comment; and
• A series of video interviews I gave in Amsterdam.
In addition to many meetings and conversations with shareholders, we also made an effort
to connect with shareholders who hold their shares through one or more custodians; time
will tell how effective this process has been.
Vision
As Chair, my role is to oversee the Company and its financial independence. I am very
pleased how the CLINUVEL team has consistently driven the progress of our strategy
and objectives, and found solutions in situations and times where there were none to
be found. We are an innovative company, and more is coming, noting that patience is
required in this industry and in the prevailing operating environment. FY2021 has shown
the resilience and sustainability of the Company’s operations, and as I said many times
the performance of the company is dependent on our managers. The Board is planning
for succession of some of our key managers and personnel so that the Company will
continue to thrive on from its current basis.
Based on the well performing and growing commercial operations and the potential
being built in the R&D pipeline, I am very optimistic for the future of CLINUVEL and the
benefit this will confer to all stakeholders, including our valued shareholders.
I thank the leadership and drive of our Managing Director, Dr Wolgen, our CSO Dr Wright
and CFO Mr Keamy, and the entire global staff of CLINUVEL for their efforts over the
past year. This is also the place to thank the Board of Directors for the work, passion and
various insights they have brought the past year to progress the Company.
I look forward with optimism to update you on our progress during FY2022.
CORPORATE
GOVERNANCE
CLINUVEL
Pharmaceuticals
Ltd and its Board
are committed to
establishing and
achieving the highest
standards of corporate
governance. The
Company’s Corporate
Governance Statement
for the year ending
30 June 2021, 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
Willem Blijdorp
Chairman, CLINUVEL Group
15
CLINUVEL Pharmaceuticals | 2021 Annual Report CLINUVEL Pharmaceuticals | 2021 Annual Report
Managing
Director’s Letter
Dear Shareholders,
Review of 2020-2021
I look back on a year marked by several distinct
highlights within our Group, and it is fair to state that it
has been far from easy to operate under the worldwide
conditions. Despite the restrictions our teams faced,
2021 will go into our history as one with unforgettable
moments to cheer our teams’ performances in serving
targeted patient populations.
16
Managing
Director’s Letter
The zenith was undoubtedly our team’s ability to overcome the numerous delays
occurring in the supply chain and drug distribution to hospitals under the COVID-19
conditions. We appointed new EU and US facilities providing cold storage for our
hormonal therapy, we succeeded in overcoming stricter import criteria and managed
to distribute, despite hospital restrictions. In categorising our treatment as innovative
medical care administered within secondary care facilities, the greatest challenge had
been to prolong the supply of SCENESSE® to selected hospitals, which were all operating
under very limited schedules.
Additionally, we faced restricted schedules of (EPP) patients’ appointments as critical
care patients had obtained priority status within hospitals.
As our teams navigated barrier nursing and protective isolation in university centres
and specialised centres, we spent most nights through various time zones finding novel
solutions for problems nobody had ever faced before. There are quite a number of senior
managers who deserve public acknowledgement for their mammoth achievements over
the past 12 months, but I would risk short-changing all others in the Group who have
equally pulled their weight behind the scenes and made 2021 the most successful year
in the Company’s history. It is one not to forget.
Another critical observation is that the silent credit our team has built over the years vis
a vis regulatory authorities, the EMA, HPRA and FDA, has led this year to a remarkable
degree of collaboration and support in assisting CLINUVEL to operate a just-in-time
drug supply in both continents. The intangible currency our team has accrued during
two decades of dialogue with the three leading agencies had become quite apparent
from the exchanges with the regulatory authorities, who are holding the final card when
it comes to drug supply. I witnessed first-hand how longstanding relationships between
our managers and regulatory decision makers in Silver Spring (USA) and Amsterdam
(Netherlands) has led to constructive dialogues in seeking solutions to serve patient
populations with a chronic disease, i.e., porphyria. The unscheduled by-product of longer
term adherence to strict plans (namely risk management plans, and quality systems), but
also the consistency of our lead managers, is a surprising working relationship between
our technical staff and these three agencies, particularly at times when it really mattered.
This year, we disclosed how the Company has gradually balanced its clinical research
attention between brain and genetic diseases. As part of our planning, we treated the
first three patients with ischaemic stroke, a condition affecting large swaths of society.
With great satisfaction, we observed how the first stroke patients with a history of
heart disease responded to treatment as part of trial CUV801. Although early days, we
recorded first safety data from this new population at risk. The COVID-19 restrictions
caused delay in recruitment and, as the site was working with limited staff, clinical
studies became secondary to clinical care of stroke patients.
17
CLINUVEL Pharmaceuticals | 2021 Annual Report We treated the first xeroderma pigmentosum (XP) patient, while Ethics Committees and
National Competent Authorities deliberated at length and with great care so as not to
expose XP patients too early to a novel hormonal treatment. At the time of writing, the
first Ethics Committee has provided a green light for the first study in XP patients. The
mid-term goal is to evaluate the effect of afamelanotide on photoproducts affecting the
DNA helix of these patients. The scientific data generated in XP trials will further assist
CLINUVEL’s scientific team in their innovative work on topical products, with the aim of
demonstrating beneficial effects on UV-provoked damage on DNA.
Another highlight was the fifth consecutive commercial year, when we adhered to
the uniform drug pricing policy in Europe, while setting a first and similar equitable
standards across all US states. The response from insurers and healthcare providers has
been undividedly positive, providing us with further affirmation of CLINUVEL’s differing
approach to pharmaceutical markets. In addition, the first market access obtained in
Israel was an unexpected event led by Mrs Colucci and her team, while discussions with
the Ministry of Health and individual insurers had been encouraging throughout 2020
and 2021. As we obtained the green light from the National Committee for Healthcare
(“Healthcare Basket”), we put the framework in place to import SCENESSE® into Israel. In
the meantime, the first Israeli EPP patients have received the drug.
A milestone was undoubtedly the 10,000th SCENESSE® implant administered, equating
to 70,000 drug exposure days. This remarkable billboard requires a longer discussion
about the product’s consistency concerning its safety profile and future implications for
our programs; we will come back to this on another occasion. However, the statistics
of safe drug administration allows for further developments of melanocortin drug
candidates in humans.
Overall, we saw our headcount increase with professionals adding new skills to our
existing teams. Working remotely brought out the advantages of saving time from
commuting, while accentuating the frustration of working from home, deprived of human
interaction. The lockdowns required from each staff member in our seven offices, longer
term discipline and focus to communicate on-screen.
Other highlights were the progress of the PRÉNUMBRA® program, the performance of
the Singapore team and the innovation driven by leading managers Mr Choy, Ms Yu and
Dr Ng and their loyal staff. All in all, our team in Singapore, led by senior managers to get
through the circuit breaker, displayed a high level of discipline.
In staying with high-risk populations, albeit in a non-medical market, our division of
Healthcare Solutions advanced the development of product lines to mitigate solar skin
damage and skin cancers. With this total focus on the wellbeing of patients and selected
populations, we expanded our company with scientific talent, a Communications,
Branding and Marketing team, and additional professionals with expertise in chemistry,
manufacturing, and control.
18
CLINUVEL Pharmaceuticals | 2021 Annual Report Quarter on quarter, we recorded better than expected revenues and higher net profits.
We managed to expand our operations and investments in research-development-
innovation, while restricting other variable costs to see the Group eventually increase
total costs by a marginal 2%. Our financial management remained scrupulous when it
concerned the overall profitability of the Group.
Our finance team expanded. New accountants and managers fitted in well, setting
out to work on the financial households of our subsidiaries. We adopted a uniform
accounting practice using new systems easing the consolidation of our financial
reporting. Our finance team passed a 16th year of biannual audits, and it has
been obvious that its accomplished leadership is one of the main reasons behind
CLINUVEL’s performance. I have shared my views on the importance of having a robust
finance team at various occasions during our frequent News Communiqués.
First-rate in execution, the excellent financial performance of FYE 2021 provides
the Company with future choices and a basis for further growth. Our consistency
in financial management answers my personal views to establish a Group able to
withstand unexpected oscillations, not rendering the Company dependent on either
equity or debt financing. While we remain aware of the cyclical nature and risks in our
sector, we prolong our chosen course by investing wisely in people and technologies.
Common Thread
Our company’s operations are centred around the unaddressed needs of patients,
and our overall success hinges on patients’ response to our therapies as well as
physicians’ assessment of efficacy. As a pharmaceutical group entirely committed
to improving the lives of patients, all our corporate functions are aligned to serve
primarily medical communities. This year, we have added wider populations at risk; we
now focus part of our efforts to serve populations at high risk of incurring a second
fatal stroke, as well as XP patients incurring debilitating and fatal skin cancers.
Throughout all our work and all divisions runs a red line, longitudinal care. Our mission
is to communicate and engage long term with our patient community, medical
community, researchers, stakeholders, regulatory authorities and shareholders. Our
management team has been together a long time, in some cases fifteen years, and
part of our business is to follow up, manage and monitor the relationships we have
built over time with all forementioned stakeholders. I regard tremendous clinical and
therefore business value in longitudinal management of key protagonists. Patients
who have remained on SCENESSE® therapy deserve a consistent and long-term
communication with and from the Company, and we take the same approach to
other stakeholders.
I look back at a fundamental discussion which took place in March. German-speaking
shareholders posed questions about CLINUVEL’s mission and its broader position
19
CLINUVEL Pharmaceuticals | 2021 Annual Report within the pharmaceutical sector. Here, my views remained unwavering, as I believe
CLINUVEL is here to serve the needs of unattended patients and populations at risk.
By communicating and fulfilling this clear mission, we stay true to a common and
recognisable course of developing and commercialising unique products. Central to our
objectives are the various unaddressed medical populations and individuals prone to
incurring cerebral damage, but also those in danger of incurring multiple often fatal skin
cancers as a consequence of the genetic disorder XP. This clear mission has already
provided value to first end-users, porphyria patients.
A pertinent question was why CLINUVEL had pursued the current strategy?
As commented on at previous occasions, this Board and managers take strategic
decisions based on a variety of criteria which remain unique to CLINUVEL and befit our
group of professionals. Our strategy could be interpreted as perhaps differing from that
of peers, however in general there is little point of comparing with motives that apply
uniquely to others. So why then this strategy?
In the case of porphyria patients, we had identified a group of individuals who had
remained unattended; no other company in the history of drug development had
bothered to pay medical attention to these patients. Having introduced the first systemic
photoprotective therapy to these patients has doubtlessly been a meaningful cause, as
we learn day to day from their families and caretakers.
In 2006, we first analysed XP and its impact on patients. It became our main objective
to treat this population using a systemically-targeted melanocortin. For those who
had followed CLINUVEL closely, a long road has been travelled to gain access to
these patients who are highly prone to develop and succumb to four types of skin
cancers. Unaffected by the passing of time, our quest to become the first company
globally to offer a systemic therapy to XP patients had never faded. However, we
were driven to execute a clinical and regulatory plan to gather necessary safety data
“beyond reasonable doubt”. In selecting EPP, a condition characterised by absolute light
intolerance, we started our journey towards XP. In simple terms, in EPP we first provide
systemic photoprotection, while in XP we not only aim to achieve effective systemic
photoprotection to slow down or mitigate the development of skin cancers, but we are
on our way to prove the effect of melanocortins on photoproducts (DNA lesions) caused
by UV and loss of cellular integrity.
When progressing the use of afamelanotide in brain diseases, in the stroke population,
we had identified the life-threatening nature and dramatic impact a brain blockage (clot)
has on patients and their immediate family. We realised that the majority of patients
suffering a cerebral infarct do not receive therapy. Empathy, and the desire to do
something about the problem, coupled with technological opportunity, drove our decision
to take on this clinical challenge.
20
CLINUVEL Pharmaceuticals | 2021 Annual Report We selected a further indication for SCENESSE® and are overcoming various hurdles
to extract and retain value of the use of afamelanotide. As we progress with regulatory
authorities, Institutional Review Boards and expert physicians, we plan the start of
an innovative trial. We are aware of the risk of translating the use of afamelanotide,
but collectively our teams assessed the long-term benefit being greater than the
numerous risks.
Furthering our line of thoughts, by grouping the three addressable populations for our first
over the counter (OTC) product line, we had strongly identified untreated and unattended
groups in the general population. Immune compromised patients, patients with a history
of skin cancer(s) and outdoors professional sportspeople at risk of chronic UV and HEV
exposure are all populations poorly addressed by the dermatocosmetics sector. Armed
with our expertise, understanding of the risks these three groups share and the long-term
effects of UV and HEV exposure, it was only natural to focus on these populations.
In numerous past News Communiqués and corporate communications, we have
highlighted the insidious enemy of CLINUVEL, its ongoing success and risk of
complacency. With that, we try to instil in our managers and staff, but also at Board
level, a continuous hunger to improve the business, vary our approach and sharpen
decision making. We work on the basis of common objectives, and this cry to remain
agile at all times is by no means sufficient to guarantee growth and success, but at least
it eliminates a silent factor one seldom wishes to address in companies.
The ongoing analyses of the CUV business, the anticipation of unknown risks, the
repetitive modelling scenarios, and courage to play out unthinkable options helps
to deliberate extreme projections. This practice triggers discussions among Board
members on dramatic scenarios one would most likely not contemplate if one would not
push each other to fathom the unthinkable scenarios, both favourable and unfavourable.
When balancing CLINUVEL’s risks versus commercial present and future rewards, I
use my experience and analyses of available information while surrounding myself
with voices, minds and professionals one has come to respect owing to their ability to
adopt unexpected viewpoints. I have exchanged with great minds, business leaders,
entrepreneurs and analysts and have concluded that a sustainable business not only
hinges on one’s ability to take risks, but equally on the ability to analyse and frame
risks in such a manner that the execution of the adopted plan becomes measurable
and segmented. The segmentation then offers frequent evaluation of direction and
performance at set timepoints. It is a formulaic approach which has worked well for us
thus far. In summary, CLINUVEL selects its direction and course of development, both for
pharmaceutical products and OTC lines, on the basis of compassion for those in society
who are left unattended, untreated and unheard.
21
CLINUVEL Pharmaceuticals | 2021 Annual Report Vision 2022
The new world, post-COVID-19, will not resemble the old one. Staff will operate in shifts,
coming to the office once per week while working remotely the next. The time of large
office spaces, all working under one roof every day of the week, seems to have fleeted
and is not destined to return. We are already selecting staff, setting up people to work
at distance while coming in for office meetings at short notice. In 2022, off-sites will be
more frequent, while flexibility will be required from employer and employee.
In this company, we are all driven to fulfil this one common mission: we share a deep
empathy for the patients and individuals at risk, who are not attended in society. Some
of us are personally affected by these conditions, some of us have family members
in our immediate environment and some of us deeply relate to these patients and
selected groups. Under this roof, without a single exception, we are all connected by
doing something meaningful for others, fulfilling a worthwhile cause for patients – and
individuals at high risk – by restoring for them a balance to resume a normal life, one free
of restrictions. In pursuing this mission, I dare to think that the first successes CLINUVEL
has attained have already brought the medical community therapeutic advantage, relief
and satisfaction. CLINUVEL will continue this journey with authority, empathy and passion.
In 2022, we are looking to further our Board’s views on the macroeconomic issues
affecting the Company, whereby we generally seek to invite the most diverse and
contradictory viewpoints asking for a healthy dissent to arrive at higher quality decisions.
This attitude to seek unorthodox discussions can be regarded somehow as
counterintuitive to build value and it certainly requires much energy. As a Board, however,
we will continue to operate from the principle that past decisions may have been sound
to bring the Company to its present level of operational success, but that the constantly
changing dynamics in the markets and tension within the sector require us to challenge
each other frequently to take adequate decisions to generate incremental value.
The foundation and legacy of a company play indelible roles in taking decisions, and the
first mandate to rebuild the Company’s ramparts may have been fulfilled, however the
second part has been looming ever since the management team had shown commercial
progress: how to build a sustainable company based on a variety of products and services.
Conclusion
Among all the euphoria of the recent increase in CLINUVEL’s value, I see the markets’
reaction as the consequence of a series of decisions our team has taken over the
decades, rather than a short-term reaction to our financial performance. Management
decisions led to a tenacious attitude to the development of a new drug product, and to
a series of choices to independently distribute the innovative pharmaceutical among
selected hospitals worldwide. During the first quarter of 2021, we saw how CUV as a
22
CLINUVEL Pharmaceuticals | 2021 Annual Report momentum stock attracted many retail shareholders (>500) from Germany,
Switzerland and Austria.
The biggest gain of 2021, however, lies in the direct corollary of these continuous
decisions, since we witnessed how porphyria patients demanded continuation of
treatment in spite of the travel to which they needed to commit under restricted
conditions, but foremost the risk of nosocomial infections they were prepared to take in
seeking treatment in hospitals. As far as I can try to be objective in my position, reflecting
on 2021, I cannot see the patients’ response to treatment under the most severe travel
restrictions other than as the best real-world evidence of efficacy of our lead product.
Without doubt, there will be many more challenges coming CLINUVEL’s way, nevertheless
I place full trust in our current team. I see the ensemble as well equipped and trained to
tackle the unforeseen and uncalculated events which may befall us, while this group of
professionals has the stamina and vision to further develop programs and products for a
variety of unattended populations.
I regard 2022 as a pivotal year when we enter non-medical distribution, expand our
pipeline of pharmaceutical products and – pending the hospital restrictions due to
COVID-19 – will see results in XP, AIS and arrive at agreements with FDA, institutions
and National Competent Authorities to add another indication for the use of
afamelanotide to our portfolio.
While progress requires much patience from all of us, I am confident that further benefit
will be generated and received by all stakeholders. On behalf of the Board of Directors
and management, I thank you for your continued support.
Philippe Wolgen
Managing Director, CLINUVEL Group
23
CLINUVEL Pharmaceuticals | 2021 Annual Report The
Door Opens
for CLINUVEL’s Expansion
24
CLINUVEL Pharmaceuticals | 2021 Annual Report for CLINUVEL’s Expansion
25
The Door Opens
for CLINUVEL’s Expansion
The door to CLINUVEL’s expansion towards a diversified
and sustainable healthcare company was opened by the
approval of SCENESSE® (afamelanotide 16mg) in October
2019 by the US Food and Drug Administration (FDA) for
adult erythropoietic protoporphyria (EPP) patients. After
decades of misfortune, CLINUVEL’s reviewed strategy to
develop a novel melanocortin for an unmet medical need
had then been validated by the two leading regulatory
bodies of the world in 2014 and 2019, enabling the Group
to evaluate how it could expand its operations and address
broader audiences.
Strategy Reset
The initial unsuccessful strategy of the Company to the end of 2005 was to develop a drug
to assist tanning of the skin as a lifestyle product. Whilst a large recreational market was
receptive to such a drug, its more cosmetic than medicinal purpose was never going to be
supported by the regulators and CLINUVEL thus had to come up with a brand new strategy.
In November 2005, Dr Philippe Wolgen was appointed CEO of CLINUVEL. Together with
the support of the Board and a revitalised management team, the Company’s strategy
was reset to focus on the development and commercialisation of one drug for one
indication with a high unmet medical need. This strategy met numerous obstacles and
was implemented over 15 years by one homogenous team. A number of indications
were researched before the genetic metabolic disorder EPP was selected as the lead
indication with which to prove the novel concept of systemic photoprotection. CLINUVEL
completed clinical studies over several years and built expertise in melanocortins and
their role in the human body, as well as the impact of light on human biology.
The Door Opens
for CLINUVEL’s Expansion
“The door not only opened for SCENESSE®
to treat EPP patients in the USA in October
2019, but also unlocked the opportunity
to expand the research and development
program to assess the application of
SCENESSE® to other indications.”
The Company had commenced first distribution of SCENESSE® for EPP patients in
Italy in 2010 and Switzerland in 2012 under special access programs, while in 2014
the European Medicines Agency (EMA) approved SCENESSE® for adult EPP patients.
Commercial operations began in the European Union in June 2016 after agreement
was reached on a rigorous risk management plan to monitor and report the patient
experience with SCENESSE®. Liaison continued with the FDA on regulatory approval
in the USA, with the FDA seeking real world evidence from the European programs. In
October 2019, the FDA granted approval to CLINUVEL to distribute SCENESSE® in the
USA and commercial operations commenced in April 2020.
Success of the strategic reset of 2005, is reflected by:
a) the increasing number of EPP patients being treated who report a positive safety
experience over time; and
b) the financial performance of the Company, achieving record revenues and profit in
June 2021, in the fifth consecutive year of positive cashflow and profit.
The Company has been and remains focused on the safety of the melanocortin first-
in-class drug. The positive real-world patient experience builds confidence as to the
implemented strategy and together with the expertise built in melanocortins, enables
the expansion of research and development activities to treat a much wider range of
indications and broader audiences..
Regulatory Approvals Unlock CLINUVEL’s Expansion
The key regulatory approvals that have been granted reflect the acceptable safety profile
of SCENESSE®, the world’s first systemic photoprotective drug. This position was reached
after many years of hard work to build credibility as a pharmaceutical company with
expertise in melanocortins. Subsequent to the EMA and FDA approvals, the Australian
Therapeutic Goods Administration and Israeli Ministry of Health granted approval to
SCENESSE® for adult EPP patients in October 2020 and February 2021, respectively.
The door was not only unbolted for SCENESSE® to treat EPP patients in the USA
in October 2019, but also unlocked the opportunity to expand the research and
development program to assess the application of SCENESSE® to other indications.
26
CLINUVEL Pharmaceuticals | 2021 Annual Report We know from our own work, and an increasing dossier of worldwide research, that
melanocortins can play a multifactorial role in the body, binding with one or more of
the five melanocortin receptors (MC1R to MC5R) to influence a range of physiological
activities. These range from photoprotection, repigmentation and DNA repair of the skin,
to inflammation, energy homoestasis, appetite and sexual function. The table shows a
global snapshot of the distribution of the five melanocortin receptors and the functions
they influence.
From a foundation built on expertise and experience, CLINUVEL has progressed to
allocate resources to target other unmet medical needs. The intention is to assess the
ability of afamelanotide to bind with different melanocortin receptors and assist different
functions of the human body. Afamelanotide is a synthetic hormone of the naturally
occurring alpha-melanocyte stimulating hormone (α-MSH), which binds to receptors
showing affinities to MC1R, MC3R, MC4R and MC5R. In addition to progressing our
commitment to develop a repigmentation treatment for vitiligo, we have expanded the
research and development program to DNA Repair – with an initial focus on xeroderma
pigmentosum (XP) – and to stroke. These indications provide the opportunity to treat
more patients and build upon our commercial success. The Company’s focus on the
research and development, regulatory approval, and commercialisation of treatments for
these indications is justified based on the acceptance and status of SCENESSE® as a safe
treatment for EPP.
The expertise developed in melanocortins will also be extended to non-pharmaceutical
products for broader audiences within the general population at risk from ultraviolet
(UV) and high energy visible (HEV) light. We assess that dermatocosmetic products are
needed by these underserved groups.
“…melanocortins can
play a multifactorial role
in the body, binding with
one or more of the five
melanocortin receptors
(MC1R to MC5R) to
influence a range of
physiological activities.”
27
CLINUVEL Pharmaceuticals | 2021 Annual Report α–MSH
ACTH
β–MSH
α–MSH
ACTH
Agonists
α–MSH
ACTH
γ–MSH
β–MSH
α–MSH
Receptor
MC1R
MC2R
MC3R
MC4R
MC5R
Adiopocytes
Adrenal cortex
Skin
Brain
Gut
Heart
Placenta
Testes
Expression
Anti-inflammatory
cells
Brain
Endothelium
Hair follicle
Melanoma cells
Melanocytes
Periaqueductal
grey
Pituitary
Skin glands
Testes
Adipose
Adipose tissue
Brain
Adrenal glands
Endothelium
Brain
Heart
Exocrine tissues
Kidneys
Leukocytes
Lung
Lymph nodes
Mammary glands
Muscles
Ovaries
Skeletal
Testes
Uterus
Function
Inflammation
Steroidgenesis
Pigmentation
Energy
homeostasis
Sexual
behaviour
Appetite
regulation
Exocrine
function
The next article covers how we are organising the Company to meet the challenges of
the future. In subsequent articles of the Annual Report, we round out the activities and
initiatives to build a diversified and sustainable group of companies with:
• an update on the growth of commercial operations based on SCENESSE® for EPP;
• details of the expansion of the research and development program and translation
of our technology to targeted indications; and
• outline the rationale and plans for a dermatocosmetic product range to assist
individuals at high risk of exposure to light.
Divisional
Expansion
The ‘hinges’ to the expansion of CLINUVEL’s
research and development program have
been unscrewed and how we organise our
company to capitalise on the opportunities
ahead is critical.
A new organisational structure has been
established in four divisions.
28
CLINUVEL Pharmaceuticals | 2021 Annual Report The Focus of Each Division
• The Pharmaceuticals Division is the core of the Group, focused on developing and
delivering treatments for patients with unmet medical needs.
• The Healthcare Solutions Division is concentrated on non-prescription products derived
from the know-how and active ingredients used in the Pharmaceuticals Division for
targeted audiences at high risk of exposure to UV and HEV light.
• The CBM Division prepares communications to wider and differentiated audiences,
positioning the Group for broader engagement and is now fully resourced and active.
• The Manufacturing Division will manufacture novel formulations and products for
CLINUVEL and for other operators in relevant sectors.
The Divisions are supported by the Research, Development & Innovation (RDI)
Centre based in Singapore which opened in August 2020 and was featured in
last year’s Annual Report.
The Purpose and Objectives of the Singapore RDI Centre are to:
• undertake a research program focused on molecular profiling, peptide chemistry and
polymer and formulation sciences; and
• commercialise innovative pharmaceuticals and new over-the-counter product lines.
Pharmaceuticals
Communications,
Branding & Marketing
Manufacturing
Research, Development
& Innovation Centre
29
HealthcareSolutionsCLINUVEL Pharmaceuticals | 2021 Annual Report Growth of
Commercial
Operations–
SCENESSE®
for EPP
The commercial operations based on the distribution
of SCENESSE® for adult patients with erythropoietic
protoporphyria (EPP) continued to progress in the 2021
financial year. The key developments and achievements in
key jurisdictions are outlined here.
30
CLINUVEL Pharmaceuticals | 2021 Annual Report In Europe
• Demand for SCENESSE® near normalised during the 2021 financial year after an initial
adverse impact of the coronavirus pandemic in the 2020 financial year
• Patient continuation on treatment remains above 94% in the European Economic Area
• Progress has been made in extending distribution of SCENESSE® to patients in more
European countries
• Expert physicians have published data on the use of SCENESSE® to treat EPP patients
In the USA
• April 2021 marked the first anniversary of the commencement of treatment in the USA
• Over 40 Specialty Centers have been trained and accredited to provide treatment to
patients across the USA
• The number of private and national insurers agreeing to reimburse the cost of
treatment exceeds 60
• Considerable effort has been exerted to obtain a set of codes for the drug and the
treatment to smooth the administrative process of reimbursement
Global Treatment Progress
Australia
• The Therapeutic Goods Administration (TGA) granted approval to prescribe
SCENESSE® to adult patients with EPP in October 2020
• We are working with the Pharmaceutical Benefits Advisory Committee to make
the drug available on the Pharmaceutical Benefits Scheme to enable access to the
treatment for patients
Israel
• The Ministry of Health granted access to distribute SCENESSE® to adult patients with
EPP in February 2021
Others
• Collaboration with our partner in China continues to focus on treating a small number
of EPP patients to establish a database of Chinese patients to enable discussions on
the path of regulatory approval to distribute SCENESSE® with Chinese authorities
• Assessment of the regulatory process in Japan is ongoing
• CLINUVEL is committed to extend the distribution of SCENESSE® for EPP to other
jurisdictions
31
CLINUVEL Pharmaceuticals | 2021 Annual Report Targeted
Technology
Translation
research
expanded pharmaceutical
CLINUVEL’s
and
development program is aimed at the translation of its
technology and know‑how developed and gained over the last
decades, to serve wider populations. The medical needs of
these patient populations have remained unmet, implying that
no current therapy exists for these patients and no products
have been developed for broader target populations.
CLINUVEL frequently reports on the direction and clinical
opportunities in which it seeks to test its drug candidates. In
brief, a number of indications are reviewed below.
Erythropoietic Protoporphyria and SCENESSE® Enfance
We continue to develop the application of an afamelanotide formulation for paediatric
patients diagnosed with the rare metabolic disorder, erythropoietic protoporphyria (EPP).
A focus of the research is the assessment of different formulations of SCENESSE®
based on four age groups. The research in the Singapore based Research, Development
& Innovation Centre (RDI) is being conducted by senior managers under the direction of
the Chief Scientific Officer.
Vitiligo
Vitiligo is a common skin depigmentation disorder which affects between 0.1-2% of the
world’s population. The pigment producing cells of the skin (melanocytes) are either
32
CLINUVEL Pharmaceuticals | 2021 Annual Report no longer functional or in some cases absent as a result of a variety of factors. As a
result, the human skin - over time - starts to develop lighter depigmented patches of skin
(vitiligous lesions) which appear across the surface of the body. The disease is resistant
to treatment and has an intense psychological and social impact on these patients. Its
devastating effect is most pronounced for patients of darker skin complexion.
CLINUVEL has successfully evaluated the efficacy of SCENESSE® in conjunction with
narrowband ultraviolet B (NB-UVB) phototherapy as a systemic treatment for the
repigmentation of darker skin types. Also being developed through the Singapore RDI are
topical pharmaceutical formulations of melanocortin analogues (such as CUV9900) for
the treatment of vitiligo and various other conditions.
CLINUVEL has undertaken studies in the past (Phase II CUV102 in 2011 and Phase
IIb CUV103 in 2014) which produced encouraging results on repigmentation with
SCENESSE® in conjunction with NB-UVB phototherapy. These results are accessible
through the CLINUVEL website. As a next step in the drug development path, CLINUVEL
plans to commence a Phase II study in North America with a focus on people with
Fitzpatrick skin types IV-VI whose need for repigmentation is greatest. Their darker skin
pigmentation shows the most distinct improvement, and therefore benefit, from treatment.
We have continued to liaise with the US Food and Drug Administration (FDA) on an
agreed design of the study.
Of importance was that in March 2021, for the first time in its history, the FDA held a
public meeting on patient-focused drug development for vitiligo with 1,155 participants.
The focus on the disorder is welcomed and indicated the demand for novel treatments,
only 24% of the participants stated that they would not use a daily topical treatment that
provided only up to 50% repigmentation.
A global update on the stages of the development progress to take SCENESSE® to a
prospective vitiligo market is provided below:
• Agreement on design;
• Recruitment of centers and participants;
• Undertake and complete the study ;
• Post study analysis and sharing of results with the FDA;
• Completion of additional research considered necessary;
• Submission and assessment of a Supplementary New Drug Application;
• Regulatory decision;
• Establishment of distribution and reimbursement arrangements; and then,
• First treatment.
A minimum time frame of three years is a realistic expectation to travel this path to first
treatment but depends on the clinical results and regulatory authorities; the Company
will provide periodic updates on its progress for the information of stakeholders.
33
CLINUVEL Pharmaceuticals | 2021 Annual Report DNA Repair and XP
Due to the frequency and length of UV exposure, large groups of the global population
are at risk of permanent skin damage, called photodamage, and high percentages
progress to solar skin damage and first stages of skin cancers. The risk of skin cancers
following UV exposure is the highest in those who are deficient in their natural DNA repair
processes, specifically base-excision repair (BER), and nucleotide-excision repair (NER).
Going deeper in the subject, UV and HEV light impacts cellular DNA, causing chemical
alterations to DNA - the preliminary step in cancer formation.
In clinical testing, afamelanotide has been shown to reduce DNA damage caused by UV
radiation and visible light (oxidative damage and pyrimidine dimers). Further research
has shown the ability of afamelanotide and other melanocortin molecules to assist skin
cells in DNA repair mechanisms (such as NER).
The Company announced the DNA Repair Program in September 2020 with an initial
focus on xeroderma pigmentosum (XP) patients who are >1,000 times more susceptible
to skin cancers than the general population.
The prevalence of XP ranges from 1:250,000 to 1,100,000 in western populations.
The fist XP-C variant patient in the world was treated in September 2020 and tolerated
the drug well during a 42 day observation period, thus providing the basis to progress
to the planned study. This study is the first-ever to have been approved by Ethics
Committee(s) in western countries, as – due to the fatal course of the disease - the
concern has been to protect XP patients from human medicinal trials and experiments.
The scope of the XP study was subsequently extended in 2021 to XP-V variant patients.
A number of studies have been designed
in collaboration with expert physicians.
We share three of these at this stage –
CUV150, 151 and 152 – while reviews
are performed by regulatory authorities
and Ethics Committees. Individual
patients have provided consent for the
studies to commence.
Clinical trial
Phase
Target population
Participants
CUV150
Phase IIb
XP-C
n = 6
CUV151
Phase II
Healthy volunteers
n =10
CUV152
Phase IIb
XP-C and XP-V
n = 6
The global objectives are to evaluate afamelanotide, a first-in-class melanocortin - in
XP-C and XP-V patients in relation to safety, the effect on the integrity of the skin,
photoproducts, NER and overall, as a systemic photoprotective drug.
These involve the administration of the drug over four months, skin biopsies to assess
UV damage, and the administration of ultraviolent radiation to assess the effect of
erythemal exposure.
34
CLINUVEL Pharmaceuticals | 2021 Annual Report Stroke – AIS
Stroke impacts 15 million people worldwide each year. Of these,
85% (12.75 million) are arterial ischemic stroke (AIS), around
85% (10.84 million) of which are untreatable due to the blood clot
prevailing in narrow and inoperable blood vessels of the brain.
Afamelanotide assists blood vessels to stimulate blood flow and
oxygen to the penumbra, the brain tissue at risk; it also provides
protection of the brain cells.
A Phase II study - CUV801 has been designed and approved by
clinical decision makers and ethical committees and commenced.
The first of six AIS patients was treated in June 2021, conducting
the world’s first human study of a systemic melanocortin in the
treatment of a life-threatening condition.
The objective is to assess whether afamelanotide’s intervention
provides a benefit to the arterial supply of the brain as measured
by Computed Tomography Perfusion and Magnetic Resonance
Imaging of the brain.
Progress of the study will be advised.
Arterial Ischaemic Stroke (AIS)
A sudden clot lodged in a brain vessel causes an acute
stroke leading to a zone of dead brain tissue, known as the
necrotic core. The area surrounding the core is at immediate
risk of further tissue death and is called the penumbra: brain
tissue which can be returned to normal function if immediate
intervention can be offered. The right side of the image
shows the middle cerebral artery (MCA) sections M1–M4.
Afamelanotide in Stroke
Before
After
Before
After
Vasodilation
Neuroprotection
Before
After
Reduction of
Brain Fluid
Protection of the
Blood-Brain Barrier
Additional Indication
We are also working towards institutional agreements to start a first study
in an additional indication.
35
CLINUVEL Pharmaceuticals | 2021 Annual Report Healthcare
Solutions
A beneficial relationship between our human skin
and light requires balance. Chronic overexposure to
light poses a direct threat to health. Yet, lack of light
exposure leads to vitamin D deficiency and depressive
disorders. In short, we need solutions that help
maintain a healthy balance.
CLINUVEL’s proven pharmaceutical technology protects
skin from light (photoprotection) for patients with one
of the most severely expressed genetic conditions.
It has also been shown to play a key role in repairing
DNA which has been damaged by light exposure. Over
decades, we have developed know-how to understand
what is required to achieve a balanced relationship
with light. As part of CLINUVEL’s expansion, we are
now working to deliver solutions to targeted audiences,
which help them achieve a lifelong balance.
36
CLINUVEL Pharmaceuticals | 2021 Annual Report UVC
UVB
UVA
HEV
Overall skin depth | 1–4mm
Stratum Corneum | 10µm
Epidermis | 50–150µm
Dermis
Subcutaneous
Skin cross section, demonstrating the depth of penetration attributed to UVC/UVB/UVA and HEV solar radiation.
We Are All at Risk of Skin Damage
Every hour of exposure to ultraviolet (UV) and high energy visible (HEV) light causes of
thousands of DNA lesions in our skin. The first of these occurs within a picosecond of
light exposure, and damage can continue to accumulate for hours after exposure.
Over time, under general conditions our bodies are expected to repair much of the light-
induced DNA damage. Yet, many of these lesions actually are left unrepaired as we age and
as the frequency of UV exposure increases, the damage ultimately leads to skin cancer.
In addition, some of us are much higher risk to incur skin cancers than others due to
variations in our ability to repair DNA damage. Genetics, age, and specific diseases or
medications can play a role in impairing our reparative functions. As a result, the potential
population numbers are high: collectively, some 2 billion people are at increased skin cancer
risk. Within these groups we have identified eligible populations for our future products.
37
CLINUVEL Pharmaceuticals | 2021 Annual Report “CLINUVEL’s pharmaceutical
technology and know-
how can be translated to
healthcare solutions for the
benefit of specific groups”
Next Generation Skin Care: Dermatocosmetics
Due to the public’s increasing awareness of the adverse impact of prolonged exposure to
solar and HEV light on the skin, there is growing demand for innovative non-prescription
skin care products. Dermatocosmetic products are being provided by a large range of
purely cosmetic and lifestyle-focused companies to meet this demand. Dermatocosmetics
are specially formulated products designed to assist skin health with a focus on anti-
ageing, repair and regeneration of the skin. To achieve this, 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. The worldwide market for dermatocosmetics
is large and growing rapidly. It is estimated that the market, at US$57 billion in 2020, will
grow by more than 7% per annum through to 2030.1 The wide range of products available
offer different benefits and their efficacy varies markedly. This is one of the opportunities
for CLINUVEL. Whilst many products promise regeneration and rejuvenation of the
skin, seldom are these based on the research into a new class of molecules tested in
human pathology over decades or the knowledge accumulated by teams focused on
photoprotection, as has been undertaken by CLINUVEL.
38
1. Prescient Strategic Intelligence, Dermacosmetics Market Research Report, July 2021.
CLINUVEL Pharmaceuticals | 2021 Annual Report From Medicinal Use to Healthcare Solutions
CLINUVEL stands for a notion that pharmaceutical technology and
know-how can be translated to healthcare solutions for the benefit of
specific groups in the general population at high risk of UV and HEV
light exposure. In October 2020, we announced the establishment of
CLINUVEL’s Healthcare Solutions Division to develop and advance
a range of non-prescription dermatocosmetic products, which will
use various ingredients, and in some product lines the melanocortin
technology developed by CLINUVEL over the decades. We aim to
prevent and assist the repair of light-induced DNA damage of the skin.
The area of acute and chronic photodamage following UV and HEV
exposure is an underdeveloped area of the dermatocosmetics market.
CLINUVEL’s Dermatocosmetic Products
CLINUVEL has identified specific target groups who are poorly
attended and with a certain unmet need to assist skin’s DNA
protection and repair. We are building a network of communities to
understand their needs and develop solutions to help them. These
groups of individuals have high sensitivity to light/UV and are prone to
long-term damage and are at high risk due to:
•
•
•
their ‘fair’ skin types;
their work or lifestyle activities; or
lifelong immunosuppression, having received an organ transplant.
The objective of CLINUVEL’s Healthcare Solutions Division is
to introduce leave-on products, topical formulations based on
melanocortin molecules, to provide photoprotection and DNA-
restoration for these groups of individuals.
We will take a prudent and gradual approach to the launch of the
dermatocosmetics product range. The first product line offers
polychromatic protection for extreme conditions; the second and third
product lines aim to provide DNA protection and repair.
CLINUVEL is introducing and adding new technology and know-how
originating from a long executed pharmaceutical program. This
specific origin, scientific focus, target groups and pharmacology itself
sets CLINUVEL apart from any of the established cosmetic houses.
CLINUVEL will provide regular updates on the progress of the
Healthcare Solutions Division through to the launch of the first
polychromatic product in FY2022.
39
CLINUVEL Pharmaceuticals | 2021 Annual Report “Recordfinancialresults,
achievedinourfifth
year of commercial
operations,validatethe
strength of CLINUVEL’s
business model and
the strategic direction
of the Company.”
DarrenKeamy,ChiefFinancialOfficer,CLINUVELGroup
40
“Recordfinancialresults,achievedinourfifthyearofcommercialoperations,validatethestrengthofCLINUVEL’sbusinessmodelandthestrategicdirection oftheCompany.”DarrenKeamy,ChiefFinancialOfficer,CLINUVELGroupCLINUVEL Pharmaceuticals | 2021 Annual Report ANNUAL RESULTS
Financial Year Ending 30 June 2021
41
CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
DDiirreeccttoorrss rreeppoorrtt
DDiirreeccttoorrss’’ RReeppoorrtt
The Directors of the Board present their report on the
Company for the financial year ended 30 June 2021
and the Auditor’s Independence Declaration thereon.
WWIILLLLEEMM BBLLIIJJDDOORRPP
Non-Executive Director, Chair since 30 November 2019,
Funda
Appointed 21 January 2015
CCoommmmiitttteeee MMeemmbbeerrsshhiipp
Chair of the Remuneration Committee
Chair of the Nomination Committee
Member of the Audit and Risk Committee
CCuurrrreenntt DDiirreeccttoorrsshhiippss aanndd OOtthheerr IInntteerreessttss
Director of the Supervisory Board of the B&S Group
(The Netherlands)
OOtthheerr LLiisstteedd CCoommppaannyy DDiirreeccttoorrsshhiippss
((llaasstt 33 yyeeaarrss))
None
RReelleevvaanntt IInntteerreesstt iinn SShhaarreess
aanndd PPeerrffoorrmmaannccee RRiigghhttss
Shares 1,743,118
Performance Rights -
RReelleevvaanntt SSkkiillllss
• entrepreneurship, commercial prowess
• general management
•
•
financial management
experienced in listed company Directorships
42
BBaacckkggrroouunndd
Mr Blijdorp is an internationally recognised
entrepreneur who has helped build the B&S Group, one
of the largest global trading houses, in a period
spanning three decades. Mr Blijdorp has led B&S’s
growth, with the Dutch group focused on specialty
distribution services to difficult to serve markets. The
B&S Group has global reach and is a leader in its
market sector.
Formerly B&S Group’s CEO, Mr Blijdorp now serves on
its Supervisory Board and is a majority shareholder,
focussing on the Group’s development and expansion
strategy. He led and oversaw the Group’s initial public
offering on Euronext Amsterdam in March 2018.
In 2014 Mr Blijdorp was recognised for his expertise in
mergers and acquisitions and commercial leadership
as the Ernst & Young Entrepreneur of the Year in the
Netherlands, and runner-up in its European Union
awards.
Since becoming a director of CLINUVEL in 2015,
Mr Blijdorp has provided a valuable contribution to
setting the Group’s long-term strategy for product
commercialisation, growth, and plans to further
diversify CLINUVEL.
4
CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
BBaacckkggrroouunndd
Mr Blijdorp is an internationally recognised
entrepreneur who has helped build the B&S Group, one
of the largest global trading houses, in a period
spanning three decades. Mr Blijdorp has led B&S’s
growth, with the Dutch group focused on specialty
distribution services to difficult to serve markets. The
B&S Group has global reach and is a leader in its
market sector.
Formerly B&S Group’s CEO, Mr Blijdorp now serves on
its Supervisory Board and is a majority shareholder,
focussing on the Group’s development and expansion
strategy. He led and oversaw the Group’s initial public
offering on Euronext Amsterdam in March 2018.
In 2014 Mr Blijdorp was recognised for his expertise in
mergers and acquisitions and commercial leadership
as the Ernst & Young Entrepreneur of the Year in the
Netherlands, and runner-up in its European Union
awards.
Since becoming a director of CLINUVEL in 2015,
Mr Blijdorp has provided a valuable contribution to
setting the Group’s long-term strategy for product
commercialisation, growth, and plans to further
diversify CLINUVEL.
DDiirreeccttoorrss rreeppoorrtt
DDiirreeccttoorrss’’ RReeppoorrtt
The Directors of the Board present their report on the
Company for the financial year ended 30 June 2021
and the Auditor’s Independence Declaration thereon.
WWIILLLLEEMM BBLLIIJJDDOORRPP
Non-Executive Director, Chair since 30 November 2019,
Funda
Appointed 21 January 2015
CCoommmmiitttteeee MMeemmbbeerrsshhiipp
Chair of the Remuneration Committee
Chair of the Nomination Committee
Member of the Audit and Risk Committee
CCuurrrreenntt DDiirreeccttoorrsshhiippss aanndd OOtthheerr IInntteerreessttss
Director of the Supervisory Board of the B&S Group
(The Netherlands)
OOtthheerr LLiisstteedd CCoommppaannyy DDiirreeccttoorrsshhiippss
((llaasstt 33 yyeeaarrss))
None
RReelleevvaanntt IInntteerreesstt iinn SShhaarreess
aanndd PPeerrffoorrmmaannccee RRiigghhttss
Shares 1,743,118
Performance Rights -
RReelleevvaanntt SSkkiillllss
• entrepreneurship, commercial prowess
• general management
financial management
•
•
experienced in listed company Directorships
BBaacckkggrroouunndd
Under Dr Wolgen’s leadership since late 2005, a long-
term strategy for CLINUVEL was devised. The lead
product SCENESSE® (afamelanotide 16mg) was
reformulated, its medical application identified,
European marketing authorisation was obtained in
2014 and distributed in the European Economic Area
from June 2016. Dr Wolgen oversaw the submission of
the scientific dossier to the US Food & Drug
Administration (FDA) under a New Drug Application,
which was approved in October 2019. First treatment
of US patients commenced in April 2020. SCENESSE®
is the first melanocortin drug to have completed a
clinical trial program and obtain marketing
authorisation in two major markets.
Dr Wolgen has been instrumental in the Company’s
corporate turnaround, rebuilding a share register of
long-term professional and institutional investors. He
led CLINUVEL to attract more than AU$110 million in
investments, 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 unique within the
sector.
Dr Wolgen is currently leading the Group’s expansion,
with an immediate focus on the US and the further
development of the product pipeline for various market
segments. His focus has been to establish a
professional management team to execute the
corporate objectives set and prepare next generation
of managers. Dr Wolgen’s long track record speaks to
a strongly focussed, competitive and conscientious
professional who is known to persevere in meeting
challenging business objectives. He holds an MBA
from Columbia University, NY. Trained as a craniofacial
surgeon, Dr Wolgen obtained his MD from the
University of Utrecht, the Netherlands.
PPHHIILLIIPPPPEE WWOOLLGGEENN
Chief Executive Officer, MBA, MD
Appointed to Board 1 October 2005, appointed Chief
Executive Officer 28 November 2005
CCoommmmiitttteeee MMeemmbbeerrsshhiipp
None
CCuurrrreenntt DDiirreeccttoorrsshhiippss aanndd OOtthheerr IInntteerreessttss
None
OOtthheerr LLiisstteedd CCoommppaannyy DDiirreeccttoorrsshhiippss
((llaasstt 33 yyeeaarrss))
None
RReelleevvaanntt IInntteerreesstt iinn SShhaarreess
aanndd PPeerrffoorrmmaannccee RRiigghhttss
Shares 3,175,321
Performance Rights 1,513,750
RReelleevvaanntt SSkkiillllss
• pharmaceutical R&D, commercialisation
•
•
•
•
•
clinical expertise
commercial & entrepreneurial outlook
executive management, corporate turnarounds
finance and capital markets
experienced in listed company Directorships
4
43
5
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
BBaacckkggrroouunndd
BBaacckkggrroouunndd
Mrs Shanahan is a pioneer in the Australian finance
community. The first female stockbroker, Mrs
Mrs Shanahan is a pioneer in the Australian finance
Shanahan has also spent more than two decades
community. The first female stockbroker, Mrs
working and investing in medical R&D and
Shanahan has also spent more than two decades
commercialisation. She is currently a non-executive
working and investing in medical R&D and
director of Phoslock Water Solutions Ltd. Mrs
commercialisation. She is currently a non-executive
Shanahan is also a non-executive director of DMP
director of Phoslock Water Solutions Ltd. Mrs
Asset Management Ltd and SG Hiscock Ltd, a director
Shanahan is also a non-executive director of DMP
of the Kimberly Foundation of Australia Ltd, and Chair
Asset Management Ltd and SG Hiscock Ltd, a director
of the Aikenhead Centre for Medical Discovery in
of the Kimberly Foundation of Australia Ltd, and Chair
Melbourne. In 2021, Mrs Shanahan was recognised as
of the Aikenhead Centre for Medical Discovery in
an Officer in the General Division of the Order of
Melbourne. In 2021, Mrs Shanahan was recognised as
Australia.
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
Previously Mrs Shanahan was a member of the
a stockbroking firm, a fund management company and
Australian Stock Exchange and an executive director of
an actuarial company. Until 2017, she was Chair of St
a stockbroking firm, a fund management company and
Vincent’s Medical Research Institute and also a non-
an actuarial company. Until 2017, she was Chair of St
executive director of Challenger Limited (ASX: CGF).
Vincent’s Medical Research Institute and also a non-
Mrs Shanahan was formerly Chair of Challenger Listed
executive director of Challenger Limited (ASX: CGF).
