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What is the focus of CLINUVEL’s business?

CLINUVEL PHARMACEUTICALS LTD is a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic and skin disorders. As pioneers in understanding the interaction of light and human skin, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for photoprotection and repigmentation. These patient groups range in size from 5,000 to 45 million worldwide.

What is CLINUVEL’s vision?

The CLINUVEL Group works to translate scientific breakthroughs into commercial products. We are relentless in our desire to excel in scientific research and development, building on our global expertise to deliver lifelong care and novel products for patients and consumers.

What are CLINUVEL’s values?

CLINUVEL’s principal values are:

  • People & Environment – being aware of the environment we work in and the people we work with and help;
  • Technology – striving to create and develop technologically advanced products to add value beyond existing offerings;
  • Approach – being innovative, optimistic and focused;
  • Respect & Appreciation – being sincere, respectful, responsible and appreciative of people; and
  • Knowledge Building & Sharing – sharing our expertise and continuously growing our knowhow for scientific breakthroughs.

These values govern how we operate and interact with each other and our stakeholders. Read more about our values here.

Where is CLINUVEL headquartered?

CLINUVEL is headquartered in Melbourne, Australia with operations in Europe, the USA and Singapore.

Who is on the board of directors for CLINUVEL?

CLINUVEL’s Board of Directors comprises:

  • Stan McLiesh (Non-Executive Chair);
  • Philippe Wolgen (Chief Executive Officer);
  • Brenda Shanahan (Non-Executive);
  • Karen Agersborg (Non-Executive); and
  • Willem Blijdorp (Non-Executive).

For fuller information on our Directors, please visit the Board of Director’s page of the CLINUVEL website or CLINUVEL’s Annual Report, also accessible on this website.

What is CLINUVEL’s Corporate Governance Policy?

Information about the Company’s corporate governance (including links to the Company’s corporate governance policies and charters) can be found on the Corporate Governance page of CLINUVEL’s website.

What is CLINUVEL’s investment proposition?

CLINUVEL’s mission is supported by a clear vision, with principal values and strategic plans to support and progress the business. Performance in the commercial phase of the business is positive with a well-developed pipeline to develop existing and new products to treat people with acute skin conditions. Like any business, CLINUVEL faces a range of risks to the achievement of its objectives, but it has a track record of successfully innovating a first-in-class treatment therapy for adult patients who experience an acute phototoxic reaction to light and is proud of its successful distribution of SCENESSE® (afamelanotide 16mg) in Europe. CLINUVEL has an experienced Board of Directors and management team with dedicated and committed staff to effectively implement its plans in the ensuing years.

Where are CLINUVEL’s shares listed?

CLINUVEL’s primary listing is on the Australian Securities Exchange (ASX) under the ticker code CUV. A secondary listing is through the XETRA-DAX (Frankfurt) under the ticker code UR9. The stock can also be purchased in the USA through a sponsored Level 1 American Depository Receipt (ADR) with the symbol CLVLY. CLVLY is issued at a ratio of 1 ADR: 1 Ordinary Share of CUV. The ADR is part of the Nasdaq International Designation and the Bank of New York Mellon provides depositary services. ADRs are traded on the over-the-counter securities market in the USA.

How do I invest in CLINUVEL?

CLINUVEL does not issue stock directly to investors. Please contact a financial advisor for more investing information.

What is the difference between CLVLY and CLVLF?

CLINUVEL’s main ADR listing (CLVLY) is sponsored by the Bank of New York Mellon. BNY-Mellon provides comprehensive information on their website covering ADRs and how they work for investors, which may be of interest. The stock CLVLF is not a company sponsored Depository Receipt (DR), rather it is a broker sponsored DR. Therefore, it is the individual broker’s responsibility to ensure the DR is backed by a purchase of the ASX listed CUV share in Australia. We encourage you to contact your broker for more information on investing.

How do I access or alter information about my existing shareholding?

CLINUVEL maintains its Australian Securities Exchange (ASX) shareholder registry with Computershare. ASX Shareholders can access the Company’s share registry with Computershare online and view their Security Holdings (Account Details, Balances, Communication Details) and Shareholding Records.  For all enquiries related to your ASX shareholding with CLINUVEL, contact:

Computershare
The Registrar
Computershare Investor Services Pty Limited
GPO Box 2975
Australia
(Aus) 1300 555 159
(International) +61 (0)3 9415 4062

You can access the Computershare website here.

Within the USA, CLINUVEL shares can be purchased through the Bank of NY Mellon’s Level 1 American Depository Receipt (ADR) program under the ticket code CLVLY. CLVLY is issued at a ratio of 1 ADR: 1 Ordinary Share of CUV. ADRs are traded on the over-the-counter securities market in the USA. For more information on ADRs, log onto the Bank of NY Mellon’s ADR investors website here.

