Plans 2025 and Beyond

Building a global pharmaceutical group

CLINUVEL commenced the third phase of its evolution in September 2020 with the announcement of
the DNA Repair Program, focused initially on evaluating SCENESSE® as the first ever treatment for xeroderma pigmentosum (XP). An important precursor to this was the opening of a new bespoke, state-of-the-art Research, Development & Innovation (RD&I) Centre in Singapore, in August 2020.
 
The Company has since established a broad new product development pipeline encompassing:
  • new pharmaceutical products – PRÉNUMBRA® and NEURACTHEL®;
  • three PhotoCosmetic product ranges – polychromatic protection (PROTECT), DNA repair (PRESERVE) and melanogenesis (BRONZE); and
  • new clinical studies and programs – vitiligo, XP, VP, stroke, and most recently, Parkinson’s disease.
The Company’s expansion is enabled by the success of the strategy formed in FY2006 to focus on one drug (SCENESSE®) for one indication (EPP). The first phase of the Company’s evolution was the period spanning FY2006 to FY2019 which involved drug development, clinical studies, and regulatory approvals. The second phase was the commercialisation of SCENESSE® to treat EPP patients – this commenced in the EU in 2016 and the US in 2020. There is some overlap between the milestones of each phase. Collectively, these phases have established a strong foundation for FY2025 and beyond. Specifically, annual revenues growth and controlled expense management has resulted in rising profitability over the FY2017 to FY2024 period and the accumulation of sufficient cash reserves to fund all our development programs simultaneously, without resorting to dilutive capital raisings.
 
This feature highlights the Company’s activities and key objectives over the next three years.

Expenses Plan

Five Years to 30 June 2025 (A$m)

Expenses FY2021, FY2022 , FY2023 and FY2024, exclude expenses associated with Communications, Branding & Marketing (CBM). Indicative path of cumulative expenses, excluding CBM expenses, is shown to projected expenses of A$175.0 million to 30 June 2025.

Investment

The Company provided a projection of the expenses that would be incurred during the five-year period from FY2021 to FY2025 to reassure stakeholders of the continued focus on controlled expenses to support its expansion initiatives. The expenses plan of A$175.0 million for the five-year period was set before the onset of the increase in global inflation and did not include capital expenditures or the expenses to be incurred by the Communications, Branding & Marketing Division (CBM) on the PhotoCosmetic product ranges. The chart below show the expenses, excluding CBM expenses, that have been incurred. At the end of the fourth year of the plan, expenses of A$125.2 million (or 72% of the plan) have been accumulated.

When the expenses plan was set, it was expected that the Company’s cash reserves would be fully utilised to finance it. However, the strong performance of the Company has resulted in annual net cash inflows which have replenished what has been expended on growth initiatives. This has resulted in a rise in cash reserves which underpin the Company’s self-financing capability. Had the Company not followed its long-term strategic path and instead resorted to issuing shares to finance the A$175.0 million expenses plan, the ownership of existing shareholders would have been significantly diluted. From certain assumptions on capital raisings of A$50 million on 30 June 2022 and 30 June 2023 and A$75.0 million on 30 June 2024, the potential dilution of shareholder ownership is estimated to be around 20%. The fact that this course of action was not required reinforces the value of the Company’s strategy and effective cost management of its expansion.

Distribution of SCENESSE® for EPP

We are committed to ensuring the ongoing supply of SCENESSE® and increased treatment centres and reimbursement arrangements to support expected growth in patient demand. The demand of EPP patients for SCENESSE® was robust in FY2024 and is expected to continue over the next three years. Step-up growth may come from access to new countries, including Latin America through our partnership with Valentech, and regulatory approval, following the completion of CUV052 and re-submission to the EMA, to treat adolescent patients.
 
In the USA we have expanded our independent network of Specialty Centers to 85 and are well on track to reach 120 centres by the end of 2025. This network will be capable of treating both EPP and other patients, with an initial focus on vitiligo.

