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

This email address is being protected from spambots. You need JavaScript enabled to view it.

 

Investors

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Last updated: 01 February 2017

Latest Company Announcements



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07 November 2017

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30 October 2017

Melbourne, Australia, and Leatherhead, UK, 30 October 2017 CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY), a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe and therapeutically unmet genetic disorders today announced its Appendix 4C – Quarterly Cashflow report for the period ended 30 September 2017.The cash balance as at 30 September 2017 was $26,180,000, an increase of $2,428,000 from the 30 June 2017 cash balance. This follows a $4,981,000 increase in the overall cash balance reported in the previous Appendix 4C report.Cash receipts for the quarter were $5,638,000 compared to $6,247,000 for the previous quarter. The level of cash receipts reflects the seasonal demand for CLINUVEL’s drug SCENESSE® (afamelanotide 16mg) in the northern hemisphere when erythropoietic protoporphyria (EPP) patients are at a heightened risk of phototoxic reactions in the warmer months. Receipts are expected to reduce in the next two quarters as demand for SCENESSE® tapers off in the colder winter months.Net operating payments for the quarter were $3,269,000 compared to $2,248,000 for the previous quarter. The increase in net operating payments from the previous quarter was primarily due to spending on product operating costs and working capital along with annual remuneration related payments which traditionally occur in the July to September period. The combination of cash receipts and expenditures contributed to a net operating activity cash inflow result of $2,470,000 for the quarter ended 30 September 2017.Overall, for the 12 months to 30 September 2017 the Company reports an increase in cash balances of $8,915,000, from $17,265,000 on 01 October 2016, to $26,180,000 on 30 September 2017. The increase in cash is primarily generated from its operations, reflecting the Company’s first full year in generating revenues from launching a novel, orphan drug in a new therapeutic area and whilst also containing its overall cost base. - End -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 CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY), a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic and skin disorders announced today its Appendix 4C – Quarterly Cashflow report for the period ended 31 March 2017. The cash balance as at 31 March 2017 was $18,772,000, a decrease of $788,000 from the end of the previous quarter. Cash receipts for the quarter were $1,597,000 compared to $4,352,000 for the previous quarter. The expected decrease in receipts reflects the seasonal supply cycles of SCENESSE® in Europe whereby treatment for erythropoietic protopophyria is expected to increase in the spring and summer months. Payments (net of GST refunds) for the quarter were $2,040,000, compared to $2,329,000 for the previous quarter. The combination of cash receipts and lower expenditures contributed to a net operating cash outflow result of $379,000 for the quarter ended 31 March 2017. - End - 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.com About CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL 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 enquiries Lachlan Hay, CLINUVEL (UK) LTD. +44 1372 860 765 This email address is being protected from spambots. You need JavaScript enabled to view it. Investor enquiries This email address is being protected from spambots. You need JavaScript enabled to view it. Forward-Looking Statements This 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.com Melbourne, Victoria 3000 F +61 3 9660 4999 Australia

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27 October 2017

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