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Successful commercialisation of Alkindi® underpins development of European commercial business

US commercialisation deal for Alkindi® Sprinkle significantly expands global footprint

Further significant inflection points expected in the next 12 months

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces its audited results for the year ended 30 June 2020.

Operational highlights

Alkindi®

• Launches of Alkindi® (hydrocortisone granules in capsules for opening) in Sweden, Denmark, Norway, Iceland (with partner FrostPharma) and Italy, following initial launches in UK, Germany and Austria
• Alkindi® Sprinkle New Drug Application (NDA) submitted to the US Food and Drug Administration (FDA) and subsequently accepted for review, with PDUFA date set as 29 September 2020
• US licensing agreement signed with Eton Pharmaceuticals (Eton) for Alkindi® Sprinkle, with upfront payment of $5.0m (of which $1.5m was satisfied through the issue to Diurnal of Eton shares) and an additional $2.5m cash milestone payment upon first commercial sale following regulatory approval and grant of Orphan Drug Status
• Progress in the rest of world with Alkindi® Marketing Authorisation Application (MAA) submission in Australia

Chronocort®

• Submission and subsequent validation of Marketing Authorisation Application (MAA) for Chronocort® (modified release hydrocortisone) to the European Medicines Agency (EMA), with recommendation for approval of Chronocort® by the EMA anticipated in Q1 2021
• Data from the Chronocort® European Phase 3 trial selected for presentation at the prestigious international 2020 ENDO meeting
• US Phase 3 clinical trial protocol updated and submitted to the US FDA for a Special Protocol Assessment meeting

DITEST™

• Positive headline results from the DITEST™ (native oral testosterone formulation) Phase I proof-of-concept clinical trial in target hypogonadal patients, with potential to be the first effective oral native testosterone treatment in an estimated $4.8bn global market

Financial overview

• Total revenues of £6.3 million (2019: £1.0 million), including £3.9m (2019: £nil) in licensing income
• Alkindi® product sales growth of 130% to £2.4 million (2019: £1.0 million)
• Successful completion of a £11.2 million Placing with institutional investors to fund further development of Diurnal's late-stage pipeline and commercial roll-out
• Substantially reduced operating loss of £5.4 million (2019: £14.5 million), reflecting increase in Alkindi® revenues, Eton licensing income and reduced operating expenses
• Strong financial position with cash and cash equivalents at 30 June 2020 of £15.4 million (30 June 2019: £9.1 million)

Post-period highlights

• Alkindi® MAA approved in Australia and Israel
• Further distribution agreements executed for Alkindi® and Chronocort® in the Benelux Union (consisting of Belgium, the Netherlands, and Luxemburg) and for Alkindi® in Switzerland
• Positive meeting with the US FDA confirming 505(b)(2) regulatory pathway for DITEST™

Martin Whitaker, CEO of Diurnal, commented:  

"During the financial year we have made significant progress as a business, both 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 next 12 months we anticipate significant value inflection points for Diurnal, with the anticipated approvals for Alkindi® Sprinkle in the US and Chronocort® in Europe, following recent approvals for Alkindi® in Australia and Israel. We will also assess the opportunities for progression of Chronocort® into Phase 3 development in the US and DITEST™ into its next clinical trial, following confirmation of the regulatory path with the FDA. Our successful fundraise in March 2020 has significantly strengthened our financial position and allows us to progress our vision of becoming a world-leading specialty pharma company in endocrinology, underpinned by the further development of our cortisol deficiency business, represented by Alkindi® and Chronocort®."

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: Rupert Dearden
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 high quality 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