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CLINUVEL Pharmaceuticals Limited (ASX: CUV), based in Melbourne, is a global biopharmaceutical company dedicated to developing and providing treatments for the patients suffering from severe genetic or UV-rays related skin disorders worldwide.

CLINUVEL’s extensive research and development in photomedicine gave birth to some innovative treatments. The company’s lead compound, SCENESSE® (afamelanotide 16mg), received approval from the European Commission in 2014 to prevent phototoxicity (anaphylactoid reactions and burns) in adult patients with the rare metabolic disorder erythropoietic protoporphyria (EPP).

In the recently released Quarterly results for the three months to 31st March 2019, CLINUVEL recorded cash receipts of $5,898,000, an increase of 126% relative to the December quarter 2018 figure ($ 2,608,000) and also up 70% compared to cash receipts of $3,480,000 for the March quarter 2018. Furthermore, the cash receipts for the financial year-to-date to March’19 amounted to $19,211,000, 44% higher than the prior corresponding period to March’18.

Generally, unit sales of SCENESSE® are lower during the winter months, mainly due to the lower ambient light intensity, which further leads to an overall lower clinical demand in most countries. On the other hand, stronger clinical demand in the northern hemisphere spring and summer boosts the cash receipts in the June and September quarters.

Most of the revenue was earned from the provision of SCENESSE® treatment for patients with EPP in the European Union and Switzerland. For the concerned quarter, the net operating payments amounted to ~$3.58 million, up from $3.33 million and $3.30 million in the quarter ended December’18 and March ’18, respectively. The surge in product manufacturing expenditure to serve the anticipated demand surge during the spring is the primary reason for the 7% rise in net operating costs in the March ’19 quarter relative to December ’18 quarter.

Moreover, during the period, CLINUVEL has largely been focused on managing its European business and responded to the US Food and Drug Administration (FDA) on its New Drug Application for approval to distribute SCENESSE®, the first-in-class treatment to EPP patients in the USA. The application is currently under priority review by the FDA with an advised date (PDUFA) of 8 July 2019 for its due decision.

Overall, the operating activities generated net cash inflows of ~ AUD 2.52 million, while the investing activities led to cash outflows of ~ AUD 27K, primarily due to payments for property, plant and equipment. The net cash balance stood at AUD 44.97 million as of 31st March 2019.

CLINUVEL Pharmaceuticals has a market capitalisation of around AUD 1.3 billion, with approximately 48.96 million outstanding shares. At the time of writing on 9th May 2019, AEST 03:44 PM, the CUV stock is trading at $28.190, edging up 5.6%. The stock price is close to the 52-week high of AUD 29.990. Besides, CUV has generated a positive YTD return of 47.78%, with the three-month and six-month returns of 16.77% and 25.24%, respectively.

Recently, the Bank of New York Mellon Corporation became a substantial shareholder in the company upon purchasing around 5,258,643 ordinary shares, representing 10.74% of the voting power.


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