Posted on Tuesday, 11/Feb/2020 Posted by admin

Strong revenue performance for Alkindi® ahead of further country launches in Europe, with operating losses reduced by 53%

Two major regulatory filings completed during the Period

Early stage pipeline progress continues; positive oral native testosterone clinical trial results

Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces its results for the six months ended 31 December 2019 (the “Period”). 

Operational highlights

  • Alkindi® (hydrocortisone granules in capsules for opening)

o   Launches in Sweden, Denmark, Norway and Iceland (with partner Frost Pharma) during the Period, following initial launches in UK, Germany and Austria

o   Launch of Alkindi® in Italy subsequent to the Period end

o   Alkindi® New Drug Application (NDA) submitted to the US Food and Drug Administration (FDA)

o   Partnering discussions for Alkindi® and Chronocort® ongoing in the US

o   Submission of Marketing Authorisation Application (MAA) in Australia following the grant of Orphan Drug Designation

  • Chronocort® (modified release hydrocortisone)

o   Submission of MAA to the European Medicines Agency (EMA) along with an application for confirmation of Orphan Drug Status

  • DITEST™ (native oral testosterone formulation)

o   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

o   Diurnal’s third product in clinical development continuing progress in early stage pipeline

Financial overview

  • Alkindi® revenues of £1.1m, representing 516% year-on-year growth (H1 2018/19: £0.2m)
  • Operating loss of £4.6m, a reduction of 53% year-on-year (H1 2018/19: £9.7m) reflecting increased revenues and decreased investment in clinical development expenses
  • Held-to-maturity financial assets, cash and cash equivalents at 31 December 2019 of £4.6m (31 December 2018: £6.9m); 30 June 2019 of £9.1m

Martin Whitaker, PhD, Chief Executive Officer of Diurnal, commented:
“Diurnal has continued to experience strong commercial traction for Alkindi® with robust growth in sales. Further Alkindi® launches are planned for 2020 in Europe, in addition to the recent launch in Italy. We also delivered on two major regulatory milestones, filing both the US NDA for Alkindi® and European MAA for Chronocort® submissions during Q4 2019. Diurnal anticipates US regulatory approval for Alkindi® in Q4 2020 and European regulatory approval for Chronocort® in Q1 2021. There also continues to be strong interest in Alkindi® and Chronocort® from potential US partners and we expect to conclude a US licensing deal in H1 2020. During the Period, Diurnal also announced positive Phase I clinical data from its oral native testosterone product, DITEST™, adding a potentially valuable clinical-stage product to its expanding endocrinology-focused pipeline. Diurnal believes that it is strongly positioned to capitalise on the progress with its pipeline and to secure funding for the next stage of its development into a world-leading endocrinology specialty pharma company.

In the Interim Results:

  • “H1” refers to the six-month period ended 31 December
  • “bn”, “m” and “k” represent billion, million and thousand, respectively
  • “Group” is the Company and its subsidiary undertakings, Diurnal Limited and Diurnal Europe B.V.

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

Cantor Fitzgerald Europe (Joint Broker) +44 (0) 20 7894 7000
Corporate Finance: Phil Davies, Will Goode, Michael Boot
Healthcare Equity Sales: Andrew Keith

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-based 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: Interim Results for the Six Months Ended 31 December 2019

Date of Preparation: February 2020      Code: CORP-GB-0048