Investments Ltd, the reporting entity for four ASX listed
Mrs Shanahan was formerly Chair of Challenger Listed
firms and formerly a non-executive director of Bell
Investments Ltd, the reporting entity for four ASX listed
Financial Group (ASX: BFG). Mrs Shanahan has also
firms and formerly a non-executive director of Bell
served and Chaired various Audit and Risk Committees
Financial Group (ASX: BFG). Mrs Shanahan has also
throughout her career, including Challenger Financial
served and Chaired various Audit and Risk Committees
Services Group Ltd, Bell Financial Group, Victoria
throughout her career, including Challenger Financial
University, JM Financial Group Ltd, SA Water, AWB
Services Group Ltd, Bell Financial Group, Victoria
International Ltd, BT Financial Group and V/Line
University, JM Financial Group Ltd, SA Water, AWB
Passenger.
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
Mrs Shanahan joined CLINUVEL in 2007 and was Non-
2010. Her depth of experience across global markets
Executive Chair of the Board from late 2007 until July
and medical research provides significant value to the
2010. Her depth of experience across global markets
current Board and Group.
and medical research provides significant value to the
current Board and Group.
BBRREENNDDAA SSHHAANNAAHHAANN
Non-Executive Director, AO, BComm, FAICD, ASIA
BBRREENNDDAA SSHHAANNAAHHAANN
Appointed 6 February 2007
Non-Executive Director, AO, BComm, FAICD, ASIA
Appointed 6 February 2007
CCoommmmiitttteeee MMeemmbbeerrsshhiipp
Chair of the Audit and Risk Committee
CCoommmmiitttteeee MMeemmbbeerrsshhiipp
Member of the Nomination Committee
Chair of the Audit and Risk Committee
Member of the Nomination Committee
CCuurrrreenntt DDiirreeccttoorrsshhiippss aanndd OOtthheerr IInntteerreessttss
CCuurrrreenntt DDiirreeccttoorrsshhiippss aanndd OOtthheerr IInntteerreessttss
Chair of the Aikenhead Centre for Medical Discovery,
Melbourne
Chair of the Aikenhead Centre for Medical Discovery,
Director of SG Hiscock Ltd
Melbourne
Chair, SG Hiscock Medtech Advisory Board
Director of SG Hiscock Ltd
Director of DMP Asset Management Ltd
Chair, SG Hiscock Medtech Advisory Board
Director of Rock Art Australia
Director of DMP Asset Management Ltd
Director of Rock Art Australia
OOtthheerr LLiisstteedd CCoommppaannyy DDiirreeccttoorrsshhiippss
((llaasstt 33 yyeeaarrss))
OOtthheerr LLiisstteedd CCoommppaannyy DDiirreeccttoorrsshhiippss
((llaasstt 33 yyeeaarrss))
Phoslock Water Solutions Ltd (ASX: PHK, since 2017)
Bell Financial Group (ASX: BFG, from 2012 to 2018)
Phoslock Water Solutions Ltd (ASX: PHK, since 2017)
Bell Financial Group (ASX: BFG, from 2012 to 2018)
RReelleevvaanntt IInntteerreesstt iinn SShhaarreess
aanndd PPeerrffoorrmmaannccee RRiigghhttss
RReelleevvaanntt IInntteerreesstt iinn SShhaarreess
aanndd PPeerrffoorrmmaannccee RRiigghhttss
Shares 233,969
Performance Rights 25,000
Shares 233,969
RReelleevvaanntt SSkkiillllss
Performance Rights 25,000
research & development in life sciences
research & development in life sciences
•
RReelleevvaanntt SSkkiillllss
• capital market understanding
•
• executive management
• capital market understanding
• experienced in listed company Directorships
• executive management
• experienced in listed company Directorships
44
6
6
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
BBaacckkggrroouunndd
Dr Agersborg is a Board-Certified Endocrinologist in
Pennsylvania, USA, currently serving as Clinical
Endocrinologist at Cape Regional Physicians
Associates specialising in Endocrinology, Diabetes &
Metabolism. Dr Agersborg had previously worked at
Easton Hospital, Steward Health, at Reading Hospital,
West Reading and at Suburban Hospital, Norristown as
Clinical Endocrinologist and served as Chief,
Endocrinology, Diabetes, Metabolism at Chestnut Hill
Hospital.
Dr Agersborg had an extensive career in managing
commercial sales & distribution at Wyeth
Pharmaceuticals (formerly Ayerst Laboratories).
Dr Agersborg has played an integral role in setting the
CLINUVEL Group’s US commercial strategy, resulting in
the US FDA’s approval of SCENESSE® in October 2019.
KKAARREENN AAGGEERRSSBBOORRGG
Non-Executive Director, MD
Appointed 29 January 2018
CCoommmmiitttteeee MMeemmbbeerrsshhiipp
Member of the Remuneration Committee
Member of the Nomination Committee
CCuurrrreenntt DDiirreeccttoorrsshhiippss aanndd OOtthheerr IInntteerreessttss
Fellow of the American Association of Clinical
Endocrinologists
Fellow of the American College of Osteopathic
Internists.
Doctorate of Osteopathic Medicine
OOtthheerr LLiisstteedd CCoommppaannyy DDiirreeccttoorrsshhiippss
((llaasstt 33 yyeeaarrss))
None
RReelleevvaanntt IInntteerreesstt iinn SShhaarreess
aanndd PPeerrffoorrmmaannccee RRiigghhttss
Shares 5,500
Performance Rights -
RReelleevvaanntt SSkkiillllss
• pharmaceutical research & development,
BBaacckkggrroouunndd
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 and also a non-
executive director of Challenger Limited (ASX: CGF).
Mrs Shanahan was formerly Chair of Challenger Listed
Investments Ltd, the reporting entity for four ASX listed
firms and formerly a non-executive director of Bell
Financial Group (ASX: BFG). Mrs Shanahan 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
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
BBRREENNDDAA SSHHAANNAAHHAANN
Non-Executive Director, AO, BComm, FAICD, ASIA
Appointed 6 February 2007
CCoommmmiitttteeee MMeemmbbeerrsshhiipp
Chair of the Audit and Risk Committee
Member of the Nomination Committee
CCuurrrreenntt DDiirreeccttoorrsshhiippss aanndd OOtthheerr IInntteerreessttss
Chair of the Aikenhead Centre for Medical Discovery,
Melbourne
Director of SG Hiscock Ltd
Chair, SG Hiscock Medtech Advisory Board
Director of DMP Asset Management Ltd
Director of Rock Art Australia
OOtthheerr LLiisstteedd CCoommppaannyy DDiirreeccttoorrsshhiippss
((llaasstt 33 yyeeaarrss))
Phoslock Water Solutions Ltd (ASX: PHK, since 2017)
Bell Financial Group (ASX: BFG, from 2012 to 2018)
Passenger.
RReelleevvaanntt IInntteerreesstt iinn SShhaarreess
aanndd PPeerrffoorrmmaannccee RRiigghhttss
Shares 233,969
Performance Rights 25,000
current Board and Group.
RReelleevvaanntt SSkkiillllss
•
research & development in life sciences
• capital market understanding
• executive management
• experienced in listed company Directorships
•
commercialisation
relevant knowledge on melanocortins, clinical
expertise
commercial knowhow in US pharmaceuticals
•
• general management
•
experience in private company Directorships
6
45
7
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
SSUUSSAANN ((SSUUEE)) SSMMIITTHH
SSUUSSAANN ((SSUUEE)) SSMMIITTHH
Non-Executive Director, Dipl ClinRisk
Non-Executive Director, Dipl ClinRisk
Appointed 23 September 2019
Appointed 23 September 2019
CCoommmmiitttteeee MMeemmbbeerrsshhiipp
CCoommmmiitttteeee MMeemmbbeerrsshhiipp
Member of the Remuneration Committee
Member of the Remuneration Committee
Member of the Nomination Committee
Member of the Nomination Committee
CCuurrrreenntt DDiirreeccttoorrsshhiippss aanndd OOtthheerr IInntteerreessttss
CCuurrrreenntt DDiirreeccttoorrsshhiippss aanndd OOtthheerr IInntteerreessttss
Non-Executive Board Chair of Women’s Health (London
Non-Executive Board Chair of Women’s Health (London
West One) Ltd
West One) Ltd
Non-Executive Director of Elite Medicine Ltd
Non-Executive Director of Elite Medicine Ltd
Trustee of the HCA International Foundation
Trustee of the HCA International Foundation
OOtthheerr LLiisstteedd CCoommppaannyy DDiirreeccttoorrsshhiippss
OOtthheerr LLiisstteedd CCoommppaannyy DDiirreeccttoorrsshhiippss
((llaasstt 33 yyeeaarrss))
((llaasstt 33 yyeeaarrss))
None
None
RReelleevvaanntt IInntteerreesstt iinn SShhaarreess
RReelleevvaanntt IInntteerreesstt iinn SShhaarreess
aanndd PPeerrffoorrmmaannccee RRiigghhttss
aanndd PPeerrffoorrmmaannccee RRiigghhttss
Shares 420
Shares 420
RReelleevvaanntt SSkkiillllss
RReelleevvaanntt SSkkiillllss
•
executive healthcare management
•
executive healthcare management
•
leadership and strategy setting in complex
•
leadership and strategy setting in complex
environments
environments
•
risk management and governance
•
risk management and governance
• customer relations
• customer relations
Performance Rights -
Performance Rights -
BBaacckkggrroouunndd
BBaacckkggrroouunndd
Mrs Smith manages an established consultancy
Mrs Smith manages an established consultancy
business, providing advisory services to a range of
business, providing advisory services to a range of
healthcare organisations, investors and boards of
healthcare organisations, investors and boards of
directors and in 2021 formed SSJ Partnership Ltd, a
directors and in 2021 formed SSJ Partnership Ltd, a
consultancy specialising in providing regulatory
consultancy specialising in providing regulatory
governance support in the healthcare sector. Mrs
governance support in the healthcare sector. Mrs
Smith has led a distinguished career, serving for 14
Smith has led a distinguished career, serving for 14
years as Chief Executive Officer of The Princess Grace
years as Chief Executive Officer of The Princess Grace
Hospital, London, and 11 years as the Chief Executive
Hospital, London, and 11 years as the Chief Executive
Officer of The Portland Hospital for Women and
Officer of The Portland Hospital for Women and
Children, London. Mrs Smith’s specific expertise is in
Children, London. Mrs Smith’s specific expertise is in
the implementation of operational strategies within
the implementation of operational strategies within
complex and acute care environments, and in the
complex and acute care environments, and in the
interaction with healthcare authorities and UK
interaction with healthcare authorities and UK
regulators. Her most recent role was as the Chief
regulators. Her most recent role was as the Chief
Executive Officer of the Independent Doctors
Executive Officer of the Independent Doctors
Federation, a membership organisation representing
Federation, a membership organisation representing
practicing physicians within the UK independent
practicing physicians within the UK independent
healthcare sector.
healthcare sector.
Her past experience is now successfully translating
Her past experience is now successfully translating
into a diverse portfolio with non-executive director
into a diverse portfolio with non-executive director
appointments, having been successful in completing
appointments, having been successful in completing
the Financial Times Non-Executive Director Advanced
the Financial TimesNon-Executive Director Advanced
Professional Diploma. She is Board Chair of the
Professional Diploma. She is Board Chair of the
Evewell (Harley St) Ltd, a fully integrated centre of
Evewell (Harley St) Ltd, a fully integrated centre of
medical excellence dedicated to caring for, and
medical excellence dedicated to caring for, and
protecting, all aspects of fertility and gynaecological
protecting, all aspects of fertility and gynaecological
health. She also sits on the Advisory Board for
health. She also sits on the Advisory Board for
SweetTree Home Care Services, providing the bridge
SweetTree Home Care Services, providing the bridge
between hospital and community care. In the face of
between hospital and community care. In the face of
the ever-changing healthcare market Mrs Smith fosters
the ever-changing healthcare market Mrs Smith fosters
first class relationships with a wide range of healthcare
first class relationships with a wide range of healthcare
stakeholders to build first class services for patients.
stakeholders to build first class services for patients.
46
8
8
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
BBaacckkggrroouunndd
Mrs Smith manages an established consultancy
business, providing advisory services to a range of
healthcare organisations, investors and boards of
directors and in 2021 formed SSJ Partnership Ltd, a
consultancy specialising in providing regulatory
governance support in the healthcare sector. Mrs
Smith 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
practicing physicians within the UK independent
Her past experience is now successfully translating
into a diverse portfolio with non-executive director
appointments, having been successful in completing
the Financial Times Non-Executive Director Advanced
Professional Diploma. She is Board Chair of the
Evewell (Harley St) Ltd, a fully integrated centre of
medical excellence dedicated to caring for, and
protecting, all aspects of fertility and gynaecological
health. She also sits on the Advisory Board for
SweetTree Home Care Services, providing the bridge
between hospital and community care. In the face of
the ever-changing healthcare market Mrs Smith fosters
first class relationships with a wide range of healthcare
stakeholders to build first class services for patients.
CCuurrrreenntt DDiirreeccttoorrsshhiippss aanndd OOtthheerr IInntteerreessttss
healthcare sector.
SSUUSSAANN ((SSUUEE)) SSMMIITTHH
Non-Executive Director, Dipl ClinRisk
Appointed 23 September 2019
CCoommmmiitttteeee MMeemmbbeerrsshhiipp
Member of the Remuneration Committee
Member of the Nomination Committee
Non-Executive Board Chair of Women’s Health (London
West One) Ltd
Non-Executive Director of Elite Medicine Ltd
Trustee of the HCA International Foundation
OOtthheerr LLiisstteedd CCoommppaannyy DDiirreeccttoorrsshhiippss
((llaasstt 33 yyeeaarrss))
None
RReelleevvaanntt IInntteerreesstt iinn SShhaarreess
aanndd PPeerrffoorrmmaannccee RRiigghhttss
Shares 420
Performance Rights -
RReelleevvaanntt SSkkiillllss
•
•
•
executive healthcare management
leadership and strategy setting in complex
environments
risk management and governance
• customer relations
BBaacckkggrroouunndd
BBaacckkggrroouunndd
Prof Rosenfeld is an internationally recognised
Prof Rosenfeld is an internationally recognised
neurosurgeon with extensive experience in senior
neurosurgeon with extensive experience in senior
healthcare and medical research executive roles and a
healthcare and medical research executive roles and a
distinguished and decorated career in the Australian
distinguished and decorated career in the Australian
Army. He is a retired Major General and a former
Army. He is a retired Major General and a former
Surgeon General, Australian Defence Force-Reserves.
Surgeon General, Australian Defence Force-Reserves.
He has served on eight deployments to Rwanda, Iraq,
He has served on eight deployments to Rwanda, Iraq,
Solomon Islands, Bougainville and East Timor. He was
Solomon Islands, Bougainville and East Timor. He was
the Founding Director of Monash University Institute of
the Founding Director of Monash University Institute of
Medical Engineering (MIME)-Melbourne. He is
Medical Engineering (MIME)-Melbourne. He is
developing a bionic vision device to restore vision in
developing a bionic vision device to restore vision in
blind people, and he is also a leader in brain injury
blind people, and he is also a leader in brain injury
research. Prof Rosenfeld was Director of Neurosurgery
research. Prof Rosenfeld was Director of Neurosurgery
at the Alfred Hospital for fifteen years, concurrently
at the Alfred Hospital for fifteen years, concurrently
holding Professor and Head of the Department of
holding Professor and Head of the Department of
Surgery at Monash University for nine years. Prof
Surgery at Monash University for nine years. Prof
Rosenfeld is active in many community organisations
Rosenfeld is active in many community organisations
and champions various charitable causes. Prof
and champions various charitable causes. Prof
Rosenfeld has been an active volunteer for the
Rosenfeld has been an active volunteer for the
Australian-Aid funded Pacific Islands Project which
Australian-Aid funded Pacific Islands Project which
transfers clinical skills and knowledge to healthcare
transfers clinical skills and knowledge to healthcare
professionals in Papua New Guinea, Fiji and the
professionals in Papua New Guinea, Fiji and the
Solomon Islands.
Solomon Islands.
In 2018, Prof Rosenfeld was awarded the Companion
In 2018, Prof Rosenfeld was awarded the Companion
of the Order of Australia, which is Australia’s highest
of the Order of Australia, which is Australia’s highest
civilian honour, the Meritorious Service Medal of the
civilian honour, the Meritorious Service Medal of the
United States of America in 2017 and Officer in the
United States of America in 2017 and Officer in the
Order of the British Empire in 2013. Prof Rosenfeld
Order of the British Empire in 2013. Prof Rosenfeld
also became an Emeritus Professor at Monash
also became an Emeritus Professor at Monash
University in January 2021.
University in January 2021.
JJEEFFFFRREEYY RROOSSEENNFFEELLDD
JJEEFFFFRREEYY RROOSSEENNFFEELLDD
Non-Executive Director, AC, OBE
Non-Executive Director, AC, OBE
Appointed 26 November 2019
Appointed 26 November 2019
CCoommmmiitttteeee MMeemmbbeerrsshhiipp
CCoommmmiitttteeee MMeemmbbeerrsshhiipp
Member of the Audit and Risk Committee
Member of the Audit and Risk Committee
Member of the Nomination Committee
Member of the Nomination Committee
CCuurrrreenntt DDiirreeccttoorrsshhiippss aanndd OOtthheerr IInntteerreessttss
CCuurrrreenntt DDiirreeccttoorrsshhiippss aanndd OOtthheerr IInntteerreessttss
Director of Vision for TBI Ltd
Director of Vision for TBI Ltd
Former Major General, Australian Defence Force (Army
Former Major General, Australian Defence Force (Army
Reserve)
Reserve)
OOtthheerr LLiisstteedd CCoommppaannyy DDiirreeccttoorrsshhiippss
OOtthheerr LLiisstteedd CCoommppaannyy DDiirreeccttoorrsshhiippss
((llaasstt 33 yyeeaarrss))
((llaasstt 33 yyeeaarrss))
None
None
RReelleevvaanntt IInntteerreesstt iinn SShhaarreess
RReelleevvaanntt IInntteerreesstt iinn SShhaarreess
aanndd PPeerrffoorrmmaannccee RRiigghhttss
aanndd PPeerrffoorrmmaannccee RRiigghhttss
Shares 2,363
Shares 2,363
RReelleevvaanntt SSkkiillllss
RReelleevvaanntt SSkkiillllss
•
•
•
•
• board and committee oversight and governance
• board and committee oversight and governance
•
•
lifetime experience in providing healthcare
lifetime experience in providing healthcare
clinical research and development
clinical research and development
leadership and management
leadership and management
Performance Rights -
Performance Rights -
8
9
47
9
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
IInnffoorrmmaattiioonn oonn CCoommppaannyy SSeeccrreettaarryy
DDAARRRREENN KKEEAAMMYY
Company Secretary, Chief Financial Officer
Qualifications: BComm, CPA, GradDip ACG
Mr Keamy, a Certified Practicing Accountant and
Company Secretary, joined CLINUVEL in November
2005 and became Chief Financial Officer of the Group
in 2006. He has previously worked in key management
accounting and commercial roles in Amcor Limited
and has experience working in Europe in financial
regulation and control within the banking and retail
pharmaceutical industries.
MMeeeettiinngg ooff DDiirreeccttoorrss
The following table summarises the number of and
attendance at all meetings of Directors during the
financial year:
He has overseen the financial management of the
Group since 2005, played a role in raising A$95 million
in capital, and assisted the steering of the Group from
a loss-making, pre-revenue position to a commercially
focussed profitable enterprise.
Director
Board
MMrrss.. BB..MM.. SShhaannaahhaann
DDrr.. PP..JJ.. WWoollggeenn
MMrr.. WW.. BBlliijjddoorrpp
DDrr.. KK.. AA.. AAggeerrssbboorrgg
MMrrss.. SS.. EE.. SSmmiitthh
PPrrooff JJ.. VV.. RRoosseennffeelldd
A
9
9
9
9
9
9
B
9
9
9
8
9
9
Audit & Risk
Committee
A
3
3
B
3
3
3
3
Remuneration
Committee
A
B
5
5
5
5
5
5
Nomination
Committee
A
1
1
1
1
1
B
1
1
1
1
1
CCoolluummnn AA iinnddiiccaatteess tthhee nnuummbbeerr ooff mmeeeettiinnggss hheelldd dduurriinngg tthhee ppeerriioodd tthhee DDiirreeccttoorr wwaass aa mmeemmbbeerr ooff tthhee BBooaarrdd aanndd//oorr BBooaarrdd CCoommmmiitttteeee..
CCoolluummnn BB iinnddiiccaatteess tthhee nnuummbbeerr ooff mmeeeettiinnggss aatttteennddeedd dduurriinngg tthhee ppeerriioodd tthhee DDiirreeccttoorr wwaass aa mmeemmbbeerr ooff tthhee BBooaarrdd aanndd//oorr BBooaarrdd CCoommmmiitttteeee..
TThhee NNoommiinnaattiioonn CCoommmmiitttteeee iinntteennddss ttoo mmeeeett ttwwiiccee aa yyeeaarr.. TThhee sseeccoonndd mmeeeettiinngg ffoorr tthhee ffiinnaanncciiaall yyeeaarr wwaass hheelldd 1166 JJuullyy,, wwiitthh aatt lleeaasstt 22 mmoorree mmeeeettiinnggss ttoo bbee hheelldd iinn
FFYY22002222..
48
10
CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
Mr Keamy, a Certified Practicing Accountant and
He has overseen the financial management of the
Company Secretary, joined CLINUVEL in November
Group since 2005, played a role in raising A$95 million
2005 and became Chief Financial Officer of the Group
in capital, and assisted the steering of the Group from
in 2006. He has previously worked in key management
a loss-making, pre-revenue position to a commercially
accounting and commercial roles in Amcor Limited
focussed profitable enterprise.
IInnffoorrmmaattiioonn oonn CCoommppaannyy SSeeccrreettaarryy
DDAARRRREENN KKEEAAMMYY
Company Secretary, Chief Financial Officer
Qualifications: BComm, CPA, GradDip ACG
and has experience working in Europe in financial
regulation and control within the banking and retail
pharmaceutical industries.
MMeeeettiinngg ooff DDiirreeccttoorrss
The following table summarises the number of and
attendance at all meetings of Directors during the
financial year:
Director
Board
Audit & Risk
Committee
Remuneration
Committee
Nomination
Committee
A
9
9
9
9
9
9
MMrrss.. BB..MM.. SShhaannaahhaann
DDrr.. PP..JJ.. WWoollggeenn
MMrr.. WW.. BBlliijjddoorrpp
DDrr.. KK.. AA.. AAggeerrssbboorrgg
MMrrss.. SS.. EE.. SSmmiitthh
PPrrooff JJ.. VV.. RRoosseennffeelldd
FFYY22002222..
B
9
9
9
8
9
9
A
3
3
3
B
3
3
3
A
5
5
5
B
5
5
5
A
1
1
1
1
1
B
1
1
1
1
1
CCoolluummnn AA iinnddiiccaatteess tthhee nnuummbbeerr ooff mmeeeettiinnggss hheelldd dduurriinngg tthhee ppeerriioodd tthhee DDiirreeccttoorr wwaass aa mmeemmbbeerr ooff tthhee BBooaarrdd aanndd//oorr BBooaarrdd CCoommmmiitttteeee..
CCoolluummnn BB iinnddiiccaatteess tthhee nnuummbbeerr ooff mmeeeettiinnggss aatttteennddeedd dduurriinngg tthhee ppeerriioodd tthhee DDiirreeccttoorr wwaass aa mmeemmbbeerr ooff tthhee BBooaarrdd aanndd//oorr BBooaarrdd CCoommmmiitttteeee..
TThhee NNoommiinnaattiioonn CCoommmmiitttteeee iinntteennddss ttoo mmeeeett ttwwiiccee aa yyeeaarr.. TThhee sseeccoonndd mmeeeettiinngg ffoorr tthhee ffiinnaanncciiaall yyeeaarr wwaass hheelldd 1166 JJuullyy,, wwiitthh aatt lleeaasstt 22 mmoorree mmeeeettiinnggss ttoo bbee hheelldd iinn
PPrriinncciippllee OObbjjeeccttiivveess aanndd AAccttiivviittiieess
OObbjjeeccttiivveess
CLINUVEL PHARMACEUTICALS LTD (CLINUVEL) is a
global biopharmaceutical company focussed on
developing and delivering treatments for patients with
genetic, metabolic, and life-threatening disorders, as
well as healthcare solutions for the general population.
CLINUVEL’s pioneering work in melanocortins aims to
translate scientific breakthroughs to innovative medical
solutions for complex problems and thus deliver
lifelong care and novel products to patient groups and
individuals at high risk of exposure to light.
CLINUVEL’s expertise in understanding the interaction
of melanocortins and human biology is focussed on
developing treatments for patients with genetic and
acute diseases who lack therapy. Research into
afamelanotide focuses on the use of the hormone in
severe light related disorders and depigmentation, and
has recently expanded into diseases of the Central
Nervous System and various other organs. The patient
populations in these diseases range in size from 5,000
to 45 million worldwide.
CLINUVEL has developed and launched the world’s first
systemic photoprotective drug, SCENESSE®
(afamelanotide 16mg), in Europe and the USA. During
the year, the scope of CLINUVEL’s research and
development program was extended to the application
of melanocortins to treat acute disorders and vascular
anomalies.
The long-term financial objective of the Group is to
maximise company value through the distribution of
treatments to patients and special populations in need.
The key to long-term sustainable performance is to
continue targeted research and development of a
portfolio of assets centred around its key drug
candidate SCENESSE® and its melanocortin derivatives;
their successful commercialisation, manufacture, and
distribution; and maintaining financial discipline and
stability.
PPeerrffoorrmmaannccee IInnddiiccaattoorrss
Management and the Board monitor the overall
performance of the Group in the achievement of its
objectives in relation to a defined strategic plan and
annual operating and financial budgets.
The Board, with management, have identified a range of
key performance indicators (KPIs) that are used
annually to monitor performance. Key managers
monitor performance against these KPIs and provide
regular reports to the Board for review, feedback, and
guidance, as necessary. This enables the Board to
actively monitor and guide the Group’s performance.
AAccttiivviittiieess
The principal activities of the Group during the financial
year were to:
• manage and expand the commercial distribution in
Europe and the USA of its leading drug candidate
SCENESSE® for the treatment of a rare, genetic
metabolic disorder, erythropoietic protoporphyria
(EPP);
progress the ongoing research and development of
the Pharmaceutical Division’s product pipeline for a
range of severe disorders, including:
•
o SCENESSE® in combination with narrowband
ultraviolet B (NB-UVB) phototherapy and topical
pharmaceutical formulations of melanocortin
analogues for the treatment of the skin
depigmentation disorder, vitiligo;
o topical based pharmaceutical formulations for
photoprotection of the skin;
o medicinal photoprotection through DNA repair of
the skin and initiating first studies in the genetic
disorder, xeroderma pigmentosum (XP);
o commencing first pilot studies to investigate the
use of SCENESSE® as a medicinal therapy for
acute arterial ischaemic stroke (AIS); and
o the ongoing development of PRÉNUMBRA®, a
new liquid formulation of afamelanotide for the
treatment of acute disorders and vascular
anomalies.
•
through the Healthcare Solutions Division, progress
the development of a range of non-prescription,
dermatocosmetic products for individuals at high
risk of exposure to ultraviolet (UV) and High Energy
Visible (HEV) light.
10
11
49
CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
RReevviieeww ooff OOppeerraattiioonnss aanndd FFiinnaanncciiaall CCoonnddiittiioonn
There was no significant change in the nature of the
Group’s activities during the financial year.
KKeeyy FFeeaattuurreess ooff BBuussiinneessss OOppeerraattiioonnss
There are several key features of CLINUVEL’s business
operations:
• The commercial operations of the Group are
undertaken in Europe and the USA.
o Since June 2016 CLINUVEL has distributed
SCENESSE® to EPP patients through accredited
EPP Expert Centres, working within the
commitments agreed with the European
Medicines Agency (EMA) as a condition for
continuous marketing authorisation.
o Since April 2020, CLINUVEL has been distributing
treatment for patients with EPP through
accredited Specialty Centers in the US, in
accordance with the approval of the FDA, granted
in October 2019.
• The net price per unit of SCENESSE® is uniform
across the jurisdictions in which it operates.
o Manufacturing and distribution costs specific to
each jurisdiction determines the gross price of
SCENESSE®.
o This approach reflects the Group’s values of
fairness and equitable access to treatment by all
patients.
• SCENESSE® is manufactured in the USA by a sole
contract manufacturer and is distributed by the
Group directly to accredited EPP Expert Centres in
Europe and Specialty Centers in the USA.
• CLINUVEL’s cash receipts are markedly higher in the
northern hemisphere from spring to autumn when
ambient light is more intense and demand for
treatment from EPP patients is higher.
• The Group has an ongoing clinical interest to further
develop SCENESSE® and its derivatives with a focus
on vitiligo, a skin depigmentation disorder; and DNA
repair of the skin with initial clinical studies to
commence in xeroderma pigmentosum (XP); in
acute arterial ischaemic stoke (AIS); and in an
undisclosed further indication.
• The research and development program has been
extended through the development of a second
formulation of afamelanotide, PRÉNUMBRA®, with a
focus on its application in acute disorders and
vascular anomalies.
• The Group’s product development program is
conducted through its fully owned Singaporean
subsidiary, VALLAURIX PTE LTD (VALLAURIX) with a
focus on developing pharmaceutical topical
products and other formulations and an over-the-
counter, dermatocosmetic product range.
• The Melbourne headquarters of the Group covers
the key regulatory affairs, scientific programme,
finance, and investor relations functions, whilst the
United Kingdom office co-ordinates global
operations, communications, and marketing.
RReevviieeww ooff OOppeerraattiioonnss
The review of operations for the year ended 30 June
2021 (FY2021) focuses on:
•
•
•
•
the distribution of SCENESSE® in Europe and the
USA;
ongoing work to obtain regulatory approval of
SCENESSE® in new jurisdictions;
the expansion of the Group’s research and
development program to develop SCENESSE® and
its analogues for the treatment of patients with a
range of severe skin and vascular disorders; and
the development of non-prescription,
dermatocosmetic products.
DDiissttrriibbuuttiioonn ooff SSCCEENNEESSSSEE®® iinn EEuurrooppee
The supply of SCENESSE® to EPP Expert Centres across
key European countries, including under a special
access scheme to Switzerland, continued in FY2021.
During the COVID-19 pandemic, the majority of EPP
Expert Centres have continued to prescribe SCENESSE®
due to strong patient demand. A small number of
Centres either deferred orders or reduced order sizes in
the initial months of the COVID-19 infections in the
second half of FY2020. These few Centres were not
able to provide treatment access to patients, or patients
were unable to travel to Centres. Despite the
uncertainty surrounding the pandemic, patient demand
for SCENESSE® remained high during FY2021, with
50
12
CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
RReevviieeww ooff OOppeerraattiioonnss aanndd FFiinnaanncciiaall CCoonnddiittiioonn
• The net price per unit of SCENESSE® is uniform
across the jurisdictions in which it operates.
USA;
o Manufacturing and distribution costs specific to
each jurisdiction determines the gross price of
There was no significant change in the nature of the
Group’s activities during the financial year.
KKeeyy FFeeaattuurreess ooff BBuussiinneessss OOppeerraattiioonnss
There are several key features of CLINUVEL’s business
operations:
• The commercial operations of the Group are
undertaken in Europe and the USA.
o Since June 2016 CLINUVEL has distributed
SCENESSE® to EPP patients through accredited
EPP Expert Centres, working within the
commitments agreed with the European
Medicines Agency (EMA) as a condition for
continuous marketing authorisation.
o Since April 2020, CLINUVEL has been distributing
treatment for patients with EPP through
accredited Specialty Centers in the US, in
accordance with the approval of the FDA, granted
in October 2019.
o This approach reflects the Group’s values of
fairness and equitable access to treatment by all
SCENESSE®.
patients.
• SCENESSE® is manufactured in the USA by a sole
contract manufacturer and is distributed by the
Group directly to accredited EPP Expert Centres in
Europe and Specialty Centers in the USA.
• CLINUVEL’s cash receipts are markedly higher in the
northern hemisphere from spring to autumn when
ambient light is more intense and demand for
treatment from EPP patients is higher.
• The Group has an ongoing clinical interest to further
develop SCENESSE® and its derivatives with a focus
on vitiligo, a skin depigmentation disorder; and DNA
repair of the skin with initial clinical studies to
commence in xeroderma pigmentosum (XP); in
acute arterial ischaemic stoke (AIS); and in an
undisclosed further indication.
• The research and development program has been
extended through the development of a second
formulation of afamelanotide, PRÉNUMBRA®, with a
focus on its application in acute disorders and
vascular anomalies.
• The Group’s product development program is
conducted through its fully owned Singaporean
subsidiary, VALLAURIX PTE LTD (VALLAURIX) with a
focus on developing pharmaceutical topical
products and other formulations and an over-the-
counter, dermatocosmetic product range.
• The Melbourne headquarters of the Group covers
the key regulatory affairs, scientific programme,
finance, and investor relations functions, whilst the
United Kingdom office co-ordinates global
operations, communications, and marketing.
RReevviieeww ooff OOppeerraattiioonnss
The review of operations for the year ended 30 June
2021 (FY2021) focuses on:
•
the distribution of SCENESSE® in Europe and the
• ongoing work to obtain regulatory approval of
SCENESSE® in new jurisdictions;
•
the expansion of the Group’s research and
development program to develop SCENESSE® and
its analogues for the treatment of patients with a
range of severe skin and vascular disorders; and
•
the development of non-prescription,
dermatocosmetic products.
DDiissttrriibbuuttiioonn ooff SSCCEENNEESSSSEE®® iinn EEuurrooppee
The supply of SCENESSE® to EPP Expert Centres across
key European countries, including under a special
access scheme to Switzerland, continued in FY2021.
During the COVID-19 pandemic, the majority of EPP
Expert Centres have continued to prescribe SCENESSE®
due to strong patient demand. A small number of
Centres either deferred orders or reduced order sizes in
the initial months of the COVID-19 infections in the
second half of FY2020. These few Centres were not
able to provide treatment access to patients, or patients
were unable to travel to Centres. Despite the
uncertainty surrounding the pandemic, patient demand
for SCENESSE® remained high during FY2021, with
12
existing patients continuing to seek treatment and new
patients receiving treatment for the first time.
We continue to progress reimbursement of the cost of
treatment with authorities in several European
countries.
insurers to reimburse the cost of treatment. These
activities were one factor driving the Company’s record
revenues and profit in FY2021.
SSCCEENNEESSSSEE®® ffoorr EEPPPP iinn NNeeww JJuurriissddiiccttiioonnss
DDiissttrriibbuuttiioonn ooff SSCCEENNEESSSSEE®® iinn tthhee UUSSAA
On 8 October 2019, the US FDA approved SCENESSE®
to increase pain free light exposure in adult patients
with a history of phototoxic reactions from EPP. This
was a milestone approval for the Group after 15 years
of research and development of SCENESSE® for EPP.
Following the FDA’s approval, the Group activated its
implementation plan for US operations and, within six
months of approval, completed the key pre-distribution
logistics to commence treatment. These logistics
included establishing the business infrastructure,
securing correct codes for treatment to ensure
seamless operations and reimbursement, initial insurer
discussions and agreement to obtain reimbursement
for the cost of treatment, and identification of the initial
Specialty Centers to be accredited and trained by
CLINUVEL.
In April 2021, CLINUVEL recorded its first anniversary of
distributing SCENESSE® for adult EPP patients in the
USA. Over 60 insurance companies are actively
involved in the reimbursement of the cost of treatment,
mainly under Prior Authorization (PA). CLINUVEL
continues to operate a Savings Program to assist with
the out-of-pocket expenses of patients and provides a
dedicated patient and healthcare professional website
to facilitate patient access to treatment. CLINUVEL
actively supports patients and Specialty Centers to
liaise with insurance companies to obtain approvals to
reimburse the cost of treatment under PA.
The initial target was to accredit up to 30 Specialty
Centers across the USA over a phased period by the
end of calendar year 2021. CLINUVEL has currently
trained and accredited over 40 Specialty Centers which
is well ahead of planning. Cash receipts for FY2021
included the first receipts from the supply of
SCENESSE® in the US market. The Company’s
experience is that payment terms are longer in duration
in the US than the 30 to 60 days average length of
payment term in Europe. After initial revenues were
recorded from first-adopter orders prior to 30 June
2020, revenues rose throughout FY2021, underpinned
by the progress achieved in the number of Specialty
Centers accredited and the approvals under PA with
The Group continues to work towards gaining
regulatory approval for SCENESSE® for EPP patients in
other important markets. This reflects our commitment
to provide EPP patients worldwide with access to
SCENESSE®.
In October 2020, the Australian Therapeutic Goods
Administration (TGA) approved the registration of
SCENESSE® for the prevention of phototoxicity in adult
patients with EPP, after a nine-month review of the
SCENESSE® scientific dossier. This is the first
treatment approved for EPP in Australia. Following the
TGA approval, SCENESSE® has been registered on the
Australian Register of Therapeutic Goods (ARTG) and
subject to the agreement of the Pharmaceutical
Benefits Advisory Committee, will be made available on
the Pharmaceutical Benefit Scheme (PBS) in Australia.
It is expected that the drug will be administered by
specialists in an outpatient setting through speciality
centres.
In February 2021, the Israeli Ministry of Health
approved SCENESSE® as a first-line treatment for the
prevention of phototoxicity to all adult patients
diagnosed with EPP. It is anticipated this first approval
of national reimbursement in the Middle East opens the
pathway to other countries in the region.
The Collaboration Agreement to treat EPP patients with
SCENESSE® under a Named Patient Program (NPP) in
the People’s Republic of China continues. The
collaboration with the local distribution partner focuses
on facilitating early access for Chinese EPP patients
while collecting data to file for a new drug application
(NDA) to the Chinese National Medical Products
Administration (NMPA). CLINUVEL and its distribution
partner is working with prominent hospitals in China to
facilitate EPP patient treatment. It is planned that the
NPP will include up to 10 Chinese EPP patients –
treated according to US and EU protocols – who will be
evaluated during a defined period. Local subsidies are
available to enable eligible EPP patients to receive
treatment. Following treatment with SCENESSE® under
the NPP, CLINUVEL and its partner will evaluate the
drug’s safety and effectiveness in Chinese EPP
patients. The collaboration will also focus on
subsequent registration of SCENESSE® on the National
51
13
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
Drug Reimbursement List. On a prevalence basis, an
estimated 5,000 Chinese residents suffer from EPP, for
which there is no approved therapy in China.
CLINUVEL plans to seek regulatory approval to
distribute SCENESSE® in other countries, including
European countries not in the EU, the Middle East,
Japan and Latin America.
EExxppaannssiioonn SSiinnggaappoorree LLaabboorraattoorryy
New state of the art and expanded laboratories in
Singapore were commissioned in August 2020 to
further progress R&D on novel melanocortins, and
prescription and over-the-counter products. After minor
delays due to the COVID-19 pandemic in opening the
expanded Company’s Research, Development &
Innovation (RDI) Centre, the facility commenced
operations with an expanded and skilled team and
fitted with specialised technical laboratory equipment
to further enhance the progress of its product pipeline
and underly a new divisional structure.
The RDI Centre is operated by the Group’s wholly
owned subsidiary, VALLAURIX Pte Ltd. The Singapore
Economic Development Board (EDB) is supporting this
expansion with an award under their Research Incentive
Scheme for Companies (RISC). This is part of the
Government of Singapore’s incentives to assist
Singaporean businesses to develop their research
capacity to advance high valued technologies. The EDB
award is up to S$500,000 (A$547,000) over three years,
subject to ongoing conditions being met.
NNeeww OOrrggaanniissaattiioonnaall SSttrruuccttuurree
To support the strategic objectives and initiatives of the
Group, a new organisational structure of four divisions
was implemented during FY2021:
•
•
•
the Pharmaceuticals Division, CLINUVEL’s core
business focussed on developing and delivering
products for patients with unmet medical need;
the Healthcare Solutions Division, concentrated on
non-prescription products derived from the know-
how and active ingredients used in the
Pharmaceuticals Division;
the Communications, Branding and Marketing
Division which prepares communications to wider
differentiated audiences, positioning the Group for
broader engagement; and the
• Manufacturing Division, focussed on novel
formulations and products for CLINUVEL and
research, development and production for other
companies and research groups in the
biopharmaceutical sector.
52
14
CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
Drug Reimbursement List. On a prevalence basis, an
estimated 5,000 Chinese residents suffer from EPP, for
which there is no approved therapy in China.
CLINUVEL plans to seek regulatory approval to
distribute SCENESSE® in other countries, including
European countries not in the EU, the Middle East,
Japan and Latin America.
EExxppaannssiioonn SSiinnggaappoorree LLaabboorraattoorryy
New state of the art and expanded laboratories in
Singapore were commissioned in August 2020 to
further progress R&D on novel melanocortins, and
prescription and over-the-counter products. After minor
delays due to the COVID-19 pandemic in opening the
expanded Company’s Research, Development &
Innovation (RDI) Centre, the facility commenced
operations with an expanded and skilled team and
fitted with specialised technical laboratory equipment
to further enhance the progress of its product pipeline
and underly a new divisional structure.
The RDI Centre is operated by the Group’s wholly
owned subsidiary, VALLAURIX Pte Ltd. The Singapore
the Pharmaceuticals Division, CLINUVEL’s core
Economic Development Board (EDB) is supporting this
business focussed on developing and delivering
expansion with an award under their Research Incentive
products for patients with unmet medical need;
Scheme for Companies (RISC). This is part of the
the Healthcare Solutions Division, concentrated on
Government of Singapore’s incentives to assist
non-prescription products derived from the know-
Singaporean businesses to develop their research
how and active ingredients used in the
capacity to advance high valued technologies. The EDB
Pharmaceuticals Division;
award is up to S$500,000 (A$547,000) over three years,
the Communications, Branding and Marketing
•
•
•
subject to ongoing conditions being met.
NNeeww OOrrggaanniissaattiioonnaall SSttrruuccttuurree
To support the strategic objectives and initiatives of the
Group, a new organisational structure of four divisions
was implemented during FY2021:
Division which prepares communications to wider
differentiated audiences, positioning the Group for
broader engagement; and the
• Manufacturing Division, focussed on novel
formulations and products for CLINUVEL and
research, development and production for other
companies and research groups in the
biopharmaceutical sector.
Underlying the divisional structure is the RDI Centre in
Singapore, researching molecular science, biology, and
follow-on formulations.
PPrroodduucctt PPiippeelliinnee
The Group has an extensive product development
pipeline that encompasses the application of
SCENESSE® and other novel treatments for patients
with severe genetic, skin, and vascular disorders which
lack therapeutic alternatives.
The pipeline includes research and development into:
• a paediatric formulation of SCENESSE® for EPP;
• SCENESSE® for adult vitiligo patients;
• next generation products based on melanocortin
analogues CUV9900 and VLRX001, currently being
evaluated as an adjuvant maintenance therapy in
vitiligo, with the intention of developing these
analogues for medicinal purposes to be
administered topically;
• a range of over-the-counter products for general
•
•
•
photoprotective application;
the use of melanocortins in DNA repair of the skin;
the role of afamelanotide in treatment of acute
stroke (AIS); and
the application of a newly developed second
formulation of afamelanotide, PRÉNUMBRA®, a non-
solid controlled-release formulation, to be evaluated
in clinical trials for acute disorders and vascular
anomalies.
VViittiilliiggoo PPrrooggrraamm
The Group continues to pursue a clinical program to
evaluate the effectiveness of SCENESSE® to activate
and repopulate melanocytes within vitiliginous lesions
(depigmented skin areas) and achieve repigmentation
in combination with NB-UVB phototherapy in patients
with vitiligo.
In FY2020 a Type C Guidance Meeting was held with
the FDA, the purpose of which was to seek agreement
on the design of a multicentre Phase IIb vitiligo clinical
study (CUV104) and the data package necessary to
support a supplemental New Drug Application (sNDA)
filing for SCENESSE® in vitiligo. Following the meeting,
CLINUVEL has been liaising with the FDA and clinical
experts to finalise the documentation and clinical trial
protocol (CUV104) to advance SCENESSE® as the first
systemic repigmentation agent in North America.
In March 2021, the FDA held a virtual public meeting on
patient-focussed drug development for vitiligo which
attracted 1,155 participants. The recognition of vitiligo
as a disease needing treatment was encouraging, as
was the majority of patients who advised in the meeting
that they may or would use a topical treatment if it
provided up to 50% repigmentation with modest side-
effects.
Subject to agreement of the clinical protocol by the FDA
and pending acceptable results on the ongoing safety
and efficacy in its vitiligo program, CLINUVEL would
seek to file a sNDA for SCENESSE®. A sNDA, referred to
as an “efficacy supplement”, is required to add a new
indication to the labelling of an approved drug in the
USA, with the submission consisting of clinical data
supporting the new indication and any additional
studies which may be required to support the efficacy
and safety in the new indication.
DDNNAA RReeppaaiirr PPrrooggrraamm
Scientific advancements on melanocortins and
CLINUVEL’s programs have shown that afamelanotide
can assist in the repair of cellular DNA damage caused
by exposure to ultraviolet radiation. In September 2020,
CLINUVEL announced the commencement of work to
evaluate this effect in humans, with an initial focus on
xeroderma pigmentosum (XP), acknowledging a
broader application of up to 2 billion people worldwide
with a deficiency in their natural DNA repair processes.
The first patient with the XP-C variant dosed with
SCENESSE® tolerated the treatment well and work
proceeded to the design and approvals necessary to
commence formal trials. In November 2020, a trial in
healthy patients was approved and, in March 2021, the
program was extended to patients with the XP-V
variant.
There has been understandable caution by authorities
and decision makers about the impact of conducting
clinical trials on XP patients during the COVID-19
pandemic. In June 2021, CLINUVEL reached agreement
with clinical and academic experts to proceed with
clinical studies focusing on patients with the XP-C and
XP-V variants. Three trials (CUV150, CUV152 and
CUV153) have been designed to assess ultraviolet (UV)
induced DNA damage and oxidative stress in XP
patients. Dosing of the drug will occur at variable
intervals for a maximum of four months. A fourth trial,
CUV151, is designed to assess DNA repair in healthy
14
53
15
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
volunteers. COVID-19 has caused some delay in
allowing XP patients to attend the clinics.
AAccuuttee SSttrrookkee PPrrooggrraamm
CLINUVEL announced its research program into the
role of afamelanotide in the treatment of acute arterial
ischaemic stroke (AIS) in October 2020. Stroke is the
second most common cause of death and a leading
cause of disability worldwide. Of 15 million strokes
worldwide, 85% are AIS cases. Existing therapies can
treat around 15% to 20% of these cases due to the
accessible location of the clot in the M1 (or first
branch) region of the main cerebral artery. In the bulk of
cases, the clot is in the smaller arteries in the upper
regions of the brain and, therefore not eligible for
existing clot removing and clot dissolving treatments.
Hence, CLINUVEL is seeking to develop a treatment for
a significant unmet medical need.
Due to the COVID-19 pandemic, the start of the clinical
trial in stroke patients (study CUV801) incurred a delay,
but the first AIS patient was treated with afamelanotide
in June 2021. In August 2021 an update was provided
on the treatment of the first three AIS patients, with
treatment well tolerated. Two patients showed
improvement in neurological deficit while one patient
showed no improvement. The CUV801 study is
ongoing.
PPRRÉÉNNUUMMBBRRAA®®
At the start of FY2021, the Group announced the
development of a second formulation of afamelanotide,
PRÉNUMBRA®. This non-solid controlled-release
formulation provides dosing flexibility as part of the
active life-cycle management of afamelanotide to
address clinical needs in acute disorders and vascular
anomalies. The Group has secured the intellectual
property rights for the dosage form in identified
indications, as well as the international trademarks for
PRÉNUMBRA®. Development of this formulation is
progressing and is managed through our RDI centre in
Singapore.
FFiinnaanncciiaall RReevviieeww
The financial year ended 30 June 2021 marks the
completion of the Group’s fifth consecutive year of
achieving a net profit, a positive cash flow result and
increased revenue growth.
The result for the Group for FY2021 was a $25.713
million profit before tax, compared to $11.541 million
for FY2020 (restated from $13.136 million), a 123%
54
increase. The result reinforces the Group’s success in
pursuing a strategy to maintain and grow its
commercial operations of SCENESSE® in the EU and
the US whilst expanding its existing activities to support
product development to prepare for future business
growth. Total expenses increased by 2% year-on-year,
compared to a 43% increase in Total Revenues and
Other Income.
Net Cash provided by Operating Activities was a
positive $19.262 million for FY2021, up from a $14.188
million positive result for FY2020. After the deployment
of cash in investing and financing activities, net cash
added $15.944 million to cash and cash equivalents on
the balance sheet after accounting for exchange rate
adjustments on foreign currencies held. Cash reserves
have increased steadily since 2016 without reliance on
debt or equity funding, from $13.845 million at 30 June
2016 to the 30 June 2021 level of $82.691 million.
