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    CUV   AU000000CUV3


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10/06CLINUVEL PHARMACEUTICALS : Operations Update Webcast II
10/05Australia shares nearly flat as financials' losses offset tech, healthcare gains
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Clinuvel Pharmaceuticals : Corporate Presentation - FY2021 Results

08/25/2021 | 08:51pm EDT

CLINUVEL Update - Financial Year Ending 30 June 2021

Investor Briefings, August - September 2021


Financial Year Ending 30 June 2021

Investor Briefings, August - September 2021




Level 1 ADR (Nasdaq Int'l Designation):






Presented by

Darren Keamy

Malcolm Bull

Chief Financial Officer

Head of Investor Relations

This briefing provides an overview of CLINUVEL encompassing the financial results for the year ending 30 June 2021.

CLINUVEL Update - Financial Year Ending 30 June 2021 www.clinuvel.com

CLINUVEL Update - Financial Year Ending 30 June 2021Investor Briefings, August - September 2021

Legal Notice

This release contains forward-looking statements, which reflect the current

the outsourced manufacturing of SCENESSE® which may lead to it being

beliefs and expectations of CLINUVEL's management. Statements may involve

unable to supply its commercial markets and/or clinical trial programs; any

a number of known and unknown risks that could cause our future results,

failures to comply with any government payment system (i.e. Medicare)

performance or achievements to differ significantly from those expressed or

reporting and payment obligations; uncertainties surrounding the legislative

implied by such forward-looking statements. Important factors that could

and regulatory pathways for the registration and approval of biotechnology and

cause or contribute to such differences include risks relating to: our ability to

consumer based products; decisions by regulatory authorities regarding

develop and commercialize pharmaceutical products, the COVID-19 pandemic

approval of our products as well as their decisions regarding label claims; any

affecting the supply chain for a protracted period of time, including our ability

failure to retain or attract key personnel and managerial talent; the impact of

to develop, manufacture, market and sell biopharmaceutical products;

broader change within the pharmaceutical industry and related industries;

competition for our products, especially SCENESSE® (afamelanotide 16mg);

potential changes to tax liabilities or legislation; environmental risks; and other

our ability to achieve expected safety and efficacy results through our

factors that have been discussed in our 2021 Preliminary Final Report.

innovative R&D efforts; the effectiveness of our patents and other protections

Forward-looking statements speak only as of the date on which they are made,

for innovative products, particularly in view of national and regional variations

and the Company undertakes no obligation, outside of those required under

in patent laws; our potential exposure to product liability claims to the extent

applicable laws or relevant listing rules of the Australian Securities Exchange,

not covered by insurance; increased government scrutiny in either Australia,

to update or revise any forward-looking statement, whether as a result of new

the U.S., Europe, China and Japan of our agreements with third parties and

information, future events or otherwise. More information on the forecasts and

suppliers; our exposure to currency fluctuations and restrictions as well as

estimates is available on request. Past performance is not an indicator of

credit risks; the effects of reforms in healthcare regulation and pharmaceutical

future performance.

pricing and reimbursement; that the Company may incur unexpected delays in

Your attention is drawn to our legal notice which highlights that there are many risks that can materialise and impact the achievement of forward-looking statements contained in this briefing.

CLINUVEL Update - Financial Year Ending 30 June 2021 www.clinuvel.com

CLINUVEL Update - Financial Year Ending 30 June 2021

Investor Briefings, August - September 2021


Functional divisions



Healthcare Solutions

Branding & Marketing


Research, Development

& Innovation Centre

The Group is headquartered in Australia with operations in Europe, Singapore, and the USA. Listed on the Australian Securities Exchange in 2001, we also trade, since 2004, on the Xetra-Dax in Germany (as UR9), and the OTC securities market in the USA as a Level One American Depositary Receipt (CLVLY).

To provide some historical perspective, the initial phase of the Company from formation in 1999 was marked by the acquisition of the core technology, afamelanotide, a synthetic peptide which mimics the naturally occurring alpha- melanocyte stimulating hormone (α-MSH). The peptide stimulates the production of eumelanin which provides protection from UV and visible light. The period to 2005 sought to apply the technology to develop a tanning preparation, but this more cosmetic than medicinal strategy did not garner support from medical practitioners and regulators. The second phase from 2005 to 2020 was focussed on drug development and commercialisation. A new management team, vision and strategy were put in place to develop and commercialise a novel drug for an unmet medical need. SCENESSE® (afamelanotide 16mg) was developed as a controlled release subcutaneous injectable implant; erythropoietic protoporphyria (EPP) was selected as the lead indication; clinical studies were completed; regulatory approvals obtained; and SCENESSE® was commercialised as the world's first systemic photoprotective. The third, current and most exciting phase of CLINUVEL's evolution commenced in 2021 to expand access to SCENESSE® in EPP and to translate our technology to new targeted indications and healthcare solutions for broader audiences.

To achieve this objective, the Group is organised across four Divisions:

  • The Pharmaceuticals Division - CLINUVEL's core business, focussed on developing and delivering drugs for patients with unmet medical need.
  • The Healthcare Solutions Division - concentrated on non-prescription products derived from the knowhow and active ingredients used in the Pharmaceuticals Division.
  • The Communications, Branding & Marketing Division - prepares communications to wider differentiated audiences, positioning the Group for broader engagement.
  • The Manufacturing Division - focussed on manufacturing novel formulations and products for CLINUVEL and research, development and production for other companies and research groups in the biopharmaceutical sector.