When does CLINUVEL’s financial year end?

CLINUVEL’s financial year end is 30 June.

Who are CLINUVEL’s independent auditors?

CLINUVEL’s independent auditor is Grant Thornton Australia Limited.

How can I obtain a copy of CLINUVEL’s Annual Report?

Annual Reports can be found on the CLINUVEL website via this link. Holders of the ASX listed stock may choose to receive a printed copy of the Annual Report by changing their preferences with Computershare.

How do I keep up to date with CLINUVEL’s latest developments?

All releases of information to the Australian Securities Exchange covering company news and financial results can be found on the CLINUVEL website. CLINUVEL also sends regular Email Updates on its progress, as well as published announcements and analyst reports. You can subscribe to this service here.

Where can I find historical data for CLINUVEL shares?

Historical data for CLINUVEL shares can be found on the Share Price page of CLINUVEL’s website here.

Where can I find the voting results for CLINUVEL’s most recent annual meeting?

The results can be found on the Announcements page of CLINUVEL’s website here.

When is your next financial release?

CLINUVEL announces its cash flow quarterly, as well as filing annual and half year reports. A calendar of key scheduled releases can be found on the Announcements Calendar page of CLINUVEL’s website here.

What were the results of the last financial year(s)?

CLINUVEL commenced commercial distribution of SCENESSE® (afamelanotide 16mg) in June 2016. CLINUVEL reported net profit after tax of $7.114 million in the 2016/17 financial year and $13.224 million in the 2017/18 financial year, in Australian currency.

Does CLINUVEL pay a dividend?

CLINUVEL declared a first unfranked dividend in 2017/18 of A$0.02 per share to acknowledge the long-term support of all investors who enabled the development of CLINUVEL’s drug SCENESSE® (afamelanotide 16mg) since the Company listed on the Australian Securities Exchange in 2001.

Where is CLINUVEL’s lead treatment SCENESSE® currently available?

SCENESSE® (afamelanotide 16mg) is currently authorised in Europe for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). The product is only available by prescription from trained and accredited EPP Expert Centres.

How is CLINUVEL’s lead treatment, SCENESSE® distributed?

SCENESSE® (afamelanotide 16mg) is distributed under an approved European risk management plan to accredited erythropoietic protoporphyria (EPP) Expert Centres. The product is only available by prescription. For further information, please speak to your doctor.

Where is CLINUVEL’s lead treatment, SCENESSE® manufactured?

SCENESSE® (afamelanotide 16mg) is contract manufactured in the USA to CLINUVEL’s specifications by a respected pharmaceutical company with a secondary manufacturing partner in Europe to test and release the product within the European Union.

What is the next key milestone for the business?

The next key milestone for the business is the decision of the US Food & Drug Administration on CLINUVEL’s New Drug Application to distribute SCENESSE® (afamelanotide 16mg) to adult patients with erythropoietic protoporphyria (EPP) in the USA. The application was lodged in June 2018 and the decision is to be advised on 6 October 2019.

What are CLINUVEL’s plans for the business?

CLINUVEL plans to consolidate its commercial operations by expanding into other European countries and the USA. We will also progress applications for approvals to distribute SCENESSE® (afamelanotide 16mg) in other countries with patient populations suffering from erythropoietic protoporphyria (EPP).

We will continue both clinical and non-clinical development into the application of SCENESSE® (afamelanotide 16mg) to other indications such as vitiligo and variegate porphyria and paediatric EPP patients. Research and development of topical applications to treat skin conditions is also underway.

The execution of these plans will transform CLINUVEL into a multi-product pharmaceutical company.

How does CLINUVEL plan to distribute SCENESSE® in the USA?

We plan to replicate in the USA the distribution model established in Europe. This will involve the accreditation of physicians in centres of porphyria expertise and an ongoing pharmacovigilance programme to monitor and report the patient experience with SCENESSE® (afamelanotide 16mg) to the US Food & Drug Administration. This will be challenging and one that will involve an expansion of the CLINUVEL team.

Where is CLINUVEL’s R&D conducted?

CLINUVEL’s key research facility is in Singapore. CLINUVEL also partners with expert medical centres on clinical trials worldwide.

What is CLINUVEL’s product pipeline for R&D?

CLINUVEL has a pipeline of products in clinical and non-clinical development. The novel product SCENESSE® (afamelanotide 16mg) is being evaluated in adult patients with the pigment loss disorder vitiligo, and the rare genetic disorder variegate porphyria. Development work is underway to arrive at a dose of afamelanotide suitable for paediatric use, intended for first use in erythropoietic protoporphyria (EPP) patients. SCENESSE® is approved in Europe for the prevention of phototoxicity in adult patients with EPP.

CLINUVEL’s development group VALLAURIX PTE LTD is currently evaluating a number of new molecules, including CUV9900 and VLRX001, for use in various formulations for patients with severe genetic and skin disorders, as well as developing topical products for patient use.

