Appendix 4C

Appendix 4C

Melbourne, Australia and Leatherhead, UK, 31 October 2018

CLINUVEL PHARMACEUTICALS LTD, a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic and skin disorders, today announced its Appendix 4C – Quarterly Cashflow report for the period 01 July to 30 September 2018. All figures are rounded and reported in Australian dollars.

Cash receipts from customers for the quarter were $10,705,000, an 89% increase compared to the same quarter last year ($5,638,000 for the July to September 2017 quarter) and a 3% increase compared to the previous quarter ($10,388,000 for the April to June 2018 quarter). Orders received from European Erythropoietic Protoporphyria (EPP) Expert Centres (EEECs) continue to reflect the seasonal demand for SCENESSE® (afamelanotide 16mg) in the northern hemisphere where orders for SCENESSE® increase in spring, summer and autumn when EPP patients are at a heightened risk of phototoxic and anaphylactoid reactions.1

Cash receipts are expected to continue to fluctuate in the quarterly reporting periods owing to the timing of customer payments following cyclical sales orders received for SCENESSE®. All revenues in the quarter were generated from the CLINUVEL Group’s innovative technology being used to treat an ‘’orphan” indication, whilst the Group continued to focus on managing its overall cost base.

The cash balance as of 30 September 2018 was $44,391,000, an increase of $8,193,000 to the 30 June 2018 cash balance and an increase of $16,452,000 to the 31 December 2017 cash balance.

Net operating payments for the quarter decreased 12% to $2,864,000 compared to $3,268,000 for the same quarter last year and compared to $3,090,000 for the previous quarter, a 7% reduction. The net operating payments were characterised by expenditures in meeting annual listing, audit, travel and tax fees, work towards the US FDA drug filing, legal and intellectual property work, and personnel-related payments. Planning and management of key expenditures is a major reason for the decline in expenditures.

The combination of cash receipts and expenditures contributed to a net operating activity positive cash flow of $7,873,000 for the quarter ended 30 September 2018. The increase in cash reserves is primarily generated from the Company’s operations, reflecting its sustained progress.

The CLINUVEL Group has incurred costs of over $185 million to date on developing and commercialising its novel drug SCENESSE®, with the product approved in the European Union as the only available and first-line therapy for the treatment of EPP.


“At this stage of the company’s evolution, we are striving for growth which enables us to invest in new technologies and in new products,” CLINUVEL’s Chief Financial Officer Mr Darren Keamy said. “As we move towards the darker months in the northern hemisphere some downward fluctuation in customer payments from SCENESSE® sales is expected each year. We remain vigilant in managing and controlling the Company’s expenditure base in a period where activity levels from US filing, European distribution and product development continue to rise. As CLINUVEL grows, the constant attention to cost management will continue to support the foundation for future success.”

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1 SCENESSE® (afamelanotide16mg) is approved in Europe as an orphan medicinal product for the prevention of phototoxicity in adult patients with EPP. Information on the product can be found on CLINUVEL’s website at


CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY; XETRA-DAX: UR9) is a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic and skin disorders. As pioneers in photomedicine and understanding the interaction of light and human biology, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for photoprotection and repigmentation. These patient groups range in size from 5,000 to 45 million worldwide. CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), was approved by the European Commission in 2014 for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). More information on EPP can be found at Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Switzerland, the US and Singapore, with the UK acting as the EU distribution centre.

For more information go to

SCENESSE® is a registered trademark of CLINUVEL PHARMACEUTICALS LTD.

Media enquiries

USA: Terri Clevenger, Continuum Health Communications, T +1 (203) 227-0209,

Europe: Lachlan Hay, CLINUVEL (UK) LTD, T +44 1372 860 765,

Investor enquiries

Forward-Looking Statements

This release to the Australian Securities Exchange and to press may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause CLINUVEL’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that the FDA may require additional studies beyond the studies planned for product candidates or may not provide regulatory clearances, including for SCENESSE®; that the FDA may not provide regulatory approval for any use of SCENESSE® or that the approval may be limited; that CLINUVEL may never file an NDA for SCENESSE® regulatory approval in the US; that the Company may not be able to access adequate capital to advance its vitiligo programs; that the Company may not be able to retain its current pharmaceutical and biotechnology key personnel and knowhow for further development of its product candidates or may not reach favourable agreements with potential pricing and reimbursement agencies in Europe and the US; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE® which may lead to it being unable to supply its commercial markets and/or clinical trial programs.

Level 6, 15 Queen Street
Melbourne, Victoria 3000

T +61 3 9660 4900
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