Annual Report

GROWTH AND EXPANSION

CLINUVEL is well positioned to build on its established commercial and research and development operations. The Company is expanding access to its drug SCENESSE® (afamelanotide 16mg) for patients with erythropoietic protoporphyria in Europe and the USA, as well as new jurisdictions, subject to regulatory approval and agreement on reimbursement. Drawing on expertise developed in the role of melanocortin drugs – including afamelanotide – in the body, CLINUVEL has expanded its research and development program focussed on SCENESSE® and new molecules to treat multiple patient groups with severe genetic, skin, and systemic disorders. CLINUVEL is on a growth and expansion path to build a diversified and integrated biopharmaceutical business.

FIFTEEN YEAR PERFORMANCE OVERVIEW

CLINUVEL completed its fourth full year of commercial operations in the financial year ending 30 June 2020, recording a fourth consecutive annual profit and declaring a third consecutive annual dividend.

A STORY OF STRATEGIC FOCUS

Over the last fifteen years, CLINUVEL has implemented a deliberate and focussed strategy to develop and commercialise one lead drug embodying a novel technology, for an unmet need. CLINUVEL has delivered on the strategic objective set in 2005 to develop and commercialise SCENESSE® (afamelanotide 16mg) which has been approved and launched for adult patients with erythropoietic protoporphyria (EPP) in Europe and the USA. Over the financial years 2005 to 2016, CLINUVEL’s operations were research and development (R&D) focussed. During this R&D phase, expenses exceeded revenues as SCENESSE® was developed; clinical studies undertaken and completed; and regulatory approvals, sought and obtained. To finance the business during this time, over A$94m was raised from capital markets in several installments. CLINUVEL’s last capital raising was in March 2016.

COMMERCIALISATION HAS DRIVEN REVENUES,
PROFITS AND CASH RESERVES

Commercial operations commenced in Europe in June 2016 following the granting of marketing authorisation by the European Commission in 2014. In the first full year of commercial operations, FY2017, the Company’s first net profit after tax of A$7.1 million was recorded. This outcome was achieved at a higher level in FY2018 (A$13.2 million) and in FY2019 (A$18.1 million) which was a record annual profit. Revenues from operations rose by 5% in FY2020 and there was a deliberate and controlled rise of 44% in expenditure
to support the expansion of the Group’s activities, including establishing commercial infrastructure in the USA following the approval of SCENESSE® by the US Food and Drug Administration (FDA). The Group delivered its fourth consecutive annual profit in FY2020, A$16.6 million. This is a positive outcome, achieved as the world has been adversely impacted by the coronavirus pandemic and resulting significant economic contraction in the second half of the year.

The Company has maintained a disciplined and conservative approach to resource management throughout its development cycle and over the last four years of commercial operations, ensuring that it is capable of withstanding global downturns, removing the need to raise capital in adverse markets and allowing the Group to self-finance its planned expansion and growth. The rise in cash reserves to A$66.7 million as of 30 June 2020 represents a 44% annual compound growth rate since the last capital raising in March 2016. This level of cash reserves covers more than three years of the Group’s FY2020 expenses.

RETURNS TO SHAREHOLDERS

Given the level of cash reserves accumulated, the Board has been able to show its appreciation of the support of shareholders over the R&D phase of operations and into the commercial phase by declaring an unfranked dividend in each of the last three financial years – A$0.02 following FY2018 and A$0.025 after each of FY2019 and FY2020. As a company with positive annual net cash flow and profitability, CLINUVEL has provided shareholders with a positive return on equity and earnings per share over the last four years – 23% and 33.8 Australian cents, respectively in FY2020.

MILESTONE FDA DECISION

FY2020 is notable for the October 2019 milestone decision of the US FDA to approve SCENESSE® for the increase of ‘pain-free’ light exposure in adult EPP patients with a history of phototoxicity. Within six months of this approval, CLINUVEL commenced first treatment of US patients in April 2020 enabling first US revenues in FY2020. CLINUVEL is committed to providing EPP patients worldwide with access to treatment and is actively pursuing regulatory approvals in other jurisdictions.

Approvals from the world’s leading regulatory bodies in the USA and Europe – validating the positive safety profile of SCENESSE® – enable the expansion and increase in pace of the Group’s product development pipeline. CLINUVEL has identified other indications where afamelanotide may provide clinical benefit to patients. This is central to the evolution of the Group’s strategy to become a diversified biopharmaceutical providing treatments to multiple patient groups. The feature in this report on the Expansion of Technology explains CLINUVEL’s path to this objective

SUMMARY

CLINUVEL is a dynamic biopharmaceutical group of companies that has developed and commercialised a novel treatment from laboratory bench to patient treatment, with a track record of positive cash flow and profit since the commencement of commercial operations. This is an achievement of which stakeholders can be proud. This Annual Report provides more detail on the result for FY2020, how it was achieved and the strategies of the Group to grow and expand its activities.

CLINUVEL’S MISSION

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 all of the Group’s working practise. CLINUVEL Group focuses its research and development on genetic metabolic and diseases not yet addressed, aiming to deliver innovative medical solutions for complex problems.

CLINUVEL’S VISION

Innovating novel solutions for unmet patient and healthcare needs.

CLINUVEL’S VALUES

PEOPLE & ENVIRONMENT

We work for physicians, consumers 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 equality. We wish to set an example of excellence in our industry.

TECHNOLOGY

We create, develop, and advance products which are driven by medical need, consumer demand or lack of available solutions. Our technologies aim to add value beyond existing offerings. We acknowledge that new technologies require regulatory environments to be primed and markets to be prepared for achieving widespread acceptance and adoption.

APPROACH

We aim to be innovative in our approach and find solutions for unique, complex and previously neglected healthcare problems. We are determined to remain leaders in our field of expertise, and be creative and diligent in all our endeavours. We admit errors, recognise our shortfalls, evaluate, analyse and learn to implement new findings. In improving ourselves we strive to enhance the lives and quality of life of those we serve. We 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.

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.

KNOWLEDGE BUILDING & SHARING

We are experts in optical physics, the interaction of light and human biology, and 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 knowhow continuously and establish a learned community. Collaboratively we seek to excel in a multifaceted field to arrive at scientific breakthroughs.

CHAIR’S LETTER

Dear Shareholders,

Which expert in business could have predicted the year 2020? The question is, were we caught by surprise and could we have managed ourselves better? The year 2020, my first complete year as Chairman of CLINUVEL, has been overshadowed by the impact of COVID-19, and has therefore seen my main tasks change, helping navigate CLINUVEL during these uncertain times.
The financial year was one of two halves. In the first half, CLINUVEL’s goal was to provide continued growth in Europe and to progress our product development pipeline. We concluded the year on a high, with a unique milestone on 8 October 2019, which was the approval by the US Food and Drug Administration (FDA) to make SCENESSE® (afamelanotide 16mg) available in the USA to adult EPP patients. We shared our celebration at the 2019 Annual General Meeting (AGM).

With much optimism, we looked forward to expanding the business into the USA, progressing our product development pipeline as we started the second half of the 2020 financial year. In January 2020, our IR Manager, Malcolm Bull, came back with considerable optimism from the JP Morgan Global Healthcare Conference in San Francisco. With much optimism, we looked forward to expanding the business into the USA, progressing our product development pipeline as we started the second half of the 2020 financial year. In January 2020, our IR Manager, Malcolm Bull, came back with considerable optimism from the JP Morgan Global Healthcare Conference in San Francisco. 

 

Governance and Leadership

I was asked how I identify executive managers to run my portfolio of companies. In my own publicly listed company BSGR, I have recently appointed a new CEO who is stress-resistant and fully understands the art of managing people to maximise their skillsets. Captains of industries are truly identified when they face changing environments and are forced to act. Therefore, this past year was particularly important to closely watch how CLINUVEL’s senior managers would handle the crises and take the most suitable measures. Entrepreneurship is much more than running successful companies when all things are going well. I expect senior management to find creative solutions, come up with ideas on how to progress a company and, above all, dare to take unpopular measures to retain value. In the past year I have again seen proof of CLINUVEL’s leadership, who managed the complex world of pharmaceuticals when maneuvering was really needed. At a time when the world went in lockdown and hospitals decided to put COVID first and other healthcare services second, our team managed to maintain supply and maintain SCENESSE® treatment.

In CLINUVEL, we have passed more than a decade of independent audits without remarkable findings.

With respect to governance, the Board sets clear goals. We have split the role of the CEO and Chairman. We did not just delegate all the responsibilities to one person, helping the Managing Director get on with his daily job of running the Company and leave the supervisory matters to myself, as well as the coordination of Board matters. In many listed companies the roles are still combined, but I think it is not a wise way of running companies.

I see success in business as a simple formula which has always worked for my companies and most successful colleagues. First, always make sure you spend less than you receive. Second, formulate a clear vision and work consistently towards this goal. Third, treat the people working around you with respect and they will do the same through putting in maximum effort. With our current CEO, we see all three.

Effective leadership is not just one person, but it is a culture created where collaboration takes place across all managers on the floor and business partners without issues or friction. In this interplay, the CEO then needs to integrate a mix of long term and new employees, guarantee diversity, possess a depth of skills and experience and report progress to go through all bottlenecks. In the last 12 months, we have expanded our workforce considerably and are all working to achieve a list of our key objectives.

Financial Leadership

What is financial leadership and why does it matter? The worst business one can arrive in is a business where processes are lacking, expenditures are varying, and little financial control exists due to high commitments of forced spending. The financial books of a company are the reflection of managers’ ability to make daily decisions. CLINUVEL’s books are not coincidental, they follow our managers’ vision.

It is clear CLINUVEL’s financial management has been very successful, both our CFO and CEO protect our financial position to a maximum.

I always wish to see clean financial processes in the companies in which I am involved. In CLINUVEL, we have passed more than a decade of independent audits without remarkable findings. This helps us concentrate on our operations. The CFO Darren Keamy has built a strong team over the years and oversees the finances of all the activities in the subsidiaries and tax. His team is managing the expansion of VALLAURIX in Singapore, and the currencies across the Company. As part of the team’s task this year, there was a need to avoid negative interest rates on the Euro and secure our working capital.

It is clear CLINUVEL’s financial management has been very successful, both our CFO and CEO protect our financial position to a maximum. We need lean companies in this industry, and the way our management is managing this globally is the modern way to do it. We shareholders benefit long-term, since no money is leaking, and no new capital needs to be raised from the markets. I have seen many investment banks offering to raise money for CLINUVEL at high discount percentages and praise ourselves that we do not need to do it. 

Cash is always king in crises and this year I have seen established companies going out of business. Many tragedies are affecting breadwinners and families. With CLINUVEL, we expand and provide people strong job security, helping our employees feel safe and motivated. The way our financial team is going about the business is the right one and as a major shareholder in the Company, I am grateful that we are rock-steady in management without unexpected or dramatic events.

For the six months to December 31 we recorded a good profit. At the end of our audited financial year, we posted a A$16.6 million profit, whereby our cash reserves have substantially grown. As a Chairman, I cannot ask more from a team during such a global financial crisis and am very happy to be involved in such a Company.

In our senior management team, we have 57% women and 43% men, a great balance based on our CEO’s aim to lead in this field.

CONTINUATION OF SPECIAL KNOWLEDGE

CLINUVEL stands out with a special team of Directors, each of whom brings special expertise, and an exact gender balance. CLINUVEL leads many other companies in this balance, showing our different approach to business. In our senior management team, we have 57% women and 43% men, a great balance based on our CEO’s aim to lead in this field.

I am a general entrepreneur without special knowledge about pharmaceutical development, but the same business principles apply to every one of my ventures. I want to see CLINUVEL keep its key people and educate new talent for the years to come. In CLINUVEL, we have become an institution whereby new graduates have started to apply for jobs since the universities have taken the CLINUVEL example of running a company in their business cases. I want to see long-term continuation in an environment where competitors are trying to emulate our approach. A strong top and talented below within our levels of hierarchy is the only way to build a company for generations to come. Looking back at the progress this year, we are well on course.

In CLINUVEL, we need special knowledge to grow, and in Singapore we are increasing our investments each year. This year we built modern facilities which are featured in subsequent pages of this report. The Singapore government started to recognise our investments in the country and our hiring of people to lead the research of new products.

In March, I shared my vision of the Company’s strategy and in October our CEO gave a detailed breakdown of how CLINUVEL will be growing. Philippe has made it clear that he has very little time to waste to perform with his team, since he wants all objectives of the Group to be met before he retires from this role. I understand his ambition is to see the name CLINUVEL strive during his time with the Company, which translates well for us shareholders. I share his frustration in a COVID-19 world, but I have confidence in him and the management team to keep surprising and impressing us, with their dedication to the Company.

I want to thank the CLINUVEL Board for the great support and guidance this year, especially during such a peculiar year, but nonetheless with great highlights.

During these difficult and uncertain times, we sympathise with all those affected by COVID-19 and hope all our stakeholders remain safe and well.

IN CONCLUSION

During these difficult and uncertain times, we sympathise with all those affected by COVID-19 and hope all our stakeholders remain safe and well. We appreciate the loyalty of our long-term shareholders and the new shareholders who have joined CUV during the past year for the ongoing journey. Despite the current adversity, CLINUVEL’s future is full of optimism and we will continue to focus without relaxing on the strategic path we have laid out. This path will lead us to adding value, pride, and satisfaction to all our stakeholders.

Willem Blijdorp
Chairman

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 2020, based on the Australian Securities Exchange Corporate Governance Council’s (ASXCGC) Corporate Governance Principles and Recommendations, 3rd Edition, can be found on our website at https://www.clinuvel.com/clinuvel/company-overview/corporate-governance.

CLINUVEL IN THE MEDIA

MANAGING DIRECTOR’S LETTER

Dear Shareholders,

INTRODUCTION

I contemplate CLINUVEL’s successful progress and financial results in 2020 in contrast with the unforeseen pandemic and various containment measures unfolding around the world. It has been a surrealistic series of events in the past year, the emergence of a new epoch and existence for all of us. In the vortex of a virus working its way methodically across all borders and has already stolen 1,000,000 lives around the world, global commerce has slowed down at a rate far beyond that seen during the Great Recession and has caused millions of workers to be laid off. 

Like most businesses, CLINUVEL was forced to adapt quickly and plan its operations in a materially different way. First, Brexit caused us to relocate some of our operations to the European Economic Area while keeping other services in the UK. We made this transition successfully and kept adding new services and structures to EU distribution.

…we were proud to learn in February that CUV’s Board was one of only 11 on the S&P/ASX-200 where at least half of the directors were female, reflecting the progressive and intentional approach to gender and cultural spread within the Company.

The past year taught us that limited travel required an indirect approach to CLINUVEL’s operations, and the curfew and inhibited ability to enter offices forced the Board and management to rethink strategy and the future of the Company. Senior management found itself defending the healthcare needs of the targeted porphyria patients both in Europe and the US. While some erythropoietic protoporphyria (EPP) patients could not gain access to treatment due to closure of specialist hospitals, other centres needed to be immediately activated to prescribe SCENESSE®. Under extraordinary circumstances, special permissions were requested from, and granted by, national competent authorities in the European Union and the US. 

Following the FDA’s approval in October 2019, there has not been a second to reflect upon – let alone celebrate – the momentous occasion. Rather, it has been an accelerated path to formulate the second product PRÉNUMBRA®, contest Ethics Committees and regulatory authorities, and introduce SCENESSE® to US insurers, all while expanding the Company on all other fronts. We invested in new facilities in Singapore, and despite a delay of several months, were able to open our laboratories on 31 August. With newly elected Chairman, Mr Willem Blijdorp and the addition of Mrs Sue Smith and Professor Jeffrey Rosenfeld as Non-Executive Directors to the Board, new insights, new strategic discussions, and different practices were introduced. The current Board with Mrs Brenda Shanahan and Dr Karen Agersborg is well diversified in skills, and we were proud to learn in February that CUV’s Board was one of only 11 on the S&P/ASX-200 where at least half of the directors were female, reflecting the progressive and intentional approach to gender and cultural spread within the Company.

