Diurnal Group PLC – Interim Results

Diurnal Group PLC – Interim 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.

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