Investors

Company snapshot

CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA‐DAX: UR9; ADR: CLVLY) is a global biopharmaceutical company focused on developing drugs for the treatment of a range of severe disorders. With its unique expertise in understanding the interaction of light and human skin, the company has identified patient populations with a clinical need for photoprotection and another population with a need for repigmentation. These patient groups range in size from 5,000 to 45 million. CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), a first‐in‐class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe, and has been approved by the European Commission for treating adults with EPP.

Based in Melbourne, Australia, CLINUVEL has operations in Europe, the US and Singapore.

 

 

 

Facts

ASX Listed

2001

 

Shares on Issue

47,725,227

 

Conditional performance rights

1,907,660

 

52 week price range (01/02/2017)

$2.86 - $9.19

 

Market cap (01/02/2017)

A$371.78m

Locations

Melbourne, Australia

Company headquarters

 

Zug, Switzerland

European operational office

 

New York, USA

US operational office

 

Leatherhead, UK

UK operational office

 

Singapore

Asian operational office

 

www.clinuvel.com

 

Stock listings

ASX

CUV

 

Xetra-DAX

UR9

 

Level 1 ADR

CLVLY

Finances

Cash/assets at bank (31/12/2016)

A$19.550m

 

Monthly spend rate (av. Q4 '14 - Q3 ’15)

A$0.65m

Products

SCENESSE® (afamelanotide 16mg implant)

First-in-class photoprotective and repigmentation drug with EMA approval for rare diseae EPP. Phase IIb trial ongoing in Singapore for vitiligo

 

CUV9900

Alpha-Melanocyte Stimulating Hormone (alpha-MSH) analogues in early development

 

VLRX001

 

People

Stanley McLiesh

Non-Executive Chair

 

Dr Philippe Wolgen

CEO, Director

 

Brenda Shanahan

Non-Executive Director

 

Elie Ishag

Non-Executive Director

 

Willem Blijdorp

Non-Executive Director

 

Dr Dennis Wright

Acting Chief Scientific Officer

 

Darren Keamy

CFO, Company Secretary

Contact

General

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Investors

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Last updated: 01 February 2017

Latest Company Announcements


12 April 2017

Melbourne, Australia, April 12, 2017CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY) wishes to advise in accordance with the terms and conditions of issue that the following unquoted conditional performance rights have lapsed and forfeited: Class Number                    Exercise price              CUVAK Conditional Performance Rights subject to various performance milestones, issued various dates under the 2009 and 2014 Plans                                                           25,400   $Nil Consequently, there are now 1,882,260 unlisted conditional performance rights on issue.- End -For more information contact:Darren KeamyCompany SecretaryCLINUVEL PHARMACEUTICALS LIMITEDT: +61 3 9660 4900E: This email address is being protected from spambots. You need JavaScript enabled to view it.-Looking StatementsThis release to the Australian Securities Exchange and to press may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause CLINUVEL’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that the FDA may require additional studies beyond the studies planned for product candidates or may not provide regulatory clearances, including for SCENESSE®; that the FDA may not provide regulatory approval for any use of SCENESSE® or that the approval may be limited; that CLINUVEL may never file an NDA for SCENESSE® regulatory approval in the US; that the Company may not be able to access adequate capital to advance its vitiligo programs; that the Company may not be able to retain its current pharmaceutical and biotechnology key personnel and knowhow for further development of its product candidates or may not reach favourable agreements with potential pricing and reimbursement agencies in Europe and the US.Level 6, 15 Queen Street           T +61 3 9660 4900         www.clinuvel.comMelbourne, Victoria 3000           F +61 3 9660 4999Australia

