31 January 2018
Melbourne, Australia and Leatherhead, UK
CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY), a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe and therapeutically unmet genetic disorders today announced its Appendix 4C – Quarterly Cashflow report for the period 01 October to 31 December 2017.1
The cash balance as at 31 December 2017 was $27,938,000, an increase of $1,758,000 to the 30 September 2017 cash balance and an increase of $4,186,000 to the 30 June 2017 cash balance.
Cash receipts for the quarter were $4,199,000 compared to $5,638,000 for the previous quarter. The cash receipts reflect the cyclical demand for SCENESSE® (afamelanotide 16mg) in the northern hemisphere where orders for SCENESSE® increase in spring and summer when EPP patients are at a heightened risk of phototoxic reactions. Cash receipts are expected to fluctuate in the following quarterly reporting periods, reflecting the timing of customer payments following sales orders received for SCENESSE®.
Net operating payments for the quarter were $2,694,000 compared to $3,269,000 for the previous quarter. The decrease in net operating payments from the previous quarter was primarily due to increased personnel costs occurring in the prior quarter following the 30 June financial year end. Reclaiming of indirect taxes paid in prior quarters was partially offset by increased working capital spending on global insurances, patent fees, legal and professional advisor fees. The combination of cash receipts and expenditures contributed to a net operating activity positive cash flow of $1,553,000 for the quarter ended 31 December 2017 (30 September 2017: $2,470,000).
The increase in cash reserves is primarily generated from its operations, reflecting the Company’s first full calendar year in generating revenues from launching a novel drug in a new therapeutic ‘’orphan” area, whilst continuing to control overall costs.
CLINUVEL has spent over $170 million to date on its novel drug SCENESSE®, with the product approved in the European Union as the only treatment for the ultra-rare disorder erythropoietic protoporphyria (EPP).2
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1 All figures are reported in Australian dollars.
2 SCENESSE® (afamelanotide 16mg) 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 www.clinuvel.com.
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About CLINUVEL PHARMACEUTICALS LIMITED
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 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 product, 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 http://www.epp.care.
Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Switzerland, the US and Singapore.
For more information go to http://www.clinuvel.com.
SCENESSE® is a registered trademark of CLINUVEL PHARMACEUTICALS LTD.
This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. Statements may involve a number of known and unknown risks that could cause our future results, performance or achievements to differ significantly from those expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialise pharmaceutical products, including our ability to develop, manufacture, market and sell biopharmaceutical products; competition for our products, especially SCENESSE® (afamelanotide 16mg); our ability to achieve expected safety and efficacy results through our innovative R&D efforts; the effectiveness of our patents and other protections for innovative products, particularly in view of national and regional variations in patent laws; our potential exposure to product liability claims to the extent not covered by insurance; increased government scrutiny in either Australia, the U.S., Europe and Japan of our agreements with third parties and suppliers; our exposure to currency fluctuations and restrictions as well as credit risks; the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement; any failures to comply with any government payment system (i.e. Medicare) reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; any failure to retain or attract key personnel and managerial talent; the impact of broader change within the pharmaceutical industry and related industries; potential changes to tax liabilities or legislation; environmental risks; and other factors that have been discussed in our 2017 Annual Report. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation, outside of those required under applicable laws or relevant listing rules of the Australian Securities Exchange, to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. More information on the forecasts
Level 6, 15 Queen Street T +61 3 9660 4900 www.clinuvel.com
Melbourne, Victoria 3000 F +61 3 9660 4999