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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 : Presentation H.C. Wainwright Global Investment Conference

09/13/2021 | 07:42pm EDT

CLINUVEL's Growth and Expansion Path

H C Wainwright 23rd Global Investment Conference


Building a Diversified and Sustainable Healthcare Business

H. C. Wainwright 23rd Annual Global Investment Conference

13 -15 September 2021




Level 1 ADR (Nasdaq Int'l Designation):






Presented by:

Malcolm Bull

Head of Investor Relations

It is a pleasure to brief you on CLINUVEL today at this prestigious conference. This presentation encompasses our evolution from a research and development focused company to a profitable group of companies with growing commercial operations and an active research and development program.

I will explain our experience and performance to date, and our focus on:

  1. the growth of commercial operations; and
  2. the expansion of the research and development pipeline to a range of pharmaceutical and healthcare solutions for patients and specific broader audiences with unmet needs.

CLINUVEL's Growth and Expansion Path - H C Wainwright 23rd Global Investment Conference www.clinuvel.com

CLINUVEL's Growth and Expansion PathH C Wainwright 23rd Global Investment Conference

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's Growth and Expansion Path - H C Wainwright 23rd Global Investment Conference www.clinuvel.com

CLINUVEL's Growth and Expansion Path

H C Wainwright 23rd Global Investment Conference


Functional divisions



Healthcare Solutions

Branding & Marketing


Research, Development

& Innovation Centre

The CLINUVEL Group is a global enterprise, 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).

CLINUVEL's initial phase from formation in 1999 to late 2005 was to acquire the core technology, afamelanotide with a view to develop a tanning preparation. A new management team reset the strategy for the second phase of evolution from 2005 to 2020 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. Details of the Company's developments to date are available on our website, www.clinuvel.com.

In 2021, we entered the third, current and most exciting phase of CLINUVEL's evolution 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-onformulations.

CLINUVEL's Growth and Expansion Path - H C Wainwright 23rd Global Investment Conference www.clinuvel.com

CLINUVEL's Growth and Expansion Path

H C Wainwright 23rd Global Investment Conference

CLINUVEL's Strategic Path

Dual strategy, pharmaceuticals and healthcare solutions

  1. Grow Commercial Operations
    • SCENESSE® for EPP patients in Europe, the USA and other regions
  2. Develop Pharmaceuticals for Multiple Indications
    • Pipeline expanded for unmet medical needs
  3. Provide Healthcare Solutions
    • Non-prescriptiondermatocosmetic products
    • For individuals at high risk of exposure to UV and HEV light

Strong Foundations to Build a Diversified and Sustainable Healthcare Business

Five Years Positive

Cashflow and Profits

Cash Reserves

Prudent Risk and

for Organic Growth

Cost Management

Commercial Operations

Long-term Safety

Strong Balance

Europe and USA




Motivated and

Business Model

Committed Team

Strategic Focus

Proven Technology

Tenacious Culture

and Expertise

CLINUVEL has established strong foundations to support its planned organic growth and expansion. These foundations include:

  • Ongoing commercial operations in Europe and the US which have delivered five years of positive cashflow and profits;
  • A strong balance sheet with high liquidity and no debt; cash reserves are sufficient to self-finance planned organic growth;
  • Proven technology and expertise; in particular, the long-term safety record of SCENESSE®;
  • A motivated and committed team, with a tenacious culture;
  • Strategic focus, with prudent risk and cost management; and
  • A highly integrated business model.

The Group is pursuing a dual strategy through the Pharmaceuticals Division and the Healthcare Solutions Division to translate its technology to targeted markets. More specifically, we aim to:

  • Grow commercial operations based on the pharmaceutical drug, SCENESSE® for EPP patients;
  • Develop pharmaceutical products to treat a range of indications with an unmet medical need; and
  • Provide non-prescription healthcare solutions to individuals in the wider population at high risk of exposure to ultraviolet (UV) and high-energy visible (HEV) light.

This strategy will build a diversified and sustainable healthcare business and serve to enhance the quality of life and well-being of many patient groups and individuals in the wider population.

Let's now delve into our proven technology, experience in Europe and the USA, and our financial performance.

CLINUVEL's Growth and Expansion Path - H C Wainwright 23rd Global Investment Conference www.clinuvel.com

CLINUVEL's Growth and Expansion Path

H C Wainwright 23rd Global Investment Conference


Proven Technology

  • SCENESSE® (afamelanotide 16mg)
    • Synthetic peptide, mimics naturally occurring α-MSH
    • First systemic photoprotective for erythropoietic protoporphyria (EPP)
  • SCENESSE® positive safety profile maintained - >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 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.

The active ingredient of SCENESSE® is 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. SCENESSE®:

  • 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's Growth and Expansion Path - H C Wainwright 23rd Global Investment Conference 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 14 September 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 September 2021 23:41:09 UTC.

© Publicnow 2021
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