On July 25, 2022 CLINUVEL PHARMACEUTICALS LTD reported its Appendix 4C – Quarterly Cashflow Report and Activity Report for the period 01 April to 30 June 2022 (Press release, Clinuvel, JUL 25, 2022, View Source [SID1234616910]).
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STRONG OPERATING CASH FLOW
CLINUVEL’s customer receipts were strong in the final quarter of the 2022 financial year (ended 30 June), driven by rising clinical demand for SCENESSE (afamelanotide 16mg) treatment. 1 The Company continued active management of expenditures across the Group, resulting in a considerable increase in net cash from operating activities. During the quarter ended 30 June 2022, more treatment centres facilitated access to SCENESSE for a larger pool of patients, as CLINUVEL personnel worked closely with insurers and government agencies enabling wider reimbursement for treatment.
"Our operating systems are getting to an optimum level following years of building the foundations for self-distribution and commercial market access," CLINUVEL’s Chief Financial Officer, Darren Keamy said. "Of course we are pleased with the strong financial result, placing the Company in an ideal position to realise its growth plans: increasing access to SCENESSE in response to demand, expanding our product portfolio, and seizing value-adding opportunities." HIGHLIGHTS CASH FLOW Q4 FY2022¹ Cash receipts2 $24,053,000 Operating cash expenditures $5,624,000 Net operating cash flow3 +$18,478,000 Cash reserves4 +19.3% Debt-free 1. Period 01 April to 30 June 2022. All dollar figures in this release are rounded and reported in Australian dollars. 2. Excludes interest income. 3. Operating cash flow excludes non-cash items. 4. % increase in cash reserves compared to previous quarter. Page 2 Appendix 4C & Activity Report In 2021, CLINUVEL outlined a growth strategy which would see the Group spend $175m over five years (to 30 June 2025). The Company is nigh on track against this forecast and is steadily increasing expenditure in its Pharmaceutical and Healthcare Solutions Divisions with the aim to expand clinical use of SCENESSE and add new products. All of CLINUVEL’s cash receipts are generated from its operations, without reliance on debt or equity funding. "CLINUVEL is one of the few life sciences companies on the ASX to generate positive cash flows and profit and seeks to set an example of prudent financial management. Part of this approach is ensuring we can protect the Company from environmental and market pressures, while we execute our longterm plans," Mr Keamy said.
CASH RECEIPTS AND OPERATING EXPENDITURES – JUNE QUARTER 2022 CLINUVEL recorded Q4 FY2022 cash receipts of $24,503,000, a 64% increase on the same quarter of 2021. Operating expenditures totalled $5,624,000 for the quarter, less than the previous four quarters and largely due to a temporary decline in supply chain and manufacturing costs. Overall costs are expected to trend back to previous levels in the near term to meet ongoing clinical demand. Increase in staff has been required to manage and implement various ongoing programs within the Pharmaceuticals and Healthcare Solutions Divisions. The net operating cash flow for the quarter was $18,478,000.
KEY ACTIVITIES – JUNE QUARTER 2022 Commercial Operations CLINUVEL’s distribution of SCENESSE to the EPP community in Europe, the USA, and Israel continued under commercial and special access programs during the June quarter 2022 to meet ongoing and growing patient demand.-$10-$5 $0 $5 $10 $15 $20 $25 Jun-17 Dec-17 Jun-18 Dec-18 Jun-19 Dec-19 Jun-20 Dec-20 Jun-21 Dec-21 Jun-22 A$m Quarter ended Quarterly Cash Flows-CLINUVEL Receipts Operating Expenditures Net Operating Cash Flows Page 3 Appendix 4C & Activity Report Progress of Clinical Programs CLINUVEL has expanded targeted clinical development programs evaluating safety and efficacy of melanocortins – including afamelanotide – for patients with genetic, metabolic, life-threatening and acute disorders. The last update on the Company’s programs was provided in News Communiqué III, released on 23 June 2022. For ease of reference, a summary is provided below.
Healthcare Solutions CLINUVEL is committed to translating its expertise in the role of melanocortins in the human body from the Pharmaceuticals Division to the general population through its Healthcare Solutions Division. A range of overthe-counter topical products is being developed and commercialised for targeted audiences at the highest risk from exposure to ultraviolet (UV) and high energy visible (HEV) light.
The first product will provide polychromatic protection across a wider spectrum of light. Future dermatocosmetic products will assist in DNA repair of the skin and the stabilisation of melanogenesis, drawing on the technology and learnings from the Pharmaceutical Division programs. Ahead of formal product launch, an extensive digital marketing campaign is being deployed to build a following amongst targeted audiences. 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 CLINUVEL announced its Strategic Update IV in May 2022, which can be accessed on the Company’s website.
The Company’s announcements in the June 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, $1,065,000 were recorded in respect to Non-Executive Directors’ fees, Managing Director’s fees and non-monetary benefits (inclusive of non-monetary and non-cash benefits and unused and long accrued annual leave entitlement to Managing Director).