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Diurnal Group PLC (DNL)

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Thursday 30 July, 2020

Diurnal Group PLC

Business and trading update

RNS Number : 5372U
Diurnal Group PLC
30 July 2020
 

30 July 2020

 

 

Diurnal Group plc

("Diurnal" or the "Company")

 

Business and trading update

 

Continued strong sales growth for Alkindi® in key markets

 

130% year-on-year revenue growth across Europe

 

 

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, today provides a business and unaudited trading update for the year ended 30 June 2020.

 

Financial highlights:

 

·   Alkindi® revenues for the year ended 30 June 2020 were £2.39m (year ended 30 June 2019: £1.04m), representing year-on-year growth of 130%. This strong performance was driven by new country launches and increased market penetration in the UK and Germany. Moreover, it was achieved despite challenges in access to hospital-based prescribing physicians due to Covid-19 restrictions, particularly in Italy where Alkindi® was launched in February 2020.

 

· Cash balance of £15.4m, reflecting the successful placing in March 2020 which resulted in gross proceeds of approximately £11.2m, and the upfront payment of $3.5m from Eton Pharmaceuticals received in April 2020.

 

Operational highlights:

 

· Alkindi® now fully launched in UK, Germany, Italy, Austria, Sweden, Norway, Denmark and Iceland.

 

· New Drug Application (NDA) for Alkindi® Sprinkle accepted for review by the US Food and Drug Administration (FDA). The PDUFA date set by the FDA, which would be the earliest date at which approval could occur, is 29 September 2020

 

· US licensing agreement signed with Eton Pharmaceuticals for Alkindi® Sprinkle, with upfront payment of $5.0m and an additional $2.5m cash milestone payment upon first commercial sale following regulatory approval and grant of Orphan Drug Status. Confirmation of Orphan Drug Status is anticipated concurrently with NDA approval.

 

· Validation of Marketing Authorisation Application (MAA) for Chronocort® to the European Medicines Agency (EMA) in April 2020 following submission in December 2019. Diurnal is anticipating recommendation for approval of Chronocort® by the EMA in Q1 2021.

 

· The Company remains vigilant to risks posed by the current Covid-19 situation. There have been no significant changes to the impacts on its business operations since the previous update in April 2020 and the Board remains confident that Diurnal is well-positioned to continue to minimise the impact of Covid-19 on the Company's business.

 

 

Martin Whitaker, CEO of Diurnal, commented:

"Over the past year we have made significant progress as a business, financially and operationally. We have increased our commercial footprint in key markets whilst advancing both Alkindi® Sprinkle in the US and Chronocort® in Europe along their respective regulatory pathways. During the remainder of 2020, we expect FDA approval for Alkindi® in the US and further approvals for Alkindi® in Australia and Israel, in addition to continuing to progress our next product, DITEST™, following confirmation of the regulatory path with the FDA, as announced today. Our successful fundraise in March 2020 allows us to progress our vision of becoming a world-leading specialty pharma company in endocrinology and is expected to take our cortisol deficiency business, represented by Alkindi® and Chronocort®, through to profitability."

 

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).

 

For further information, please visit www.diurnal.co.uk or contact:

 

 

Diurnal Group plc

+44 (0)20 3727 1000

Martin Whitaker, Chief Executive Officer

 

Richard Bungay, Chief Financial Officer

 

 

 

Panmure Gordon (UK) Limited (Nominated Adviser and Sole Broker)

+44 (0)20 7886 2500

Corporate Finance: Freddy Crossley, Emma Earl

 

Corporate Broking: James Stearns

 

 

 

FTI Consulting (Media and Investor Relations)

+44 (0)20 3727 1000

Simon Conway

 

Victoria Foster Mitchell

 

 

Notes to Editors

 

About Diurnal Group plc

Founded in 2004, Diurnal is a UK-headquartered, European specialty pharma company developing pharmaceutical products for the global market for the life-long treatment of chronic endocrine conditions, including congenital adrenal hyperplasia and adrenal insufficiency. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena.

 

For further information about Diurnal, please visit www.diurnal.co.uk  

 

Date of Preparation: July 2020  Code: CORP-GB-0060

 


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