In terms of cost-efficiency, we have continued to improve with operating expenditure as a percentage of total revenues reaching 26.9%. We also saw an improvement in our overall return on invested capital to 14.2% this year (up from 13.7% in 2019). This performance demonstrates considerable momentum as we enter 2021. We built and kept our balance sheet clean to create options for the ensuing years, increased our cash reserves by 23% and expanded the Group with an eye to overall sustainability. Along a chartered course, our R&D activities gathered momentum to provide for the next generation of products. I see CLINUVEL’s output the past year as one of the most memorable achievements by our dedicated team in the midst of the most severe economic recession in recent history.

As much as we could, we changed our pharmaceutical product supply and worked for weeks 24/7 to secure continued distribution. We witnessed how authorities, distribution centres and customs at various borders were tapering or shuttering operations all together. As supply chains slowed down, we were asked to find most original ways to distribute SCENESSE® under specialised transport, against the time ticking to get the hormonal therapy to hospitals on the hour. In March, northern Italy was under siege from COVID, and many porphyria patients became understandably too anxious to travel or seek treatment in designated hospitals. 

It is an understatement to say 2020 has been quite a test, but not at any time have I detected a sense of panic or loss of control across our group of companies. Rather, a silent confidence underpinned our staff that they would collectively manage the uncertainty even if it meant accepting some delays. Surprisingly, during the global lockdown there was a high percentage of requests from known EPP patients for continued SCENESSE® treatment at the peak of the daily COVID hazards. As seen from our operational results, we have steadily grown the Company, despite the spread of the pandemic. In analysing the rate of continuation of SCENESSE® treatment on 30 June, we found 96.6% of patients who had started treatment in 2016 were still requesting and receiving the drug. Overall, through qualitative surveys patients have reported a positive change and or improvement in their behaviours and activities undertaken, as recorded by an inventory of daily activities. Even in 2020, the number of treatments increased year on year as well as the number of new patients.

We built and kept our balance sheet clean to create options for the ensuing years, increased our cash reserves by 23% and expanded the Group with an eye to overall sustainability.

GOVERNMENTS’ ROLE

In the wake of the global pandemic we have witnessed the rise of the state’s role in choosing which workers to defend, which companies to assist and where to allocate resources among the general population. Households in G8 countries were handed free money, while relief was given to businesses for rents and additional incentives to retain workers. In a Keynesian doctrine where the state plays a central role, central banks have kept interest rates low while state debt is now predicted to rise to 15-17% of GDP as borrowed funds among western countries. The stimulus seen in Europe, the USA and Australia seems to have no boundaries with an aim to keep economies fluid.

There are many ifs and nobody, including our central banks, really knows how to forecast our economies for the next 12 months. We are in unchartered territory.

However, I continue to believe that a deflationary environment cannot be maintained, nor can prices be kept low long-term, and when inflation eventually creeps in, the concern will be how this will affect businesses and specific sectors. Without having foresight, I see it as management’s task to read the markets as well as we possibly can and conceptualise how to protect the group of companies against these macro-economic waves.

Central banks are now openly intervening in public markets. In parallel, the state’s financial regulators find themselves overburdened in combatting distortion of equity markets where algorithms and short selling dominate daily trades. At CLINUVEL, we have had our fair share of these practices as witnessed since April 2019. Having gone through these episodes in the past (most conspicuously in 2007), I know from experience that continued corporate performance, generating further intrinsic value will eventually wash out these short sellers. In the meantime, the pain is borne by all shareholders, including CLINUVEL’s staff, ergo holding steady is the mandatory approach.

Economies are seeing the delayed effects of the pandemic, whereby the surplus nations such as Germany, Japan and China have seen a sharp decline in exports, while overall consumption has been reduced to the necessary goods and services. While the International Monetary Fund and US Federal Reserve have revised their forecast to a fall of GDP in 2021 to under 5%, the European Central Bank has been more moderate and predicts negative growth of 3% for 2021. As a footnote, the further global recovery is contingent on the fiscal and economic stimulus by the richer nations slowly waning off, central policies to remain effective, foreign demand to pick up and societal uncertainty to ebb away. There are many ifs and nobody, including our central banks, really knows how to forecast our economies for the next 12 months. We are in unchartered territory.

Reviewing 2020, chaos ruled in China first, followed by confusion on the European continent and eventually, lockdowns in the US and Australia and periods of circuit-breakers in Singapore and South-East Asia. Just when the world prepared to resume to normality in May, the second wave of the pandemic struck Europe, Australia, and parts of Asia, whereby the US had remained throughout the year in a state of nationwide restriction. At the time of going to print, there seems to be a renewed emergence of the viral spread, with an R-factor of 1.6 in the European Economic Zone and steady spread in the US. Thus, prolongation of restrictive measures seems unavoidable.

ADAPTIVE MINDSET REQUIRED

Adaptation – as in rapidly accepting a changing environment – comes to mind as the main hymn when reflecting on 2020. I have been most impressed by our teams and their interconnectedness. New professionals joining the Group were without warning asked to work from home, some of them not properly set up to work remotely and unfamiliar with the processes of the new company they had joined. Communication has become the key attribute to cross functional flow, operating procedures, and advancement of R&D, while financial discipline is maintained. Thus far, CLINUVEL’s staff have stood up to the task and the same talented pool of people will continue to rise to the challenges as the economies and markets continue to oscillate.

At the peak of the first wave of COVID, we introduced an individual monitoring system for tracking communications. The weekly reports provide us insight into the Group’s activities hour by hour, since we needed a baseline number of outward and inbound emails, video conferences and connectivity between our global teams.

With a mindset to globalisation, we concluded paradoxically that crisis management needed to take place locally. While Brexit had been postponed twice and the definitive transition period is set to end on 31 December 2020, we were forced to consolidate our UK operations while establishing two new hubs within the European Economic Area. Integration of the Group is key to continued success, meaning that the same procedures, rules, and financial rigour needs to be adopted by all subsidiaries.

Talent joined the Company, and in a remote world very little time is available to young professionals to immerse themselves in our work that is heavily dictated by deadlines and due dates. I am of the belief that young people need to be endowed with responsibilities early on and I repeat this phrase in many interviews with candidates. At CLINUVEL we have laid a basis whereby staff are accountable early on in their career, errors are accepted but a thorough evaluation and avoidance of repeat is required. In these unexpected times and economic reversal of fortunes, individual responsibility is more important than ever. I have seen rays of light and real prodigies shining through our R&D, clinical, commercial, and financial management. 

The new Chairman introduced advanced measures to align all staff with the corporate’s objectives, while the Risk Charter and governance were reviewed in depth. The financial management of the Group remains one of our core strengths, the IR and PR efforts of our team reaped benefits and the media and communications team increased its activities by putting out more published news than previously through various social media channels, ASX announcements and translating technical news for broader audiences.

In the new economic era, I view radical changes to CLINUVEL’s business plan as imperative. Less will be more: less face to face interactions, fewer meetings, and faster and more effective decisions to be taken. A relaxation of risk management implies that more errors can creep in, therefore increased controls and contingency plans are needed as part of processes. For instance, in R&D one would expect less time to repeat and reproduce experiments but more time to validate methods, a greater number of formulations, more analytics run simultaneously and increased number of planning to increase the generation of replicable data. In terms of clinical trials, it will translate to more trials sponsored by CLINUVEL, more proofs of concept studies in less centres.

For the third year in a row we have issued a dividend. With the year dominated by global turmoil we wanted to demonstrate our gratitude to the long-term shareholders staying with the CLINUVEL story.

In reviewing each single crisis I have endured with our senior staff the past decades, I can confidently say that specific to CLINUVEL at each of the troubling times, new gains were found when we put our minds to original solutions. This attitude is a repetitive trait by our people, perhaps it has even become an asset of the Company, attracting to CLINUVEL new talented professionals with the same attitude. The reality of the viral threat puts the CLINUVEL team to the test – our output, financial results and handling of suppliers and hospitals during these sensitive times speaks volumes and I am proud of our staff’s resolve and perseverance exhibited during these challenging times . 

I assign the current success to the discipline bonding the Company across staff and Board. Many of the features of our team over the past months have reminded me how our key managers handled the 2007-2009 crisis. It certainly gives me courage that this assembly of professionals will be able to weather unexpected events in the future. While in 2007, the loss of CUV value was due to the managers of a hedge fund dumping their portfolio of illiquid stocks on the open market, causing a steep decline in share price, the current crisis has been triggered by global events causing externalities. The management of these seismic events is not new to our team. In effect, crisis management is part of our fire-drills across many disciplines of the Group, such as in pharmacovigilance and quality control, acted out as simulation exercises. 

As Managing Director, I see it as my principal task to enable staff to excel in their performance by creating and maintaining a positive and conducive professional environment.

CLINUVEL’S EXPANSION

In a discussion first initiated by analyst Sarah Mann (of Moelis Australia Securities), other colleagues had debated the value of diversification versus focus, whereby CLINUVEL has been taken as an example with a long-term business focus. I have written about this in various News Communiqués in past years. There is no absolute answer whether this is right or wrong or whether one increases inherent business risks by focussing a company on one technology and expanding onwards. Each project, each company needs to be evaluated on its own merits, as a separate business case with specific characteristics which do not lend themselves to equal comparison. However, specialisation originating from dedication and focus often leads to domination in one area of technology, science, and operations. Naturally, success attracts others to the space, and unsurprisingly CLINUVEL will have its competitors in time to come. However, focus is difficult to replicate. Diversified companies will most likely not commit to causes like focussed entities are able to do, and whether this advantage translates to long-term sustainable value will be played out in time. Furthermore, concentration on business segments generally leads to translational use of technology and more opportunities to open-up.

Under this scenario, CLINUVEL scaled up its R&D activities in-house in Singapore (VALLAURIX PTE LTD). The Singaporean government, through the Economic Development Board, recognised our investment and decided in February to contribute up to S$500,000 in funding allocated to equipment and the hiring of local personnel. 

At the time of going to print, the state-of-the-art VALLAURIX Research & Development Centre has been delivered to our Group, albeit still working in shifts under the circuit breakers put in place by Lee Hsien Loong, Singapore’s ‘Chief-in-Command’. The laboratories are being equipped with modern technology, whereby both a biological and analytical laboratory are at the centre of our facilities. With this R&D hub, we have attracted a pool of talented individuals, scientists with a drive to develop Singapore’s first commercial pharmaceutical products to market. As VALLAURIX is expanding, daily coordination between our Singapore and global teams take place by various channels to ensure total integration within the Company. The VALLAURIX Research & Development Centre is part of our aim to vertically integrate all facilities in-house. This will require a further diversification of disciplines across the Group in a controlled manner. I intimated before that expansion too fast carries the risk of loss of focus and eventually failure, too slow a lack of targeted progress. Two more disciplines will be added to CLINUVEL’s armamentarium before the foundations of the house can be considered complete. 

The pipeline of molecules and products coming out of VALLAURIX aims to address various markets ranging from acute diseases to over-the-counter markets complementing our current treatment and providing name recognition among wider consumer communities. The first follow-on product, the liquid formulation of afamelanotide, PRÉNUMBRA® was announced in July 2020. By working on several fronts, I am certain our research teams will continue to surprise us all with further output the next year.

Diversification from within is the mantra, and expansion of pharmaceutical products originating from the knowledge and progressive insights from our professionals is the safest way to bring CLINUVEL forward. Under the authority of Chief Scientific Officer Dr Dennis Wright, VP Scientific Affairs Dr Tim Zhao, and Head of our R&D Centre Dr Uma Rai, we have ample to look forward to. Our teams have chosen the least degree of risk in diversifying yet staying within the field of melanocortins.  

In planning all the Group’s activities, Board and management is cautiously balancing receipts, profits versus investments. The past year we discreetly invested up to 20% of annual turnover in related technology and more in personnel but stayed well within our preferred financial parameters. Here, risk versus rate of progress is reviewed periodically to balance the company between prudent expansion and financial strength.  

When entering a recession, the learnings from past downturns are multi-fold. Firstly, adverse market reactions last longer than most analysts predict, the economic reverberations run deeper. The current European plunge into recession will affect many sectors permanently: hospitality, travel, and catering, but also healthcare. A second take-away is that each company and business unit must keep its output high. Economic output is partially determined by the supply side, and of course the demand originating from the market served. Third, the ability to manage cash receipts obviates the need for capital, an invaluable protection of value. Although much jubilation exists about the records booked on US exchanges and the ASX, we remain cautious as to the possibility of major market corrections and its impact on shareholder sentiment. Our IR manager and finance team have had a plentiful year engaging actively with major institutions, and subsequently we have seen the emergence of two new and large US institutions on CLINUVEL’s register, holding collectively over 6%. As CLINUVEL consolidates its financial position and expands its offerings, it will attract new international investors.

For the third year in a row we have issued a dividend. With the year dominated by global turmoil we wanted to demonstrate our gratitude to the long-term shareholders staying with the CLINUVEL story. The success of this program started with a detailed planned financial strategy and under the auspices of Darren Keamy, it has been well executed. In my last period as Managing Director, I intend to see the financial management continue for the Company to secure its longevity. With that objective, we will exert our maximum effort to diversify and generate profits within the group of companies.

As Managing Director, I see it as my principal task to enable staff to excel in their performance by creating and maintaining a positive and conducive professional environment. Remaining close to my beliefs, we demand much from our staff, but take a constructive and supportive approach when it comes to the time needed to adapt and learn new skills. With that hybrid approach to the business, we pride ourselves to attract unique talent, retain staff for the longer term and thereby increase the knowhow within the Company. In 2020, there has been a balanced mix of new professionals and seasoned managers who had reached their career objectives at CLINUVEL. Some of these managers left CLINUVEL not only as accomplished professionals, but also as shareholders with substantial experience to be used in life sciences elsewhere.

At this point in time, the Company is in the best financial position since its inception.

CONCLUSION

I see it as my duty to direct an orchestra of gifted individuals, reacting and putting measures in place to secure a future for patients, staff members and shareholders in times of desperate economic conditions. The past months, we have effectively secured the supply of product and cashflow to the Company.

At this point in time, the Company is in the best financial position since its inception. The financial strategy has been executed with accuracy and expansion has supported the growth in earnings. 

An increasing percentage of patients is receiving SCENESSE® treatment in more countries, and in April 2020 the distribution of the pharmaceutical product started in the United States. Our teams have been active in Europe, the United States and China, and are awaiting the Australian regulatory outcome. R&D output is forthcoming, while the second product PRÉNUMBRA® was announced in July. While I daily observe sufficient areas for improvement within the Group, we have also arrived at a point where many of us at the start of the journey could not have predicted the current position. Of course, success is a fickle definition and can be measured by various parameters such as stock price, products in pipeline and rate of expansion: higher, bigger, and more. Realistically, the success of CLINUVEL is one to build and reflect on. 

I am more optimistic than ever on the future of the Company and that all our teams are collectively working towards the same objectives, (first published in 2019) outlined below:

RATIONALE OBJECTIVES (See the 2019 Notice of Meeting for further Details
1
To promote growth in value of the Company
Market Cap ranging from A$1.7B to A$7.5B (i.e. a share price +/- A$34 to A$151)
2
To provide financial stability and protection
A$60 million to A$150 million in cash for minimum of two quarters
3
To diversify the Company while maintaining profitability
Successful acquisition, profitable within 3 years
4
To increase the revenue base
US revenues, increasing 10%, >$10 million p/a
5
To build further value from internal product development
OTC product line, topical formulation, paediatric formulation
6
To expand the use of the lead pharmaceutical product, entering new markets
Vitiligo or other indication/molecule progressing to Phase IIb and Phase III, with results published
7
New products, markets, revenue base
New regulatory approvals in EU, US, AU, JP, or CH
8
Unanticipated opportunities, which are value accretive
Extraordinary and unanticipated value accretive achievements
These self-imposed objectives are ambitious for any pharmaceutical company, and certainly for us since we opted to vertically integrate the Group. These objectives will add value to the Group and form the foundation for years of growth. Intellectual property is being secured, knowledge protected, and qualified staff groomed to become senior management. Together with my management team, I look forward to the unfolding of the CLINUVEL story over the next 22 months.
 

To all those who wished us well in the weeks following the announcement of the quarterly and annual financial results, I reciprocate and wish you a healthy and prosperous year ahead in holding CLINUVEL in your portfolio. To the patients and families who have long waited for SCENESSE® in the United States, we express our appreciation for your patience. On behalf of CLINUVEL’s Board of Directors, we express our appreciation for your continued support.  

