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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)
  • Launches in Sweden, Denmark, Norway and Iceland (with partner Frost Pharma) during the Period, following initial launches in UK, Germany and Austria
  • Launch of Alkindi® in Italy subsequent to the Period end
  • Alkindi® New Drug Application (NDA) submitted to the US Food and Drug Administration (FDA)
  • Partnering discussions for Alkindi® and Chronocort® ongoing in the US
  • Submission of Marketing Authorisation Application (MAA) in Australia following the grant of Orphan Drug Designation

• Chronocort® (modified release hydrocortisone)
  • Submission of MAA to the European Medicines Agency (EMA) along with an application for confirmation of Orphan Drug Status

• DITEST™ (native oral testosterone formulation)
  • 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
  • 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 (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-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.

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