On November 1, 2022 CLINUVEL recorded its highest quarterly results from customer receipts since the commencement of commercial operations in Europe in June 2016 and United States in April 2020 (Press release, Clinuvel, NOV 1, 2022, View Source;mc_eid=a3338e0afe [SID1234622637]). New patient uptake of CLINUVEL’s drug SCENESSE (afamelanotide 16mg) coincided with peak treatment demand from both continents. CLINUVEL’s receipts from customers for the July to September quarter were $25.152 million, with net operating expenditures of $8.270 million and net operating cashflow totalling $17.338 million.

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The quarter-on-quarter increase of overall net operating expenditures (47%) reflects the impact of the timing of certain payments as well as a controlled increased in overall expenditures as CLINUVEL expands its R&D activities. On an annual basis, operating expenditures demonstrates a 31.9% increase for the 12 months to 30 September 2022, indicating an ongoing commitment to re-invest in the business.

FULL YEAR DIVIDEND
Total cash reserves were impacted by CLINUVEL paying, on 21 September 2022, a
full year unfranked dividend distribution of $0.04 per share, translating to a $1,976,000 payment to registered holders. This was a 60% increase to the dividend distribution made in September 2021. The strong performance of the Company for the 2021/22 financial year allowed the Board to declare the increase in dividend, most of all recognising the loyalty and patience of long-term shareholders.

"The positive net cash inflow results reflects the demand over the spring and summer months in the northern hemisphere, the efficiency of the Company’s commercial infrastructure, coupled with a focus on containing cost increases," CLINUVEL’s Chief Financial Officer, Darren Keamy said.

"The growth in the cash position enables management to dedicate itself to pursuing further strategic initiatives, while research and development are ongoing to expand the Company’s pipeline. Global economic conditions are dire and an energy crisis is looming in many parts of the world, yet we are on course to realise CLINUVEL’s growth plans, allowing us to come out stronger when the global economies recover."

POSITION TO SELF-FINANCE GROWTH
CLINUVEL has communicated a strategic commitment to spend $175m on the growth of the business over the five years to 30 June 2025. Expenses are steadily increasing but well within the window projected for its Pharmaceutical and Healthcare Solutions Divisions to expand clinical use of SCENESSE and to add new products. The Company’s investments remain on track with its forecast with just over $55 million spent in FY2021/22, and therefore, around $120 million to be expended over the next three years. This excludes capital expenditures.

KEY ACTIVITIES
Key activities in the September quarter 2022 are summarised below.
Commercial Operations
During the past quarter, treatment was extended to more patients and the close relationships with healthcare professionals, insurers, and government agencies continued to facilitate access to treatment for erythropoietic protoporphyria (EPP) patients.

Progress of Clinical Programs
CLINUVEL is focused on an expanded range of targeted clinical development programs evaluating the safety and efficacy of melanocortins – including afamelanotide – for patients with genetic, metabolic, life-threatening and acute disorders. A summary of the clinical programs is provided below:

Healthcare Solutions
CLINUVEL differentiates itself from most pharmaceutical companies by translating its expertise and technology (the class of melanocortins) to non-prescription products for wider use and for specialised populations in need of strong and long term skin care. These populations are characterised as being at Highest Risk of photodamage and skin cancers.

CLINUVEL continues to work towards the launch of a range of dermatocosmetic products aimed at specialised populations at highest risk from exposure to ultraviolet (UV) and high energy visible (HEV) light. The first product CYACÊLLE provides polychromatic protection against light in the invisible and visible spectrum. Research & development of future product lines is underway. These products will assist in DNA repair of affected skin, while aiming to stabilise melanogenesis.

Ahead of formal product launch, staggered digital marketing campaigns are underway to establish specialized audiences at highest risk of solar damage and prone to skin cancers and melanoma. New digital platforms, including LightSkinScience.com, and dedicated social media channels have been launched, with a team of CLINUVEL Ambassadors (CUVAs) engaged to educate and build connectivity with the targeted audiences.

Other Activities and Announcements

The Company’s Annual Report for the past financial year (ended 30 June 2022) was
announced on 30 August 2022 and, following a briefing to shareholders first in Basel and later in Monaco, the Company released its fifth Strategic Update on 19 September. The Company’s announcements in the September quarter 2022 are available on the CLINUVEL website, with other updates available on the CLINUVEL News website.

Although the Company is no longer obligated under ASX Listing Rules to publish quarterly cash flow results, it elects to continue to do so to keep its global investors updated regularly. A copy of the Appendix 4C – Quarterly Cash Flow Report for the final quarter of FY2022 is attached.
Pursuant to Listing Rule 4.7C and as disclosed in Item 6.1 to the attached
Appendix 4C, $2,648,000 were recorded in respect to Non-Executive Directors’
fees, Managing Director’s fees and payments towards non-monetary benefits
(inclusive of short-term incentive and long-term retention benefit entitlement
to Managing Director).
1 SCENESSE (afamelanotide 16mg) is approved in the European Union and Australia as an orphan medicinal product for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (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.