MANAGING DIRECTOR’S MESSAGE TO GERMAN SPEAKING SHAREHOLDERS

Mein besonderer Dank gilt allen deutschsprachigen Aktionaeren fuer die Unterstuetzung von CLINUVEL. Wir haben von Ihnen ein gutes Feedback zu unseren deutschen Nachrichtenmitteilungen erhalten und werden diese auch weiterhin veroeffentlichen. Der diesjaehrige Geschaeftsbericht befasst sich mit Wachstum und Expansion und spiegelt den Wendepunkt in der Unternehmensgeschichte wider, der durch die Zulassung von SCENESSE® durch die US amerikanische FDA fuer die Behandlung von erwachsenen EPP-Patienten im vergangenen Oktober gekennzeichnet ist. Diese Meilensteinentscheidung ist der Katalysator, der CLINUVEL das Potenzial eroeffnet, SCENESSE® und seine Derivate auf ein breiteres Spektrum von Patientengruppen zu diversifizieren. Als langjaehrige Aktionaere wissen Sie, dass der Weg der Produktentwicklung im Pharmasektor lang sein kann. Wie in meinem Schreiben dargelegt, ist das CLINUVEL-Team entschlossen und fokussiert, diese Behandlungen fuer Patienten mit Prioritaet zum Nutzen aller voranzutreiben. Vielen Dank.

Philippe Wolgen
Managing Director, CLINUVEL Group

CLINUVEL IN THE NEW WORLD ORDER

INTRODUCTION

The coronavirus pandemic has changed the world in which we live and operate. How we engage with one another, manage work and life, produce goods and services, and manage the impact of the increase in public spending incurred to support people and economic activity has changed to varying degrees and will continue to do so. The purpose of this piece is not to analyse the changes in societal norms and structural changes in economies, as this requires more time to interpret emerging trends. Rather it serves to highlight that CLINUVEL is entering a new world order in which the potential implications for people and economies are forever changed by the materialisation of a key risk – global pandemics and the way we will communicate and do business.

There is a multitude of known and unknown risks facing people, governments, businesses, and other operators in the economy. For businesses across the globe, as for other economic entities, the need for prudent risk management has been underscored by the coronavirus pandemic and its direct and indirect impact on their viability and future performance. This timely feature provides an overview of CLINUVEL’s approach to risk management and its commitment to the prudent management of Environmental, Social and Governance (ESG) criteria which are now integrated within risk management and investment decisions, and closely linked to sustainable corporate performance.

CLINUVEL’S PRUDENT APPROACH TO RISK MANAGEMENT

The prudent management of risk is essential to the achievement of CLINUVEL’s strategic initiatives and the progress of the Company towards a diverse and integrated biopharmaceutical aimed at providing treatments to multiple patient groups. CLINUVEL has a conservative risk culture and this is reflected in its thrifty financial management over the years to develop and commercialise SCENESSE® (afamelanotide 16mg) for the treatment of adult patients with erythropoietic protoporphyria (EPP). The Board of Directors has mandated its executive management to execute a conservative strategy while growing the Group of companies. Specifically, the development cost of SCENESSE® has been well below the cost of comparable pharmaceutical company orphan drug development focused on a new molecular entity. In addition, CLINUVEL’s decision to self-distribute SCENESSE® in Europe and the USA has proven cost effective and ensures value for shareholders. With careful cost control and prudent management decisions, CLINUVEL has strengthened its balance sheet after four years of commercial operations, with no debt and a cash position sufficient to finance its immediate future expansion. CLINUVEL is risk adverse and deliberate in its actions, and actively seeks to identify and proactively manage various risks. 

The core of our risk approach is the maintenance of a risk register that details and ranks identified risks and their mitigation. The risk register enables the formal consideration of risk by senior management and the Board, while also highlighting potential opportunities. This in turn helps to ensure that all significant risks are suitably identified, assessed, and managed. A key part of risk management is ensuring we meet societal expectations, regulations and laws on corporate standards and conduct. Thus, since ESG criteria cover essential aspects of our operations and adherence to these serves to minimise risk, these are very much a part of our risk management approach and are included in the risk register. There is a multitude of benefits to maintaining an active risk register, the most obvious being ensuring the Company is well-run and keeping Board and management alert to the risks which need attention.

THE UNITED NATIONS GLOBAL COMPACT AND ESG

The United Nations Global Compact (Global Compact) was established in 2000 by then United Nations (UN) Secretary-General Kofi Annan to implement universal principles in business that advance responsible corporate citizenship, better aligned to the UN’s global development objectives. In January 2004, Annan wrote to 55 of the world’s leading financial institutions to invite them to develop guidelines and recommendations to better integrate ESG criteria in the operation of financial markets. Twenty financial institutions participated and endorsed the resulting report, “Who Cares Wins”, in December 2004. The report was completed under the auspices of the Global Compact and contained a “call to action” to stakeholders in the financial and business world: companies were asked to lead the implementation of ESG principles and policies by providing information and reporting on related performance and to identify and communicate the key challenges and value drivers associated with ESG issues.

Since then, ESG has gained prominence throughout the global investment community, playing a key role in the analytical assessment of companies and investment decisions. (ESG-based investment is often referred to as sustainable investing, responsible investing, impact investing or socially responsible investing.) Large and influential institutional investors have aligned prudent management of ESG criteria with sustainable long-term growth and have integrated ESG criteria into their due diligence of investments. An online search for the term “ESG and company performance” reveals a multitude of studies that support a positive correlation between responsible ESG management and enhanced financial performance, efficiency, and firm value. A review by Friede, Busch and Bassen (2015) of around 2,200 individual studies since the 1970s concluded that roughly 90% of studies found a non-negative correlation between ESG criteria and corporate financial performance, with a stable link evident over time.

The Global Compact is a call to action to companies around the world to align their strategies and operations with five defining characteristics of corporate sustainability and ten universal principles in the areas of human rights, labour, environment, and anti-corruption. The UN vision is that appropriate action in these areas will support their broader sustainable development goals. The Global Compact is the world’s largest global voluntary corporate sustainability initiative with over 8,000 companies and 4,000 non-business participants in over 160 countries. The five defining features of corporate sustainability and ten universal principles promoted by the Global Compact are outlined below:

Five Defining Features of Corporate Sustainability Ten Universal Principles
1. Principled Business

Operating with integrity in alignment with ten principles in the areas of human rights, labour, the environment, and anti-corruption.

Human Rights

1. Businesses should support and respect the protection of internationally proclaimed human rights; and

2. Make sure that they are not complicit in human rights abuses.

2. Strengthening Society

Taking action and collaborating with others to advance global challenges.

Labour

3. Businesses should uphold the freedom of association and the effective recognition of the right to collective bargaining;

4. The elimination of all forms of forced and compulsory labour;

5. The effective abolition of child labour; and

6. The elimination of discrimination in respect of employment and occupation.

3. Leadership Commitment

Effective long-term change begins with a company’s leadership.

4.Reporting Progress

Transparency in business practice is crucial for sustainability.

Environment

7. Businesses should support a precautionary approach to environmental challenges;

8. Undertake initiatives to promote greater environmental responsibility; and

9. Encourage the development and diffusion of environmentally friendly technologies.

5. Local Action

Viewing sustainability through a local lense.

Anti-Corruption

10. Businesses should work against corruption in all its forms, including extortion and bribery.

Source: United Nations Global Compact (2014), Guide to Corporate Sustainability, Shaping A Sustainable Future

CLINUVEL’S ESG FRAMEWORK

The Global Compact and UN tenets on ESG and sustainability inform CLINUVEL’s approach. As a responsible corporate citizen and active manager of risk, CLINUVEL embraces the ESG Framework below, as outlined in the Company’s 2019 Annual Report to Shareholders.

CLINUVEL’S ESG Framework
Environment
Social
Governance
Conscious of our World
Fairness and Equity
Responsibility and Compliance
recognise climate change
human rights
honesty and integrity
energy management
freedom of association
honesty and integrity
supplier standards
equal opportunity
corporate governance
safe and responsible materials handling
value diversity
compliance
no adverse impact on global objectives
work-life balance
ethics
training and education
supplier standards
supplier standards
CLINUVEL Values

CLINUVEL’s values are placed at the base of the framework to reflect their fundamental foundation in governing our behaviours and how we conduct our business. The key tenets of this framework are explained further below.

FOCUS ON THE ENVIRONMENT

We are conscious of the world in which we operate and importantly, have no adverse impact on the achievement of the UN’s global environmental objectives. Our management of environmental risk is appropriate for a relatively small company (with less than 100 employees), striving to minimise energy and water use and exercise prudence in the management of office waste as we work towards a paperless office. SCENESSE® and its key input, afamelanotide, are manufactured by reputable contactors in developed countries under World Health Organization Good Laboratory Practice (GLP) and manufacturing standards. Our new laboratory facility in Singapore is working towards ISO 17025 and GLP certification. CLINUVEL’s product SCENESSE® is administered by subcutaneous injection and dissolves in the human body and has no adverse environmental impact. We also regularly assess the commitment of our suppliers to minimise their use of scarce resources and act in and environmentally responsible manner in accordance with ESG criteria.

SOCIAL RESPONSIBILITY

CLINUVEL is a responsible corporate citizen and reflects international community standards in our policies. The UN tenets on human rights and labour standards embedded in the UN International Covenant on Economic Social and Cultural Rights (1966) and International Covenant on Civil and Political Rights (1966) are reflected in our Employee Handbook. These covenants recognise the right to work, including the opportunity to earn a living by work that is freely chosen and accepted (Article 6); the right to enjoy just and favourable conditions of work, including minimum remuneration, safe and healthy conditions of work, equal opportunities for all, rest, leisure, initiation of working hours and holidays with pay (Article 7); and the freedom of association and collective bargaining and the right to strike (Article 8). Specifically, CLINUVEL is committed:

  • on Human Rights, to
  1. freedom of association; and 
  2. supporting a diverse and inclusive workplace, with equality of opportunity of all employees regardless of race, colour, gender, religion, ethnicity, culture, political opinion, age, and disability.
  • on Labour Standards, to
  1. the right to organise and collective bargaining;
  2. zero tolerance of child labour, forced labour and discrimination, harassment, and abuse of any kind;
  3. providing a decent workplace focused on the health and safety of employees;
  4. supporting the training and education of all employees.

Opportunity is equal to all people in CLINUVEL and procedures are in place to escalate, review and address any human rights and labour standard concerns. The Group’s employees span 16 nationalities and gender representation is balanced, as reflected in the following table on the composition of genders on the Board, in senior management and across all employees.

Gender Representation in CLINUVEL
Category Date Female Male
Board
30 June 2020
50%
50%
30 June 2019
40%
60%
30 June 2018
40%
60%

Top 7 salaried
employees 1

30 June 2020
57%
43%
30 June 2019
57%
43%
30 June 2018
57%
43%

All Employees 2

30 June 2020
60%
40%
30 June 2019
66%
34%
30 June 2018
66%
34%

1 excludes Executive Director.

2 consolidated entity.

Work-life balance is supported by our Employee Handbook and a new Remote Working Policy. Necessitated by the coronavirus pandemic, CLINUVEL initiated the Remote Working Policy to ensure the ongoing health and safety of all CLINUVEL employees and provides guidelines to enable an appropriate work-life balance with overall flexibility in the conduct of employees’ work, during and beyond the coronavirus pandemic. Employment security is conducted in accordance with labour laws and regulations in each of the countries in which we operate. All staff are encouraged to own an active training and development plan to support their professional fulfilment and job satisfaction.

We take a responsible approach to product development and distribution. CLINUVEL has no adverse impact on UN social objectives and makes a positive contribution through its pharmaceutical product development and distribution for unmet medical needs. 

CLCLINUVEL’s research and development program is highly ethical. We undertake the minimum studies necessary to obtain the regulatory approvals required to distribute our treatments in man. We use Ethics Committees for study approval, adhere to OECD Testing Guidelines and the principles of GLP. 

We are committed to the OECD Replacement Reduction and Refinement Principles for non-human studies and ensure all studies undertaken are responsibly designed and conducted by laboratories certified by internationally recognised and respected bodies. CLINUVEL disseminates its research and encourages the independent publication of the results of its clinical studies in peer-reviewed scientific journals.

A rigorous pharmacovigilance program is maintained and reported to the European Medicines Agency (EMA) in the European Union and the United States Food and Drug Administration (FDA) on the real-world experience of SCENESSE® for adult patients with EPP. SCENESSE® is carefully managed to ensure no off-label usage. Marketing and communications are aligned to the approval terms and conditions of distribution of the EMA and FDA.

CLINUVEL is responsible for ensuring that its suppliers are fit for purpose throughout the product lifecycle (from product development to commercial distribution), through risk-based quality control procedures and open communication. CLINUVEL qualifies suppliers and reviews existing relationships according to a range of expectations and standards before commencing or continuing supply arrangements. 

CLINUVEL has over 15 key suppliers, most of which are domiciled in well-regulated countries that are signatories to the UN standards and objectives on sustainability and ESG criteria. CLINUVEL has a high proportion of medium- to long-term supplier relationships, enabling us to develop a good understanding of their values and commitment to ESG criteria. This diligent approach also applies to the assessment of our relationship with collaborative partners.

Should an area of concern be identified during a review of a supplier, a risk assessment is conducted to ensure the supplier is functioning within contracted capacity and standards. CLINUVEL then applies a collaborative approach with the supplier to engage in discussions with the aim of improving their qualification status and strengthening the relationship. These procedures enable CLINUVEL to maintain the qualified status of its medium to long term tenured suppliers. Furthermore, it ensures CLINUVEL’s ESG principles and those of its suppliers are consistently aligned.

CORPORATE CONDUCT AND ETHICS

Corporate governance is a key to effective risk management as it provides the policy, procedures, and compliance framework for a company’s operations. Our corporate conduct and ethics are guided by our key corporate values and governed by our Corporate Governance Protocol and annual Corporate Governance Statement. 

CLINUVEL’s Board of Directors comprises the Managing Director, Dr Philippe Wolgen, and five independent Directors. They are, individually and collectively, well credentialed, with a breadth of qualifications and depth of experience in a range of fields to provide appropriate guidance to the Company. In the last year, the number of Directors has increased by one to six. The Board operates in accordance with a Board Charter that is set out in the Corporate Governance Protocol. The election and tenure of Directors is managed in accordance with the Australian Securities Exchange (ASX) Listing Guidelines. The gender representation at Board level is uniquely balanced, reflecting the broader Company. The compensation of Directors and key executives, covering key performance indicators for the assessment of short-term and long-term performance awards, are detailed annually in the Remuneration Report in the Annual Report. 

CLINUVEL is focused on the maintenance of a long-term shareholder base which includes employees and a balanced composition of private, corporate, and institutional investors. CLINUVEL seeks an active and constructive dialogue with its shareholders, in accordance with ASX Listing Guidelines. We communicate frequently with shareholders, as outlined below, by operating an active program of regulatory and discretionary disclosure of information on the Company through announcements to the ASX.  This includes regular corporate updates to keep shareholders informed on the Company’s performance and progress on key strategic initiatives.

CLINUVEL’s Corporate Governance Protocol meets the requirements of ASX principles and recommendations and includes a Code of Conduct and Ethics and policies on Conflicts of Interest, Share Trading and Shareholder Communications. CLINUVEL has zero tolerance of corruption of any kind. We operate a training schedule to ensure compliance with laws and regulations in the countries in which we operate. CLINUVEL staff are also encouraged to report any breaches of company values, regulations and laws and are protected from harassment and abuse on any reports of non-compliance or breaches. CLINUVEL engages with the leading law firms across the continents to ensure adherence to the highest level of governance.

CLINUVEL’s Corporate Governance Protocol sets out the code of conduct and ethics and other policies to ensure conflicts of interest are avoided and honesty and integrity prevails. We are law abiding and comply with anti-bribery and anti-corruption laws in the countries in which we operate.

