CLINUVEL delivers second positive financial result

MELBOURNE, Australia, Aug. 29, 2018 (GLOBE NEWSWIRE) --

CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) today announced its annual financial results for the year ended 30 June 2018, with the Group achieving its second consecutive profitable year.

Net profits before tax increased 82% on the previous financial year to $12.937m on revenue growth of 52%. Total revenues for the year were $25.750m. The Group concluded the year with $36.198m in cash and financial assets, with current liabilities of $3.470m.

All of the Group’s revenues were generated through sales of the novel product SCENESSE^® (afamelanotide 16mg) in Europe, where it is approved for use in adult patients diagnosed with the rare genetic disorder erythropoietic protoporphyria (EPP), and Switzerland, where treatment of EPP patients is facilitated through special access schemes.¹ In June 2018 CLINUVEL submitted a new drug application to the US Food and Drug Administration (FDA), seeking marketing authorisation for SCENESSE^® for EPP patients in the US.

Since 2006 CLINUVEL has raised over $95m to finance the development of SCENESSE^®, with total funds committed to the program to date of $172m. The financial year ended 30 June 2017 produced the first profit ever delivered by the Group. CLINUVEL today announced it would issue a maiden unfranked dividend of A$0.02 per share to shareholders following the end of financial year.

Commentary

“Both revenues and net profit increased this year as a result of stronger clinical demand for SCENESSE^®,” CLINUVEL’s CFO, Darren Keamy said. “Expenditures also increased, reflecting the Group’s scale up, both to meet demand in Europe and prepare for submissions to the US FDA.”

“Behind these positive results lies the persistence of the CLINUVEL team to facilitate treatment for EPP patients in Europe while maintaining – over more than a decade – a level of financial discipline that enabled us to arrive at this point,” CLINUVEL’s CEO, Dr Philippe Wolgen said.

“Having relied on equity funding to facilitate our first product’s successful development, we have committed to re-investing revenues into delivering further medical solutions for patients who lack viable alternatives, and providing a first-time distribution of earnings to shareholders. New products are already in development by our team in Singapore, while in parallel we are actively exploring further avenues for growing the Group,” Dr Wolgen said.

Note to editors: all figures reported in Australian dollars. CLINUVEL’s Appendix 4E and Preliminary Financial Report can be found on the Company’s website at .

¹SCENESSE^® (afamelanotide 16mg) is approved in Europe as an orphan medicinal product for the prevention of phototoxicity in adult patients with EPP. Information on the product can be found on CLINUVEL’s website at .

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 photomedicine and 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 .

Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Switzerland, the US and Singapore, with the UK acting as the EU distribution centre.

For more information go to .

SCENESSE^® is a registered trademark of CLINUVEL PHARMACEUTICALS LTD.

About erythropoietic protoporphyria (EPP)

Erythropoietic protoporphyria (EPP) is a rare metabolic disorder that causes severe anaphylactoid reactions to light (phototoxicity). Patients incur physical burns and ulcers, and are in state of crisis following light exposure, summarised as phototoxicity. This usually occurs within minutes of exposure to bright lights, especially sunlight.

EPP symptoms can be acute, or delayed (subacute), most often expressed as generalised oedema, effusion in tissue and distortion of the skin. As little as a few minutes of light outdoors (even when it is overcast or transmitted through a window) or artificial light exposure may be sufficient to evoke EPP symptoms.

Phototoxicity is unresponsive to traditional pain and burn management techniques and patients can be incapacitated for days before reactions subside. Most patients withdraw from light exposure in order to manage their phototoxic symptoms.

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; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE^® which may lead to it being unable to supply its commercial markets and/or clinical trial programs.