SSuummmmaarryy FFiinnaanncciiaallss FFYY22002211
CCoonnssoolliiddaatteedd EEnnttiittyy
FY2021
FY2020
restated
$
$
RReevveennuueess aanndd OOtthheerr
IInnccoommee
48,450,599
+43%
33,909,670
+4%
NNeett PPrrooffiitt bbeeffoorree
iinnccoommee ttaaxx
25,712,644
+123%
11,540,811
-36.3%
PPrrooffiitt aafftteerr iinnccoommee ttaaxx
eexxppeennssee
24,728,247
+64%
15,051,199
-17%
BBaassiicc eeaarrnniinnggss ppeerr
sshhaarree
NNeett ttaannggiibbllee aasssseettss
bbaacckkiinngg ppeerr sshhaarree
0.500
+64%
1.911
+41%
0.306
-18.6%
1.351
+17%
DDiivviiddeennddss
2.5 cents
2.5 cents
NNoottee:: CCLLIINNUUVVEELL hhaass oonnee ooppeerraattiinngg sseeggmmeenntt ffoorr rreeppoorrttiinngg ppuurrppoosseess..
There is an increase in expenses and a corresponding
decrease in Net Profit before tax of $1.596 million for
FY2020. Further details are provided in Note 1 to the
Financial Statements.
RReevveennuueess
The Group achieved a Total Revenue result of $47.976
million for FY2021. This strong top line result is a 47.3%
increase on the prior year of $32.565 million.
Total revenues have continued to grow year on year
since initial launch of SCENESSE® in FY2016, reflecting
16
CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
volunteers. COVID-19 has caused some delay in
increase. The result reinforces the Group’s success in
allowing XP patients to attend the clinics.
pursuing a strategy to maintain and grow its
AAccuuttee SSttrrookkee PPrrooggrraamm
commercial operations of SCENESSE® in the EU and
the US whilst expanding its existing activities to support
CLINUVEL announced its research program into the
product development to prepare for future business
role of afamelanotide in the treatment of acute arterial
growth. Total expenses increased by 2% year-on-year,
ischaemic stroke (AIS) in October 2020. Stroke is the
compared to a 43% increase in Total Revenues and
second most common cause of death and a leading
Other Income.
cause of disability worldwide. Of 15 million strokes
worldwide, 85% are AIS cases. Existing therapies can
treat around 15% to 20% of these cases due to the
accessible location of the clot in the M1 (or first
branch) region of the main cerebral artery. In the bulk of
cases, the clot is in the smaller arteries in the upper
regions of the brain and, therefore not eligible for
existing clot removing and clot dissolving treatments.
Hence, CLINUVEL is seeking to develop a treatment for
a significant unmet medical need.
Due to the COVID-19 pandemic, the start of the clinical
trial in stroke patients (study CUV801) incurred a delay,
Net Cash provided by Operating Activities was a
positive $19.262 million for FY2021, up from a $14.188
million positive result for FY2020. After the deployment
of cash in investing and financing activities, net cash
added $15.944 million to cash and cash equivalents on
the balance sheet after accounting for exchange rate
adjustments on foreign currencies held. Cash reserves
have increased steadily since 2016 without reliance on
debt or equity funding, from $13.845 million at 30 June
2016 to the 30 June 2021 level of $82.691 million.
SSuummmmaarryy FFiinnaanncciiaallss FFYY22002211
but the first AIS patient was treated with afamelanotide
CCoonnssoolliiddaatteedd EEnnttiittyy
FY2021
At the start of FY2021, the Group announced the
development of a second formulation of afamelanotide,
PRÉNUMBRA®. This non-solid controlled-release
BBaassiicc eeaarrnniinnggss ppeerr
in June 2021. In August 2021 an update was provided
on the treatment of the first three AIS patients, with
treatment well tolerated. Two patients showed
improvement in neurological deficit while one patient
showed no improvement. The CUV801 study is
ongoing.
PPRRÉÉNNUUMMBBRRAA®®
formulation provides dosing flexibility as part of the
active life-cycle management of afamelanotide to
address clinical needs in acute disorders and vascular
anomalies. The Group has secured the intellectual
property rights for the dosage form in identified
indications, as well as the international trademarks for
PRÉNUMBRA®. Development of this formulation is
progressing and is managed through our RDI centre in
Singapore.
FFiinnaanncciiaall RReevviieeww
The financial year ended 30 June 2021 marks the
completion of the Group’s fifth consecutive year of
achieving a net profit, a positive cash flow result and
increased revenue growth.
The result for the Group for FY2021 was a $25.713
million profit before tax, compared to $11.541 million
for FY2020 (restated from $13.136 million), a 123%
FY2020
restated
$
$
RReevveennuueess aanndd OOtthheerr
48,450,599
33,909,670
IInnccoommee
+43%
+4%
NNeett PPrrooffiitt bbeeffoorree
25,712,644
11,540,811
iinnccoommee ttaaxx
+123%
-36.3%
PPrrooffiitt aafftteerr iinnccoommee ttaaxx
24,728,247
15,051,199
eexxppeennssee
sshhaarree
NNeett ttaannggiibbllee aasssseettss
bbaacckkiinngg ppeerr sshhaarree
+64%
0.500
+64%
1.911
+41%
-17%
0.306
-18.6%
1.351
+17%
DDiivviiddeennddss
2.5 cents
2.5 cents
NNoottee:: CCLLIINNUUVVEELL hhaass oonnee ooppeerraattiinngg sseeggmmeenntt ffoorr rreeppoorrttiinngg ppuurrppoosseess..
There is an increase in expenses and a corresponding
decrease in Net Profit before tax of $1.596 million for
FY2020. Further details are provided in Note 1 to the
Financial Statements.
RReevveennuueess
The Group achieved a Total Revenue result of $47.976
million for FY2021. This strong top line result is a 47.3%
increase on the prior year of $32.565 million.
Total revenues have continued to grow year on year
since initial launch of SCENESSE® in FY2016, reflecting
16
the progress made from achieving marketing
authorisation in two major markets and the subsequent
agreements to establish a price for the medicinal
product. The graph below depicts the growth in Total
Revenues year on year since FY2017.
GGrroowwiinngg rreevveennuueess ssiinnccee iinniittiiaall
llaauunncchh ((AA$$mmiilllliioonn))
FY2021
FY2020
FY2019
FY2018
FY2017
0
20
40
60
Commercial Sales
Special Access Scheme Reimbursements
Other Income
A comparison of the FY2021 reported and constant
currency results against the FY2020 reported results for
Commercial Sales and Special Access Scheme
Reimbursements is shown in the table below.
Throughout FY2021, the Australian dollar currency was
stronger relative to most other currencies the Group
had an exposure to when compared to FY2020. As a
result, movements in foreign exchange rates against
the Australian dollar presentation currency resulted in a
$3.888 million adverse impact to the reported Total
Revenue result for the year.
CCoommmmeerrcciiaall
SSaalleess
SSAASS
RReeiimmbbuurrssee--
mmeennttss ––
SSwwiittzzeerrllaanndd,,
OOtthheerr
TToottaall
42.603
5.373
47.976
46.236
5.627
51.864
26.306
6.259
32.565
75.8%
-10.1%
65.7%
62.0%
-14.2%
47.8%
AAUU $$ mmiilllliioonn
FFYY22002211
RReeppoorrtteedd
FFYY22002211
CCoonnssttaanntt**
FFYY22002200
RReeppoorrtteedd
%% cchhaannggee
((CCoonnssttaanntt))
%% cchhaannggee
((RReeppoorrtteedd))
* FY2021 revenues converted to A$ monthly at the average conversion
rate of the same month of FY2020
CCoommmmeerrcciiaall SSaalleess
Commercial sales for FY2021 were $42.603 million, a
62% increase to the commercial sales result for FY2020
($26.306 million). On a constant currency basis,
commercial sales revenues of SCENESSE® increased
75.8% for the year. The Group views its commercial
sales as a single operating segment for reporting
purposes but provide insights into the trends in key
markets below
The increase in commercial sales was also driven by
the impact of recognising commercial sales in the USA
across a full financial year for the first time. At the end
of FY2020, more than forty insurance companies had
agreed to reimburse SCENESSE® either via Prior
Authorization (PA) or through acceptance of the drug
on individual formularies. This number had increased to
over 60 by the end of FY2021. The number of Specialty
Centers participating in the distribution program who
are trained and accredited has now grown to over 40.
Unit sales by month in the US was relatively consistent
from the start of the financial year through the winter
months in the northern hemisphere, progressively
increasing in the latter months of the year, reflecting
higher patient enrolment in the time of year where the
level of ambient light emission intensifies for EPP
patients. This indicates a level of year-round demand
for SCENESSE® in the US.
Commercial sales in Europe improved in FY2021 after
some disruption was experienced by select EPP Expert
Centres in the latter half of FY2020 in responding to the
COVID-19 pandemic. There were some competing
trends in patient demand and the experience of EPP
Expert Centres during the year:
•
•
Patients unwilling or unable to travel to seek
treatment during FY2020 returned to seek and
receive treatment in FY2021;
Some EPP Expert Centres treated new patients for
the first time, increasing the number of patients
they were able to treat;
A few Centres treating smaller patient numbers
reduced orders of SCENESSE®; and
• Other EPP Expert Centres who have been
•
participating under the post-authorisation safety
setting for multiple years are gradually reaching a
critical mass and experienced relatively steady
patient numbers.
A stronger Australian dollar in FY2021 affected the
year-on-year increase in commercial sales recorded in
55
17
CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
original Euro currency, however the Group still recorded
a 4% increase upon converting Euro sales into the
Australian reporting currency.
RReeiimmbbuurrsseemmeennttss –– SSppeecciiaall AAcccceessss SScchheemmeess
The distribution of SCENESSE® under Special Access
Schemes continued to provide a preventative treatment
for adult EPP patients, primarily to Switzerland.
SCENESSE® was also supplied outside Switzerland to
select countries under a special access arrangement
whereby CLINUVEL received full cost compensation,
linked to the uniform price of SCENESSE® sold in the
European Economic Area under the marketing
authorisation.
On a constant currency basis, sales reimbursements
from special access schemes decreased 10.0% for the
year. The result was driven by a decline in the number
of patients seeking treatment in Switzerland, either due
to the COVID-19 pandemic, or who are now understood
to be receiving treatment in other countries.
The Group recorded other income of $0.130 million in
government grants received in Australia and Singapore
to assist companies respond to the economic impact
of the COVID-19 pandemic.
EExxppeennddiittuurreess
Total Expenses for the Group for FY2021 were $22.738
million, up 2% from FY2020 ($22.369 million). Expenses
were well contained in a period where the Group was
focussed to re-invest in the business to expand its
activities across the four recently announced divisions:
(a) Pharmaceutical, (b) Healthcare Solutions, (c)
Communications, Branding & Marketing, and (d)
Manufacturing, supported by the RDI Centre. This result
occurred in a challenging environment of escalating
cost of goods and services across all key inputs to the
business.
New expense groupings are reported for FY2021 and
FY2020, to reflect the expansion and diversification of
activities of the Group.
OOtthheerr IInnccoommee
CClliinniiccaall && nnoonn--CClliinniiccaall DDeevveellooppmmeenntt
IInntteerreesstt RReevveennuuee aanndd OOtthheerr IInnccoommee
Interest received from funds held in bank accounts and
term deposits for FY2021 was $0.342 million compared
to $0.563 million for FY2020.
The positive financial performance of the Group saw an
increase over the 12 months to 30 June 2021 of
$15.944 million to its cash reserves. Over the course of
FY2021 the Group continued the trend in prior years to
transfer more funds into higher-yielding Australian
dollar fixed-rate term deposits. The average amount of
cash held in term deposits was 27.6% higher than for
FY2020. However, the higher cash balances were offset
by a lower interest rate yield earned on holding interest-
bearing term deposits, averaging 96 basis points less
year-on-year. The decrease in interest rate yield
reflected the impact of Australian government
monetary policy on term deposit rates on offer
throughout the year. The Group’s policy to maintain
lower-yielding foreign currencies to cover working
capital requirements is reflected in this result. Funds
held in non-Australian dollar currency providing a
natural hedge against downward movement on the
Australian dollar. The average amount of funds held in
non-Australian dollar currency in FY 2021 has remained
stable, decreasing 3% on average when compared to
FY2020. The average amount of Australian currency
held year-on-year increased 44%.
Clinical & non-clinical development expenses reflect the
direct investment of the Group in its clinical trial
programs targeting the expanded use of SCENESSE®
beyond the field of EPP, along with the product
development initiatives and paediatric and alternative
formulations, including PRÉNUMBRA®. This category
includes analytical testing, pre-clinical and non-clinical
activities.
Clinical and non-clinical development fees increased
82% from $0.341 million in FY2020 to $0.548 million in
FY2021. The increase reflects the Group’s strategy to
advance its research and development initiatives, led by
the VALLAURIX operations, after a sustained period of
focus on the commercialisation activities following
European and US regulatory approval in 2014 and 2019,
respectively.
This expense result for FY2021 was driven by:
•
• Growth in product development and testing
services in the VALLAURIX laboratories;
Completion of pre-clinical studies to support the
Group’s strategic focus to develop solutions for
population groups most at risk of skin damage and
cancers; and
Trial fees toward the stroke study CUV801.
•
56
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CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
original Euro currency, however the Group still recorded
The Group recorded other income of $0.130 million in
a 4% increase upon converting Euro sales into the
government grants received in Australia and Singapore
Australian reporting currency.
to assist companies respond to the economic impact
RReeiimmbbuurrsseemmeennttss –– SSppeecciiaall AAcccceessss SScchheemmeess
The distribution of SCENESSE® under Special Access
EExxppeennddiittuurreess
of the COVID-19 pandemic.
Schemes continued to provide a preventative treatment
Total Expenses for the Group for FY2021 were $22.738
for adult EPP patients, primarily to Switzerland.
million, up 2% from FY2020 ($22.369 million). Expenses
SCENESSE® was also supplied outside Switzerland to
were well contained in a period where the Group was
select countries under a special access arrangement
focussed to re-invest in the business to expand its
whereby CLINUVEL received full cost compensation,
activities across the four recently announced divisions:
linked to the uniform price of SCENESSE® sold in the
(a) Pharmaceutical, (b) Healthcare Solutions, (c)
European Economic Area under the marketing
Communications, Branding & Marketing, and (d)
authorisation.
On a constant currency basis, sales reimbursements
from special access schemes decreased 10.0% for the
year. The result was driven by a decline in the number
business.
Manufacturing, supported by the RDI Centre. This result
occurred in a challenging environment of escalating
cost of goods and services across all key inputs to the
of patients seeking treatment in Switzerland, either due
New expense groupings are reported for FY2021 and
to the COVID-19 pandemic, or who are now understood
FY2020, to reflect the expansion and diversification of
to be receiving treatment in other countries.
activities of the Group.
OOtthheerr IInnccoommee
CClliinniiccaall && nnoonn--CClliinniiccaall DDeevveellooppmmeenntt
IInntteerreesstt RReevveennuuee aanndd OOtthheerr IInnccoommee
Clinical & non-clinical development expenses reflect the
direct investment of the Group in its clinical trial
Interest received from funds held in bank accounts and
programs targeting the expanded use of SCENESSE®
term deposits for FY2021 was $0.342 million compared
beyond the field of EPP, along with the product
to $0.563 million for FY2020.
The positive financial performance of the Group saw an
increase over the 12 months to 30 June 2021 of
$15.944 million to its cash reserves. Over the course of
activities.
development initiatives and paediatric and alternative
formulations, including PRÉNUMBRA®. This category
includes analytical testing, pre-clinical and non-clinical
FY2021 the Group continued the trend in prior years to
Clinical and non-clinical development fees increased
transfer more funds into higher-yielding Australian
82% from $0.341 million in FY2020 to $0.548 million in
dollar fixed-rate term deposits. The average amount of
FY2021. The increase reflects the Group’s strategy to
cash held in term deposits was 27.6% higher than for
advance its research and development initiatives, led by
FY2020. However, the higher cash balances were offset
the VALLAURIX operations, after a sustained period of
by a lower interest rate yield earned on holding interest-
focus on the commercialisation activities following
bearing term deposits, averaging 96 basis points less
European and US regulatory approval in 2014 and 2019,
year-on-year. The decrease in interest rate yield
respectively.
reflected the impact of Australian government
monetary policy on term deposit rates on offer
throughout the year. The Group’s policy to maintain
lower-yielding foreign currencies to cover working
capital requirements is reflected in this result. Funds
held in non-Australian dollar currency providing a
natural hedge against downward movement on the
This expense result for FY2021 was driven by:
• Growth in product development and testing
services in the VALLAURIX laboratories;
• Completion of pre-clinical studies to support the
Group’s strategic focus to develop solutions for
population groups most at risk of skin damage and
Australian dollar. The average amount of funds held in
cancers; and
non-Australian dollar currency in FY 2021 has remained
• Trial fees toward the stroke study CUV801.
stable, decreasing 3% on average when compared to
FY2020. The average amount of Australian currency
held year-on-year increased 44%.
18
CCoommmmeerrcciiaall DDiissttrriibbuuttiioonn
CCoommmmuunniiccaattiioonn,, BBrraannddiinngg aanndd MMaarrkkeettiinngg
Commercial distribution expenditures ensure our
product is provided to end users under Good
Distribution Practice and to satisfy our risk
management commitments with regulatory agencies.
These activities include pharmacovigilance, quality
systems, safety reporting, PASS Registry data capture
and dossier updates.
During the year new distribution centres with
contracted parties and third-party service providers
were established in the US to support supply to EPP
Specialty Centers. Permits and licenses across
participating US states were established. Regulatory
dossier changes were submitted and approved.
Assistance on market access initiatives in new
countries and further pricing negotiation continued
throughout the year.
These expenditures in FY2021 were a 1% improvement
to FY2020, from $2.443 million to $2.421 million,
noting:
•
Increased freight, product handling, distribution and
manufacturing royalty expenses from higher
transportation volumes, largely offset by:
• Reduced costs in responding to regulatory audits
relating to the manufacturing and quality systems
MMaatteerriiaallss EExxppeennssee
Materials and related expenses primarily reflect some
of the acquisition purchases to support the production
of finished product by the Group’s contract
manufacturer, along with other materials purchases.
The Group continues to prepare for future sales growth
and to meet short-term and long-term inventory
requirements. The Group concluded a manufacturing
campaign to secure raw material peptide via a critical
process change to support future scale-up. This is in
final stages of validation. Multiple batch manufacturing
campaigns were conducted throughout FY2021 and
continue into FY2022.
Expenditures on essential materials increased 34%,
from $2.350 million in FY2020 to $3.650 million in
FY2021. The increase reflects both an increase in both
the volume and cost of materials required to support
manufacture to meet product requirements.
Communication, Branding and Marketing fees
decreased 47%, from $0.589 million in FY2020 to
$0.314 million in FY2021.
The Group has invested in resources to expand its
visibility and to engage with new audiences. It is
building a team of professionals experienced in, and
capable of, expanding the Company’s reach using
various media tools and channels to prepare for new
product launches whilst communicating the CLINUVEL
brand.
The decrease in this expense result is due to:
• Services previously conducted by external parties
have being brought in-house;
• Conference attendance and presentation costs in
FY2020 not being repeated in FY2021 due to the
COVID-19 pandemic
LLeeggaall,, IInnssuurraannccee aanndd IIPP
Legal, insurance and IP-related fees decreased 5% from
$1.148 million in FY2020 to $1.095 million in FY2021.
Incurring expenditures in external legal support, in
patent & trademark expenses and various insurances
provides the Group with vital property protection and a
competitive advantage over others. It also plays an
important part in the Group’s risk management plans
This expense result was driven by a tapering in overall
IP fees, partly offset by increases in annual insurances
reflecting the growth in scale of the business amid a
general softening of the global insurance market.
PPeerrssoonnnneell
People are integral to the Group’s success and are the
key driver for executing the Company strategy. The
Group increased its workforce in the current year, with
an emphasis on distribution, clinical and non-clinical
development roles, primarily to drive business growth.
The personnel expense result for FY2021 was $10.158
million, a 3% reduction from FY2020 of $10.490 million.
FY2020 was restated and included first-time
recognition of long-term employee retention benefits of
$1.596 million (FY2021: $0.118 million).
SShhaarree BBaasseedd PPaayymmeenntt
The share-based payment charge increased 57% from
$1.659 million in FY2020 to $2.602 million. This is a
non-cash accounting charge for share-based payments
57
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provided to the Managing Director and other staff. The
prior year’s non-cash charge was less than 12 months
charge as the majority of the share-based payments
were granted part way through FY2020.
FFiinnaannccee,, CCoorrppoorraattee aanndd GGeenneerraall
Expenditures from finance, corporate and general
activities decreased 21% from $2.054 million in FY2020
to $1.618 million in FY2021.
Finance, corporate and general costs are reflective of
the support function necessary to ensure the execution
of the Company’s demanding near-term and long-term
expansion strategy. The Group operates in seven
different locations, with a workforce across four
different continents who require the infrastructure and
support to execute their important functions. Examples
of expenditures include IT, corporate support, listing
and registry fees, travel and short-term rents.
The improvement in this expense result year on year
was due to a near absence of local and international
staff travel, brought on by restrictions in movement by
countries dealing with the COVID-19 pandemic.
DDeepprreecciiaattiioonn aanndd AAmmoorrttiissaattiioonn
Depreciation and amortisation increased by $0.415
million, from $0.446 million to $0.861 million. The
increase is attributable to 12 months depreciation of
the expanded RDI Centre in Singapore.
CChhaannggeess iinn iinnvveennttoorriieess ooff rraaww mmaatteerriiaallss,,
wwoorrkk iinn pprrooggrreessss aanndd ffiinniisshheedd ggooooddss
Changes in inventories of raw materials, work in
progress and finished goods represents the adjustment
to inventory acquisition expenditures in excess of
commercial sales. For FY2021, an adjustment was
recorded increasing inventory levels by $1.899 million,
demonstrating the Group’s strategy to prepare for
future near-term sales demand. For FY2020, the result
was a $0.848 million charge to the expense result,
reflecting reduction in inventory levels.
UUnnrreeaalliisseedd lloossss oonn rreessttaattiinngg ffoorreeiiggnn
ccuurrrreennccyy bbaallaanncceess aanndd ccuurrrreenncciieess hheelldd
The presentation currency of the Group is Australian
dollars. The Group invoices its commercial sales and
special access reimbursement invoices in non-
Australian dollar currency. Trade debtors are
recognised in non-Australian currency and cash
receipts are received in non-Australian dollar currency.
Unrealised adjustments are brought to account to
restate trade debtors and creditors and foreign
currencies held to Australian dollar currency as at 30
June.
As a result of the movement in the Australian dollar
during FY2021, the Group recorded a $1.368 million
loss as at 30 June 2021 (30 June 2020: $0.537 million
gain).
DDeeffeerrrreedd TTaaxx AAsssseett
In FY2020, the Group brought to account a deferred tax
asset (DTA) relating to previously unrecognised prior
period tax losses, resulting in a credit to income tax
benefit of $3.510 million.
In FY2021, the Group utilised carry forward tax losses in
the DTA, resulting in a debit to income tax expense of
$0.984 million.
The amount of the DTA account reflects:
•
•
the benefit to be received from utilising unused tax
losses against the temporary differences that result
in a deferred tax liability for the business; and
the expected utilisation of unused tax losses
against probable near term taxable profits
BBaallaannccee SShheeeett
One of the key objectives of the Company is to ensure
its Balance Sheet is sufficiently positioned and robust
to allow investment in future performance with a
financial buffer to respond to unexpected adverse
events. The Company has continued to preserve cash
and cash equivalents held without need to raise capital
and diluting shareholder returns, nor has it raised debt
capital and increasing the debt leverage of the Group.
The cash position has enabled the Group to withstand
anticipated increases to short term liabilities to support
the growth of the business and to sudden adverse
economic conditions following unexpected events such
as the coronavirus pandemic. This remains a deliberate
and planned strategy, reflecting CLINUVEL’s prudent
approach to risk management.
58
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CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
provided to the Managing Director and other staff. The
recognised in non-Australian currency and cash
prior year’s non-cash charge was less than 12 months
receipts are received in non-Australian dollar currency.
charge as the majority of the share-based payments
were granted part way through FY2020.
FFiinnaannccee,, CCoorrppoorraattee aanndd GGeenneerraall
Expenditures from finance, corporate and general
activities decreased 21% from $2.054 million in FY2020
to $1.618 million in FY2021.
June.
Unrealised adjustments are brought to account to
restate trade debtors and creditors and foreign
currencies held to Australian dollar currency as at 30
As a result of the movement in the Australian dollar
during FY2021, the Group recorded a $1.368 million
loss as at 30 June 2021 (30 June 2020: $0.537 million
Finance, corporate and general costs are reflective of
the support function necessary to ensure the execution
gain).
of the Company’s demanding near-term and long-term
DDeeffeerrrreedd TTaaxx AAsssseett
expansion strategy. The Group operates in seven
different locations, with a workforce across four
different continents who require the infrastructure and
support to execute their important functions. Examples
of expenditures include IT, corporate support, listing
and registry fees, travel and short-term rents.
In FY2020, the Group brought to account a deferred tax
asset (DTA) relating to previously unrecognised prior
period tax losses, resulting in a credit to income tax
benefit of $3.510 million.
In FY2021, the Group utilised carry forward tax losses in
the DTA, resulting in a debit to income tax expense of
The improvement in this expense result year on year
was due to a near absence of local and international
$0.984 million.
staff travel, brought on by restrictions in movement by
The amount of the DTA account reflects:
countries dealing with the COVID-19 pandemic.
DDeepprreecciiaattiioonn aanndd AAmmoorrttiissaattiioonn
Depreciation and amortisation increased by $0.415
million, from $0.446 million to $0.861 million. The
increase is attributable to 12 months depreciation of
the expanded RDI Centre in Singapore.
CChhaannggeess iinn iinnvveennttoorriieess ooff rraaww mmaatteerriiaallss,,
wwoorrkk iinn pprrooggrreessss aanndd ffiinniisshheedd ggooooddss
Changes in inventories of raw materials, work in
progress and finished goods represents the adjustment
to inventory acquisition expenditures in excess of
commercial sales. For FY2021, an adjustment was
recorded increasing inventory levels by $1.899 million,
demonstrating the Group’s strategy to prepare for
future near-term sales demand. For FY2020, the result
was a $0.848 million charge to the expense result,
reflecting reduction in inventory levels.
UUnnrreeaalliisseedd lloossss oonn rreessttaattiinngg ffoorreeiiggnn
ccuurrrreennccyy bbaallaanncceess aanndd ccuurrrreenncciieess hheelldd
The presentation currency of the Group is Australian
dollars. The Group invoices its commercial sales and
special access reimbursement invoices in non-
Australian dollar currency. Trade debtors are
•
•
the benefit to be received from utilising unused tax
losses against the temporary differences that result
in a deferred tax liability for the business; and
the expected utilisation of unused tax losses
against probable near term taxable profits
BBaallaannccee SShheeeett
One of the key objectives of the Company is to ensure
its Balance Sheet is sufficiently positioned and robust
to allow investment in future performance with a
financial buffer to respond to unexpected adverse
events. The Company has continued to preserve cash
and cash equivalents held without need to raise capital
and diluting shareholder returns, nor has it raised debt
capital and increasing the debt leverage of the Group.
The cash position has enabled the Group to withstand
anticipated increases to short term liabilities to support
the growth of the business and to sudden adverse
economic conditions following unexpected events such
as the coronavirus pandemic. This remains a deliberate
and planned strategy, reflecting CLINUVEL’s prudent
approach to risk management.
KKeeyy BBaallaannccee SShheeeett hhiigghhlliigghhttss ooff tthhee yyeeaarr::
The positive cash flows generated by the Company’s
commercial distribution programs drove the key
changes to the balance sheet, increasing cash reserves
by 24% from $66.747 million in FY2020 to $82.691
million in FY2021.
The increase in US sales combined with longer cash
receipt cycle on sales of SCENESSE® in the US when
compared to Europe was the main reason for the
increase of 143% in trade receivables on the balance
sheet in FY2021.
Total liabilities increased 4%, from $9.475 million to
$9.830 million, with no long-term debt. The ratio of the
Company’s overall debt to equity is 10%.
RReettuurrnnss oonn EEqquuiittyy
Returns for FY2021 remain strong and are
summarised by:
FY2021
FY2020
Restated
FY2019
FY2018
FY2017
FY2016
$24.728
$15.051*
$18.134
$13.224
$7.180
($3.121)
AAUU $$ mmiilllliioonn
PPrrooffiitt
aattttrriibbuuttaabbllee
ttoo oowwnneerrss ooff
ppaarreenntt
BBaassiicc EEPPSS
50.0 cents
30.6 cents*
37.6 cents
27.7 cents
14.9 cents
(7.0) cents
DDiivviiddeennddss PPaaiidd
iinn YYeeaarr
DDiivviiddeennddss ppeerr
SShhaarree
DDeeccllaarreedd
CChhaannggee iinn
SShhaarree PPrriiccee
YYooYY
RReettuurrnn oonn
EEqquuiittyy
$1.235
$1.224
$0.957
-
2.5 cents
2.5 cents
2.5 cents
2.0 cents
-
-
-
-
20%
(24%)
206%
58%
62%
52%
25%
21%*
32%
34%
28%
(18%)
Shareholder rreettuurrnnss hhaavvee bbeeeenn ggeenneerraatteedd iinn bbootthh tthhee sshhoorrtt--tteerrmm aanndd tthhee lloonnggeerr--tteerrmm tthhrroouugghh::
ccaappiittaall aapppprreecciiaattiioonn ((tthhrroouugghh TToottaall SShhaarreehhoollddeerr RReettuurrnn eexxcceeeeddiinngg tthhee NNaassddaaqq BBiiootteecchh IInnddeexx aanndd AASSXX220000 HHeeaalltthhccaarree IInnddeexx ssiinnccee ffiirrsstt pprroodduucctt llaauunncchh,, aanndd
ddiivviiddeenndd ddiissttrriibbuuttiioonn iinn tthhee ppaasstt 33 ffiinnaanncciiaall yyeeaarrss..
** RReessttaatteedd
20
59
21
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
IInnvveessttmmeennttss ffoorr FFuuttuurree PPeerrffoorrmmaannccee
The Group’s key objectives are to progress CLINUVEL
as a world leader in medicinal photoprotection and
repigmentation and to support the expansion into
other, similar genetic and skin-related disorders, as
well as acute disorders and vascular anomalies. In
addition to the ongoing development of its active and
expanded product pipeline, the Group is actively
considering the integration of new functions and
capabilities through one or more selective
acquisitions.
The Group has deployed working capital throughout
the year to prepare for future performance across the
following areas:
PPeeooppllee
RReesseeaarrcchh &&
DDeevveellooppmmeenntt
CClliinniiccaall
MMaannuuffaaccttuurriinngg
• Created new roles across all business
functions
• Created new roles across all business
functions
• Commenced operation of larger
laboratory with expanded analytical
capabilities & fixed asset purchases
• non-solid dosage formulation
development
• non-clinical development
Activities in progress to obtain approvals
to move into next phase clinical studies to
pursue potential new markets for
SCENESSE® in:
• Vitiligo
• DNA Repair, focussed on XP
• Acute Stroke (AIS)
• Undisclosed indication
• Program to manufacture raw material
peptide
via a process change to support future
scale-up.
• Increase product inventories to meet
expected commercial and clinical
demand
IIPP
• Continued to renew and maintain new
and existing patents to strengthen its
intellectual property position
CCaappiittaall SSttrruuccttuurree
The Group is debt free and has a consistent capital
structure of ordinary shares on issue plus unlisted
securities in the form of conditional performance
rights, which will vest on the Group meeting certain
performance conditions.
CLINUVEL’s outstanding shares on issue remained at
49,410,338 shares to 30 June 2021. There was no
issue of new shares through the exercise of
performance rights under the Group’s performance
rights plans or from capital raising.
DDiivviiddeennddss PPaaiidd oorr RReeccoommmmeennddeedd
Declared &
paid in
2020/21
Cents
per
Share
Amount
Date of
Payment
FFiinnaall
2.50
$1,235,266
18
September
2020
On 25 August 2021, the Board of Directors declared
an unfranked dividend of $0.025 per ordinary share in
relation to the full year ended 30 June 2021.
60
22
CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
PPeeooppllee
• Created new roles across all business
• Created new roles across all business
functions
functions
Declared &
Cents
paid in
2020/21
per
Share
Amount
Date of
Payment
CCaappiittaall SSttrruuccttuurree
The Group is debt free and has a consistent capital
structure of ordinary shares on issue plus unlisted
securities in the form of conditional performance
rights, which will vest on the Group meeting certain
performance conditions.
CLINUVEL’s outstanding shares on issue remained at
49,410,338 shares to 30 June 2021. There was no
issue of new shares through the exercise of
performance rights under the Group’s performance
rights plans or from capital raising.
DDiivviiddeennddss PPaaiidd oorr RReeccoommmmeennddeedd
FFiinnaall
2.50
$1,235,266
September
18
2020
On 25 August 2021, the Board of Directors declared
an unfranked dividend of $0.025 per ordinary share in
relation to the full year ended 30 June 2021.
IInnvveessttmmeennttss ffoorr FFuuttuurree PPeerrffoorrmmaannccee
The Group’s key objectives are to progress CLINUVEL
as a world leader in medicinal photoprotection and
repigmentation and to support the expansion into
other, similar genetic and skin-related disorders, as
well as acute disorders and vascular anomalies. In
addition to the ongoing development of its active and
expanded product pipeline, the Group is actively
considering the integration of new functions and
capabilities through one or more selective
acquisitions.
The Group has deployed working capital throughout
the year to prepare for future performance across the
following areas:
RReesseeaarrcchh &&
DDeevveellooppmmeenntt
CClliinniiccaall
• Commenced operation of larger
laboratory with expanded analytical
capabilities & fixed asset purchases
• non-solid dosage formulation
development
• non-clinical development
Activities in progress to obtain approvals
to move into next phase clinical studies to
pursue potential new markets for
SCENESSE® in:
• Vitiligo
• DNA Repair, focussed on XP
• Acute Stroke (AIS)
• Undisclosed indication
• Program to manufacture raw material
peptide
via a process change to support future
• Increase product inventories to meet
expected commercial and clinical
demand
MMaannuuffaaccttuurriinngg
scale-up.
IIPP
• Continued to renew and maintain new
and existing patents to strengthen its
intellectual property position
CCaasshh ffrroomm OOppeerraattiioonnss aanndd OOtthheerr SSoouurrcceess
ooff CCaasshh
Overall, the Company generated cash from its
operating activities by $19.262 million in FY2021
(FY2020: $14.188 million)
Cash inflows from customer receipts increased 32%
to $38.724 million in FY2021, compared to $29.288
million for FY2020.
Cash outflows for payments to suppliers and
employees increased by 23%, from $16.281 million to
$20.032 million.
There were also cash outflows of $0.854 million for
the acquisition of property, plant and equipment,
$0.245 million of repayment of borrowing and leasing
liabilities, and $1.235 million for the payment of an
unfranked dividend to shareholders in relation to
FY2020.
The Groups’ policy towards cash management is to:
• Hold cash in at-call bank accounts and place
additional cash in short-term term deposits
providing favourable rates of interest; and
• Actively manage foreign currency exposure,
taking account of recent and expected currency
trends, holding foreign currencies as a natural
hedge, using market orders, foreign exchange
forward contracts and other foreign exchange
risk management products, as considered
appropriate.
The Group’s financial liquidity as at 30 June 2021 is
reflected in:
• A quick ratio of 11.3:1 (30 June 2020 8.9:1); and
• Cash and cash equivalents of $82.691 million,
accounting for 80.4% of total current assets
(FY2020: $66.747 million, 88.8% of total current
assets).
CCaasshh FFlloowwss ((AA$$mmiilllliioonn))
Other
Dividends Paid
Investing & Financing Outflows
Operating Outflows
Customer Receipts
-30
-20
-10
0
10
20
30
40
50
FY2020
FY2021
22
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CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
MMaatteerriiaall BBuussiinneessss RRiisskkss
The following specific business risks are reviewed continually by the Board and management, as they have the
potential to affect the Group’s achievement of the business goals detailed above. This list is not exhaustive.
TTeecchhnnoollooggyy
• Despite obtaining marketing authorisations, those products may ultimately prove not to be safe
and/or of clinical or other benefit.
SSuuppppllyy
• Manufacturing processes may not result in product batches meeting minimum specification
levels, that raw material components could not be sourced to specification, that the
manufacturing process may encounter process issues not previously identified and controlled,
and of non-controllable disruptions to the operations of the products’ contract manufacturers.
These factors may lead to non-supply of product and/or adverse regulatory outcomes.
CClliinniiccaall && RReegguullaattoorryy
• Clinical trials may not yield the expected and desired results for the investigational medicinal
product(s) to obtain further regulatory approvals.
DDrruugg PPrriicciinngg
• Third-party payors may not provide coverage or will not be willing to accept the prices agreed
with other third-party payors, adversely affecting revenues and profitability. Furthermore,
reductions in government insurance programs may result in lower prices for our products and
could materially adversely affect our ability to operate profitably.
IInntteelllleeccttuuaall PPrrooppeerrttyy
• Future sales could be impacted to the extent that there is not sufficiently robust patent
protection across the Group’s product portfolio that will prevent competitors from entering the
marketplace to compete with the Group’s approved products. Also, competitors infringing the
Group’s IP rights may adversely impact the Group’s ability to maximise the value to be made
from product commercialisation.
FFuunnddiinngg
• Cash outflows from its operations over the long-term may be higher than cash inflows over the
long-term. Therefore, the ability of the Group to successfully bring its products to market and
achieve a state of consistent positive cash flow is dependent on its ability to maintain a revenue
stream and to access sources of funding while containing its expenditures.
MMaarrkkeett CCoommppeettiittoonn
• New entrants could enter the same market to directly compete against CLINUVEL's products with
new products proven to be safer, more effective and priced lower than CLINUVEL's.
MMaannaaggeemmeenntt
• The Group’s corporate strategy could be impacted adversely if the Group was not able to retain
its specialised knowledge and areas of expertise, key management, members of staff and/or
Board.
62
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CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
MMaatteerriiaall BBuussiinneessss RRiisskkss
The following specific business risks are reviewed continually by the Board and management, as they have the
potential to affect the Group’s achievement of the business goals detailed above. This list is not exhaustive.
TTeecchhnnoollooggyy
and/or of clinical or other benefit.
• Despite obtaining marketing authorisations, those products may ultimately prove not to be safe
SSuuppppllyy
• Manufacturing processes may not result in product batches meeting minimum specification
levels, that raw material components could not be sourced to specification, that the
manufacturing process may encounter process issues not previously identified and controlled,
and of non-controllable disruptions to the operations of the products’ contract manufacturers.
These factors may lead to non-supply of product and/or adverse regulatory outcomes.
CClliinniiccaall && RReegguullaattoorryy
• Clinical trials may not yield the expected and desired results for the investigational medicinal
product(s) to obtain further regulatory approvals.
DDrruugg PPrriicciinngg
• Third-party payors may not provide coverage or will not be willing to accept the prices agreed
with other third-party payors, adversely affecting revenues and profitability. Furthermore,
reductions in government insurance programs may result in lower prices for our products and
could materially adversely affect our ability to operate profitably.
IInntteelllleeccttuuaall PPrrooppeerrttyy
• Future sales could be impacted to the extent that there is not sufficiently robust patent
protection across the Group’s product portfolio that will prevent competitors from entering the
marketplace to compete with the Group’s approved products. Also, competitors infringing the
Group’s IP rights may adversely impact the Group’s ability to maximise the value to be made
from product commercialisation.
FFuunnddiinngg
• Cash outflows from its operations over the long-term may be higher than cash inflows over the
long-term. Therefore, the ability of the Group to successfully bring its products to market and
achieve a state of consistent positive cash flow is dependent on its ability to maintain a revenue
stream and to access sources of funding while containing its expenditures.
MMaarrkkeett CCoommppeettiittoonn
• New entrants could enter the same market to directly compete against CLINUVEL's products with
new products proven to be safer, more effective and priced lower than CLINUVEL's.
MMaannaaggeemmeenntt
Board.
• The Group’s corporate strategy could be impacted adversely if the Group was not able to retain
its specialised knowledge and areas of expertise, key management, members of staff and/or
IImmppaacctt ooff tthhee CCoorroonnaavviirruuss PPaannddeemmiicc oonn
CCLLIINNUUVVEELL’’ss BBuussiinneessss
The coronavirus pandemic continues to adversely
impact both people’s health and global economic
activity. Many countries are focussed on vaccinating
their populations to provide ongoing protection from
the variants of the virus. However, the impact and
consequences on how we live, work, and interact will
be felt for years.
CLINUVEL is no exception to being impacted by the
coronavirus pandemic. However, CLINUVEL’s
business has proven resilient and is relatively well
positioned to manage the difficult operating
environment and progress its strategic initiatives.
DDeemmaanndd ffoorr SSCCEENNEESSSSEE®®
Access for patients seeking treatment in hospitals
was affected during the initial months when
population lockdowns across Europe were first
instituted in the latter months of FY2020. EPP Expert
Centres either deferred orders or reduced order sizes
in the initial months of the COVID-19 infections
because they were unable to provide treatment
access to patients, or patients were unable to travel
to them. Notwithstanding the uncertainty
surrounding the pandemic, patient demand for
SCENESSE® in Europe remained strong, with existing
patients continuing to demand treatment and new
patients receiving treatment for the first time.
CLINUVEL is conscious of the patients it serves and
the anxiety and uncertainty they face during the
coronavirus-pandemic and it has worked to continue
to meet their demand for SCENESSE®.
RReesseeaarrcchh aanndd DDeevveellooppmmeenntt
CLINUVEL’s research and development program
continued to progress in FY2021. The operations of
the laboratory facilities in Singapore were restricted
during the circuit-breaker period which overlapped
FY2020 to FY2021, with some remote working
required. The circuit-breaker also resulted in minor
delays to the laboratory expansion project, which
was completed in 2020.
SSuuppppllyy ooff SSCCEENNEESSSSEE®®
The sourcing, manufacturing and controlled
distribution of SCENESSE® continued without
material disruption or delay from the coronavirus
pandemic. Raw material sourcing, manufacturing
activities and movement of goods were able to be
conducted without materially adversely impacting
timeframes. CLINUVEL continuously reviews its
operations to assess ongoing supply of SCENESSE®
which may be impacted by the coronavirus
pandemic.
CCLLIINNUUVVEELL’’ss PPeeooppllee
CLINUVEL has played a responsible role to assist the
global effort to manage the spread of COVID-19.
CLINUVEL personnel have adapted to work remotely,
attending the office only as necessary and when
permitted under government regulations. Video-
based communications technology has been
maximised whilst local and international travel has
been minimised, and in most cases, ceased.
Diligence and adaptation under a difficult operating
environment by the entire CLINUVEL team has seen
productivity and focus remain largely unaffected.
24
25
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CChhaannggeess iinn TThhee SSttaattee ooff AAffffaaiirrss
The Directors are not aware of any matter or
circumstance not otherwise dealt with in this report
that has significantly or may significantly affect the
operations of the Group.
SSiiggnniiffiiccaanntt EEvveennttss aafftteerr tthhee RReeppoorrttiinngg DDaattee
There has not been any matter, other than reference
to the financial statements that has arisen since the
end of the financial year that has affected or could
significantly affect the operations of the Group,
other than:
• On 25 August 2021, the Board of Directors
declared an unfranked dividend of $0.025 per
ordinary share.
LLiikkeellyy DDeevveellooppmmeennttss aanndd EExxppeecctteedd RReessuullttss
The Group launched SCENESSE® in Europe in June
2016. As part of the conditions attached to the
European marketing authorisation, the Group
operates an agreed long-term risk management plan
under the supervision of the EMA. The Group has
been assisted by third parties to support the
European EPP Disease Registry to monitor long-term
safety and it will continue to invest in existing and
new personnel with the appropriate skills and
expertise to maintain the ongoing requirements of
the post-authorisation program in Europe. The
ongoing requirements will remain in place until such
time the EMA decides these are no longer necessary.
The Group has established a reference price for
SCENESSE® as part of its uniform pricing strategy in
Europe and has entered into pricing agreements with
several European countries, and state and private
insurance groups. The Group has established a
distribution-focused workforce in Europe to support
the increase in product volumes and will continue to
increase staff numbers as additional pricing
agreements per country are established with payors,
and as the required pharmacovigilance activities
continue to expand.
The Group has focused on its manufacturing
requirements by working with its contract
manufacturer and raw material supplier to meet
commercial product supply in line with its timing
64
expectations and to pursue ongoing process
improvement initiatives to support future increases
in supply. These initiatives are part of continuous
improvement and will form part of the Group’s
expenditure base moving forward. The contract
manufacturer bear responsibility for the
manufacturing standards of the commercial drug
product. The Group announced in March 2021 it will
establish a Manufacturing Division where it will
manufacture own products and will be eventually set
up as a contract manufacturer for other
pharmaceutical companies and research groups.
SCENESSE® was launched in the US in April 2020.
The Group is focussed on securing agreement on
reimbursement of SCENESSE® with insurers to make
SCENESSE® available to all US patients receptive to
the treatment. The Group will continue to expand its
resources and activities to support US market entry
which includes operating a risk management plan
similar to what has been instituted in Europe.
The Group will continue its North American clinical
program to evaluate the effectiveness of its lead
product to repigment vitiliginous lesions
(depigmented skin areas) in combination with NB-
UVB light therapy in patients with vitiligo and also as
a standalone therapy. This program would include
advancing into the next phases of clinical studies to
demonstrate the efficacy and long-term safety of
SCENESSE® in combination with NB-UVB in the
treatment of vitiligo.
The Group also intends to further progress its clinical
program with SCENESSE® in other indications,
including VP, in DNA Repair with a focus on treating
patients with XP, in AIS and in another yet to be
disclosed acute indication. To support this likely
development, CLINUVEL is advancing PRÉNUMBRA®,
a non-solid dosage form of afamelanotide as a
potent haemodynamic, vasoactive and anti-oncotic
therapeutic agent, initially in adult patients.
The Group expects to advance its product pipeline,
progressing the development of the molecules
CUV9900 and VLRX001 through the various
development phases which may include formulation
development, non-clinical and human testing. In
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CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CChhaannggeess iinn TThhee SSttaattee ooff AAffffaaiirrss
The Directors are not aware of any matter or
circumstance not otherwise dealt with in this report
that has significantly or may significantly affect the
operations of the Group.
SSiiggnniiffiiccaanntt EEvveennttss aafftteerr tthhee RReeppoorrttiinngg DDaattee
There has not been any matter, other than reference
to the financial statements that has arisen since the
end of the financial year that has affected or could
significantly affect the operations of the Group,
other than:
• On 25 August 2021, the Board of Directors
declared an unfranked dividend of $0.025 per
ordinary share.
LLiikkeellyy DDeevveellooppmmeennttss aanndd EExxppeecctteedd RReessuullttss
The Group launched SCENESSE® in Europe in June
2016. As part of the conditions attached to the
European marketing authorisation, the Group
operates an agreed long-term risk management plan
under the supervision of the EMA. The Group has
been assisted by third parties to support the
European EPP Disease Registry to monitor long-term
safety and it will continue to invest in existing and
new personnel with the appropriate skills and
expertise to maintain the ongoing requirements of
the post-authorisation program in Europe. The
ongoing requirements will remain in place until such
time the EMA decides these are no longer necessary.
The Group has established a reference price for
SCENESSE® as part of its uniform pricing strategy in
Europe and has entered into pricing agreements with
several European countries, and state and private
insurance groups. The Group has established a
distribution-focused workforce in Europe to support
the increase in product volumes and will continue to
increase staff numbers as additional pricing
agreements per country are established with payors,
and as the required pharmacovigilance activities
continue to expand.
The Group has focused on its manufacturing
requirements by working with its contract
manufacturer and raw material supplier to meet
commercial product supply in line with its timing
expectations and to pursue ongoing process
improvement initiatives to support future increases
in supply. These initiatives are part of continuous
improvement and will form part of the Group’s
expenditure base moving forward. The contract
manufacturer bear responsibility for the
manufacturing standards of the commercial drug
product. The Group announced in March 2021 it will
establish a Manufacturing Division where it will
manufacture own products and will be eventually set
up as a contract manufacturer for other
pharmaceutical companies and research groups.
SCENESSE® was launched in the US in April 2020.
The Group is focussed on securing agreement on
reimbursement of SCENESSE® with insurers to make
SCENESSE® available to all US patients receptive to
the treatment. The Group will continue to expand its
resources and activities to support US market entry
which includes operating a risk management plan
similar to what has been instituted in Europe.
The Group will continue its North American clinical
program to evaluate the effectiveness of its lead
product to repigment vitiliginous lesions
(depigmented skin areas) in combination with NB-
UVB light therapy in patients with vitiligo and also as
a standalone therapy. This program would include
advancing into the next phases of clinical studies to
demonstrate the efficacy and long-term safety of
SCENESSE® in combination with NB-UVB in the
treatment of vitiligo.