MANAGEMENT OF STAKEHOLDER COMMUNICATIONS

The twenty-first century has heralded new and improved innovation in communication channels that enable the instantaneous worldwide dissemination of information – in itself, this constitutes a new world order. These advances are advantageous for the operation of capital markets and investment activities. A key part of CLINUVEL’s approach to communicating to stakeholders is the use of multiple online channels to provide up to date information on the Company’s strategy and performance. The process of dissemination starts with an announcement to the ASX, after which CLINUVEL distributes to multiple news media outlets, our ‘email updates’ list, and posts on various social media platforms. We also maintain a library of announcements and information on the Company on our website, www.clinuvel.com. However, the technological advances in communications and information exchange are not without significant potential risk to companies and orderly investment activities in general. 

Information dissemination online has become the social norm and has outpaced the protection of privacy and copyright regulation and enforcement. Laws and regulatory instruments have been unable to keep up with these real-world practices and trading activities on equity markets. Identified and anonymous parties can copy and post information in breach of copyright and can make false and misleading statements, either intentionally or unintentionally, in many online channels near-simultaneously. 

Parties involved in stock shorting activity actively seek to drive a company’s share price down to make a profit from share trading – they buy shares at a lower price than the shares they have borrowed to sell. Katz and Hancock (2017) of Ropes and Gray LLP note that ‘shorters’ actively use online communications either directly or indirectly through antagonists, to post reports on business platforms and discussion forums to undermine the confidence of shareholders and induce them to sell their shares at lower prices. CLINUVEL has not been immune to this type of conduct with shorting activity of CUV increasing from less than 1% of issued capital in April 2019 to a peak of 9.65% of issued capital in April 2020, before lowering to around 8.2% in late September 2020, at the time of writing this article. There has been an increase in false and misleading comment on CLINUVEL in discussion groups, which Katz and Hancock (2017) normally associate with an active shorting campaign. 

CLINUVEL’s approach in the face of this activity is to focus on the progression of publicly stated strategic initiatives and provide regular and objective information to markets on the Company’s progress. This approach enables market participants to assess an objective flow of information to appropriately inform their investment decision in CLINUVEL. In the medium- to long-term, the performance of the Company should improve the demand for CUV and curtail the activity of ‘shorters’. This approach in action is reflected in the pace of the progress of the Company which has enabled more frequent material announcements to the ASX. The number of CLINUVEL announcements to the ASX increased from 44 in the year ending June 2018 to 62 and 67 in the 2019 and 2020 financial years, respectively. The Company’s discretionary announcements providing updates of the business in Chair Letters and News Communiqués are more frequent than other companies or peers in the ASX / S&P 200 Index and are authored by the Chairman and Managing Director to communicate directly to shareholders. This is a peer group leading practice. We also play a role to point regulators in the countries in which our shares are actively traded – CUV on the ASX in Australia, UR9 on the Xetra-DAX in Germany and CLVLY in the US through over-the-counter traded American Depositary Receipts administered by the Bank of New York Mellon – to inappropriate activities.

We feel a responsibility to protect key stakeholders, patients, and doctors as well as shareholders, from inappropriate online activities. This extends to us liaising with online service providers and moderators of online channels when laws and regulations are breached. There are recent indications that regulation may be starting to make up some ground in the area of online defamation with precedent setting court decisions in Australia and the United Kingdom providing clarity of what constitutes a ‘publisher’ under defamation law. Online service providers and owners of online discussion forums have been held liable as a ‘publisher’ under defamation law with the trigger of culpability being their inaction upon being made aware of defamatory posts. Interestingly, each view, like or retweet of a defamatory post is considered a new publication and individuals who anonymously post defamatory material online are at risk of being identified by online service providers and owners of online channels in response to court orders issued during pre-trial discovery. US courts have made mixed judgements depending on the circumstances of the case, but some have held online service providers liable for defamation. In the US, plaintiffs have one year to take legal action against the initial defamation and cannot claim against successive and multiple re-publications. We will not cite the sources of legal precedent here, but they can be found online. The point of these comments is to highlight that your Company is focused on reducing the risk of misinformation and breaches of the law for the sake of objective information and the protection of key stakeholders.

SUMMARY AND CONCLUSIONS

CLINUVEL has a conservative and prudent risk management culture with a firm commitment to environmental and social responsibility with appropriate corporate governance as a key accountability to underpin long-term sustainability and performance. The commitment to prudently manage risk and adhere to ESG criteria as a responsible corporate citizen is strongly held at Board level, by executive management and extends to all CLINUVEL staff. The Company’s vision and values, presented in subsequent pages of this report, support effective operations aligned to the achievement of ESG and sustainability criteria. We regard our journey to sustainability as an ongoing process of continuous review and improvement to enhance our ESG performance and to share our progress with stakeholders in periodic announcements and reports, such as this Annual Report. All stakeholders should be comforted by this responsible and prudent approach, particularly as we enter a new world order.

Sources

The Global Compact (2004), Who Cares Wins, Connecting Financial Markets to a Changing World

UNEP Finance Initiative, A legal framework for the integration of environmental, social and governance issues into institutional investment, October 2005

New York Stock Exchange (2006), Principles for Responsible Investment

Gunnar Friede, Timo Busch and Alexander Bassen (2015) ESG and financial performance: aggregated evidence from more than 2000 empirical studies, Journal of Sustainable Finance & Investment, 5:4, 210-233, DOI: 10.1080/20430795.2015.1118917

United Nations Global Compact (2014), Guide to Corporate Sustainability, Shaping A Sustainable Future

United Nations Global Compact (2017), United Nations Global Compact Progress Report, Business Solutions to Sustainable Development

International Labour Organization (2015), Compendium of International Labour Conventions and Recommendations, http://www.ilo.org/wcmsp5/groups/public/—ed_norm/—normes/documents/publication/wcms_413175.pdf

Jeff Katz and Annie Hancock, Ropes and Gray LLP (2017), Short Activism: The Risk in Anonymous Online Short Attacks, Harvard Law School Forum on Corporate Governance, November 27

INNOVATION IN DNA REPAIR

CLINUVEL’S FOCUS ON DNA REGENERATION

The backbone of human life is created by two structures forming our genetic material: pyrimidines and purines, which in turn consist of four nucleotides adenine (A), thymine (T), guanine (G), and cytosine (C). These form the DNA-helix which carries our present and future make-up, our genetic codes. Human physiology tries to keep DNA strands intact at all costs. As we are exposed to daily oxidative stress, skin cells work hard to preserve our genetic program. 

At CLINUVEL, we have focussed for two decades on the interaction of light and human biology, whereby our scientific teams have worked on replicating the deleterious effects of solar radiation through standardised conditions in our laboratories. We have used broadband ultraviolet B (UVB), narrowband UVB, ultraviolet A 1 and 2 and High Energy Visible (HEV) light to irradiate human skin and observe the instantaneous reactions and damage to the epidermis and dermis. Both in healthy and diseased individuals, skin reactions can be predicted and mapped out. In most of CLINUVEL’s clinical trials, skin surfaces of various patient groups were exposed to light sources to provoke typical sun-related symptoms. In testing the lead drug afamelanotide, we collected this data and assessed its potency for systemic photoprotection.


Pyrimidines and purines are the backbone of our DNA helix

SCENESSE®(afamelanotide 16mg)

Going a step further, CLINUVEL evaluated its drug afamelanotide in various photodermatoses and lightinduced disorders such as polymorphic light eruption (PLE), solar urticaria (SU), acne, and Hailey-Hailey Disease, and in genodermatoses erythropoietic protoporphyria (EPP), congenital erythropoietic porphyria (CEP) and xeroderma pigmentosum (XP), all diseases where radiation at certain wavelengths play a part in the triggering of severe symptoms.  

In optics and physics precision is key, and in some disorders, one specifies action spectra and the inhibition spectra at particular wavelengths causing the start of symptoms in patients. Mapping out each monochromatic wavelength along the electromagnetic spectrum is part of the disciplines of photobiology, photodermatology and radiation biology, deriving scientific knowledge from optics and physics. This knowledge has become part of our in-house strength, expertise and starting point to transgress into the area of UV-provoked DNA damage.

As genetics and cellular biology took a flight the past decennia, the knowledge of the effects of ultraviolet radiation (UVR) on human cells (skin, eyes, and organs) has increased. Most are aware of the beneficial effects of 15-30 minutes of UVR per day to stimulate the synthesis of vitamin D in our skin. However, we are also made aware of how longer periods of exposure to UVR and HEV light may lead to sunburns, photodamage, actinic damage (elastosis) and an increased risk of skin cancers as skin damage becomes chronic and permanent.

The progression from healthy human volunteers to genetic disorders has been logical for CLINUVEL, whereby the most severe diseases have deserved treatment first, not least as these stand the greatest chance of regulatory approval in global pharmaceutical markets, such as Europe, the United States, Australia and Asia. That is not to say that other disorders would not benefit from afamelanotide or melanocortins, but the development route is best justified when regulatory support is given early on in a program.


UVR and the cell

HISTORY OF DNA RESEARCH

Damage to DNA provoked by UV radiation received first attention in 1893, when Robert Bowles published an article in the British Journal of Dermatology suggesting that sunlight may be responsible for skin cancers: “If the sun’s rays will produce sunburn, erythema, eczema solare, inflammation, and blistering, it is clearly capable of producing deep and intractable ulcerations of a low and chronic nature.” This finding was corroborated one year later by Paul Gerson Unna, who associated the severe degenerative changes on exposed areas of sailors’ skin with the development of skin cancer and rapid aging. In the last three decades, various renowned research institutions have focussed on the acute and chronic damage of UV and HEV radiation to human skin. Latitudinal predispositions, localisation, skin type, family history of skin damage and skin cancers were among the variables studied. As cellular biology attracted attention the cellular signalling, expressions of genes and proteins, became a focus. As the human genome project gathered momentum at the start of the millennium, the importance of MAP kinases, endothelin, WNT, cKIT, MITF and MC1R pathways in providing skin cells with the right input, directions and stimulus became widely known.

DNA REPAIR

The double-page figure to this article explains the DNA Damage Response (DDR). Starting on the left-hand side, one sees the DDR by skin cells which leads to a human defence reaction. The activation of MC1R leads to a cascade of reactions seen within the cell. Human biology is fascinating in that many reactions take place simultaneously at the speed of nanoseconds. The signalling of a skin cell – there are many different types – occurs from top to bottom, starting with a particular receptor.

XP Damage Response

The PKA-ATM-ATR axis, or the communication between these intracellular proteins, causes multiple reactions further down the cell. Following solar (UV-HEV) exposure, human reactions are needed to protect cellular structures: organelles and proteins, but specifically the nucleus which may also require reinforcement. In many ways, all the process and activity taking place above the nucleus aim to protect the genomic information, DNA, within the core of each skin cell. 

UV radiation can lead to double or single strand DNA breaks, although the scientific experts tend to focus on single strand breaks. UV causes typical mutations to DNA, known as UVsignature mutations, connotated as C→T or CC→TT substitutions of nucleotides within a DNA strand. Thus, we can detect and recognise the kind of DNA damage caused by solar exposure. UV also causes some of the protein expressions to be downgraded, suppressed, and dysfunctional, making the cell work at a suboptimal level, in turn causing an inferior output by the skin cell. Together, the cellular dysfunction and substitutions of nucleotides are a cause of great concern since human biology is forced to restore the balance immediately by repairing the cellular structures. Sun exposure makes skin cells work overtime. In the doublepage figure, one sees the result of this UV cascade, the formation of Cyclobutane Pyrimidine Dimers (CPDs) and 6-4 Pyrimidine Pyrimidone Dimers (6-4PPs), or photoproducts within the nucleus caused by the sun/UVR/HEV light.

Our task after each sun exposure and sunburn is to eliminate these photoproducts by replacing a piece of DNA. Under normal circumstances, the human body is quite effective at doing so, although fair-skinned individuals (skin type I, II and III) are less efficient than darker skin types (IV, V, VI). In the first group the risk of permanent mutations is increased and in these individuals the incidence of skin cancers is much higher. 

While we are interested in one pathway, the breakthrough in knowledge gained the last 15 years is that various pathways and genes within a cell communicate with each other; “horizontal discussions” occur between pathways. Therefore, the dysfunction along one pathway is sought to be compensated along another, all with the aim to restore function and UV damage. 

On the right-hand side of the double-page figure one reads the properties of alpha-melanocyte stimulating hormone and its reinforced analogue – afamelanotide – in its role restoring UV damage. There are more than 30 cellular domains where the protein and DNA function are aided by alpha-melanocyte stimulating hormone, and here the 17 most important ones are listed. From CLINUVEL’s data and specific scientific work performed, one expects that afamelanotide will be a determinant in the DNA reparative processes within the cell, specifically needed for those individuals at higher risk of developing skin cancers due to genetic receptors, and their ability to respond to the UV signal.

AN EXCITING FUTURE IN PROSPECT

The coming year, CLINUVEL will be furthering this field of research in human subjects (XP patients and healthy volunteers) to confirm the efficiency of afamelanotide in these cellular and DNA reparative processes.

Fitzpatrick Types l-Vl

Skin Type
l
ll
lll
lV
V-Vl
Sunburn and Tan Tendency
Always burns; Seldom tans
Usually burns; Sometimes tans
Sometimes burns: Usually tans
Seldom burns; Always Tans
Never burns; Always Tans
Skin, Hair and Eye Color
White skin, freckles; blond or red hair; blue or green eyes
White skin; blond hair; blue or green eyes
White skin; Usually dark hair; brown eyes
Darker skin; usually dark hair; brown eyes
Naturally brown to dark skin; brown or black hair; brown eyes

CLINUVEL’s DNA Repair Program aims to confirm that intervention with SCENESSE®causes elimination of DNA damage (photoproducts) and regeneration of DNA. The figure shows that SCENESSE® has been proven to protect skin from light (photoprotection) and shown to repair DNA damage. Since photoprotection and regeneration are necessary to reduce the risk of skin cancer, the role of SCENESSE® is obvious. In the figure, “P” stands for probability.

Having taken more than a decade of clinical and scientific research, it is exciting to ‘close the loop’ in using afamelanotide from: 

(i) assessing UV-induced skin damage in healthy volunteers, to

(ii) systemic photoprotection in diseases patients (photodermatoses), and finally, to

(iii) reducing the risk of cellular and DNA damage caused by sun/UVR/HEV light in higher risk populations (both healthy and diseased individuals), and therefore reducing the risk of skin cancer(s).

Skin cancer comes in many forms, but the three most frequently seen in the clinic are basal cell carcinoma, squamous cell carcinoma and melanoma (various types). Common to all three forms is that UV and sun exposure play a part in the development, whereby other genetic and epigenetic factors play a role. However, the ability to eliminate or reduce the UV-inducing factor in the genesis of skin cancer is a big step forward. Hormonal therapy with a melanocortin may well be the future answer, since the use of the hormone simulates the biological function of the peptide in our body, protecting us against the insult of solar radiation. Within seconds of sun exposure, alpha-melanocyte stimulating hormone is detected as being released by our skin cells as a protective  measure.

A reinforced version of alpha-melanocyte stimulating hormone was developed and formulated as afamelanotide, and the vision is to use the drug as a DNA-protectant in many formulations. The requisite is and remains the safety of afamelanotide in patients and healthy volunteers, but each day that goes by is one extra day towards the 100,000 plus patient exposure days providing evidence of safe use.

Biomimicry is the phenomenon found in biology capturing and replicating nature’s ability to provide function and protection. In afamelanotide, CLINUVEL has developed a long used potent hormone to prevent sun and light damage in those who need this most, namely, those who are at risk and those who suffer from genetic disorders affecting their ability to go outdoors. Over the next 12 months, the CLINUVEL story will unfold and the significance of our progress in DNA repair in XP and healthy individuals to the general population at risk of UV-HEV damage will become apparent.

SCENESSE® (afamelanotide 16mg) REPAIRS DNA DAMAGE CAUSED BY UV AND LOWERS RISKS OF SKIN CANCERS

Click below to expand the image

SINGAPORE RESEARCH, DEVELOPMENT & INNOVATION CENTRE

DIRECTORS’ REPORT

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

DIRECTORS

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

WILLEM BLIJDORP

Non-Executive Director, Funda

Appointed 21 January 2015, Chair since 30 November 2019

Background

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

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

In 2014 Mr Blijdorp was recognised for his expertise in merger and acquisitions and commercial leadership as the Ernst & YoungbEntrepreneur of the Year in the Netherlands, and runner-up in its European Union awards. Since becoming a director of CLINUVEL in 2015, Mr Blijdorp has provided a valuable contribution to setting the Group’s long-term strategy for product commercialisation, growth, and future plans to further diversify CLINUVEL.

