About CLINUVEL

CLINUVEL sustains profitability first-half of year

CLINUVEL sustains profitability first-half of year
Financial performance to reinvest in global expansion
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EXECUTIVE SUMMARY
• total revenues: A$7.19 million1
• 3% increase in total revenues PRP
• commercial sales revenues: A$5.33 million
• cash increase from 30 June 2017: A$4.19 million
• net profit after tax: A$1.41 million (44% decrease PRP)
• growth in number of expert treatment centres prescribing SCENESSE®
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28 FEBRUARY 2018, MELBOURNE - CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY) today announced financial results for the half year ended 31 December 2017, reporting net profit after tax of A$1.41m, and total revenues of A$7.19m.

FINANCIAL RESULT

The financial result reflects overall increased revenues of 3% compared to the previous reporting period (PRP) to the half year ended 31 December 2016 and an increase of 28% for the commercial sales of SCENESSE® (afamelanotide 16mg) compared to the PRP (A$5.33 million in 2017 against A$4.18 million in 2016). The number of expert centres prescribing SCENESSE® increased to 13 centres in comparison to 4 centres for the PRP. Total revenues were A$7.19 million for the period. Cash and cash equivalents increased by A$4.19 million for the six months to 31 December 2017.

As a result of an increase in overall expenses across the Group’s global operations, the net profit of A$1.41 million for the period was down 44% compared to the PRP. The increase in expenses were primarily associated with the distribution activities for making SCENESSE® available to a growing number of expert centres which provide treatment to patients with the rare genetic disorder erythropoietic protoporphyria (EPP).2 Increased staff numbers and key personnel remuneration-related costs was also a contributing factor, resulting in a 27% increase in general operations (A$2.73 million in 2017 compared to the PRP of A$2.15 million). CLINUVEL is currently preparing to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) aiming to obtain marketing approval. Costs related to regulatory and non-clinical work for the NDA contributed to an increase of 86% in regulatory and non-clinical expenses compared to the PRP (A$0.91 million in 2017 against A$0.49 million in 2016).

CLINUVEL’s CEO, Dr Philippe Wolgen said “In remembering where this program started in 2005 with a mere scientific concept requiring ample equity funding and the objectives we had set ourselves, we are pleased to report sustained half year profits for the Group. The focus remains to advance the market access to European - and eventually to US - EPP patients who have no other therapeutic options.”

“We have sufficient grounds to maintain our reputed cost management while maximizing the output. As we see more prescriptions of SCENESSE® we will progressively be in the position to broaden the infrastructure enabling growth on multiple fronts. CLINUVEL’s mandate is to substantially reinvest in novel products and services, and therefore the obligatory art is to balance cash flows with expenditures required for long term growth. Overall, we are on track against our own financial expectations, comfortable with financial ratios we adhere to and optimistic for the future direction of the company.” Dr Wolgen said.

1 Figures in this release are presented in Australian dollars and may not reflect reporting due to rounding. See the Company’s Appendix 4D for exact figures.

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.

Media enquiries
Lachlan Hay, CLINUVEL (UK) LTD,     +44 1372 860 765     This email address is being protected from spambots. You need JavaScript enabled to view it.

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Forward-Looking Statements
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
Australia

Additional Info

  • customtext: CLINUVEL PHARMACEUTICALS LTD today announced financial results for the half year ended 31 December 2017, reporting net profit after tax of A$1.41m, and total revenues of A$7.19m.
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