FIFTEEN YEAR PERFORMANCE OVERVIEW
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.