The Group also intends to further progress its clinical
program with SCENESSE® in other indications,
including VP, in DNA Repair with a focus on treating
patients with XP, in AIS and in another yet to be
disclosed acute indication. To support this likely
development, CLINUVEL is advancing PRÉNUMBRA®,
a non-solid dosage form of afamelanotide as a
potent haemodynamic, vasoactive and anti-oncotic
therapeutic agent, initially in adult patients.
The Group expects to advance its product pipeline,
progressing the development of the molecules
CUV9900 and VLRX001 through the various
development phases which may include formulation
development, non-clinical and human testing. In
26
addition, complementary OTC products are being
developed and manufactured for clinical use. The
Group has increased its resources and expanded its
capabilities to progress these projects underway at
VALLAURIX.
Ultimately, the long-term financial objective of the
Group is to establish a sustainable commercial
enterprise serving the needs of unattended
populations. Key to longer-term profitability is not
only continuing the successful research and
development of its portfolio of assets but also their
successful commercialisation, manufacturing and
distribution, and the ability to attract additional
funding to support these activities should the need
arise.
EEnnvviirroonnmmeennttaall RReegguullaattiioonn aanndd PPeerrffoorrmmaannccee
The Group’s operations are not regulated by any
significant environmental regulation under a law of
the Commonwealth, or of a State or Territory, or of
any other jurisdiction.
RRoouunnddiinngg ooff aammoouunnttss
The Group is a type of company referred to in ASIC
Corporations (Rounding in Financial/Directors’
Reports) Instrument 2016/91 and therefore the
amounts contained in this report and in the financial
report may have been rounded to the nearest
$1,000,000 or in most other cases, to the nearest
dollar.
IInnddeemmnniiffiiccaattiioonn aanndd IInnssuurraannccee ooff DDiirreeccttoorrss
aanndd OOffffiicceerrss
During or since the end of the financial year the
Group has given or agreed to indemnify, or paid or
agreed to pay, insurance premiums to insure each of
the Directors against liabilities for costs and
expenses incurred by them in defending any legal
proceedings arising from their conduct while acting
in the capacity of Director of the Group, other than
conduct involving wilful breach of duty in relation to
the Group. Details of the amount of the premium
paid in respect of insurance policies are not
disclosed as such disclosure is prohibited under the
terms of the contract.
DDiirreeccttoorrss’’ BBeenneeffiittss aanndd IInntteerreesstt iinn CCoonnttrraaccttss
Since the end of the previous financial year no
Director has received or become entitled to receive a
benefit (other than a benefit included in the total
amount of emoluments received or due and
receivable by Directors shown in the financial
statements and the remuneration report), because of
a contract that the Director or a firm of which the
Director is a member, or an entity in which the
Director has a substantial interest has made with a
controlled entity.
Further information on these contracts is included in
Note 20 to the financial statements.
65
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RReemmuunneerraattiioonn RReeppoorrtt
The Remuneration Report, which forms part of the Directors’ Report, provides information about the remuneration
of the Directors of CLINUVEL PHARMACEUTICALS LTD and Other Key Management
Personnel for the year ended 30 June 2021.
Key Management Personnel (‘KMP’) has the meaning given in the Australian Corporations Act and who together
have the authority and responsibility for planning, directing and controlling the activities of the Group, being:
NNaammee
PPoossiittiioonn
TTeerrmm aass KKMMPP
NNoonn--EExxeeccuuttiivvee DDiirreeccttoorrss
MMrrss.. BB..MM.. SShhaannaahhaann
Non-Executive Director
MMrr.. WW..AA.. BBlliijjddoorrpp
Non-Executive Director
DDrr.. KK..AA.. AAggeerrssbboorrgg
Non-Executive Director
MMrrss.. SS.. EE.. SSmmiitthh
Non-Executive Director
PPrrooff.. JJ.. VV.. RRoosseennffeelldd
Non-Executive Director
EExxeeccuuttiivvee KKMMPP
DDrr.. PP..JJ.. WWoollggeenn
Managing Director and Chief Executive Officer
DDrr.. DD..JJ.. WWrriigghhtt
Chief Scientific Officer
MMrr.. DD..MM.. KKeeaammyy
Chief Financial Officer and Company Secretary
The remuneration report is set out under the following main headings:
A.
Introduction by the Chair of the Remuneration Committee
B. Response To Shareholder Feedback and the first strike in FY2020
Full Year
Full Year
Full Year
Full Year
Full Year
Full Year
Full Year
Full Year
C. Remuneration Governance
D. Executive Remuneration
E. Non-Executive Remuneration
F. Service Agreements FY2021
G. Share Based Remuneration
H. Details of Remuneration
66
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CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
RReemmuunneerraattiioonn RReeppoorrtt
AA
IINNTTRROODDUUCCTTIIOONN BBYY TTHHEE CCHHAAIIRR OF THE REMUNERATION
COMMITTEE
The Remuneration Report, which forms part of the Directors’ Report, provides information about the remuneration
of the Directors of CLINUVEL PHARMACEUTICALS LTD and Other Key Management
Personnel for the year ended 30 June 2021.
Key Management Personnel (‘KMP’) has the meaning given in the Australian Corporations Act and who together
have the authority and responsibility for planning, directing and controlling the activities of the Group, being:
NNaammee
PPoossiittiioonn
TTeerrmm aass KKMMPP
NNoonn--EExxeeccuuttiivvee DDiirreeccttoorrss
MMrrss.. BB..MM.. SShhaannaahhaann
Non-Executive Director
MMrr.. WW..AA.. BBlliijjddoorrpp
Non-Executive Director
DDrr.. KK..AA.. AAggeerrssbboorrgg
Non-Executive Director
MMrrss.. SS.. EE.. SSmmiitthh
Non-Executive Director
PPrrooff.. JJ.. VV.. RRoosseennffeelldd
Non-Executive Director
EExxeeccuuttiivvee KKMMPP
DDrr.. PP..JJ.. WWoollggeenn
Managing Director and Chief Executive Officer
DDrr.. DD..JJ.. WWrriigghhtt
Chief Scientific Officer
MMrr.. DD..MM.. KKeeaammyy
Chief Financial Officer and Company Secretary
The remuneration report is set out under the following main headings:
A.
Introduction by the Chair of the Remuneration Committee
B. Response To Shareholder Feedback and the first strike in FY2020
Full Year
Full Year
Full Year
Full Year
Full Year
Full Year
Full Year
Full Year
C. Remuneration Governance
D. Executive Remuneration
E. Non-Executive Remuneration
F. Service Agreements FY2021
G. Share Based Remuneration
H. Details of Remuneration
CChhaaiirrmmaann ooff tthhee RReemmuunneerraattiioonn CCoommmmiitttteeee:: MMrr WWiilllleemm BBlliijjddoorrpp
Dear Shareholder,
On behalf of the Remuneration Committee (Committee), I am pleased to present to you our Remuneration Report
for the year ended 30 June 2021. Our FY2021 Remuneration Report details our remuneration policy for our
Executive KMP and Directors and explains how FY2021 remuneration outcomes for Executive KMP align with
CLINUVEL’s performance, long-term objectives, and shareholder outcomes.
OOuurr yyeeaarr
FY2021 was another challenging year due to the ongoing COVID-19 pandemic adversely affecting our people and
the broader community, as well as impacting CLINUVEL’s commercial operations, product supply, productivity, and
clinical program. While CLINUVEL’s business performance should be assessed in the context of this difficult
operating environment, our Board is extremely proud of how our executives, the RDI Centre, finance, clinical,
regulatory and the overall team have responded to these challenges and continued to execute our strategy, while
ensuring the well-being of our employees and customers.
Despite these impacts, CLINUVEL delivered another year of positive financial performance. FY2021 marked our
fifth consecutive year of annual profit (FY2021: PBIT of A$25.7m) and positive cashflow, which has provided
shareholders with a positive return on equity (FY2021: 25%) and earnings per share (FY2021: A$0.500 cents) over
this period. Shareholders have been rewarded with consistent annual dividends over the last three years, and
substantial Total Shareholder Return (TSR) growth over the last 15 years as of 30 June 2021 (28% over 1 year,
147% over 3 years, 591% over 5 years, 692% over 15 years).
FY2021 has seen significant expansion in CLINUVEL’s research and development (R&D) program, as part of the
overall strategy to translate CLINUVEL’s proven technology and expertise to a range of pharmaceutical and non-
prescription products for unmet patient and consumer needs. Due to the cash reserves accumulated over the last
five years, CLINUVEL is in a strong position to fund this expansion.
RReemmuunneerraattiioonn OOuuttccoommeess
CLINUVEL relies on a management team with the right innovative mindset and entrepreneurial spirit to execute our
ambitious growth strategy, which will continue to deliver sustainable returns to shareholders. Rewarding and
recognising our people fairly is a key priority for the Committee, to ensure we continue to attract, motivate and
retain top talent. The Committee believes that the overall remuneration structure appropriately considers short,
medium, and long-term strategic priorities across a mix of financial and non-financial measures that contribute to
value creation for both the Company and shareholders.
Fixed remuneration increases of 3.5% were applied to the CFO and CSO in FY2021 to improve market positioning,
with no fixed pay increases to apply to the CEO for the remainder of his service agreement (other than CPI
adjustments).
28
29
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CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
As outlined above, despite the challenging external environment, several key milestones were achieved in FY2021
across CLINUVEL’s commercial operations, financial performance, R&D program, communications and analyst
coverage, and strategy development. Reflecting these achievements, and the effort required to navigate the issues
and challenges from the COVID-19 pandemic, the Board determined to award the CEO a FY2021 short-term
As outlined above, despite the challenging external environment, several key milestones were achieved in FY2021
incentive (STI) award of 70% of maximum opportunity but capped at 53%. The CFO and CSO received STI awards
across CLINUVEL’s commercial operations, financial performance, R&D program, communications and analyst
of 82% and 65% of maximum, respectively.
coverage, and strategy development. Reflecting these achievements, and the effort required to navigate the issues
Some of the progress resulted in 6% of the CEO’s FY2020 grant of LTI performance rights to vest up to the end of
and challenges from the COVID-19 pandemic, the Board determined to award the CEO a FY2021 short-term
FY2021 (with a final vesting date of 20 November 2023 for this grant).
incentive (STI) award of 70% of maximum opportunity but capped at 53%. The CFO and CSO received STI awards
of 82% and 65% of maximum, respectively.
OOuurr rreessppoonnssee ttoo tthhee ssttrriikkee aaggaaiinnsstt tthhee FFYY22002200 RReemmuunneerraattiioonn RReeppoorrtt
Some of the progress resulted in 6% of the CEO’s FY2020 grant of LTI performance rights to vest up to the end of
Following the strike against our FY2020 Remuneration Report, the Committee engaged extensively with major
FY2021 (with a final vesting date of 20 November 2023 for this grant).
shareholders and proxy advisors to understand any concerns with our remuneration framework, and to keep apace
of both Australian and global market practice. In addition, a robust review of CLINUVEL’s remuneration practices
OOuurr rreessppoonnssee ttoo tthhee ssttrriikkee aaggaaiinnsstt tthhee FFYY22002200 RReemmuunneerraattiioonn RReeppoorrtt
and disclosures were completed in FY2021 with support from independent external advisors.
Following the strike against our FY2020 Remuneration Report, the Committee engaged extensively with major
We appreciate and respect all the feedback from our key stakeholders, and we strive to consider a balanced view
shareholders and proxy advisors to understand any concerns with our remuneration framework, and to keep apace
of all perspectives. However, achieving this balance is no easy feat, given our diverse Australian and international
of both Australian and global market practice. In addition, a robust review of CLINUVEL’s remuneration practices
shareholder base. The table in section B details the Committee’s response to the main concerns raised by
and disclosures were completed in FY2021 with support from independent external advisors.
stakeholders, which include enhanced disclosure and transparency of STI outcomes and how our remuneration
We appreciate and respect all the feedback from our key stakeholders, and we strive to consider a balanced view
approach reflects our significant global presence.
of all perspectives. However, achieving this balance is no easy feat, given our diverse Australian and international
The Committee recognises that improving our remuneration practices will be an iterative process that will consider
shareholder base. The table in section B details the Committee’s response to the main concerns raised by
your ongoing feedback, whilst ensuring we continue to appropriately reward and motivate the best talent for
stakeholders, which include enhanced disclosure and transparency of STI outcomes and how our remuneration
CLINUVEL. The Committee is confident that CLINUVEL’s remuneration framework remains strongly aligned to our
approach reflects our significant global presence.
vision and strategy, and focuses our executive team on delivering sustainable, long-term value for shareholders.
The Committee recognises that improving our remuneration practices will be an iterative process that will consider
We thank you all for your thoughtful feedback and look forward to continuing to engage with our stakeholders.
your ongoing feedback, whilst ensuring we continue to appropriately reward and motivate the best talent for
CLINUVEL. The Committee is confident that CLINUVEL’s remuneration framework remains strongly aligned to our
vision and strategy, and focuses our executive team on delivering sustainable, long-term value for shareholders.
Yours sincerely.
We thank you all for your thoughtful feedback and look forward to continuing to engage with our stakeholders.
Willem Blijdorp, Chairman of the Remuneration Committee
Yours sincerely.
Amsterdam
Willem Blijdorp, Chairman of the Remuneration Committee
Amsterdam
68
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CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
As outlined above, despite the challenging external environment, several key milestones were achieved in FY2021
across CLINUVEL’s commercial operations, financial performance, R&D program, communications and analyst
coverage, and strategy development. Reflecting these achievements, and the effort required to navigate the issues
and challenges from the COVID-19 pandemic, the Board determined to award the CEO a FY2021 short-term
As outlined above, despite the challenging external environment, several key milestones were achieved in FY2021
incentive (STI) award of 70% of maximum opportunity but capped at 53%. The CFO and CSO received STI awards
across CLINUVEL’s commercial operations, financial performance, R&D program, communications and analyst
of 82% and 65% of maximum, respectively.
coverage, and strategy development. Reflecting these achievements, and the effort required to navigate the issues
Some of the progress resulted in 6% of the CEO’s FY2020 grant of LTI performance rights to vest up to the end of
and challenges from the COVID-19 pandemic, the Board determined to award the CEO a FY2021 short-term
FY2021 (with a final vesting date of 20 November 2023 for this grant).
incentive (STI) award of 70% of maximum opportunity but capped at 53%. The CFO and CSO received STI awards
of 82% and 65% of maximum, respectively.
OOuurr rreessppoonnssee ttoo tthhee ssttrriikkee aaggaaiinnsstt tthhee FFYY22002200 RReemmuunneerraattiioonn RReeppoorrtt
Some of the progress resulted in 6% of the CEO’s FY2020 grant of LTI performance rights to vest up to the end of
Following the strike against our FY2020 Remuneration Report, the Committee engaged extensively with major
FY2021 (with a final vesting date of 20 November 2023 for this grant).
shareholders and proxy advisors to understand any concerns with our remuneration framework, and to keep apace
of both Australian and global market practice. In addition, a robust review of CLINUVEL’s remuneration practices
OOuurr rreessppoonnssee ttoo tthhee ssttrriikkee aaggaaiinnsstt tthhee FFYY22002200 RReemmuunneerraattiioonn RReeppoorrtt
and disclosures were completed in FY2021 with support from independent external advisors.
Following the strike against our FY2020 Remuneration Report, the Committee engaged extensively with major
We appreciate and respect all the feedback from our key stakeholders, and we strive to consider a balanced view
shareholders and proxy advisors to understand any concerns with our remuneration framework, and to keep apace
of all perspectives. However, achieving this balance is no easy feat, given our diverse Australian and international
of both Australian and global market practice. In addition, a robust review of CLINUVEL’s remuneration practices
shareholder base. The table in section B details the Committee’s response to the main concerns raised by
and disclosures were completed in FY2021 with support from independent external advisors.
stakeholders, which include enhanced disclosure and transparency of STI outcomes and how our remuneration
We appreciate and respect all the feedback from our key stakeholders, and we strive to consider a balanced view
approach reflects our significant global presence.
of all perspectives. However, achieving this balance is no easy feat, given our diverse Australian and international
The Committee recognises that improving our remuneration practices will be an iterative process that will consider
shareholder base. The table in section B details the Committee’s response to the main concerns raised by
your ongoing feedback, whilst ensuring we continue to appropriately reward and motivate the best talent for
stakeholders, which include enhanced disclosure and transparency of STI outcomes and how our remuneration
CLINUVEL. The Committee is confident that CLINUVEL’s remuneration framework remains strongly aligned to our
approach reflects our significant global presence.
vision and strategy, and focuses our executive team on delivering sustainable, long-term value for shareholders.
The Committee recognises that improving our remuneration practices will be an iterative process that will consider
We thank you all for your thoughtful feedback and look forward to continuing to engage with our stakeholders.
your ongoing feedback, whilst ensuring we continue to appropriately reward and motivate the best talent for
CLINUVEL. The Committee is confident that CLINUVEL’s remuneration framework remains strongly aligned to our
vision and strategy, and focuses our executive team on delivering sustainable, long-term value for shareholders.
Yours sincerely.
We thank you all for your thoughtful feedback and look forward to continuing to engage with our stakeholders.
Willem Blijdorp, Chairman of the Remuneration Committee
Yours sincerely.
Amsterdam
Willem Blijdorp, Chairman of the Remuneration Committee
Amsterdam
BB RREESSPPOONNSSEE TTOO SSHHAARREEHHOOLLDDEERR FFEEEEDDBBAACCKK AND THE FIRST
STRIKE IN FY2020
In FY2020, the company received a first strike against the Remuneration Report, and has responded to key items of
concern that were raised as follows:
RReemmuunneerraattiioonn
CCoommppoonneenntt
IIssssuuee RRaaiisseedd
FFYY22002200
CCLLIINNUUVVEELL’’ss RReessppoonnssee
TToottaall FFiixxeedd
RReemmuunneerraattiioonn ((TTFFRR))
Significant increase in the
CEO’s fixed remuneration in
FY2020 relative to ASX-listed
peers
The Committee acknowledges the feedback received regarding the increase in the
CEO’s remuneration in FY2020, as part of his new service agreement.
In determining the CEO’s new remuneration last year, the Board considered that
CLINUVEL is a truly global company, with most of its commercial operations and
revenues generated in Europe and the US, a RDI Centre located in Singapore, and its
CEO based in Europe. As such, CLINUVEL faces the challenge of attracting and
retaining high-calibre executives in an increasingly competitive global talent market
in the pharmaceutical/biotech industry – particularly given the strong focus on
healthcare across the world.
The Board is strongly of the view that the CEO’s remuneration should reflect this
global context, and more importantly, acknowledge Dr Wolgen’s proven track record
in delivering outstanding business performance and TSR* growth since he became
CEO in late 2005 (28% over 1 year, 147% over 3 years, 591% over 5 years, 1,487%
over 10 years).*
The Board also waited until CLINUVEL’s R&D phase was completed and sustained
profitability was achieved, before adjusting Dr Wolgen’s remuneration in FY2020 to
better align with global peers. FY2020 marked the fourth consecutive year of annual
profit for the Company (NPAT of A$15.1 million, EBIT of A$11.5 million), and the
CEO and his team have delivered again in FY2021, with CLINUVEL achieving NPAT
of A$24.7 million and PBIT of A$25.7 million this year.
The CEO will not receive further fixed pay increase for the remainder of his service
agreement (other than for CPI adjustments).
To provide stakeholders with confidence around how CLINUVEL reviews and sets
executive remuneration levels, we have provided enhanced disclosure and
transparency in section D. This includes details of benchmarking completed by
independent external consultants in March 2021.
SSTTII PPllaann
Lack of disclosure of STI
performance targets.
The Committee continues to consider ways to enhance the levels of disclosure of
STI measures and targets, where commercial sensitivity does not prohibit this given
the stage of CLINUVEL’s development and competitive environment.
STI performance measures are carefully selected by the Board, ensuring an
appropriate balance between measures that management can influence, and which
drive long-term decision making and ultimately shareholder value accretion. A
rigorous process is also followed to ensure robust targets are established for all
measures to drive high levels of business and individual performance.
In FY2021, the Committee has provided greater transparency and granularity to
shareholders of STI performance measures and outcomes, without compromising
the confidential nature of some of the operational data and information used in
compiling these performance measures. Refer to section D for detail.
LLTTII PPllaann
Prior LTI grants to the
Executive KMP (excluding
the CEO) are not linked to
profitability or other financial
measures.
No LTI performance rights were granted to the other Executive KMP in FY2021, with
LTIs last granted in FY2016.
LTI performance rights will be granted to the other Executive KMP in FY2022, under
a similar structure to the CEO’s FY2020 LTI grant to ensure consistency of measures
linked to CLINUVEL’s long-term strategy.
As disclosed on pages 38 to 40 of this report, the CEO’s FY2020 LTI grant includes
69
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Significant quantum of LTI
granted to the CEO in
FY2020, despite a significant
number of votes against the
allocation at the 2019 AGM
(approx. 40%).
OOnnee--ooffff rreetteennttiioonn
aawwaarrddss
The CEO and CFO are entitled
to additional cash-based
loyalty/retention awards for
each month of service.
several KPIs critical to the commercial growth of CLINUVEL, which are designed
around the unique risks and complexities of our business. These KPIs include
various financial measures linked to milestones for market capitalisation, cash
reserves and sales revenues; all with significantly stretching targets that will likely
increase shareholder value, if achieved.
The Committee acknowledges that at face value, the LTI grant would attract
commentary from stakeholders.
However, the CEO’s reported LTI quantum of A$1.65 million for FY2020 (based on a
total grant valuation of A$8.2 million to be realised over the 4-year vesting period) is
well below (55%) the median of US-listed peer companies and within range of
Australian-listed peers, based on benchmarking completed by an independent
external consultant.
More importantly, as described above, the Committee is confident that the LTI KPIs
represent significantly stretching targets for the CEO, with strong alignment to
shareholders returns. As of 30 June 2021, only 6% of the rights have vested, with
only 29 months left for Dr Wolgen to achieve vesting of any further awards. If the
CEO delivers minimal hurdles over the remainder of the 4-year vesting period, he will
earn significantly less given the grant covers a multi-year period.
The Committee acknowledges that loyalty/retention awards are a variation from
Australian market practice. However, as broader economic conditions continue to
improve and competition for global talent increases, the Committee believes that
attracting, motivating, and retaining high-performing executive KMP is key to
maintaining CLINUVEL’s outperformance and management stability during this
critical stage of our development and commercialisation.
The loyalty award is only intended to form part of the remuneration packages of the
CEO and CFO for the foreseeable future, with no awards to be granted to any other
Executive KMP.
** TTSSRR iiss ccaallccuullaatteedd uussiinngg aa mmeeddiiaann sshhaarree pprriiccee ffoorr tthhee tthhrreeee mmoonntthhss ttoo JJuunnee 3300 ffoorr eeaacchh rreelleevvaanntt yyeeaarr.. DDiivviiddeennddss wweerree iiggnnoorreedd
dduuee ttoo iimmmmaatteerriiaalliittyy..
70
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several KPIs critical to the commercial growth of CLINUVEL, which are designed
around the unique risks and complexities of our business. These KPIs include
various financial measures linked to milestones for market capitalisation, cash
reserves and sales revenues; all with significantly stretching targets that will likely
increase shareholder value, if achieved.
Significant quantum of LTI
The Committee acknowledges that at face value, the LTI grant would attract
granted to the CEO in
commentary from stakeholders.
FY2020, despite a significant
number of votes against the
allocation at the 2019 AGM
(approx. 40%).
However, the CEO’s reported LTI quantum of A$1.65 million for FY2020 (based on a
total grant valuation of A$8.2 million to be realised over the 4-year vesting period) is
well below (55%) the median of US-listed peer companies and within range of
Australian-listed peers, based on benchmarking completed by an independent
external consultant.
More importantly, as described above, the Committee is confident that the LTI KPIs
represent significantly stretching targets for the CEO, with strong alignment to
shareholders returns. As of 30 June 2021, only 6% of the rights have vested, with
only 29 months left for Dr Wolgen to achieve vesting of any further awards. If the
CEO delivers minimal hurdles over the remainder of the 4-year vesting period, he will
earn significantly less given the grant covers a multi-year period.
OOnnee--ooffff rreetteennttiioonn
aawwaarrddss
The CEO and CFO are entitled
The Committee acknowledges that loyalty/retention awards are a variation from
to additional cash-based
Australian market practice. However, as broader economic conditions continue to
loyalty/retention awards for
improve and competition for global talent increases, the Committee believes that
each month of service.
attracting, motivating, and retaining high-performing executive KMP is key to
maintaining CLINUVEL’s outperformance and management stability during this
critical stage of our development and commercialisation.
The loyalty award is only intended to form part of the remuneration packages of the
CEO and CFO for the foreseeable future, with no awards to be granted to any other
Executive KMP.
** TTSSRR iiss ccaallccuullaatteedd uussiinngg aa mmeeddiiaann sshhaarree pprriiccee ffoorr tthhee tthhrreeee mmoonntthhss ttoo JJuunnee 3300 ffoorr eeaacchh rreelleevvaanntt yyeeaarr.. DDiivviiddeennddss wweerree iiggnnoorreedd
dduuee ttoo iimmmmaatteerriiaalliittyy..
CC REMUNERATION GGOOVVEERRNNAANNCCEE
((ii)) RReemmuunneerraattiioonn CCoommmmiitttteeee
The Board has provided a mandate to the Remuneration Committee to assist and advise on determining
appropriate remuneration policies for its KMP over time, taking into account the relationship between pay and
performance, and the results of any evaluations or review processes. The Board has also provided a mandate to
the Remuneration Committee to provide advice on non-executive director fees and advice on setting salaries and
fees, short- and long-term incentives and employment terms and conditions for its key executives.
TThhee oobbjjeeccttiivveess ooff tthhee RReemmuunneerraattiioonnss CCoommmmiitttteeee’’ss rreessppoonnssiibbiilliittiieess aarree ttoo eennssuurree tthhaatt::
a)
b)
c)
d)
e)
Remuneration of the Company’s KMP is aligned with the interests of the Company and its
shareholders within an appropriate control framework, taking into account the Company’s
strategies and risks.
The level and composition of remuneration attract, retain and motivate people of high
calibre and with unique specialist industry knowledge to work towards the long-term growth
and success of the Company.
The role that total fixed remuneration and short- and long-term incentives play is clearly
defined and provides a clear relationship between performance and remuneration.
The levels and structure of remuneration are benchmarked against relevant international
peers and considered against global employment market conditions.
The Company gives due consideration to applicable legal requirements and appropriate
standards of governance.
The methods used by the Remuneration Committee to assess Board performance is disclosed in the Corporate
Governance Protocol.
((iiii)) RReemmuunneerraattiioonn RReeccoommmmeennddaattiioonnss
Under the provisions of the Committee’s Charter, the Committee may engage the assistance and advice from
external remuneration advisors. To ensure that any recommendations made by remuneration consultants are
provided without undue influence being exerted by Executives, external remuneration consultants deliver their
advice directly to members of the Committee.
In the year ended 30 June 2021, the Remuneration Committee engaged the services of remuneration advisors
to provide comparable peer company market data. No remuneration recommendations as defined by the
Corporations Act were received from external consultants during the financial year.
((iiiiii)) VVoottiinngg aanndd ffeeeeddbbaacckk aatt tthhee CCoommppaannyy’’ss llaasstt AAnnnnuuaall GGeenneerraall MMeeeettiinngg
In the 2020 Annual General Meeting (AGM), the Company obtained 67.50% of the proxy votes (including votes at
the Board’s discretion) in favour of adopting the 2019/20 remuneration report, and this resolution was carried in
favour by poll with 64.65% of votes cast. As more than 25% of the number of votes cast was against this resolution,
this constituted a first strike for purposes of the Corporations Act 2001 (Cth). The Company did not receive any
further specific feedback at the AGM on its remuneration practices.
32
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CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
DD EXECUTIVE RREEMMUUNNEERRAATTIIOONN
((ii)) EExxeeccuuttiivvee RReemmuunneerraattiioonn FFrraammeewwoorrkk
The following diagram links each of the executive remuneration components to the Company’s mission and
strategy.
To translate scientific breakthroughs into commercial products,
aiming to deliver innovative medical solutions for complex products
To be creative, to be diligent and to be vigilant in pur focus over the
long-term
TThhee CCLLIINNUUVVEELL VViissiioonn
World Leader in Melanocortins
Diversify and Grow
Establish New Markets
DDeelliivveerreedd tthhrroouugghh tthhee CCoorrppoorraattee SSttrraatteeggyy
Revenue Growth
Market Capitalisation Growth
Development and commercial progress, set
business targets are met
AAnndd AAcchhiieevviinngg PPeerrffoorrmmaannccee
IIss LLiinnkkeedd ttoo TToottaall EExxeeccuuttiivvee RReemmuunneerraattiioonn
* Managing Director and CFO only
AA.. FFiixxeedd
RReemmuunneerraattiioonn
Fixed remuneration
comprises base
salary,
superannuation and
non-monetary
benefits
BB.. SShhoorrtt--TTeerrmm
IInncceennttiivvee
Annual awards for
achieving financial,
regulatory,
development,
commercial and
operational
outcomes
CC.. RReetteennttiioonn AAwwaarrdd
Longevity-based
awards are
designed to retain
and recognise an
executive’s ongoing
commitment to CUV
DD.. LLoonngg--TTeerrmm
IInncceennttiivvee
Performance Rights
and business
generation
incentives are
granted to
executives to drive
CUV’s long-term
strategic growth
and shareholder
wealth
Year 1
Year 3
Year 4
The Company’s reward framework has historically provided for a mix of fixed pay and variable pay. The variable pay
is structured to incentivise:
• Short-term (generally cash payments in the form of performance-based incentives awarded at a fixed amount
or as a percentage of base salary).
Long-term (generally based upon the issue of performance rights to acquire shares in the Company, and in
relation to the Managing Director and to the Chief Financial Officer, other fixed amount cash incentives,
including retention awards to recognise ongoing commitment to the Company).
72
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CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
DD EXECUTIVE RREEMMUUNNEERRAATTIIOONN
((ii)) EExxeeccuuttiivvee RReemmuunneerraattiioonn FFrraammeewwoorrkk
The following diagram links each of the executive remuneration components to the Company’s mission and
strategy.
To translate scientific breakthroughs into commercial products,
To be creative, to be diligent and to be vigilant in pur focus over the
aiming to deliver innovative medical solutions for complex products
long-term
TThhee CCLLIINNUUVVEELL VViissiioonn
((iiii)) EExxeeccuuttiivvee RReemmuunneerraattiioonn SSttrruuccttuurree 22002200--2211
AA.. FFiixxeedd
RReemmuunneerraattiioonn
BBaassee SSaallaarryy
aanndd NNoonn--
MMoonneettaarryy
BBeenneeffiittss
Fixed remuneration comprises base salary, superannuation and non-monetary benefits including health insurance,
accommodation, relocation, travel and statutory benefits
Base salary is set at a level to attract and retain talent with the requisite capabilities to deliver on CLINUVEL’s
objectives, taking into account seniority, qualifications, skill, experience, length of service, leadership, industry
knowledge and level of strategic oversight.
Base salary is regularly tested for market competitiveness by reference to appropriate benchmarks sourced
externally and comparing to industry-relevant local and international peer companies.
Base salary may be adjusted each year for changes to CPI. Any adjustments above CPI are in response to individual
performance or change in job scope and reviewed and approved by the Remuneration Committee.
BB.. SShhoorrtt TTeerrmm
IInncceennttiivvee
Short Term Incentives (STIs) are annual payments to reward executives for achieving certain regulatory,
development, commercial and operational outcomes which are expected to contribute to increasing shareholder
value.
for 2020/21 are:
Details of the STI arrangements are as follows:
Euros
Setting and Assessment
OOtthheerr KKMMPP
Are reset at the start of each
financial year by the Managing
Director and are recommended
to the Remuneration Committee
for their review and approval.
Managing Director, the weighting for 2019/20 was 30% financial targets and 70% in individual performance targets. The
Chief Financial Officer: 17% of
Board considers the specific performance-based targets to be commercially sensitive and are not provided in detail. The targets
Base Salary
for 2019/20 were connected to:
MMaannaaggiinngg DDiirreeccttoorr
Are reset at the start of each financial
year by the Remuneration Committee
and are assessed at the end of the
financial year.
100% of Base Salary, payment capped
at 465,000 Euros.
Maximum Opportunity *
2.
1.
3.
Performance hurdles
Cessation of employment
2021, the Remuneration Committee assessed the Managing Director’s performance targets which form his Short-Term
Incentive and awarded a 70% assessment against the targets.
STIs will be evaluated for the current
performance period on a pro-rata
basis.
A mix of financial and non-financial
targets. All targets are set having
regard to the achievements and
performance of the prior year, market
conditions and internal forecasts.
Relationship Between Remuneration And Performance” section which follows
several pages lat
Chief Scientific Officer: 9% of
Base Salary
Must be employed by the
Company and not serving a
period of notice prior to the end
of the relevant financial year. It
will not be paid pro-rata should
the Other KMP leave
employment during the relevant
financial year.
A mix of financial and non-
financial targets. All targets are
set having regard to the
achievements and performance
of the prior year, market
conditions and internal
forecasts.
In the year following the year of
In the year following the year of
achievement.
achievement.
Other Executives, the short-term incentive targets can be a mix of individual performance-based incentives and have a
The Company’s policy is not to
The Company’s policy is not to
component for time served to encourage staff retention. Each performance-based target is based on specific individual
disclose commercially sensitive
disclose commercially sensitive
responsibilities and objectives typical for these roles in a global life sciences company at its stage of development and
information, consistent with best
information, consistent with best
commercialisation. The performance-based incentives covered revenue generation, business expansion and optimisation,
practice disclosure obligations
practice disclosure obligations but will
regulatory progress, manufacturing, research and development and corporate affairs. the Managing Director assessed overall
but will provide information on
provide information on achieving the
performance for the 2020/21 year against the short-term incentives and recommended to the Remuneration Committee and who
achieving the performance
performance hurdles to the extent
approved the following assessments against the maximum short-term incentives:
hurdles to the extent
commercially practicable. See the
commercially practicable. See
section titled “Relationship between
22%%
the section titled “Relationship
Remuneration and Performance” on
between Remuneration and
pages 43 and 44.
Performance” on pages 43 & 44.
had autonomously chosen to forego the STI awarded for the year and for it to be waived in solidarity with the millions of
people who have been impacted and the lives lost due to the coronavirus pandemic and for the monies to be re-invested in
the Company’s further research and development.
Disclosure of Performance
Payment
9955%%
• Short-term (generally cash payments in the form of performance-based incentives awarded at a fixed amount
* For 2021/22 the target opportunity for the Managing Director shall be 100% of Base Salary
Long-term (generally based upon the issue of performance rights to acquire shares in the Company, and in
relation to the Managing Director and to the Chief Financial Officer, other fixed amount cash incentives,
including retention awards to recognise ongoing commitment to the Company).
For the year ended 30 June 2021, the Remuneration Committee assessed the MMaannaaggiinngg DDiirreeccttoorr’s performance
targets which form his Short-Term Incentive and awarded a 70% assessment against the targets.
For the year ended 30 June 2020, the Managing Director had autonomously chosen to forego the STI awarded for
the year and for it to be waived in solidarity with the millions of people who have been impacted and the lives lost
34
73
35
World Leader in Melanocortins
Diversify and Grow
Establish New Markets
DDeelliivveerreedd tthhrroouugghh tthhee CCoorrppoorraattee SSttrraatteeggyy
Revenue Growth
Market Capitalisation Growth
Development and commercial progress, set
business targets are met
AAnndd AAcchhiieevviinngg PPeerrffoorrmmaannccee
IIss LLiinnkkeedd ttoo TToottaall EExxeeccuuttiivvee RReemmuunneerraattiioonn
* Managing Director and CFO only
AA.. FFiixxeedd
RReemmuunneerraattiioonn
Fixed remuneration
comprises base
salary,
superannuation and
non-monetary
benefits
BB.. SShhoorrtt--TTeerrmm
IInncceennttiivvee
Annual awards for
achieving financial,
regulatory,
development,
commercial and
operational
outcomes
CC.. RReetteennttiioonn AAwwaarrdd
Longevity-based
awards are
designed to retain
and recognise an
executive’s ongoing
commitment to CUV
DD.. LLoonngg--TTeerrmm
IInncceennttiivvee
Performance Rights
and business
generation
incentives are
granted to
executives to drive
CUV’s long-term
strategic growth
and shareholder
wealth
Year 1
Year 3
Year 4
The Company’s reward framework has historically provided for a mix of fixed pay and variable pay. The variable pay
is structured to incentivise:
or as a percentage of base salary).
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
due to the coronavirus pandemic and for the monies to be re-invested in the Company’s further research and
development
For the OOtthheerr KKMMPP, For the year ended 30 June 2021 the Managing Director assessed overall performance for the
2020/21 year against the short-term incentives and recommended to the Remuneration Committee and who
approved the following assessments against the maximum short-term incentives:
CChhiieeff SScciieennttiiffiicc OOffffiicceerr:: 6655%%
CChhiieeff FFiinnaanncciiaall OOffffiicceerr:: 8822%%
CC.. RReetteennttiioonn
AAwwaarrdd
Longevity-based awards are remuneration payments to encourage key management retention and to recognise an
ongoing commitment to the Company.
In 2019/20 the Managing Director and Chief Financial Officer entered into new service agreements with the
Company which included longevity-based award payments as part of overall remuneration. The executives are
entitled to receive the following payments for each full month of service to CLINUVEL and its subsidiaries since their
original employment start in November 2005.
MMaannaaggiinngg DDiirreeccttoorr
€5,025
CChhiieeff FFiinnaanncciiaall OOffffiicceerr
A$1,000
The longevity-based awards were at risk of forfeiture for the first 12 months following the 1 July 2019 Effective Date
if the executives had provided a notice of termination during this period. The longevity-based award shall be paid to
the executives no less than 36 months following the Effective Date of the service agreement unless the service
agreement is terminated sooner.
DD..
PPeerrffoorrmmaannccee
RRiigghhttss
Performance Rights, being an option to acquire ordinary shares of CLINUVEL PHARMACEUTICALS LTD for nil exercise
•
price, are offered to Executive KMP and to staff from time to time to:
•
• retain and motivate staff and Other Executive KMP to drive the long-term growth and success of the Company;
• to align their interests with increased shareholder wealth over the longer term.
Unlike other equity remuneration plans internationally, performance rights are nnoott ggrraanntteedd ttoo EExxeeccuuttiivveess aannnnuuaallllyy.
Historically, by virtue of the nature of the Company being primarily focussed on business expansion through ongoing
ith uncertain and long-term anticipated milestone dates.
research and development, the Performance Conditions attached to Performance Rights have been based on a mix
of financial and commercial objectives and non-financial operational targets strongly linked to shareholder value, such
as enterprise value and revenue growth.
The Remuneration Committee assesses and recommends to the Board the quantum of Performance Rights amounts
based on:
length of time served prior to issue of performance rights;
responsibility levels within the Group;
weighted average share price levels at time of issue;
• length of time served prior to issue of performance rights;
• weighted average share price levels at time of issue;
• responsibility levels within the Group;
• current base pay including variable short-term incentive levels;
• industry trends;
• impact on share dilution; and
• nature of vesting (time and/or performance) conditions attached to the issue of Performance Rights.
current base pay including variable short-term incentive levels;
industry trends;
impact on share dilution; and
Performance Rights have vesting periods either up to nearly three years, four years, seven years or undated in duration
whereby if the performance conditions are not met by the vesting date, the Performance Rights will lapse. Performance
Rights will generally only vest if the Executive remains in employment within the CLINUVEL group of entities at the
time of vesting.
nature of vesting (performance) conditions attached to the issue of performance rights.
either four years, seven years or undated in duration whereby if the performance conditions are not met by the vesting
The achievement of the Performance Condition is assessed and approved by the Board when it is considered satisfied,
date, the performance rights will lapse. Performance rights will generally only vest if the Executive remains in
or the condition has otherwise been waived by the Board.
employment within the CLINUVEL group of entities at the time of vesting.
Prior to 2020/21, the Performance Rights are exercised into new Shares and are acquired by a Plan Trustee and then,
from time to time, transferred to the beneficiary, but generally only when the beneficiary ceases employment (or
Directorship). The Company may determine and conclude agreements with the Plan Trustee and enforce or prosecute
any rights and obligations under such agreements, without reference or recourse to a participant under the Plan. For
74
36
OOtthheerr EExxeeccuuttiivvee KMP. The Other Executive KMP were last issued performance rights in the 2015/16 financial year.
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
due to the coronavirus pandemic and for the monies to be re-invested in the Company’s further research and
development
For the OOtthheerr KKMMPP, For the year ended 30 June 2021 the Managing Director assessed overall performance for the
2020/21 year against the short-term incentives and recommended to the Remuneration Committee and who
approved the following assessments against the maximum short-term incentives:
CChhiieeff SScciieennttiiffiicc OOffffiicceerr:: 6655%%
CChhiieeff FFiinnaanncciiaall OOffffiicceerr:: 8822%%
CC.. RReetteennttiioonn
AAwwaarrdd
Longevity-based awards are remuneration payments to encourage key management retention and to recognise an
ongoing commitment to the Company.
In 2019/20 the Managing Director and Chief Financial Officer entered into new service agreements with the
Company which included longevity-based award payments as part of overall remuneration. The executives are
entitled to receive the following payments for each full month of service to CLINUVEL and its subsidiaries since their
original employment start in November 2005.
MMaannaaggiinngg DDiirreeccttoorr
€5,025
CChhiieeff FFiinnaanncciiaall OOffffiicceerr
A$1,000
The longevity-based awards were at risk of forfeiture for the first 12 months following the 1 July 2019 Effective Date
if the executives had provided a notice of termination during this period. The longevity-based award shall be paid to
the executives no less than 36 months following the Effective Date of the service agreement unless the service
agreement is terminated sooner.
DD..
PPeerrffoorrmmaannccee
RRiigghhttss
•
•
Performance Rights, being an option to acquire ordinary shares of CLINUVEL PHARMACEUTICALS LTD for nil exercise
price, are offered to Executive KMP and to staff from time to time to:
• retain and motivate staff and Other Executive KMP to drive the long-term growth and success of the Company;
• to align their interests with increased shareholder wealth over the longer term.
Unlike other equity remuneration plans internationally, performance rights are nnoott ggrraanntteedd ttoo EExxeeccuuttiivveess aannnnuuaallllyy.
Historically, by virtue of the nature of the Company being primarily focussed on business expansion through ongoing
ith uncertain and long-term anticipated milestone dates.
research and development, the Performance Conditions attached to Performance Rights have been based on a mix
of financial and commercial objectives and non-financial operational targets strongly linked to shareholder value, such
as enterprise value and revenue growth.
The Remuneration Committee assesses and recommends to the Board the quantum of Performance Rights amounts
based on:
length of time served prior to issue of performance rights;
• length of time served prior to issue of performance rights;
weighted average share price levels at time of issue;
• weighted average share price levels at time of issue;
• responsibility levels within the Group;
responsibility levels within the Group;
• current base pay including variable short-term incentive levels;
current base pay including variable short-term incentive levels;
• industry trends;
• impact on share dilution; and
industry trends;
• nature of vesting (time and/or performance) conditions attached to the issue of Performance Rights.
impact on share dilution; and
Performance Rights have vesting periods either up to nearly three years, four years, seven years or undated in duration
whereby if the performance conditions are not met by the vesting date, the Performance Rights will lapse. Performance
nature of vesting (performance) conditions attached to the issue of performance rights.
Rights will generally only vest if the Executive remains in employment within the CLINUVEL group of entities at the
time of vesting.
The achievement of the Performance Condition is assessed and approved by the Board when it is considered satisfied,
either four years, seven years or undated in duration whereby if the performance conditions are not met by the vesting
or the condition has otherwise been waived by the Board.
date, the performance rights will lapse. Performance rights will generally only vest if the Executive remains in
employment within the CLINUVEL group of entities at the time of vesting.
Prior to 2020/21, the Performance Rights are exercised into new Shares and are acquired by a Plan Trustee and then,
from time to time, transferred to the beneficiary, but generally only when the beneficiary ceases employment (or
Directorship). The Company may determine and conclude agreements with the Plan Trustee and enforce or prosecute
any rights and obligations under such agreements, without reference or recourse to a participant under the Plan. For
OOtthheerr EExxeeccuuttiivvee KMP. The Other Executive KMP were last issued performance rights in the 2015/16 financial year.
36
future issues of Performance Rights, it is intended for new Shares to be transferred directly to the participant upon
successful achievement of time and performance-based vesting conditions.
For the financial years ended 30 June 2021 and 30 June 2020, no Performance Rights were granted to the OOtthheerr
EExxeeccuuttiivvee KMP. The Other Executive KMP were last issued performance rights in the 2015/16 financial year.
The Performance Conditions attached to Performance Rights previously issued to Executives (and to non-executive
Directors in previous years) issued and unvested at any time during 2020/21 relate to long-term (multi-year) strategic,
non-financial objectives and they were chosen because they are considered to be significant for long-term
sustainability of the Group and longer-term value creating in nature.
At the 2019 Annual General Meeting, shareholders approved the grant of 1,513,750 Performance Rights to the
MMaannaaggiinngg DDiirreeccttoorr and these Performance Rights were offered and issued to the Managing Director, who accepted
the offer, on 26 August 2020. Prior to this, the Managing Director was last issued Performance Rights 5 years previous,
in the 2014/15 financial year.
By shareholders approving the issue of Performance Rights, the cash-based Business Generation Incentives included
in the Managing Director’s 2019 service agreement were replaced in its entirety by equity based remuneration to vest
upon the Company meeting specific performance conditions.
These Performance Rights have a vesting period of up to four years from date of grant. If the Performance Conditions
are not achieved by 20 November 2023, they shall be forfeited and will lapse.
The Board regarded each performance hurdle for the performance conditions at the time of issue to be extremely
challenging. This is currently demonstrated in the number of Performance Rights that have vested since date of grant
at the 2019 AGM. As at 30 June 2021, of the 1,513,750 granted to the Managing Director at the 2019 AGM, 95,375
performance rights, or 6%, have achieved their vesting conditions.
A summary of the performance conditions granted to the Managing Director in respect of the Performance Rights
approved by shareholders at the 2019 AGM are set out in the following pages 38 to 40:
The rationale behind the issue of the performance rights issued to the Managing Director and presented in the
“Description of Performance Conditions” are tabled below:
PPeerrffoorrmmaannccee
CCoonnddiittiioonn
RRaattiioonnaallee
PC1
PC2
PC3
PC4
PC5
PC6
PC7
PC8
• To promote growth in Company value
• To diversify the Group whilst maintaining profitability
• To ensure conscious and risk-free financial management for further Company
growth
• To provide for financial stability to protect Shareholder value and to act as a counter
cyclical buffer during adverse economic conditions
• To increase the revenue base
• To build further value from internal product development
• To expand its existing pharmaceutical product into a new market and increase
commercial opportunities
• To expand new products in new or existing markets and increase potential revenue
base
• To incentivise and reward for unanticipated commercial opportunities which are
demonstrably value accretive
BBuussiinneessss
GGeenneerraattiioonn
IInncceennttiivvee aanndd
DDiissccrreettiioonnaarryy
PPaayymmeennttss
Business Generation Incentives (BGIs) are Individual longer-term cash incentive components based on specified
performance-based targets which remain for the term of an Executive’s service agreement.
BGIs are aimed to:
• reward exceptional business outcomes that contribute to creating significant corporate value without
shareholder dilution through equity remuneration; and
• to act as a key retention tool.
The Remuneration Committee reviews BGIs each time there is a renewal to a service agreement to ensure these
incentives are linked to the Company’s longer-term strategies it considers most likely to achieve the best possible
outcomes for the Company and its shareholders.
75
37
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
Managing Director: Consequent to shareholder approval to grant performance rights to the Managing Director at the
2019 Annual General Meeting, Business Generation Incentives were removed from the Managing Director’s service
agreement.
Other Executives: Upon a change to the Chief Financial Officer’s service agreement from 1 July 2019, BGI targets
which form part of the overall remuneration package were amended. These longer-term incentives are based on set
performance targets which must be achieved before 30 June 2022 and are linked to the Company achieving
exceptional business outcomes that contribute to creating corporate value and to act as a key retention tool.
The BGIs for the Chief Financial Officer vary between $30,000 and $60,000 per BGI, linked to:
• BGI1: successful regulatory outcome resulting in the first US approval for the use of SCENESSE® (achieved in
2019/20);
• BGI2: expansion of the Company through acquisition and integration of a new entity with demonstrated positive
cash flows of the acquired entity for four consecutive quarters post-acquisition; and
• BGI3: participation in an equity or debt funding event if deemed necessary to meet the business needs of the
Company
For the 2020/21 financial year, no BGIs were achieved by the Chief Financial Officer.
MMaannaaggiinngg DDiirreeccttoorr OOnnllyy: only in the event of exceptional performance, innovation, expansion, acquisitions,
manufacturing and business development which do not form part of the STI or not otherwise anticipated at the time
of execution of the service agreement.
No discretionary payment was awarded to the Managing Director for the year ended 30 June 2021 or 30 June 2020.