Relevant Skills

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

Committee Membership

Chair of the Remuneration Committee

Chair of the Nomination Committee

Member of the Audit and Risk Committee

Current Directorships and other interests

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

Relevant interest in Shares and performance rights

Shares: 1,743,118

Performance Rights: –

Other listed company Directorships (last 3 years)

None

PHILIPPE WOLGEN

Chief Executive Officer, MBA, MD

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

Background

Under Dr Wolgen’s leadership since late 2005, a long-term strategy for CLINUVEL was devised. The lead product SCENESSE® (afamelanotide 16mg) was reformulated, its medical application identified, European marketing authorisation was obtained in 2014 and distributed in the European Economic Area from June 2016. Dr Wolgen oversaw the submission of the scientific dossier to the US Food & Drug Administration (FDA) under a New Drug Application, which was approved in October 2019. First treatment of US patients commenced in April 2020. SCENESSE® is the first melanocortin drug to have completed a clinical trial program and obtain marketing authorisation in two major markets. 

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

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

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

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

Relevant Skills

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

Current Directorships and other interests

None

Other listed company Directorships (last 3 years)

None

Relevant interest in Shares and performance rights

Shares: 3,504,696

Performance Rights: 1,513,750*

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

BRENDA SHANAHAN

Non-Executive Director, BComm,
FAICD, ASIA

Appointed 6 February 2007

Background

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

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

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

Relevant Skills

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

Committee Membership

Chair of the Audit and Risk Committee

Member of the Nomination Committee

Current Directorships and other interests

Chair of the Aikenhead Centre for Medical Discovery, Melbourne

Director of SG Hiscock Ltd

Director of DMP Asset Management Ltd

Director of Kimberly Foundation of Australia Ltd

Other listed company Directorships (last 3 years)

Phoslock Environmental Technologies Ltd (ASX: PET, since 2017)

Bell Financial Group (ASX: BFG, from 2012 to 2018)

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

Relevant interest in Shares and performance rights

Shares: 258,969

Performance Rights: 25,000

KAREN AGERSBORG

Non-Executive Director, MD

Appointed 29 January 2018

Background

Dr Agersborg is a Board-Certified Endocrinologist in Pennsylvania, USA, currently serving as Clinical Endocrinologist at Easton Hospital, Steward Health, specialising in Endocrinology, Diabetes & Metabolism. Dr Agersborg had previously worked 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.

Relevant Skills

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

Committee Membership

Member of the Remuneration Committee

Member of the Nomination Committee

Current Directorships and other interests

Member of the American Osteopathic Association

Fellow of the American Association of Clinical Endocrinologists

Fellow of the American College of Osteopathic Internists.

Doctorate of Osteopathic Medicine

Other listed company Directorships (last 3 years)

None

Relevant interest in Shares and performance rights

Shares: 5,500

Performance Rights: –

SUSAN (SUE) SMITH

Non-Executive Director, Dipl ClinRisk

Appointed 23 September 2019 

Background

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

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

 

Relevant Skills

  •  executive healthcare management
  • leadership and strategy setting in complex environments
  • risk management and governance
  • customer relations

Committee Membership

Member of the Remuneration Committee

Member of the Nomination Committee

Current Directorships and other interests

Non-Executive Board Chair of the Evewell (Harley St) Ltd 

Non-Executive Director of Elite Medicine Ltd

Trustee of the HCA International Foundation

Other listed company Directorships (last 3 years)

None

Relevant interest in Shares and performance rights

Shares: –

Performance Rights: – 

JEFFREY ROSENFELD AC, OBE

Non-Executive Director

Appointed 29 January 2018

Background

Prof Rosenfeld is an internationally recognised  neurosurgeon with extensive experience in senior healthcare medical and research executive roles and a distinguished and decorated career in the Australian Army. He is a retired Major General and a former Surgeon General, Australian Defence Force-Reserves. He has served on eight deployments to Rwanda, Iraq, Solomon Islands, Bougainville and East Timor.  He was the Founding Director of Monash University Institute of Medical Engineering (MIME-Melbourne).

He is developing a bionic vision device to restore vision in blind people and he is also a leader in brain injury research. Prof Rosenfeld was Director of Neurosurgery at the Alfred Hospital for fifteen years, concurrently holding Professor and Head of the Department of Surgery at Monash University, for nine years. Prof Rosenfeld is active in many community organisations and champions various charitable causes. Prof Rosenfeld is an active volunteer in the Australian-Aid funded Pacific Islands Project which transfers clinical skills and knowledge to healthcare professionals in Papua New Guinea, Fiji and the Solomon Islands.

In 2018, Prof Rosenfeld was awarded the Companion of the Order of Australia, which is Australia’s highest civilian honour, the Meritorious Service Medal of the United States of America in 2017 and Officer in the Order of the British Empire in 2013.

Relevant Skills

  • lifetime experience in providing healthcare
  • clinical research and development
  • board and Committee oversight and governance
  • leadership and management

Committee Membership

Member of the Audit and Risk Committee 

Member of the Nomination Committee

Current Directorships and other interests

Director of Vision for TBI Ltd

Former Major General, Australian Defence Force (Army Reserve)

Other listed company Directorships (last 3 years)

None

Relevant interest in Shares and performance rights

Shares: 1,693

Performance Rights: – 

STAN MCLIESH

Non-Executive Chair, B Ed

Appointed 12 September 2002, Ceased Directorship 30 November 2019

Background

Mr McLiesh has vast experience across pharmaceutical research and development, and distribution and commercialisation of pharmaceutical products. He was closely involved in the transition of CSL Limited (ASX: CSL) from government ownership through corporatisation to a highly successful listed company as General Manager. During this time, he helped CSL expand its international reach, brokering numerous in-licensing agreements, M&A transactions and partnerships with 

multinational firms, becoming the most successful Australian life-sciences company. Mr McLiesh has previously served in non-executive roles in the medical device field. As Chair of CLINUVEL from 2010 to 2019, Mr McLiesh was involved in formulating the successful European commercial strategy for SCENESSE® (afamelanotide 16mg) and overseeing the continuity and stability of the CLINUVEL Group.

He has taken a leading role in setting US commercial strategy, culminating in US FDA’s approval of SCENESSE® in October 2019.

His ability to navigate through crises and oversee clear pathways towards finding solutions made him highly capable to steer management over many years, up until his retirement in November 2019.

Relevant Skills

  • pharmaceutical research & development, commercialisation
  • commercial acumen
  • general management
  • experienced in listed company Directorships

Committee Membership

Member of the Remuneration Committee 

Member of the Audit and Risk Committee 

Member of the Nomination Committee 

Current Directorships and other interests

Vice President of the Board of Ivanhoe Girls 

Grammar School, Melbourne

Relevant interest in Shares and performance rights

Shares: 187,774

Performance Rights: – 

Other listed company Directorships (last 3 years)

None

INFORMATION ON COMPANY SECRETARY

DARREN KEAMY

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

MEETING OF DIRECTORS

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

Director Board Audit & Risk Committee Remuneration Committee Nomination Committee*
A
B
A
B
A
B
A
B
Mrs. B.M. Shanahan
10
10
3
3
2
2
Mr. S.R. McLiesh
5
5
2
2
2
2
2
2
Dr. P.J. Wolgen *
10
10
1
1
2
2
Mr. W. A. Blijdorp
10
10
2
2
2
2
2
2
Dr. K. A. Agersborg
10
8
2
2
Mrs. S. E. Smith
7
7
1
1
Prof. J. V. Rosenfeld
5
5
Column A indicates the number of meetings held during the period the Director was a member of the Board and/or Board Committee

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

PRINCIPAL OBJECTIVES AND ACTIVITIES

Objectives

CLINUVEL PHARMACEUTICALS LTD (CLINUVEL) is a global biopharmaceutical company focussed on developing and delivering treatments for patients with a range of genetic and vascular disorders. 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 patients and consumers.

CLINUVEL’s expertise in understanding the interaction of light and human biology is focussed on preventing the symptoms of genetic diseases related to the exposure to the visible light spectrum and UV radiation along with addressing a range of depigmentation disorders. These patient groups range in size from 5,000 to 45 million worldwide. 

CLINUVEL has developed and launched the world’s first systemic photoprotective drug 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 in need. The key to long term sustainable performance is:

  • continuing the successful research and development of a portfolio of assets centred around its key drug candidate SCENESSE® and its melanocortin derivatives;
  • the successful commercialisation, manufacture and distribution of these products; and
  • maintaining financial discipline and stability.
A key facilitator of these objectives is the ability to attract funding to support CLINUVEL’s activities, should the need arise.

 

Performance Indicators

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.

Activities

The principal activities of the Group during the financial year were to:

  • manage the commercial distribution in Europe of its leading drug product SCENESSE® (afamelanotide 16mg) for the treatment of a rare, genetic metabolic disorder, erythropoietic protoporphyria (EPP);
  • establish commercial distribution of SCENESSE® in the USA following the approval of the US Food and Drug Administration (FDA) in October 2019 of SCENESSE® for the treatment of adult EPP patients;
  • progress the ongoing research and development of its product pipeline for a range of severe disorders, including:
  1. 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;
  2. topical over-the-counter formulations for photoprotection of the skin;
  3. medicinal photoprotection through DNA repair of the skin; and
  4. the development of PRÉNUMBRA®, a new liquid formulation of afamelanotide for the treatment of critical indications to be announced.
There was no significant change in the nature of the Group’s activities during the financial year.

REVIEW OF OPERATIONS AND FINANCIAL CONDITION

Key Features of Business Operations

There are several key features of CLINUVEL’s business operations:

  • The commercial operations of the Group are undertaken in Europe and the USA.
  1. Since June 2016 CLINUVEL has distributed SCENESSE® to EPP patients through accredited Expert Centres, working within the commitments agreed with the European Medicines Agency (EMA) as a condition for continuous marketing authorisation.
  2. Since April 2020, CLINUVEL has been treating 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.
  1. Distribution costs specific to each jurisdiction determines the gross price of SCENESSE®.
  2. This 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 Expert Centres in Europe and Specialty Centers in the USA.
  • CLINUVEL’s cash receipts are markedly higher in the northern hemisphere during spring and summer when ambient light is more intense and demand for treatment from EPP patients is higher than in autumn and winter.
  • 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, in an undisclosed 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 to acute disorders and vascular anomalies in indications to be announced.
  • The Group’s product development program is conducted through its fully owned Singaporean subsidiary, VALLAURIX PTE LTD (VALLAURIX).
  • 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.

Review of Operations

The review of operations for FY2020 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 laboratory facilities in Singapore, and the progression of the product pipeline to develop SCENESSE® and its analogues for the treatment of patients with a range of severe genetic, skin, and vascular disorders.

Distribution of SCENESSE® in Europe

The supply of SCENESSE® to EPP Expert Centres across key European countries, including under a special access scheme to Switzerland, continued in the year ended 30 June 2020 (FY2020). During the corona-pandemic, the majority of EPP Expert Centres continued prescription of SCENESSE® due to the ongoing clinical demand, while a small number of Centres either deferred orders or reduced order sizes in the initial months of the COVID infections. 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, with 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 other European countries. 

Distribution of SCENESSE® in the USA

On 8 October 2019, the 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 which had an unmet medical need for treatment. 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, identification of the correct codes for treatment to ensure smooth operations and reimbursement, initial insurer discussions and agreement to reimburse the cost of treatment, and identification of the initial Specialty Centers to be accredited and trained by CLINUVEL. 

In April 2020, CLINUVEL commenced distribution of SCENESSE® for adult EPP patients with the first US insurance companies initiating reimbursement for treatment under Prior Authorization (PA). Over 40 insurance companies have now agreed to consider SCENESSE® under PA. CLINUVEL has established 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 in their applications to insurance companies for approval to reimburse the cost of treatment of SCENESSE®.

Our plan is to accredit 30 Specialty Centers over a phased period. At the time of writing, 17 Specialty Centers have been accredited, which is ahead of our planning. Cash receipts for the financial year ending 30 June 2020 did not include any receipts from the supply of SCENESSE® in the US market. The Company expects, in these early stages of US launch, that payment terms may be longer in duration than the 30 to 60 days average length of payment term in Europe. Modest revenue was recorded in the first few months of treatment to 30 June 2020 and the outlook for the US business is underpinned by the progress being achieved in the number of Specialty Centers accredited and patients treated. 

SCENESSE® for EPP in New Jurisdictions

With regulatory approvals from the EMA in Europe and more recently, the FDA in the USA, and information on the patient experience in Europe generated from its post-marketing commitments, 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 2019, the Australian Therapeutic Goods Administration (TGA) granted SCENESSE® the right to be filed under its priority registration process. In December 2019, CLINUVEL applied to the TGA for SCENESSE® to be registered in the Australian Register of Therapeutic Goods (ARTG). If registered, SCENESSE® would be made available by prescription in Australia for the prevention of phototoxicity in adult patients with EPP. In January 2020, the TGA accepted the registration dossier for review. A decision is expected during the fourth quarter of calendar 2020. In parallel, interactions with the Pharmaceutical Benefit Scheme (PBS) have occurred to exchange information on risk, benefit, and budget impact in Australia. The aim is to assess whether SCENESSE® can become listed on the PBS in Australia. It is expected that the drug will be made available exclusively through outpatient departments of speciality centres since it will be administered by specialists only.

In April 2020, the Group commenced a Collaboration Agreement to launch SCENESSE® (afamelanotide 16mg) under a Named Patient Program (NPP) for the treatment of EPP patients in the People’s Republic of China. The collaboration with HK Winhealth Pharma Group Co. Limited (Winhealth) focuses on facilitating early access for Chinese EPP patients while collecting data for a new drug application (NDA) to the Chinese National Medical Products Administration (NMPA). CLINUVEL and Winhealth will work with prominent hospitals in China to facilitate EPP patient treatment. 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 Winhealth will evaluate the safety and effectiveness in Chinese EPP patients. The collaboration will also focus on subsequent registration of SCENESSE® on the National Drug Reimbursement List. On a prevalence basis, an estimated 5,000 Chinese residents suffer from EPP, for which there is no approved therapy. 

An application was also lodged during the year for regulatory approval to distribute SCENESSE® in a non-EU country, and submissions to regulatory authorities in Japan and Latin America are planned.

Expansion Singapore Laboratory

During FY2020, CLINUVEL invested in the further expansion of its facilities in Singapore with new state of the art and expanded laboratories to further progress R&D on novel melanocortins, and prescription and over-the-counter products. In February 2020, the Group announced that the research and development capacity of its wholly owned subsidiary, VALLAURIX, will be expanded through both a new biological and analytical laboratory, which are planned to work according to both ISO17025 and Good Laboratory Practice (GLP) specifications. CLINUVEL has added new highly skilled local personnel to its existing team and specialised technical laboratory equipment to further enhance the progress of its product pipeline. VALLAURIX has received support of its expansion plan from the Singapore Economic Development Board (EDB) 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 3 years. The opening of the laboratory was planned for July 2020, but due to the introduction of prudent regulations by the Singapore Government to contain the corona-pandemic, it is expected the new facilities will be completed by the end of the third quarter of calendar year 2020.

Product Pipeline

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:

  • 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; and
  • the application of a newly developed second formulation of afamelanotide, PRÉNUMBRA®, a liquid controlled-release formulation, to be evaluated in clinical trials for acute disorders and vascular anomalies.
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 February 2020, the Group requested a Type C Guidance Meeting with the FDA and they consented to a meeting held on 29 April 2020. The purpose of the meeting 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 is proceeding 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.
 
Subject to acceptance of the clinical protocol by the FDA, and depending on 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. 
 
Scientific advancements and CLINUVEL’s programs have shown that afamelanotide can assist in the repair of cellular DNA damage caused by exposure to ultraviolet radiation. CLINUVEL is working to evaluate this effect in humans, with protocols prepared in target patient populations currently pending approvals.
 
In July 2020, at the start of the new financial year, the Group announced the development of a second formulation of afamelanotide, PRÉNUMBRA®. This liquid controlled-release formulation is aimed at dosing flexibility as part of the active life-cycle management of afamelanotide to address clinical needs in acute disorders and vascular anomalies. The indications of focus are to be announced when ethics committee and regulatory approvals are held. The Group has secured the intellectual property rights for the dosage form in the identified indications, as well as the international trademarks for PRÉNUMBRA®.