Underlying the divisional structure is the Research, Development & Innovation (RDI) Centre in Singapore, researching molecular science, biology, and follow-on formulations.

CLINUVEL Update - Financial Year Ending 30 June 2021


CLINUVEL Update - Financial Year Ending 30 June 2021

Investor Briefings, August - September 2021


Proven Technology

  • SCENESSE® (afamelanotide 16mg)
    • Synthetic peptide, mimics naturally occurring α-MSH
    • First systemic photoprotective for erythropoietic protoporphyria (EPP)
  • SCENESSE® positive safety profile - over 10,000 doses
  • α-MSHpart of melanocortin family of peptides that bind to melanocortin receptors throughout the body
  • Growing scientific recognition of melanocortins in function of key organs of the body

The Group's lead technology is SCENESSE®, the only approved treatment for erythropoietic protoporphyria (EPP), a poorly characterised, metabolic disorder, causing lifelong light intolerance. Patients suffer acute phototoxic reactions after exposure to light. Without treatment, patients must avoid exposure to light and thus lead a life of social isolation.

Afamelanotide is the active ingredient in SCENESSE® which:

  • was developed as a controlled-release subcutaneous injectable implant formulation, administered in an outpatient setting;
  • has been shown to reduce the incidence and severity of phototoxic reactions and increase the time EPP patients can expose to light without phototoxicity;
  • is monitored in post-authorisation use in EPP patients by an extensive pharmacovigilance program; and
  • has maintained a positive safety profile from over 10,000 doses to over 1,400 individuals worldwide.

α-MSH is part of a family of peptides known as melanocortins, all of which are cleaved from the precursor polypeptide proopiomelanocortin (POMC) and bind to specific melanocortin receptors throughout the body. There is growing recognition of their role in the function of key organs of the body.

The safety and potential of SCENESSE® and other melanocortins to address other unmet medical and healthcare needs is the basis of CLINUVEL's strategy to translate the technology to new indications.

CLINUVEL Update - Financial Year Ending 30 June 2021 www.clinuvel.com

CLINUVEL Update - Financial Year Ending 30 June 2021

Investor Briefings, August - September 2021


Systemic photoprotection in EPP

Commercial operations established in Europe and the USA

EEA launched June 2016

USA launched April 2020

Five financial years of post-authorisation operations

First full year of commercial operations FY2021

Standard of care established in EPP Expert Centres

Direct distribution to network of Specialty Centers

Study of long-termpost-authorisation use confirms

Patients able to receive 'all year round' treatment

safety, effectiveness (Wensink et al)

We first distributed SCENESSE® for EPP in Italy in 2010 and Switzerland in 2012 under special access programs. Regulatory approval to distribute SCENESSE® in the European Union was granted by the European Medicines Agency (EMA) in 2014 and in the United States (US) by the US Food and Drug Administration (FDA) in 2019. First supply under the EMA approval followed in June 2016 and under the FDA approval in April 2020.

Distribution in Europe is through EPP Expert Centres, trained and accredited by CLINUVEL. Demand for SCENESSE® in Europe has been strong, with patient retention of 94 to 97% in the European Economic Area. COVID-19 impacted the treatment of EPP patients in March to May 2020 when a few Centres were not able to provide treatment due to priority to COVID-19 patients, and some EPP patients could not travel to get treatment. Since then, notwithstanding new waves of COVID-19 and associated restrictions, treatment has largely normalised in Europe.

In the US, we distribute largely through certified dermatologists. We have trained and accredited over 40 Specialty Centers, compared to 30 planned by the end of 2021. Treatment is under Prior Authorization which means each patient confirms insurance coverage before treatment by their Specialty Center. Additionally, Centers require confirmation from the insurer of the treatment codes to charge for the medical consultation and drug administration. A Savings Program is operating for US EPP patients working off individual Insurance Plans. The US label allows one implant every two months.

SCENESSE® was approved by the Australian Therapeutic Goods Administration (TGA) in October 2020 for the prevention of phototoxicity in adult patients with EPP and granted market access in Israel as a first line treatment for the prevention of phototoxicity in adult patients with EPP in February 2021. We are committed to facilitating treatment access to SCENESSE® for EPP patients worldwide.

CLINUVEL Update - Financial Year Ending 30 June 2021 www.clinuvel.com

This is an excerpt of the original content. To continue reading it, access the original document here.


Clinuvel Pharmaceuticals Limited published this content on 26 August 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 26 August 2021 00:50:01 UTC.

© Publicnow 2021
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Sales 2022 64,6 M 47,9 M 47,9 M
Net income 2022 30,9 M 22,9 M 22,9 M
Net cash 2022 108 M 80,1 M 80,1 M
P/E ratio 2022 66,4x
Yield 2022 0,11%
Capitalization 2 000 M 1 482 M 1 485 M
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Nbr of Employees -
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Philippe Jacques Wolgen Chief Executive Officer, MD & Director
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