DDeessccrriippttiioonn ooff PPeerrffoorrmmaannccee CCoonnddiittiioonnss
PPeerrffoorrmmaannccee
RRiigghhttss
ggrraanntteedd ttoo
MMaannaaggiinngg
DDiirreeccttoorr
PPCC11
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,
(ii) Market capitalisation of a minimum A$2,100,000,000 - as measured by a minimum of 15 trading days
during the vesting period - 15% of the performance rights under PC1 shall vest,
(iii) Market capitalisation of a minimum A$2,700,000,000 - as measured by a minimum of 15 trading days
during the vesting period - 25% of the performance rights under PC1 shall vest,
(iv) Market capitalisation of a minimum A$5,000,000,000 - as measured by a minimum of 15 trading days
during the vesting period - 25% of the performance rights under PC1 shall vest,
(v) Market capitalisation of a minimum A$7,500,000,000 - as measured by a minimum of 15 trading days
during the vesting period - 25% of the performance rights under PC1 shall vest.
To achieve these targets within the vesting period, the Company must generate returns well above the
performance of global biotech indices over a similar period, such as the Nasdaq Biotech Index which performed
30.32% over 5 years (ending June 2019) and 5.54% on an annualised basis over the same period.
450,000
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,
76
38
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
• BGI1: successful regulatory outcome resulting in the first US approval for the use of SCENESSE® (achieved in
(ii) Upon quarterly reporting of A$70 million in cash and cash equivalents held for 2 consecutive quarters, a
(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
PPCC22
(i) Upon quarterly reporting of A$60 million in cash and cash equivalents held for 2 consecutive quarters, 15%
of PC2 shall vest,
further 20% of PC2 shall vest,
(iii) Upon quarterly reporting of A$80 million in cash and cash equivalents held for 2 consecutive quarters, a
further 30% of PC2 shall vest,
(iv) Upon quarterly reporting of more than A$150 million in cash and cash equivalents held for 2 consecutive
quarters, a further 35% of PC2 will be achieved.
Dividends paid out during the vesting period shall be added back to the calculation of the cash reserves. At any
time during the vesting period, the ratio between cash and cash equivalents internally generated from the
Company’s operations and any debt and/or equity financing which increases cash and cash equivalents must
be at minimum 2:3 ratio for any of the 5 performance targets under PC2 to be achieved.
105,000
PPCC33
Successful acquisition of a business entity, defined by:
PPeerrffoorrmmaannccee
RRiigghhttss
ggrraanntteedd ttoo
MMaannaaggiinngg
DDiirreeccttoorr
PPCC44
PPCC55
(i) The acquired entity must have generated sales revenue within 6 months of transaction, 50% of PC3 shall vest,
(ii) CUV Group becomes or remains profitable within 3 years (plus variability of one year) of transaction as
measured by two successive quarters reporting profitability of the two or more combined entities, 50% of
PC3 shall vest.
105,000
For PC3 to be achieved, the acquisition must be considered synergistic to the Company’s business operations
at the time of acquisition.
(i) Upon receipt of first US revenues under the US post-marketing authorization for SCENESSE®, 34% of PC4
shall vest,
(ii) US revenues in year 3 to exceed revenues by a minimum of 10% in year 2, a further 33% of PC4 shall vest,
(iii) US revenues greater than US$10,000,000 in a 12-month period leads to vesting of 33% of PC4.
87,500
(i) Market launch of first non-pharmaceutical (‘OTC’) product(s) line developed by the VALLAURIX subsidiary
entity,15% of PC5 shall vest,
(ii) Total revenues from OTC product lines developed by the VALLAURIX subsidiary entity achieving greater
than A$250,000 in accumulated gross sales, a further 30% of PC5 shall vest
175,000
(iii) First topical melanogenic formulation to be used either in animal or in human testing, a further 25% of PC5
shall vest,
(iv) Upon the completion of the first clinical study of a SCENESSE® paediatric formulation (being the completion
of a final clinical study report), a further 30% of PC5 shall vest
Managing Director: Consequent to shareholder approval to grant performance rights to the Managing Director at the
2019 Annual General Meeting, Business Generation Incentives were removed from the Managing Director’s service
agreement.
Other Executives: Upon a change to the Chief Financial Officer’s service agreement from 1 July 2019, BGI targets
which form part of the overall remuneration package were amended. These longer-term incentives are based on set
performance targets which must be achieved before 30 June 2022 and are linked to the Company achieving
exceptional business outcomes that contribute to creating corporate value and to act as a key retention tool.
The BGIs for the Chief Financial Officer vary between $30,000 and $60,000 per BGI, linked to:
2019/20);
Company
• BGI2: expansion of the Company through acquisition and integration of a new entity with demonstrated positive
cash flows of the acquired entity for four consecutive quarters post-acquisition; and
• BGI3: participation in an equity or debt funding event if deemed necessary to meet the business needs of the
For the 2020/21 financial year, no BGIs were achieved by the Chief Financial Officer.
MMaannaaggiinngg DDiirreeccttoorr OOnnllyy: only in the event of exceptional performance, innovation, expansion, acquisitions,
manufacturing and business development which do not form part of the STI or not otherwise anticipated at the time
of execution of the service agreement.
No discretionary payment was awarded to the Managing Director for the year ended 30 June 2021 or 30 June 2020.
DDeessccrriippttiioonn ooff PPeerrffoorrmmaannccee CCoonnddiittiioonnss
PPCC11
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,
(ii) Market capitalisation of a minimum A$2,100,000,000 - as measured by a minimum of 15 trading days
during the vesting period - 15% of the performance rights under PC1 shall vest,
(iii) Market capitalisation of a minimum A$2,700,000,000 - as measured by a minimum of 15 trading days
during the vesting period - 25% of the performance rights under PC1 shall vest,
(iv) Market capitalisation of a minimum A$5,000,000,000 - as measured by a minimum of 15 trading days
during the vesting period - 25% of the performance rights under PC1 shall vest,
(v) Market capitalisation of a minimum A$7,500,000,000 - as measured by a minimum of 15 trading days
during the vesting period - 25% of the performance rights under PC1 shall vest.
To achieve these targets within the vesting period, the Company must generate returns well above the
performance of global biotech indices over a similar period, such as the Nasdaq Biotech Index which performed
30.32% over 5 years (ending June 2019) and 5.54% on an annualised basis over the same period.
450,000
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
(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
(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,
under PC1 shall vest,
under PC1 shall vest,
PPCC66
(i) Upon start (being the closure of recruitment period) of a Phase IIb vitiligo study in North America, 20% of
PC6 shall vest,
(ii) Upon disclosure to the securities exchange of the results to the Phase IIb vitiligo study in North America,
20% of PC6 shall vest,
(iii) After the completion of the Phase IIb vitiligo study in North America and prior to the subsequent Phase
(iv) Upon start (being the closure of recruitment period) of the subsequent Phase IIb/III vitiligo study in North
America, a further 20% of PC6 shall vest,
(v) Upon disclosure to the securities exchange of the results to the subsequent Phase IIb/III vitiligo study in
North America, 20% of PC6 shall vest.
PPCC77
(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,
212,500
(ii) Upon the regulatory approval by either of EMA, FDA, TGA, PMDA and Swissmedic of SCENESSE® or any
other molecule constituting a successful evaluation of a scientific dossier, a further 75% of PC7 shall vest.
38
77
39
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,
262,500
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
PPCC88
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 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.
116,250
These corporate events shall include, but are not limited to, business generation in new markets without the
Company engaging in merger and acquisition activity.
((iiiiii)) MMaannaaggiinngg DDiirreeccttoorr RReemmuunneerraattiioonn –– FFuurrtthheerr IInnffoorrmmaattiioonn
The inherent risk of failure within pharmaceutical development is high and this risk is magnified for the Company
due to its specialised and narrow focus on developing and commercialising novel, first-in-class and first-in-line
therapies in diseases where there is an unmet clinical need.
The current progress and success of the Company needs to be set against the previous managerial attempts which
had posed operational, regulatory and financial challenges. To mitigate the risk and to provide a strong platform to
achieve meaningful progress, the Board has followed a business model where most operational skills are retained
in-house, where possible, and many management responsibilities are concentrated between the Managing Director
(acting in a dual capacity as Chief Executive Officer and Chief Medical Officer) and the Chief Scientific Officer. The
Managing Director has the responsibility of guiding and overseeing the execution of the overall corporate strategy,
has global responsibility for the safety aspects of the drug (including pharmacovigilance and quality management)
and is responsible for market access. The Chief Scientific Officer is responsible for pre-clinical programs,
toxicology, the manufacturing of the drug delivery program, clinical program and setting the regulatory strategies in
close coordination with the Board of Directors. As the business evolves and progresses through its development
path, this centralised management model will continue to evolve, and key management responsibilities will be
shared across new and existing senior management throughout the Group.
The Managing Director’s remuneration structure is reviewed every three years to ensure:
• A maximum level of incentivisation to lead and advance the Company’s program from its current stages of
development and commercial growth to serve the long-term interest of the Company, taking into account the
unique risk and complexity within the business model; and
It is competitive in international markets, industry and related fields of expertise and providing for specific
skillsets.
•
In the 2019/20 year the Managing Director’s service agreement was renewed for a further three years, from 1 July
2019 to 30 June 2022. In determining the level and structure of the remuneration agreed with the Managing
Director, the Remuneration Committee considered the following criteria:
•
•
•
•
longevity of his 15 years of service as CEO compared against local and international peers;
track record, integrity and professional qualifications for the position;
the enterprise value created over the past decade and since first employment;
the shareholder value created in the past three years leading up to the renewal to the service agreement (from
1 July 2016 to 30 June 2019);
capability to sustain the Company’s focus to maximise profitability following market access; and
•
• a demonstrated result to attain stability of the business and management team over the long term.
((iivv)) EExxeeccuuttiivvee RReemmuunneerraattiioonn –– PPeeeerr BBeenncchhmmaarrkkiinngg
One of the objectives of the Remuneration Committee’s responsibilities is to ensure that the levels and structure of
remuneration are benchmarked against relevant peers and considered against global employment market
conditions. CLINUVEL refers to a select group of publicly listed companies on the ASX and, importantly, on
international securities exchanges for the purpose of peer group analyses. CLINUVEL is a company operating
globally with the bulk of its operations and financial exposure falling outside Australia. Its remuneration structure
requires to be competitive to international benchmarks in order to attract and retain existing executive talent at the
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CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
highest management levels. The Board firmly contends it cannot limit its benchmarking and consequent setting of
the level and structure of its executive remuneration to local Australian companies only.
The selection criteria for these companies are broadly based on comparison of:
a) businesses of similar complexity and innovative nature;
b) businesses of similar scope and scale;
c) sectors requiring highly technical and specialised skills;
d) businesses of similar value, reflected in market capitalisation;
e) businesses who have demonstrated similar progress in achieving business outcomes; and
f) business of similar risk profile.
During the year the Managing Director’s remuneration was benchmarked against relevant local and international
(US) companies using the following quantitative criteria, consistent to the selection criteria listed above:
Benchmarking Criteria
Australian Companies
US Companies
Market Capitalisation:
Between A$100 million and A$3
billion
Between US$500 million and US$5
billion
Generating Product Revenues:
Yes
Yes
Financial Status:
Positive EBITDA
Positive EBITDA
Six Australian and 13 US life science peer companies (being a mix of medical device, pharmaceutical product and
diagnostic focussed companies) were identified. The results of the peer analyses concluded that in the past 5
years, CLINUVEL:
1. had raised far less capital;
2. had incurred significantly less shareholder dilution;
3. had accelerated its revenue growth,
4. had outstripped reported profit and earnings per share, and
5. had delivered a higher total shareholder return than most peers included in the analysis.
The table below compares the Total Shareholder Return between CLINUVEL and the peer companies over the past
5 years:
PPCC88
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 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
116,250
performances which was unanticipated at the time of business planning.
These corporate events shall include, but are not limited to, business generation in new markets without the
Company engaging in merger and acquisition activity.
((iiiiii)) MMaannaaggiinngg DDiirreeccttoorr RReemmuunneerraattiioonn –– FFuurrtthheerr IInnffoorrmmaattiioonn
The inherent risk of failure within pharmaceutical development is high and this risk is magnified for the Company
due to its specialised and narrow focus on developing and commercialising novel, first-in-class and first-in-line
therapies in diseases where there is an unmet clinical need.
The current progress and success of the Company needs to be set against the previous managerial attempts which
had posed operational, regulatory and financial challenges. To mitigate the risk and to provide a strong platform to
achieve meaningful progress, the Board has followed a business model where most operational skills are retained
in-house, where possible, and many management responsibilities are concentrated between the Managing Director
(acting in a dual capacity as Chief Executive Officer and Chief Medical Officer) and the Chief Scientific Officer. The
Managing Director has the responsibility of guiding and overseeing the execution of the overall corporate strategy,
has global responsibility for the safety aspects of the drug (including pharmacovigilance and quality management)
and is responsible for market access. The Chief Scientific Officer is responsible for pre-clinical programs,
toxicology, the manufacturing of the drug delivery program, clinical program and setting the regulatory strategies in
close coordination with the Board of Directors. As the business evolves and progresses through its development
path, this centralised management model will continue to evolve, and key management responsibilities will be
shared across new and existing senior management throughout the Group.
The Managing Director’s remuneration structure is reviewed every three years to ensure:
• A maximum level of incentivisation to lead and advance the Company’s program from its current stages of
development and commercial growth to serve the long-term interest of the Company, taking into account the
unique risk and complexity within the business model; and
It is competitive in international markets, industry and related fields of expertise and providing for specific
skillsets.
In the 2019/20 year the Managing Director’s service agreement was renewed for a further three years, from 1 July
2019 to 30 June 2022. In determining the level and structure of the remuneration agreed with the Managing
Director, the Remuneration Committee considered the following criteria:
longevity of his 15 years of service as CEO compared against local and international peers;
track record, integrity and professional qualifications for the position;
the enterprise value created over the past decade and since first employment;
the shareholder value created in the past three years leading up to the renewal to the service agreement (from
1 July 2016 to 30 June 2019);
capability to sustain the Company’s focus to maximise profitability following market access; and
• a demonstrated result to attain stability of the business and management team over the long term.
•
•
•
•
•
•
((iivv)) EExxeeccuuttiivvee RReemmuunneerraattiioonn –– PPeeeerr BBeenncchhmmaarrkkiinngg
One of the objectives of the Remuneration Committee’s responsibilities is to ensure that the levels and structure of
remuneration are benchmarked against relevant peers and considered against global employment market
conditions. CLINUVEL refers to a select group of publicly listed companies on the ASX and, importantly, on
international securities exchanges for the purpose of peer group analyses. CLINUVEL is a company operating
globally with the bulk of its operations and financial exposure falling outside Australia. Its remuneration structure
requires to be competitive to international benchmarks in order to attract and retain existing executive talent at the
40
79
41
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
Throughout FY2021 CLINUVEL was trading at significantly higher P/E multiples than nearly all its Australian and US
peers, indicating shareholder expectation that CLINUVEL will deliver superior growth than its peers, a reflection of
shareholders’ confidence in management executing on the stated strategy.
In comparing Managing Director remuneration to the peer group, the fixed base remuneration was positioned
above the median level, whereas the total remuneration level was positioned below the median level. The Board
considers the level of fixed base remuneration to be appropriate, considering the long-term outperformance of the
Company and the relatively unusual long-term tenure of the Managing Director who has led the Company since
2005, building a profitable and sustainable business whilst delivering higher than normal shareholder return.
To further demonstrate this outperformance throughout the Managing Director’s tenure, the following graph
discloses the relationship between performance and shareholder value since 2005:
((vv)) RReellaattiioonnsshhiipp BBeettwweeeenn RReemmuunneerraattiioonn AAnndd PPeerrffoorrmmaannccee
The Group has been solely dedicated to the research, development and commercialisation of its unique and
medically beneficial technology. The remuneration and incentive framework, which has been put in place by the
Board, has ensured executive personnel are focussed on both maximising short-term operating performance and
long-term strategic growth to promote shareholder value. The focus on growth in shareholder value has been
centred on achievement of regulatory, development, commercial and operational outcomes, where financial
metrics are not necessarily an appropriate measure of executive performance and is commonly expected in other
market segments. In recent years the Board has recognised that both financial and non-financial performance
measures have been a key link to driving share price performance and this has been reflected in various
performance conditions attached to the long-term equity incentives. The following performance outcomes tabled
in the following page, as aligned with the CLINUVEL strategy, were achieved resulting in a performance based STI
80
42
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
Throughout FY2021 CLINUVEL was trading at significantly higher P/E multiples than nearly all its Australian and US
peers, indicating shareholder expectation that CLINUVEL will deliver superior growth than its peers, a reflection of
shareholders’ confidence in management executing on the stated strategy.
In comparing Managing Director remuneration to the peer group, the fixed base remuneration was positioned
above the median level, whereas the total remuneration level was positioned below the median level. The Board
considers the level of fixed base remuneration to be appropriate, considering the long-term outperformance of the
Company and the relatively unusual long-term tenure of the Managing Director who has led the Company since
2005, building a profitable and sustainable business whilst delivering higher than normal shareholder return.
To further demonstrate this outperformance throughout the Managing Director’s tenure, the following graph
incentive rating of 70% of the maximum potential opportunity for the Managing Director. In assessing the KPIs, the
Board considered the significant achievements made during the reporting period and the effort required to navigate
the issues and challenges facing the company from the COVID-19 pandemic. This included supplying treatment
centres across Europe and the United States with uninterrupted supply, working with the centres to access patients
and to prepare centres to treat new patients under pending clinical, investigational settings.
Additional objectives were taken into consideration when assessing Other KMP performance by the Board which
were considered an essential element of achieving individual performance. However, these are considered
commercially sensitive.
discloses the relationship between performance and shareholder value since 2005:
SSTTII OOuuttccoommeess
YYeeaarr EEnnddeedd 3300 JJuunnee 22002211
SSTTIIss ssuummmmaarriisseedd iinnttoo
SSttrraatteeggiicc GGrroouuppiinngg
MMaannaaggiinngg DDiirreeccttoorr
WWeeiigghhttiinngg
RRaattiinngg
OOuuttccoommee
GGrroowwtthh aanndd TTeecchhnnoollooggyy
TTrraannssllaattiioonn
20%
Partially Met
preparing for commercial scale manufacture
• Progress made in the development of the PRÉNUMBRA®
second afamelanotide formulation
• Formulations developed for non-pharmaceutical topicals,
MMaannuuffaaccttuurriinngg
25%
Partially Met
FFiinnaanncciiaall
35%
Partially Met
PPeeooppllee aanndd CCuullttuurree
10%
Met
NNeeww IInniittiiaattiivveess
10%
Partially Met
TToottaall
110000%%
7700%%
((vv)) RReellaattiioonnsshhiipp BBeettwweeeenn RReemmuunneerraattiioonn AAnndd PPeerrffoorrmmaannccee
The Group has been solely dedicated to the research, development and commercialisation of its unique and
medically beneficial technology. The remuneration and incentive framework, which has been put in place by the
Board, has ensured executive personnel are focussed on both maximising short-term operating performance and
long-term strategic growth to promote shareholder value. The focus on growth in shareholder value has been
centred on achievement of regulatory, development, commercial and operational outcomes, where financial
metrics are not necessarily an appropriate measure of executive performance and is commonly expected in other
market segments. In recent years the Board has recognised that both financial and non-financial performance
measures have been a key link to driving share price performance and this has been reflected in various
performance conditions attached to the long-term equity incentives. The following performance outcomes tabled
in the following page, as aligned with the CLINUVEL strategy, were achieved resulting in a performance based STI
42
• Constructing and opening of new VALLAURIX Research,
Development & Innovation (RDI) Centre in Singapore
• Identifying potential acquisition targets to support inorganic
expansion of the Group
• Inventory management of SCENESSE® to support future
commercial and clinical supply
• Raw material supply secured
• Targeted alternative manufacturing solutions to allow eventual
vertical integration of supply chain within the Group
• Fourth Consecutive Annual Profit Announced, 123% increase in
PBIT
• Increase in Cash Reserves, Receipts and Revenues
• Third Consecutive Annual Dividend Paid
• Recognised as one of the Financial Times High-Growth
Companies of the Asia-Pacific Region for 2020
• Maintained uniform pricing in EU, set US price
• Communications, Branding & Marketing Division established,
new team of staff appointed
• Increased personnel upon expanded RDI Centre in Singapore
• Key leadership appointments following internal management
re-structure
• DNA Repair Program announced in XP Patients:
• Initially XP-C patients, extended to XP-V patients
• Local approvals granted
• First patient dosed
• Positive safety assessment of first patient
• Supporting non-clinical project for assay development
completed
• Stroke Program Announced, with commencement of Phase II
pilot study and first patients recruited and dosed
• DNA Repair Program Announced for Healthy Volunteers
• Local approvals granted
81
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CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
The table below shows the progress made in moving through the clinical pathway and into the commercialisation
pathway, reflecting the performance of executive management under the leadership of the Managing Director. The
table also links to share price performance.
RReegguullaattoorryy,, CClliinniiccaall && CCoommmmeerrcciiaall MMiilleessttoonneess
Year Ended 30 June
2017
2018
2019
2020
2021
PPhh IIII VViittiilliiggoo SSttuuddyy -- SSiinnggaappoorree
VVAALLLLAAUURRIIXX PPTTEE LLTTDD –– ffoorrmmuullaattiioonn && mmeellaannooccoorrttiinn ddeevveellooppmmeenntt
FFiirrsstt ccoommmmeerrcciiaall ssaalleess iinn EEUU
SSuubbmmiissssiioonn aanndd ssuubbsseeqquueenntt aapppprroovvaall ffoorr mmaarrkkeettiinngg aauutthhoorriissaattiioonn bbyy tthhee UUSS FFDDAA
SSuubbmmiissssiioonn aanndd ssuubbsseeqquueenntt aapppprroovvaall ffoorr mmaarrkkeettiinngg aauutthhoorriissaattiioonn bbyy tthhee AAuussttrraalliiaann TTGGAA
FFiirrsstt ccoommmmeerrcciiaall ssaalleess iinn UUSS
PPhh IIII AArrtteerriiaall IIsscchhaaeemmiicc SSttrrookkee SSttuuddyy -- MMeellbboouurrnnee
MMaarrkkeett ccaappiittaalliissaattiioonn ((AA$$ mmiilllliioonn))
333
527
1,649
1,267
1,517
SShhaarree PPrriiccee HHiigghh (($$))
SShhaarree PPrriiccee LLooww (($$))
CClloossiinngg SShhaarree PPrriiccee (($$))
CChhaannggee iinn SShhaarree PPrriiccee oovveerr 11 YYeeaarr ((%%))
CChhaannggee iinn SShhaarree PPrriiccee oovveerr 33 YYeeaarrss ((%%))
CChhaannggee iinn SShhaarree PPrriiccee oovveerr 55 YYeeaarrss ((%%))
DDiivviiddeenndd PPaaiidd ((cceennttss))
9.19
13.52
39.85
45.88
31.23
4.10
5.91
9.43
12.92
19.53
6.98
11.01
33.68
25.65
30.70
62
311
328
-
58
288
206
680
(24)
20
268
179
508
1881
803
611%
-
2.0
2.5
2.5
((vvii)) EExxeeccuuttiivvee RReemmuunneerraattiioonn PPaayy MMiixx
The Board believes the remuneration mix aligns the Managing Director and Other Executive KMP to shareholder
interest. The remuneration mix for 2020/21 is demonstrated as follows:
Position
Fixed Remuneration
STI Cash
LTI Cash1
LTI Equity2
Managing Director
100%
48% of Base Salary
6.9% of Base Salary
134% of Base
Salary
Other Executive KMP 100%
Between 9% and
17% of Base Salary
4.6% of Base Salary
-
1. Retention Award earned during 2020/21. For Other Executive KMP, relates to CFO only
2. Shown as total value of performance rights calculated under AASB2 divided by 4 years being the vesting period of the performance rights granted in the year,
and includes accelerated expensing of those performance rights which vest during the year
82
44
CLINUVEL Pharmaceuticals | 2021 Annual Report
table also links to share price performance.
RReegguullaattoorryy,, CClliinniiccaall && CCoommmmeerrcciiaall MMiilleessttoonneess
Year Ended 30 June
2017
2018
2019
2020
2021
VVAALLLLAAUURRIIXX PPTTEE LLTTDD –– ffoorrmmuullaattiioonn && mmeellaannooccoorrttiinn ddeevveellooppmmeenntt
PPhh IIII VViittiilliiggoo SSttuuddyy -- SSiinnggaappoorree
FFiirrsstt ccoommmmeerrcciiaall ssaalleess iinn EEUU
SSuubbmmiissssiioonn aanndd ssuubbsseeqquueenntt aapppprroovvaall ffoorr mmaarrkkeettiinngg aauutthhoorriissaattiioonn bbyy tthhee UUSS FFDDAA
SSuubbmmiissssiioonn aanndd ssuubbsseeqquueenntt aapppprroovvaall ffoorr mmaarrkkeettiinngg aauutthhoorriissaattiioonn bbyy tthhee AAuussttrraalliiaann TTGGAA
FFiirrsstt ccoommmmeerrcciiaall ssaalleess iinn UUSS
PPhh IIII AArrtteerriiaall IIsscchhaaeemmiicc SSttrrookkee SSttuuddyy -- MMeellbboouurrnnee
SShhaarree PPrriiccee HHiigghh (($$))
SShhaarree PPrriiccee LLooww (($$))
CClloossiinngg SShhaarree PPrriiccee (($$))
CChhaannggee iinn SShhaarree PPrriiccee oovveerr 11 YYeeaarr ((%%))
CChhaannggee iinn SShhaarree PPrriiccee oovveerr 33 YYeeaarrss ((%%))
CChhaannggee iinn SShhaarree PPrriiccee oovveerr 55 YYeeaarrss ((%%))
DDiivviiddeenndd PPaaiidd ((cceennttss))
4.10
5.91
9.43
12.92
19.53
6.98
11.01
33.68
25.65
30.70
62
311
328
-
58
288
206
680
(24)
20
268
179
508
1881
803
611%
-
2.0
2.5
2.5
((vvii)) EExxeeccuuttiivvee RReemmuunneerraattiioonn PPaayy MMiixx
The Board believes the remuneration mix aligns the Managing Director and Other Executive KMP to shareholder
interest. The remuneration mix for 2020/21 is demonstrated as follows:
Position
Fixed Remuneration
STI Cash
LTI Cash1
LTI Equity2
Managing Director
100%
48% of Base Salary
6.9% of Base Salary
134% of Base
Salary
Other Executive KMP 100%
Between 9% and
17% of Base Salary
4.6% of Base Salary
-
1. Retention Award earned during 2020/21. For Other Executive KMP, relates to CFO only
2. Shown as total value of performance rights calculated under AASB2 divided by 4 years being the vesting period of the performance rights granted in the year,
and includes accelerated expensing of those performance rights which vest during the year
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
The table below shows the progress made in moving through the clinical pathway and into the commercialisation
pathway, reflecting the performance of executive management under the leadership of the Managing Director. The
EE NON-EXECUTIVE RREEMMUUNNEERRAATTIIOONN
The Board seeks an appropriate mix of skill, diversity, experience and specific expertise to steward the Company’s
success. The Remuneration Committee recommends to the Board individual Non-Executive Director fee levels to
attract and retain those with the aforementioned attributes, having regard to global employment market conditions
and consultation with specialist remuneration consultants with experience in the healthcare and biotechnology
industries.
NNoonn--EExxeeccuuttiivvee DDiirreeccttoorr FFeeeess
Non-Executive Director fees consist of base fees and committee fees and are inclusive of superannuation and all
other contributions. There are no further retirement benefits. The fees are outlined in the table below:
AAnnnnuuaall NNoonn--EExxeeccuuttiivvee DDiirreeccttoorr ffeeeess ((iinncclluussiivvee ooff ssuuppeerraannnnuuaattiioonn))::
MMaarrkkeett ccaappiittaalliissaattiioonn ((AA$$ mmiilllliioonn))
333
527
1,649
1,267
1,517
9.19
13.52
39.85
45.88
31.23
CChhaaiirr
NNoonn--EExxeeccuuttiivvee DDiirreeccttoorr
CCoommmmiitttteeee CChhaaiirr
CCoommmmiitttteeee MMeemmbbeerr
BBooaarrdd FFeeeess
AAuuddiitt && RRiisskk
CCoommmmiitttteeee
RReemmuunneerraattiioonn
CCoommmmiitttteeee
NNoommiinnaattiioonn
CCoommmmiitttteeee
PPrriioorr ttoo JJaannuuaarryy
11 22002211
AAfftteerr JJaannuuaarryy 11
22002211
115,000
70,000
110,000
65,000
-
-
-
-
15,000
5,000
-
-
15,000
5,000
-
-
-
-
* The Chair of the Board is a member of all Committees but does not receive any additional Committee fees in addition to the base fee.
From 1 January 2021, the Board agreed to increase the Non-Executive Director fees by $5,000 per annum. The
increase was to ensure the level of Non-Executive Director fees remain competitive to attract and retain high-
calibre Directors. It was the first increase to Non-Executive Director fees since 2015/16.
Under the Company’s Constitution, the maximum aggregate remuneration available for division among the Non-
Executive Directors is to be determined by the shareholders in a General Meeting and was set at $700,000 at the
2019 AGM. This amount (or some part of it) is to be divided among the Non-Executive Directors as determined by
the Board. The aggregate amount paid to Non-Executive Directors for the year ended 30 June 2021 was $412,500.
NNoonn--EExxeeccuuttiivvee DDiirreeccttoorr LLoonngg--TTeerrmm IInncceennttiivvee –– EEqquuiittyy CCoommppeennssaattiioonn
The long-term equity remuneration was formerly provided to Non-Executive Directors via the CLINUVEL Conditional
Rights Plan and the Performance Rights Plan. Any issue of Performance Rights to Non-Executive Directors requires
shareholder approval.
The Board had previously considered the relatively small management team comparative to peer companies when
setting Non-Executive Director remuneration policy. The Board considered that from time to time its Non-Executive
Directors would become involved in steering management and engage in certain operational matters that would
not commonly be expected of those in a non-executive capacity. Furthermore, the Company ensured the interests
of all its KMP, including those in a non-executive capacity, were aligned with the interests of the Company and its
shareholders within an appropriate control framework, addressing the preference of some shareholders to see
Non-Executive Directors have shareholdings in the Group.
It is no longer planned for Non-Executive Directors to participate in long-term equity compensation plans. Only one
current Non-Executive Director in Mrs Shanahan still holds Performance Rights, the last date of issue being
November 2014.
44
83
45
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
FF SERVICE AGREEMENTS FFYY22002211
Remuneration and other terms of employment for the Managing Director are formalised by a service agreement
determined by the Remuneration Committee. The agreement provides for base salary, short- and long-term
incentives, other benefits and participation, when eligible, in the CLINUVEL Performance Rights Plan.
The Managing Director, in consultation with the Remuneration Committee, oversees the service agreements
entered into with other Executive KMP, providing for base salary, incentives, other benefits and participation, when
eligible, in the CLINUVEL Conditional Rights Plan.
On appointment to the Board, all Non-Executive Directors enter into a service agreement with the Company in the
form of a letter of appointment. The letter summarises the Board’s policies, the Director’s responsibilities and
compensation for holding office. The details of the service agreements to the Managing Director and Executive
KMP are:
NNaammee
DDrr PPhhiilliippppee WWoollggeenn11
DDrr DDeennnniiss WWrriigghhtt MMrr DDaarrrreenn KKeeaammyy22
DDuurraattiioonn ooff ccoonnttrraacctt
3 years
No fixed term
3 years
NNoottiiccee PPeerriioodd (from Company)
12 months
3 months
12 months
NNoottiiccee PPeerriioodd (from Managing Director)
12 months
-
-
NNoottiiccee PPeerriioodd (from Executive KMP)
-
3 months
12 months
TTeerrmmiinnaattiioonn PPaayymmeenntt wwiitthhoouutt CCaauussee
12 months
3 months
12 months
TTeerrmmiinnaattiioonn PPaayymmeenntt wwiitthh CCaauussee
None
None
None
1. Expiry Date 30 June 2022
2. Expiry Date 30 June 2022
GG SHARE-BASED RREEMMUUNNEERRAATTIIOONN
The Group has an ownership based scheme for Directors, Other Executive KMP, employees and select consultants
of the Company which is designed to provide long-term incentives to deliver long-term value.
PPeerrffoorrmmaannccee RRiigghhttss::
All Performance Rights that have been issued fall under two Performance Rights plans:
a.
b.
the CLINUVEL Conditional Performance Rights Scheme (2009); and
the CLINUVEL Performance Rights Plan (2014).
1,513,750 Performance rights were approved by shareholders to grant to the Managing Director at the 2019 AGM.
aa.. CCoonnddiittiioonnaall PPeerrffoorrmmaannccee RRiigghhttss SScchheemmee ((22000099))
The Conditional Performance Rights Scheme (2009) is available to eligible employees of the Company. Any issue
of rights to Directors requires shareholder approval in accordance with ASX Listing Rules. All rights convert to one
ordinary share of the Group and are issued for nil consideration, have no voting rights, are non-transferable and are
not listed on the ASX. These can be converted to ordinary shares at any time once the vesting conditions attached
84
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CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
FF SERVICE AGREEMENTS FFYY22002211
to the rights have been achieved, whereby these will be held in a Scheme Trust on behalf of the eligible employee
for up to seven years.
Remuneration and other terms of employment for the Managing Director are formalised by a service agreement
determined by the Remuneration Committee. The agreement provides for base salary, short- and long-term
incentives, other benefits and participation, when eligible, in the CLINUVEL Performance Rights Plan.
The eligible employee can request for shares to be transferred from the Scheme Trust after seven years or at an
earlier date if the eligible employee is no longer employed by the Company or all transfer restrictions are satisfied
or waived by the Board in its discretion. It is no longer intended to issue Performance Rights under the 2009 Plan.
The Managing Director, in consultation with the Remuneration Committee, oversees the service agreements
138,335 Performance Rights issued under the 2009 Scheme remain unvested as at 30 June 2021
entered into with other Executive KMP, providing for base salary, incentives, other benefits and participation, when
eligible, in the CLINUVEL Conditional Rights Plan.
bb.. PPeerrffoorrmmaannccee RRiigghhttss PPllaann ((22001144))
On appointment to the Board, all Non-Executive Directors enter into a service agreement with the Company in the
form of a letter of appointment. The letter summarises the Board’s policies, the Director’s responsibilities and
compensation for holding office. The details of the service agreements to the Managing Director and Executive
KMP are:
NNaammee
DDrr PPhhiilliippppee WWoollggeenn11
DDrr DDeennnniiss WWrriigghhtt MMrr DDaarrrreenn KKeeaammyy22
DDuurraattiioonn ooff ccoonnttrraacctt
3 years
No fixed term
3 years
NNoottiiccee PPeerriioodd (from Company)
12 months
3 months
12 months
NNoottiiccee PPeerriioodd (from Managing Director)
12 months
-
-
NNoottiiccee PPeerriioodd (from Executive KMP)
-
3 months
12 months
TTeerrmmiinnaattiioonn PPaayymmeenntt wwiitthhoouutt CCaauussee
12 months
3 months
12 months
TTeerrmmiinnaattiioonn PPaayymmeenntt wwiitthh CCaauussee
None
None
None
1. Expiry Date 30 June 2022
2. Expiry Date 30 June 2022
GG SHARE-BASED RREEMMUUNNEERRAATTIIOONN
The Group has an ownership based scheme for Directors, Other Executive KMP, employees and select consultants
of the Company which is designed to provide long-term incentives to deliver long-term value.
PPeerrffoorrmmaannccee RRiigghhttss::
All Performance Rights that have been issued fall under two Performance Rights plans:
a.
b.
the CLINUVEL Conditional Performance Rights Scheme (2009); and
the CLINUVEL Performance Rights Plan (2014).
1,513,750 Performance rights were approved by shareholders to grant to the Managing Director at the 2019 AGM.
aa.. CCoonnddiittiioonnaall PPeerrffoorrmmaannccee RRiigghhttss SScchheemmee ((22000099))
The Conditional Performance Rights Scheme (2009) is available to eligible employees of the Company. Any issue
of rights to Directors requires shareholder approval in accordance with ASX Listing Rules. All rights convert to one
ordinary share of the Group and are issued for nil consideration, have no voting rights, are non-transferable and are
not listed on the ASX. These can be converted to ordinary shares at any time once the vesting conditions attached
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. All rights convert to one ordinary
share of the Group and are issued for nil consideration, have no voting rights, are not listed on the ASX and are non-
tradeable (other than with prior written Board consent). They can be converted to ordinary shares at any time once
the vesting conditions attached to the rights have been achieved, whereby, at the discretion of the Board, they will
be held in a Plan Trust on behalf of the eligible person.
If shares are held in trust, the eligible person cannot trade the shares held by the Plan Trustee without prior written
Board consent until the earlier of seven years from grant date of Performance Rights, when the eligible person
ceases employment or when all transfer restrictions are satisfied or waived by the Board in its discretion. Unless
the Performance Rights are granted with a shorter vesting period, Performance Rights under this plan lapses after
seven years from grant date.
Performance Rights are valued for financial reporting purposes using either a Monte Carlo simulation pricing model
or a probability-adjusted binomial valuation pricing model and are represented as accounting values only in the
financial statements. Holders of Performance Rights may or may not receive a benefit from these amounts, either
in the current or future reporting periods. The value of all performance rights granted, exercised and lapsed during
the financial year is detailed in the tables within the Remuneration Report.
1,646,250 Performance Rights have been issued and 1,550,875 remain unvested under the 2014 Plan. 95,375
Performance Rights have vested but are not yet exercised.
FFYY22002222 PPllaannnneedd IIssssuuee ooff PPeerrffoorrmmaannccee RRiigghhttss ttoo SSttaaffff
The Performance Rights Plan is an important component of the Company’s remuneration reward framework which,
amongst other things, strives to retain, motivate and incentivise employees to build company value and to align
their interests with those of the shareholders of CLINUVEL. The Board wishes to continue incentivising those
employees (‘participants’) who are considered by the Board to be integral to CLINUVEL achieving its future goals of
successfully commercialising the Company and executing the expansion of its various R&D and commercial and
programs.
In FY2022 the Board intends to issue Performance Rights to select staff. The conditions attached to these
Performance Rights will be consistent to the performance conditions and the timelines to those granted to the
Managing Director and approved by shareholders at the 2019 AGM. They will also consist of individual-based
performance conditions tailored to each participant designed to add to company value should these conditions be
met within the vesting period.
The last time employees of the Company were issued with Performance Rights was FY2015.
46
85
47
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
HH DETAILS OF RREEMMUUNNEERRAATTIIOONN
KKMMPP rreemmuunneerraattiioonn ooff tthhee ccoommppaannyy ffoorr tthhee yyeeaarrss eennddeedd 3300 JJuunnee 22002211 aanndd 3300 JJuunnee 22002200
–– CCaasshh BBaasseedd BBeenneeffiittss
YYeeaarr
GGrroossss SSaallaarryy ³³
SShhoorrtt TTeerrmm
IInncceennttiivvee
BBuussiinneessss
GGeenneerraattiioonn
IInncceennttiivvee
RReetteennttiioonn AAwwaarrdd
OOtthheerr¹¹
SSuuppeerraannnnuuaattiioonn//
PPeennssiioonn FFuunndd
TToottaall ((EExxcclluuddiinngg
SShhaarree--BBaasseedd
PPaayymmeennttss))
$
$
$
$
$
DDrr.. PP..JJ.. WWoollggeenn22
22002211
1,532,499
732,976
105,152
296,911
1,422,022
152,299
22002200
rreessttaatteedd
1,577,235
22002211
75,343
22002200
73,059
22002211
112,500
22002200
99,167
22002211
72,500
22002200
67,917
22002211
72,500
22002200
52,667
22002211
66,210
22002200
38,204
22002211
-
22002200
41,857
-
-
-
-
-
-
-
-
-
-
-
-
-
264,818
257,105
288,468
15,492
17,355
40,385
22002211
22002200
22002211
22002200
rreessttaatteedd
MMrrss.. BB..MM.. SShhaannaahhaann
MMrr.. WW..AA.. BBlliijjddoorrpp
DDrr.. KK..AA.. AAggeerrssbboorrgg
MMrrss.. SS.. EE.. SSmmiitthh
PPrrooff.. JJ.. VV.. RRoosseennffeelldd
MMrr.. SS..RR.. MMccLLiieesshh
Ceased directorship
30 November 2019
DDrr.. DD..JJ.. WWrriigghhtt
MMrr.. DD..MM.. KKeeaammyy
TToottaall
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
13,331
$
-
-
7,157
6,941
-
-
-
-
-
-
6,290
3,629
-
$
22,,666677,,553388
33,,115511,,555566
8822,,550000
8800,,000000
111122,,550000
9999,,116677
7722,,550000
6677,,991177
7722,,550000
5522,,666677
7722,,550000
4411,,883333
--
3,976
4455,,883333
21,694
21,003
21,694
21,003
330022,,000044
229955,,446633
336633,,887788
554455,,771166
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
278,713
42,364
30,000
173,636
22002211
22,,448844,,883388
778888,,885533
--
111188,,448833
229966,,991111
5566,,883355
33,,774455,,992200
22002200
rreessttaatteedd
22,,448855,,992244
5599,,771199
3300,,000000
11,,559955,,665588
115522,,229999
5566,,555522
44,,338800,,115522
‘Other’ includes health insurance, housing and other allowances that may be subject to fringe benefits tax.
In 2019/20 Dr Wolgen’s salary is paid in Singapore dollars (SGD) and in Euro currency. In 2020/21 the salary was paid in Euro currency
1
3
3 Does not include movement in annual leave and long service leave provisions.
The natural accretion to Dr Wolgen’s annual leave and long service leave entitlements for 2020/21 was $231,314 (year ending 30 June 2020: $172,950). For Mr
Keamy and Dr Wright, the accretive movement to their annual leave and long service leave entitlements was $11,172 and $20,223 respectively (year ending 30
June 2020: $24,000 and $3,277 increase respectively)
In 2019/20, upon the renewal of Dr Wolgen’s service agreement and the increase to his base salary, the value of his unused annual leave and long service leave
entitlements were reset, resulting in a $365,923 increase to annual leave and long service leave entitlements available to Dr Wolgen.
⁴ The retention award shall be paid to the executives no less than 1 July 2022 unless their service agreement is terminated sooner. See page 36 for further
information.
86
48
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
HH DETAILS OF RREEMMUUNNEERRAATTIIOONN
KKMMPP rreemmuunneerraattiioonn ooff tthhee ccoommppaannyy ffoorr tthhee yyeeaarrss eennddeedd 3300 JJuunnee 22002211 aanndd 3300 JJuunnee 22002200
KKMMPP rreemmuunneerraattiioonn ooff tthhee ccoommppaannyy ffoorr tthhee yyeeaarrss eennddeedd 3300 JJuunnee 22002211 aanndd 3300 JJuunnee 22002200
–– NNoonn--CCaasshh BBeenneeffiittss
YYeeaarr
GGrroossss SSaallaarryy ³³
SShhoorrtt TTeerrmm
IInncceennttiivvee
GGeenneerraattiioonn
RReetteennttiioonn AAwwaarrdd
OOtthheerr¹¹
BBuussiinneessss
IInncceennttiivvee
SSuuppeerraannnnuuaattiioonn//
PPeennssiioonn FFuunndd
TToottaall ((EExxcclluuddiinngg
SShhaarree--BBaasseedd
PPaayymmeennttss))
$
$
$
$
$
DDrr.. PP..JJ.. WWoollggeenn³³
22002211
1,532,499
732,976
105,152
296,911
1,422,022
152,299
MMrrss.. BB..MM.. SShhaannaahhaann
MMrr.. WW..AA.. BBlliijjddoorrpp
DDrr.. KK..AA.. AAggeerrssbboorrgg
MMrrss.. SS.. EE.. SSmmiitthh
PPrrooff.. JJ.. VV.. RRoosseennffeelldd
MMrr.. SS..RR.. MMccLLiieesshh
Ceased directorship
30 November 2019
DDrr.. DD..JJ.. WWrriigghhtt
MMrr.. DD..MM.. KKeeaammyy
TToottaall
SShhaarree--bbaasseedd ppaayymmeennttss (accounting
charge only) ¹¹
YYeeaarr
TToottaall ((EExxcclluuddiinngg
SShhaarree--BBaasseedd
PPaayymmeennttss))
PPeerrffoorrmmaannccee
RRiigghhttss
TToottaall ((IInncclluuddiinngg
SShhaarree--BBaasseedd
PPaayymmeennttss))
%% ppeerrffoorrmmaannccee--
bbaasseedd
22002211
22002200
rreessttaatteedd
22002211
22002200
22002211
22002200
22002211
22002200
22002211
22002200
22002211
22002200
22002211
22002200
22002211
22002200
22002211
22002200
rreessttaatteedd
22002211
22002200
rreessttaatteedd
$
$
$
22,,666677,,553388
2,312,308
44,,997799,,884466
33,,115511,,555566
1,645,205
44,,779966,,776611
6611%%
3344%%
8822,,550000
8800,,000000
111122,,550000
9999,,116677
7722,,550000
6677,,991177
7722,,550000
5522,,666677
7722,,550000
4411,,883333
--
4455,,883333
330022,,000044
229955,,446633
336633,,887788
554455,,771166
-
-
-
-
-
-
-
-
-
-
-
-
-
8822,,550000
8800,,000000
111122,,550000
9999,,116677
7722,,550000
6677,,991177
7722,,550000
5522,,666677
7722,,550000
4411,,883333
--
4455,,883333
330022,,000044
1,284
229966,,774477
-
336633,,887788
4,174
554499,,889900
33,,774455,,992200
22,,331122,,330088
66,,005588,,222288
44,,338800,,115522
11,,665500,,666633
66,,003300,,881155
55%%
66%%
1111%%
1144%%
1 As these values represent accounting values the KMP may or may not actually receive any benefit from these amounts, either in the current or future reporting
periods. Any benefit obtained by the KMP is contingent upon the Company achieving certain performance conditions. The value of all performance rights and
share options granted, exercised and lapsed during the financial year is detailed in the following tables within the Remuneration Report. Performance rights were
priced using either the Monte Carlo simulation pricing model or a binomial pricing model. The amount expensed each reporting period includes adjustments to
the life-to-date expense of the grants based on the reassessed estimate of achieving non-market performance criteria.
87
49
–– CCaasshh BBaasseedd BBeenneeffiittss
DDrr.. PP..JJ.. WWoollggeenn22
MMrrss.. BB..MM.. SShhaannaahhaann
22002200
rreessttaatteedd
1,577,235
22002211
75,343
22002200
73,059
22002211
112,500
22002200
99,167
22002211
72,500
22002200
67,917
22002211
72,500
22002200
52,667
22002211
66,210
22002200
38,204
22002211
-
22002200
41,857
22002211
22002200
22002211
22002200
rreessttaatteedd
22002200
rreessttaatteedd
MMrr.. WW..AA.. BBlliijjddoorrpp
DDrr.. KK..AA.. AAggeerrssbboorrgg
MMrrss.. SS.. EE.. SSmmiitthh
PPrrooff.. JJ.. VV.. RRoosseennffeelldd
MMrr.. SS..RR.. MMccLLiieesshh
Ceased directorship
30 November 2019
DDrr.. DD..JJ.. WWrriigghhtt
MMrr.. DD..MM.. KKeeaammyy
TToottaall
1
3
information.
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
--
-
-
-
-
-
-
-
-
-
-
-
-
-
-
264,818
257,105
288,468
15,492
17,355
40,385
278,713
42,364
30,000
173,636
13,331
22002211
22,,448844,,883388
778888,,885533
111188,,448833
229966,,991111
5566,,883355
33,,774455,,992200
22,,448855,,992244
5599,,771199
3300,,000000
11,,559955,,665588
115522,,229999
5566,,555522
44,,338800,,115522
‘Other’ includes health insurance, housing and other allowances that may be subject to fringe benefits tax.
In 2019/20 Dr Wolgen’s salary is paid in Singapore dollars (SGD) and in Euro currency. In 2020/21 the salary was paid in Euro currency
3 Does not include movement in annual leave and long service leave provisions.
The natural accretion to Dr Wolgen’s annual leave and long service leave entitlements for 2020/21 was $231,314 (year ending 30 June 2020: $172,950). For Mr
Keamy and Dr Wright, the accretive movement to their annual leave and long service leave entitlements was $11,172 and $20,223 respectively (year ending 30
June 2020: $24,000 and $3,277 increase respectively)
In 2019/20, upon the renewal of Dr Wolgen’s service agreement and the increase to his base salary, the value of his unused annual leave and long service leave
entitlements were reset, resulting in a $365,923 increase to annual leave and long service leave entitlements available to Dr Wolgen.
