(Alliance News) - Diurnal Group PLC on Tuesday posted a narrowed loss for its most recent financial year as a result of reduced research and development expenditure and the launch of its drug Alkindi in the UK and Germany.
Shares in Diurnal were up 4.7% at 30.50 pence in London in late morning trade.
The pharmaceutical company posted a pretax loss of GBP14.4 million for its year ended June 30, shrinking from a GBP16.9 million loss the year before.
This reduction came about through a combination of a 17% reduction in research and development expense to GBP8.7 million from GBP10.0 million and a rise in revenue to GBP1.0 million from GBP73,000 from Alkindi.
Diurnal launched Alkindi, which treats adrenal insufficiency syndrome, in Germany back in May 2018 and then in the UK in September 2018. Adrenal insufficiency is caused by a lack of the hormone cortisol. It causes chronic fatigue and can result in death if untreated.
"The roll-out of Alkindi has been impacted by the unpredictability of timing of pricing discussions, which are conducted on a country-by-country basis, by activities required to prepare for the UK's planned exit from the EU (including the establishment of a subsidiary company within the EU and securing the required licenses and authorisations) and the impact of the Falsified Medicines Directive. Nevertheless, the group expects a series of country launches during the remainder of 2019 that will continue to provide strong revenue growth for Alkindi and the group's supply chain is fully prepared for the UK's departure from the EU," said Diurnal.
The company is also planning to submit a marketing authorisation application for its Chronocort drug to treat congenital adrenal hyperplasia, an orphan condition in which patients have a block in cortisol production. This lack of cortisol causes the over-production of male hormones, and can lead to infertility and increased mortality.
Diurnal Chief Executive Martin Whitaker said: "Alkindi, our first commercialised product, demonstrated strong market uptake, which we believe validates our strategy of focusing on the treatment of underserved chronic endocrine diseases, as well as our expertise in developing, registering and commercialising high-quality products. Importantly, we have also built a valuable sales infrastructure in Europe for Alkindi, which we can use to commercialise future products including Chronocort. As further testament to the expert team at Diurnal, we are pleased that following our detailed analysis of data from our Phase 3 clinical programme of Chronocort in Europe and our discussion with the [European Medicines Agency], the product remains on track for submission of an [marketing authorisation application] in Q4 2019.
"Additionally, as we look ahead, we expect further country launches in Europe for Alkindi during H2 2019, along with a planned [new drug application] submission of the product in the US during Q4 2019. Diurnal has received strong interest in Alkindi and Chronocort for the US and we are progressing with licensing discussions."
By Anna Farley; annafarley@alliancenews.com
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