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Appendix 4D Half Yearly Report

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 financial result for the six months ended 31 December 2019. All figures are rounded and reported in Australian dollars.

FINANCIAL RESULT

CLINUVEL achieved positive results in the half year to 31 December 2019:

  • Net Profit result of $1.059m, the eighth consecutive half year net profit result;
  • Total Revenues of $9.971m, up 11% compared to the same period 2018;
  • Expenses up 54%, compared to the same period 2018, with investment in key areas of the business to allow the Company’s growing activities;
  • As a result, net profit was 74% lower than in the half year ended December 2018;
  • Balance Sheet remains strong, featuring nil Debt, Cash of $57.432m and Net Equity of $58m; and
  • Positive Earnings Per Share of $0.022.

Full details of the financial results are in the following Appendix 4D Half Year Financial Report.

EUROPEAN GROWTH

The Company’s European business continues to demonstrate revenue growth from distributing SCENESSE® (afamelanotide 16mg) for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).1 More patients are receiving treatment for the first time and product supply has been expanded in those countries receiving SCENESSE® for up to the past four years where high patient retention rates approximate 95%. The Company has implemented a uniform pricing policy in the European Economic Area whereby the price of SCENESSE® remained consistent between the two reporting periods.

INVESTING IN STRATEGIC EXPANSION

CLINUVEL has focussed heavily on maintaining a deliberately prudent approach to containing expenses in the prior reporting periods, leading up to the decision by the US Food and Drug Administration (FDA) to approve SCENESSE®. With this essential regulatory highlight in October 2019, the Group is now in the position to increase its cost base to allow for expansion into new markets, in both existing and new R&D activities. This has been witnessed in part by the Group investing in additional personnel across its research and development, regulatory affairs and business support functions, as well as in activities across its manufacturing supply and distribution chain. These investments were a core consideration in the six months as it provides a platform for the Group to pursue its near- and longer-term objectives to expand into the USA and to further progress its product development pipeline. This includes SCENESSE® as a treatment for the skin depigmentation disorder, vitiligo,2 along with the new product development program underway at CLINUVEL’s research and development facilities in Singapore, currently being expanded.3 Ultimately, the expenses incurred to support these strategic initiatives are expected to result in new sources of revenue for the Group in future periods.

COMMENTARY

“The eighth consecutive half year profit is a timed and well-managed outcome as it has been sustained in a period where the Group further re-invested in the business which, as expected, had an effect on the net profit result,” CLINUVEL’s Chief Financial Officer, Darren Keamy said. “We had long planned to establish cash reserves to accommodate for any economic downturns, allowing CLINUVEL to execute its plans without significant concerns about building a promising business.
“As part of our long-term plans, growth in the existing revenue base from distribution of SCENESSE® in the Eurozone has enabled the Group to self-finance its growth which include expansion into the US. In balancing the entry into new territories, diffusion in new medical indications and control over our costs, we continue to progress the strategic initiatives set by the Board for long term performance of the Group.”

1 SCENESSE® (afamelanotide 16mg) is approved in the European Union as an orphan medicinal product for the prevention of phototoxicity in adult patients with EPP. SCENESSE® is approved in the USA to increase pain free light exposure in adult EPP patients with a history of phototoxicity. Information on the product can be found on CLINUVEL’s website at www.clinuvel.com.

2 Refer Company Announcement, 10 February 2020. CLINUVEL PHARMACEUTICALS LTD announced it has requested a Type C Guidance meeting with the FDA to seek agreement on the design of a multicentre Phase IIb vitiligo clinical study (CUV104) and the data package necessary to support a supplemental New Drug Application (sNDA) filing for CLINUVEL’s drug SCENESSE® in vitiligo.

3
Refer Company Announcement, 24 February 2020. CLINUVEL PHARMACEUTICALS LTD announced it is expanding its Singapore laboratories with the support of a grant from the Singapore Economic Development Board.

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