⁴ The retention award shall be paid to the executives no less than 1 July 2022 unless their service agreement is terminated sooner. See page 36 for further
7,157
6,941
$
-
-
-
-
-
-
-
-
-
6,290
3,629
21,694
21,003
21,694
21,003
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
3,976
4455,,883333
$
22,,666677,,553388
33,,115511,,555566
8822,,550000
8800,,000000
111122,,550000
9999,,116677
7722,,550000
6677,,991177
7722,,550000
5522,,666677
7722,,550000
4411,,883333
--
330022,,000044
229955,,446633
336633,,887788
554455,,771166
48
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
RReemmuunneerraattiioonn PPeerrffoorrmmaannccee RRiigghhttss hhoollddiinnggss ooff KKMMPP –– 22002211
BBaallaannccee aatt
SSttaarrtt ooff YYeeaarr
IIssssuueedd aass
CCoommppeennssaattiioonn**
EExxeerrcciisseedd
LLaappsseedd aanndd
EExxppiirreedd
BBaallaannccee aatt
EEnndd ooff YYeeaarr
VVeesstteedd aanndd
EExxeerrcciissaabbllee
DDiirreeccttoorrss
MMrrss.. BB..MM.. SShhaannaahhaann
25,000
-
DDrr.. PP..JJ.. WWoollggeenn
MMrr.. WW..AA.. BBlliijjddoorrpp
DDrr.. KK..AA.. AAggeerrssbboorrgg
MMrrss.. SS.. EE.. SSmmiitthh
PPrrooff.. JJ.. VV.. RRoosseennffeelldd
OOtthheerr KKMMPP
DDrr.. DD..JJ.. WWrriigghhtt
MMrr.. DD..MM.. KKeeaammyy
-
-
-
-
-
18,125
32,360
1,513,750
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
25,000
-
1,513,750
95,375
-
-
-
-
18,125
32,360
-
-
-
-
-
-
All Performance Rights held at the end of the year are unvested.
* Relates to the approval by shareholders to grant performance rights to the Managing Director at the 2019 AGM.
SShhaarreess hheelldd bbyy KKMMPP
The number of ordinary shares in the Company during the 2020/21 reporting period held by each of the Group’s
KMP, including their related parties, is set out below:
YYeeaarr EEnnddeedd 3300 JJuunnee 22002211
PPeerrssoonnnneell
MMrrss.. BB..MM.. SShhaannaahhaann
DDrr.. PP..JJ.. WWoollggeenn
MMrr.. WW..AA.. BBlliijjddoorrpp
DDrr.. KK..AA.. AAggeerrssbboorrgg
MMrrss.. SS.. EE.. SSmmiitthh
PPrrooff.. JJ.. VV.. RRoosseennffeelldd
OOtthheerr KKMMPP
DDrr.. DD..JJ.. WWrriigghhtt
MMrr.. DD..MM.. KKeeaammyy
88
BBaallaannccee aatt SSttaarrtt ooff
YYeeaarr
GGrraanntteedd aass
RReemmuunneerraattiioonn
RReecceeiivveedd oonn
EExxeerrcciissee
OOtthheerr CChhaannggeess
HHeelldd aatt tthhee EEnndd ooff
RReeppoorrttiinngg PPeerriioodd
258,969
3,504,696
1,743,118
5,500
-
1,693
301,874
331,343
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
(25,000)
(329,375)
-
-
420
670
(45,000)
(17,755)
233,969
3,175,321
1,743,118
5,500
420
2,363
256,874
313,588
50
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
RReemmuunneerraattiioonn PPeerrffoorrmmaannccee RRiigghhttss hhoollddiinnggss ooff KKMMPP –– 22002211
TTeerrmmss aanndd ccoonnddiittiioonnss ooff eeaacchh ggrraanntt ooff rriigghhttss aaffffeeccttiinngg rreemmuunneerraattiioonn iinn tthhee ccuurrrreenntt oorr ffuuttuurree
rreeppoorrttiinngg ppeerriiooddss
BBaallaannccee aatt
IIssssuueedd aass
SSttaarrtt ooff YYeeaarr
CCoommppeennssaattiioonn**
EExxeerrcciisseedd
LLaappsseedd aanndd
EExxppiirreedd
BBaallaannccee aatt
EEnndd ooff YYeeaarr
VVeesstteedd aanndd
EExxeerrcciissaabbllee
EEnnttiittyy
NNuummbbeerr ooff
RRiigghhttss
GGrraanntteedd
VVaalluuee ppeerr
RRiigghhtt
oonn GGrraanntt
DDaattee
CCllaassss
GGrraanntt DDaattee
IIssssuuee ddaattee
EExxppiirryy DDaattee
NNuummbbeerr ooff
RRiigghhttss VVeesstteedd
EExxeerrcciissaabbllee
DDaattee
MMrrss.. BB..MM.. SShhaannaahhaann
25,000
25,000
CCLLIINNUUVVEELL
450,000
$10.86
Ordinary
20/11/2019
26/08/2020
20/11/2023
0
-
1,513,750
1,513,750
95,375
CCLLIINNUUVVEELL
1,063,750
$26.87
Ordinary
20/11/2019
26/08/2020
20/11/2023
21,000
29/01/2021
45,500
26/08/2020
CCLLIINNUUVVEELL
37,976
$8.97
Ordinary
24/12/2020
24/12/2020
20/11/2023
CCLLIINNUUVVEELL
94,524
$20.73
Ordinary
24/12/2020
24/12/2020
20/11/2023
28,875
20/05/2021
0
0
-
-
For each cash incentive and right granted, the percentage of the available grant or cash incentive that was paid or
vested in the financial year, and the percentage forfeited due to unmet milestones (including service length), is set
out below. Cash incentives are paid in the year following the period of performance.
RReemmuunneerraattiioonn ddeettaaiillss ooff EEqquuiittyy IInncceennttiivveess ((PPeerrffoorrmmaannccee RRiigghhttss))
All Performance Rights held at the end of the year are unvested.
* Relates to the approval by shareholders to grant performance rights to the Managing Director at the 2019 AGM.
EEqquuiittyy IInncceennttiivveess ((PPeerrffoorrmmaannccee RRiigghhttss))
NNaammee
YYeeaarr GGrraanntteedd
LLaatteesstt YYeeaarr ooff
VVeessttiinngg
VVeesstteedd iinn YYeeaarr
FFoorrffeeiitteedd iinn YYeeaarr
MMaaxx VVaalluuee ooff RRiigghhtt
aatt GGrraanntt DDaattee YYeett ttoo
VVeesstt
DDrr.. PP..JJ.. WWoollggeenn
2019/20 *
2023/24
6%
0%
7,542,604
The number of ordinary shares in the Company during the 2020/21 reporting period held by each of the Group’s
MMrrss.. BB..MM.. SShhaannaahhaann
2011/12
no limitation
MMrr.. WW..AA.. BBlliijjddoorrpp
DDrr.. KK..AA.. AAggeerrssbboorrgg
MMrrss.. SS.. EE.. SSmmiitthh
PPrrooff.. JJ.. VV.. RRoosseennffeelldd
OOtthheerr KKMMPP
-
-
-
-
-
-
-
-
DDrr.. DD..JJ.. WWrriigghhtt
2011/12
no limitation
MMrr.. DD..MM.. KKeeaammyy
2011/12
no limitation
-
-
-
-
-
-
-
-
-
-
-
-
-
-
16,682
-
-
-
-
12,853
23,126
The maximum value of outstanding Performance Rights is unable to be estimated. On exercise, each Performance Right entitles the KMP to one fully paid ordinary
share in the Company. The share price of the Company at the time of exercise is not known. The minimum value of unvested performance rights is nil. The exercise
price for those Rights granted between 2010/11 and 2014/15 was $Nil.
* At the 2019 Annual General Meeting, shareholders approved the grant of 1,513,750 performance rights to the Managing Director and these Performance Rights
were issued on 26 August 2020.
89
51
DDiirreeccttoorrss
DDrr.. PP..JJ.. WWoollggeenn
MMrr.. WW..AA.. BBlliijjddoorrpp
DDrr.. KK..AA.. AAggeerrssbboorrgg
MMrrss.. SS.. EE.. SSmmiitthh
PPrrooff.. JJ.. VV.. RRoosseennffeelldd
OOtthheerr KKMMPP
DDrr.. DD..JJ.. WWrriigghhtt
MMrr.. DD..MM.. KKeeaammyy
PPeerrssoonnnneell
MMrrss.. BB..MM.. SShhaannaahhaann
DDrr.. PP..JJ.. WWoollggeenn
MMrr.. WW..AA.. BBlliijjddoorrpp
DDrr.. KK..AA.. AAggeerrssbboorrgg
MMrrss.. SS.. EE.. SSmmiitthh
PPrrooff.. JJ.. VV.. RRoosseennffeelldd
OOtthheerr KKMMPP
DDrr.. DD..JJ.. WWrriigghhtt
MMrr.. DD..MM.. KKeeaammyy
-
-
-
-
-
18,125
32,360
258,969
3,504,696
1,743,118
5,500
-
1,693
301,874
331,343
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
18,125
32,360
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
(25,000)
(329,375)
-
-
420
670
(45,000)
(17,755)
233,969
3,175,321
1,743,118
5,500
420
2,363
256,874
313,588
50
SShhaarreess hheelldd bbyy KKMMPP
KMP, including their related parties, is set out below:
YYeeaarr EEnnddeedd 3300 JJuunnee 22002211
BBaallaannccee aatt SSttaarrtt ooff
YYeeaarr
GGrraanntteedd aass
RReemmuunneerraattiioonn
RReecceeiivveedd oonn
EExxeerrcciissee
OOtthheerr CChhaannggeess
HHeelldd aatt tthhee EEnndd ooff
RReeppoorrttiinngg PPeerriioodd
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
RReemmuunneerraattiioonn ddeettaaiillss ooff ccaasshh iinncceennttiivveess
CCaasshh IInncceennttiivveess
NNaammee
Max Potential Opportunity (%)
STI Awarded (%)
STI Forfeited (%)
Total Granted ($)
DDrr.. PP..JJ.. WWoollggeenn
DDrr.. DD..JJ.. WWrriigghhtt
MMrr.. DD..MM.. KKeeaammyy
53%
9%
17%
70%
65%
82%
30%
35%
18%
732,976
15,492
40,385
LLooaannss ttoo DDiirreeccttoorrss aanndd EExxeeccuuttiivveess
No loans were granted to Directors or executives for the years ended 30 June 2021 and 30 June 2020.
EENNDD OOFF AAUUDDIITTEEDD RREEMMUUNNEERRAATTIIOONN RREEPPOORRTT
SShhaarreess PPrroovviiddeedd UUppoonn EExxeerrcciissee ooff RRiigghhttss
DDeettaaiillss ooff SShhaarreess iissssuueedd dduurriinngg tthhee ffiinnaanncciiaall yyeeaarr aass aa rreessuulltt ooff eexxeerrcciissee ooff rriigghhttss
EEnnttiittyy
NNuummbbeerr ooff sshhaarreess iissssuueedd¹¹
IIssssuuee PPrriiccee ffoorr SShhaarreess
CCllaassss
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD
Nil
Nil$
Ordinary
¹¹These shares were issued by the Group during the year after performance conditions attached to the rights were considered met. Those shares issued by the Group
to Directors and Employees are held for retention by the Trustee for the 2009 Scheme and the 2014 Plan Trust. Shares issued by the Group to eligible participants
were issued directly to the Trustee.
DDEETTAAIILLSS OOFF SSHHAARREESS TTRRAANNSSFFEERRRREEDD DDUURRIINNGG TTHHEE YYEEAARR TTOO EEMMPPLLOOYYEEEESS FFRROOMM TTHHEE 22000099
SSCCHHEEMMEE TTRRUUSSTT AANNDD TTHHEE 22001144 PPLLAANN TTRRUUSSTT
EEnnttiittyy
NNuummbbeerr ooff sshhaarreess iissssuueedd¹¹
IIssssuuee PPrriiccee ffoorr SShhaarreess
CCllaassss
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD
1,750,528
Nil$
Ordinary
¹¹These shares were issued by the Trustee to the 2009 Scheme and the 2014 Plan to departing employees who resigned from the Group during the year or to existing
employees who had their transfer restrictions waived by the Board in their discretion.
90
52
CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
RReemmuunneerraattiioonn ddeettaaiillss ooff ccaasshh iinncceennttiivveess
UUNNIISSSSUUEEDD SShhaarreess UUnnddeerr OOppttiioonn
CCaasshh IInncceennttiivveess
DDrr.. PP..JJ.. WWoollggeenn
DDrr.. DD..JJ.. WWrriigghhtt
MMrr.. DD..MM.. KKeeaammyy
NNaammee
Max Potential Opportunity (%)
STI Awarded (%)
STI Forfeited (%)
Total Granted ($)
EEnnttiittyy
NNuummbbeerr ooff SShhaarreess
uunnddeerr RRiigghhttss
EExxeerrcciissee
PPrriiccee
CCllaassss
EExxppiirryy DDaattee
53%
9%
17%
70%
65%
82%
30%
35%
18%
732,976
15,492
40,385
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD
1,784,583
$Nil
Ordinary
Upon achievement of specific
performance and time-based
milestones or upon cessation
of employment
TToottaall aass aatt 3300 JJuunnee 22002211
1,784,583
-
-
-
LLooaannss ttoo DDiirreeccttoorrss aanndd EExxeeccuuttiivveess
NNoonn--AAuuddiitt SSeerrvviicceess
No loans were granted to Directors or executives for the years ended 30 June 2021 and 30 June 2020.
EENNDD OOFF AAUUDDIITTEEDD RREEMMUUNNEERRAATTIIOONN RREEPPOORRTT
SShhaarreess PPrroovviiddeedd UUppoonn EExxeerrcciissee ooff RRiigghhttss
DDeettaaiillss ooff SShhaarreess iissssuueedd dduurriinngg tthhee ffiinnaanncciiaall yyeeaarr aass aa rreessuulltt ooff eexxeerrcciissee ooff rriigghhttss
EEnnttiittyy
NNuummbbeerr ooff sshhaarreess iissssuueedd¹¹
IIssssuuee PPrriiccee ffoorr SShhaarreess
CCllaassss
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD
Nil
Nil$
Ordinary
¹¹These shares were issued by the Group during the year after performance conditions attached to the rights were considered met. Those shares issued by the Group
to Directors and Employees are held for retention by the Trustee for the 2009 Scheme and the 2014 Plan Trust. Shares issued by the Group to eligible participants
were issued directly to the Trustee.
DDEETTAAIILLSS OOFF SSHHAARREESS TTRRAANNSSFFEERRRREEDD DDUURRIINNGG TTHHEE YYEEAARR TTOO EEMMPPLLOOYYEEEESS FFRROOMM TTHHEE 22000099
SSCCHHEEMMEE TTRRUUSSTT AANNDD TTHHEE 22001144 PPLLAANN TTRRUUSSTT
EEnnttiittyy
NNuummbbeerr ooff sshhaarreess iissssuueedd¹¹
IIssssuuee PPrriiccee ffoorr SShhaarreess
CCllaassss
For the year ended 30 June 2021, Grant Thornton Australia provided audit services to the Company. Grant Thornton
Australia also provided non-audit services, specifically tax related services. Details of amounts paid or payable to
the auditor for non-audit services provided during the year by the auditor are outlined in Note 19 to the financial
statements.
The Directors are satisfied that the provision of non-audit services, during the year, by the auditor is compatible
with the general standard of independence for auditors imposed by the Corporations Act 2001. The Directors are of
the opinion that the services as disclosed in Note 19 to the financial statements do not compromise the external
auditor’s independence, based on advice received from the Audit Committee, for the following reasons:
•
•
all non-audit services have been reviewed and approved to ensure that they do not impact the integrity and
objectivity of the auditor; and
none of the services undermine the general principles relating to auditor independence as set out in APES 110
‘Code of Ethics for Professional Accountants’ issued by the Accounting Professional & Ethical Standards
Board, including reviewing or auditing the auditor’s own work, acting in a management or decision-making
capacity for the Company, acting as advocate for the Company or jointly sharing economic risks and rewards.
AAuuddiittoorr’’ss IInnddeeppeennddeennccee DDeeccllaarraattiioonn
The auditor’s independence declaration as required by s.307C of the Corporations Act 2001 is included and forms
part of this Directors’ Report.
PPrroocceeeeddiinnggss OOnn BBeehhaallff OOff tthhee CCoommppaannyy
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.
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD
1,750,528
Nil$
Ordinary
The Company was not party to any such proceedings during the year.
¹¹These shares were issued by the Trustee to the 2009 Scheme and the 2014 Plan to departing employees who resigned from the Group during the year or to existing
employees who had their transfer restrictions waived by the Board in their discretion.
Signed in accordance with a resolution of the Board of Directors pursuant to s.298(2) of The Corporations Act
2001.
Dr. Philippe Wolgen, MBA MD
Director
Dated this 25th day of August, 2021
52
91
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CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
SSttaatteemmeenntt ooff PPrrooffiitt aanndd OOtthheerr CCoommpprreehheennssiivvee IInnccoommee
ffoorr tthhee YYeeaarr EEnnddeedd 3300 JJuunnee 22002211
Total revenues
Interest income
Other income
Total expenses
Note
2(a)
2(b)
2(c)
2(d)
Consolidated Entity
2021
2020 Restated
$
$
47,975,583
32,565,423
342,203
562,928
132,813
781,319
(22,737,955)
(22,368,859)
PPrrooffiitt bbeeffoorree iinnccoommee ttaaxx eexxppeennssee ((bbeenneeffiitt))
2255,,771122,,664444
1111,,554400,,881111
IInnccoommee ttaaxx eexxppeennssee ((bbeenneeffiitt))
33((aa))
998844,,339977
((33,,551100,,338888))
PPrrooffiitt aafftteerr iinnccoommee ttaaxx eexxppeennssee ((bbeenneeffiitt))
2244,,772288,,224477
1155,,005511,,119999
NNeett pprrooffiitt ffoorr tthhee yyeeaarr
2244,,772288,,224477
1155,,005511,,119999
OOtthheerr ccoommpprreehheennssiivvee iinnccoommee
Items that may be re-classified subsequently to profit or loss
Exchange differences of foreign exchange translation of foreign
operations
Other comprehensive income/(loss) for the period, net of
income tax
(575,253)
592,857
(575,253)
592,857
TToottaall ccoommpprreehheennssiivvee iinnccoommee ffoorr tthhee ppeerriioodd
2244,,115522,,999944
1155,,664444,,005566
Basic earnings per share - cents per share
Diluted earnings per share - cents per share
16
16
50.0
48.4
30.6
29.8
The accompanying notes form part of these financial statements.
92
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CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
SSttaatteemmeenntt ooff PPrrooffiitt aanndd OOtthheerr CCoommpprreehheennssiivvee IInnccoommee
SSttaatteemmeenntt ooff FFiinnaanncciiaall PPoossiittiioonn aass aatt 3300 JJuunnee 22002211
ffoorr tthhee YYeeaarr EEnnddeedd 3300 JJuunnee 22002211
Total revenues
Interest income
Other income
Total expenses
Consolidated Entity
2021
$
2020 Restated
$
47,975,583
32,565,423
342,203
562,928
132,813
781,319
(22,737,955)
(22,368,859)
Note
2(a)
2(b)
2(c)
2(d)
33((aa))
PPrrooffiitt bbeeffoorree iinnccoommee ttaaxx eexxppeennssee ((bbeenneeffiitt))
2255,,771122,,664444
1111,,554400,,881111
IInnccoommee ttaaxx eexxppeennssee ((bbeenneeffiitt))
998844,,339977
((33,,551100,,338888))
PPrrooffiitt aafftteerr iinnccoommee ttaaxx eexxppeennssee ((bbeenneeffiitt))
2244,,772288,,224477
1155,,005511,,119999
NNeett pprrooffiitt ffoorr tthhee yyeeaarr
2244,,772288,,224477
1155,,005511,,119999
OOtthheerr ccoommpprreehheennssiivvee iinnccoommee
Items that may be re-classified subsequently to profit or loss
Exchange differences of foreign exchange translation of foreign
operations
income tax
Other comprehensive income/(loss) for the period, net of
(575,253)
592,857
(575,253)
592,857
TToottaall ccoommpprreehheennssiivvee iinnccoommee ffoorr tthhee ppeerriioodd
2244,,115522,,999944
1155,,664444,,005566
Basic earnings per share - cents per share
Diluted earnings per share - cents per share
16
16
50.0
48.4
30.6
29.8
The accompanying notes form part of these financial statements.
CCuurrrreenntt aasssseettss
Cash and cash equivalents
Trade and other receivables
Inventories
Other assets
TToottaall ccuurrrreenntt aasssseettss
NNoonn--ccuurrrreenntt aasssseettss
Property, plant and equipment - net
Right-Of-Use assets - net
Intangible asset - net
Deferred tax assets - net
TToottaall nnoonn--ccuurrrreenntt aasssseettss
TToottaall aasssseettss
CCuurrrreenntt lliiaabbiilliittiieess
Trade and other payables
Lease liabilities
Provisions
TToottaall ccuurrrreenntt lliiaabbiilliittiieess
NNoonn--ccuurrrreenntt lliiaabbiilliittiieess
Lease liabilities
Provisions
TToottaall nnoonn--ccuurrrreenntt lliiaabbiilliittiieess
TToottaall lliiaabbiilliittiieess
NNeett aasssseettss
EEqquuiittyy
Contributed equity
Reserves
Accumulated losses
TToottaall eeqquuiittyy
The accompanying notes form part of these financial statements.
CCoonnssoolliiddaatteedd EEnnttiittyy
Note
2021
2020 Restated
$
$
17(a)
82,690,982
66,746,521
4
5
6
7
8
9
3(c)
11
8
12
8
12
13
14
16,088,527
3,186,670
882,034
6,612,684
1,287,914
508,818
110022,,884488,,221133
7755,,115555,,993377
1,384,422
1,218,721
185,030
2,931,188
55,,771199,,336611
1,075,441
1,313,937
185,030
3,811,500
66,,338855,,990088
110088,,556677,,557744
8811,,554411,,884455
4,751,138
258,236
3,697,579
88,,770066,,995533
1,045,236
77,951
11,,112233,,118877
99,,883300,,114400
4,771,581
212,331
3,278,175
88,,226622,,008877
1,107,224
105,727
11,,221122,,995511
99,,447755,,003388
9988,,773377,,443344
7722,,006666,,880077
151,849,375
151,849,375
5,017,827
1,850,375
(58,129,768)
(81,632,943)
9988,,773377,,443344
7722,,006666,,880077
54
93
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CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
SSttaatteemmeenntt ooff CCaasshh FFlloowwss ffoorr tthhee YYeeaarr EEnnddeedd 3300 JJuunnee 22002211
CCaasshh fflloowwss ffrroomm ooppeerraattiinngg aaccttiivviittiieess
Receipts from customers
Payments to suppliers and employees
Interest received
GST and VAT refunds
Government grants
NNoottee
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
22002200
$$
38,723,858
29,287,833
(20,031,810)
(16,281,001)
390,970
79,684
99,359
636,631
423,370
121,535
NNeett ccaasshh pprroovviiddeedd bbyy ooppeerraattiinngg aaccttiivviittiieess
1177((bb))
1199,,226622,,006611
1144,,118888,,336688
Cash flows from investing activities
Payments for property, plant and equipment
NNeett ccaasshh uusseedd iinn iinnvveessttiinngg aaccttiivviittiieess
CCaasshh fflloowwss ffrroomm ffiinnaanncciinngg aaccttiivviittiieess
Dividends paid
Payment of lease liabilities
Payment of interest
NNeett ccaasshh uusseedd iinn ffiinnaanncciinngg aaccttiivviittiieess
NNeett iinnccrreeaassee iinn ccaasshh hheelldd
(854,325)
(888,826)
((885544,,332255))
((888888,,882266))
(1,235,266)
(1,224,021)
(200,280)
(243,341)
(44,405)
(18,501)
((11,,447799,,995511))
((11,,448855,,886633))
1166,,992277,,778855
1111,,881133,,667799
CCaasshh aanndd ccaasshh eeqquuiivvaalleennttss aatt bbeeggiinnnniinngg ooff tthhee yyeeaarr
6666,,774466,,552211
5544,,226688,,775588
Effects of exchange rate changes on foreign currency held
(983,324)
664,084
CCaasshh aanndd ccaasshh eeqquuiivvaalleennttss aatt eenndd ooff tthhee yyeeaarr
1177((aa))
8822,,669900,,998822
6666,,774466,,552211
The accompanying notes form part of these financial statements.
94
56
CLINUVEL Pharmaceuticals | 2021 Annual Report SSttaatteemmeenntt ooff CChhaannggeess iinn EEqquuiittyy ffoorr tthhee YYeeaarr EEnnddeedd 3300 JJuunnee 22002211
SSttaatteemmeenntt ooff CChhaannggeess iinn EEqquuiittyy ffoorr tthhee YYeeaarr EEnnddeedd 3300 JJuunnee 22002211
SSttaatteemmeenntt ooff CChhaannggeess iinn EEqquuiittyy ffoorr tthhee YYeeaarr EEnnddeedd 3300 JJuunnee 22002211
Statement of Changes in Equity
for the Year Ended 30 June 2021
SSttaatteemmeenntt ooff CChhaannggeess iinn EEqquuiittyy ffoorr tthhee YYeeaarr EEnnddeedd 3300 JJuunnee 22002211
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
BBaallaannccee aatt 3300 JJuunnee 22001199
BBaallaannccee aatt 3300 JJuunnee 22001199
BBaallaannccee aatt 3300 JJuunnee 22001199
BBaallaannccee aatt 3300 JJuunnee 22001199
Exercise of Performance Rights under share-based payment
Exercise of Performance Rights under share-based payment
Exercise of Performance Rights under share-based payment
Exercise of Performance Rights under share-based payment
SShhaarree CCaappiittaall
SShhaarree CCaappiittaall
SShhaarree CCaappiittaall
PPeerrffoorrmmaannccee
RRiigghhttss RReesseerrvvee
PPeerrffoorrmmaannccee
RRiigghhttss RReesseerrvvee
PPeerrffoorrmmaannccee
RRiigghhttss RReesseerrvvee
SShhaarree CCaappiittaall
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
115511,,331144,,117755
115511,,331144,,117755
115511,,331144,,117755
665544,,332244
665544,,332244
115511,,331144,,117755
665544,,332244
535,200
535,200
535,200
(535,200)
(535,200)
535,200
(535,200)
Employee share-based payment options
Employee share-based payment options
Employee share-based payment options
Employee share-based payment options
Dividends Paid
Dividends Paid
Dividends Paid
Dividends Paid
-
-
-
-
-
-
TTrraannssaaccttiioonnss wwiitthh oowwnneerrss
TTrraannssaaccttiioonnss wwiitthh oowwnneerrss
TTrraannssaaccttiioonnss wwiitthh oowwnneerrss
TTrraannssaaccttiioonnss wwiitthh oowwnneerrss
115511,,884499,,337755
115511,,884499,,337755
115511,,884499,,337755
1,632,099
1,632,099
1,632,099
-
-
-
-
(1,224,021)
(1,224,021)
(1,224,021)
-
(1,224,021)
(1,224,021)
(1,224,021)
(1,224,021)
(1,224,021)
11,,775511,,222233
11,,775511,,222233
115511,,884499,,337755
11,,775511,,222233
Profit for the year
Profit for the year
Profit for the year
Profit for the year
Prior Year Restatement (Note 1(y))
Prior Year Restatement (Note 1(y))
Prior Year Restatement (Note 1(y))
Prior Year Restatement (Note 1(y))
PPrrooffiitt ffoorr tthhee yyeeaarr rreessttaatteedd
PPrrooffiitt ffoorr tthhee yyeeaarr rreessttaatteedd
PPrrooffiitt ffoorr tthhee yyeeaarr rreessttaatteedd
PPrrooffiitt ffoorr tthhee yyeeaarr rreessttaatteedd
OOtthheerr ccoommpprreehheennssiivvee iinnccoommee::
OOtthheerr ccoommpprreehheennssiivvee iinnccoommee::
OOtthheerr ccoommpprreehheennssiivvee iinnccoommee::
OOtthheerr ccoommpprreehheennssiivvee iinnccoommee::
Exchange differences of foreign exchange translation of foreign operations
Exchange differences of foreign exchange translation of foreign operations
Exchange differences of foreign exchange translation of foreign operations
Exchange differences of foreign exchange translation of foreign operations
TToottaall ootthheerr ccoommpprreehheennssiivvee iinnccoommee
TToottaall ootthheerr ccoommpprreehheennssiivvee iinnccoommee
TToottaall ootthheerr ccoommpprreehheennssiivvee iinnccoommee
TToottaall ootthheerr ccoommpprreehheennssiivvee iinnccoommee
-
-
--
-
-
-
-
--
-
-
-
-
--
-
-
-
-
--
-
-
-
-
--
-
-
--
-
-
-
-
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
FFoorreeiiggnn CCuurrrreennccyy
FFoorreeiiggnn CCuurrrreennccyy
PPeerrffoorrmmaannccee
FFoorreeiiggnn CCuurrrreennccyy
TTrraannssllaattiioonn RReesseerrvvee
TTrraannssllaattiioonn RReesseerrvvee
RRiigghhttss RReesseerrvvee
TTrraannssllaattiioonn RReesseerrvvee
FFoorreeiiggnn CCuurrrreennccyy
RReettaaiinneedd EEaarrnniinnggss
RReettaaiinneedd EEaarrnniinnggss
RReettaaiinneedd EEaarrnniinnggss
TTrraannssllaattiioonn RReesseerrvvee
TToottaall EEqquuiittyy
RReettaaiinneedd EEaarrnniinnggss
TToottaall EEqquuiittyy
TToottaall EEqquuiittyy
TToottaall EEqquuiittyy
669988,,009922
669988,,009922
665544,,332244
669988,,009922
((9955,,448866,,773388))
((9955,,448866,,773388))
669988,,009922
((9955,,448866,,773388))
5577,,117799,,885533
5577,,117799,,885533
((9955,,448866,,773388))
5577,,117799,,885533
5577,,117799,,885533
-
-
-
-
-
-
26,614
26,614
-
26,614
1,658,713
1,658,713
26,614
1,658,713
1,658,713
$
-
$
-
(535,200)
-
-
1,632,099
-
-
-
-
-
-
-
-
-
-
-
2,592,199
-
-
-
-
-
-
-
-
669988,,009922
669988,,009922
11,,775511,,222233
669988,,009922
((9966,,668844,,114455))
((9966,,668844,,114455))
669988,,009922
((9966,,668844,,114455))
5577,,661144,,554455
5577,,661144,,554455
((9966,,668844,,114455))
5577,,661144,,554455
5577,,661144,,554455
16,646,859
16,646,859
16,646,859
-
16,646,859
16,646,859
16,646,859
16,646,859
16,646,859
(6,083)
(6,083)
-
(6,083)
(1,595,657)
(1,595,657)
(6,083)
(1,595,657)
(1,601,740)
(1,601,740)
(1,595,657)
(1,601,740)
(1,601,740)
((66,,008833))
((66,,008833))
--
((66,,008833))
1155,,005511,,220022
1155,,005511,,220022
((66,,008833))
1155,,005511,,220022
1155,,004455,,111199
1155,,004455,,111199
1155,,005511,,220022
1155,,004455,,111199
1155,,004455,,111199
(592,857)
(592,857)
(592,857)
-
(592,857)
(592,857)
(592,857)
-
(592,857)
-
-
(592,857)
-
-
(592,857)
(592,857)
(592,857)
-
(592,857)
(592,857)
(592,857)
-
(592,857)
(592,857)
9999,,115522
11,,775511,,222233
9999,,115522
9999,,115522
((8811,,663322,,994433))
((8811,,663322,,994433))
9999,,115522
((8811,,663322,,994433))
7722,,006666,,880077
7722,,006666,,880077
((8811,,663322,,994433))
7722,,006666,,880077
7722,,006666,,880077
10,194
10,194
-
10,194
2,602,393
2,602,393
10,194
2,602,393
2,602,393
(1,235,266)
(1,235,266)
(1,235,266)
(1,235,266)
(1,235,266)
(1,235,266)
(1,235,266)
(1,235,266)
9999,,115522
44,,334433,,442222
9999,,115522
9999,,115522
((8822,,885588,,001155))
((8822,,885588,,001155))
9999,,115522
((8822,,885588,,001155))
7733,,443333,,993344
7733,,443333,,993344
((8822,,885588,,001155))
7733,,443333,,993344
7733,,443333,,993344
$
-
-
-
-
-
-
-
-
-
--
-
-
-
-
-
667744,,440055
667744,,440055
44,,334433,,442222
667744,,440055
((5588,,112299,,776688))
((5588,,112299,,776688))
667744,,440055
((5588,,112299,,776688))
9988,,773377,,443344
9988,,773377,,443344
((5588,,112299,,776688))
9988,,773377,,443344
9988,,773377,,443344
Profit for the year
Profit for the year
Profit for the year
Profit for the year
24,728,247
24,728,247
24,728,247
24,728,247
24,728,247
24,728,247
24,728,247
24,728,247
OOtthheerr ccoommpprreehheennssiivvee iinnccoommee::
OOtthheerr ccoommpprreehheennssiivvee iinnccoommee::
OOtthheerr ccoommpprreehheennssiivvee iinnccoommee::
OOtthheerr ccoommpprreehheennssiivvee iinnccoommee::
Exchange differences of foreign exchange translation of foreign operations
Exchange differences of foreign exchange translation of foreign operations
Exchange differences of foreign exchange translation of foreign operations
Exchange differences of foreign exchange translation of foreign operations
TToottaall ootthheerr ccoommpprreehheennssiivvee iinnccoommee
TToottaall ootthheerr ccoommpprreehheennssiivvee iinnccoommee
TToottaall ootthheerr ccoommpprreehheennssiivvee iinnccoommee
TToottaall ootthheerr ccoommpprreehheennssiivvee iinnccoommee
-
-
-
-
-
-
-
-
-
-
-
-
575,253
575,253
575,253
-
573,253
573,253
573,253
-
575,253
-
-
573,253
-
-
575,253
575,253
575,253
-
573,253
573,253
573,253
-
575,253
573,253
BBaallaannccee aatt 3300 JJuunnee 22002211
BBaallaannccee aatt 3300 JJuunnee 22002211
BBaallaannccee aatt 3300 JJuunnee 22002211
BBaallaannccee aatt 3300 JJuunnee 22002211
115511,,884499,,337755
115511,,884499,,337755
115511,,884499,,337755
44,,334433,,442222
44,,334433,,442222
115511,,884499,,337755
44,,334433,,442222
95
57
57
57
57
BBaallaannccee aatt 3300 JJuunnee 22002200 rreessttaatteedd
BBaallaannccee aatt 3300 JJuunnee 22002200 rreessttaatteedd
BBaallaannccee aatt 3300 JJuunnee 22002200 rreessttaatteedd
BBaallaannccee aatt 3300 JJuunnee 22002200 rreessttaatteedd
115511,,884499,,337755
115511,,884499,,337755
115511,,884499,,337755
Exercise of Performance Rights under share-based payment
Exercise of Performance Rights under share-based payment
Exercise of Performance Rights under share-based payment
Exercise of Performance Rights under share-based payment
Employee share-based payment options
Employee share-based payment options
Employee share-based payment options
Employee share-based payment options
Dividends Paid
Dividends Paid
Dividends Paid
Dividends Paid
-
-
-
-
-
-
TTrraannssaaccttiioonnss wwiitthh oowwnneerrss
TTrraannssaaccttiioonnss wwiitthh oowwnneerrss
TTrraannssaaccttiioonnss wwiitthh oowwnneerrss
TTrraannssaaccttiioonnss wwiitthh oowwnneerrss
115511,,884499,,337755
115511,,884499,,337755
115511,,884499,,337755
11,,775511,,222233
11,,775511,,222233
115511,,884499,,337755
11,,775511,,222233
-
-
-
-
-
-
-
-
-
-
-
44,,334433,,442222
44,,334433,,442222
115511,,884499,,337755
44,,334433,,442222
2,592,199
2,592,199
2,592,199
-
CLINUVEL Pharmaceuticals | 2021 Annual Report SSttaatteemmeenntt ooff CChhaannggeess iinn EEqquuiittyy ffoorr tthhee YYeeaarr EEnnddeedd 3300 JJuunnee 22002211
SSttaatteemmeenntt ooff CChhaannggeess iinn EEqquuiittyy ffoorr tthhee YYeeaarr EEnnddeedd 3300 JJuunnee 22002211
SSttaatteemmeenntt ooff CChhaannggeess iinn EEqquuiittyy ffoorr tthhee YYeeaarr EEnnddeedd 3300 JJuunnee 22002211
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
$
$
$
$
$
$
$
$
$
$
$
$
$
$
$
FFoorreeiiggnn CCuurrrreennccyy
TTrraannssllaattiioonn RReesseerrvvee
FFoorreeiiggnn CCuurrrreennccyy
TTrraannssllaattiioonn RReesseerrvvee
FFoorreeiiggnn CCuurrrreennccyy
TTrraannssllaattiioonn RReesseerrvvee
115511,,884499,,337755
115511,,884499,,337755
115511,,884499,,337755
11,,775511,,222233
11,,775511,,222233
11,,775511,,222233
669988,,009922
BBaallaannccee aatt 3300 JJuunnee 22001199
BBaallaannccee aatt 3300 JJuunnee 22001199
BBaallaannccee aatt 3300 JJuunnee 22001199
115511,,331144,,117755
115511,,331144,,117755
115511,,331144,,117755
665544,,332244
665544,,332244
665544,,332244
669988,,009922
669988,,009922
669988,,009922
Exercise of Performance Rights under share-based payment
Exercise of Performance Rights under share-based payment
Exercise of Performance Rights under share-based payment
535,200
535,200
535,200
(535,200)
(535,200)
(535,200)
Employee share-based payment options
Employee share-based payment options
Employee share-based payment options
1,632,099
1,632,099
1,632,099
-
-
-
-
-
-
-
-
-
Dividends Paid
Dividends Paid
Dividends Paid
TTrraannssaaccttiioonnss wwiitthh oowwnneerrss
TTrraannssaaccttiioonnss wwiitthh oowwnneerrss
TTrraannssaaccttiioonnss wwiitthh oowwnneerrss
Profit for the year
Profit for the year
Profit for the year
Prior Year Restatement (Note 1(y))
Prior Year Restatement (Note 1(y))
Prior Year Restatement (Note 1(y))
PPrrooffiitt ffoorr tthhee yyeeaarr rreessttaatteedd
PPrrooffiitt ffoorr tthhee yyeeaarr rreessttaatteedd
PPrrooffiitt ffoorr tthhee yyeeaarr rreessttaatteedd
OOtthheerr ccoommpprreehheennssiivvee iinnccoommee::
OOtthheerr ccoommpprreehheennssiivvee iinnccoommee::
OOtthheerr ccoommpprreehheennssiivvee iinnccoommee::
Exchange differences of foreign exchange translation of foreign operations
Exchange differences of foreign exchange translation of foreign operations
Exchange differences of foreign exchange translation of foreign operations
TToottaall ootthheerr ccoommpprreehheennssiivvee iinnccoommee
TToottaall ootthheerr ccoommpprreehheennssiivvee iinnccoommee
TToottaall ootthheerr ccoommpprreehheennssiivvee iinnccoommee
SShhaarree CCaappiittaall
SShhaarree CCaappiittaall
SShhaarree CCaappiittaall
PPeerrffoorrmmaannccee
PPeerrffoorrmmaannccee
PPeerrffoorrmmaannccee
RRiigghhttss RReesseerrvvee
RRiigghhttss RReesseerrvvee
RRiigghhttss RReesseerrvvee
-
-
-
-
--
-
-
-
-
-
-
-
-
-
-
--
-
-
-
-
-
-
-
-
-
-
--
-
-
-
-
-
-
-
-
-
--
-
-
-
-
-
-
-
-
--
-
-
-
-
-
-
-
-
--
-
-
-
-
-
BBaallaannccee aatt 3300 JJuunnee 22002200 rreessttaatteedd
BBaallaannccee aatt 3300 JJuunnee 22002200 rreessttaatteedd
BBaallaannccee aatt 3300 JJuunnee 22002200 rreessttaatteedd
115511,,884499,,337755
115511,,884499,,337755
115511,,884499,,337755
11,,775511,,222233
11,,775511,,222233
11,,775511,,222233
9999,,115522
9999,,115522
9999,,115522
Exercise of Performance Rights under share-based payment
Exercise of Performance Rights under share-based payment
Exercise of Performance Rights under share-based payment
Employee share-based payment options
Employee share-based payment options
Employee share-based payment options
2,592,199
2,592,199
2,592,199
-
-
-
-
-
-
115511,,884499,,337755
115511,,884499,,337755
115511,,884499,,337755
44,,334433,,442222
44,,334433,,442222
44,,334433,,442222
9999,,115522
9999,,115522
9999,,115522
Dividends Paid
Dividends Paid
Dividends Paid
TTrraannssaaccttiioonnss wwiitthh oowwnneerrss
TTrraannssaaccttiioonnss wwiitthh oowwnneerrss
TTrraannssaaccttiioonnss wwiitthh oowwnneerrss
Profit for the year
Profit for the year
Profit for the year
OOtthheerr ccoommpprreehheennssiivvee iinnccoommee::
OOtthheerr ccoommpprreehheennssiivvee iinnccoommee::
OOtthheerr ccoommpprreehheennssiivvee iinnccoommee::
-
-
-
(6,083)
(6,083)
(6,083)
((66,,008833))
((66,,008833))
((66,,008833))
(592,857)
(592,857)
(592,857)
(592,857)
(592,857)
(592,857)
669988,,009922
RReettaaiinneedd EEaarrnniinnggss
RReettaaiinneedd EEaarrnniinnggss
RReettaaiinneedd EEaarrnniinnggss
TToottaall EEqquuiittyy
TToottaall EEqquuiittyy
TToottaall EEqquuiittyy
((9955,,448866,,773388))
((9955,,448866,,773388))
((9955,,448866,,773388))
5577,,117799,,885533
5577,,117799,,885533
5577,,117799,,885533
-
-
-
-
-
-
26,614
26,614
26,614
(1,224,021)
(1,224,021)
(1,224,021)
669988,,009922
((9966,,668844,,114455))
((9966,,668844,,114455))
((9966,,668844,,114455))
16,646,859
16,646,859
16,646,859
(1,595,657)
(1,595,657)
(1,595,657)
1155,,005511,,220022
1155,,005511,,220022
1155,,005511,,220022
-
-
-
-
-
-
((8811,,663322,,994433))
((8811,,663322,,994433))
((8811,,663322,,994433))
1,658,713
1,658,713
1,658,713
(1,224,021)
(1,224,021)
(1,224,021)
5577,,661144,,554455
5577,,661144,,554455
5577,,661144,,554455
16,646,859
16,646,859
16,646,859
(1,601,740)
(1,601,740)
(1,601,740)
1155,,004455,,111199
1155,,004455,,111199
1155,,004455,,111199
(592,857)
(592,857)
(592,857)
(592,857)
(592,857)
(592,857)
7722,,006666,,880077
7722,,006666,,880077
7722,,006666,,880077
-
-
-
-
-
-
10,194
10,194
10,194
(1,235,266)
(1,235,266)
(1,235,266)
((8822,,885588,,001155))
((8822,,885588,,001155))
((8822,,885588,,001155))
24,728,247
24,728,247
24,728,247
2,602,393
2,602,393
2,602,393
(1,235,266)
(1,235,266)
(1,235,266)
7733,,443333,,993344
7733,,443333,,993344
7733,,443333,,993344
24,728,247
24,728,247
24,728,247
Exchange differences of foreign exchange translation of foreign operations
Exchange differences of foreign exchange translation of foreign operations
Exchange differences of foreign exchange translation of foreign operations
TToottaall ootthheerr ccoommpprreehheennssiivvee iinnccoommee
TToottaall ootthheerr ccoommpprreehheennssiivvee iinnccoommee
TToottaall ootthheerr ccoommpprreehheennssiivvee iinnccoommee
575,253
575,253
575,253
573,253
573,253
573,253
-
-
-
-
-
-
575,253
575,253
575,253
573,253
573,253
573,253
BBaallaannccee aatt 3300 JJuunnee 22002211
BBaallaannccee aatt 3300 JJuunnee 22002211
BBaallaannccee aatt 3300 JJuunnee 22002211
115511,,884499,,337755
115511,,884499,,337755
115511,,884499,,337755
44,,334433,,442222
44,,334433,,442222
44,,334433,,442222
667744,,440055
667744,,440055
667744,,440055
57
57
57
((5588,,112299,,776688))
((5588,,112299,,776688))
((5588,,112299,,776688))
9988,,773377,,443344
9988,,773377,,443344
9988,,773377,,443344
Open out flap
to view data
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
NNootteess TToo AAnndd FFoorrmmiinngg
PPaarrtt OOff TThhee FFiinnaanncciiaall
SSttaatteemmeennttss FFoorr TThhee YYeeaarr
EEnnddeedd 3300 JJuunnee 22002211
11.. BBaassiiss OOff PPrreeppaarraattiioonn
The financial report is a general purpose financial report
that has been prepared in accordance with Australian
Accounting Standards, other authoritative
pronouncements of the Australian Accounting
Standards Board and the Corporations Act 2001.
Compliance with Australian Accounting Standards
ensures the consolidated financial statements and
notes of the consolidated entity with International
Financial Reporting Standards (‘IFRS’). CLINUVEL
PHARMACEUTICALS LTD is a for-profit entity for the
purposes of reporting under Australian Accounting
Standards.
The financial report has been prepared on an accruals
basis and is based on historical costs and does not
take into account changing money values or, except
where stated, current valuations of financial assets.
Cost is based on the fair values of the consideration
given in exchange for assets. The accounting policies
have been consistently applied, unless otherwise
stated.
Both the functional and presentation currency of the
Group and its Australian controlled entities is Australian
dollars. The functional currency of certain non-
Australian controlled entities is not Australian dollars.
As a result, the results of these entities are translated to
Australian dollars for presentation in the CLINUVEL
PHARMACEUTICALS LTD financial report.
In applying Australian Accounting Standards
management must make judgments regarding carrying
values of assets and liabilities that are not readily
apparent from other sources. Assumptions and
estimates are based on historical experience and any
other factor that are believed reasonable in light of the
relevant circumstances. These estimates are reviewed
on an ongoing basis and revised in those periods to
which the revision directly affects.
96
All accounting policies are chosen to ensure the
resulting financial information satisfies the concepts of
relevance and reliability.
aa)) PPrriinncciipplleess OOff CCoonnssoolliiddaattiioonn
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 Accounting Standard AASB 10 Consolidated
Financial Statements. Consistent accounting policies
are employed in the preparation and presentation of the
consolidated financial statements.
The consolidated financial statements include the
information and results of each subsidiary from the
date on which the Company obtains control and until
such time as the Company ceases to control such
entity. In preparing the consolidated financial
statements, all intercompany balances and
transactions, and unrealised profits arising within the
consolidated entity are eliminated in full.
Non-controlling interests, presented as part of equity,
represent the portion of a subsidiary’s profit or loss and
net assets that is not held by the Group. The Group
attributes total comprehensive income or loss of
subsidiaries between the owners of the parent and the
non-controlling interests based on their respective
ownership interests.
All the Group’s subsidiaries are wholly-owned and there
are no longer non-controlling interests with ownership
interests in any of the Group’s subsidiaries.
bb)) GGooiinngg CCoonncceerrnn
The financial statements of the consolidated entity
have been prepared on a going concern basis. The
consolidated entity’s operations are subject to major
risks due primarily to the nature of research,
development and the commercialisation to be
undertaken. The risk factors set out may materially
impact the financial performance and position of the
consolidated entity.
The going concern basis assumes that, if required,
future capital raisings will be available to enable the
consolidated entity to acquire new entities with projects
of interest and to undertake the research, development
and commercialisation of existing projects and that the
subsequent commercialisation of products will be
successful. The financial statements take no account
of the consequences, if any, of the inability of the
consolidated entity to obtain adequate funding or of the
58
CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
NNootteess TToo AAnndd FFoorrmmiinngg
PPaarrtt OOff TThhee FFiinnaanncciiaall
SSttaatteemmeennttss FFoorr TThhee YYeeaarr
EEnnddeedd 3300 JJuunnee 22002211
11.. BBaassiiss OOff PPrreeppaarraattiioonn
All accounting policies are chosen to ensure the
resulting financial information satisfies the concepts of
relevance and reliability.
aa)) PPrriinncciipplleess OOff CCoonnssoolliiddaattiioonn
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
The financial report is a general purpose financial report
defined in Accounting Standard AASB 10 Consolidated
that has been prepared in accordance with Australian
Financial Statements. Consistent accounting policies
Accounting Standards, other authoritative
pronouncements of the Australian Accounting
Standards Board and the Corporations Act 2001.
Compliance with Australian Accounting Standards
ensures the consolidated financial statements and
notes of the consolidated entity with International
Financial Reporting Standards (‘IFRS’). CLINUVEL
PHARMACEUTICALS LTD is a for-profit entity for the
purposes of reporting under Australian Accounting
Standards.
The financial report has been prepared on an accruals
basis and is based on historical costs and does not
take into account changing money values or, except
where stated, current valuations of financial assets.
Cost is based on the fair values of the consideration
given in exchange for assets. The accounting policies
have been consistently applied, unless otherwise
stated.
Both the functional and presentation currency of the
Group and its Australian controlled entities is Australian
dollars. The functional currency of certain non-
Australian controlled entities is not Australian dollars.