Financial Review

The financial year ended 30 June 2020 marks the completion of the Group’s fourth consecutive year of achieving a net profit, a positive cash flow result and increased revenue growth.

The result for the Group for FY2020 was a $13.136 million profit before tax, compared to $18.115 million for FY2019, a 27% decrease. The result reinforces the Group’s primary strategic focus to grow its commercial operations of SCENESSE® in the EU and the US and to prepare for future product growth and business expansion. Total expenses increased by 44% year-on-year, complemented by a combined increase in total revenues, interest income and other income of 4% year-on-year. 

Net Cash provided by Operating Activities was $14.188 million for FY2020. After the deployment of cash in investing and financing activities, net cash added $12.478 million to cash and cash equivalents on the balance sheet. Cash reserves have increased steadily since 2016, from $14.170 million to the 30 June 2020 level of $66.747 million, a 44% compound annual growth rate over the last 4 years

Financial Summary

Consolidated Entity FY2020 FY2019
$
$
Revenues and Other Income
33,909,670
32,498,470
+4%
+24%
Net Profit before income tax
13,136,471
18,114,827
-27%
+40%
Profit after income tax expense
16,646,859
18,134,160
-8%
+37%
Basic earnings per share
0.338
0.376
-10%
+36%
Net tangible assets backing per share

1.3831

1.158
19%
+42%
Dividends
2.5 cents
2.0 cents

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

Note: CLINUVEL has one operating segment for reporting purposes.

Revenues

The Group achieved Total Revenues of $32.565 million for FY2020, a 5% increase on the prior year revenue result of $31.048 million.

A comparison of the FY2020 reported and constant currency results against the FY2019 reported results for Commercial Sales and Special Access Scheme Reimbursements is shown below:

AU $ million FY2020 Reported FY2020 Constant* FY2019 Reported % change
Commercial Sales – Europe
25.407
24.409
26.488
(7.9)
Commercial Sales – USA
0.899
n/a
n/a
SAS Reimbursements – SUI+Other
6.259
5.922
4.559
+29.9

Commercial Sales – Europe

On a constant currency basis commercial sales revenues of SCENESSE® in Europe decreased 7.9% for the year. The result was driven by a combination of:

  • EPP Expert Centres located in regions severely affected by COVID19 either deferring or reducing orders at a time when orders typically increase in the warmer months;
  • EPP Expert Centres running down inventories, offset by
  • Further increases in new patients enrolled under the post-authorisation safety setting and treated by EPP Expert Centres before and during lockdown.
Despite difficult conditions from the coronavirus pandemic in Europe to access patients during the second half of FY2020 when demand for SCENESSE® generally increases, EPP Expert Centres continued to prescribe SCENESSE® to existing and to new patients receptive to the treatment. 
Whilst the price of SCENESSE® remained constant in FY2020, in line with CLINUVEL’s policy to charge a net uniform price across all European countries, commercial sales in Europe were positively impacted by favourable foreign exchange rate movements by $0.998 million. 

 

Commercial Sales – USA

First commercial sales occurred in the latter part of FY2020 to one EPP treatment centre. Reimbursement of SCENESSE® was initiated by first-mover US insurance companies for treatment under Prior Authorization (‘PA’) arrangements. More than forty insurers have agreed to reimburse SCENESSE® either via PA or through acceptance of the drug on individual formularies. 

Reimbursements – Special Access Schemes

The distribution of SCENESSE® under Special Access Schemes continued to provide a preventative treatment for adult EPP patients primarily to Switzerland. SCENESSE® was also exceptionally supplied outside Switzerland under a special access arrangement whereby CLINUVEL received full cost compensation, linked to the uniform price of SCENESSE® sold in Europe under the marketing authorisation. 

On a constant currency basis, sales reimbursements from special access schemes increased 29.9% for the year. The result was driven by:

  • Growth in the average number of presciptions per patient throughout the course of the year, and
  • New patients receiving treatment for the first time

Other Income

Interest Revenue and Other Income

This exposure in holding funds in non-Australian dollar currency, combined with revaluing end date trade debtors and creditors from their original currency into Australian dollar presentation currency, contributed to the Group reporting a gain of $0.537 million for FY2020 (FY2019: $0.886 million gain).

The Group recorded other income of $0.127 million in government grants received in Australia and Singapore to assist companies responding to the economic impact of the COVID19 pandemic. The Group also benefited from realising exchange rate gains on transactions in non-Australian currency throughout the year of $0.117 million.

Interest received from funds held in bank accounts and term deposits for the year ended 30 June 2020 was $0.563 million compared to $0.565 million for year ended 30 June 2019. 

The positive financial performance of the Group saw an increase over the 12 months to 30 June of $12.478 million to its cash reserves. Over the course of FY2020 the Company was able to transfer more funds into higher-yielding Australian dollar fixed-rate term deposits. 

The average amount of cash held in term deposits was 55% higher than for FY2019. However, the higher cash balances were offset by a lower interest rate yield it earned on holding interest-bearing term deposits, averaging 95 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 2020 has remained stable, decreasing 4% on average when compared to FY2019. 

Expenditures

Total Expenses for the Group for FY2020 were $20.773 million. There was a deliberate and controlled increase in expenses of 44% during the year compared to FY2019 to support the Company’s strategic initiatives, including investment in the research and development program for future organic growth.

The Group maintained its focus on its expenditure mix as it has done throughout the SCENESSE® development program. Overall, total R&D and commercialisation expenditures accounted for 46% of the Group’s total expense result for FY2020, compared to 48% for FY2019. Whilst the expenditure mix showed a 2% decline, the total expenditures on R&D and commercialisation costs, comprising clinical study costs, drug formulation research, manufacture and distribution, regulatory fees and research, development and commercialisation-specific overheads such as personnel, were $9.630 million in FY2020, increasing 40% from $6.871 million in FY2019. The increase in these overall expenditures reflects the Group’s focus throughout the year to further invest in its commercial rollout to secure revenues in the EU and for the first-time, the USA. 

Clinical Development

Clinical development fees increased 102% from $0.091 million in FY2019 to $0.185 million in FY2020.

Since the granting of market authorisation by the EMA in late 2014, the Group has prioritised its commercialisation activities in the EU and in pursuing a regulatory approval in the USA ahead of advancing its clinical trial program. This has been reflected in expenses towards clinical development representing approximately 1% of total expenses in each year since the year of European regulatory approval. Moving forward, the Group intends to invest funds in its clinical activities, both in the use of SCENESSE® in various therapeutic fields and in the clinical development and testing activities of the new products and formulations as part of the VALLAURIX operations. 

This expense result for FY2020 was driven by:

  • Increased clinical expert support services to advise on initiatives on the expanded use of SCENESSE®, and
  • Growth in product development and testing services in the VALLAURIX operations under laboratory setting.

Drug Formulation R&D, Manufacture & Distribution

Expenses toward further research, development, manufacture and optimisation of the implant drug formulation and the freighting and distribution to the end user increased 52%, from $2.388 million in FY2019 to $3.624 million in FY2020. 

The Group continues to invest in its manufacturing supply chain to prepare for future sales growth and to meet short-term and long-term inventory requirements. During the year the Group embarked on a manufacturing program to replenish raw material peptide via a process change to support future scale-up. Validation of the process change is underway and will extend into FY2021. Continuous process improvement initiatives with the implant contract manufacturer were a part of the batch manufacturing campaigns that were conducted during FY2020. New distribution centres with contracted parties and third-party service providers were established in Europe to respond to the UK’s pending departure from the EU as part of Brexit and to support supply to US EPP Expert Centres. Drug formulation R&D also includes the development work and usage of derivative peptide material within the VALLAURIX Singapore operations.

This expense result for FY2020 was driven by:

  • Cost increases passed to the Group from its contract manufacturer as part of FY2020 implant manufacturing campaigns;
  • Investment in process development of afamelanotide raw material peptide manufacturing which had commenced in FY2020;
  • Growth in handling and freighting activities to support the movement of serialised goods around Europe under the Falsified Medicines Directive and to move goods in the US; and
  • Increased formulation development work in topical formulations, recognising the usage of derivative peptides.

Clinical, Regulatory & Commercial (C,R&C) Overheads

C,R&C overheads increased 32% from $2.948 million in FY2019 to $3.893 million in FY2020.

As part of CLINUVEL’s longer term objectives, increasing the C,R&C personnel headcount is considered an essential investment to: 

  • drive the new product development program in its internal innovation centre, VALLAURIX PTE LTD;
  • establish and grow a commercial distribution program in the USA;
  • further sustain the ongoing commercial activities in Europe; and
  • investigate the further use of SCENESSE® in indications other than EPP for the aim to expand its market potential.
FY2020 follows the trend since SCENESSE® was first launched in Europe in 2016 of gradually increasing C,R&C staff count in those key business areas to drive organic growth. As the Company continues to expand, C,R&C overheads will follow. 
This expense result for FY2020 was driven by:
  • Increased global staff headcount across its scientific affairs and commercial affairs teams.

Regulatory (Pre- & Post-Marketing) & Non-clinical

Regulatory and non-clinical fees increased 33% from $1.444 million in FY2019 to $1.928 million in FY2020. 

Fees related to regulatory affairs for both pre- and post-marketing activities are directly related to the Group’s strategic focus in the current year to meet its ongoing regulatory compliance activities to distribute SCENESSE® in Europe and in the USA. These activities include pharmacovigilance, safety reporting, PASS registry data capture and dossier updates. SCENESSE® is established as standard of care in a number of European countries. The first treatment results from the European EPP Disease Registry study were independently published during FY2020, showing ongoing longer-term maintenance of the safety profile of SCENESSE® and clinical benefit for patients receiving treatment.

Pre-marketing regulatory fees for FY2020 included finalising and submitting an application to the Australian Therapeutic Goods Administration for the use of SCENESSE® in EPP. An outcome is anticipated in late 2020.

Regulatory and non-clinical fees also include the support required for pricing dossier submissions and in responding to the pricing negotiations. 

This expense result for FY2020 was driven by:

  • Growth in ongoing pharmacovigilance services; and
  • Fees to prepare and respond to an increased number of audits and inspections from various regulatory bodies including the UK MHRA and FDA.

Business Marketing & Listing

Business marketing and listing fees increased 26% from $1.502 million in FY2019 to $1.889 million in FY2020. 

The Group has been further investing in its marketing and brand-building resources throughout the year. The focus to this business function has been to build a greater online awareness of the CLINUVEL brand in consideration of the US FDA’s approval of SCENESSE®. In addition, as the product development program in VALLAURIX progresses, resources and stragies are being put in place to support future product launch. Brand-awareness strategies were implemented during industry conferences at the start of FY2020 but were later impacted by the onset of COVID19. 

This expense result was driven by:
 
  • Additional in-house marketing resources through more personnel to support the building of CLINUVEL’s brand exposure across multiple forums and the promotion of VALLAURIX’s over the counter (OTC) products leading up to launch; and
  • Increases to listing, share registry and corporate regulatory fees tied to market capitalisation growth and investor mix.

Patents and Trademarks

Patent fees increased 69% from $0.305 million in FY2019 to $0.516 million in FY2020.

Incurring expenditures in patent and trademarks provides the Group with essential protection and a competitive advantage over others. 

This expense result was driven by:

  • Further fortification of the intellectual property position on the new product development and complementary formulations within the VALLAURIX business;
  • Further maintaining, strengthening and validating the position of the existing patent portfolio, including patent term extension requests; and
  • Investments in trademarks of new product names including PRÉNUMBRA®, CLINUVEL’s new non-solid (liquid) presentation of its drug afamelanotide.

General Operations (incl Board)

Expenditures from general operations increased 61% from $4.923 million in FY2019 to $7.963 million in FY2020. General operations are reflective of the support function necessary to ensure the execution of the Company’s demanding near-term and long-term expansion strategy. Personnel costs including the remuneration of senior management is considered part of general operations along with IT, corporate support, legal, Board and various non-cash items. 

This expense result for FY2020 was driven by:

  • Growth in non-cash expensing of share-based payments, the accounting charge directly related to the approval by shareholders of performance rights to the Managing Director at the 2019 AGM;
  • changes to the remuneration arrangements of key management personnel, impacting salary and employee benefit expenses; and
  • General increases to recruitment and insurances to support business growth, offset by savings to legal-related fees, principally from FY2019 including legal fees in connection to matters related to the EMA marketing authorisation and in responding to negotiations with England’s National Institute for Health and Care Excellence (NICE).

Other Expenses

Other expenses decreased less than 1% from $0.755 million in FY2019 to $0.750 million in FY2020.

Other expenses include travel and ad-hoc staff-related expenses. Whilst there was a steep increase in travel related costs in the first half of FY2020, staff mobility was severely restricted in the second half of FY2020. 

Deferred Tax Asset

The Group has 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 (FY2019: $0.019 million). The amount of the DTA brought to 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.

Balance Sheet

One of the key objectives of the Company is to ensure its Balance Sheet is sufficiently positioned and robust enough 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 and, in doing so, is able 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 has been a deliberate and planned strategy, reflecting CLINUVEL’s conservative approach to risk management. 

Key Balance Sheet highlights of the year:

The changes to the Balance Sheet was generated from positive cashflows flowing into the company from its commercial distribution program in the EU, increasing cash reserves by 23% from $54.269 million at FY2019 to $66.747 million at FY2020. Into FY2021, cashflows are expected to be received from the distribution of SCENESSE® in the US.

Total liabilities increased 52%, from $5.166 million to $7.873 million, with no long-term debt. The ratio of the Company’s overall debt to equity is 12%.

Shareholder Returns

Shareholder returns for FY2020 remain strong and are summarised (see first table right).

A$M FY2020 FY2019 FY2018 FY2017 FY2016
Profit attributable to owners of parent
$16.647
$18.134
$13.224
$7.180
($3.121)
Basic EPS
33.8 cents
37.6 cents
27.7 cents
14.9 cents
(7.0) cents
Dividends paid
$1.224
$0.957
Dividends per Share
2.5 cents
2.0 cents
Change in Share Price YoY
(24%)
206%
58%
62%
52%
Return on Equity
23%
32%
34%
28%
(18%)
Shareholder returns have been generated in both the short-term and the longer-term through:
  • capital appreciation (Total Shareholder Return exceeding the Nasdaq Biotech Index and ASX200 Healthcare Index since first product launch),and
  • dividend distribution in the past two financial years

Investments for Future Performance

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 open to consider 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 (see second table on right).

People
  • Created new roles across all business functions
  • Supported senior management and key personnel in ongoing professional development
Research & Development
  • Relocating its laboratory to larger premises with expanded analytical capabilities
  • Fixed asset purchases
  • Non-solid dosage formulation development
Clinical

Activities in progress to obtain approvals to move into next phase clinical studies to pursue potential new markets for SCENESSE” in :

  • Vitiligo
  • Other indications (to be disclosed)
Manufacturing
  • Program to manufacture raw material peptide via a process change to support future scale-up
IP
  • Continued to renew and maintain new and existing patents to strengthen its intellectual property position

Capital Structure

The Group is debt free and has a sound capital structure of ordinary shares on issue plus unlisted securities in the form of conditional performance rights. 

CLINUVEL’s outstanding shares on issue increased to 49,410,338 shares to 30 June 2020. The increase of 449,705 issued shares was through the exercise of performance rights under the Group’s performance rights plans.

Dividends Paid or Recommended

Dividends paid or declared by the Group to members since the end of the previous financial year were (see right).

On 26 August 2020, the Board of Directors declared an unfranked dividend of $0.025 per ordinary share in relation to the full year ended 30 June 2020. 

 

Declared & paid in 2019/20 Cents per Share Amount Date of Payment
Final
2.50
$1,224,021
19 September 2019

Cash from Operations and Other Sources of Cash

Overall, the Company generated $14.188 million in cash from its operating activities in FY2020 (FY2019: $18.456 million) 

Cash inflows from customer receipts decreased 9% to $29.288 million compared to $32.221 million for FY2019. 

Cash outflows from operations increased by 14%, from $14.241 million to $16.281 million. 