Does CLINUVEL have patents over its technology and products?

CLINUVEL has a range of patents to protect SCENESSE® with expiry dates ranging from 2026 to 2033.

What will happen when CLINUVEL’s exclusive marketing period in the EU expires?

The approval of the European Medicines Agency (EMA) of an exclusive marketing period for SCENESSE® (afamelanotide 16mg) to treat patients with erythropoietic protoporphyria (EPP) was granted in June 2014. As an orphan designation, the period of exclusivity is ten years.

The market exclusivity is extended by a further two years for an orphan-designated condition when the results of specific studies addressing the paediatric population are acceptable and completed in a fully compliant paediatric investigation plan. Assuming no extension to the original period, expiry of exclusivity will be June 2024.

Any new, alternative treatment for EPP would be expected to obtain regulatory approval from the EMA with an obligation to substantiate the efficacy and safety attributes of the treatment. This would need to be based on clinical research and Phase II and III studies.

It is important to note that SCENESSE® (afamelanotide 16mg) is a complex formulation, not easily replicated and is also patent protected for a period beyond the expiry of the exclusive marketing period. CLINUVEL has also built a distribution network of accredited porphyria centres in which physicians prescribe SCENESSE® as part of their consultative relationship with EPP patients. CLINUVEL has also reached agreements on the reimbursement of the cost of SCENESSE® with insurers in each of the countries in which it distributes SCENESSE®. Any new pharmaceutical business seeking to treat EPP patients would need to do the same.

These arrangements are not easily or quickly replicated. Therefore, a reasonable assessment would be that there are a range of barriers to entry to a new or alternative treatment of EPP in Europe, even after the regulatory exclusive marketing period expires.

What is SCENESSE® (afamelanotide 16mg)?

SCENESSE® (afamelanotide 16mg) is CLINUVEL’s proprietary first-in-class photoprotective drug which has been approved in Europe for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is administered as an injectable controlled release implant by a trained healthcare professional. More information on the use of SCENESSE® in EPP can be found here.

How does SCENESSE® work?

For insight into how SCENESSE® (afamelanotide 16mg) works, please refer to the Pharmaceutical pages on this website here.

Can I access SCENESSE®?

CLINUVEL’s drug SCENESSE® (afamelanotide 16mg) has been approved in Europe for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). More information on the use of the drug in EPP can be found here. The drug is only available by prescription from trained and accredited European EPP Expert Centres.

What is the safety profile of SCENESSE®?

For information on the safety profile of SCENESSE® (afamelanotide 16mg), please see this document.

Is SCENESSE® the same as ‘melanotan’?

CLINUVEL’s stated goal is to register SCENESSE® (afamelanotide 16mg) for those patients most severely affected by UV and light and those living with vitiligo. SCENESSE® is approved in Europe for the prevention of phototoxicity in adult patients with EPP. This was after years of research and development and extensive application and review process with the European Medicines Agency. CLINUVEL has plans to obtain approval from appropriate authorities to distribute SCENESSE® in other regions and countries of the world.

In contrast, products sold online and elsewhere as ‘melanotan’ are unlicensed unregulated chemicals which are wholly unrelated to CLINUVEL’s development program. The sale of ‘melanotan’ for human use is illegal in most countries. Due to the unlicensed nature of the ‘melanotan’ products, they may pose a serious threat to human health and under no circumstances does CLINUVEL recommend their purchase or use.

What is CLINUVEL’s plan for a treatment for vitiligo?

At present SCENESSE® (afamelanotide 16mg) is not authorised for the treatment of vitiligo. Clinical trials further evaluating SCENESSE® as an adjunct therapy to narrowband UVB (NB-UVB) in generalised vitiligo are planned, pending approval of SCENESSE® in the USA for patients with erythropoietic protoporphyria.

All details of our vitiligo program can be found here – a site we update with any new news. Updates are posted to our Facebook group. You can also view a brief introductory video explaining our vitiligo program on our YouTube Channel.

Clinical trials evaluating SCENESSE® in vitiligo were announced in 2010, with the first of these trials completed in late 2012 and results are available on our website. Follow up results were subsequently announced in September 2013. A subsequent Phase II study, conducted in Singapore, commenced in May 2014, with preliminary results released in December 2015. Full results from the Singaporean Phase II vitiligo study were released in December 2018. Results from these studies can be accessed on our website.

The clinical trial process takes time and we appreciate the patience of persons with vitiligo while the Company progresses its program. If you are interested in participating in clinical research, it is best to speak with your treating dermatologist first – they are best placed to evaluate your suitability for any study. At present there are no open clinical trials and it is not possible to purchase the drug for vitiligo anywhere in the world, nor can we provide any estimate on when these may become available. We expect to have more information on next stages of the vitiligo program available during 2019.