Posted on Tuesday, 15/Sep/2020 Posted by michelle

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 withAlkindi® 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 Joint Broker) +44 (0) 20 7886 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: James Stearns

FTI Consulting +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

Forward looking statements

Certain information contained in this announcement, including any information as to the Group’s strategy, plans or future financial or operating performance, constitutes “forward-looking statements”. These forward-looking statements may be identified by the use of forward-looking terminology, including the terms “believes”, “estimates”, “anticipates”, “projects”, “expects”, “intends”, “aims”, “plans”, “predicts”, “may”, “will”, “seeks” “could” “targets” “assumes” “positioned” or “should” or, in each case, their negative or other variations or comparable terminology, or by discussions of strategy, plans, objectives, goals, future events or intentions. These forward-looking statements include all matters that are not historical facts. They appear in a number of places throughout this announcement and include statements regarding the intentions, beliefs or current expectations of the Directors concerning, among other things, the Group’s results of operations, financial condition, prospects, growth, strategies and the industries in which the Group operates. The directors of the Company believe that the expectations reflected in these statements are reasonable but may be affected by a number of variables which could cause actual results or trends to differ materially. Each forward-looking statement speaks only as of the date of the particular statement.

By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future or are beyond the Group’s control. Forward-looking statements are not guarantees of future performance. Even if the Group’s actual results of operations, financial condition and the development of the industries in which the Group operates are consistent with the forward-looking statements contained in this document, those results or developments may not be indicative of results or developments in subsequent periods.

View full document: Results for the year ended 30 June 2020

Date of Preparation: September 2020 Code: CORP-GB-0075