Posted on Monday, 12/Mar/2018 Posted by michelle

European marketing authorisation for first product received post period end
Transformational year ahead with first country launch planned for Q2 2018
On track to becoming a world-leading specialty pharma company in endocrinology

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 2017 (the “Period”). 

Operational highlights (during the period and post Period end) 
• Grant of a paediatric use marketing authorisation by the European Commission for Alkindi®1 (hydrocortisone granules in capsules for opening) as replacement therapy of paediatric adrenal insufficiency
    - Followed CHMP positive opinion in December 2017
    - First country launch planned for Q2 2018
• Alkindi® Investigational New Drug application successfully opened with the US FDA
    - Alkindi® food matrix compatibility study, designed as part of package to support US regulatory submission, met primary endpoint with high statistical significance 
• Completion of patient recruitment for the European Phase III trial of Chronocort® (modified release hydrocortisone) in congenital adrenal hyperplasia
• Appointment of global CRO for Chronocort® US development programme to commence during 2018 (see separate announcement today)
    - Followed written feedback received from FDA on Phase III pivotal trial design
• Grant of first US patent for Chronocort® and grant of first Japanese patents for Alkindi® and Chronocort®
• Continued development of the Company’s European commercial organisation and supply chain 
    - Includes establishment of wholly-owned subsidiary Diurnal Europe B.V. in The Netherlands to mitigate Brexit risk
• Marketing and distribution agreement with Emerge Health for Alkindi® and Chronocort® in Australia and New Zealand executed

Financial overview
• Operating loss of £7.7m (H1 2016/17: £5.7m) reflecting increased investment in clinical and development activities and build-out of commercial organisation
• Held-to-maturity financial assets, cash and cash equivalents at 31 December 2017 of £14.0m (31 December 2016: £25.6m); 30 June 2017 of £19.9m 
• Net cash used in operating activities was £5.9m (H1 2016/17: £4.5m), in line with the Board’s expectations
• Net assets of £10.8m (31 December 2016: £20.6m); 30 June 2017 of £10.1m

Martin Whitaker, PhD, Chief Executive Officer of Diurnal, commented:
“Since our last results announcement, the Company has made significant steps towards becoming a revenue-generating specialty pharma company focused on endocrinology. The approval of our first product, Alkindi®, in Europe in early 2018 highlights the Company’s ability to take a product from concept through to commercialisation, with market launch planned in Q2 2018. We are also pleased to complete patient recruitment in the European Chronocort® Phase III study, with data expected later in 2018. Our experience in the development, registration and preparation for launch of Alkindi® will be invaluable in the progression of Chronocort® towards potential approval and launch in 2020. This positive momentum is also reflected in our US programmes; we have made significant progress with the development of Alkindi® and Chronocort® for this important market, with activities to support the planned Alkindi® Phase III regulatory package ongoing and Chronocort® Phase III development expected to commence later in 2018.”

In the Interim Results:

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

Reference:

https://www.medicines.org.uk/emc/search?q=alkindi

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 

Numis Securities Ltd (Nominated Adviser) +44 (0)20 7260 1000
Nominated Adviser: Michael Meade, Paul Gillam, Freddie Barnfield 
Corporate Broking: James Black 

Panmure Gordon (UK) Limited (Joint Broker) +44 (0) 20 7886 2500
Corporate Finance: Freddy Crossley 
Corporate Broking: Tom Salvesen 

FTI Consulting +44 (0)20 3727 1000
Simon Conway 
Victoria Foster Mitchell

Notes to Editors

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 2017