There were also cash outflows of $0.889 million for the acquisition of property, plant and equipment, $0.262 million of repayment of borrowing and leasing liabilities and $1.224 million for the payment of an unfranked dividend to shareholders in relation to FY2019.

The Group’s 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 foreign exchange forward contracts and other foreign exchange risk management products, as considered appropriate.

 

The Group’s financial liquidity as at 30 June 2020 is reflected in: 

  • A quick ratio of 11.0:1 (30 June 2019 11.8:1); and
  • Cash and cash equivalents of $66.747 million, accounting for 88.8% of total current assets (FY2019: $54.269 million, 88.7%of total current assets).

Material Business Risks

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 (see table below).

Technology
Despite obtaining marketing authorizations, those products may ultimately prove not to be safe and/or of clinical or other benefit.
Supply
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.
Clinical & Regulatory
Clinical trials may not yield the expected and desired results for the investigational medicinal product(s) to obtain further regulatory approvals.
Drug pricing
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.
Intellectual Property
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 maximize the value to be made from product commercialization.
Funding
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.
Market Competition
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.
Management
The Group’s corporate strategy could be impacted adversely if the Group was not able to retain its specialized knowledge and areas of expertise. key management. members of staff and/or Board.

Impact of the Coronavirus Pandemic on CLINUVEL’s Business

The impact of the coronavirus pandemic on the human population across the globe is significant and has caused the most severe contraction in the world economy since the 1929 Great Depression. 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. CLINUVEL’s business has proven resilient and is relatively well positioned to manage the difficult operating environment and progress its strategic initiatives. 

Demand for SCENESSE®

Access to patients was affected particularly during the initial months when population lockdowns across Europe were first instituted. EPP Expert Centres either deferred orders or reduced order sizes in the initial months of the COVID infections because they were not able 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 seek 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®.

Research and Development

CLINUVEL’s research and development program continued to progress in FY2020. The operations of the laboratory facilities in Singapore were restricted during the circuit-breaker period, with some remote working required. The circuit-breaker also resulted in minor delays to the laboratory expansion project, now set to be completed by the end of the third quarter of calendar year 2020.

Supply of SCENESSE®

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 adversely impacting timeframes. CLINUVEL continuously reviews its operations to assess ongoing supply of SCENESSE® which may be impacted by the coronavirus pandemic. 

CLINUVEL’s People

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. Diligence under a difficult operating environment by the entire CLINUVEL team has seen productivity and focus remain largely unaffected. 

Summary

CLINUVEL recorded a fourth consecutive annual positive cash flow and profit in FY2020. The impact of the corona-pandemic on the business during the second half of FY2020 has been managed and it has been able to respond to this challenge through the sound foundations established over a long period of time by management and the Board. CLINUVEL has entered FY2021 with cash reserves sufficient to respond to unforeseen negative global economic events. 

Changes In The State Of Affairs

The Directors are not aware of any matter or circumstance not otherwise dealt with in this report that has significantly or may significantly affect the operations of the Group.

Significant Events After The Reporting Date

There has not been any matter, other than reference to the financial statements that has arisen since the end of the financial year that has affected or could significantly affect the operations of the Group, other than:

  • On 26 August 2020, the Board of Directors declared an unfranked dividend of $0.025 per ordinary share.

Likely Developments And Expected Results

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 more 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 bears responsibility for the manufacturing standards of the commercial drug product.

The US FDA approved SCENESSE® for the use in EPP during the financial year. 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. 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 yet to be disclosed acute and critical disorders. 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 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 achieve and maintain sustainable profitability. 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.

Environmental Regulations And Performance

The Group’s operations are not regulated by any significant environmental regulation under a law of the Commonwealth, or of a State or Territory, or of any other jurisdiction.

Rounding Of Amounts

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

Indemnification And Insurance Of Directors And Officers

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

Directors’ Benefits And Interest In Contracts

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

Further information on these contracts is included in Note 20 to the financial statements.

REMUNERATION REPORT

The Remuneration Report, which forms part of the Directors’ Report, provides information about the remuneration of the Directors of CLINUVEL PHARMACEUTICALS LTD and Other Key Management Personnel for the year ended 30 June 2020.

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 (see right).

The Remuneration Report is set out under the following main headings: 

A. Introduction by the Chair of the Remuneration Committee

B. Remuneration Governance

C. Executive Remuneration

D. Non-Executive Remuneration

E. Service Agreements 2019/20

F. Share Based Remuneration

G. Details of Remuneration

H. Additional Information – Remuneration

A$M FY2020 FY2019 FY2018 FY2017 FY2016
Profit attributable to owners of parent
$16.647
$18.134
$13.224
$7.180
($3.121)
Basic EPS
33.8 cents
37.6 cents
27.7 cents
14.9 cents
(7.0) cents
Dividends paid
$1.224
$0.957
Dividends per Share
2.5 cents
2.0 cents
Change in Share Price YoY
(24%)
206%
58%
62%
52%
Return on Equity
23%
32%
34%
28%
(18%)
Shareholder returns have been generated in both the short-term and the longer-term through:
  • capital appreciation (Total Shareholder Return exceeding the Nasdaq Biotech Index and ASX200 Healthcare Index since first product launch),and
  • dividend distribution in the past two financial years

A. INTRODUCTION BY THE CHAIR OF THE REMUNERATION COMMITTEE

Chairman of the Remuneration Committee: Mr Willem Blijdorp

As the Chair of the Remuneration Committee, I am pleased to present our Board’ Remuneration Report for the year ended 30 June 2020. 

We have kept the format of this year’s Remuneration Report consistent with last year’s since there have not been any significant changes in internal policies or regulations. 

I oversee the Group’s remuneration philosophy which aims to attract, retain and motivate talented professionals we require for the Company to meet its strategic objectives. In this process, we wish to see professionals receive appropriate acknowledgement and remuneration.

The Remuneration Committee oversees a remuneration policy of the Group to ensure it is fair, competitive with international peers and transparent. All in all, we strongly believe that a remuneration policy well implemented should help us drive growth strategy and sustainability of CLINUVEL, and thus far we have been proven right.

 

In 2020, CLINUVEL delivered another year of growth despite the global pandemic and lockdowns affecting all EU countries and the US. Whilst many peer companies have been posting losses and have been required to raise capital, CLINUVEL’s Board and shareholders were fortunate to have a prudent executive management team who had foreseen and planned for the economic downturn and maneuvered the Company through tough times.

In the past year, we increased our revenues by 4%, our cash reserves by 23% and expanded the distribution of SCENESSE® across Europe. Standing tall and with some Dutch pride I look at how CLINUVEL posted an NPAT of A$16.6M and PBIT of A$13.1M in the middle of a global crisis and when many hospitals in Europe and US were not seeing out-patients in the first half of 2020. Our management skilfully came up with a plan to guarantee continuity of treatment for these patients able to travel under the national restrictions imposed by governments.

The Remuneration Committee with consensus of the full Board designed a Performance Rights Plan, which had received shareholder approval in November 2019 and which outlines step by step the Performance Conditions which need to be met for the Company to grow on all fronts within a vesting period of 4 years. This progressive but realistic business plan is being implemented and incentivizes executives and staff along the way. Assuming these Performance Conditions are met the Company should have grown significantly in value, providing commensurate returns for shareholders.

As I had stated in relation to the Committee’s intentions in 2019, this year we reformed the Executive Agreements by eliminating cash-based Business Generating Incentives, and substituting these by a Performance Rights Plan vesting over 4 years. This PRP aims to incentivize and align the interests of the management team with those of shareholders, and in a dual position as Chairman of the Remuneration Committee and also as larger investor of the Company I fully support this direction. 

In building this Company, a careful financial and operational approach is taken which is receiving much recognition from the financial community I am in contact with and despite the shortselling we have seen in CLINUVEL the past year. The cost of issuing shares repetitively, the dilution caused to shareholders and the distraction to a management has been successfully avoided, and in terms of risk management we could not have asked for more. 

In 2020, we also implemented the decision which forms part of the Company’s policy that non executive directors will not participate in a Performance Rights Plan or Options Scheme since we wish to retain the independence of the non-executive directors.

In recent weeks, the Remuneration Committee and Board has been surprised, impressed but proud to learn that our CEO has waived and rejected his STI awarded to him for achieving 70% of the KPIs for 2020. His decision reflects an unusual and amazing leadership in the industry, awareness of the world and extraordinary sensitivities to ask the Remuneration Committee to reinvest these monies for further growth of the Company. In my long career it is rare to find executives who independently pass on their incentives and financial awards for the greater benefit of the Company, shareholders and patients: in Philippe we have long identified a professional of different calibre.

Finally, to summarize in a more personal way, I see the current performance of the Company as follows. The approach and policies of the Remuneration Committee need to change with the times we are living in, and therefore a company and management team needs to be innovative and behave in an entrepreneurial way. For this to succeed, the Company needs to provide a working environment for them to stay on and incentivize them for their achievements.

In CLINUVEL, we have a CFO, CSO and CEO who have this mindset and are not getting out of the boat half-way down the trip: their trip is far from easy, but they have delivered and continue to perform and have built a Company to survive all challenges. As Chairman of the Remuneration Committee this is amazing, I am not sure I would have the stamina to stay on this project for 2 decades.

My vision is simple, entrepreneurship is to implement new combinations, create new business models and change when the environment asks you to do this. With this mindset, this management team is beating all challenges even in the face of economic hard times.

I recommend the Remuneration Report 2020 to all our shareholders and proxy representatives.

 

Willem Blijdorp, Chairman of the Remuneration Committee

Amsterdam 

B. REMUNERATION GOVERNANCE

(i) Remuneration Committee

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.

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

a) 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.

b) The level and composition of remuneration attracts, retains and motivates people of high calibre and with unique specialist industry knowledge to work towards the long-term growth and success of the Company.

c) 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.

d) The levels and structure of remuneration are benchmarked against relevant peers and considered against global employment market conditions.

e) The Company gives due consideration to applicable legal requirements and appropriate standards of governance.

The methods used by the Remuneration Committee to assess Board performance is disclosed in the Corporate Governance Protocol.

(ii) Remuneration Recommendations

Under the provisions of the Committee’s Charter, the Committee may engage the assistance and advice from external remuneration 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 2020, the Remuneration Committee engaged the services of remuneration advisors to assist with a review of the remuneration framework, to benchmark executive KMP salaries and to provide comparable peer company market data. No remuneration recommendations as defined by the Corporations Act was received from external consultants during the financial year. 

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

In the 2019 Annual General Meeting (AGM), the Company obtained 88.96% of the proxy votes (including votes at the Board’s discretion) in favour of adopting the 2018/19 Remuneration Report, and this resolution was carried in favour by poll with 87.69% of votes cast. The Company did not receive any further specific feedback at the AGM on its remuneration practices.

(iv) Historical voting at the Company’s Annual General Meetings since 2006

Since 2006 the Company has obtained a historical average of 92%of proxy votes received (including votes at the proxy’s discretion), either carried by a show of hands prior to and including the 2014 AGM or by a poll result after the 2014 AGM, in favour of adopting the Remuneration Reports presented.

C. EXECUTIVE REMUNERATION

(i) Executive Remuneration Framework

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

  1. Short-term (generally cash payments in the form of performance-based incentives awarded at a fixed amount or as a percentage of base salary).
  2. 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).

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

The CLINUVEL Vision
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 our focus over the long term.
Delivered through the Corporate Strategy
World Leader in Melanocortins.
Diversity and grow.
Establish new markets.
And Achieving Performance
Revenue Growth
Market Capitalisation Growth
Development and commercial progress, set business targets are met.
Is Linked to Total Executive Remuneration
Fixed Remuneration
+
Short-Term Incentives
+
Retention Award*
+
Long-Term Incentives

* Managing Director and CFO only

(ii) Executive Remuneration Structure 2019-20
a. Fixed Remuneration
Base Salary and Non-Monetary Benefits
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.

b. Variable Remuneration – Cash Based
Short-Term Incentive

Short-Term Incentives are annual payments to reward executives for achieving certain regulatory, development, commercial and operational outcomes which are expected to contribute to increasing shareholder value.

The Managing Director’s performance targets are set at the start of each financial year by the Remuneration Committee and are assessed at the end of the financial year. The other Executive performance targets are set at the start of each financial year by the Managing Director and are recommended to the Remuneration Committee for their review and approval.

Payment occurs in the year following the year of achievement.
The target opportunity for the Executives for 2019/20 are:

  • Managing Director: $750,000 Singapore dollars
  • Chief Financial Officer: 17% of Base Salary
    Chief Scientific Officer: 9% of Base Salary

Short-term incentive targets are a mix between 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.
For the Managing Director, the weighting for 2019/20 was 30% financial targets and 70% in individual performance targets. The Board considers the specific performance-based targets to be commercially sensitive and are not provided in detail. The targets for 2019/20 were connected to:

  1. Material progress in regulatory filings and in establishing price agreements with final payors, with an emphasis on the US; 
  2. Profitability and cash preservation; and 
  3. Progress in products and formulations under research & development by the VALLAURIX subsidiary entity.

For the year ended 30 June 2020, the Remuneration Committee assessed the Managing Director’s performance targets which form his Short-Term Incentive and awarded a 70% assessment against the targets. The Managing Director has autonomously chosen to forego this year’s STI award 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. The remainder of CLINUVEL’s staff and executives will receive their awards towards Key Performance Indicators for FY2020.

For the Other Executives, the Short-Term Incentive targets can be a mix of individual performance-based incentives and have a component for time served to encourage staff retention. Each performance-based target is based on specific individual responsibilities and objectives typical for these roles in a global life sciences company at its stage of development and commercialisation. The performance-based incentives covered revenue generation, business expansion and optimisation, regulatory progress, manufacturing, research and development and corporate affairs. The Managing Director assessed overall performance for the 2019/20 year against the Short-Term Incentives and recommended to the Remuneration Committee and who approved the following assessments against the maximum Short-Term Incentives:

  • Chief Scientific Officer: 95%
  • Chief Financial Officer: 89%
Business Generation Incentive
Business Generation Incentives (BGI) 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.

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 July 1 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®;

  • 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 2019/20 financial year, BGI1 was achieved by the Chief Financial Officer.

Retention Award

 

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 employment start.

Managing Director: A$7,500

Chief Financial Officer: A$1,000

There is a risk of forfeiture of 100% of the longevity-based award for 12 months following the July 1 2019 Effective Date of the 2019/20 service agreement should the executives provide a notice of termination during this period. Once the forfeiture period lapses, 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.

Discretionary Payment

 

Managing Director Only: 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 2020 or 30 June 2019.

c. Variable Remuneration – Equity Based
Performance Rights
Performance Rights, being an option to acquire ordinary shares of CLINUVEL PHARMACEUTICALS LTD for nil exercise price, are offered to Executives from time to time to:
  • retain and motivate the Other Executive KMP to drive the long-term growth and success of the Company
  • align their interests with increased shareholder wealth over the longer term

Unlike other equity remuneration plans internationally, performance rights are not granted to Executives annually.

Historically, by virtue of the nature of the Company being primarily focussed on business expansion through ongoing research and development, the Performance Conditions attached to Performance Rights have been based on 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;
  • 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 (performance) conditions attached to the issue of performance rights.

Performance Rights have vesting periods either up to 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.

The achievement of the Performance Condition is assessed and approved by the Board when it is considered satisfied or the condition has otherwise been waived by the Board.

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 the financial years ended 30 June 2020 and 30 June 2019, no Performance Rights were granted to the Other Executive 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 2019/20 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. These unvested Performance Conditions are:

A. Granting market approval for SCENESSE® by the US FDA (not attached to Non-Executive Directors) – achieved in 2019/20;

B. Securing sufficient funding to secure 5 performance conditions (including the performance condition ‘Granting market approval for SCENESSE® by the US FDA’) (not attached to Non-Executive Directors) – achieved in 2019/20;

C. Announcement of commercial partnership to distribute SCENESSE® (or derivative of) (One Non-Executive Director, and Other Executive KMP and staff only); and

D. The earlier of: (a) second molecule in new formulation, or (b) paediatric formulation for afamelanotide (Other Executive KMP and staff only)

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. 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 entirely 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.

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 below:

Description of Performance Conditions Performance Rights
PC1

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

i) Market capitalisation of a minimum A$1,600,000,000 – 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.

