Melbourne, Australia and Leatherhead, UK, 30 July 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 and skin disorders, today announced its Appendix 4C – Quarterly Cashflow report for the period 01 April to 30 June 2018. All figures are rounded and reported in Australian dollars.
Cash receipts from customers for the quarter were $10,388,000, a 66% increase compared to the same quarter last year ($6,247,000 for the April to June 2017 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 anaphylactoid reactions.1
Cash receipts are expected to continue 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 30 June 2018 was $36,198,000, an increase of $8,260,000 to the 31 December 2017 cash balance and an increase of $12,446,000 to the 30 June 2017 cash balance.
Net operating payments for the quarter increased 37% to $3,090,000 compared to $2,248,000 for the same quarter last year and compared to $3,304,000 for the previous quarter, a 6% reduction. The net operating payments continue to be characterised by expenditures towards product manufacturing processes, servicing the regulatory commitments to supply SCENESSE® to EEECs, work towards the US regulatory filing, legal and intellectual property work, and long-term personnel-related payments. A $53,000 receipt was received under the Australian R&D tax incentive regime relating to the 2016/17 year.
The combination of cash receipts and expenditures contributed to a net operating activity positive cash flow of $7,440,000 for the quarter ended 30 June 2018. This compares to an increase to net operating cash flow of $4,626,000 for the quarter ended 30 June 2017 and an increase of $230,000 to net operating cash flow in the previous quarter ended 31 March 2018.
The increase in cash reserves is primarily generated from the Company’s operations, reflecting its sustained 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 available and first-line therapy for the treatment of EPP.
“This quarter has seen the highest positive operating cash flow result for the Company, with the increase in sales receipts influenced by the seasonal ordering of SCENESSE®,” CLINUVEL’s Chief Financial Officer Mr Darren Keamy said. “We continue to focus on expanding the use of SCENESSE® in Europe whilst exercising diligence in pursuing both the US filing and our product development.”
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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 photomedicine and understanding the interaction of light and human biology, CLINUVEL’s research and development has led to innovative treatment(s) 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 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.
Lachlan Hay, CLINUVEL (UK) LTD.
+44 1372 860 765
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 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 T +61 3 9660 4900 www.clinuvel.com
Melbourne, Victoria 3000 F +61 3 9660 4999