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12 April 2017

Melbourne, Australia and Leatherhead, UK, US, 12 April 2017 CLINUVEL [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced that it had reached agreement with the German National Association of Statutory Health Insurance Funds (GKV-Spitzenverband or GKV-SV) for the treatment of erythropoietic protoporphyria (EPP) patients with CLINUVEL’s drug SCENESSE® (afamelanotide 16mg).CLINUVEL had been in mandatory ‘negotiation’ with GKV-SV since August 2016. Under the German Pharmaceuticals Market Reorganisation Act (AMNOG) a pricing agreement was reached after an Arbitration Board was called. The outcome of the Arbitration Board is legally binding for all state insurers (‘Krankenkassen’) in Germany.aEPP TREATMENT WITH SCENESSE®SCENESSE® is a first-in-class therapy for the treatment of adults with EPP, a poorly characterised and an ultra-rare metabolic disorder which causes severe phototoxic and anaphylactoid reactions in patients. In Germany, the disease affects between 500 and 1,090 patients (based on disease prevalence).Reports from clinical studies and during conditions of use over the last decade have indicated that EPP patients treated with SCENESSE® obtain an ‘improved life’ by:(i) losing their prodromal reactions (‘warning signals’ triggered by accidental light exposure);(ii) losing their anxiety for burns and anaphylactoid reactions;(iii) being able to gradually expose their skin to light sources; and(iv) participating in daily activities which had been impossible prior to treatment.CLINUVEL monitors the ongoing use of SCENESSE® in EPP patients during its indefinite post-marketing authorisation program, which includes post authorisation safety study (PASS) protocols and a European EPP Disease Registry.UNIFORM EUROPEAN PRICINGCLINUVEL has adopted a uniform global pricing policy and provides its clear rationale, acknowledging the facts that patients are migrating across borders to seek treatment, expert physicians are associated through porphyria networks, and hospitals collaborate internationally to purchase pharmaceutical products for orphan diseases. The company bears the risk of foreign exchange fluctuation over a period of 24 months (as of 15 February 2017) and will not make inflationary adjustments to the uniform price.The annual costs of therapy with SCENESSE® range between €56,404 and €84,606 per EPP patient per annum. Figure 1. (below) highlights the main factors which were published by GKV-SV.FIGURE 1: ANNUAL COSTS OF THERAPY IN GERMANY – SCENESSE® IN EPP1¹Price of treatment depends on number of implant injections per annum²No alternative effective therapy exists for SCENESSE®³Price in Lauer-Taxe is published by IFA GmbHCOMMENTARY“The company is constrained as to the insight it can provide on the ‘negotiations’ and GKV-SV story,” CLINUVEL’s UK General Manager, Mr Lachlan Hay said. “It has been shown that SCENESSE® is priced uniformly in Europe, there is no alternative effective treatment for EPP, and as per EMA approval in 2014 there are no scientific instruments to quantify and measure the impact of disease or therapy.“In an era where pharmaceutical companies are scrutinised by media, the general public, and insurers, we intend to set an example through our uniform product pricing policy. We run the company in an open and simple manner and therefore we will not engage in any incentivisation programme with any party. There is not an exception to this principle.“This outcome is a well-deserved and long-awaited blessing for the German EPP patients and healthcare providers, who have been seeking clarity on pricing and supply conditions since the drug’s European approval in October 2014. CLINUVEL commends the German Arbitration Board and its judges for its professionalism, independence and clear mind in its ruling. I thank my team who have worked very hard over a long time to arrive at this justified result,” Mr Hay said.- End -Notesa According to Sozialgesetzbuch Fünftes Buch (SGB V) section 130b, available online (German only) at https://www.gesetze-im-internet.de/sgb_5/.About SCENESSE® (afamelanotide 16mg)SCENESSE® (afamelanotide 16mg) is approved in Europe as an orphan medicinal product for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with EPP. The innovative nature of the therapy in an orphan disorder, the lack of available scientific instruments to adequately measure the therapy, ethical considerations and the drug’s positive safety profile were some of the factors which led to the European marketing authorisation of SCENESSE®. Information on the product can be found on CLINUVEL’s website at www.clinuvel.comAbout CLINUVEL PHARMACEUTICALS LIMITEDCLINUVEL PHARMACEUTICALS LTD (ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY; XETRA-DAX: UR9) 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 biology, 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. CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), was approved by the European Commission in 2014 for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). More information on EPP can be found at http://www.epp.care.Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Switzerland, the US and Singapore.For more information go to http://www.clinuvel.com.SCENESSE® is a registered trademark of CLINUVEL PHARMACEUTICALS LTD.Media enquiriesLachlan Hay, CLINUVEL (UK) LTD. +44 1372 860 765 This email address is being protected from spambots. You need JavaScript enabled to view it.r This email address is being protected from spambots. You need JavaScript enabled to view it. Forward-Looking StatementsThis release to the Australian Securities Exchange and to press may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause CLINUVEL’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that the FDA may require additional studies beyond the studies planned for product candidates or may not provide regulatory clearances, including for SCENESSE®; that the FDA may not provide regulatory approval for any use of SCENESSE® or that the approval may be limited; that CLINUVEL may never file an NDA for SCENESSE® regulatory approval in the US; that the Company may not be able to access adequate capital to advance its vitiligo programs; that the Company may not be able to retain its current pharmaceutical and biotechnology key personnel and knowhow for further development of its product candidates or may not reach favourable agreements with potential pricing and reimbursement agencies in Europe and the US.Level 6, 15 Queen Street         T +61 3 9660 4900        www.clinuvel.comMelbourne, Victoria 3000         F +61 3 9660 4999Australia 

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24 February 2017

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