This release contains forward-looking statements, which reflect the current beliefs and intentions of CLINUVEL’s management. Statements may involve a number of known and unknown risks that could cause our future results, performance, achievements or output 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; the COVID-19 pandemic and/or other world, regional or national events affecting the supply chain for a protracted period of time, including our ability to develop, manufacture, market and sell biopharmaceutical products; competition for our products, especially SCENESSE® (afamelanotide 16mg), PRÉNUMBRA® or NEURACTHEL®; our ability to achieve expected safety and efficacy results in a timely manner through our innovative R&D efforts; the effectiveness of our patents, trademark 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, Israel, China 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; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE®, PRÉNUMBRA® or NEURACTHEL® which may lead to it being unable to supply its commercial markets and/or clinical trial programs; 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 and consumer based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; our ability 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; risks originating from equity markets, and other factors that have been discussed in our 2021 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 material information, future events or otherwise. More information on preliminary and uncertain forecasts and estimates is available on request, whereby it is stated that past performance is not an indicator of future performance.
Establishing a specialty pharmaceutical group which is
diversified,
vertically integrated,
and which serves unmet patient and
healthcare needs.
We aim to provide a safe and accountable environment,
where our staff are able to grow, thrive and build
a career. In pursuing this mission we provide
long-term value for society and
our shareholders.
Specialty Pharmaceuticals
Value Chain
Healthcare Solutions
Risk Management
Finance
Human Capital
Protoporphyria (EPP)
Intolerance
to UV & HEV
• 5,000 - 10,000 patients globally
Addressable market
• unmet need, no alternative therapy
• SCENESSE® (afamelanotide 16mg)
Therapy
Clinical Profile
• intolerance to UV-HEV = 320 – 450 – 650 nm
• phototoxicity – anaphylactoid reactions
• isolated life, indoors existence
Genetics
• prevelance 1:140,000
• chromosomal defects: 18q21, FECH deficiency
• defective in haem synthesis
Pigmentosum
(XP)
repair DNA
skin damage
from UV +
HEV
European Expert in Genodermatoses: “A systemic treatment in XP would be revolutionary, with afamelanotide we are half-way there.”
Addressable Market
Therapy
• 1,000EU/US/LATAM patients
• high unmet need, no alternative treatment
Clinical problems
• highest risk of exposure to UV-HEV: λ = 320 – 450 nm
• highest rate of skin cancer(s)
• short life expectancy
Genetics
• Prevelance 1:250,000 to 1,000,000
• Chromosomal defects:
XPC: on 3p25.1
XPV: on 6p21.1
• Defective in DNA repair: nucleotide excision repair (NER)
Program
2021-2022
• open label study of 6 adult patients: XP-C
• multiple dosing with afamelanotide
• analyses of afamelanotide treatment
- safety (systemic/cutaneous)
- anti-oxidative effects
- DNA repair capacities
- UV + HEV light tolerance
- quality of life
Division of Healthcare Solutions
OTC Product Lines
• immune suppressed
• history of skin cancer
• extreme outdoor exposure
Technology
Translation
Division of Pharmaceuticals
Rx Product Lines
Xeroderma Pigmentosum
• Afamelanotide evaluated: DNA skin
damage caused by ultraviolet radiation
• Validation of model: assisting populations
at highest risk of solar damage
An estimated 5.4 million non-melanoma skin cancers and >100,000 melanomas are diagnosed in the USA each year.⁴
By 2040, 2.7 million new skin cancer cases are predicted.³
• introduce personal care solutions
• build communities
4.5% to 13.3% of OTRs have had at least 1 skin cancer treatment. Of those, approx. 50% will develop further skin cancers within 2 years.⁷
lack of longitudinal care and communication
fragmented, lack of strong online community
² Snyder et al (2020). Solar UV Exposure in Individuals Who Perform Outdoor Sport Activities. Sports Med – Open. 6(42).
³ Global Cancer Statistics 2020: GLOBOCAN
⁴ American Cancer Society (2021). Key Statistics for Basal and Squamous Cell Skin Cancers. https://www.cancer.org/cancer/basal-and-squamous-cell-skin-cancer/about/key-statistics.html. Key Statistics for Melanoma Skin Cancer. https://www.cancer.org/cancer/melanoma-skin-cancer/about/key-statistics.html
⁵ American Society of Clinical Oncology (2020). Skin Cancer (Non-Melanoma): Risk Factors and Prevention. https://www.cancer.net/cancer-types/skin-cancer-non-melanoma/risk-factors-and-prevention.
⁶ Wei, Li & Nan (2019). Having a first-degree relative with melanoma increases lifetime risk of melanoma, squamous cell carcinoma, and basal cell carcinoma. JAAD. 81(2): 489-99.
⁷ 2019 Statistics: Global Observatory on Donation and Transplantation
⁸ Risks of Multiple Skin Cancers in Organ Transplant Recipients. Mackenzie R. Wehner, MD, MPhil1,2,3; Jiangong Niu, PhD2; Lee Wheless, MD, PhD4; et al
⁹ RunRepeat. Marathon Statistics 2019 Worldwide. https://runrepeat.com/research-marathon-performance-across-nations.
¹⁰ SurferToday. How many surfers are there in the world? https://www.surfertoday.com/surfing/how-many-surfers-are-there-in-the-world. Sports & Fitness Industry Association – Surfing Participation Report 2019.
Individuals with a family history of melanoma, have a markedly increased risk of being diagnosed with melanoma (74% increased), squamous cell carcinoma (22%) and basal cell carcinoma (27%), compared to those without a family history of melanoma.⁶
1.2m people completed a marathon in 2018, nearly 500,000 of whom were in the USA.⁸
The global surfing population is estimated to be between 17-35m people, >2.8m in the USA.⁹
People who practice outdoor sports experience much higher UV exposure, exceed recommended exposure limits, and are at a higher risk of developing skin cancer.²
We set out to connect and increase awareness of the common risks shared by these groups
We engage and offer social native content and solutions
We facilitate a new digital world, one where they connect and form communities
(Fitzpatrick IV-V)
Inclusion > 10% depigmentation
Endpoints: face, head & neck
>70% repigmentation
Inclusion: multiple lesions p/a
Endpoints: reduction in blister formation
Controlled photo-provocation
First three patients completed treatment
Improvement neurological functions (n=3)
Read out 2022
Ischaemic
Stroke
Indication
The rate of reinvestment is only possible due to the high level of financial discipline across the group and managed by our finance team. The ability to retain much of the services within the group enabled CLINUVEL to contain its cost base and gradually increase its experimental output.
The illustration shows the cautious approach to managing available funds over the years, as well as the revenues versus expenditures. Ten years after starting the program, and 3 years after EMA approval of SCENESSE® the company became profitable. CLINUVEL’s entrenched ways of approaching its operational and capital expenditures make returns on deployed capital (ROCE) more likely, and plays a part in the perception of the company’s conduct by state and private insurers. Our shareholders have reaped the benefit from the fiscal discipline.
The CAGR over the years has reached double digits, while the earnings per share was recorded at A$0.50 in FY2021.
As the Company increases its operations, the operating and capital expenditures will increase to ensure further growth, but most of all for us to realize our objectives.
Financial Discipline
the optimist expects it to change
the realist adjusts the sails