As a result, the results of these entities are translated to
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.
Non-controlling interests, presented as part of equity,
represent the portion of a subsidiary’s profit or loss and
net assets that is not held by the Group. The Group
attributes total comprehensive income or loss of
subsidiaries between the owners of the parent and the
non-controlling interests based on their respective
ownership interests.
All the Group’s subsidiaries are wholly-owned and there
are no longer non-controlling interests with ownership
interests in any of the Group’s subsidiaries.
bb)) GGooiinngg CCoonncceerrnn
Australian dollars for presentation in the CLINUVEL
The financial statements of the consolidated entity
PHARMACEUTICALS LTD financial report.
have been prepared on a going concern basis. The
In applying Australian Accounting Standards
management must make judgments regarding carrying
values of assets and liabilities that are not readily
apparent from other sources. Assumptions and
estimates are based on historical experience and any
other factor that are believed reasonable in light of the
consolidated entity’s operations are subject to major
risks due primarily to the nature of research,
development and the commercialisation to be
undertaken. The risk factors set out may materially
impact the financial performance and position of the
consolidated entity.
relevant circumstances. These estimates are reviewed
The going concern basis assumes that, if required,
on an ongoing basis and revised in those periods to
future capital raisings will be available to enable the
which the revision directly affects.
consolidated entity to acquire new entities with projects
of interest and to undertake the research, development
and commercialisation of existing projects and that the
subsequent commercialisation of products will be
successful. The financial statements take no account
of the consequences, if any, of the inability of the
consolidated entity to obtain adequate funding or of the
58
effects of unsuccessful research, development and
commercialisation of the consolidated entity projects.
The consolidated entity has successfully raised
additional working capital in past years. Should cash
flows from its commercialisation activities not provide
adequate funding to finance potential acquisitions or
sustain its research, development and
commercialisation projects in the coming financial year,
the Directors would consider the need to bring in
additional funds from various funding sources.
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 given 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.
In March 2020, the World Health Organisation declared
the outbreak of a novel coronavirus (COVID-19) as a
pandemic, which continues to spread worldwide. The
spread of COVID-19 has caused significant volatility in
Australian and international markets. There is
significant uncertainty around the breadth and duration
of business disruptions related to COVID-19, as well as
its impact on the Australian and international
economies. The length or severity of this pandemic
cannot be reasonably estimated. The Company does
not consider the impact of COVID-19 produced a
material adverse impact on its consolidated financial
position, consolidated results of operations, and
consolidated cash flows in the financial year 2021.
The Company has sufficient amounts of cash to be able
to continue as a going concern and therefore will be
able to realise its assets and extinguish its liabilities in
the normal course of business and at the amounts
stated in the financial statements.
cc)) IInnccoommee TTaaxx
CCuurrrreenntt TTaaxx
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 (or
asset) to the extent it is unpaid (or refundable).
DDeeffeerrrreedd TTaaxx
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
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.
TTaaxx CCoonnssoolliiddaattiioonn
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.
CCuurrrreenntt AAnndd DDeeffeerrrreedd TTaaxx FFoorr TThhee PPeerriioodd
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
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deferred tax is also recognised directly in equity, or
where it arises from the initial accounting for a
business combination, in which case it is taken into
account in the determination of goodwill or discount on
acquisition.
The deferred tax asset has been recognised as at 30
June 2021 and 30 June 2020 after management
judgement was applied to assess whether its unused
tax losses and tax offsets could be utilised by future
taxable profits. It was determined:
• The consolidated entity has experienced
consecutive years of profitability and revenue
growth;
• Current pricing agreements with European payors
are not expected to change in the next financial
year;
• An increase to consolidated entity revenues are
expected in the near term from making SCENESSE®
available in the USA;
• 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.
dd)) CCaasshh AAnndd CCaasshh EEqquuiivvaalleennttss
Cash and cash equivalents comprise of cash on hand,
at call deposits with banks or financial institutions, bank
bills and investments in money market instruments
where it is easily convertible to a known amount of cash
and subject to an insignificant risk of change in value.
ee)) PPrrooppeerrttyy,, PPllaanntt AAnndd EEqquuiippmmeenntt
Plant and equipment are stated at cost less
accumulated depreciation and impairment. Cost
includes expenditure that is directly attributable to the
acquisition of the item. In the event that settlement of
all or part of the purchase consideration is deferred,
cost is determined by discounting the amounts payable
in the future to their present value as at the date of
acquisition.
Depreciation is calculated on diminishing value so as to
write off the net cost of each asset over its expected
useful life to its estimated residual value. The estimated
useful lives, residual values and depreciation method
are reviewed at the end of each annual reporting period
and adjusted if appropriate. An asset’s carrying amount
is written off immediately to its recoverable amount if
the asset’s carrying amount is greater than its
estimated recoverable amount.
The following diminishing value percentages are used
in the calculation of depreciation:
• Computers and software: 40%
• Leasehold improvement: 40%
• All other assets: 7.5% to 33.3%
Gains and losses on disposal of assets are determined
by comparing proceeds upon disposal with the asset’s
carrying amount. These are included in the Profit or
Loss.
ff)) IInnvveessttmmeennttss AAnndd OOtthheerr FFiinnaanncciiaall AAsssseettss
RReeccooggnniittiioonn aanndd ddeerreeccooggnniittiioonn
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.
CCllaassssiiffiiccaattiioonn aanndd iinniittiiaall mmeeaassuurreemmeenntt ooff
ffiinnaanncciiaall aasssseettss
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).
SSuubbsseeqquueenntt mmeeaassuurreemmeenntt ooff ffiinnaanncciiaall
aasssseettss
For the purpose of subsequent measurement, financial
assets, other than those designated and effective as
hedging instruments, are classified into the following
categories upon initial recognition:
•
•
financial assets at amortised cost;
financial assets at fair value through profit or loss
(FVPL);
• debt instruments at fair value through other
comprehensive income (FVOCI); and
equity instruments at FVOCI.
•
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CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
deferred tax is also recognised directly in equity, or
The following diminishing value percentages are used
Classifications are determined by both:
where it arises from the initial accounting for a
in the calculation of depreciation:
business combination, in which case it is taken into
account in the determination of goodwill or discount on
acquisition.
The deferred tax asset has been recognised as at 30
June 2021 and 30 June 2020 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
• Current pricing agreements with European payors
are not expected to change in the next financial
growth;
year;
• An increase to consolidated entity revenues are
expected in the near term from making SCENESSE®
available in the USA;
• 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.
ff)) IInnvveessttmmeennttss AAnndd OOtthheerr FFiinnaanncciiaall AAsssseettss
RReeccooggnniittiioonn aanndd ddeerreeccooggnniittiioonn
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.
• Whilst internal targets continue to expect ongoing
Subsequent measurement of financial assets and
profitability in the near term, there is uncertainty
financial liabilities are described below.
around expected future taxable income in the
longer term as part of the business strategy to
expand the Company.
dd)) CCaasshh AAnndd CCaasshh EEqquuiivvaalleennttss
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,
Cash and cash equivalents comprise of cash on hand,
cancelled or expired.
at call deposits with banks or financial institutions, bank
bills and investments in money market instruments
CCllaassssiiffiiccaattiioonn aanndd iinniittiiaall mmeeaassuurreemmeenntt ooff
where it is easily convertible to a known amount of cash
ffiinnaanncciiaall aasssseettss
and subject to an insignificant risk of change in value.
ee)) PPrrooppeerrttyy,, PPllaanntt AAnndd EEqquuiippmmeenntt
Plant and equipment are stated at cost less
accumulated depreciation and impairment. Cost
includes expenditure that is directly attributable to the
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).
acquisition of the item. In the event that settlement of
SSuubbsseeqquueenntt mmeeaassuurreemmeenntt ooff ffiinnaanncciiaall
all or part of the purchase consideration is deferred,
aasssseettss
cost is determined by discounting the amounts payable
in the future to their present value as at the date of
acquisition.
Depreciation is calculated on diminishing value so as to
write off the net cost of each asset over its expected
For the purpose of subsequent measurement, financial
assets, other than those designated and effective as
hedging instruments, are classified into the following
categories upon initial recognition:
useful life to its estimated residual value. The estimated
financial assets at amortised cost;
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.
•
•
(FVPL);
financial assets at fair value through profit or loss
• debt instruments at fair value through other
comprehensive income (FVOCI); and
•
equity instruments at FVOCI.
60
•
•
the entity’s business model for managing the
financial assets; and
the contractual cash flow characteristics of the
financial assets.
All income and expenses relating to financial assets
that are recognised in profit or loss are presented within
finance costs, finance income or other financial items,
except for impairment of trade receivables which is
presented within other expenses.
FFiinnaanncciiaall aasssseettss aatt aammoorrttiisseedd ccoosstt
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
IImmppaaiirrmmeenntt ooff ffiinnaanncciiaall aasssseettss
TTrraaddee aanndd ootthheerr rreecceeiivvaabblleess
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 using a provision matrix.
The Group assess impairment of trade receivables on a
collective basis as they possess credit risk
characteristics based on the days past due.
CCllaassssiiffiiccaattiioonn aanndd mmeeaassuurreemmeenntt ooff
ffiinnaanncciiaall lliiaabbiilliittiieess
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.
gg)) IInnvveennttoorriieess
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.
hh)) RReesseeaarrcchh AAnndd DDeevveellooppmmeenntt EExxppeennddiittuurree
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 judgment in
continually assessing whether development
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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.
ii)) IInnttaannggiibbllee AAsssseettss –– TTrraaddeemmaarrkkss aanndd PPaatteennttss
Trademarks and patents have a finite useful life and are
recorded at cost less accumulated amortisation and
impairment losses. Amortisation is charged on a
straight-line basis over the shorter of the relevant
agreement or useful life. The trademarks and patents
had been fully amortised.
jj)) PPaayyaabblleess
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.
kk)) EEmmppllooyyeeee BBeenneeffiittss
Provision is made for benefits accruing to employees in
respect of wages and salaries, loyalty payment, annual
leave and long service leave when it is probable that
settlement will be required and they are capable of
being measured reliably.
Provisions made in respect of employee benefits
expected to be settled within 12 months, are measured
at their nominal values using the remuneration rate
expected to apply at the time of settlement.
Provisions made in respect of employee benefits which
are not expected to be settled within 12 months are
measured as the present value of the estimated future
cash outflows to be made by the consolidated entity in
respect of services provided by employees up to
reporting date. The discount rate used to estimate
future cash flows is per the Australian high quality
corporate bond rates as commissioned by the Group of
100 and published by Milliman Australia at reporting
date.
ll)) RReevveennuuee AAnndd OOtthheerr IInnccoommee
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
100
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 a single patient on a case-by-case
basis.
To determine whether to recognise revenue, the Group
follows a 5-step process:
identifying the contract with a customer;
identifying the performance obligations;
1)
2)
3) determining the transaction price;
4) allocating the transaction price to the
performance obligations; and
5) recognising revenue when/as performance
obligation(s) are satisfied.
Based on the above revenue recognition process and
the nature of all revenue streams from contracts with
customers, the Group recognises revenues as earned
from commercial sales of goods and sales
reimbursements as earned when performance
obligations are satisfied at a point in time, which is
when control of the product passes to the customer,
or generally upon receipt of shipment.
SSeeaassoonnaall nnaattuurree ooff rreevveennuuee ffrroomm ccoonnttrraaccttss
wwiitthh ssuupppplliieerrss
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 Group’s operations.
Note “Revenue” provides additional disclosures
disaggregating revenue by geographical market and the
timing of revenue recognition.
IInntteerreesstt
Interest income is recognised on a proportional basis
that takes into account the effective yield on the
financial asset.
GGoovveerrnnmmeenntt RR&&DD ttaaxx iinncceennttiivvee
Other income from the Australian government R&D tax
incentive program is 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. The Group’s R&D tax
incentive program is currently derived from expenditure
only. There was no other income from the government
R&D tax incentive for the year ended 30 June 2021.
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CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
expenditures meet the recognition criteria of an
commercial sales of SCENESSE® implants in Europe
GGoovveerrnnmmeenntt GGrraanntt
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
basis.
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 a single patient on a case-by-case
generated intangible asset.
To determine whether to recognise revenue, the Group
ii)) IInnttaannggiibbllee AAsssseettss –– TTrraaddeemmaarrkkss aanndd PPaatteennttss
follows a 5-step process:
Trademarks and patents have a finite useful life and are
recorded at cost less accumulated amortisation and
impairment losses. Amortisation is charged on a
straight-line basis over the shorter of the relevant
agreement or useful life. The trademarks and patents
had been fully amortised.
jj)) PPaayyaabblleess
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.
kk)) EEmmppllooyyeeee BBeenneeffiittss
1)
2)
identifying the contract with a customer;
identifying the performance obligations;
3) determining the transaction price;
4) allocating the transaction price to the
performance obligations; and
5) recognising revenue when/as performance
obligation(s) are satisfied.
Based on the above revenue recognition process and
the nature of all revenue streams from contracts with
customers, the Group recognises revenues as earned
from commercial sales of goods and sales
reimbursements as earned when performance
obligations are satisfied at a point in time, which is
when control of the product passes to the customer,
or generally upon receipt of shipment.
Provision is made for benefits accruing to employees in
SSeeaassoonnaall nnaattuurree ooff rreevveennuuee ffrroomm ccoonnttrraaccttss
respect of wages and salaries, loyalty payment, annual
leave and long service leave when it is probable that
wwiitthh ssuupppplliieerrss
settlement will be required and they are capable of
Due to patients seeking treatment in the spring,
being measured reliably.
Provisions made in respect of employee benefits
expected to be settled within 12 months, are measured
summer and autumn months, there remains a seasonal
demand for SCENESSE®. As such, fluctuations caused
by seasonal demand impact the Group’s operations.
at their nominal values using the remuneration rate
Note “Revenue” provides additional disclosures
expected to apply at the time of settlement.
disaggregating revenue by geographical market and the
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
IInntteerreesstt
timing of revenue recognition.
cash outflows to be made by the consolidated entity in
Interest income is recognised on a proportional basis
respect of services provided by employees up to
that takes into account the effective yield on the
reporting date. The discount rate used to estimate
financial asset.
future cash flows is per the Australian high quality
corporate bond rates as commissioned by the Group of
100 and published by Milliman Australia at reporting
date.
ll)) RReevveennuuee AAnndd OOtthheerr IInnccoommee
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
GGoovveerrnnmmeenntt RR&&DD ttaaxx iinncceennttiivvee
Other income from the Australian government R&D tax
incentive program is 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. The Group’s R&D tax
incentive program is currently derived from expenditure
only. There was no other income from the government
R&D tax incentive for the year ended 30 June 2021.
62
Government grants represents the Job Support
Scheme, Property Tax Rebate and the Boosting Cash
Flow for Employer schemes from Australian and
Singaporean governments in response to ongoing novel
coronavirus (COVID-19) pandemic. 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.
mm)) SShhaarree CCaappiittaall
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.
nn)) EEaarrnniinnggss PPeerr SShhaarree
BBaassiicc EEaarrnniinnggss PPeerr SShhaarree
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.
DDiilluutteedd EEaarrnniinnggss PPeerr SShhaarree
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.
oo)) GGooooddss AAnndd SSeerrvviicceess TTaaxx//VVaalluuee AAddddeedd
TTaaxx ((GGSSTT))
Revenues, expenses and assets are recognised net of
the amount of ‘goods and services tax’ or ‘valued added
tax’ as it is known in certain jurisdictions (GST), except:
• where the amount of GST incurred is not
recoverable from the taxation authority, it is
recognised as part of the costs of acquisition of an
asset or as part of an item of expense; or
•
for receivables and payables which are recognised
inclusive of GST.
The net amount of GST recoverable from, or payable to,
the taxation authority is included as part of receivables
or payables. Cash flows are included in the Statement
of Cash Flow on a gross basis. The GST component of
cash flows arising from investing and financing
activities which is recoverable from, or payable to, the
taxation authority is classified as operating cash flows.
pp)) IImmppaaiirrmmeenntt OOff AAsssseettss
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.
101
63
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
qq)) LLeeaasseess
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 2 – 6 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.
rr)) CCoommppaarraattiivveess
Where necessary, comparatives have been reclassified
and repositioned for consistency with current year
disclosure.
ss)) PPrroovviissiioonnss
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.
102
64
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
qq)) LLeeaasseess
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
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 2 – 6 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.
implicitly specified by being identified at the time
Lease payments included in the measurement of the
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
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.
the Group has the right to direct the use of the
Subsequent to initial measurement, the liability will be
identified asset throughout the period of use. The
reduced for payments made and increased for interest.
Group assess whether it has the right to direct ‘how
It is remeasured to reflect any reassessment or
and for what purpose’ the asset is used throughout
modification, or if there are changes in in-substance
the period of use.
fixed payments.
•
•
•
At lease commencement date, the Group recognises
The Group has elected to account for short-term leases
right-of-use assets and lease liabilities on the balance
and leases of low-value assets using the practical
sheet. The right-of-use asset is measured at cost, which
expedients. Instead of recognising a right-of-use asset
is made up of the initial measurement of the lease
and lease liability, the payments in relation to these are
liability, any initial direct costs incurred by the Group, an
recognised as an expense in profit or loss on a straight-
estimate of any costs to dismantle and remove the
line basis over the lease term.
asset at the end of the lease, and any lease payments
made in advance of the lease commencement date (net
rr)) CCoommppaarraattiivveess
of any incentives received).
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.
tt)) FFoorreeiiggnn CCuurrrreennccyy TTrraannssaaccttiioonnss AAnndd
BBaallaanncceess
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: The Effects of Changes in Foreign
Exchange Rates.
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.
Where necessary, comparatives have been reclassified
and repositioned for consistency with current year
uu)) OOtthheerr CCuurrrreenntt AAsssseettss
disclosure.
ss)) PPrroovviissiioonnss
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.
64
Other current assets comprise prepayments of drug
peptide still in development stage and yet to be used in
the Group’s R&D program and prepayments for certain
insurances yet to expire, along with other general
prepayments. The expenditures represent an unused
expense and therefore a decrease in future economic
benefit has yet to be incurred.
vv)) SShhaarree--bbaasseedd PPaayymmeenntt TTrraannssaaccttiioonnss
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.
103
65
CLINUVEL Pharmaceuticals | 2021 Annual Report
predict the resolution of the uncertainty). There has
been no significant impact from the adoption of
Interpretation 23 in this reporting period.
xx)) SSeeggmmeenntt RReeppoorrttiinngg
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 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
consolidated entity has one operating segment within
the definition of AASB 8 Operating Segments.
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
ww)) CCrriittiiccaall AAccccoouunnttiinngg EEssttiimmaatteess AAnndd
JJuuddggmmeenntt
The Directors evaluate estimates and judgments
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.
KKeeyy eessttiimmaatteess –– sshhaarree--bbaasseedd ppaayymmeennttss
ttrraannssaaccttiioonnss
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
binomial or a trinomial model, using the assumptions
detailed in Note 23. The total expense is brought to
account over the vesting period which for some
instruments requires the group to form judgements
associated with the timing and probability of vesting
conditions.
KKeeyy jjuuddggeemmeennttss –– ttaaxx lloosssseess
Given the Company’s and each individual entities’
history of losses, the Group has recognised a deferred
tax asset with regard to unused tax losses and other
temporary differences. The Directors have determined
the Group will generate sufficient taxable income
against which the unused tax losses and other
temporary differences can be utilised. The value of tax
losses both recognised and not recognised is included
in Note 3.
UUnncceerrttaaiinnttyy OOvveerr IInnccoommee TTaaxx TTrreeaattmmeennttss
The Group has adopted Interpretation 23 from 1 July
2019, based on an assessment of 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
104
66
CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
ww)) CCrriittiiccaall AAccccoouunnttiinngg EEssttiimmaatteess AAnndd
JJuuddggmmeenntt
The Directors evaluate estimates and judgments
incorporated into the financial report based on
historical knowledge and best available current
information. Estimates assume a reasonable
predict the resolution of the uncertainty). There has
been no significant impact from the adoption of
Interpretation 23 in this reporting period.
xx)) SSeeggmmeenntt RReeppoorrttiinngg
A segment is a component of the consolidated entity
that earns revenues or incurs expenses whose results
expectation of future events and are based on current
are regularly reviewed by the chief operating decision
trends and economic data, obtained both externally and
makers and for which discrete financial information is
within the Group.
prepared.
KKeeyy eessttiimmaatteess –– sshhaarree--bbaasseedd ppaayymmeennttss
ttrraannssaaccttiioonnss
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
binomial or a trinomial model, using the assumptions
detailed in Note 23. The total expense is brought to
account over the vesting period which for some
instruments requires the group to form judgements
associated with the timing and probability of vesting
conditions.
KKeeyy jjuuddggeemmeennttss –– ttaaxx lloosssseess
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
Given the Company’s and each individual entities’
history of losses, the Group has recognised a deferred
revenues earned from external customers by
geographical location is detailed above. The
tax asset with regard to unused tax losses and other
consolidated entity has one operating segment within
temporary differences. The Directors have determined
the definition of AASB 8 Operating Segments.
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.
UUnncceerrttaaiinnttyy OOvveerr IInnccoommee TTaaxx TTrreeaattmmeennttss
The Group has adopted Interpretation 23 from 1 July
2019, based on an assessment of 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
There is no impact on the cash flow position of the
Group reported as at 1 July 2019 and 30 June 2020 as
the adjustment represents a non-cash entry.
The accounting treatment has been corrected by
restating each of the affected financial statement line
items for the prior period as follows:
yy)) RReessttaatteemmeenntt ooff CCoommppaarraattiivvee AAmmoouunnttss
The Group has restated its comparatives for the year
ended 30 June 2020 in these consolidated statements
after re-assessing the accounting treatment of the
Loyalty Payment employee benefits granted to the
Managing Director and Chief Financial Officer upon the
renewal of their employment contracts, the benefits
disclosed in the Remuneration Report to the 2020
Annual Report. The re-assessment of the treatment of
the benefits determined the amount to be recognised
over its service period commencing at the time of
renewal of employment agreement to its vesting date.
The impact of this treatment on the 30 June 2020 profit
and loss is an overstatement of profit of $1.596 million.
Provisions-current
Liabilities – current
Liabilities - total
Net Assets
Reserves
Accumulated losses
TToottaall EEqquuiittyy
1,676,435
6,660,347
7,873,298
1,601,740
3,278,175
1,601,740
8,262,087
1,601,740
9,475,038
73,668,547
(1,601,740)
72,066,807
1,856,458
(6,083)
1,850,375
(80,037,286)
(1,595,657)
(81,632,943)
7733,,666688,,554477
(1,601,740)
7722,,006666,,880077
Total expenses
(20,773,199)
(1,595,660)
(22,368,859)
Profit before income tax expense (benefit)
13,136,471
(1,595,660)
11,540,811
Net Profit for the year
16,646,859
(1,595,660)
15,051,199
Other comprehensive income/(loss) for the period,
net of income tax
592,857
0
592,857
TToottaall ccoommpprreehheennssiivvee iinnccoommee ffoorr tthhee ppeerriioodd
1177,,223399,,771166
((11,,559955,,666600))
1155,,664444,,005566
Liabilities – current
Liabilities - total
Accumulated losses
Total Equity
Net Profit for the year
2,460,733
2,466,023
173,636
173,636
2,634,369
2,639,659
(76,805,002)
(173,636)
(76,978,638)
76,795,596
(173,636)
76,621,960
16,769,727
(173,636))
16,596,091
TToottaall ccoommpprreehheennssiivvee iinnccoommee ffoorr tthhee ppeerriioodd
1166,,776699,,772277
((117733,,663366))
1166,,559966,,009911
66
105
67
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
22.. PPrrooffiitt//((LLoossss)) FFrroomm CCoonnttiinnuuiinngg OOppeerraattiioonnss
((aa)) RReevveennuueess**
Commercial sales of goods
Sales reimbursements
TToottaall rreevveennuueess
((bb)) IInntteerreesstt iinnccoommee
Interest income
TToottaall iinntteerreesstt iinnccoommee
((cc)) OOtthheerr iinnccoommee
Unrealised gain on restating foreign currency balances and currencies
held
Government grants
Realised foreign currency gain on transactions
Miscellaneous
TToottaall ootthheerr iinnccoommee
((dd)) EExxppeennsseess
Clinical and non-clinical development
Commercial distribution
Changes in inventories of raw materials, work in progress and finished
goods
Communication, branding and marketing
Depreciation and amortisation
Finance, corporate and general
Legal, insurance and IP
Personnel-related
Materials and related expenses
Share-based payments
Unrealised loss on restating foreign currency balances and currencies
held
TToottaall eexxppeennsseess
((ee)) PPrrooffiitt//((lloossss)) bbeeffoorree iinnccoommee ttaaxx iinncclluuddeess
tthhee ffoolllloowwiinngg ssppeecciiffiicc eexxppeennsseess
Employee benefits expense
Share-based payments
Expense relating to short-term leases
Depreciation of right-of-use assets
Depreciation on property, plant & equipment
Loss on sale of property, plant and equipment
*Revenues have been disaggregated by pattern of revenue at a point in time.
106
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
22002200 RReessttaatteedd
$$
42,602,594
5,372,989
4477,,997755,,558833
26,306,148
6,259,275
3322,,556655,,442233
342,203
334422,,220033
-
129,734
3,079
-
113322,,881133
547,553
2,421,204
(1,898,756)
313,986
861,432
1,618,430
1,095,415
562,928
556622,,992288
537,460
126,611
116,584
664
778811,,331199
341,304
2,443,435
848,170
589,458
446,129
2,053,990
1,147,508
10,157,625
10,489,716
3,650,304
2,602,393
1,368,369
2,350,347
1,658,802
-
2222,,773377,,995555
2222,,336688,,885599
9,630,783
2,602,393
241,385
319,962
499,625
90,136
9,588,568
1,658,713
296,481
263,154
164,474
-
68
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
22.. PPrrooffiitt//((LLoossss)) FFrroomm CCoonnttiinnuuiinngg OOppeerraattiioonnss
33.. IInnccoommee TTaaxx EExxppeennssee
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
22002200 RReessttaatteedd
$$
42,602,594
5,372,989
4477,,997755,,558833
26,306,148
6,259,275
3322,,556655,,442233
((aa)) IInnccoommee ttaaxx eexxppeennssee ((bbeenneeffiitt))
Current
Deferred
IInnccoommee ttaaxx eexxppeennssee ((bbeenneeffiitt))
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
22002200 RReessttaatteedd
$$
104,085
$$
-
880,312
(3,510,388)
998844,,339977
((33,,551100,,338888))
Unrealised gain on restating foreign currency balances and currencies
Increase (decrease) in deferred tax liabilities
(731,930)
240,855
DDeeffeerrrreedd ttaaxx iinncclluuddeedd iinn iinnccoommee ttaaxx eexxppeennssee ((bbeenneeffiitt)) ccoommpprriisseess::
(Increase) decrease in deferred tax assets
1,612,242
(3,751,243)
Changes in inventories of raw materials, work in progress and finished
Permanent differences - Australia
417,537
1,182,470
77,,110022,,882244
44,,335566,,119933
((bb)) NNuummeerriiccaall rreeccoonncciilliiaattiioonn ooff iinnccoommee ttaaxx eexxppeennssee ((bbeenneeffiitt)) aanndd ttaaxx aatt tthhee ssttaattuuttoorryy rraattee
Profit before income tax benefit
25,712,644
11,540,811
Tax at the statutory tax rates of 26.0% in 2021 and 27.5% in 2020
6,685,287
3,173,723
Tax effect amounts which are not deductible/(taxable) in calculating taxable income:
888800,,331122
((33,,551100,,338888))
Recognition of DTA on additional losses utilised in year
(1,075,497)
(1,389,312)
Recognition of DTA on losses at year end
(5,042,930)
(6,742,994)
10,157,625
10,489,716
Recognition of temporary differences - Australia
IInnccoommee ttaaxx eexxppeennssee ((bbeenneeffiitt))
TTaaxx lloosssseess nnoott rreeccooggnniisseedd
-
265,725
998844,,339977
((33,,551100,,338888))
2222,,773377,,995555
2222,,336688,,885599
Unused tax losses for which no deferred tax asset has been recognised
25,737,879
46,780,392
Potential tax benefit at 26.0% in 2021 and 27.5% in 2020
6,691,849
12,864,608
((cc)) DDeeffeerrrreedd ttaaxx aasssseettss
Deferred tax asset comprises temporary differences attributable to:
Carry forward tax losses
Intangibles
Provisions
Accrued Expenses
5,042,930
6,742,993
433,722
449,065
210,094
126,932
26,797
39,617
107
69
((aa)) RReevveennuueess**
Commercial sales of goods
Sales reimbursements
TToottaall rreevveennuueess
((bb)) IInntteerreesstt iinnccoommee
Interest income
TToottaall iinntteerreesstt iinnccoommee
((cc)) OOtthheerr iinnccoommee
held
Government grants
Miscellaneous
TToottaall ootthheerr iinnccoommee
((dd)) EExxppeennsseess
Realised foreign currency gain on transactions
Clinical and non-clinical development
Commercial distribution
goods
Communication, branding and marketing
Depreciation and amortisation
Finance, corporate and general
Legal, insurance and IP
Personnel-related
Materials and related expenses
Share-based payments
held
TToottaall eexxppeennsseess
((ee)) PPrrooffiitt//((lloossss)) bbeeffoorree iinnccoommee ttaaxx iinncclluuddeess
tthhee ffoolllloowwiinngg ssppeecciiffiicc eexxppeennsseess
Employee benefits expense
Share-based payments
Expense relating to short-term leases
Depreciation of right-of-use assets
Depreciation on property, plant & equipment
Loss on sale of property, plant and equipment
*Revenues have been disaggregated by pattern of revenue at a point in time.
Unrealised loss on restating foreign currency balances and currencies
342,203
334422,,220033
129,734
3,079
-
-
113322,,881133
547,553
2,421,204
(1,898,756)
313,986
861,432
1,618,430
1,095,415
3,650,304
2,602,393
1,368,369
9,630,783
2,602,393
241,385
319,962
499,625
90,136
562,928
556622,,992288
537,460
126,611
116,584
664
778811,,331199
341,304
2,443,435
848,170
589,458
446,129
2,053,990
1,147,508
2,350,347
1,658,802
-
9,588,568
1,658,713
296,481
263,154
164,474
-
68
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
Lease liabilities
MMoovveemmeennttss
Opening balance
Carry forward tax losses
Deferred tax assets utilised
Intangibles
Lease liabilities
Accrued Expenses
Provisions
((cc)) DDeeffeerrrreedd ttaaxx lliiaabbiilliittiieess
48,719
15,897
55,,776622,,226622
77,,337744,,550044
7,374,504
3,623,260
6,118,426
8,571,113
(7,818,490)
(4,866,870)
(15,343)
57,803
32,823
(35,573)
(12,821)
19,681
83,163
5,090
55,,776622,,226622
77,,337744,,550044
Deferred tax liability comprises temporary differences attributable to:
Unrealised gains/loss on loans to subsidiaries
(2,774,312)
(3,525,637)
Accrued income
Right-of-use assets
Intangibles
MMoovveemmeennttss
Opening balance
(16,787)
(32,429)
(49,195)
(15,142)
9,220
10,204
((22,,883311,,007744))
((33,,556633,,000044))
(3,563,004)
(3,322,148)
Unrealised gains/loss on loans to subsidiaries
751,326
(305,891)
Right-of-use assets
Accrued income
Intangibles
TToottaall
The tax rates used in this report are the corporate tax rate of 26% in 2021 and 27.5% in 2020.
(34,053)
15,642
(985)
36,983
20,276
7,776
((22,,883311,,007744))
((33,,556633,,000044))
22,,993311,,118888
33,,881111,,550000
108
70
CLINUVEL Pharmaceuticals | 2021 Annual Report
Lease liabilities
MMoovveemmeennttss
Opening balance
Carry forward tax losses
Deferred tax assets utilised
Intangibles
Lease liabilities
Accrued Expenses
Provisions
((cc)) DDeeffeerrrreedd ttaaxx lliiaabbiilliittiieess
Accrued income
Right-of-use assets
Intangibles
MMoovveemmeennttss
Opening balance
Right-of-use assets
Accrued income
Intangibles
TToottaall
48,719
15,897
55,,776622,,226622
77,,337744,,550044
7,374,504
3,623,260
6,118,426
8,571,113
(7,818,490)
(4,866,870)
(15,343)
57,803
32,823
(35,573)
(12,821)
19,681
83,163
5,090
55,,776622,,226622
77,,337744,,550044
(49,195)
(15,142)
9,220
10,204
((22,,883311,,007744))
((33,,556633,,000044))
(3,563,004)
(3,322,148)
(34,053)
15,642
(985)
36,983
20,276
7,776
((22,,883311,,007744))
((33,,556633,,000044))
22,,993311,,118888
33,,881111,,550000
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
44.. TTrraaddee aanndd OOtthheerr RReecceeiivvaabblleess
CCuurrrreenntt
Trade debtors
Interest receivables
Sundry debtors
TToottaall
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
22002200
$$
15,811,629
6,349,664
64,565
117,923
212,333
145,097
1166,,008888,,552277
66,,661122,,668844
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.
Trade debtors are generally due for settlement within 30 to 90 days from date of invoice. Collectability is regularly reviewed at an operating unit level. The Group
does not have a history of bad debts and the review of trade debtors outside the normal terms indicate full recoverability.
Deferred tax liability comprises temporary differences attributable to:
Unrealised gains/loss on loans to subsidiaries
(2,774,312)
(3,525,637)
(16,787)
(32,429)
CCuurrrreenntt
55.. IInnvveennttoorriieess
Unrealised gains/loss on loans to subsidiaries
751,326
(305,891)
Raw materials – at cost
Provision for obsolescence – raw materials
Work in progress – at cost
Finished goods – at cost
TToottaall
66.. OOtthheerr AAsssseettss
CCuurrrreenntt
Prepaid peptide
Other prepayments
TToottaall
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
22002200
$$
504,565
255,037
(159,712)
(51,655)
2,637,386
380,882
204,431
703,650
33,,118866,,667700
11,,228877,,991144
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
22002200
$$
472,184
105,139
409,850
403,679
888822,,003344
550088,,881188
The tax rates used in this report are the corporate tax rate of 26% in 2021 and 27.5% in 2020.
(cid:3)
(cid:3)
(cid:3)
70
109
71
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
77.. PPrrooppeerrttyy,, PPllaanntt AAnndd EEqquuiippmmeenntt
PPllaanntt aanndd eeqquuiippmmeenntt
At cost
Less: accumulated depreciation
SSuubb--ttoottaall
FFuurrnniittuurree aanndd ffiittttiinnggss
At cost
Less: accumulated depreciation
SSuubb--ttoottaall
LLeeaasseehhoolldd iimmpprroovveemmeennttss
At cost
Less: accumulated amortisation
SSuubb--ttoottaall
TToottaall pprrooppeerrttyy,, ppllaanntt aanndd eeqquuiippmmeenntt
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
22002200
$$
775,324
560,483
(292,057)
(216,643)
448833,,226677
334433,,884400
40,629
(18,181)
122,555
(82,916)
2222,,444488
3399,,663399
1,253,373
(374,666)
758,299
(66,337)
887788,,770077
669911,,996622
11,,338844,,442222
11,,007755,,444411
MMoovveemmeennttss iinn CCaarrrryyiinngg AAmmoouunnttss –– PPrrooppeerrttyy,, PPllaanntt aanndd EEqquuiippmmeenntt
Movements in the carrying amounts for each class of property, plant and equipment between the beginning and the
end of the financial year.
PPllaanntt aanndd
EEqquuiippmmeenntt
FFuurrnniittuurree
aanndd FFiittttiinnggss
LLeeaasseehhoolldd
IImmpprroovveemmeennttss
CCaarrrryyiinngg aammoouunntt aatt 3300 JJuunnee 22001199
Additions
Disposals
Depreciation written back on disposals
Depreciation expense
CCaarrrryyiinngg aammoouunntt aatt 3300 JJuunnee 22002200
Additions
Disposals
Depreciation written back on disposals
Depreciation expense
CCaarrrryyiinngg aammoouunntt aatt 3300 JJuunnee 22002211
$$
179,004
264,686
(1,792)
1,513
(99,571)
343,840
260,291
(45,450)
37,279
(112,693)
448833,,226677
$$
59,703
7,639
(16,432)
16,432
$$
99,144
630,017
-
-
TToottaall
$$
337,851
902,342
(18,224)
17,945
(27,703)
(37,199)
(164,473)
39,639
7,944
691,962
1,075,441
623,356
891,591
(89,871)
(128,282)
(263,603)
70,680
(5,944)
2222,,444488
69,552
177,511
(377,881)
(496,518)
887788,,770077
11,,338844,,442222
110
72
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
77.. PPrrooppeerrttyy,, PPllaanntt AAnndd EEqquuiippmmeenntt
88.. RRiigghhtt--ooff--UUssee AAsssseettss aanndd LLeeaassee LLiiaabbiilliittiieess
PPllaanntt aanndd eeqquuiippmmeenntt
Less: accumulated depreciation
At cost
SSuubb--ttoottaall
At cost
SSuubb--ttoottaall
At cost
SSuubb--ttoottaall
FFuurrnniittuurree aanndd ffiittttiinnggss
Less: accumulated depreciation
LLeeaasseehhoolldd iimmpprroovveemmeennttss
Less: accumulated amortisation
TToottaall pprrooppeerrttyy,, ppllaanntt aanndd eeqquuiippmmeenntt
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
22002200
$$
775,324
560,483
(292,057)
(216,643)
448833,,226677
334433,,884400
40,629
(18,181)
122,555
(82,916)
2222,,444488
3399,,663399
1,253,373
(374,666)
758,299
(66,337)
887788,,770077
669911,,996622
11,,338844,,442222
11,,007755,,444411
RRiigghhtt--ooff--uussee aasssseettss
At cost
Less: accumulated depreciation
TToottaall rriigghhtt--ooff--uussee aasssseettss
LLeeaassee lliiaabbiilliittiieess
Lease liabilities - Current
Lease liabilities - Non-current
TToottaall lleeaassee lliiaabbiilliittiieess
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
22002200
$$
1,538,929
1,693,596
(320,208)
(379,659)
11,,221188,,772211
11,,331133,,993377
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
22002200
$$
258,236
212,331
1,045,236
1,107,224
11,,330033,,447722
11,,331199,,555555
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 borrowing rate of 3.5% in 2021 and 2020.
MMoovveemmeennttss iinn CCaarrrryyiinngg AAmmoouunnttss –– PPrrooppeerrttyy,, PPllaanntt aanndd EEqquuiippmmeenntt
Movements in the carrying amounts for each class of property, plant and equipment between the beginning and the
end of the financial year.
99.. IInnttaannggiibbllee aasssseett
GGooooddwwiillll
At cost
Less: impairment
TToottaall
CCoonnssoolliiddaatteedd EEnnttiittyy
22002200
$$
22001199
$$
185,030
185,030
-
-
118855,,003300
118855,,003300
(27,703)
(37,199)
(164,473)
Goodwill is not amortised but is measured at cost less any accumulated impairment losses. Impairment occurs when a business unit’s recoverable amount falls
below the carrying value of its net assets. The method used to determine the recoverable amount is price analysis of peer companies. The results of the impairment
test show that the business unit’s recoverable amount exceeds the carrying value of its net assets, inclusive of goodwill. Consequently, there is no goodwill
impairment as at 30 June 2021.
CCaarrrryyiinngg aammoouunntt aatt 3300 JJuunnee 22001199
Additions
Disposals
Additions
Disposals
Depreciation written back on disposals
Depreciation expense
CCaarrrryyiinngg aammoouunntt aatt 3300 JJuunnee 22002200
Depreciation written back on disposals
Depreciation expense
CCaarrrryyiinngg aammoouunntt aatt 3300 JJuunnee 22002211
PPllaanntt aanndd
EEqquuiippmmeenntt
FFuurrnniittuurree
LLeeaasseehhoolldd
aanndd FFiittttiinnggss
IImmpprroovveemmeennttss
$$
179,004
264,686
(1,792)
1,513
(99,571)
343,840
260,291
(45,450)
37,279
(112,693)
448833,,226677
$$
59,703
7,639
(16,432)
16,432
39,639
7,944
70,680
(5,944)
2222,,444488
$$
99,144
630,017
-
-
TToottaall
$$
337,851
902,342
(18,224)
17,945
691,962
1,075,441
623,356
891,591
69,552
177,511
(377,881)
(496,518)
887788,,770077
11,,338844,,442222
(89,871)
(128,282)
(263,603)
72
111
73
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
1100.. IInntteerreessttss iinn SSuubbssiiddiiaarriieess
NNaammee OOff EEnnttiittyy
CCoouunnttrryy OOff IInnccoorrppoorraattiioonn ss
OOwwnneerrsshhiipp IInntteerreesstt
PPaarreenntt eennttiittyy
CLINUVEL PHARMACEUTICALS LTD
Australia
-
-
22002211
22002200
CCoonnttrroolllleedd eennttiittiieess
A.C.N. 108 768 896 PTY LTD
Australia
CLINUVEL (UK) LTD
United Kingdom
CLINUVEL, INC.
CLINUVEL AG
CLINUVEL SINGAPORE PTE LTD
VALLAURIX PTE LTD
CLINUVEL EUROPE LIMITED
VALLAURIX MC SARL
United States of America
Switzerland
Singapore
Singapore
Ireland
Monaco
1111.. TTrraaddee aanndd OOtthheerr PPaayyaabblleess
CCuurrrreenntt
Unsecured trade creditors
Sundry creditors and accrued expenses
TToottaall
((aa)) AAggggrreeggaattee aammoouunnttss ppaayyaabbllee ttoo::
Directors and Director-related entities*
((bb)) AAuussttrraalliiaann ddoollllaarr eeqquuiivvaalleennttss ooff aammoouunnttss ppaayyaabbllee iinn ffoorreeiiggnn ccuurrrreenncciieess
nnoott eeffffeeccttiivveellyy hheeddggeedd aanndd iinncclluuddeedd iinn TTrraaddee aanndd SSuunnddrryy ccrreeddiittoorrss::
Danish Krone
Israeli Shekel
Other
For an analysis of the sensitivity of trade and other payables to foreign currency risk refer to Note 22.
*Accrued short-term employee benefits
cc)) TTeerrmmss aanndd ccoonnddiittiioonnss::
Trade and sundry creditors are non-interest bearing and normally settled on 30 day terms..
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
2,323,560
2,427,578
44,,775511,,113388
22002200
$$
1,429,855
3,341,726
44,,777711,,558811
735,701
865,192
271
105
-
337766
-
10,875
-
1100,,887755
112
74
CLINUVEL Pharmaceuticals | 2021 Annual Report
CLINUVEL PHARMACEUTICALS LTD
Australia
-
-
PPaarreenntt eennttiittyy
CCoonnttrroolllleedd eennttiittiieess
A.C.N. 108 768 896 PTY LTD
Australia
CLINUVEL (UK) LTD
United Kingdom
United States of America
CLINUVEL, INC.
CLINUVEL AG
CLINUVEL SINGAPORE PTE LTD
VALLAURIX PTE LTD
CLINUVEL EUROPE LIMITED
VALLAURIX MC SARL
Switzerland
Singapore
Singapore
Ireland
Monaco
1111.. TTrraaddee aanndd OOtthheerr PPaayyaabblleess
Unsecured trade creditors
Sundry creditors and accrued expenses
CCuurrrreenntt
TToottaall
((aa)) AAggggrreeggaattee aammoouunnttss ppaayyaabbllee ttoo::
Directors and Director-related entities*
Danish Krone
Israeli Shekel
Other
((bb)) AAuussttrraalliiaann ddoollllaarr eeqquuiivvaalleennttss ooff aammoouunnttss ppaayyaabbllee iinn ffoorreeiiggnn ccuurrrreenncciieess
nnoott eeffffeeccttiivveellyy hheeddggeedd aanndd iinncclluuddeedd iinn TTrraaddee aanndd SSuunnddrryy ccrreeddiittoorrss::
For an analysis of the sensitivity of trade and other payables to foreign currency risk refer to Note 22.
*Accrued short-term employee benefits
cc)) TTeerrmmss aanndd ccoonnddiittiioonnss::
Trade and sundry creditors are non-interest bearing and normally settled on 30 day terms..
22002211
22002200
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
100%
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
2,323,560
2,427,578
44,,775511,,113388
22002200
$$
1,429,855
3,341,726
44,,777711,,558811
735,701
865,192
271
105
-
337766
10,875
-
-
1100,,887755
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
1100.. IInntteerreessttss iinn SSuubbssiiddiiaarriieess
1122.. PPrroovviissiioonnss
NNaammee OOff EEnnttiittyy
CCoouunnttrryy OOff IInnccoorrppoorraattiioonn ss
OOwwnneerrsshhiipp IInntteerreesstt
CCuurrrreenntt
Employee benefits
TToottaall
NNoonn--ccuurrrreenntt
Employee benefits
Provision for make good
TToottaall
1133.. CCoonnttrriibbuutteedd EEqquuiittyy
((aa)) IIssssuueedd aanndd PPaaiidd--UUpp CCaappiittaall
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
22002200 RReessttaatteedd
$$
3,697,579
3,278,175
33,,669977,,557799
33,,227788,,117755
13,166
64,785
7777,,995511
5,290
100,437
110055,,772277
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
22002200
$$
49,410,338 fully paid ordinary shares (2020: 49,410,338)
151,849,375
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.
((bb)) MMoovveemmeennttss iinn OOrrddiinnaarryy SShhaarree CCaappiittaall
NNoo..
22002211
$$
CCoonnssoolliiddaatteedd EEnnttiittyy
NNoo..
22002200
$$
AAtt tthhee bbeeggiinnnniinngg ooff tthhee ffiinnaanncciiaall yyeeaarr
4499,,441100,,333388
115511,,884499,,337755
4488,,996600,,663333
115511,,331144,,117755
Issued during the year
Conditional rights issues and transferred
from conditional rights reserve
Less: transaction costs
-
-
-
-
-
-
-
-
449,705
535,200
-
-
BBaallaannccee aatt tthhee eenndd ooff tthhee ffiinnaanncciiaall yyeeaarr
4499,,441100,,333388
115511,,884499,,337755
4499,,441100,,333388
115511,,884499,,337755
74
113
75
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
((cc)) CCoonnddiittiioonnaall PPeerrffoorrmmaannccee RRiigghhttss
During the year to 30 June 2021, no conditional performance rights were exercised,
resulting in the issue of fully paid ordinary shares:
EExxppiirryy ddaattee
EExxeerrcciissee PPrriiccee
NNuummbbeerr ooff SSeeccuurriittiieess
UUppoonn aacchhiieevveemmeenntt ooff vvaarriioouuss ppeerrffoorrmmaannccee mmiilleessttoonneess
NNiill$$
00
As at 30 June 2020, the year the following conditional performance
rights were exercised, resulting in the issue of fully paid ordinary shares:
EExxppiirryy ddaattee
EExxeerrcciissee PPrriiccee
NNuummbbeerr ooff CCoonnddiittiioonnaall RRiigghhttss
UUppoonn aacchhiieevveemmeenntt ooff vvaarriioouuss ppeerrffoorrmmaannccee mmiilleessttoonneess
NNiill$$
444499,,770055
1144.. RReesseerrvveess
CCoonnddiittiioonnaall PPeerrffoorrmmaannccee RRiigghhttss rreesseerrvvee::
BBaallaannccee aatt tthhee bbeeggiinnnniinngg ooff ppeerriioodd
Share-based payment
Transfer to share capital
Lapsed, forfeited rights
BBaallaannccee aatt tthhee eenndd ooff ppeerriioodd
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
22002200 RReessttaatteedd
$$
$$
11,,775511,,222233
665544,,332244
2,602,393
1,658,713
-
(535,200)
(10,194)
(26,614)
44,,334433,,442222
11,,775511,,222233
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:
BBaallaannccee aatt tthhee bbeeggiinnnniinngg ooff ppeerriioodd
Translating foreign subsidiary to current rate at reporting date
BBaallaannccee aatt tthhee eenndd ooff ppeerriioodd
Prior Year Restatement
BBaallaannccee aatt tthhee eenndd ooff ppeerriioodd rreessttaatteedd
TToottaall rreesseerrvveess
9999,,115522
575,253
667744,,440055
-
667744,,440055
669988,,009922
(592,857)
110055,,223355
(6,083)
9999,,115522
55,,001177,,882277
11,,885500,,337755
114
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CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
((cc)) CCoonnddiittiioonnaall PPeerrffoorrmmaannccee RRiigghhttss
During the year to 30 June 2021, no conditional performance rights were exercised,
resulting in the issue of fully paid ordinary shares:
EExxppiirryy ddaattee
EExxeerrcciissee PPrriiccee
NNuummbbeerr ooff SSeeccuurriittiieess
UUppoonn aacchhiieevveemmeenntt ooff vvaarriioouuss ppeerrffoorrmmaannccee mmiilleessttoonneess
NNiill$$
00
As at 30 June 2020, the year the following conditional performance
rights were exercised, resulting in the issue of fully paid ordinary shares:
EExxppiirryy ddaattee
EExxeerrcciissee PPrriiccee
NNuummbbeerr ooff CCoonnddiittiioonnaall RRiigghhttss
UUppoonn aacchhiieevveemmeenntt ooff vvaarriioouuss ppeerrffoorrmmaannccee mmiilleessttoonneess
NNiill$$
444499,,770055
1144.. RReesseerrvveess
CCoonnddiittiioonnaall PPeerrffoorrmmaannccee RRiigghhttss rreesseerrvvee::
BBaallaannccee aatt tthhee bbeeggiinnnniinngg ooff ppeerriioodd
Share-based payment
Transfer to share capital
Lapsed, forfeited rights
BBaallaannccee aatt tthhee eenndd ooff ppeerriioodd
Translating foreign subsidiary to current rate at reporting date
Foreign currency translation reserve:
BBaallaannccee aatt tthhee bbeeggiinnnniinngg ooff ppeerriioodd
BBaallaannccee aatt tthhee eenndd ooff ppeerriioodd
Prior Year Restatement
BBaallaannccee aatt tthhee eenndd ooff ppeerriioodd rreessttaatteedd
TToottaall rreesseerrvveess
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
22002200 RReessttaatteedd
$$
$$
11,,775511,,222233
665544,,332244
2,602,393
1,658,713
-
(535,200)
(10,194)
(26,614)
44,,334433,,442222
11,,775511,,222233
9999,,115522
575,253
667744,,440055
-
667744,,440055
669988,,009922
(592,857)
110055,,223355
(6,083)
9999,,115522
55,,001177,,882277
11,,885500,,337755
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.