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

i) The Company’s growth in share price outperforms either the Nasdaq Biotech Index or ASX Healthcare Index for 1 quarter – after the country has entered a recession – by more than 3.0%, 10% of the performance rights under PC1 shall vest,

ii) The Company’s growth in share price outperforms either the Nasdaq Biotech Index or ASX Healthcare Index for 1 quarter – after the country has entered a recession – by more than 4.0%, 15% of the performance rights under PC1 shall vest,

iii) The Company’s growth in share price outperforms either the Nasdaq Biotech Index or ASX Healthcare Index for 1 quarter – after the country has entered a recession – by more than 5.0%, 25% of the performance rights under PC1 shall vest,

iv) The Company’s growth in share price outperforms either the Nasdaq Biotech Index or ASX Healthcare Index for 1 quarter – after the country has entered a recession – by more than 7.0%, 25% of the performance rights under PC1 shall vest,

v) The Company’s growth in share price outperforms either the Nasdaq Biotech Index or ASX Healthcare Index for 1 quarter – after the country has entered a recession – by more than 9.0%, 25% of the performance rights under PC1 shall vest

450,000
PC2

i) Upon quarterly reporting of A$55 million in cash and cash equivalents held for 2 consecutive quarters, 15% of PC2 shall vest,

ii) Upon quarterly reporting of A$65 million in cash and cash equivalents held for 2 consecutive quarters, a further 20% of PC2 shall vest,

iii) Upon quarterly reporting of A$80 million in cash and cash equivalents held for 2 consecutive quarters, a further 30% of PC2 shall vest,

iv) Upon quarterly reporting of more than A$100million 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
PC3

Successful acquisition of a business entity, defined by:

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

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

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

105,000
PC4

i) Upon receipt of first US revenues under the US post-marketing authorisation 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
PC5

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,

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

175,000
PC6

i) Upon start (being the closure of recruitment period) of a Phase IIb vitiligo study in North America, 20% of PC6 shall vest,

ii) Upon disclosure to the securities exchange of the results to the Phase IIb vitiligo study in North America, 20% of PC6 shall vest,

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

iv) Upon start (being the closure of recruitment period) of the subsequent Phase IIb/III vitiligo study in North America, a further 20%of PC6 shall vest,

v) Upon disclosure to the securities exchange of the results to the subsequent Phase IIb/III vitiligo study in North America, 20% of PC6 shall vest.

262,500
PC7

i) Upon the regulatory submission to either of EMA, FDA, TGA, PMDA and Swissmedic to approve SCENESSE® or any other molecule or product enhancing the pharmaceutical product line-only offerings of the Company, 25% of PC7 shall vest,

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

212,500
PC8

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.

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

116,250

(iii) Managing Director Remuneration – Further Information

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 a 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 most 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 commercial drug pricing and reimbursement negotiations. 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 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.
 

(iV) Executive Remuneration Benchmarking

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 on international securities exchanges for the purpose of peer group analyses. The selection criteria for these companies is 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) businesses of similar risk profile.

CLINUVEL aims to provide competitive remuneration for the Managing Director based on both local and international comparable positions in the relevant market(s). 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. 

During the year the Managing Director’s remuneration was benchmarked against 6 revenue-generating Australian-listed life science companies with market capitalisation between $400 million and $2 billion, along with 11 profit-generating US-listed pharmaceutical companies with market capitalisation between US$200 million and US$10 billion. The current total remuneration level of the Managing Director remains below the median level.

(V) Relationship Between Remuneration And Performance

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 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.

Regulatory, Clinical & Commercial Milestones
Year Ended 30 June
2016
2017
2018
2019
2020
Ph II Vitiligo Study – Singapore
VALLAURIX PTE LTD — formulation & melanocortin development
Post-marketing authorization commitments
First commercial sales in EU
Submission and subsequent approval for marketing authorization by the US FDA
Application for marketing authorization submitted with TGA
First commercial sales in US
~
Market capitalization (A$ million)
203
333
527
1,649
1,267
Share Price High ($)
5.00
9.19
13.52
39.85
45.88
Share Price Low ($)
2.50
4.10
5.91
9.43
12.92
Closing Share Price ($)
4.32
6.98
11.01
33.68
25.65
Change in Share Price over 1 Year (%)
57
62
58
206
(24)
Change in Share Price over 3 Years (%)
139
311
288
680
268
Change in Share Price over 5 Years (%)
162
328
508
1881
803
Dividend Paid (cents)
2.0
2.5

(vi) Executive Remuneration Pay Mix

The Board believes the remuneration mix aligns the Managing Director and Other Executive KMP to shareholder interest. The remuneration mix for 2019/20 is demonstrated as follows:

Position Fixed Remuneration STI Cash

LTI Cash1

LTI Equity2

Managing Director
100%
56% of Base Salary
138% of Baser Salary
Other Executives
100%
Between 9% and 17% of Base Salary
Up to 43% of Base Salary (CFO Only)

1 Does not include Retention Award unearned as at 30 June 2020

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.

A comparison of the 3-Year and 5-Year Total Shareholder Return (TSR) of life science peer companies (being a mix of medical device, pharmaceutical product and diagnostic focussed companies) referred above in section (iv) with CLINUVEL’s TSR for the same period shows CLINUVEL is ranked fourth and third respectively.

D. NON-EXECUTIVE REMUNERATION

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.

Non-Executive Director Fees

Non-Executive Director fees consist of base fees and committee fees and are inclusive of superannuation and all other contributions. There are no further retirement benefits. The fees are outlined in the table below (see right).

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 2020 was $387,417.

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

Board
Fees
Audit &
Risk Committee
Remuneration
Committee
Nomination
Committee
Chair
110,000
Non-Executive Director
65,000
Committee Chair
15,000
15,000
Committee Member
5,000
5,000

Non-Executive Director Long-Term Incentive – Equity Compensation

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

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.

E. SERVICE AGREEMENTS 2019/20

Remuneration and other terms of employment for the Managing Director is 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:

Name

Dr Philippe
Wolgen2

Dr Dennis
Wright

Mr Darren
Keamy3

Duration of contract
3 years
No fixed term
3 years
Notice Period (from Company)
12 months
3 months
12 months
Notice Period (from Managing Director)
12 months
Notice Period (from Executive KMP)
3 months
12 months
Termination Payment without Cause
12 months
3 months
12 months
Termination Payment with Cause
None
None
None

2, 3 Expiry Date 30 June 2022

F. SHARE-BASED REMUNERATION

The Group has an ownership based scheme for Directors4, Other Executive KMP, employees and select consultants of the Company which is designed to provide long-term incentives to deliver long-term value.

Performance Rights

All Performance Rights that have been issued fall under two Performance Rights plans: 

a) the CLINUVEL Conditional Performance Rights Scheme (2009); and

b) the CLINUVEL Performance Rights Plan (2014).

152,710 Performance Rights issued under the 2009 Scheme remain unvested as at 30 June 2020 and there are no further performance rights issued under the 2014 Plan remaining unvested at 30 June 2020. 1,513,750 Performance rights were approved by shareholders to grant to the Managing Director at the 2019 AGM under the 2014 Plan. It is no longer intended to issue performance rights under the 2009 Plan.

a) Conditional Performance Rights Scheme (2009)

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 to the rights have been achieved, whereby these will be held in a Scheme Trust on behalf of the eligible employee for up to seven years. 

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

4 It is no longer planned for Non-Executive Directors to participate in long-term equity compensation plans. Please refer to ‘Non-Executive Director Long-Term Incentive – Equity Compensation’ in section D to this Remuneration Report

b) Performance Rights Plan (2014)

The Performance Rights Plan (2014) is available to eligible persons of the Company. Any issue of rights to Directors requires shareholder approval in accordance with ASX Listing Rules. 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. 

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 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. 

G. DETAILS OF REMUNERATION

2 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 Carol simulation pricing model or a binomial pricing model. The amount expensed each reporting period includes adjustments to the life-to-dale expense of the grants based on the reassessed estimate of achieving non-market performance criteria.
4 Does not include movement in annual leave and long service leave provisions. Upon the renewal of Dr Wolgen’s service agreement in 2019/20 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 avaialble to Dr Wolgen. The natural accretion to his annual leave and long service leave entitlements for 2019/20 was $172,950 (year ending 30 June 2019: $64,483). For Mr Kearny and Dr Wright, the accretive movement to their annual leave and long service leave entitlements was S24,000 and $3,277 respectively (year ending 30 June 2019: $7,429 increase for Mr Keamy and $11,603 decrease for Dr Wright)

KMP REMUNERATION OF THE COMPANY FOR THE YEARS ENDED 30 JUNE 2020 AND 30 JUNE 2019

Post-employment
benefits

Share-based payments (accounting charge only) 2

Year

Gross Salary 4

Short-Term Incentive
Business Generation Incentive

Other 1

Super-annuation/Pension Fund
total (Excluding Share-Based Payments)
Performance rights
Total (Including Share-Based Payments)
$
$
$
$
$
$
$
$

Dr. P.J. Wolgen 3

2020
1,577,235
152,299
1,729,534
1,645,205
3,374,739
2019
893,660
422,747
30,373
1,346,780
68,346
1,415,126
Mr. S.R. Mcliesh
2020
41,857
3,976
45,833
45,833
2019
100,457
9,543
110,000
2,520
112,520
Mrs. B.M. Shanahan
2020
73,059
6,941
80,000
80,000
2019
99,167
6,941
80,000
2,520
82,520
Mr. W.A. Blijdorp
2020
99,167
99,167
99,167
2019
80,000
80,000
80,000
Dr. K.A. Agersborg
2020
67,917
67,917
67,917
2019
65,000
65,000
65,000
Mrs. S. E. Smith
2020
52,667
52,667
52,667
2019
Prof. J. V. Rosenfeld
2020
38,204
3,629
41,833
41,833
2019
Other KMP
Dr. D.J. Wright
2020
257,105
17,355
21,003
295,463
1,284
296,747
2019
252,064
18,149
20,531
290,744
5,608
296,747
Mr. D.M. Keamy
2020
278,713
42,364
30,000
21,003
372,080
4,174
376,254
2019
265,441
32,384
20,531
318,356
18,141
336,497
Total
2020
2,485,924
59,719
30,000
152,299
56,552
2,784,494
1,650,663
4,435,157
2019
1,729,681
473,280
30,373
57,546
2,290,880
97,135
2,388,015

1 Other’ includes health insurance, housing and other allowances that may be subject to fringe benefits tax.

3 In 2019/20 Dr Wolgen’s salary is paid in Singapore dollars (SGD) and in Euro currency.

2 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 Carol simulation pricing model or a binomial pricing model. The amount expensed each reporting period includes adjustments to the life-to-dale expense of the grants based on the reassessed estimate of achieving non-market performance criteria.

4 Does not include movement in annual leave and long service leave provisions. Upon the renewal of Dr Wolgen’s service agreement in 2019/20 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 avaialble to Dr Wolgen. The natural accretion to his annual leave and long service leave entitlements for 2019/20 was $172,950 (year ending 30 June 2019: $64,483). For Mr Kearny and Dr Wright, the accretive movement to their annual leave and long service leave entitlements was S24,000 and $3,277 respectively (year ending 30 June 2019: $7,429 increase for Mr Keamy and $11,603 decrease for Dr Wright)

REMUNERATION PERFORMANCE RIGHTS HOLDINGS OF KMP – 2020

Balance at Start
of Year
Issued as
Compensation
Exercised Lapsed and Expired Balance at End
of Year
Issued as
Compensation after
30 June 2020*
Directors
Mr. S.R. McLiesh
40,000
(40,000)
Mrs. B.M. Shanahan
25,000
25,000
Dr. P.J. Wolgen
208,332
(208,332)
1,513,750
Mr. W.A. Blijdorp
Dr. K.A. Agersborg
Mrs. S. E. Smith
Prof. J. V. Rosenfeld
Other KMP
Dr. D.J. Wright
50,625
(32,500)
18,125
Mr. D.M. Keamy
98,440
(66,080)
32,360
All performance rights held at the end of the year ae unvested.
* Relates to the approval by shareholders to grant performance rights to the Managing Director at the 2019 AGM

SHARES HELD BY KMP

The number of ordinary shares in the Company during the 2019/20 reporting period held by each of the Group’s KMP, including their related parties, is set out below:

Year Ended 30 June 2020
Personnel
Balance at Start of
Year
Granted as
Remuneration
Received on Exercise
Other Changes
Held at the End of
Reporting Period
Mr. S.R. McLiesh
187,774
187,774
Mrs. B.M. Shanahan
258,969
258,969
Dr. P.J. Wolgen
3,296,364
208,332
3,504,696
Mr. W.A. Blijdorp
1,743,118
1,743,118
Dr. K.A. Agersborg
4,100
1,400
5,500
Mrs. S.E. Smith
Prof. J.V. Rosenfeld
1,693
1,693
Other KMP
Dr. D.J. Wright
314,374
32,500
(45,000)
301,874
Mr. D.M. Keamy
306,720
66,080
(41,457)
331,343

TERMS AND CONDITIONS OF EACH GRANT OF RIGHTS AFFECTING REMUNERATION IN THE CURRENT OR FUTURE REPORTING PERIODS

Entity Number of rights Value per Right on
Grant Date
Class Grant Date Vesting Date
for Retention in
Scheme Trust
Lapsing Date
CLINUVEL
91,667
$1.04
Ordinary
25/11/2010
09/10/2019
CLINUVEL
116,667
$1.04
Ordinary
25/11/2010
09/10/2019
CLINUVEL
105,875
$2.16
Ordinary
17/03/2015
09/10/2019

H. ADDITIONAL INFORMATION – REMUNERATION

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.

 

REMUNERATION DETAILS OF EQUITY INCENTIVES (PERFORMANCE RIGHTS)

Equity Incentives (Performance Rights)
Name
Year Granted
Latest Year of
Vesting
Vested in Year
Forfeited in Year
Max Value of Right
at Grant Date Yet
to Vest
Mr. S.R. McLiesh
2011/12
no limitation
100%
Dr. P.J. Wolgen
2010/11
no limitation
100%
2019/20*
2023/24
0%
0%
8,226,311
Mrs. B.M. Shanahan
2011/12
no limitations
16,682
Mr. W.A. Blijdorp
Dr. K.A. Agersborg
Mrs. S.E. Smith
Prof. J.V. Rosenfeld
Other KMP
Dr. D.J. Wright
2011/12
no limitation
55%
12,853
2014/15
2021/22
100%
Mr. D.M. Keamy
2011/12
no limitations
51%
23,126
2014/15
2021/22
100%
The maximum value of outstanding Performance Rights is unable to be estimated. On excercise, 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 used on 26 August 2020

REMUNERATION DETAILS OF CASH INCENTIVES

Name Max Potential Opportunity (%) STI Awarded (%) STI Forfeited (%) Total Granted ($)
DR. P.J. Wolgen
100%
0%
100%
Dr. D.J. Wright
9%
95%
5%
21,982
Mr. D.M. Keamy
17%
89%
11%
42,634

LOANS TO DIRECTORS AND EXECUTIVES

No loans were granted to Directors or executives for the years ended 30 June 2020 and 30 June 2019.

SHARES PROVIDED UPON EXERCISE OF RIGHTS

DETAILS OF SHARES ISSUED DURING THE FINANCIAL YEAR AS A RESULT OF EXERCISE OF RIGHTS

Entity

Number of shares issued 1

Issue Price for Shares Class
CLINUVEL PHARMACEUTICALS LTD
449,705
Nil$
Ordinary

1 These 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.

DETAILSOF SHARES ISSUED DURING THE YEAR TO EMPLOYEES FROM THE 2009 SCHEME TRUST AND THE 2014 PLAN TRUST

Entity

Number of shares issued 1

Issue Price for Shares Class
CLINUVEL PHARMACEUTICALS LTD
359,938
Nil$
Ordinary

1 These 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.

Consolidated Entity
Note
2020
2019
$
$
Total revenues
2(a)
32,565,423
31,047,776
Interest income
2(b)
562,928
564,657
Other income
2(c)
781,319
886,037
Total expenses
2(d)
(20,773,199)
(14,383,643)
Profit before income tax benefit
13,136,471
18,114,827
Income tax benefit
3(a)
3,510,388
19,333
Profit after income tax benefit
16,646,859
18,134,160