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


09 August 2017

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31 July 2017

Melbourne, Australia, and Leatherhead, UK, 31 July 2017 The Appendix 4C lodged earlier today reported in item 4.2 a “Net cash from / (used in) operating activities” result of (4,626) for the current quarter. This number should read 4,626, as referred to in item 1.9. Furthermore, item 4.5 “Effect of movement in exchange rates on cash held” should read 375 for the current quarter, instead of (375). This has now been corrected and reflected in the Appendix 4C attached. - End -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 announced today its Appendix 4C – Quarterly Cashflow report for the period ended 30 June 2017.The cash balance as at 30 June 2017 was $23,752,000, an increase of $4,981,000 from the end of the previous quarter.Cash receipts for the quarter were $6,247,000 compared to $1,597,000 for the previous quarter. The increase in receipts reflects the expanding rollout of the commercial distribution of SCENESSE®. Payments were received from accredited expert centres reflecting the seasonal fluctuations for the demand of SCENESSE® leading into warmer months in the northern hemisphere when patients are at a heightened risk of phototoxic reactions. In addition, during the quarter a R&D tax incentive refund was received from the Australian Taxation Office of $588,000 for the 2015/16 financial year.Net payments (net of GST refunds) for the quarter were $2,248,000 compared to $2,040,000 for the previous quarter. The combination of cash receipts including the Australian R&D tax incentive and expenditures contributed to a net operating cash inflow result of $4,626,000 for the quarter ended 30 June 2017.Overall, for the 12 months to 30 June 2017 the Company reports an increase in cash balances of $9,907,000, from $13,845,000 at July 1 2016 to $23,752,000. The increase in cash is primarily generated from its operations, reflecting the Company’s initial success in generating revenues from launching a novel, orphan drug in a new market 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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25 July 2017

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