1155.. SShhoorrtt--TTeerrmm LLeeaassee CCoommmmiittmmeennttss
SShhoorrtt--tteerrmm lleeaassee ccoommmmiittmmeennttss
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
later than 1 year but not later than 5 years
TToottaall
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
22002200
$$
111,817
104,983
17,177
7,873
112288,,999944
111122,,885566
Short-term leases comprise commitments for limited license agreement of furnished office accommodation. The limited
license agreement has no contingent rental clauses and contains renewal options.
1166.. EEaarrnniinnggss PPeerr SShhaarree ((EEPPSS))
(a) Basic earnings per share (cents per share)
(a) Diluted earnings per share (cents per share)
CCoonnssoolliiddaatteedd EEnnttiittyy
22002200 RReessttaatteedd
$$
30.6
29.8
22002211
$$
50.0
48.4
(b) The Weighted Average Number of Ordinary Shares (WANOS) used in the
calculation of basic earnings per share
49,410,338
49,260,026
(b) Weighted average number of performance rights on issue in respect of
share based payments during the year
1,720,732
1,198,897
(b) The Weighted Average Number of Ordinary Shares (WANOS) used in the
calculation of diluted earnings per share
51,131,070
50,458,922
(c) The numerator used in the calculation of basic earnings per share ($)
24,728,247
15,051,199
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.
76
115
77
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
1177.. CCaasshh FFllooww IInnffoorrmmaattiioonn
((aa)) RReeccoonncciilliiaattiioonn ooff ccaasshh::
CCaasshh aatt tthhee eenndd ooff tthhee ffiinnaanncciiaall yyeeaarr aass sshhoowwnn iinn tthhee SSttaatteemmeenntt ooff CCaasshh FFlloowwss iiss
rreeccoonncciilleedd ttoo tthhee rreellaatteedd iitteemmss iinn tthhee bbaallaannccee sshheeeett aass ffoolllloowwss::
Cash at bank
Cash on hand
Deposits on call
Term deposits
Security bonds
TToottaall ccaasshh aanndd ccaasshh eeqquuiivvaalleennttss
((bb)) RReeccoonncciilliiaattiioonn ooff ccaasshh fflloowwss ffrroomm ooppeerraattiinngg aaccttiivviittiieess wwiitthh ooppeerraattiinngg pprrooffiitt ((lloossss))
OOppeerraattiinngg pprrooffiitt aafftteerr iinnccoommee ttaaxx
Prior year restatement
OOppeerraattiinngg pprrooffiitt aafftteerr iinnccoommee ttaaxx rreessttaatteedd
NNoonn ccaasshh fflloowwss iinn ooppeerraattiinngg pprrooffiitt aafftteerr iinnccoommee ttaaxx::
Depreciation expense on property, plant & equipment
Amortisation expense on right-of-use assets
Exchange rate effect on foreign currencies held
Executive share option expense
Unrealised loss (gain) on foreign exchange translation
Loss on sale of non-current assets
CChhaannggeess iinn aasssseettss aanndd lliiaabbiilliittiieess::
(Increase)/decrease in receivables
(Increase)/decrease in inventories
(Increase)/decrease in other assets
Increase/(decrease) in payables
(Increase)/decrease in deferred tax assets
Increase/(decrease) in provisions
NNeett ccaasshh uusseedd iinn ooppeerraattiinngg aaccttiivviittiieess
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
22002200 RReessttaatteedd
$$
$$
34,572,626
23,872,909
1,317
574
2,241,903
1,480,550
45,550,000
41,094,576
325,136
297,912
8822,,669900,,998822
6666,,774466,,552211
2244,,772288,,224477
1166,,664466,,885599
-
(1,595,660)
2244,,772288,,224477
1155,,005511,,119999
499,625
319,962
983,325
164,474
263,154
(664,084)
2,602,393
1,658,713
575,253
(592,857)
90,136
-
(9,475,843)
(2,456,468)
(1,898,756)
848,170
(413,782)
82,698
(20,443)
2,661,315
880,312
(3,510,388)
391,632
682,442
1199,,226622,,006611
1144,,118888,,336688
Cash at bank earns floating rates based on daily bank deposit rates. The carrying amounts of cash and cash equivalents represent fair value. Cash equivalents
are held for the purpose of meeting short-term cash commitments rather than for investment or other purposes. The term deposits are readily convertible to cash
and subject to an insignificant risk of changes in value. The effective interest rate on short-term deposits was 0.70% (2020: 1.55%). These deposits have an
average maturity date of 233 days (2020: 199 days).
116
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CLINUVEL Pharmaceuticals | 2021 Annual Report
((aa)) RReeccoonncciilliiaattiioonn ooff ccaasshh::
CCaasshh aatt tthhee eenndd ooff tthhee ffiinnaanncciiaall yyeeaarr aass sshhoowwnn iinn tthhee SSttaatteemmeenntt ooff CCaasshh FFlloowwss iiss
rreeccoonncciilleedd ttoo tthhee rreellaatteedd iitteemmss iinn tthhee bbaallaannccee sshheeeett aass ffoolllloowwss::
Cash at bank
Cash on hand
Deposits on call
Term deposits
Security bonds
TToottaall ccaasshh aanndd ccaasshh eeqquuiivvaalleennttss
OOppeerraattiinngg pprrooffiitt aafftteerr iinnccoommee ttaaxx
Prior year restatement
OOppeerraattiinngg pprrooffiitt aafftteerr iinnccoommee ttaaxx rreessttaatteedd
NNoonn ccaasshh fflloowwss iinn ooppeerraattiinngg pprrooffiitt aafftteerr iinnccoommee ttaaxx::
Depreciation expense on property, plant & equipment
Amortisation expense on right-of-use assets
Exchange rate effect on foreign currencies held
Executive share option expense
Unrealised loss (gain) on foreign exchange translation
Loss on sale of non-current assets
CChhaannggeess iinn aasssseettss aanndd lliiaabbiilliittiieess::
(Increase)/decrease in receivables
(Increase)/decrease in inventories
(Increase)/decrease in other assets
Increase/(decrease) in payables
(Increase)/decrease in deferred tax assets
Increase/(decrease) in provisions
NNeett ccaasshh uusseedd iinn ooppeerraattiinngg aaccttiivviittiieess
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
22002200 RReessttaatteedd
$$
$$
34,572,626
23,872,909
1,317
574
2,241,903
1,480,550
45,550,000
41,094,576
325,136
297,912
8822,,669900,,998822
6666,,774466,,552211
2244,,772288,,224477
1166,,664466,,885599
-
(1,595,660)
2244,,772288,,224477
1155,,005511,,119999
499,625
319,962
983,325
164,474
263,154
(664,084)
2,602,393
1,658,713
575,253
(592,857)
90,136
-
(9,475,843)
(2,456,468)
(1,898,756)
848,170
(413,782)
82,698
(20,443)
2,661,315
880,312
(3,510,388)
391,632
682,442
1199,,226622,,006611
1144,,118888,,336688
Cash at bank earns floating rates based on daily bank deposit rates. The carrying amounts of cash and cash equivalents represent fair value. Cash equivalents
are held for the purpose of meeting short-term cash commitments rather than for investment or other purposes. The term deposits are readily convertible to cash
and subject to an insignificant risk of changes in value. The effective interest rate on short-term deposits was 0.70% (2020: 1.55%). These deposits have an
average maturity date of 233 days (2020: 199 days).
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
1177.. CCaasshh FFllooww IInnffoorrmmaattiioonn
1188.. KKeeyy MMaannaaggeemmeenntt PPeerrssoonnnneell
((bb)) RReeccoonncciilliiaattiioonn ooff ccaasshh fflloowwss ffrroomm ooppeerraattiinngg aaccttiivviittiieess wwiitthh ooppeerraattiinngg pprrooffiitt ((lloossss))
1199.. AAuuddiittoorrss’’ RReemmuunneerraattiioonn
Short-term employee benefits
Post-employment benefits
Long-term benefits
Share-based payments
TToottaall
No loans existed with key management personnel, except accrued short-term employee benefits.
Amounts received or due and receivable by Grant Thornton for:
audit services and review
tax and advisory services
TToottaall
2200.. RReellaatteedd PPaarrttyy DDiisscclloossuurreess
WWhhoollllyy--oowwnneedd ggrroouupp ttrraannssaaccttiioonnss
LLooaannss
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
22002200 RReessttaatteedd
$$
3,570,602
2,697,942
56,835
118,483
2,312,308
66,,005588,,222288
56,552
1,625,658
1,650,663
66,,003300,,881155
22002211
$$
113,000
10,000
112233,,000000
CCoonnssoolliiddaatteedd EEnnttiittyy
22002200
$$
97,000
43,000
114400,,000000
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. The loan to A.C.N. 108 768 896 Pty Ltd as at
30 June 2021 is $4,370,640 (2020: $4,370,640).
The loan receivable by CLINUVEL PHARMACEUTICALS LTD from CLINUVEL, INC. 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, INC. The loan to CLINUVEL, INC. as at 30 June 2021 is $21,780,429 (2020:
$12,840,377).
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. The loan to CLINUVEL AG as at 30 June 2021 is $13,972,152 (2020: $13,945,079).
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 2021 is $642,292 (2020: $604,342).
78
117
79
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
The loan receivable by CLINUVEL PHARMACEUTICALS LTD from CLINUVEL (UK) 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 (UK) LTD. The loan to CLINUVEL (UK) LTD as at 30 June 2021 is $13,900,471 (2020:
$15,661,324).
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 2021 is $5,752,040 (2020:
$3,615,257).
The loan payable by CLINUVEL PHARMACEUTICALS LTD to 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 from VALLAURIX MC SARL as at 30 June 2021 is -$3,973,021
(2020: -$1,949,434). VALLAURIX MC SARL was incorporated as a wholly- owned entity of the consolidated group
during 2019-20.
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 2021 is $5,039,479 (2020: $0). CLINUVEL EUROPE LIMITED was incorporated as a wholly- owned entity
of the consolidated group during 2018-19.
Director related and Key Management Personnel transactions and entities:
There are no loan transactions and relationships in existence as at 30 June 2021 between Directors and the
Company and its related entities.
118
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CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
The loan receivable by CLINUVEL PHARMACEUTICALS LTD from CLINUVEL (UK) 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 (UK) LTD. The loan to CLINUVEL (UK) LTD as at 30 June 2021 is $13,900,471 (2020:
$15,661,324).
$3,615,257).
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 2021 is $5,752,040 (2020:
The loan payable by CLINUVEL PHARMACEUTICALS LTD to 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 from VALLAURIX MC SARL as at 30 June 2021 is -$3,973,021
(2020: -$1,949,434). VALLAURIX MC SARL was incorporated as a wholly- owned entity of the consolidated group
during 2019-20.
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 2021 is $5,039,479 (2020: $0). CLINUVEL EUROPE LIMITED was incorporated as a wholly- owned entity
of the consolidated group during 2018-19.
Director related and Key Management Personnel transactions and entities:
There are no loan transactions and relationships in existence as at 30 June 2021 between Directors and the
Company and its related entities.
2211.. SSeeggmmeenntt IInnffoorrmmaattiioonn
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 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 consolidated entity has one operating segment within the definition of AASB 8
Operating Segments.
The Group’s revenue disaggregated by primary geographical markets is as follows:
The Group’s revenue disaggregated by pattern of revenue recognition and the Group recognises all revenue based
on a point in time.
2222.. FFiinnaanncciiaall IInnssttrruummeennttss
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.
aa)) MMaarrkkeett RRiisskk
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
80
119
81
CLINUVEL Pharmaceuticals | 2021 Annual Report
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
manage market risk is to ensure exposures are contained within acceptable parameters, to minimise costs and to
stabilise existing assets.
FFoorreeiiggnn CCuurrrreennccyy RRiisskk
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 2021 and as at 30 June 2020.
TThhee ccoonnssoolliiddaatteedd eennttiittiieess eexxppoossuurree ttoo ffoorreeiiggnn ccuurrrreennccyy rriisskk aatt 3300 JJuunnee 22002211
CCaasshh
aanndd CCaasshh
EEqquuiivvaalleennttss
TTrraaddee
DDeebbttoorrss aanndd
OOtthheerr
AAsssseettss
TTrraaddee,, OOtthheerr
PPaayyaabblleess aanndd
PPrroovviissiioonn
Consolidated Entity
22002211
$$
TTOOTTAALL
CCaasshh
aanndd CCaasshh
EEqquuiivvaalleennttss
TTrraaddee
DDeebbttoorrss aanndd
OOtthheerr AAsssseettss
TTrraaddee,,
OOtthheerr
PPaayyaabblleess
aanndd
PPrroovviissiioonn
22002200
$$
TTOOTTAALL
UUSSDD
5,089,237
6,829,485
(1,888,178) 1100,,003300,,554444
2,026,377
1,325
(513,704)
11,,551133,,999988
EEUURR
9,330,841
3,709,227
(2,956,578) 1100,,008833,,449900
9,405,452
2,472,442
(1,720,287
)
1100,,115577,,660077
CCHHFF
GGBBPP
SSGGDD
IILLSS
DDKKKK
1,623,549
664,643
(137,695)
22,,115500,,449977
2,118,158
1,057,956
(322,229)
22,,885533,,888855
420,266
100,453
(205,788)
331144,,993311
456,886
32,982
(336,497)
115533,,337711
521,309
233,263
(283,017)
447711,,555555
1,559,596
150,072
(171,080)
11,,553388,,558888
-
-
214,500
(255)
221144,,224455
-
(1,272)
((11,,227722))
-
-
-
-
(25,771)
((2255,,777711))
--
--
SSeennssiittiivviittyy AAnnaallyyssiiss
During the financial year the Company had a principal foreign currency transaction risk exposure to the US dollar.
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 10% appreciation of the Australian dollar against the US currency would have
decreased profit and loss and equity by $1,447,684 for the year ended 30 June 2021 (2020: $50,077 increase), on
the basis that all other variables remain constant. 10% is considered representative of the market volatility in the
Australian dollar/US dollar rate for the period.
120
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CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
manage market risk is to ensure exposures are contained within acceptable parameters, to minimise costs and to
stabilise existing assets.
FFoorreeiiggnn CCuurrrreennccyy RRiisskk
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 2021 and as at 30 June 2020.
TThhee ccoonnssoolliiddaatteedd eennttiittiieess eexxppoossuurree ttoo ffoorreeiiggnn ccuurrrreennccyy rriisskk aatt 3300 JJuunnee 22002211
22002211
$$
Consolidated Entity
22002200
$$
CCaasshh
aanndd CCaasshh
EEqquuiivvaalleennttss
TTrraaddee
DDeebbttoorrss aanndd
OOtthheerr
AAsssseettss
TTrraaddee,, OOtthheerr
PPaayyaabblleess aanndd
PPrroovviissiioonn
TTOOTTAALL
aanndd CCaasshh
DDeebbttoorrss aanndd
PPaayyaabblleess
TTOOTTAALL
CCaasshh
TTrraaddee
EEqquuiivvaalleennttss
OOtthheerr AAsssseettss
TTrraaddee,,
OOtthheerr
aanndd
PPrroovviissiioonn
UUSSDD
5,089,237
6,829,485
(1,888,178)
1100,,003300,,554444
2,026,377
1,325
(513,704)
11,,551133,,999988
EEUURR
9,330,841
3,709,227
(2,956,578)
1100,,008833,,449900
9,405,452
2,472,442
(1,720,287
1100,,115577,,660077
CCHHFF
GGBBPP
SSGGDD
IILLSS
DDKKKK
1,623,549
664,643
(137,695)
22,,115500,,449977
2,118,158
1,057,956
(322,229)
22,,885533,,888855
420,266
100,453
(205,788)
331144,,993311
456,886
32,982
(336,497)
115533,,337711
521,309
233,263
(283,017)
447711,,555555
1,559,596
150,072
(171,080)
11,,553388,,558888
-
-
-
(1,272)
((11,,227722))
-
-
-
-
)
--
SSeennssiittiivviittyy AAnnaallyyssiiss
Australian dollars.
During the financial year the Company had a principal foreign currency transaction risk exposure to the US dollar.
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
For the consolidated entity, a 10% appreciation of the Australian dollar against the US currency would have
decreased profit and loss and equity by $1,447,684 for the year ended 30 June 2021 (2020: $50,077 increase), on
the basis that all other variables remain constant. 10% is considered representative of the market volatility in the
Australian dollar/US dollar rate for the period.
--
82
For the consolidated entity, an appreciation of the Australian dollar against the US 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.
IInntteerreesstt RRaattee RRiisskk
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 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.
SSeennssiittiivviittyy AAnnaallyyssiiss
For the consolidated entity, at 30 June 2021, if interest rates had changed by +/- 15 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 $106,400 higher/lower (2020:
$89,952 higher/ lower). This analysis assumes all other variables are held constant.
PPrriiccee RRiisskk
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. The
consolidated entity no longer holds income securities. Neither the consolidated entity nor the parent is exposed to
commodity price risk.
bb)) CCrreeddiitt RRiisskk
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 nearly thirty 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.
214,500
(255)
221144,,224455
(25,771)
((2255,,777711))
cc)) LLiiqquuiiddiittyy RRiisskk
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.
FFaaiirr VVaalluuee EEssttiimmaattiioonn
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 carrying value of trade payables is assumed to approximate their fair values due to their short-term nature.
121
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CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
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.
TTrraaddee aanndd ootthheerr ppaayyaabblleess
Carrying amount
6 months or less
Greater than 6 months
TToottaall
LLeeaassee lliiaabbiilliittiieess
Carrying amount
6 months or less
Greater than 6 months
TToottaall
CCaappiittaall RRiisskk MMaannaaggeemmeenntt
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
22002200
$$
4,751,138
4,771,581
4,737,110
4,659,117
14,028
112,464
44,,775511,,113388
44,,777711,,558811
1,303,472
1,319,555
147,447
144,170
1,156,025
1,175,385
11,,330033,,447722
11,,331199,,555555
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 and
from commercial sales currently in the European Economic Area, USA and Switzerland. 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.
CCoonnttrraaccttuuaall mmaattuurriittiieess ooff ffiinnaanncciiaall aasssseettss aass aatt 3300 JJuunnee 22002211
CCaasshh aanndd ccaasshh eeqquuiivvaalleennttss
Carrying amount
6 months or less
Greater than 6 months
TToottaall
OOtthheerr ffiinnaanncciiaall aasssseettss ((iinncclluuddeess ttrraaddee aanndd ootthheerr rreecceeiivvaabblleess))
Carrying amount
6 months or less
Greater than 6 months
TToottaall
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
22002200
$$
82,690,982
66,746,521
69,053,415
52,406,687
13,637,567
14,339,834
8822,,669900,,998822
6666,,774466,,552211
16,088,527
6,612,684
15,619,400
6,597,634
469,127
15,050
1166,,008888,,552277
66,,661122,,668844
122
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CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
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.
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 and
from commercial sales currently in the European Economic Area, USA and Switzerland. 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.
CCoonnttrraaccttuuaall mmaattuurriittiieess ooff ffiinnaanncciiaall aasssseettss aass aatt 3300 JJuunnee 22002211
TTrraaddee aanndd ootthheerr ppaayyaabblleess
Carrying amount
6 months or less
Greater than 6 months
TToottaall
LLeeaassee lliiaabbiilliittiieess
Carrying amount
6 months or less
Greater than 6 months
TToottaall
CCaappiittaall RRiisskk MMaannaaggeemmeenntt
CCaasshh aanndd ccaasshh eeqquuiivvaalleennttss
Carrying amount
6 months or less
Greater than 6 months
TToottaall
Carrying amount
6 months or less
Greater than 6 months
TToottaall
OOtthheerr ffiinnaanncciiaall aasssseettss ((iinncclluuddeess ttrraaddee aanndd ootthheerr rreecceeiivvaabblleess))
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
22002200
$$
4,751,138
4,737,110
14,028
44,,775511,,113388
1,303,472
147,447
1,156,025
11,,330033,,447722
4,771,581
4,659,117
112,464
44,,777711,,558811
1,319,555
144,170
1,175,385
11,,331199,,555555
CCoonnssoolliiddaatteedd EEnnttiittyy
22002211
$$
22002200
$$
82,690,982
66,746,521
69,053,415
52,406,687
13,637,567
14,339,834
8822,,669900,,998822
6666,,774466,,552211
16,088,527
15,619,400
469,127
6,612,684
6,597,634
15,050
1166,,008888,,552277
66,,661122,,668844
84
2233.. SShhaarree--BBaasseedd PPaayymmeennttss
The consolidated entity has two conditional performance rights schemes which are ownership based for key
management personnel and select consultants (including Directors) of the Company. The number of rights granted
is subject to approval by the Remuneration Committee. Rights currently have specific terms and conditions, being
the achievement of performance milestones set by the Directors of the consolidated entity.
CCoonnddiittiioonnaall PPeerrffoorrmmaannccee RRiigghhttss PPllaann ((22000099))
The Conditional Performance Rights Plan (2009) is 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. It is no longer intended to issue
performance rights under the 2009 Plan.
PPeerrffoorrmmaannccee RRiigghhttss PPllaann ((22001144))
The Performance Rights Plan (2014) is available to eligible persons of the Company. Any issue of rights to
executive Directors requires shareholder approval in accordance with ASX Listing Rules. All rights convert to one
ordinary share of the consolidated entity are issued for nil consideration, have no voting rights, are not listed on the
ASX and are non-tradeable (other than with prior written Board consent). They can be converted to ordinary shares
at any time once the vesting conditions attached to the rights have been achieved, whereby, at the discretion of the
Board, they will be held by a Scheme Trustee on behalf of the eligible person. The eligible person cannot trade in
the shares held by the Scheme Trust without prior written Board consent until the earlier of seven years from grant
date of performance right, when the eligible person ceases employment or when all transfer restrictions are
satisfied or waived by the Board in its discretion. Performance Rights under this plan lapse after seven years from
grant date.
As at 30 June 2021, the Company via its wholly owned subsidiary ACN 108768896 Pty Ltd acting in its capacity as
trustee for the 2009 Scheme Trust and the 2014 Plan Trust, holds 2,780,840 shares (2020: 4,530,568 shares).
TThhee ffoolllloowwiinngg sshhaarree--bbaasseedd ppaayymmeenntt aarrrraannggeemmeennttss wweerree iinn eexxiisstteennccee aatt 3300 JJuunnee 22002211
PPeerrffoorrmmaannccee
RRiigghhttss SSeerriieess
NNuummbbeerr
GGrraanntt DDaattee
EExxppiirryy DDaattee
Issued 16/09/2011
113,335
16/09/2011
Issued 16/11/2011
25,000
16/11/2011
The earlier of achievement of
specific performance milestones
and cessation of employment/
directorship
The earlier of achievement of
specific performance milestones
and cessation of
employment/directorship
Issued 26/08/2020
1,513,750
20/11/2019
20/11/2023
Issued 24/12/2020
132,500
24/12/2020
20/11/2023
EExxeerrcciissee
PPrriiccee
FFaaiirr VVaalluuee aatt
GGrraanntt DDaattee
$ Nil
between
$0.55 and
$0.72
$ Nil
$0.67
$ Nil
$ Nil
between
$10.86 &
$26.87 *
between
$8.98 &
$20.74 *
123
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CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
HHoollddiinnggss ooff AAllll IIssssuueedd CCoonnddiittiioonnaall PPeerrffoorrmmaannccee RRiigghhttss –– 22002211
BBaallaannccee
aatt SSttaarrtt ooff
YYeeaarr
127,710
25,000
PPeerrffoorrmmaannccee
RRiigghhttss SSeerriieess
Issued
16/09/2011
Issued
16/11/2011
Issued
26/08/2020
Issued
24/12/2020
GGrraanntteedd aass
CCoommppeennssaattiioonn
EExxeerrcciisseedd
EExxppiirreedd
&&
LLaappsseedd
BBaallaannccee aatt EEnndd ooff
YYeeaarr
VVeesstteedd aanndd
EExxeerrcciissaabbllee
UUnnvveesstteedd
-
-
-
-
1,513,750
132,500
-
-
(14,375)
113,335
25,000
-
-
113,335
25,000
-
1,513,750
95,375
1,418,375
132,500
-
132,500
TToottaall
115522,,771100
11,,664466,,225500
--
((1144,,337755))
11,,778844,,558855
9955,,337755
11,,668899,,221100
$Nil
Weighted
average
exercise price
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.
$Nil
$Nil
$Nil
$Nil
$Nil
$Nil
For Performance Rights issued in 2020
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 y ears
from date of grant of rights or 20 November 2023. 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 24 December 2020, an illiquidity discount was applied
to the pricing model.
HHoollddiinnggss ooff AAllll IIssssuueedd CCoonnddiittiioonnaall PPeerrffoorrmmaannccee RRiigghhttss –– 22002200
PPeerrffoorrmmaannccee
RRiigghhttss SSeerriieess
BBaallaannccee aatt
SSttaarrtt ooff YYeeaarr
GGrraanntteedd aass
CCoommppeennssaattiioonn
EExxeerrcciisseedd
EExxppiirreedd
&& LLaappsseedd
BBaallaannccee aatt
EEnndd ooff YYeeaarr
VVeesstteedd aanndd
EExxeerrcciissaabbllee
UUnnvveesstteedd
Issued 25/11/2010
208,332
Issued 16/09/2011
263,206
Issued 16/11/2011
65,000
Issued 17/03/2015
105,875
-
-
-
-
(208,332)
(135,496)
-
-
-
127,710
-
(40,000)
25,000
(105,875)
-
-
-
-
Issued 05/09/2017
Market
-
-
TToottaall
664422,,441133
--
((444499,,770033))
((4400,,000000))
115522,,771100
-
-
-
-
-
--
-
127,710
25,000
-
-
115522,,771100
Weighted average
exercise price
$Nil
$Nil
$Nil
$Nil
$Nil
$Nil
$Nil
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.
On 26 August 2020 1,513,750 conditional performance rights were issued to the Managing Director, consequent to shareholder approval at the 2019 Annual General
Meeting. These performance rights were priced using Monte Carlo simulation pricing model for those performance rights with market capitalisation hurdles and a
binomial model for those performance rights linked to non-market vesting conditions. The vesting period is up to 4 years from date of shareholder approval.
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.
124
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CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
HHoollddiinnggss ooff AAllll IIssssuueedd CCoonnddiittiioonnaall PPeerrffoorrmmaannccee RRiigghhttss –– 22002211
2244.. CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD PPaarreenntt CCoommppaannyy
IInnffoorrmmaattiioonn
AAsssseettss
Current assets
Non-current assets
TToottaall aasssseettss
LLiiaabbiilliittiieess
Current liabilities
Non-current liabilities
TToottaall lliiaabbiilliittiieess
EEqquuiittyy
Issued equity
Share–based payments reserve
Accumulated losses
TToottaall eeqquuiittyy
FFiinnaanncciiaall ppeerrffoorrmmaannccee
Net profit for the year
TToottaall ccoommpprreehheennssiivvee iinnccoommee
CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD
22002211
$$
22002200 RReessttaatteedd
$$
73,061,479
34,530,668
110077,,559922,,114477
3,284,678
126,355
33,,441111,,003333
58,556,682
20,704,937
7799,,226611,,661199
2,634,369
5,290
22,,663399,,665599
151,849,375
151,849,375
4,343,422
1,751,223
(52,011,683)
110044,,118811,,111144
(76,978,638)
7766,,662211,,996600
23,741,882
2233,,774411,,888822
16,596,091
1166,,559966,,009911
PPeerrffoorrmmaannccee
RRiigghhttss SSeerriieess
BBaallaannccee aatt
SSttaarrtt ooff YYeeaarr
GGrraanntteedd aass
CCoommppeennssaattiioonn
EExxeerrcciisseedd
EExxppiirreedd
&& LLaappsseedd
BBaallaannccee aatt
EEnndd ooff YYeeaarr
VVeesstteedd aanndd
EExxeerrcciissaabbllee
UUnnvveesstteedd
2255.. SSuubbsseeqquueenntt EEvveennttss
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 25th August 2021, the Board of Directors declared an unfranked dividend of $0.025 per ordinary share
2266.. AAddddiittiioonnaall CCoommppaannyy IInnffoorrmmaattiioonn
CLINUVEL PHARMACEUTICALS LTD is a listed public company incorporated and operating in Australia.
TThhee RReeggiisstteerreedd ooffffiiccee iiss::
Level 11, 535 Bourke Street
Melbourne VIC 3000
Ph: (03) 9660 4900
125
87
PPeerrffoorrmmaannccee
RRiigghhttss SSeerriieess
Issued
16/09/2011
Issued
16/11/2011
Issued
26/08/2020
Issued
24/12/2020
BBaallaannccee
aatt SSttaarrtt ooff
YYeeaarr
127,710
25,000
-
-
Weighted
average
exercise price
For Performance Rights issued in 2011
GGrraanntteedd aass
CCoommppeennssaattiioonn
EExxeerrcciisseedd
&&
BBaallaannccee aatt EEnndd ooff
YYeeaarr
VVeesstteedd aanndd
EExxeerrcciissaabbllee
UUnnvveesstteedd
EExxppiirreedd
LLaappsseedd
-
-
(14,375)
113,335
25,000
113,335
25,000
1,513,750
-
1,513,750
95,375
1,418,375
132,500
132,500
132,500
-
-
-
-
-
TToottaall
115522,,771100
11,,664466,,225500
--
((1144,,337755))
11,,778844,,558855
9955,,337755
11,,668899,,221100
$Nil
$Nil
$Nil
$Nil
$Nil
$Nil
$Nil
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
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 y ears
from date of grant of rights or 20 November 2023. 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 24 December 2020, an illiquidity discount was applied
to the pricing model.
HHoollddiinnggss ooff AAllll IIssssuueedd CCoonnddiittiioonnaall PPeerrffoorrmmaannccee RRiigghhttss –– 22002200
Issued 25/11/2010
208,332
(208,332)
Issued 16/09/2011
263,206
(135,496)
127,710
Issued 16/11/2011
65,000
(40,000)
25,000
-
-
-
-
-
-
-
-
-
Issued 17/03/2015
105,875
(105,875)
Issued 05/09/2017
Market
-
-
-
-
-
--
TToottaall
664422,,441133
((444499,,770033))
((4400,,000000))
115522,,771100
115522,,771100
Weighted average
exercise price
$Nil
$Nil
$Nil
$Nil
$Nil
$Nil
$Nil
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.
On 26 August 2020 1,513,750 conditional performance rights were issued to the Managing Director, consequent to shareholderapproval at the 2019 Annual General
Meeting. These performance rights were priced using Monte Carlo simulation pricing model for those performance rights with market capitalisation hurdles and a
binomial model for those performance rights linked to non-market vesting conditions. The vesting period is up to 4 years from date of shareholder approval.
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.
127,710
25,000
-
-
-
-
-
--
-
-
-
86
CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
DDiirreeccttoorrss’’ DDeeccllaarraattiioonn
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)
b)
c)
giving a true and fair view of the consolidated entity’s financial position as at 30 June 2021
and of its performance for the year ended on that date; and
complying with Accounting Standards; and
complying with International Financial Reporting Standards as disclosed in Note 1
2.
3.
there are reasonable grounds to believe that the Company will be able to pay its debts as and when they
become due and payable; and
the audited remuneration disclosures set out in pages 28 to 53 of the Directors Report comply with Section
300A of the Corporations Act 2001
42 to 90
This declaration is made in accordance with a resolution of the Board of Directors. The Directors have been given
the declarations by the Chief Executive Officer and Chief Financial Officer required by Section 295A of the
Corporations Act 2001.
Dr. Philippe Wolgen, MBA MD
Director
Dated this 25th day of August, 2021
126
88
CLINUVEL Pharmaceuticals | 2021 Annual Report CCLLIINNUUVVEELL PPHHAARRMMAACCEEUUTTIICCAALLSS LLTTDD – Consolidated Entity - A.B.N. 88 089 644 119
DDiirreeccttoorrss’’ DDeeccllaarraattiioonn
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 2021
and of its performance for the year ended on that date; and
complying with Accounting Standards; and
complying with International Financial Reporting Standards as disclosed in Note 1
there are reasonable grounds to believe that the Company will be able to pay its debts as and when they
b)
c)
2.
3.
become due and payable; and
300A of the Corporations Act 2001
the audited remuneration disclosures set out in pages 28 to 53 of the Directors Report comply with Section
This declaration is made in accordance with a resolution of the Board of Directors. The Directors have been given
the declarations by the Chief Executive Officer and Chief Financial Officer required by Section 295A of the
Corporations Act 2001.
Dr. Philippe Wolgen, MBA MD
Director
Dated this 25th day of August, 2021
Collins Square, Tower 5
727 Collins Street
Melbourne VIC 3008
Correspondence to:
GPO Box 4736
Melbourne VIC 3001
T +61 3 8320 2222
F +61 3 8320 2200
E info.vic@au.gt.com
W www.grantthornton.com.au
Independent Auditor’s Report
To the Members of Clinuvel Pharmaceuticals Limited
Report on the audit of the financial report
Opinion
We have audited the financial report of Clinuvel Pharmaceuticals Limited (the Company) and its subsidiaries (the Group),
which comprises the consolidated statement of financial position as at 30 June 2021, the consolidated statement of profit
or loss and other comprehensive income, consolidated statement of changes in equity and consolidated statement of cash
flows for the year then ended, and notes to the consolidated financial statements, including a summary of significant
accounting policies, and the Directors’ declaration.
In our opinion, the accompanying financial report of the Group is in accordance with the Corporations Act 2001, including:
a giving a true and fair view of the Group’s financial position as at 30 June 2021 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.
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.
Grant Thornton Audit Pty Ltd ACN 130 913 594
a subsidiary or related entity of Grant Thornton Australia Ltd ABN 41 127 556 389
www.grantthornton.com.au
‘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 Ltd 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 and its Australian subsidiaries and related entities. GTIL is not an Australian related entity to
Grant Thornton Australia Limited.
Liability limited by a scheme approved under Professional Standards Legislation.
88
89
127
CLINUVEL Pharmaceuticals | 2021 Annual Report Key audit matter
Deferred tax asset – Note 3
The Group has recognised deferred tax assets of $2.93m
(2020: $3.81m) in accordance with AASB 112 Income Taxes.
These are primarily attributable to historic losses generated by
the income tax consolidated group.
There are also $25.74m (2020: $46.78m) of unused carry-
forward tax losses from its foreign subsidiaries not currently
sitting on the balance sheet.
An assessment is required as to whether sufficient future
taxable profits are likely to be generated to enable the assets
to be realised.
This is a key audit area due to the following:
•
•
•
The degree of judgement required in assessing
management’s estimates of future taxable profits to
enable the asset to be realised;
The Group undertaking transactions in a number of
tax jurisdictions which require the Group to make
significant judgements about the interpretation of tax
legislation and the application of accounting
standard; and
The nature of cross-border tax arrangements and our
need to involve taxation specialists with cross border
transactions experience and expertise in transfer
pricing in key jurisdictions.
How our audit addressed the key audit matter
Our procedures included, amongst others:
•
•
•
•
•
•
•
•
Holding discussions with management to obtain an
understanding of the policy applied for the recognition of
deferred tax and assessment of profitability of the group
in the near future;
Evaluating management’s forecast of future taxable
income by assessing the key underlying assumptions
such as future taxable income against historic
performance and market trends;
Utilising our internal taxation specialists to assess that
carry-forward losses are available for use;
Assessing the competence and objectivity of
managements tax expert used, to assist in the
preparation of the valuation of the deferred tax asset;
Checking the accuracy of input data and evaluating
formulas and assumptions applied in the computation of
the deferred tax asset;
Utilising our transfer pricing specialists to assist in our
assessment of the cross-border transactions made
between Group entities in different tax jurisdictions;
Utilising our internal taxation specialists to assist in the
assessment of the determination of the tax bases; and
Assessing the adequacy of the group’s disclosure in
relation to the carrying value of deferred tax assets.
Share based payments – Note 23
In December 2020, the Group issued 132,500 rights to the
Group’s Director of International Operations. The performance
rights issued were allocated in two tranches:
1. Tranche A is conditional on market capitalisation over a
three-year period from the Grant date.
2. Tranche B is conditional on achieving non-market based
performance conditions over a three year period from the
Grant date.
Performance rights were valued at $1.1m for accounting and
reporting purposes using the Monte Carlo simulation and
Binomial Options Valuation method. The value will be
expensed over the vesting period (up to 3 years).
The share-based payments expense for FY21 is $2.60m
(2020: $1.66m), which is inclusive of the 1,513,750
performance rights issued to the Group’s CEO in December
2019. 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.
Our procedures included, amongst others:
•
Reviewing the relevant agreements to obtain an
understanding of the contractual nature of the share-
based payment arrangements;
• Obtaining management's option valuations and
associated share-based payment support;
•
•
•
•
•
•
Utilising our internal valuation specialist to review the
valuation performed by management’s expert;
Holding discussions with management to understand the
share-based payment arrangements in place and, where
applicable, evaluating management’s assessment of the
likelihood of meeting the performance conditions
attached to the share-based payments;
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;
Assessing the allocation of the share-based payment
expense over the relevant vesting period (assessing
appropriateness of the vesting period);
Evaluating management’s forecasts to validate
consistency of vesting dates for performance
milestones; and
Assessing the adequacy of the disclosures in the
financial report.
90
128
CLINUVEL Pharmaceuticals | 2021 Annual 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 2021, 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.
Responsibilities of the Directors for the financial report
The Directors of the Company are responsible for the preparation of the financial report that gives a true and fair view in
accordance with Australian Accounting Standards and the Corporations Act 2001 and for such internal control as the Directors
determine is necessary to enable the preparation of the financial report that gives a true and fair view and is free from material
misstatement, whether due to fraud or error.
In preparing the financial report, the Directors are responsible for assessing the Group’s ability to continue as a going concern,
disclosing, as applicable, matters related to going concern and using the going concern basis of accounting unless the Directors
either intend to liquidate the Group or to cease operations, or have no realistic alternative but to do so.
Auditor’s responsibilities for the audit of the financial report
Our objectives are to obtain reasonable assurance about whether the financial report as a whole is free from material
misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our opinion. Reasonable assurance is
a high level of assurance, but is not a guarantee that an audit conducted in accordance with the Australian Auditing Standards
will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered
material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken
on the basis of this financial report.
A further description of our responsibilities for the audit of the financial report is located at the Auditing and Assurance Standards
Board website at: https://www.auasb.gov.au/auditors_responsibilites/ar1_2020.pdf. This description forms part of our auditor’s
report.
Report on the remuneration report
Opinion on the remuneration report
We have audited the Remuneration Report included in pages 28 to 53 of the Directors’ report for the year ended
30 June 2021.
In our opinion, the Remuneration Report of Clinuvel Pharmaceuticals Limited, for the year ended 30 June 2021 complies
with section 300A of the Corporations Act 2001.
Responsibilities
The Directors of the Company are responsible for the preparation and presentation of the Remuneration Report in accordance
with section 300A of the Corporations Act 2001. Our responsibility is to express an opinion on the Remuneration Report, based
on our audit conducted in accordance with Australian Auditing Standards.
Grant Thornton Audit Pty Ltd
Chartered Accountants
M A Cunningham
Partner – Audit & Assurance
Melbourne, 25 August 2021
91
129
CLINUVEL Pharmaceuticals | 2021 Annual Report Collins Square, Tower 5
727 Collins Street
Melbourne VIC 3008
Correspondence to:
GPO Box 4736
Melbourne VIC 3001
T +61 3 8320 2222
F +61 3 8320 2200
E info.vic@au.gt.com
W www.grantthornton.com.au
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 2021, I declare that, to the best of my knowledge and belief,
there have been:
a
b
no contraventions of the auditor independence requirements of the Corporations Act 2001 in relation to the audit; and
no contraventions of any applicable code of professional conduct in relation to the audit.
Grant Thornton Audit Pty Ltd
Chartered Accountants
M A Cunningham
Partner – Audit & Assurance
Melbourne, 25 August 2021
Grant Thornton Audit Pty Ltd ACN 130 913 594
a subsidiary or related entity of Grant Thornton Australia Ltd ABN 41 127 556 389
www.grantthornton.com.au
‘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 Ltd 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 and its Australian subsidiaries and related entities. GTIL is not an Australian related entity to
Grant Thornton Australia Limited.
Liability limited by a scheme approved under Professional Standards Legislation.
92
130
CLINUVEL Pharmaceuticals | 2021 Annual Report Shareholder
Information
Additional information as at 17 September 2021 required by
the ASX and not shown elsewhere in this report is as follows:
1. Shareholding
a. Distribution Of Shareholder Numbers
Ordinary Fully Paid Shares
Category (Size Of Holding)
Total Holders
Units
% Of Issued Capital
1–1,000
1,001–5,000
5,001–10,000
10,001–100,000
100,001 & Over
TOTAL
3,715
836
135
176
27
4,889
1,110,040
1,901,207
985,723
4,776,758
40,636,610
49,410,338
b. Shareholdings Held In Less Than Marketable Parcels
Total
Minimum Parcel Size
Holders
Minimum $500.00 parcel at $41.71 per unit
3,715
231
2.25
3.85
1.99
9.67
82.24
100.00
Units
451
c. Substantial Shareholdings
Name
No. Ordinary Shares & American Depository Receipts
The Bank of New York Mellon Corporation1
A.C.N. 108 768 896 Pty Ltd2
Ender 1 LLC3
1. As disclosed in substantial holder notice dated 6 December 2019.
4,807,380
2,927,928
2,340,824
2. As disclosed in substantial holder notice dated 22 December 2020. This is inclusive of the relevant interest of shareholder Dr Philippe Jacques Wolgen,
for 2,199,810 quoted ordinary shares, as disclosed in substantial holder notice dated 05 July 2021. Actual registered shareholding as at 17 September
2021 is 2,780,040.
3. As disclosed in substantial holder notice dated 16 September 2013. Actual registered shvareholding as at 17 September 2021 is 2,590,824.
131
CLINUVEL Pharmaceuticals | 2021 Annual Report d. Voting Rights
The voting rights attaching to each class of equity securities are set out below:
(i) ORDINARY SHARES
Ordinary shares entitle their holder to one vote, either in person or by proxy, at a meeting of the Company
(ii) 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
HSBC CUSTODY NOMINEES (AUSTRALIA) LIMITED
11,368,759
5,942,326
5,130,894
3,819,117
2,780,040
2,590,824
2,385,285
975,511
856,796
632,947
603,990
547,563
452,391
271,419
241,539
238,237
222,222
200,000
192,758
187,000
39,639,618
9,770,720
23.01
12.03
10.38
7.73
5.63
5.24
4.83
1.97
1.73
1.28
1.22
1.11
0.92
0.55
0.49
0.48
0.45
0.40
0.39
0.38
80.23
19.77
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
BNP PARIBAS NOMINEES PTY LTD ACF CLEARSTREAM
BNP PARIBAS NOMINEES PTY LTD SIX SIS LTD
J P MORGAN NOMINEES AUSTRALIA PTY LIMITED
ACN 108 768 896 PTY LTD
ENDER 1 LLC
CITICORP NOMINEES PTY LIMITED
DR PHILIPPE JACQUES WOLGEN
BNP PARIBAS NOMINEES PTY LTD
M BADCOCK AND P CHU SUPERANNUATION FUND PTY LTD
NATIONAL NOMINEES LIMITED
DR MARK EDWIN BADCOCK
BNP PARIBAS NOMS PTY LTD
BNP PARIBAS NOMINEES PTY LTD
BNP PARIBAS NOMS (NZ) LTD
MERRILL LYNCH (AUSTRALIA) NOMINEES PTY LIMITED
MR DAVID WILLIAM TREVORROW
TRUEBELL CAPITAL PTY LTD
HSBC CUSTODY NOMINEES (AUSTRALIA) LIMITED - A/C 2
MR DAVID JOHN LEWIS
Totals: Top 20 Holders Of Ordinary Fully Paid Shares (Total)
Total Remaining Holders Balance
132
CLINUVEL Pharmaceuticals | 2021 Annual Report 2. Company Secretary
6. Restricted Securities
The name of the Company Secretary is:
Darren Keamy
Restricted securities on issue at June 30, 2021:
Nil.
3. Registered Office
The principle registered office in Australia is:
7. Directory
NON‑EXECUTIVE CHAIR
Willem Blijdorp
Level 11, 535 Bourke Street
Melbourne, VIC 3000, Australia
Telephone: +61 3 9660 4900
Fax: +61 3 9660 4999
Email: mail@clinuvel.com
Website: http://www.clinuvel.com
4. Register Of Securities
Computershare Investor Services Pty Ltd
Yarra Falls, 453 Johnston St, Abbotsford,
VIC 3067, Australia
Telephone: +61 3 9415 4000
5. Australian Securities Exchange
Limited
Quotation has been granted for all the ordinary
shares on all Member Exchanges of the
Australian Securities Exchange Limited (ASX):
(ASX: CUV).
The Company’s shares are also traded on XETRA,
an electronic trading system, based in Frankfurt,
Germany, under the code UR9.
In the USA, the Company’s Level 1, American
Depositary Receipts (ADRs), trade 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.
NON‑EXECUTIVE DIRECTORS
Brenda Shanahan, Dr Karen Agersborg, Susan
Smith, Prof Jeffrey Rosenfeld
MANAGING DIRECTOR AND
CHIEF EXECUTIVE OFFICER
Dr Philippe Wolgen
ACTING CHIEF SCIENTIFIC OFFICER
Dr Dennis Wright
CHIEF FINANCIAL OFFICER AND
COMPANY SECRETARY
Darren Keamy
AUDITOR
Grant Thornton Australia Limited
Collins Square, Tower 5, Level 22, 727 Collins
Street, Melbourne,
VIC 3008, Australia
BANKER
National Australia Bank (NAB)
Western Branch, 460 Collins St, Melbourne, VIC
3000, Australia
LEGAL COUNSEL
Arnold Bloch Leibler
Level 21, 333 Collins St, Melbourne, VIC 3000,
Australia
Sidley Austin LLP
Woolgate Exchange, 25 Basinghall Street, London,
EC2V 5HA, United Kingdom
IP LAWYER
Dipl.-Ing Peter Farago
Baadestr 3, Munich 80, Germany
133
CLINUVEL Pharmaceuticals | 2021 Annual Report Market
Performance
ASX:CUV – Share Price (A$)
30
25
20
15
134
Jul 20
Aug 20
Sep 20
Oct 20
Nov 20
Dec 20
Jan 21
Feb 21 Mar 21
Apr 21 May 21
Jun 21
CLINUVEL Pharmaceuticals | 2021 Annual Report ASX:CUV Daily Trading Volume (No)
450,000
400,000
350,000
300,000
250,000
200,000
150,000
100,000
50,000
Jul 20
Aug 20
Sep 20
Oct 20
Nov 20
Dec 20
Jan 21
Feb 21 Mar 21
Apr 21 May 21
Jun 21
135
CLINUVEL Pharmaceuticals | 2021 Annual Report 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
Dermatocosmetics are specially formulated products designed to assist skin health with a focus on anti-aging,
and repair and regeneration of the skin. Dermatocosmetics combine a dermatological action to treat the skin
and a cosmetic action to cleanse, moisturise, and alter the appearance of an individual’s skin.
EUROPEAN MEDICINES AGENCY (EMA)
The decentralised body of the European Union regulating 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 devices.
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) and 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.
136
CLINUVEL Pharmaceuticals | 2021 Annual Report CLINUVEL Pharmaceuticals | 2021 Annual Report
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.
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.
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.
An extensive glossary of terms relevant to CLINUVEL’s work can be found at:
https://www.clinuvel.com/glossary
www.clinuvel.com
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Pharmaceuticals Ltd 2021