Clinical Programs

Clinical programs are expected to progress through typical study phases to support compelling dossiers to obtain the approval of regulatory authorities. It is important to note that clinical and regulatory timelines are subject to change according to a range of internal and external factors.
Program FY2025 FY2026-FY2027
Vitiligo
  • CUV105 Phase III recruitment completed
  • CUV107 Phase III recruitment commenced
  • CUV105 Phase III first results
  • CUV107 Phase III first results
  • FDA meeting
  • Submission FDA
DNA Repair – XP
  • CUV152 and 156 Phase II results
  • Commence CUV154, late-stage study
  • New Phase II study results
  • Regulatory approval, label expansion
VP
  • Further clinical studies to commence
  • Further study results
Arterial Ischaemic Stroke
  • CUV803 Phase II study first results
  • Further clinical development
Parkinson’s Disease
  • CUV901 Phase IIa study to commence patient treatment
  • CUV901 Phase IIa study first results
  • Further clinical development

Pharmaceutical products

PRÉNUMBRA® has been developed and its use is to be expanded in the clinic from stroke to Parkinson’s.

NEURACTHEL® in instant and modified-release formulations will continue to be developed. An update on manufacturing will be provided during FY2025. The objective is to seek approval of an Abbreviated New Drug Application (ANDA) to treat Infantile Spasms and Multiple Sclerosis which are underserved in the current market.

PhotoCosmetics

CLINUVEL is looking to breakthrough into the industry by being the first company to launch a line of cosmetics based on melanocortin technology. Melanogenesis is the action of our category defining product, which comes from the knowledge and translation of the technology that is delivering breakthrough therapies for vitiligo. The objective is to safely enhance the natural process of bronzing.

Our desire is global, and so are our campaigns; please join us on the journey in the next year, we will focus on medical channels, starting with dematologists and medical practitioners. This will work as a catalyst for everything to come in the next two years. Influencers in the beauty industry, beauty editors and industry publications will come to our briefings and become aware of CLINUVEL’s evolution into cosmetics. Exciting plans of scale are underway, and the CLINUVEL team is growing at a rapid pace to accommodate an inevitable shift towards global visibility. Who wouldn’t respond to the call of
a bronzed skin, not only without the solar risk, but as a means of protection? Or to preserve our biggest organ, the skin. Our objective is clear; to become a household name by 2026.
 
In 2025 we will initiate global product launches of the PROTECT range, in preparation of the M-lines, the melanocortin-containing
topical formulations. Subject to formulation and manufacturing development work, the first products of the melanocortin product lines are expected to be launched in calendar year 2026. This next generation product will be the first of its kind, putting CLINUVEL at centre stage of a total addressable market of US$6.2 billion.

This will be the time for the wider world to know CLINUVEL’s PhotoCosmetic offerings. We will have global events, launching around the world in locations synonymous with sunshine and luxury: Cannes, Ibiza, Saint-Tropez, Malibu, Venice Beach, St Morritz & Aspen, as well as key urban cities. This will be amplified by a global media program, focusing on magazines, digital media and brand partnerships. Our launch will be targeted to specific audiences via luxury stockists, digital media and specialised digital clientele. We will foster a global ambassador programme, amplifying the knowledge and experience of survivors, experts and athletes who effortlessly align with CLINUVEL. Exciting times lie ahead.

Acquisition plans

We continue to assess inorganic growth opportunities and have a keen eye out for assets that add value to the Group, whether they be at late clinical stage
or involved in the manufacture of healthcare products. The intention is to complete a revenue adding acquisition over the coming few years.By the end of FY2027 we expect to have achieved our product objectives and progressed the conditions to be treated. Whilst stroke and Parkinson’s are medium to long-term programs, the vitiligo program is expected to have progressed towards FDA approval. The treatment of vitiligo offers the prospect of revenues of US$490 – 570 million in the first two years of distribution from the treatment of approximately 6,000 patients. This will transform the financial profile of the Company.
 
The Company may also have completed the acquisition of a new asset, thus adding to sustainable future earnings.
 
This is an exciting time to be a CLINUVEL shareholder and witness the incremental long-term value being added. We expect the market to reflect the advances being made on these initiatives and step-up demand for CUV accordingly.

Summary

We are working towards a diversified biopharmaceutical for long-term sustainability based on:

3

Pharmaceutical products

8

Conditions treated

3

PhotoCosmetic product lines

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