Melbourne, Australia and Leatherhead, UK, 30 April 2018
CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY), a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic disorders, today announced its Appendix 4C – Quarterly Cashflow report for the period 01 January to 31 March 2018. All figures are reported in Australian dollars.
Cash receipts from customers for the quarter were $3,480,000, a 118% increase compared to the same quarter last year ($1,597,000 for the January to March 2017 quarter). Orders received from European Erythropoietic Protoporphyria (EPP) Expert Centres 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 fluctuate in the quarterly reporting periods, reflecting the timing of customer payments following cyclical sales orders received for SCENESSE®.
The cash balance as at 31 March 2018 was $28,915,000, an increase of $977,000 to the 31 December 2017 cash balance and an increase of $5,163,000 to the 30 June 2017 cash balance. Net operating payments for the quarter were $3,304,000 compared to $2,040,000 for the same quarter last year and $2,694,000 for the previous one. The increase in net operating payments from the previous quarter was primarily due to a combination of increases in expenditures towards product manufacturing processes, further preparatory work for US regulatory filing, and long-term personnel-related payments. Expenditures also increased for general working capital, with further increases in patent fees, and legal and professional advisor fees to the prior quarter.
The combination of cash receipts and expenditures contributed to a net operating activity positive cash flow of $230,000 for the quarter ended 31 March 2018 (31 December 2017: $1,553,000).
Additionally, favourable exchange rate movements on foreign currencies held resulted in an effect of movement in exchange rates on cash held result of a $752,000 for the quarter (prior quarter: $208,000).
Other than the effect of managing foreign currencies on cash held, the increase in cash reserves is primarily generated from the Company’s operations, reflecting its steady progress. All revenues in the quarter were generated from the CLINUVEL Group’s innovative technology being used to treat an ‘’orphan” indication, whilst the Group focussed on managing its overall cost base.
The CLINUVEL Group has spent over $170 million to date on R&D for its novel drug SCENESSE®, with the product approved in the European Union as the only effective treatment for EPP.
“This is the first time CLINUVEL achieved a positive operating cash flow result for the January to March period, the quarterly period our cash flows are most affected by the seasonal ordering of SCENESSE®,” CLINUVEL’s Chief Financial Officer Mr Darren Keamy said. “We are pleased with the ongoing progress of CLINUVEL and continue to exert financial discipline in our operations.”
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¹ 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.
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
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