FRONT COVER: 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.
CONTENTS
4 | 6 | 8 | |
Mission, Vision | Chair's Letter | Media, Events & | |
& Values | Peer Reviews |
9 | 13 | 17 | 22 |
Managing | CLINUVEL | Innovation in | Singapore |
Director's | in the New | DNA Repair | RDI Centre |
Letter | World Order |
24 | 36 | 49 | 50 |
Directors' | Remuneration | Statement of | Statement |
Report | Report | Comprehensive | of Financial |
Income | Position |
51 | 52 | 53 | 71 |
Statement of | Statement | Notes to the | Directors' |
Cash Flows | of Changes | Financial | Declaration |
in Equity | Statements |
72 | 77 | 80 | 81 |
Independent | Shareholder | Market | Glossary |
Auditor's | Performance | ||
Information | |||
Report | |||
1
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 focused 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 of 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.
Financial Performance, 2005 to 2020, $Am
70.0
R&D, Pre-Commercial Phase | Commercial Phase |
60.0
50.0
40.0
30.0
20.0
10.0
0.0
2005 | 2006 | 2007 | 2008 | 2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019 | 2020 |
-10.0-20.0-30.0
Expenses Revenues Net Profit Cash Reserves
Financial years ending 30 June, revenues include all other income, cash reserves are cash & cash equivalents, net profit after tax
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.
2
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Clinuvel Pharmaceuticals Limited published this content on 09 October 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 October 2020 00:44:06 UTC